CARDAMYST Nasal spray Ref.[116097] Active ingredients: Etripamil

Source: FDA, National Drug Code (US)  Revision Year: 2025 

Product description

Etripamil, the active ingredient of CARDAMYST is a calcium channel blocker.

The chemical name of etripamil is benzoic acid, 3-[2-[[(4S)-4-cyano-4-(3,4-dimethoxyphenyl)-5-methylhexyl]methylamino]ethyl]-, methyl ester.

Its molecular weight is 452.59 and its molecular formula is C27H36N2O4.

The structural formula is:

Etripamil is a colorless to slightly yellow oil. Etripamil has a pKa of 8.57 and is very soluble in methyl tert-butyl ether, freely soluble in methanol, dichloromethane and acetone, sparingly soluble in ethanol and hexane, and insoluble in water.

CARDAMYST is a spray intended for nasal administration. Each device of CARDAMYST delivers two metered sprays of etripamil with a total of 70 mg. CARDAMYST contains 350 mg/mL of etripamil and the following inactive ingredients: acetic acid, edetate disodium, sulfuric acid for pH adjustment, and water for injection.

Dosage Forms and Strengths

Nasal Spray: Clear colorless to yellow solution. 70 mg of etripamil per device.

How Supplied

CARDAMYST is supplied in cartons (NDC 83468-070-03) of 2 disposable nasal spray devices contained in a plastic carrying case.

Each nasal spray device delivers two sprays containing a total of 70 mg etripamil.

Manufactured for: Milestone Pharmaceuticals USA, Inc. 6210 Ardrey Kell Road, Suite 650, Charlotte, NC, 28277

Drugs

Drug Countries
CARDAMYST United States

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