Reduxin, 10 mg+158, 5 mg capsules 60 pcs

Obesity, Type 2 Diabetes

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 in combination with other risk factors due to excess body weight (type 2 diabetes/insulin-independent/ or dyslipoproteinemia).

Composition

1 capsule contains: sibutramine hydrochloride monohydrate 10 mg; microcrystalline cellulose 158.5 mg.

Excipients:

calcium stearate.

Capsule shell composition:

titanium dioxide dye, azorubin dye, patented blue dye, gelatin.

How to take, the dosage

Reduxin is prescribed orally once a day. The dose is set individually, depending on tolerability and clinical efficacy. The recommended initial dose is 10 mg; in case of poor tolerance, a dose of 5 mg is possible. Capsules should be taken in the morning, without chewing and with plenty of liquid. The drug can be taken both on an empty stomach and in combination with a meal.

If within 4 weeks of initiating treatment 5% or more weight loss has not been achieved, the dose is increased to 15 mg/day. The duration of therapy with Reduxin should not exceed 3 months in patients who do not respond well to therapy (i.e., who do not achieve a 5% weight loss from baseline body weight within 3 months of treatment). Treatment should not be continued if the patient regains 3 kg or more in body weight during further therapy (after the achieved weight loss).

The total duration of therapy should not exceed 2 years, because there are no data on efficacy and safety for longer periods of sibutramine.

The therapy with Reduxin should be performed by a physician with practical experience in the treatment of obesity. Taking the drug should be combined with diet and exercise.

Interaction

Microsomal oxidation inhibitors, including cytochrome P450 isoenzyme 3A4 inhibitors (including ketoconazole, erythromycin, cyclosporine) increase plasma concentrations of sibutramine metabolites with increased HR and clinically not significant increase in QT interval. Rifampicin, antibiotics from macrolide group, phenytoin, carbamazepine, phenobarbital and dexamethasone may accelerate sibutramine metabolism. Simultaneous use of several drugs that increase serotonin levels in the blood can lead to the development of serious interactions. So-called serotonin syndrome may develop in rare cases when Reduxin is used simultaneously with selective serotonin reuptake inhibitors (drugs for treatment of depression), with some drugs for treatment of migraine (sumatriptan, dihydroergotamine), with potent analgesics (pentazocine, pethidine, fentanyl) or anti-cough medications (dextromethorphan). Sibutramine does not affect the effect of oral contraceptives.

In concomitant use of sibutramine and ethanol no increase in the negative effect of ethanol has been noted. However, the use of alcohol is absolutely not combined with the recommended dietary measures when taking sibutramine.

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Special Instructions

Reduxin should only be used when all non-medicinal weight loss measures are ineffective – if the weight loss within 3 months is less than 5 kg.

The treatment with Reduxin should be used as part of a comprehensive weight loss therapy under the supervision of a physician with practical experience in the treatment of obesity.

The complex treatment of obesity includes both changing diet and lifestyle and increasing physical activity. An important component of therapy is the creation of the prerequisites for lasting changes in eating and lifestyle habits, which are necessary to maintain the achieved weight loss even after withdrawal of drug therapy. Patients need to change their lifestyle and habits as part of therapy with Reduxin in such a way as to ensure the maintenance of the achieved weight loss after treatment completion. Patients should be clear that failure to do so will result in weight gain and repeat visits to the physician.

In patients taking Reduxin, BP and HR should be measured. These parameters should be monitored every 2 weeks in the first 2 months of treatment and then monthly thereafter. In patients with arterial hypertension (who have BP higher than 145/90 mmHg on antihypertensive therapy) this monitoring should be done particularly carefully and, if necessary, at shorter intervals. In patients whose BP exceeded 145/90 mmHg twice at repeat measurements, treatment with Reduxin should be suspended.

Particular caution is required when concomitant administration of drugs that prolong the QT interval. These drugs include histamine H1-receptor blockers (astemizole, terfenadine); antiarrhythmic QT interval prolongers (amiodarone, quinidine, flecainide, mexiletine, propafenone, sotalol); GI motility stimulators (cisapride, pimozide, sertindol and tricyclic antidepressants). Caution should be exercised when using the drug against the background of conditions that are risk factors for QT interval prolongation (hypokalemia, hypomagnesemia).

The interval between taking MAO inhibitors and Reduxin should be at least 2 weeks.

The association between taking Reduxin and the development of primary pulmonary hypertension has not been established, but given the well-known risks of the drugs in this group, special attention should be paid to symptoms such as progressive dyspnea (impaired breathing), chest pain, and edema in the legs during regular medical monitoring.

Impact on driving and operating machinery

The use of Reduxin may limit the patient’s ability to drive and operate machinery.

Contraindications

– presence of organic causes of obesity (e.g., hypothyroidism);

– serious eating disorders (anorexia nervosa or bulimia nervosa);

– mental illness;

Gilles de la Tourette syndrome (generalized tics);

– concomitant use of MAO inhibitors (e.g., phentermine, phenfluramine, dexfenfluramine, ethylamphetamine, ephedrine) or their use for 2 weeks prior to the prescription of Reduxin; use of other CNS-acting drugs (e.g., antidepressants, neuroleptics) Drugs prescribed for sleep disorders containing tryptophan, as well as other drugs of central action for weight loss;

– CHD, decompensated chronic heart failure, congenital heart disease, peripheral artery occlusive disease, tachycardia, arrhythmias, cerebrovascular disease (stroke, transient cerebrovascular events);

– uncontrolled arterial hypertension (BP over 145/90 mm Hg).Hg).

– thyrotoxicosis;

– severe liver function disorders;

– severe renal function disorders;

– benign prostatic hyperplasia;

– pheochromocytoma;

– closed-angle glaucoma;

– established drug, drug or alcohol dependence;

– pregnancy;

– lactation (breastfeeding);

– childhood and adolescence under 18 years of age;

– older than 65 years of age;

– established hypersensitivity to sibutramine or other components of the drug.

With caution, the drug should be prescribed in the following conditions: history of arrhythmias, chronic circulatory failure, coronary artery disease (including in anamnesis), cholelithiasis, arterial hypertension (controlled and in anamnesis), neurological disorders, including mental retardation and convulsions (including in anamnesis), liver and/or kidney function disorders of mild to moderate severity, motor and verbal tics in anamnesis.

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Side effects

Side effects, depending on the effect on organs and organ systems are presented in the following order (often – >10%, sometimes – 1-10%, rarely – < 1%).

CNS and peripheral nervous system: often – dry mouth, insomnia; sometimes – headache, dizziness, anxiety, paresthesias, as well as changes in taste; in single cases – back pain, depression, somnolence, emotional lability, anxiety, irritability, nervousness, seizures.

One patient with schizoaffective disorder, which was presumed to exist before treatment, developed acute psychosis after treatment.

Cardiovascular system: sometimes – tachycardia, palpitations, increased BP, vasodilation. A moderate increase of resting BP by 1-3 mmHg and a moderate increase of heart rate by 3-7 beats per minute have been observed. In some cases, more pronounced elevations of BP and HR are not excluded. Clinically significant changes in BP and pulse rate are registered predominantly at the beginning of treatment (in the first 4-8 weeks).

Dermatological reactions: sometimes – sweating; in single cases – skin itching, Schoenlein-Henoch purpura (hemorrhages in the skin).

Any adverse effects of the body in general: the following adverse clinically significant events have been described in single cases: dysmenorrhea, edema, flu-like syndrome, thirst, rhinitis, acute interstitial nephritis, bleeding, thrombocytopenia.

Withdrawal reactions, such as headache or increased appetite, are rare. There is no evidence of withdrawal, withdrawal syndrome, or mood disorders after treatment.

The most frequent side effects occur at the beginning of treatment (in the first 4 weeks). Their severity and frequency decrease over time. The side effects are generally mild and reversible.

Overdose

There are very limited data on sibutramine overdose. In case of overdose, the patient should consult a physician.

Symptoms: there may be an increase in the severity of side effects. Specific signs of overdose are unknown.

Treatment: intake of activated charcoal, gastric lavage, symptomatic therapy, in case of increase in BP and tachycardia – prescription of beta-adrenoblockers. There is no special treatment or specific antidotes. It is necessary to perform general measures: ensure free breathing, monitor the state of the cardiovascular system, as well as, if necessary, conduct supportive symptomatic therapy. The effectiveness of forced diuresis or hemodialysis has not been established.

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Pregnancy use

The drug should not be used in pregnancy due to the lack of a sufficiently conclusive number of studies on the safety of fetal effects of sibutramine.

Women of childbearing age should use contraceptives while taking Reduxin.

Reduxin should not be used while breastfeeding.