Alevazol

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Alevazol, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Alevazol. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Alevazol (clotrimazole cream, ointment, and solution).

Review Date: October 4, 2017

Applies to clotrimazole topical: topical cream, topical lotion, topical solution

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

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

• Skin rash, hives, blistering, burning, itching, peeling, redness, stinging, swelling, or other sign of skin irritation not present before use of this medicine

Applies to clotrimazole topical: compounding powder, topical cream, topical lotion, topical powder, topical solution, topical spray, vaginal cream with applicator, vaginal kit, vaginal tablet

Dermatologic

Dermatologic side effects have included erythema, stinging, blistering, peeling, edema, itching, burning, and general skin irritation. Contact dermatitis, confirmed by patch testing, has been documented.[Ref]

Genitourinary

Genitourinary system effects associated with intravaginal use have included burning, itching, cramping, pain, and bleeding. Vulvar lesions and rash have rarely been reported.[Ref]

Some side effects of clotrimazole topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Apply clotrimazole topical in a quantity sufficient to cover the affected area and immediately surrounding skin twice a day for 4 to 8 weeks, depending on the nature and severity of the infection.

Apply clotrimazole topical in a quantity sufficient to cover the affected area and immediately surrounding skin twice a day for 2 to 4 weeks, depending on the nature and severity of the infection.

Regimen 1: 100 mg (one 100 mg vaginal suppository) intravaginally once a day for 7 consecutive days alone or in combination with topical application of 1% clotrimazole cream to affected area two times daily for 7 consecutive days.

Regimen 2: 200 mg (one 200 mg vaginal suppository) intravaginally once a day for 3 consecutive days alone or in combination with topical application of 1% clotrimazole cream to affected area two times daily for 7 consecutive days.

Regimen 3: 500 mg (one 500 mg vaginal suppository) intravaginally once.

Regimen 4: One applicatorful of 1% clotrimazole vaginal cream intravaginally once daily (preferably at bedtime) for 7 consecutive days.

Regimen 5: One applicatorful of 2% clotrimazole vaginal cream intravaginally once daily (preferably at bedtime) for 3 consecutive days.

Studies have shown the three and seven day courses of clotrimazole to be equally effective. Patient compliance may be increased with a three day course. Patients who fail to achieve a cure with a single 500 mg dose should be treated with a 3 or 7 day course of clotrimazole.

Weekly or monthly clotrimazole vaginal suppositories appear to be effective topical regimens for chronic suppressive therapy in female patients with HIV.

> 3 years: Apply clotrimazole topical in a quantity sufficient to cover the affected area and immediately surrounding skin twice a day for 2 to 4 weeks, depending on the nature and severity of the infection.

There are no data on the excretion of clotrimazole into human milk. However, systemic absorption is minimal after topical and vaginal administration. The manufacturer recommends that caution be used when administering clotrimazole topical to nursing women.

Summary of Use during Lactation

Because clotrimazole has poor oral bioavailability, it is unlikely to adversely affect the breastfed infant, including topical application to the nipples. It has been used orally in infants with thrush, sometimes successfully after nystatin has failed.[1] Any excess cream or ointment should be removed from the nipples before nursing. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.[2]

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Fluconazole, Miconazole, Nystatin

References

1. Johnstone HA, Marcinak JF. Candidiasis in the breastfeeding mother and infant. J Obstet Gynecol Neonatal Nurs. 1990;19:171-3. PMID: 2319366

2. Noti A, Grob K, Biedermann M et al. Exposure of babies to C(15)-C(45) mineral paraffins from human milk and breast salves. Regul Toxicol Pharmacol. 2003;38:317-25. PMID: 14623482