Isordil Titradose Side Effects

Generic name: isosorbide dinitrate

Note: This document contains side effect information about isosorbide dinitrate. Some of the dosage forms listed on this page may not apply to the brand name Isordil Titradose.

Some side effects of Isordil Titradose may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to isosorbide dinitrate: oral capsule extended release, oral tablet, oral tablet extended release, sublingual tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking isosorbide dinitrate (the active ingredient contained in Isordil Titradose) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• fast, slow, pounding, or uneven heart rate;

• worsening angina pain;

• blurred vision or dry mouth;

• nausea, vomiting, sweating, pale skin, feeling like you might pass out; or

• blue-colored skin, tiredness, and feeling short of breath.

Less serious side effects may be more likely to occur, such as:

• headache, mild dizziness;

• weakness; or

• warmth, redness, or tingly feeling under your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to isosorbide dinitrate: oral capsule extended release, oral tablet, oral tablet chewable, oral tablet extended release, sublingual tablet

Nervous system

Headache is probably due to vasodilation and may respond to acetaminophen analgesia.

A case of isosorbide dinitrate-associated transient ischemic attack has been reported, supposedly due to an arterial "steal phenomenon" secondary to drug-induced vasodilation.

A case of visual hallucinations, suicidal ideation, and depression associated with isosorbide dinitrate (the active ingredient contained in Isordil Titradose) has been reported, even upon blind rechallenge of the drug.

Nervous system side effects have included headache and dizziness.

Cardiovascular

Organic nitrates may induce a sudden drop in systemic blood pressure and enhanced vagal tone, resulting in possible inhibition of reflex tachycardia and syncope.

Cardiovascular side effects include flushing, hypotension, diaphoresis, weakness, sinus bradycardia, and unusual case reports of AV heart block. Unusual cases of edema have also been reported. Frequent dosing, high dosages, and long-acting preparations giving constant 24-hour nitroglycerin levels can result in tolerance to the drug. The risk of tolerance is significantly decreased by withholding the drug, so called "nitrate-free" intervals. Rebound symptoms may occur during this time.

Gastrointestinal

Gastrointestinal side effects include mild nausea and constipation.

Hypersensitivity

Hypersensitivity reactions including rare cases of pruritus and drug rash have been reported.

Hematologic

In vitro data show decreased platelet aggregation when exposed to isosorbide dinitrate (the active ingredient contained in Isordil Titradose)

Nitrates, after conversion to nitrites, may accelerate the oxidation of hemoglobin, resulting in abnormally high plasma concentrations of methemoglobin. While most cases of methemoglobinemia are asymptomatic, methemoglobin levels greater than 60% usually induce symptoms (dyspnea, chest pain), particularly in the presence of underlying coronary artery disease. Treatment in symptomatic persons is methylene blue 1% solution 2 mg/kg intravenously over 10 minutes. It is recommended that affected patients be screened for NADP-methemoglobin reductase deficiency.

Hematologic side effects are rare and include methemoglobinemia and a case of isosorbide dinitrate-induced hemolytic anemia in a patient with underlying glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Renal

Renal side effects of isosorbide dinitrate (the active ingredient contained in Isordil Titradose) (ISDN) are described in nonazotemic patients with liver cirrhosis. ISDN can cause a reduction of glomerular filtration rate and free water clearance associated with significant increases in plasma renin and aldosterone in patients with liver cirrhosis. The changes are most remarkable in patients with ascites.

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