Generic name: Clonafit 0.5mg
Dosage form: tablets
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Clonafit is available as a tablet. The tablets should be administered with water by swallowing the tablet whole.
The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses. Dosage may be increased in increments of 0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase. Maintenance dosage must be individualized for each patient depending upon response. Maximum recommended daily dose is 20 mg.
The use of multiple anticonvulsants may result in an increase of depressant adverse effects. This should be considered before adding Clonafit to an existing anticonvulsant regimen.
Clonafit is administered orally. In order to minimize drowsiness, the initial dose for infants and children (up to 10 years of age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in two or three divided doses. Dosage should be increased by no more than 0.25 to 0.5 mg every third day until a daily maintenance dose of 0.1 to 0.2 mg/kg of body weight has been reached, unless seizures are controlled or side effects preclude further increase. Whenever possible, the daily dose should be divided into three equal doses. If doses are not equally divided, the largest dose should be given before retiring.
There is no clinical trial experience with Clonafit in seizure disorder patients 65 years of age and older. In general, elderly patients should be started on low doses of Clonafit and observed closely.
The initial dose for adults with panic disorder is 0.25 mg bid. An increase to the target dose for most patients of 1 mg/day may be made after 3 days. The recommended dose of 1 mg/day is based on the results from a fixed dose study in which the optimal effect was seen at 1 mg/day. Higher doses of 2, 3 and 4 mg/day in that study were less effective than the 1 mg/day dose and were associated with more adverse effects. Nevertheless, it is possible that some individual patients may benefit from doses of up to a maximum dose of 4 mg/day, and in those instances, the dose may be increased in increments of 0.125 to 0.25 mg bid every 3 days until panic disorder is controlled or until side effects make further increases undesired. To reduce the inconvenience of somnolence, administration of one dose at bedtime may be desirable.
Treatment should be discontinued gradually, with a decrease of 0.125 mg bid every 3 days, until the drug is completely withdrawn.
There is no body of evidence available to answer the question of how long the patient treated with Clonafit should remain on it. Therefore, the physician who elects to use Clonafit for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
There is no clinical trial experience with Clonafit in panic disorder patients under 18 years of age.
There is no clinical trial experience with Clonafit in panic disorder patients 65 years of age and older. In general, elderly patients should be started on low doses of Clonafit and observed closely.
Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for depression or anxiety can add to sleepiness caused by Clonafit. Tell your doctor if you regularly use any of these medicines, or any other seizure medications or benzodiazepines.
Also tell your doctor if you are using any of the following drugs:
an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek);
an antifungal medicine such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);
an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), nefazodone, nortriptyline (Pamelor), and others;
a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton);
an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate); or
medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), droperidol (Inapsine), haloperidol (Haldol), mesoridazine (Serentil), pimozide (Orap), thioridazine (Mellaril), or thiothixene (Navane).
This list is not complete and other drugs may interact with Clonafit. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Effect of Clonafit on the Pharmacokinetics of Other Drugs: Clonafit does not appear to alter the pharmacokinetics of phenytoin, carbamazepine, or phenobarbital. The effect of Clonafit on the metabolism of other drugs has not been investigated.
Effect of Other Drugs on the Pharmacokinetics of Clonafit: Literature reports suggest that ranitidine, an agent that decreases stomach acidity, does not greatly alter Clonafit pharmacokinetics.
In a study in which the 2 mg Clonafit orally disintegrating tablet was administered with and without propantheline (an anticholinergic agent with multiple effects on the GI tract) to healthy volunteers, the AUC of Clonafit was 10% lower and the Cmax of Clonafit was 20% lower when the orally disintegrating tablet was given with propantheline compared to when it was given alone.
Fluoxetine does not affect the pharmacokinetics of Clonafit. Cytochrome P-450 inducers, such as phenytoin, carbamazepine and phenobarbital, induce Clonafit metabolism, causing an approximately 30% decrease in plasma Clonafit levels. Although clinical studies have not been performed, based on the involvement of the cytochrome P-450 3A family in Clonafit metabolism, inhibitors of this enzyme system, notably oral antifungal agents, should be used cautiously in patients receiving Clonafit.
Pharmacodynamic Interactions: The CNS-depressant action of the benzodiazepine class of drugs may be potentiated by alcohol, narcotics, barbiturates, nonbarbiturate hypnotics, antianxiety agents, the phenothiazines, thioxanthene and butyrophenone classes of antipsychotic agents, monoamine oxidase inhibitors and the tricyclic antidepressants, and by other anticonvulsant drugs.
|Once in a day||4||50.0%|
|3 times in a day||2||25.0%|
|Twice in a day||1||12.5%|
|4 times in a day||1||12.5%|
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Information checked by Dr. Sachin Kumar, MD Pharmacology