Odistad 120 Stella treats obesity and prevents weight gain in adults (2 blisters x 21 tablets)

Dosage form Hard capsules
Specifications Box of 2 blisters x 21 tablets
Ingredient Orlistat

Ingredient

Composition information	Content
Orlistat	120mg

Uses

indications

What effect does Odistad 120 have?

Obesity treatment and prevent weight gain again by combining with a calorie mitigation diet in patients with body mass index (BMI) ≥ 30 kg/m2 or overweight patient (BMI ≥ 28 kg/m2) with risk factors (such as hypertension, diabetes, hyperlipidemia). reversible lipase.

The drug shows the therapeutic activity in the stomach and small intestine by creating a covalent bond at the serin position of the stomach and pancreatic lipase.

Enzyme inactivity should lose the ability to hydrolyze fat in food in the form of triglycerides into free fatty acids and absorbing monoglycerides.

Non -digested triglycerides are not absorbed, the results of calories deficiency, have a positive effect in controlling weight.

In the treatment dose of 120 mg x 3 times/day, Orlistat inhibits the absorption of fat in food about 30%.

The effect of Orlistate causes increased fat in stools from 24 to 48 hours after drinking. When stopped, the amount of fat in the stool is back before treatment, usually within 48 - 72 hours.

Dynamic pharmacokinetics

absorption

The absorption of Orlistat is very little.

The intact concentration in the plasma of the orlistate is not measured (

In general, at the treatment dose, it is difficult to detect orlistat in plasma and the concentration is also very low (

distribution

There is no determination of the distribution volume because the drug is absorbed very little and therefore the body kinetics cannot be determined.

On Vitro, Orlistat is connected to more than 99% of plasma proteins (mainly lipoprotein and albumin). A small amount of orlistat attached to red blood cells.

transformation

In obesity patients, the small part of the absorbed dose, converted into two main metabolites: M1 (hydrolyzed in 4 -branch lacton ring) and M3 (M1 with the N - Formyl Leucin part being separated), accounting for about 42% of the total drug concentration in plasma.

Two metabolites M1 and M3 have opened beta-lacton ring and very weak lipase inhibitors (less than the activity of orlistat 1000 times with M1 and 2500 times with M3).

In terms of weak inhibition and low plasma concentrations at the treatment dose (M1 has an average concentration of 26 ng/ml and M3 has an average concentration of 108 ng/mL), it can be seen that these metabolites do not have an important pharmacological effect.

Elimination

About 97% of the oral oral medications are eliminated in feces and among them is about 83% in the form of primitive orlistate.

All accumulated orlistat amounts are only discharged through the kidney

Orlistat's distribution between people can be normal and equivalent. Orlistat, M1 and M3 are excreted through the honey.

Before taking Odistad 120 Stella treats obesity and prevents weight gain in adults (2 blisters x 21 tablets)

How to use

Odistad 120 should take medicine with water right before, while eating or until 1 hour after each main meal. If you miss a meal or a non -fat meal, there is no need to use Orlistat.

Dosage more than 3 times/day does not increase benefits. If the patient cannot lose weight after 12 weeks of treatment with Orlistat, consult a doctor or pharmacist. If needed can stop treatment. .

Diet and exercise are important parts of the weight loss program.

Recommendations to start the diet and exercise program before starting treatment with Orlistat.

Patients should follow a nutritional balance and mitigate calories, containing about 30% calories from fat. The amount of fat, carbohydrate and protein should be distributed daily at 3 main meals.

Should continue the diet and exercise program after stopping treatment with Orlistat. Safety and effectiveness of drugs for more than 4 years have not been evaluated.

Dosage

Dosage in case of obesity treatment and weight gain back:

Adults: 1 tablet 120 mg x 3 times/day at each main meal with fat.

The effect of Orlistat on people with liver failure and/or kidney failure has not been studied. However, because Orlistat is absorbed very little, there is no need to adjust the dose in the elderly and people with liver and/ or kidney failure.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose?

In case of overdose orlistat, patients should be monitored for 24 hours. The whole body effect is related to the lipase inhibitors of Orlistat should be recovered quickly.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

Unwanted effects when using Odistad 120 that you may encounter.

Common, ADR> 1/100

Body: flu, fatigue.

Metabolism: hypoglycemia.

Neurology: Anxiety, headache.

Respiratory: upper and lower respiratory infections.

Digestive: uncomfortable/ abdominal pain, mucus in the rectum, medium, acute diarrhea, fat stool, flatulence, loose stool, fat bowel movement, increased defecation. Uncomfortable/ rectal pain, soft stools, uncontrolled bowel movements, bloating, dental disorders and gums.

Kidney and urinary: Urinary tract infections.

Reproduction: irregular menstruation.

rarely, 1/1000

No report.

Unknown frequency

Gastrointestinal: Rectal bleeding, appendicitis, pancreatitis.

Kidney and urinary: Oxalate kidney disease can lead to kidney failure.

Immune: Hypersensitivity reactions (itching, rash, urticaria, angioedema, bronchospasm and anaphylactic reaction).

Liver: gallstones, serious hepatitis (can die or have liver transplant).

Skin and subcutaneous tissue: blisters.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using Odistad 120 you need to read the instructions carefully and refer to the information below.

Contraindicated

Odistad 120 contraindications in the following cases:

Hypersensitivity to orlistat or any ingredient of the drug.

Chronic or cholestiasis syndrome.

Simultaneous treatment with cyclosporin.

Pregnant and lactating women.

Simultaneous treatment with warfarin or other oral anticoagulants.

Be cautious when using

need to be very careful when taking the drug for patients in the following cases:

Symptoms of gastrointestinal tract:

Patients should have an appropriate diet. The likelihood of gastrointestinal disorders can occur during orlistat treatment with individual meals or rich in fat.

oil -soluble vitamins:

When treated with Orlistat, it can reduce the absorption of oil -soluble vitamins (A, D, E and K).

Diabetes medicine:

Because weight loss may come with improved metabolic control in diabetes, patients who are being treated with diabetes drug should consult a doctor before starting treatment with orlistat, in case of necessity can adjust the dose of diabetes.

Hypertension or hypertension drugs:

Weight loss may be accompanied by improving hypertension and blood cholesterol level.

amiodaron:

Patients who are being treated with amiodaron should consult a doctor before starting treatment with Orlistat.

Rectal bleeding:

Rectal bleeding is reported in patients using Orlistat.

If this happens, the patient should consult a doctor.

Oral contraceptive pills:

Recommended the use of supplementary contraception to prevent the possible failure of oral contraceptive pills, in case of severe diarrhea.

Kidney disease:

Patients with kidney disease should consult a doctor before treatment with orlistat.

levothyroxin:

Impaired thyroid impairment and/or reducing control of thyroid impairment may occur when used in combination with orlistat and levothyroxin.

Anti -epileptic drugs:

Patients who are being treated with anti -epileptic drugs, should consult a doctor before starting treatment with Orlistat, need to monitor the frequency and severity of seizures.

antiviral drugs HIV:

Patients should consult a doctor before using simultaneously orlistat with antiviral drugs HIV.

Odistad 120 contains lactose:

Do not use this medication for patients with rare genetic problems galactose intolerance, total lactase enzyme deficiency or poorly absorbent glucose-galactose.

The ability to drive and operate machinery

orlistat does not affect the ability to drive and operate machinery.

During pregnancy

no complete and strict studies on the use of orlistat in pregnant women. The recommendation does not use orlistat during pregnancy.

Breastfeeding period

It is unknown whether oral orlistat is distributed into breast milk or not. Therefore, Orlistat is not used for breastfeeding women.

Drug interaction

ciclosporin: A study of drug interaction has seen a decrease in plasma concentrations of ciclosporin when using orlistat with ciclosporin.

Acarbose: There is no pharmacokinetic interaction research, so avoid simultaneous use of orlistat with acarbose.

Oral anticoagulant: When using simultaneously Warfarin or other anticoagulants along with Orlistat, should monitor the international standardized ratio (INR).

Oil -soluble vitamins: Treatment with orlistat has the ability to reduce the absorption of oil -soluble vitamins (A, D, E and K).

levothyroxin: Reducing thyroid function has been reported in patients using simultaneous orlistat and levothyroxin. Should monitor changes in thyroid function in patients who use simultaneous orlistat and levothyroxin. Should use levothyroxin and orlistat at least 4 hours apart.

Amiodaron: Reducing amiodaron's plasma concentrations, when used simultaneously with the only dose of orlistate: the clinical related of this effect in patients treated with amiodaron is not known. Patients who are taking amiodaron should consult a doctor before starting treatment with Orlistat. Amiodaron dose may need to be adjusted during treatment with Orlistat.

Anti -epileptic drugs: Convulsions have been reported in patients who use simultaneously orlistat with anti -epileptic drugs such as Valproat, Lamotrigin, which does not rule out the cause of drug interaction. Orlistat reduces the absorption of anti -epileptic drugs, leading to convulsions.

Oral contraceptives: Lack of research data on interaction between birth control pills and Orlistat. However, Orlistat can reduce the effects of birth control pills, in a few cases that can lead to unwanted pregnancy. Some additional methods of contraception should be used in case of severe diarrhea when using this drug.

HIV Retrovirus, antidepressants, psychotic drugs and benzodiazepin: reduces the effectiveness of HIV Retrovirus anti -Retrovirus, antidepressants, psychotic drugs (including lithium) and benzodiazepines that have been reported when used with orlistate in well -controlled patients before. So start treating with Orlistat, after careful consideration, the effect may be in these patients.

Storage

Store in closed packaging, dry place. The temperature does not exceed 30 ° C.

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