19 Nov 2012

Zidoval (Metronidazole) - United Kingdom

Updated: 19 Nov 2012

Zidoval

Zidoval vaginal gel is indicated for the treatment of bacterial vaginosis.

Zidoval Description, Presentation and Dosage

Zidoval Description

Zidoval Drug Class Description

Antiprotozoal-antibacterials - ATC classification: G01AF01

Zidoval Drug Description

Metronidazole 0.75% w/w, 7.5 mg/g

Zidoval Generic Name

Metronidazole

Zidoval Presentation

Zidoval Presentation

Vaginal gel

A colourless to straw coloured gel

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Zidoval Dosage

Zidoval Adult Dosage

For vaginal administration.

Adults

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.

Elderly

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

Children

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

Zidoval Precautions, Reactions and Contraindications

Zidoval Special Precautions

Zidoval 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.

Zidoval Adverse Reactions

Zidoval Adverse Reactions

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

Infections and infestations

 

Common (≥1/100, <1/10):

Vaginal candidiasis.

Metabolism and nutrition disorders

 

Common (≥1/100, <1/10):

Decreased appetite

Psychiatric Disorders

 

Uncommon (≥1/1000, <1/100):

Depression, difficulty sleeping.

Nervous system disorders

 

Common (≥1/100, <1/10):

Headache, dizziness.

Uncommon (≥1/1000, <1/100):

Abnormal sensation of limbs, metallic taste.

Gastrointestinal disorders

 

Common (≥1/100, <1/10):

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

Uncommon (≥1/1000, <1/100):

Diarrhoea, constipation, abdominal bloating/noises, dry mouth.

Skin and subcutaneous tissue disorders

 

Uncommon (≥1/1000, <1/100):

Itching.

Musculoskeletal and connective tissue disorders

 

Uncommon (≥1/1000, <1/100):

Cramp.

Renal and Urinary disorders

 

Uncommon (≥1/1000, <1/100):

Urine discolouration, urinary tract infection symptoms.

Reproductive system and breast disorders

 

Common (≥1/100, <1/10):

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

Uncommon (≥1/1000, <1/100):

Oedema vulva, menstrual discomfort/irregularities, vaginal spotting/bleeding.

General disorders and administration site conditions

 

Uncommon (≥1/1000, <1/100):

Fatigue, irritability.

Zidoval Contraindications

Zidoval Contraindications

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.

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