GENERIC NAME OF MEDICINAL PRODUCT:

A. Esmolol Hydrochloride Injection IP 10mg/ml (100mg/10ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Esmolol Hydrochloride Injection IP 100mg/10ml (10mg/ml)
Each ml contains:
Esmolol Hydrochloride IP…………10mg
Sodium Chloride IP……………………5.9mg
Sodium Acetate IP……………………2.8mg
Glacial Acetic Acid IP………………..0.546mg
Sodium Hydroxide IP…………………q.s for pH
Hydrochloric Acid IP………………….q.s for pH
Water for Injections IP ……………..q.s
*No preservatives

THERAPEUTIC INDICATION:

Esmolol Injection is used to control rapid heartbeats or abnormal heart rhythms. This medicine is also used to treat fast heartbeat and high blood pressure during surgery, after surgery, or during other medical procedures.

DIRECTION OF USE:

For Intravenous use only.
Please refer accompanying package insert for detailed dosage, directions of use and precautions.

CAUTION AND SCHEDULE:

CAUTION: • Avoid contact with alkalies. Do not use if discolored or if precipitate is present.
• Do not use if any foreign particulate matter is visible the vial.
• DISCARD UNUSED PORTION.
• KEEP OUT OF REACH AND SIGHT OF CHILDREN.
SCHEDULE: SCHEDULE 'H PRESCRIPTION DRUG-CAUTION Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE:
Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
Protect from light.
Protect from freezing.
Avoid excessive heat.
DOSAGE: As directed by the Physician.

Esmolol Hydrochloride Injection IP 100mg/10ml Technical Specification:

Product Name:Esmolol Hydrochloride Injection IP
Brand Name:Generic
Strength:10mg/ml (100mg/10ml)
Dosage Form:Liquid Injection
Packing:10ml Ready-to-Use Vial
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:Anti-Hypertensive, Antiarrhythmic
Indication: Esmolol Injection is used to control rapid heartbeats or abnormal heart rhythms. This medicine is also used to treat fast heartbeat and high blood pressure during surgery, after surgery, or during other medical procedures.
Storage:Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).Protect from light. Protect from freezing. Avoid excessive heat.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Esmolol Hydrochloride Injection IP 10mg/ml (100mg/10ml)

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Esmolol Hydrochloride Injection IP 10mg/ml (100mg/10ml)
    Each ml contains:
    Esmolol Hydrochloride IP…………10mg
    Sodium Chloride IP……………………5.9mg
    Sodium Acetate IP……………………2.8mg
    Glacial Acetic Acid IP………………..0.546mg
    Sodium Hydroxide IP…………………q.s to pH
    Hydrochloric Acid IP………………….q.s to pH
    Water for Injections IP ……………..q.s
    *No preservatives

THERAPEUTIC INDICATION:

Esmolol Injection is used to control rapid heartbeats or abnormal heart rhythms. This medicine is also used to treat fast heartbeat and high blood pressure during surgery, after surgery, or during other medical procedures.

DIRECTION OF USE:

For Intravenous use only.
Please refer accompanying package insert for detailed dosage, directions of use and precautions.

CAUTION AND SCHEDULE:

CAUTION:

  • Avoid contact with alkalies. Do not use if discolored or if precipitate is present.
  • Do not use if any foreign particulate matter is visible the vial.
  • DISCARD UNUSED PORTION. 
  • KEEP OUT OF REACH AND SIGHT OF CHILDREN. 

SCHEDULE: SCHEDULE ‘H PRESCRIPTION DRUG-CAUTION Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
Protect from light.
Protect from freezing.
Avoid excessive heat.

DOSAGE: As directed by the Physician.