COMPOSITION :
Each capsule contains : Orlistat USP 120 mg. DESCRIPTION :
Smart Look (Orlistat) is a potent, specific and long-acting lipase inhibitor. It exerts its therapeutic activity in the lumen of the stomach and upper small intestine by forming a covalent bond with the active serine site of gastric and pancreatic lipases. These effect lead to prevention of hydrolysis of dietary fats in the form of triglycerides into absorbable free fatty acids and monoglyceride. Therefore systemic absorption of Orlistat is not needed for activity. In vitro, more than 99% of Orlistat is bound to plasma proteins. The metabolism of Orlistat occurs mainly within the gastrointestinal wall then approximately 97% of the administered dose is excreted in feces. The excretion is completed within 3 - 5 days.
INDICATIONS :
Smart Look is indicated in the treatment of obese patients and overweight patients associated with risk factors such as type II diabetes, hyperlipidemia and hypertension in conjunction with a mildly hypocaloric diet.
Treatment with Orlistat in nondiabetic patients should be started only if diet alone has previously produced a weight loss of at least 2.5 kg over a period of 4 weeks.
DOSAGE & ADMINISTRATION :
The recommended dose of Smart look is one capsule (120 mg) to be taken immediately before, during or up to one hour after each main meal.
- If a meal is missed or contains no fat the dose of Orlistat should be omitted.
- The patient should be on a nutritionally balanced, mildly hypocaloric diet in which approximately 30% of the calories are from fat. The diet should be rich in fruit and vegetables and the daily intake of fat, carbohydrate, and protein should be distributed between three main meals.
- The duration of treatment with Orlistat should not exceed 2 years.
- Treatment with Orlistat should be discontinued after 12 weeks in patients who have not lost at least 5% of their body weight as measured at the start of drug therapy.
- Orlistat is not intended for the treatment of children.
RESTRICTIONS ON USE : Contraindications
- Patients who are sensitive to Orlistat.
- Patients with chronic malabsorption syndrome or patients with cholestasis. Precautions
- The tolerability and efficacy of Orlistat have not been studied in children under 18 years of age, elderly patients or patients with hepatic and / or renal impairment.
- The probability of occurrence of gastrointestinal side effects may increase when Orlistat is taken with a fatty meal. Use in pregnancy and lactation No clinical data are available on pregnancies exposed to Orlistat. It should not be used during breast feeding.
DRUG INTERACTIONS :
- Antidiabetic drug treatment should be closely monitored during Orlistat therapy.
- If Orlistat co-administered with Cyclosporine A plasma concentration of Cyclosporine A should be closely monitored when used with Orlistat and an interval of three hours between ingestion of Orlistat and Cyclosporine A is recommended.
- Concomitant administration of Orlistat with Acarbose, Thiazolidinediones (Glitazones), Glinides or anorectic drugs is not recommended.
- When anticoagulants are given in combination with Orlistat ( in high dose or long term therapy) international normalized ratio (INR) values should be monitored.
- A therapeutic effect of Amiodarone may reduced when used during Orlistat treatment.
- Hormonal contraceptive failure may occur in the event of severe diarrhea with Orlistat and patients are advised to use an additional contraceptive method.
- If a multivitamin supplement is recommended, it should be taken at least 2 hours after the ingestion of Orlistat or at bed time.
ADVERSE EFFECTS :
The main adverse reactions of Orlistat are in gastrointestinal and the incidence of events decreased with prolonged use of Orlistat.
- The common side effects are oily spotting from the rectum, flatulence, fecal urgency, oily or fatty stool, increased defecation and fecal incontinence. The higher fat content diet,
the higher in the incidence of these undesirable effects. Abdominal pain and watery stool can also occur.
- Rare cases of hypersensitivity have been reported such as pruritus, rash, urticaria, angioedema and anaphylaxis.
- Other side effects are anxiety, headache, upper and lower respiratory tract infections, abdominal pain / discomfort, flatulence, rectal pain, tooth and gingival disorders, urinary tract infection, irregularity of menstruation and fatigue.
- Hypoglycemia and feeling of abdominal tightness may appear in type II diabetic patients.
OVERDOSAGE :
Doses above recommended dose of (120 mg) three times daily do not lead to any apprecia- ble increase in effect and may increase gastrointestinal side effects. If a significant overdose of Orlistat occur, it is recommended that the patient should be observed for 24 hours and any systemic effects attributable to the lipas-inhibiting properties of Orlistat should be rapidly reversible.
STORAGE INSTRUCTIONS :
Store below 25°C. Protect from moisture.
PRESENTATIONS :
Smart Look capsules : Pack of 30 capsules and hospital packs of different sizes.
INSTRUCTIONS TO THE PATIENT
- Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you.
- Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are experts in medicine, its benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed for you.
- Do not repeat the same prescription without consulting your doctor.
Keep medicament out of reach of children Mfd. By
P.O. Box : 4265 Sana’a /Yemen.
Council of Arab Health Ministers Union of Arab Pharmacists
012-06-098 3/14