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PROMAGEN 10 ORAL MIXTURE 10mg/5ml

Product Information

Registration Status: Active

SIN09073P

PROMAGEN 10 ORAL MIXTURE 10mg/5ml is approved to be sold in Singapore with effective from 1996-12-14. It is marketed by ICM PHARMA PTE LTD, with the registration number of SIN09073P.

This product contains Promethazine 10mg/5ml in the form of SYRUP. It is approved for ORAL use.

This product is manufactured by ICM PHARMA PTE LTD in SINGAPORE.

It is a Pharmacy Only Medicine that can be obtained from a pharmacist at a retail pharmacy.

Product Reference
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Description

A phenothiazine derivative with histamine H1-blocking, antimuscarinic, and sedative properties. It is used as an antiallergic, in pruritus, for motion sickness and sedation, and also in animals. [PubChem]

Indication

For the treatment of allergic disorders, and nausea/vomiting.

Mechanism of Action

Like other H1-antagonists, promethazine competes with free histamine for binding at H1-receptor sites in the GI tract, uterus, large blood vessels, and bronchial muscle. The relief of nausea appears to be related to central anticholinergic actions and may implicate activity on the medullary chemoreceptor trigger zone.

Pharmacokinetics

Absorption
On average, 88% of a promethazine dose is absorbed after oral administration; however, the absolute bioavailability is only 25% because of first-pass clearance.
Distribution
Metabolism
Hepatic
Elimination

Toxicity

Symptoms of overdose include mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). LD50=55mg/kg (I.V. in mice)

Active Ingredient/Synonyms

(2-dimethylamino-2-methyl)ethyl-N-dibenzoparathiazine | 10-(2-Dimethylaminopropyl)phenothiazine | 10-[2-(dimethylamino)Propyl]phenothiazine | N-(2'-dimethylamino-2'-Methyl)ethylphenothiazine | N,N,alpha-Trimethyl-10H-phenothiazine-10-ethanamine | N,N,α-trimethyl-10H-phenothiazine-10-ethanamine | Proazamine | Prometazina | Promethazine | Promethazinum | Promethazine |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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