Meridia - instructions for use

Medication for the treatment of obesity. Sibutramine exerts its action in vivo due to metabolites, which are secondary and primary amines.

Inhibits the reuptake of monoamines (primarily serotonin and norepinephrine) and reduces appetite (increases the feeling of saturation) by changing (increasing synergistic interactions) central noradrenergic and 5-HT functions and increases thermogenesis through indirect activation of beta3-adrenoreceptors. It also affects brown adipose tissue.

Sibutramine and its metabolites do not release monoamines and are not MAO inhibitors. They do not have affinity for a large number of neurotransmitter receptors, including serotonergic (5-HT1, 5-HT1A, 5-HT1B, 5-HT2a, 5-HT2cadrenergic (alpha1alpha2beta beta1beta3), dopaminergic (D1, D2), muscarinic, histaminergic (H1), benzodiazepine and NMDA receptors.

Indications drug Meridia

Supportive care for patients with overweight in the following cases:

- alimentary obesity with a body mass index of 30 kg / m 2 or more,

- alimentary obesity with a body mass index of 27 kg / m 2 or more in the presence of other risk factors due to overweight, such as diabetes mellitus type 2 or dyslipoproteinemia (lipid metabolism).

Contraindications

Installed hypersensitivity to sibutramine or to other components of the drug.

Organic causes of obesity.

Known and established serious eating disorders are anorexia nervosa (exhaustion) or bulimia nervosa (unlimited passion for food).

Gilles de la Tourette syndrome (neurological pathology).

Simultaneous use or a period of less than 2 weeks after discontinuation of the use of MAO inhibitors (drugs for the treatment of depression), as well as when using other drugs acting on the central nervous system: for mental disorders (for example, antidepressants, neuroleptics), for sleep disorders (tryptophan), for use other drugs for weight loss.

Established coronary artery disease, chronic heart failure in the stage of decompensation, congenital heart defects, occlusive peripheral artery disease, tachycardia, arrhythmia, cerebrovascular diseases (stroke, transient cerebrovascular accident).

The presence of inadequately controlled arterial hypertension (BP> 145/90 mm Hg) (see also "Precautions").

Hyperthyroidism (increased thyroid function).

Severe abnormal liver function.

Severe renal dysfunction.

Benign prostatic hyperplasia (benign enlargement of the prostate with residual urine formation).

Pheochromocytoma (hormonally active adrenal tumor).

Established pharmacological, drug and alcohol dependence.

Pregnancy and lactation period.

Do not use Meridia 15 mg in children and adolescents under the age of 18 years and the elderly over 65 years of age due to the lack of sufficient clinical experience.

Use during pregnancy and lactation

During pregnancy, this drug should not be taken, because so far there is not a sufficiently convincing amount of research into the safety of the effects of Meridia on the fetus.

Women of childbearing age should use contraceptives while taking the drug.

Do not use Meridia during breastfeeding.

Side effects

Most often, side effects appear at the beginning of treatment (in the first 4 weeks). Their severity and frequency weaken over time. The side effects are, in general, not heavy and reversible. Criteria for assessing the incidence of side effects: often -> 10%, sometimes - 1-10%, rarely - blood pressure, vasodilation (reddening of the skin with a sensation of heat). There is a moderate rise in blood pressure at rest at 1–3 mm Hg. and a moderate increase in pulse rate at 3–7 beats per minute. In some cases - a more pronounced increase in blood pressure and increased heart rate. Clinically significant changes in blood pressure and heart rate are recorded mainly at the beginning of treatment (in the first 4–8 weeks). On the use of Meridia in patients with elevated blood pressure, see "Contraindications" and "Precautions."

From the digestive system: often - loss of appetite, constipation, sometimes - nausea, exacerbation of hemorrhoids.

From the nervous system and sensory organs: often - dry mouth, insomnia, sometimes - headache, dizziness, anxiety, paresthesia (violation of skin sensitivity), change in taste.

From the skin: sometimes sweating.

In isolated cases, the following clinically significant side effects are described with sibutramine:

- acute interstitial nephritis, mesangiocapillary glomerulonephritis (kidney disease),

- Schonlein-Henoch purpura (hemorrhage into the skin),

- transient increase in liver enzymes,

- In one patient with schizoaffective disorder, which presumably existed before the start of therapy, acute psychosis developed after treatment.

Interaction

The simultaneous use of sibutramine with drugs that inhibit the activity of the CYP3A4 enzyme (ketoconazole, erythromycin, troleandomycin, cyclosporine) leads to an increase in plasma concentration of sibutramine metabolites and an increase in heart rate of 2.5 beats per minute and a clinically insignificant lengthening of the QT interval by 9.5 ms .

Rifampicin, phenytoin, carbamazepine, phenobarbital, dexamethasone, and macrolide antibiotics can accelerate sibutramine metabolism.

With simultaneous use with drugs that increase the level of serotonin neurotransmitter in the blood plasma (selective serotonin reuptake inhibitors, sumatriptan, dihydroergotamine, potent analgesics - pentazocine, petidine, fentanyl, antitussive drugs - dextromethorphan), the risk of developing serotonin increases, and the serotonin is increased.

Meridia does not affect the action of hormonal contraceptive drugs.

The data on drug interactions are given for drugs used for a short period.

When taken simultaneously with alcohol, there was no increase in the negative effect of the latter. However, alcohol is absolutely not combined with the recommended dietary measures when taking sibutramine.

Dosage and administration

Inside, the capsules should be taken in the morning, without chewing and washing down with a sufficient amount of liquid (a glass of water). The drug can be taken on an empty stomach or combined with a meal.

Initial dose - 1 capsule Meridia 10 mg daily. In patients who do not respond well to this dose (the criterion is a reduction in body weight of less than 2 kg in 4 weeks), provided that it is well tolerated, the daily dose can be increased to 15 mg. In patients who do not respond well to taking Meridia 15 mg (the criterion is weight loss of less than 2 kg in 4 weeks), further treatment with this drug should be discontinued.

When you skip taking the drug in a dose of 10 or 15 mg, you should not take a double dose, but you must continue taking the prescribed regimen. Treatment should not continue for more than 3 months in patients who do not respond well to therapy (a decrease in body weight of less than 5% of the initial level within 3 months of treatment). Treatment should not be continued if, with further therapy after the achieved reduction in body weight, the patient gains 3 kg or more in weight. The duration of treatment Meridia 10 or 15 mg should not exceed 1 year (data on the efficacy and safety of the drug for a longer time are not available).

During therapy with Meridia, patients are recommended to change their lifestyle and habits so that, after the treatment is completed, to ensure that the achieved reduction in body weight is maintained (if these requirements are not followed, a repeated increase in body weight and access to a doctor are unavoidable).

These instructions on the route of administration and dosage are considered valid until the attending physician prescribes a new regimen for you. To achieve effectiveness, you should follow the prescribed regimen.

Overdose

Data on sibutramine overdose is limited. The specific signs of overdose are unknown, however, the possibility of a more pronounced manifestation of side effects should be considered.

There is no specific treatment for overdose and specific antidotes. It is necessary to carry out general activities aimed at maintaining breathing, cardiovascular function, supporting symptomatic therapy, gastric lavage and taking activated charcoal. With increased blood pressure and tachycardia, it is possible to assign beta-blockers.

Precautionary measures

Apply only under clearly defined conditions and special precautions. Mandatory medical consultation.

In patients taking Meridia, it is necessary to control blood pressure and heart rate. In the first 2 months of therapy, these parameters should be monitored every 2 weeks, and then monthly. In patients with arterial hypertension (BP above 145/90 mm Hg), monitoring of these parameters should be carried out very carefully and, if necessary, more often. If blood pressure during repeated measurement twice exceeded 145/90 mm Hg , treatment should be suspended.

Care should be taken when used simultaneously with drugs that increase the QT interval (astemizole, terfenadine, amiodarone, quinidine, flekainid, meksiletin, propafenone, sotalol, cisapride, pimozide, sertindole, tricyclic antidepressants), and in conditions that can increase the interval. such as hypokalemia and hypomagnesemia.

When conducting regular medical monitoring of the patient taking the drug, special attention should be paid to progressive dyspnea, chest pain and swelling in the legs, although the relationship between taking Meridia and the development of primary pulmonary hypertension has not been established.

With extreme caution prescribed to patients with epilepsy.

With extreme caution, Meridia should be prescribed to patients with mild to moderate hepatic impairment (elevated plasma sibutramine concentrations are possible).

Given that the inactive metabolites of the drug are excreted by the kidneys, the drug should be used with particular caution in patients with impaired renal mild or moderate severity.

It should be used with caution in patients with a history of motor or verbal tics (uncontrolled spontaneous muscle contractions, as well as articulation disorders).

Reactions to drug withdrawal (headache, increased appetite) are rarely observed. There is no data on the development of withdrawal symptoms, withdrawal syndrome or mood disorders.

During treatment should not drink alcohol because of the need for diet.

With caution prescribed simultaneously with drugs that increase blood pressure and heart rate (including drugs used for cough, allergies and colds).

Drugs acting on the central nervous system, can limit mental activity, memory, reaction rate. And although studies have not noted the effect of sibutramine on these functions, nevertheless care should be taken when prescribing the drug to drivers of vehicles and people whose profession is associated with increased concentration of attention.

Special instructions

The drug should be used only in cases where all measures to reduce body weight are ineffective (ie, weight loss is less than 5 kg for 3 months).

Treatment should be carried out only in the framework of complex therapy for weight loss under the supervision of a physician with practical experience in the treatment of obesity. Combined therapy includes a change in diet and lifestyle, which are necessary to maintain the achieved weight loss after discontinuation of drug therapy.

The period of taking the drug should be limited in time.

Release form and composition

Meridia is produced in the form of capsules: hard gelatin, with a blue lid and a yellow (10 mg) or white (15 mg) color, labeled (depending on the dose) “10” or “15”, the contents of the capsules are almost free-flowing powder white or white (10 mg each: 7 pieces in blister packs, 2 packs in a carton pack, 14 packs in blister packs, 1.2 or 6 packs in a carton pack, 15 mg each 14 pieces in packs, 2 packs in a carton box).

The composition of 1 capsule includes:

  • Active ingredient: sibutramine hydrochloride monohydrate - 10 mg,
  • Auxiliary components: sodium lauryl sulfate, microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, magnesium stearate, gelatin, titanium dioxide (E171), indigotin (E132), gray ink, quinoline yellow (E104 dye).

Indications for use

Meridia is prescribed for the maintenance therapy of patients with overweight with the following indications:

  • Alimentary obesity with a body mass index of 30 kg / m 2 and more,
  • Alimentary obesity with a body mass index of 27 kg / m 2 and more in the presence of other risk factors that are caused by overweight, such as a disturbance of lipid metabolism (dyslipoproteinemia) or type 2 diabetes.

Dosing and Administration

Meridia is taken orally without chewing and drinking a sufficient amount of liquid (a glass of water), preferably in the morning. Capsules can be combined with meals or taken on an empty stomach.

At the beginning of therapy prescribed 10 mg of Meridia daily. In the absence of effectiveness (the criterion is a reduction in weight of less than 2 kg per month), in the case of good tolerability of the drug, it is possible to increase the daily dose to 15 mg In patients who are not responsive to receiving 15 mg of Meridia (the criterion is a weight reduction of less than 4 kg per month), further therapy is not appropriate.

In the case of skipping the drug to take a double dose, changing the usual dosing regimen should not be. In patients who do not respond well enough to therapy (weight loss less than 5% of the initial level within 3 months of therapy), the course should not last longer than 3 months. It is not necessary to continue the treatment if, against the background of further administration after the achieved weight reduction, the patient gains 3 kg or more in weight.

The duration of therapy (using 10 or 15 mg of Meridia) should not exceed 1 year (due to the lack of sufficient information about the safety and efficacy of therapy over a period longer than the specified period).

During treatment, patients are recommended to change their habits and lifestyle so that, after completing the course of therapy, to ensure that the weight loss achieved is maintained (if these requirements are not observed, a repeated increase in body weight is inevitable).

The doctor may change the dosage recommended in the instructions.

Meridia (sibutramine).

Active substance: Sibutramine.

Pharmacological group: Appetite regulators

Indications for use Meridia:
Comprehensive maintenance therapy for patients with overweight during alimentary obesity with a body mass index of 30 kg / m2 or more or with a body mass index of 27 kg / m2 or more, but with other risk factors due to overweight (diabetes mellitus type 2, dyslipoproteinemia).

Contraindications Meridia:
Hypersensitivity, the presence of organic causes of obesity, anorexia nervosa, bulimia, mental illness, Gilles syndrome de la Tourette's syndrome, coronary heart disease, decompensated heart failure, congenital heart disease, occlusive peripheral arterial disease, tachycardia, arrhythmia, cerebrovascular disease (stroke, transient cerebrovascular blood circulation), arterial hypertension (BP> 145/90 mm Hg), hyperthyroidism, severe dysfunction of the liver or kidneys, benign hyperplasia Asia of the prostate gland, accompanied by the presence of residual urine, pheochromocytoma, glaucoma, established pharmacological, drug and alcohol dependence, simultaneous use or a period of less than 2 weeks after discontinuation of MAO inhibitors or other drugs acting on the CNS (including antidepressants, neuroleptics, tryptophan), as well as other drugs for weight loss, pregnancy, breast-feeding.

Restrictions on the use of Meridia:
Epilepsy, motor-verbal tic (involuntary muscle contractions, impaired articulation), childhood and old age (safety and efficacy of use in children under 18 years of age and in people over 65 years of age are not defined).

Meridia use during pregnancy and lactation:
Contraindicated (adequate controlled studies in women have not been conducted).

Side effects of Meridia:

  • From the nervous system and sensory organs:> 10% - insomnia, 1-10% - headache, dizziness, anxiety, paresthesia, change in taste, in rare cases - seizures (0.1%), acute psychosis (in one patient with schizoaffective disorder).
  • Since the cardiovascular system and blood (hematopoiesis, hemostasis): 1-10% - tachycardia, palpitations, increased blood pressure, vasodilation (skin flushing with a sensation of heat), in rare cases - Shenlein-Genoch disease, thrombocytopenia.
  • On the part of the digestive tract:> 10% - dry mouth, loss of appetite, constipation, diarrhea, 1-10% - nausea, exacerbation of hemorrhoids.
  • From the urinary system: in rare cases - acute interstitial nephritis, mesangiocapillary glomerulonephritis.
  • Other: 1-10% - sweating, increase in serum concentrations of AST, ALT, gamma-glutamyltransferase, LDH, alkaline phosphatase, bilirubin (less than 1.6% of cases).

Interaction:
Inhibitors of microsomal oxidation, incl. P450 3A4 inhibitors (ketoconazole, erythromycin, cyclosporin, etc.) decrease Cl of sibutramine. Means with serotonergic activity, increase the risk of serotonin syndrome (agitation, sweating, diarrhea, fever, arrhythmia, convulsions, etc.).

Overdose of Meridia:
Symptoms: increased severity of side effects.
Treatment: reception of activated carbon, symptomatic therapy, monitoring of vital functions, with an increase in blood pressure and tachycardia - the appointment of beta-blockers.

Dosing and Administration Meridia:
Inside, 1 time per day (in the morning), the initial dose is 10 mg (with poor tolerance, 5 mg can be taken), in case of insufficient efficacy, after 4 weeks, the dose is increased to 15 mg / day. The duration of treatment is 1 year.

Precautionary measures:
It is necessary to monitor the level of blood pressure and pulse rate every 2 weeks in the first 2 months of treatment and then once a month. In patients with arterial hypertension at a blood pressure level of 145/90 mm Hg. treatment should be discontinued. The appearance during treatment of chest pain, progressive dyspnea (breathing disorder) and edema of the lower extremities may indicate the development of pulmonary hypertension (in this case, it is necessary to consult a doctor).
The simultaneous use of drugs that increase the QT interval (astemizole, terfenadine, antiarrhythmic and other drugs), agents containing ephedrine, phenylpropanolamine, pseudoephedrine, etc. (the danger of increasing blood pressure and increasing heart rate), as well as other anorectic drugs with a central mechanism, is not recommended. actions. Precautions should be prescribed on the background of hypokalias and hypomagnesemia, in violation of the functions of the liver and kidneys of mild and moderate severity.
It should be borne in mind that sibutramine can reduce salivation and promote the development of caries, periodontal diseases, candidiasis and oral discomfort. During treatment it is recommended to limit alcohol intake. Should not be used while working drivers of vehicles and people whose profession is associated with increased concentration of attention. Women of childbearing age during treatment should use adequate contraceptive measures.

Special instructions:
Application is possible only in cases where all other activities aimed at reducing body weight, are ineffective. Treatment should be carried out under the supervision of a physician with experience in correcting obesity in the framework of complex therapy (diet, changing dietary habits and lifestyle, increasing physical activity). The period of administration in a dose of 15 mg should be limited in time.

Package insert (Meridia Information for Consumers)

Trade names: Meridia

International title: Sibutramine

Pharmachologic effect: Anorexic agent. Inhibits the reuptake of monoamines (serotonin (5-HT) and norepinephrine) and exerts its action in vivo due to metabolites, which are secondary and primary amines. Sibutramine and its metabolites are neither monoamine releasing agents, nor monoamine oxidase inhibitors, and have no affinity for a large number of neurotransmitter receptors, including serotonergic (5-HT1-, 5-HT1-, 5-HT1b-, 5-НТ2-, 5- NT2s-), adrenergic (beta1-, beta2-, beta3-, alpha1-, alpha2-), dopaminergic (D1-, D2-), muscarinic, histaminergic (H1-), benzodiazepine and NMDA receptors. A decrease in body weight occurs due to an increase in the feeling of saturation, an increase in thermogenesis.

Indications: Nutritional obesity with a body mass index of 30 kg / sq. M and more, alimentary obesity with a body mass index of 27 kg / sq. M and more, which have, due to overweight, risk factors (type II diabetes, dyslipoproteinemia).

Contraindications: Hypersensitivity, anorexia nervosa, bulimia nervosa, simultaneous administration of MAO inhibitors, coronary artery disease, heart failure, congenital heart disease, occlusive peripheral artery disease, tachycardia, arrhythmias, stroke, arterial hypertension, hyperthyroidism, liver failure, renal insufficiency, renal failure, liver failure. with the formation of residual urine), pheochromocytoma, glaucoma, drug and alcohol dependence, pregnancy, lactation, childhood (up to 18 l em), old age. With care - epilepsy, motor-verbal tick (involuntary muscle contractions, impaired articulation).

Dosing regimen: Inside, on 10 mg in the morning, without chewing and washing down with 200 ml of liquid, at inefficiency (decrease in body weight less than 2 kg for 4 weeks) the dose is increased to 15 mg / days. In patients who do not respond well to a dose of 15 mg (a reduction in body weight of less than 2 kg in 4 weeks), further treatment should be stopped. The course of treatment is no more than 3 months in patients who do not respond well enough to therapy (5% of the initial weight loss cannot be achieved, the treatment should not be continued if, with further therapy, after the weight loss achieved, the patient regains weight by 3 kg and more). The duration of treatment is 1 year. Within the framework of drug therapy, patients need to change their lifestyle and habits so that, after completion of treatment, to ensure that the achieved weight loss is maintained. Failure to comply with these requirements will lead to a new increase in body weight.

Side effects: Tachycardia, palpitations, increased blood pressure, skin hyperemia, anorexia, constipation, nausea, exacerbation of hemorrhoids, dryness of the oral mucosa, insomnia, headache, dizziness, anxiety, skin paresthesia, sweating, acute interstitial nephritis, mesangiocapillary, idiopia, idiopia, idiopathic, idiopathic, idiopic, idiopic, idiopic, idiopic, idiotic, idiopathic, idiotic, idiopathic, idiotic , convulsions, thrombocytopenia, transient increase in the activity of "hepatic transaminases".

Special instructions: Treatment is carried out only in cases where all other activities aimed at reducing body weight, are ineffective. During the period of treatment measures are dietary in nature, it is advisable to increase physical activity. Women who are in childbearing should use contraceptives. Do not take the drug while working for transport drivers and other people whose profession requires a quick mental and motor response. During the period of treatment, it is necessary to monitor the level of blood pressure, heart rate in the first 2 months of treatment (every 14 days), and then monthly. In case of skipping the drug, continue to receive the prescribed scheme further.

Interaction: Increasing concentration and toxicity (slowing metabolism) with simultaneous use of microsomal oxidation inhibitors (ketoconazole, erythromycin, toleandomycin, cyclosporine, cimetidine). Inductors of microsomal oxidation reduce efficiency. Drugs that increase the level of serotonin in the blood (sumatriptan, dihydroergotamine, pentazocine, fentanyl, dextromethorphan) increase the risk of developing "serotonin syndrome" (due to the selective blocking of serotonin reuptake).

Storage conditions

The drug Meridia should be stored and transported in its original packaging at a temperature of from 15 to 25 degrees Celsius.
When storage conditions are met, Meridia is suitable for use within 3 years after release.

Reduxen, Lindax, Talia.

1 capsule drug Meridia 10 contains:
Sibutramine hydrochloride (in the form of monohydrate) - 10 mg,
Additional ingredients, including lactose (in the form of monohydrate).

1 capsule drug Meridia 15 contains:
Sibutramine hydrochloride (in the form of monohydrate) - 15 mg,
Additional ingredients, including lactose (in the form of monohydrate).

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