Meridia and Reductil Diet Pills Review

Sibutramine, Meridia & Reductil, what relation?

Sibutramine (marketed as Meridia in the USA, Reductil in Europe), is an orally administered agent used to treat very overweight (obese) patients who have not been able to lose weight using a low calorie diet and exercise. It is a centrally acting stimulant chemically related to amphetamines. Sibutramine is classified as a Schedule IV controlled substance in the United States.

Sibutramine Manufacturer:

Sibutramine's manufacturer is Abbott Laboratories.

Sibutramine (Meridia & Reductil) Pharmacological aspects

Sibutramine (Meridia & Reductil) acts by increasing serotonin and norepinephrine levels in the brain. The serotonergic action, in particular, is thought to influence appetite. Despite its actions upon the neurotransmitters, sibutramine has never demonstrated any antidepressant properties. It was approved by the U.S. Food and Drug Administration (FDA) in November 1997 for the treatment of obesity.

Sibutramine (Meridia & Reductil) Contraindications

Sibutramine (Meridia & Reductil ) is contraindicated in:

• Psychiatric conditions as bulimia nervosa, anorexia nervosa, serious depression or preexisting mania
  
• Patients with a history of or a predisposition to drug or alcohol abuse
  Hypersensitivity to the drug
  
• Patients below 18 years of age
  
• Concomitant treatment with a MAO inhibitor, antidepressant or other centrally active drugs, particular other anoretics
  
• Hypertension that is not sufficiently controlled (caution in controlled hypertension)
  
• Existing pulmonary hypertension
  
• Existing damage on heart valves, coronary heart disease, congestive heart failure, serious arrhythmias, previous myocardial infarction
  
• Stroke or transient ischemic attack (TIA)
  
• Hyperthyroidism (overactive thyroid gland)
  
• Closed angle glaucoma
  
• Seizure disorders
  
• Enlargement of the prostate gland with urinary retention
  
• Pheochromocytoma
  
• Pregnant and lactating women
  

Sibutramine (Meridia & Reductil ) Side effects

Frequently encountered side effects are: dry mouth, paradoxically increased appetite, nausea, strange taste in the mouth, anorgasmia and delayed ejaculation, upset stomach, constipation, trouble sleeping, dizziness, drowsiness, menstrual cramps/pain, headache, flushing, or joint/muscle pain.


Sibutramine (Meridia & Reductil ) can substantially increase blood pressure and pulse in some patients. Therefore all patients treated with sibutramine should have regular monitoring of blood pressure and pulse.


The following side effects are infrequent but serious and require immediate medical attention: cardiac arrhythmias, paresthesia, mental/mood changes (e.g., excitement, restlessness, confusion, depression, rare thoughts of suicide).


Symptoms that require urgent medical attention are seizures, problems urinating, abnormal bruising or bleeding, melena, hematemesis, jaundice, fever and rigors, chest pain, hemiplegia, abnormal vision, dyspnea and edema.


Currently, no case of pulmonary hypertension has been noted, although related compounds (such as Fen-Phen) have shown this rare but clinically significant problem.

Sibutramine (Meridia & Reductil) Interactions

Sibutramine (Meridia & Reductil) has a number of clinically significant interactions. The concomitant use of sibutramine and monoamine oxidase inhibitors (MAOIs, such as selegiline) is not indicated, as it may increase the risk of serotonin syndrome, a somewhat rare but serious adverse drug reaction. Sibutramine should not be taken less than two weeks after stopping or before starting use of an MAOI. Taking both sibutramine and certain medications used in the treatment of migraines—such as ergolines and triptans—, as well as opioids, may also increase the risk for serotonin syndrome, as may the use of more than one serotonin reuptake inhibitor at the same time.


The concomitant use of sibutramine and drugs which inhibit CYP3A4, such as ketoconazole and erythromycin, may increase plasma levels of sibutramine. Sibutramine has no effect on the efficacy of oral contraceptives.

Sibutramine (Meridia & Reductil) Dosage

10 mg once daily (usually in the morning), if this proves insufficient the dose may be increased to 15 mg daily after 4 weeks.

Sibutramine (Meridia & Reductil) Safety concerns

Studies are ongoing into reports of sudden death, heart failure, renal failure and gastrointestinal problems. Despite a petition by Ralph Nader-founded NGO Public Citizen, the FDA made no attempts to withdraw the drug, but was part of a Senate hearing in 2005. Similarly, Dr. David Graham, FDA "whistleblower", testified before a Senate Finance Committee hearing that sibutramine may be more dangerous than the conditions it is used for.

Sibutramine Interference With Cognitive and Motor Performance

Although sibutramine did not affect psychomotor or cognitive performance in healthy volunteers, any CNS active drug has the potential to impair judgment, thinking or motor skills.

MERIDIA Information For Patients

Physicians should instruct their patients to read the patient package insert before starting therapy with MERIDIA and to reread it each time the prescription is renewed.
Physicians should also discuss with their patients any part of the package insert that is relevant to them. In particular, the importance of keeping appointments for follow-up visits should be emphasized.

• Patients should be advised to notify their physician if they develop a rash, hives, or other allergic reactions.
• Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, especially weight-reducing agents, decongestants, antidepressants, cough suppressants, lithium, dihydroergotamine, sumatriptan (Imitrex®), or tryptophan, since there is a potential for interactions.
• Patients should be reminded of the importance of having their blood pressure and pulse monitored at regular intervals.

MERIDIA & Pregnancy

No adequate and well controlled studies with MERIDIA® (sibutramine hydrochloride monohydrate) Capsules have been conducted in pregnant women. The use of MERIDIA during pregnancy is not recommended. Women of child-bearing potential should employ adequate contraception while taking MERIDIA. Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy.

MERIDIA & Nursing Mothers

It is not known whether sibutramine or its metabolites are excreted in human milk. MERIDIA is not recommended for use in nursing mothers. Patients should be advised to notify their physician if they are breast-feeding.

MERIDIA Pediatric Use

The safety and effectiveness of MERIDIA in pediatric patients under 16 years of age have not been established.

MERIDIA DOSAGE AND ADMINISTRATION

The recommended starting dose of MERIDIA® (sibutramine hydrochloride monohydrate) Capsules 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 a total of 15 mg once daily. The 5 mg dose should be reserved for patients who do not tolerate the 10 mg dose. Blood pressure and heart rate changes should be taken into account when making decisions regarding dose titration.
Doses above 15 mg daily are not recommended. In most of the clinical trials, MERIDIA was given in the morning.

Analysis of numerous variables has indicated that approximately 60% of patients who lose at least 4 pounds in the first 4 weeks of treatment with a given dose of MERIDIA in combination with a reduced-calorie diet lose at least 5% (placebo-subtracted) of their initial body weight by the end of 6 months to 1 year of treatment on that dose of MERIDIA. Conversely, approximately, 80% of patients who do not lose at least 4 pounds in the first 4 weeks of treatment with a given dose of MERIDIA do not lose at least 5% (placebo-subtracted) of their initial body weight by the end of 6 months to 1 year of treatment on that dose. If a patient has not lost at least 4 pounds in the first 4 weeks of treatment, the physician should consider reevaluation of therapy which may include increasing the dose or discontinuation of MERIDIA.

HOW is MERIDIA® SUPPLIED

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

• 5 mg, NDC 0048-0605-01, blue/yellow capsules imprinted with “MERIDIA” on the cap and “-5-” on the body, in bottles of 100 capsules.
• 10 mg, NDC 0048-0610-01, blue/white capsules imprinted with “MERIDIA” on the cap and “-10-” on the body, in bottles of 100 capsules.
• 15 mg, NDC 0048-0615-01, yellow/white capsules imprinted with “MERIDIA” on the cap and “-15-” on the body, in bottles of 100 capsules.
  

Storage: Store at 25C (77 F); excursions permitted to 15-30C (59-86F). Protect capsules from heat and moisture. Dispense in a tight, light-resistant container as defined in USP.

MERIDIA Manufacturer

MERIDIA is a registered trademark of Knoll Pharmaceutical Company.
Knoll Pharmaceutical Company
3000 Continental Drive – North
Mount Olive, New Jersey 07828-1234
1-800-526-0221

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