DROPIZOL Oral drops, solution Ref.[9176] Active ingredients: Opium

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Pharmanovia A/S, Jรฆgersborg Allรฉ 164, DK-2820 Gentofte, Denmark, Tel: +45 3333 7633, Fax: +45 3332 3107, e-mail: info@pharmanovia.com

Pharmacodynamic properties

Pharmacotherapeutic group: Antipropulsives
ATC code: A07DA02

The constipating effect is caused by inhibition of the intestines' peristalsis.

Opium alkaloids (opioids and isoquinoline derivatives) induce constipation, euphoria, analgesia and sedation dependent on the dose and derivative.

Pharmacokinetic properties

Is absorbed from the gastrointestinal tract and is eliminated primarily as metabolites excreted in the urine.

The duration of action is 3 to 4 hours.

Preclinical safety data

Studies have indicated an association between regular use of opium and increased risk of gastric adenocarcinoma and cancers in the oesophagus, larynx, bladder and lung.

The mechanism of this association is not fully understood.

Adverse reactions not observed in clinical studies, but seen in animals at exposures in excess of usual human exposure were as follows; Foetal growth retardation and increased rate of defects in the nervous system and the skeleton.

The relevance to clinical use is not known.

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