The official letter 5074/QLD-ĐK updating the pharmacological information of statin drugs

The official letter 5074/QLD-ĐK updating the pharmacological information of statin drugs

To:   

• Provincial/municipal Health Departments;
• Hospitals, institutes with beds;
• Applicants, manufacturers have drugs marketing in Vietnam.

On December 04, 2008, Drug Administration of Vietnam had the official letter No. 12048/QLD-ĐK about updating the relevant pharmacological information for statin drugs in the PI and the SMPC of drugs based on the reports of WHO and Drug Administration of other countries.

From June 2011 to March 2012, U.S. Food and Drug Administration (FDA) had continuously put out notices about safety information accompanying the requirements about changing the information on PI of Statins for Dyslipidemia. The key changes on PI of these drugs related to dosage limits, undesirable effects, drug interactions, warnings and caution when using all statins, especially the addition of contraindication of drug combination and dose limits when administered concomitantly with medicines known to increase the risk of myopathy and/or rhabdomyolysis syndrome of lovastatin and simvastatin.

In Vietnam, the statin class currently in circulation in the form of single-ingredient preparations (atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin) and combination preparations (simvastatin with ezetimib or atorvastatin with amlodipine).

Based on the conclusions of the medicine review board – the Ministry of Health, to statin drugs; to ensure objective the use of drug reasonable, safe and effective, the Drug Administration of Vietnam notices as follow:

1. For provincial/municipal Health Departments, hospitals, institutes with beds belong to Ministry of Health.

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(Contraindicated to combine these drugs with preparations has simvastatin ≥ 20 mg)

4. Do not exceed 20 mg simvastatin daily with:

• Amiodarone
• Amlodipine
• Ranolazine

The official letter 5074/QLD-ĐK updating the pharmacological information of statin drugs

Vietnamese Version Click here

DOWNLOAD FULL ENGLISH VERSION HERE

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English version: 5074_QLD_DK_English version

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