(mi kon' a zole)
P : Caution when used during pregnancy
L : Caution when used during lactation
|| See TERMINOLOGY & ABBREVIATIONS ||
|Indication(s) & Dosage||Mouth/Throat
Intestinal or oropharyngeal candidiasis
Adult: As oral gel containing 20 mg/g (24 mg/ml): 5-10 ml after food 4 times a day. Retain near oral lesions before swallowing. Continue treatment until 48 hr after lesions have healed. For treatment of oral lesions, apply directly onto the lesions 4 times a day for 5-7 days. Continue treatment until 48 hr after lesions have healed.
Child: As oral gel containing 20 mg/g: 1 mth-2 y: 2.5 ml bid. 2-6 yr: 5 ml bid. >6 yr: 5 ml 4 times a day. Retain near oral lesions before swallowing. Continue treatment until 48 hr after lesions have healed.
Adult: 100 mg (as pessary or 5 g of 2% cream) inserted at night for 7-14 days. Alternatively, 100 mg bid for 7 days; 200 or 400 mg (as pessaries) daily for 3 days or 1200 mg (as pessary) as a single dose.
Skin fungal infections
Adult: Apply 2% cream once daily.
Child: Apply 2% cream once daily.
be taken with food. Take immediately before or during breakfast, or the 1st main meal of the day. Do not skip meals.
|Contraindications||Hypersensitivity; hepatic impairment (oral gel). Porphyria.|
|Special Precautions||For external use only; discontinue if sensitization or irritation occurs. Pregnancy and lactation.|
|Adverse Drug Reaction(s)||Nausea, vomiting, febrile reactions,
rash, drowsiness, diarrhoea, anorexia and flushing, hepatitis. Local irritation and sensitisation, contact dermatitis.
Potentially Fatal: IV: Anaphylactic reaction and cardiac arrest.
|Drug Interactions||Increased toxicity reported with carbamazepine. Miconazole acts as an inhibitor of CYP3A4 and CYP2D6 and may,
therefore, interact with a large number of drugs e.g. statins, HIV protease inhibitors, ciclosporin, tacrolimus, sildenafil, quinidine, pimozide.
Potentially Fatal: Potentiates anticoagulant effect of warfarin. Increased risk of cardiotoxicity with cisapride, astemizole or terfenadine. Please consult detailed drug interactions before prescribing.
|Pregnancy Category (FDA)||Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.|
|Pharmacology||Miconazole inhibits ergosterol biosynthesis thus damaging fungal cell wall membrane and increases its permeability, allowing leakage of
Absorption: Incomplete from the GI tract (oral); minimal (topical).
Metabolism: Hepatic; converted to inactive metabolites.
Excretion: 10-20% of an oral dose will be excreted in urine (as metabolites), 50% of an oral dose is excreted as unchanged drug in the faeces. Elimination half-life: 40 minutes (initial), 126 minutes (secondary), 24 hr (terminal).
|ATC Classification||D01AC02 - miconazole; Belongs to the class of imidazole and triazole
derivatives for topical use. Used in the treatment of fungal infection.
A07AC01 - miconazole; Belongs to the class of imidazole derivative antiinfectives. Used for the treatment of intestinal infections.
S02AA13 - miconazole; Belongs to the class of antiinfectives used in the treatment of ear infections.
J02AB01 - miconazole; Belongs to the class of systemic imidazole derivative antimycotics. Used in the treatment of mycotic infections.
A01AB09 - miconazole; Belongs to the class of local antiinfective and antiseptic preparations. Used in the treatment of diseases of the mouth.
G01AF04 - miconazole; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections.
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|A-MIGEL||The Acme Laboratories Ltd.||Miconazole base USP 2% w/w||Oral Gel||15gm: 50.20 MRP|
|CANDORAL||Beximco Pharmaceuticals Ltd||Miconazole BP 20mg/gm (2%w/w)||Gel||15gm: 52.00 MRP|
|DAKRIN||General Pharmaceuticals Ltd||Miconazole base USP 2% w/w||Oral Gel||15gm: 50.19 MRP|
|FUNGIMIN||Kumudini Pharma Ltd||Miconazole nitrate 2% (20mg/gm)||Cream||10gm: 30.00 MRP|
|G-MICONAZOLE||Gonoshasthaya Pharmaceuticals Ltd||Miconazole nitrate 2% (20mg/gm)||Cream||5gm & 10gm: 18.28 & 34.52 MRP|
|GELORA||Square Pharmaceuticals Ltd.||Miconazole 2%||Oral Gel||15gm: 50.20 MRP|
|GELORA O-GEL||Square Pharmaceuticals Ltd.||Miconazole 2%||Oral Gel||15 gm: 60.18 MRP|
|MIC||Globe Pharmaceuticals Ltd||Miconazole nitrate 2% (20mg/gm)||Cream||10gm: 35.00 MRP|
|MICODERM||Drug International Ltd||Miconazole base USP 2% w/w||Oral Gel||15gm: 50.00 MRP|
|MICONEX||ACI Ltd.||Miconazole nitrate 2% (20mg/gm)||Cream||10gm: 35.13 MRP|
|MICORAL||ACI Ltd.||Miconazole base USP 2% w/w||Oral Gel||15gm: 50.19 MRP|
|MIRGAL||Everest Pharmaceuticals Ltd.||Miconazole base USP 2% w/w||Oral Gel||15gm: 48.00 MRP|
|MITIGAL||Ad-din pharmaceuticals Ltd.||Miconazole nitrate 2% (20mg/gm)||Cream||10gm: 30.00 MRP|
|MIZOL||Medicon Laboratories Ltd||Miconazole base USP 2% w/w||Oral Gel||15gm: 50.00 MRP|
|MYCO-OG||Pharmasia Limited||Miconazole base USP 2% w/w||Oral Gel||15gm: 50.00 MRP|
|MYCON||Aristopharma Ltd.||Miconazole base USP 2% w/w||Oral Gel||15gm: 50.00 MRP|
|OROCARE||Novo Healthcare and Pharma Ltd.||Miconazole base USP 2% w/w||Oral Gel||15gm: 50.00 MRP|
|Oroconazol gel||Incepta Pharmaceuticals Limited||Miconazole BP 20mg/gm||Oral Gel||15gm x 1:MRP 50 Tk|
|OROGURD||Eskayef Bangladesh Ltd||Miconazole BP 20mg/gm||Oral Gel||15gm MRP: 50.00|
|TOPICAZOLE||Incepta Pharmaceuticals Limited||Miconazole Nitrate BP 20mg/gm||Cream||10gm: 35.00 MRP|
Why is Miconazole prescribed?
Miconazole, an antifungal agent, is used for skin infections such as athlete's foot and jock itch and for vaginal yeast infections.
Miconazole is sometimes prescribed for other uses; ask your doctor for more information.
How should Miconazole be used?
Miconazole comes as a cream, lotion, powder, spray liquid, and spray powder to be applied to the skin. It also comes as a cream and suppository to be inserted into the vagina. Miconazole is usually used once or twice a day for 1 month for athlete's foot or 2 weeks for other skin infections. For vaginal infections, it is used once a day at bedtime for 3 or 7 days. Follow the directions on the package or on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use miconazole exactly as directed. Do not use more or less of it or use it more often than directed by your doctor.
It probably will take several days for improvement to be seen in skin infections.
Apply the topical forms of miconazole sparingly to the infected area after washing and drying the skin thoroughly. The cream and lotion should be rubbed gently into the skin. Wash your hands promptly.
If you are using miconazole vaginal cream or suppositories, read the instructions provided with the medication and follow these steps:
Fill the special applicator that comes with the cream to the level indicated, or unwrap a suppository and place it on the applicator as shown in the instructions.
Lie on your back with your knees drawn upward and spread apart.
Gently insert the applicator into the vagina, and push the plunger to release the medication.
Withdraw the applicator.
Discard the applicator if it is disposable. If the applicator is reusable, pull it apart and clean it with soap and warm water after each use.
Wash your hands promptly to avoid spreading the infection.
The dose should be applied when you lie down to go to bed. It works best if you do not get up after applying it except to wash your hands. You may wish to wear a sanitary napkin while using the suppositories or vaginal cream to protect your clothing against stains. Do not use a tampon because it will absorb the drug. Do not douche unless your doctor informs you to do so. Continue using miconazole vaginal cream or suppositories even if you get your period during treatment.
What special precautions to follow?
Before using miconazole,
- inform your doctor if you are allergic to miconazole or any other drugs.
- inform your doctor what prescription and nonprescription medications you are taking, including vitamins.
- inform your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking miconazole, call your doctor. Before using miconazole, inform your doctor if you are using a diaphragm or condom for birth control and are being treated for a vaginal infection. Miconazole vaginal cream and suppositories can interact with the latex in diaphragms and condoms, so use another method of birth control.
What to do if I forget a dose?
Apply the missed dose as soon as you remember it. If you remember a missed dose at the time you are scheduled to apply the next one, omit the missed dose completely and use only the regularly scheduled dose. Do not use a double dose to make up for a missed one.
What side effects can Miconazole cause?
Miconazole may cause side effects. If you experience any of the following symptoms, call your doctor immediately:
increased burning, itching, or irritation of the skin or vagina
foul-smelling vaginal discharge
What to know about storage and disposal of Miconazole?
Keep Miconazole in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What other information to know?
Keep all appointments with your doctor. Miconazole is for external use only. Do not let miconazole get into your eyes, nose, or mouth, and do not swallow it. Do not apply dressings, bandages, cosmetics, lotions, or other skin medications to the area being treated unless your doctor informs you.
If you obtained the topical form of miconazole without a prescription and your symptoms do not improve within 4 weeks (2 weeks for jock itch), stop using it and talk to a pharmacist or doctor.
If this is the first time you have had vaginal itching and discomfort, talk to a doctor before using miconazole. If a doctor has told you before that you had a yeast infection and you have the same symptoms again, use the vaginal cream or suppositories as directed on the package.
Do not let anyone else use your medication. If you still have symptoms of infection after you finish the miconazole, call your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Ref: U.S. National Library of Medicine.
This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.