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What is Meridia (Sibutramine Hcl)and how is it used?

Meridia (Sibutramine Hcl) is a prescription medicine used to treat the symptoms of obesity, weight loss and maintenance of weight loss. Meridia (Sibutramine Hcl) may be used alone or with other medications.

Meridia (Sibutramine Hcl) belongs to a class of drugs called Schedule IV controlled substances.

It is not known if Meridia (Sibutramine Hcl) is safe and effective in children younger than 16 years of age.

What are the possible side effects of Meridia (Sibutramine Hcl)?

Meridia (Sibutramine Hcl) may cause serious side effects including:

  • fever,
  • diarrhea,
  • gas,
  • stomach pain,
  • tooth disorder,
  • swelling in hands or feet,
  • joint pain,
  • agitation,
  • leg cramps,
  • hypertonia,
  • unusual thoughts,
  • upper respiratory infection,
  • dyspnea,
  • pruritus,
  • amblyopia, and
  • menstrual disorders

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Meridia include:

  • dry mouth,
  • loss of appetite,
  • difficulty sleeping (insomnia),
  • constipation, and
  • headache

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Meridia. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

MERIDIA® (sibutramine hydrochloride monohydrate) is an orally administered agent for the treatment of obesity. Chemically, the active ingredient is a racemic mixture of the ( ) and (-) enantiomers of cyclobutanemethanamine, 1-(4-chlorophenyl)-N,N-dimethyl-α-(2-methylpropyl)-, hydrochloride, monohydrate, and has an empirical formula of C17H29Cl2NO. Its molecular weight is 334.33.

The structural formula is shown below:

 

 

MERIDIA® (sibutramine hydrochloride monohydrate) Structural Formula Illustration

 

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.

Each MERIDIA capsule contains 5 mg, 10 mg, and 15 mg 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].

INDICATIONS

MERIDIA (sibutramine hydrochloride monohydrate) 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 (sibutramine hydrochloride monohydrate) 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).

Below is a chart of Body Mass Index (BMI) based on various heights and weights.

BMI is calculated by taking the patient’s weight, in kg, and dividing by the patient’s height, in meters, squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches

DOSAGE AND ADMINISTRATION

The recommended starting dose of MERIDIA (sibutramine hydrochloride monohydrate) 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. Blood pressure and heart rate changes should be taken into account when making decisions regarding dose titration (see WARNINGS and PRECAUTIONS).

Doses above 15 mg daily are not recommended. In most of the clinical trials, MERIDIA (sibutramine hydrochloride monohydrate) was given in the morning.

Analysis of numerous variable s 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 (sibutramine hydrochloride monohydrate) in combination with a reduced-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 (sibutramine hydrochloride monohydrate) . 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 (sibutramine hydrochloride monohydrate) 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 (sibutramine hydrochloride monohydrate) .

The safety and effectiveness of MERIDIA (sibutramine hydrochloride monohydrate) , as demonstrated in double-blind, placebo-controlled trials, have not been determined beyond 2 years at this time.

HOW 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 0074-2456-12, blue/yellow capsules imprinted with “MERIDIA (sibutramine hydrochloride monohydrate) ” on the cap and ”-5-“ on the body, in bottles of 30 capsules.

10 mg, NDC 0074-2457-12, blue/white capsules imprinted with ”MERIDIA (sibutramine hydrochloride monohydrate) ” on the cap and “-10-” on the body, in bottles of 30 capsules.

15 mg, NDC 0074-2458-12, yellow/white capsules imprinted with “MERIDIA (sibutramine hydrochloride monohydrate) ” on the cap and “-15-” on the body, in bottles of 30 capsules.

Storage

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP controlled room temperature]. Protect capsules from heat and moisture. Dispense in a tight, light-resistant container as defined in USP.

Also check:Phentermine 37.5 mg – 180 Pills

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