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04-19-2015, 04:06 PM

* NITRONAL (Glyceryl Trinitrate) 1 mg/ml 50 ml... aqueous.
- For intravenous (i.v.) administration (for I.V. infusion).
- One 50 ml vial, for single dose use only.
- Each vial contains: 50 mg glyceryl trinitrate in isotonic aqueous solution (1 mg/ml) (50 mg/50 ml).
* Indications:
- Angina pectoris, unstable vasospastic.
- Acute myocardial infarction.
- Acute left ventricular failure.
- Controlled hypotension.
- Hypertensive crisis with cardiac decompensation.
- Catheter - induced coronary spasms.
- To increase ischaemia tolerance during PTCA.

http://www.meduweb.com/attachment.php?attachmentid=121&stc=1&d=1429459332Therapeutic indications
The following indications exist for Glyceryl Trinitrate:
- Unresponsive congestive heart failure, including that secondary to acute myocardial infarction; acute left-sided heart failure and acute myocardial infarction,
- Refractory unstable angina pectoris and coronary insufficiency, including Prinzmetal's angina,
- Control of hypertensive episodes and/or myocardial ischaemia during and after cardiac surgery,
- Induction of controlled hypotension for surgery.

Posology and 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.
For instructions on dilution of the product before administration, see section 6.6.
Adults and the elderly - the dose should be titrated against the individual clinical response.
Unresponsive congestive heart failure, acute myocardial infarction and left-sided heart failure. The normal dose range is 10-100 micrograms / minute administered as a continuous intravenous infusion with frequent monitoring of blood pressure and heart rate. The infusion should be started at the lower rate and increased cautiously until the desired clinical response is achieved. Other haemodynamic measurements are extremely important in monitoring response to the drug: These may include pulmonary capillary wedge pressure, cardiac output and precordial electrocardiogram depending on the clinical picture.
Refractory unstable angina pectoris. An initial infusion rate of 10-15 micrograms / minute is recommended; this may be increased cautiously in increments of 5-10 micrograms until either relief of angina is achieved, headache prevents further increase in dose, or the mean arterial pressure falls by more than 20 mm Hg.
Use in surgery. An initial infusion rate of 25 micrograms / minute is recommended; this should be increased gradually until the desired systolic arterial pressure is attained. The usual dose is 25-200 micrograms / minute.
Children Glyceryl Trinitrate 1 mg/ml solution for infusion is not recommended for use in children.

Glyceryl Trinitrate should not be used in the following cases: Known hypersensitivity to nitrates, 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. Sildenafil potentiates the hypotensive effects of nitrates and its co-administration with Glyceryl Trinitrate is contraindicated.
Glyceryl Trinitrate should be administered with caution and under continuous monitoring to patients with acute left-sided heart failure or acute myocardial infarction and only when the systolic blood pressure exceeds 90 mm Hg.

Special warnings and precautions for use
Caution should be exercised in patients with severe liver or renal disease, hypothermia, hypothyroidism.
Glyceryl Trinitrate should not be given by bolus injection.

Interaction with other medicinal products and other forms of interaction
Glyceryl trinitrate may potentiate the action of other hypotensive drugs, and the hypotensive and anticholinergic effects of tricyclic antidepressants; it may also slow the metabolism of morphine-like analgesics.
The hypotensive effects of nitrates are potentiated by concurrent administration of sildenafil. A severe and possibly dangerous fall in blood pressure may occur. This can result in collapse, unconsciousness and may be fatal. Such use is therefore contraindicated (section 4.3).

Pregnancy and lactation
This product should not be used in pregnancy or in women who are breast feeding infants unless considered essential by the physician.

Effects on ability to drive and use machines
Not applicable, because the product is used in hospitalised patients.

Undesirable effects
Frequencies of the adverse reactions are listed according to the following convention:
Very common (≥ 1/10),
Common (≥ 1/100, < 1/10),
Uncommon (≥ 1/1000, < 1/100)
Rare (≥ 1/10000, < 1/1000),
Very rare (< 1/10000),
Not known (cannot be estimated from the available data).

Nervous system disorders:
Very Common: Headache*
Cardiac disorders:
Common: Paradoxical Bradycardia
Uncommon: Tachycardia*

Vascular disorders:
Very common: Hypotension*
Common: Dizziness*

Gastrointestinal disorders:
Common: Nausea
Not known: Retrosternal discomfort

General disorders and administration site conditions:
Not known: Diaphoresis, Flushing*, Restlessness, Abdominal pain
*particularly if the infusion is administered too rapidly.
These symptoms should be readily reversible on reducing the rate of infusion or, if necessary, discontinuing treatment.