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Reductil (Meridia) additional information

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Reductil - common uses

Meridia and Reductil are the most common brand names for sibutramine which is a systematic agent that affects the brain's appetite control centers without completely suppressing appetite. Reductil blocks serotonin and norepinephrine reuptake, and does not cause neurotransmitter release. Reductil promotes gradual, sustained weight loss and works without inducing feelings of euphoria.

Reductil is indicated for the treatment of obesity, including weight loss and maintenance of weight loss, and should be used in conjunction with a reduced calorie diet. Reductil can help people eat less, and still eat the foods they like.

Reductil - directions

Reductil comes as a capsule containing 15 mg. sibutramine, to take by mouth.

The recommended starting dose of Reductil 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. 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 clinical trials, Meridia and Reductil was given in the morning.

If you miss a dose, take it as soon as remembered if it is within an hour or so. If you do not remember until later, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up.

Reductil - precautions

The active ingredient in Reductil, sibutramine hydrochloride monohydrate, is a norepinephrine serotonin and dopamine reuptake inhibitor and should not be used concomitantly with MAOIs. There should be at least a 2-week interval after stopping MAOIs before commencing treatment with Reductil. Similarly, there should be at least a 2-week interval after stopping Reductil before starting treatment with MAOIs.

Treatment with Reductil has been associated with increases in heart rate and or blood pressure. Therefore Reductil should not be used by individuals with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

Because Reductil can cause mydriasis it should be used with caution by individuals with narrow angle glaucoma.

Organic causes of obesity (e. g. untreated hypothyroidism) should be excluded before using Reductil.

Certain centrally acting weight loss agents that cause release of serotonin from nerve terminals have been associated with pulmonary hypertension, a rare but lethal disease. In pre-marketing clinical studies no cases of PPH have been reported with Meridia or Reductil. Because of the low incidence of this disease in the underlying population however it is not known whether or not Meridia and Reductil may cause this disease.

Reductil should be used cautiously by individuals with a history of seizures and it should be discontinued if seizures are developed.

Weight loss can precipitate or exacerbate gallstone formation.

Patients with severe renal impairment or severe hepatic dysfunction have not been systematically studied. Reductil should therefore not be used by such individuals.

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

Notify your physician if they develop a rash, hives, or other allergic reactions.

Before starting the treatment with Reductil, inform your physician if you are taking or plan to take any prescription or over the counter drugs especially weight reducing agents, decongestants, antidepressants, cough suppressants, lithium, dihydroergotamine, sumatriptan or tryptophan since there is a potential for interactions.

The use of Reductil in combination with other CNS active drugs, particularly serotonergic agents has not been systematically evaluated. Consequently caution is advised if the concomitant administration of Reductil with other centrally acting drugs is indicated.

The rare but serious constellation of symptoms termed serotonin syndrome has been reported with the concomitant use of selective serotonin reuptake inhibitors and agents for migraine therapy such as Imitrex and dihydroergotamine, certain opioids such as meperidine, pentazocine, and fentanyl, lithium, or tryptophan. Serotonin syndrome has also been reported with the concomitant use of two serotonin reuptake inhibitors. The syndrome requires immediate medical attention and may include one or more of the following symptoms excitement, hypomania, restlessness, loss of consciousness, confusion, disorientation, anxiety, agitation, motor weakness, myoclonus, tremor, hemiballismus, hyperreflexia, ataxia, dysarthria, incoordination, hyperthermia, shivering, pupillary dilation, diaphoresis, emesis, and tachycardia.

Because Reductil inhibits serotonin reuptake, they should not be administered with other serotonergic agents such as those listed above.

Caution should be used when using Reductil to if also using medications that may raise the blood pressure or heart rate, such as certain decongestants, cough cold and allergy medications.

The concomitant use of Reductil and excess alcohol is not recommended.

No adequate and well controlled studies with Reductil have been conducted in pregnant women. The use of Reductil during pregnancy is not recommend. Women of child bearing potential should employ adequate contraception while taking Reductil. Notify your physician if you become pregnant or intend to become pregnant during therapy.

It is not known whether sibutramine or its metabolites are excreted in human milk. Reductil are not recommended for use in nursing mothers. Notify your physician if you are breast feeding.

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

Dose selection for an elderly individual should be cautious reflecting the greater frequency of decreased hepatic renal or cardiac function and of concomitant disease or other drug therapy.

Reductil - possible side effects

The most frequently observed side effects of the treatment with Reductil are dry mouth, anorexia, insomnia and constipation.

Other, less common, side effects include fever, diarrhea, flatulence, gastroenteritis, tooth disorder, peripheral edema, arthritis, agitation, leg cramps, hypertonia, thinking abnormal, bronchitis, dyspnea, pruritus, amblyopia and menstrual disorder.

If you notice other effects not listed above, contact your doctor.

Reductil - overdose

If overdose of Reductil is suspected, contact your local poison control center or emergency room immediately.

There is no specific antidote to Reductil. Treatment should consist of general measures employed in the 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 beta-blockers may be indicated to control elevated blood pressure or tachycardia. The benefits of forced diuresis and hemodialysis are unknown.

Reductil - additional information

Keep Reductil in a tightly closed container and out of reach of children. Store Reductil at room temperature and away from excess heat and moisture (not in the bathroom).

Note

The above information is intended to supplement, not substitute for, the expertise and judgment of your physician, or other healthcare professional. It should not be construed to indicate that use of Reductil is safe, appropriate, or effective for you.
Consult your health care professional before you buy Reductil (Meridia).

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