Lindax is an anorexigenic drug of central action for the treatment of obesity.
Release form and composition
Lindax dosage form - capsules: hard gelatin, with dose labeling ("10" or "15"), contents - white or almost white powder (10 pieces in blisters, 3 or 9 blisters in a cardboard box.
The active ingredient of the drug is sibutramine hydrochloride monohydrate. Its content in capsules depending on the color:
- Yellow case and brown cap - 10 mg;
- Yellow case and blue cap - 15 mg.
Excipients: colloidal anhydrous silicon dioxide, microcrystalline cellulose, lactose monohydrate, magnesium stearate.
- Body: gelatin, titanium dioxide, dye sunset yellow, dye quinoline yellow, black ink 1012 (soy lecithin, n-butanol, shellac, denatured ethanol, antifoam DC 1510, ferric oxide black);
- Lid: gelatin, titanium dioxide and dyes: in capsules 10 mg - iron oxide black and iron oxide red, in capsules 15 mg - indigo carmine.
Indications for use
Lindax is intended for the treatment of alimentary obesity in patients with a body mass index of 30 kg / m 2 or more.
Also, the drug is prescribed for the treatment of alimentary obesity in patients with a body mass index of 27 kg / m 2 or more in the presence of overweight risk factors such as dyslipoproteinemia and type 2 diabetes.
- Severe eating disorders (bulimia or anorexia);
- Organic cause of obesity;
- Benign prostatic hyperplasia;
- Severe abnormal liver and / or kidney function;
- Angle-closure glaucoma;
- Tourette syndrome (chronic generalized tic);
- Mental illness;
- Uncontrolled arterial hypertension (arterial pressure above 145/90 mm Hg. Art.);
- Diseases of the cardiovascular system, incl. congenital heart defects, decompensated chronic heart failure, arrhythmia, tachycardia, coronary heart disease, cerebrovascular diseases (transient disorders of cerebral circulation, stroke), occlusive diseases of peripheral arteries;
- Established drug, drug or alcohol addiction;
- Simultaneous use of monoamine oxidase inhibitors (for example, fenfluramine, phentermine, dexfenfluramine, ephedrine, ethylamphetamine) and within 2 weeks after their withdrawal;
- The simultaneous use of hypnotic drugs, serotonin reuptake inhibitors, drugs with tryptophan in the composition and other drugs of central action to reduce body weight;
- Age up to 18 and over 65 years;
- Hypersensitivity to the drug.
- History of arrhythmias;
- Chronic heart failure;
- Arterial hypertension (controlled or history);
- Neurological disorders (including mental retardation and convulsions, including a history of);
- A history of verbal and motor tics;
- Mild and moderate kidney / liver dysfunction.
Dosing and Administration
The drug should be taken orally 1 time per day in the first half of the day on an empty stomach or during meals, swallowing the capsule whole and drinking a glass of water.
The doctor determines the dose individually, depending on the clinical efficacy and tolerability of Lindax.
The initial dose is 10 mg. In case of insufficient effectiveness (if within 4 weeks the reduction in body weight was less than 2 kg), but with the condition of good tolerability of the drug, the daily dose is increased to 15 mg. If after the dose has been increased, the effectiveness remains insufficient (there is no decrease in body weight by at least 2 kg for 4 weeks), the continuation of treatment is not advisable.
After 3 months, an assessment of therapy is carried out. Treatment should be discontinued if during this time it was not possible to achieve a weight loss of 5% from the initial one, and also if after the achieved weight loss the patient gains 3 kg or more.
The maximum duration of treatment is 2 years. There are no data on the safety and efficacy of longer treatment.
Side effects are most often noted in the first 4 weeks of treatment. As a rule, they are light and reversible, their intensity and frequency weaken with time.
Side effects are classified as follows: often - more than 10%, sometimes - from 1 to 10%, rarely - less than 1%:
- Central and peripheral nervous system: often - insomnia; sometimes - a change in taste, dizziness, anxiety, headache, paresthesias;
- Digestive system: often - loss of appetite, dry mouth, constipation; sometimes nausea;
- Cardiovascular system: sometimes - feeling of palpitations, tachycardia (increase in pulse by 3-7 beats / minute), vasodilation (flushing, skin flushing), increase in blood pressure (at rest by 1-3 mm Hg. Art.); in some cases, a more pronounced increase in heart rate and blood pressure is possible;
- Others: sometimes - aggravation of hemorrhoids, increased sweating.
Described isolated cases of the following clinically significant side effects: flu-like syndrome, edema, skin itching, dysmenorrhea, back pain, thirst, paradoxical increase in appetite, abdominal pain, emotional lability, drowsiness, anxiety, nervousness, depression, irritability, rhinitis, acute interstitial nephritis, Schönlein-Henoch purpura, bleeding, convulsions, transient increase in liver enzymes in plasma, thrombocytopenia.
Also known is a single case of acute psychosis in a patient with schizoaffective disorder, which presumably existed before the use of Lindax.
The drug should be prescribed only if non-drug methods of weight loss (exercise and diet) were ineffective (weight loss for 3 months was less than 5 kg).
Treatment with Lindax should be carried out under the supervision of a medical professional with practical experience in treating obesity, as part of a combination therapy involving increased physical activity, lifestyle changes and eating habits. Patients need to change their lifestyle so that, after the end of the course of treatment, they can maintain the achieved weight loss. Patients should clearly understand that non-compliance with these requirements will lead to a re-gain of weight and the need for a repeated course of therapy.
The entire period of Lindax should be monitored for blood pressure and heart rate: the first 2 months - once in 2 weeks, then - once a month. Particularly careful and more frequent monitoring is necessary for patients with arterial hypertension. If at the control measurement the pressure twice exceeded the mark 145/90 mm Hg. Art., the treatment must be suspended.
Lindax should be prescribed with caution simultaneously with drugs that contribute to lengthening the QT interval, including antiarrhythmic drugs (meksiletin, flekainid, propafenone, quinidine, sotalol, amiodarone), histamine H 1 -receptor blockers (terfenadine, astemizole), tricyclic steps, anti-arrhythmias, tricyclic steps, tricyclic steps, tricyclic steps, anti-inflammatory drugs as well as sertindole, pimozide, cisapride. The same applies to conditions that can lead to a prolongation of the QT interval (for example, hypomagnesemia).
And although the relationship between the development of primary pulmonary hypertension and the administration of sibutramine has not been reliably established, it is recommended to pay attention to the appearance of chest pain, progressive respiratory failure, edema in the legs during treatment. In the case of skipping the next reception to double the dose in the next reception can not be.
In the application of Lindax should refrain from the use of alcoholic beverages, because alcohol is absolutely not combined with dietary measures recommended during the period of treatment with this drug.
The entire period of therapy is recommended to be careful when driving and performing work associated with the speed of reactions and increased concentration of attention.
Inhibitors of the isoenzyme CYP3A4 (erythromycin, ketoconazole, troleandomycin, cyclosporine) increase the concentration of sibutramine metabolites and heart rate, clinically slightly prolong the QT interval.
Macrolide antibiotics, dexamethasone, carbamazepine, phenytoin, phenobarbital and rifampicin can accelerate sibutramine metabolism.
With the simultaneous use of potent analgesics (pethidine, fentanyl, pentazocine), drugs for the treatment of migraine (sumatriptan, dihydroergotamine), antitussives (dextromethorphan), selective serotonin reuptake inhibitors (antidepressants) there is a risk of developing serotonin syndrome.
Terms and conditions of storage
Keep out of the reach of children at a temperature not exceeding 30 ° C.
Shelf life - 2 years.