Clotrimazole and Betamethasone Dipropionate (Page 3 of 4)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of the combination of clotrimazole and betamethasone dipropionate or either component individually.

Betamethasone was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli) and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay.

Reproductive studies with betamethasone dipropionate conducted in rabbits at doses of 1.0 mg/kg/day by the intramuscular route and in mice up to 33 mg/kg/day by the intramuscular route indicated no impairment of fertility except for dose-related increases in fetal resorption rates in both species.

In a combined study of the effects of clotrimazole on fertility, embryofetal development, and postnatal development, male and female rats were dosed orally (diet admixture) with dose levels of 5, 10, 25, or 50 mg/kg/day from 10 weeks prior to mating until 4 weeks postpartum. No adverse effects on the duration of estrous cycle, fertility, or duration of pregnancy were noted.

14 CLINICAL STUDIES

In clinical trials of tinea corporis, tinea cruris, and tinea pedis, subjects treated with clotrimazole and betamethasone dipropionate cream showed a better clinical response at the first return visit than subjects treated with clotrimazole cream. In tinea corporis and tinea cruris, the subject returned 3 to 5 days after starting treatment, and in tinea pedis, after 1 week. Mycological cure rates observed in subjects treated with clotrimazole and betamethasone dipropionate cream were as good as, or better than, in those subjects treated with clotrimazole cream. In these same clinical studies, patients treated with clotrimazole and betamethasone dipropionate cream showed better clinical responses and mycological cure rates when compared with subjects treated with betamethasone dipropionate cream.

16 HOW SUPPLIED/STORAGE AND HANDLING

Clotrimazole and Betamethasone Dipropionate Cream USP is available as follows:

15 gram tube in a carton (NDC 0472-0379-15)

45 gram tube in a carton (NDC 0472-0379-45)

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-Approved patient labeling (Patient Information).

Inform the patient of the following:

Pregnancy

Advise pregnant women that clotrimazole and betamethasone dipropionate cream may increase the risk of having a low birthweight infant and to use clotrimazole and betamethasone dipropionate cream on the smallest area of skin and for the shortest duration possible [see Use in Specific Populations (8.1)].

Lactation

Advise a woman to use clotrimazole and betamethasone dipropionate cream on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply clotrimazole and betamethasone dipropionate cream directly to the nipple and areola to avoid direct infant exposure [see Use in Specific Populations (8.2)].

Important Administration Instructions

Inform patients of the following:

  • Use clotrimazole and betamethasone dipropionate cream as directed by the physician. It is for external use only.
  • Avoid contact with the eyes, the mouth, or intravaginally.
  • Advise patients to report any visual symptoms to their healthcare providers.
  • Do not use clotrimazole and betamethasone dipropionate cream on the face or underarms.
  • Do not use more than 45 grams of clotrimazole and betamethasone dipropionate cream per week.
  • When using clotrimazole and betamethasone dipropionate cream in the groin area, patients should use the medication for 2 weeks only, and apply the cream sparingly. Patients should wear loose-fitting clothing. Notify the physician if the condition persists after 2 weeks.
  • Do not use clotrimazole and betamethasone dipropionate cream for any disorder other than that for which it was prescribed.
  • Do not bandage, cover or wrap the treatment area unless directed by the physician. Avoid use of clotrimazole and betamethasone dipropionate cream in the diaper area, as diapers or plastic pants may constitute occlusive dressing.
  • Report any signs of local adverse reactions to the physician. Advise patients that local reactions and skin atrophy are more likely to occur with occlusive use or prolonged use.
  • This medication is to be used for the full prescribed treatment time, even though the symptoms may have improved. Notify the physician if there is no improvement after 1 week of treatment for tinea cruris or tinea corporis, or after 2 weeks for tinea pedis.

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Rev. A 11/2019

PATIENT INFORMATION

Clotrimazole (kloe trim’ a zole) and
Betamethasone Dipropionate (bay” ta meth’ a sone dye proe’ pee oh nate)
Cream, 1%/0.05% (base)

Important information: Clotrimazole and betamethasone dipropionate cream is for use on skin only. Do not use clotrimazole and betamethasone dipropionate cream in your eyes, mouth, or vagina.

What is clotrimazole and betamethasone dipropionate cream?

  • Clotrimazole and betamethasone dipropionate cream is a prescription medication used on the skin (topical) to treat fungal infections of the feet, groin, and body in people 17 years of age and older. Clotrimazole and betamethasone dipropionate cream is used for fungal infections that are inflamed and have symptoms of redness or itching.
  • Clotrimazole and betamethasone dipropionate cream should not be used in children under 17 years of age.

Before using clotrimazole and betamethasone dipropionate cream, tell your healthcare provider about all your medical conditions, including if you:

  • are pregnant or plan to become pregnant. It is not known if clotrimazole and betamethasone dipropionate cream will harm your unborn baby. If you use clotrimazole and betamethasone dipropionate cream during pregnancy, use clotrimazole and betamethasone dipropionate cream on the smallest area of the skin and for the shortest time needed.
  • are breastfeeding or plan to breastfeed. It is not known if clotrimazole and betamethasone dipropionate passes into your breast milk. Breastfeeding women should use clotrimazole and betamethasone dipropionate cream on the smallest area of skin and for the shortest time needed while breastfeeding. Do not apply clotrimazole and betamethasone dipropionate cream directly to the nipple and areola to avoid contact with your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin or scalp that contain corticosteroids.

What should I avoid while using clotrimazole and betamethasone dipropionate cream?

Clotrimazole and betamethasone dipropionate cream should not be used to treat diaper rash or redness. You should avoid applying clotrimazole and betamethasone dipropionate cream in the diaper area.

How should I use clotrimazole and betamethasone dipropionate cream?

  • Use clotrimazole and betamethasone dipropionate cream exactly as your healthcare provider tells you to use it.
  • Use clotrimazole and betamethasone dipropionate cream for the prescribed treatment time, even if your symptoms get better.
  • Do not use more than 45 grams of clotrimazole and betamethasone dipropionate cream in 1 week.
  • Do not bandage, cover, or wrap the treated area unless your healthcare provider tells you to. Wear loose-fitting clothing if you use clotrimazole and betamethasone dipropionate cream in the groin area.
  • Do not use clotrimazole and betamethasone dipropionate cream on your face or underarms (armpits).
  • For treatment of fungal infections of the groin and body:
    • Apply a thin layer of clotrimazole and betamethasone dipropionate cream to the affected skin area 2 times a day for 1 week.
    • Tell your healthcare provider if the treated skin area does not improve after 1 week of treatment.
    • Do not use clotrimazole and betamethasone dipropionate cream for longer than 2 weeks.
  • For treatment of fungal infections of the feet:
    • Apply a thin layer of clotrimazole and betamethasone dipropionate cream to the affected skin area 2 times a day for 2 weeks.
    • Tell your healthcare provider if the treated skin area does not improve after 2 weeks of treatment. Do not use clotrimazole and betamethasone dipropionate cream longer than 4 weeks.
    • Wash your hands after applying clotrimazole and betamethasone dipropionate cream.

What are the possible side effects of clotrimazole and betamethasone dipropionate cream?

Clotrimazole and betamethasone dipropionate cream may cause serious side effects, including:

  • Clotrimazole and betamethasone dipropionate cream can pass through your skin. Too much clotrimazole and betamethasone dipropionate cream passing through your skin can cause your adrenal glands to stop working. Your healthcare provider may do blood tests to check for adrenal gland problems.
  • Vision problems. Topical corticosteroids may increase your chance of developing cataracts and glaucoma. Tell your healthcare provider if you develop blurred vision or other vision problems during treatment with clotrimazole and betamethasone dipropionate cream.

The most common side effects of clotrimazole and betamethasone dipropionate cream include burning, tingling, rash, swelling, and infections.

These are not all the possible side effects of clotrimazole and betamethasone dipropionate cream.

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

How should I store clotrimazole and betamethasone dipropionate cream?

  • Store clotrimazole and betamethasone dipropionate cream at room temperature between 68 to 77°F (20 to 25°C).
  • Keep clotrimazole and betamethasone dipropionate cream and all medicines out of the reach of children.

General information about the safe and effective use of clotrimazole and betamethasone dipropionate cream.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about clotrimazole and betamethasone dipropionate cream that is written for health professionals. Do not use clotrimazole and betamethasone dipropionate cream for a condition for which it was not prescribed. Do not give clotrimazole and betamethasone dipropionate cream to other people, even if they have the same symptoms that you have. It may harm them.

What are the ingredients in clotrimazole and betamethasone dipropionate cream?

Active ingredients: clotrimazole and betamethasone dipropionate

Inactive ingredients: Ceteareth-30, cetyl alcohol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic monohydrate, stearyl alcohol and white petrolatum; benzyl alcohol as preservative.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Rev. A 11/2019

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