isosorbide dinitrate and hydralazine hydrochloride 37.5 mg/1
hydralazine hydrochloride and isosorbide dinitrate · TABLET, FILM COATED · Bryant Ranch Prepack
isosorbide dinitrate and hydralazine hydrochloride is a tablet, film coated containing hydralazine hydrochloride and isosorbide dinitrate at 37.5 mg/1, taken oral. Manufactured by Bryant Ranch Prepack.
Key Facts
- Brand Name
- isosorbide dinitrate and hydralazine hydrochloride
- Generic Name
- hydralazine hydrochloride and isosorbide dinitrate
- NDC Code (Product)
72162-2343- Manufacturer
- Bryant Ranch Prepack
- Strength
- 37.5 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA020727
- Drug Class
- Nitrate Vasodilator [EPC]
- Marketing Start
- 04/15/2022
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Isosorbide dinitrate and hydralazine hydrochloride tablets are a combination of isosorbide dinitrate, a nitrate vasodilator, and hydralazine hydrochloride, an arteriolar vasodilator, indicated for: the treatment of heart failure as an adjunct therapy to standard therapy in self-identified black patients to improve survival, prolong time to hospitalization for heart failure and to improve patient-reported functional status ( 1.1 ) Limitations of use: There is little experience in patients with NYHA class IV heart failure ( 1.2 ) 1.1 Treatment of Heart Failure in Self-identified Black Patients 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. 1.2 Limitations of Use There is little experience in patients with NYHA class IV heart failure.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Isosorbide dinitrate and hydralazine hydrochloride tablets should be initiated at a dose of one isosorbide dinitrate and hydralazine hydrochloride tablet, three times a day. Titrate to a maximum of two tablets three times daily, if tolerated. Although titration of isosorbide dinitrate and hydralazine hydrochloride tablets can be rapid (3-5 days), some patients may experience side effects and may take longer to reach their maximum tolerated dose. The dosage may be decreased to as little as one-half isosorbide dinitrate and hydralazine hydrochloride tablet three times a day if intolerable side effects occur. Efforts should be made to titrate up as soon as side effects subside. One tablet three times a day titrated to a maximum tolerated dose up to two tablets three times a day ( 2 ) Dosage may be decreased to as little as one-half tablet three times a day if intolerable side effects occur. Efforts should be made to titrate up as soon as side effects subside ( 2 )
Contraindications
4 CONTRAINDICATIONS 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. Patients who are allergic to organic nitrates ( 4 ) Use of phosphodiesterase type 5 (PDE5) inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulator (riociguat). ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Phosphodiesterase Inhibitors Isosorbide dinitrate and hydralazine hydrochloride tablets are contraindicated in patients who are using a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5), PDE5 inhibitors such as avanafil, sildenafil, vardenafil, and tadalafil have been shown to potentiate the hypotensive effects of organic nitrates. 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 [see Contraindications (4) ] .
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (≥ 5% more on isosorbide dinitrate and hydralazine hydrochloride tablets than on placebo) were headache and dizziness ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Wilshire Pharmaceuticals, Inc. at 1-877-495-6856 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Isosorbide dinitrate and hydralazine hydrochloride tablets have been evaluated for safety in 517 heart failure patients in A-HeFT. A total of 317 of these patients received isosorbide dinitrate and hydralazine hydrochloride tablets for at least 6 months, and 220 received isosorbide dinitrate and hydralazine hydrochloride tablets for at least 12 months. In A-HeFT, 21% of the patients discontinued isosorbide dinitrate and hydralazine hydrochloride tablets for adverse reactions compared to 12% who discontinued placebo. Overall, adverse reactions were more common in isosorbide …
Frequently Asked Questions
What is isosorbide dinitrate and hydralazine hydrochloride used for?
isosorbide dinitrate and hydralazine hydrochloride contains hydralazine hydrochloride and isosorbide dinitrate. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is isosorbide dinitrate and hydralazine hydrochloride a controlled substance?
isosorbide dinitrate and hydralazine hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for isosorbide dinitrate and hydralazine hydrochloride?
The generic name for isosorbide dinitrate and hydralazine hydrochloride is hydralazine hydrochloride and isosorbide dinitrate. There are 1 other brand versions of hydralazine hydrochloride and isosorbide dinitrate.
What is the NDC code for isosorbide dinitrate and hydralazine hydrochloride 37.5 mg/1?
The NDC (National Drug Code) for isosorbide dinitrate and hydralazine hydrochloride 37.5 mg/1 is 72162-2343, listed by Bryant Ranch Prepack.