Usual Adult Dose for Acne Rosacea

1% Topical Cream or Gel: Apply and rub in a thin film to entire affected area(s) once a day

0.75% Topical Cream, Gel, or Lotion: Apply and rub in a thin layer to entire affected area(s) twice a day (morning and evening)

Comments:

• Areas to be treated should be washed with a mild/gentle cleanser prior to application of this drug.
• Patients may use cosmetics after application of this drug.
• Topical lotion formulation: Patients should wait until dry (at least 5 minutes) to use cosmetics.

Uses:

• For 0.75% topical cream, gel, or lotion: For the topical treatment of inflammatory papules and pustules of rosacea
• For 1% topical cream: For the topical treatment of inflammatory lesions and erythema of rosacea
• For 1% topical gel: For the topical treatment of inflammatory lesions of rosacea

Usual Adult Dose for Bacterial Vaginosis

1.3% Vaginal Gel: Insert 1 applicatorful intravaginally once at bedtime.

0.75% Vaginal Gel: Insert 1 applicatorful intravaginally once a day (at bedtime) or twice a day for 5 days.

• Vandazole: Insert 1 applicatorful intravaginally once a day at bedtime for 5 days.

Use: For the treatment of bacterial vaginosis

• Vandazole: In nonpregnant women

Usual Pediatric Dose for Bacterial Vaginosis

1.3% Vaginal Gel:

• Females 12 years or older: Insert 1 applicatorful intravaginally once at bedtime.

Vandazole (0.75% Vaginal Gel):

• Postmenarchal females: Insert 1 applicatorful intravaginally once a day at bedtime for 5 days.

Use: For the treatment of bacterial vaginosis

• Vandazole: In nonpregnant women

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Comments:

• According to at least 1 manufacturer, the vaginal gel (0.75%) should be administered cautiously in patients with severe liver disease.

Precautions

CONTRAINDICATIONS:
Topical Formulations:

• History of hypersensitivity to the active component or any of the ingredients

Vaginal Formulations:

• History of hypersensitivity to the active component, any of the ingredients (including parabens), or other nitroimidazole derivatives
• Concomitant use of disulfiram or use within 2 weeks of disulfiram
• Consumption of alcohol/ethanol or propylene glycol during and for at least 24 hours (1.3% vaginal gel) or for at least 3 days (Vandazole [0.75% vaginal gel]) after therapy

Topical formulations: Safety and efficacy have not been established in patients younger than 18 years.

Vaginal formulations: Safety and efficacy of the 1.3% vaginal gel have not been established in patients younger than 12 years; safety and efficacy of Vandazole (0.75% vaginal gel) have not been established in premenarchal females.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Topical formulations: For topical use only; not for oral, ophthalmic, or intravaginal use.
• Vaginal formulations: For intravaginal use only; not for ophthalmic, dermal, or oral use.

Storage requirements:

• Store at controlled room temperature 20C to 25C (68F to 77F).
• For 0.75% topical cream, 0.75% topical lotion, and vaginal gel: Protect from freezing.
• For Vandazole (0.75% vaginal gel): Avoid exposure to extreme heat or cold.
• For 1.3% vaginal gel: Do not refrigerate.

Patient advice (topical formulations):

• Use this product as directed by physician.
• For external use only
• Avoid contact with the eyes.
• Report any side effects to physician.
• For 0.75% topical formulations: If local irritation occurs, use the product less often or discontinue use.
• For 1% topical formulations: If local irritation occurs, discontinue use.

Patient advice (vaginal formulations):

• Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
• Do not consume alcohol or products containing ethanol or propylene glycol during therapy and for at least 3 days (Vandazole [0.75% vaginal gel]) or for at least 24 hours (1.3% gel) after treatment.
• Do not engage in vaginal intercourse or use other vaginal products (e.g., tampons, douches) during therapy with the 0.75% vaginal gel or after the single administration of the 1.3% vaginal gel.
• Discontinue use and contact healthcare provider if vaginal irritation occurs.