Orlistat capsules. 60 mg 42 pcs

$13.74

Orlistat capsules. 60 mg 42 pcs

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Description

Composition
Active substance:
1 capsule contains: Orlistat – 60.00 ;.
Excipients:
Microcrystalline cellulose – 28.55; Sodium carboxymethyl – 20.75; colloidal silicon dioxide – 4.55; Sodium lauryl sulfate – 1.15; capsule shell: hard gelatin capsule № 3 (Gelatin – 47.01; titanium dioxide (E171) – 0.96; indigo carmine (E132) – 0.03).
Description:
Hard gelatin capsules are light blue. Capsule size №3. The contents of the capsule is a white powder or lightly compressed agglomerates.
Product form:
Capsules of 60 mg.
At 14 or 15 capsules per blister foil Al / PVC / PVDC. 3 blisters 14 capsules or blisters 4 to 15 capsules or blisters 6 to 14 capsules or blisters 6 to 15 capsules (42 or 60 or 84 or 90 capsules, respectively), together with instructions for use placed in a cardboard box.
Contraindications
Hypersensitivity to any component of the drug;
chronic malabsorption syndrome;
cholestasis;
Concomitant therapy with warfarin or other oral anticoagulants;
Concomitant therapy with cyclosporine;
During pregnancy and lactation;
Children up to age 18 years.
Dosage
60 mg
Indications
Reduction of overweight (BMI> 28 kg / m2) when used in conjunction with a hypocaloric diet moderately low in fat.
Interaction with other drugs
With simultaneous use of orlistat and cyclosporine may decrease the concentration of cyclosporine in the blood plasma, and therefore the need to monitor the content of the cyclosporin in the blood plasma. The simultaneous use of orlistat and cyclosporine contraindicated.
With simultaneous use of orlistat with amiodarone recommended clinical observation and ECG monitoring, since it is possible decrease the amiodarone concentration in blood plasma.
At the same time taking orlistat and warfarin or other anticoagulants may experience a decrease in the concentration of prothrombin time and INR increase, which leads to changes in hemostatic parameters. Concomitant use of orlistat and warfarin or other oral anticoagulants is contraindicated.
Orlistat can reduce the absorption of fat-soluble vitamins A, D, E, K and beta-carotene. If multivitamin shown, they should be taken no earlier than after 2 hours after administration of orlistat or at bedtime.
Orlistat can reduce the absorption of antiepileptic drugs, which may lead to occurrence of seizures.
Orlistat can reduce the absorption of anti-retroviral drugs to treat HIV and adversely affect their efficiency. In case of receiving antiretroviral therapy should consult a physician before taking the drug.
In the absence of pharmacokinetic interaction studies, concomitant administration of orlistat and acarbose should be avoided.
In some cases, orlistat may indirectly reduce the bioavailability of oral contraceptives. In the case of severe diarrhea it is recommended to use an additional method of contraception.
Together with the admission levothyroxine sodium, due to the reduced intake of inorganic iodine and / or sodium levothyroxine may develop hypothyroidism and / or reduced control of hypothyroidism.
There were no drug interactions c amitriptyline, atorvastatin, biguanides, digoxin, fibrates, fluoxetine, losartan, phenytoin, phentermine, pravastatin, nifedipine, sibutramine and ethanol.
Overdose
In subjects with normal body weight and obesity receiving a single dose of orlistat (800 mg) and multiple (up to 400 mg of orlistat three times daily for 15 days) did not cause adverse effects. In addition, obese patients receiving orlistat 240 mg 3 times a day for 6 months, was not accompanied by increased adverse events.
In most reported cases of overdoses orlistat noted that no undesirable reactions or undesired reactions were similar to those observed when applying the recommended doses of orlistat.
In case of significant overdose of orlistat recommended observation of the patient for 24 hours. According to preclinical and clinical studies, systemic effects associated with lipazingibiruyuschimi properties of orlistat should be rapidly reversible.
pharmachologic effect
Pharmacological group:
Lipase inhibitor of the gastrointestinal tract.
Pharmacodynamics:
Orlistat – a specific inhibitor of gastrointestinal lipases long-acting. It acts in the lumen of the stomach and small intestine by forming a covalent bond with the active serine site of gastric and pancreatic lipases. The inactivated enzyme is not able to cleave the food fats coming in the form of triglycerides, to absorbable free fatty acids and monoglycerides. Undigested triglycerides are not absorbed, and therefore, decreases the intake of calories in the body, leading to a decrease in body weight. The therapeutic effect of the drug is carried out without absorption into the systemic circulation. Increases concentration of fat in the feces 24-48 h after administration. It ensures effective control of body weight, reducing fat depot.
In adults with a body mass index (BMI)> 28 kg / m2 orlistat at a dose of 60 mg three times a day is effective in conjunction with hypocaloric diet low in fat. In this case, the main body weight loss occurs during the first 6 months of treatment.
Weight loss due to the use of orlistat at a dose of 60 mg three times a day and is accompanied by other beneficial effects: a decrease in total cholesterol concentration, LDL cholesterol, and decrease in waist circumference.
Pharmacokinetics:
Suction
Absorption – low. After 8 hours after the ingestion of therapeutic doses of unmodified orlistat plasma practically determined (concentration
Distribution
The volume of distribution can not be installed because orlistat is practically not absorbed and does not have the system installed pharmacokinetics. Orlistat is more than 99% protein bound in vitro blood plasma (mainly with lipoproteins and albumin). Orlistat in minimum quantities may penetrate into erythrocytes.
Metabolism
Metabolism orlistat is performed mainly in the intestinal wall to form pharmacologically inactive metabolites: M1 (four membered lactone ring hydrolysed) and M3 (M1 cleaved residue N-formilleytsina).
breeding
The main route of elimination is the excretion through the intestine – about 97% of the dose, 83% of them in the form of unchanged orlistat. Total renal excretion of metabolites of orlistat
Pregnancy and breast-feeding
Preclinical studies have not revealed teratogenic and embryotoxic effects of orlistat. However, due to the lack of clinical data on the use in pregnant women, orlistat is contraindicated during pregnancy.
Since it is not known whether orlistat passes into breast milk, it is contraindicated during breast-feeding.
Conditions of supply of pharmacies
Without recipe.
side effects
Adverse events were noted when taking orlistat mainly from the gastrointestinal tract and were driven by higher amounts of fat in the feces.
During prolonged treatment with orlistat number of adverse events is reduced.
The following side effects are according to the following gradation frequency of occurrence: very often (> 1/10); common (> 1/100, 000 1/1, 1/10, 000,
On the part of the gastrointestinal tract. Very common: oily discharge from the rectum; gases with an amount of discharge; urgency to defecate; steatorrhea; flatulence; unformed stool. Common: abdominal pain; fecal incontinence; diarrhea; increased frequency of bowel movements.
Other. Common: anxiety.
Below are the side effects registered in post-marketing period (the frequency is unknown):
On the part of the gastrointestinal tract: a slight bleeding from the rectum; diverticulitis; pancreatitis.
The kidneys and the urinary tract: hyperoxaluria, oxalate nephropathy, which can sometimes lead to renal failure.
Of the liver and biliary tract: increased activity of “liver” transaminases and alkaline phosphatase, hepatitis, cholelithiasis.
Other: reducing the concentration of prothrombin, increased international normalized ratio (INR) in patients taking orlistat in conjunction with anticoagulants; bullous rash; hypersensitivity reactions (itching, rash, urticaria, angioneurotic edema, bronchospasm, and anaphylaxis).
special instructions
Orlistat is used for long-term control of body weight (weight loss, maintaining it at the appropriate level and preventing re weight gain).
By reducing weight in patients receiving orlistat may improve carbohydrate metabolism in patients with type 2 diabetes, which may allow to reduce the dose of hypoglycemic drugs.
The patient must be in a balanced moderately low calorie diet containing no more than 30% of calories as fat. It is recommended that such a diet was rich in fruits and vegetables. The daily intake of fat should be distributed between the three main meals. A diet low in fat reduces the likelihood of adverse effects from the gastrointestinal tract.
If after 12 weeks of treatment did not occur weight loss of at least 5%, taking orlistat should be discontinued.
Treatment should not last more than 2 years.
When symptoms such as weakness, fatigue, fever, jaundice and dark urine, need to consult with a physician to exclude abnormal liver function.
The use of orlistat may be associated with hyperoxaluria and oxalate nephropathy, which sometimes leads to kidney failure. Increased risk are patients with underlying chronic kidney disease and / or dehydration.
According to literature data and post-marketing experience application, orlistat may reduce the absorption of anti-retroviral drugs to treat HIV and adversely affect their efficiency.
Impact on the ability to drive vehicles and operate machinery
It does not reveal any negative effect of orlistat on the ability to drive vehicles and mechanisms.
Storage conditions
The original package to protect from light at a temperature not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
Inside, with water, at the recommended dose of 60 mg before each main meal, together with food or not later than one hour after ingestion. If you miss a meal or the meal contains no fat, orlistat also be skipped.
Within 24 hours, should not take more than 3 capsules of 60 mg.
If after 12 weeks of treatment did not occur weight loss, orlistat should be discontinued. Treatment should not exceed 6 months.
In elderly patients, patients with impaired liver and kidney function dose adjustment is required.
Orlistat should not be used in children and adolescents under 18 years of age due to lack of safety and efficacy data.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

QUINACRINE INN

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