Usual Adult Dose for Acne

Recommended dose: Apply a thin film to the affected area(s) 2 times a day

Comment:

• More than 1 pledget may be used at the same time (e.g., larger surface areas).

• Treatment of acne vulgaris

Usual Adult Dose for Bacterial Vaginosis

Non-pregnant patients:
Vaginal cream: 1 applicatorful intravaginally once at bedtime for 3 consecutive days
Vaginal suppository: Insert 1 suppository intravaginally once a day at bedtime for 3 to 7 consecutive days

Pregnant patients:

• Vaginal cream: 1 applicatorful intravaginally once at bedtime for 7 consecutive days

• A diagnosis of bacterial vaginosis should be confirmed prior to initiating therapy.

• Treatment of bacterial vaginosis in non-pregnant women
• Treatment of bacterial vaginosis in non-pregnant women and pregnant women in the second or third trimester

Usual Pediatric Dose for Acne

12 years and older:
Recommended dose: Apply a thin film to the affected area(s) 2 times a day

Comment:

• More than 1 pledget may be used at the same time (e.g., larger surface areas).

• Treatment of acne vulgaris

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Safety and efficacy have not been established in patients younger than 12 years (topical gel, lotion, pledget, and solution formulations). Vaginal products are not recommended for use in children.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• The intravaginal cream formulation is for vulvovaginal use only; not for ophthalmic or oral use.
• Pledgets should be used promptly after opening and should only be used once, then properly discarded.
• Lotion formulations should be thoroughly shaken immediately prior to use.

• The manufacturer product information should be consulted.

• Bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge with the following: a pH greater than 4.5, 'fishy' amine odor when mixed with 10% KOH solution, and/or the presence of clue cells on microscopic examination.
• Diagnosis should be reconfirmed by smears and/or cultures and other pathogens commonly associated with vulvovaginitis ruled out prior to prescribing another course of therapy.
• Healthcare providers should consider the potential risk of pseudomembranous colitis associated with this drug; other agents may be more appropriate for use.
• If the condition does not improve or worsens during treatment, modification and/or alternative therapy should be considered.

• Signs/symptoms of pseudomembranous colitis/Clostridium difficile associated diarrhea (CDAD)

• Patients should be instructed to avoid vaginal intercourse or use of other vaginal products (including tampons or douches) during and up to 72 hours after treatment.
• Patients should be told to notify their healthcare provider if signs/symptoms of CDAD occur during or after use (e.g., severe diarrhea, abdominal pain).
• Patients should be advised that decreases in acne may not occur for 2 to 6 weeks, and some patients may require up to 8 weeks of treatment for definitive beneficial effects.