MERIDIA (sibutramine hydrochloride monohydrate) Capsules contain 5 mg, 10 mg, or 15 mg of sibutramine hydrochloride monohydrate and are supplied as follows :

- 5 mg, blue/yellow capsules imprinted with "MERIDIA" on the cap and "-5-" on the body, in bottles of 100 capsules.
- 10 mg, blue/white capsules imprinted with "MERIDIA" on the cap and "-10-" on the body, in bottles of 100 capsules.
- 15 mg, yellow/white capsules imprinted with "MERIDIA" on the cap and "-15-" on the body, in bottles of 100 capsules.

HOW DOES MERIDIA WORK?

Drugs of this class are thought to suppress appetite by inhibiting the reuptake of serotonin, dopamine and norepiniphrine thereby modifying appetite centers in the brain.

HOW TO TAKE MERIDIA :

The recommended starting dose of MERIDIA is 10-milligrams administered once daily with or without food. If there is inadequate weight loss, the dose may be titrated after 4 weeks to a total of 15-milligrams taken once daily. The 5-milligram dose should be reserved for those patients that do not tolerate the 10-milligram dose. Blood pressure and heart rate changes should betaken into consideration when making decisions regarding dose titration. Take this medication as prescribed. Do not take it more often or longer than directed. Use in combination with other appetite suppressant medicine is generally not recommended.

HOW EFFECTIVE IS MERIDIA?

Patients treated with MERIDIA while on a reduced calorie diet showed significant weight loss during the first 6 months of treatment, and significant weight loss was maintained for one year. In one 12-month study, the average weight loss in patients taking MERIDIA, 10 mg daily, was about 10 lbs. and in those taking 15 mg daily was about 14 lbs. The average weight loss in persons on only a reduced calorie diet alone was 3 1/2 lbs. Thus, MERIDIA is proven effective therapy for the obese patient who needs to loose weight to decease morbidity. Nonetheless, the magnitude of the weight loss will ultimately depend on the degree of concomitant caloric restriction and the concomitant use of a graded exercise program.

HOW LONG CAN I CONTINUE TO USE MERIDIA?

MERIDIA is a short-term drug that helps you to start losing weight and then keep on going when you are ready to carry on, on your own. Your body starts to build up a resistance to the effects of MERIDIA after a few weeks of treatment, which is when you should be well on your way to a new lifestyle and ready to stop MERIDIA.

Appetite suppressants are not a substitute for proper diet. For maximum effects, this must be used in conjunction with a diet and exercise program.

BE SURE TO TELL US ON YOU MEDICAL HISTORY/PERSONAL PROFILE IF :

- You have high blood pressure.
- You have an over-active thyroid.
- You have glaucoma.
- You have Diabetes Mellitus.
- You have emotional problems.
- You are pregnant.
- You are currently breast-feeding.

DRUG INTERACTIONS :

Included on your medical history/personal profile questionnaire all the medicines you use, (prescription and nonprescription), especially other weight reducing agents (e.g., diethylpropion), drugs that can raise blood pressure such as decongestants (e.g., pseudoephedrine, phenylpropanolamine), cough suppressants (e.g., dextromethorphan), antidepressants (e.g., nefazodone, fluoxetine, paroxetine, sertraline, fluvoxamine, venlafaxine), lithium, psychiatric medications (e.g., MAO Inhibitors such as selegiline, moclobemide, furazolidone, phenelzine, tranylcypromine), drugs for migraines (e.g., dihydroergotamine, sumatriptan), tryptophan, certain narcotic pain relievers (e.g., meperidine, pentazocine, fentanyl), ketoconazole, erythromycin, high blood pressure medicine or any drugs which can cause drowsiness, including certain antihistamines (e.g., diphenhydramine), sedatives and anti-seizure drugs. Antihistamines and decongestants may be found in many nonprescription drugs for cough and cold. MAO inhibitors and MERIDIA should not be taken together.

SIDE EFFECTS :

Dry mouth, sleeplessness, irritability, back pain, stomach upset or constipation may occur the first few days as you body adjusts to the medication. Stop MERIDIA if you experience; rash, hives, seizures, worsening of vision, decreased amount of urine or unusual bleeding or bruising. Stop MERIDIA immediately if you experience the following side effects or symptoms of toxicity; excitement, restlessness, loss of consciousness, confusion, agitation, weakness, shivering, clumsiness or unsteadiness, fast heartbeat, large-unchanging pupils, vomiting, trouble breathing, shortness of breath, chest pains, swelling of feet/ankles or legs, fainting, disorientation, depression, high fever, eye pain, tremor or increased sweating.

CONTRAINDICATIONS :

MERIDIA is contraindicated in patients with arteriosclerosis, cardiovascular disease, and moderate to severe hypertension.