MedPath
FDA Approval

Nitroglycerin

March 29, 2022

HUMAN PRESCRIPTION DRUG LABEL

Nitroglycerin(0.4 mg in 1 1)

Registrants (1)

Manufacturing Establishments (1)

Zydus Lifesciences Limited

Zydus Pharmaceuticals (USA) Inc.

Zydus Pharmaceuticals (USA) Inc.

863362789

Products (3)

Nitroglycerin

70710-1019

ANDA210153

ANDA (C73584)

SUBLINGUAL

March 29, 2022

CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
Code: G59M7S0WS3Class: ACTIBQuantity: 0.4 mg in 1 1
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT

Nitroglycerin

70710-1020

ANDA210153

ANDA (C73584)

SUBLINGUAL

March 29, 2022

Code: G59M7S0WS3Class: ACTIBQuantity: 0.6 mg in 1 1
CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT

Nitroglycerin

70710-1018

ANDA210153

ANDA (C73584)

SUBLINGUAL

March 29, 2022

CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
Code: G59M7S0WS3Class: ACTIBQuantity: 0.3 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT

Drug Labeling Information

OVERDOSAGE SECTION

OVERDOSAGE

Hemodynamic Effects

The effects of nitroglycerin overdose are generally the results of nitroglycerin's capacity to induce vasodilatation, venous pooling, reduced cardiac output, and hypotension. These hemodynamic changes may have protean manifestations, including increased intracranial pressure, with any or all of persistent throbbing headache, confusion, and moderate fever; vertigo; palpitations; tachycardia; visual disturbances; nausea and vomiting (possibly with colic and even bloody diarrhea); syncope (especially in the upright posture); dyspnea, later followed by reduced ventilatory effort; diaphoresis, with the skin either flushed or cold and clammy; heart block and bradycardia; paralysis; coma; seizures; and death.

No specific antagonist to the vasodilator effects of nitroglycerin is known, and no intervention has been subject to controlled study as a therapy of nitroglycerin overdose. Because the hypotension associated with nitroglycerin overdose is the result of venodilatation and arterial hypovolemia, prudent therapy in this situation should be directed toward increase in central fluid volume. Passive elevation of the patient's legs may be sufficient, but intravenous infusion of normal saline or similar fluid may also be necessary.

The use of epinephrine or other arterial vasoconstrictors in this setting is likely to do more harm than good.

In patients with renal disease or congestive heart failure, therapy resulting in central volume expansion is not without hazard. Treatment of nitroglycerin overdose in these patients may be subtle and difficult, and invasive monitoring may be required.

Methemoglobinemia

Methemoglobinemia has been rarely reported in association with organic nitrates. The diagnosis should be suspected in patients who exhibit signs of impaired oxygen delivery despite adequate cardiac output and adequate arterial PO2. Classically, methemoglobinemic blood is described as chocolate brown, without color change on exposure to air.

If methemoglobinemia is present, intravenous administration of methylene blue, 1 to 2 mg/kg of body weight, may be required.


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