thanks
-----Original Message-----
From: Lactation Information and Discussion
[mailto:[log in to unmask]] On Behalf Of Cee Miller
Sent: Thursday, May 25, 2006 10:34 AM
To: [log in to unmask]
Subject: Re: [LACTNET] Reductil - sibutramine hydrochloride
Nina Berry <[log in to unmask]> wrote:
> Does anyone know about RID/ safety of this medication while
breastfeeding
> (two year old).
From MMM online:
SIBUTRAMINE Trade: Meridia Can/Aus/UK: Meridia
Uses: Appetite suppressant LRC: L4 AAP: Not reviewed
Sibutramine is a nonamphetamine appetite suppressant. Due to its effect on
serotonin and norepinephrine reuptake, it is considered an antidepressant as
well. Sibutramine is rather small in molecular weight, active in the CNS,
extremely lipid soluble, and has two 'active' metabolites with long
half-lives (14-16 hours).[1-3] Although no data are available on its
transfer into human milk, the pharmacokinetics of this drug theoretically
suggest that it might have a rather high milk/plasma ratio and could enter
milk in significant levels. Until we know more, a risk assessment may not
support the use of this product in breastfeeding mothers. Pregnancy
Risk Category: C Lactation Risk Category: L4 Adult
Concerns: Adult side effects include headache, insomnia, back pain, flu-like
syndrome, abdominal
pain, seizures (rarely), and elevated liver enzymes. Cardiovascular events
include tachycardia, hypertension. Pediatric Concerns: None reported
via milk. Caution is recommended. Drug Interactions: Use of
Sibutramine with drugs that may increase blood pressure (decongestants,
cough and cold remedies) could be hazardous. Do not use with MAO inhibitors.
Do not admix with drugs that inhibit cytochrome P450 enzymes in the liver
(ketoconazole, cimetidine, erythromycin (minor effect). Theoretic
Infant Dose: Relative Infant Dose: Adult Dose: 5-15 mg
daily Alternatives:
T½ = 12.5-21.8 hours M/P = PHL = PB = 94%
Tmax = 3-4 hours Oral = 77% MW = 334 pKa = Vd =
References: 1. Lean ME. Sibutramine--a review of clinical
efficacy. Int J Obes Relat Metab Disord 1997; 21 Suppl 1:S30-S36.
2. Stock MJ. Sibutramine: a review of the pharmacology of a novel
anti-obesity agent. Int J Obes Relat Metab Disord 1997; 21 Suppl 1:S25-S29.
3. Pharmaceutical Manufacturer Prescribing Information.
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