Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3305
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MERIDIA (Capsule)
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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 andPRECAUTIONS). 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 doseof 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.
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| dailymed-instance:descripti... |
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-��-(2-methylpropyl)-, hydrochloride,
monohydrate, and has an empirical formula of CHClNO. Its molecular weight is 334.33. The structural formula is shown below: 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].
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Mode of Action: Sibutramine produces
its therapeutic effects by norepinephrine, serotonin and dopamine
reuptake inhibition. Sibutramine and its major pharmacologically
active metabolites (Mand M) do not act
via release of monoamines.<br/>Pharmacodynamics: Sibutramine exerts
its pharmacological actions predominantly via its secondary (M) and primary (M) 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 Mand Minhibit the
reuptake of these neurotransmitters both in vitro and in vivo. In human
brain tissue, Mand Malso inhibit dopamine
reuptake in vitro, but with
~3-fold lower potency than for the reuptake inhibition of serotonin
or norepinephrine. A study using
plasma samples taken from sibutramine-treated volunteers showed monoamine
reuptake inhibition of norepinephrine>serotonin>dopamine; maximum
inhibitions were norepinephrine = 73%, serotonin = 54% and dopamine
= 16%. Sibutramine
and its metabolites (Mand M) are not serotonin,
norepinephrine or dopamine releasing agents. Following chronic administration
of sibutramine to rats, no depletion of brain monoamines has been
observed. Sibutramine,
Mand Mexhibit no evidence of anticholinergic
or antihistaminergic actions. In addition, receptor binding profiles
show that sibutramine, Mand Mhave low affinity
for serotonin (5-HT, 5-HT, 5-HT, 5-HT, 5-HT), norepinephrine (��,��,��,��and��), dopamine (Dand D),
benzodiazepine, and glutamate (NMDA) receptors. These compounds also
lack monoamine oxidase inhibitory activity in vitro and in vivo.<br/>Pharmacokinetics:<br/>Absorption: Sibutramine
is rapidly absorbed from the GI tract (Tof 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 di-desmethyl metabolites
Mand M. Peak plasma concentrations of Mand Mare 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.<br/>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, Mand Mare extensively bound (97%, 94% and 94%, respectively)
to human plasma proteins at plasma concentrations seen following therapeutic
doses.<br/>Metabolism: Sibutramine
is metabolized in the liver principally by the cytochrome P450 (3A) isoenzyme, to desmethyl metabolites, Mand M. These active metabolites are further metabolized by hydroxylation
and conjugation to pharmacologically inactive metabolites, Mand M. Following oral administration of radiolabeled
sibutramine, essentially all of the peak radiolabeled material in
plasma was accounted for by unchanged sibutramine (3%), M(6%), M(12%), M(52%), and M(27%). Mand Mplasma 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 Mand M, 14 and 16 hours, respectively, were unchanged
following repeated dosing.<br/>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 Mand M; unchanged sibutramine,
M, and Mwere not detected. The primary route
of excretion for Mand Mis hepatic metabolism
and for Mand Mis renal excretion.<br/>Effect of Food: Administration
of a single 20 mg dose of sibutramine with a standard breakfast resulted
in reduced peak Mand Mconcentrations (by
27% and 32%, respectively) and delayed the time to peak by approximately
three hours. However, the AUCs of Mand Mwere not significantly altered.<br/>Special Populations:<br/>Drug-Drug Interactions: In vitro studies
indicated that the cytochrome P450 (3A)-mediated metabolism
of sibutramine was inhibited by ketoconazole and to a lesser extent
by erythromycin. Phase 1 clinical trials were conducted to assess
the interactions of sibutramine with drugs that are substrates and/or
inhibitors of various cytochrome P450 isozymes. The potential for
studied interactions is described below.
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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.
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MERIDIA (sibutramine hydrochloride monohydrate) Capsules contain 5 mg, 10
mg, or 15 mg sibutramine hydrochloride monohydrate and are supplied
as follows: 5 mg, NDC 0074-2456-12, blue/yellow
capsules imprinted with "MERIDIA���on the cap and "-5-"
on the body, in bottles of 30 capsules. 10
mg, NDC 0074-2457-12, blue/white capsules imprinted with "MERIDIA���on the cap and "-10-���on the body, in bottles of 30 capsules. 15 mg, NDC 0074-2458-12, yellow/white capsules imprinted
with "MERIDIA���on the cap and "-15-���on the body, in
bottles of 30 capsules. 5 mg, NDC 0074-2456-13, blue/yellow capsules imprinted with "MERIDIA"
on the cap and "-5-" on the body, in bottles of 100 capsules. 10 mg, NDC 0074-2457-13, blue/white
capsules imprinted with "MERIDIA" on the cap and "-10-" on the body,
in bottles of 100 capsules. 15 mg, NDC 0074-2458-13, yellow/white capsules imprinted with "MERIDIA"
on the cap and "-15-" on the body, in bottles of 100 capsules.<br/>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. Manufactured for Abbott Laboratories, North Chicago,
IL 60064 USA by KNOLL LLC B.V. Jayuya, PR, 00664. IMITREX is a registered trademark of Glaxo Group Limited.Sibutramine
is covered by US Patent Nos. 4,746,680; 4,929,629; and 5,436,272. ��Abbott
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dailymed-ingredient:D&C_Yellow_No._10,
dailymed-ingredient:FD&C_Blue_No._2,
dailymed-ingredient:colloidal_silicon_dioxide,
dailymed-ingredient:gelatin,
dailymed-ingredient:lactose_monohydrate,
dailymed-ingredient:magnesium_stearate,
dailymed-ingredient:microcrystalline_cellulose,
dailymed-ingredient:titanium_dioxide
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Pulmonary Hypertension: Certain centrally-acting
weight loss agents that cause release of serotonin from nerve terminals
have been associated with pulmonary hypertension (PPH), a rare but
lethal disease. In premarketing 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.<br/>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.<br/>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.<br/>Gallstones: Weight loss can
precipitate or exacerbate gallstone formation.<br/>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).<br/>Hepatic Dysfunction: Patients with severe
hepatic dysfunction have not been systematically studied; MERIDIA
should therefore not be used in such patients.<br/>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.<br/>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 monitoredat regular intervals.<br/>Drug Interactions:<br/>CNS Active Drugs:: The use
of MERIDIA in combination with other CNS-active drugs, particularly
serotonergic agents, 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,
motorweakness, 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.<br/>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.<br/>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.<br/>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.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility:<br/>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.<br/>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.<br/>Impairment of Fertility: In rats,
there were no effects on fertility at doses generating combined plasma
AUC's of the two major active metabolites up to 32 times those
following a human dose of 15 mg. At 13 times the human combined AUC,
there was maternal toxicity, and the dams' nest-building behavior
was impaired, leading to a higher incidence of perinatal mortality;
there was no effect at approximately 4 times the human combined AUC.<br/>Pregnancy:<br/>Teratogenic Effects:<br/>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.<br/>Pediatric Use: The efficacy of
sibutramine in adolescents who are obese has not been adequately studied. Sibutramine'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%. No placebo-controlled trials of sibutramine
have been conducted in children or adolescents with MDD, OCD, or other
psychiatric disorders. In a study of adolescents with obesity in which
368 patients were treated with sibutramine and 130 patients with placebo,
one patient in the sibutramine group and one patient in the placebo
group attempted suicide. Suicidal ideation was reported by 2 sibutramine-treated
patients and none of the placebo patients. It is unknown if sibutramine
increases the risk of suicidal behavior or thinking inpediatric patients. The data are inadequate to recommend the use of sibutramine
for the treatment of obesity in pediatric patients.<br/>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."
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Overdose Management: There is limited
experience of overdose with sibutramine. The most frequently noted
adverse events associated with overdose are tachycardia, hypertension,
headache and dizziness. Treatment should consist of general measures
employed in the management of overdosage: an airway should be established
as needed; cardiac and vital sign monitoring is recommended; general
symptomatic and supportive measures should be instituted. Cautious
use of��-blockers may be indicated to control elevated blood
pressure or tachycardia. The results from a study in patients with
end-stage renal disease on dialysis showed that sibutramine metabolites
were not eliminated to a significant degree with hemodialysis. (see Pharmacokinetics-Special Populations-Renal Insufficiency).
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sibutramine hydrochloride
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MERIDIA (Capsule)
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In placebo-controlled studies,
9% of patients treated with sibutramine (n = 2068) and 7% of patients
treated with placebo (n = 884) withdrew for adverse events. In placebo-controlled studies,
the most common events were dry mouth, anorexia, insomnia, constipation
and headache. Adverse events in these studies occurring in���1%
of sibutramine treated patients and more frequently than in the placebo
group are shown in the following table. The following additional
adverse events were reported in���1% of all patients who
received sibutramine in controlled and uncontrolled premarketing studies.<br/>Body as a Whole: fever.<br/>Digestive System: diarrhea, flatulence, gastroenteritis, tooth disorder.<br/>Metabolic and Nutritional: peripheral edema.<br/>Musculoskeletal System: arthritis.<br/>Nervous System: agitation, leg cramps, hypertonia, thinking abnormal.<br/>Respiratory System: bronchitis, dyspnea.<br/>Skin and Appendages: pruritus.<br/>Special Senses: amblyopia.<br/>Urogenital System: menstrual disorders.<br/>Other Adverse Events:<br/>Clinical Studies:<br/>Postmarketing Reports: Voluntary reports
of adverse events temporally associated with the use of sibutramine
are listed below. It is important to emphasize that although these
events occurred during treatment with sibutramine, they may have no
causal relationship with the drug. Obesity itself, concurrent disease
states/risk factors, or weight reduction may be associated with an
increased risk for some of these events.<br/>Psychiatric: Cases of
depression, suicidal ideation and suicide have been reported rarely
in patients on sibutramine treatment. However, a relationship has
not been established between the occurrence of depression and/or suicidal
ideation and the use of sibutramine. If depression occurs during
treatment with sibutramine, further evaluation may be necessary.<br/>Hypersensitivity: Allergic
hypersensitivity reactions ranging from mild skin eruptions and urticaria
to angioedema and anaphylaxis have been reported (see CONTRAINDICATIONS and PRECAUTIONS-Information For Patients, and
other reports of allergic reactions listed below).<br/>Other Postmarketing Reported Events::
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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 approximately 4 to 5 beats per
minute. Larger increases were seen in some patients, particularly
when therapy with sibutramine was initiated at the higher doses (see
table below). In premarketing placebo-controlled obesity studies,
0.4% of patients treated with sibutramine were discontinued for hypertension
(SBP���160 mm Hg or DBP���95 mm Hg), compared
with 0.4% in the placebo group, and 0.4% of patients treated with
sibutramine were discontinued for tachycardia (pulse rate���100
bpm), compared with 0.1% in the placebo group. Blood pressure and pulse should be measured prior to starting therapy
with MERIDIA and should be monitored at regular intervals thereafter. For patients who experience a sustained increase in blood pressure
or pulse rate while receiving MERIDIA, either dose reduction or discontinuation
should be considered. MERIDIA should be given with caution to those
patients with a history of hypertension (see DOSAGE AND ADMINISTRATION), and should not be given to
patients with uncontrolled or poorly controlled hypertension.<br/>Potential Interaction With Monoamine Oxidase Inhibitors: MERIDIA is a norepinephrine,
serotonin and dopamine reuptake inhibitor and should not be used concomitantly
with MAOIs (see PRECAUTIONS, Drug
Interactions subsection). There should be at least a 2-week interval
after stopping MAOIs before commencing treatment with MERIDIA. Similarly,
there should be at least a 2-week interval after stopping MERIDIA
before starting treatment with MAOIs.<br/>Concomitant Cardiovascular Disease: 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.<br/>Glaucoma: Because MERIDIA
can cause mydriasis, it should be used with caution in patients with
narrow angle glaucoma.<br/>Miscellaneous: Organic causes of
obesity (e.g., untreated hypothyroidism) should be excluded before
prescribing MERIDIA.
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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/m, or���27
kg/min the presence of other risk factors (e.g., diabetes,
dyslipidemia, controlled hypertension). Below is a chart of Body Mass Index (BMI) based on
various heights and weights. BMI is calculated by taking the patient's weight, in kg, and
dividing by the patient's height, in meters, squared. Metric
conversions are as follows: pounds��2.2 = kg; inches��0.0254 = meters.
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MERIDIA
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