I.S.D. Uses

• I.S.D. indications
• Uses of I.S.D. in details
• I.S.D. description
• I.S.D. dosage
• I.S.D. interactions
• I.S.D. side effects
• I.S.D. contraindications

What is I.S.D.?

Preventing symptoms of angina (chest pain) caused by heart disease. I.S.D. extended-release capsules is used alone or with other medicines. I.S.D. extended-release capsules is NOT intended for the immediate relief of acute attacks of angina. It may also be used for other conditions as determined by your doctor.

I.S.D. extended-release capsules is a nitrate. It works by relaxing the blood vessels in the body, allowing them to widen. This lets more blood flow through the blood vessels, which reduces the work the heart has to do to pump blood. This reduces the oxygen needs of the heart and makes chest pain go away.

I.S.D. indications

Angina Pectoris:

Oral Tablet:

Prophylaxis of ischemic heart pain associated with coronary insufficiency. I.S.D. may reduce the frequency, duration and severity of anginal attacks. Exercise tolerance may be improved and the need for nitroglycerin may be reduced. The oral tablets are not indicated for the treatment of an anginal attack.

Sublingual Tablet: Treatment of angina pectoris and prophylaxis in situations likely to provoke an anginal attack ie, physical or emotional stress.

Congestive Heart Failure: Acute and chronic congestive heart failure (including that associated with myocardial infarction). Based on current knowledge, I.S.D. should be considered only as an adjunct to the more conventional modes of therapy (cardiac glycosides and diuretics); however, in refractory cases, it may be used alone or concomitantly with other vasodilators. I.S.D. is particularly effective in patients with increased left ventricular end diastolic pressure (LVEDP), "backward failure" and normal or approximately normal cardiac output in whom pulmonary congestion or edema is the primary problem. I.S.D. is especially recommended when coronary artery disease is the cause of congestive heart failure, in which case its antianginal effect is of additional value.

How should I use I.S.D.?

Use I.S.D. extended-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take I.S.D. extended-release capsules by mouth on an empty stomach with a full glass of water (8 oz [240 mL]).
• Swallow I.S.D. extended-release capsules whole. Do not break, crush, or chew before swallowing.
• If you miss a dose of I.S.D. extended-release capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use I.S.D. extended-release capsules.

Uses of I.S.D. in details

Use: Labeled Indications

Angina pectoris, prevention: Prevention of angina pectoris due to coronary artery disease.

Note: Due to slower onset of action, I.S.D. is not the drug of choice to abort an acute anginal episode.

Off Label Uses

Achalasia

Based on the American College of Gastroenterology (ACG) guidelines on the diagnosis and management of achalasia, I.S.D. may be considered for patients with achalasia who cannot use or refuse more definitive therapies (pneumatic dilation or surgical myotomy) and patients who have failed botulinum toxin injections.

Heart failure with reduced ejection fraction

Data from a randomized, double-blind trial comparing enalapril and hydralazine plus I.S.D. in patients with chronic heart failure support the use of I.S.D. (in combination with hydralazine) in patients with intolerance to ACE inhibitor therapy.

I.S.D. description

Each tablet of I.S.D. 5 mg contains 5 mg of I.S.D..

Each tablet of I.S.D. 10 mg contains 10 mg of I.S.D..

Each sustained-release tablet of I.S.D. 20 mg contains 20 mg of I.S.D..

Each sustained-release tablet of I.S.D. 40 mg contains 40 mg of I.S.D..

I.S.D. dosage

As noted under "CLINICAL PHARMACOLOGY," multiple-dose studies with I.S.D. and other nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. Every dosing regimen for I.S.D. tablets must provide a daily dose-free interval to minimize the development of this tolerance. With immediate-release I.S.D., it appears that one daily dose-free interval must be at least 14 hours long.

As also noted under "CLINICAL PHARMACOLOGY," the effects of the second and later doses have been smaller and shorter-lasting than the effects of the first.

Large controlled studies with other nitrates suggest that no dosing regimen with I.S.D. tablets should be expected to provide more than about 12 hours of continuous anti-anginal efficacy per day.

As with all titratable drugs, it is important to administer the minimum dose which produces the desired clinical effect. The usual starting dose of I.S.D. is 5 mg to 20 mg, two or three times daily. For maintenance therapy, 10 mg to 40 mg, two or three times daily is recommended. Some patients may require higher doses. A daily dose-free interval of at least 14 hours is advisable to minimize tolerance. The optimal interval will vary with the individual patient, dose and regimen.

I.S.D. interactions

See also:
What other drugs will affect I.S.D.?

Blood Pressure Lowering Agents: The concomitant use of drugs with blood pressure lowering properties, e.g. vasodilators, beta-blockers, calcium channel antagonists, ACE inhibitors, neuroleptics or tricyclic antidepressants and alcohol may potentiate the antihypertensive effect of I.S.D..

Phosphodiesterase Inhibitors: A blood pressure lowering effect of I.S.D. will be increased, if used together with phosphodiesterase inhibitors (e.g. sildenafil, tadalafil, vardenafil). This might lead to life-threatening cardiovascular complications. Patients who are on I.S.D. therapy therefore must not use phosphodiesterase inhibitors (e.g. sildenafil, tadalafil, vardenafil).

Patients who have recently taken phosphodiesterase inhibitors (e.g. sildenafil, vardenafil, tadalafil) therefore must not receive acute I.S.D. therapy.

Dihydroergotamine: I.S.D. used in combination with dihydroergotamine may lead to higher blood concentration of dihydroergotamine and thus increase the effect of this medicinal product.

Sapropterine: Sapropterine contains the API Tetrahydrobiopterine (BH4). BH4 is a cofactor for nitric oxide synthetase. Caution is recommended during concomitant use of sapropterine-containing medicine with all agents that cause vasodilation by affecting nitric oxide (NO) metabolism or action, including classical NO donors [e.g. glyceryl trinitrate (GTN), I.S.D. (ISDN), I.S.D. mononitrate and others].

I.S.D. side effects

See also:
What are the possible side effects of I.S.D.?

Adverse reactions to I.S.D. are generally dose-related, and almost all of these reactions are the result of I.S.D.'s activity as a vasodilator. Headache, which may be severe, is the most commonly reported side effect. Headache may be recurrent with each daily dose, especially at higher doses. Transient episodes of lightheadedness, occasionally related to blood pressure changes, may also occur. Hypotension occurs infrequently, but in some patients it may be severe enough to warrant discontinuation of therapy. Syncope, crescendo angina, and rebound hypertension have been reported but are uncommon.

Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal-seeming patients. Methemoglobinemia is so infrequent at these doses that further discussion of its diagnosis and treatment is deferred.

Data are not available to allow estimation of the frequency of adverse reactions during treatment with I.S.D. tablets.

To report SUSPECTED ADVERSE REACTIONS contact AvKARE, Inc. at 1-855-361-3993; email drugsafety@avkare.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

I.S.D. contraindications

See also:
What is the most important information I should know about I.S.D.?

Do not use I.S.D. if you are taking sildenafil (Viagra). Serious, life-threatening side effects can occur if you take I.S.D. while you are using sildenafil.

You should not use this medication if you are allergic to I.S.D., I.S.D. mononitrate (Imdur, ISMO, Monoket), or nitroglycerin, or if you have early signs of a heart attack (chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling).

Before taking I.S.D., tell your doctor if you have congestive heart failure, low blood pressure, or kidney disease.

I.S.D. can cause severe headaches, especially when you first start using it. These headaches may gradually become less severe as you continue to use the medication. Do not stop taking I.S.D.. Ask your doctor before using any headache pain medication.

Only the sublingual tablet should be used to treat an angina attack that has already begun.

I.S.D. regular and extended-release tablets are used to prevent angina attacks but will not treat an angina attack.

It is important to keep taking this medicine as directed to prevent an angina attack. Get your prescription refilled before you run out of medicine completely.

Do not stop taking I.S.D. suddenly. Stopping suddenly could cause a severe angina attack.

Active ingredient matches for I.S.D.:

Isosorbide DINITRATE

List of I.S.D. substitutes (brand and generic names)	Sort by popularity
Unit description / dosage (Manufacturer)	Price, USD
Hexanitrat Retard
Capsule, Retard; Oral; Isosorbide Dinitrate 40 mg
IBD 20
Imtack (Ireland)
Insucar (Mexico)
Isacardin (Russian Federation)
ISD
Isdin (Pakistan)
ISDN
Tablet; Oral; Isosorbide Dinitrate 20 mg
Tablet; Oral; Isosorbide Dinitrate 5 mg
Tablet; Oral; Isosorbide Dinitrate 10 mg
Tablet; Oral; Isosorbide Dinitrate 40 mg
Isdn tablet 5 mg (Aa Pharma Inc (Canada))
Isdn tablet 10 mg (Aa Pharma Inc (Canada))
Isdn tablet 30 mg (Aa Pharma Inc (Canada))
ISDN AA Pharma (Canada)
ISDN AL (Germany)
ISDN AL retard (Germany)
ISDN Heumann (Germany)
ISDN Hexal (Germany)
ISDN Hexal retard (Germany)
ISDN Retard
Capsule, Retard; Oral; Isosorbide Dinitrate 20 mg
Capsule, Retard; Oral; Isosorbide Dinitrate 40 mg
Capsule, Retard; Oral; Isosorbide Dinitrate 60 mg
Capsule, Retard; Oral; Isosorbide Dinitrate 80 mg
Capsule, Retard; Oral; Isosorbide Dinitrate 120 mg
Tablet, Retard; Oral; Isosorbide Dinitrate 20 mg
Capsule, Retard; Oral; Isosorbide Dinitrate 100 mg
ISDN Rth (Latvia)
ISDN Sandoz (Germany)
ISDN Stada (Germany)
ISDN-CT (Germany)
ISDN-Isis (Germany)
ISDN-ratiopharm (Estonia, Germany, Latvia, Lithuania, Luxembourg)
Iso (Spain)
ISO 10mg TAB / 10 (Ascent Remedies Pvt. Ltd.)	$ 0.13
ISO 20mg TAB / 10 (Ascent Remedies Pvt. Ltd.)	$ 0.23
Iso 10 mg Tablet (Ascent Remedies Pvt. Ltd.)	$ 0.01
ISO 10 mg Zee Labs Tablet (Ascent Remedies Pvt. Ltd.)	$ 0.02
ISO 100 mg Tablet (Ascent Remedies Pvt. Ltd.)	$ 0.01
Iso 20 mg Tablet (Ascent Remedies Pvt. Ltd.)	$ 0.02
ISO 300 mg Tablet (Ascent Remedies Pvt. Ltd.)	$ 0.02
ISO 20MG TABLET 1 strip / 10 tablets each (Ascent Remedies Pvt. Ltd.)	$ 0.74
ISO 10mg TAB / 10 (Ascent Remedies Pvt. Ltd.)	$ 0.13
See 751 substitutes for I.S.D.

References

1. DailyMed. "ISOSORBIDE DINITRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. PubChem. "ISOSORBIDE DINITRATE". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "ISOSORBIDE DINITRATE". http://www.drugbank.ca/drugs/DB00883 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology