Epitra 0.5 mg

Description

Indications

Epitra is prescribed for the treatment of panic disorder, with or without agoraphobia. Panic disorder is characterized by sudden, unexpected panic attacks accompanied by ongoing concern about experiencing further attacks and worry about their implications or consequences.

Epitra is also used alone or as an adjunctive therapy in the treatment of Lennox-Gastaut Syndrome (petit mal variant), akinetic seizures, and myoclonic seizures. Additionally, it may be indicated for patients with absence seizures (petit mal) who have not responded to succinimide therapy.

The effectiveness of Epitra for long-term use beyond nine weeks has not been systematically evaluated in controlled clinical trials. Physicians considering prolonged use should periodically reassess the drug’s continued benefit for each patient.

Take this medication only as prescribed by a registered physician.

Pharmacology Clonazepam, the active ingredient in Epitra, belongs to the benzodiazepine class and exhibits anticonvulsant, sedative, muscle relaxant, and anxiolytic properties. It enhances the activity of gamma-aminobutyric acid (GABA), an inhibitory neurotransmitter, by increasing the receptor’s affinity for GABA, resulting in enhanced chloride ion flux and neuronal inhibition.

Animal studies suggest that clonazepam may also influence serotonin levels. Electroencephalographic (EEG) studies indicate that clonazepam rapidly suppresses various types of paroxysmal activity, including spike-and-wave discharges associated with absence seizures, generalized and focal spike-wave abnormalities, and irregular spike-wave patterns. These effects contribute to its efficacy in treating both generalized and focal epilepsies.

Dosage & Administration

Oral Administration:

• Adults with Seizures: Initial dose should not exceed 1.5 mg/day, divided into three doses. Dosage may be increased in increments of 0.5 to 1 mg every three days until seizures are controlled or side effects prevent further dosage increases. The maximum recommended daily dose is 20 mg.
• Adults with Panic Disorder: The initial dose is 0.25 mg, divided into two doses daily. It may be increased to 1 mg/day after three days, depending on patient response.
• Pediatric Patients: Infants and children (up to 10 years or weighing up to 30 kg) should begin with 0.01 to 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) via slow IV injection or IV infusion.
• Adults: 1 mg (one vial) via slow IV injection or IV infusion. This may be repeated as needed, with typical doses ranging from 1-4 mg. The maximum total dose should not exceed 10 mg. IV administration should not exceed 0.25-0.5 mg per minute.

Take this medication only as prescribed by a registered physician.

Drug Interactions Epitra does not significantly alter the pharmacokinetics of phenytoin, carbamazepine, or phenobarbital. However, its effects on the metabolism of other drugs have not been fully studied.

Contraindications Epitra should not be used in individuals with hypersensitivity to benzodiazepines or in those with significant liver disease. It may be used in patients with open-angle glaucoma under appropriate therapy but is contraindicated in acute narrow-angle glaucoma.

Side Effects Common side effects include drowsiness (in approximately 50% of patients), ataxia (in about 30%), and behavioral changes (in roughly 25%). Other possible adverse effects include abnormal eye movements, confusion, depression, memory disturbances, hallucinations, sleep disturbances, tremors, and palpitations.

Pregnancy & Lactation

• Pregnancy: Clonazepam may have teratogenic effects. The decision to use it during pregnancy should be based on a risk-benefit assessment by the physician. High doses during the last trimester or labor may cause fetal heart irregularities, respiratory depression, hypotonia, and feeding difficulties.
• Lactation: Clonazepam is excreted in breast milk in small amounts. Breastfeeding should be avoided if treatment is necessary.

Precautions & Warnings

• In patients with multiple seizure types, Epitra may increase the incidence of generalized tonic-clonic seizures, requiring dose adjustments or additional anticonvulsant therapy.
• Concomitant use with valproic acid may induce absence status.
• Special caution is advised in elderly patients due to heightened benzodiazepine sensitivity.

Use in Special Populations

• Pediatric Use: May increase saliva and bronchial secretions, necessitating airway management.
• Geriatric Use: Effects are more pronounced in elderly patients.
• Renal Impairment: No dose adjustment required.
• Hepatic Impairment: Reduced clearance may occur in cirrhotic patients.

Overdose Effects Overdose symptoms include drowsiness, ataxia, speech difficulties, confusion, nystagmus, hypotension, respiratory depression, and, in severe cases, coma. Monitoring of vital signs and supportive care is essential. Gastric lavage and activated charcoal may be administered within 1-2 hours of ingestion. Flumazenil, a benzodiazepine antagonist, may be used under close medical supervision.

Therapeutic Class Benzodiazepine hypnotics, Adjunct anti-epileptic drugs

Reconstitution & Administration

• IV Injection: Dilute vial contents with 1 ml of water for injection. Administer slowly while monitoring EEG, respiration, and blood pressure.
• IV Infusion: Dilute one vial (1 mg) with at least 85 ml of an appropriate diluent (e.g., sodium chloride 0.9%, glucose 5%) and administer within 24 hours.
• IM Injection: Use only if IV administration is not possible.

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

Common Questions

• Is Epitra a sleeping pill? No, it is not intended as a sleep aid.
• Can Epitra be used long-term? Use should be as directed by a physician, and long-term use requires periodic evaluation.
• Does Epitra cause weight changes? It may cause weight gain or loss in some individuals.
• Can Epitra be taken with zolpidem or quetiapine? These combinations should be avoided due to increased risk of side effects.

Quick Tips

• Epitra has a high potential for dependence. Use only as prescribed.
• Avoid driving or operating heavy machinery until its effects are known.
• Alcohol should be avoided as it may enhance drowsiness.
• Do not stop Epitra suddenly without consulting a doctor, as withdrawal symptoms may occur.