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Goldline® PLUS 15mg 60caps (sibutramine to weight loss)

Obesity treatment based on sibutramine hydrochloride monohydrate and microcrystalline cellulose.

Release form: capsules 15 мг + 153,5 мг, 60pcs

Base price: 199,00 €
199,00 €
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Description

Goldline® PLUS is indicated for weight loss in the following conditions: - nutritional obesity with a body mass index (BMI) of 30 kg/m2 or more; - nutritional obesity with a body mass index of 27 km/m2 or more in combination with type 2 diabetes mellitus and dyslipidemia.

Dosage form:

Hard gelatin capsules No. 2, the capsule body is yellow, the cap is blue. The contents of the capsule are powder or compacted powder mass of white or almost white color.

Compound:

1 capsule 15mg + 153.5 mg contains:

Active ingredients: sibutramine hydrochloride monohydrate - 15.0 mg, microcrystalline cellulose - 153.5 mg.
Excipients: colloidal silicon dioxide - 2.0 mg, calcium stearate - 1.5 mg.
Composition of the capsule cap: azorubine dye (E122) - 0.057%; indigo carmine (E132) - 0.3079%; sodium lauryl sulfate - 0.08%; titanium dioxide - 1.00%; gelatin - up to 100%.
Composition of the capsule body: sunset yellow dye (E110) - 0.0027%; yellow quinoline dye (E104) - 0.9193%; sodium lauryl sulfate - 0.08%; titanium dioxide - 2.00%; gelatin - up to 100%.

Pharmacotherapeutic group: obesity treatment

Pharmacodynamics:

Goldline® PLUS is a combination drug, the effect of which is determined by the components included in its composition. Sibutramine is a prodrug and exhibits its effect in vivo due to metabolites (primary and secondary amines) that inhibit the reuptake of monoamines (serotonin, norepinephrine, dopamine). An increase in the content of neurotransmitters in synapses increases the activity of central 5HT-serotonin and adrenergic receptors, which increases the feeling of satiety and reduces the need for food, as well as an increase in thermal production. By indirectly activating beta3-adrenergic receptors, sibutramine acts on brown adipose tissue. A decrease in body weight is accompanied by an increase in plasma concentrations of high-density lipoproteins (HDL) and a decrease in the amount of triglycerides, total cholesterol, low-density lipoproteins (LDL) and uric acid. Sibutramine and its metabolites do not affect the release of monoamines and do not inhibit monoamine oxidase (MAO); have low affinity for a large number of neurotransmitter receptors, including serotonin
(5-HT1, 5-HT1A, 5-HT1B, 5-HT2C), adrenergic (beta1, beta2, beta3, alpha1, alpha2), dopamine (Dl, D2), muscarinic, histamine (H1), benzodiazepine and glutamate (NMDA ) receptors. Microcrystalline cellulose is an enterosorbent, has sorption properties and a nonspecific detoxification effect. Binds and removes from the body various microorganisms, their metabolic products, toxins of exogenous and endogenous nature, allergens, xenobiotics, as well as an excess of certain metabolic products and metabolites responsible for the development of endogenous toxicosis.

Pharmacokinetics:

SUCTION
After oral administration, it is quickly absorbed from the gastrointestinal tract (GIT) by at least 77%. During the “primary passage” through the liver, it undergoes biotransformation under the influence of the CYP3A4 isoenzyme with the formation of two active metabolites (monodesmethylsibutramine (M1) and didesmethylsibutramine (M2)). After taking a single dose of 15 mg, the maximum plasma concentration (Cmax) of M1 is 4 ng/ml (3.2-4.8 ng/ml), M2 - 6.4 ng/ml (5.6-7.2 ng /ml). Cmax is achieved after 1.2 hours (sibutramine), 3-4 hours (M1 and M2). Simultaneous food intake reduces the Cmax of metabolites by 30% and increases the time to reach it by 3 hours, without changing the area of the concentration-time curve (AUC).
DISTRIBUTION
Quickly distributed throughout tissues. Protein binding is 97% (sibutramine) and 94% (M1 and M2). The equilibrium concentration of active metabolites in the blood plasma is achieved within 4 days after the start of use and is approximately 2 times higher than the concentration in the blood plasma after taking a single dose.
METABOLISM AND EXCRETION
Active metabolites undergo hydroxylation and conjugation to form inactive metabolites, which are excreted primarily by the kidneys. The half-life of sibutramine is 1.1 hours, M1 - 14 hours, M2 - 16 hours.
Pharmacokinetics in special clinical situations
The limited data currently available do not indicate the existence of clinically significant differences in pharmacokinetics between men and women.
Pharmacokinetics in elderly healthy individuals (average age 70 years) are similar to those in young people.
Kidney failure
Renal impairment has no effect on the AUC of the active metabolites M1 and M2, except for the M2 metabolite in patients with end-stage renal disease on dialysis.
Liver failure
In patients with moderate hepatic impairment, after a single dose of sibutramine, the AUC of active metabolites M1 and M2 is 24% higher than in healthy individuals.

Indications:

Goldline® PLUS is indicated for weight loss in the following conditions:
- nutritional obesity with a body mass index (BMI) of 30 kg/m2 or more;
- nutritional obesity with a body mass index of 27 km/m2 or more in combination with type 2 diabetes mellitus and dyslipidemia.

 Contraindications:

- established hypersensitivity to sibutramine or other components of the drug;
- presence of organic causes of obesity (for example, hypothyroidism);
- serious eating disorders - anorexia nervosa or bulimia nervosa;
- mental illness;
- Gilles de la Tourette syndrome (generalized tics);
- simultaneous use of MAO inhibitors (for example, phentermine, fenfluramine, dexfenfluramine, ethylamphetamine, ephedrine) or use within 2 weeks before taking the drug Goldline® PLUS and 2 weeks after the end of its use of other drugs acting on the central nervous system, inhibitors of serotonin reuptake (for example, antidepressants, antipsychotics); sleeping pills containing tryptophan, as well as other centrally acting drugs for weight loss or for the treatment of mental disorders;
- cardiovascular diseases (history or current): coronary heart disease (myocardial infarction (MI), angina pectoris); chronic heart failure in the stage of decompensation, occlusive diseases of peripheral arteries, tachycardia, arrhythmia, cerebrovascular diseases (stroke, transient cerebrovascular accidents);
- uncontrolled arterial hypertension (blood pressure (BP) is higher
145/90 mmHg);
- angle-closure glaucoma;
- thyrotoxicosis;
- severe dysfunction of the liver and/or kidneys;
- benign prostatic hyperplasia;
- pheochromocytoma;
- established pharmacological, drug or alcohol dependence;
- pregnancy and breastfeeding;
- age under 18 and over 65 years.
The drug should be prescribed with caution in the following conditions: a history of arrhythmias, chronic circulatory failure, coronary artery diseases (including a history), except for coronary heart disease (MI, angina); glaucoma, except for angle-closure glaucoma, cholelithiasis, arterial hypertension (controlled and with a history), neurological disorders, including mental retardation and seizures (including a history), epilepsy, impaired liver and/or kidney function of mild to moderate severity , a history of motor and verbal tics, a tendency to bleeding, bleeding disorders, taking drugs that affect hemostasis or platelet function.
Use during pregnancy and breastfeeding
Since to date there is not a sufficiently large number of studies regarding the safety of the effects of sibutramine on the fetus, this drug is contraindicated during pregnancy. Women of reproductive age should use contraception while taking Goldline® PLUS.
It is contraindicated to take Goldline® PLUS while breastfeeding.

Directions for use and dosage:

Goldline® PLUS is taken orally once a day. The dose is set individually, depending on tolerability and clinical effectiveness.
The recommended starting dose of sibutramine is 10 mg/day. Capsules should be taken in the morning, without chewing and with a sufficient amount of liquid (a glass of water). The drug can be taken on an empty stomach or combined with meals. If within 4 weeks from the start of treatment a reduction in body weight of less than 2 kg is not achieved, then the dose of sibutramine is increased to 15 mg/day. Treatment with Goldline® PLUS should not continue for more than 3 months in patients who do not respond well to therapy, i.e. who fail to achieve a 5% reduction in body weight from the initial value within 3 months of treatment. Treatment should not be continued if, with further therapy, after achieving a reduction in body weight, the patient again gains 3 kg or more in body weight. The duration of treatment should not exceed 1 year, since there are no data on efficacy and safety for a longer period of taking sibutramine.
Treatment with Goldline® PLUS should be carried out in combination with diet and exercise under the supervision of a physician with practical experience in the treatment of obesity.

Release form: capsules 15 мг + 153,5 мг, 60pcs

DETAILED PRODUCT DESCRIPTION ON REQUEST.

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Guaranteed authenticity and quality:

100% Original from IZVARINO PHARMA (Russian Federation)

IZVARINO PHARMA is a Russian pharmaceutical company focused on the development and production of medicines used in various fields of medicine (obstetrics and gynecology, endocrinology, transplantology, cardiology, neurology, etc.) Today, the company’s portfolio includes more than 40 drugs. All products, in addition to mandatory registration and certification, have proven effectiveness and long-term successful experience of use. Among branded generics, one can distinguish a group of drugs with improved consumer properties, which belong to the “generic+” class.
The area of the enterprise is 3 hectares, on which two buildings are located. One of them is a complex of production, laboratory and office areas, the second is a warehouse for finished products.
The area of the complex is 6200 sq.m., which allows for a full production cycle of solid dosage forms - granulation and creation of mixtures, tableting and encapsulation, coating, primary and secondary packaging, analysis and quality control, storage, distribution and logistics, research and analytical work.
As a result of modernization, the company was able to increase production capacity, and currently the production volume is 12 million packages per year.

Development and production:

IZVARINO PHARMA (Russian Federation)

At all stages of drug production, Izvarino Pharma constantly follows modern principles of quality management. These are, first of all, GMP (Good Manufacturing Practice) standards. Since its founding, Izvarino Pharma has constantly pursued a policy of introducing, maintaining and improving the quality management system. Strict quality control allows us to be sure that the medicinal products produced by Izvarino Pharma provide Russian patients with the European level of healthcare.

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