ARROW ORNIDAZOLE Film coated tablet Ref.[9715] Active ingredients: Ornidazole

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2018  Publisher: SPONSOR: Teva Pharma (New Zealand) Limited, PO Box 128 244, Remuera, Auckland 1541, Telephone: 0800 800 097

Therapeutic indications

ARROW-ORNIDAZOLE is an antimicrobial agent for the treatment of infections due to trichomonads, amoebae, Giardia lamblia and anaerobic bacteria.

  1. Bacterial vaginosis (non-specific vaginitis).
  2. Trichomoniasis. Genitourinary infections in women and men due to Trichomonas vaginalis.
  3. Amoebiasis. All intestinal infections due to Entamoeba histolytica, including amoebic dysentery. All extraintestinal forms of amoebiasis, especially amoebic liver abscess.
  4. Giardiasis (lambliasis).
  5. Infections due to anaerobic bacteria. Treatment of infections such as septicaemia, meningitis, peritonitis, postoperative wound infections, puerperal sepsis, septic abortion, and endometritis, with demonstrated or suspected involvement of susceptible bacteria (see section 5.1 Pharmacodynamic properties).
  6. Prophylaxis during surgical interventions, particularly those involving the colon, and in gynaecological operations.

Posology and method of administration

Dose

Trichomoniasis

Adults

There are two possible therapeutic regimens:

  • Single-dose therapy (for acute trichomoniasis)
  • Five-day therapy (for chronic forms of trichomoniasis)
Type of Treatment Daily Dosage (500 mg tablets)
(a) Single dose therapy 3 tablets in the evening
(b) Five-day therapy 2 tablets (1 tablet mornings and evenings)

In all cases, the sexual partner should also be treated using the same oral dosage so as to avoid reinfection.

Children

The dosage for children is 25 mg per kg bodyweight per day, given in a single dose

Amoebiasis

  • Three-day treatment of patients with amoebic dysentery
  • Five-to-ten-day treatment for all forms of amoebiasis
Duration of Treatment Daily Dosage
 Adults and children over 35 kg Children up to 35 kg
Three days 3 tablets in one evening dose. Over 60 kg bodyweight: 4 tablets (2 tablets mornings and evenings) 125 mg per 3 kg body weight in one dose (equivalent to 40 mg per kg)
Five to ten days 2 tablets (1 tablet mornings and evenings) 125 mg per 5 kg body weight in one dose (equivalent to 25 mg per kg)

Giardiasis (lambliasis)

Duration of Treatment Daily Dosage
 Adults and children over 35 kg Children up to 35 kg
One to two days 3 tablets in the evening in one dose 125 mg per 3 kg body weight in one dose (equivalent to 40 mg per kg)

Anaerobic Infections

Prophylaxis: 1500 mg orally, 12 hours before surgery then 500 mg 12-hourly for 3 to 5 days postoperatively.

Method of administration

The tablets must always be taken after meals. Arrow – Ornidazole does not have the strengths or dose forms available to deliver the smaller doses required for some paediatric patients therefore other pharmaceutical forms/strengths may be more appropriate for administration to this population.

Overdose

In the event of overdose, the symptoms referred to under section 4.8 Undesirable Effects occur with greater severity.

There is no specific antidote to ornidazole. In the event of cramps occurring, it is recommended that diazepam be given.

For advice on the management of overdose please contact the National Poisons Centre on 0800 POISON (0800 764766).

Shelf life

60 months.

Special precautions for storage

Store at or below 30°C. Protect from light.

Nature and contents of container

PVC/Aluminium foil blister packs. Pack size of 10 tablets.

Not all pack types or pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements for disposal.

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