Indications
Evalin Tablet is used for:
Agitation, Anxiety, Anaesthesia, Seizures, Insomnia, Muscle spasms, Alcohol withdrawal syndrome
Adult Dose
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
Elderly: Should not exceed half the adult dose.
Hepatic impairment: Dose reduction may be required.
Child Dose
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 Dose
Renal impairment: Dose reduction may be required.
Administration
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
Contra Indications
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.
Precautions
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.
Lactation: Enters breast milk; not recommended
Pregnancy-Lactation
Pregnancy category: D
Lactation: Enters breast milk; not recommended
Minor tranquilizers should be avoided in first trimester of pregnancy due to increased risk of congenital malformations
Maternal use shortly before delivery is associated with floppy infant syndrome (good and consistent evidence)
Prenatal benzodiazepine exposure slightly increased oral cleft risk (limited or inconsistent evidence)
Interactions
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
Side effects of Diazepam :
1-10%
Atax (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.
Mode of Action
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.
Note
Evalin 5mg Tablet generic name is Diazepam. Evalin 5mg Tablet is manufactured by Aristopharma LimitedEvalin is availble in all over Bangladesh.
Mes BD drug index information on Evalin Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.