Epitra 0.5

Generic

Clonazepam

 

Indications

It's used to treat panic disorder, both with and without agoraphobia. Panic disorder is defined by the occurrence of sudden panic attacks, as well as the fear of having further attacks and anxiety about the implications or repercussions of the episodes.

It's also used to treat Lennox-Gastaut Syndrome (petit mal type), akinetic seizures, and myoclonic seizures, either alone or in combination. Patients with absence seizures (petit mal) who have not responded to succinimides may benefit from it.

Clonazepam's efficacy in long-term usage, defined as longer than 9 weeks, has not been well investigated in controlled clinical research. If a physician decides to use Epitra 0.5 mg for a lengthy period of time, he or she should review the drug's long-term effectiveness for the patient on a regular basis.

 

Pharmacology

Clonazepam has benzodiazepine-like pharmacological characteristics, such as anticonvulsive, sedative, muscle relaxing, and anxiolytic actions. Benzodiazepines' central effects are mediated by an increase in GABAergic neurotransmission at inhibitory synapses. Positive allosteric modulation of the GABA receptor for the neurotransmitter is increased in the presence of benzodiazepines, resulting in greater effect of released GABA on the postsynaptic transmembrane chloride ion flow.

There is additional evidence of clonazepam's impact on serotonin in animals. Clonazepam suppresses many types of paroxysmal activity, including spike and wave discharge in absence of seizures (petit mal), slow spike wave, generalized spike wave, spikes with temporal or other locations, as well as irregular spikes and waves, according to animal data and electroencephalographic investigations in humans. EEG abnormalities, in general, are repressed more frequently than abnormalities in specific areas. Clonazepam appears to be helpful in both widespread and localized epilepsies, according to these studies.

 

Dosage & Administration

Oral:

• Adults: For adults with seizure disorders, the first dosage should not exceed 1.5 mg/day, split into three doses. Dosage can be raised in 0.5 to 1 mg increments every 3 days until seizures are under control or adverse effects prevent further increases. Depending on the patient's reaction, the maintenance dosage must be customized for each patient. The maximum daily dose that is suggested is 20 mg.
• For individuals with panic disorder, the first dose is 0.25 mg split into two doses. After 3 days, most patients may get a 1 mg/day increase in their target dosage.
• Pediatric Patients: The first dose for babies 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, divided into two or three divided doses, to reduce drowsiness.

Injection:

• Infants and children: half of a vial (0.5 mg) by slow IV injection or by IV infusion.
• Adults: 1 vial (1 mg) by slow IV injection or by IV infusion. This dose can be repeated as required (1-4 mg are usually sufficient to reverse the status). In adults, the rate of injection must not exceed 0.25 - 0.5 mg per minute (0.5-1.0 ml of the prepared solution) and a total dose of 10 mg should not be exceeded.

 

Interaction

Phenytoin, carbamazepine, and phenobarbital pharmacokinetics do not appear to be affected by Epitra 0.5 mg tablet. Clonazepam's impact on the metabolism of other medications has not been studied.

 

Contraindications

It should not be used in individuals who have a history of benzodiazepine hypersensitivity, as well as those who have clinical or biochemical indications of severe liver damage. It can be utilized in individuals with open angle glaucoma who are on the right medication, but it's not recommended for acute narrow angle glaucoma.

 

Side Effects

Epitra 0.5 mg tablet's most common adverse effects include depression of the central nervous system (CNS). Drowsiness has been reported in around 50 percent of patients treated for seizures, with ataxia occurring in approximately 30 percent. These may improve with time in some situations; behavior issues have been reported in about 25% of individuals. Aphonia, coma, tremor, vertigo, disorientation, sadness, forgetfulness, hallucinations, hysteria, increased libido, sleeplessness, psychosis, and palpitations are some of the symptoms that might arise.

 

Pregnancy & Lactation

Pregnancy: It is impossible to rule out the potential of Epitra 0.5 mg tablet causing congenital abnormalities based on preclinical research. Anticonvulsant medicines have been shown to be teratogens in epidemiological studies. However, determining which medication or combination of medicines is responsible for neonatal abnormalities from published epidemiological studies is challenging. The possibility also exists that other factors e.g. genetic factors or the epileptic condition itself may be more important than drug therapy in leading to birth defects. Under these circumstances, the drug should only be administered to pregnant women if the potential benefits outweigh the risk to the foetus. During pregnancy, Epitra 0.5 mg tablet may be administered only if there is a compelling indication. Administration of high doses in the last trimester of pregnancy or during labour can cause irregularities in the heartbeat of the unborn child and hypothermia, hypotonia, mild respiratory depression and poor feeding in the neonate. It should be borne in mind that both pregnancy itself and abrupt discontinuation of the medication can cause exacerbation of epilepsy. Withdrawal symptoms in newborn infants have occasionally been reported with benzodiazepines.

Nursing Women: Although Clonazepam's active component has been proven to enter into breast milk in trace levels, mothers who are taking this medication should not nurse. Breastfeeding should be stopped unless there is a compelling need to use Epitra 0.5 mg tablet.

 

Precautions & Warnings

Epitra 0.5 mg tablet may increase the incidence or hasten the start of generalized tonic-clonic seizures in individuals who have multiple distinct forms of seizure disorders. This may necessitate the addition of or an increase in the dosage of anticonvulsants. The use of valproic acid and Clonazepam at the same time might cause absent status.

 

Therapeutic Class

Adjunct anti-epileptic drugs, Benzodiazepine hypnotics

 

Storage Conditions

Keep away from light and heat in a dry area. Keep out of children's reach.

 

Pharmaceutical Name

Square Pharmaceuticals Ltd.

 

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