Meridia is a centrally acting drug for the treatment of obesity.
Release form and composition
Meridia is available in the form of hard gelatin capsules:
- With a yellow case, a blue lid, overprint “10” - 7 pcs. Each. in blisters, in a carton box, 2 packs; on 14 pieces in blisters, in a carton pack of 1, 2, or 6 packs;
- With white case, blue lid, overprint “15” - 14 pcs. Each. in blisters, in a carton box 2 packs.
1 capsule contains:
- Active ingredient: sibutramine hydrochloride monohydrate - 10 or 15 mg;
- Auxiliary components: sodium lauryl sulfate, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, lactose monohydrate, titanium dioxide (E171), quinoline yellow, indigodine (E132), ink (gray).
Indications for use
Meridia is used to treat alimentary obesity in patients with a body mass index (BMI) of 30 kg / m 2 , as well as alimentary obesity in people with a BMI of 27 kg / m 2 , combined with dyslipoproteinemia or type 2 diabetes mellitus (non-insulin-dependent).
The use of Meridia is strictly contraindicated in the following cases:
- Serious eating disorders (bulimia nervosa or anorexia);
- Organic causes of obesity (eg, hypothyroidism);
- Severe abnormal liver and / or kidney function;
- Uncontrolled arterial hypertension (blood pressure above 145/90 mm Hg);
- Cardiovascular diseases (including history): decompensated chronic heart failure, coronary heart disease (myocardial infarction, angina), arrhythmia, tachycardia, occlusive peripheral arterial disease, cerebrovascular disease (transient cerebrovascular disease, transient cerebrovascular disease, transient cerebrovascular disease, transient cerebrovascular disease, transient cerebrovascular disease, transient cerebrovascular disease, transient cerebrovascular disease, transient cerebrovascular disease, transient cerebrovascular disease (transient cerebrovascular disease, transient cerebrovascular disease (transient cerebrovascular disease, transient cerebrovascular disease, transient cerebrovascular disease)
- Chronic generalized tic (Tourette syndrome);
- Mental illness;
- Angle-closure glaucoma;
- Benign prostatic hyperplasia;
- Lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
- Established alcohol, drug or drug addiction;
- Simultaneous use, as well as 2 weeks before or after administration of MAO inhibitors; hypnotic drugs containing tryptophan, other drugs acting on the central nervous system that inhibit serotonin reuptake (for example, antipsychotics or antidepressants); other drugs for losing weight or treating mental disorders of central action;
- Lactation period;
- Age up to 18 years and over 65 years;
- Hypersensitivity to sibutramine or auxiliary components of the drug.
Meridia should be carefully prescribed in the following cases:
- Convulsions (including history);
- A history of verbal and motor tics;
- Chronic circulatory failure;
- History of hypertension;
- Coronary artery disease (including history);
- Disorders of blood clotting, bleeding tendency, taking drugs that affect platelet function or hemostasis;
- Liver / kidney dysfunction mild to moderate severity;
Dosing and Administration
Meridia should be taken orally, swallowing capsules whole and squeezed with a glass of water, on an empty stomach or during meals, in the morning.
The doctor sets a specific dose individually depending on the clinical efficacy and tolerability of the drug.
The initial daily dose is 10 mg of sibutramine. In case of insufficient weight loss during the first 4 weeks (less than 2 kg), but under the condition of good tolerance of Meridia, the dose is increased to 15 mg. If in the future the response to the drug is weak (with a low rate of weight loss), long-term use of the drug is not appropriate.
The duration of therapy is determined individually. It should not exceed 3 months in patients who do not respond well enough to Meridia, i.e. which during this period can not achieve weight loss of 5% from the original. Treatment also should not be continued for those patients in whom, after the achieved weight loss, there is a weight gain of 3 kg or more.
The maximum duration of treatment is 1 year.
The most common adverse reactions that occur while taking Meridia are:
- Central nervous system: anxiety, insomnia, dizziness, paresthesias, headache, change in taste;
- Digestive system: nausea, dry mouth, constipation, exacerbation of hemorrhoids;
- Cardiovascular system: rapid heartbeat, tachycardia, increased blood pressure, vasodilation or skin flushing;
- Skin: sweating.
The following side effects have been described in post-marketing studies:
- Cardiovascular system: atrial fibrillation;
- Blood system: thrombocytopenia;
- The digestive system: thirst, increased appetite, abdominal pain, vomiting, diarrhea, a reversible increase in the levels of liver enzymes in the blood;
- Body of vision: misting (blurred vision);
- Nervous system: emotional lability, drowsiness, short-term memory impairment, convulsions;
- Mental disorders: psychosis, depression, suicidal thoughts, mania, suicide;
- Urinary system: urinary retention, acute interstitial nephritis;
- Reproductive system: uterine bleeding, menstrual disorders, orgasm / ejaculation disorders, impotence;
- Immune system: hypersensitivity reactions (from itching, mild skin rash and urticaria to angioedema or angioedema and anaphylaxis);
- Skin: Schonlein-Henoch purpura, alopecia;
- Other: flu-like syndrome, sinusitis, rhinitis, back pain, bleeding, peripheral edema.
In rare cases, after the abolition of Meridia, such reactions as increased appetite or headache are noted.
Meridia should be prescribed only if all non-drug methods of weight loss were ineffective, i.e. within 3 months, the weight loss was less than 5 kg.
The decision on taking the drug should be made only after consulting with a doctor, even if he had previously had to apply for weight loss.
Treatment should be carried out in the framework of complex therapy, including an increase in physical activity, lifestyle changes and diet, under the supervision of a specialist with practical experience in the treatment of obesity. An important component of successful treatment is the creation of prerequisites for the stable formation of the correct eating habits and lifestyle that are necessary to maintain the achieved result after the abolition of Meridia. That is, patients need to change their lifestyle so that even after the end of therapy to ensure the preservation of reduced body weight. Every person should be clearly aware that failure to comply with these requirements will lead to a re-gain of weight and the need for a new course of treatment.
Women of childbearing age during treatment with this drug should use reliable methods of contraception.
Patients with comorbidities associated with obesity, treatment can be continued only if, against the background of weight loss, there is a clinical improvement in other indicators, for example, an improvement in the glycemic profile in patients with diabetes mellitus or a lipid profile in people with dyslipidemia.
In patients with sleep apnea during the period of Meridia, blood pressure must be carefully monitored.
Although the relationship of sibutramine with the development of primary pulmonary hypertension has not been established, given the well-known risk of drugs in this group, during regular medical examinations, special attention should be paid to symptoms such as swelling in the legs, chest pain and respiratory failure.
During the period of use of Meridia, it is recommended to refrain from the use of alcoholic beverages. In addition, care should be taken when driving vehicles and performing all types of work that require psychomotor speed reactions and increased concentration.
Possible interaction reactions in the case of simultaneous use of Meridia with other drugs:
- Cytochrome CYP3A4 inhibiting drugs (erythromycin, ketoconazole, cimetidine): increase in plasma sibutramine concentration;
- Drugs affecting hemostasis and platelet function: bleeding is possible (although a causal relationship with Meridia has not been proven, care should be taken when prescribing the drug to patients prone to bleeding, as well as other drugs that affect platelet function or hemostasis) ;
- MAO inhibitors: risk of developing serotonin syndrome.
Care should be taken when it is necessary to use Meridia simultaneously with drugs that increase blood pressure and heart rate (anti-allergic, anti-cough and cough suppressants, decongestants).
Terms and conditions of storage
Store at a temperature not exceeding 25 ° C. Avoid exposure to moisture. Keep out of the reach of children.
Shelf life - 3 years.