bharatheeyam

Sibutramine hydrochloride mono hydrate-appetite suppressantan orally administered agent for the treatment of obesityIt is a centrally-acting serotonin-norepinephrine reuptake inhibitorIt is classified as a Schedule IV controlled substancePharmacokineticsSibutramine is well absorbed from the GI tract (77%), but undergoes considerable first-pass metabolism, reducing its bioavailability. The drug itself reaches its peak plasma level after 1 hour and has also a half-life of 1 hour. Sibutramine is metabolized by cytochrome P450 isozyme CYP3A4 into two pharmacologically-active primary and secondary amines (called active metabolites 1 and 2) with half-lives of 14 and 16 hours, respectively. Peak plasma concentrations of active metabolites 1 and 2 are reached after three to four hours. The following metabolic pathway mainly results in two inactive conjugated and hydroxylated metabolites (called metabolites 5 and 6). Metabolites 5 and 6 are mainly excreted in the urine. Mechanism of actionSibutramine is a neurotransmitter reuptake inhibitor that reduces the reuptake of serotonin (by 53%), norepinephrine (by 54%), and dopamine (by 16%), thereby increasing the levels of these substances in synaptic clefts and helping enhance satiety; the serotonergic action, in particular, is thought to influence appetite. Older anorectic agents such as amphetamine and fenfluramine force the release of these neurotransmitters rather than affecting their reuptake. ContraindicationsSibutramine 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 ageConcomitant treatment with a MAO inhibitor, antidepressant or other centrally active drugs, particularly other anoreticsHypertension that is not sufficiently controlled (caution in controlled hypertension)
Side effectsFrequently encountered side effects are: dry mouth, paradoxically increased appetite, nausea, strange taste in the mouth, upset stomach, constipation, trouble sleeping, dizziness, drowsiness, menstrual cramps/pain, headache, flushing, or joint/muscle pain.
Sibutramine 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.InteractionsSibutramine 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.[4] Sibutramine should not be taken within two weeks of stopping or starting 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.[4]The concomitant use of sibutramine and drugs which inhibit CYP3A4, such as ketoconazole and erythromycin, may increase plasma levels of sibutramine.[5] Sibutramine does not affect the efficacy of hormonal contraception.[4]
Dosage10 mg once daily (usually in the morning), if this proves insufficient the dose may be increased to 15 mg daily after 4 weeks.

®
(sibutramine hydrochloride monohydrate) Capsules
CS-IV DESCRIPTION
MERIDIA® (sibutramine hydrochloride monohydrate) is an orally administered agent for
the treatment of obesity. Chemically, the active ingredient is a racemic mixture of the (+)
and (-) enantiomers of cyclobutanemethanamine, 1-(4-chlorophenyl)-N,N-dimethyl-a-(2methylpropyl)-, hydrochloride, monohydrate, and has an empirical formula of
C17H29Cl2NO. Its molecular weight is 334.33.
Sibutramine hydrochloride monohydrate is a white to cream crystalline powder with a
solubility of 2.9 mg/mL in pH 5.2 water. Its octanol: water partition coefficient is 30.9 at pH 5.0.Each MERIDIA capsule contains 5 mg, 10 mg, and 15 mg of sibutramine hydrochloride monohydrate. It also contains as inactive ingredients: lactose monohydrate, NF; microcrystalline cellulose, NF; colloidal silicon dioxide, NF; and magnesium stearate, NF in a hard-gelatin capsule [which contains titanium dioxide, USP; gelatin; FD&C Blue No. 2 (5- and 10-mg capsules only); D&C Yellow No. 10 (5- and 15-mg capsules only), and other inactive ingredients]. CLINICAL PHARMACOLOGY
Mode of Action Sibutramine produces its therapeutic effects by norepinephrine, serotonin and dopamine reuptake inhibition. Sibutramine and its major pharmacologically active metabolites (M1 and M2) do not act via release of monoamines. Pharmacodynamics
Sibutramine exerts its pharmacological actions predominantly via its secondary (M1) and
primary (M2) amine metabolites. The parent compound, sibutramine, is a potent inhibitor
of serotonin (5-hydroxytryptamine, 5-HT) and norepinephrine reuptake in vivo, but not
in vitro. However, metabolites M1 and M2 inhibit the reuptake of these neurotransmitters
both in vitro and in vivo. In human brain tissue, M1 and M2 also inhibit dopamine reuptake in vitro, but with ~3-fold lower potency than for the reuptake inhibition of serotonin or norepinephrine. Potencies of Sibutramine, M1 and M2 as In Vitro Inhibitors of Monoamine Reuptake in Human Brain Potency to Inhibit Monoamine Reuptake (Ki;nM)
Serotonin Norepinephrine Dopamine Sibutramine and its metabolites (M1 and M2) are not serotonin, norepinephrine or dopamine releasing agents. Following chronic administration of sibutramine to rats, no depletion of brain monoamines has been observed.
Sibutramine, M1 and M2 exhibit no evidence of anticholinergic or antihistaminergic actions. In addition, receptor binding profiles show that sibutramine, M1 and M2 have low affinity for serotonin (5-HT1, 5-HT1A, 5-HT1B, 5-HT2A, 5-HT2C), norepinephrine (ß, ß1, ß3, a1 and a2), dopamine (D1 and D2), benzodiazepine, and glutamate (NMDA) receptors. These compounds also lack monoamine oxidase inhibitory activity in vitro and in vivo.
Pharmacokinetics Absorption
Sibutramine is rapidly absorbed from the GI tract (Tmax of 1.2 hours) following oral
administration and undergoes extensive first-pass metabolism in the liver (oral clearance
of 1750 L/h and half-life of 1.1 h) to form the pharmacologically active mono- and didesmethyl metabolites M1 and M2. Peak plasma concentrations of M1 and M2 are reached within 3 to 4 hours. On the basis of mass balance studies, on average, at least 77% of a single oral dose of sibutramine is absorbed. The absolute bioavailability of sibutramine has not been determined.
Distribution Radiolabeled studies in animals indicated rapid and extensive distribution into tissues: highest concentrations of radiolabeled material were found in the eliminating organs, liver and kidney. In vitro, sibutramine, M1 and M2 are extensively bound (97%, 94% and 94%, respectively) to human plasma proteins at plasma concentrations seen following therapeutic doses. Metabolism
Sibutramine is metabolized in the liver principally by the cytochrome P450 (3A4)
isoenzyme, to desmethyl metabolites, M1 and M2. These active metabolites are further
metabolized by hydroxylation and conjugation to pharmacologically inactive metabolites,
M5 and M6. Following oral administration of radiolabeled sibutramine, essentially all of the peak radiolabeled material in plasma was accounted for by unchanged sibutramine (3%), M1 (6%), M2 (12%), M5 (52%), and M6 (27%). M1 and M2 plasma concentrations reached steady-state within four days of dosing and
were approximately two-fold higher than following a single dose. The elimination half-lives of M1 and M2, 14 and 16 hours, respectively, were unchanged following repeated dosing. Excretion Approximately 85% (range 68-95%) of a single orally administered radiolabeled dose was excreted in urine and feces over a 15-day collection period with the majority of the dose (77%) excreted in the urine. Major metabolites in urine were M5 and M6; unchangeSibutramine induced weight loss has been accompanied by reductions in serum uric acid. Certain centrally-acting weight loss agents that cause release of serotonin from nerve terminals have been associated with cardiac valve dysfunction. The possible occurrence of cardiac valve disease was specifically investigated in two studies. In one study 2-D anNormal diurnal variation of blood pressure was maintained.

INDICATIONS AND USAGE

MERIDIA is indicated for the management of obesity, including weight loss and
maintenance of weight loss, and should be used in conjunction with a reduced calorie diet.
MERIDIA is recommended for obese patients with an initial body mass index = 30 kg/m2, or = 27 kg/m2 in the presence of other risk factors (e.g., diabetes, dyslipidemia, controlled hypertension).
CONTRAINDICATIONS
MERIDIA is contraindicated in patients receiving monoamine oxidase inhibitors (MAOIs)
(see WARNINGS).

MERIDIA is contraindicated in patients with hypersensitivity to sibutramine or any of the
inactive ingredients of MERIDIA.

MERIDIA is contraindicated in patients who have a major eating disorder (anorexia
nervosa or bulimia nervosa).

MERIDIA is contraindicated in patients taking other centrally acting weight loss drugs.

WARNINGS

Blood Pressure and Pulse

MERIDIA SUBSTANTIALLY INCREASES BLOOD PRESSURE AND/OR PULSE RATE
IN SOME PATIENTS. REGULAR MONITORING OF BLOOD PRESSURE AND PULSE
RATE IS REQUIRED WHEN PRESCRIBING MERIDIA.

In placebo-controlled obesity studies, sibutramine 5 to 20 mg once daily was associated
with mean increases in systolic and diastolic blood pressure of approximately 1 to
3 mm Hg relative to placebo, and with mean increases in pulse rate relative to placebo of

Concomitant Cardiovascular Diseasae
MERIDIA substantially increases blood pressure and/or pulse rate in some patients.
Therefore, MERIDIA should not be used in patients with a history of coronary artery
disease, congestive heart failure, arrhythmias, or stroke.
Glaucoma
Because MERIDIA can cause mydriasis, it should be used with caution in patients with
narrow angle glaucoma.
Miscellaneous Organic causes of obesity (e.g., untreated hypothyroidism) should be excluded before prescribing MERIDIA.
PRECAUTIONS
Pulmonary Hypertension Certain centrally-acting weight loss agents that cause release oserotonin from nerve
terminals have been associated with pulmonary hypertension (PPH), a rare but lethal
disease. In pre-marketing clinical studies, no cases of PPH have been reported with
sibutramine capsules. Because of the low incidence of this disease in the underlying
population, however, it is not known whether or not MERIDIA may cause this disease.
Seizures During premarketing testing, seizures were reported in < 0.1% of sibutramine treated
patients. MERIDIA should be used cautiously in patients with a history of seizures.
It should be discontinued in any patient who develops seizures.
Bleeding There have been reports of bleeding in patients taking sibutramine. While a causal relationship is unclear, caution is advised in patients predisposed to bleeding events and
those taking concomitant medications known to affect hemostasis or platelet function.
GallstonesWeight loss can precipitate or exacerbate gallstone formation.
Renal Impairment MERIDIA should be used with caution in patients with mild to moderate renal impairment. MERIDIA should not be used in patients with severe renal impairment, including those
with end stage renal disease on dialysis (see Pharmacokinetics-Special Populations-
Renal Insufficiency).
Hepatic Dysfunction Patients with severe hepatic dysfunction have not been systematically studied; MERIDIA
should therefore not be used in such patients.
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. 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.
Drug Interactions
CNS Active Drugs:
The use of MERIDIA in combination with other CNS-active drugs, particularly serotonergicagents, has not been systematically evaluated. Consequently, caution is advised if the concomitant administration of MERIDIA with other centrally-acting drugs is indicated (see
CONTRAINDICATIONS and WARNINGS). In patients receiving monoamine oxidase inhibitors (MAOIs) (e.g., phenelzine, selegiline)
in combination with serotonergic agents (e.g., fluoxetine, fluvoxamine, paroxetine,
sertraline, venlafaxine), there have been reports of serious, sometimes fatal, reactions
("serotonin syndrome;" see below). Because sibutramine inhibits serotonin reuptake,
MERIDIA should not be used concomitantly with a MAOI (see CONTRAINDICATIONS ).
At least 2 weeks should elapse between discontinuation of a MAOI and initiation of
treatment with MERIDIA. Similarly, at least 2 weeks should elapse between
discontinuation of MERIDIA and initiation of treatment with a MAOI.
The rare, but serious, constellation of symptoms termed "serotonin syndrome" has also
been reported with the concomitant use of selective serotonin reuptake inhibitors and
agents for migraine therapy, such as Imitrex® (sumatriptan succinate) and
dihydroergotamine, certain opioids, such as dextromethorphan, 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 sibutramine inhibits serotonin reuptake, in general, it should not be administered
with other serotonergic agents such as those listed above. However, if such a combination
is clinically indicated, appropriate observation of the patient is warranted.
Drugs That May Raise Blood Pressure and/or Heart Rate
Concomitant use of MERIDIA and other agents that may raise blood pressure or heart
rate have not been evaluated. These include certain decongestants, cough, cold, and
allergy medications that contain agents such as ephedrine, or pseudoephedrine. Caution
should be used when prescribing MERIDIA to patients who use these medications.Alcohol
In a double-blind, placebo-controlled, crossover study in 19 volunteers, administration of a single dose of ethanol (0.5 mL/kg) together with 20 mg of sibutramine resulted in no
psychomotor interactions of clinical significance between alcohol and sibutramine.
However, the concomitant use of MERIDIA and excess alcohol is not recommended.
Oral Contraceptives
The suppression of ovulation by oral contraceptives was not inhibited by sibutramine. In a crossover study, 12 healthy female volunteers on oral steroid contraceptives received
placebo in one period and 15 mg sibutramine in another period over the course of
8 weeks. No clinically significant systemic interaction was observed; therefore, no
requirement for alternative contraceptive precautions are needed when patients taking
oral contraceptives are concurrently prescribed sibutramine.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity Sibutramine was administered in the diet to mice (1.25, 5 or 20 mg/kg/day) and rats (1, 3, or 9 mg/kg/day) for two years generating combined maximum plasma AUC's of the
two major active metabolites equivalent to 0.4 and 16 times, respectively, those following
a daily human dose of 15 mg. There was no evidence of carcinogenicity in mice or in
female rats. In male rats there was a higher incidence of benign tumors of the testicular
interstitial cells; such tumors are commonly seen in rats and are hormonally mediated.
The relevance of these tumors to humans is not known.
Mutagenicity Sibutramine was not mutagenic in the Ames test, in vitro Chinese hamster V79 cell mutation assay, in vitro clastogenicity assay in human lymphocytes or micronucleus assay in mice. Its two major active metabolites were found to have equivocal bacterial mutagenic activity in the Ames test. However, both metabolites gave consistently negative results in
the in vitro Chinese hamster V79 cell mutation assay, in vitro clastogenicity assay in
human lymphocytes, in vitro DNA-repair assay in HeLa cells, micronucleus assay in mice and in vivo unscheduled DNA-synthesis assay in rat hepatocytes.
Impairment of Fertility . The use of MERIDIA during pregnancy is not recommended. Women of childbearing 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 while taking 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. Pediatric Use The efficacy of sibutramine in adolescents who are obese has not been adequately
studiedSibutramine's mechanism of action inhibiting the reuptake of serotonin and norepinephrine is similar to the mechanism of action of some antidepressants. Pooled analyses of short-
term placebo-controlled trials of antidepressants in children and adolescents with major
depressive disorder (MDD), obsessive compulsive disorder (OCD), and other psychiatric
disorders have revealed a greater risk of adverse events representing suicidal behavior or
thinking during the first few months of treatment in those receiving antidepressants. The
average risk of such events in patients receiving antidepressants was 4%, twice the
placebo risk of 2%. Geriatric Use
Clinical studies of sibutramine did not include sufficient numbers of patients aged 65 and
over to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug
therapy. Pharmacokinetics in elderly patients are discussed in "CLINICAL
PHARMACOLOGY."

predisposing factors (one had a prior history of epilepsy; one had a subsequent diagnosis
of brain tumor). The incidence in all subjects who received sibutramine (three of 4,588
subjects) was less than 0.1%.

Ecchymosis/Bleeding Disorders

Ecchymosis (bruising) was observed in 0.7% of sibutramine treated patients and in 0.2%
of placebo-treated patients in pre-marketing placebo-controlled obesity studies. One
patient had prolonged bleeding of a small amount which occurred during minor facial
surgery. Sibutramine may have an effect on platelet function due to its effect on serotonin
uptake.

Interstitial Nephritis

Acute interstitial nephritis (confirmed by biopsy) was reported in one obese patient
receiving sibutramine during pre-marketing studies. After discontinuation of the
medication, dialysis and oral corticosteroids were administered; renal function normalized.
The patient made a full recovery.

DOSAGE AND ADMINISTRATION
The recommended starting dose of MERIDIA 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 (see WARNINGS and
PRECAUTIONS). 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.
The safety and effectiveness of MERIDIA, as demonstrated in double-blind, placebo-
controlled trials, have not been determined beyond 2 years at this time.

Storage
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP controlled
room temperature]. Protect capsules from heat and moisture. Dispense in a tight, light-
resistant container as defined in USP.
MERIDIA
®
(mer-ID-dee-uh)
(sibutramine hydrochloride monohydrate) Capsules CS-IV
PATIENT INFORMATION Read the Patient Information that comes with MERIDIA before you start using it and each
time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or treatment.
What is the most important information I should know about MERIDIA?
Some people taking MERIDIA can have a large increase in blood pressure or heart rate
(pulse). Do not take MERIDIA if your blood pressure is not well controlled. Contact your
doctor if you experience an increase in blood pressure while taking MERIDIA.

Your doctor should check your blood pressure and heart rate before you start MERIDIA
and continue checking it regularly while you are using MERIDIA. It is important to have
regular check-ups while taking MERIDIA.
What is MERIDIA?MERIDIA is a medicine that may help obese people, as determined by their doctor, lose weight and keep weight off. MERIDIA may help with weight loss because it affects areas
of the brain that control hunger. You should use MERIDIA with a low calorie diet.
The use of MERIDIA for more than 2 years has not been studied.
MERIDIA has not been studied in children under 16 years of age.
Who should not take MERIDIA?
Do not take MERIDIA if you: • have uncontrolled or poorly controlled high blood pressure. • are taking or have taken a medicine called a monoamine oxidase inhibitor
(MAOI). Ask your doctor or pharmacist if you are not sure if any of your medicine
are MAOIs. Do not take MAOIs for at least 2 weeks before using MERIDIA. Do not
take MAOIs for at least 2 weeks after stopping MERIDIA. • have an eating disorder called anorexia nervosa or bulimia nervosa. • are taking weight loss medicines to control your appetite. • are allergic to MERIDIA. The active ingredient is sibutramine hydrochloride monohydrate. See the end of this leaflet for a complete list of ingredients in MERIDIA. How should I take MERIDIA?
• Take MERIDIA exactly as prescribed. Your doctor may adjust your dose. Do
not change your dose unless your doctor tells you to do so.
• You can take MERIDIA with or without food. • If you miss a dose of MERIDIA, just skip it. Do not take an extra dose to make
up for missed doses. What should I avoid while taking MERIDIA?
MERIDIA may not be the right medicine for you if you have certain medical conditions.
Tell your doctor about all of your medical conditions, especially if you:
• have high blood pressure. • have or had heart problems such as a heart attack, heart failure, chest pain or
an irregular heartbeat. • had a stroke or stroke symptoms. • have liver or kidney problems. • have an eye problem called glaucoma. • have a thyroid problem (hypothyroidism). • have or had seizures (convulsions, fits). • have bleeding problems. • have or had gallstones• have depression. • are over age 65. • are under age 16. • are pregnant or planning to become pregnant. The effects of MERIDIA on your
unborn baby are not known. If you can become pregnant, you should use birth
control while taking MERIDIA. Tell your doctor right away if you get pregnant while
taking MERIDIA. • are breastfeeding. It is not known if MERIDIA passes into your milk. The effects of MERIDIA on your baby are not known. You should not breastfeed while
taking MERIDIA. Do not drive, operate heavy machinery or do other dangerous activities until you know how MERIDIA affects you.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Taking MERIDIA and certain other medicines may affect each other and may cause serious and in some cases life-threatening side effects. Make sure you tell your doctor if you take:
•What are the possible side effects of MERIDIA?
Common side effects of MERIDIA include: dry mouth, headache, loss of appetite, trouble sleeping, and constipation.
The following serious side effects have been reported with MERIDIA:
• a large increase in blood pressure or heart rate in some people. See "What is
the most important information I should know about MERIDIA?"
• seizures • bleeding • a rare, but life-threatening problem called "serotonin syndrome." It may occuwhen people take drugs that affect a brain chemical called serotonin along with
MERIDIA. Do not take other medicines with MERIDIA unless your doctor has told
you it is okay to do so. Get medical help right away if you have any of the following
symptoms especially when taking other medicines with MERIDIA:
o feel weak, restless, confused, or anxious o lose consciousness
o have a fever, vomiting, sweating, shivering or shaking
o have a fast heartbeat Certain weight loss medicines have been associated with a rare, but life-threatening condition that affects the blood pressure in lungs (pulmonary hypertension). Because the condition is so rare it is not known if MERIDIA may cause this disease. If you experience MERIDIA is a controlled substance (CIV). This means that MERIDIA can bea target for people who abuse prescription medicines. Keep your MERIDIA in a safe place. Selling or How should I store MERIDIA? Store MERIDIA at room temperature between 59° to 86° F (15° to 30° C). Never leave it in a hot or moist place.
What are the ingredients in MERIDIA? Active Ingredient: sibutramine hydrochloride monohydrate Inactive Ingredients: lactose monohydrate, NF; microcrystalline cellulose, NF; colloidal silicon dioxide, NF; and magnesium stearate, NF in a hard-gelatin capsule [which contains titanium dioxide, USP;
gelatin; FD&C Blue No. 2 (5- and 10-mg capsules only); D&C Yellow No. 10 (5- and 15
mg capsules only), and other inactive ingredients]
.

bharatheeyam

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