Edurant Description

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Full Prescribing Info

Description

EDURANT (rilpivirine) tablets contain rilpivirine hydrochloride equivalent to 25 mg of rilpivirine.
Drug Substance: Proper name: rilpivirine hydrochloride.
Chemical name: 4-[[4-[[4-[(E)-2-cyanoethenyl]-2,6-dimethylphenyl]amino]-2-pyrimidinyl]amino] benzonitrile monohydrochloride.
Molecular formula and molecular mass: C₂₂H₁₈N₆·HCl; 402.88 - rilpivirine hydrochloride; 366.42 - rilpivirine.
Physicochemical properties: Description: Rilpivirine hydrochloride is a white to almost white powder.
Solubility: Rilpivirine hydrochloride is practically insoluble in water over a wide pH range.
pKa: The pKa is 5.6 (pyrimidine moiety).
Excipients/Inactive Ingredients: croscarmellose sodium, hypromellose 2910 6 mPa.s, lactose monohydrate, magnesium stearate, polyethylene glycol 3000, polysorbate 20, povidone K30, silicified microcrystalline cellulose, titanium dioxide and triacetin.

rilpivirine

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare