Goldline - instructions for use, analogs, reviews and release forms (capsules or tablets 10 mg and 15 mg) drugs for the treatment of obesity and weight loss in adults, children and pregnancy. Composition
In this article, you can read the instructions for using the drug Goldline. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Goldline in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Goldline in the presence of existing structural analogs. Use for the treatment of obesity and weight loss in adults, children, as well as in pregnancy and lactation. Composition of the preparation.
Goldline - a drug for the treatment of centralized obesity.Sibutramine (active ingredient of Goldline preparation) is a prodrug and exerts its effect due to metabolites (primary and secondary amines) inhibiting the reuptake of monoamines (mainly serotonin and norepinephrine). An increase in the content of neurotransmitters in synapses increases the activity of central serotonin 5HT receptors and adrenoreceptors, which contributes to an increase in satiety and a decrease in the need for food, as well as an increase in thermal production. By indirectly activating beta3-adrenoreceptors, Sibutramine acts on brown fatty tissue.
The decrease in body weight is accompanied by an increase in the concentration in the blood serum of HDL and lowering the amount of triglycerides, total cholesterol, LDL and uric acid.
Sibutramine and its metabolites do not affect the release of monoamines, do not inhibit MAO, do not have affinity for a large number of neurotransmitter receptors, including serotonin (5HT1-, 5HT1A-, 5HT1B-, 5HT2A-, 5HT2C-), adrenergic (beta-, beta2-, beta3-, alpha1-, alpha2-), dopamine (D1-, D2-), muscarinic, histamine (H1-), benzodiazepine and NMDA receptors.
Composition
Sibutramine hydrochloride monohydrate + excipients.
Pharmacokinetics
After oral administration, it is rapidly absorbed from the digestive tract by at least 77%. At the "first passage" through the liver is subjected to biotransformation under the influence of cytochrome P450 3A4 isoenzyme with the formation of two active metabolites (mono- and didesmethylsibutramine). Quickly distributed to tissues. Active metabolites undergo hydroxylation and conjugation with the formation of inactive metabolites, which are excreted mainly by the kidneys.
Indications
- alimentary obesity with a body mass index (BMI) of more than 30 kg / m2;
- alimentary obesity with a BMI greater than 27 kg / m2 in combination with type 2 diabetes mellitus or dyslipoproteinemia.
Forms of release
Capsules 10 mg and 15 mg (sometimes mistakenly called tablets).
Instructions for use and dosing regimen
Goldline is prescribed orally once a day. The dose is set individually, depending on the tolerability and clinical effectiveness. An initial dose of 10 mg is recommended, with a poor tolerance of 5 mg. Capsules should be taken in the morning without chewing and drinking with a sufficient amount of liquid (a glass of water). The drug can be taken as an empty stomach or combined with a meal.If within 4 weeks from the beginning of treatment there is no reduction in body weight by 5% or more, the dose increases to 15 mg per day.
Treatment by Goldline should not last more than 3 months in patients who do not respond well enough to therapy, i.e. who during the 3 months of treatment fail to achieve a 5% reduction in body weight from the baseline. Treatment should not be continued if, in further therapy, after the body weight reduction is achieved, the patient again adds 3 kg or more in the body mass. The duration of treatment should not exceed 2 years, since there is no data on efficacy and safety for a longer period of sibutramine intake.
Treatment Goldlaynom should be carried out in conjunction with diet and exercise under the supervision of a doctor who has practical experience in the treatment of obesity.
Side effect
- insomnia;
- headache;
- dizziness;
- anxiety;
- paresthesia;
- tachycardia;
- palpitation;
- increased blood pressure;
- symptoms of vasodilation (including skin hyperemia);
- exacerbation of hemorrhoids;
- dry mouth;
- loss of appetite;
- constipation;
- nausea;
- change in taste;
- increased sweating;
- dysmenorrhea;
- edema;
- influenza-like syndrome;
- itching of the skin;
- backache;
- paradoxical increase in appetite;
- thirst;
- rhinitis;
- depression;
- drowsiness;
- emotional lability;
- anxiety;
- irritability;
- nervousness;
- acute interstitial nephritis;
- bleeding;
- purple Shenlaine-Genocha (hemorrhages in the skin);
- convulsions;
- thrombocytopenia.
Contraindications
- the presence of organic causes of obesity (eg, hypothyroidism);
- severe eating disorders (anorexia nervosa or bulimia nervosa);
- mental illness;
- Gilles de la Tourette syndrome (generalized tics);
- simultaneous administration of MAO inhibitors or their use within 2 weeks prior to the appointment of Goldline;
- the use of other drugs acting on the central nervous system (eg, antidepressants, antipsychotics);
- use of drugs prescribed for sleep disorders containing tryptophan, as well as other drugs of central action to reduce body weight;
- IHD, decompensated chronic heart failure, congenital heart disease, occlusive diseases of peripheral arteries, tachycardia, arrhythmia, cerebrovascular diseases (stroke, transient disorders of cerebral circulation);
- uncontrolled arterial hypertension (blood pressure above 145/90 mm Hg);
- thyrotoxicosis;
- severe dysfunction of the liver and / or kidney;
- benign prostatic hyperplasia;
- pheochromocytoma;
- angle-closure glaucoma;
- established pharmacological, narcotic or alcohol dependence;
- pregnancy;
- lactation period (breastfeeding);
- age is 18 years and over 65;
- established hypersensitivity to sibutramine or to other components of the drug.
Application in pregnancy and lactation
Since there is not yet a sufficiently convincing number of studies regarding the safety of sibutramine exposure to fetuses, this drug should not be used during pregnancy.
Do not take Goldline during breastfeeding.
Women of childbearing age should take contraceptives while taking Goldline.
Application in elderly patients
Contraindicated elderly over the age of 65 years.
Use in children
Contraindicated in children under the age of 18 years.
special instructions
Goldline should be used only in those cases when all non-medicamentous measures for weight loss are ineffective if the weight loss for 3 months was less than 5 kg.
Treatment Goldline should be carried out as part of a comprehensive therapy to reduce body weight under the supervision of a doctor who has practical experience in the treatment of obesity. Complex therapy includes both changing diet and lifestyle, and increasing physical activity. An important component of therapy is the creation of prerequisites for a permanent change in eating habits and lifestyle that are necessary to maintain the achieved weight loss and after the abolition of drug therapy. Patients should, within the Goldline therapy, change their lifestyle and habits in such a way as to ensure that the achieved weight reduction is maintained after the treatment is completed. Patients should clearly realize that failure to comply with these requirements will lead to a second increase in body weight and repeated calls to the treating physician.
In patients taking Goldline, it is necessary to measure the level of blood pressure and heart rate. In the first 2 months of treatment, these parameters should be monitored every 2 weeks, and then monthly.In patients with hypertension who have a blood pressure level above 145/90 mm Hg in the presence of antihypertensive therapy. This control should be carried out particularly carefully and, if necessary, at shorter intervals. In patients in whom blood pressure twice exceeded the level of 145/90 mm Hg on repeated measurement. The treatment with Goldline should be suspended.
Special attention should be paid to the simultaneous administration of drugs that increase the QT interval. These drugs include blockers of histamine H1 receptors (astemizole, terfenadine), antiarrhythmic drugs that increase the QT interval (amiodarone, quinidine, flecainide, mexiletine, propafenone, sotalol), cisapride, pimozide, sertindole and tricyclic antidepressants. This also applies to conditions that can lead to an increase in the QT interval, such as hypokalemia and hypomagnesemia.
The interval between taking MAO inhibitors and Goldline preparation should be at least 2 weeks.
Although there is no relationship between the administration of Goldline and the development of primary pulmonary hypertension, however, given the generally known risk of drugs in this group,with regular medical supervision, special attention should be paid to symptoms such as progressive dyspnea, chest pain and swelling on the legs.
If you miss a dose of Goldline, do not take the next dose of a double dose of the drug, it is recommended to continue taking the drug on a prescribed schedule.
Duration of reception Goldlayn should not exceed 2 years.
Impact on the ability to drive vehicles and manage mechanisms
Taking Goldline can limit the ability to drive vehicles and manage mechanisms.
Drug Interactions
Inhibitors of microsomal oxidation, incl. inhibitors of the isoenzyme CYP3A4 (ketoconazole, erythromycin, cyclosporine), increase the plasma concentrations of sibutramine metabolites with increased heart rate and clinically insignificant increase in the QT interval.
Rifampicin, macrolide antibiotics, phenytoin, carbamazepine, Phenobarbital and Dexamethasone can accelerate the metabolism of sibutramine.
The simultaneous use of several drugs that increase serotonin levels in the blood can lead to the development of serious interaction.
Serotonin syndrome can develop in rare cases with simultaneous application of Goldline preparation with selective serotonin reuptake inhibitors (drugs for depression treatment), with some preparations for the treatment of migraine (sumatriptan, dihydroergotamine), with opioid analgesics (pentazocine, pethidine, fentanyl) or antitussive drugs (dextromethorphan).
Goldline does not affect the effect of oral contraceptives.
Drugs that increase blood pressure or heart rate (ephedrine, phenylpropanolamine, pseudoephedrine, as well as combined drugs for the treatment of colds containing these drugs) increase the risk of increased blood pressure and heart rate.
With the simultaneous administration of Goldline and alcohol, there was no increase in the negative effect of ethanol. However, alcohol is absolutely not compatible with the recommended dietary measures when taking sibutramine.
Analogues of the drug Goldline
Structural analogs for the active substance:
- Lindax;
- Meridia;
- Reduxine;
- Reduxin Light;
- Sibutramine;
- Slimia.
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