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DRUGS & SUPPLEMENTS
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Redumed
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Redumed uses
Redumed consists of L-Carnitine Tartrate, Sibutramine Hydrochloride Monohydrate.L-Carnitine Tartrate:
Constituent of striated muscle and liver. It is used therapeutically to stimulate gastric and pancreatic secretions and in the treatment of hyperlipoproteinemias.
Indication: For treatment of primary systemic carnitine deficiency, a genetic impairment of normal biosynthesis or utilization of levocarnitine from dietary sources, or for the treatment of secondary carnitine deficiency resulting from an inborn error of metabolism such as glutaric aciduria II, methyl malonic aciduria, propionic acidemia, and medium chain fatty acylCoA dehydrogenase deficiency. Used therapeutically to stimulate gastric and pancreatic secretions and in the treatment of hyperlipoproteinemias. Parenteral levocarnitine is indicated for the prevention and treatment of carnitine deficiency in patients with end-stage renal disease.
Levocarnitine is a carrier molecule in the transport of long chain fatty acids across the inner mitochondrial membrane. It also exports acyl groups from subcellular organelles and from cells to urine before they accumulate to toxic concentrations. Lack of carnitine can lead to liver, heart, and muscle problems. Carnitine deficiency is defined biochemically as abnormally low plasma concentrations of free carnitine, less than 20 µmol/L at one week post term and may be associated with low tissue and/or urine concentrations. Further, this condition may be associated with a plasma concentration ratio of acylcarnitine/levocarnitine greater than 0.4 or abnormally elevated concentrations of acylcarnitine in the urine. Only the L isomer of carnitine (sometimes called vitamin BT) affects lipid metabolism. The "vitamin BT" form actually contains D,L-carnitine, which competitively inhibits levocarnitine and can cause deficiency. Levocarnitine can be used therapeutically to stimulate gastric and pancreatic secretions and in the treatment of hyperlipoproteinemias.
Sibutramine Hydrochloride Monohydrate:
Pharmacological action
Redumed is an drug for the treatment of central action obesity. The mechanism of action is due to selective inhibition of serotonin reuptake of norepinephrine and, to a lesser extent, of dopamine. This medication accelerates the onset and prolong satiety, which leads to a decrease in food consumption. It increases energy expenditure by stimulating thermogenesis mediated by activation of beta3-adrenergic receptors. Acts on both sides of the balance of energy and helps reduce body weight.
Sibutramine and its metabolites did not release monoamines, and they are not MAO inhibitors, have no affinity for serotonergic, adrenergic, dopaminergic, muscarinic, histamine, benzodiazepine and NMDA receptors.
Pharmacokinetics
After oral administration Redumed (Sibutramine Hydrochloride Monohydrate) is rapidly absorbed from the gastrointestinal tract. Almost completely metabolized in the liver, with the participation of cytochrome isozymes CYP3A4, as well as by hydroxylation and conjugation to form inactive metabolites. Cmax of sibutramine is achieved in 1.2 h. This medicine is quickly and widely distributed in tissues. The plasma protein binding is 97%. T1/2 is 1.1 h. Redumed (Sibutramine Hydrochloride Monohydrate) derived primarily by the kidneys as inactive metabolites.
Why is Redumed prescribed?
As part of the supporting complex treatment of patients with overweight in alimentary obesity with a body mass index of 30 kg / m2 or more, with alimentary obesity with a body mass index of 27 kg / m2 or more in the presence of other risk factors due to overweight, including diabetes mellitus type 2 (insulin independent), or hyperlipidemia.
Dosage and administration
The initial dose is 10 mg / day. With lack of effectiveness when used in this dose and if tolerated the dose can be increased to 15 mg / day.
If no effect when Redumed (Sibutramine Hydrochloride Monohydrate) used in doses of 15 mg / day (weight loss less than 2 kg per 4 weeks), this drug should be discontinued.
In patients not adequately responding to treatment, that is who within 3 months can not reach the level of 5% weight loss from baseline, the duration of use this medication should not exceed 3 months.
The course of treatment is not more than 1 year since no data on efficacy and safety of longer use.
Do not use sibutramine, if after made weight loss achieved in the course of further therapy, the patient again adds to the weight of 3 kg or more.
Redumed (Sibutramine Hydrochloride Monohydrate) side effects, adverse reactions
Digestive system: frequently - anorexia, constipation, dry mouth, nausea, transient increases in liver enzymes.
CNS and peripheral nervous system: insomnia, headaches, dizziness, anxiety, paresthesia, increased sweating, change in taste, seizures; one patient with schizoaffective disorder, which presumably existed prior to initiating therapy with sibutramine after treatment developed acute psychosis.
Cardiovascular system: tachycardia, palpitations, increased blood pressure (moderate rise of blood pressure at rest of 1-3 mm Hg and a moderate increase in heart rate by 3-7 beats / min), vasodilation (flushing with a sensation of heat), exacerbation of hemorrhoids; in some cases - a more pronounced increase in blood pressure and heart rate acceleration.
Urinary system: in rare cases - acute interstitial nephritis, mesangiocapillary glomerulonephritis.
Blood coagulation system: thrombocytopenia, Henoch-Schonlein purpura.
Most often side effects occur early in therapy (the first 4 weeks), their severity and frequency of occurrence over time are weaken.
Redumed contraindications
Organic cause of obesity, well-known and established severe eating disorders (anorexia nervosa or bulimia nervosa), mental illness, Tourette syndrome, IBS, chronic heart failure in the stage of decompensation, congenital heart disease, occlusive peripheral artery disease, tachycardia, arrhythmias, cerebrovascular accident (including transient), uncontrolled hypertension (BP is more than 145/90 mm Hg), hyperthyroidism, severe renal dysfunction, severe hepatic dysfunction, benign prostatic hyperplasia with the formation of residual urine, pheochromocytoma, glaucoma, established pharmaceutical drug and alcohol abuse, pregnancy, lactation (breastfeeding), simultaneous taking or up to 2 weeks after discontinuation of MAO inhibitors or other drugs that have a dampening effect on the central nervous system (antidepressants, antipsychotics, tryptophan), or other medicines for weight loss, increased sensitivity to sibutramine.
Using during pregnancy and breastfeeding
Redumed is contraindicated during pregnancy and lactation (breastfeeding).
Women of childbearing age in the period of treatment should apply adequate methods of contraception.
Category of the fetus by FDA - C.
Special instructions
Use Redumed (Sibutramine Hydrochloride Monohydrate) only in cases where all activities are ineffective weight loss (when weight loss is less than 5 kg within 3 months).
Treatment should only be undertaken within the framework of the treatment of weight loss under medical supervision, which has practical experience in the treatment of obesity. Combined therapy includes both changes in diet and lifestyle and increased physical activity.
With caution use Redumed (Sibutramine Hydrochloride Monohydrate) in combination with drugs that increase the range of QT, in patients with hypokalemia and hypomagnesemia, epilepsy, impaired liver function with mild to moderate severity, with impaired renal function and mild to moderate severity, in patients with motor tics or family history of vocalism, simultaneously with drugs that increase blood pressure and heart rate (including medications used for coughs, colds and allergies).
Do not use in persons over 65 years due to lack of sufficient clinical experience with sibutramine in geriatrics.
Reactions to the cancellation of sibutramine (headache, increased appetite) are rare.
During the period of treatment you should not drink alcohol because of the need to diet.
Should not be used in children and adolescents under the age of 18 years due to lack of sufficient clinical experience with this category of patients.
There is currently no established effect on the ability of Redumed (Sibutramine Hydrochloride Monohydrate) to employment in potentially hazardous activities.
Redumed drug interactions
When this drug applied simultaneously with:
- drugs inhibiting isoenzyme CYP3A4 (ketoconazole, erythromycin, troleandomycin, cyclosporine) increased plasma concentrations of metabolites of sibutramine, slightly increased the interval of QT.
- rifampin, phenytoin, carbamazepine, phenobarbital, dexamethasone, macrolide antibiotics may accelerate the metabolism of this medication.
- selective serotonin reuptake inhibitors (citalopram, fluoxetine, paroxetine, sertraline), agonist 5-HT1-receptors, derivatives of ergot alkaloids, opioids, centrally acting antitussives increases the risk of serotonin syndrome.
Redumed in case of emergency / overdose
Symptoms: increased severity of side effects, most often - tachycardia, increased blood pressure, headache and dizziness.
Treatment: taking activated charcoal, symptomatic therapy, monitoring of vital functions, if an increase in blood pressure and tachycardia - a prescription of beta-blockers.
Redumed pharmaceutical active ingredients containing related brand and generic drugs:
Redumed available forms, composition, doses:
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.