Hydrochloride Monohydrate Capsules, 10 mg )
Each capsule contains sibutramine
HCI monohydrate 10 mg.
Sibutramine HCI monohydrate is a
racemic mixture of the (+) and (-) enantiomers of N-(1-[1-(4--chlorophenyl)
cyclobutyl]-3-methylbutyl)-N, N-dimethylamine hydrochloride monohydrate, and
has an empirical formula of C17H28CI2NO.
Its molecular weight is 334.33.
Sibutramine is an anti-obesity
agent with selective serotonin & norepinephrine reuptake inhibitor activity.
Adjunctive therapy within a
weight management programme for patients with nutritional obesity and a body
mass index ( BMI ) of ≥ 30 kg/m2; or patients with nutritional
excess weight and a BMI of ≥ 27 kg/m2, if other obesity-related
risk factors eg, type II diabetes or dyslipidaemia are present.
Note : Slenfig may only be
prescribed to patients who have not adequately responded to an appropriate
weight-reducing regimen alone ie, patients who have difficulty achieving or
maintaining > 5% weight loss within 3 months. Treatment with Slenfig should
only be given as part of a long-term integrated therapeutic approach for
weight reduction under the care of physician experienced in the
treatment of obesity. An appropriate approach to obesity management should
include dietary and behavioural modification as well as increased physical
activity. This integrated approach is essential for a lasting change in
eating habits and behaviour which is fundamental to the long-term
maintenance of the reduced weight level once Slenfig is stopped. Patients
should change their lifestyle while on Slenfig so that they are able to
maintain their weight once drug treatment has ceased. They should be
informed that if they fail to do so, they may regain weight. Even after
cessation of Slenfig, continued monitoring of the patient by the physician
should be encouraged.
Adults : Initial
Dose : One 10-mg cap swallowed whole once daily, in the morning, with liquid
( eg, a glass of water ). The capsule can be taken with or without food.
In those patients with an
inadequate response to Slenfig 10mg ( defined as < 2 kg weight loss in 4
weeks treatment ), the dose may be increased to one 15-mg cap once daily,
provided that Slenfig 10mg was well tolerated.
Treatment must be discontinued in
patients who have responded inadequately to Slenfig 15mg ( defined as < 2 kg
weight loss in 4 weeks treatment ). Non-responders are at a higher risk of
undesirable effects ( see Side Effects ). Duration of Treatment : Treatment
must be discontinued in patients who have not responded adequately ie, whose
weight loss stabilises at < 5% of their initial body weight or whose weight
loss within 3 months after starting therapy has been < 5% of their initial
body weight. Treatment should not be continued in patients who regain ≥ 3kg
after having previously achieved weight loss. In patients with associated
co-morbid conditions, it is recommended that treatment with Slenfig should
only be continued if it can be shown that the weight loss induced is
associated with other clinical benefits eg, improvements in lipid profile in
patients with dyslipidaemia or glycaemic control of type II diabetes.
Slenfig should only be given for periods up to 2 years. Data on use over 2
years is limited.
Known hypersensitivity to
sibutramine HCI monohydrate or any other component of Slenfig. Organic
causes of obesity; history of major eating disorders eg, anorexia nervosa
and bulimia nervosa ( No data are available for sibutramine in the treatment
of patients with binge (compulsive) eating disorder ); psychiatric illness (
Sibutramine has shown potential antidepressant activity in animal studies.
Therefore, it cannot be excluded that sibutramine could induce a manic
episode in bipolar patients. ); Gilles de la Tourette's syndrome.
Concomitant use, or use during the past 2 weeks, of MAOIs or of other
centrally-acting drugs for the treatment of psychiatric disorders ( eg,
antidepressants, antipsychotics ) or for weight reduction, or tryptophan for
sleep disturbances. History of coronary artery disease, congestive heart
failure, tachycardia, peripheral arterial occlusive disease, arrhythmia or
cerebrovascular disease ( stroke or TIA ). Inadequately controlled
hypertension ( >145/90 mm Hg ) ( see Precautions ); hyperthyroidism; severe
hepatic and renal impairment; benign prostatic hyperplasia with urinary
retention; phaeochromocytoma; narrow angle glaucoma; history of drug,
medication or alcohol abuse.
Use in pregnancy :
Sibutramine should not be used during pregnancy. It is generally considered
inappropriate for weight-reducing drugs to be used during pregnancy, so
women of childbearing potential should employ an adequate method of
contraception while taking sibutramine and notify a physician if they become
pregnant or intend to become pregnant during therapy. No controlled studies
with Sibutramine have been conducted in pregnant women. Studies in pregnant
rabbits have shown effects on reproduction at maternally toxic doses ( see
Toxicology : Preclinical Safely Data under Actions ). The relevance of these
findings to humans is unknown.
Use in lactation : It is
not whether sibutramine is excreted in human breast milk and therefore
administration of Sibutramine is contraindicated during lactation.
Use in children : Not to
be used in children and young adults up to 18 years, owing to insufficient
data. Use in the elderly : Not to be used in patients > 65 years, owing to