Cloma Tablet

Clonazepam
1mg
Biopharma Ltd.
Pack size 50's pack
Dispensing mode
Source
Agent
Retail Price 8.00 AED

Indications

Cloma Tablet is used for: Panic disorder, Epilepsy, Tardive dyskinesia, Restless leg syndrome, Rapid eye movement, Burning mouth syndrome Panic disorder, with or without agoraphobia. Epilepsy and other seizure disorders including status epilepticus. As an adjunct or refractory cases in the management of myoclonic and akinetic seizures, petit mal variant (Lennox-Gastaut syndrome) and infantile spasm. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam may be useful. Clonazepam is may also an option for treating tardive dyskinesia, restless leg syndrome, rapid eye movement and burning mouth syndrome.

Adult Dose

Oral Epilepsy Adult: Initially, 1 mg given at night for 4 days, gradually increased over 2-4 weeks. Maintenance: 4-8 mg/day. Max: 20 mg/day. Panic disorder Adult: Initially, 0.25 mg bid, increased after 3 days up to 1 mg/day. Max: 4 mg/day. Intravenous Emergency management of status epilepticus Adult: 1 mg by slow IV inj over at least 2 min or by infusion, repeated if necessary. Max: 20 mg.

Child Dose

Oral Epilepsy Child: <10 yr or <30 kg: Initially, 0.01-0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in 2 or 3 divided doses. May be increased by no more than 0.25-0.5 mg every 3rd day until seizure control is achieved. Maintenance: 0.1-0.2 mg/kg/day divided 3 times daily. Max: 0.2 mg/kg/day. >10 years or >30 kg 1.5 mg/day PO divided 8 hourly; increase by 0.5-1 mg every 3rd day until desired effect achieved; not to exceed 20 mg/day Maintenance: 2-8 mg PO; not to exceed 20 mg/day Intravenous Emergency management of status epilepticus Child: 500 mcg by slow IV inj or by infusion.

Renal Dose

Administration

May be taken with or without food.

Contra Indications

Patients who are hypersensitive to other benzodiazepines, this drug, or to any ingredient in the formulation. Severe respiratory insufficiency Severe hepatic impairment as benzodiazepines, may precipitate hepatic encephalopathy. Sleep apnea syndrome Myasthenia gravis Narrow angle glaucoma

Precautions

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. The use of benzodiazepines, including Clonazepam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing Clonazepam and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction. The continued use of benzodiazepines, including Clonazepam, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of Clonazepam after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Clonazepam or reduce the dosage Use caution in COPD, sleep apnea, renal/hepatic disease, open-angle glaucoma (questionable), depression, suicidal ideation Not recommended in patients with depressed neuroses, psychotic reactions, severe respiratory depression, myasthenia gravis (allowable in limited circumstances), acute alcohol intoxication Anterograde amnesia reported benzodiazepine use May cause CNS depression and impairs ability to perform hazardous tasks Hyperactive or aggressive behavior reported with benzodiazepines in pediatric/adolescent patients and in psychiatric patients Increased risk of suicidal thoughts/behavior reported with antiepileptic agents; monitor patient for suicidal behavior and notify health-care provider immediately Use with caution in patients with a history of drug abuse or acute alcoholism; drug dependency possible; prolonged use may result in psychological and physical dependence Use with caution in patients with compromised respiratory function May have porphyrogenic effect; use with caution in patients with porphyria Not for concomitant administration with alcohol or other CNS-depressant drugs When used in patients in whom several different types of seizure disorders coexist, clonazepam may increase incidence or precipitate onset of generalized tonic-clonic seizures (grand mal); may require addition of appropriate anticonvulsants or increase in dosages; concomitant use of valproic acid and clonazepam may produce absence status Abrupt withdrawal, particularly in patients on long-term, high-dose therapy, may precipitate status epilepticus; when discontinuing clonazepam, gradual withdrawal essential; while being gradually withdrawn, simultaneous substitution of another anticonvulsant may be indicated Use of drug, particularly in patients at elevated risk, necessitates counseling about risks and proper use of drug along with monitoring for signs and symptoms of abuse, misuse, and addiction; do not exceed recommended dosing frequency Avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (eg, opioid analgesics, stimulants); advise patients on proper disposal of unused drug; if a substance use disorder is suspected, evaluate patient and institute (or refer them for) early treatment, as appropriate For patients using treated more frequently than recommended, to reduce risk of withdrawal reactions, use a gradual taper to discontinue therapy (a patient-specific plan should be used to taper the dose) Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months May produce increase in salivation; consider before giving drug to patients who have difficulty handling secretions In some studies, up to 30% of patients who initially responded have shown a loss of anticonvulsant activity, often within 3 months of administration; in some cases, dosage adjustment may reestablish efficacy Paradoxical reactions, such as agitation, irritability, aggression, anxiety, anger, nightmares, hallucinations, and psychoses may occur when using benzodiazepines; discontinue therapy, should this occur; paradoxical reactions are more likely to occur in children and in the elderly

Pregnancy-Lactation

Pregnancy There are no adequate and well-controlled studies of Klonopin in pregnant women; available human data on risk of teratogenicity are inconclusive; there is insufficient evidence in humans to assess effect of benzodiazepine exposure during pregnancy on neurodevelopment; administration of benzodiazepines immediately prior to or during childbirth can result in a syndrome of hypothermia, hypotonia, respiratory depression, and difficulty feeding; in addition, infants born to mothers who have taken benzodiazepines during later stages of pregnancy can develop dependence, and subsequently withdrawal, during the postnatal period Data for other benzodiazepines suggest possibility of adverse developmental effects (long-term effects on neurobehavioral and immunological function) in animals following prenatal exposure to benzodiazepines Lactation Effects on breastfed infant and on milk production are unknown; developmental and health benefits of breastfeeding should be considered along with mother's clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition

Interactions

Additive depressant effect w/ TCAs, MAOIs, sedative and hypnotics, barbiturates, anxiolytics, antipsychotics, and opiate agonists. May increase serum phenytoin levels. Contraindicated (0) Serious (32) apalutamide benzhydrocodone/acetaminophen buprenorphine subdermal implant buprenorphine transdermal buprenorphine, long-acting injection calcium/magnesium/potassium/sodium oxybates carbamazepine conivaptan fentanyl fentanyl intranasal fentanyl iontophoretic transdermal system fentanyl transdermal fentanyl transmucosal fexinidazole hydrocodone idelalisib ivosidenib lonafarnib methohexital metoclopramide intranasal oliceridine olopatadine intranasal opicapone remifentanil selinexor sodium oxybate sufentanil SL thalidomide tolcapone tucatinib valerian zuranolone

Adverse Effects

Side effects of Clonazepam : >10% Somnolence (37%) 1-10% Abnormal coordination (5-10%),Ataxia (5-10%),Depression (5-10%),Dizziness (5-10%),Fatigue (5-10%),Memory impairment (5-10%),Upper respiratory infection (5-10%),Confusion (1-5%),Dysarthria (1-5%),Rhinitis (1-5%),Coughing (1-5%),Urinary frequency (1-5%),Impotence (1-5%),Decreased libido (1-5%) Frequency Not Defined Increased salivation,Worsening tonic-clonic seizures Potentially Fatal: Salivary or bronchial hypersecretion leading to respiratory problems (children). May produce diminished reflexes or coma. Rarely, blood dyscrasias.

Mechanism of Action

Clonazepam reduces the nerve transmission in the motor cortex which suppresses the spike and wave discharge in absence seizures. Its mechanism is believed to be related to its ability to enhance the activity of GABA. Clinically, it improves focal epilepsy and generalised seizures.

Note

Cloma 1mg Tablet manufactured by Biopharma Ltd.. Its generic name is Clonazepam. Cloma is availble in Bangladesh. Farmaco BD drug index information on Cloma Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

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