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  • Nitro-Bid
    (Nitroglycerin) - Fougera

    THERAPEUTIC CLASS

    Nitrate vasodilator

    DEA CLASS

    RX

    INDICATIONS

    Prevention of angina pectoris due to coronary artery disease.

    ADULT DOSAGE

    Adults: Initial: Apply 0.5 inch bid (once in the am and 6 hrs later). Titrate: May increase to 1 inch bid, then to 2 inches bid. Should have 10-12 hr nitrate-free period.

    HOW SUPPLIED

    Oint: 2% (15mg/inch) [1g (48s), 30g, 60g]

    WARNINGS/PRECAUTIONS

    Monitor with acute MI or CHF. Severe hypotension and tachycardia may occur; caution with volume depletion and hypotension. May aggravate angina caused by hypertrophic cardiomyopathy. Tolerance to other forms of nitrates may decrease effects. Chest pains, acute myocardial infarction, and death may occur during temporary withdrawal. Not useful in aborting an acute anginal episodes.

    ADVERSE REACTIONS

    Headache, lightheadedness, hypotension.

    DRUG INTERACTIONS

    Additive vasodilating effects with other vasodilators (eg, alcohol). Severe hypotension with sildenafil. Marked orthostatic hypotension reported with CCBs, possibly requiring dose adjustment.

    PREGNANCY

    Category C, caution in nursing.

    MECHANISM OF ACTION

    Nitrate vasodilator; relaxes vascular smooth muscle, and consequent dilatation of peripheral arteries and veins, especially the latter. Dilatation of veins leads to reduced left ventricular end-diastolic pressure and pulmonary capillary wedge pressure (preload). Arteriolar relaxation reduces systemic vascular resistance, systolic arterial pressure, and mean arterial pressure (afterload). It also dilates the coronary artery.

    PHARMACOKINETICS

    Distribution: Vd=3L/kg. Metabolism: Extrahepatic metabolism (RBC and vascular walls), inorganic nitrate and 1,2-and 1,3-dinitrogylcerin (metabolites). Dinitrates are metabolized to mononitrates, gycerol and CO2. Elimination: T1/2 =3 mins.

    ASSESSMENT

    Assess for severe hypotension or volume-depletion in patients, angina caused by hypertrophic cardiomyopathy, alcohol intake, and possible drug interactions.

    MONITORING

    Careful clinical or hemodynamic monitoring for hypotension and tachycardia. Monitor for paradoxical bradycardia and increased angina pectoris, rebound and decreased exercise tolerance, headaches and lightheadedness on standing, manifestation of true physical dependence (chest pain, acute MI after withdrawal), and methemoglobinemia.

    PATIENT COUNSELING

    Counsel to carefully follow dosing regimen, including a 10-12 hr nitrate-free period. Inform about headaches (markers of drug activity). Furthermore, inform patients to contact MD if patient experiences lightheadedness on standing. Avoid alcohol consumption. Topical use only.

    ADMINISTRATION/STORAGE

    Administration: Topical route. Place applicator on flat surface, printed side down. Squeeze necessary amount from tube onto applicator. Place applicator on desired area of skin, spread ointment, and tape into place. Storage: 20o-25°C (68°-77oF).