Calm 10 mg (Tablet)

Indications

• Anxiety treatment
• Restlessness relief
• Sleep disturbance management
• Emotional instability therapy
• Adjunctive therapy for epilepsy
• Treatment of psychovegetative and psychosomatic disorders
• Treatment of tension and excitement

Pharmacology

• Binds to distinct binding sites at chloride ionopore
• Increases the duration of time for which the chloride ionopore is open
• Enhances the post-synaptic inhibitory effect of GABA
• Results in hyperpolarization and membrane stabilization

Dosage

• Initial dose of 20 mg clobazam daily for adults and adolescents
• Maintenance dose of 10 to 15 mg clobazam daily for elderly
• Daily dose of 5 to 10 mg clobazam for children from 3 to 15 years of age
• Maximum daily dose of about 80 mg for adults and adolescents

Administration

• Tablets can be administered whole or crushed
• Can be mixed in applesauce
• 10 mg tablets can be divided into equal halves of 5 mg
• Can be taken with or without food

Interaction

• Increased bioavailability when consumed with alcohol
• Potentiating effect with central nervous system depressant drugs
• Increased risk of sedation and respiratory depression when used concomitantly with opioids
• Possible rise in plasma valproic acid concentration when administered with anticonvulsants

Contraindications

• Hypersensitivity to clobazam or any excipients
• Myasthenia gravis
• Severe respiratory insufficiency
• Sleep apnoea syndrome
• Severe impairment of liver function
• Breastfeeding women
• Children between 6 months and 3 years

Side Effects

• Decreased appetite
• Irritability and restlessness
• Somnolence and sedation
• Dizziness and disturbance in attention
• Dry mouth and nausea
• Rash and muscle weakness
• Fatigue and weight increased

Pregnancy & Lactation

• Not recommended during the first trimester of pregnancy
• Limited data available on exposed pregnancies
• Not recommended in breastfeeding women

Precautions & Warnings

• Serious skin reactions
• Respiratory depression
• Muscle weakness
• Renal and hepatic impairment
• Increased sensitivity in elderly patients
• Possible decrease in anticonvulsant efficacy
• Increased risk of suicide and suicidality
• Concomitant use of CYP2C19 inhibitors

Therapeutic Class

• Benzodiazepine hypnotics

Storage Conditions

• Do not use after the date of expiry
• Store below 30°C
• Protect from light
• Keep out of reach of children

Related Brands