Butoconazole
(Redirected from Gynazole-1)
What is Butoconazole?[edit | edit source]
- Butoconazole (Femstat 3; Gynazole-1) is an imidazole derivative with antifungal activity used in gynecology. It is administered as a vaginal cream.
What are the uses of this medicine?[edit | edit source]
- Butoconazole (Femstat 3; Gynazole-1) is used to treat yeast infections of the vagina.
- Butoconazole Nitrate Vaginal Cream USP, 2% is indicated for the local treatment of vulvovaginal candidiasis (infections caused by Candida).
How does this medicine work?[edit | edit source]
- The nitrate salt form of butaconazole, a synthetic imidazole derivative with fungistatic properties.
- Butoconazole nitrate interferes with steroid biosynthesis by inhibiting the conversion of lanosterol to ergosterol, thereby changing the fungal cell membrane lipid composition.
- This alters cell permeability and leads to growth inhibition.
- Butaconazole nitrate is active against many dermatophytes and yeasts.
- It also contains antibacterial effects against some gram-positive organisms.
- Butoconazole nitrate is an imidazole derivative that has fungicidal activity in vitro against Candida spp. and has been demonstrated to be clinically effective against vaginal infections due to Candida albicans.
- Candida albicans has been identified as the predominant species responsible for vulvovaginal candidiasis.
Who Should Not Use this medicine ?[edit | edit source]
This medicine cannot be used in patients with:
- a history of hypersensitivity to any of the components of the product.
What drug interactions can this medicine cause?[edit | edit source]
- Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Be sure to mention any of the following:
- antibiotic medications
Is this medicine FDA approved?[edit | edit source]
- Yes, it is FDA approved.
How should this medicine be used?[edit | edit source]
Recommended dosage:
- The recommended dose of Butoconazole Nitrate Vaginal Cream USP, 2% is one applicatorful of cream (approximately 5 grams of the cream) intravaginally.
- This amount of cream contains approximately 100 mg of butoconazole nitrate.
Administration:
- Butoconazole comes as a cream to insert into the vagina. It is usually used daily at bedtime.
- The dose should be applied when you lie down to go to bed. T
- he drug works best if you do not get up again after applying it except to wash your hands.
- You may wish to wear a sanitary napkin to protect your clothing against stains.
- Do not use a tampon because it will absorb the drug.
- Do not douche unless your doctor tells you to do so.
What are the dosage forms and brand names of this medicine?[edit | edit source]
This medicine is available in fallowing doasage form:
- As Butoconazole Nitrate Vaginal Cream USP, 2%
This medicine is available in fallowing brand namesː
- Femstat 3; Gynazole-1
What side effects can this medication cause?[edit | edit source]
The most common side effects of this medicine include:
- vulvar/vaginal burning
- itching, soreness and swelling
- pelvic or abdominal pain or cramping
- fever
- foul-smelling discharge
What special precautions should I follow?[edit | edit source]
- This cream contains mineral oil. Mineral oil may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms; therefore, use of such products within 72 hours following treatment with Butoconazole Nitrate Vaginal Cream USP, 2% is not recommended.
- If clinical symptoms persist, tests should be repeated 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.
- Tell your doctor if you have or have ever had diabetes, problems with your immune system, human immunodeficiency virus infection (HIV), or acquired immunodeficiency syndrome (AIDS).
- There are no adequate and well-controlled studies in pregnant women. Butoconazole Nitrate Vaginal Cream USP, 2% should be used during pregnancy only under the supervision of a physician.
- It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when butoconazole nitrate is administered to a nursing woman.
What to do in case of emergency/overdose?[edit | edit source]
- In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.
- Overdose related information is also available online at poisonhelp.org/help.
- In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
Can this medicine be used in pregnancy?[edit | edit source]
- Pregnancy Category C.
- There are, however, no adequate and well-controlled studies in pregnant women.
- Butoconazole Nitrate Vaginal Cream USP, 2% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Can this medicine be used in children?[edit | edit source]
- Safety and effectiveness in children have not been established.
What are the active and inactive ingredients in this medicine?[edit | edit source]
Active ingredient:
- BUTOCONAZOLE NITRATE
Inactive ingredients:
- EDETATE DISODIUM
- GLYCERYL ISOSTEARATE
- METHYLPARABEN
- MINERAL OIL
- POLYGLYCERYL-3 OLEATE
- PROPYLENE GLYCOL
- PROPYLPARABEN
- SILICON DIOXIDE
- SORBITOL
- WATER
- MICROCRYSTALLINE WAX
Who manufactures and distributes this medicine?[edit | edit source]
- Made in Israel
Manufactured By:
- Perrigo
- Yeruham , Israel
Distributed By:
- Perrigo®
- Allegan, MI
What should I know about storage and disposal of this medication?[edit | edit source]
- Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).
- Avoid heat above 30°C (86°F).
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