Cabergolin dura

Cabergolin dura may be available in the countries listed below.

Ingredient matches for Cabergolin dura

Cabergoline

Cabergoline is reported as an ingredient of Cabergolin dura in the following countries:

• Germany

International Drug Name Search

Ibuprofeno Lafedar

Ibuprofeno Lafedar may be available in the countries listed below.

Ingredient matches for Ibuprofeno Lafedar

Ibuprofen

Ibuprofen is reported as an ingredient of Ibuprofeno Lafedar in the following countries:

• Argentina

International Drug Name Search

Conclyte-A

Conclyte-A may be available in the countries listed below.

Ingredient matches for Conclyte-A

Ammonium Chloride

Ammonium Chloride is reported as an ingredient of Conclyte-A in the following countries:

• Japan

International Drug Name Search

Tau Kit

Tau Kit may be available in the countries listed below.

Ingredient matches for Tau Kit

Urea

Urea ?1?3C (a derivative of Urea) is reported as an ingredient of Tau Kit in the following countries:

• Spain

International Drug Name Search

Cefraden

Cefraden may be available in the countries listed below.

Ingredient matches for Cefraden

Ceftriaxone

Ceftriaxone disodium salt (a derivative of Ceftriaxone) is reported as an ingredient of Cefraden in the following countries:

• Mexico

International Drug Name Search

Prosma

Prosma may be available in the countries listed below.

Ingredient matches for Prosma

Ketotifen

Ketotifen fumarate (a derivative of Ketotifen) is reported as an ingredient of Prosma in the following countries:

• Bangladesh

International Drug Name Search

Chino

Chino may be available in the countries listed below.

Ingredient matches for Chino

Chenodeoxycholic Acid

Chenodeoxycholic Acid is reported as an ingredient of Chino in the following countries:

• Japan

International Drug Name Search

Alrex

Generic Name: loteprednol ophthalmic (lo te PRED nol off THAL mik)

Brand Names: Alrex, Lotemax

What is Alrex (loteprednol ophthalmic)?

Loteprednol is in a group of drugs called corticosteroids. It prevents the release of substances in the body that cause inflammation.

Loteprednol ophthalmic (for the eye) is used to treat eye swelling caused by surgery, infection, allergies, and other conditions.

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

What is the most important information I should know about Alrex (loteprednol ophthalmic)?

Do not use this medication while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using loteprednol before putting your contact lenses in. Do not allow the dropper to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye. Stop using loteprednol and call your doctor at once if you have signs of a new eye infection such as swelling, redness, irritation, or drainage, or if you have problems with your vision, or severe pain, burning, or stinging when you use the eye drops. Call your doctor if your symptoms do not improve after 2 days of treatment.

What should I discuss with my healthcare provider before using Alrex (loteprednol ophthalmic)?

You should not use this medication if you are allergic to loteprednol, or if you have any type of fungal, viral, or bacterial infection of your eye.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• 
  

  glaucoma;

  
  


• 
  

  cataracts (or if you have recently had cataract surgery); or

  
  


• 
  

  herpes infection of your eye.

  
  

FDA pregnancy category C. It is not known whether loteprednol is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether loteprednol 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 Alrex (loteprednol ophthalmic)?

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

Do not use this medication for longer than 2 weeks unless your doctor tells you to.

Wash your hands before using the eye drops.

Shake the eye drops well just before each use.

To apply the eye drops:

• 
  

  Tilt your head back slightly and pull down on the lower eyelid. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper. Squeeze out a drop and close your eye.

  
  


• 
  

  Gently press your finger to the inside corner of the eye (near the nose) for about 1 minute to keep the liquid from draining into your tear duct.

  
  

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

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

Call your doctor if your symptoms do not improve after 2 days of treatment.

To be sure loteprednol is not causing harmful effects, your vision may need to be checked after using the medication for 10 days or longer. Do not miss any scheduled visits to your doctor.

Store loteprednol ophthalmic with the cap on at room temperature, away from moisture and heat. Do not use the eye drops if the liquid changes colors or has particles in it. Call your doctor for a new prescription.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of loteprednol ophthalmic is not likely to cause life-threatening symptoms.

What should I avoid while using Alrex (loteprednol ophthalmic)?

Avoid using other medications in your eyes during treatment with loteprednol ophthalmic unless your doctor has told you to.

Alrex (loteprednol ophthalmic) side effects

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

• 
  

  signs of a new eye infection such as swelling, redness, irritation, or drainage;

  
  


• 
  

  problems with your vision; or

  
  


• 
  

  severe pain, burning or stinging when using the eye drops.

  
  

Less serious side effects may include:

• 
  

  minor burning when using the eye drops;

  
  


• 
  

  dry, red, itchy, or watery eyes;

  
  


• 
  

  feeling that something is in your eye;

  
  


• 
  

  being more sensitive to light;

  
  


• 
  

  headache; or

  
  


• 
  

  runny nose, sore throat.

  
  

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 Alrex (loteprednol ophthalmic)?

It is not likely that other drugs you take orally or inject will have an effect on loteprednol used in the eyes. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Alrex resources

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

• Alrex Prescribing Information (FDA)


• Alrex Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Alrex Advanced Consumer (Micromedex) - Includes Dosage Information


• Lotemax Prescribing Information (FDA)


• Lotemax Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Alrex with other medications

• Conjunctivitis
• Cyclitis
• Iritis
• Keratitis
• Postoperative Ocular Inflammation
• Rosacea
• Seasonal Allergic Conjunctivitis

Where can I get more information?

• Your pharmacist can provide more information about loteprednol ophthalmic.

See also: Alrex side effects (in more detail)

Betamethasone Valerate Foam

Pronunciation: bay-ta-METH-a-sone VAL-eh-rate
Generic Name: Betamethasone Valerate
Brand Name: Luxiq

Betamethasone Valerate Foam is used for:

Reducing itching, redness, and swelling associated with skin conditions of the scalp. It may also be used for other conditions as determined by your doctor.

Betamethasone Valerate Foam is a topical corticosteroid. It works by depressing the formation, release, and activity of different cells and chemicals that cause swelling, redness, and itching.

Do NOT use Betamethasone Valerate Foam if:

• you are allergic to any ingredient in Betamethasone Valerate Foam or to another corticosteroid (eg, prednisone)

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

Before using Betamethasone Valerate Foam:

Some medical conditions may interact with Betamethasone Valerate Foam. 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 thinning of the skin, a skin infection, tuberculosis, chickenpox, shingles, measles, a positive TB skin test, or have recently been vaccinated

Some MEDICINES MAY INTERACT with Betamethasone Valerate Foam. Because little, if any, of Betamethasone Valerate Foam is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Betamethasone Valerate Foam 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 Betamethasone Valerate Foam:

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

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


• Before using for the first time, break the tiny plastic piece at the base of the can's rim by gently pushing back (away from the piece) on the nozzle.


• Turn the can upside down and dispense a small amount of Betamethasone Valerate Foam onto a clean saucer or other cool, clean surface. Do not dispense directly onto your hands because the foam will begin to melt immediately upon contact with warm skin.


• Pick up small amounts of foam with fingers and gently massage into the affected area until foam disappears. Repeat until entire affected area has been treated. Use only enough to cover the entire affected area.


• When applying, move the hair away so that the foam can be applied directly to the affected skin.


• Wash your hands immediately after using Betamethasone Valerate Foam.


• Throw away any unused medicine that has been dispensed from the container.


• Do not wash or rinse the treated areas immediately after applying Betamethasone Valerate Foam.


• Do not cover the treating area with bandages, wrappings, or other dressings unless advised to do so by your health care provider.


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

Ask your health care provider any questions you may have about how to use Betamethasone Valerate Foam.

Important safety information:

• Betamethasone Valerate Foam is for external use only. Avoid contact with the eyes. If you get Betamethasone Valerate Foam in your eyes, immediately flush with cool tap water.


• If your symptoms do not get better within 2 weeks or if they get worse, check with your doctor.


• Do not use Betamethasone Valerate Foam for other skin conditions at a later time.


• Betamethasone Valerate Foam has a corticosteroid in it. Before you start any new medicine, check the label to see if it has a corticosteroid in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Check with your doctor before you have any vaccinations while you are using Betamethasone Valerate Foam.


• Betamethasone Valerate Foam is flammable. Do not store or use near a fire or other open flame, or while you are smoking.


• Dispose of empty containers as directed on the container or by your health care provider. Do not puncture or burn container even if it appears to be empty.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Betamethasone Valerate Foam.


• Betamethasone Valerate Foam should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


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

Possible side effects of Betamethasone Valerate Foam:

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:

Dry skin; mild, temporary stinging when applied.

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); acne-like rash; burning, cracking, irritation, or peeling not present before you began using Betamethasone Valerate Foam; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

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

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.

Proper storage of Betamethasone Valerate Foam:

Store Betamethasone Valerate Foam between 68 and 77 degrees F (20 and 25 degrees C). Avoid temperatures above 120 degrees F (40 degrees C). Store away from heat, moisture, and light. Do not freeze. Keep Betamethasone Valerate Foam out of the reach of children and away from pets.

General information:

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


• Betamethasone Valerate Foam 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 Betamethasone Valerate Foam. 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 Betamethasone Valerate resources

• Betamethasone Valerate Use in Pregnancy & Breastfeeding
• Betamethasone Valerate Drug Interactions
• Betamethasone Valerate Support Group
• 13 Reviews for Betamethasone Valerate - Add your own review/rating

Compare Betamethasone Valerate with other medications

• Atopic Dermatitis
• Dermatitis
• Dermatological Disorders
• Lichen Planus
• Lichen Sclerosus

Carbocisteina Francia

Carbocisteina Francia may be available in the countries listed below.

Ingredient matches for Carbocisteina Francia

Carbocisteine

Carbocisteine is reported as an ingredient of Carbocisteina Francia in the following countries:

• Italy

International Drug Name Search

Krimizole

Krimizole may be available in the countries listed below.

Ingredient matches for Krimizole

Albendazole

Albendazole is reported as an ingredient of Krimizole in the following countries:

• Bangladesh

International Drug Name Search

Apracal

Apracal may be available in the countries listed below.

Ingredient matches for Apracal

Haloperidol

Haloperidol is reported as an ingredient of Apracal in the following countries:

• Colombia

International Drug Name Search

Cotenolol-Mepha-Neo

Cotenolol-Mepha-Neo may be available in the countries listed below.

Ingredient matches for Cotenolol-Mepha-Neo

Atenolol

Atenolol is reported as an ingredient of Cotenolol-Mepha-Neo in the following countries:

• Switzerland

Chlortalidone

Chlortalidone is reported as an ingredient of Cotenolol-Mepha-Neo in the following countries:

• Switzerland

International Drug Name Search

Venlafaxina Combix

Venlafaxina Combix may be available in the countries listed below.

Ingredient matches for Venlafaxina Combix

Venlafaxine

Venlafaxine hydrochloride (a derivative of Venlafaxine) is reported as an ingredient of Venlafaxina Combix in the following countries:

• Spain

International Drug Name Search

Calfalead

Calfalead may be available in the countries listed below.

Ingredient matches for Calfalead

Alfacalcidol

Alfacalcidol is reported as an ingredient of Calfalead in the following countries:

• Japan

International Drug Name Search

Flusporan

Flusporan may be available in the countries listed below.

Ingredient matches for Flusporan

Flutrimazole

Flutrimazole is reported as an ingredient of Flusporan in the following countries:

• Costa Rica


• Dominican Republic


• El Salvador


• Guatemala


• Honduras


• Nicaragua


• Panama


• Spain

International Drug Name Search

Cortos

Cortos may be available in the countries listed below.

Ingredient matches for Cortos

Ambroxol

Ambroxol hydrochloride (a derivative of Ambroxol) is reported as an ingredient of Cortos in the following countries:

• Argentina

International Drug Name Search

Citrex

Citrex may be available in the countries listed below.

Ingredient matches for Citrex

Citalopram

Citalopram hydrobromide (a derivative of Citalopram) is reported as an ingredient of Citrex in the following countries:

• Turkey

International Drug Name Search

Cal-Sup

Cal-Sup may be available in the countries listed below.

Ingredient matches for Cal-Sup

Calcium Carbonate

Calcium Carbonate is reported as an ingredient of Cal-Sup in the following countries:

• Australia

International Drug Name Search

Maxiflu CD

Pronunciation: SOO-doe-e-FED-rin/KOE-deen/gwye-FEN-e-sin/a-SEET-a-MIN-oh-fen
Generic Name: Pseudoephedrine/Codeine/Guaifenesin/Acetaminophen
Brand Name: Examples include Maxiflu CD and Maxiflu CDX

Maxiflu CD contains acetaminophen. Severe and sometimes fatal liver problems, including the need for liver transplant, have been reported with the use of acetaminophen. Most cases of these liver problems occurred in patients taking excessive doses of acetaminophen (more than 4,000 mg per day). Also, patients who developed these liver problems were often using more than 1 medicine that contained acetaminophen. Discuss any questions or concerns with your doctor.

Maxiflu CD is used for:

Relieving pain, congestion, cough, fever, and throat and airway irritation due to respiratory tract infections and other related conditions. It may also be used for other conditions as determined by your doctor.

Maxiflu CD is a decongestant, narcotic cough suppressant, expectorant, and analgesic combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The expectorant works by loosening mucus and lung secretions in the chest, making coughs more productive. The cough suppressant works in the brain to help decrease the cough reflex. The analgesic works in the brain to reduce pain and fever.

Do NOT use Maxiflu CD if:

• you are allergic to any ingredient in Maxiflu CD


• you are breast-feeding


• you have severe or uncontrolled high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)


• you have an enlarged prostate


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

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

Before using Maxiflu CD:

Some medical conditions may interact with Maxiflu CD. 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 had an allergic reaction to any other codeine- or morphine-related medicine (eg, oxycodone, dihydrocodeine, hydromorphone)


• if you have a history of glaucoma or increased pressure in the eye; heart problems, (eg, cor pulmonale; fast, slow, or irregular heartbeat; heart disease); diabetes; high or low blood pressure; blood vessel problems (eg, in the brain, in the heart); adrenal gland problems (eg, Addison disease, pheochromocytoma); mental or mood problems (eg, depression); prostate problems; stomach or bowel problems (eg, inflammatory bowel disease, ulcerative colitis, ulcers); seizures; stroke; liver problems (eg, hepatitis); kidney problems; thyroid problems; trouble sleeping; or recent stomach, bowel, or urinary surgery


• if you have a history of asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea, slow or irregular breathing), or chronic cough, or if your cough occurs with large amounts of mucus


• if you have severe drowsiness, increased pressure in the brain, an unusual growth in the brain (eg, tumor), a recent head or brain injury, or infection of the brain or nervous system


• if you have difficulty urinating; low blood volume; a certain bowel problem (pseudomembranous colitis); stomach pain; constipation; a blockage of your bladder, stomach, or bowels; or poor health


• if you are very overweight or are dehydrated


• if you drink alcohol, or you have a history of alcohol or drug abuse or dependence, or suicidal thoughts or behaviors


• if you take medicine for high blood pressure or depression

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

• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Beta-blockers (eg, propranolol), furazolidone, indomethacin, linezolid, MAOIs (eg, phenelzine), tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, sodium bicarbonate) because they may increase the risk of Maxiflu CD's side effects


• Anticoagulants (eg, warfarin) or bromocriptine because the risk of their side effects may be increased by Maxiflu CD


• Guanadrel, guanethidine, mecamylamine, medicines for high blood pressure, methyldopa, or reserpine because their effectiveness may be decreased by Maxiflu CD


• Medicines that may harm the liver (eg, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver

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

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

• Take Maxiflu CD by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Take Maxiflu CD with a full glass of water (8 oz/240 mL).


• Drinking extra fluids while you are taking Maxiflu CD is recommended.


• If you miss a dose of Maxiflu CD and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

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


• Maxiflu CD may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Do not drink alcohol while you are taking Maxiflu CD.


• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Maxiflu CD; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Maxiflu CD may cause or worsen constipation. Talk with your doctor or pharmacist about using a stool softener or laxative to prevent constipation. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation. If you become constipated while taking Maxiflu CD, talk with your doctor or pharmacist.


• Do not take appetite suppressants while you are taking Maxiflu CD without checking with your doctor.


• Maxiflu CD contains acetaminophen, a decongestant (pseudoephedrine), a narcotic cough suppressant (codeine), and an expectorant (guaifenesin). Before you start any new prescription or nonprescription medicine, check the label to see if it has any of these medicines, other narcotic pain relievers or cough suppressants, or other decongestants in it too. If it does or if you are not sure, contact your doctor or pharmacist.


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


• Maxiflu CD may harm your liver. Your risk may be greater if you drink alcohol while you are taking Maxiflu CD. Talk to your doctor before you take Maxiflu CD or other fever reducers if you drink alcohol.


• Contact your doctor right away if you take more than 4,000 mg of acetaminophen per day, even if you feel well.


• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.


• If your cough does not improve within 5 days, goes away and comes back, or occurs along with a high fever, rash, or persistent headache, check with your doctor.


• Maxiflu CD may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Maxiflu CD. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Maxiflu CD may interfere with certain lab test results. Make sure that all of your doctors and laboratory personnel know that you are taking Maxiflu CD.


• Tell your doctor or dentist that you take Maxiflu CD before you receive any medical or dental care, emergency care, or surgery


• Use Maxiflu CD with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, excitability, low blood pressure, and trouble urinating.


• Caution is advised when using Maxiflu CD in CHILDREN; they may be more sensitive to its effects.


• Maxiflu CD should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Maxiflu CD while you are pregnant. Maxiflu CD may be found in breast milk. Do not breast-feed while taking Maxiflu CD.

When used for long periods of time or at high doses, Maxiflu CD may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Maxiflu CD stops working well. Do not take more than prescribed.

When used for long periods of time or at high doses, some people develop a need to continue taking Maxiflu CD. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Maxiflu CD, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Maxiflu CD:

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:

Constipation; dizziness; drowsiness; excitability; headache; irritability; light-headedness; nausea; sweating; trouble sleeping; vomiting; weakness.

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, throat, or tongue); confusion; difficulty urinating or inability to urinate; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; involuntary muscle movements; mental or mood changes (eg, anxiety, nervousness); persistent trouble sleeping; restlessness; seizures; severe or persistent dizziness, drowsiness, light-headedness, or headache; slow, difficult, or shallow breathing; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, yellowing of the skin or eyes); tremor; vision problems.

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: Maxiflu CD 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 blurred vision; cold and clammy skin; coma; confusion; decreased urination; difficulty urinating; fainting; fast, slow, or irregular heartbeat; hallucinations; increased or decreased pupil size; increased sweating; limp muscles; paleness; restlessness; seizures; severe dizziness, light-headedness, or headache; severe drowsiness; severe excitability; severe nausea, vomiting, or weakness; slow, fast, difficult, or shallow breathing; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, yellowing of the skin or eyes); tremor; unusual bruising or bleeding.

Proper storage of Maxiflu CD:

Store Maxiflu CD at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Maxiflu CD out of the reach of children and away from pets.

General information:

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


• Maxiflu CD 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 Maxiflu CD. 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.

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Calciumfolinat

Calciumfolinat may be available in the countries listed below.

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Calcium Folinate

Calcium Folinate is reported as an ingredient of Calciumfolinat in the following countries:

• Norway

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Verapamil

Verapamil hydrochloride (a derivative of Verapamil) is reported as an ingredient of Falicard in the following countries:

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Carboplatin

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Oxybuprocaine

Oxybuprocaine hydrochloride (a derivative of Oxybuprocaine) is reported as an ingredient of Oxybuprocaine Minims in the following countries:

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Darvon-N

propoxyphene napsylate

Dosage Form: tablet, film coated
Darvon-N - propoxyphene napsylate tablet, film coated

Darvon-N Description

Darvon-N contains propoxyphene napsylate, USP which is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water and soluble in methanol, ethanol, chloroform, and acetone. Chemically, it is (αS,1R)-α-[2-(Dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate, which can be represented by the accompanying structural formula. Its molecular weight is 565.72

Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride.

Each tablet of Darvon-N contains 100 mg (176.8 μmol) propoxyphene napsylate. The tablet also contains cellulose, cornstarch, iron oxides, lactose, magnesium stearate, silicon dioxide, stearic acid, and titanium dioxide.

Darvon-N - Clinical Pharmacology

Pharmacology

Propoxyphene is a centrally acting opiate analgesic. In vitro studies demonstrated propoxyphene and the metabolite norpropoxyphene inhibit sodium channels (local anesthetic effect) with norpropoxyphene being approximately 2-fold more potent than propoxyphene and propoxyphene approximately 10-fold more potent than lidocaine. Propoxyphene and norpropoxyphene inhibit the voltage-gated potassium current carried by cardiac rapidly activating delayed rectifier (hERG) channels with approximately equal potency. It is unclear if the effects on ion channels occur within therapeutic dose range.

Pharmacokinetics Absorption

Peak plasma concentrations of propoxyphene are reached in 2 to 2.5 h. After a 65-mg oral dose of propoxyphene hydrochloride, peak plasma levels of 0.05 to 0.1 μg/mL for propoxyphene and 0.1 to 0.2 μg/mL for norpropoxyphene (major metabolite) are achieved. Repeated doses of propoxyphene at 6 h intervals lead to increasing plasma concentrations, with a plateau after the ninth dose at 48 h. Propoxyphene has a half-life of 6 to 12 h, whereas that of norpropoxyphene is 30 to 36 h.

Distribution

Propoxyphene is about 80% bound to proteins and has a large volume of distribution, 16 L/kg.

Metabolism

Propoxyphene undergoes extensive first-pass metabolism by intestinal and hepatic enzymes. The major route of metabolism is cytochrome CYP3A4 mediated N-demethylation to norpropoxyphene, which is excreted by the kidneys. Ring hydroxylation and glucuronide formation are minor metabolic pathways.

Excretion

In 48 h, approximately 20 to 25% of the administered dose of propoxyphene is excreted via the urine, most of which is free or conjugated norpropoxyphene. The renal clearance rate of propoxyphene is 2.6 L/min.

SPECIAL POPULATIONS Geriatric Patients

After oral administration of propoxyphene in elderly patients (70-78 years), much longer half-lives of propoxyphene and norpropoxyphene have been reported (propropoxyphene 13 to 35 h, norpropoxyphene 22 to 41 h). In addition, the AUC was an average of 3-fold higher and the Cmax was an average of 2.5-fold higher in the elderly when compared to a younger (20-28 years) population. Longer dosage intervals may be considered in the elderly because the metabolism of propoxyphene may be reduced in this patient population. After multiple oral doses of propoxyphene in elderly patients (70-78 years), the Cmax of the metabolite (norpropoxyphene) was increased 5-fold.

Pediatric Patients

Propoxyphene has not been studied in pediatric patients.

Hepatic Impairment

No formal pharmacokinetic study of propoxyphene has been conducted in patients with mild, moderate or severe hepatic impairment.

After oral administration of propoxyphene in patients with cirrhosis, plasma concentrations of propoxyphene were considerably higher and norpropoxyphene concentrations were much lower than in control patients. This is presumably because of a decreased first-pass metabolism of orally administered propoxyphene in these patients. The AUC ratio of norpropoxyphene: propoxyphene was significantly lower in patients with cirrhosis (0.5 to 0.9) than in controls (2.5 to 4).

Renal Impairment

No formal pharmacokinetic study of propoxyphene has been conducted in patients with mild, moderate or severe renal impairment.

After oral administration of propoxyphene in anephric patients, the AUC and Cmax values were an average of 76% and 88% greater, respectively. Dialysis removes only insignificant amounts (8%) of administered dose of propoxyphene.

Drug Interactions

The metabolism of propoxyphene may be altered by strong CYP3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazadone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil) leading to enhanced propoxyphene plasma levels. On the other hand, strong CYP3A4 inducers such as rifampin may lead to enhanced metabolite (norpropoxyphene) levels.

Propoxyphene is also thought to possess CYP3A4 and CYP2D6 enzyme inhibiting properties. Coadministration with a drug that is a substrate of CYP3A4 or CYP2D6, may result in higher plasma concentrations and increased pharmacologic or adverse effects of that drug.

INDICATION

Darvon-N is indicated for the relief of mild to moderate pain.

Contraindications

Darvon-N is contraindicated in patients with known hypersensitivity to propoxyphene.

Darvon-N is contraindicated in patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe asthma or hypercarbia.

Darvon-N is contraindicated in any patient who has or is suspected of having paralytic ileus.

Warnings

Risk of Overdose

There have been numerous cases of accidental and intentional overdose with propoxyphene products either alone or in combination with other CNS depressants, including alcohol. Fatalities within the first hour of overdosage are not uncommon. Many of the propoxyphene-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation/attempts and/or concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants, or other CNS-depressant drugs. Do not prescribe propoxyphene for patients who are suicidal or have a history of suicidal ideation.

Respiratory Depression

Respiratory depression is the chief hazard from all opioid agonist preparations. Respiratory depression occurs most frequently in elderly or debilitated patients, usually following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration. Darvon-N should be used with extreme caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale, and in patients having substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression. In such patients, even usual therapeutic doses of Darvon-N may decrease respiratory drive to the point of apnea. In these patients alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose.

Hypotensive Effect

Darvon-N, like all opioid analgesics, may cause severe hypotension in an individual whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines or other agents which compromise vasomotor tone. Darvon-N may produce orthostatic hypotension in ambulatory patients. Darvon-N, like all opioid analgesics, should be administered with caution to patients in circulatory shock, since vasodilatation produced by the drug may further reduce cardiac output and blood pressure.

Head Injury and Increased Intracranial Pressure

The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.

Drug Interactions

The concomitant use of propoxyphene and CNS depressants, including alcohol, can result in potentially serious adverse events including death. Because of its added depressant effects, propoxyphene should be prescribed with caution for those patients whose medical condition requires the concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants, or other CNS-depressant drugs.

Usage in Ambulatory Patients

Propoxyphene may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery. The patient should be cautioned accordingly.

Use with Alcohol

Patients should be cautioned about the concomitant use of propoxyphene products and alcohol because of potentially serious CNS-additive effects of these agents that can lead to death.

BOXED WARNING

Warnings

There have been numerous cases of accidental and intentional overdose with propoxyphene products either alone or in combination with other CNS depressants, including alcohol.  Fatalities within the first hour of overdosage are not uncommon. Many of the propoxyphene-related deaths have occurred in patients with previous histories of emotional disturbance or suicidal ideation/attempts and /or concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants, or other CNS-depressant drugs. Do not prescribe propoxyphene for patients who are suicidal or have a history of suicidal ideation.

The metabolism of propoxyphene may be altered by strong CYP3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazadone, amiodarone, amprenavir, aprepitant, diltiazem, erthromycin, fulconazole, fosamprenavir, grapefruit juice, and verapamil) leading to enhanced propoxyphene plasma levels. Patients receiving propoxyphene and any CYP3A4 inhibitor should be carefully monitored for an extended period of time and dosage adjustments should be made if warranted (see Clinical Pharmacology - Drug Interactions, Warnings, Precautions and Dosage and Administration for further information.)

Precautions

Tolerance and Physical Dependence

Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and tolerance are not unusual during chronic opioid therapy.

The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. In general, opioids should not be abruptly discontinued (see Dosage and Administration: Cessation of Therapy).

If Darvon-N is abruptly discontinued in a physically dependent patient, an abstinence syndrome may occur (see Drug Abuse and Dependance). If signs and symptoms of withdrawal occur, patients should be treated by reinstitution of opioid therapy followed by gradual tapered dose reduction of Darvon-N combined with symptomatic support (see Dosage and Administration: Cessation of Therapy).

Use in Pancreatic/Biliary Tract Disease

Darvon-N may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis. Opioids like Darvon-N may cause increases in the serum amylase level.

Hepatic or Renal Impairment

Insufficient information exists to make appropriate dosing recommendations regarding the use of either propoxyphene in patients with hepatic or renal impairment as a function of degree of impairment. Higher plasma concentrations and/or delayed elimination may occur in case of impaired hepatic function and/or impaired renal function (see Clinical Pharmacology). If the drug is used in these patients, it should be used with caution because of the hepatic metabolism and renal excretion of propoxyphene metabolites.

Information for Patients/Caregivers

1. Patients should be advised to report pain and adverse experiences occurring during therapy. Individualization of dosage is essential to make optimal use of this medication.


2. Patients should be advised not to adjust the dose of Darvon-N without consulting the prescribing professional.


3. Patients should be advised that Darvon-N may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery).


4. Patients should not combine Darvon-N with central nervous system depressants (e.g., sleep aids, tranquilizers) except by the orders of the prescribing physician, because additive effects may occur.


5. Patients should be instructed not to consume alcoholic beverages, including prescription and over-the-counter medications that contain alcohol, while using Darvon-N because of risk of serious adverse events including death.


6. Women of childbearing potential who become, or are planning to become, pregnant should be advised to consult their physician regarding the effects of analgesics and other drug use during pregnancy on themselves and their unborn child.


7. Patients should be advised that Darvon-N is a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.


8. Patients should be advised that if they have been receiving treatment with Darvon-N for more than a few weeks and cessation of therapy is indicated, it may be appropriate to taper the Darvon-N dose, rather than abruptly discontinue it, due to the risk of precipitating withdrawal symptoms. Their physician can provide a dose schedule to accomplish a gradual discontinuation of the medication.

Drug Interactions with Propoxyphene

Propoxyphene is metabolized mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4), therefore potential interactions may occur when propoxyphene is administered concurrently with agents that affect CYP3A4 activity.

The metabolism of propoxyphene may be altered by strong CYP3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazadone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil) leading to enhanced propoxyphene plasma levels. Coadministration with agents that induce CYP3A4 activity may reduce the efficacy of propoxyphene. Strong CYP3A4 inducers such as rifampin may lead to enhanced metabolite (norpropoxyphene) levels.

Propoxyphene is also thought to possess CYP3A4 and CYP2D6 enzyme inhibiting properties and coadministration with drugs that rely on either of these enzymes for metabolism may result in increased pharmacologic or adverse effects of that drug. Severe neurologic signs, including coma, have occurred with concurrent use of carbamazepine (metabolized by CYP3A4).

Increased risk of bleeding has been observed with warfarin-like agents when given along with propoxyphene; however, the mechanistic basis of this interaction is unknown.

CNS Depressants

Patients receiving narcotic analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with propoxyphene may exhibit an additive CNS depression. Interactive effects resulting in respiratory depression, hypotension, profound sedation, or coma may result if these drugs are taken in combination with the usual dosage of Darvon-N. When such combined therapy is contemplated, the dose of one or both agents should be reduced.

Mixed Agonist/Antagonist Opioid Analgesics

Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol and buprenorphine) should be administered with caution to patients who have received or are receiving a course of therapy with a pure opioid agonist analgesic such as Darvon-N. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of Darvon-N and/or may precipitate withdrawal symptoms in these patients.

Monoamine Oxidase Inhibitors (MAOIs)

MAOIs have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant depression of respiration or coma. The use of Darvon-N is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.

Carcinogenesis, Mutagenesis, Impairment of Fertility

The mutagenic and carcinogenic potential of propoxyphene has not been evaluated.

In animal studies there was no effect of propoxyphene on mating behavior, fertility, duration of gestation, or parturition when rats were fed propoxyphene as a component of their daily diet at estimated daily propoxyphene intake up to 8-fold greater than the maximum human equivalent dose (HED) based on body surface area comparison. At this highest dose, fetal weight and survival on postnatal day 4 was reduced.

Pregnancy Risk summary Pregnancy category C.

There are no adequate and well-controlled studies of propoxyphene in pregnant women. While there are limited data in the published literature, adequate animal reproduction studies have not been conducted with propoxyphene. Therefore, it is not known whether propoxyphene can affect reproduction or cause fetal harm when administered to a pregnant woman. Propoxyphene should be given to a pregnant woman only if clearly needed.

Clinical considerations

Propoxyphene and its major metabolite, norpropoxyphene, cross the human placenta. Neonates whose mothers have taken opiates chronically may exhibit respiratory depression or withdrawal symptoms.

Data

In published animal reproduction studies, no teratogenic effects occurred in offspring born to pregnant rats or rabbits that received propoxyphene during organogenesis. Pregnant animals received propoxyphene doses approximately 10-fold (rats) and 4-fold (rabbits) the maximum recommended human dose (based on mg/m2 body surface area comparison).

Nursing Mothers

Propoxyphene, norpropoxyphene (major metabolite), are excreted in human milk. Published studies of nursing mothers using propoxyphene detected no adverse effects in nursing infants. Based on a study of six mother-infant pairs, an exclusively breastfed infant receives approximately 2% of the maternal weight-adjusted dose. Norpropoxyphene is renally excreted and renal clearance is lower in neonates than in adults. Therefore, it is possible that prolonged maternal propoxyphene use could result in norpropoxyphene accumulation in a breastfed infant. Watch breastfeeding infants for signs of sedation including poor feeding, somnolence, or respiratory depression. Caution should be exercised when Darvon-N is administered to a nursing woman.

Pediatric Patients

Safety and effectiveness in pediatric patients have not been established.

Elderly Patients

Clinical studies of Darvon-N did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, postmarketing reports suggest that patients over the age of 65 may be more susceptible to CNS-related side effects. Therefore, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Decreased total daily dosage should be considered (see Dosage and Administration).

Adverse Reactions

In hospitalized patients, the most frequently reported were dizziness, sedation, nausea, and vomiting. Other adverse reactions include constipation, abdominal pain, skin rashes, lightheadedness, headache, weakness, euphoria, dysphoria, hallucinations, and minor visual disturbances.

The most frequently reported postmarketing adverse events have included completed suicide, accidental and intentional overdose, drug dependence, cardiac arrest, coma, drug ineffective, drug toxicity, nausea, respiratory arrest, cardio-respiratory arrest, death, vomiting, dizziness, convulsion, confusional state, and diarrhea.

Additional adverse experiences reported through postmarketing surveillance include:

Cardiac disorders: arrhythmia, bradycardia, cardiac/respiratory arrest, congestive arrest, congestive heart failure (CHF), tachycardia, myocardial infarction (MI)

Eye disorder: eye swelling, vision blurred

General disorder and administration site conditions: drug ineffective, drug interaction, drug tolerance, influenza type illness, drug withdrawal syndrome

Gastrointestinal disorder: gastrointestinal bleed, acute pancreatitis

Hepatobiliary disorder: hepatic steatosis, hepatomegaly, hepatocellular injury

Immune system disorder: hypersensitivity

Injury poisoning and procedural complications: drug toxicity, hip fracture, multiple drug overdose, narcotic overdose

Investigations: blood pressure decreased, heart rate elevated/abnormal

Metabolism and nutrition disorder: metabolic acidosis

Nervous system disorder: ataxia, coma, dizziness, somnolence, syncope

Psychiatric: abnormal behavior, confusional state, hallucinations, mental status change

Respiratory, thoracic, and mediastinal disorders: respiratory depression, dyspnoea

Skin and subcutaneous tissue disorder: rash, itch

Liver dysfunction has been reported in association with Darvon-N. Propoxyphene therapy has been associated with abnormal liver function tests and, more rarely, with instances of reversible jaundice (including cholestatic jaundice).

Subacute painful myopathy has been reported following chronic propoxyphene overdosage.

Drug Abuse and Dependence

Controlled Substance

Darvon-N is a Schedule IV narcotic under the U.S. Controlled Substances Act. Darvon-N can produce drug dependence of the morphine type, and therefore, has the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration. Darvon-N should be prescribed and administered with the same degree of caution appropriate to the use of other narcotic-containing medications.

Abuse

Since Darvon-N is a mu-opioid agonist, it may be subject to misuse, abuse, and addiction. Addiction to opioids prescribed for pain management has not been estimated. However, requests for opioids from opioid-addicted patients occur. As such, physicians should take appropriate care in prescribing Darvon-N.

Dependence

Opioid analgesics may cause psychological and physical dependence. Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug after long term administration. Also, symptoms of withdrawal may be precipitated through the administration of drugs with mu-opioid antagonist activity, e.g., naloxone or mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine, dezocine) (see Overdosage). Physical dependence usually does not occur to a clinically significant degree, until after several weeks of continued opioid usage. Tolerance, in which increasingly larger doses are required to produce the same degree of analgesia, is initially manifested by a shortened duration of an analgesic effect and subsequently, by decreases in the intensity of analgesia.

In chronic pain patients, and in opioid-tolerant cancer patients, the administration of Darvon-N should be guided by the degree of tolerance manifested and the doses needed to adequately relieve pain.

The severity of the Darvon-N abstinence syndrome may depend on the degree of physical dependence. Withdrawal is characterized by rhinitis, myalgia, abdominal cramping, and occasional diarrhea. Most observable symptoms disappear in 5 to 14 days without treatment; however, there may be a phase of secondary or chronic abstinence which may last for 2 to 6 months characterized by insomnia, irritability, and muscular aches. The patient may be detoxified by gradual reduction of the dose. Gastrointestinal disturbances or dehydration should be treated with supportive care.

Overdosage

Overdose of Darvon-N may present with the signs and symptoms of propoxyphene overdose. Fatalities within the first hour of overdosage are not uncommon.

In all cases of suspected overdosage, call your regional Poison Control Center to obtain the most up-to-date information about the treatment of overdose. This recommendation is made because, in general, information regarding the treatment of overdosage may change more rapidly than do package inserts.

Initial consideration should be given to the management of the CNS effects of propoxyphene overdosage. Resuscitative measures should be initiated promptly.

Symptoms of Propoxyphene Overdosage

The manifestations of acute overdosage with propoxyphene are those of narcotic overdosage. The patient is usually somnolent but may be stuporous or comatose and convulsing. Respiratory depression is characteristic. The ventilatory rate and/or tidal volume is decreased, which results in cyanosis and hypoxia. Pupils, initially pinpoint, may become dilated as hypoxia increases. Cheyne-Stokes respiration and apnea may occur. Blood pressure and heart rate are usually normal initially, but blood pressure falls and cardiac performance deteriorates, which ultimately results in pulmonary edema and circulatory collapse, unless the respiratory depression is corrected and adequate ventilation is restored promptly. Cardiac arrhythmias and conduction delay may be present. A combined respiratory-metabolic acidosis occurs owing to retained CO2 (hypercapnia) and to lactic acid formed during anaerobic glycolysis. Acidosis may be severe if large amounts of salicylates have also been ingested. Death may occur.

Treatment of Propoxyphene Overdosage

Attention should be directed first to establishing a patent airway and to restoring ventilation. Mechanically assisted ventilation, with or without oxygen, may be required, and positive pressure respiration may be desirable if pulmonary edema is present. The opioid antagonist naloxone will markedly reduce the degree of respiratory depression, and should be administered promptly, preferably intravenously. The duration of action of the antagonist may be brief. If no response is observed after 10 mg of naloxone have been administered, the diagnosis of propoxyphene toxicity should be questioned.

In addition to the use of an opioid antagonist, the patient may require careful titration with an anticonvulsant to control convulsions. Activated charcoal can adsorb a significant amount of ingested propoxyphene. Dialysis is of little value in poisoning due to propoxyphene. Efforts should be made to determine whether other agents, such as alcohol, barbiturates, tranquilizers, or other CNS depressants, were also ingested, since these increase CNS depression as well as cause specific toxic effects or death.

DOSAGE AND ADMINISTRATION

Darvon-N is intended for the management of mild to moderate pain. The dose should be individually adjusted according to severity of pain, patient response and patient size.

Darvon-N is given orally. The usual dosage is one 100 mg propoxyphene napsylate tablet every 4 hours as needed for pain. The maximum dose of Darvon-N is 6 tablets per day. Do not exceed the maximum daily dose.

Patients receiving propoxyphene and any CYP3A4 inhibitor should be carefully monitored for an extended period of time and dosage adjustments should be made if warranted.

Consideration should be given to a reduced total daily dosage in elderly patients and in patients with hepatic or renal impairment.

Cessation of Therapy

For patients who used Darvon-N on a regular basis for a period of time, when therapy with Darvon-N is no longer needed for the treatment of their pain, it may be useful to gradually discontinue the Darvon-N over time to prevent the development of an opioid abstinence syndrome (narcotic withdrawal). In general, therapy can be decreased by 25% to 50% per day with careful monitoring for signs and symptoms of withdrawal (see Drug Abuse and Dependence for description of the signs and symptoms of withdrawal). If the patient develops these signs or symptoms, the dose should be raised to the previous level and titrated down more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both.

How is Darvon-N Supplied

Darvon-N Tablets are available in:

The 100 mg tablets are buff colored, elliptical shaped, film coated, and imprinted with the script “Darvon-N 100” on one side of the tablet, using edible black ink. They are available as follows:

Bottles of 100

NDC 66479-512-10

Store at 25°C (77°F); excursions are permitted to 15°- 30°C (59°- 86°F) [see USP Controlled Room Temperature].

Inform patients of the availability of a Medication Guide for Darvon/Darvon-N that accompanies each prescription dispensed. Instruct patients to read the Darvon/Darvon-N Medication Guide prior to using Darvon.

Darvon, Darvon-N, Darvocet, and Darvocet-N are registered trademarks of

Xanodyne Pharmaceuticals, Inc.

© 2009 Xanodyne Pharmaceuticals, Inc.

Marketed by:

Xanodyne Pharmaceuticals, Inc.

Newport, KY

41071

PI-512-A

REV. 09-2009

MEDICATION GUIDE

Darvon-N® [dar-von-N] (C-IV)

(propoxyphene napsylate)

Tablets

DARVON® [dar-von](C-IV)

(propoxyphene hydrochloride capsules)

Puvules®

Read this Medication Guide before you start taking Darvon-N or Darvon, and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information I should know about Darvon-N and Darvon?

Darvon-N and Darvon, and other medicines that contain propoxyphene can cause serious side effects, including:

Overdoses by accident or on purpose (intentional overdose). Overdoses with Darvon-N and Darvon may happen when it is taken by itself, or with alcohol or other medicines that can also decrease your breathing and make you very sleepy.

• 
  

  Death can happen within 1 hour of taking an overdose of Darvon-N or Darvon.

  
  

  Many of the deaths that happen in people who take Darvon-N and Darvon happen in those who:

  
  
  • have emotional problems
  
  
  • have thoughts of suicide or attempted suicide, or
  
  
  • also take antidepressants, sedatives, tranquilizers, muscle relaxants, or other medicines that affect your breathing and make you very sleepy. You should not use any of these medicines with Darvon-N or Darvon without talking to your doctor.
  
  


• Before taking Darvon-N or Darvon tell your doctor if you:
  
  • have a lung problem, such as COPD or cor pulmonale
  
  
  • have liver or kidney problems
  
  
  • have problems with your pancreas or gallbladder
  
  
  • have a history of head injury
  
  
  • are over age 65
  
  
  • have a history of drug or alcohol abuse or addiction
  
  

Take Darvon-N and Darvon exactly as prescribed. Do not change your dose or stop taking Darvon-N or Darvon without first talking to your doctor.

 

• If you take Darvon-N, do not take more than 6 tablets in one day.


• If you take Darvon, do not take more than 6 capsules in one day.

• Before taking Darvon-N or Darvon, tell your doctor about all the medicines you take. Darvon-N or Darvon and many other medicines may interact with each other and may cause serious side effects. Certain medicines can affect how your liver breaks down other medicines. See “What should I tell my doctor before taking Darvon-N or Darvon?”


• Do not drink grapefruit juice or eat grapefruit while you take Darvon-N or Darvon. Grapefruit juice may interact with Darvon-N or Darvon.

• Do not drink alcohol while using Darvon-N or Darvon. Using alcohol with Darvon-N or Darvon may increase your risk of having dangerous side effects.

What are Darvon-N and Darvon?

• Darvon-N and Darvon are prescription medicines used to treat mild to moderate pain.

Darvon-N and Darvon are federally controlled substances (C-IV) because they are strong opioid pain medicines that can be abused by people who abuse prescription medicines or street drugs. Prevent theft, misuse or abuse. Keep Darvon-N or Darvon in a safe place to protect it from being stolen. Darvon-N and Darvon can be a target for people who misuse or abuse prescription medicines or street drugs. Never give Darvon-N or Darvon to anyone else, even if they have the same symptoms that you have. It may harm them or even cause death. Selling or giving away this medicine is against the law.

It is not known if Darvon-N and Darvon are safe and effective in children younger than age 18.

Who should not take Darvon-N or Darvon?

Do not take Darvon-N or Darvon if you:

• are allergic to propoxyphene. Ask your doctor if you are not sure. See the end of this Medication Guide for a list of the ingredients in Darvon-N and Darvon.


• are having an asthma attack or have severe asthma, trouble breathing, or have a lung problem


• have a bowel blockage called paralytic ileus

What should I tell my doctor before taking Darvon-N or Darvon?

Before you take Darvon-N or Darvon, tell your doctor:

• if you have any of the conditions listed in the section “What is the most important information I should know about Darvon-N and Darvon?”


• if you are allergic to propoxyphene


• if you plan to have surgery with general anesthesia


• if you are pregnant or plan to become pregnant.


• if you take Darvon-N or Darvon regularly before your baby is born, your newborn baby may have withdrawal symptoms because their body has become used to the medicine. Symptoms of withdrawal in a newborn baby may include:

irritability crying more than usual) shaking (tremors jitteriness breathing faster than normal

diarrhea or more stools than normal vomiting fever

• if you take Darvon-N or Darvon right before your baby is born, your baby could have breathing problems.


• if you are breast-feeding or plan to breast-feed. Some Darvon-N or Darvon passes into breast milk.

Tell your doctor about all the medicines you take, including prescription, and non-prescription medicines, vitamins, and herbal supplements. Darvon-N and Darvon interacts with many medicines and may lead to serious side effects. The doses of certain medicines may need to be changed.

Especially tell your doctor if you take:

See “What is the most important information I should know about Darvon-N and Darvon?”

• certain medicines that can affect how your liver breaks down other medicines


• a monoamine oxidase inhibitor (MAOI) medicine


• other medicines that make you sleepy, such as: other medicines for pain, including other opioid medicines, anti-depressant medicines, sleeping pills, anti-anxiety medicines, muscle relaxants, anti-nausea medicines, or tranquilizers


• a blood pressure medicine


• a blood-thinner medicine. You may have an increased risk of bleeding while also taking Darvon-N or Darvon.

Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.

Know the medicines you take. Keep a list of them to show to your doctor and pharmacist when you get a new medicine.

How should I take Darvon-N or Darvon?

See “What is the most important information I should know about Darvon-N and Darvon?”

• Take Darvon-N or Darvon exactly as prescribed.


• If you take too much Darvon-N or Darvon, or take it with alcohol or other medicines, you may overdose. See “What is the most important information I should know about Darvon-N or Darvon?” You will need medical help right away if you think you have taken an overdose of Darvon-N or Darvon. A large overdose could cause you to become unconscious and die.

Signs and symptoms of an overdose of Darvon-N or Darvon include:

• you are very sleepy or do not respond to others


• confusion


• have trouble breathing or stop breathing


• changes in blood pressure and heart rate

What are the possible side effects of Darvon-N and Darvon?

Darvon-N and Darvon can cause serious side effects, including:

See “What is the most important information I should know about Darvon-N and Darvon?”

• Serious breathing problems that can become life-threatening. This is especially true if you already have a serious lung or breathing problem, or your body is not used to opioid pain medicines. This can happen even if you take Darvon-N or Darvon exactly as prescribed by your doctor. Call your doctor or get medical help right away if:
  
  • your breathing slows down
  
  
  • you have shallow breathing (little chest movement with breathing)
  
  
  • you feel faint, dizzy, confused, or
  
  
  • you have any other unusual symptoms
  
  


• Darvon-N and Darvon can cause your blood pressure to drop. This can make you feel dizzy and faint if you get up too fast from sitting or lying down. Low blood pressure is also more likely to happen if you take other medicines that can also lower your blood pressure. Severe low blood pressure can happen if you lose blood or take certain other medicines.


• Sleepiness. Darvon-N and Darvon can cause sleepiness and may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other dangerous activities until you know how Darvon-N or Darvon affects you.


• Darvon-N and Darvon can cause physical dependence if you take it for more than a few weeks. Do not stop taking Darvon-N or Darvon all of a sudden. You could become sick with uncomfortable withdrawal symptoms (for example, nausea, vomiting, diarrhea, anxiety, and shivering) because your body has become used to the medicine. Physical dependence is not the same as drug addiction. Your doctor can tell you more about the differences between physical dependence and drug addiction.

Tell your doctor if you have any of these withdrawal symptoms while you slowly stop taking Darvon-N or Darvon. You may need to stop Darvon-N or Darvon more slowly.

Common side effects of Darvon-N and Darvon include:

dizziness feeling sleepy nausea and vomiting constipation stomach area (abdominal) pain skin rashes lightheadedness headache weakness feeling of excitement (elation) or discomfort

seeing, hearing, or sensing things that are not really there (hallucinations) blurred vision

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

You may also report side effects to Xanodyne Pharmaceuticals, Inc. at 1-877-773-7793.

How should I store Darvon-N and Darvon?

• Store Darvon-N between 59°F to 86°F (15°C to 30°C).


• Store Darvon between 68°F to 77°F (20°C to 25°C).

Keep Darvon-N, Darvon and all medicines out of the reach of children.

General information about Darvon-N and Darvon

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Darvon-N or Darvon for a purpose for which it was not prescribed. Do not give Darvon-N or Darvon to others even if they have the same symptoms you have. It may harm them and is against the law.

This Medication Guide summarizes the most important information about Darvon-N and Darvon. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Darvon-N and Darvon that is written for health professionals. For more information, go to www.Xanodyne.com or call 1-877-773-7793.

What are the ingredients in Darvon-N and Darvon?

Darvon-N:

Active ingredient: propoxyphene napsylate

Inactive ingredients: cellulose, cornstarch, iron oxides, lactose, magnesium stearate, silicon dioxide, stearic acid, and titanium dioxide

Darvon:

Active ingredient: propoxyphene hydrochloride

Inactive ingredients: D and C Red No. 33, FD and C Yellow No. 6, gelatin, magnesium stearate, silicone, starch, titanium dioxide, and other inactive ingredients

Xanodyne Pharmaceuticals, Inc.

Newport, KY 41071

Issued 09/2009

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Darvon, Darvon-N, Darvocet-N and Darvocet are registered trademarks of Xanodyne Pharmaceuticals, Inc.

© 2009 Xanodyne Pharmaceuticals, Inc.

Marketed by:

Xanodyne Pharmaceuticals, Inc.

MG-510/512-A

Rev. 09/2009

Revised: 09/2009Xanodyne Pharmaceuticals, Inc.  

PRODUCT LABEL

Darvon-N  propoxyphene napsylate  tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 16590-874 (66479-512) Route of Administration ORAL DEA Schedule CIV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength propoxyphene napsylate (propoxyphene) propoxyphene napsylate 100 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color yellow Score no score Shape OVAL Size 14mm Flavor Imprint Code DARVON;N;100 Contains

Packaging # NDC Package Description Multilevel Packaging 1 16590-874-30 30 TABLET In 1 BOTTLE None 2 16590-874-60 60 TABLET In 1 BOTTLE None 3 16590-874-90 90 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA016862	09/25/2009

Labeler - Stat Rx USA (786036330)

Revised: 10/2009Stat Rx USA

More Darvon-N resources

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

• Darvon-N Concise Consumer Information (Cerner Multum)


• Darvon-N MedFacts Consumer Leaflet (Wolters Kluwer)


• Darvon-N Advanced Consumer (Micromedex) - Includes Dosage Information


• Propoxyphene Professional Patient Advice (Wolters Kluwer)


• Propoxyphene Hydrochloride Monograph (AHFS DI)

Compare Darvon-N with other medications

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