Sunday, 7 October 2012

Iski




Iski may be available in the countries listed below.


Ingredient matches for Iski



Diltiazem

Diltiazem is reported as an ingredient of Iski in the following countries:


  • India

International Drug Name Search

Saturday, 6 October 2012

fluticasone and salmeterol Inhalation, oral/nebulization


floo-TIK-a-sone PROE-pee-oh-nate, sal-ME-ter-ol zye-NAF-oh-ate


Inhalation, oral/nebulization route(Disk;Aerosol)

Long-acting beta 2-adrenergic agonists (LABA) increase the risk of asthma-related deaths. In a large trial that compared the safety of salmeterol or placebo added to usual asthma therapy, there was an increase in asthma-related deaths with salmeterol. Available data have not determined whether concurrent inhaled corticosteroid or other long-term asthma control drug use mitigates the increased risk of asthma-related death from LABA. Data from pediatric and adolescent trials suggest that LABA increase the risk of asthma-related hospitalization. Therefore, when treating patients with asthma, fluticasone propionate/salmeterol inhalation powder or aerosol should only be used for patients not adequately controlled on a long-term asthma control medication or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (eg, discontinue fluticasone propionate/salmeterol) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication. Do not use fluticasone propionate/salmeterol for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids .



Commonly used brand name(s)

In the U.S.


  • Advair Diskus

  • Advair Diskus 100/50

  • Advair Diskus 250/50

  • Advair Diskus 500/50

  • Advair HFA

In Canada


  • Advair

  • Advair Inhalation Aerosol

Available Dosage Forms:


  • Aerosol Liquid

  • Disk

  • Aerosol Powder

Therapeutic Class: Antiasthma, Anti-Inflammatory/Bronchodilator Combination


Pharmacologic Class: Fluticasone


Uses For fluticasone and salmeterol


Fluticasone and salmeterol is a combination of two medicines that are used to help control the symptoms of asthma and improve breathing. It is used when a patient's asthma has not been controlled sufficiently on other asthma medicines, or when a patient's condition is so severe that more than one medicine is needed every day. fluticasone and salmeterol will not relieve an asthma attack that has already started.


fluticasone and salmeterol is also used to treat air flow blockage and reduce the worsening of chronic obstructive pulmonary disease (COPD). This includes chronic bronchitis and emphysema.


Inhaled fluticasone belongs to the family of medicines known as corticosteroids or steroids (cortisone-like medicines). It works by preventing certain cells in the lungs and breathing passages from releasing substances that cause asthma symptoms.


Inhaled salmeterol is a long-acting bronchodilator. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. It relieves cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.


fluticasone and salmeterol must be used with a short-acting medicine (e.g. albuterol) for an asthma attack or asthma symptoms that need attention right away.


fluticasone and salmeterol is available only with your doctor's prescription.


Before Using fluticasone and salmeterol


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For fluticasone and salmeterol, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to fluticasone and salmeterol or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Advair® Diskus® to treat asthma in children older than 4 years of age. Safety and efficacy have not been established in children younger than 4 years of age.


Appropriate studies have not been performed on the relationship of age to the effects of Advair® HFA oral inhalation in children younger than 12 years of age. Safety and efficacy have not been established.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluticasone and salmeterol combination in the elderly. However, elderly people with heart and blood vessel problems may require special caution when receiving fluticasone and salmeterol combination.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking fluticasone and salmeterol, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using fluticasone and salmeterol with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Cisapride

  • Dronedarone

  • Fluconazole

  • Mesoridazine

  • Pimozide

  • Posaconazole

  • Sparfloxacin

  • Thioridazine

Using fluticasone and salmeterol with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Acebutolol

  • Alfuzosin

  • Alprenolol

  • Amiodarone

  • Apomorphine

  • Arotinolol

  • Arsenic Trioxide

  • Asenapine

  • Astemizole

  • Atazanavir

  • Atenolol

  • Azithromycin

  • Befunolol

  • Betaxolol

  • Bevantolol

  • Bisoprolol

  • Boceprevir

  • Bopindolol

  • Brofaromine

  • Bucindolol

  • Bupranolol

  • Bupropion

  • Carteolol

  • Carvedilol

  • Celiprolol

  • Chloroquine

  • Chlorpromazine

  • Ciprofloxacin

  • Citalopram

  • Clarithromycin

  • Clorgyline

  • Clozapine

  • Crizotinib

  • Darunavir

  • Dasatinib

  • Dilevalol

  • Disopyramide

  • Dofetilide

  • Dolasetron

  • Droperidol

  • Esmolol

  • Flecainide

  • Fosamprenavir

  • Furazolidone

  • Gatifloxacin

  • Gemifloxacin

  • Granisetron

  • Halofantrine

  • Haloperidol

  • Ibutilide

  • Iloperidone

  • Indinavir

  • Iproniazid

  • Isocarboxazid

  • Itraconazole

  • Ketoconazole

  • Labetalol

  • Landiolol

  • Lapatinib

  • Lazabemide

  • Levobetaxolol

  • Levobunolol

  • Levofloxacin

  • Linezolid

  • Lopinavir

  • Lumefantrine

  • Mefloquine

  • Mepindolol

  • Methadone

  • Metipranolol

  • Metoprolol

  • Moclobemide

  • Moxifloxacin

  • Nadolol

  • Nebivolol

  • Nefazodone

  • Nelfinavir

  • Nialamide

  • Nilotinib

  • Nipradilol

  • Norfloxacin

  • Octreotide

  • Ofloxacin

  • Ondansetron

  • Oxprenolol

  • Paliperidone

  • Pargyline

  • Pazopanib

  • Penbutolol

  • Perflutren Lipid Microsphere

  • Phenelzine

  • Pindolol

  • Procainamide

  • Procarbazine

  • Prochlorperazine

  • Promethazine

  • Propafenone

  • Propranolol

  • Protriptyline

  • Quetiapine

  • Quinidine

  • Quinine

  • Ranolazine

  • Rasagiline

  • Ritonavir

  • Saquinavir

  • Selegiline

  • Sodium Phosphate

  • Sodium Phosphate, Dibasic

  • Sodium Phosphate, Monobasic

  • Solifenacin

  • Sorafenib

  • Sotalol

  • Sunitinib

  • Talinolol

  • Telaprevir

  • Telavancin

  • Telithromycin

  • Terfenadine

  • Tertatolol

  • Tetrabenazine

  • Timolol

  • Tipranavir

  • Toloxatone

  • Toremifene

  • Tranylcypromine

  • Trazodone

  • Trifluoperazine

  • Vandetanib

  • Vardenafil

  • Vemurafenib

  • Voriconazole

  • Ziprasidone

Using fluticasone and salmeterol with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Erythromycin

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of fluticasone and salmeterol. Make sure you tell your doctor if you have any other medical problems, especially:


  • Asthma attack, acute or

  • Bronchospasm (difficulty with breathing), acute or

  • COPD flare-up or

  • Milk protein allergy, severe—Should not be used in patients with these conditions.

  • Blood vessel disease (e.g., Churg-Strauss syndrome) or

  • Bone problems (e.g., osteoporosis) or

  • Cataracts or

  • Diabetes or

  • Glaucoma or

  • Heart disease or

  • Heart rhythm problems (e.g., arrhythmia) or

  • Hypertension (high blood pressure) or

  • Hyperthyroidism (overactive thyroid) or

  • Hypokalemia (low potassium in the blood) or

  • Ketoacidosis (high ketones in the blood) or

  • Seizures, history of—Use with caution. May make these conditions worse.

  • Chickenpox (including recent exposure) or

  • Herpes simplex (virus) infection of the eye or

  • Infections (virus, bacteria, or fungus) or

  • Measles or

  • Tuberculosis, active or history of—Inhaled fluticasone can reduce the body's ability to fight off these infections.

  • Infection or

  • Stress or

  • Surgery or

  • Trauma—Supplementary oral corticosteroids may be needed. Check with your doctor.

  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of fluticasone and salmeterol


Inhaled fluticasone and salmeterol is used to prevent asthma attacks and to treat chronic obstructive pulmonary disease (COPD). It is not used to relieve an asthma attack that has already started. For relief of an asthma attack that has already started, you should use another medicine. If you do not have another medicine to use for an attack or if you have any questions about this, check with your doctor.


Inhaled fluticasone and salmeterol is used with a special inhaler that comes with patient directions or a medication guide. Read the directions carefully before using fluticasone and salmeterol. If you do not understand the directions or you are not sure how to use the Diskus® or inhaler, ask your doctor to show you what to do. Also, ask your doctor to check regularly how you use the Diskus® or inhaler to make sure you are using it properly.


Use fluticasone and salmeterol only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using fluticasone and salmeterol without telling your doctor. To do so may increase the chance of side effects.


In order for fluticasone and salmeterol to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor.


Do not stop using fluticasone and salmeterol or other asthma medicines that your doctor has prescribed for you unless you have discussed this with your doctor.


When you use the Advair® HFA inhaler for the first time, or if you have not used it for 7 days or longer, or if the inhaler has been dropped, it may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, prime it by spraying the medicine four times into the air away from the face, and shaking it well for 5 seconds before each spray. Avoid spraying it in your eyes.


Rinsing your mouth with water after each dose may help prevent hoarseness, throat irritation, and infection in the mouth. However, do not swallow the water after rinsing.


To use the Diskus®:


  • Open the foil pouch containing the Diskus®.

  • To open the Diskus®, push the thumb grip away from you as far as it will go. You will hear a click and feel a snap. When open, the mouthpiece will appear.

  • Slide the mouthpiece lever away from you as far as it will go until it clicks. The Diskus® is now ready to use. If you close the Diskus® or push the lever again, you will lose medicine.

  • Turn your head away from the Diskus®, and breathe out to the end of a normal breath. Do not breathe into the Diskus®.

  • Holding the Diskus® level, put the mouthpiece between your lips and teeth, and close your lips around the mouthpiece. Do not bite down on the mouthpiece. Do not block the mouthpiece with your teeth or tongue.

  • Breathe in through your mouth as deeply as you can until you have taken a full deep breath. Do not breathe through your nose.

  • Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath as long as you can up to 10 seconds before breathing out slowly. This gives the medicine time to settle in your airways and lungs.

  • Turn your head away from the Diskus®, and breathe out slowly to the end of a normal breath. Do not breathe into the Diskus®.

  • If your doctor has told you to inhale more than one puff of medicine at each dose, take the second puff following exactly the same steps you used for the first puff.

  • When you are finished, close the Diskus®. Place your thumb on the thumb grip, and slide it back toward you as far as it will go. You will hear it click shut.

  • Keep the Diskus® dry. Do not wash the mouthpiece, or any other part of the Diskus®. You may use a dry cloth to wipe it clean.

  • The Diskus® has a window that shows the number of doses that are left. This tells you when you are getting low on medicine. When the Diskus® has 5 doses left, the numbers from 5 to 0 will show up in red to remind you to refill your prescription.

To use the Advair® HFA inhaler:


  • Take the inhaler out of the pouch before you use it for the first time.

  • Do not use the inhaler for fluticasone and salmeterol with any other medicine.

  • Remove the cap and look at the mouthpiece to make sure it is clean.

  • Prime the inhaler before use by shaking the inhaler well and then releasing 4 test sprays.

  • To inhale fluticasone and salmeterol, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece fully into your mouth and close your lips around it. Do not block the mouthpiece with your teeth or tongue.

  • While pressing down firmly and fully on the purple top of the inhaler, breathe in through your mouth as deeply as you can until you have taken a full deep breath.

  • Wait for 30 seconds and repeat these steps for the next puff, starting with shaking the inhaler.

  • Gargle and rinse your mouth with water after each dose; this will help prevent hoarseness, throat irritation, and infection in the mouth. Do not swallow the water after rinsing.

  • Replace the mouthpiece cover after using the medicine.

  • The inhaler has a window that shows the number of doses remaining. This tells you when you are getting low on medicine. The doses counting down from 20 to 0 will show up in red to remind you to refill your prescription. Throw away the inhaler when the count is 000. You may not receive the right amount of medicine.

Dosing


The dose of fluticasone and salmeterol will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of fluticasone and salmeterol. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For inhalation dosage form (aerosol):
    • For preventing an asthma attack:
      • Adults, teenagers, and children 12 years of age and older—Two puffs in the morning and another two puffs in the evening. The doses should be at least 12 hours apart.

      • Children younger than 12 years of age—Use and dose must be determined by your child's doctor.



  • For inhalation dosage form (powder):
    • For preventing an asthma attack:
      • Adults, teenagers, and children 4 years of age and older—One inhalation two times per day (morning and evening). The doses should be at least 12 hours apart.

      • Children younger than 4 years of age—Use and dose must be determined by your doctor.


    • For maintenance treatment of COPD:
      • Adults—One inhalation (250/50) two times per day (morning and evening). The doses should be at least 12 hours apart.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of fluticasone and salmeterol, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep fluticasone and salmeterol inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.


Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using fluticasone and salmeterol


If you will be using fluticasone and salmeterol for a long time, it is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.


Tell your doctor if you or your child are also using other medicines for your COPD. Your doctor may want you to stop using the medicine and use it only during a severe COPD attack. Follow your doctor's instructions on how you should take your medicine.


fluticasone and salmeterol should not be used if you are having a severe COPD attack, or if symptoms of a COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack. If the other medicine does not work as well, tell your doctor right away.


fluticasone and salmeterol should only be used as an additional treatment for patients who cannot be treated with other asthma medicines (such as inhaled corticosteroids) or for asthma patients that require two medicines, including salmeterol. Ask your doctor if you have any questions.


Although fluticasone and salmeterol decreases the number of asthma episodes, it may increase the chance of a severe asthma attack when they do occur. Be sure to read about these risks in the Medication Guide and talk to your doctor or pharmacist about any questions or concerns that you have.


You should not use fluticasone and salmeterol if your asthma attack has already started. Your doctor will prescribe another medicine (e.g., a short-acting inhaler) for you to use in case of an acute asthma attack. Make sure you understand how to use the short-acting inhaler. Talk to your doctor if you need instructions.


Talk with your doctor or get medical care right away if:


  • Your or your child's symptoms do not improve after using fluticasone and salmeterol for 1 week or if they become worse.

  • Your short-acting inhaler does not seem to work as well as it used to and you or your child need it more often than normal (e.g., you use 1 whole canister of the short-acting inhaler in 8 weeks time, or you need to use 4 or more inhalations of the short-acting inhaler for 2 or more days in a row).

  • You or your child have a big decrease in your peak flow when measured as directed by your doctor.

Do not use fluticasone and salmeterol to treat wheezing that is getting worse. Call your doctor right away if wheezing worsens while using fluticasone and salmeterol.


Do not use any other asthma medicine or medicine for breathing problems without talking to your doctor. fluticasone and salmeterol should not be used with other inhalers that contain budesonide and formoterol combination (Symbicort®), formoterol (Foradil® Aerolizer®, Perforomist™), or arformoterol (Brovona™).


fluticasone and salmeterol may cause a fungus infection of the mouth or throat (thrush). Tell your doctor right away if you have white patches in the mouth or throat; or pain when eating or swallowing.


Patients with COPD may be more likely to have pneumonia. Call your doctor if you or your child start having increased sputum (spit) production, change in sputum color, fever, chills, increased cough, or an increase in breathing problems.


Do not change your dose or stop using your medicine without first asking your doctor.


Your doctor may want you to carry a medical identification (ID) card stating that you or your child are using fluticasone and salmeterol. The card will say that you may need additional medicine during an emergency, a severe asthma attack or other illness, or unusual stress.


Using too much of fluticasone and salmeterol or using it for a long time may cause may increase your risk of having adrenal gland problems. Talk to your doctor if you or your child have more than one of these symptoms while you are using fluticasone and salmeterol: darkening of the skin; diarrhea; dizziness; fainting; loss of appetite; mental depression; nausea; skin rash; unusual tiredness or weakness; or vomiting.


fluticasone and salmeterol may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Stop using fluticasone and salmeterol and check with your doctor right away if you or your child are having a cough, difficulty with breathing, shortness of breath, or wheezing after using fluticasone and salmeterol.


If you or your child develop a skin rash, hives, or any allergic reaction to fluticasone and salmeterol, stop using the medicine and check with your doctor as soon as possible.


Check with your doctor right away if you or your child have chest pain, a fast heartbeat, nervousness, shaking of the hands or feet, noisy breathing, a feeling of choking, or tightness or irritation of the throat while using fluticasone and salmeterol.


fluticasone and salmeterol may affect blood sugar and potassium levels. If you have heart disease or are diabetic and notice a change in the results of your blood or urine sugar or potassium tests, check with your doctor.


Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).


fluticasone and salmeterol may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor.


fluticasone and salmeterol may cause children to grow more slowly than usual. Talk to your child's doctor if you have any concerns.


fluticasone and salmeterol may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


fluticasone and salmeterol Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


More common
  • Black, tarry stools

  • blindness

  • blurred vision

  • burning, tingling, numbness, or pain in the hands, arms, feet, or legs

  • chills

  • cough

  • decreased vision

  • difficulty with breathing or swallowing

  • eye pain

  • fast heartbeat

  • fever

  • headache

  • hives or welts

  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

  • nausea or vomiting

  • noisy breathing

  • painful or difficult urination

  • sensation of pins and needles

  • shortness of breath

  • skin itching, rash, or redness

  • sore throat

  • sores, ulcers, or white spots on the lips or in the mouth

  • stabbing pain in the arms or legs

  • swelling of the face, throat, or tongue

  • swollen glands

  • tearing

  • unusual bleeding or bruising

  • wheezing

Incidence not known
  • Abdominal or stomach pain

  • backache

  • bruising

  • darkening of the skin

  • decrease in height

  • diarrhea

  • difficulty with moving

  • dizziness

  • facial hair growth in females

  • fainting

  • fast, slow, pounding, or irregular heartbeat or pulse

  • flushed, dry skin

  • fractures

  • fruit-like breath odor

  • full or round face, neck, or trunk

  • heavy bleeding

  • increased hunger

  • increased thirst or urination

  • irritability

  • large, flat, blue, or purplish patches in the skin

  • loss of sexual desire or ability

  • menstrual irregularities

  • mental depression

  • muscle pain or stiffness

  • muscle wasting

  • pain in the back, ribs, arms, or legs

  • pain in the joints

  • sweating

  • troubled breathing

  • unexplained weight loss

  • unusual tiredness or weakness

  • weight gain

Get emergency help immediately if any of the following symptoms of overdose occur:


Symptoms of overdose
  • Chest pain or tightness

  • confusion

  • convulsions (seizures)

  • decreased urine output

  • dry mouth

  • faintness, or lightheadedness when getting up suddenly from a lying or sitting position

  • general feeling of discomfort or illness

  • high blood pressure

  • loss of appetite

  • mood changes

  • nervousness

  • numbness or tingling in the hands, feet, or lips

  • sudden sweating

  • tremors

  • trouble with sleeping

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Body aches or pain

  • choking

  • congestion

  • dryness of the throat

  • high-pitched noise when breathing

  • hoarseness

  • runny nose

  • sneezing

  • trouble with swallowing

  • voice changes

Less common
  • Cough-producing mucus

  • flu-like symptoms

  • irritation or inflammation of the eye

  • muscle pain

  • pain or tenderness around the eyes and cheekbones

  • sleep disorders

  • stuffy nose

  • white patches in the mouth or throat or on the tongue

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: fluticasone and salmeterol Inhalation,/nebulization side effects (in more detail)



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Friday, 5 October 2012

Nydrazid


Generic Name: isoniazid (Oral route, Intramuscular route)

eye-soe-NYE-a-zid

Intramuscular route(Solution)

Severe and sometimes fatal hepatitis has been reported with isoniazid therapy and may occur even after many months of treatment. The risk for hepatitis increases with advancing age and alcohol use. Patients given isoniazid should be carefully monitored and interviewed at monthly intervals. For persons 35 and older, in addition to monthly symptom reviews, hepatic enzymes (specifically, AST and ALT (formerly SGOT and SGPT, respectively) should be measured prior to starting isoniazid therapy and periodically throughout treatment. An increased risk of fatal hepatitis associated with isoniazid has been reported in women, particularly black and Hispanic women. The risk may also be increased during the post partum period. More careful monitoring should be considered in these groups, possibly including more frequent laboratory monitoring .


Oral route(Tablet;Syrup)

Severe and sometimes fatal hepatitis has been reported with isoniazid therapy and may occur even after many months of treatment. The risk for hepatitis increases with advancing age and alcohol use. Patients given isoniazid should be carefully monitored and interviewed at monthly intervals. For persons 35 and older, in addition to monthly symptom reviews, hepatic enzymes (specifically, AST and ALT (formerly SGOT and SGPT, respectively) should be measured prior to starting isoniazid therapy and periodically throughout treatment. An increased risk of fatal hepatitis associated with isoniazid has been reported in women, particularly black and Hispanic women. The risk may also be increased during the post partum period. More careful monitoring should be considered in these groups, possibly including more frequent laboratory monitoring .



Commonly used brand name(s)

In the U.S.


  • Nydrazid

In Canada


  • Pms-Isoniazid

Available Dosage Forms:


  • Syrup

  • Tablet

  • Solution

Therapeutic Class: Antitubercular


Chemical Class: Isonicotinic Acid


Uses For Nydrazid


Isoniazid is used to treat tuberculosis (TB) or prevent its return (reactivation). It may be given alone, or in combination with other medicines, to treat TB or to prevent its return (reactivation). This medicine may also be used for other problems as determined by your doctor.


This medicine may cause some serious side effects, including damage to the liver. Liver damage is more likely to occur in patients over 50 years of age. You and your doctor should talk about the good this medicine will do, as well as the risks of taking it.


If you are being treated for active tuberculosis (TB): To help clear up your TB infection completely, you must keep taking this medicine for the full time of treatment, even if you begin to feel better. This is very important. It is also important that you do not miss any doses.


Isoniazid is available only with your doctor's prescription.


Before Using Nydrazid


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Isoniazid can cause serious side effects in any patient. Therefore, it is especially important that you discuss with the child's doctor the good that this medicine may do as well as the risks of using it.


Geriatric


Hepatitis may be especially likely to occur in patients over 50 years of age, who are usually more sensitive than younger adults to the effects of isoniazid.


Breast Feeding


Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Itraconazole

  • Levodopa

  • Rifampin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Acetaminophen

  • Aminosalicylic Acid

  • Carbamazepine

  • Diazepam

  • Disulfiram

  • Enflurane

  • Ethionamide

  • Fosphenytoin

  • Ketoconazole

  • Meperidine

  • Phenytoin

  • Warfarin

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.


  • Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.


  • food

  • Tyramine Containing Food

Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Alcohol abuse (or history of) or

  • Liver disease—There may be an increased chance of hepatitis with daily drinking of alcohol or in patients with liver disease

  • Kidney disease (severe)—There may be an increased chance of side effects in patients with severe kidney disease

  • Seizure disorders such as epilepsy—There may be an increased chance of seizures (convulsions) in some patients

Proper Use of isoniazid

This section provides information on the proper use of a number of products that contain isoniazid. It may not be specific to Nydrazid. Please read with care.


Make certain your health care professional knows if you are on a low-sodium, low-sugar, or any other special diet. Most medicines contain more than just the active ingredient, and many liquid medicines contain alcohol.


If you are taking isoniazid by mouth and it upsets your stomach, take it with food. Antacids may also help. However, do not take aluminum-containing antacids within 1 hour of taking isoniazid. They may keep this medicine from working properly.


For patients taking the oral liquid form of isoniazid:


  • Use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

To help clear up your tuberculosis (TB) completely, it is very important that you keep taking this medicine for the full time of treatment, even if you begin to feel better after a few weeks. You may have to take it every day for as long as 6 months to 2 years. It is important that you do not miss any doses.


Your doctor may also want you to take pyridoxine (e.g., Hexa-Betalin, vitamin B 6) every day to help prevent or lessen some of the side effects of isoniazid. This is not usually needed in children, who receive enough pyridoxine in their diet. If it is needed, it is very important to take pyridoxine every day along with this medicine. Do not miss any doses.


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage forms (tablets, syrup):
    • For preventing the return (reactivation) of tuberculosis:
      • Adults and teenagers—300 milligrams (mg) once a day.

      • Children—Dose is based on body weight. The usual dose is 10 mg per kilogram (kg) (4.5 mg per pound) of body weight, up to 300 mg, once a day.


    • For treatment of tuberculosis:
      • Adults and teenagers—300 mg once a day; or 15 mg per kg (6.8 mg per pound) of body weight, up to 900 mg, two times a week or three times a week, depending on the schedule your doctor chooses for you.

      • Children—Dose is based on body weight. The usual dose is 10 to 20 mg per kg (4.5 to 9.1 mg per pound) of body weight, up to 300 mg, once a day; or 20 to 40 mg per kg (9.1 to 18.2 mg per pound) of body weight, up to 900 mg, two times a week or three times a week, depending on the schedule your doctor chooses for you.



  • For injection dosage form:
    • For preventing the return (reactivation) of tuberculosis:
      • Adults and teenagers—300 mg once a day.

      • Children—Dose is based on body weight. The usual dose is 10 mg per kg (4.5 mg per pound) of body weight, up to 300 mg, once a day.


    • For treatment of tuberculosis:
      • Adults and teenagers—300 mg once a day; or 15 mg per kg (6.8 mg per pound) of body weight, up to 900 mg, two times a week or three times a week, depending on the schedule your doctor chooses for you.

      • Children—Dose is based on body weight. The usual dose is 10 to 20 mg per kg (4.5 to 9.1 mg per pound) of body weight, up to 300 mg, once a day; or 20 to 40 mg per kg (9.1 to 18.2 mg per pound) of body weight, up to 900 mg, two times a week or three times a week, depending on the schedule your doctor chooses for you.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Nydrazid


It is very important that your doctor check your progress at regular visits. Also, check with your doctor immediately if blurred vision or loss of vision, with or without eye pain, occurs during treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).


If your symptoms do not improve within 2 to 3 weeks, or if they become worse, check with your doctor.


Certain foods such as cheese (Swiss or Cheshire) or fish (tuna, skipjack, or Sardinella) may rarely cause reactions in some patients taking isoniazid. Check with your doctor if redness or itching of the skin, hot feeling, fast or pounding heartbeat, sweating, chills or clammy feeling, headache, or lightheadedness occurs while you are taking this medicine.


Liver problems may be more likely to occur if you drink alcoholic beverages regularly while you are taking this medicine. Also, the regular use of alcohol may keep this medicine from working properly. Therefore, you should strictly limit the amount of alcoholic beverages you drink while you are taking this medicine.


If this medicine causes you to feel very tired or very weak; or causes clumsiness; unsteadiness; a loss of appetite; nausea; numbness, tingling, burning, or pain in the hands and feet; or vomiting, check with your doctor immediately. These may be early warning signs of more serious liver or nerve problems that could develop later.


  • For diabetic patients:

  • This medicine may cause false test results with some urine sugar tests. Check with your doctor before changing your diet or the dosage of your diabetes medicine.

Nydrazid Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


More common
  • Clumsiness or unsteadiness

  • dark urine

  • loss of appetite

  • nausea or vomiting

  • numbness, tingling, burning, or pain in hands and feet

  • unusual tiredness or weakness

  • yellow eyes or skin

Rare
  • Blurred vision or loss of vision, with or without eye pain

  • convulsions (seizures)

  • fever and sore throat

  • joint pain

  • mental depression

  • mood or other mental changes

  • skin rash

  • unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Diarrhea

  • stomach pain

For injection form
  • Irritation at the place of injection

Dark urine and yellowing of the eyes or skin (signs of liver problems) are more likely to occur in patients over 50 years of age.


Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Nydrazid side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Nydrazid resources


  • Nydrazid Side Effects (in more detail)
  • Nydrazid Use in Pregnancy & Breastfeeding
  • Nydrazid Drug Interactions
  • Nydrazid Support Group
  • 0 Reviews for Nydrazid - Add your own review/rating


  • Nydrazid MedFacts Consumer Leaflet (Wolters Kluwer)

  • Isoniazid Injection Prescribing Information (FDA)

  • Isoniazid Monograph (AHFS DI)

  • isoniazid Concise Consumer Information (Cerner Multum)



Compare Nydrazid with other medications


  • Mycobacterium kansasii
  • Tuberculosis, Active
  • Tuberculosis, Latent
  • Tuberculosis, Prophylaxis

Herpes Zoster Peripheral Neuropathy Medications


There are currently no drugs listed for "Herpes Zoster Peripheral Neuropathy".

Learn more about Herpes Zoster Peripheral Neuropathy





Drug List:

Wednesday, 3 October 2012

Boots Pain Relief heat Spray





1. Name Of The Medicinal Product



Pain Relief Warming Spray or Warming Pain Relief Spray or Boots Pain Relief Heat Spray


2. Qualitative And Quantitative Composition












Active ingredients




 



 




Ethyl nicotinate




1.1% w/w




Methyl salicylate




1.25% w/w




Racemic camphor




0.625% w/w



3. Pharmaceutical Form



Topical spray.



4. Clinical Particulars



4.1 Therapeutic Indications



For the relief of muscular and rheumatic pains, lumbago, fibrositis, sciatica, sprains, strains and stiffness.



For topical administration.



4.2 Posology And Method Of Administration



Adults and children over 5 years: Spray the site of pain using 2 or 3 short bursts, holding the container about 6 inches (15cm) from the skin.



Children under 5 years: Not to be used by children under 5 years.



Elderly: The normal adult dose is still appropriate in the elderly.



4.3 Contraindications



Hypersensitivity to any of the ingredients.



Children under 5 years.



4.4 Special Warnings And Precautions For Use



For external use only.



Use sparingly as over-application can cause discomfort.



Discontinue use of the product if excessive irritation occurs.



Keep away from the eyes, face, mucous membranes and other sensitive parts of the body.



Do not use on broken or damaged skin or on open cuts.



If symptoms persist, consult your doctor.



Avoid inhalation.



Keep all medicines out of the reach of children.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



No clinically significant drug interactions known.



4.6 Pregnancy And Lactation



Although there are no data available to support the use of this product during pregnancy and lactation it is unlikely that use of this product would constitute a hazard to the foetus or breast fed infant.



4.7 Effects On Ability To Drive And Use Machines



No adverse effect known.



4.8 Undesirable Effects



Occasional hypersensitivity reactions.



4.9 Overdose



It is unlikely that overdosage will occur, but in the event, symptomatic treatment only should be sufficient.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Methyl salicylate has local analgesic and counter irritant properties.



Ethyl nicotinate has vasodilator properties and produces rubefacient activity.



Camphor acts as a mild analgesic, rubefacient and counter irritant.



5.2 Pharmacokinetic Properties



None stated.



5.3 Preclinical Safety Data



There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Denatured ethanol



Hydrocarbon 40



6.2 Incompatibilities



Not applicable



6.3 Shelf Life



36 months



6.4 Special Precautions For Storage



Pressurised container:



Protect from sunlight; do not expose to temperatures above 50EC; do not pierce or burn even when empty.



6.5 Nature And Contents Of Container



A tinplate internally lacquered aerosol can, having an aervalve and a white/black polypropylene actuator spray fitted with a polyethylene or polypropylene cover.



Pack size: 125ml



6.6 Special Precautions For Disposal And Other Handling



Do not spray on a naked flame or any incandescent material. Do not use near, and do not place container on, polished or painted surfaces.



7. Marketing Authorisation Holder



The Boots Company PLC



Nottingham



NG2 3AA



8. Marketing Authorisation Number(S)



PL 00014/0275



9. Date Of First Authorisation/Renewal Of The Authorisation



19 July 1982 / 7 December 2002



10. Date Of Revision Of The Text



March 2004




FML S.O.P.


Generic Name: fluorometholone ophthalmic (FLURE oh METH oh lone)

Brand Names: Flarex, FML Forte Liquifilm, FML Liquifilm, FML S.O.P.


What is FML S.O.P. (fluorometholone ophthalmic)?

Fluorometholone is a steroid medicine. It prevents the release of substances in the body that cause inflammation.


Fluorometholone ophthalmic (for the eyes) is used to treat eye swelling caused by infections, injury, surgery, or other conditions.

Fluorometholone ophthalmic may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about FML S.O.P. (fluorometholone ophthalmic)?


Do not use this medication if you are allergic to fluorometholone, or if you have any type of viral or fungal eye infection, ocular herpes, tuberculosis, or an untreated infection in your eye or elsewhere, including chickenpox.

Before using fluorometholone ophthalmic, tell your doctor if you are allergic to any drugs, if you have herpes, or if you are also taking an oral steroid medication such as prednisone (Deltasone, Orasone, others), methylprednisolone (Medrol), hydrocortisone (Cortef, Hydrocortone), and others.


Do not use fluorometholone ophthalmic while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses and cause discoloration. Wait at least 15 minutes after using fluorometholone before putting your contact lenses in. Shake the eye drops gently before each use.

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.


Do not stop using fluorometholone suddenly without first talking to your doctor. Tell your doctor if your symptoms do not improve after 2 weeks of treatment with fluorometholone ophthalmic.


What should I tell my healthcare provider before using FML S.O.P. (fluorometholone ophthalmic)?


Do not use this medication if you are allergic to fluorometholone, or if you have any type of infection, especially:

  • a fungal eye infection;




  • any type of viral eye infection, such as ocular herpes;




  • tuberculosis; or




  • an untreated infection in your eye or elsewhere, including chickenpox.



Before using fluorometholone ophthalmic, tell your doctor if you are allergic to any drugs, or if you have herpes. You may need a dose adjustment or special tests to safely use fluorometholone.


FDA pregnancy category C. Fluorometholone ophthalmic may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether fluorometholone ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use FML S.O.P. (fluorometholone ophthalmic)?


Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.


Wash your hands before using your eye drops or ointment.


To apply the eye drops:


  • Shake the bottle gently before each use to be sure the medicine is well mixed.


  • Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.




  • Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct. If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.




  • Use only the number of drops your doctor has prescribed.




  • Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.




Do not use the eye drops if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.

To apply the ointment:



  • You may warm the ointment by holding the medicine tube in your hand for a few minutes before use. Tilt your head back slightly and pull down gently on your lower eyelid. Apply a thin film of the ointment into your lower eyelid. Close your eye and roll your eyeball around for 1 to 2 minutes. If you are applying another eye medication, allow at least 10 minutes before your next application.




Do not stop using fluorometholone suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely. Tell your doctor if your symptoms do not improve after 2 weeks of treatment with fluorometholone ophthalmic.

To be sure this medication is not causing harmful effects, your eyes will need to be checked on a regular basis. Do not miss any scheduled visits to your doctor.


Store fluorometholone ophthalmic at room temperature away from moisture and heat. Keep the bottle or tube tightly capped. Do not allow this medicine to freeze.

What happens if I miss a dose?


Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine. An overdose of fluorometholone ophthalmic is not expected to produce life-threatening symptoms.

What should I avoid while using FML S.O.P. (fluorometholone ophthalmic)?


Do not wear any contact lens that has not been approved by your doctor.

Do not use fluorometholone ophthalmic while you are wearing regular contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses and cause discoloration. Wait at least 15 minutes after using fluorometholone before putting your contact lenses in.


Do not use any other eye medications unless your doctor has prescribed them.


Fluorometholone can cause side effects that may impair your vision. Be careful if you drive or do anything that requires you to see clearly.

FML S.O.P. (fluorometholone ophthalmic) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • pain behind your eyes, sudden vision changes, severe headache;




  • sudden eye irritation;




  • blurred vision, tunnel vision, eye pain, or seeing halos around lights; or




  • signs of new eye infection, such as swelling, draining, or crusting of your eyes.



Less serious side effects may include:



  • increased sensitivity to light; or




  • mild stinging, burning, itching, or irritation in your eyes.



This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect FML S.O.P. (fluorometholone ophthalmic)?


Before using fluorometholone, tell your doctor if you are also taking an oral steroid medication such as prednisone (Deltasone, Orasone, others), methylprednisolone (Medrol), hydrocortisone (Cortef, Hydrocortone), and others.


This list is not complete and there may be other drugs that can interact with fluorometholone ophthalmic. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More FML S.O.P. resources


  • FML S.O.P. Side Effects (in more detail)
  • FML S.O.P. Use in Pregnancy & Breastfeeding
  • FML S.O.P. Drug Interactions
  • FML S.O.P. Support Group
  • 0 Reviews for FML S.O.P. - Add your own review/rating


  • Flarex Prescribing Information (FDA)

  • Flarex Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

  • Fluor-Op Prescribing Information (FDA)

  • Fluor-Op MedFacts Consumer Leaflet (Wolters Kluwer)



Compare FML S.O.P. with other medications


  • Eye Dryness/Redness
  • Eye Redness/Itching
  • Eyelash Hypotrichosis


Where can I get more information?


  • Your pharmacist can provide more information about fluorometholone ophthalmic.

See also: FML S.O.P. side effects (in more detail)


Monday, 1 October 2012

Edluar


Generic Name: zolpidem (zole PI dem)

Brand Names: Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist


What is zolpidem?

Zolpidem is a sedative, also called a hypnotic. It affects chemicals in your brain that may become unbalanced and cause sleep problems (insomnia).


Zolpidem is used to treat insomnia. The immediate-release forms of zolpidem are Ambien, Intermezzo, Edluar, and Zolpimist, which are used to help you fall asleep. The extended-release form of zolpidem is Ambien CR, which has a first layer that dissolves quickly to help you fall asleep, and a second layer that dissolves slowly to help you stay asleep.


Ambien, Edluar, and Zolpimist are used to help you fall asleep when you first go to bed. Intermezzo, is used to help you fall back to sleep if you wake up in the middle of the night and then have trouble sleeping.


Your doctor will determine which form of zolpidem is best for you.


Zolpidem may also be used for purposes not listed in this medication guide.


What is the most important information I should know about zolpidem?


Zolpidem may cause a severe allergic reaction. Stop taking zolpidem and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking zolpidem and talk with your doctor about another treatment for your sleep disorder. Zolpidem may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Wait at least 4 hours or until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert. Do not take this medicine if you have consumed alcohol during the day or just before bed. Zolpidem may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

It is dangerous to try and purchase zolpidem on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of zolpidem purchased on the Internet have been found to contain haloperidol (Haldol), a potent antipsychotic drug with dangerous side effects. For more information, contact the U.S. Food and Drug Administration (FDA) or visit www.fda.gov/buyonlineguide.


What should I discuss with my healthcare provider before taking zolpidem?


Some people using this medicine have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking zolpidem and talk with your doctor about another treatment for your sleep disorder. You should not use this medication if you are allergic to zolpidem. Zolpidem tablets may contain lactose. Use caution if you are sensitive to lactose.

To make sure you can safely take zolpidem, tell your doctor if you have any of these other conditions:


  • kidney disease;

  • liver disease;


  • lung disease such as asthma, bronchitis, emphysema, or chronic obstructive pulmonary disease (COPD);




  • sleep apnea (breathing stops during sleep);




  • myasthenia gravis;




  • a history of depression, mental illness, or suicidal thoughts; or




  • a history of drug or alcohol addiction.




Zolpidem may be habit forming and should be used only by the person it was prescribed for. Never share zolpidem with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. FDA pregnancy category C. It is not known whether zolpidem will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Zolpidem can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. The sedative effects of zolpidem may be stronger in older adults. Do not give this medicine to anyone younger than 18 years of age.

It is dangerous to try and purchase zolpidem on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of zolpidem purchased on the Internet have been found to contain haloperidol (Haldol), a potent antipsychotic drug with dangerous side effects. For more information, contact the U.S. Food and Drug Administration (FDA) or visit www.fda.gov/buyonlineguide.


How should I take zolpidem?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.


Zolpidem comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.


Never take Ambien, Edluar, or Zolpimist if you do not have a full 7 to 8 hours to sleep before being active again.


Do not take Intermezzo for middle-of-the-night insomnia unless you have 4 hours of sleep time left before being active.


Zolpidem is for short-term use only. Tell your doctor if your insomnia symptoms do not improve, or if they get worse after using this medication for 7 to 10 nights in a row. Do not take zolpidem for longer than 4 or 5 weeks without your doctor's advice. Do not stop using zolpidem suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using the medicine.

Insomnia symptoms may also return after you stop taking zolpidem. These symptoms may seem to be even worse than before you started taking the medication. Call your doctor if you still have worsened insomnia after the first few nights without taking zolpidem.


Do not crush, chew, or break an Ambien CR tablet. Swallow the pill whole. Breaking the pill may cause too much of the drug to be released at one time.

Do not swallow the Edluar or Intermezzo tablet whole. Place the tablet under your tongue and allow it to dissolve in your mouth without water.


Spray Zolpimist directly into your mouth over your tongue. Prime the spray before the first use by pumping 5 test sprays into the air, away from your face. Prime the spray with 1 test spray if it has not been used for longer than 14 days.


Store at room temperature away from moisture and heat. Do not freeze. Keep the Zolpimist bottle upright when not in use.

What happens if I miss a dose?


Since zolpidem is taken only at bedtime, you will not be on a frequent dosing schedule.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of zolpidem can be fatal when it is taken together with other medications that can cause drowsiness.

Overdose symptoms may include sleepiness, confusion, shallow breathing, feeling light-headed, fainting, or coma.


What should I avoid while taking zolpidem?


Zolpidem may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Wait at least 4 hours or until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

Avoid taking zolpidem during travel, such as to sleep on an airplane. You may be awakened before the effects of the medication have worn off. Amnesia (forgetfulness) is more common if you do not get a full 7 to 8 hours of sleep after taking zolpidem.


Do not take this medicine if you have consumed alcohol during the day or just before bed.

Zolpidem side effects


Zolpidem may cause a severe allergic reaction. Stop taking zolpidem and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Report any new or worsening symptoms to your doctor, such as: depression, anxiety, aggression, agitation, confusion, unusual thoughts, hallucinations, memory problems, changes in personality, risk-taking behavior, decreased inhibitions, no fear of danger, or thoughts of suicide or hurting yourself. Stop using zolpidem and call your doctor at once if you have a serious side effects:

  • chest pain, fast or irregular heartbeat, feeling short of breath;




  • trouble breathing or swallowing; or




  • feeling like you might pass out.



Less serious side effects may include:



  • daytime drowsiness, dizziness, weakness, feeling "drugged" or light-headed;




  • tired feeling, loss of coordination;




  • dry mouth, nose or throat irritation;




  • nausea, constipation, diarrhea, upset stomach;




  • stuffy nose, sore throat; or




  • headache, muscle pain.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect zolpidem?


You may need a lower dose of zolpidem if you take other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxants, and medicine for depression or anxiety). Tell your doctor if you are currently taking any of these medications.

Tell your doctor about all other medicines you use, especially:



  • chlorpromazine (Thorazine);




  • itraconazole (Sporanox), ketoconazole (Nizoral);




  • rifampin (Rifadin, Rimactane, Rifater); or




  • antidepressants such as imipramine (Tofranil), or sertraline (Zoloft).



This list is not complete and other drugs may interact with zolpidem. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Edluar resources


  • Edluar Side Effects (in more detail)
  • Edluar Use in Pregnancy & Breastfeeding
  • Edluar Drug Interactions
  • Edluar Support Group
  • 5 Reviews for Edluar - Add your own review/rating


  • Edluar Prescribing Information (FDA)

  • Edluar Advanced Consumer (Micromedex) - Includes Dosage Information

  • Edluar MedFacts Consumer Leaflet (Wolters Kluwer)

  • Edluar Consumer Overview

  • Zolpidem Prescribing Information (FDA)

  • Ambien Monograph (AHFS DI)

  • Ambien Prescribing Information (FDA)

  • Ambien MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ambien Consumer Overview

  • Ambien CR Prescribing Information (FDA)

  • Ambien CR Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Intermezzo Consumer Overview

  • ZolpiMist Consumer Overview

  • Zolpimist Prescribing Information (FDA)

  • Zolpimist Oral Spray MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Edluar with other medications


  • Insomnia


Where can I get more information?


  • Your pharmacist can provide more information about zolpidem.

See also: Edluar side effects (in more detail)


Sunday, 30 September 2012

Epinephrine Aerosol



Pronunciation: ep-i-NEF-rin
Generic Name: Epinephrine
Brand Name: Examples include Asthmahaler and Primatene Mist


Epinephrine Aerosol is used for:

Treating shortness of breath, chest tightness, and wheezing associated with asthma, emphysema, and other breathing problems. It may also be used for other conditions as determined by your doctor.


Epinephrine Aerosol is an alpha- and beta-receptor stimulant. It works by widening the airway, which makes it easier to breathe.


Do NOT use Epinephrine Aerosol if:


  • you are allergic to any ingredient in Epinephrine Aerosol

  • you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.



Before using Epinephrine Aerosol:


Some medical conditions may interact with Epinephrine Aerosol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have an overactive thyroid, urinary problems, an enlarged prostate, diabetes, high blood pressure, ischemic heart disease, irregular heartbeat, or other heart problems

Some MEDICINES MAY INTERACT with Epinephrine Aerosol. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Beta-blockers (eg, propranolol), droxidopa, or phenothiazines (eg, chlorpromazine) because the risk of high or low blood pressure and fast or slow heartbeat may be increased

  • Bromocriptine, furazolidone, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects, such as headache, high temperature, and high blood pressure, may be increased

  • Catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), digoxin, or medicines for irregular heartbeat (eg, quinidine) because they may increase the risk of Epinephrine Aerosol's side effects

  • Guanethidine because its effectiveness may be decreased by Epinephrine Aerosol

This may not be a complete list of all interactions that may occur. Ask your health care provider if Epinephrine Aerosol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Epinephrine Aerosol:


Use Epinephrine Aerosol as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.


  • An extra patient leaflet is available with Epinephrine Aerosol. Talk to your pharmacist if you have questions about this information.

  • Before using Epinephrine Aerosol, be sure that the canister is properly placed in the inhaler unit. Shake well. Breathe out slowly and completely. Place the mouthpiece between your lips and try to rest your tongue flat, unless your doctor has told you otherwise. Your doctor may have told you to hold the inhaler 1 or 2 inches (2 or 3 centimeters) away from the open mouth or to use a special spacing device. As you start to take a slow deep breath, press the canister and mouthpiece together at exactly the same time. This will release a dose of Epinephrine Aerosol. Continue breathing in slowly and deeply and hold for as long as comfortable, then breathe out slowly through pursed lips or your nose. If more than 1 inhalation is to be used, wait a few minutes and repeat the above steps. Keep the spray away from your eyes.

  • If you miss a dose of Epinephrine Aerosol, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Epinephrine Aerosol.



Important safety information:


  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

  • If your symptoms do not get better or if they get worse, check with your doctor.

  • Epinephrine Aerosol may cause dry mouth or an unpleasant taste in your mouth. Rinsing your mouth with water after each dose may help relieve these effects.

  • Epinephrine Aerosol should not be used in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Epinephrine Aerosol while you are pregnant. Epinephrine Aerosol is found in breast milk. If you are or will be breast-feeding while you use Epinephrine Aerosol, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Epinephrine Aerosol:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Difficulty sleeping; fast heartbeat; headache; loss of appetite; nausea; nervousness; tremors.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); wheezing.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.



If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include headache; irregular heartbeat; nausea; tremor; vomiting; weakness.


Proper storage of Epinephrine Aerosol:

Store Epinephrine Aerosol at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not puncture, break, or burn the canister even if it appears to be empty. Keep Epinephrine Aerosol out of the reach of children and away from pets.


General information:


  • If you have any questions about Epinephrine Aerosol, please talk with your doctor, pharmacist, or other health care provider.

  • Epinephrine Aerosol is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Epinephrine Aerosol. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Epinephrine resources


  • Epinephrine Use in Pregnancy & Breastfeeding
  • Epinephrine Drug Interactions
  • Epinephrine Support Group
  • 11 Reviews for Epinephrine - Add your own review/rating


Compare Epinephrine with other medications


  • Adams-Stokes Syndrome
  • Allergic Reactions
  • Asthma, acute
  • Asystole
  • AV Heart Block
  • COPD, Acute
  • Electromechanical Dissociation
  • Shock

Tuesday, 25 September 2012

Estradiol Emulsion


Pronunciation: ES-tra-DYE-ol
Generic Name: Estradiol
Brand Name: Estrasorb

Estradiol Emulsion should not be used to prevent heart disease, heart attacks, strokes, or dementia. Estrogens with or without progestins have been shown to increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots (eg, in the lungs or legs), cancer of the uterus, and breast cancer in some women. Tell your doctor right away if you have unusual vaginal bleeding while you use Estradiol Emulsion. Talk with your doctor if you have questions about the benefits and risks of using Estradiol Emulsion.


Estradiol Emulsion should be used for the shortest possible time at the lowest effective dose to minimize the risk of these side effects. Talk with your doctor regularly about your need to use Estradiol Emulsion.





Estradiol Emulsion is used for:

Treating certain conditions caused by menopause (eg, hot flashes; vaginal itching, burning, or dryness).


Estradiol Emulsion is an estrogen hormone used to provide the female hormone when the body no longer produces enough.


Do NOT use Estradiol Emulsion if:


  • you are allergic to any ingredient in Estradiol Emulsion

  • you are pregnant or suspect you may be pregnant

  • you have abnormal vaginal bleeding of unknown cause

  • you have known, suspected, or a history of breast cancer

  • you have known or suspected cancers that are estrogen-dependent

  • you have blood clots (eg, in the legs or lungs) or a history of blood clots

  • you have had a recent (within the past year) heart attack or stroke

  • you have liver problems

Contact your doctor or health care provider right away if any of these apply to you.



Before using Estradiol Emulsion:


Some medical conditions may interact with Estradiol Emulsion. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are planning to become pregnant

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have had yellowing of the eyes or skin during pregnancy or with past estrogen use

  • if you have asthma, cancer, certain blood disorder (porphyria), depression, diabetes, epilepsy (seizures), eye or vision problems, fluid retention or swelling (edema), gallbladder disease, heart disease or other heart problems, high blood pressure, high cholesterol or triglyceride levels, high or low calcium levels in the blood, kidney problems, a certain type of liver growth (hemangioma), migraine headaches, pancreatitis, or thyroid problems

  • if you have a history of an abnormal mammogram or breast lumps, endometriosis, ovarian cancer, or a family history of breast cancer

  • if you or a family member have a history of blood clots (eg, in the legs or lungs) or lupus, or have been very overweight

  • if you smoke or use tobacco products, you will be having surgery, or you will be on bedrest

  • if you have had your uterus removed (hysterectomy)

Some MEDICINES MAY INTERACT with Estradiol Emulsion. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Anticoagulants (eg, warfarin), corticosteroids (eg, prednisone), succinylcholine, or tacrine because their actions and the risk of their side effects may be increased by Estradiol Emulsion

  • Anticoagulants (eg, warfarin) or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Estradiol Emulsion

  • Barbiturates (eg, phenobarbital), hydantoins (eg, phenytoin), or rifampin because they may decrease Estradiol Emulsion's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Estradiol Emulsion may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Estradiol Emulsion:


Use Estradiol Emulsion as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • An extra patient leaflet is available with Estradiol Emulsion. Talk to your pharmacist if you have questions about this information.

  • If you are switching from oral estrogen to Estradiol Emulsion, stop taking the oral estrogen and wait 1 week before using Estradiol Emulsion. However, if symptoms return, you may start using Estradiol Emulsion sooner.

  • Wash your hands with soap and water both before and after using Estradiol Emulsion.

  • Sit in a comfortable sitting position and apply Estradiol Emulsion to clean, dry skin of the leg. Cut or tear the pouch of medicine and empty the entire contents of the pouch onto the top of the thigh. Rub the medicine in well into the thigh and calf of the leg for 3 minutes until it is completely absorbed. Rub any medicine remaining on the hands onto the buttocks. If you are using two pouches of Estradiol Emulsion, apply the second pouch of medicine to the opposite leg in the same way.

  • Allow the medicine to dry completely before covering with clothing to avoid transfer to other people.

  • Grapefruit and grapefruit juice may increase the risk of Estradiol Emulsion's side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Estradiol Emulsion.

  • If you miss a dose of Estradiol Emulsion, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Estradiol Emulsion.



Important safety information:


  • Estradiol Emulsion may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Estradiol Emulsion with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Estradiol Emulsion may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.

  • Do NOT apply sunscreen to the application site for at least 25 minutes after applying Estradiol Emulsion.

  • Estradiol Emulsion may increase the risk of blood clots. The risk may be greater if you smoke (especially in women older than 35 years).

  • Contact your doctor if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention.

  • Contact your doctor if vaginal discomfort occurs or if you suspect you have developed an infection while taking Estradiol Emulsion.

  • Follow your doctor's instructions for examining your breasts, and report any lumps immediately.

  • If you wear contact lenses and you develop problems with them, contact your doctor.

  • If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. You may need to stop taking Estradiol Emulsion at least 4 to 6 weeks beforehand as directed by your doctor.

  • Nonprescription therapy to help prevent bone loss includes a weight-bearing exercise plan, as well as adequate daily calcium and vitamin D intake. Consult your doctor or pharmacist for more details.

  • Estradiol Emulsion may increase the risk of breast and endometrial cancer.

  • Diabetes patients - Estradiol Emulsion may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

  • Estradiol Emulsion may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Estradiol Emulsion.

  • Lab tests, including physical exams and blood pressure, may be performed while you use Estradiol Emulsion. You should have breast and pelvic exams, and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Estradiol Emulsion with caution in the ELDERLY; they may be more sensitive to its effects.

  • Estradiol Emulsion should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: Do not use Estradiol Emulsion if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Estradiol Emulsion may be found in breast milk. If you are or will be breast-feeding while you use Estradiol Emulsion, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Estradiol Emulsion:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Breast pain or tenderness; headache; hair loss; mild irritation or redness at the application site; mild nausea or vomiting; spotting or breakthrough bleeding; stomach cramps or bloating.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; breast discharge or lump in the breast; calf or leg pain or swelling; chest pain; confusion; coughing up blood; dark urine; depression; dizziness; fainting; fever; memory problems; mental or mood changes; migraine; muscle pain; one-sided weakness; nipple discharge; painful or difficult urination; persistent or severe breast pain or tenderness; persistent or severe headache, nausea, or vomiting; severe stomach pain or swelling; slurred speech; sudden shortness of breath; swelling of the hands, legs, or feet; unusual vaginal bleeding, discharge, itching, or odor; vision changes (eg, double vision, loss of vision); weakness or numbness of an arm or leg; yellowing of the skin or eyes.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.



If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include excessive vaginal bleeding; severe nausea; vomiting.


Proper storage of Estradiol Emulsion:

Store Estradiol Emulsion at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in original packaging until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Estradiol Emulsion out of the reach of children and away from pets.


General information:


  • If you have any questions about Estradiol Emulsion, please talk with your doctor, pharmacist, or other health care provider.

  • Estradiol Emulsion is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Estradiol Emulsion. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.