LOPROX Topical suspension Ref.[10863] Active ingredients: Ciclopirox olamine

General

LOPROX Topical Suspension is not for ophthalmic use.

Keep out of reach of children.

In the controlled clinical trial with 89 patients using LOPROX Topical Suspension and 89 patients using the vehicle, the incidence of adverse reactions was low. Those considered possibly related to treatment or occurring in more than one patient were pruritus, which occurred in two patients using ciclopirox suspension and one patient using the suspension vehicle, and burning, which occurred in one patient using ciclopirox suspension.

If a reaction suggesting sensitivity or chemical irritation should occur with the use of LOPROX Topical Suspension, treatment should be discontinued and appropriate therapy instituted.

The patient should be told to:

• Use the medication for the full treatment time even though signs/symptoms may have improved and notify the physician if there is no improvement after four weeks.
• Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing) indicative of possible sensitization.
• Avoid the use of occlusive wrappings or dressings

Teratogenic Effects

Pregnancy Category B.

There are no adequate or well-controlled studies in pregnant women. Therefore, LOPROX Topical Suspension 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 11, 37, 51 and 24 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 27 and 49 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. Caution should be exercised when LOPROX Topical Suspension is administered to a nursing woman.

Safety and effectiveness in pediatric patients below the age of 10 years have not been established.