Isoket

Uses

What is Isoket® (isosorbide dinitrate) used for?

Isoket® is commonly used for the treatment and prophylaxis of:

• Acute angina pectoris attacks
• Acute MI and left ventricular failure
• CAD
• Severe chronic heart failure in combination with cardiac glycosides, diuretics, ACE inhibitors or arterial vasodilators
• Pulmonary HTN
• CHD

How should I take Isoket® (isosorbide dinitrate)?

Isoket® should be taken

• With an empty stomach
• 30 minutes before meals
• Swallow whole, do not chew/crush

How do I store Isoket® (isosorbide dinitrate)?

Isoket® is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Isoket® in the bathroom or the freezer. There may be different brands of Isoket® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Isoket® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Isoket® (isosorbide dinitrate)?

Before using Isoket®, tell your doctor if you have:

• Hypersensitivity to isosorbide dinitrate or other nitro comps
• Phosphodiesterase inhibitors (e.g., sildenafil, tadalafil, vardenafil)
• Acute circulatory failure
• Cardiogenic shock
• Hypertrophic obstructive cardiomyopathy
• Constrictive pericarditis
• Cardiac tamponade
• Severe hypotension
• Hypovolemia
• Anemia
• Low filling pressures e.g., acute MI
• Impaired left ventricular function
• Aortic/mitral stenosis
• Diseases associated with increased intracranial pressure
• Orthostatic dysfunction

Also, Isoket® could lead to:

• Severe renal or hepatic impairment
• Ability to drive or operate machinery

Is it safe during pregnancy or breastfeeding?

There are no adequate studies in women for determining risk when using this medication during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking this medication. Isoket® is pregnancy risk category C, according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

• A=No risk
• B=No risk in some studies
• C=There may be some risk
• D=Positive evidence of risk
• X=Contraindicated
• N=Unknown

Side effects

What side effects can occur from Isoket® (isosorbide dinitrate)?

When taking Isoket®, some side effects can occur.

• Headache
• Apprehension
• Restlessness
• Weakness
• Vertigo
• Dizziness
• Faintness
• Tachycardia
• Retrosternal discomfort
• Palpitations
• Hypotension
• Syncope
• Collapse
• Orthostatic hypotension
• Angina
• Rebound hypertension
• Atrial fibrillation
• Postural hypertension
• Rash
• Exfoliation dermatitis
• Cutaneous vasodilation with flushing
• Nausea
• Vomiting
• Incontinence of urine and feces
• Abdominal pain
• Diarrhea
• Dysuria
• Impotence
• Urinary frequency
• Muscle twitching
• Pallor
• Perspiration
• Cold sweat
• Arthralgia
• Bronchitis

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Isoket® (isosorbide dinitrate)?

Isoket® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Isoket® (isosorbide dinitrate)?

Isoket® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Isoket® (isosorbide dinitrate)?

Isoket® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Isoket® (isosorbide dinitrate).

What is the dose of Isoket® (isosorbide dinitrate) for an adult?

Angina pectoris:

Starting dose, 2.5–5 mg sublingual, 5-mg chewable tablets, 5- to 20-mg oral tablets. For maintenance, 10–40 mg q 6 hr oral tablets or capsules.

SR, initially 40 mg, then 40–80 mg PO q 8–12 hr.

Acute prophylaxis:

Initial dosage, 5–10 mg sublingual or chewable tablets q 2–3 hr.

Prevention of angina:

20 mg PO bid given 7 hr apart; ER tablets—30–60 mg/day PO may be increased to 120 mg/day if needed.

In smaller patients, start with 5 mg (one-half of 10-mg tablet) but then increase to at least 10 mg by day 2 or 3 of therapy. Give first dose when waking and second dose 7 hr later. This creates a nitrate-free period and minimizes tolerance to drug.

What is the dose of Isoket® (isosorbide dinitrate) for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Isoket® (isosorbide dinitrate) available?

Isoket® is available in the following dosage forms and strengths:

• Isoket® SR tab 20 mg
• Isoket® retard tab 40 mg
• Isoket® tab 10 mg
• Isoket® tab 5 mg

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Isoket®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.