Sunday, 30 September 2012

Ibugel Forte 10%





IBUGEL FORTE



ibuprofen 10% w/w




Read all of this leaflet carefully before using this product.



Keep this leaflet. You may need to read it again.



Ask your doctor or pharmacist if you need more information or advice.



This medicine has been prescribed for you.



Do not pass it on to others, even if their symptoms are the same as yours.



If any of the side effects get serious or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.





In this leaflet:



  • 1. What Ibugel Forte is and what it is used for

  • 2. Before you use Ibugel Forte

  • 3. How to use Ibugel Forte

  • 4. Possible side effects

  • 5. How to store Ibugel Forte

  • 6. Further information





What Ibugel Forte Is And What It Is Used For



  • Ibugel Forte is an anti-inflammatory painkiller applied to, and absorbed through, the skin.

  • It is for the treatment of the following conditions involving the musculoskeletal system:

    • backache

    • rheumatic or muscular pain

    • sprains

    • strains

    • neuralgia.



  • It is also for pain relief in common arthritic conditions.

  • Ibugel Forte is recommended for use by adults, the elderly and children over the age of 12 years. Children under the age of 12 may also use it if recommended by their doctor.

  • The active ingredient in this product is ibuprofen. This is one of a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).

  • Ibuprofen works by:

    • relieving pain

    • reducing swelling and inflammation.





Before You Use Ibugel Forte




Do not use Ibugel Forte:



  • if you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of Ibugel Forte listed in section 6;

  • if you are asthmatic, or suffer from rhinitis (allergic runny nose) or urticaria (hives) and have ever had a bad reaction to aspirin, ibuprofen or other NSAIDs in the past;

  • if you are pregnant or breast-feeding;

  • on broken, damaged, infected or diseased skin.




Before applying this product for the first time, make sure it is suitable for you to use:



Because Ibugel Forte is delivered through the skin, directly over the painful area, there is less risk of the complications that sometimes occur when ibuprofen (or a similar anti-inflammatory painkiller) is taken by mouth. However, in rare cases you may be at risk:



  • if you have a stomach ulcer (also called a peptic or gastric ulcer);

  • if you have ever had kidney problems;

  • if you have ever had asthma;

  • if you have ever had a bad reaction to aspirin or ibuprofen taken by mouth.

If any of the above apply to you, only use this product on advice from your doctor.





Take special care when using this product:



  • Use it only on the skin.

  • Do not use it on children under 12 years old unless advised by a doctor.

  • Keep the gel away from the eyes, nose and mouth.




Using other medicines



  • Interaction between Ibugel Forte and blood pressure lowering drugs and anticoagulants is possible, in theory, although very unlikely. If you would like more advice about this, speak to your doctor or pharmacist.

  • If you are also taking aspirin or other NSAIDs by mouth, discuss this beforehand with your doctor or pharmacist because these may increase the risk of undesirable effects.

  • Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including other medicines obtained without prescription.




Pregnancy and breast-feeding



You should not use Ibugel Forte if you are pregnant or breast-feeding.





Driving and using machinery



Using this product is not known to affect your ability to drive or use machinery.






How To Use Ibugel Forte




Before using this tube of gel for the first time, open it as follows:



  • Unscrew the cap, turn it upside down and then use the sharp point of the cap to pierce the membrane in the neck of the tube.




The tube squeezer key:



To make Ibugel Forte easier and more economical to use, a red tube squeezer key has been provided. Once fitted to the tube, simply turning the key will dispense the gel more easily for patients who experience difficulties in squeezing tubes. For economy, the key will also help expel the last few grams of Ibugel Forte when the tube is nearly empty.





To fit the tube squeezer key:



  • Ensure that the tube nozzle has been pierced using the point of the cap.

  • Slide the slit of the key over the folded end of the tube.

  • Carefully turn the key to roll up the tube until the required amount of gel has been expelled.

  • Always replace the cap after use, leaving the key in place on the end of the tube.




To use the gel (for adults, the elderly and children over 12 years old):



  • Use the gel up to three times a day, or as often as advised by your doctor.

  • Lightly apply the gel to intact skin over the painful area.

  • Apply 2 to 5 cm of gel (50 to 125 mg ibuprofen), then massage gently into the skin over and around the affected area until absorbed.

  • Wash hands after use, unless treating them.

  • Carry on using the gel in this way until your condition gets better (you may find you need to use it for a few weeks, and your doctor may want you to continue using it for longer than this).

  • If your symptoms worsen or continue for more than a few weeks, discuss this with your doctor before continuing treatment.




If the gel comes into contact with broken skin or gets into the eyes, nose or mouth



  • The product may cause irritation if it comes into contact with broken skin or gets into the eyes, nose or mouth. If this happens, rinse the affected areas with plenty of water. If rinsing one eye, take care to avoid washing product into the other eye. If irritation persists, tell your doctor or pharmacist.




If the gel is accidentally swallowed



  • Symptoms may include headache, vomiting, drowsiness and low blood pressure.

  • If you experience any of these symptoms, contact a doctor or hospital straight away.




If you forget to use this product



Do not worry if you occasionally forget to use this product, just carry on using it when you remember.




If you have any further questions on the use of this product, ask your doctor or pharmacist.





Possible Side Effects



Like all medicines, Ibugel Forte can cause side effects, although not everybody gets them.



Occasionally, mild skin rashes, itching or irritation can sometimes occur at the site of application.



If this is unacceptable, or persists, stop using the product and tell your doctor or pharmacist.



Very rarely, the following side effects can happen with ibuprofen, although these are extremely uncommon with products such as Ibugel Forte that are applied to the skin.




If you experience any of the following, stop using Ibugel Forte immediately and tell your doctor:



  • Allergic reactions (particularly in people who have a history of asthma or allergic problems), such as:

    • unexplained runny nose and watery eyes, or, in more serious cases asthma or aggravated asthma involving breathing difficulties, wheezing or chest tightness;

    • generalised allergic skin reactions involving itch, swelling, inflammation, redness and perhaps blistering and light sensitivity;

    • other more serious generalised allergic reactions possibly involving unexplained nausea and vomiting, swollen eyes, face or tongue, difficulty swallowing, dizziness or light-headedness. Unconsciousness could perhaps occur in the most serious cases.



  • Kidney problems (particularly in people who have a history of kidney disease), such as:

    • decreased urine volume;

    • loss of appetite / weight loss;

    • swelling to abdomen.



  • Problems with the digestive system (particularly in people who have a history of stomach ulcers etc), such as:

    • stomach pain;

    • heartburn / indigestion.




If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.





How To Store Ibugel



  • Keep it out of the reach and sight of children.

  • Always replace the cap tightly after use.

  • Do not store the product above 25°C.

  • Do not use after the expiry date shown on the fold of the tube and the carton. The expiry date refers to the last day of that month.

  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.




Further Information About Ibugel Forte




What Ibugel Forte contains:



The active ingredient is ibuprofen (10% w/w).



The other ingredients are industrial methylated spirit, carbomers, diethylamine and purified water.





What Ibugel Forte looks like and contents of the pack



  • The product is a clear or slightly hazy gel that is non-greasy and contains no fragrance.


  • The gel is available in tubes containing 100g.

    The packs also contain a tube key.




The Marketing Authorisation holder is




Dermal Laboratories

Tatmore Place

Gosmore

Hitchin

Herts

SG4 7QR

UK





The Manufacturer is




Fleet Laboratories Ltd

94 Rickmansworth Road

Watford

Herts

WD18 7JJ

UK





This leaflet was last approved in October 2007.



To listen to or request a copy of this leaflet in Braille, large print or audio, please call free of charge: 0800 198 5000 (UK only).



Please be ready to give the following information: Ibugel Forte, 00173/0175. This is a service provided by the Royal National Institute of Blind People (RNIB).



GP15/07/7






Saturday, 29 September 2012

Stimate


Generic Name: desmopressin (Nasal route, Oral route, Injection route)

des-moe-PRES-in

Injection route(Solution)

Desmopressin acetate is not indicated for the treatment of hemophilia A with factor VIII coagulant activity levels equal to or less than 5%, or for the treatment of hemophilia B, or in patients who have factor VIII antibodies .



Commonly used brand name(s)

In the U.S.


  • DDAVP

  • DDAVP Rhinal Tube

  • Minirin

  • Stimate

Available Dosage Forms:


  • Solution

  • Spray

  • Tablet

Therapeutic Class: Endocrine-Metabolic Agent


Pharmacologic Class: Vasopressin (class)


Uses For Stimate


Desmopressin is a hormone taken through the nose, by mouth, or given by injection to prevent or control the frequent urination, increased thirst, and loss of water associated with diabetes insipidus (water diabetes). It is used also to control bed-wetting and frequent urination and increased thirst associated with certain types of brain injuries or brain surgery. Desmopressin works by acting on the kidneys to reduce the flow of urine.


Desmopressin is also given by injection to treat some patients with certain bleeding problems such as hemophilia or von Willebrand's disease.


Desmopressin is available only with your doctor's prescription.


Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, desmopressin is used in certain patients to determine the cause of Cushing's syndrome.


Before Using Stimate


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


Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of nasal desmopressin in children and infants. However, infants may be more sensitive to the effects of nasal desmopressin, which may require caution in patients receiving this medicine .


Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of oral desmopressin in infants and children with diabetes insipidus. However, safety and efficacy have not been established in children below 6 years of age with bed-wetting problems .


Appropriate studies have not been performed on the relationship of age to the effects of desmopressin injection in infants below 3 months of age for the treatment of hemophilia A or Von Willebrand's disease, and in children below 12 years of age with diabetes insipidus. Safety and efficacy have not been established in these age groups .


Geriatric


Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of desmopressin in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment of dosage in patients receiving desmopressin .


Pregnancy








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

Breast Feeding


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


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


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:


  • Blood clots—Use with caution. Desmopressin injection may worsen this condition .

  • Cystic fibrosis or

  • Dehydration or

  • Fluid or electrolyte imbalance or

  • Heart failure—Loss of sodium from the blood and serious side effects may be more likely to occur in patients with these conditions .

  • Headache, severe, or migraine or

  • Heart or blood vessel disease or

  • High blood pressure—Large doses of desmopressin can cause an increase or decrease in blood pressure.

  • Hyponatremia, or history of or

  • Kidney problems—Desmopressin should NOT be used in patients with these conditions .

  • Stuffy nose caused by cold or allergy—May prevent nasal desmopressin from being absorbed through the lining of the nose into the blood stream.

Proper Use of desmopressin

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


Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.


Your doctor may want you to decrease the amount of fluids that you drink while you are using this medicine .


For patients using the nasal solution form of this medicine:


  • This medicine comes with patient instructions. Read and follow these instructions carefully.

  • Before using the medicine, gently blow your nose to clear the nostrils.

  • If you are using the nasal spray for the first time, you will need to prime the spray. To do this, press the pump down four times or until some of the medicine sprays out. If you have not used the medicine for one week or longer, re-prime the pump by pressing once.

  • Do not use the nasal spray more times than the number indicated on the label. If you do, you may not receive the correct amount of medicine.

  • After using the nasal spray, wipe the tip of the bottle with a clean tissue and put the cap back on.

  • The Rhinal Tube is a soft plastic tube with numbers (doses) marked on the side. Draw the drops into the tube until the liquid reaches the number of your dose. Put one end of the tube into your nose and the other end into your mouth. Blow gently until all the medicine has sprayed into your nose. Do not let any medicine run down through the tube into your mouth.

  • After using the rhinal tube, wash it with water and shake thoroughly until no more water is left. Put the seal back on the dropper tip and close the bottle with the plastic cap .

For patients using the tablet form of this medicine:


  • Do not drink water or any other liquids from 1 hour before to 8 hours after taking the tablets .

For patients using the injection form of this medicine:


  • A nurse or other trained health professional will give you this medicine. Sometimes you, a family member, or a friend can also be taught to give your medicine .

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 nasal dosage form (nasal solution):
    • For preventing or controlling diabetes insipidus (water diabetes):
      • Adults and teenagers—0.1 to 0.4 milliliters (ml) or 10 to 40 micrograms (mcg) given as a single dose or divided into two or three doses a day .

      • Children 3 months to 12 years of age— 0.05 to 0.3 milliliters (ml) or 5 to 30 micrograms (mcg) given as a single dose or divided into two doses a day .

      • Children up to 3 months of age—Use and dose must be determined by your doctor .



  • For oral dosage form (tablets):
    • For preventing or controlling diabetes insipidus (water diabetes):
      • Adults, teenagers, and children—At first, 0.05 milligram (mg) two times a day. Then, your doctor may change the dose to 0.1 to 0.8 mg. The dose may be divided into several doses a day.


    • For controlling bed-wetting:
      • Adults, teenagers, and children 6 years of age or older—At first, 0.2 mg once a day at bedtime. Then, your doctor may increase the dose to as much as 0.6 mg a day.

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



  • For parenteral dosage form (injection):
    • For preventing or controlling frequent urination:
      • Adults and teenagers—2 to 4 mcg injected into a vein or under the skin. This dose is usually divided into two doses a day, one given in the morning, and the other given in the evening.

      • Children up to 12 years of age—Use and dose must be determined by your doctor .


    • For treating some bleeding problems such as hemophilia or von Willebrand's disease (Type I):
      • Adults, teenagers, and children 11 months of age or older weighing more than 10 kg (22 pounds)—The dose is based on body weight and must be determined by your doctor. It is usually 0.3 micrograms (mcg) per kilogram (kg) (0.14 mcg per pound) of body weight mixed in 50 milliliters (mL) of 0.9% sodium chloride. This solution is injected into a vein slowly over fifteen to thirty minutes. Your doctor may repeat this treatment if needed.

      • Children 3 months of age or older weighing 10 kg (22 pounds) or less—The dose is based on body weight and must be determined by your doctor. It is usually 0.3 micrograms (mcg) per kilogram (kg) (0.14 mcg per pound) of body weight mixed in 10 mL of 0.9% sodium chloride. This solution is injected into a vein slowly over fifteen to thirty minutes. Your doctor may repeat this treatment if needed.

      • Children up to 3 months of age—Use and dose must be determined by your doctor .



Missed Dose


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


Has a bulleted list describing how to handle missed doses for various possible dosing schedules.


Storage


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


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


Store as directed on the label or by your health care professional.


Precautions While Using Stimate


It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Urine tests may be needed to check for unwanted effects .


This medicine lowers the amount of sodium in your blood. Check with your doctor right away if you have confusion, nausea, vomiting, muscle cramps or spasms, or unusual tiredness or weakness .


Check with your doctor right away and stop using this medicine if you have fever, severe vomiting or diarrhea, or other conditions that may make you thirsty (such as during hot weather or having a strenuous exercise). This medicine may cause fluid or electrolyte imbalance which can lead to seizures and other serious conditions .


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


Desmopressin may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble breathing; or chest pain after you use this medicine .


Stimate Side Effects


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


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


Rare
  • Chills

  • confusion

  • convulsions (seizures)

  • decreased urination

  • drowsiness

  • fast heartbeat

  • fever

  • headache (continuing)

  • shortness of breath, tightness in chest, trouble in breathing, or wheezing

  • skin rash, hives, or itching

  • weight gain (rapid)

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:


Less common or rare
  • Abdominal or stomach cramps

  • flushing or redness of skin

  • nausea

  • pain in the vulva (genital area outside of the vagina)

With intranasal (through the nose) use
  • Cough

  • nosebleed

  • runny or stuffy nose

  • sneezing

  • sore throat

With intravenous use
  • Pain, redness, or swelling at place of injection

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


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

See also: Stimate side effects (in more detail)



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


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


More Stimate resources


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


  • Stimate nasal Concise Consumer Information (Cerner Multum)

  • Stimate Spray MedFacts Consumer Leaflet (Wolters Kluwer)

  • Stimate Prescribing Information (FDA)

  • Desmopressin Prescribing Information (FDA)

  • DDAVP Prescribing Information (FDA)

  • DDAVP Concise Consumer Information (Cerner Multum)

  • DDAVP MedFacts Consumer Leaflet (Wolters Kluwer)

  • Desmopressin Acetate Monograph (AHFS DI)

  • Minirin Spray MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Stimate with other medications


  • Hemophilia A
  • von Willebrand's Disease

Miconazole Nitrate


Class: Azoles
ATC Class: D01AC02
VA Class: DE102
CAS Number: 22832-87-7
Brands: Desenex, Femizol-M, Fungoid, Lotrimin AF, Micatin, Monistat, Ting, Vusion, Zeasorb-AF

Introduction

Antifungal; azole (imidazole derivative).a


Uses for Miconazole Nitrate


Dermatophytoses


Treatment of tinea corporis (body ringworm) and tinea cruris (jock itch) caused by Epidermophyton floccosum, Trichophyton mentagrophytes, or T. rubrum.a d h


Treatment of tinea pedis (athlete’s foot) caused by Epidermophyton floccosum, Trichophyton mentagrophytes, or T. rubrum.a d f g


Topical antifungals usually effective for treatment of uncomplicated tinea corporis or tinea cruris.104 105 106 108 An oral antifungal preferred when tinea corporis or tinea cruris is extensive, dermatophyte folliculitis is present, infection is chronic or does not respond to topical therapy, or patient is immunocompromised because of coexisting disease or concomitant therapy.104 105 106 108


Topical antifungals usually effective for treatment of uncomplicated tinea pedis.104 105 106 107 108 An oral antifungal may be necessary for treatment of hyperkeratotic areas on the palms and soles,105 108 for chronic moccasin-type (dry-type) tinea pedis,104 105 107 and for tinea unguium (fingernail or toenail dermatophyte infections, onychomycosis).104 105 106 107 108


Pityriasis (Tinea) Versicolor


Treatment of pityriasis (tinea) versicolor caused by Malassezia furfur (Pityrosporum orbiculare or P. ovale).a


Topical treatment usually effective;104 105 107 110 111 112 an oral antifungal (alone or in conjunction with a topical antifungal) may be necessary in patients who have extensive or severe infections or who fail to respond to or have frequent relapses with topical therapy.107 110 111


Cutaneous Candidiasis


Treatment of cutaneous candidiasis caused by Candida albicans.a d


Treatment of candidal diaper dermatitis.b i Treatment of choice is a topical antifungal (e.g., nystatin, clotrimazole, miconazole).i Most infants with candidal diaper dermatitis harbor C. albicans in their intestines and infected feces appear to be an important source of the cutaneous infection.i Some clinicians recommend that an oral antifungal (e.g., oral nystatin) be administered concomitantly to treat the intestinal infection,i but studies have not provided evidence that concomitant oral and topical therapy is more effective than topical therapy alone.i


Vulvovaginal Candidiasis


Treatment of uncomplicated vulvovaginal candidiasis (mild to moderate, sporadic or infrequent, most likely caused by Candida albicans, occurring in immunocompetent women).100 102 113 114 115 118 119 135 j l m A drug of choice.100 102 113 114 115 118 119 135 j l m


Self-medication (OTC use) for treatment of uncomplicated vulvovaginal candidiasis in otherwise healthy, nonpregnant women who have been previously diagnosed by a clinician and are having a recurrence of similar symptoms.c e


Treatment of complicated vulvovaginal candidiasis, including infections that are recurrent (≥4 episodes in 1 year), severe (extensive vulvar erythema, edema, excoriation, fissure formation), caused by Candida other than C. albicans, or occurring in women with underlying medical conditions (uncontrolled diabetes mellitus, HIV infection, immunosuppressive therapy, pregnancy).100 k l Complicated infections generally require more prolonged treatment than uncomplicated infections.100 l k


Miconazole Nitrate Dosage and Administration


Administration


Administer topically to skin or intravaginally in appropriate formulations.a


Topical skin preparations are for external use only and should not be used orally, intravaginally, or near or in eyes or mucous membranes.a b


Intravaginal preparations are for intravaginal administration only and should not be used orally, topically on the skin, or near or in eyes.a


Topical Administration


Administer topically to the skin as a 0.25% ointment, 2% aerosol, 2% aerosol powder, or 2% cream, lotion, powder, or tincture.a


Do not use on the scalp or nails.a d e f g


Wash hands after applying.b


Shake sprays and lotions well before using.a g h f


Do not use tincture for self-medication in patients with diabetes, circulatory, renal, or hepatic problems.d


When treating dermatomycoses or cutaneous candidiasis, apply sparingly to cleansed, dry, infected area.a


When treating tinea pedis, pay special attention to spaces between toes.a d f g Also, wear well-fitting, ventilated shoes and change shoes and socks at least once daily.a d f g


When treating candidal diaper dermatitis, apply at each diaper change.b Gently cleanse skin with lukewarm water and pat dry with a soft towel.b Gently apply thin layer to diaper area with fingertips; do not rub into skin since this may cause additional irritation.b


Intravaginal Topical Administration


Administer intravaginally as a 2% cream or 100- or 200-mg suppository.a


Use for self-medication only in otherwise healthy, nonpregnant women with recurrent vulvovaginal candidiasis who were previously diagnosed by a clinician.100 c e


Dosage


Pediatric Patients


Dermatophytoses

Tinea Corporis or Tinea Cruris

Topical

Children ≥2–11 years of age: Apply twice daily (morning and evening) for 2 weeks.a d h


If clinical improvement does not occur after treatment, reevaluate the diagnosis.a


Tinea Pedis

Topical

Children ≥2–11 years of age: Apply twice daily (morning and evening) for 1 month.a d g


If clinical improvement does not occur after treatment, reevaluate the diagnosis.a


Pityriasis (Tinea) Versicolor

Topical

Children ≥2–11 years of age: Apply once daily for 2 weeks.a


If clinical improvement does not occur after 2 weeks of treatment, reevaluate the diagnosis.a


Cutaneous Candidiasis

Topical

Children ≥2–11 years of age: Apply twice daily (morning and evening) for 2 weeks.a d


If clinical improvement does not occur after treatment, reevaluate the diagnosis.a


Diaper Dermatitis

Topical

Infants ≥4 weeks of age: Apply to affected area at each diaper change for 7 days.b


Continue treatment for 7 days, even if improved.b


Ointment is not a substitute for frequent diaper changes;b do not use for prevention of diaper dermatitis.b (See Selection and Use of Antifungals for Diaper Dermatitis under Cautions.)


Uncomplicated Vulvovaginal Candidiasis

Intravaginal

Children ≥12 years of age: 100-mg suppository at bedtime for 7 days or 200-mg suppository at bedtime for 3 days.100 a Alternatively, applicatorful of 2% intravaginal cream once daily at bedtime for 7 days.100 a May be used for self-medication.100 a


If clinical symptoms do not improve within 3 days, persist for >7 days, or recur within 2 months, discontinue self-medicationand consult a clinician.a Confirm diagnosis and rule out other pathogens and conditions that may predispose a patient to recurrent vaginal fungal infections.100


Topical

For adjunctive relief of external vulvar itching: Apply 2% topical vulvar cream twice daily (morning and evening) for up to 7 days as needed.a e


HIV-infected Adolescents

Intravaginal

Use same regimen recommended for other patients.100 k Some experts recommend a duration of 3–7 days.k Maintenance regimen of an intravaginal azole can be considered for those with recurrent episodes;k routine primary or secondary prophylaxis (long-term suppressive or chronic maintenance therapy) not recommended.100 k


Complicated Vulvovaginal Candidiasis

Recurrent Vulvovaginal Infections Caused by Candida albicans

Intravaginal

Adolescents: CDC and others recommend an initial intensive regimen (7–14 days of an intravaginal azole or 3-dose regimen of oral fluconazole) to achieve mycologic remission, followed by an appropriate maintenance regimen (6-month regimen of once-weekly oral fluconazole or, alternatively, an intravaginal azole given intermittently).100 j l


Other Complicated Vulvovaginal Infections

Intravaginal

Adolescents: CDC and others recommend 7–14 days of an intravaginal azole for vulvovaginal candidiasis that is severe, caused by Candida other than C. albicans, or occurring in women with underlying medical conditions.100 l


Adults


Dermatophytoses

Tinea Corporis or Tinea Cruris

Topical

Apply twice daily (morning and evening) for 2 weeks.a d h


If clinical improvement does not occur after treatment, reevaluate the diagnosis.a


Tinea Pedis

Topical

Apply twice daily (morning and evening) for 1 month.a d g


If clinical improvement does not occur after treatment, reevaluate the diagnosis.a


Pityriasis (Tinea) Versicolor

Topical

Apply once daily for 2 weeks.a


If clinical improvement does not occur after treatment, reevaluate the diagnosis.a


Cutaneous Candidiasis

Topical

Apply twice daily (morning and evening) for 2 weeks.a


If clinical improvement does not occur after treatment, reevaluate the diagnosis.a


Uncomplicated Vulvovaginal Candidiasis

Intravaginal

100-mg suppository at bedtime for 7 days or 200-mg suppository at bedtime for 3 days.100 a Alternatively, applicatorful of 2% intravaginal cream once daily at bedtime for 7 days.100 a May be used for self-medication.100 a


If clinical symptoms do not improve within 3 days, persist for >7 days, or recur within 2 months, discontinue self-medicationand consult a clinician.a Confirm diagnosis and rule out other pathogens and conditions that may predispose a patient to recurrent vaginal fungal infections.100


Topical

For adjunctive relief of external vulvar itching: Apply 2% topical vulvar cream twice daily (morning and evening) for up to 7 days as needed.a e


HIV-Infected Adults

Intravaginal

Use same regimen recommended for other patients.100 k Some experts recommend a duration of 3–7 days.k Maintenance regimen of an intravaginal azole can be considered for those with recurrent episodes;k routine primary or secondary prophylaxis (long-term suppressive or chronic maintenance therapy) not recommended.100 k


Complicated Vulvovaginal Candidiasis

Recurrent Vulvovaginal Infections Caused by Candida albicans

Intravaginal

CDC and others recommend an initial intensive regimen (7–14 days of an intravaginal azole or 3-dose regimen of oral fluconazole) to achieve mycologic remission, followed by an appropriate maintenance regimen (6-month regimen of once-weekly oral fluconazole or, alternatively, an intravaginal azole given intermittently).100 j l


Other Complicated Vulvovaginal Infections

Intravaginal

CDC and others recommend 7–14 days of an intravaginal azole for vulvovaginal candidiasis that is severe, caused by Candida other than C. albicans, or occurring in women with underlying medical conditions.100 l


Pregnant women: CDC and others recommend a 7-day regimen of an intravaginal azole antifungal (e.g., miconazole).100 l


Prescribing Limits


Pediatric Patients


Diaper Dermatitis

Topical

Infants ≥4 weeks of age: Maximum treatment duration is 7 days; safety of longer treatment not known.b


Special Populations


Hepatic Impairment


No specific dosage recommendations at this time.a


Renal Impairment


No specific dosage recommendations at this time.a


Geriatric Patients


No specific dosage recommendations at this time.a


Cautions for Miconazole Nitrate


Contraindications


Known hypersensitivity to miconazole or any ingredient in the formulation.a b


Warnings/Precautions


Warnings


Use of Latex or Rubber Products

Miconazole vaginal suppositories contain petroleum base that can weaken latex or rubber products (including condoms and vaginal contraceptive diaphragms).a Concurrent use not recommended.a Consider use of miconazole vaginal cream as an alternative to the suppositories.a


Sensitivity Reactions


Hypersensitivity Reactions

Contact dermatitis reported following topical application of miconazole or other imidazole-derivative azole antifungals.125 126 127 128 129 130


If irritation or sensitivity occurs, discontinue the drug and contact a clinician.a


Possible cross-sensitization among the imidazoles.125 126 127 128 129 130 a


General Precautions


Selection and Use of Antifungals for Diaper Dermatitis

Prior to use of ointment for adjunctive treatment of diaper dermatitis, confirm diagnosis of candidiasis with microscopic evidence of pseudohyphae and/or budding yeast.b A positive fungal culture for C. albicans is not adequate evidence of candidal infection since colonization with C. albicans can result in a positive culture.b


Use ointment as part of a treatment regimen that includes measures directed at the underlying diaper dermatitis; the ointment is not a substitute for frequent diaper changes.b Do not use to prevent diaper dermatitis; preventive use may result in development of drug resistance.b


Safety and efficacy of ointment for treatment of diaper dermatitis in immunocompromised patients not established.b


Safety and efficacy of ointment have not been evaluated in incontinent adults; do not use in an attempt to prevent occurrence of diaper dermatitis (e.g., in adult institutional settings).b


Selection and Use of Antifungals for Vulvovaginal Candidiasis

Prior to initial use in a woman with signs and symptoms of vulvovaginal candidiasis, confirm the diagnosis by potassium hydroxide (KOH) microscopic mounts and/or cultures.100 102


Candida identified by culture in the absence of symptoms is not an indication for antifungal treatment since approximately 10–20% of women harbor Candida or other yeasts in the vagina.100


If clinical symptoms persist, repeat tests to rule out other pathogens, to confirm the original diagnosis, and to rule out other conditions that may predispose a patient to recurrent vaginal fungal infections.a


Do not use for self-medication in women who have never had a vaginal yeast infection diagnosed by a clinician,c e in women who are or think they may be pregnant, or in women with HIV infection or exposure.c e


Other Administration Precautions

Topical skin preparations are for external use only.a Do not administer orally or intravaginally.a Avoid contact with eyes, nose, mouth, and other mucous membranes.a


Intentional misuse by deliberately concentrating and inhaling the contents of the aerosols can be harmful or fatal.f g


Specific Populations


Pregnancy

Category C.b


CDC and others state that a 7-day regimen of an intravaginal azole antifungal can be used, if necessary, for treatment of vulvovaginal candidiasis in pregnant women.100 l


Lactation

Not known whether miconazole is distributed into milk; use with caution in nursing women.a b


Pediatric Use

Topical skin preparations: Use in children <2 years of age only if directed by a clinician.a d f g Use in children ≥2–11 years of age only under adult supervision.a


Ointment for candidal diaper dermatitis: Safety and efficacy not established in infants <4 weeks of age (premature or term) or very-low-birth weight infants.b (See Selection and Use of Antifungals for Diaper Dermatitis under Cautions.)


Intravaginal preparations: Safety and efficacy for self-medication not established in children <12 years of age.a e


Geriatric Use

Clinical studies evaluating miconazole ointment for treatment of candidal diaper dermatitis did not include any adults ≥65 years of age; safety and efficacy of the ointment have not been evaluated in geriatric adults.b


Common Adverse Effects


Irritation, burning, itching.a b


Interactions for Miconazole Nitrate


Weak inhibitor of CYP2C9.133 134


Drugs Metabolized by Hepatic Microsomal Enzymes


Drugs metabolized by CYP2C9: possible increased plasma concentrations.133 134


Specific Drugs









Drug



Interaction



Comments



Warfarin



Potential for increased plasma warfarin concentrations with intravaginal miconazole133 134


Potential for interaction with miconazole applied topically to skin is unknownb



Do not use intravaginal miconazole forself-medication if taking warfarin132 133 134 c


Miconazole Nitrate Pharmacokinetics


Absorption


Bioavailability


Minimal systemic absorption following topical application to skin.a b


Only small amounts absorbed systemically following intravaginal administration.a


Distribution


Extent


Not known whether systemically absorbed miconazole is distributed into milk.a


Elimination


Elimination Route


Following intravaginal administration, systemically absorbed drug excreted in urine and feces (1% of dose).a


Stability


Storage


Topical


Ointment

20–25°C (may be exposed to 15–30°C).b


Aerosol

2–30°C (Lotrimin AF);f 20–25°C (Desenex).g Do not use near fire or flame; do not expose to temperatures >49°C.f g


Aerosol Powder

2–30°C.h


Cream, Lotion, and Powder

Tight container at 15–30°C.a


Tincture

Protect from freezing; if crystals form, leave at room temperature for 2 days or immerse bottle in warm water for 6 hours until crystals dissolve, then shake well.d


Intravaginal


Cream

15–30°C.a


Suppository

20–25°C.e


Actions and SpectrumActions



  • Imidazole-derivative azole antifungal.a




  • Usually fungistatic in action; can be fungicidal at high concentrations or against very susceptible organisms (e.g., Candida).a




  • Presumably exerts its antifungal activity by altering cellular membranes, resulting in increased membrane permeability.a Interferes with ergosterol biosynthesis.b




  • Spectrum of antifungal activity includes many fungi, including yeasts and dermatophytes.a Also has in vitro activity against some gram-positive bacteria.a




  • Candida: Active against Candida albicans,a b C. guilliermondii,a and C. tropicalis.a




  • Dermatophytes and other fungi: Active against Epidermophyton floccosum, Microsporum canis, Trichophyton mentagrophytes, and T. rubrum.a




  • Bacteria: Active against Staphylococcus aureus.a




  • Cross-resistance can occur among the azole antifungals.



Advice to Patients


  • Topical Administration


  • Importance of completing full course of therapy, even if symptoms improve.d




  • Importance of contacting clinician if condition worsens during treatment or if improvement does not occur after completing full course of therapy.d




  • Importance of discontinuing use and consulting clinician if treated area becomes irritated (e.g., itching, burning, blistering, swelling, oozing).d




  • Importance of applying topical skin preparations to affected areas as directed and avoiding contact with eyes, nose, mouth, or mucous membranes.b d




  • Importance of washing hands after applying miconazole.b




  • Importance of consulting a clinician before using tincture if diagnosed with diabetes, circulatory, renal, or hepatic problems.d




  • For patients with tinea pedis (athlete’s foot), importance of wearing well-fitting, ventilated shoes and changing socks at least once daily.a d




  • For patients with candidal diaper dermatitis, importance of using ointment only for diaper dermatitis complicated by documented candidiasis.b Not for preventative use;b should not be used as a substitute for frequent diaper changes and should not be used long term.b




  • For patients with candidal diaper dermatitis, importance of gently cleansing diaper area with lukewarm water or a very mild soap and patting dry with a soft towel before applying ointment.b Importance of not rubbing ointment into skin since this may cause additional irritation.b




  • Importance of not using ointment on children for whom it is not prescribed.b



  • Intravaginal Administration


  • Importance of reading and understanding manufacturer’s patient instructions regarding use of applicator for intravaginal administration.c e




  • Not for self-medication in women who have never had a vaginal yeast infection diagnosed by a clinician.c e




  • Not for intravaginal self-medication in women who think they are pregnant or have been exposed to HIV, unless otherwise directed by a clinician.a c




  • Importance of discontinuing self-medication of vulvovaginal candidiasis and consulting clinician if rash or hives, fever, abdominal pain, foul-smelling vaginal discharge, or flu-like symptoms (fever, chills, nausea, vomiting) develop; if symptoms do not improve within 3 days, if condition persists beyond 7 days; or if symptoms recur within 2 months.c e




  • Importance of not using latex or rubber products such as condoms or vaginal contraceptive diaphragms within 72 hours following intravaginal miconazole treatment.a c




  • Importance of not douching after an intravaginal dose of miconazole.c




  • If used during menstruation, importance of using sanitary napkins instead of vaginal tampons.a c e




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and concomitant illnesses, including diabetes mellitus and HIV infection.a c




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




  • Importance of informing patients of other important precautionary information. (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



































































































































































Miconazole Nitrate

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Topical



Aerosol



2%



Desenex Spray Liquid (with alcohol SD 40-B 15% w/w and dimethyl ether propellant)



Novartis



Lotrimin AF Athlete’s Foot Spray Liquid (with alcohol SD-40 17% w/w, propylene glycol, and isobutane propellant)



Schering-Plough



Micatin Athlete’s Foot Spray Liquid (with alcohol 17%, benzyl alcohol, and hydrocarbon propellants)



Pfizer



Aerosol Powder



2%



Desenex Jock Itch Spray Powder (with alcohol SD 40-B 10% w/w and isobutane/propane propellant)



Novartis



Desenex Athlete’s Foot Spray Powder (with alcohol SD 40-B 10% w/w and isobutane/propane propellant)



Novartis



Lotrimin AF Athlete’s Foot Deodorant Spray Powder (with alcohol SD 40-B 10% w/w, talc, and isobutane propellant)



Schering-Plough



Lotrimin AF Athlete’s Foot Spray Powder (with alcohol SD-40 10% w/w and isobutane propellant)



Schering-Plough



Lotrimin AF Jock Itch Spray Powder (with alcohol SD-40 10% w/w and isobutane propellant)



Schering-Plough



Micatin Athlete’s Foot Spray Powder (with alcohol 10% and hydrocarbon propellants)



Pfizer



Micatin Jock Itch Spray Powder (with alcohol 10% and hydrocarbon propellants)



Pfizer



Ting Antifungal Spray Powder (with alcohol SD 40-B 10% w/w and isobutane/propane propellant)



Insight



Cream



2%



Micatin Athlete’s Foot Cream



Pfizer



Micatin Jock Itch Cream



Pfizer



Miconazole Nitrate Cream



Actavis, Fougera, G&W, Taro



Monistat-Derm



Ortho Neutrogena



Lotion



2%



Zeasorb-AF Lotion (with alcohol 36% w/w)



Stiefel



Ointment



0.25%



Vusion Ointment (with zinc oxide and white petrolatum)



Barrier Therapeutics



Powder



2%



Desenex Athlete’s Foot Shake Powder



Novartis



Lotrimin AF Athlete’s Foot Powder (with talc)



Schering-Plough



Zeasorb-AF



Stiefel



Tincture



2%



Fungoid (with benzyl alcohol, glacial acetic acid, and isopropyl alcohol; with or without Nail Scrub and brush)



Pedinol



Vaginal



Cream



2%*



Femizol-M



Lake



Miconazole Nitrate Vaginal Cream



Actavis, Perrigo, Teva



Monistat 7



Personal Products



Kit



9 g Cream, topical, Miconazole Nitrate 2% (Monistat External Vulvar Cream)


7 Suppositories, vaginal, Miconazole Nitrate 100 mg (Monistat 7)



Monistat 7 Combination Pack



Personal Products



9 g Cream, topical, Miconazole Nitrate 2% (Monistat)


3 Suppositories, vaginal, Miconazole Nitrate 200 mg (Monistat 3)



Monistat 3 Combination Pack



Personal Products



9 g Cream, topical, Miconazole Nitrate 2% (Monistat External Vulvar Cream)


1 Suppositories, vaginal, Miconazole Nitrate 1200 mg (Monistat)



Monistat1 Combination Pack Dual-Pak



Personal Products



Suppositories



100 mg



Miconazole Nitrate Vaginal Suppository



Actavis, Perrigo



Monistat 7 (in a hydrogenated vegetable oil base)



Personal Products



200 mg



Miconazole Nitrate Vaginal Suppository



Actavis



Monistat 3 (in a hydrogenated vegetable oil base)



Personal Products


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.


Miconazole Nitrate 2% Cream (ACTAVIS MID ATLANTIC): 28/$12.99 or 56/$14.98


Monistat 3 200MG Suppositories (ORTHO-MCNEIL PHARMACEUTICAL): 3/$51.99 or 9/$147.96


Zeasorb-AF 2% Powder (GLAXO SMITH KLINE): 71/$16.99 or 142/$22.97



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 2007. 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.



100. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines 2006. MMWR Morb Mortal Wkly Rep. 2006; 55(No. RR-11):1-85. [PubMed 16410759]



101. Anon. Drugs for sexually transmitted diseases. Med Lett Treat Guid. 2004; 2:67-74.



102. Doering PL, Santiago TM. Drugs for treatment of vulvovaginal candidiasis: comparative efficacy of agents and regimens. DICP. 1990; 24:1078-83. [IDIS 274670] [PubMed 2275233]



103. Sobel JD. Pathogenesis and treatment of recurrent vulvovaginal candidiasis. Clin Infect Dis. 1992; 14(Suppl 1):S148-53.



104. Gupta AK, Einarson TR, Summerbell RC et al. An overview of topical antifungal therapy in dermatomycoses: a North American perspective. Drugs. 1998; 55:645-74. [PubMed 9585862]



105. Piérard GE, Arrese JE, Piérard-Franchimont C. Treatment and prophylaxis of tinea infections. Drugs. 1996; 52:209-24. [PubMed 8841739]



106. Lesher JL. Recent developments in antifungal therapy. Dermatol Clin. 1996; 14:163-9. [PubMed 8821170]



107. Hay RJ. Dermatophytosis and other superficial mycoses. In: Mandel GL, Douglas RG Jr, Bennett JE, eds. Principles and practices of infectious disease. 4th ed. New York: Churchill Livingston; 1995:2375-86.



108. Drake LA, Dincehart SM, Farmer ER et al. Guidelines of care for superficial mycotic infections of the skin: tinea corporis, tinea cruris, tinea faciei, tinea manuum, and tinea pedis. J Am Acad Dermatol. 1996; 34:282-6. [IDIS 363962] [PubMed 8642094]



109. Reviewers’ comments (personal observations) on Sulconazole 84:04.08.



110. Sunenshine PJ, Schwartz RA, Janniger CK. Tinea versicolor: an update. Cutis. 1998; 61:65-72. [PubMed 9515210]



111. Assaf RR, Weil ML. The superficial mycoses. Dermatol Clin. 1996; 14:57-67. [PubMed 8821158]



112. Drake LA, Dinehart SM, Farmer ER et al. Guidelines of care for superficial mycotic infections of the skin: pityriasis (tinea) versicolor. J Am Acad Dermatol. 1996; 34:287-9. [IDIS 363963] [PubMed 8642095]



113. Hay RJ. Yeast infections. Dermatol Clin. 1996; 14:113-24. [PubMed 8821164]



114. Sobel JD. Vaginitis. N Engl J Med. 1997; 337:1896-903. [IDIS 401347] [PubMed 9407158]



115. Sobel JD, Faro S, Force RW et al. Vulvovaginal candidiasis: epidemiologic, diagnostic, and therapeutic considerations. Am J Obstet Gynecol. 1998; 178:203-11. [IDIS 402301] [PubMed 9500475]



116. Bisschop MPJM, Merkus JMWM, Scheygrond H et al. Co-treatment of the male partner in vaginal candidosis: a double-blind randomized control study. Br J Obstet Gynecol. 1986; 93:79-81.



117. Bohannon NJV. Treatment of vulvovaginal candidiasis in patients with diabetes. Diabetes Care. 1998; 21:451-6. [IDIS 402373] [PubMed 9540031]



118. Tobin MJ. Vulvovaginal candidiasis: topical vs. oral therapy. Am Fam Physician. 1995; 51:1715-24. [IDIS 348350] [PubMed 7754931]



119. Sobel JD. Controversial aspects in the management of vulvovaginal candidiasis. J Am Acad Dermatol. 1994; 31:S10-3. [IDIS 335764] [PubMed 8077494]



120. Spinillo A, Capuzzo E, Gulminetti R et al. Prevalence of and risk factors for fungal vaginitis caused by non-albicans species. Am J Obstet Gynecol. 1997; 176:138-41. [PubMed 9024104]



121. Chaim W. Fungal vaginitis caused by nonalbicans species. Am J Obstet Gynecol. 1997; 177:485. [IDIS 393344] [PubMed 9290485]



122. Spinillo A, Capuzzo E. Fungal vaginitis caused by nonalbicans species. Am J Obstet Gynecol. 1997; 177:485-6. [IDIS 393344] [PubMed 9290485]



123. Redondo-Lopez V, Lynch M, Schmitt C et al. Torulopsis glabrata vaginitis: clinical aspects and susceptibility to antifungal agents. Obstet Gynecol. 1990; 76:651-5. [IDIS 273142] [PubMed 2216197]



124. Reviewers’ comments (personal observations) on Tioconazole 84:04.08.



125. Bigardi AS, Pigatto PD, Altomare G. Allergic contact dermatitis due to sulconazole. Contact Dermatitis. 1992; 26:281-2. [PubMed 1395584]



126. Machet L, Vaillant L, Muller C et al. Contact dermatitis and cross-sensitivity from sulconazole nitrate. Contact Dermatitis. 1992; 26:352-3. [PubMed 1395603]



127. Jones SK, Kennedy CTC. Contact dermatitis from tioconazole. Contact Dermatitis. 1990; 22:122-3. [PubMed 2138969]



128. Baes H. Contact sensitivity to miconazole with ortho-chloro cross-sensitivity to other imidazoles. Contact Dermatitis. 1991; 24:89-93. [PubMed 1828223]



129. Marren P, Powell S. Contact sensitivity to tioconazole and other imidazoles. Contact Dermatitis. 1992; 27:129-30. [PubMed 1395626]



130. Stubb S, Heikkila H, Reitamo S et al. Contact allergy to tioconazole. Contact Dermatitis. 1992; 26:155-8. [PubMed 1387056]



132. Anon. Miconazole vaginal cream and suppositories safety information. FDA Talk Paper. Rockville, MD: Food and Drug Administration; 2001 Feb 28.



133. Thirion DJG, Zanetti LAF. Potentiation of warfarin’s hypoprothrombinemic effect with miconazole vaginal suppositories. Pharmacotherapy. 2000; 20:98-99. [IDIS 439283] [PubMed 10641982]



134. Lansdorp D, Bressers HP, Dekens-Konter JA et al. Potentiation of acenocoumarol during vaginal administration of miconazole. Br J Clin Pharmacol. 1999; 47:225-6. [IDIS 424781] [PubMed 10190660]



135. Anon. Drugs for vulvovaginal candidiasis. Med Lett Drugs Ther. 2001; 43:3-4. [PubMed 11151090]



a. AHFS drug information 2007. McEvoy GK, ed. Miconazole. Bethesda, MD: American Society of Health-System Pharmacists; 2007:3472-5.



b. Barrier Therapeutics, Inc. Vusion

Friday, 28 September 2012

Combunox


Generic Name: oxycodone and ibuprofen (Oral route)


eye-bue-PROE-fen, ox-i-KOE-done hye-droe-KLOR-ide


Oral route(Tablet)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Ibuprofen/oxycodone hydrochloride is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .



Commonly used brand name(s)

In the U.S.


  • Combunox

Available Dosage Forms:


  • Tablet

Therapeutic Class: Opioid/NSAID Combination


Pharmacologic Class: NSAID


Chemical Class: Propionic Acid (class)


Uses For Combunox


Ibuprofen and oxycodone combination is used to relieve acute, moderate to severe pain.


Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used in this combination to relieve inflammation, swelling, and pain.


Oxycodone is a narcotic analgesic that acts in the central nervous system to relieve pain. If oxycodone is used for a long time, it may become habit-forming (causing mental or physical dependence). Physical dependence may lead to withdrawal side effects when you stop taking the medicine. Since ibuprofen and oxycodone combination is only used for short-term (7 days or less) relief of pain, physical dependence probably will not occur.


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


Before Using Combunox


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


Appropriate studies have not been performed on the relationship of age to the effects of ibuprofen and oxycodone combination in children below 14 years of age. Safety and efficacy have not been established.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxycodone and ibuprofen combination in the elderly. However, elderly patients who may be more sensitive than younger adults to the effects of ibuprofen and oxycodone combination, are more likely to have kidney, lung, or stomach problems, which may require caution in patients receiving oxycodone and ibuprofen combination.


Pregnancy














Pregnancy CategoryExplanation
1st TrimesterCAnimal 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.
2nd TrimesterCAnimal 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.
3rd TrimesterDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding


Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.


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.


  • Ketorolac

  • Naltrexone

  • Pentoxifylline

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.


  • Abciximab

  • Acetophenazine

  • Adinazolam

  • Alfentanil

  • Alprazolam

  • Amobarbital

  • Anileridine

  • Aprobarbital

  • Ardeparin

  • Argatroban

  • Atazanavir

  • Beta Glucan

  • Bivalirudin

  • Brofaromine

  • Bromazepam

  • Brotizolam

  • Buprenorphine

  • Buspirone

  • Butabarbital

  • Butalbital

  • Butorphanol

  • Carisoprodol

  • Certoparin

  • Chloral Hydrate

  • Chlordiazepoxide

  • Chlorpromazine

  • Chlorzoxazone

  • Cilostazol

  • Citalopram

  • Clarithromycin

  • Clobazam

  • Clonazepam

  • Clopidogrel

  • Clorazepate

  • Clorgyline

  • Clovoxamine

  • Codeine

  • Dabigatran Etexilate

  • Dalteparin

  • Danaparoid

  • Dantrolene

  • Desflurane

  • Desirudin

  • Dexmedetomidine

  • Dezocine

  • Diazepam

  • Diphenhydramine

  • Dipyridamole

  • Doxylamine

  • Enflurane

  • Enoxaparin

  • Erythromycin

  • Escitalopram

  • Estazolam

  • Eszopiclone

  • Ethchlorvynol

  • Ethopropazine

  • Femoxetine

  • Fentanyl

  • Flesinoxan

  • Flumazenil

  • Flunitrazepam

  • Fluoxetine

  • Fluphenazine

  • Flurazepam

  • Fluvoxamine

  • Fondaparinux

  • Fospropofol

  • Furazolidone

  • Ginkgo

  • Halazepam

  • Halothane

  • Heparin

  • Hydrocodone

  • Hydromorphone

  • Hydroxyzine

  • Indinavir

  • Iproniazid

  • Isocarboxazid

  • Isoflurane

  • Itraconazole

  • Ketamine

  • Ketazolam

  • Ketoconazole

  • Lazabemide

  • Lepirudin

  • Levorphanol

  • Linezolid

  • Lorazepam

  • Lormetazepam

  • Medazepam

  • Meperidine

  • Mephenesin

  • Mephobarbital

  • Meprobamate

  • Mesoridazine

  • Metaxalone

  • Methdilazine

  • Methocarbamol

  • Methohexital

  • Methotrexate

  • Midazolam

  • Moclobemide

  • Morphine

  • Morphine Sulfate Liposome

  • Nadroparin

  • Nalbuphine

  • Nefazodone

  • Nelfinavir

  • Nialamide

  • Nitrazepam

  • Nitrous Oxide

  • Nordazepam

  • Opium

  • Oxazepam

  • Oxycodone

  • Oxymorphone

  • Pargyline

  • Parnaparin

  • Paroxetine

  • Pemetrexed

  • Pentazocine

  • Pentobarbital

  • Perphenazine

  • Phenelzine

  • Phenobarbital

  • Prazepam

  • Procarbazine

  • Prochlorperazine

  • Promazine

  • Promethazine

  • Propiomazine

  • Propofol

  • Propoxyphene

  • Protein C

  • Quazepam

  • Ramelteon

  • Rasagiline

  • Remifentanil

  • Reviparin

  • Ritonavir

  • Rivaroxaban

  • Saquinavir

  • Secobarbital

  • Selegiline

  • Sertraline

  • Sevoflurane

  • Sibutramine

  • Sodium Oxybate

  • Sufentanil

  • Tacrolimus

  • Tapentadol

  • Telithromycin

  • Temazepam

  • Thiethylperazine

  • Thiopental

  • Thioridazine

  • Ticlopidine

  • Tinzaparin

  • Tirofiban

  • Toloxatone

  • Tranylcypromine

  • Triazolam

  • Trifluoperazine

  • Triflupromazine

  • Trimeprazine

  • Vilazodone

  • Zaleplon

  • Zimeldine

  • Zolpidem

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


  • Acebutolol

  • Acetohexamide

  • Alacepril

  • Alprenolol

  • Amikacin

  • Amiloride

  • Arotinolol

  • Aspirin

  • Atenolol

  • Azilsartan Medoxomil

  • Azosemide

  • Befunolol

  • Bemetizide

  • Benazepril

  • Bendroflumethiazide

  • Benzthiazide

  • Betaxolol

  • Bevantolol

  • Bisoprolol

  • Bopindolol

  • Bucindolol

  • Bumetanide

  • Bupranolol

  • Buthiazide

  • Candesartan Cilexetil

  • Canrenoate

  • Captopril

  • Carteolol

  • Carvedilol

  • Celiprolol

  • Chlorothiazide

  • Chlorpropamide

  • Chlorthalidone

  • Cilazapril

  • Clopamide

  • Cyclopenthiazide

  • Cyclosporine

  • Delapril

  • Desipramine

  • Desvenlafaxine

  • Dilevalol

  • Duloxetine

  • Enalaprilat

  • Enalapril Maleate

  • Eprosartan

  • Esmolol

  • Ethacrynic Acid

  • Fosinopril

  • Furosemide

  • Gliclazide

  • Glimepiride

  • Glipizide

  • Gliquidone

  • Glyburide

  • Hydrochlorothiazide

  • Hydroflumethiazide

  • Imidapril

  • Indapamide

  • Irbesartan

  • Labetalol

  • Landiolol

  • Levobetaxolol

  • Levobunolol

  • Lisinopril

  • Lithium

  • Losartan

  • Mepindolol

  • Methyclothiazide

  • Metipranolol

  • Metolazone

  • Metoprolol

  • Miconazole

  • Milnacipran

  • Moexipril

  • Nadolol

  • Nebivolol

  • Nipradilol

  • Olmesartan Medoxomil

  • Oxprenolol

  • Penbutolol

  • Pentopril

  • Perindopril

  • Phenytoin

  • Pindolol

  • Piretanide

  • Polythiazide

  • Propranolol

  • Quinapril

  • Ramipril

  • Rifampin

  • Sotalol

  • Spirapril

  • Spironolactone

  • St John's Wort

  • Tacrine

  • Talinolol

  • Tasosartan

  • Telmisartan

  • Temocapril

  • Tertatolol

  • Timolol

  • Tolazamide

  • Tolbutamide

  • Torsemide

  • Trandolapril

  • Triamterene

  • Trichlormethiazide

  • Valsartan

  • Venlafaxine

  • Voriconazole

  • Xipamide

  • Zofenopril

Interactions with Food/Tobacco/Alcohol


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


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


  • Ethanol

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:


  • Addison's disease (adrenal gland problem) or

  • Alcohol abuse, history of or

  • Brain disease or

  • Depression or

  • Enlarged prostate (BPH, prostatic hypertrophy) or

  • Head injury or

  • Hypothyroidism (underactive thyroid) or

  • Kidney disease, severe or

  • Kyphoscoliosis (curvature of spine that can cause breathing problems) or

  • Liver disease, severe or

  • Lung disease, severe or

  • Problems with urination or

  • Psychosis (mental illness) or

  • Seizure disorders or

  • Systemic lupus erythematosus (SLE) or

  • Weakened physical condition—Use with caution. May increase risk for more serious side effects.

  • Anemia or

  • Breathing problems (e.g., asthma, hypercapnia, hypoxia) or

  • Bleeding problems or

  • Dehydration or

  • Edema (fluid retention) or

  • Heart attack, history of or

  • Heart disease (e.g., congestive heart failure) or

  • Hypertension (high blood pressure) or

  • Hypotension (low blood pressure) or

  • Kidney disease or

  • Liver disease or

  • Lung disease (e.g., chronic obstructive pulmonary disease [COPD], cor pulmonale) or

  • Pancreatitis (inflammation of the pancreas) or

  • Shock or

  • Stomach ulcers or bleeding, history of or

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

  • Aspirin-sensitive asthma or

  • Aspirin sensitivity, history of or

  • Bronchial asthma, acute or severe, or other chronic lung disease or

  • Hypercarbia (large amount of carbon dioxide in the blood) or

  • Paralytic ileus (bowel blockage) or

  • Respiratory depression (troubled breathing)—Should not be used in patients with these conditions.

  • Drug abuse or dependence, or history of—Dependence may be more likely to develop.

  • Heart surgery (e.g., coronary artery bypass graft [CABG])—Should not be used to relieve pain right before or after the surgery.

Proper Use of Combunox


For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Taking too much of this medicine may increase the chance of unwanted effects.


This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.


Dosing


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


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


  • For oral dosage form (tablets):
    • For pain:
      • Adults and teenagers 14 years of age and older—One tablet every 4 to 6 hours as needed. However, the dose is usually not more than 4 tablets per day, and should not be taken for longer than 7 days, unless directed by your doctor.

      • Children and teenagers younger than 14 years of age—Use and dose must be determined by your doctor.



Missed Dose


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


Storage


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


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


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


Precautions While Using Combunox


It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.


Your doctor will want to check your blood pressure at the beginning of treatment and monitor it throughout treatment with this medicine. If high blood pressure occurs or worsens while taking this medicine, it may lead to serious heart problems.


This medicine may increase your risk of having a heart attack or stroke. This is more likely to occur in people who already have heart disease. People who use this medicine for a long time might also have a higher risk. Some signs of serious heart problems are chest pain, tightness in the chest, fast or irregular heartbeat, or unusual flushing or warmth of the skin. Stop taking this medicine and check with your doctor right away if you notice any of these warning signs.


Ibuprofen and oxycodone combination will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, allergies, or colds; sedatives, tranquilizers, sleeping medicine, or other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Do not drink alcoholic beverages, and check with your medical doctor or dentist before taking any of the medicines listed above, while you are using this medicine.


This medicine may cause bleeding in your stomach or intestines. This is more likely to occur if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain other medicines (such as steroids or a blood thinner). These problems can occur at any time with or without warning, and can be fatal. You should contact your doctor immediately if any of the following symptoms occur including black, tarry stools; bloody stools; vomiting of blood or material that looks like coffee grounds; severe or continuing stomach pain, cramping, or burning; trouble breathing; severe or continuing nausea, heartburn and/or indigestion.


Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you have more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.


This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.


Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; a severe skin rash or acne; sores or ulcers on the skin; or fever or chills while you are using this medicine.


Using this medicine during late pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. Do not use this medicine during the later part of a pregnancy unless your doctor tells you to.


This medicine may cause some people to become drowsy, dizzy, lightheaded, or to feel a false sense of well-being. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded. If these reactions are especially bothersome, check with your doctor.


Dizziness, lightheadedness, or fainting may occur, especially when getting up suddenly from a lying or sitting position. Getting up slowly may lessen this problem.


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


Ibuprofen and oxycodone combination may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.


Call your doctor right away if you have confusion, drowsiness, fever, a general feeling of illness, a headache, loss of appetite, nausea, a stiff neck or back, or vomiting. These could be symptoms of a serious condition called meningitis.


If you have heart disease or congestive heart failure (CHF), tell your doctor if you have unexplained weight gain or edema (fluid retention or body swelling) with this medicine.


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


Combunox Side Effects


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


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


Less common
  • Feeling faint, dizzy, or lightheaded

  • feeling of warmth or heat

  • flushing or redness of the skin, especially on the face and neck

  • headache

  • sweating

Rare
  • Abdominal or stomach pain

  • blurred vision

  • changes in skin color

  • chest pain

  • confusion

  • convulsions

  • decrease in frequency of urination

  • decreased urine

  • difficulty with breathing

  • difficulty in passing urine (dribbling)

  • dizziness

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

  • dry mouth

  • excessive muscle tone

  • fainting

  • fast heartbeat

  • fast, pounding, or irregular heartbeat or pulse

  • increased need to urinate

  • increased thirst

  • loss of appetite

  • mood changes

  • muscle pain or cramps

  • muscle stiffness

  • muscle tension or tightness

  • nausea or vomiting

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

  • pain, tenderness, or swelling of the foot or leg

  • painful urination

  • pale skin

  • passing urine more often

  • severe constipation

  • severe vomiting

  • shortness of breath

  • troubled breathing with exertion

  • unusual bleeding or bruising

  • unusual tiredness or weakness

  • weakness

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


Symptoms of overdose
  • Change in consciousness

  • chest pain or discomfort

  • cold and clammy skin

  • constricted pupils

  • continuing ringing or buzzing or other unexplained noise in the ears

  • decreased awareness or responsiveness

  • difficult or troubled breathing

  • difficulty with sleeping

  • disorientation

  • drowsiness to profound coma

  • fainting

  • hallucination

  • hearing loss

  • irregular, fast or slow, or shallow breathing

  • lethargy

  • loss of bladder control

  • loss of consciousness

  • muscle spasm or jerking of all extremities

  • pale or blue lips, fingernails, or skin

  • severe sleepiness

  • skeletal muscle flaccidity

  • sleepiness or unusual drowsiness

  • sudden fainting

  • sudden loss of consciousness

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:


Less common
  • Acid or sour stomach

  • belching

  • bloated full feeling

  • diarrhea

  • difficulty having a bowel movement (stool)

  • excess air or gas in the stomach or intestines

  • fever

  • heartburn

  • indigestion

  • lack or loss of strength

  • passing gas

  • stomach discomfort, upset, or pain

Rare
  • Back pain

  • body aches or pain

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

  • changes in vision

  • chills

  • congestion

  • cough or hoarseness

  • delusions

  • dementia

  • difficult urination

  • difficulty with moving

  • dryness or soreness of the throat

  • enlarged abdomen or stomach

  • false or unusual sense of well-being

  • fear

  • hoarseness

  • impaired vision

  • increase in body movements

  • lower back or side pain

  • nervousness

  • pain, swelling, or redness in the joints

  • rash

  • runny nose

  • sleeplessness

  • swelling

  • taste perversion

  • tender, swollen glands in the neck

  • trouble with sleeping

  • trouble with swallowing

  • unable to sleep

  • voice changes

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


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

See also: Combunox side effects (in more detail)



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More Combunox resources


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


  • Combunox Prescribing Information (FDA)

  • Combunox MedFacts Consumer Leaflet (Wolters Kluwer)

  • Combunox Consumer Overview



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