Promethazine Tablets 10 mg, 25 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 10 mg, 25 mg

Reference Brands: Phenergan (USA), Avomine (EU)

Category: Antiemetic

Promethazine hydrochloride tablets 10 mg and 25 mg, a sedating phenothiazine antihistamine used for allergy, nausea, motion sickness and short-term sedation. For importers, distributors and hospitals.

Product Description:

Promethazine is a first-generation antihistamine of the phenothiazine group. It blocks H1 receptors, has strong anticholinergic and sedative effects, and acts on the brain's vomiting centre, which explains its use against nausea and motion sickness. This page covers promethazine hydrochloride tablets at 10 mg and 25 mg. Tablets are the routine form for adults and older children; the oral liquid suits children who cannot swallow tablets, and the injection is for hospital use.

Promethazine tablets are used for allergic rhinitis, urticaria and itching, nausea and vomiting, motion sickness, with a dose taken before travel, and short-term sedation, including night-time sleeplessness. It must not be given to children under two because of the risk of fatal respiratory depression. Next-day drowsiness affects driving, and alcohol adds to it. Anticholinergic effects call for caution in angle-closure glaucoma, urinary retention, prostatic enlargement and older people, who are prone to confusion. It adds to other sedatives and opioids, and caution is needed in epilepsy.

Sourcing notes. Promethazine tablets are pharmacy medicines in some countries and prescription-only in others. Promethazine hydrochloride slowly oxidises and darkens on exposure to air and light, so specify opaque or aluminium blisters, or tightly closed light-resistant bottles, and ask for stability at 30 °C/75% RH for tropical markets. No cold chain is needed. Each batch should come with a CoA covering assay, dissolution and related substances, and the CTD or ACTD dossier should include bioequivalence data or a justified biowaiver. Request the GMP certificate and a CoPP.