Clepam 1 mg (Tablet)

Indications

• Treatment of panic disorder with or without agoraphobia
• Treatment of Lennox-Gastaut Syndrome
• Treatment of akinetic and myoclonic seizures
• Adjunct in the treatment of absence seizures (petit mal)
• Long-term use effectiveness not systematically studied
• Physician reevaluation for extended periods use

Pharmacology

• Exhibits anticonvulsive effects
• Exhibits sedative effects
• Exhibits muscle relaxing effects
• Exhibits anxiolytic effects
• Enhancement of GABAergic neurotransmission
• Positive allosteric modulation of GABA receptors

Dosage and administration

• Initial adult dose for seizure disorders not exceeding 1.5 mg/day divided into three doses
• Adult initial dose for panic disorder at 0.25 mg given in two divided doses
• Pediatric initial dose between 0.01 and 0.03 mg/kg/day up to a maximum of 0.05 mg/kg/day
• Infants and children dosage for injection is half or 0.5 mg, adults dosage for injection is 1 mg
• Recommended maximum daily dose is 20 mg

Interaction

• No alteration of phenytoin pharmacokinetics
• No alteration of carbamazepine pharmacokinetics
• No alteration of phenobarbital pharmacokinetics
• Effect on metabolism of other drugs not investigated

Contraindications

• Hypersensitivity to benzodiazepines
• Clinical or biochemical evidence of significant liver disease
• Contraindicated in acute narrow angle glaucoma

Side effects

• Frequently occurring side effects are referable to CNS depression
• Common occurrence of drowsiness in approximately 50% of patients
• Common occurrence of ataxia in approximately 30% of patients
• Other side effects include abnormal eye movements, aphonia, coma, tremor, vertigo, confusion, depression, amnesia, hallucinations, hysteria, and more

Pregnancy and lactation

• Potential for producing congenital malformations
• Evidence of anticonvulsant drugs acting as teratogens
• Administer only if potential benefits outweigh the risk to the fetus
• High doses in the last trimester or during labor can cause irregularities in the heartbeat of the unborn child and other effects
• Active ingredient found to pass into maternal milk in small amounts

Precautions and warnings

• May increase the incidence of generalized tonic-clonic seizures in certain patients
• Concomitant use with valproic acid may produce absence status
• In infants and small children, may cause increased production of saliva and bronchial secretion
• Greater pharmacologic effects in elderly patients

Special population use

• Increased pharmacologic effects in elderly patients
• Renal impairment does not affect pharmacokinetics
• No dose adjustment required in patients with renal impairment
• Plasma protein binding significantly different in cirrhotic patients
• Clearance of unbound Clonazepam might be reduced in liver cirrhosis

Overdose effects

• Common symptoms include drowsiness, ataxia, dysarthria, and nystagmus
• Overdose seldom life-threatening when taken alone
• May lead to areflexia, apnea, hypotension, cardiorespiratory depression, and coma
• Increased frequency of seizures at supratherapeutic plasma concentrations
• Respiratory depressant effects more serious in patients with respiratory disease

Therapeutic class

• Adjunct anti-epileptic drugs
• Benzodiazepine hypnotics

Reconstitution

• Contents of vial must be diluted with 1 ml of water for injection prior to administration
• IV injection should be administered slowly with continuous monitoring of EEG, respiration, and blood pressure
• Clepam can be diluted for infusion in different diluting media
• Intramuscular route should be used only in exceptional cases or if IV administration is not feasible

Storage conditions

• Keep in a dry place away from light and heat
• Keep out of the reach of children

Chemical structure

• Molecular formula: C15H10ClN3O3

Common questions

• Clepam 1 mg Tablet is not used as a sleeping pill as it might cause difficulty in sleeping
• Take Clepam 1 mg Tablet as long as the doctor has advised to avoid seizures recurrence
• Common symptoms after stopping Clepam 1 mg Tablet include difficulty in sleeping, changes in mood, increased sweating, muscle pain, headache, shaking, feeling restless, and more
• Pay attention to sudden changes in mood, behaviors, thoughts, or feelings to look for early symptoms of suicidal thoughts and actions
• Clepam 1 mg Tablet may cause weight gain and weight loss, consult the doctor before consuming it
• Clepam 1 mg Tablet does not affect memory, but may cause partial recall of the recent past
• Overdose can cause sleepiness, change in speech, confusion, abnormalities in eye movement, avoid combination with zolpidem and quetiapine
• The addiction / habit-forming potential of Clepam 1 mg Tablet is very high, and may cause dizziness, avoid consuming alcohol, consult the doctor if pregnant or planning to conceive and breastfeeding, and do not stop taking Clepam 1 mg Tablet suddenly without talking to the doctor

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