Agro Industy in india Fetrasil (Sibutramine hydrochloride monohydrate)

Each Fetrasil Tablets 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 Tablets [which contains titanium dioxide, USP; gelatin; FD&C Blue No. 2 (5- and 10-mg Tabletss only) Fetrasil 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. Fetrasil 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). DOSAGE AND ADMINISTRATION The recommended starting dose of Fetrasil 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, Fetrasil was given in the morning. Storage Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP controlled room temperature]. Protect Tabletss from heat and moisture. Dispense in a tight, light-resistant container as defined in USP. WARNINGS Blood Pressure and Pulse Fetrasil SUBSTANTIALLY INCREASES BLOOD PRESSURE AND/OR PULSE RATE IN SOME PATIENTS. REGULAR MONITORING OF BLOOD PRESSURE AND PULSE RATE IS REQUIRED WHEN PRESCRIBING Fetrasil. In placebo-controlled obesity studies, sibutramine 5 to 20 mg once daily was associated with mean increases in systolic and diastolic blood pressure of approximately 1 to 3 mm Hg relative to placebo, and with mean increases in pulse rate relative to placebo of approximately 4 to 5 beats per minute. Larger increases were seen in some patients, particularly when therapy with sibutramine was initiated at the higher doses (see table below). In premarketing placebo-controlled obesity studies, 0.4% of patients treated with sibutramine were discontinued for hypertension (SBP ≥ 160 mm Hg or DBP ≥ 95 mm Hg), compared with 0.4% in the placebo group, and 0.4% of patients treated with sibutramine were discontinued for tachycardia (pulse rate ≥ 100 bpm), compared with 0.1% in the placebo group. Blood pressure and pulse should be measured prior to starting therapy with Fetrasil and should be monitored at regular intervals thereafter. For patients who experience a sustained increase in blood pressure or pulse rate while receiving Fetrasil, either dose reduction or discontinuation should be considered. Fetrasil should be given with caution to those patients with a history of hypertension (see DOSAGE AND ADMINISTRATION), and should not be given to patients with uncontrolled or poorly controlled hypertension. PRECAUTIONS Pulmonary Hypertension Certain centrally-acting weight loss agents that cause release of serotonin from nerve terminals have been associated with pulmonary hypertension (PPH), a rare but lethal disease. In premarketing clinical studies, no cases of PPH have been reported with sibutramine Tabletss. Because of the low incidence of this disease in the underlying population, however, it is not known whether or not Fetrasil may cause this disease. Seizures During premarketing testing, seizures were reported in <> Presentation Loravan Tablets Blister of 10 Tablets

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].
Sibutramine (trade name Meridia in the U.S. and Canada, Ectiva in South Africa, Reductil in Europe and most other countries), usually as sibutramine hydrochloride monohydrate, is an orally administered agent for the treatment of obesity, as an appetite suppressant. It is a centrally-acting serotonin-norepinephrine reuptake inhibitor structurally related to amphetamines,[1] although its mechanism of action is distinct.
Sibutramine is manufactured by Abbott Laboratories. It is classified as a Schedule IV controlled substance in the United States, despite having virtually no potential for abuse (due to its lack of appreciable dopaminergic effects). It is likely that the compound's use as an anorectic is the sole reason is it classified as a controlled drug, as "overprescription" of anorectics (as a class) in the mid-20th century resulted in a number of cases of abuse or addiction.
Pharmacokinetics
Sibutramine is well absorbed from the GI tract (77%), but undergoes considerable first-pass metabolism, reducing its bioavailability. The drug itself reaches its peak plasma level after 1 hour and has also a half-life of 1 hour. Sibutramine is metabolized by cytochrome P450 isozyme CYP3A4 into two pharmacologically-active primary and secondary amines (called active metabolites 1 and 2) with half-lives of 14 and 16 hours, respectively. Peak plasma concentrations of active metabolites 1 and 2 are reached after three to four hours. The following metabolic pathway mainly results in two inactive conjugated and hydroxylated metabolites (called metabolites 5 and 6). Metabolites 5 and 6 are mainly excreted in the urine.
Contraindications
Sibutramine is contraindicated in:
• Psychiatric conditions as bulimia nervosa, anorexia nervosa, serious depression or preexisting mania
• Patients with a history of or a predisposition to drug or alcohol abuse
• Hypersensitivity to the drug
• Patients below 18 years of age
• Concomitant treatment with a MAO inhibitor, antidepressant or other centrally active drugs, particularly other anoretics
• Hypertension that is not sufficiently controlled (caution in controlled hypertension)
• Existing pulmonary hypertension
• Existing damage on heart valves, coronary heart disease, congestive heart failure, serious arrhythmias, previous myocardial infarction
• Stroke or transient ischemic attack (TIA)
• Hyperthyroidism (overactive thyroid gland)
• Closed angle glaucoma
• Seizure disorders
• Enlargement of the prostate gland with urinary retention (relative C.I.)
• Pheochromocytoma
• Pregnant and lactating women (relative C.I.)
Sibutramine Hydrochloride Monohydrate
Browse eMedTV's wide range of articles related to sibutramine hydrochloride monohydrate including topics such as side effects of sibutramine, precautions and warnings with sibutramine, and what is sibutramine used for?. Use the search box at the top-right corner of the page to find information about other health topics.
Description of Articles in Sibutramine Hydrochloride Monohydrate
• Sibutramine
Sibutramine is often prescribed as an aid to weight loss and weight maintenance. This eMedTV resource provides a detailed overview of sibutramine, explaining how it works, when and how it should be taken, possible side effects, and dosing guidelines.
• Side Effects of Sibutramine
Headaches, a dry mouth, and a loss of appetite are among the most common side effects of sibutramine. This eMedTV Web page lists common side effects seen with the drug, rare side effects, and side effects that may require prompt medical attention.
• What Is Sibutramine Used For?
Sibutramine uses consist of helping adults lose weight and keeping the weight off. This eMedTV article explains in detail how the drug works to achieve these effects, and also discusses why it is not used in children younger than 16 years old.
• Sibutramine Dosing
The recommended starting sibutramine dosage is typically 10 mg once a day. This portion of the eMedTV archives offers helpful tips on sibutramine dosing, including when and how to take the drug and factors that may affect your dosage.
• Drug Interactions With Sibutramine
This page on the eMedTV Web site covers the potentially negative consequences of combining sibutramine with certain medicines. This page lists the medicines that can cause drug interactions with sibutramine and also describes how they may be avoided.
• Precautions and Warnings With Sibutramine
Sibutramine may cause seizures, gallstones, or increased bleeding. This selection from the eMedTV Web site discusses other important precautions and warnings with sibutramine, and describes who should not take the medication.
Uses: Beuter is used together with a reduced-calorie diet helps you to lose weight and to help keep the lost weight from returning. Beuter is thought to work by increasing the activity of certain chemicals, called norepinephrine and serotonin, in the brain. This medicine is approved for use only in people who are very overweight. Storage: Store in a cool, dry place & Keep away from children. Package: 10mg/ capsule, 10 capsule /strip, 5strips/box 15mg/ capsule, 10 capsule /strip, 5strips/box Dosage: 10 mg once daily. Doses above 15mg daily are not recommended. How should this medicine be used? It may be taken with or without food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Beuter exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Buy Sibutramine without prescription Losing weight has developed into a fascination for most people. They used every way they can think of gizmos and paraphernalia they could find that could possible assist them lose weight but to no avail. Diet pills have also made their fare share of headlines. One of the more widely known weight loss pill is Sibutramine.

Meridia and Reductil are some of the branded names of Sibutramine. Sibutramine is an oral treatment medication that is known as an appetite suppressant. When you buy Sibutramine online or offline, it is generally prescribed as a weight loss pill; however, people who go through from other health problems such as high-blood pressure and diabetes can also make use of from its effects. Once you start taking in Sibutramine, it is recommended that you couple it with a low-calorie diet for best results.

When Sibutramine goes inside body, it increases your brain hormones such as serotonin, dopamine, and norephinephrine. It is supposed to control your craving if there is an increase in your brain’s serotonin. When taken in a span of four weeks ingested in according to your physicians instructions, you can lose up to 25lbs in a year from the moment you buy Sibutramine online or offline. Throughout the process, however, you need to maintain a healthy lifestyle to aid your weight loss.

Your physician should be careful you from the instance you buy Sibutramine online or offline and start your medication. There should be continuous checkups for any signs of weight loss as well as a record of your heartbeat and blood pressure kept during this period. One indication that the drug is not for you to t the person is if there is an increase in the blood pressure and heart rate.

This is a big decision to make so before you click that mouse and buy Sibutramine online, be certain that you are ready to make a commitment. Patience and determination is a key factor in losing weight; it will not ensue overnight like what most products out there claim.

Cardiac valve dysfunction and primary pulmonary hypertension have been associated with the use of centrally acting appetite suppressants. Sibutramine does not promote the release of serotonin (5-hydroxytryptamine, 5-HT) from nerve terminals as do the appetite suppressants that were associated with these adverse events most commonly {01} {09}. A comparison of echocardiograms performed on patients after 0.5 to 16 months (mean 7.6 months) of treatment with 15 mg per day of sibutramine (132 patients) or placebo (77 patients) showed no difference in the incidence of valvular heart disease between the two groups {01}. A second study in 25 patients comparing echocardiograms administered at baseline with those administered after 3 months of treatment with 5 to 30 mg per day of sibutramine detected no cases of valvular heart disease {01}.

In two 12-month studies of sibutramine in obese subjects, maximum weight loss was achieved by 6 months and statistically significant weight loss was maintained over 12 months {01}. Among patients receiving 15 mg per day of sibutramine in clinical weight-loss trials, more than 50% lost ³ 5% of their baseline body weight and about 25% lost ³ 10% of their baseline body weight. However, some weight was regained after discontinuation of sibutramine

Sibutramine is a serotonin (5-hydroxytryptamine, 5-HT) and norepinephrine (NE) reuptake inhibitor (SNRI) {09} {18}. In vitro testing found sibutramine to be much less potent than its primary and secondary amine metabolites in inhibiting monoamine reuptake. Therefore, the pharmacological actions of sibutramine are thought to be due predominantly to its active metabolites. The metabolites of sibutramine inhibit 5-HT and NE reuptake with potencies comparable to those of fluoxetine and desipramine, respectively {21}. Combined NE and 5-HT reuptake inhibition is thought to promote a sense of satiety, leading to a decrease in energy intake, and, possibly, to increase resting metabolic rate {12}. Randomized, placebo-controlled, double-blind studies in obese and in nonobese subjects have shown significant reductions in self-rated premeal hunger and in energy intake with sibutramine use, even in the absence of an imposed reduced-calorie diet. One study found no difference in the decrease in resting energy expenditure associated with weight loss between subjects receiving sibutramine and subjects receiving placebo, in spite of significantly greater weight loss in the sibutramine group {17}. In another study, basal metabolic rate, as measured by indirect calorimetry, increased more in sibutramine-treated patients than in patients receiving placebo }; however, this finding has not been consistent.

The degree of weight loss occurring with sibutramine use is dose-related {10} {15} {16}. Also, the subcutaneous to visceral fat ratio was found to be significantly increased from baseline in sibutramine-treated patients, possibly indicating a preferential reduction in visceral fat.

Studies in rodents indicate that sibutramine administration leads to rapid down-regulation of alpha 2-adrenergic receptors, with a greater effect on postsynaptic than on presynaptic receptors, and down-regulation of beta 1-adrenergic receptors. Sibutramine's metabolites inhibit the reuptake of dopamine in vivo , but much less potently than they inhibit the reuptake of NE and 5-HT. Neither sibutramine nor its active metabolites, at clinically relevant concentrations, cause the release of monoamines or inhibit monoamine oxidase {18} {21}. Also, all active moieties have low affinity for serotonin (5-HT 1, 5-HT 1A, 5-HT 1B, 5-HT 2A, 5-HT 2C), norepinephrine (beta 1, beta 2, beta 3, alpha 1, alpha 2) {21}, dopamine (D 1, D 2) {01} {21}, benzodiazepine, and glutamate (NMDA) receptors, and they show no evidence of anticholinergic or antihistaminergic actions.

Why is Sibutramine hydrochloride prescribed?
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Meridia helps the seriously overweight shed pounds and keep them off. It is especially recommended for those who in addition to being overweight have other health problems such as high blood pressure, diabetes, or high cholesterol. It is used in conjunction with a low-calorie diet.

Meridia works by boosting levels of certain chemical messengers in the nervous system, including serotonin, dopamine, and norepinephrine.
Most important fact about Sibutramine hydrochloride

Make a point of keeping follow-up appointments with your doctor. Meridia can increase your blood pressure, so it's important to have your blood pressure and pulse monitored at the beginning of therapy and regularly thereafter.