Adults: The dose of glyceryl trinitrate should be adjusted to meet the individual needs of the patient.
The recommended dosage range is 10-200 micrograms/minute but up to 400 micrograms/minute may be necessary during some surgical procedures.
Pediatric population: The safety and efficacy of glyceryl trinitrate has not yet been established in children.
Elderly population: There is no evidence that a dosage adjustment is required in the elderly.
Patients with renal and hepatic impairment: Additional dosage adjustments in patients with severe hepatic insufficiency or severe renal failure may be necessary and require additional monitoring.
Use in surgery: A starting dose of 25 micrograms/minute is recommended for the control of hypertension, or to produce hypotension during surgery. This may be increased by increments of 25 micrograms/minute at 5-minute intervals until the blood pressure is stabilized. Doses between 10-200 micrograms/minute are usually sufficient during surgery, although doses of up to 400 micrograms/minute have been required in some cases.
Myocardial ischemia: The treatment of perioperative myocardial ischemia may be started with a dose of 15-20 micrograms/minute, with subsequent increments of 10-15 micrograms/minute until the required effect is obtained.
Unresponsive congestive heart failure: The recommended starting dose is 20-25 micrograms/minute. This may be decreased to 10 micrograms/minute or increased in steps of 20-25 micrograms/minute every 15-30 minutes until the desired effect is obtained.
Unstable angina: An initial dose of 10 micrograms/minute is recommended with increments of 10 micrograms/minute being made at approximately 30-minute intervals according to the needs of the patient.
Method of administration: For intravenous use. Glyceryl trinitrate should be administered by means of a microdrip set infusion pump or similar device which permits maintenance of constant infusion rate.
Glyceryl trinitrate can be administered undiluted by slow intravenous infusion using a syringe pump incorporating a glass or rigid plastic syringe. Alternatively, glyceryl trinitrate may be administered intravenously as an admixture using a suitable vehicle such as sodium chloride injection BP or dextrose injection BP. In case of dilution, glyceryl trinitrate must be mixed under aseptic conditions immediately after opening. For further instructions on dilution of the product before administration, see Instruction for use and handling under Cautions for Usage. Prepared admixtures should be given by intravenous infusion or with the aid of a syringe pump to ensure a constant rate of infusion.
During glyceryl trinitrate administration, there should be close hemodynamic monitoring of the patient. The posology of glyceryl trinitrate IV should be adjusted to achieve the desired clinical response.
Example of admixture preparation: To obtain an admixture of glyceryl trinitrate at a concentration of 100 micrograms/ml, add 50 ml glyceryl trinitrate solution (containing 50 mg glyceryl trinitrate) to 450 ml of infusion vehicle to give a final volume of 500 ml.
A dosage of 100 micrograms/minute can be obtained by giving 60 ml of the admixture per hour.