País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
MEXILETINE HYDROCHLORIDE (UNII: 606D60IS38) (MEXILETINE - UNII:1U511HHV4Z)
Camber Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
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).
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
Abbreviated New Drug Application
MEXILETINE HYDROCHLORIDE - MEXILETINE HYDROCHLORIDE CAPSULE CAMBER PHARMACEUTICALS, INC. ---------- 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 Leia o documento completo