Data from FDA (Food and Drug Administration, USA) - Curated by Marshall Pearce - Last updated 02 September 2017

Indication(s)

1 INDICATIONS AND USAGE LOPROX Shampoo is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults. •LOPROX Shampoo is an antifungal indicated for the topical treatment of seborrheic dermatitis of the scalp in adults. (1)

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Advisory information

contraindications
4 CONTRAINDICATIONS None. None (4)
Adverse reactions
6 ADVERSE REACTIONS •The most frequently reported adverse reactions are pruritus, burning, and erythema. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 drug and may not reflect the rates observed in clinical practice. In 626 subjects treated with LOPROX Shampoo twice weekly in the two pivotal clinical trials, the most frequent adverse events were increased itching in 1% of subjects, and application site reactions, such as burning, erythema, and itching, also in 1% of subjects. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of LOPROX Shampoo: hair discoloration and abnormal hair texture, alopecia, irritation, and rash. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION LOPROX Shampoo is not for ophthalmic, oral, or intravaginal use. Wet hair and apply approximately 1 teaspoon (5 mL) of LOPROX Shampoo to the scalp. Up to 2 teaspoons (10 mL) may be used for long hair. Lather and leave on hair and scalp for 3 minutes. A timer may be used. Avoid contact with eyes. Rinse off. Treatment should be repeated twice per week for 4 weeks, with a minimum of 3 days between applications. If a patient with seborrheic dermatitis shows no clinical improvement after 4 weeks of treatment with LOPROX Shampoo, the diagnosis should be reviewed. • Apply approximately 1 teaspoon of LOPROX Shampoo to the scalp twice per week for 4 weeks. (2) • For topical use only. Not for ophthalmic, oral, or intravaginal use. (2)
Use in special populations
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic Effects: Pregnancy Category B There are no adequate or well-controlled studies in pregnant women. Therefore, LOPROX Shampoo should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral embryofetal developmental studies were conducted in mice, rats, rabbits, and monkeys. Ciclopirox or ciclopirox olamine was orally administered during the period of organogenesis. No maternal toxicity, embryotoxicity or teratogenicity were noted at the highest doses of 77, 125, 80, and 38.5 mg/kg/day ciclopirox in mice, rats, rabbits, and monkeys, respectively (approximately 13, 42, 54, and 26 times the maximum recommended human dose based on body surface area comparisons, respectively). Dermal embryofetal developmental studies were conducted in rats and rabbits with ciclopirox olamine dissolved in PEG 400. Ciclopirox olamine was topically administered during the period of organogenesis. No maternal toxicity, embryotoxicity, or teratogenicity were noted at the highest doses of 92 mg/kg/day and 77 mg/kg/day ciclopirox in rats and rabbits, respectively (approximately 31 and 54 times the maximum recommended human dose based on body surface area comparisons, respectively). 8.3 Nursing Mothers 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 LOPROX Shampoo is administered to a nursing woman. 8.4 Pediatric Use No clinical trials have been conducted in subjects younger than 16 years. 8.5 Geriatric Use In clinical trials, the safety and tolerability of LOPROX Shampoo in the population 65 years and older was comparable to that of younger subjects. Results of the efficacy analysis in those subjects 65 years and older showed effectiveness in 25 of 85 (29%) subjects treated with LOPROX Shampoo, and in 15 of 61 (25%) subjects treated with the vehicle; due to the small sample size, a statistically significant difference was not demonstrated. Other reported clinical experience has not identified differences in responses between the elderly and younger subjects, but greater sensitivity to adverse effects in some older individuals cannot be ruled out.
Pregnancy and lactation
8.3 Nursing Mothers 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 LOPROX Shampoo is administered to a nursing woman.

More information

Category Value
Authorisation number NDA021159
Agency product number 19W019ZDRJ
Orphan designation No
Product NDC 99207-010
Date Last Revised 12-06-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 544743
Storage and handling Store between 15°to 30°C (59°to 86°F). Keep out of reach of children.
Marketing authorisation holder Valeant Pharmaceuticals North America LLC