Usual Adult Dose for Trichomoniasis

2 g orally once

Comments:

• Appropriate diagnostic procedures should be used to identify organism.
• The patient's sexual partner(s) should be treated with the same dose at the same time to prevent reinfection.
• Current guidelines should be consulted for additional information.

Use: For the treatment of trichomoniasis due to Trichomonas vaginalis

Usual Adult Dose for Giardiasis

2 g orally once

Use: For the treatment of giardiasis due to Giardia duodenalis (also termed G lamblia)

Usual Adult Dose for Amebiasis

2 g orally once a day

Duration of Therapy:

• Intestinal: 3 days
• Amebic liver abscess: 3 to 5 days

Comments:

• This drug is not indicated to treat asymptomatic cyst passage.

Use: For the treatment of intestinal amebiasis and amebic liver abscess due to Entamoeba histolytica

Some Experts Recommend: 2 g orally once a day

Duration of Therapy:

• Mild to moderate intestinal disease: 3 days
• Severe intestinal and extraintestinal disease: 5 days

Comments:

• Treatment with an intraluminal amebicide should follow this 3- or 5-day therapy.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Bacterial Vaginosis

2 g orally once a day for 2 days OR 1 g orally once a day for 5 days

Comments:

• Formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, or anaerobic vaginosis
• Should rule out other pathogens commonly associated with vulvovaginitis (e.g., T vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans, Herpes simplex virus)
• Use of this drug in pregnant patients has not been studied for bacterial vaginosis.
• Current guidelines should be consulted for additional information.

Use: For the treatment of bacterial vaginosis

Usual Pediatric Dose for Giardiasis

Older than 3 years: 50 mg/kg orally once
Maximum dose: 2 g/dose

Use: For the treatment of giardiasis due to G duodenalis (also termed G lamblia)

Some Experts Recommend:
3 years or older: 50 mg/kg orally once
Maximum dose: 2 g/dose

Comments:

• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Amebiasis

Older than 3 years: 50 mg/kg orally once a day
Maximum dose: 2 g/day

Duration of Therapy:

• Intestinal: 3 days
• Amebic liver abscess: 3 to 5 days

Comments:

• This drug is not indicated to treat asymptomatic cyst passage.
• Limited pediatric data available on use beyond 3 days; small number of children treated for 5 days had no additional reported side effects. Close monitoring is recommended when duration of therapy exceeds 3 days.

Use: For the treatment of intestinal amebiasis and amebic liver abscess due to E histolytica

Some Experts Recommend:
3 years or older: 50 mg/kg orally once a day
Maximum dose: 2 g/day

Duration of Therapy:

• Mild to moderate intestinal disease: 3 days
• Severe intestinal and extraintestinal disease: 5 days

Comments:

• Treatment with an intraluminal amebicide should follow this 3- or 5-day therapy.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Trichomoniasis

Some Experts Recommend: 50 mg/kg orally once
Maximum dose: 2 g/dose

Comments:

• Recommended for trichomoniasis due to T vaginalis
• The patient's sexual partner(s) should be treated with the same dose at the same time.
• Current guidelines should be consulted for additional information.

Renal Dose Adjustments

Renal dysfunction: No adjustment recommended.

Liver Dose Adjustments

Liver dysfunction: Caution recommended.

Precautions

US BOXED WARNING:

• POTENTIAL RISK FOR CARCINOGENICITY: Carcinogenicity observed in mice and rats treated chronically with metronidazole (another nitroimidazole agent); although such data have not been reported for this drug, the 2 drugs are structurally related and have similar biologic effects. Use of this drug should be limited to approved indications only; chronic use should be avoided.

CONTRAINDICATIONS:
Prior history of hypersensitivity to the active component or other nitroimidazole derivatives

Safety and efficacy have not been established in patients younger than 18 years, except for use in the treatment of giardiasis and amebiasis in pediatric patient older than 3 years.

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis: If this drug is administered the same day as and prior to hemodialysis session, an additional dose equal to one-half the recommended dose should be administered after the end of the session.
Peritoneal dialysis: Data not available

Other Comments

Administration advice:

• Administer with food (to minimize epigastric distress and other gastrointestinal side effects); oral bioavailability is not affected by food.
• For patients unable to swallow tablets, may crush the tablets in artificial cherry syrup and administer with food; shake the oral suspension well before each administration.

Storage requirements:

• Store tablets at controlled room temperature 20C to 25C (68F to 77F), excursions permitted to 15C to 30C (59F to 86F); protect from light.
• The oral suspension of crushed tablets in artificial cherry syrup is stable for 7 days at room temperature.

Reconstitution/preparation techniques:
For extemporaneous pharmacy compounding of the oral suspension:
(a) Crush four 500 mg oral tablets to a powder with mortar and pestle.
(b) Add about 10 mL cherry syrup to the powder and mix until smooth.
(c) Transfer the suspension to a graduated amber container.
(d) Use several small rinses of cherry syrup to transfer any remaining drug in the mortar to the final suspension for a total volume of 30 mL.

General:

• To reduce the development of drug-resistant organisms and maintain effective therapy, this drug should be used only to treat or prevent infections proven or strongly suspected to be caused by susceptible bacteria.
• Culture and susceptibility information should be considered when selecting/modifying antibacterial therapy or, if no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy.

Monitoring:

• Hematologic: Total and differential leukocyte counts (if retreatment is necessary)

Patient advice:

• Avoid alcoholic beverages and ethanol- or propylene glycol-containing preparations during therapy and for 72 hours after the last dose.
• Avoid missing doses and complete the entire course of therapy.