Drug Interaction:
Benzodiapines include-
Alprozolam, Chlordiazepoxide, Clonazepam, Clorazepate,Diazepam, Halazepam, Lorazepam, Oxazepam, Prazazepam
Refer Diazepam
Interacting drugs - summary
+ Clobazam
Alcohol
additive CNS depressant effects CNS depressants
Indication:
ONFI® (clobazam) tablets, for oral use,
ONFI® (clobazam) oral suspension, CIV
Initial U.S. Approval: 2011
Drug Name- Onfi
Active Ingredient - Clobazam
For use an an adjunctive (add-on) treatment for seizures associated with
Lennox -Gastaut syndrome in adults in children 2 years of age and older
Indication-
Adjunctive (add-on) treatment for seizures associated with
Lennox -Gastaut syndrome in adults in children 2 years of age and older
Approved by FDA on 24-10--2011 (Ref- FDA approved List- 2011)
Anxiety, tension and agitation
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Clobazam Anti-epileptic 11-11-1997
Benzodiapines include- Alprozolam, Chlordiazepoxide, Clonazepam, Clorazepate,Diazepam, Halazepam, Lorazepam,Oxazepam, Prazazepam
Refer Diazepam
Adverse Reaction:
Refer Diazepam
Asthenia and symptoms of tiredness, especially at the start of treatment and with higher doses, may occur.
Others include dryness of mouth, constipation, anorexia, nausea, dizziness and fine tremors.
Restlessness, irritability, agitation, anxiety, suicidal tendencies, frequent muscle spasms.
Worsening of respiratory symptoms and respiratory depression can occur.
Contra-Indications:
Hypersensitivity to other benzodiazepines
Myasthenia gravis, Severe respiratory insufficiency.
CAL with incipient respiratory failure Sleep apnea,
History of drug/ alcohol dependence,
Severe hepatic impairment
Pregnancy/ lactation
Special precaution:
Pregnany and lactation not recommended.
Extreme caution is necessary if clobazam is required to be administered to patients with myasthenia gravis, spinal cerebellar ataxia, serious liver damage or sleep apnea syndrome. In patients with history of respiratory diseases.
Dosages/ Overdosage Etc:
Date of Approval 1997
Indication-
Anxiety, tension and agitation
Dosage-
Adults 10 -30 mg Elderly- 10- 20 mg all daily in divided doses
Max daily- 60mg Lower the dose in renal/hepatic impairment
Not recommended for children below 3 years - 3-12 years - half the adult dose
Patient Information:
Refer Diazepam
Pharmacology/ Pharmacokinetics:
Pharmacology-
Clobazam is structurally and pharmacologically related to approved benzodiazepines.
Pharmacokinetics:
Oral clobazam is 87% absorbed. Concomittant administration with alcohol increases clobazam's bioavailabity by 50% Food may slow the rate, but not the total absorption.
The mean half-life of the unchanged drug is 18 hrs and upto 77 hrs for metabolites.
Clobozam is 81% to 97% excreted in the urine, accumulation is expected in impaired renal function.
Interaction with Food:
Food may slow rate,but does not alter the absorption.
Pregnancy and lactation:
Pregnancy-
Not recommended during first trimester of pregnancy & should be given in later stages only if there are compelling reasons
Lactation:
Clobazepam is excreted into breast milk and should not be used during lactation. If there are compelling reasons for its use, then nursing should be stopped.
Manufacturer Details