LOTRISONE Cream (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Merck Sharp & Dohme Corp.

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1. Indications and Usage

LOTRISONE cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to ...

2. Dosage and Administration

Treatment of tinea corporis or tinea cruris: Apply a thin film of LOTRISONE cream into the affected skin areas twice a day for one week. Do not use more than 45 grams per week. Do not use with occlusive ...

3. Dosage Forms and Strengths

Cream, 1%/0.05%. Each gram of LOTRISONE cream contains 10 mg of clotrimazole and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a white to off-white cream base.

4. Contraindications

None.

5. Warnings and Precautions

5.1 Effects on Endocrine System LOTRISONE cream can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. ...

8.1. Pregnancy

Risk Summary There are no available data on topical betamethasone dipropionate or clotrimazole use in pregnant women to identify a LOTRISONE cream associated risk of major birth defects, miscarriage, or ...

8.2. Lactation

Risk Summary There are no data regarding the excretion of betamethasone dipropionate or clotrimazole into breast milk, the effects on the breastfed infant, or the effects on milk production after topical ...

8.4. Pediatric Use

The use of LOTRISONE cream in patients under 17 years of age is not recommended. Adverse events consistent with corticosteroid use have been observed in pediatric patients treated with LOTRISONE cream. ...

8.5. Geriatric Use

Clinical studies of LOTRISONE cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, greater sensitivity of ...

11. Description

LOTRISONE (clotrimazole and betamethasone dipropionate) cream, 1%/0.05%, contains combinations of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, for topical use. ...

12.1. Mechanism of Action

Clotrimazole is an azole antifungal [see Clinical Pharmacology (12.4)]. Betamethasone dipropionate is a corticosteroid. Corticosteroids play a role in cellular signaling, immune function, inflammation, ...

12.2. Pharmacodynamics

Vasoconstrictor Assay Studies performed with LOTRISONE cream indicate that these topical combination antifungal/corticosteroids may have vasoconstrictor potencies in a range that is comparable to high-potency ...

12.3. Pharmacokinetics

Skin penetration and systemic absorption of clotrimazole and betamethasone dipropionate following topical application of LOTRISONE cream has not been studied. The extent of percutaneous absorption of topical ...

12.4. Microbiology

Mechanism of Action Clotrimazole, an azole antifungal agent, inhibits 14-α-demethylation of lanosterol in fungi by binding to one of the cytochrome P-450 enzymes. This leads to the accumulation of 14-α-methylsterols ...

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 ...

14. Clinical Studies

In clinical trials of tinea corporis, tinea cruris, and tinea pedis, subjects treated with LOTRISONE cream showed a better clinical response at the first return visit than subjects treated with clotrimazole ...

16.1. How Supplied

LOTRISONE cream is white to off-white and supplied in 15-gram (NDC 0085-0924-01) and 45-gram tubes (NDC 0085-0924-02), boxes of one. Rx only Distributed by: Merck Sharp & Dohme Corp., a subsidiary ...

16.2. Storage and Handling

Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°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 LOTRISONE cream may increase the risk ...