Pricing
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All price changes →Isozine
Rx20 mg + 37.5 mg • Tablet
Indications & Uses
Isozine is indicated for:
Pharmacology
The way isosorbide dinitrate and hydralazine hydrochloride work together to benefit people with heart failure has not been established. Isosorbide dinitrate is a vasodilator, and it acts on both arteries and veins. It releases nitric oxide, which activates guanylyl cyclase, and this finally relaxes the smooth muscle of the blood vessels.
Several well-controlled clinical trials used exercise testing to assess how well nitrates given over a long period work against angina. In the large majority of these trials, the active agents were no more effective than placebo after 24 hours (or less) of continuous therapy. Researchers tried to overcome this nitrate tolerance by raising the dose, even to levels far above those used for short-term treatment, but these attempts have consistently failed. The response to nitrates returns only after they have been absent from the body for several hours.
Hydralazine hydrochloride is a selective dilator of arterial smooth muscle. Animal data suggests that hydralazine may also lessen tolerance to nitrates.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Route of administration: Isosorbide Dinitrate + Hydralazine Hydrochloride is taken by mouth. The usual starting dose is one tablet, three times a day. If the patient tolerates it, the dose can be raised up to a maximum of two tablets three times daily. Titration can be quick (3 to 5 days), but some patients get side effects and may need longer to reach the highest dose they can tolerate. If the side effects are not tolerable, the dose may be cut down to one-half tablet three times a day. The aim is to increase the dose again as soon as the side effects settle.
Use in children and adolescents: The safety and effectiveness of this combination in children have not been established.
Side Effects
These side effects have been identified after approval, while people were using Isosorbide Dinitrate + Hydralazine Hydrochloride tablets. They are grouped by the part of the body affected. Cardiac disorders: palpitations. Ear and labyrinth disorders: tinnitus and vertigo. Eye disorders: eyelid edema and blurred vision. Gastrointestinal disorders: abdominal discomfort and constipation. Under general disorders and administration site conditions, the reports include facial pain, flushing, chest discomfort, chest pain and peripheral edema. Musculoskeletal and connective tissue disorders include pain in extremity and myalgia. Nervous disorders include dysgeusia, hypoaesthesia, migraine and syncope. Renal and urinary disorders include chromaturia and pulmonary renal syndrome. Respiratory, thoracic and mediastinal disorders include dyspnea. Reproductive system and breast disorders include erectile dysfunction. Skin and subcutaneous tissue disorders include erythema, hyperhidrosis, pruritus and face swelling.
Cautions & Contraindications
Warnings & Precautions
Even small doses of Isosorbide Dinitrate + Hydralazine Hydrochloride can cause symptomatic hypotension, especially when a person stands up. It is most likely in patients who have lost fluid or salt, so this should be corrected before starting Isosorbide Dinitrate + Hydralazine Hydrochloride. Hydralazine hydrochloride has been reported to cause a drug-induced systemic lupus erythematosus (SLE) syndrome. The symptoms and signs usually go away once hydralazine hydrochloride is stopped. It can also cause tachycardia and hypotension, which may lead to myocardial ischemia and angina, particularly in patients with hypertrophic cardiomyopathy. Peripheral neuritis has also been linked to hydralazine hydrochloride. It shows up as paresthesia, numbness and tingling, and it may be related to an antipyridoxine effect. If these symptoms develop, pyridoxine should be added to the therapy.
Contraindications
Don't use the isosorbide dinitrate and hydralazine hydrochloride combination if you are known to be hypersensitive to isosorbide dinitrate, hydralazine hydrochloride, or any organic nitrates. The same applies if you are hypersensitive to any other component of this product. It must also not be used in people who are taking PDE-5 inhibitors, or the soluble guanylate cyclase (sGC) stimulator riociguat.
Pregnancy & Breastfeeding
Pregnancy
There are no data on the use of isosorbide dinitrate with hydralazine hydrochloride in pregnant women. The data on its individual components are also too limited to judge whether first trimester use carries a risk of major birth defects or miscarriage. For hydralazine, the published data on use in the second and third trimesters have not shown any link with adverse pregnancy outcomes.
Lactation
Think about the benefits of breastfeeding for the child's development and health, and set them against the mother's clinical need for this combination. Also consider any possible adverse effects on the breastfed child, whether they come from this combination or from the mother's underlying condition.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Geriatric use
Studies of the isosorbide dinitrate and hydralazine hydrochloride tablet did not include enough people aged 65 and over to show whether they respond differently from younger people. Other reported clinical experience hasn't found any difference in response between elderly and younger patients. In general, an elderly patient should start at the low end of the dosing range, because decreased liver and kidney function are more common in this age group, and so are other diseases and other drug therapies. Isosorbide dinitrate, its active metabolites and hydralazine may be eliminated more slowly in elderly patients.
Renal impairment
There are no studies of kidney impairment using this tablet. No dose adjustment is required for hydralazine or isosorbide dinitrate. Whether hydralazine can be removed by dialysis has not been determined. Dialysis is not an effective way to remove isosorbide dinitrate or its metabolite isosorbide-5-mononitrate from the body.
Hepatic impairment
The effect of liver impairment on the pharmacokinetics of hydralazine alone has not been determined. Isosorbide dinitrate concentrations increase in patients with cirrhosis. There are no studies of liver impairment using this tablet.
Overdose
No cases of overdosage with Isosorbide Dinitrate + Hydralazine Hydrochloride have been documented, and no deaths from acute poisoning have been reported. There is no specific antidote. Supporting the cardiovascular system is the main concern. Dialysis does not effectively remove circulating isosorbide dinitrate, and it is not known whether hydralazine can be removed by dialysis.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Store Isosorbide Dinitrate + Hydralazine Hydrochloride below 30°C, away from light and moisture. Keep it out of the reach of children.
Drug Interactions
Common questions about Isozine 20 mg + 37.5 mg
What is Isozine 20 mg + 37.5 mg Tablet?
Isozine 20 mg + 37.5 mg Tablet is a medicine that contains Isosorbide Dinitrate + Hydralazine Hydrochloride. It is made by Advanced Chemical Industries PLC.
What is Isozine used for?
Isozine is used for: Heart Failure.
What are the side effects of Isozine?
These side effects have been identified after approval, while people were using Isosorbide Dinitrate + Hydralazine Hydrochloride tablets. They are grouped by the part of the body affected.
Can I take Isozine during pregnancy or while breastfeeding?
Pregnancy There are no data on the use of isosorbide dinitrate with hydralazine hydrochloride in pregnant women. The data on its individual components are also too limited to judge whether first trimester use carries a risk of major birth defects or miscarriage. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Isozine?
No cases of overdosage with Isosorbide Dinitrate + Hydralazine Hydrochloride have been documented, and no deaths from acute poisoning have been reported. There is no specific antidote. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Isozine?
Store Isosorbide Dinitrate + Hydralazine Hydrochloride below 30°C, away from light and moisture. Keep it out of the reach of children.
Can I take other medicines with Isozine?
Some medicines can interact with Isosorbide Dinitrate + Hydralazine Hydrochloride, for example: Sildenafil, Tadalafil, Avanafil, Vardenafil. Tell your doctor or pharmacist about every medicine you take.
Is there a cheaper medicine with the same ingredient?
Isozine is already among the lowest-priced brands of Isosorbide Dinitrate + Hydralazine Hydrochloride at this strength.
Do I need a prescription for Isozine?
Isozine is a prescription (Rx) medicine. Take it as your doctor advises.