Epitra 2 mg

Description

Indications

Epitra is prescribed for the treatment of panic disorder, with or without agoraphobia. Panic disorder is characterized by unexpected panic attacks and the persistent concern of experiencing additional episodes, along with worry about their implications or consequences.

Additionally, Epitra is used alone or as an adjunct in managing Lennox-Gastaut Syndrome (petit mal variant), akinetic, and myoclonic seizures. It may also be beneficial for patients with absence seizures (petit mal) who have not responded to succinimides.

The long-term effectiveness of Epitra beyond nine weeks has not been systematically studied in controlled clinical trials. Physicians prescribing this medication for extended periods should periodically reassess its continued benefit for individual patients.

Pharmacology Clonazepam, the active ingredient in Epitra, belongs to the benzodiazepine class and exhibits anticonvulsant, sedative, muscle relaxant, and anxiolytic properties. Its central effects are mediated through the enhancement of GABAergic neurotransmission at inhibitory synapses. Benzodiazepines increase the affinity of GABA receptors for neurotransmitters, thereby amplifying the inhibitory effects on the central nervous system.

Animal studies suggest that clonazepam also affects serotonin levels. Electroencephalographic studies in humans have shown that clonazepam rapidly suppresses various types of paroxysmal activity, including spike-and-wave discharges in absence seizures (petit mal), generalized spike-wave patterns, and other irregular brain wave abnormalities. These findings indicate that clonazepam is beneficial for both generalized and focal epileptic conditions.

Dosage & Administration

Oral Administration:

• Adults (Seizure Disorders): Initial dose should not exceed 1.5 mg per day, divided into three doses. Dosage may be increased by 0.5–1 mg every three days until seizures are controlled or side effects prevent further dose escalation. The maximum recommended daily dose is 20 mg.
• Adults (Panic Disorder): Initial dose is 0.25 mg twice daily. After three days, the target dose of 1 mg/day may be reached.
• Pediatric Patients: To minimize drowsiness, infants and children (up to 10 years of age or 30 kg body weight) should start with a dose of 0.01–0.03 mg/kg/day, not exceeding 0.05 mg/kg/day, divided into two or three doses.

Injection Administration:

• Infants and Children: 0.5 mg (half a vial) by slow IV injection or infusion.
• Adults: 1 mg (one vial) by slow IV injection or infusion. If necessary, the dose can be repeated (usual effective dose: 1–4 mg). Maximum rate of IV injection should not exceed 0.25–0.5 mg per minute, and the total dose should not exceed 10 mg.

Drug Interactions Epitra does not appear to alter the pharmacokinetics of phenytoin, carbamazepine, or phenobarbital. The effect on the metabolism of other drugs remains unstudied.

Contraindications Epitra should not be used in patients with a known hypersensitivity to benzodiazepines or those with significant liver disease. While it may be used in patients with open-angle glaucoma receiving appropriate treatment, it is contraindicated in acute narrow-angle glaucoma.

Side Effects The most common side effects of Epitra are related to central nervous system depression. Approximately 50% of patients experience drowsiness, and 30% experience ataxia. These effects may lessen over time. Other side effects include abnormal eye movements, tremors, confusion, depression, hallucinations, amnesia, insomnia, psychosis, and palpitations.

Pregnancy & Lactation

Pregnancy: Evidence suggests that anticonvulsants, including clonazepam, may have teratogenic effects. However, it is difficult to determine whether congenital malformations are caused by the drug, genetic factors, or the epileptic condition itself. Epitra should only be prescribed during pregnancy if the benefits outweigh the risks. High doses during the last trimester or labor may cause neonatal complications such as irregular heartbeat, respiratory depression, hypotonia, or feeding difficulties.

Nursing Mothers: Although only small amounts of clonazepam pass into breast milk, breastfeeding should be avoided during treatment. If necessary, breastfeeding must be discontinued.

Precautions & Warnings

• In patients with multiple seizure types, Epitra may increase the frequency of generalized tonic-clonic seizures, requiring adjustments in other anticonvulsant medications.
• Co-administration with valproic acid may lead to absence status.
• In infants and young children, Epitra may increase saliva and bronchial secretions, necessitating airway maintenance.
• Elderly patients may exhibit heightened benzodiazepine effects due to age-related changes in metabolism.
• No dose adjustment is necessary for patients with renal impairment. However, in liver cirrhosis, clearance of unbound Epitra may be reduced.

Overdose Effects

Symptoms: Overdose symptoms include drowsiness, ataxia, slurred speech, and nystagmus. Severe overdose may result in respiratory depression, hypotension, coma, and cardiorespiratory failure. Overdose is rarely life-threatening unless combined with other CNS depressants such as alcohol.

Treatment: Supportive measures should be initiated based on the patient’s condition. If necessary, activated charcoal may be used within 1–2 hours of ingestion. In severe CNS depression, flumazenil (a benzodiazepine antagonist) may be administered under close monitoring.

Therapeutic Class Epitra belongs to the therapeutic class of adjunct anti-epileptic drugs and benzodiazepine hypnotics.

Reconstitution

• IV Injection: The vial’s contents should be diluted with 1 ml of sterile water before administration to prevent local vein irritation.
• IV Infusion: One vial (1 mg) should be diluted in at least 85 ml of diluting media such as sodium chloride 0.9%, sodium chloride 0.45% with glucose 2.5%, glucose 5%, or glucose 10%. The prepared solution remains stable for 24 hours at room temperature. If using PVC infusion bags, the mixture should be infused within four hours.
• IM Injection: This route should only be used in exceptional cases when IV administration is not feasible.

Storage Conditions Store in a dry place away from light and heat. Keep out of reach of children.

Common Questions about Epitra 2 mg Tablet

• Is Epitra a sleeping pill? No, it is not a sleeping pill but may cause drowsiness.
• Can Epitra be taken long-term? Only as prescribed. Sudden discontinuation may cause seizures to recur.
• What are withdrawal symptoms? Symptoms may include mood changes, sweating, muscle pain, headaches, tremors, anxiety, and agitation.
• Can Epitra cause weight changes? Yes, it may lead to weight gain or loss.
• Does Epitra affect memory? No, but patients may experience difficulty recalling recent events.
• Is overdose dangerous? Overdose may cause severe drowsiness, confusion, and breathing difficulties.
• Can Epitra be taken with zolpidem or quetiapine? These combinations may increase drowsiness and other side effects; consult a doctor before use.

Quick Tips

• Epitra has a high potential for dependence. Take it only as prescribed.
• It may cause dizziness; avoid driving or activities requiring concentration.
• Avoid alcohol as it can increase drowsiness.
• Inform your doctor if you are pregnant, planning pregnancy, or breastfeeding.
• Do not stop taking Epitra suddenly; withdrawal symptoms may occur.