Lindaxa

Release form and composition

Dosage form of Lindaxa - capsules: gelatin, hard, with a yellow body and a blue cap marked “15”, or a brown cap marked “10”, inside - white or almost white powder (10 capsules in a blister, 3 in a cardboard pack or 9 blisters).

Composition of capsules:

Active substance: sibutramine hydrochloride monohydrate – 10 or 15 mg (equivalent to 8.37 or 12.55 mg of sibutramine), respectively, in a capsule labeled “10” or “15”;
Additional components: microcrystalline cellulose, lactose monohydrate, magnesium stearate, colloidal anhydrous silicon dioxide;
Capsule body and cap: sunset yellow dye, quinoline yellow dye, gelatin, titanium dioxide, black ink 1012 (black iron oxide, shellac, n-butanol, soy lecithin, denatured ethanol (industrial methylated alcohol), defoamer DC 1510) , red iron oxide dye or indigo carmine dye.

Chemical composition and principle of action

The main active substance of Lindaxy is sibutramine, a drug that provides the body with a feeling of fullness even with low food consumption. In addition to it, the composition also includes:

Gelatin, from which capsule shells are made.
Dyes (quinoline, sunset, black ink 1012, etc.).
Colloidal silicon dioxide.
Microcrystalline cellulose.
Lactose monohydrate.
Magnesium stearate.

Thanks to this composition, the drug significantly slows down the consumption of serotonin (“the hormone of happiness”) in the body and equalizes its levels with norepinephrine. This, in turn, helps you feel full even with small meals.

As a result, the amount of food consumed by a person is reduced by about 20-25%, and he himself more easily switches to a more correct diet. At the same time, the negative phenomena characteristic of a change in diet (such as stress, increased irritability, loss of strength) are absent here.

Contraindications

Organic cause of obesity;
Presence of anorexia or bulimia (including history);
Gilles de la Tourette's syndrome;
Mental illnesses;
Concomitant use of monoamine oxidase inhibitors (MAOIs) or a period of less than 2 weeks after their discontinuation;
Combination with centrally acting drugs for the treatment of sleep disorders (tryptophan), mental disorders (antidepressants, antipsychotics) or for weight loss;
Uncontrolled arterial hypertension - blood pressure (BP) above 145/90 mmHg (Hg);
Diseases of the cardiovascular system, such as chronic heart failure in the decompensation stage, coronary heart disease (CHD), arrhythmia, congenital heart defects, tachycardia, occlusive diseases of peripheral arteries, cerebrovascular diseases (transient cerebrovascular accidents, stroke);
Severe impairment of the liver and/or kidneys;
Thyrotoxicosis;
Pheochromocytoma;
Benign prostatic hyperplasia;
Angle-closure glaucoma;
Established drug, medication or alcohol dependence;
Breastfeeding period and pregnancy;
Age under 18 years and over 65 years (due to lack of sufficient clinical experience);
Hypersensitivity to sibutramine or other components of the drug.

The drug is prescribed with extreme caution for the following conditions: chronic heart failure, history of arrhythmias, arterial hypertension (controlled and in history), neurological disorders (including mental retardation and seizures, including history), cholelithiasis, dysfunction liver and/or kidney problems of mild to moderate severity, history of motor and verbal tics.

Directions for use and dosage

Lindaxa is taken orally, regardless of food intake, 1 time per day in the morning, swallowing the capsules whole, without breaking or chewing, with plenty of water (1 glass). The dose is set individually depending on the effectiveness and tolerability of the drug; usually 10 mg per day is used at the beginning of therapy.

If there is insufficient effectiveness (loss of body weight less than 2 kg in 4 weeks) and the drug is well tolerated, the daily dose may be increased to 15 mg. If after increasing the dose the effectiveness of the drug does not increase, continuation of therapy is inappropriate.

It is also necessary to stop taking it if, during 3 months of treatment, the patient was unable to reduce body weight by 5% from the initial level. You should not continue using Lindaxa if, after achieving the desired therapeutic effect, there was a weight gain of 3 kg or more.

It is not recommended to continue therapy for more than 2 years, due to the lack of data on the effectiveness and safety of using the drug for longer periods.

general information

Lindaxa is an anorexigenic anti-obesity tablet. They were sold in packs of 30 and 90 capsules and marked with the numbers “10” and “15” depending on the content of sibutramine (10 and 15 mg, respectively).

The production and release of the drug was carried out by the Czech pharmacological company Zentiva. To date, this product has been discontinued and is not officially sold in Russia.

Side effects

Most often, the development of undesirable effects can be observed in the first 4 weeks of drug therapy. Side effects, as a rule, are uncomplicated and reversible; over time, their severity and frequency decrease.

The following unwanted side effects from using Lindaxa are possible:

Cardiovascular system: sometimes - a feeling of palpitations, tachycardia (increased heart rate by 3-7 beats per minute), hot flashes, skin flushing, increased blood pressure (at rest by 1-3 mm Hg); in some cases, a more pronounced increase in blood pressure and heart rate (HR) is possible;
Nervous system: often – insomnia; sometimes - anxiety, dizziness, headache, paresthesia;
Sense organs: sometimes – changes in taste sensations;
Digestive system: often – dry mouth, constipation, loss of appetite; sometimes - nausea;
Other: sometimes - exacerbation of hemorrhoids, increased sweating.

In isolated cases, the following adverse reactions were observed: skin itching, flu-like syndrome, edema, dysmenorrhea, back pain, thirst, abdominal pain, paradoxical increase in appetite, rhinitis, drowsiness, nervousness, depression, anxiety, emotional lability, irritability, convulsions , Henoch-Schönlein purpura, bleeding, thrombocytopenia, acute interstitial nephritis, transient increase in liver enzyme activity.

One patient with schizoaffective disorder, diagnosed before starting Lindaxa, developed acute psychosis after therapy.

There is limited information about drug overdose; the specific signs of this condition are unknown, but the possibility of developing more pronounced manifestations of undesirable effects must be taken into account. A specific antidote is currently unknown; in case of such reactions, the state of the cardiovascular system should be monitored; if necessary, symptomatic therapy, gastric lavage, the use of activated charcoal are indicated; for tachycardia and increased blood pressure, beta-blockers are indicated.

special instructions

The drug is recommended for use only if non-drug measures (diet and exercise) aimed at reducing body weight are ineffective - when body weight loss over 3 months is less than 5 kg.

Taking the drug is part of a combined weight loss program and should be carried out under the supervision of a physician with practical experience in treating patients with obesity. Complex treatment includes increasing physical activity, changing lifestyle, and correcting eating habits. Patients should be informed that after stopping the drug, in order to maintain the achieved results, it is necessary to continue to lead the recommended lifestyle and diet.

During treatment, it is necessary to monitor blood pressure and heart rate levels in the first 2 months every 2 weeks (and subsequently monthly). Particularly careful monitoring, carried out at shorter intervals, is necessary for patients with arterial hypertension. In the case when the control blood pressure indicators twice exceeded the level of 145/90 mm Hg. Art., you should stop taking the drug.

With extreme caution, Lindax is prescribed in combination with drugs that prolong the QT interval, which include: terfenadine and astemizole (histamine H1 receptor blockers); amiodarone, flecainide, quinidine, sotalol, propafenone, mexiletine (antiarrhythmic drugs); cisapride, sertindole, pimozide and tricyclic antidepressants. This also applies to conditions that contribute to an increase in the QT interval (hypomagnesemia, hypokalemia).

There is no data confirming the occurrence of withdrawal symptoms, mood disorders or withdrawal symptoms after discontinuation of the drug.

When using sibutramine, patients of reproductive age are required to use reliable contraception.

Despite the fact that the connection between taking Lindaxa and the development of primary pulmonary hypertension has not been established, it is necessary to pay attention to the occurrence of symptoms such as chest pain, progressive shortness of breath, and swelling in the legs.

During therapy, it is not recommended to consume ethanol, since its intake is not consistent with the recommended dietary regimen.

If you miss a dose of sibutramine the next day, you do not need to take a double dose of the drug; therapy must be continued according to the usual regimen.

Due to the fact that drugs that act on the central nervous system can negatively affect memory, mental activity and the speed of psychomotor reactions, during the treatment period you should drive vehicles and other complex mechanisms with caution.

Use during pregnancy and breastfeeding

The drug is contraindicated for use during pregnancy and breastfeeding.

Use for liver dysfunction

The drug is contraindicated in severe liver dysfunction.
The drug should be prescribed with caution for mild to moderate liver dysfunction.

Use for renal impairment

The drug is contraindicated in severe renal impairment.

The drug should be prescribed with caution in cases of mild to moderate renal dysfunction.

special instructions

Lindaxa should be used only in cases where non-drug weight loss measures (diet and exercise) are ineffective (weight loss over 3 months was less than 5 kg).

Treatment with sibutramine should be carried out as part of complex weight loss therapy under the supervision of a physician with practical experience in the treatment of obesity. Complex therapy includes both changing eating habits and lifestyle, as well as increasing physical activity. Patients need to change their lifestyle and habits in such a way as to ensure that the achieved weight loss is maintained after completion of treatment. Patients should be clear that failure to comply with these requirements will result in weight gain and the need for repeat treatment.

During the period of taking Lindaxa, it is necessary to monitor blood pressure and heart rate in the first 2 months every 2 weeks, and then monthly. In patients with arterial hypertension, monitoring must be carried out especially carefully and at shorter intervals. If during the control measurement the blood pressure twice exceeded the level of 145/90 mmHg. Art., taking Lindaxa should be suspended.

Drug interactions

It should be remembered that when taken simultaneously with Lindaxa:

Cyclosporine, erythromycin, troleandomycin, ketoconazole (CYP3A4 isoenzyme inhibitors) - increase the concentration of sibutramine metabolites, increase heart rate, and also clinically slightly prolong the QT interval;
Antibiotics from the macrolide group, rifampicin, carbamazepine, phenytoin, dexamethasone and phenobarbital - accelerate the metabolism of sibutramine;
Selective serotonin reuptake inhibitors, antitussives (dextromethorphan), potent analgesics (fentanyl, pentazocine, pethidine), drugs for the treatment of migraines (dihydroergotamine, sumatriptan) can lead in rare cases to the development of serotonin syndrome.

The drug interaction of Lindaxa with drugs intended for the treatment of allergies and colds, which increase blood pressure and heart rate, as well as with antitussive drugs and some decongestants, has not been studied enough, therefore, if it is necessary to combine them, caution must be exercised.

Sibutramine has no effect on the action of oral contraceptives.

Simultaneous single use of the drug and alcohol does not enhance the effect of the latter.