Relaxen Tablet

Relaxen Tablet is used for: Agitation, Anxiety, Anaesthesia, Seizures, Insomnia, Muscle spasms, Alcohol withdrawal syndrome

Anxiety 2-10 mg PO q6-12hr, OR 2-10 mg IV/IM q6-12hr; no more than 30 mg/8 hours Alcohol Withdrawal 10 mg PO q6-8hr during first 24hr; reduce to 5 mg PO q6-8hr PRN Initial: 10 mg IV/IM, may give additional doses of 5-10 mg IV q6-8hr as needed Endoscopy IV: Titrate dose to 10 mg or less immediately before procedure, not to exceed cumulative dose of 20 mg; reduce dose of narcotic by one third or omit, OR IM: 5-10 mg 30 minutes before procedure Preoperative Sedation 10 mg IM before surgery Sedation in the ICU 5-10 mg IV 1-2 hours before surgery; 0.03-0.1 mg/kg q30min to 6hr Muscle Spasm 2-10 mg PO q6-8hr PRN, OR 5-10 mg IV/IM initially; THEN q3-4hr if necessary Seizure Disorder 2-10 mg PO q6-12hr as adjunct, OR 0.2 mg/kg PR, repeat after 4-12 hours PRN Status Epilepticus 5-10 mg IV/IM q5-10min; not to exceed 30 mg, OR 0.5 mg/kg PR (using parenteral solution), THEN 0.25 mg/kg in 10 minutes PRN

Sedative/Muscle Relaxant Potentially toxic dose in patients <6 years: >0.5 mg/kg <6 months: Not recommended >12 years 0.12-0.8 mg/kg/day PO divided q6-8hr, OR 0.04-0.2 mg/kg IV/IM q2-4hr; no more than 0.6 mg/kg within 8 hours Status Epilepticus Potentially toxic dose in patients <6 years: >0.5 mg/kg PR 2-6 years: 0.5 mg/kg; may repeat in 4-12 hours PRN 6-12 years: 0.3 mg/kg; may repeat in 4-12 hours PRN >12 years: 0.2 mg/kg; may repeat in 4-12 hours PRN IV 6 months-5 years: 0.2-0.5 mg IV initially, repeat every 2-5 minutes; do not exceed 5 mg; may repeat 2-4 hours later PRN >5 years: 1 mg IV given slowly every 2-5 min; not to exceed 10 mg total dose; may repeat in 2-4 hours if necessary

Renal impairment: Oral: Data not available No dose adjustment recommended unless administered for prolonged period; decrease dose in prolonged periods Rectal gel: Not studied; use caution

May be taken with or without food. IV Preparation Compatibility with D5W, NS, and Ringer's controversial. If infusion is selected, adding the infusion solution to the diazepam injection (and not the other way around) may prevent precipitate formation IV Administration Administer over 3 min; no more than 5 mg/min Monitor respiration q5-15min and before each IV dose Have airway support ready until effects of IV administration are known Rectal Administration Place patient on side facing you with upper leg bent forward, lubricate rectal applicator tip, gently insert syringe tip in rectum and slowly push plunger

Hypersensitivity; myasthenia gravis, preexisting CNS depression or coma, respiratory depression; acute pulmonary insufficiency or sleep apnoea syndrome; severe hepatic impairment; acute narrow angle glaucoma; children <6 mth (oral); pregnancy and lactation.

Impaired renal and hepatic function, respiratory disease, organic cerebral changes, elderly, psychotic patients, epileptics, history of alcohol or drug addiction, impaired gag reflux, obese patients. May cause CNS depression. Discontinue treatment if patient develops psychiatric and paradoxical reactions. Caution when used in patients with depression or anxiety associated with depression, especially if patient has suicidal risk. May increase risk of falls. Safety and efficacy of the inj have not been established in children <1 mth of age. Safety and efficacy of oral use have not been established in children <6 mth of age. Safety and efficacy of rectal gel have not been established in children <2 yr of age. Abrupt withdrawal or large dose reduction may cause rebound or withdrawal symptoms.

Pregnancy Infants born to mothers using benzodiazepines late in pregnancy reported to experience symptoms of sedation and/or neonatal withdrawal Advise pregnant females that use of this medication late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in newborns Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects Neonatal withdrawal and floppy infant syndrome Neonatal withdrawal syndrome and symptoms suggestive of floppy infant syndrome associated with administration of benzodiazepines during the later stages of pregnancy and peripartum period have been reported Benzodiazepines cross the placenta and may produce respiratory depression, hypotonia, and sedation in neonates; monitor neonates exposed to therapy during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems; monitor neonates exposed to therapy during pregnancy for signs of withdrawal; manage these neonates accordingly Animal data Produced increased incidences of fetal malformations in mice and hamsters when given orally at single doses ?100 mg/kg (approximately 20 times maximum recommended adult dose [0.4 mg/kg/day] or greater on mg/m2 basis) Cleft palate and exencephaly are the most common and consistently reported malformations produced in these species by administration of high, maternally-toxic doses of diazepam during organogenesis Administration of benzodiazepines or other drugs that enhance GABAergic inhibition to neonatal rats has been reported to result in widespread apoptotic neurodegeneration in the developing brain at plasma concentrations relevant for seizure control in humans The window of vulnerability to these changes in rats (postnatal days 0-14) includes a period of brain development that takes place during the third trimester of pregnancy in humans Lactation Present in breastmilk Because diazepam and its metabolites may be present in human breast milk for prolonged periods of time after acute use, patients should be advised not to breastfeed for an appropriate period of time after receiving treatment There are no data specifically for diazepam intranasal Reports of sedation, poor feeding and poor weight gain in infants exposed to diazepam through breast milk; there are no data on effects of diazepam on milk production Instruct patients to inform their healthcare provider if they are breastfeeding or plan to breastfeed; instruct breastfeeding patients to monitor their infants for excessive sedation, poor feeding and poor weight gain, and to seek medical attention if they notice these signs Consider developmental and health benefits of breastfeeding along with the mother's clinical need for therapy and any potential adverse effects on breastfed infant therapy or from the underlying maternal condition

May significantly enhance CNS depressant effect w/ antivirals (e.g. amprenavir, ritonavir). May enhance CNS depressant effect w/ anaesth, narcotic analgesics, antidepressants, antipsychotics, anxiolytics, antiepileptics, antihistamines, antihypertensives, muscle relaxants (e.g. tizanidine, baclofen), nabilone. May decrease clearance w/ antibacterials that interfere w/ metabolism by hepatic enzymes (e.g. isoniazid and erythromycin), OC, cimetidine, omeprazole. May increase clearance w/ antibacterials which are known inducers of hepatic enzymes (e.g. rifampicin). May increase serum level w/ disulfiram. May reduce clearance of digoxin. May reduce therapeutic effect w/ theophylline. Reversible deterioration of parkinsonism w/ levodopa.

Side effects of Diazepam : 1-10% Ataxia (3%),Euphoria (3%, rectal gel),Incoordination (3%, rectal gel),Somnolence (>1%),Rash (3%, rectal gel),Diarrhea (4%, rectal gel) Frequency Not Defined Common,Hypotension,Fatigue,Muscle weakness,Respiratory depression,Urinary retention,Depression,Incontinence,Blurred vision,Dysarthria,Headache,Skin rash,Changes in salivation,Serious,Neutropenia,Jaundice Local effects: Pain, swelling, thrombophlebitis, carpal tunnel syndrome, tissue necrosis,Phlebitis if too rapid IV push Potentially Fatal: Respiratory and CNS depression, coma.

Diazepam is a long-acting benzodiazepine w/ anticonvulsant, anxiolytic, sedative, muscle relaxant and amnestic properties. It increases neuronal membrane permeability to Cl ions by binding to stereospecific benzodiazepine receptors on the postsynaptic GABA neuron w/in the CNS and enhancing the GABA inhibitory effects resulting in hyperpolarisation and stabilisation.

Relaxen 5mg Tablet manufactured by Sonear Laboratories Ltd.. Its generic name is Diazepam. Relaxen is availble in Bangladesh. Farmaco BD drug index information on Relaxen Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.