Sibutramine

Product name: Sibutramine

manufacturer: Abbott Laboratories

Active substance: Sibutramine Hydrochloride Monohydrate

Brand names: Apetcor, Atenix, Butramin, Diet Max, Meridia, Mesura, Reductil, Regitrim, Cetonid, Controlex, Lindaxa, Obenil, Plenty, Redux, Sibutramina Farmandina, Sibutramina Genamerica, Sibutramina Genfar, Sibutramina MK, Sibutrex, Accent, Aderan, Adisar, Adisar, Biomag, Shapedesign, Sibulin, Sibus, Sibuthin, Sibutramine 1A Pharma, Sibutramine Shou Chan, Sibutramine Teva, Sibutril, Sibutrin

Strength: 20 MG

Quantity: 100 – 750 Capsules

Category:

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Description

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DESCRIPTION

Sibutramine – 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.

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

Sibutramine is used in the management of obesity, including weight loss and management of weight loss. It should be used in conjunction with a reduced caloric diet. Sibutramine is recommended for obese patients with an initial body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, dyslipidemia)

INTERACTIONS

Sibutramine has a number of clinically significant interactions. The concomitant use of sibutramine and monoamine oxidase inhibitors (MAOIs, such as selegiline) is not indicated, as it may increase the risk of serotonin sibutramine , a somewhat rare but serious adverse drug reaction.[17] Sibutramine should not be taken within two weeks of stopping or starting an MAOI. Taking both sibutramine and certain medications used in the treatment of migrainessuch as ergolines and triptansas well as opioids, may also increase the risk for serotonin syndrome, as may the use of more than one serotonin reuptake inhibitor at the same time.[17]

The concomitant use of sibutramine and drugs which inhibit CYP3A4, such as ketoconazole and erythromycin, may increase plasma levels of sibutramine.[18] Sibutramine does not affect the efficacy of hormonal contraception.[17]

PRECAUTIONS

Use caution when prescribing Sibutramine with other agents that may raise blood pressure or heart rate including certain decongestant, cough, cold and allergy medications that contain agents such as phenylpropanolamine, ephedrine or pseudoephedrine.

DOSAGE AND ADMINISTRATION

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. Blood pressure and heart rate changes should be taken into account when making decisions regarding dose titration

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

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 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. 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% (placebosubtracted) 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.

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

Analysis of numerous variables has indicated that ≈ 60% of patients who lose at least 4 lbs in the first 4 weeks of treatment with a given dose of Sibutramine 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. Conversely, ≈ 80% of patients who do not lose at least 4 lbs in the first 4 weeks of treatment with a given dose 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.

SIDE EFFECTS

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using sibutramine and call your doctor at once if you have a serious side effect such as:fast, pounding, or uneven heartbeats; new or worsening shortness of breath; agitation, hallucinations, fever, tremor, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, dilated pupils;

very stiff (rigid) muscles, high fever, sweating, confusion, feeling like you might pass out; easy bruising or bleeding (nosebleeds, bleeding gums, or any bleeding that will not stop);

dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, seizure);

chest pain or heavy feeling, pain spreading to the arm or shoulder, general ill feeling; or

sudden numbness or weakness (especially on one side of the body), problems with vision, speech, or balance.Less serious side effects may include:dry mouth, upset stomach;changes in appetite;constipation, stomach pain; headache, back pain, joint pain;feeling nervous, dizzy, or depressed;flu symptoms, runny or stuffy nose, sore throat, cough; warmth, redness, or tingly feeling under your skin;trouble sleeping (insomnia); ormild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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Sibutramine