Clonium 0.5 mg

Description

Indications Clonium is prescribed for the treatment of panic disorder, with or without agoraphobia. Panic disorder is characterized by sudden, unexpected panic attacks, along with persistent concerns about experiencing further attacks and their potential consequences.

Additionally, Clonium is used alone or in combination with other treatments for 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 adequately to succinimide medications.

The long-term efficacy of Clonium beyond nine weeks has not been systematically studied in clinical trials. Physicians prescribing Clonium for extended use should periodically assess the continued necessity of the medication for each patient.

Take medication only as directed by a registered physician.

Pharmacology Clonazepam, the active component of Clonium, belongs to the benzodiazepine class and exhibits anticonvulsant, sedative, muscle relaxant, and anxiolytic effects. Its mechanism of action involves enhancing GABAergic neurotransmission at inhibitory synapses by positively modulating the GABA receptor, increasing the efficiency of naturally released GABA.

Animal studies indicate that clonazepam also affects serotonin levels. Electroencephalographic research has demonstrated that clonazepam quickly suppresses various types of abnormal paroxysmal activity, including spike-and-wave discharges seen in absence seizures (petit mal) and other seizure-related abnormalities. These findings support its use in both generalized and focal epilepsies.

Dosage & Administration Oral Administration:

• Adults with seizure disorders: Start with 1.5 mg daily, divided into three doses. Increase the dose in increments of 0.5 to 1 mg every three days until seizures are controlled or side effects prevent further increases. The maximum daily dose should not exceed 20 mg.
• Adults with panic disorder: Start with 0.25 mg daily, divided into two doses. Increase to a target dose of 1 mg per day after three days as needed.
• Pediatric patients: For infants and children (up to 10 years old or 30 kg body weight), the initial dose should be between 0.01 and 0.03 mg/kg/day, not exceeding 0.05 mg/kg/day, divided into two or three doses.

Injection Administration:

• Infants and children: Administer 0.5 mg (half of a vial) via slow IV injection or IV infusion.
• Adults: Administer 1 mg (one vial) via slow IV injection or IV infusion. This dose may be repeated as necessary. Typically, 1-4 mg is sufficient to manage status epilepticus. The injection rate should not exceed 0.25 – 0.5 mg per minute, and the total dose should not exceed 10 mg.

Take medication only as directed by a registered physician.

Drug Interactions

• Clonium does not significantly affect the metabolism of phenytoin, carbamazepine, or phenobarbital.
• The effects of Clonium on the metabolism of other drugs have not been extensively studied.

Contraindications Clonium is contraindicated in patients with:

• A known hypersensitivity to benzodiazepines.
• Significant liver disease.
• Acute narrow-angle glaucoma (though it may be used in open-angle glaucoma with appropriate therapy).

Side Effects Common side effects include:

• Drowsiness (approximately 50% of patients).
• Ataxia (about 30% of patients).
• Behavioral disturbances (around 25% of patients).

Other possible side effects include abnormal eye movements, aphonia, coma, tremors, vertigo, confusion, depression, memory impairment, hallucinations, agitation, changes in libido, insomnia, and palpitations.

Pregnancy & Lactation

• Pregnancy: Some evidence suggests anticonvulsants may have teratogenic effects. Due to potential risks, Clonium should be used during pregnancy only when absolutely necessary. High doses administered during late pregnancy or labor may cause irregular fetal heart rates, hypotonia, respiratory depression, and poor neonatal feeding.
• Lactation: Since small amounts of Clonazepam may be excreted in breast milk, breastfeeding should be discontinued if treatment is essential.

Precautions & Warnings

• In patients with multiple seizure disorders, Clonium may increase the frequency of generalized tonic-clonic seizures. This may necessitate adjusting other anticonvulsant medications.
• Co-administration with valproic acid may lead to absence status epilepticus.
• Special care is required for pediatric patients, as Clonium may increase saliva and bronchial secretions, potentially obstructing the airways.
• Elderly patients may experience stronger pharmacological effects due to age-related physiological changes.
• While renal impairment does not affect Clonium’s metabolism significantly, liver disease may reduce clearance and require dosage adjustments.

Overdose Effects Symptoms of overdose include excessive drowsiness, ataxia, speech difficulties, confusion, nystagmus, respiratory depression, hypotension, and coma. Severe cases require symptomatic treatment and close monitoring. Activated charcoal may help limit absorption if administered early. In cases of severe CNS depression, the benzodiazepine antagonist flumazenil may be considered, but only under strict medical supervision.

Therapeutic Class Clonium belongs to the following drug classes:

• Adjunct anti-epileptic drugs
• Benzodiazepine hypnotics

Reconstitution Instructions

• IV injection: Dilute the vial’s contents with 1 ml of sterile water before administration to prevent vein irritation. Use the solution immediately.
• IV infusion: Dilute one vial (1 mg) in at least 85 ml of an appropriate diluent (e.g., sodium chloride 0.9%, glucose 5%, or glucose 10%). The solution remains stable for 24 hours at room temperature. If using PVC infusion bags, infuse immediately or within four hours.
• IM injection: Should be used only when IV administration is not feasible.

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