Smartan

Company name: Memphis Co. for Pharm. & Chem. Ind.

Trade name: Smartan tablets

Generic name: Sibutramine hydrochloride

Composition:

Each tablet contains:
Sibutramine hydrochloride monohydrate        10 mg
Excipients:
Lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate.

Pharmaceutical form:
Tablets

Pharmacological actions:
Sibutramine produces its therapeutic effects by inhibition of norepinephrine, serotonin and dopamine reuptake.
Sibutramine produces its major pharmacological actions predominantly via its pharmacologically active metabolites (M1, M2).
Receptor binding profiles show that sibutramine, M1 and M2 have low affinity for serotonin, norepinephrine, dopamine receptors.

Pharmacokinetics:
Sibutramine is rapidly absorbed from GIT following oral administration and undergoes extensive first pass metabolism in the liver, to form the pharmacologically active metabolites (M1, M2).
Peak plasma concentrations of M1 and M2 are reached within 3 to 4 hours.
Sibutramine M1 and M2 are extensively bound to human plasma proteins.
Sibutramine is mainly excreted in urine and feaces.

Indications:
Smartan is indicated for the management of obesity (including weight loss and maintenance of weight loss).

Dosage and administration:

The recommended starting dose is 10 mg administered once daily with or without food.
If there is inadequate weight loss, the dose may be titrated after four weeks to reach a total of 15 mg once daily.

Contraindications:
Smartan tablets are contraindicated in the following cases:
- Patients receiving monoamine oxidase inhibitors.
- Patients with hypersensitivity to sibutramine.
- Patients taking other centrally acting appetite suppressant drugs.

Side effects:
The most common side effects include dry mouth, anorexia, insomnia, constipation, peripheral edema, agitation and pruritus.

Drug interactions:
- Smartan should not be used concomitantly with MAO inhibitors at least 2 weeks should elapse between discontinuation of a MAOI and initiation of treatment with smartan.

- Rare but serious interaction may occur with sumatriptan and dihydroergotamine and dextromethorphan.

- Smartan should not be administered with serotonergic agents such as fluoxetine and sertraline.

Pregnancy and lactation:
Smartan is not recommended for use in pregnancy and lactation.

Warnings and precautions:

- Smartan increases blood pressure in some patients, so Patients should be reminded of the importance of having their blood pressure and pulse monitored at regular intervals.
- Smartan should be used with caution in patients with narrow angle glaucoma or with a history of seizures and discontinued in any patient who develops seizures.
- Weight loss can precipitate or exacerbate gallstone formation.

Overdosage:
The most frequently noted adverse events associated by overdose are: tachycardia, hypertension, headache and dizziness.
Management of overdosage: an airway should be established; cardiac and vital sign monitoring is recommended, general symptomatic and supportive measures should be instituted. Cautious use of ß blockers may be indicated to control elevated blood pressure or tachycardia.

Therapeutic category: Appetite suppressant.

Legal category:
POM.

Package:

Storage:

 

THIS IS A MEDICAMENT
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 the experts in medicines, their benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed.
- Do not repeat the same prescription without consulting your doctor.
- Keep all medicaments out of reach of children.

Council of Arab Health Ministers, Union of Arab Pharmacists.