Meridia

Meridia or Reductil ( sibutramine hydrochloride monohydrate ) is diet pill that may help obese people, as determined by their doctor, lose weight and keep weight off. . Sibutramine was approved by the FDA in 1997.

Sibutramine hydrochloride monohydrate is a white to cream crystalline powder with a solubility of 2.9 mg/mL in pH 5.2 water. Its octanol: water partition coefficient is 30.9 at pH 5.0.

Sibutramine is in a class of medications called appetite suppressants. It works by acting on appetite control centers in the brain to decrease appetite. Sibutramine is a medication that assists with weight-loss by altering neurotransmitters within the brain.

Each Meridia capsule contains 5mg (blue and yellow); 10mg (blue and white); 15mg (white and yellow) of sibutramine hydrochloride monohydrate. It also contains as inactive ingredients: lactose monohydrate, NF; microcrystalline cellulose, NF; colloidal silicon dioxide, NF; and magnesium stearate, NF in a hard-gelatin capsule [which contains titanium dioxide, USP; gelatin; FD&C Blue No. 2 (5- and 10-mg capsules only); D&C Yellow No. 10 (5- and 15-mg capsules only), and other inactive ingredients].

Meridia pills are supplied as :

  • 5 mg blue/yellow capsules in bottles of 30 capsules and in bottles of 100 capsules.
  • 10 mg blue/white capsules in bottles of 30 capsules and in bottles of 100 capsules.
  • 15 mg yellow/white capsules in bottles of 30 capsules and in bottles of 100 capsules.

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 obese patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., diabetes, dyslipidemia, controlled hypertension).

Usage
Take Meridia by mouth exactly as directed by your doctor, it is usually taken once daily, generally in the morning with or without food. Therapy usually is started with one 10mg Meridia tablet per day. The 5 mg dose reserved for patients who do not tolerate the 10 mg dose.

Your doctor may start you on a low dose of sibutramine and increase your dose to 15mg to achieve the desired effect, after you have been taking sibutramine for at least 4 weeks.

The full effect on weight may require four to six weeks.

You may not continue to lose weight after your first 6 months of treatment. However, you should continue to take sibutramine even if you have stopped losing weight. If you stop taking sibutramine, you may gain weight. Do not stop taking sibutramine without talking to your doctor.

Analysis of numerous variables has indicated that approximately 60% of patients who lose at least 4 pounds in the first 4 weeks of treatment with a given dose of Meridia in combination with a low calorie diet lose at least 5% (placebo-subtracted) of their initial body weight by the end of 6 months to 1 year of treatment on that dose of Meridia. Conversely, approximately 80% of patients who do not lose at least 4 pounds in the first 4 weeks of treatment with a given dose of Meridia do not lose at least 5% (placebo-subtracted) of their initial body weight by the end of 6 months to 1 year of treatment on that dose.

If a patient has not lost at least 4 pounds in the first 4 weeks of treatment, the physician should consider reevaluation of therapy which may include increasing the dose or discontinuation of Meridia.

PRECAUTIONS
In general, Meridia is well-tolerated.

The most common side effects have been dry mouth, drowsiness, constipation, difficulty sleeping, or headache. If any of these effects persist or worsen, notify your doctor promptly.

If you notice any other Meridia side effects contact your doctor or pharmacist.

In patients receiving one of the drugs from a class of drugs known as selective serotonin reuptake inhibitors (SSRIs)–e.g., fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft)–at the same time as monoamine oxidase inhibitor drugs (MAO inhibitors), there have been reports of serious reactions (serotonin syndrome). The serotonin syndrome may include one or more of the following: agitation, anxiety, dizziness, confusion, excessive sweating, disorientation, painful joints, vomiting, hyperexcitement, fever, loss of coordination, loss of consciousness, shivering, fast heart rate, tremor, and weakness. Meridia, like the SSRIs, blocks the reuptake of serotonin and may also cause the serotonin syndrome. Therefore, sibutramine should not be used with MAO inhibitors, and there should be at least a 2-week interval between stopping an MAO inhibitor and starting sibutramine.

MERIDIA should be used with caution in patients with mild to moderate renal impairment. MERIDIA should not be used in patients with severe renal impairment, including those with end stage renal disease on dialysis

Some people taking MERIDIA can have a large increase in blood pressure or heart rate (pulse). Do not take MERIDIA if your blood pressure is not well controlled. .

MERIDIA is contraindicated in patients taking other centrally acting weight loss drugs.

Patients taking Meridia may achieve a 5-10% reduction from their baseline weight. Additionally, sibutramine-assisted weight loss has been accompanied by improvement in blood lipids (e.g, cholesterol).

Do not take more or less of it or take it more often or for a longer time than prescribed by your doctor. You will probably lose weight soon after you begin taking sibutramine and following your diet and exercise program. Be sure to monitor your weight, and call your doctor if you do not lose at least 4 pounds during your first 4 weeks of therapy.

The efficacy of sibutramine in adolescents who are obese has not been adequately studied.

It is unknown whether sibutramine or its active products accumulate in breast milk. Sibutramine, therefore, is not recommended for nursing mothers.

How should I store MERIDIA?

Keep Meridia in the container it came in, tightly closed, and out of reach of children. Store at room temperature between 59 and 86 degrees F (15-30 degrees C) . Protect capsules from heat and moisture.