Dosing & Uses
Dosage Forms & Strengths
Indicated for maintenance of alcohol abstinence in patients who are abstinent at treatment initiation
666 mg PO TID
CrCl 30-50 mL/min: 333 mg PO TID
CrCl <30 mL/min: Do not administer
Fragile X Syndrome (Orphan)
Orphan designation for treatment of fragile X syndrome
- Confluence Pharmaceuticals, LLC; Box 528, 351 West 10th Street; Indianapolis, IN 46202
Safety and efficacy have not been established
Serious - Use Alternative
Significant - Monitor Closely
Accidental injury (3%)
Dry mouth (2%)
Frequency Not Defined
Severe renal impairment
Does not diminish withdrawal symptoms
May impair ability to operate heavy machinery or drive
Efficacy not established in promoting abstinence in non-abstinent patients
Check for suicidal tendencies
Use as part of a conprehensive to treat alcohol dependence
Possibility of acute renal failure (ARF)
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Excretion in milk unknown; use with caution
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Not fully understood; may act by interacting with glutamate & GABA neurotransmitter systems
Does not cause alcohol aversion or a disulfiram-like reaction on ethanol ingestion
Protein Bound: Negligible
Vd: 1 L/kg
Peak PlasmaTime: 3-8 hr
Concentration: 350 ng/mL for a dose of 666 mg TID
Bioavailability: 11%, decreased by food
Half-life: 20-33 hr
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
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