Saturday, 30 June 2012

Hair Regrowth Treatment for Men




Generic Name: minoxidil

Dosage Form: solution
CVS Pharmacy, Inc. Hair Regrowth Treatment for Men Drug Facts

Active ingredient


Minoxidil 5% w/v



Purpose


Hair Regrowth Treatment for Men



Uses


to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)



Warnings


For external use only. For use by men only.


Flammable: Keep away from fire or flame



Do not use if


  • you are a woman

  • your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline.

  • you have no family history of hair loss

  • your hair loss is sudden and/or patchy

  • you do not know the reason for your hair loss

  • you are under 18 years of age. Do not use on babies and children.

  • your scalp is red, inflamed, infected, irritated, or painful

  • you use other medicines on the scalp


Ask a doctor before use if you have


heart disease



When using this product


  • do not apply on other parts of the body

  • avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.

  • some people have experienced changes in hair color and/or texture

  • it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results.

  • the amount of hair regrowth is different for each person. This product will not work for all men.


Stop use and ask a doctor if


  • chest pain, rapid heartbeat, faintness, or dizziness occurs

  • sudden, unexplained weight gain occurs

  • your hands or feet swell

  • scalp irritation or redness occurs

  • unwanted facial hair growth occurs

  • you do not see hair regrowth in 4 months


May be harmful if used when pregnant or breast-feeding.



Keep out of reach of children.


If swallowed, get medical help or contact a Poison Control Center right away.



Directions


  • apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area

  • using more or more often will not improve results

  • continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again


Other information


  • see hair loss pictures on side of this carton

  • before use, read all information on carton and enclosed leaflet

  • keep the carton. It contains important information.

  • hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil topical solution 5% for men

  • in clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical solution 5% for men provided more hair regrowth than minoxidil topical solution 2%

  • store at 20° to 25°C (68° to 77°F). Keep tightly closed.


Inactive ingredients


alcohol (30% v/v), propylene glycol (50% v/v), purified water



Questions or comments?


1-800-719-9260



Principal Display Panel


Hair Regrowth Treatment for Men


Minoxidil Topical Solution USP 5%


Hair Regrowth Treatment


Extra Strength


Clinically Proven to Help Regrow Hair


Revitalizes Hair Follicles


Not For Use By Women


Compare to Men’s Rogaine® Extra Strength active ingredient


# Month Supply


Hair Regrowth Treatment for Men Carton










Hair Regrowth Treatment for Men 
minoxidil  solution










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)59779-380
Route of AdministrationTOPICALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (MINOXIDIL)MINOXIDIL5 g  in 100 mL





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      






















Packaging
#NDCPackage DescriptionMultilevel Packaging
159779-380-161 BOTTLE In 1 CARTONcontains a BOTTLE
160 mL In 1 BOTTLEThis package is contained within the CARTON (59779-380-16)
259779-380-303 BOTTLE In 1 CARTONcontains a BOTTLE
260 mL In 1 BOTTLEThis package is contained within the CARTON (59779-380-30)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07559807/18/2005


Labeler - CVS Pharmacy (062312574)
Revised: 07/2009CVS Pharmacy




More Hair Regrowth Treatment for Men resources


  • Hair Regrowth Treatment for Men Use in Pregnancy & Breastfeeding
  • Hair Regrowth Treatment for Men Drug Interactions
  • Hair Regrowth Treatment for Men Support Group
  • 7 Reviews for Hair Regrowth Treatment for Men - Add your own review/rating


Compare Hair Regrowth Treatment for Men with other medications


  • Alopecia

Thursday, 28 June 2012

Atacand HCT


Generic Name: hydrochlorothiazide and candesartan (HYE droe KLOR oh THYE a zide and KAN de SAR tan)

Brand Names: Atacand HCT


What is Atacand HCT (hydrochlorothiazide and candesartan)?

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.


Candesartan is an angiotensin II receptor antagonists. Candesartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.


The combination of hydrochlorothiazide and candesartan is used to treat high blood pressure (hypertension).


Hydrochlorothiazide and candesartan may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Atacand HCT (hydrochlorothiazide and candesartan)?


Do not use hydrochlorothiazide and candesartan if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. You should not use this medication if you are allergic to candesartan or hydrochlorothiazide (Carozide, Diaqua, Ezide HCTZ, HydroDiuril, Microzide, and others), or if you are unable to urinate.

Before you take this medication, tell your doctor if you have kidney or liver disease, congestive heart failure, glaucoma, low or high levels of potassium in your blood, asthma or allergies, high cholesterol or triglycerides, gout, lupus, diabetes, or an allergy to sulfa drugs or penicillin.


Hydrochlorothiazide and candesartan may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid drinking alcohol. It can lower your blood pressure and may increase some of the side effects of hydrochlorothiazide and candesartan.

What should I discuss with my healthcare provider before taking Atacand HCT (hydrochlorothiazide and candesartan)?


You should not use this medication if you are allergic to candesartan or hydrochlorothiazide (Carozide, Diaqua, Ezide HCTZ, HydroDiuril, Microzide, and others), or if you are unable to urinate.

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


  • kidney disease;

  • liver disease;


  • congestive heart failure;




  • glaucoma;




  • low or high levels of potassium in your blood;




  • asthma or allergies;




  • high cholesterol or triglycerides (a type of fat in the blood);




  • gout;




  • lupus;




  • diabetes; or




  • an allergy to sulfa drugs or penicillin.




FDA pregnancy category D. Do not use hydrochlorothiazide and candesartan if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Hydrochlorothiazide and candesartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control while taking hydrochlorothiazide and candesartan. It is not known whether hydrochlorothiazide and candesartan passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take Atacand HCT (hydrochlorothiazide and candesartan)?


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


Your doctor may occasionally change your dose to make sure you get the best results.


Take this medication with a full glass (8 ounces) of water.

Your blood pressure will need to be checked often. Your blood and urine may also be tested if you have been vomiting or are dehydrated. Visit your doctor regularly.


Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medication, which can lead to severely low blood pressure or a serious electrolyte imbalance.

Hydrochlorothiazide can interfere with the results of a thyroid test. Tell any doctor who treats you that you are using this medication.


It may take up to 4 weeks for this medication to control your blood pressure. Keep using this medication even if you feel fine. High blood pressure often has no symptoms.


If you need surgery, tell the surgeon ahead of time that you are using hydrochlorothiazide and candesartan. You may need to stop using the medicine for a short time. Store at room temperature away from moisture and heat.

What happens if I miss a dose?


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.


What happens if I overdose?


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

Overdose symptoms may include fast or slow heartbeat, feeling light-headed, or fainting.


What should I avoid while taking Atacand HCT (hydrochlorothiazide and candesartan)?


This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid drinking alcohol. It can lower your blood pressure and may increase some of the side effects of hydrochlorothiazide and candesartan.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.


Do not use potassium supplements or salt substitutes while you are taking hydrochlorothiazide and candesartan, unless your doctor has told you to.

Atacand HCT (hydrochlorothiazide and candesartan) 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. In rare cases, hydrochlorothiazide and candesartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine. Call your doctor at once if you have any other serious side effect, such as:

  • eye pain, vision problems;




  • feeling like you might pass out;




  • chest pain, feeling short of breath, even with mild exertion;




  • fever;




  • swelling, rapid weight gain;




  • urinating less than usual or not at all;




  • jaundice (yellowing of the skin or eyes); or




  • dry mouth, increased thirst, drowsiness, restless feeling, confusion, increased urination, fast heart rate, feeling light-headed, fainting, or seizure (convulsions).



Less serious side effects may include:



  • stomach pain;




  • back pain;




  • dizziness, drowsiness;




  • headache;




  • runny or stuffy nose, sore throat; or




  • dry cough.



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 Atacand HCT (hydrochlorothiazide and candesartan)?


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



  • other diuretics (water pills) or blood pressure medications;




  • steroids (prednisone and others);




  • lithium (Eskalith, Lithobid);




  • cholestyramine (Prevalite, Questran) or colestipol (Colestid);




  • insulin or diabetes medicine you take by mouth;




  • a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton);




  • aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others;




  • a muscle relaxer such as baclofen (Lioresal), carisoprodol (Soma), cyclobenzaprine (Flexeril), dantrolene (Dantrium), metaxalone (Skelaxin), or methocarbamol (Robaxin), orphenadrine (Norflex), or tizanidine (Zanaflex); or




  • a narcotic medication such as hydrocodone (Lortab, Vicodin), meperidine (Demerol), methadone (Methadose), oxycodone (OxyContin), propoxyphene (Darvon, Darvocet), and others.



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



More Atacand HCT resources


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


  • Atacand HCT Prescribing Information (FDA)

  • Atacand HCT Advanced Consumer (Micromedex) - Includes Dosage Information

  • Atacand HCT MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Atacand HCT with other medications


  • High Blood Pressure


Where can I get more information?


  • Your pharmacist can provide more information about hydrochlorothiazide and candesartan.

See also: Atacand HCT side effects (in more detail)


Tur-Bi-Cal



Generic Name: phenylephrine (Nasal route)

fen-il-EF-rin

Commonly used brand name(s)

In the U.S.


  • Neo-Synephrine

  • Nostril

  • Pretz-D

  • Rhinall

  • Tur-Bi-Cal

  • Vicks Sinex

Available Dosage Forms:


  • Solution

  • Gel/Jelly

  • Spray

Therapeutic Class: Decongestant


Pharmacologic Class: Sympathomimetic


Chemical Class: Alkylarylamine


Uses For Tur-Bi-Cal


Phenylephrine is used for the temporary relief of congestion or stuffiness in the nose caused by hay fever or other allergies, colds, or sinus trouble. It may also be used in ear infections to relieve congestion.


This medicine may also be used for other conditions as determined by your doctor.


This medicine is available without a prescription.


Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .


Before Using Tur-Bi-Cal


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


Allergies


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


Pediatric


Children may be especially sensitive to the effects of nasal phenylephrine. This may increase the chance of side effects during treatment.


Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .


Geriatric


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


Pregnancy








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

Breast Feeding


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


Interactions with Medicines


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


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


  • Rasagiline

  • Selegiline

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.


  • Amitriptyline

  • Amoxapine

  • Clomipramine

  • Desipramine

  • Dothiepin

  • Doxepin

  • Imipramine

  • Lofepramine

  • Nortriptyline

  • Opipramol

  • Protriptyline

  • Trimipramine

Interactions with Food/Tobacco/Alcohol


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


Other Medical Problems


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


  • Type 2 diabetes mellitus or

  • Heart or blood vessel disease or

  • High blood pressure or

  • Overactive thyroid—Nasal phenylephrine may make the condition worse

Proper Use of phenylephrine

This section provides information on the proper use of a number of products that contain phenylephrine. It may not be specific to Tur-Bi-Cal. Please read with care.


To use the nose drops:


  • Blow your nose gently. Tilt the head back while standing or sitting up, or lie down on a bed and hang head over the side. Place the drops into each nostril and keep the head tilted back for a few minutes to allow the medicine to spread throughout the nose.

  • Rinse the dropper with hot water and dry with a clean tissue. Replace the cap right after use.

  • To avoid spreading the infection, do not use the container for more than one person.

To use the nose spray:


  • Blow your nose gently. With the head upright, spray the medicine into each nostril. Sniff briskly while squeezing the bottle quickly and firmly. For best results, spray once or twice into each nostril and wait 3 to 5 minutes to allow the medicine to work. Then, blow your nose gently and thoroughly. Repeat until the complete dose is used.

  • Rinse the tip of the spray bottle with hot water, taking care not to suck water into the bottle, and dry with a clean tissue. Replace the cap right after use.

  • To avoid spreading the infection, do not use the container for more than one person.

To use the nose jelly:


  • Blow your nose gently. Wash your hands before applying the medicine. With your finger, place a small amount of jelly (about the size of a pea) up each nostril. Sniff it well back into the nose.

  • Wipe the tip of the tube with a clean, damp tissue and replace the cap right after use.

Use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for longer than 3 days without first checking with your doctor. To do so may make your runny or stuffy nose worse and may also increase the chance of side effects.


Dosing


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


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


  • For stuffy nose:
    • For nose jelly dosage form:
      • Adults—Use a small amount in the nose every three or four hours as needed.

      • Children—Use is not recommended.


    • For nose drops dosage form:
      • Adults and children 12 years of age and older—Use two or three drops of a 0.25 to 0.5% solution in the nose every four hours as needed.

      • Children 6 to 12 years of age—Use two or three drops of a 0.25% solution in the nose every four hours as needed.

      • Children 4 to 6 years of age—Use two or three drops of a 0.125 or 0.16% solution in the nose every four hours as needed.

      • Children and infants up to 4 years of age—Use is not recommended .


    • For nose spray dosage form:
      • Adults and children 12 years of age and older—Use two or three sprays of a 0.25 to 0.5% solution in the nose every four hours as needed.

      • Children 6 to 12 years of age—Use two or three sprays of a 0.25% solution in the nose every four hours as needed.

      • Children 4 to 6 years of age—Use and dose must be determined by your doctor.

      • Children and infants up to 4 years of age—Use is not recommended .



Missed Dose


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


Storage


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


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Tur-Bi-Cal Side Effects


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


Check with your doctor as soon as possible if any of the following side effects occur:


Symptoms of too much medicine being absorbed into the body

Note: The above side effects are more likely to occur in children because there is a greater chance that too much of this medicine may be absorbed into the body.


  • Fast, irregular, or pounding heartbeat

  • headache or dizziness

  • increased sweating

  • nervousness

  • paleness

  • trembling

  • trouble in sleeping

  • Increase in runny or stuffy nose

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:


  • Burning, dryness, or stinging of inside of nose

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.



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


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


More Tur-Bi-Cal resources


  • Tur-Bi-Cal Use in Pregnancy & Breastfeeding
  • Tur-Bi-Cal Drug Interactions
  • Tur-Bi-Cal Support Group
  • 4 Reviews for Tur-Bi-Cal - Add your own review/rating


Compare Tur-Bi-Cal with other medications


  • Nasal Congestion

Tuesday, 26 June 2012

Xerese Cream


Pronunciation: ay-SYE-kloe-vir/HYE-droe-KOR-ti-sone
Generic Name: Acyclovir/Hydrocortisone
Brand Name: Xerese


Xerese Cream is used for:

Treating cold sores on the lips or around the mouth that are caused by the herpes virus. It may also be used for other conditions as determined by your doctor.


Xerese Cream is an antiviral and topical corticosteroid combination. The antiviral works by stopping viral replication. The topical corticosteroid works by decreasing inflammation, swelling, redness, and itching. Xerese Cream decreases the chance of ulcer-like cold sores and also shortens the time it takes for cold sores to heal.


Do NOT use Xerese Cream if:


  • you are allergic to any ingredient in Xerese Cream or valacyclovir

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



Before using Xerese Cream:


Some medical conditions may interact with Xerese Cream. 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 immune system problems (eg, weakened immune system, HIV infection)

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


Ask your health care provider if Xerese Cream 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 Xerese Cream:


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


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

  • Wash and completely dry your hands and the affected area before using Xerese Cream. Apply a thin layer of Xerese Cream to the affected area, including the outer margin. Do not rub the cold sore because it may spread to other areas or make the cold sore worse. Wash your hands after using Xerese Cream.

  • Apply Xerese Cream 5 times every day for 5 days or as directed by your doctor.

  • Do not bandage or wrap the area unless directed to do so by your doctor.

  • Do not bathe, shower, or swim until 30 minutes after using Xerese Cream.

  • To clear up your infection completely, use Xerese Cream for the full course of treatment. Keep using it even if you feel better in a few days.

  • For best results, use Xerese Cream at the first sign of a cold sore (tingling, redness, itching, or bump).

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

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



Important safety information:


  • Do not use Xerese Cream for genital herpes.

  • Do not get Xerese Cream in your eyes or on the inside of your nose or mouth. If Xerese Cream gets in your eyes, flush them with cool tap water.

  • Do not use other skin products such as cosmetics, sunscreen, or lip balm on the cold sore area while you are using Xerese Cream unless otherwise instructed by your doctor.

  • If treated cold sores get worse or if they do not heal within 2 weeks, check with your doctor.

  • Xerese Cream is not a cure for cold sores and it does not prevent the spread of the virus to others. Do not share drinking cups, eating utensils, razors, towels, or toothbrushes. Ask your doctor if you have questions about preventing the spread of cold sores.

  • Xerese Cream may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.

  • Xerese Cream should be used with extreme caution in CHILDREN younger than 12 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 Xerese Cream while you are pregnant. It is not known if Xerese Cream is found in breast milk after topical use. If you are or will be breast-feeding while you use Xerese Cream, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Xerese Cream:


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 taste; burning, drying, flaking, irritation, redness, tingling at the application site.



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); dizziness; excessive itching; swelling or skin color changes to the application site.



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: Xerese 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.


Proper storage of Xerese Cream:

Store Xerese Cream at room temperature, between 68 to 77 degrees F (20 to 25 degrees C) in a tightly capped container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not freeze or leave in a car in cold or hot weather. Keep Xerese Cream out of the reach of children and away from pets.


General information:


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

  • Xerese Cream 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 summary only. It does not contain all information about Xerese Cream. 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 Xerese resources


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


Compare Xerese with other medications


  • Cold Sores

Monday, 25 June 2012

Microgestin 1/20


Generic Name: ethinyl estradiol and norethindrone (ETH in il ess tra DYE ole and nor ETH in drone)

Brand Names: Aranelle, Balziva, Brevicon, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Estrostep Fe, Femcon FE, Generess Fe, Gildess FE 1.5/0.03, Gildess FE 1/0.2, Junel 1.5/30, Junel 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Lo Loestrin Fe, Loestrin 21 1.5/30, Loestrin 21 1/20, Loestrin 24 Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin 1/20, Microgestin FE 1.5/30, Microgestin FE 1/20, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norinyl 1+35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 35 Fe, Ovcon 50, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent Fe, Zeosa


What is Microgestin 1/20 (ethinyl estradiol and norethindrone)?

Ethinyl estradiol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.


Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.


Ethinyl estradiol and norethindrone may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Microgestin 1/20 (ethinyl estradiol and norethindrone)?


Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.


Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. 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.


What should I discuss with my healthcare provider before taking Microgestin 1/20 (ethinyl estradiol and norethindrone)?


This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). You should not take birth control pills if you have:

  • coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;




  • a history of a stroke, blood clot, or circulation problems;




  • a hormone-related cancer such as breast or uterine cancer;




  • unusual vaginal bleeding that has not been checked by a doctor;




  • liver disease or liver cancer;




  • severe migraine headaches; or




  • a history of jaundice caused by pregnancy or birth control pills.



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



  • high blood pressure or a history of heart disease;




  • high cholesterol, gallbladder disease, or diabetes;




  • migraine headaches or a history of depression; or




  • a history of breast cancer or an abnormal mammogram.




The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take Microgestin 1/20 (ethinyl estradiol and norethindrone)?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).


You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.


The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.


You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.


The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.


If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.


Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.


Store at room temperature away from moisture and heat.

What happens if I miss a dose?


Missing a pill increases your risk of becoming pregnant. If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.


If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.


If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.


If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Microgestin 1/20 (ethinyl estradiol and norethindrone)?


Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.


Microgestin 1/20 (ethinyl estradiol and norethindrone) side effects


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

  • sudden numbness or weakness, especially on one side of the body;




  • sudden severe headache, confusion, problems with vision, speech, or balance;




  • sudden cough, wheezing, rapid breathing, coughing up blood;




  • pain, swelling, warmth, or redness in one or both legs;




  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;




  • a change in the pattern or severity of migraine headaches;




  • pain in your upper stomach, jaundice (yellowing of the skin or eyes);




  • a lump in your breast;




  • swelling in your hands, ankles, or feet; or




  • symptoms of depression (sleep problems, weakness, mood changes).



Less serious side effects may include:



  • mild nausea or vomiting, appetite or weight changes;




  • breast swelling or tenderness;




  • headache, nervousness, dizziness;




  • problems with contact lenses;




  • freckles or darkening of facial skin, loss of scalp hair; or




  • vaginal itching or discharge.



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 Microgestin 1/20 (ethinyl estradiol and norethindrone)?


Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:



  • acetaminophen (Tylenol) or ascorbic acid (vitamin C);




  • bosentan (Tracleer);




  • prednisolone (Orapred);




  • St. John's wort;




  • theophylline (Elixophyllin, Theo-24, Uniphyl);




  • an antibiotic;




  • HIV or AIDS medications;




  • phenobarbital (Solfoton) and other barbiturates; or




  • seizure medication.



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



More Microgestin 1/20 resources


  • Microgestin 1/20 Side Effects (in more detail)
  • Microgestin 1/20 Use in Pregnancy & Breastfeeding
  • Drug Images
  • Microgestin 1/20 Drug Interactions
  • Microgestin 1/20 Support Group
  • 7 Reviews for Microgestin/20 - Add your own review/rating


  • Aranelle Prescribing Information (FDA)

  • Balziva Prescribing Information (FDA)

  • Brevicon Prescribing Information (FDA)

  • Briellyn Prescribing Information (FDA)

  • Cyclafem 1/35 Prescribing Information (FDA)

  • Cyclafem 7/7/7 Prescribing Information (FDA)

  • Estrostep Fe Prescribing Information (FDA)

  • Femcon FE Prescribing Information (FDA)

  • Femcon Fe Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Femhrt Consumer Overview

  • Femhrt Prescribing Information (FDA)

  • Femhrt MedFacts Consumer Leaflet (Wolters Kluwer)

  • Jevantique Prescribing Information (FDA)

  • Jinteli Prescribing Information (FDA)

  • Leena Prescribing Information (FDA)

  • Lo Loestrin Fe MedFacts Consumer Leaflet (Wolters Kluwer)

  • Lo Loestrin Fe Consumer Overview

  • Lo Loestrin Fe Advanced Consumer (Micromedex) - Includes Dosage Information

  • Lo Loestrin Fe Prescribing Information (FDA)

  • Loestrin 24 FE Prescribing Information (FDA)

  • Loestrin 24 Fe Consumer Overview

  • Loestrin Fe 1/20 MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ovcon 35 MedFacts Consumer Leaflet (Wolters Kluwer)

  • Tilia FE Prescribing Information (FDA)

  • Tri-Norinyl Prescribing Information (FDA)

  • Zenchent FE Prescribing Information (FDA)

  • Zeosa Prescribing Information (FDA)



Compare Microgestin 1/20 with other medications


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  • Postmenopausal Symptoms
  • Prevention of Osteoporosis


Where can I get more information?


  • Your pharmacist can provide more information about ethinyl estradiol and norethindrone.

See also: Microgestin/20 side effects (in more detail)


Lidex-E Cream


Pronunciation: floo-oh-SIN-oh-nide
Generic Name: Fluocinonide
Brand Name: Examples include Lidex and Lidex-E


Lidex-E Cream is used for:

Treating inflammation and itching due to certain skin conditions. It may also be used for other conditions as determined by your doctor.


Lidex-E Cream is a topical adrenocortical steroid. It works by reducing skin inflammation (redness, swelling, itching, and irritation) by a way that is not clearly understood.


Do NOT use Lidex-E Cream if:


  • you are allergic to any ingredient in Lidex-E Cream

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



Before using Lidex-E Cream:


Some medical conditions may interact with Lidex-E Cream. 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 any kind of skin infection, cuts, scrapes, or lessened blood flow to your skin

  • if you have had a recent vaccination; have measles, tuberculosis, chickenpox, or shingles; or have had a positive tuberculosis test

  • if you are taking prednisone or similar medicines

Some MEDICINES MAY INTERACT with Lidex-E Cream. Because little, if any, of Lidex-E Cream is absorbed into the blood, the risk of it interacting with another medicine is low.


Ask your health care provider if Lidex-E Cream 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 Lidex-E Cream:


Use Lidex-E Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Apply a small amount of medicine to the affected area. Gently rub the medicine in until it is evenly distributed. Wash your hands after applying Lidex-E Cream, unless your hands are part of the treated area.

  • Do not bandage or cover the treated skin area unless directed by your doctor.

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

Ask your health care provider any questions you may have about how to use Lidex-E Cream.



Important safety information:


  • Lidex-E Cream is for external use only. Do not get Lidex-E Cream in your eyes. If contact is made with the eyes, flush them immediately with tap water.

  • If Lidex-E Cream is applied to the diaper area, apply a very small amount and do not use tight-fitting diapers or plastic pants.

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

  • Talk with your doctor before you receive any vaccine while you are using Lidex-E Cream.

  • Do not use Lidex-E Cream for other skin conditions at a later time.

  • Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Lidex-E Cream.

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


Possible side effects of Lidex-E Cream:


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:



Dryness; itching.



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 Lidex-E Cream; 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.


See also: Lidex-E 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. Lidex-E Cream may be harmful if swallowed.


Proper storage of Lidex-E Cream:

Store Lidex-E Cream at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lidex-E Cream out of the reach of children and away from pets.


General information:


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

  • Lidex-E Cream 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 Lidex-E Cream. 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 Lidex-E resources


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


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  • Atopic Dermatitis
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Saturday, 23 June 2012

Anturane


Generic Name: Sulfinpyrazone
Class: Uricosuric Agents
VA Class: MS400
CAS Number: 57-96-5

Introduction

Uricosuric agent,a b platelet aggregation inhibitor. a


Uses for Anturane


Hyperuricemia Associated with Gout


Treatment of chronic or intermittent gouty arthritis and tophaceous gout.a b


Used in patients with frequent disabling attacks of gout.a b


Used when tophi are visible or serum urate concentrations are >8.5–9 mg/dL in patients with family history of tophi or low uric acid excretion.a


Not recommended for management of asymptomatic hyperuricemia; however, some clinicians initiate therapy when serum urate concentrations are >9 mg/dL (by colorimetric method) because such concentrations often are associated with increased joint changes and renal complications.a b


Goal of therapy is to lower serum urate concentrations to about 6 mg/dL. a


Alternative to probenecid, which generally is better tolerated.a May be used with allopurinol for additive effect, especially in the presence of tophaceous deposits.a May be used with probenecid if the uricosuric response to one drug is insufficient at maximum therapeutic dosage.a


Not effective in patients with moderate to severe chronic renal insufficiency.a (See Renal Impairment under Cautions.)


Of no value in the treatment of acute gout attacks.a b (See Actions and also see Acute Gout under Cautions.)


Hyperuricemia Secondary to Other Causes


Has been used effectively and is commonly employed to promote uric acid excretion in hyperuricemia secondary to administration of thiazide and related diuretics, furosemide, ethacrynic acid, pyrazinamide, or ethambutol.a


Do not use to treat hyperuricemia secondary to cancer chemotherapy, radiation, or myeloproliferative neoplastic diseases; may increase risk of uric acid nephropathy.a


Platelet Aggregation Inhibition


Has been used to decrease platelet aggregation and increase platelet survival time in cardiovascular disorders, including angina, MI, TIAs, amaurosis fugax, peripheral arterial atherosclerosis, DVT and recurrent venous thrombosis, and in patients with arteriovenous dialysis shunts and prosthetic mitral valves. a


Not associated with benefit in patients with unstable angina or non-ST-segment elevation MI; not recommended by ACC/AHA as antiplatelet therapy in such patients.201


Has been used to maintain graft patency in patients undergoing CABG surgery; however, not consistently effective and not recommended by the American College of Chest Physicians (ACCP) for this use.200


Anturane Dosage and Administration


General



  • All patients should maintain daily urine output at ≥2–3 L; alkalinization of urine desirable.a



Administration


Oral Administration


Take with meals, milk, or antacids to minimize adverse GI effects.a b


Dosage


Adjust dosage according to the response and tolerance of the patient.a


Use low dosages initially to reduce possibility of acute gout attacks and prevent massive uricosuria.a


Adults


Hyperuricemia Associated with Gout

Oral

Initially, 100–200 mg twice daily during the first week of therapy, then increase as needed to full maintenance dosage of 200–400 mg twice daily.a b Serum urate concentrations usually fall to minimum levels within a few days; once controlled, may attempt to reduce dosage to 200 mg daily in divided doses.a b


Patients previously controlled with other uricosuric therapy may begin sulfinpyrazone at full maintenance dosage.a b


Uricosuric therapy should be continued indefinitely and without interruption; irregular dosage schedules may result in increased serum urate concentrations.a b


Inhibition of Platelet Aggregation

Oral

600–800 mg daily has been used.a


Special Populations


Hepatic Impairment


No specific dosage recommendations at this time.a


Renal Impairment


No specific dosage recommendations at this time.a (See Renal Impairment under Cautions.)


Geriatric Patients


No specific dosage recommendations at this time.a


Cautions for Anturane


Contraindications



  • Active peptic ulcer or symptoms of GI inflammation or ulceration.b




  • Known hypersensitivity to sulfinpyrazone or any ingredient in the formulation, or to other pyrazolone derivatives such as phenylbutazone.a b




  • Past or present blood dyscrasias.b (See Hematologic Effects.)



Warnings/Precautions


Sensitivity Reactions


Sulfite Sensitivity

Some formulations contain sulfites, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.a


General Precautions


Hematologic Effects

Pyrazole compound; closely monitor patients and perform periodic blood counts.a b


Acute Gout

Of no value in treatment of acute gout attacks; will prolong and exacerbate inflammation during the acute phase.a b May increase frequency of acute attacks during the first 6–12 months of therapy despite maintenance of normal or subnormal serum urate concentrations.a b Therefore, administer prophylactic doses of colchicine concurrently during first 3–6 months of therapy.a


Acute attacks usually become less severe and of briefer duration after several months; during acute attacks, continue sulfinpyrazone and give full therapeutic doses of colchicine or other anti-inflammatory agents.a


Urolithiasis

May promote development of uric acid stones; may cause renal colic and hematuria, especially early in therapy.a Advise patient to ingest large amounts of fluids to maintain large volumes of alkaline urine to reduce risk of stone formation.a Allopurinol preferred in patients with urinary uric acid excretion >900 mg/day or with gouty nephropathy, urinary tract stones or obstruction, or azotemia.a


GI Effects

May reactivate or aggravate peptic ulcers.a b May use with caution in patients with history of healed peptic ulcer.a b


Specific Populations


Pregnancy

No reports of congenital malformation.a Use caution in pregnant women, weighing possible risks against potential benefits.a


Pediatric Use

Safety and efficacy not established.b


Renal Impairment

Use caution in patients with mild renal impairment; avoid when Clcr <50 mL/minute.a Assess renal function periodically in patients with impaired renal function.a


Common Adverse Effects


Nausea,a dyspepsia,a GI pain and blood loss,a reactivation or aggravation of peptic ulcer,a b rash,a b dizziness,a vertigo,a tinnitus,a edema.a


Interactions for Anturane


Weak Organic Acids


Competitively inhibits renal tubular secretion of many weak organic acids, possibly potentiating their effects by elevating plasma concentrations.a Substantially increases plasma concentrations of acidic drugs eliminated principally by renal secretion, but increases plasma concentrations only slightly if the drug is eliminated mainly by glomerular filtration.a Drugs for which high urinary concentrations are desired (i.e. nitrofurantoin) may be less effective due to blocked renal secretion.a


Protein-bound Drugs


Because of high protein binding, could interact with other protein-bound drugs; observe for signs of toxicity if such drugs used concurrently.a c


Drugs that Increase Serum Uric Acid


Increase in sulfinpyrazone dosage may be necessary.a Avoid uricosurics in patients receiving cancer chemotherapy due to risk of uric acid nephropathy.a


Specific Drugs and Laboratory Testsa b c





































































Drug



Interaction



Comments



Alcohol



Increased serum urate concentration



Higher sulfinpyrazone dose may be required



Allopurinol



Additive uricosuric effects



Used to therapeutic advantage



Aminohippuric acid test



Sulfinpyrazone decreases urinary excretion



Evaluate test results accordingly



Aminosalicylic acid



Increased plasma aminosalicylic acid concentration



Importance unknown



Antineoplastic agents



Increased serum urate concentration, risk of uric acid nephropathy



Avoid concurrent use



Cholestyramine



Binds and delays absorption of sulfinpyrazone



Give sulfinpyrazone >1 hour before or 4–6 hours after cholestyramine



Colchicine



Risk of acute myeloblastic leukemia and multiple myeloma



Careful hematologic examinations recommended if used concurrently



Diazoxide



Increased serum urate concentration



Higher sulfinpyrazone dose may be required



Diuretics



Increased serum urate concentration



Higher sulfinpyrazone dose may be required



Insulin



Increased plasma insulin concentration



Use with caution



Mecamylamine



Increased serum urate concentration



Higher sulfinpyrazone dose may be required



Nitrofurantoin



Reduced nitrofurantoin efficacy and possible toxicity



Avoid concurrent use



Penicillins



Increased plasma penicillin concentration



Not clinically important or useful



Phenolsulfonphthalein test



Sulfinpyrazone decreases urinary excretion



Evaluate test results accordingly



Probenecid



Inhibits secretion of sulfinpyrazone and active metabolite



No clinically important interaction; may be used concurrently



Pyrazinamide



Increased serum urate concentration



Higher sulfinpyrazone dose may be required



Salicylates



Antagonize uricosuric action of sulfinpyrazone



Concurrent use contraindicated; acetaminophen may be used



Sulfonamides



Increased plasma sulfonamide concentration



Not clinically important or useful



Sulfonylureas



Increased plasma sulfonylurea concentration



Theoretical risk of hypoglycemia; use with caution



Thrombolytics



GI bleeding, decreased platelet aggregation



Avoid concurrent use



Warfarin



Enhanced hypoprothrombinemic effect



Use with caution and close monitoring; consider different uricosuric agent


Anturane Pharmacokinetics


Absorption


Bioavailability


Rapidly and completely absorbed from GI tract.a Peak plasma concentrations reached 1–2 hours after single oral dose.a


Duration


Usually 4–6 hours (up to 10 hours).a


Distribution


Plasma Protein Binding


Approximately 98% bound to plasma proteins.a


Elimination


Metabolism


Rapidly metabolized in liver to glucuronide conjugate and three oxidation products: a sulfone, a 4-hydroxy, and a p-hydroxy compound, which possesses uricosuric activity. a


Elimination Route


Small amounts of sulfinpyrazone filtered at glomeruli; most actively secreted at proximal tubule.a Minimal amounts then reabsorbed by kidney tubule.a After 2 days, approximately 45% of a single oral 200-mg dose is excreted in urine as unchanged drug, 25% as sulfinpyrazone glucuronide, and 10% as the other 3 metabolites.a Approximately 5% of dose excreted in feces.a


Half-life


3 hours (range 1–9 hours). a


Stability


Storage


Oral


Capsules and Tablets

15–30°C in tight containers.a b


ActionsActions



  • Pyrazolone-derivative renal tubular blocking agent; competitively inhibits active reabsorption of uric acid at proximal convoluted tubule, promoting urinary excretion of uric acid and resorption of tophi and reducing serum urate concentrations.a b


    May reduce plasma protein binding of urate and, in subtherapeutic doses, may inhibit renal secretion of uric acid.a Has no effect on glomerular filtration rate or tubular reabsorption of normal urinary constituents such as sodium, potassium, and water in healthy patients.a




  • Exerts no clinically apparent analgesic or anti-inflammatory activity.a b (See Acute Gout under Cautions.)




  • Inhibits release of adenosine monophosphate, diphosphate, and triphosphate and 5-hydroxytryptamine (5-HT); inhibition of adenosine diphosphate and 5-HT results in decreased platelet adhesiveness and increases platelet survival time.a No effect on plasma prothrombin or thromboplastin levels but may increase platelet count.a Blood clotting time not altered.a




  • A small but significant lowering of serum cholesterol has been demonstrated in gouty patients receiving sulfinpyrazone.a



Advice to Patients



  • Importance of informing patient that sulfinpyrazone is not intended for relief of an acute gout attack. a b




  • Importance of drinking plenty of fluids and maintaining alkaline urine.a




  • Importance of taking with meals, milk, or antacids to minimize adverse GI effects.a b




  • Importance of informing patient that acute gout attacks may increase in frequency during the first 6–12 months of therapy, then diminish.a b Continue sulfinpyrazone during attacks; other drugs for acute gout attack may be prescribed by clinician.a b




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.b




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.b




  • Importance of informing patients of other important precautionary information.b (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name


















Sulfinpyrazone

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Capsules



200 mg*



Anturane (with sodium bisulfite)



Novartis



Tablets



100 mg*



Anturane (scored)



Novartis



Disclaimer

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 August 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.


† Use is not currently included in the labeling approved by the US Food and Drug Administration.




References


Only references cited for selected revisions after 1984 are available electronically.



200. Stein PD, Schunemann HJ, Dalen JE et al. Antithrombotic therapy in patients with saphenous vein and internal mammary artery bypass grafts. The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004; 126:600S–608S.



201. Braunwald E, Antman E, Beasley JW et al. ACC/AHA 2002 guideline update for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients with Unstable Angina). 2002. Available at



a. AHFS Drug Information 2008. McEvoy GK, ed. Sulfinpyrazone. Bethesda, MD: American Society of Health-System Pharmacists; 2008:[page 2795-6].



b. Ciba-Geigy. Anturane (sulfinpyrazone) tablets and capsules prescribing information. Summit, NJ; 2006. (). Dated 1996 Apr. Accessed 9/21/07.



c. Jack Ansell J, Hirsh J, Poller L et al. The pharmacology and management of the vitamin K antagonists. The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004; 204S-33S.



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Flexeril



Generic Name: Cyclobenzaprine
Class: Centrally Acting Skeletal Muscle Relaxants
VA Class: MS200
Chemical Name: 3-(5H-dibenzo[a,d]cyclohepten-5-ylidine)-N,N-dimethyl-1-propanamine hydrochloride
Molecular Formula: C20H21N·HCl
CAS Number: 6202-23-9

Introduction

Centrally acting skeletal muscle relaxant; structurally and pharmacologically related to tricyclic antidepressants.101


Uses for Flexeril


Muscular Conditions


Adjunct to rest and physical therapy for the relief of muscular spasm associated with acute, painful musculoskeletal conditions.101


For low back pain, generally reserve skeletal muscle relaxants for adjunctive treatment when pain is unresponsive to OTC analgesics (e.g., NSAIAs).104 105 106 107 108 109


Skeletal muscle relaxants less well tolerated than NSAIAs, and clinical superiority to NSAIAs not established for low back pain.104 105 106 107 108 109


Various skeletal muscle relaxants appear to have comparable efficacy for low back pain relief101 104 and are more effective than placebo.104 106 108


Initially, symptomatic control of acute low back pain focuses on providing sufficient comfort to allow maximum possible activity while awaiting spontaneous recovery; later, as aid to overcome specific activity intolerance.108


Because of rapid spontaneous recovery rate, efficacy of various therapies may be difficult to establish;108 improvement of low back pain usually occurs within 2 weeks, substantial improvement within 4 weeks.107


Insufficient evidence to indicate whether cyclobenzaprine enhances the effects of aspirin or other analgesics, or vice versa, in the management of painful musculoskeletal conditions.101


Ineffective for the treatment of cerebral or spinal disease-associated spasticity or in children with cerebral palsy.101


Flexeril Dosage and Administration


Administration


Administer orally.101


Dosage


Available as cyclobenzaprine hydrochloride; dosage expressed in terms of the salt.101


Pediatric Patients


Muscular Conditions

Oral

Adolescents ≥15 years of age: 5 mg 3 times daily; may increase dosage to 10 mg 3 times daily depending on response.101


Adults


Muscular Conditions

Oral

5 mg 3 times daily; may increase dosage to 10 mg 3 times daily depending on response.101


Prescribing Limits


Pediatric Patients


Muscular Conditions

Oral

Do not administer for more than 2–3 weeks.101


Adults


Muscular Conditions

Oral

Do not administer for more than 2–3 weeks.101


Special Populations


Hepatic Impairment


Initiate with caution in patients with mild hepatic impairment.101 Consider less frequent dosing; start with 5-mg dose and increase slowly.101


Use not recommended in patients with moderate or severe hepatic impairment.101


Geriatric Patients


Consider less frequent dosing; start with 5-mg dose and increase slowly.101


Cautions for Flexeril


Contraindications



  • Known hypersensitivity to cyclobenzaprine or any ingredient in the formulation.101




  • Concomitant or recent (within 14 days) therapy with MAO inhibitor.101




  • Acute recovery phase of MI.101




  • Arrhythmias, heart block or conduction disorders, or CHF.101




  • Hyperthyroidism.101



Warnings/Precautions


Warnings


Similarity to Tricyclic Antidepressants

Shares the toxic potentials of tricyclic antidepressants; observe the usual precautions associated with tricyclic antidepressant therapy.101 a


Cardiac Effects

Arrhythmias, sinus tachycardia, prolongation of the conduction time leading to MI, and stroke reported with tricyclic antidepressants.101


CNS Effects

May cause serious CNS effects, especially when recommended dosage is exceeded.101


Performance of activities requiring mental alertness or physical coordination may be impaired.101


Concurrent use of other CNS depressants may potentiate CNS depression.101 (See Interactions: Specific Drugs.)


General Precautions


Anticholinergic Effects

Potential for adverse anticholinergic effects.101 Use with caution in patients with history of urinary retention, angle-closure glaucoma, or increased intraocular pressure or in patients receiving anticholinergic drugs.101


Specific Populations


Pregnancy

Category B.101 a


Lactation

Not known whether cyclobenzaprine is distributed into milk; however, distribution into milk is likely, since other tricyclic drugs distribute into milk.101 b Use with caution.101 a b


Pediatric Use

Safety and efficacy not established in children <15 years of age.101


Geriatric Use

Increased plasma concentrations.101


Increased frequency and severity of adverse effects (with or without concomitant drug therapy).101 Increased risk of adverse CNS effects (e.g., hallucinations, confusion, sedation), adverse cardiovascular effects resulting in falls or other sequelae, and interactions with other drugs or diseases.101


Use only if clearly needed.101 Cautious dosing recommended.101 (See Geriatric Patients under Dosage and Administration.)


Hepatic Impairment

Increased plasma concentrations and susceptibility to sedation.101


Initiate with caution in patients with mild hepatic impairment.101 (See Hepatic Impairment under Dosage and Administration.)


Use not recommended in patients with moderate or severe hepatic impairment.101


Common Adverse Effects


Drowsiness, dry mouth, dizziness, fatigue, headache.101


Interactions for Flexeril


Metabolized by CYP3A4, 1A2, and (to a lesser extent) 2D6.101


Shares the drug interaction potential of tricyclic antidepressants; consider the usual interactions of tricyclic antidepressant therapy.101


Specific Drugs
























Drug



Interaction



Comments



Aspirin



No substantial change in plasma concentrations or bioavailability of either drug.101



CNS depressants (e.g., alcohol, barbiturates)



Additive effects.101



Hypotensive agents (e.g., guanethidine)



May block uptake and antihypertensive effects of guanethidine and other similarly acting drugs.101



MAO inhibitors



Possible hyperpyretic crisis, seizures, and death.101



Cyclobenzaprine contraindicated in patients currently or recently (within 14 days) receiving MAO inhibitor.101



Naproxen



Possible increased risk of drowsiness.101



Tramadol



Increased risk of seizures.101


Flexeril Pharmacokinetics


Absorption


Bioavailability


Well absorbed following oral administration110 111 but appears to undergo first-pass metabolism;112 113 115 mean oral bioavailability is 33–55%.101 110 111 113 114 Undergoes enterohepatic circulation.101 110 113


Special Populations


In patients ≥65 years of age, mean steady-state AUC is about 1.7 times greater than AUC in younger adults.101


In patients with mild to moderate hepatic impairment, peak plasma concentration and AUC are twice the values in healthy individuals.101 110


Distribution


Extent


Widely distributed into most body tissues.110


Plasma Protein Binding


About 93%.101 111


Elimination


Metabolism


Extensively metabolized in the liver via oxidation and conjugation.101 110 112 113 115 Oxidative N-demethylation mediated by CYP3A4, 1A2, and (to a lesser extent) 2D6.101 110


Elimination Route


Eliminated mainly in urine as inactive glucuronide metabolites; <1% eliminated as unchanged drug.101 110 112 113


Half-life


About 18 hours (range: 8–37 hours).101 110


Stability


Storage


Oral


Tablets

25°C (may be exposed to 15–30°C).101


ActionsActions



  • CNS depressant with sedative and skeletal muscle relaxant effects.101 a




  • Precise mechanism of action not known.101 a Does not directly relax skeletal muscle and, unlike neuromuscular blocking agents, does not depress neuronal conduction, neuromuscular transmission, or muscle excitability.101 a




  • Like tricyclic antidepressants, potentiates the effects of norepinephrine and has anticholinergic effects.101 a



Advice to Patients



  • Potential for drug to impair mental alertness and physical coordination, particularly when used with alcohol or other CNS depressants.101 Use caution when driving or operating machinery.101




  • Potential for more frequent or severe adverse effects in geriatric patients.101




  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.101 a b




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.101 a b




  • Importance of informing patients of other important precautionary information.101 (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name


















Cyclobenzaprine Hydrochloride

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Tablets, film-coated



5 mg



Flexeril



McNeil



10 mg*



Flexeril



McNeil


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Cyclobenzaprine HCl 10MG Tablets (CADISTA): 30/$13.99 or 60/$16.98


Cyclobenzaprine HCl 5MG Tablets (CADISTA): 30/$13.99 or 60/$16.98


Fexmid 7.5MG Tablets (VICTORY PHARMA): 30/$135.99 or 90/$365.97


Flexeril 10MG Tablets (MCNEIL CONSUMER): 30/$66.48 or 90/$176.6


Flexeril 5MG Tablets (MCNEIL CONSUMER): 30/$60.44 or 90/$168.38



Disclaimer

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 July 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References


Only references cited for selected revisions after 1984 are available electronically.



100. Gatter RA. Pharmacotherapeutics in fibrositis. Am J Med. 1986; 81(Suppl 3A):63-6. [IDIS 222657] [PubMed 3464210]



101. McNeil. Cyclobenzaprine hydrochloride (Flexeril) tablets prescribing information. Fort Washington, PA: 2003 Feb.



102. Liebelt EL, Francis PD. Cyclic Antidepressants. In: Goldfrank’s Toxicologic Emergencies. 7th Ed. 2002. McGraw-Hill New York, NY.



103. Borenstein DG, Korn S. Efficacy of a low-dose regimen of cyclobenzaprine acute skeletal muscle spasm: results of two placebo-controlled trials. Clin Ther. 2003; 25:1056-73. [IDIS 497263] [PubMed 12809957]



104. van Tulder MW, Touray T, Furlan AD et al. Muscle relaxants for non-specific low back pain. The Cochrane Library. From their web site (). Accessed 11/10/2003.



105. van Tulder MW, Scholten RJPM, Kowes BW, et al. Non-steroidal anti-inflammatory drugs for low back pain. The Cochrane Library. From their web site (). Accessed 11/10/2003.



106. Department of Veterans Affairs Veterans Health Administration Office of Quality & Performance. Management of Person with Low Back Pain/Sciatica in Primary Care. From the web site (). Accessed 8/25/2003.



107. Agency for Healthcare Research and Quality. Adult low back pain. From the National Guideline Clearinghouse website. (). Accessed 8/25/2003.



108. U.S. Department of Health and Human Services. Public Health Service. Agency for Halath Care Policy and Research. Acute low back problems in adults. Clinical Practice Guideline.1994; No. 14



109. U.S. Department of Health and Human Services. Public Health Service. Agency for Health Care Policy and Research. Acute low back problems in adults: Assessment and treatment. Clinical Practice Guideline. Quick Reference Guide for Clinicians.1994; No. 14



110. Winchell GA, King JD, Chavez-Eng CM et al. Cyclobenzaprine pharmacokinetics, including the effects of age, gender, and hepatic insufficiency. J Clin Pharmacol. 2002;42:61-9. IDIS 475544



111. Hucker HB, Stauffer SC, Balletto AJ et al. Physiological disposition and metabolism of cyclobenzaprine in the rat, dog, rhesus monkey, and man. Drug Metab Dispos. 1978; 6:659-72. [IDIS 118762] [PubMed 33029]



112. Hucker HB, Stauffer SC, Albert KS et al. Plasma levels and bioavailability of cyclobenzaprine in human subjects. J Clin Pharmacol. 1977; Nov-Dec:719-27.



113. Till AE, Constanzer ML, Demetriades J et al. Evidence for route dependent biotransformation of cyclobenzaprine hydrochloride. Biopharm Drug Dispos. 1982; 3:19-28. [IDIS 147637] [PubMed 7082776]



114. Nugent LW, Irvin JD, Till AE et al. Cyclobenzaprine hydrochloride: Pharmacokinetics and bioavailability following oral and intramuscular administration. J Clin Pharmacol. 1982; 22(Suppl): 12A.



115. Hucker HB, Stauffer SC. GLC determination of cyclobenzaprine in plasma and urine. J Pharm Sci. 1976; 65:1253-5. [IDIS 70381] [PubMed 978450]



a. AHFS Drug Information 2003. McEvoy GK, ed. Cyclobenzaprine hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; 2004:1330-2.



b. AHFS Drug Information 2003. McEvoy GK, ed. Tricyclic antidepressants general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2004:2234-41.



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