📋 Indications & Clinical Dosage
*Treatment or prophylaxis of angina:*
BY SUBLINGUAL AEROSOL SPRAY: Adult: 1-2 sprays, dose be administered under tongue and then close mouth
ORAL: Adults: 2.5-9 mg 2-4 times daily up to 26 mg 4 times/day. Children: Not recommended.
BY TAB BUCCAL: Adults: Initial 1 mg every 3-5 hr while awake (3 times day), increase dose upward if angina occurs with tablet in place. Children: Not recommended.
BY SUBLINGUAL TABLETS: Adults: 0.2-0.6 mg every 5 min for max of 3 doses in 15 min; may also be used prophylactically 5-10 min prior to activities which may provoke an attack. Children: Not recommended.
TRANSDERMAL PATCH: Adults: Initial 0.2-0.4 mg/hr, increase to doses of 0.4-0.8 mg/hr; tolerance is minimized by using a patch-on period of 12-14 hr and patch-off period of 10-12 hr. Children: Not recommended.
*Control of hypertension and myocardial ischaemia during and after cardiac surgery, Induction of controlled hypotension during surgery, Congestive heart failure, unstable angina:*
BY IV INF: Adult: 10-200 mcg/min (max. per dose 400 mcg/min), adjusted according to response, consult product literature for recommended starting doses specific to indication
*Pulmonary hypertension:*
Children: Initially 0.25-0.5 mcg/kg/min and increase by 1 mcg/kg/min at 20 to 60 min intervals to desired effect. Usual dose: 1-3 mcg/kg/min; max 5 mcg/kg/min.
💊 Mode of Administration
Must be prepared in glass bottles & use special sets intended for nitroglycerin glass IV bottles & ad-ministration sets provided by manufacturer. Standard diluent: 50 mg/250 ml D5W; 50 mg/500 ml D5W. Minimum volume: 100 mg/250 ml D5W, concentration should not exceed 400 mcg/ml.
⛔ Contraindications
Glaucoma, hypovolaemia, hypertrophic cardiomyopathy, aortic or mitral stenosis, cardiac tamponade, constrictive pericarditis, toxic pulmonary oedema, head trauma, cerebral haemorrhage, cerebrovascular disease, marked anaemia, raised intracranial pressure, hypersensitivity to nitrates.
⚠️ Precautions & Warnings
Hypothyroidism, hepatic or renal impairment, lung desease, hypothermia, recent history of myocardial infarction, heart failure due to obstruction, hypoxaemia or other ventilation and perfusion abnormalities, susceptibility to angle-closure glaucoma, cardio-version, or diathermy, avoid abrupt withdrawal, monitor blood pressure and heart rate during IV infusion.
🔄 Drug Interactions
Sildenafil, tadalafil, vardenafil, ethanol, heparin, alteplase, ergot alkaloids.
⚠️ Adverse Reactions / Side Effects
Tachycardia, bradycardia, headache, dizziness, collapse, hypotension, nausea, vomiting, palpitation, metabolic acidosis, heartburn, flushing, syncope, temporary hypoxaemia, rash, application site reactions with transdermal patches, urinary and fecal incontinence, very rarely angle-closure glaucoma. Injection Specific side-effects include severe hypotension, diaphoresis, apprehension, restlessness, muscle twitching, retrosternal discomfort, palpitation, abdominal pain; methaemolobinaemia.
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Caution advised, risk cannot be ruled out.
Lactation / Breastfeeding:
Caution advised.
🧪 Compatibility & Storage Stability
Compatibility: Stable in D5LR, D5 Y NS, D5NS, LR, 1/2 NS.
Stability & Storage: Store nitroglycerin for injection at controlled room temperature of 15C-30C (59F-86F). Discard unused portion. Protect from freezing and light. Store premixed nitroglycerin with dextrose at room temperature (25o C), avoid excessive heat.
📚 Official Regulatory & Clinical References
- Drug Regulatory Authority of Pakistan (DRAP): Drug Registration, S.R.O. Price Gazettes & National Essential Medicines List (NEML).
- World Health Organization (WHO): Collaborating Centre for Drug Statistics Methodology (ATC/DDD Index).
- Formulary Standards: British National Formulary (BNF) & Pakistan National Formulary (PNF) guidelines.