Dimenhydrinate Tablets

Composition:

·         Each uncoated tablet contains: Dimenhydrinate BP 50 mg, excipients q s

Category:

·         Histamine H1 receptor antagonist, Antihistamine

Indications

·         Nausea, Vomiting associated with surgery, Anesthesia, Abrynthine disturbance

·         Radiation sickness, Vertigo, Meniere`s syndrome

Dosage

·         Adults: 50-100mg 3-4 times daily.

·         Children: 5 mg/kg/day in 2-3 divided doses

·         Not recommended for children below 2 years.

Adverse effect:

·         Sedation, Dizziness, Dry mouth

Special precautions:

·         Prostate hypertrophy, Asthma, Cardiovascular disease

TEST

SPECIFICATION

Appearance

White or almost white, crystalline powder or colourless crystals

Solubility

Slightly soluble in water, freely soluble in ethanol (96%)

Identification:

A, B, C

Should Comply

Appearance of solution

The solution should be clear & colourless

pH

pH of filtrate 7.1 to 7.6

LOD

NMT 0.5%

Sulfated Ash

NMT 0.2%

Related Substances (HPLC)

Should Comply

Assay:

·        Diphenhydramine

·        8-chlorotheophylline

·   53.00% to 55.50% (ODB)

·   44.00% to 46.50% (ODB)