Meridia

Meridia – the drug used for the supporting treatment of patients with alimentary obesity.

Form of release and structure

The Meridi is released in the form of capsules: firm gelatinous, with a blue lid and the case yellow (10 mg) or white (15 mg) colors, with a text (depending on a dose) "10" or "15"; contents of capsules – easily loose powder of almost white or white color (on 10 mg: on 7 pieces in blister strip packagings, on 2 packagings in a cardboard pack; on 14 pieces in blister strip packagings, on 1,2 or 6 packagings in a cardboard pack; on 15 mg – on 14 pieces in packagings, on 2 packagings in a cardboard pack).

Is a part of 1 capsule:

• Active agent: monohydrate of a hydrochloride of a sibutramin – 10 mg;
• Auxiliary components: sodium lauryl sulfate, microcrystallic cellulose, monohydrate of lactose, colloid silicon dioxide, magnesium stearate, gelatin, titanium dioxide (E171), indigotin (E132), gray ink, quinolinic yellow (E104 dye).

Indications to use

The Meridi is appointed at a maintenance therapy of patients with excess body weight in the presence of the following indications:

• Alimentary obesity with a body weight index from 30 ^kg/sq.m and more;
• Alimentary obesity with a body weight index from 27 ^kg/sq.m and more with other risk factors which are caused by excess body weight, such as lipid metabolism disturbance (dislipoproteinemiya) or a diabetes mellitus 2 types.

Contraindications

• Obesity, the having organic reasons;
• Glaucoma;
• The serious violations of food (established and known) in the form of nervous anorexia (exhaustion) or nervous bulimia (unlimited passion to food);
• Neurologic pathology (Giles de la Tourett's syndrome);
• Diseases of mental character;
• The established disturbances of cardiovascular system: chronic heart failure in a decompensation stage, coronary heart disease, arrhythmia, inborn heart diseases, tachycardia, occlusal diseases of peripheral arteries, cerebrovascular diseases (tranzitorny disturbances of cerebral circulation, a stroke);
• Heavy functional disturbances of a liver and kidneys;
• Increase in function of a thyroid gland (hyperthyroidism);
• Hormonal active tumor of adrenal glands (pheochromocytoma);
• Existence of inadequately controlled arterial hypertension (arterial pressure> of 145/90 mm hg);
• The established pharmacological, alcohol and drug addiction;
• High-quality increase in a prostate with formation of a residual urine (benign hyperplasia of a prostate);
• Simultaneous use of monoamine oxidase inhibitors, and also the period of 14 days after their cancellation (after reception of Meridia it is also necessary to sustain a two-week interval before reception of MAO inhibitors);
• Combination therapy with other medicines for decrease in weight or the drugs operating on the central nervous system (neuroleptics, antidepressants), the drugs used at sleep disorders (tryptophane) or mental disorders;
• Pregnancy and period of feeding by a breast;
• Age up to 18 years;
• Age of 65 years;
• Hypersensitivity to drug components.

Women of childbearing age during reception of Meridia need to use contraceptives.

Route of administration and dosage

The Meridi is accepted inside, without chewing and washing down with enough liquid (a glass of water), it is more preferable – in the morning. Capsules can be combined with meal or to accept on an empty stomach.

At the beginning of therapy appoint 10 mg of Meridia daily. In the absence of efficiency (criterion weight reduction less than on 2 kg in a month is), in case of good tolerance of drug, increase in a daily dose up to 15 mg is possible. At 15 mg of Meridia of patients which are poorly reacting to reception (criterion weight reduction less than on 4 kg in a month is) performing further therapy is inexpedient.

In case of the admission of administration of drug to accept a double dose, changing the usual mode of dosing, does not follow. At the patients who insufficiently are well reacting to therapy (decrease in body weight less than 5% of initial level in 3 months of therapy), the course should not proceed longer than 3 months. It is not necessary to continue treatment if against the background of further reception after the reached weight reduction of the patient puts on the weight of 3 kg and more.

Therapy duration (using 10 or 15 mg of Meridia) should not exceed 1 year (due to the lack of sufficient data on safety and efficiency of therapy throughout the period more than the specified term).

During treatment it is recommended to patients to change habits and a way of life so that after end of a course of therapy to provide preservation of the reached weight reduction (at non-compliance with these requirements inevitably repeated increase in body weight).

The doctor can change the dosing mode recommended in the instruction.

Side effects

Most often side effects develop for the first month of therapy. Their frequency and expressiveness weaken over time. In general, disturbances have reversible and not character (> 10% – are frequent, 1-10% – sometimes, <1% – is rare):

• Alimentary system: often – a lock, appetite loss; sometimes – an exacerbation of hemorrhoids, nausea;
• Cardiovascular system and blood (hemostasis, hemopoiesis): sometimes – heartbeat, tachycardia, increase in arterial pressure, a vazodilatation (erubescence with a caumesthesia), moderate increase in pulse (on 3-7 beats per minute) and moderate rise in arterial pressure at rest (on 1-3 mm hg); in some cases – more expressed increase in arterial pressure and increase of heart rate (clinically significant changes of pulse and arterial pressure are registered preferential in an initiation of treatment (in the first 1-2 months));
• Integuments: sometimes – perspiration;
• Nervous system and sense bodys: often – sleeplessness, dryness in a mouth; sometimes – concern, a headache, dizziness, change of taste, paresthesia (disturbance of sensitivity of skin).

In isolated cases at use of Meridia the following clinically significant disturbances are described:

• Diseases of kidneys in the form of acute intersticial nephrite, a mezangiokapillyarny glomerulonephritis;
• Tranzitorny increase in activity of liver enzymes;
• Shenleyna-Genokh's purpura;
• Thrombocytopenia;
• Convulsive attacks;
• Acute psychosis (at one patient with the schizoaffective disturbance which was presumably existing prior to administration of drug).

Special instructions

It is necessary to accept Meridia only with observance of accurately certain conditions and special precautionary measures. Before performing therapy it is necessary to consult with the specialist.

The Meridi is recommended to be accepted in cases when all actions for reduction of weight are ineffective (criterion decrease in body weight less than on 5 kg for 3 months is).

Therapy needs to be carried out only in a complex (including the change of a way of life and a diet necessary for preservation of the reached weight reduction after cancellation of drug treatment), observing recommendations of the specialist with practical experience of treatment of obesity.

The patients accepting Meridia need to control the arterial pressure and heart rate. For 2 first months of treatment it is necessary to control these parameters each 14 days, then once a month. At arterial hypertension (arterial pressure over 145/90 mm hg) control of these parameters, if necessary, needs to be carried out more often and especially carefully. Therapy should be interrupted in cases if at repeated measurement arterial pressure exceeds 145/90 mm hg twice.

It is necessary to be careful at a combination therapy with the medicines increasing QT interval (sertindoly, terfenadiny, astemizoly, Amiodaronum, quinidine, flekainidy, propafenony, meksiletiny, sotaloly, Pimozidum, tsizapridy, tricyclic antidepressants), and at states which are capable to lead to increase in an interval of QT (for example, at a hypopotassemia and a hypomagnesiemia).

When carrying out regular medical control of a condition of accepting Meridia of the patient special attention needs to be paid on thorax pain, progressing диспноэ and hypostases standing (communication between administration of drug and development of primary pulmonary hypertensia is not established).

It is also necessary to be careful in the presence of the following diseases / states:

• Epilepsy;
• Functional disturbances of a liver of average and easy severity (because of possible increase in concentration of a sibutramin in a blood plasma);
• Functional disturbances of kidneys of average and easy severity (because of removal by kidneys of inactive metabolites of drug);
• Anamnestic data on motor or verbal tics (uncontrollable spontaneous muscular contractions, and also disturbances of an articulation);
• Simultaneous use with the drugs promoting increase in arterial pressure and heart rate (including the medicines applied at cough, an allergy and cold).

At cancellation of Meridia development of disturbances in the form of a headache and increase in appetite is in rare instances possible; there are no data on development of an abstinence syndrome, disturbances of mood or a withdrawal.

Because of need of observance of a diet to take alcohol during therapy it is not recommended.

The drugs operating on the central nervous system can limit memory, intellectual activity, speed of reactions. In this regard drivers of vehicles and patients whose profession is connected with the increased concentration of attention need to be careful at purpose of Meridia.

Medicinal interaction

At a combination therapy of Meridia with some drugs there can be following effects:

• The medicines inhibiting activity of CYP3A4 enzyme (тролеандомицин, кетоконазол, erythromycin, cyclosporine): increase in concentration in plasma of metabolites of a sibutramin, clinically insignificant lengthening of an interval of QT (on 9,5 ms), increase in heart rate (on 2,5 beats per minute);
• Rifampicin, dexamethasone, Phenytoinum, phenobarbital, carbamazepine, antibiotic drugs of group of macroleads: acceleration of metabolism of a sibutramin;
• The drugs increasing serotonin neurotransmitter level in a blood plasma (dihydroergotamine, суматриптан, selective serotonin reuptake inhibitors, the strong anesthetizing medicines (pethidine, pentazocine, fentanyl), antibechic drugs (including dextromethorphan)): increase in risk of development of a serotoninovy syndrome.

Does not render on effect of hormonal contraceptive drugs of Meridia of influence.

The provided data on medicinal interaction belong to the drugs used during the short period.

At a concomitant use of Meridia with alcohol strengthening of negative effect of the last was not noted. However alcohol is not combined with the dietary actions recommended at drug use.

Terms and storage conditions

To store in the place, dry, unavailable to children, at a temperature up to 25 °C.

Period of validity – 3 years.