Frisium Tablet
Clobazam
10mg
Sanofi India Ltd.
| Pack size | 1 |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 14.69 NPR |
Available as:
Indications
Frisium Tablet is used for:
Anxiety, tension, irritability, restlessness, epilepsy.
Adult Dose
Seizures
Indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients aged 2 years or older
>30 kg: Initiate at 5 mg PO q12hr; may titrate as tolerated up to 40 mg/day divided q12hr
Dose escalation should not proceed more rapidly than once weekly
Hepatic impairment
Limited data to characterize the effect of hepatic impairment on the pharmacokinetics; proceed with low and slow titration
Mild-to-moderate (Child-Pugh 5-9): Starting dose should be 5 mg/day and titrated according to weight, but to half the typical adult dose; additional titration to the maximum dose (20 mg/day or 40 mg/day), depending on the weight group may be started on day 21
Severe hepatic impairment: Not recommended
Child Dose
Seizures
Indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients aged 2 years or older
<30 kg
Starting dose: 5 mg PO qDay; titrate as tolerated up to 20 mg PO daily
After 7 days, may increase to 5 mg PO q12hr; if needed, may increase to 10 mg PO q12hr after an additional 7 days
>30 kg
Starting dose: 5 mg PO q12hr; titrate as tolerated up to 40 mg PO daily
After 7 days, may increase to 10 mg PO q12hr; if needed, may increase to 20 mg PO q12hr after an additional 7 days
Renal Dose
Renal impairment
Mild or moderate renal impairment: No dose adjustment required
Severe renal impairment or ESRD: No experience
Administration
May be taken with or without food.
Individualize weight-based dose according to clinical efficacy and tolerability
Doses above 5 mg/day should be administered in divided doses twice daily (5 mg dose can be administered as a single daily dose)
May be administered whole, or crushed and mixed in applesauce
When discontinuing, withdraw gradually; taper by decreasing the total daily dose by 5-10 mg/day on a weekly basis until discontinued
Contra Indications
Hypersensitivity; history of drug dependence; myasthaenia gravis; pregnancy (1st trimester), lactation; serious liver damage; sleep apnoea syndrome; impaired respiratory function.
Precautions
May impair ability to perform skilled tasks and hazardous activities; elderly; renal or hepatic impairment; alcoholics; obesity; withdrawal should be gradual.
Lactation: Excreted in breast milk; effects of exposure on infants unknown
Pregnancy-Lactation
Interactions
Increased hepatic clearance of clobazam when administered with phenytoin, phenobarbital or carbamazepine. Cimetidine may increase levels of clobazam.
Potentially Fatal: Concurrent alcohol, hypnotics and sedative antidepressants can potentiate CNS side effects of clobazam
Adverse Effects
Side effects of Clobazam :
>10%
Somnolence or sedation (26%),Somnolence (22%),Pyrexia (13%),Upper respiratory tract infection (12%)
1-10%
Drooling (9%),Aggression (8%),Irritability (7%),Vomiting (7%),Insomnia (5%),Ataxia (5%),Sedation (5%),Constipation (5%),Fatigue (5%),Cough (5%),Psychomotor hyperactivity (4%),Pneumonia (4%),Urinary tract infection (4%),Dysarthria (3%),Decreased appetite (3%),Increased appetite (3%),Bronchitis (2%),Dysphagia (2%)
Potentially Fatal: Respiratory depression.
Mechanism of Action
Clobazam binds to one or more specific GABA receptors at several sites within the CNS including the limbic system and reticular formation. Increased permeability of neuronal membrane to chloride ions results in GABA's inhibitory effect leading to hyperpolarisation and stabilisation.
Note
Frisium 10mg Tablet manufactured by Sanofi India Ltd.. Its generic name is Clobazam. Frisium is availble in Nepal.
Farmaco Nepal drug index information on Frisium Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.