MEXILETINE HYDROCHLORIDE- mexiletine hydrochloride capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MEXILETINE HYDROCHLORIDE (UNII: 606D60IS38) (MEXILETINE - UNII:1U511HHV4Z)

Available from:

Camber Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mexiletine hydrochloride capsules are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of mexiletine, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of mexiletine treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias. Mexiletine hydrochloride capsules are contraindicated in the presence of cardiogenic shock or preexisting second- or third-degree AV block (if no pacemaker is present).

Product summary:

Mexiletine hydrochloride capsules USP, 150 mg are white opaque/light blue opaque colored size '2', hard gelatin capsules, imprinted with “V1” on cap and “30” on body, filled with white to off white granular powder. They are supplied as follows: Bottles of 100                             NDC 31722-036-01 Mexiletine hydrochloride capsules USP, 200 mg are white opaque/light blue opaque colored size '1', hard gelatin capsules, imprinted with “V1” on cap and “33” on body, filled with white to off white granular powder. They are supplied as follows: Bottles of 100                             NDC 31722-037-01 Mexiletine hydrochloride capsules USP, 250 mg are white opaque/light blue opaque colored size '0', hard gelatin capsules, imprinted with “V1” on cap and “34” on body, filled with white to off white granular powder. They are supplied as follows: Bottles of 100                             NDC 31722-038-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). For more information, call Annora Pharma Private Limited at 1-866-495-1995. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 Manufactured by: Annora Pharma Private Limited                                          Sy. No. 261, Annaram Village, Gummadidala Mandal, Sangareddy District-502313 Telangana, India. Revised: 11/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MEXILETINE HYDROCHLORIDE - MEXILETINE HYDROCHLORIDE CAPSULE
CAMBER PHARMACEUTICALS, INC.
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DESCRIPTION
Mexiletine hydrochloride, USP is an orally active antiarrhythmic
agent. It is a white or
almost white powder, freely soluble in dehydrated alcohol and water.
Mexiletine
hydrochloride, USP has a pKa of 8.30. The chemical name of mexiletine
hydrochloride,
USP is 2-Propanamine, 1-(2,6-dimethylphenoxy), hydrochloride,(±)- and
its structural
formula is:
Each capsule for oral administration, contains 150 mg, 200 mg, or 250
mg of mexiletine
hydrochloride, USP. 100 mg of mexiletine hydrochloride, USP is
equivalent to 83.31 mg
of mexiletine base. In addition, each capsule contains the following
excipients: colloidal
silicon dioxide, corn starch, magnesium stearate. The capsule shell
contains: D&C Red
#28, FD&C Blue #1, gelatin and titanium dioxide. The imprinting ink
contains: black iron
oxide, potassium hydroxide, propylene glycol, shellac and strong
ammonia solution.
Meets USP _Dissolution Test 2_
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Mexiletine hydrochloride is a local anesthetic, antiarrhythmic agent,
structurally similar to
lidocaine, but orally active. In animal studies, mexiletine has been
shown to be effective
in the suppression of induced ventricular arrhythmias, including those
induced by
glycoside toxicity and coronary artery ligation. Mexiletine, like
lidocaine, inhibits the
inward sodium current, thus reducing the rate of rise of the action
potential, Phase 0.
Mexiletine decreased the effective refractory period (ERP) in Purkinje
fibers. The
decrease in ERP was of lesser magnitude than the decrease in action
potential duration
(APD), with a resulting increase in the ERP/APD ratio.
ELECTROPHYSIOLOGY IN MAN
Mexiletine is a Class 1B antiarrhythmic compound with
electrophysiologic properties in
man similar to those of lidocaine, but dissimilar from quinidine,
procainamide, and
disopyramide.
In patients with normal conduction systems, mexiletine has a minimal
effect on cardiac
impulse generation and