ivermectin
Generic: IVERMECTIN
Basic Information
Manufacturer
Viona Pharmaceuticals Inc
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
6b4a7400-d34c-4947-90e6-340f7087a702
Indications & Usage
1 INDICATIONS AND USAGE Ivermectin cream is indicated for the treatment of inflammatory lesions of rosacea.
Ivermectin cream is indicated for the treatment of inflammatory lesions of rosacea.
( 1 )
Ivermectin cream is indicated for the treatment of inflammatory lesions of rosacea.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS In controlled clinical trials with ivermectin the most common adverse reactions (incidence ≤ 1 %) included skin burning sensation and skin irritation.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viona Pharmaceuticals Inc.
at 1-888-304-5011 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 practice.
During clinical trials, 2,047 subjects with inflammatory lesions of rosacea received ivermectin cream once daily.
A total of 1,555 subjects were treated once daily for more than 12 weeks and 519 for approximately one year.
Adverse reactions, reported in ≤ 1% of subjects treated with ivermectin cream for at least 3 months in vehicle-controlled clinical trials, included skin burning sensation and skin irritation.
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.
Local adverse reactions: contact dermatitis and allergic dermatitis.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viona Pharmaceuticals Inc.
at 1-888-304-5011 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 practice.
During clinical trials, 2,047 subjects with inflammatory lesions of rosacea received ivermectin cream once daily.
A total of 1,555 subjects were treated once daily for more than 12 weeks and 519 for approximately one year.
Adverse reactions, reported in ≤ 1% of subjects treated with ivermectin cream for at least 3 months in vehicle-controlled clinical trials, included skin burning sensation and skin irritation.
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.
Local adverse reactions: contact dermatitis and allergic dermatitis.