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Nitro – G

Manufacturer

PT. Ferron Par Pharmaceuticals, Indonesia

Applicant company

PT. Dexa Medica

Active ingredient

Nitroglycerin

Content

10 mg / 10 ml

Shelf life

24 months

Dosage Form

Solution for injection

Package

Box of 10 ampoules x 10 ml

Visa Number

VN-21940-19

Issuing Date

March 20, 2019

Expiration Date

March 20, 2024

Therapeutic area

Cardiovascular drug

Indication

- Surgical procedures:
+ Rapid control of hypertension in cardiac surgery
+ Induction of controlled hypotension during surgical procedures
+ Management/control of myocardial ischemia during and following surgery
- Congestive heart failure (as adjunctive therapy in combination with other agents).
- Unstable angina pectoris refractory to treatment with beta-blockers and sublingual nitrates.

Dosage

The dosage of nitroglycerin should be adjusted according to individual patient requirements and the hemodynamic response monitored. The recommended dose ranges from 10 to 200 mcg/min, although doses up to 400 mcg/min may be required during certain surgical procedures.
Surgery:
A starting dose of 25 mcg/min is recommended for the control of hypertension or induction of controlled hypotension during surgical procedures. This may be titrated up by increments of 25 mcg/min at 5-minute intervals until target blood pressure is stabilized. A dose between 10 and 200 mcg/min is usually sufficient during surgery, although doses up to 400 mcg/min have been required in some cases.
Treatment of perioperative myocardial ischemia is initiated at a dose of 15 to 20 mcg/min, with subsequent increases of 10 to 15 mcg/min until the desired effect is achieved.
Unresponsive Congestive Heart Failure:
The recommended starting dose is 20 to 25 mcg/min. This dose may be reduced to 10 mcg/min or titrated upwards by 20 to 25 mcg/min every 15 to 30 minutes until the desired clinical response is obtained.
Unstable Angina Pectoris:
The recommended initial dose is 10 mcg/min, with titrations of 10 mcg/min increments approximately every 30 minutes according to the patient’s clinical response.

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