ALOGLIPTIN 12.5MG 30CT TAB
Generic: Ivermectin
ALOGLIPTIN 12.5MG 30CT TAB
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Identification
Ivermectin
Ivermectin
Padagis Israel Pharmaceuticals Ltd
HUMAN PRESCRIPTION DRUG
Administration
CREAM
TOPICAL
ANDA210225
Active Ingredients
| Ingredient | Strength |
|---|---|
| IVERMECTIN | 10 mg/g |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Drug Resources
Clinical Drug Information
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 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Apply to the affected areas of the face once daily. Use a pea-size amount for each area of the face (forehead, chin, nose, each cheek) that is affected. Spread as a thin layer, avoiding the eyes and lips. Ivermectin cream is not for oral, ophthalmic, or intravaginal use. • Apply to the affected areas once daily. ( 2 ) • Not for oral, ophthalmic or intravaginal use. ( 2 )
Adverse Reactions
6 ADVERSE REACTIONS In controlled clinical trials with ivermectin cream the most common adverse reactions (incidence ≤ 1%) included skin burning sensation and skin irritation. ( 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 practice. During clinical trials, 2047 subjects with inflammatory lesions of rosacea received ivermectin cream once daily. A total of 1555 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.
Information for Patients
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Instructions for Use). Patients using ivermectin cream should receive the following instruction: Keep out of reach of children. Manufactured by Padagis ® , Yeruham, Israel www.padagis.com Rev 03-24 3Y100 RC PH4
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.