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. Betaz indirectly activating the 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-HTi, 5-HTia, 5-HTm, b-NTgs), adrenergic (beta betag, betaz alpha] alfag), dopamine (Di, D2), muscarinic , histamine (Hi), 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.
Sibutramine, [Cellulose microcristallic]
Izvarino Pharma, Russia
sibutramine hydrochloride monohydrate, microcrystalline cellulose.
calcium stearate – 1.5 mg.
azorubin dye (E122) – 0.0570%;
indigo carmine (E132) – 0.3079%;
sodium lauryl sulfate – 0.0800%;
titanium dioxide – 1.0000%;
gelatin – up to 100%.
sodium lauryl sulfate – 0.0800%;
titanium dioxide – 2.0000%;
gelatin -up to 100%.
- Goldlayn® PLUS is indicated for weight loss in 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.
- Installed hypersensitivity to sibutramine or to other components of the drug;
- The presence of organic causes of obesity (eg hypothyroidism);
- The serious eating disorders – anorexia nervosa or bulimia nervosa;
- Mental illness;
- Gilles de la Tourette syndrome (generalized tics);
- Simultaneous reception of 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 reuptake of serotonin (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 “Specific guidance».);
- Angle-closure glaucoma;
- Severe liver and / or kidney;
- Benign prostatic hyperplasia;
- Installed pharmacological, drug or alcohol dependence;
- Pregnancy and lactation;
- Age 18 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 , ^ motor and verbal tics in the history of the propensity to bleeding, bleeding disorders, taking drugs that affect haemostasis or platelet function.
The main side effects when taking Goldline Plus observed within the first month of administration, they are not heavy in nature, do not require pharmacological correction and independently pass through the month.
Basically, you experience the following side effects: dry mouth, insomnia, headache, dizziness, anxiety, increased heart rate, increased blood pressure, loss of appetite, constipation, nausea, sweating
How to accept, acceptance rate and dosage
Goldline Plus take one capsule per day in the first half of the day. Treatment is initiated with smaller dosages of 10 mg. If after 4 weeks of treatment is not achieved weight loss of more than 2 kg, transferred to a large dose – 15 mg.
Effect of the drug develops gradually during the first month, the maximum effect is observed after 3 months of continuous reception. At the admission of the drug should not be on the next day to take a double dose. Goldline Plus is recommended to take the course of 6 months, as during this time is not only achieved a significant reduction in body weight, but also the correct food habits are formed.
Due to this partial effect after discontinuation is stored up to 2 years. The maximum duration of administration should not exceed one year, because there are no clinical data on the efficacy and safety over prolonged use.
Admission Goldline Plus should be discontinued if a patient responds poorly to therapy – if within three months of application of weight loss was less than 5%. It should be remembered that the Goldline Plus is only used in combination therapy with a reduced-calorie diet and exercise.
Sibutramine, [Cellulose microcristallic]
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 0009analgetikami (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.
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 > 000 910 beats per minute or systolic / diastolic blood pressure > 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. Art., treatment with Goldlayn® PLUS should be abolished (see. 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 Hi-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.
Although not established an association between sibutramine and the development of primary pulmonary hypertension, however, given the well-known risk of drugs of this group, with regular medical monitoring is necessary to pay special attention to symptoms such as progressive dyspnea (breathing problems), chest pain and swelling in the legs .
When skipping doses Goldlayn® PLUS should not be taken in the following method a double dose of the drug, it is recommended to continue the further reception of a prescribed drug scheme.
Duration of the drug Goldlayn® PLUS should not exceed 1 year.
When co-administered sibutramine and other serotonin reuptake inhibitors are at increased risk of bleeding. In patients predisposed to bleeding, as well as taking drugs that affect hemostasis or platelet function, sibutramine should be used with caution.
Although clinical data on addiction to sibutramine no, you should find out if there was any in the patient’s history of drug addiction, and pay attention to possible signs of drugs of abuse.
Effects on ability to drive vehicles and mechanisms The drug Goldlayn® PLUS may limit the ability to drive vehicles and mechanisms. During the period of preparation Goldlayn® PLUS must be careful when driving and occupation of other potentially hazardous activities that require high concentration and psychomotor speed reactions.