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Safety Advices
বাংলা
English
UNSAFE
It is unsafe to consume alcohol with Sedapen.
CONSULT YOUR DOCTOR
Sedapen is unsafe to use during pregnancy as there is definite evidence of risk to the developing baby. However, the doctor may rarely prescribe it in some life-threatening situations if the benefits are more than the potential risks. Please consult your doctor.
CONSULT YOUR DOCTOR
Sedapen is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby.
UNSAFE
Sedapen may cause side effects which could affect your ability to drive.
Sedapen can make you sleepy, forgetful, and have poor co-ordination. This may affect your ability to drive.
CAUTION
Sedapen should be used with caution in patients with kidney disease. Dose adjustment of Sedapen may be needed. Please consult your doctor.
Dose adjustment may be required if it is to be given for a long period
CAUTION
Sedapen should be used with caution in patients with liver disease. Dose adjustment of Sedapen may be needed. Please consult your doctor.
Medicine Overview of Sedapen 5mg Tablet
Introduction
Sedapen is a prescription medicine used in the treatment of short-term anxiety. It can also be used to treat acute alcohol withdrawal, to relieve muscle spasm and as adjunctive therapy for seizures. This medicine relaxes the nerve cells and calms the brain. Sedapen may be taken with or without food. However, take it at the same time each day as this helps to maintain a consistent level of medicine in the body. Take this medicine in the dose and duration as advised by your doctor as it has a high potential of habit-forming. If you have missed any doses, take...
... Show moreUses of Sedapen
- Short term anxiety
- Alcohol withdrawal
- Muscle spasm
- Epilepsy
Side effects of Sedapen
Common
- Fatigue
- Impaired coordination
- Drowsiness
- Muscle weakness
How to use Sedapen
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Sedapen may be taken with or without food, but it is better to take it at a fixed time.
How Sedapen works
Sedapen is a benzodiazepine. It works by increasing the action of a chemical messenger (GABA) which suppresses the abnormal and excessive activity of the nerve cells in the brain.
What if you forget to take Sedapen?
If you miss a dose of Sedapen, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.
Quick Tips
- Sedapen helps treat short term anxiety.
- Safety of this medicine is not established for long-term use. Do not use it for more than 4 weeks.
- The addiction / habit-forming potential of this medicine is very high. Take it only as per the dose and duration advised by your doctor
- It may cause dizziness. Do not drive or do anything that requires mental focus until you know how this medicine affects you.
- Avoid consuming alcohol as it may increase dizziness and drowsiness.
- Inform your doctor if you are pregnant, planning to conceive or breastfeeding.
- Do not stop taking medication suddenly without talking to your doctor as that may lead to nausea, anxiety, agitation, flu-like symptoms, sweating, tremor, and confusion.
Brief Description
Indication
Agitation, Anxiety, Anaesthesia, Seizures, Insomnia, Muscle spasms, Alcohol withdrawal syndrome
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
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...
... Show moreChild Dose
Sedative/Muscle Relaxant Potentially toxic dose in patients 0.5 mg/kg 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 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...
... Show moreRenal Dose
Renal impairment: Dose reduction may be required.
Contraindication
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.
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.
Precaution
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...
... Show moreSide Effect
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.
Pregnancy Category Note
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)
Interaction
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.
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