CAMPRAL *
Manufacturer Details
FOREST INC
Compositions:
Acamprosate Calcium 333mg delayed release tablets,
Strength
|
Rate
|
Packing Style
|
333mg
|
0.00
|
180s tablets
|
List of Related Indications:
List Of Drugs:
- 1/14.Acamposate Calcium - @ - Antialcoholic Agents(Dec 2002)
Indication Type Description:
Drug Interaction:
Naltrexone- coadmin of naltrexone with acampostate produced an increase in AUC.
No dosage adjustments of dosage is recommended in such patients
Indication:
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
1.Acamprosate Calcium For Alcohol dependency 30-12-2002
Alcoholism
Adverse Reaction:
CNS - 38%- anxiety 7% depression 7% dizziness 3% dry mouth 3% insomnia 8%
Dermatologic - 7% pruritus 3% sweating 2%
GI - 20% - anorexia 4% diarrhea 10% nausea 3%
Miscellaneous - 30% accidental injury 3% asthenia 6% pain 2%
Contra-Indications:
Hypersensity to the drug
Special Precautions-
Withdrawal symptoms- use of acamprosate does not eliminate or diminish withdrawal symptoms
Suicide- Alert families of patients being treated with acomposate of the need to monitor patients
for the emergence of depression or suicidality and to report such symptoms to their doctor.
Pregnancy- use acomprosate during pregnancy only if the potential benefit justifies the potential
risk to the fetus.
Lactation- excercise caution when acomprosate is administered to a woman who is breast feeding
Children- safety and efficacy of acamposate in children is not established
Elderly- use care in dose selection , it may be useful to monitor renal function.
Dosages/ Overdosage Etc:
Indication-
Alcoholism
Dosage-
Adults- two 333mg tablets ( each dose should total 666mg ) given 3 times a day.
A lower dose may be effective in some patients
Elderly- because elderly patients are more likely to have decreased renal clearance, use
care in dose selection.
Renal function impairment- for patients with moderate renal impairment ( creatinine clearance
CrCl 30 to 50mL/min ) a starting dose of one 333mg tablet 3 times daily is recommended.
Do not give acamposate calcium to patients with severe renal impairment
(CrCl 30mL/min or less )
Although dosing may be done without regards to meals, during clinical trials dosing with
meals was employed. It was suggested as an aid to compliance in those patients
who regularly eat 3 meals daily.
Patient Information:
1. The drug may impair judgement, thinking, or motor skills
2. Caution patients about operating hazardous machinery including automobiles, unitl
they are reasonably certain that acomprosate therapy does not affect their ability to
engage in such activites.
Interaction with Food:
Can be taken with meals if required
Pregnancy and lactation:
Pregnancy-
Use acomprosate during pregnancy only if the potential benefit justifies the potential
risk to the fetus.
Lactation-
Excecise caution when acomprosate is administered to a woman who is breast feeding
Children-
Safety and efficacy of acamposate in children is not established
Elderly-
Use care in dose selection , it may be useful to monitor renal function.