GENERIC NAME OF THE MEDICINAL PRODUCT:

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

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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

THERAPEUTIC INDICATIONS:

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.
See package insert for complete information on dosage and administration.

CAUTION & WARNING:

CAUTION: Do not use if any foreign particulate matter is visible the vial.
Avoid contact with alkalies. Do not use if discolored or if precipitate is present.
Discard unused portion.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & 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.
Keep all medicines out of reach of children.
Dosage: See package insert for complete information on dosage and administration.

Esmolol Hydrochloride Injection 100mg/10ml Technical Specification:

Product Name:Esmolol Hydrochloride Injection
Brand Name:Generic
Strength:10mg/ml (100mg/10ml)
Dosage Form:Liquid Injection (preservative free and Iso-Osmotic)
Packing:10ml Ready-to-Use Single Dose Vial/ Ampoule
Route of Administration:For I.V. use only
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-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 THE MEDICINAL PRODUCT:

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

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

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

THERAPEUTIC INDICATIONS:

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.
See package insert for complete information on dosage and administration.

CAUTION & Warning:

CAUTION: Do not use if any foreign particulate matter is visible the vial.
Avoid contact with alkalies. Do not use if discolored or if precipitate is present.
Discard unused portion.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & 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.
Keep all medicines out of reach of children.

Dosage: As directed by the Physician.