o_reduksin-10mg-n60-caps-the-antiobesity-d56e

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o_reduksin-10mg-n60-caps-the-antiobesity-d56e

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Dosage Form

Capsules
Composition
Sibutramine hydrochloride monohydrate 10 mg;

Other ingredients: microcrystalline cellulose, calcium stearate.

Capsule:

colorant titanium dioxide, patent blue dye, gelatin.
pharmachologic effect
Sibutramine is a prodrug and exerts its effects in vivo due to metabolites (primary and secondary amines) which inhibit the reuptake of monoamines (serotonin and noradrenaline predominantly). The increase of neurotransmitters in the synapses increases the activity of the central 5HT serotonin and adrenergic receptors, which increases satiety and reduce the need for food, as well as an increase in termoproduktsii. Indirectly activating beta3-adrenergic receptors, sibutramine acts on the brown adipose tissue.

Weight loss accompanied by an increase in the serum concentration of HDL cholesterol and lowering of triglyceride, total cholesterol, LDL cholesterol and uric kisloty.Sibutramin and its metabolites do not affect the release of monoamines, do not inhibit MAO; It has no affinity to a large number of neurotransmitter receptors, including serotonergic (5-HT1, 5-HT1A, 5-NT1V, 5-HT2A, 5-HT2C), adrenergic (beta1, beta2, beta3, alpha 1, alpha 2), dopamine (Dl, D2), muscarinic, histamine (H1), benzodiazepine and NMDA receptors.
Pharmacokinetics
After intake of rapidly absorbed from the gastrointestinal tract is not less than 77%. The «first pass» through the liver biotransformation under the influence of cytochrome P450 3A4 isoenzyme to form two active metabolites (mono and didesmetilsibutramin). After administration of a single dose of 15 mg maximum blood concentration (Cmax) monodesmetilsibutramina is 4 ng / mL (3.2-4.8 ng / ml) didesmetilsibutramina — 6.4 ng / ml (5,6-7,2 ng / ml). Cmax achieved through 1.2 hours (sibutramine), 3-4 hours (active metabolites). Simultaneous food intake lowers Cmax of metabolites by 30% and increases time to achieve 3 hours without changing the AUC.

Rapidly distributed to tissues. Contact proteins is 97% (sibutramine) and 94% (mono- and didesmetilsibutramin). The equilibrium concentration of the active metabolite in the blood is reached within 4 days after the initiation of treatment, and about 2 times higher than the plasma levels after administration of a single dose. The half-life of sibutramine — 1.1 hours, monodesmetilsibutramina — 14 hours didesmetilsibutramina — 16 hours. The active metabolites are hydroxylation and conjugation with the formation of active metabolites, which are excreted primarily by the kidneys.
Side effects
In most cases, side effects occur at the beginning of treatment (first 4 weeks). Their severity and frequency over time weaken. Side effects are generally reversible and not heavy. Side effects, depending on the effects on organs and organ systems in the following order (often> 10%, 1-10% sometimes, rarely ).

The interval between taking MAO inhibitors (including furazolidone, procarbazine, selegiline) and Reduxine should be at least 2 weeks.

Although no association between the intake of Reduxine and development of primary pulmonary hypertension, however, given the well-known risks of drugs in this group, with regular medical monitoring is necessary to pay special attention to symptoms such as progressive dyspnea (breathing problems), chest pain and swelling in the legs .

Omitting Reduxine dose should not be taken to the next receiving a double dose, further encouraged to continue taking the drug for a prescribed pattern.

Duration of Reduxine should not exceed 2 years.
Indications
Reduxine indicated for weight loss in the following conditions:

• alimentary obesity with a body mass index (BMI) of 30 kg / m2 or more;

• alimentary obesity with a BMI of 27 kg / m2 or more, if there are other risk factors are overweight, such as type 2 diabetes or dyslipoproteinemia (violation of lipid metabolism).
Contraindications
• Installed hypersensitivity to sibutramine or to other components of the drug;

• presence of organic causes of obesity (eg hypothyroidism);

• severe eating disorders — anorexia nervosa or bulimia nervosa;

• mental illness;

• syndrome of Gilles de la Tourette (generalized tics);

• simultaneous MAO inhibitors (eg, phentermine, fenfluramine, dexfenfluramine, ethylamphetamine, ephedrine) or using them for 2 weeks prior to administration of the drug Reduxine; the use of other drugs acting on the central nervous system (e.g., antidepressants, antipsychotics); drugs prescribed and sleep disorders, containing tryptophan and other central acting drugs to reduce body weight;

• coronary heart disease, decompensated chronic heart failure, congenital heart disease, peripheral arterial occlusive disease, tachycardia, arrhythmia, cerebrovascular disease
Drug Interactions
Inhibitors of microsomal oxidation, including P450 3A4 inhibitors (ketoconazole, erythromycin, cyclosporin, etc.) increase in the plasma concentration of metabolites of sibutramine with an increase in heart rate and clinically unimportant increase QT interval. Rifampicin, macrolide antibiotics, phenytoin, carbamazepine, phenobarbital and dexamethasone may accelerate sibutramine metabolism. The simultaneous use of several drugs that increase serotonin in the blood can lead to serious interactions. The so-called serotonin syndrome may develop in rare cases, the concomitant use of Reduxine with selective serotonin reuptake inhibitors (medications to treat depression), with certain drugs for the treatment of migraine (sumatriptan, dihydroergotamine), a potent analgesic (pentazocine, pethidine, fentanyl), or antitussive drugs (dextromethorphan).
Dosage
Reduxine appointed interior 1 time per day. Dose set individually, depending on tolerability and clinical efficacy. Recommended initial dose of 10 mg, with poor tolerance can receive 5 mg. The capsules should be taken in the morning, without chewing and drinking plenty of fluids (water glass). The drug can be taken on an empty stomach, and combined with the meal. If within 4 weeks of starting treatment is not achieved weight loss of 5% or more, the dose increases to 15 mg / day. Reduxine Treatment should not last more than 3 months in patients who respond well enough to treatment, ie, that during 3 months of treatment fails to reach the level of 5% weight loss from baseline. Treatment should not be continued, if further therapy after weight loss achieved, the patient is re-gaining body weight of 3 kg or more. The duration of treatment should not exceed 2 years, as against a longer period of sibutramine data on efficacy and safety are absent. Reduxine Treatment should be administered in combination with diet and exercise under the supervision of a physician with experience treating obesity.