Goldline plus caps. 10mg, 90 pcs 158.5mg

$68.33

Goldline plus caps. 10 + 90 pcs 158.5mg

15 in stock

Quantity:

Description

Composition
Active substance:
1 capsule contains: sibutramine hydrochloride monohydrate – 10.0 mg Microcrystalline cellulose 158.5 mg or sibutramine hydrochloride monohydrate – 15.0 mg Microcrystalline cellulose 153.5 mg.
Excipients:
Calcium stearate.
the composition of the capsule shell: cap: azorubin dye; indigo; sodium lauryl sulfate; titanium dioxide; gelatin. casing: sunset yellow colorant (for a dosage of 10 mg + 158.5 mg); quinoline yellow dye (for a dosage of 10 mg + 158.5 mg); sodium lauryl sulfate; titanium dioxide; gelatin.
Description:
Capsules of 10 mg + 158.5 mg: Hard gelatin capsules № 2, the capsule housing yellow cap – blue. Contents of capsules – powder or compacted powder mass of white or nearly white.
Capsules of 15 mg + 153.5 mg: Hard gelatin capsules № 2, the capsule housing white or almost white, cap – blue. Contents of capsules – powder or compacted powder mass of white or nearly white.
Product form:
Capsules of 10 mg + 158.5 mg; 15 mg + 153.5 mg. 10 or; 15 capsules in blisters made of PVC film and aluminum foil printed patent.
At 1, 3, 6, 9 or 12 contour cell packs of 10 capsules, or 2, 4, 6 or 8 of cellular contour packs of capsules 15 together with instructions for medical application is placed in a pile of cardboard boxed.
Contraindications
Installed Hypersensitivity to sibutramine or to other components of the formulation; presence of organic causes of obesity (e.g., hypothyroidism); serious eating disorders – anorexia nervosa or bulimia nervosa; mental illness; Gilles de la Tourette syndrome (generalized tics); simultaneous MAO inhibitors (e.g., phentermine, fenfluramine, dexfenfluramine, ethylamphetamine ephedrine) or the use for 2 weeks before taking the drug Goldlayn® PLUS and 2 weeks after its administration of other drugs acting on the central nervous system inhibiting serotonin reuptake (e.g., antidepressants, antipsychotics); hypnotic drugs containing tryptophan and other central acting drugs for weight loss or for treating psychiatric disorders; cardiovascular disease (history of or current): ischemic heart disease (myocardial infarction (MI), angina pectoris); chronic heart failure decompensation, peripheral arterial occlusive disease, tachycardia, arrhythmia, cerebrovascular disease (stroke, transient cerebrovascular accidents); uncontrolled hypertension (blood pressure (BP) above 145/90 mm Hg..) (see also section “Special instructions.”); closure glaucoma; hyperthyroidism; severe dysfunction of the liver and / or kidney; benign prostatic hyperplasia; pheochromocytoma; established pharmacological, drug or alcohol addiction; pregnancy and lactation; age 18 years and older than 65 years.
Precautions should be prescribed for the following conditions: a history arrhythmia, chronic circulatory insufficiency, coronary artery disease (including history), except for coronary heart disease (myocardial infarction, angina pectoris); glaucoma, angle-closure glaucoma besides, cholelithiasis, hypertension (controlled and history), neurological disorders, including mental retardation and seizures (including history), epilepsy, hepatic dysfunction and / or renal mild and moderate severity , verbal and motor tics a history propensity to bleeding, coagulation disorders, taking drugs affecting hemostasis or platelet function.
Dosage
10 mg + 158.5 mg
Indications
Goldlayn® PLUS shown to reduce body weight at the following conditions: alimentary obesity with a body mass index (BMI) of 30 kg / m or more; alimentary obesity with a body mass index of 27 km / m2 or more in combination with type 2 diabetes and dyslipidemia.
Interaction with other drugs
Microsomal oxidation inhibitors, including inhibitors isoenzyme CYP3A4 (ketoconazole, erythromycin, cyclosporin, etc.) increase in plasma concentration of metabolites of sibutramine with an increase in heart rate and clinically unimportant increase the interval QT. Rifampicin, antibiotics of the macrolide, phenytoin, carbamazepine, phenobarbital and dexamethasone may accelerate metabolism of sibutramine. Simultaneous use of several drugs that increase blood plasma serotonin may lead to serious interactions. The so-called serotonin syndrome may occur in rare cases, while the use of sibutramine with selective serotonin reuptake inhibitors (drugs for treating depression), with some drugs for treating migraine (sumatriptan, dihydroergotamine), a potent analgesics (pentazocine, pethidine, fentanyl) or antitussive drugs (dextromethorphan). Sibutramine does not affect the action of oral contraceptives.
At the same time taking sibutramine and alcohol was not marked by negative effects of alcohol. However, alcohol is absolutely not compatible with the recommended dietary measures taking sibutramine.
While the use of sibutramine other drugs affecting hemostasis or platelet function, increased risk of bleeding. Drug interaction while the use of sibutramine with drugs that increase blood pressure and heart rate, is currently not fully understood. This group of drugs include decongestants, antitussives, cough and antiallergic drugs, which include ephedrine or pseudoephedrine. Therefore, in the case of simultaneous reception of these drugs with sibutramine caution. The combined use of sibutramine with drugs to lower body weight acting on the central nervous system, or drugs for the treatment of mental disorders is contraindicated.
Overdose
There are very limited data about sibutramine overdose. The most common adverse reactions associated with overdose: tachycardia, increased blood pressure, headache, dizziness. You should notify your doctor in case of suspected overdose. In case of overdose, immediately stop using the product.
Special treatment and specific antidotes exist. It is necessary to carry out common activities: to provide free breathing, monitor the health of the cardiovascular system, as well as to implement supportive symptomatic therapy if necessary. Timely use of activated charcoal and gastric lavage can reduce the intake of sibutramine. Patients with high blood pressure and tachycardia can be assigned to beta-blockers. The effectiveness of forced diuresis or hemodialysis has not been established.
pharmachologic effect
Pharmacological group:
Obesity means of treatment.
Pharmacodynamics:
Goldlayn® PLUS – Combined drug action is due to its constituent components. Sibutramine is a prodrug and exerts its effects in vivo due to metabolites (primary and secondary amines) inhibiting the reuptake of monoamines (serotonin, norepinephrine, dopamine). The increase of neurotransmitters in the synapses increases the activity of central 5HT-adrenergic receptors and serotonin, which increases the feeling of satiety and reduce the need for food and increase termoproduktsii. Indirectly activating beta3-adrenergic receptors, sibutramine affects the brown adipose tissue. Weight loss accompanied by an increase in high density in the plasma concentration of lipoprotein (HDL) and decreasing amounts of triglycerides, total cholesterol, low density lipoprotein (LDL) cholesterol, and uric acid. Sibutramine and its metabolites do not affect the release of monoamines, do not inhibit monoamine oxidase (MAO); have low affinity to a large number of neurotransmitter receptors, including serotonergic (5-HT1, 5-HT1A, 5-HT1b, 5-NT1s), adrenergic (beta1, beta2, beta3, alpha 1, alpha 2), dopamine (D1, D2), muscarinic , histamine (H1), benzodiazepine and glutamate (NMDA) receptors. Microcrystalline cellulose is enterosorbent has sorptive properties and nonspecific detoxification effect. Binds and removes from the body various microorganisms, their metabolic products, toxins exogenous and endogenous nature, allergens, xenobiotics, as well as some excess metabolic products and metabolites responsible for the development of endogenous toxicosis.
Pharmacokinetics:
Suction.
After ingestion rapidly absorbed from the gastrointestinal tract (GIT) of not less than 77%. By “primary pass” through the liver biotransformation influenced isoenzyme CYP3A4 to form two active metabolites (monodesmetilsibutramin (M1) and didesmetilsibutramin (M2)). After administration of a single 15 mg dose maximum plasma concentration (Cmax) M1 is 4 ng / mL (3.2-4.8 ng / ml) M2 – 6.4 ng / ml (5,6-7,2 ng / ml). Cmax is reached after 1.2 hours (sibutramine), 3-4 h (M1 and M2). Simultaneous food intake lowers Cmax metabolites by 30% and increases the time to achieve for 3 h without changing the area of ​​the curve “concentration-time» (AUC).
Distribution.
Rapidly distributed to tissues. Communication with the proteins was 97% (sibutramine) and 94% (Ml and M2). The equilibrium concentration of the active metabolite in plasma is achieved within 4 days after the start of application and about 2 times higher than the concentration in the blood plasma after administration of a single dose.
Metabolism and excretion.
Active metabolites are hydroxylation and conjugation to inactive metabolites that are derived mainly kidneys. The half-life of sibutramine -1,1ch, M1-14ch M2 -16 hours.
Pharmacokinetics in special clinical situations.
The currently available limited data do not indicate the existence of clinically relevant differences in the pharmacokinetics of males and females. Pharmacokinetics in elderly healthy subjects (mean age 70 years) is similar to that of the young.
Renal insufficiency.
Renal failure no effect on AUC active metabolites M1 and M2, except M2 metabolite in patients with end-stage renal failure undergoing dialysis.
Liver failure.
Patients with liver failure moderate after a single dose of sibutramine AUC active metabolites M1 and M2 is 24% higher than in healthy individuals.
Pregnancy and breast-feeding
Because to date there are no sufficiently large number of studies on the safety effects of sibutramine on the fetus, the drug is contraindicated during pregnancy. Women who are of childbearing age, while taking the drug Goldlayn® PLUS should use contraceptives.
Contraindicated to take the drug Goldlayn® PLUS while breast-feeding.
Conditions of supply of pharmacies
On prescription.
side effects
In most cases, side effects occur at the beginning of treatment (first 4 weeks). Their severity and frequency over time weakens. Side effects are generally not heavy and reversible. Side effects, depending on the effects on organs and organ systems, are presented as follows: very common (> 10%), common (> 1%, but
Disorders of the nervous system: Very common side effects are dry mouth and insomnia, are often marked by headache, dizziness, anxiety, paresthesia, and changes in taste.
Violations of the heart: frequent tachycardia, palpitations. There has been a moderate increase in heart rate by 3-7 beats per minute. In some cases, it is not excluded more pronounced increase in heart rate. Clinically significant changes in heart rate are recorded predominantly in the early treatment (in the first 4-8 weeks).
Violations by vessels a frequent elevation of blood pressure, vasodilatation. There is a moderate elevation of blood pressure alone at 1-3 mm Hg. Art. In some cases, are not excluded more pronounced blood pressure increases. Clinically significant changes in blood pressure are recorded mainly early in treatment (during the first 4-8 weeks).
Disorders of the gastrointestinal tract: often observed loss of appetite and constipation, often nausea and worsening of hemorrhoids. A tendency to constipation in the early days should be monitored for the evacuation function of the intestine. If you experience constipation receiving end and take a laxative.
Violations of the skin and subcutaneous tissue disorders: often marked by increased sweating.
In rare cases, the treatment with sibutramine describes the following undesirable clinically significant phenomenon: dysmenorrhea, edema, flu-like symptoms, itchy skin, back pain, abdominal pain, paradoxically increased appetite, thirst, rhinitis, depression, lethargy, emotional lability, anxiety, irritability, anxiety, acute interstitial nephritis, bleeding, Henoch-Schönlein purpura (bleeding into the skin), seizures, thrombocytopenia, transient increase in activity of “liver” enzymes in the blood.
Use of the drug Goldlayn® PLUS in patients with high blood pressure: see section “Contraindications” and “Special instructions”.
During the additional post-marketing studies adverse events were described by the following organ systems:
Violations of the heart: atrial fibrillation.
Disorders of immune system: hypersensitivity reactions (from mild skin rash and urticaria to angioedema (Quincke’s edema) and anaphylaxis).
Mental disorders: psychosis, suicidal oriented thinking, suicide and mania. In the event of such conditions it is necessary to stop the drug.
Disorders of the nervous system: convulsions, transient memory loss.
Violations by the organ of vision: blurred vision ( “blurred vision”). Disorders of the gastrointestinal tract: diarrhea, vomiting.
Violations of the skin and subcutaneous tissue disorders: alopecia.
Violations of the kidneys and urinary tract: urinary retention.
Violations by the genitals and breast: abnormal ejaculation / orgasm, impotence, irregular menstruation, uterine bleeding.
special instructions
Goldlayn® PLUS should be applied only in cases where all the non-pharmacological interventions to reduce weight are ineffective – if the body weight reduction within 3 months was less than 5 kg. Treatment with Goldlayn® PLUS should be carried out within the framework of a comprehensive therapy for weight loss under medical supervision, with practical experience in the treatment of obesity. Complex therapy includes both the change in diet and lifestyle, as well as increased physical activity. An important component of therapy is to create prerequisites for persistent changes in eating and lifestyle choices that are necessary to maintain the achieved weight loss after discontinuation of drug therapy. Patients should be under the therapy with Goldlayn® PLUS to change their lifestyle and habits so that after completion of treatment to ensure preservation of the achieved weight reduction. Patients should be clear to imagine that noncompliance will lead to a re-increase in body weight and repeated treatment of the attending physician. Patients taking Goldlayn® PLUS, you need to regularly measure blood pressure and heart rate. In the first 3 months of treatment, these parameters should be monitored every 2 weeks, and then monthly. If, during the two consecutive visits revealed an increase in heart rate at rest more than 10 beats per minute or systolic / diastolic pressure of 10 mm Hg. Art., it is necessary to discontinue treatment. Patients with hypertension whose antihypertensive therapy on the background of blood pressure greater than 145/90 mm Hg. Art., this control must be carried out very carefully and, if necessary, at shorter intervals.
Patients whose blood pressure is measured twice during the second level higher than 145/90 mm Hg. v., treatment with Goldlayn® PLUS should be canceled (see. the section “Side effect”).
In patients with sleep apnea syndrome particular care to control blood pressure.
Special attention should be given co-administration of drugs that increase the QT interval. These medications include H1-histamine blockers (astemizole, terfenadine); antiarrhythmic drugs that increase the interval QT (amiodarone, quinidine, flecainide, mexiletine, propafenone, sotalol); stimulator of motility of the gastrointestinal tract, cisapride; pimozide, sertindole, and tricyclic antidepressants. This applies to the conditions which can lead to an increase of the interval QT, such as hypokalemia and hypomagnesemia (see. Also “interaction with other drugs”).
The interval between the reception of MAO inhibitors (including furazolidone, procarbazine, selegiline) and PLUS Goldlayn® preparation should be at least 2 weeks.
Хотя не установлена связь между приемом сибутрамина и развитием первичной легочной гипертензии, однако, учитывая общеизвестный риск препаратов данной группы, при регулярном медицинском контроле необходимо особое внимание обращать на такие симптомы, как прогрессирующее диспноэ (нарушение дыхания), боль в грудной клетке и отеки на ногах.
При пропуске дозы препарата Голдлайн® ПЛЮС не следует принимать в следующий прием двойную дозу препарата, рекомендовано продолжать дальнейший прием препарата по предписанной схеме.
Длительность приема препарата Голдлайн® ПЛЮС не должна превышать 1 год.
При совместном приеме сибутрамина и других ингибиторов обратного захвата серотонина существует повышенный риск развития кровотечений. У пациентов, предрасположенных к кровотечениям, а также принимающих препараты, влияющие на гемостаз или функцию тромбоцитов, сибутрамин следует применять с осторожностью.
Хотя клинические данные о привыкании к сибутрамину отсутствуют, следует выяснить, не было ли в анамнезе пациента случаев лекарственной зависимости, и обратить внимание на возможные признаки злоупотребления лекарственными препаратами.
Влияние на способность к управлению транспортными средствами и механизмами.
Прием препарата Голдлайн® ПЛЮС может ограничить способность к управлению транспортными средствами и механизмами. В период применения препарата Голдлайн® ПЛЮС необходимо соблюдать осторожность при управлении транспортными средствами и занятии другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Storage conditions
In the dark place at a temperature not higher than 25 ° C.
Keep out of the reach of children.
Dosing and Administration
Голдлайн® ПЛЮС принимают внутрь 1 раз в сутки. Дозу устанавливают индивидуально, в зависимости от переносимости и клинической эффективности.
Рекомендуемая начальная доза сибутрамина 10 мг/сутки. Капсулы следует принимать утром, не разжевывая и запивая достаточным количеством жидкости (стакан воды). The drug can be taken on an empty stomach, and combined with the meal. Если в течение 4-х недель от начала лечения не достигнуто снижение массы тела менее 2 кг, то доза сибутрамина увеличивается до 15 мг/сутки.
Лечение препаратом Голдлайн® ПЛЮС не должно продолжаться более 3-х месяцев у пациентов, которые недостаточно хорошо реагируют на терапию, т.е. которым в течение 3-х месяцев лечения не удается достичь снижения массы тела на 5 % от исходного показателя.
Лечение не следует продолжать, если при дальнейшей терапии, после достигнутого снижения массы тела, пациент вновь прибавляет в массе тела 3 кг и более. Длительность лечения не должна превышать 1 год, поскольку в отношении более продолжительного периода приема сибутрамина данные об эффективности и безопасности отсутствуют.
Лечение препаратом Голдлайн® ПЛЮС должно осуществляться в комплексе с диетой и физическими упражнениями под контролем врача, имеющего практический опыт лечения ожирения.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

Izvarin

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