Meridia

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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.

What is Meridia?

How does Meridia work?

How to take Meridia:

How effective is Meridia?

How to Use Meridia:

Take by mouth exactly as directed by your doctor, usually one Meridia daily. The full effect on weight may require four to six weeks. Do not increase your dose, take Meridia more frequently or use Meridia for a longer period of time than prescribed because Meridia can be habit-forming. Also, if used for a longer period of time, do not suddenly stop using Meridia without your doctor's approval. Over time, Meridia may not work as well as it did at the beginning. Consult your doctor if weight increases.

If you Miss a Dose of Meridia:

If you miss a dose of Meridia, take it as soon as you remember. If it is near the time of the next Meridia dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

How long should I take Meridia?

Be Sure To Tell Us About Your Medical History If:

• You have high blood pressure.
• You have an overactive thyroid.
• You have glaucoma.
• You have Diabetes Mellitus.
• You have emotional problems.
• You are pregnant.
• You are currently breast-feeding
• You are / have been taking Meridia / diet pills.

Drug Interactions with Meridia:

Tell your doctor of all nonprescription and prescription drugs you may use, 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, procarbazine, linezolid), drugs for migraines (e.g., dihydroergotamine, sumatriptan), tryptophan, certain narcotic pain relievers (e.g., meperidine, pentazocine, fentanyl), ketoconazole, erythromycin, high blood pressure medicine. Tell your doctor if you take drugs that cause drowsiness: medicine for sleep, sedatives, tranquilizers, anti-anxiety drugs (e.g., diazepam), narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., phenothiazines or tricyclics), anti- seizure drugs (e.g., carbamazepine), muscle relaxants, antihistamines that cause drowsiness (e.g., diphenhydramine). Antihistamines and decongestants may be found in many nonprescription drugs for cough and cold. Consult your pharmacist. MAO inhibitors (see above) and Meridia should not be taken together. If an MAO inhibitor or Meridia is stopped, wait 2 weeks before starting the other drug. Do not start or stop any medicine without doctor or pharmacist approval.

Side Effects of Meridia:

Meridia may cause dry mouth, drowsiness, constipation, difficulty sleeping, or headache may occur. If any of these effects persist or worsen, notify your doctor promptly. Report promptly: Meridia induced dizziness, back pain, arthritis, increased appetite, stomach pain, mood/mental changes, persistent sore throat, sinus congestion. Unlikely but report promptly: chest pain, fast or irregular heartbeat, flushing or fever, increased thirst, arm or leg swelling, muscle pain or weakness, leg cramps, numbness, vision changes, one-sided weakness, sweating, painful menstruation. Very unlikely but report promptly: seizures, bruising, change in frequency/amount/color of urine, painful urination, yellowing skin or eyes. In the unlikely event you have an allergic reaction to Meridia, seek medical attention immediately. Symptoms of an allergic reaction include: rash, itching, swelling, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions when taking Meridia:

Before using Meridia, tell your doctor your entire medical history, including: any allergies (especially drug allergies), liver or kidney disease, high blood pressure, heart disease, history of stroke or seizures, certain eating disorders (e.g., anorexia nervosa), glaucoma (narrow angle), history of gallstones. Limit alcohol intake, as it may worsen certain side effects of Meridia. Since Meridia may cause dizziness or fatigue, use extreme caution if operating machinery or performing hazardous tasks (e.g., driving). It is recommended that women of child-bearing age should use effective birth control while taking Meridia. Meridia is not recommended for use during pregnancy. Consult your doctor before using Meridia. It is not known whether Meridia is excreted into breast milk. Because of the potential risk to the infant, breast-feeding while using Meridia is not recommended. Consult your doctor before breast-feeding. Elderly patients may be more sensitive to the effects of Meridia. Use cautiously.

Contraindications:

Overdose of Meridia:

If Meridia overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include fast heartbeat.

Important Note about Meridia:

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using Meridia.

Storage of Meridia:

Store Meridia room temperature between 59 and 86 degrees F (15-30 degrees C) away from light and moisture.

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