GLYCERYL TRINITRATE-HAMELN INJECTION 1MG/ML [SIN15105P]

Product Info

GLYCERYL TRINITRATE-HAMELN INJECTION 1MG/ML

[SIN15105P]

4.1 Therapeutic indications

Surgery:
Glyceryl Trinitrate-hameln is indicated for:

1. the rapid control of hypertension during cardiac surgery.

2. reducing blood pressure and maintaining controlled hypotension during surgical procedures.

3. controlling myocardial ischaemia during and after cardiovascular surgery

Unresponsive congestive heart failure:
Glyceryl Trinitrate-hameln may be used to treat unresponsive congestive heart failure secondary to acute myocardial infarction.

Unstable angina:
Glyceryl Trinitrate-hameln may be used to treat unstable angina, which is refractory to treatment with beta blockers and sublingual nitrates.

4.2 Posology and method of administration

Posology

Adults
The dose of Glyceryl Trinitrate-hameln should be adjusted to meet the individual needs of the patient.

The recommended dosage range is 10–200 micrograms/min but up to 400 micrograms/min may be necessary during some surgical procedures.

Paediatric population
The safety and efficacy of Glyceryl Trinitrate-hameln has not yet been established in children.

Elderly population
There is no evidence that a posology adjustment is required in the elderly.

Patients with renal and hepatic impairment
Additional dose 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/min is recommended for the control of hypertension, or to produce hypotension during surgery. This may be increased by increments of 25 micrograms/min at 5 minute intervals until the blood pressure is stabilized. Doses between 10–200 micrograms/min are usually sufficient during surgery, although doses of up to 400 micrograms/min have been required in some cases.

Myocardial ischaemia
The treatment of perioperative myocardial ischaemia may be started with a dose of 15–20 micrograms/min, with subsequent increments of 10–15 micrograms/min until the required effect is obtained.

Unresponsive congestive heart failure:
The recommended starting dose is 20–25 micrograms/min. This may be decreased to 10 micrograms/min, or increased in steps of 20–25 micrograms/min every 15–30 minutes until the desired effect is obtained.

Unstable angina:
An initial dose of 10 micrograms/min is recommended with increments of 10 micrograms/min 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 micro-drip set infusion pump or similar device which permits maintenance of constant infusion rate.

Glyceryl Trinitrate-hameln can be administered undiluted by slow intravenous infusion using a syringe pump incorporating a glass or rigid plastic syringe.

Alternatively, Glyceryl Trinitrate-hameln may be administered intravenously as an admixture using a suitable vehicle such as Sodium Chloride Injection B.P. or Dextrose Injection B.P. In case of dilution, Glyceryl Trinitrate-hameln must be mixed under aseptic conditions immediately after opening. For further instructions on dilution of the product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

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-hameln administration there should be close haemodynamic monitoring of the patient.

The posology of GTN i.v. should be adjusted to achieve the desired clinical response.

Example of admixture preparation
To obtain an admixture of GTN at a concentration of 100 micrograms/ml, add 50 ml Glyceryl Trinitrate-hameln 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/min. can be obtained by giving 60 ml of the admixture per hour.

Vials of Glyceryl Trinitrate are for single use only and should not be regarded as multi-dose containers.

4.3 Contraindications
Glyceryl Trinitrate-hameln should not be used in the following cases:

• Known hypersensitivity to the active substance, other nitro compounds or any of the excipients listed in Section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

• Acute circulatory failure (shock, collapse)

• Cardiogenic shock (unless a sufficient end-diastolic pressure is maintained by appropriate measures)

• Severe anaemia

• Severe cerebral haemorrhage

• Head trauma

• Uncorrected hypovolaemia and hypotensive shock

• Arterial hypoxaemia and angina caused by hypertrophic obstructive cardiomyopathy

• Constrictive pericarditis

• Pericardial tamponade

• Toxic pulmonary oedema

• During nitrate therapy, phosphodiesterase inhibitors type 5 (PDE5) (e. g. sildenafil, vardenafil, tadalafil) must not be used because PDE5 inhibitors may amplify the vasodilatory effects of GTN resulting in severe hypotension (see sections 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).