Product Information
Registration Status: ActiveAXCEL PROMETHAZINE-5 SYRUP 5mg/5ml is approved to be sold in Singapore with effective from 1998-11-12. It is marketed by KOTRA PHARMA MARKETING, with the registration number of SIN10539P.
This product contains Promethazine 5mg/5ml in the form of SYRUP. It is approved for ORAL use.
This product is manufactured by KOTRA PHARMA (M) SDN BHD in MALAYSIA.
It is a Pharmacy Only Medicine that can be obtained from a pharmacist at a retail pharmacy.
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.