LOPROX Shampoo Ref.[10861] Active ingredients: Ciclopirox olamine

5.1 Local Effects

If a reaction suggesting sensitivity or irritation occurs with the use of LOPROX Shampoo, treatment should be discontinued and appropriate therapy instituted.

Contact of LOPROX Shampoo with the eyes should be avoided. If contact occurs, rinse thoroughly with water.

In patients with lighter hair color, hair discoloration has been reported.

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.

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.

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).

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.

No clinical trials have been conducted in subjects younger than 16 years.

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.