Infex may be available in the countries listed below.
Clarithromycin is reported as an ingredient of Infex in the following countries:
Clindamycin dihydrogen phosphate (a derivative of Clindamycin) is reported as an ingredient of Infex in the following countries:
International Drug Name Search
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.
Medical conditions associated with benzodiazepine anticonvulsants:
Generic Name: erythromycin ophthalmic (e RITH row MYE sin off THAL mik)
Brand names: Eyemycin, Roymicin, Ilotycin
Erythromycin ophthalmic is an antibiotic.
Erythromycin ophthalmic may also be used for purposes other than those listed in this medication guide.
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.
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.
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.
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.
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.
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.
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.
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.
Generic Name: erythromycin (Topical route)
e-rith-roe-MYE-sin
In the U.S.
In Canada
Available Dosage Forms:
Therapeutic Class: Antiacne
Chemical Class: Macrolide
Erythromycin belongs to the family of medicines called antibiotics. Erythromycin topical preparations are used on the skin to help control acne. They may be used alone or with one or more other medicines that are applied to the skin or taken by mouth for acne. They may also be used for other problems, such as skin infections, as determined by your doctor.
Erythromycin is available only with your doctor's prescription.
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:
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.
Erythromycin topical solution has been tested in children 12 years of age and older and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.
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. Although there is no specific information comparing use of topical erythromycin in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.
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.
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.
This section provides information on the proper use of a number of products that contain erythromycin. It may not be specific to Theramycin Z. Please read with care.
Before applying this medicine, thoroughly wash the affected area with warm water and soap, rinse well, and pat dry. After washing or shaving, it is best to wait 30 minutes before applying the pledget (swab), topical gel, or topical liquid form. The alcohol in them may irritate freshly washed or shaved skin.
For patients using the pledget (swab), topical gel, or topical liquid form of erythromycin:
This medicine will not cure your acne. However, to help keep your acne under control, keep using this medicine for the full time of treatment, even if your symptoms begin to clear up after a few days. You may have to continue using this medicine every day for months or even longer in some cases. If you stop using this medicine too soon, your symptoms may return. It is important that you do not miss any doses.
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.
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.
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.
If your acne does not improve within 3 to 4 weeks, or if it becomes worse, check with your health care professional. However, treatment of acne may take up to 8 to 12 weeks before you see full improvement.
For patients using the pledget (swab), topical gel, or topical liquid form of erythromycin:
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.
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:
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: Theramycin Z Topical side effects (in more detail)
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Generic Name: topical emollients (TOP i kal ee MOL i ents)
Brand Names: Aloe Vesta Cream, AlphaSoft, AmeriPhor, Aqua Glycolic, Aqua Lube, Aquaphor, Aveeno, Baby Lotion, Baby Oil, Bag Balm, Baza-Pro, Beta Care, Blistex Lip Balm, Carmex, CarraKlenz, CeraVe, CeraVe AM, Cetaphil Lotion, Chap Stick, Citraderm, CoolBottoms, Corn Huskers Lotion, Curel Moisture Lotion, Derma Soothe, Dr Scholl's Essentials Cracked Skin Repair, Eucerin, Herpecin-L, K-Y Jelly, Keri Lotion, Lamisilk Heel Balm, Lubri-Soft, Lubriderm, Mederma, Moisturel, Natural Ice, NeutrapHor, NeutrapHorus Rex, Neutrogena Cleansing, Neutrogena Lotion, Nivea, Nutraderm, Pacquin, Phisoderm, Pretty Feet & Hands, Proshield Skincare Kit, Remedy 4-in-1 Cleansing Lotion, Replens, Secura, Sensi-Care, Soft Sense, St. Ives, Theraplex Lotion, Vaseline Intensive Care
Emollients are substances that moisten and soften your skin.
Topical (for the skin) emollients are used to treat or prevent dry skin. Topical emollients are sometimes contained in products that also treat acne, chapped lips, diaper rash, cold sores, or other minor skin irritation.
There are many brands and forms of topical emollients available and not all are listed on this leaflet.
Topical emollients may also be used for purposes not listed in this medication guide.
Ask a doctor or pharmacist before using this medication if you have deep wounds or open sores, swelling, warmth, redness, oozing, bleeding, large areas of skin irritation, or any type of allergy.
Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:
deep wounds or open sores;
swelling, warmth, redness, oozing, or bleeding;
large areas of skin irritation;
any type of allergy; or
Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Clean the skin where you will apply the topical emollient. It may help to apply this product when your skin is wet or damp. Follow directions on the product label.
Apply a small amount of topical emollient to the affected area and rub in gently.
If you are using a stick, pad, or soap form of topical emollient, follow directions for use on the product label.
If your skin appears white or gray and feels soggy, you may be applying too much topical emollient or using it too often.
Store as directed away from moisture, heat, and light. Keep the bottle, tube, or other container tightly closed when not in use.
Since this product is used as needed, it does not have a daily dosing schedule. Seek medical advice if your condition does not improve after using a topical emollient.
Less serious side effects are more likely, and you may have none at all.
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.
It is not likely that other drugs you take orally or inject will have an effect on topically applied products. 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.
Tell your doctor you use Enoxaparin before you have any type of spinal puncture or epidural/spinal anesthesia. Patients who have these procedures while they use Enoxaparin are at risk for developing a blood clot on or near the spinal cord. This could result in long-term or permanent paralysis.
The risk is increased in patients who have an indwelling epidural catheter, traumatic or repeated epidural or spinal puncture, history of a deformed spine or spinal surgery, and in patients who use medicines that may affect blood clotting such as warfarin, aspirin, platelet inhibitors (eg, clopidogrel), and nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen).
If you have a spinal puncture or epidural/spinal anesthesia while you use Enoxaparin, tell your doctor immediately if you notice any signs or symptoms of nerve problems, such as numbness or tingling, muscle weakness, or paralysis.
Preventing blood clots in patients who have certain illnesses or who will be having certain types of surgery. It is also used along with other medicine to treat blood clots. It is also used along with other medicine to prevent certain problems caused by heart attack or unstable angina (chest pain). It is also used to decrease the risk of recurring heart attack in certain patients. It may also be used for other conditions as determined by your doctor.
Enoxaparin is a low molecular weight heparin (LMWH). It works by blocking the formation of blood clots.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Enoxaparin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Enoxaparin. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Enoxaparin 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.
Use Enoxaparin as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Enoxaparin.
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:
Diarrhea; mild pain, irritation, swelling, redness, bleeding, or bruising at the injection site; nausea.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody, black, or tarry stools; confusion; difficulty walking; fainting; fever; pale skin; pink or red urine; severe or persistent dizziness, tiredness, or weakness; swelling; tingling, numbness (especially in the legs and feet), and muscle weakness; unusual bleeding or bruising; vomit that looks like coffee grounds.
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: Enoxaparin side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bruising; excessive bleeding.
Store Enoxaparin at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Enoxaparin out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Enoxaparin. 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.
Generic Name: acetaminophen and diphenhydramine (a SEET a MIN oh fen and DYE fen HYE dra meen)
Brand Names: Anacin P.M. Aspirin Free, Coricidin Night Time Cold Relief, Excedrin PM, Excedrin PM Caplet, Excedrin PM Express Gels, Headache Relief PM, Legatrin PM, Mapap PM, Midol PM, Night Time Pain, Percogesic Extra Strength, Percogesic Original Strength, Tylenol Cold Relief Caplet, Tylenol Cold Relief Nighttime, Tylenol Cold Relief Nighttime Caplet, Tylenol Extra Strength PM, Tylenol Extra Strength PM Rapid Release Gelcaps, Tylenol Extra Strength PM Vanilla Caplet, Tylenol PM, Tylenol Sore Throat Nighttime, Unisom with Pain Relief
Acetaminophen is a pain reliever and fever reducer.
Diphenhydramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
The combination of acetaminophen and diphenhydramine is used to treat headache, fever, body aches, runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.
Acetaminophen and diphenhydramine may also be used for purposes not listed in this medication guide.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:
liver disease, cirrhosis, or a history of alcoholism;
a blockage in your digestive tract (stomach or intestines);
kidney disease;
cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;
enlarged prostate or urination problems;
low blood pressure; or
if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).
Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.
Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.
Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.
Overdose symptoms may also include severe forms of some of the side effects listed in this medication guide.
chest pain, rapid pulse, fast or uneven heart rate;
confusion, hallucinations, severe nervousness;
tremor, seizure (convulsions);
easy bruising or bleeding, unusual weakness;
urinating less than usual or not at all; or
nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes).
Less serious side effects may include:
dizziness, drowsiness;
mild headache;
dry mouth, nose, or throat;
constipation;
blurred vision;
feeling nervous; or
sleep problems (insomnia);
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.
Tell your doctor about all other medicines you use, especially:
leflunomide (Arava);
topiramate (Topamax);
zonisamide (Zonegran);
diphenhydramine (Benadryl) applied to the skin;
an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;
an antidepressant;
birth control pills or hormone replacement therapy;
bladder or urinary medications;
blood pressure medication;
a bronchodilator;
cancer medicine;
cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;
gout or arthritis medications (including gold injections);
HIV/AIDS medication;
medication for nausea and vomiting, stomach ulcers, or irritable bowel syndrome;
medicines to treat psychiatric disorders;
an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or
seizure medication.
This list is not complete and other drugs may interact with acetaminophen and diphenhydramine. 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.
See also: Unisom with Pain Relief side effects (in more detail)
Treating elevated pressure inside the eye in patients with open-angle glaucoma or ocular hypertension.
Azopt Drops are a carbonic anhydrase inhibitor. It works by decreasing the production of fluid inside the eye, thereby lowering pressure within the eye.
Contact your doctor or health care provider right away if this applies to you.
Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Azopt Drops. Because little, if any, of Azopt Drops are absorbed into the blood, the risk of it interacting with another medicine is low.
Ask your health care provider if Azopt Drops 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.
Use Azopt Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Azopt Drops.
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:
Bitter, sour, or unusual taste; blurred vision; discomfort, tearing, or dryness of the eyes when first applied; dry eyes; eye discharge; foreign body sensation in the eye; headache; inflammation of the eyelids; runny nose; swelling of the cornea.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); eye pain or itching; irritated eyelids.
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: Azopt side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Azopt Drops may be harmful if swallowed.
Store Azopt Drops at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Azopt Drops out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Azopt Drops. 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.
Generic Name: calcium carbonate (KAL see um KAR boe nate)
Brand Names: Alka-Mints, Cal-Gest, Calcarb, Calci Mix, Calci-Chew, Calci-Mix, Calcium Concentrate, Calcium Liquid Softgel, Calcium Oyster Shell, Caltrate, Chooz, Extra Strength Mylanta Calci Tabs, Icar Prenatal Chewable Calcium, Maalox Antacid Barrier, Maalox Childrens', Maalox Quick Dissolve, Maalox Quick Dissolve Maximum Strength, Maalox Regular Strength, Mylanta Child, Nephro Calci, Os-Cal 500, Oysco 500, Oyst Cal 500, Oyster Cal, Oyster Calcium, Oyster Shell, Pepto Children's, Rolaids Sodium Free, Rolaids Soft Chew, Titralac, Tums, Tums 500, Tums E-X, Tums Kids, Tums QuikPak, Tums Ultra
Calcium is a mineral that is found naturally in foods. Calcium is necessary for many normal functions of the body, especially bone formation and maintenance. Calcium can also bind to other minerals (such as phosphate) and aid in their removal from the body.
Calcium carbonate is used to prevent and to treat calcium deficiencies.
Calcium carbonate may also be used for purposes not listed in this medication guide.
To make sure you can safely take calcium carbonate, tell your doctor if you have any of these other conditions:
a history of kidney stones; or
a parathyroid gland disorder.
Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
The chewable tablet should be chewed before you swallow it.
Use the calcium carbonate powder as directed. Allow the powder to dissolve completely, then consume the mixture.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Overdose symptoms may include nausea, vomiting, decreased appetite, constipation, confusion, delirium, stupor, and coma.
Follow your healthcare provider's instructions about any restrictions on food, beverages, or activity.
Less serious side effects may include:
nausea or vomiting;
decreased appetite;
constipation;
dry mouth or increased thirst; or
urinating more than usual.
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.
Calcium carbonate can make it harder for your body to absorb other medications you take by mouth. Tell your doctor if you are taking:
digoxin (Lanoxin, Lanoxicaps);
antacids or other calcium supplements;
calcitriol (Rocaltrol) or vitamin D supplements; or
doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).
This list is not complete and other drugs may interact with calcium carbonate. 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.
See also: Calcarb side effects (in more detail)
Class: Antineoplastic Agents
VA Class: AN900
Chemical Name: (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R) - 1,18 - Dihydroxy - 12 - [(1R) - 2 - [(1S,3R,4R) - 4 - (2 - hydroxyethoxy) - 3 - methoxycyclohexyl] - 1 - methylethyl] - 19,30 - dimethoxy - 15,17,21,23,29,35 - hexamethyl - 11,36 - dioxa - 4 - azatricyclo[30.3.1.04,9]hexatriaconta - 16,24,26,28 - tetraene - 2,3,10,14,20 - pentaone
Molecular Formula: C53H83NO14
CAS Number: 159351-69-6
Brands: Afinitor
REMS:
FDA approved a REMS for everolimus to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of everolimus and consists of the following: medication guide and communication plan. See the FDA REMS page () or the ASHP REMS Resource Center ().
Antineoplastic agent; inhibitor of mammalian target of rapamycin (mTOR) kinase.1 2 3 4 5 7 8 9 10 11
Treatment of advanced renal cell carcinoma following failure of sunitinib and/or sorafenib therapy.1 2 3
Improves median progression-free survival;1 3 effects on overall survival remain to be established.12
Administer orally once daily1 2 3 at the same time every day with or without food.1
Swallow everolimus tablets whole with a glass of water; do not chew or crush.1
10 mg once daily.1
Continue therapy for as long as patient derives benefit from the drug or until unacceptable toxicity occurs.1
Consider dosage adjustments when used in conjunction with potent inducers of CYP3A4.1 (See Interactions.)
Temporarily interrupt therapy or reduce everolimus dosage to 5 mg once daily if severe and/or intolerable adverse effects (e.g., noninfectious pneumonitis, invasive fungal infection) occur.1
Patients with radiographic changes suggestive of noninfectious pneumonitis who have few or no symptoms: Continue everolimus therapy without any dosage adjustment.1
Patients experiencing moderate respiratory symptoms: Consider interrupting everolimus therapy and initiating corticosteroids (as indicated) until symptoms improve; when therapy is resumed, reduce everolimus dosage to 5 mg once daily.1
Patients experiencing severe respiratory symptoms: Discontinue everolimus therapy and initiate corticosteroids (as indicated) until clinical symptoms resolve; when therapy is resumed, reduce everolimus dosage to 5 mg once daily based on individual clinical assessment.1
Discontinue everolimus and initiate appropriate antifungal therapy.1
Moderate (Child-Pugh class B) hepatic impairment: Decrease dosage to 5 mg daily.1
Severe (Child-Pugh class C) hepatic impairment: Use not recommended.1 (See Hepatic Impairment under Precautions.)
Dosage adjustment not required.1
Dosage adjustment not required.1
Known hypersensitivity to everolimus, other rapamycin derivatives (e.g., sirolimus, temsirolimus), or any ingredient in the formulation.1
Anaphylaxis, dyspnea, flushing, chest pain, or angioedema (e.g., swelling of the airways or tongue, with or without respiratory impairment) reported with everolimus and other rapamycin derivatives.1
Potentially severe or fatal noninfectious pneumonitis reported.1
Consider the diagnosis of noninfectious pneumonitis in patients presenting with nonspecific respiratory signs and symptoms (e.g., hypoxia, pleural effusion, cough, dyspnea) and in whom other causes (e.g., infection, cancer) have been excluded.1
If moderate or severe symptoms of noninfectious pneumonitis develop, temporarily interrupt therapy and reduce subsequent dosage.1 (See Dosage Modification for Toxicity under Dosage and Administration.)
Immunosuppression may occur and may predispose patients to infections, particularly opportunistic infections.1 Potentially severe or fatal localized and systemic infections (e.g., pneumonia, other bacterial infections, invasive aspergillosis or candidiasis) reported.1
Monitor vigilantly for signs and symptoms of infection and institute appropriate treatment.1 If invasive systemic fungal infection occurs, discontinue everolimus and initiate appropriate antifungal therapy.1 Complete treatment of a preexisting invasive fungal infection prior to initiating therapy with everolimus.1
Avoid use of live vaccines and close contact with individuals who have received live vaccines.1
Mouth ulcers, stomatitis, and oral mucositis, mostly grade 1 and 2, reported.1
Topical therapy recommended if oral ulceration occurs.1 Avoid alcohol- or peroxide-containing mouthwashes because they may exacerbate the condition.1 Do not use topical preparations containing an antifungal agent unless fungal infection has been diagnosed.1
Increases in Scr concentrations, usually mild, reported.1 2 Acute renal failure also reported.1
Monitor renal function (e.g., BUN, Scr) prior to and periodically during therapy.1
Hyperglycemia reported.1 2 6
Monitor fasting glucose concentrations prior to and periodically during therapy.1 When possible, achieve optimal glycemic control prior to initiation of everolimus therapy.1
Hyperlipidemia (e.g., hypercholesterolemia, hypertriglyceridemia) reported.1 2 6
Monitor serum lipids prior to and periodically during therapy.1 When possible, achieve optimal lipid control prior to initiation of therapy.1
Anemia, lymphopenia, neutropenia, and thrombocytopenia reported.1 2 6 Monitor CBC prior to and periodically during therapy.1
Concomitant use with certain drugs (e.g., moderate or potent inhibitors of CYP3A4) or foods (e.g., grapefruit juice) is not recommended or requires adjustment of everolimus dosage (e.g., potent inducers of CYP3A4).1 (See Interactions.)
May cause fetal harm; teratogenicity and embryolethality demonstrated in animals.1 No adequate and well-controlled studies in humans.1 12
Women of childbearing potential should use an effective method of contraception during and for up to 8 weeks following discontinuance of therapy.1
If used during pregnancy or if patient becomes pregnant occurs, apprise of potential fetal hazard.1
Monitor fasting glucose and lipid profiles, CBC, and renal function tests prior to and periodically during therapy.1
Category D.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
Distributed into milk in rats; not known whether distributed into human milk.1 Discontinue nursing or the drug, taking into account the importance of the drug to the woman.1
Safety and efficacy not established in children <18 years of age.1
No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.1
Not studied in patients with severe (Child-Pugh class C) hepatic impairment; use not recommended.1
Dosage adjustment recommended for patients with moderate (Child-Pugh class B) hepatic impairment.1 (See Special Populations under Dosage and Administration)
Safety and efficacy in patients with renal impairment not studied specifically to date.1 (See Special Populations under Pharmacokinetics: Elimination.)
Stomatitis,1 2 3 infections,1 2 asthenia,1 2 3 fatigue,1 2 3 diarrhea,1 2 3 cough,1 2 rash,1 2 3 6 nausea,1 2 peripheral edema,1 anorexia,1 2 dyspnea,1 2 vomiting,1 2 pyrexia,1 mucosal inflammation,1 2 headache,1 epistaxis,1 pneumonitis,1 2 pruritus,1 dry skin,1 2 dysgeusia,1 pain in extremity.1
Metabolized principally by CYP3A4; competitive inhibitor of CYP3A4 and mixed inhibitor of CYP2D6 in vitro.1 Also a substrate and moderate inhibitor of the efflux transporter P-glycoprotein.1
CYP3A4 inhibitors: Potential pharmacokinetic interaction (increased peak plasma concentrations and AUC of everolimus).1 Avoid concomitant use with potent or moderately potent CYP3A4 inhibitors.1 (See Specific Drugs and Foods under Interactions.)
CYP3A4 inducers: Potential pharmacokinetic interaction (decreased peak plasma concentrations and AUC of everolimus).1 Avoid concomitant use with potent CYP3A4 inducers; if concomitant use cannot be avoided, consider an increase in everolimus dosage.1 (See Specific Drugs and Foods under Interactions.)
Substrates of CYP3A4 and CYP2D6: Pharmacokinetic interaction unlikely.1
Inhibitors of P-glycoprotein: Potential pharmacokinetic interaction (increased peak plasma concentrations and AUC of everolimus).1 Avoid concomitant use with P-glycoprotein inhibitors.1
Inducers of P-glycoprotein: Potential pharmacokinetic interaction.1 If concomitant use with potent P-glycoprotein inducers cannot be avoided, consider an increase in everolimus dosage.1
Drug | Interaction | Comments |
|---|---|---|
Anticonvulsants (carbamazepine, phenobarbital, phenytoin) | Decreased plasma everolimus concentrations1 | Avoid concomitant use; if concomitant use cannot be avoided, increase everolimus dosage from 10 to 20 mg daily (titrated in 5-mg increments); if potent CYP3A4 inducer is discontinued, reduce everolimus dosage to the usual recommended dosage1 12 |
Antifungals, azole (fluconazole, ketoconazole, itraconazole, voriconazole) | Increased plasma everolimus concentrations1 | Avoid concomitant use1 |
Antimycobacterials, rifamycins (rifabutin, rifampin) | Decreased plasma everolimus concentrations1 | Avoid concomitant use; if concomitant use cannot be avoided, increase everolimus dosage from 10 to 20 mg daily (titrated in 5-mg increments); if potent CYP3A4 inducer is discontinued, reduce everolimus dosage to the usual recommended dosage1 12 |
Aprepitant | Increased plasma everolimus concentrations1 | Avoid concomitant use1 |
Calcium-channel blocking agents (diltiazem, verapamil) | Increased plasma everolimus concentrations1 | Avoid concomitant use1 |
Delavirdine | Increased plasma everolimus concentrations1 | Avoid concomitant use1 |
Dexamethasone | Decreased plasma everolimus concentrations1 | Avoid concomitant use; if concomitant use cannot be avoided, increase everolimus dosage from 10 to 20 mg daily (titrated in 5-mg increments); if potent CYP3A4 inducer is discontinued, reduce everolimus dosage to the usual recommended dosage1 12 |
Grapefruit juice | Increased plasma everolimus concentrations1 | Avoid concomitant use1 |
HIV protease inhibitors (amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir) | Increased plasma everolimus concentrations1 | Avoid concomitant use1 |
HMG-CoA reductase inhibitors (atorvastatin, pravastatin, simvastatin) | Pharmacokinetic interaction unlikely1 | |
Macrolide antibiotics (clarithromycin, erythromycin, telithromycin) | Increased plasma everolimus concentrations1 | Avoid concomitant use1 |
Nefazodone | Increased plasma everolimus concentrations1 | Avoid concomitant use1 |
Vaccines | Possible decreased immune response to vaccination1 | Avoid use of live vaccines1 |
Peak everolimus concentrations attained within 1–2 hours following oral administration of doses ranging from 5–70 mg in patients with advanced solid tumors.1
Increases in peak plasma concentrations dose-proportional following single doses of 5–10 mg.1 4 10 Increases in peak plasma concentrations less than dose-proportional following single doses of ≥20 mg;1 4 10 considered unlikely to be clinically important.10 Increases in AUC dose-proportional over dosage range of 5–70 mg.1
Steady-state concentrations achieved within 2 weeks of once-daily dosing.1
Administration of 10 mg tablet with a high-fat meal in healthy individuals reduced peak plasma concentrations and AUC of everolimus by 54 and 22%, respectively; light fat meals reduced peak plasma concentrations and AUC of everolimus by 42 and 32%, respectively.a However, food had no apparent effect on the post absorption phase concentration-time profile.a
Crosses the placenta and is distributed into milk in rats.1
Approximately 74%.1
Moderate hepatic impairment does not alter plasma protein binding.1
Metabolized by CYP3A4 to inactive metabolites;1 10 12 also a substrate for P-glycoprotein.1
Excreted in feces (80%) and urine (5%) as inactive metabolites.1 12
Approximately 30 hours.1 4
Moderate hepatic impairment increases AUC twofold.1
No significant correlation between Clcr (range: 25–178 mL/minute) and everolimus clearance; renal impairment not expected to influence drug exposure.1
Higher exposure to everolimus among Japanese patients compared with non-Japanese patients.1 However, relevance to safety and efficacy of everolimus in Japanese patients not established.1
Clearance is 20% higher in black patients than in Caucasian patients.1 However, relevance to safety and efficacy of everolimus in black patients not established.1
Original container at 25°C (may be exposed to 15–30°C); protect from light and moisture.1
Inhibits mammalian target of rapamycin (mTOR) kinase.1 2 3 4 5 7 8 9 10 11
Binds with high affinity to the intracellular protein FK506 binding protein-12 (FKBP-12), forming a drug-protein complex that inhibits the activation of mTOR.1 2 5 6 9 10
Disruption of mTOR reduces the activity of downstream effectors (i.e., S6 ribosomal protein kinase [S6K1], eukaryotic elongation factor 4E-binding protein [4E-BP1]), thereby blocking progression of cells from G1 into S phase and, subsequently, inducing cell growth arrest and apoptosis.4 6 9 10 11
Also inhibits expression of hypoxia-inducible factor (e.g., HIF-1α), thereby reducing the expression of vascular endothelial growth factor (VEGF).1 7 9
Reduces cell proliferation, angiogenesis, and glucose uptake in vitro and/or in vivo.1 5 10
Importance of providing patient a copy of manufacturer’s patient information.1
Importance of taking everolimus tablets as directed; take at the same time each day, swallowing the tablets whole with a glass of water.1
If a dose of everolimus is missed by ≤6 hours, take dose as soon as it is remembered, and take the next dose at the regularly scheduled time; if a dose is missed by >6 hours, omit the dose and take the next dose at the regularly scheduled time.1 Do not take a double dose to make up for a missed dose.1
Importance of informing patients about risks, including serious allergic reactions (e.g., anaphylaxis), noninfectious pneumonitis, and increased susceptibility to infection.1 Importance of patients promptly reporting any facial swelling,12 new or worsening respiratory symptoms (e.g., cough, shortness of breath, difficulty breathing, wheezing), or any signs or symptoms of infection (e.g., fever, chills).1
Risk of mouth ulcers, stomatitis, or oral mucositis.1 Importance of reporting any signs or symptoms of oral ulceration (e.g., pain, discomfort, or open sores in the mouth).1 Use of mouthwashes and/or topical treatments is recommended; however, avoid alcohol- or peroxide-containing preparations.1
Risk of increased blood glucose, triglyceride, and/or cholesterol concentrations; risk of adverse renal and hematologic effects.1 Fasting glucose and lipid profiles, CBC, and renal function tests are required; importance of adherence to laboratory appointment schedules.1
Importance of avoiding use of live vaccines and close contact with those who have received live vaccines.1
Importance of avoiding grapefruit juice during everolimus therapy.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal products (e.g., St. John's wort), as well as any concomitant illnesses (e.g., hepatic impairment, diabetes mellitus or hyperglycemia, hyperlipidemia).1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed; necessity for clinicians to advise women of childbearing potential to avoid pregnancy and to use effective contraceptive methods during therapy and for 8 weeks following discontinuance of therapy.1
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 5 mg | Afinitor | Novartis |
10 mg | Afinitor | Novartis |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Zortress 0.25MG Tablets (NOVARTIS): 30/$195.99 or 90/$555.97
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
1. Novartis Pharmaceuticals Inc. Afinitor (everolimus) tablets prescribing information. East Hanover, NJ: 2009 Mar.
2. Motzer RJ, Escudier B, Oudard S et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet. 2008; 372:449-56. [PubMed 18653228]
3. Kay A, Motzer R, Figlin R, et al. Updated data from a phase III randomized trial of everolimus (RAD001) versus PBO in metastatic renal cell carcinoma (mRCC). Abstract No. 278. Presented at ASCO Genitourinary Symposium, Orlando FL, 28 Mar 2009.
4. Dasanu CA, Clark BA, Alexandrescu DT et al. mTOR-blocking agents in advanced renal cancer: an emerging therapeutic option. Expert Opin Investig Drugs. 2009; 18:175-87. [PubMed 19236264]
5. Tanaka C, O'Reilly T, Kovarik JM et al. Identifying optimal biologic doses of everolimus (RAD001) in patients with cancer based on the modeling of preclinical and clinical pharmacokinetic and pharmacodynamic data. J Clin Oncol. 2008; 26:1596-602. [PubMed 18332467]
6. Hudes GR. Targeting mTOR in renal cell carcinoma. Cancer. 2009; 115:2313-2320. [PubMed 19402072]
7. Motzer RJ, Bukowski RM. Targeted therapy for metastatic renal cell carcinoma. J Clin Oncol. 2006; 24:5601-8. [PubMed 17158546]
8. Atkins MB, Ernstoff MS, Figlin RA et al. Innovations and challenges in renal cell carcinoma: summary statement from the Second Cambridge Conference. Clin Cancer Res. 2007; 13:667s-670s. [PubMed 17255291]
9. Cho D, Signoretti S, Regan M et al. The role of mammalian target of rapamycin inhibitors in the treatment of advanced renal cancer. Clin Cancer Res. 2007; 13:758s-763s. [PubMed 17255306]
10. O'Donnell A, Faivre S, Burris HA et al. Phase I pharmacokinetic and pharmacodynamic study of the oral mammalian target of rapamycin inhibitor everolimus in patients with advanced solid tumors. J Clin Oncol. 2008; 26:1588-95. [PubMed 18332470]
11. Reddy GK, Mughal TI, Rini BI. Current data with mammalian target of rapamycin inhibitors in advanced-stage renal cell carcinoma. Clin Genitourin Cancer. 2006; 5:110-3. [PubMed 17026798]
12. Novartis Pharmaceuticals Corporation, East Hanover, NJ: Personal communication.
a. Novartis Pharmaceuticals Inc. Afinitor (everolimus) tablets prescribing information. East Hanover, NJ: 2010 May.
