Calm10 mg

Calm 10 mg is a benzodiazepine used for:

• Adjunctive (add-on) treatment of seizures associated with Lennox-Gastaut syndrome, in patients 2 years of age or older
• Adjunctive treatment for other seizure types, including generalized or partial seizures, and Dravet syndrome, in some clinical settings, alongside other antiepileptic medicines
• Short-term treatment of anxiety, in some markets where it is approved for this use

Calm 10 mg's approved indications vary by country; confirm the specific approved use for the product dispensed with the prescribing physician.

Contains Calm 10 mg as the active ingredient, available as oral tablets, commonly in 10 mg and 20 mg strengths, and, in some markets, 5 mg tablets or an oral suspension.

Calm 10 mg is a benzodiazepine medicine used as an add-on treatment alongside other antiepileptic medicines to help control seizures in certain seizure disorders, including Lennox-Gastaut syndrome. In some countries, it is also used for short-term treatment of anxiety. It works by enhancing the calming effect of a natural brain chemical, which helps reduce abnormal electrical activity in the brain that leads to seizures, and produces sedative and anti-anxiety effects.

Therapeutic Class: Anticonvulsant / Anxiolytic (Benzodiazepine)

Calm 10 mg is metabolized in the liver to an active metabolite, N-desmethylCalm 10 mg, which itself has significant anticonvulsant activity and a longer half-life than the parent drug. Serum concentrations of Calm 10 mg and its active metabolite take approximately 5 and 9 days respectively to reach steady state, which is why dose increases are not made more often than weekly. Patients who are poor metabolizers of the CYP2C19 enzyme may have higher levels of the active metabolite and may require lower doses.

• Tablets may be swallowed whole, broken in half along the score line, or crushed and mixed with a small amount of soft food (such as applesauce), depending on the specific product
• Can be taken with or without food
• Take doses at consistent times each day
• Do not stop taking Calm 10 mg suddenly without medical advice, due to the risk of withdrawal reactions and, in patients being treated for seizures, increased seizure risk

The following should be assessed by a healthcare professional before combining with Calm 10 mg:

• Other central nervous system depressants, including opioids, other benzodiazepines, sedating antihistamines, and alcohol, which increase the risk of profound sedation, respiratory depression, coma, and death when combined with Calm 10 mg
• Strong inhibitors or inducers of CYP3A4 and CYP2C19 enzymes, which can raise or lower Calm 10 mg and its active metabolite's blood levels
• Hormonal contraceptives, whose effectiveness may be reduced by Calm 10 mg; an additional non-hormonal method of contraception is generally recommended
• Other antiepileptic drugs, since dose adjustments of Calm 10 mg or the other medicine may be needed based on interactions and combined sedative effects

Common side effects

• Sedation or drowsiness
• Somnolence in children specifically treated for seizures
• Constipation
• Drooling (more common in pediatric patients)
• Ataxia (unsteadiness) or lethargy
• Fever, particularly in pediatric patients

Serious side effects (seek urgent medical attention)

• Signs of a severe skin reaction: rash, blistering, peeling skin, especially in combination with fever - can be life-threatening (Stevens-Johnson syndrome and related reactions have been reported)
• Signs of severe respiratory depression, especially if combined with other sedating substances
• Paradoxical reactions: increased agitation, aggression, or hyperactive behaviour, particularly in children or elderly patients
• Signs of physical dependence or withdrawal after stopping abruptly: increased seizures, tremor, anxiety, hallucinations
• Suicidal thoughts or behaviour (a risk associated with antiepileptic drugs as a class)

Pregnancy

Benzodiazepines including Calm 10 mg may cause fetal harm, and use late in pregnancy has been associated with floppy infant syndrome and neonatal withdrawal symptoms. Calm 10 mg should be used during pregnancy only if the treating physician determines the benefit clearly outweighs the risk, since untreated seizure disorders themselves pose a risk to mother and fetus; do not stop antiepileptic treatment without medical guidance.

Breastfeeding

Calm 10 mg and its active metabolite pass into breast milk; the nursing infant should be monitored for sedation and feeding difficulties, and use should be discussed with a healthcare professional.

• CNS depression and respiratory depression: Increased risk when combined with other sedating substances; use extreme caution with concurrent opioids.
• Serious skin reactions: Stevens-Johnson syndrome and other severe cutaneous reactions have been reported, particularly in the first 8 weeks of treatment; discontinue immediately if a rash develops.
• Dependence and withdrawal: Physical dependence can occur, particularly with prolonged use; taper the dose gradually rather than stopping abruptly.
• Suicidal thoughts and behaviour: Antiepileptic drugs as a class carry an increased risk; monitor for mood changes, particularly at the start of treatment or during dose changes.
• Use with caution in patients with hepatic or renal impairment, and in elderly or debilitated patients, who may require lower doses.
• Avoid abrupt discontinuation, particularly in patients being treated for seizures, due to the risk of withdrawal seizures or status epilepticus.

Overdose may cause pronounced drowsiness, confusion, impaired coordination, slowed or difficult breathing, and, in severe cases, coma. The risk of severe or fatal outcome is significantly increased when Calm 10 mg is combined with alcohol or other central nervous system depressants, particularly opioids. Suspected overdose is a medical emergency requiring immediate care; do not attempt home treatment.

Store at room temperature, protected from moisture and light, as directed on the product label. Keep out of reach of children, and store securely given the potential for misuse.

• Elderly: More sensitive to sedative effects; a lower starting dose and careful titration are generally recommended.
• Hepatic impairment: Requires dose reduction in mild to moderate impairment; use is generally avoided or approached with great caution in severe impairment.
• Renal impairment: Use with caution; specific dose adjustment should be confirmed with the prescribing physician.
• CYP2C19 poor metabolizers: May have higher levels of the active metabolite and may require a lower starting dose and slower titration.

For seizure disorders, Calm 10 mg is typically used as long-term, ongoing adjunctive therapy, with the dose reviewed periodically by the treating specialist. For short-term anxiety treatment where approved, use is generally limited to a few weeks, given the risk of dependence with prolonged benzodiazepine use. Any discontinuation should be gradual, under medical supervision.

Drug Class: 1,5-Benzodiazepine

Calm 10 mg enhances the effect of gamma-aminobutyric acid (GABA), the brain's main inhibitory (calming) neurotransmitter, at GABA-A receptors. This increases inhibitory signaling in the brain, which raises the seizure threshold (making seizures less likely to occur) and produces sedative, muscle-relaxant, and anti-anxiety effects.

Calm 10 mg is established for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in children 2 years of age and older, with weight-based dosing as shown in the dosage table. Somnolence, drooling, and fever have been reported more frequently in pediatric patients than in adults. Use in children for other indications, or below 2 years of age, should only occur under specialist guidance.