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Drug Details

DALACIN CREAM

• Drug Class Description
  Antibacterials.
• Generic Name
  Clindamycin
• Presentation
  Cream White, semi-solid.
• Description
  Each gram of cream contains clindamycin phosphate equivalent to 20 mg or 2.0% w/w clindamycin.
• Indications
  Antibiotic for the treatment of bacterial vaginosis.
• Adult Dosage
  

  One applicator full (approximately 5 grams) intravaginally at bedtime for 7 consecutive days.

  In patients in whom a shorter treatment course is desirable, a 3 day regimen has been shown to be effective.

   

• Child Dosage
  

  Children and the elderly: No clinical studies have been conducted in populations younger than 15 or older than 60. Dalacin Cream is not recommended in children under 12 years of age.

• Contra Indications
  

  Dalacin Cream is contra-indicated in patients previously found to be hypersensitive to preparations containing clindamycin or any of the components of the cream base (see "Presentation"). Although cross-sensitisation to lincomycin has not been demonstrated, it is recommended that Dalacin Cream should not be used in patients who have demonstrated lincomycin sensitivity.

• Special Precautions
  

  As there are no data available on the use of Dalacin Cream in patients younger than 12 years of age, it should not be used in this population. The use of clindamycin may result in the overgrowth of non-susceptible organisms, particularly yeasts.

  Virtually all antibiotics have been associated with diarrhoea and in some cases pseudomembranous colitis. Therefore, even though only a minimal amount of drug is absorbed, if significant diarrhoea occurs, the drug should be discontinued and appropriate diagnostic procedures and treatment provided as necessary.

  Dalacin Cream contains oil-based components. Some of these have been shown to weaken the rubber of condoms and diaphragms and make them less effective as a barrier method of contraception or as protection from sexually transmitted disease, including AIDS. Do not rely on condoms and diaphragms when using Dalacin Cream.

• Interactions
  

  Cross resistance has been demonstrated between clindamycin and lincomycin, and erythromycin and clindamycin. Antagonism has been demonstrated between clindamycin and erythromycin in vitro.

  No information is available on concomitant use with other intravaginal products, which is not recommended.

• Adverse Drug Reactions
  

  In clinical trials medical events judged to be related, probably related, or possibly related to vaginally administered clindamycin phosphate cream were reported for (24%) of patients as indicated below:

  Genital tract: cervicitis/vaginitis (14%); vulvo-vaginal irritation (6%).
   
  Central nervous system: dizziness, headache, vertigo.
   
  Gastro-intestinal: heartburn, nausea, vomiting, diarrhoea, constipation, abdominal pain.
   
  Dermatological: rash, exanthema.
   
  Hypersensitivity: urticaria. 
  
  (Events without percentages were reported by less than 1% of the patients.)