MEPTID Solution for injection Ref.[27610] Active ingredients: Meptazinol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Almirall, S.A., Ronda General Mitre 151, 08022 Barcelona, Spain

4.1. Therapeutic indications

Meptid Injection is indicated for the treatment of moderate to severe pain, including post-operative pain, obstetric pain and the pain of renal colic.

4.2. Posology and method of administration

Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with meptazinol in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4).

Posology

Adults

Intramuscular dosage: 75-100mg Meptid. The injection may be repeated 2-4 hourly as required. For obstetric pain a dose of 100-150mg should be used according to weight. This dose should approximate 2mg/kg.

Intravenous dosage: 50-100mg Meptid by slow intravenous injection. The injection may be repeated 2-4 hourly as required. If vomiting occurs, a suitable antiemetic should be given.

Epidural/intrathecal use: This formulation is not suitable for these routes.

Elderly

The adult dosage schedule can be used in the elderly.

Paediatric population

No data are available.

4.9. Overdose

Overdose with Meptid Injection has not been reported. Large doses, including seven times the recommended therapeutic dose, have been given in balanced and total intravenous anaesthesia without significant respiratory depressant effects.

In the event of cardiovascular and respiratory collapse, normal resuscitative procedures should be employed. Respiratory depression caused by overdosage with meptazinol may only be partially reversed with therapeutic doses of naloxone. Naloxone has a short duration of action in comparison with meptazinol. Repeated administration or administration by continuous intravenous infusion may be considered necessary.

Patients should be informed of the signs and symptoms of overdose and to ensure that family and friends are also aware of these signs and to seek immediate medical help if they occur.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store below 25°C.

6.5. Nature and contents of container

1 ml clear glass ampoules. The glass complies with the requirements of the European Pharmacopoeia Type I. The ampoules will be packed in cartons of 10.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Single use only. Discard any unused contents.

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