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Drug Details

ZIDOVAL

• Drug Class Description
  Antiprotozoal-antibacterials.
• Generic Name
  Metronidazole
• Presentation
  A colourless to straw coloured Vaginal gel
• Description
  Metronidazole 0.75% w/w, 7.5 mg/g
• Indications
  Bacterial vaginosis.
• Adult Dosage
  

  One application of Zidoval vaginal gel (5g) inserted into the vagina once daily, at bedtime, for 5 consecutive days.

  Directions for use: Pierce sealed end of tube and screw open end of applicator tightly onto tube of gel. Squeeze tube, filling the applicator with gel. Remove applicator from tube and gently insert applicator into vagina as far as it will comfortably go. Push the plunger to release the gel. Dispose of applicator as instructed.

• Child Dosage
  

  Not recommended for use in children and adolescents under 18 years since safety and efficacy have not been established.

• Elderly Dosage
  

  Bacterial vaginosis is not commonly seen in the elderly population and consequently clinical assessment in this age group has not been carried out.

• Contra Indications
  

  Zidoval vaginal gel is contraindicated in patients with a prior history of hypersensitivity to metronidazole, other nitroimidazoles, parabens or any other ingredient of the gel.

• Special Precautions
  

  Use during menses is not recommended.

  Known or previously unrecognised candidiasis may present more prominent symptoms during therapy with Zidoval vaginal gel and may require treatment with a candicidal agent.

  Metronidazole is a nitroimidazole and should be used with care in patients with evidence of a history of blood dyscrasias.

  As with all vaginal infections, sexual intercourse during the infection and during treatment with Zidoval vaginal gel is not recommended.

• Interactions
  

  Oral metronidazole has been associated with a disulfiram-like reaction in combination with alcohol. Acute psychotic reactions and confusion have occurred during concomitant use of disulfiram with oral metronidazole. At the low serum concentrations which result from the use of Zidoval vaginal gel, the possibility of similar reactions is unlikely although cannot be excluded.

  Oral metronidazole has been shown to increase the plasma concentrations of warfarin, lithium, cyclosporin and 5-fluorouracil. Similar effects after vaginal administration of metronidazole are not expected due to the low plasma concentrations but cannot be completely ruled out.

  Metronidazole may interfere with certain types of determination of serum chemistry values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactic dehydrogenase (LDH), triglycerides and hexokinase glucose. Values of zero may be observed.

• Adverse Drug Reactions
  

  In controlled clinical trials involving 759 patients, the most commonly reported ADRs were urogenital (26%) and gastrointestinal (14%).

  Common: (>1/100, <1/10)  Neurological: Headache, dizziness

  GI: GI discomfort/abdominal cramps, nausea and/or vomiting, unpleasant taste/unusual feeling on tongue, decreased appetite.

  Urogenital: Vaginal candidiasis, vaginal itching/irritation/burning/numbness, pelvic discomfort, vaginal discharge.

  Uncommon: (>1/1000, <1/100) Psychiatric: Depression, fatigue, irritability, trouble sleeping. Neurological: Unusual sensation in extremities.

  GI: Diarrhoea, constipation, stomach gurgling/bloating/gas, thirsty/dry mouth, metallic taste.

  Skin: Itching.

  Urinary: Urinary tract infection symptoms, darkened urine.

  Urogenital: Vulvar swelling, menstrual discomfort/irregularities, vaginal spotting/bleeding, medication leakage.

  General: Cramping.