EpiPen Auto-Injector

Pronunciation: EP-i-NEF-rin
Generic Name: Epinephrine
Brand Name: Examples include EpiPen and Twinject

EpiPen Auto-Injector is used for:

Treating severe allergic reactions (eg, difficulty breathing; rash; hives; itching; tightness in the chest; severe dizziness; swelling of the mouth, lips, or tongue) caused by insect stings or bites, foods, drugs, or other causes. It may also be used for other conditions as determined by your doctor.

EpiPen Auto-Injector is a sympathomimetic. It works on blood vessels to improve blood pressure and on the smooth muscle of the lungs to help breathing. It also works by decreasing rash, hives, and swelling.

Do NOT use EpiPen Auto-Injector if:

• you are allergic to any ingredient in EpiPen Auto-Injector, unless your doctor tells you otherwise

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

Before using EpiPen Auto-Injector:

Some medical conditions may interact with EpiPen Auto-Injector. 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 (eg, sulfites)


• if you have heart disease, chest pain, high blood pressure, blood vessel problems, diabetes, Parkinson disease, thyroid problems, mood or mental disorders (eg, depression), asthma, or an irregular heartbeat

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

• Bromocriptine, furazolidone, or linezolid, because the risk of side effects, such as headache, high temperature, and high blood pressure, may be increased


• Antiarrhythmics (eg, quinidine), digoxin, diuretics (eg, furosemide, hydrochlorothiazide), or droxidopa because the risk of irregular heartbeat may be increased


• Alpha-blockers (eg, prazosin), beta-blockers (eg, propanolol), droxidopa, ergot alkaloids (eg, ergotamine), or phenothiazines (eg, chlorpromazine) because the risk of high or low blood pressure and fast or slow heartbeat may be increased


• Antihistamines (eg, chlorpheniramine), catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), levothyroxine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of EpiPen Auto-Injector's side effects


• Alpha-blockers (eg, prazosin), beta-blockers (eg, propanolol), ergot alkaloids (eg, ergotamine), and phenothiazines (eg, chlorpromazine) because they may increase the risk of EpiPen Auto-Injector's side effects


• Guanethidine because its effectiveness may be decreased by EpiPen Auto-Injector

This may not be a complete list of all interactions that may occur. Ask your health care provider if EpiPen Auto-Injector 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 EpiPen Auto-Injector:

Use EpiPen Auto-Injector as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with EpiPen Auto-Injector. Talk to your pharmacist if you have questions about this information.


• EpiPen Auto-Injector may be given as an injection at your doctor's office, hospital, or clinic. If you will be using EpiPen Auto-Injector at home, a health care provider will teach you how to use it. Be sure you understand how to use EpiPen Auto-Injector. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Check EpiPen Auto-Injector regularly. Replace EpiPen Auto-Injector if the expiration date has passed, if it contains particles or is discolored (pink or darker than slightly yellow), or if it is cracked or damaged in any way. If EpiPen Auto-Injector has been dropped, inspect it for damage or leakage and replace it if necessary.


• Inject EpiPen Auto-Injector only into the outer thigh, as directed by your health care provider. Do not inject into the buttocks or into a vein.


• Go to the nearest hospital emergency room immediately after use. You may need further medical attention. Tell the doctor or health care provider that you have received an injection of epinephrine. Show the thigh where the injection was given to the doctor. Give your used auto-injector to the doctor for inspection and proper disposal.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• EpiPen Auto-Injector is usually given in an emergency situation. If you are unable to use EpiPen Auto-Injector, seek medical attention immediately.


• If you miss a dose of EpiPen Auto-Injector, seek immediate medical attention.

Ask your health care provider any questions you may have about how to use EpiPen Auto-Injector.

Important safety information:

• Never put your thumb, fingers, or hand over the tip of the auto-injector. Do NOT remove the cap until you are ready to use EpiPen Auto-Injector.


• Only inject EpiPen Auto-Injector into the outer thigh. Never inject EpiPen Auto-Injector into hands, fingers, feet, or toes. Doing so may cause a loss of blood flow and result in tissue damage to these areas. If you accidentally inject EpiPen Auto-Injector into any of these areas, seek immediate emergency medical attention.


• It may be helpful to train others how to give EpiPen Auto-Injector in case you are unable to give it to yourself during a reaction.


• Diabetes patients - EpiPen Auto-Injector may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur or persist, tell your doctor right away.


• Patients with Parkinson disease may notice a temporary worsening of symptoms (eg, uncontrolled muscle movements). If these symptoms persist, contact your doctor.


• Use EpiPen Auto-Injector with caution in the ELDERLY; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using EpiPen Auto-Injector while you are pregnant. It is not known if EpiPen Auto-Injector is found in breast milk. If you are or will be breast-feeding while you use EpiPen Auto-Injector, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of EpiPen Auto-Injector:

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:

Dizziness; feeling anxious, nervous, or fearful; headache; nausea; nervousness; paleness; restlessness; shakiness or weakness; sweating; vomiting.

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); chest pain; fast or irregular heartbeat; 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.

See also: EpiPen side effects (in more detail)

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 chest pain; confusion; extreme paleness or coldness of the skin; fast or irregular heartbeat; one-sided weakness; severe headache or dizziness; slurred speech; trouble breathing; vision problems.

Proper storage of EpiPen Auto-Injector:

Store EpiPen Auto-Injector at room temperature, between 60 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 the carrying case provided. Do not refrigerate or freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep EpiPen Auto-Injector out of the reach of children and away from pets.

General information:

• If you have any questions about EpiPen Auto-Injector, please talk with your doctor, pharmacist, or other health care provider.


• EpiPen Auto-Injector 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 EpiPen Auto-Injector. 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 EpiPen resources

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

• EpiPen Auto-Injector Concise Consumer Information (Cerner Multum)


• Adrenaclick Advanced Consumer (Micromedex) - Includes Dosage Information


• Adrenaclick Prescribing Information (FDA)


• Epinephrine Monograph (AHFS DI)


• Epinephrine Professional Patient Advice (Wolters Kluwer)


• Epinephrine (Mydriatic) eent Monograph (AHFS DI)


• Medihaler-Epi Prescribing Information (FDA)


• Twinject Auto-Injector Prescribing Information (FDA)

Compare EpiPen with other medications

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

Angiomax

Pronunciation: bye-VAL-ih-ruh-din
Generic Name: Bivalirudin
Brand Name: Angiomax

Angiomax is used for:

Thinning the blood in patients with unstable angina who are undergoing percutaneous transluminal coronary angioplasty (PTCA) and in patients undergoing percutaneous coronary intervention (PCI). Angiomax is used in conjunction with other medicines. It may also be used for other conditions as determined by your doctor.

Angiomax is a thrombin inhibitor. It works by blocking the formation of blood clots.

Do NOT use Angiomax if:

• you are allergic to any ingredient in Angiomax


• you have active major bleeding

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

Before using Angiomax:

Some medical conditions may interact with Angiomax. 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 a history of blood clots or bleeding problems (eg, hemophilia)

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

• Anticoagulants (eg, warfarin, heparin), glycoprotein IIb/IIIa inhibitors (eg, abciximab), platelet inhibitors (eg, cilostazol), or thrombolytics (eg, alteplase) because the risk of serious side effects, such as bleeding, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Angiomax 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 Angiomax:

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

• Angiomax is administered as an injection at your doctor's office, hospital, or clinic.


• If you miss a dose of Angiomax, contact your doctor immediately.

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

Important safety information:

• Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Angiomax. Using Angiomax alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Angiomax reduces the ability of the blood to clot. To prevent bleeding, avoid situations in which bruising or injury may occur.


• LAB TESTS, including blood clotting tests and blood pressure, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Use Angiomax with caution in the ELDERLY because they may be more sensitive to its effects, such as bleeding.


• Use Angiomax with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.


• If you become pregnant, discuss with your doctor the benefits and risks of using Angiomax during pregnancy. It is unknown if Angiomax is excreted in breast milk. If you are or will be breast-feeding, discuss with your doctor the risks to your baby.

Possible side effects of Angiomax:

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:

Anxiety; back, stomach, or pelvic pain; headache; nausea; nervousness; pain at the injection site; trouble sleeping; upset stomach; vomiting.

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); calf pain or tenderness; chest pain or tightness; confusion; difficulty urinating; dizziness; easy bruising or bleeding; fainting; fast, slow, or irregular heartbeat; fever; loss of consciousness; one-sided weakness; paralysis of the face; severe bleeding; shortness of breath; vision or speech changes.

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.

See also: Angiomax side effects (in more detail)

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 bleeding.

Proper storage of Angiomax:

Angiomax is usually handled and stored by a health care provider. If you are using Angiomax at home, store Angiomax as directed by your pharmacist or health care provider. Keep Angiomax out of the reach of children and away from pets.

General information:

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


• Angiomax 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 Angiomax. 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 Angiomax resources

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

• Angiomax Prescribing Information (FDA)


• Angiomax Advanced Consumer (Micromedex) - Includes Dosage Information


• Angiomax Concise Consumer Information (Cerner Multum)


• Angiomax Monograph (AHFS DI)


• Bivalirudin Professional Patient Advice (Wolters Kluwer)

Compare Angiomax with other medications

• Angina
• Percutaneous Coronary Intervention

Ethmozine

Generic Name: moricizine (Oral route)

mor-I-si-zeen

Oral route(Tablet)

Considering the known proarrhythmic properties of moricizine and the lack of evidence of improved survival for any antiarrhythmic drug in patients without life-threatening arrhythmias, the use of moricizine, as well as other antiarrhythmic agents, should be reserved for patients with life-threatening ventricular arrhythmias .

Commonly used brand name(s)

In the U.S.

• Ethmozine

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiarrhythmic, Group I

Uses For Ethmozine

Moricizine belongs to the group of medicines known as antiarrhythmics. It is used to correct irregular or rapid heartbeats to a normal rhythm by making the heart tissue less sensitive.

There is a chance that moricizine may cause new or make worse existing heart rhythm problems when it is used. Since other antiarrhythmic medicines have been shown to cause severe problems in some patients, moricizine is only used to treat serious heart rhythm problems. Discuss this possible effect with your doctor.

This medicine was available only with your doctor's prescription.

Effective August 28, 2007, the manufacturer will discontinue Ethmozine® (moricizine) due to lack of demand for the product. If you are taking moricizine right now, do not stop taking it or any other medicines until you have talked with your doctor. Your doctor may have special instructions for tapering you off of moricizine slowly. You or your doctor can contact the manufacturer at 1-800-828-2088 and choose the option "Medical Information" if you have questions .

Before Using Ethmozine

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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of moricizine in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of moricizine in the elderly with use in other age groups, although the risk of some unwanted effects may be increased.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Cisapride


• Sparfloxacin


• Thioridazine

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.

• Amiodarone


• Amitriptyline


• Amoxapine


• Ciprofloxacin


• Clomipramine


• Desipramine


• Dofetilide


• Doxepin


• Gatifloxacin


• Ibutilide


• Imipramine


• Levofloxacin


• Lidocaine


• Moxifloxacin


• Norfloxacin


• Nortriptyline


• Ofloxacin


• Prilocaine


• Procainamide


• Protriptyline


• Sotalol


• Trimipramine


• Vardenafil

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.

• Diltiazem


• 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. 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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease or


• Liver disease—Effects may be increased because of slower removal of moricizine from the body.

• Heart disease or


• Recent heart attack or


• If you have a pacemaker—Risk of irregular heartbeats may be increased.

Proper Use of Ethmozine

Take moricizine exactly as directed by your doctor, even though you may feel well. Do not take more or less of it than your doctor ordered.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take each dose at evenly spaced times day and night. For example, if you are to take 3 doses a day, doses should be spaced about 8 hours apart. If you need help in planning the best times to take your medicine, check with your health care professional.

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 form (tablets):
  
  • For irregular heartbeat (arrhythmias):
    
    • Adults—600 to 900 milligrams (mg) a day. This is divided into three doses and taken every eight hours.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

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 Ethmozine

It is important that your doctor check your progress at regular visits to make sure the medicine is working properly. This will allow changes to be made in the amount of medicine you are taking, if necessary.

Your doctor may want you to carry a medical identification card or bracelet stating that you are using this medicine.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

Moricizine may cause some people to become dizzy or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy.

Ethmozine 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:

Less common

• Chest pain


• fast or irregular heartbeat


• shortness of breath


• swelling of the feet or lower legs

Rare

• Fever (sudden, high)

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

• Dizziness

Less common

• Blurred vision


• diarrhea


• dry mouth


• headache


• nausea or vomiting


• nervousness


• numbness or tingling in the arms or legs or around the mouth


• pain in the arms or legs


• stomach pain


• trouble with sleeping


• unusual tiredness or weakness

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: Ethmozine 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 Ethmozine resources

• Ethmozine Side Effects (in more detail)
• Ethmozine Dosage
• Ethmozine Use in Pregnancy & Breastfeeding
• Drug Images
• Ethmozine Drug Interactions
• Ethmozine Support Group
• 1 Review for Ethmozine - Add your own review/rating

• Ethmozine Prescribing Information (FDA)


• Ethmozine Concise Consumer Information (Cerner Multum)


• Ethmozine MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Ethmozine with other medications

• Ventricular Tachycardia

Guna-Lumbar

Dosage Form: injection, solution
GUNA®-LUMBAR (Homeopathic complex preparation) INJECTION SC, ID, IM

1. INDICATIONS AND USAGE

1.1    Lumbar pain due to degenerative lumbar spine disorders (lumbar and lumbar-sacral arthrosis)

1.2    Lumbar vertebral osteophytes

1.3    Low back pain due to muscular and tendinous trigger points. The simultaneous administration of GUNA®-MUSCLE gives wider therapeutic coverage.

1.4    Simple lumbar pain (low back syndrome)

1.5    Weak low back syndrome

1.6    Postural low back ache

1.7    Lumbar and lumbo-sacral mechanical imbalance

1.8    Lumbar and lumbo-sacral spinal malalignment syndrome

1.9    Sacro-iliac syndrome

1.10    Spinal Enthesopathy/Ligament Laxity

1.11    Spinal lumbar and lumbo-sacral nerve root pain. The simultaneous administration of GUNA®-NEURAL gives wider therapeutic coverage.

2. DOSAGE AND ADMINISTRATION

2.1.    Standard protocol for IM administration: 1 vial 1-3 times a week according to severity and clinical progress.

2.2.    Standard protocol according to mesotherapy technique using 1 vial per treatment: 2 treatments for the first 2 weeks, 1 treatment a week till pain relief (average 8-10 sessions). For chronic pathologies: continue 1 treatment a week for 1 month till pain relief, then 1 treatment a month.

Select application site according to trigger points, tender points, referred pain zones, acupuncture points, nerve key points, Head zones or “local pain points”. Using a 13 mm, 30G or a 4 mm, 27G needle, make the classic intradermal injection according to mesotherapy technique.

Discard unused solution.

2.3.    Opening of Vials: Use sterile needles and sterile syringe. Do not reuse. Do not use if foreign particles are present. Draw 1 cc of air into syringe, insert needle into vial inject air and withdraw the solution

3. DOSAGE FORMS AND STRENGTHS

3.1.    2 ml glass vials

Each ingredient is attenuated according to the procedures stated in the Homeopathic Pharmacopeia of the United States.

Active ingredients:  Alumina 8X;  Anti interleukin 1 alpha 4C, Beta-Endorphin 4C, Bryonia alba 4X, Hamamelis virginiana 6X, Natrum sulphuricum 8X, Phosphoricum acidum 6X, Sepia 4X; Anti interleukin 1 beta 4C,  Intervertebral disk 4X.

Inactive ingredient: Sterile isotonic sodium chloride solution.

4. CONTRAINDICATIONS

4.1.    There is no history of hypersensitivity to GUNA®-LUMBAR. However patients with a known hypersensitivity to any ingredient should be tested before use, making a spot injection into one arm and be kept under observation for 1 hour.

5. WARNINGS AND PRECAUTIONS

5.1.    Spinal pain requires differential diagnosis for for musculoskeletal, neurological, and soft tissue pathologies including but not limited to: disck injuries, herniated disc, and referred pain from organ pathologies and primary or secondary cancer pain. Classification according to muscular pain, radicular nerve pain, skeletal pain, and osteoarticular pain should be made.

5.2.    Skin cleansing/disinfection is required before application. Saprophytic bacteria may produce injection site abscesses with improper skin preparation.

6. ADVERSE REACTIONS

6.1.    The most common mild adverse reaction is slight reddening at the injection site due to the mechanical effect of the needle or a superficial skin reaction of mild erythema.

7. DRUG INTERACTIONS

7.1.    None Known.

8. USE IN SPECIFIC POPULATIONS

8.1    Pregnancy:  Pregnancy  category  C.  Animal  reproduction  studies  have  not  been conducted  with  GUNA®-LUMBAR.  GUNA®- LUMBAR should  not  be  given  to  a pregnant woman. 

8.2    Nursing mothers:    It is not known whether any of the ingredients in GUNA®- LUMBAR  are  secreted  in  human milk.  However, since many drugs are secreted in human milk, caution should be exercised when GUNA®- LUMBAR is administered to a nursing woman. 8.3    Pediatric use: No restrictions.

8.4    Geriatric use: No restrictions.

9. DRUG ABUSE AND DEPENDENCE

9.1.    No Known.

10. OVERDOSAGE

10.1.    No Known.

11. DESCRIPTION

11.1.    GUNA®-LUMBAR is a sterile solution made with isotonic sodium chloride solution.

It is a homeopathic complex medicine, whose active ingredients have been selected in order to promote 2 main activities:

•    Detoxification of the connective tissue matrix

•    Pain modulation through stimulation of the physiological mechanism of pain control.

Attenuation of the biological substrates acts to target the area of activity of the product.

12. CLINICAL PHARMACOLOGY

12.1.    Mechanism of Action

Due to the homeopathic nature of the active ingredients, receptors may be activated by feedback regulation. Beta-endorphins at the 4C dose activate the membrane receptors for endogenous endorphins that play a key role in pain relief. Anti IL-1 induces a down regulation of IL-1 inflammatory activity.

12.2.    Pharmacodynamics

The physiological effects of GUNA®-LUMBAR are due to the action of the ingredients, as described in the Homeopathic Materia Medica.

In Homeopathy there is no direct relationship between dose and effect, but rather there is a relationship between attenuation and a balancing effect on biochemical pathways.

In GUNA®-LUMBAR the attenuation of each ingredient has been selected according to the Arndt-Schulz Principle (inverted effect law). The attenuation of the physiological ingredients promotes membrane receptor feedback in order to normalize altered biological pathways. In Addition the attenuation technique activates the low dilutions and stabilizes clinical activity of the compound.

12.3.    Pharmacokinetics

The homeopathic attenuation provides complete bioavailability of the active ingredients.

13. NONCLINICAL TOXICOLOGY

13.1.    GUNA®-LUMBAR has no level of toxicity due to the attenuation of the ingredients.

14. CLINICAL STUDIES

14.1.    GUNA®-LUMBAR formulation is based on classical Homeopathy and each ingredient has been selected according to its description in the Homeopathic Materia Medica. The product is intended for application to target points such as acupuncture points, Weihe points, and key neurological points.

Clinical indications of the key ingredients:

Anti interleukin 1 alpha 4C / Anti interleukin 1 beta 4C:

•    Biological classification: Interleukin 1 receptor antagonist (IL-1ra) belongs to the IL-1 family. Endogenous IL-1ra is produced in human autoimmune and chronic inflammatory diseases.

•    Etiopathogenesis: It binds to IL-1 receptors in competition with IL-1, but does not elicit intracellular response from this binding. Its key role is counteracting the proinflammatory effects of IL-1.

•    Space-time localization: It is near to Arnica. Reference group: Arnica-Mercurius.

•    Clinical: Immunological based diseases, autoimmune and chronic inflammatory diseases, acute and chronic pain, osteoarthritis, chronic arthritis, inflammatory psoriasis, wet eczema, localized inflammatory swelling. Appropriate for local application.

•    Modalities: It worsens with cold and movement. It improves with rest and warm.

•    Association with other cell mediators: TNF 15C / IL8 4C /

NT4 4C / GCSF 4C.

Beta- Endorphin 4C:

•    Biological classification: Neuropeptide  and neurotransmitter. It is produced by the  anterior lobe of the hypophysis  and by the hypothalamus.

•    Etiopathogenesis: It acts on the mechanism that enhances pain. It suppresses the memory of painful events and negative experiences.

•    Space-time localization: next to Arnica.

 Reference group: Mercurius.

•    Clinical: Pain management by enhancing the immune response. It acts on modulating pain, cardiac, gastric and vascular function as well as panic syndrome and satiation. Organic and functional pain. Remedy for somatization disorders. It enhances acupuncture sessions. Antidepressive activity. It may improve individual positive attitudes.

•    Modalities: Worsens with fatigue and intensive exercise.

•    Association with other cell mediators: Sepia / Arnica / Aconitum / Bromum / Aurum / Iodium / IL6 4C / Melatonin 15C, 30C, 12LM, 18LM, 30LM / NT4 4C / BDNF 4C.

15. REFERENCES

15.1.    I. Bianchi: Citochine e Interferoni. Farmacologia e Clinica. Nuova IPSA Editore.

15.2.    L. Milani: Weihe e altri Punti tra Agopuntura e Omeopatia. Guna Editore.

15.3.    J. Malzac: Materia Medica Immunologia. IPSA Editore.

15.4.    H.H. Reckeweg: Homeopathic Materia medica omeopatica. Aurelia Verlag.

16. HOW SUPPLIED/STORAGE AND HANDLING

16.1.    NDC  17089-287-31    10 glass vials packaged in carton box

16.2.    NDC  17089-287-32    50 glass vials packaged in carton box

16.3.    Store at room temperature, 20-25°C (68-77° F). Avoid  freezing  and  excessive  heat.

17. PATIENT COUNSELING INFORMATION

17.1.    Patients should be informed about Homeopathy and Acupuncture and the main differences with conventional clinical approaches.

PACKAGE LABEL

Guna-Lumbar  aluminum oxide - bryonia alba root - canakinumab - metenkefalin - natrum sulphuricum - phosphoric acid - sepia officinalis juice - sus scrofa intervertebral disk - witch hazel - anti-interleukin-1.alpha. immunoglobulin g rabbit -   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 17089-287 Route of Administration INTRADERMAL, SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALUMINUM OXIDE (ALUMINUM OXIDE) ALUMINUM OXIDE 8 [hp_X]  in 2 mL ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT (ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT) ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT 4 [hp_C]  in 2 mL CANAKINUMAB (CANAKINUMAB) CANAKINUMAB 4 [hp_C]  in 2 mL METENKEFALIN (METENKEFALIN) METENKEFALIN 4 [hp_C]  in 2 mL BRYONIA ALBA ROOT (BRYONIA ALBA ROOT) BRYONIA ALBA ROOT 4 [hp_X]  in 2 mL HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 6 [hp_X]  in 2 mL SUS SCROFA INTERVERTEBRAL DISK (SUS SCROFA INTERVERTEBRAL DISK) SUS SCROFA INTERVERTEBRAL DISK 4 [hp_X]  in 2 mL SODIUM SULFATE (SODIUM CATION) SODIUM SULFATE 8 [hp_X]  in 2 mL PHOSPHORIC ACID (PHOSPHORIC ACID) PHOSPHORIC ACID 6 [hp_X]  in 2 mL SEPIA OFFICINALIS JUICE (SEPIA OFFICINALIS JUICE) SEPIA OFFICINALIS JUICE 4 [hp_X]  in 2 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.018 mL  in 2 mL WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 17089-287-31 10 VIAL In 1 BOX contains a VIAL, GLASS 1 2 mL In 1 VIAL, GLASS This package is contained within the BOX (17089-287-31) 2 17089-287-32 50 VIAL In 1 BOX contains a VIAL, GLASS 2 2 mL In 1 VIAL, GLASS This package is contained within the BOX (17089-287-32)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/29/2006

Labeler - Guna spa (430538264)

Establishment
Name	Address	ID/FEI	Operations
Guna spa		430538264	manufacture

Revised: 06/2010Guna spa

Infex

Infex may be available in the countries listed below.

Ingredient matches for Infex

Clarithromycin

Clarithromycin is reported as an ingredient of Infex in the following countries:

• Chile


• Ecuador

Clindamycin

Clindamycin dihydrogen phosphate (a derivative of Clindamycin) is reported as an ingredient of Infex in the following countries:

• Colombia

International Drug Name Search

Benzodiazepine anticonvulsants

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Benzodiazepines enhance activation of GABA receptors and act as central nervous system depressants. They inhibit spread of discharge that causes seizures in epileptics.

Benzodiazepines are effective anticonvulsants but due to their sedative effect they are rarely used as maintenance therapy. Diazepam, a benzodiazepine, is given intravenously to treat status epilepticus, which can be a life threatening condition where seizures occur almost continuously.

See also

Medical conditions associated with benzodiazepine anticonvulsants:

• Alcohol Withdrawal
• Anxiety
• Benzodiazepine Withdrawal
• Bipolar Disorder
• Burning Mouth Syndrome
• Cervical Dystonia
• Dysautonomia
• Endoscopy or Radiology Premedication
• Hyperekplexia
• ICU Agitation
• Insomnia
• Lennox-Gastaut Syndrome
• Light Anesthesia
• Light Sedation
• Meniere's Disease
• Migraine Prevention
• Muscle Spasm
• Nausea/Vomiting
• Nausea/Vomiting, Chemotherapy Induced
• Night Terrors
• Panic Disorder
• Periodic Limb Movement Disorder
• Restless Legs Syndrome
• Sedation
• Seizure Prevention
• Seizures
• Status Epilepticus
• Temporomandibular Joint Disorder
• Tetanus

Drug List:

Diazepam-Intensol-Concentrate

Klonopin

Valium

Klonopin-Wafer-Orally-Disintegrating-Tablets

Ativan

Diastat-Gel

Lorazepam-Intensol

Diastat-Acudial-Gel

Diastat-Pediatric

Onfi

Valrelease

erythromycin ophthalmic

Generic Name: erythromycin ophthalmic (e RITH row MYE sin off THAL mik)

Brand names: Eyemycin, Roymicin, Ilotycin

What is erythromycin ophthalmic?

Erythromycin ophthalmic is an antibiotic.

Erythromycin ophthalmic (for the eyes) is used to treat bacterial infections of the eyes.

Erythromycin ophthalmic may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about erythromycin ophthalmic?

You should not use erythromycin ophthalmic if you are allergic to it, or if you have a viral or fungal infection in your eye. This medication is used to only treat infections caused by bacteria. Do not allow the tip of the tube to touch any surface, including your eyes or hands. If the tip becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Erythromycin ophthalmic will not treat a viral infection such as the common cold or flu.

Erythromycin ophthalmic may cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

Do not use other eye medications during treatment with erythromycin ophthalmic unless your doctor tells you to.

What should I discuss with my healthcare provider before using erythromycin ophthalmic?

You should not use erythromycin ophthalmic if you are allergic to it, or if you have a viral or fungal infection in your eye. This medication is used to only treat infections caused by bacteria. FDA pregnancy category B. Erythromycin ophthalmic is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether erythromycin 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 erythromycin ophthalmic?

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

Wash your hands before using the eye ointment.

To apply the ointment:

• 
  

  Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the ointment tube with the tip pointing toward this pocket. Look up and away from the tip.

  
  


• 
  

  Squeeze out a ribbon of ointment 1/2-inch long into the lower eyelid pocket without touching the tip of the tube to your eye. Look down and close your eyes for a few minutes. Rolling your eyes around gently will help spread the ointment evenly.

  
  


• 
  

  After opening your eyes, you may have blurred vision for a short time. Avoid driving or doing anything that requires you to be able to see clearly.

  
  

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

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Erythromycin ophthalmic will not treat a viral infection such as the common cold or flu.

Store at room temperature away from moisture and heat. Keep the tube tightly closed when not in use.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using erythromycin ophthalmic?

Erythromycin ophthalmic may cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

Do not use this medication while wearing contact lenses. Wait at least 15 minutes after using erythromycin ophthalmic before putting your contact lenses in.

Do not use other eye medications during treatment with erythromycin ophthalmic unless your doctor tells you to.

Erythromycin ophthalmic side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using erythromycin ophthalmic and call your doctor at once if you have severe burning, stinging, or other irritation after using the ointment.

Less serious side effects may include:

• 
  

  mild stinging or eye irritation;

  
  


• 
  

  mild itching or redness

  
  


• 
  

  blurred vision; or

  
  


• 
  

  increased sensitivity to light.

  
  

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 erythromycin ophthalmic?

It is not likely that other drugs you take orally or inject will have an effect on erythromycin ophthalmic used in the eyes. But many drugs can interact with each other. 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 erythromycin ophthalmic resources

• Erythromycin ophthalmic Use in Pregnancy & Breastfeeding
• Erythromycin ophthalmic Support Group
• 0 Reviews for Erythromycin - Add your own review/rating

• Ilotycin Advanced Consumer (Micromedex) - Includes Dosage Information


• ilotycin Prescribing Information (FDA)

Compare erythromycin ophthalmic with other medications

• Conjunctivitis, Bacterial

Where can I get more information?

• Your pharmacist can provide more information about erythromycin ophthalmic.