The Recall of Isosorbide Mononitrate Extended Release Tablets

Isosorbide Mononitrate Extended Release Tablets are a type of prescription nitrate drug that relax blood vessels to improve the flow of blood and oxygen to a patient’s heart. The drug is often used to prevent the chest pain associated with angina.

Proper and consistent dosing is very important to the efficacy of this drug. Patients are advised to maintain consistent dosing in order for the drug to be effective. However, in 2008 certain batches of the drug were recalled because of concerns that tablets contained more than the stated dosage.

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Why was it recalled?

Isosorbide Mononitrate Extended Release Tablets were recalled, along with several other drugs manufactured by the Ethex Corporation, because of the potential for an overdose. Some of the pills sent to pharmacists and other distributors were oversized. Distributors were directed to send back any remaining tablets from the recalled lots, however, some of the pills had already been distributed to patients. Without the recall, patients would not be aware that the pills were oversized and that they risked an overdose of medication by taking the prescribed pills that were the wrong size and dosage.

How to identify recalled tablets?

The tablets affected in this recall include Isosorbide Mononitrate Extended Release Tablets of 30 mg and 60 mg. The affected tablets can be identified as follows:

• 30 mg tablets: oval, reddish pink film coated tablets with an E bisecting a 30 on one side.
• 60 mg tablets: oval, yellow film coated tablets with an E bisecting a 60 on one side.

The 120 mg tablets were not included in the November 2008 recall.

Symptoms of overdose/adverse reactions

An overdose of Isosorbide Mononitrate can be deadly. If a patient starts to experience symptoms of an overdose or believes that he or she ingested one of the oversized pills, the patient should seek emergency medical attention.

Some common symptoms of an overdose may include an intense headache, confusion, fever, vertigo, palpitations, visual disturbances, nausea, vomiting, difficulty breathing, bradycardia, paralysis, coma and seizures.

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Treatment of an overdose

Treatment of an Isosorbide Mononitrate overdose can be difficult. It is especially challenging in patients with renal disease or congestive heart failure. To date, there has been no controlled study of interventions that could safely treat an overdose of this drug.

Patients are advised to closely check their supply of this drug and to discontinue use of the existing batch of medication. They should immediately replace it with drugs from an unaffected supply batch and speak to their doctors and pharmacists about any health concerns.

 

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