Mexiletine Hydrochloride Capsule USP 50mg

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Mexiletine Hydrochloride Capsule USP 50mg
B) Mexiletine Hydrochloride Capsule USP 150mg
C) Mexiletine Hydrochloride Capsule USP 200mg
D) Mexiletine Hydrochloride Capsule USP 250mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Mexiletine Hydrochloride Capsule USP 50mg
Each Hard gelatin capsule contains:
Mexiletine Hydrochloride USP…...........50mg
Excipients………………………………………..q.s.

B) Mexiletine Hydrochloride Capsule USP 150mg
Each Hard gelatin capsule contains:
Mexiletine Hydrochloride USP…...........150mg
Excipients………………………………………..q.s.

C) Mexiletine Hydrochloride Capsule USP 200mg
Each Hard gelatin capsule contains:
Mexiletine Hydrochloride USP…...........200mg
Excipients………………………………………..q.s.

D) Mexiletine Hydrochloride Capsule USP 250mg
Each Hard gelatin capsule contains:
Mexiletine Hydrochloride USP…...........250mg
Excipients………………………………………..q.s.

THERAPEUTIC INDICATIONS:

Mexiletine belongs to the group of medicines known as antiarrhythmics. It is used to correct irregular heartbeats to a normal rhythm. Mexiletine produces its helpful effects by slowing nerve impulses in the heart and making the heart tissue less sensitive. Mexiletine is available only with your doctor's prescription

CAUTION & WARNING:

CAUTION: DISPENSE IN WELL-CLOSED CONTAINERS.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F).
Dosage: As directed by the Physician
Attach dispensing label here.

Mexiletine Hydrochloride Capsule USP 50mg Technical Specification:

Product Name:Mexiletine Hydrochloride Capsule USP
Brand Name:Generic
Strength:50mg, 150mg, 200mg, 250mg
Dosage Form:Capsules (Hard gelatin)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-arrhythmic
Indication: Mexiletine belongs to the group of medicines known as antiarrhythmics. It is used to correct irregular heartbeats to a normal rhythm. Mexiletine produces its helpful effects by slowing nerve impulses in the heart and making the heart tissue less sensitive. Mexiletine is available only with your doctor’s prescription
Storage:Store at 20° to 25°C (68° to 77°F)

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Mexiletine Hydrochloride Capsule USP 50mg 
  • Mexiletine Hydrochloride Capsule USP 150mg
  • Mexiletine Hydrochloride Capsule USP 200mg
  • Mexiletine Hydrochloride Capsule USP 250mg

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Mexiletine Hydrochloride Capsule USP 50mg
    Each Hard gelatin capsule contains:
    Mexiletine Hydrochloride USP…………..50mg
    Excipients………………………………………..q.s.
  • Mexiletine Hydrochloride Capsule USP 150mg
    Each Hard gelatin capsule contains:
    Mexiletine Hydrochloride USP…………..150mg
    Excipients………………………………………..q.s.
  • Mexiletine Hydrochloride Capsule USP 200mg
    Each Hard gelatin capsule contains:
    Mexiletine Hydrochloride USP…………..200mg
    Excipients………………………………………..q.s.
  • Mexiletine Hydrochloride Capsule USP 250mg
    Each Hard gelatin capsule contains:
    Mexiletine Hydrochloride USP…………..250mg
    Excipients………………………………………..q.s. 

THERAPEUTIC INDICATIONS:

Mexiletine belongs to the group of medicines known as antiarrhythmics. It is used to correct irregular heartbeats to a normal rhythm. Mexiletine produces its helpful effects by slowing nerve impulses in the heart and making the heart tissue less sensitive. Mexiletine is available only with your doctor’s prescription

CAUTION & WARNING:

CAUTION:  Dispense in well-closed containers.
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning:  To be sold by retail on the prescription of a Registered Medical Practitioner only. 

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F). 

Dosage: As directed by the Physician
Attach dispensing label here.