United States - English - NLM (National Library of Medicine)

carilion materials management - isosorbide mononitrate (unii: lx1oh63030) (isosorbide mononitrate - unii:lx1oh63030) - isosorbide mononitrate 20 mg - isosorbide mononitrate tablets are indicated for the prevention and treatment of angina pectoris due to coronary artery disease. the onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode. isosorbide mononitrate is contraindicated in patients who are allergic to it. do not use isosorbide mononitrate in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, or vardenafil. concomitant use can cause severe hypotension, syncope, or myocardial ischemia. do not use isosorbide mononitrate in patients who are taking the soluble guanylate cyclase stimulator riociguat. concomitant use can cause hypotension.

United States - English - NLM (National Library of Medicine)

carilion materials management - isosorbide mononitrate (unii: lx1oh63030) (isosorbide mononitrate - unii:lx1oh63030) - isosorbide mononitrate 60 mg - isosorbide mononitrate extended-release tablets are indicated for the prevention of angina pectoris due to coronary artery disease. the onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode. isosorbide mononitrate extended-release tablets are contraindicated in patients who have shown hypersensitivity or idiosyncratic reactions to other nitrates or nitrites.

United States - English - NLM (National Library of Medicine)

a-s medication solutions - isosorbide mononitrate (unii: lx1oh63030) (isosorbide mononitrate - unii:lx1oh63030) - isosorbide mononitrate 30 mg - isosorbide mononitrate extended-release tablets are indicated for the prevention of angina pectoris due to coronary artery disease. the onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode. isosorbide mononitrate extended-release tablets are contraindicated in patients who have shown hypersensitivity or idiosyncratic reactions to other nitrates or nitrites.

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - isosorbide mononitrate (unii: lx1oh63030) (isosorbide mononitrate - unii:lx1oh63030) - isosorbide mononitrate 60 mg - isosorbide mononitrate extended-release tablets are indicated for the prevention of angina pectoris due to coronary artery disease. the onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode. isosorbide mononitrate extended-release tablets are contraindicated in patients who have shown hypersensitivity or idiosyncratic reactions to other nitrates or nitrites.

United States - English - NLM (National Library of Medicine)

schwarz pharma - isosorbide dinitrate (unii: ia7306519n) (isosorbide dinitrate - unii:ia7306519n) - capsule, extended release - 40 mg - dilatrate®-sr sustained release capsules are indicated for the prevention of angina pectoris due to coronary artery disease. the onset of action of controlled-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode. allergic reactions to organic nitrates are extremely rare, but they do occur. isosorbide dinitrate is contraindicated in patients who are allergic to it.

United States - English - NLM (National Library of Medicine)

lannett company, inc. - isosorbide mononitrate (unii: lx1oh63030) (isosorbide mononitrate - unii:lx1oh63030) - isosorbide mononitrate 10 mg - monoket® is indicated for the prevention and treatment of angina pectoris due to coronary artery disease. the onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode. isosorbide mononitrate is contraindicated in patients who are allergic to it. do not use monoket® in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, or vardenafil.  concomitant use can cause severe hypotension, syncope, or myocardial ischemia. do not use monoket® in patients who are taking the soluble guanylate cyclase stimulator riociguat.  concomitant use can cause hypotension.

United States - English - NLM (National Library of Medicine)

azurity - hydralazine hydrochloride (unii: fd171b778y) (hydralazine - unii:26nak24ls8), isosorbide dinitrate (unii: ia7306519n) (isosorbide dinitrate - unii:ia7306519n) - hydralazine hydrochloride 37.5 mg - bidil is indicated for the treatment of heart failure as an adjunct to standard therapy in self-identified black patients to improve survival, to prolong time to hospitalization for heart failure, and to improve patient-reported functional status. there is little experience in patients with nyha class iv heart failure. bidil is contraindicated in patients who are allergic to organic nitrates. do not use bidil in patients who are taking pde-5 inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil. concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see drug interactions (7.1)] . do not use bidil in patients who are taking the soluble guanylate cyclase (sgc) stimulator riociguat. concomitant use can cause hypotension. risk summary there are no data on bidil use in pregnant women, and insufficient data on its components (hydralazine and isosorbide dinitrate) to assess a drug-associated risk of major birth defects or miscarriage with first trimester use. available published

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - isosorbide mononitrate, quantity: 60 mg - tablet, modified release - excipient ingredients: hypromellose; carnauba wax; stearic acid; lactose monohydrate; magnesium stearate; purified talc; titanium dioxide; iron oxide yellow; macrogol 4000; colloidal anhydrous silica - prophylactic treatment of angina pectoris. isodur mr 60mg sustained release tablets are not recommended for the management of acute attacks of angina pectoris.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - isosorbide mononitrate, quantity: 60 mg - tablet, modified release - excipient ingredients: purified talc; titanium dioxide; lactose monohydrate; hypromellose; stearic acid; magnesium stearate; iron oxide yellow; macrogol 4000; carnauba wax; colloidal anhydrous silica - prophylactic treatment of angina pectoris. apo- isosorbide mononitrate 60mg sustained release tablets are not recommended for the management of acute attacks of angina pectoris (see precautions).

United States - English - NLM (National Library of Medicine)

i3 pharmaceuticals, llc - isosorbide dinitrate (unii: ia7306519n) (isosorbide dinitrate - unii:ia7306519n), hydralazine hydrochloride (unii: fd171b778y) (hydralazine - unii:26nak24ls8) - isosorbide dinitrate and hydralazine hydrochloride tablets are indicated for the treatment of heart failure as an adjunct to standard therapy in self-identified black patients to improve survival, to prolong time to hospitalization for heart failure, and to improve patient-reported functional status. there is little experience in patients with nyha class iv heart failure. isosorbide dinitrate and hydralazine hydrochloride tablets are contraindicated in patients who are allergic to organic nitrates. do not use isosorbide dinitrate and hydralazine hydrochloride tablets in patients who are taking pde-5 inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil. concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see drug interactions (7.1)]. do not use isosorbide dinitrate and hydralazine hydrochloride tablets in patients who are taking the soluble guanylate cyclase (sgc) stimulator riociguat. concomitant use can cause hypotension. risk summary there are no data on isosorbide dinitrate and hydralazine hydrochloride tablets use in pregnant women, and insufficient data on its components (hydralazine and isosorbide dinitrate) to assess a drug-associated risk of major birth defects or miscarriage with first trimester use. available published data on hydralazine use in pregnancy during the second and third trimesters have not shown an association with adverse pregnancy-related outcomes. hydralazine hydrochloride is teratogenic in mice at 66 mg/kg and possibly in rabbits at 33 mg/kg (2 and 3 times the mrhd of isosorbide dinitrate and hydralazine hydrochloride tablets on a body surface area basis). isosorbide dinitrate has been shown to cause a dose-related increase in embryo-toxicity (excess mummified pups) in rabbits at 70 mg/kg (12 times the mrhd of isosorbide dinitrate and hydralazine hydrochloride tablets on a body surface area basis). all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnant women with heart failure are at increased risk for preterm birth. clinical classification of heart disease may worsen with pregnancy and lead to maternal death and/or stillbirth. risk summary there are no data on the presence of isosorbide dinitrate and hydralazine hydrochloride tablets in human or animal milk, the effects on the breastfed infant or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for isosorbide dinitrate and hydralazine hydrochloride tablets and any potential adverse effects on the breastfed child from isosorbide dinitrate and hydralazine hydrochloride tablets or from the underlying maternal condition. the safety and effectiveness of isosorbide dinitrate and hydralazine hydrochloride tablets in children have not been established. clinical studies of isosorbide dinitrate and hydralazine hydrochloride tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in response between elderly and younger patients. in general, dose selection for an elderly patient should start at the low end of the dosing range, reflecting the greater frequency of decreased hepatic and renal function, and of concomitant disease or other drug therapies. isosorbide dinitrate, its active metabolites, and hydralazine may be eliminated more slowly in elderly patients. there are no studies of renal impairment using isosorbide dinitrate and hydralazine hydrochloride tablets. no dose adjustment is required for hydralazine or isosorbide dinitrite [see clinical pharmacology (12.3)] . dialyzability of hydralazine has not been determined. dialysis is not an effective method for removing isosorbide dinitrate or its metabolite isosorbide-5-mononitrate from the body. the effect of hepatic impairment on the pharmacokinetics of hydralazine alone has not been determined. isosorbide dinitrate concentrations increase in patients with cirrhosis. there are no studies of hepatic impairment using isosorbide dinitrate and hydralazine hydrochloride tablets.