Denixil 2 mg

Description

Indications

Denixil is primarily used for the management of panic disorder, both with and without agoraphobia. This condition is marked by the onset of sudden, unexpected panic attacks accompanied by ongoing concerns about future attacks and their potential consequences.

Additionally, Denixil is prescribed either alone or in combination with other treatments for Lennox-Gastaut Syndrome (petit mal variant), akinetic seizures, and myoclonic seizures. It is also suitable for patients suffering from absence seizures (petit mal) who have not responded adequately to succinimides.

It should be noted that the effectiveness of Denixil for long-term use, beyond 9 weeks, has not been studied in controlled clinical trials. Doctors opting for prolonged use should continually assess its ongoing effectiveness for each patient.

Pharmacology

Clonazepam, the active ingredient in Denixil, shares common pharmacological properties with other benzodiazepines, such as anticonvulsive, sedative, muscle-relaxing, and anxiolytic effects. Its central actions are facilitated through the enhancement of GABAergic neurotransmission at inhibitory synapses. By promoting a stronger binding of GABA to its receptor, Clonazepam amplifies the inhibitory effects of GABA, which results in increased chloride ion flux across the postsynaptic membrane.

In animal studies, Clonazepam has shown effects on serotonin, and electroencephalographic investigations in humans have demonstrated its ability to suppress various types of paroxysmal activity. These include spike and wave discharges seen in absence seizures, generalized spike-wave patterns, and irregular spikes. Clonazepam is particularly effective in suppressing generalized EEG abnormalities.

Dosage & Administration

• Oral Dosage:

  • Adults (Seizure Disorders): Begin with an initial dose of 1.5 mg/day divided into three doses. This can be increased by 0.5 to 1 mg every 3 days, based on the patient’s response, up to a maximum of 20 mg/day.

  • Adults (Panic Disorder): Start with 0.25 mg, divided into two doses. After 3 days, the dose may be increased to a target of 1 mg/day.

  • Pediatric Patients (up to 10 years or 30 kg): The initial dose should be between 0.01 and 0.03 mg/kg/day to minimize drowsiness, with a maximum dose of 0.05 mg/kg/day, divided into two or three doses.

• Injection Dosage:

  • Infants and Children: Administer half a vial (0.5 mg) via slow intravenous (IV) injection or infusion.

  • Adults: Administer 1 vial (1 mg) via slow IV injection or infusion. This dose may be repeated as needed, typically between 1-4 mg for reversing status epilepticus. Ensure that the rate of injection does not exceed 0.25-0.5 mg per minute, with a total dose not exceeding 10 mg.

Interaction

Denixil does not appear to alter the pharmacokinetics of phenytoin, carbamazepine, or phenobarbital. The interaction between Denixil and other drugs has not been fully investigated.

Contraindications

Denixil is contraindicated in patients with a history of hypersensitivity to benzodiazepines, and in those with significant liver disease. It can be used in patients with open-angle glaucoma if they are receiving appropriate therapy, but should be avoided in those with acute narrow-angle glaucoma.

Side Effects

Common side effects of Denixil are typically related to CNS depression. These include drowsiness (in approximately 50% of patients) and ataxia (in about 30%). Over time, some of these effects may diminish. Behavioral problems have been noted in around 25% of patients, while other side effects may include abnormal eye movements, tremors, confusion, depression, amnesia, and hallucinations, among others.

Pregnancy & Lactation

• Pregnancy: Clonazepam may cause congenital malformations and is known to be a teratogen. The drug should only be used during pregnancy if the benefits to the mother outweigh the risks to the fetus. High doses during the third trimester or labor can result in cardiovascular irregularities in the newborn, including hypotonia, hypothermia, and respiratory depression. Withdrawal symptoms may also occur in newborns.

• Lactation: Clonazepam passes into breast milk in small amounts, but it is recommended that mothers using Denixil discontinue breastfeeding.

Precautions & Warnings

In patients with multiple seizure disorders, Denixil may increase the incidence of generalized tonic-clonic seizures. Caution is also needed when combining Denixil with valproic acid, as this combination may result in absence status.

Use in Special Populations

• Pediatric Use: In younger children and infants, Denixil may cause increased salivation and bronchial secretion. Care should be taken to maintain clear airways.

• Geriatric Use: Older adults may experience more pronounced pharmacological effects due to age-related changes in drug-receptor interactions and organ function.

• Renal Impairment: No dose adjustment is necessary for patients with renal impairment.

• Hepatic Impairment: In patients with liver cirrhosis, Clonazepam’s plasma protein binding is altered, potentially reducing the clearance of the drug. Close monitoring is recommended.

Overdose Effects

Overdose symptoms of Denixil may include drowsiness, ataxia, nystagmus, and in severe cases, coma. Life-threatening conditions are rare unless Denixil is taken with other CNS depressants. Immediate medical attention should be sought, and supportive measures should be provided.

Treatment of Overdose: Activated charcoal may be administered within 1-2 hours to prevent further absorption, and flumazenil, a benzodiazepine antagonist, may be used under closely monitored conditions if CNS depression is severe.

Therapeutic Class

Denixil belongs to the adjunct anti-epileptic drug class and is also classified as a benzodiazepine hypnotic.

Reconstitution for Injection

• IV Injection: Dilute the contents of the vial with 1 ml of water for injection to avoid irritation. Administer slowly while monitoring EEG, respiration, and blood pressure.
• IV Infusion: Dilute with at least 85 ml of suitable diluent (e.g., sodium chloride 0.9% or glucose 5%). Use within 4 hours if using PVC infusion bags, and do not use sodium bicarbonate as it may cause precipitation.

Storage Conditions

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

Chemical Structure

• Molecular Formula: C15H10ClN3O3
• Chemical Structure: Clonazepam

Common Questions about Denixil 2 mg Tablet

• Is Denixil 2 mg Tablet a sleeping pill?
  Denixil is not prescribed as a sleep aid, as it may actually cause sleep disturbances.

• Can Denixil be used for the long term?
  You should follow your doctor’s advice on the duration of treatment.

• What happens when Denixil is stopped?
  Withdrawal symptoms may include mood changes, anxiety, muscle pain, and tremors.

• Does Denixil cause weight gain?
  Denixil may cause weight fluctuations in some patients.