Drug Interaction:
Nitrates include Amyl Nitrate, Nitroglycerin, Isosorbide dinitrate, Isosorbide mononitrate
Refer - Isorbide 5- mononitrate
Other vasodilators,cal antagonists,ACE inhibitors,beta blkrs diuretics,antihypertensives, tricylic antidepressants,major tranquilisers may alter the effect
Alcohol may potentiate the blood pressure lowering effect of concurrently administered nitroglycerine Alcohol may produce severe hypotension and collapse.
Bioavailabilty of dihydroergometrine may be increased and may lead to coronary vasoconstriction.
Therapeutic response may be reduced by aspirin and NSAIDs.
Indication:
Prophylaxis, treatment and management of angina
Nitrates include Erythrityl tetranitrate, Isosorbide dinitrate, Isosorbide mononitrate, nitroglycerin , pentraerythritrol tetranitrate, glyceryl trinitrate
Refer - Isorbide 5- mononitrate
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Nitroglycerine 10/20/40mg + 02-04-2002
Dextrose hydrous 5gm injection
For treatment of perioperative hypertension for control
of congestive heart failure in setling of acute MI, angina
Pectoris in patients who have not responded to sublingual
nitroglycerine and Beta blockers for intra operative
hypertension
Adverse Reaction:
Headache(treat with mild analgesics if unbearable,failing which discontinue therapy). Reddening of skin,allergic contact dermititis.Mild local itching or burning sensation.Local irritation(change application site frequently)
Facial flushing,faintness,or light headedness,dizziness,postural hypotension,associated reflux-induced tachycardia.Nausea, vomiting(rare)
. I.V.administration: I.V.preparations contain substantial quantities of alcohol and reports of alcohol intoxification. Topical application: Contact dermatitis
Sub lingual/Buccal tablets: Localised burning sensation, delayed dissolution in dry mouth, rate of dissolution enhanced by hot liquids.Risk of aspiration.
Contra-Indications:
Known htpersens to nitroglycerine and related organic nitrate compounds.Acute circulatory failure associated with marked hypotension.Conditions associated with elevated intracranial pressure. Myocardial insuffiency due to obstruction.
Special precautions:
Hypoxemia.Hypertrophic cardiomyopathy,increased angina and tolerance to sublingual nitroglycerine, renal/hepatic impairment,hypothyroidism.
Dosages/ Overdosage Etc:
Indications:
Sublingual Prophylaxis, treatment and management of angina
Dosage:
Dissolve 1 tablet under tongue or in buccal pouch (between cheek and gum ) at first sign of an acute anginal attack. Repeat every 5 minutes until relef is obtained.
Take no more than 3 tablets in 15 minutes. If pain continues, notify physician
Patient Information:
Nitrates include Erythrityl tetranitrate, Isosorbide dinitrate, Isosorbide mononitrate, nitroglycerin , pentraerythritrol tetranitrate
Refer - Isorbide 5- mononitrate
Pharmacology/ Pharmacokinetics:
Nitrates include Erythrityl tetranitrate, Isosorbide dinitrate, Isosorbide mononitrate, nitroglycerin ,
pentraerythritrol, tetranitrate, glyceryl trinitrate
Refer - Isorbide 5- mononitrate
Ref- Drug Facts and Comparison (2010)
Pharmacokinetics-
Mean Nitroglycerin (SD) Values
Parameter 2 x 0.3mg 1x 0.6mg
Nitrostar tablets Nitrostar tablets
Cmax (ng/mL) 2.3 (1.7) 2.1 (1.5)
Tmax (min) 6.4 (2.5) 7.2 (3.2)
AUC (0-x) (min) 14.9 (8.2) 14.9(11.4)
t 1/2 (min) 2.8 (1.1) 2.6(0.6)
Manufacturer Details