Ciclopirox
Generic: CICLOPIROX
Basic Information
Manufacturer
Padagis Israel Pharmaceuticals Ltd
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
c3722d52-407c-499b-a08b-b299609f203c
Indications & Usage
1 INDICATIONS AND USAGE Ciclopirox Shampoo, 1% is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults.
• Ciclopirox Shampoo, 1% is an antifungal indicated for the topical treatment of seborrheic dermatitis of the scalp in adults.
( 1 )
• Ciclopirox Shampoo, 1% is an antifungal indicated for the topical treatment of seborrheic dermatitis of the scalp in adults.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS • The most frequently reported adverse reactions are pruritus, burning, and erythema.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis at 1-866-634-9120 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 ciclopirox shampoo, 1% 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 Post Marketing Experience The following adverse reactions have been identified during post approval use of Ciclopirox Shampoo, 1%: 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.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis at 1-866-634-9120 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 ciclopirox shampoo, 1% 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 Post Marketing Experience The following adverse reactions have been identified during post approval use of Ciclopirox Shampoo, 1%: 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.