OMNOPON Solution for injection Ref.[51213] Active ingredients: Codeine Morphine Papaverine

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2023  Publisher: Fresenius Kabi Manufacturing SA (Pty) Ltd, 6 Gibaud Road, Korsten 6020, Gqeberha, South Africa

5.1. Pharmacodynamic properties

Category and class: A 2.9 Other analgesics
Pharmacotherapeutic group: Natural opium alkaloids
ATC code: N02AA10

OMNOPON 20 FRESENIUS contains both the phenanthrene and isoquinoline groups of opium alkaloids. The former includes codeine and morphine which exert a marked narcotic action on the central nervous system. The second group is represented by papaverine which acts as an antispasmodic in vitro. Its effects in vivo are limited. OMNOPON 20 FRESENIUS has the analgesic and narcotic properties of morphine.

5.2. Pharmacokinetic properties

Morphine

Morphine is distributed throughout the body, but mainly in the kidneys, liver, lungs and spleen. It crosses the placenta and traces are found in sweat and milk. It is about 35% plasma protein bound. t½ is about 2–3 hours.

Codeine

Codeine is widely distributed throughout the body. t½ is about 3–4 hours.

Papaverine

Papaverine is widely distributed throughout the body. t½ is about 100 minutes.

5.3. Preclinical safety data

No information of relevance available.

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