Posology : מינונים

4.2     Posology and method of administration
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Adults and Adolescents Over 14 Years of Age

Intravenous Administration as an Analgesic
1 g (2 ml), administered by slow injection, up to 4 times daily. In severe pain, 2.5 g (5 ml) may be administered twice daily (the maximum daily dosage is 5 g).

Intravenous administration of dipyrone should be carried out slowly over a period of at least 5 minutes, followed by reasonable clinical observation.

Intramuscular administration of dipyrone for relief of pain is not recommended. However, if medical circumstances require such administration, all due precautions should be exercised to permit reasonable clinical observation.

Intramuscular Administration as an Antipyretic
2.5 g (5 ml), to be repeated only if deemed necessary.

Infants and Children
Use of dipyrone is contraindicated in infants under 3 months of age or 5 kg/body weight.
In infants 3-12 months, Optalgin® Teva 1 g/2 ml solution for injection must be administered by the intramuscular route only. In older children, the injection may be administered by either the intramuscular or intravenous routes.

Dosage guidelines for the administration of Optalgin® Teva 1 g/2 ml solution for injection as an analgesic and/or antipyretic, in infants over 3 months of age and in children, are presented in the table below.

Optalgin® Teva 1 g/2 ml solution for injection - Dosage Guidelines in Infants and Children 
Age                 Smallest        Maximum
Single Dosage     Daily Dosage
3-5 months             0.1 ml I.M. only    4 x 0.2 ml
6-11 months            0.1 ml I.M. only    4 x 0.3 ml
1-2 years              0.2 ml I.M./I.V.    4 x 0.4 ml
3-4 years              0.2 ml I.M./I.V.    4 x 0.6 ml
5-7 years              0.4 ml I.M./I.V.    4 x 0.8 ml
8-11 years             0.5 ml I.M./I.V.    4 x 1.0 ml
12-14 years            0.8 ml I.M./I.V.    4 x 1.6 ml

Special populations

Elderly population, debilitated patients and patients with reduced creatinine clearance 
The dose should be reduced in elderly people, in debilitated patients and in those with reduced creatinine clearance, as elimination of the metabolic products of dipyrone may be prolonged.

Hepatic and renal impairment

As the elimination rate is reduced when renal or hepatic function is impaired, multiple high doses should be avoided. No dose reduction is needed when used only for a short time. To date, there has been insufficient experience with long-term use of dipyrone in patients with severe hepatic and renal impairment.

Duration of administration

The duration of administration depends on the nature and severity of the disorder. In the case of prolonged treatment with dipyrone, regular blood counts, including differential blood count, are necessary.