Meridia Information

What is Meridia?

Meridia is indicated for the management of obesity including weight loss and maintenance of weight loss and should be used in conjunction with a reduced calorie diet. Meridia is recommended for over weight patients with an initial Body Mass Index (BMI) greater than 27 and in the presence of other risk factors i.e., hypertension, diabetes, dyslipidemia. BMI is a useful measure of an individual's current weight related to an ideal body weight. An ideal BMI is generally between 20.5 and 21.5. A BMI greater than 30 is associated with increased cardiovascular risk and other health problems related to obesity

How is Meridia supplied?

MERIDIA (sibutramine hydrochloride monohydrate) Capsules contain 5 mg, 10 mg, or 15 mg, sibutramine hydrochloride monohydrate and are supplied as follows:

5 mg, NDC 0048-0605-01, blue/ yellow capsules imprinted with "MERIDIA" on the cap  and "5" on the body in bottles of 100 capsules.

10 mg, NDC 0048-0610-01, blue/ white capsules imprinted with "MERIDIA" on the cap  and "10" on the body in bottles of 100 capsules.

15 mg, NDC 0048-0615-01, yellow/ white capsules imprinted with "MERIDIA" on the cap and "15" on the body in bottles of 100 capsules.

What is the recommended dose of Meridia?

The recommended starting dose of Meridia is 10 mg administered once daily with or without food. If there is inadequate weight loss the dose may be titrated after four weeks to a total of 15 mg once daily. The 5 mg dose should be reserved for patients who do not tolerate the 10 mg dose.

Doses above 15 mg daily are not recommended. In most clinical trials Meridia was given in the morning.

What are the side effects?

In placebo-controlled obesity studies the most common events were dry mouth, anorexia, insomnia and constipation.  Other less commonly reported side effects include:

• Headaches
• Asthenia
• Tachycardia
• Anorexia
• Constipation
• Dry Mouth
• Dizziness
• Nervousness

Are there any drug interactions associated with Meridia ?

The use of Meridiain combination with other CNS active drugs particularly serotonergic agents has not been systematically evaluated Consequently caution is advised if the concomitant administration of Meridia with other centrally acting drugs is indicated.

In patients receiving monoamine  oxidaseinhibitors MAOIs e g phenelzine, selegiline in combination with serotonergic agents e. g. fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, there have been reports of serious sometimes fatal reactions (serotonin syndrome see below). Because Meridia inhibits serotonin reuptake Meridia should not be used concomitantly with MAOI. At least 2 weeks should elapse between discontinuation of a M.AOI. and initiation of treatment with Meridia. Similarly at least 2 weeks should elapse between discontinuation of Meridia and initiation of treatment with MAOI.

The rare but serious constellation of symptoms termed serotoninsyndrome has also been reported with the concomitant use of selective serotonin reuptake inhibitors and agents for migraine  therapy  such as Imitrex (sumatriptan succinate) and dihydroergotamine certain opioids such as dextramethorphan, meperidine, pentazocine, and fentanyl, lithium, or tryptophan. Serotonin syndrome has also been reported with the concomitant  use of two serotonin reuptake inhibitors.

Concomitant use of MERIDIA and other agents that may raise blood  pressure or heart rate have not been evaluated. These include certain decongestants, (cough cold and allergy  medications) that contain agents such as phenylpropanolamine, ephedrine or pseudoephedrine. Caution should be used when prescribing Meridia to patients who use these medications

Other medications that are contraindicated:

• Ketoconazole
• Erythromycin
• Cimetidine
• Oral Contraceptives
• Warfarin
• Phentoin
• Alcohol