Goldline Plus, 10 mg+158, 5 mg capsules 90 pcs
€124.77 €103.98
Goldline® PLUS is a combination drug whose action is due to its constituent components. Sibutramine is a prodrug and exerts its effect in vivo due to metabolites (primary and secondary amines) that inhibit monoamine reuptake (serotonin, norepinephrine, dopamine).
The increase of neurotransmitters in synapses increases the activity of central 5NT-serotonin and adrenergic receptors, which contributes to an increased feeling of satiety and decreased need for food, as well as increased heat production. By activating betaz-adrenoreceptors indirectly, sibutramine affects brown adipose tissue. Reduction of body weight is accompanied by an increase in plasma concentration of high density lipoproteins (HDL) and a decrease in triglycerides, total cholesterol, low-density lipoproteins (LDL) and uric acid.
Sibutramine and its metabolites do not affect the release of monoamines, do not inhibit monoamine oxidase (MAO); have low affinity for a large number of neurotransmitter receptors, including serotonin (5-HTi, 5-HTia, 5-HTm, b-NTgs), adrenergic (beta, betaz, alpha], alphag), dopamine (Di, D2), muscarinic, histamine (Hi), benzodiazepine and glutamate (NMDA) receptors. Microcrystalline cellulose is an enterosorbent, has sorption properties and non-specific detoxifying action. It binds and removes from the body various microorganisms, products of their vital functions, toxins of exogenous and endogenous nature, allergens, xenobiotics as well as excess of certain metabolic products and metabolites responsible for the development of endogenous toxicosis.
Indications
Type 2 Diabetes, Obesity
- Goldline® PLUS is indicated for weight loss in the following conditions:
- alimentary obesity with a body mass index (BMI) of 30 kg/m2 or more;
- alimentary obesity with a BMI of 27 km/m2 or more in combination with type 2 diabetes and dyslipidemia.
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Active ingredient
Sibutramine, Microcrystalline cellulose
Composition
Active ingredients:
sibutramine hydrochloride monohydrate,
cellulose microcrystalline.
Excipients:
calcium stearate – 1.5 mg.
Contents of the capsule shell:
caps:
dye azorubin (E122) – 0.0570 %;
indigo carmine (E132) – 0.3079 %;
p> sodium lauryl sulfate – 0.0800 %;
titanium dioxide – 1.0000 %;
gelatin – up to 100%.
Case:
sodium lauryl sulfate – 0.0800 %;
titanium dioxide – 2.0000 %;
gelatin – up to 100%.
How to take, the dosage
Goldline Plus is taken one capsule a day in the first half of the day.
The treatment starts with a smaller dosage of 10 mg. If within 4 weeks of taking the drug weight loss of more than 2 kg is not achieved, the larger dosage of 15 mg is switched to. The drug action develops gradually during the first month, the maximum effect is observed after 3 months of continuous use. If you miss taking the drug, you should not take a double dose the next day. Goldline Plus is recommended to take a course of 6 months, as during this time is achieved not only a significant reduction in body weight, but also formed the correct eating habits. Due to this partial effect after stopping the drug remains up to 2 years. The maximum duration of use should not exceed 1 year, because there are no data from clinical studies on the efficacy and safety of longer use.
Prescription of Goldline Plus should be discontinued if the patient responds poorly to therapy – if in three months of use the decrease in body weight was less than 5%. Remember that Goldline Plus is only used in combination therapy with a hypocaloric diet and exercise.
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Interaction
Microsomal oxidation inhibitors, including CYP3A4 isoenzyme inhibitors (ketoconazole, erythromycin, cyclosporine, etc.) increase plasma concentrations of sibutramine metabolites with increased heart rate and clinically not significant increase in QT interval. Rifampicin, antibiotics from macrolide group, phenytoin, carbamazepine, phenobarbital and dexamethasone may accelerate sibutramine metabolism. Simultaneous use of several drugs that increase serotonin levels in blood plasma may lead to the development of serious interaction. So-called serotonin syndrome may develop in rare cases when sibutramine is used simultaneously with selective serotonin reuptake inhibitors (drugs for treatment of depression), with some drugs for treatment of migraine (sumatriptan, dihydroergotamine), with potent analgesics (pentazocine, pethidine, fentanyl) or anti-cough medications (dextromethorphan). Sibutramine does not affect the effect of oral contraceptives.
When taking sibutramine and alcohol concomitantly, no increase in the negative effects of alcohol has been noted. However, alcohol is absolutely not combined with the recommended dietary measures when taking sibutramine.
When concomitant use with sibutramine of other drugs that affect hemostasis or platelet function, the risk of bleeding increases. Drug interaction when using sibutramine concomitantly with drugs that increase blood pressure and heart rate has not been fully studied. This group of drugs includes decongestants, anti-cough, anti-inflammatory and anti-allergic drugs containing ephedrine or pseudoephedrine. Therefore, in cases of concomitant use of these drugs with sibutramine, caution should be exercised. Concomitant use of sibutramine with drugs for weight loss, acting on the central nervous system, or drugs for the treatment of mental disorders is contraindicated.
Special Instructions
Goldline® PLUS should be used only in cases where all non-medicinal weight loss measures are ineffective – if the weight loss within 3 months is less than 5 kg. Treatment with Goldline® PLUS should be carried out as part of a comprehensive therapy for weight loss under the supervision of a physician with practical experience in treating obesity. Complex therapy includes both changes in diet and lifestyle and an increase in physical activity.
An important component of therapy is the creation of the prerequisites for lasting changes in eating habits and lifestyle, which are necessary to maintain the achieved weight loss even after withdrawal of drug therapy. As part of therapy with Goldline® PLUS, patients need to change their lifestyle and habits so that the achieved weight loss can be maintained after treatment ends. Patients should clearly understand that failure to comply with these requirements will result in a second weight gain and a second visit to the attending physician. In patients taking Goldline® PLUS, blood pressure and heart rate should be measured regularly.
In the first 3 months of treatment, these parameters should be monitored every 2 weeks, and then monthly. If an increase in resting heart rate >