6/16/2016

Phenobarbital"DLF"

Phenobarbital "DLF"
phenobarbital

N03AA02

Antiepileptic . Barbiturate.

Applications
Treatment of all types of seizures except absence seizures
withdrawal
Preeclampsia.
See also:
Barbituric (epilepsy)
Withdrawal treatment with sedatives

Dosage Proposal
epilepsy
Adults. 1-2 mg / kg body weight one time. A day at bedtime.
Toddlers. Drench 6-8 mg / kg body weight orally in 2 days, then maintenance dose of 3-4
mg / kg body weight / day in 2 divided doses.
Older children have the same loading dose, but only 1-4 mg / kg body weight / day in 2
divided doses as maintenance treatment.
Note: For children should phenobarbital administered 2 times DGL. Should due. The cognitive
side eects not used for a long time for children.
abstinence
Individually. Usually, 200 mg 3 times. A day initially, later (after 3-5 days) 100 mg DGL.
Note : Specialist Treatment.
General information about dosage suggestions

Contraindications
Poisoning with other barbiturates or opioids, as this can cause life-threatening depression
of the respiratory or vascular center
Severe hepatic impairment
renal impairment
Lung disease characterized by dyspnea or obstruction
porphyria
Alcohol abuse.

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Side eects
Very common (> 10%) Lethargy, Sedation.
Skin rash, urticaria.
Angioedema.
Common (1-10%)

Arthralgia, Osteopenia.
Headache, dizziness.

Uncommon (0.1-1%)

Respiratory depression.

Rare (0.01-0.1%)

Agranulocytosis, anemia, leucopenia, Methaemoglobinaemia,

Thrombocytopenic purpura.
Ataxia, Dyskinesia.

Very rare (<0.01%)

Porphyria.
Stevens-Johnson syndrome, toxic epidermal necrolysis.
Interstitial nephritis, Nephrotic Syndrome.

Long-term treatment is associated with risk of decreased bone mineral density, osteopenia,
osteoporosis and fractures. For this reason it is recommended vitamin D supplements, eg
in the form of a multivitamin tablet.
Risk of cumulation for prolonged use, especially in the elderly.
Addiction can occur after prolonged use.
Irritability, drowsiness or hyperactivity in children.
Described increased bleeding in newborns if the mother is treated with phenobarbital.
See also generally about side eects

Interactions
The respiratory depressant eects of barbiturates potentiated by opioids.
Barbiturates, especially phenobarbital increases through enzyme induction, elimination of
androgens, carbamazepine, ethosuximide, felodipine, glucocorticoids, lamotrigine,
oxcarbazepine, metronidazole, oral anticoagulants, phenytoin, tricyclic antidepressants,
valproic acid and estrogen, thereby reducing the plasma concentration of these substances.
Thus, low-dose hormonal contraceptives become ineective with prolonged use of
barbiturates.
Barbiturates inhibit the hypoglycaemic eect of oral antidiabetics (sulphonylureas).
Barbiturates reduce the eect of theophylline by enzyme induction.
When prolonged treatment with phenobarbital may occur accelerated vitamin D catabolism
and decreased serum concentrations of 25-hydroxyvitamin D, which can lead to
osteomalacia.
Valproate and MAO inhibitors inhibit the metabolism of barbituric at risk of poisoning.
MAO inhibitors potentiate the action of barbiturates.
Dicoumarol and possibly warfarin enhances the clinical eect of phenobarbital.
The eect is enhanced by alcohol, hypnotics, antipsychotics and anti-histamines.
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Phenobarbital"DLF"

Pregnancy
To be used under certain conditions.
Background: There is data about 200 1st trimester-exposed with an increased malformation
rate of approximately 10%, in particular cardiac malformations. Using should be given vitamin
K (phytomenadione 20 mg. A day) prophylactically in the last month of pregnancy.
See also Epilepsy in adults .
see also
Classication - pregnancy

breastfeeding
Do not use. Discrepancy Between medicin.dk and SPC.
Background: The relative weight-adjusted dose is high, ca. 25%. Described sedative side
eects in the child - although relatively rarely.
see also
Classication - breastfeeding

Trac
Caution is advised when motor driving or operating machinery.
See also trac

Blood donor
Do not tapped. (Announces the blood donor corps).
See also blood donors quarantine

Poisoning
See Barbiturates (poisoning) .

pharmacokinetics
Is almost completely absorbed from the gastrointestinal tract.
Bioavailability 80-100%.
Crosses the blood-brain barrier.
Is metabolized in the liver to inactive metabolites.
The process is the microsomal enzyme induction and results in causing a more rapid
degradation by continuous use.
Plasma half-life 3-5 days - in children somewhat shorter and more variable.
Renal elimination is increased by urine alkalinisation .
Therapeutic plasma concentration range is 40-170 micromol / L.
Onset after about 1 hour.
See also Table 1 in Antiepileptic drugs .

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Phenobarbital"DLF"

pharmaceutical
Tablets. 1 tablet contains 15 mg, 50 mg or 100 mg (scoring) phenobarbital.

ingredients
phenobarbital

excipients
other :
Lactose: 15 mg tablets

Company
DLF

subsidies
Conditional reimbursement for the treatment of:
Epilepsy.

For the patients who meet the clause, endorsed prescription with the word "supplement".

Packages, prices, subsidies and extradition

subsidies extradition Disp.form and

Vnr.

Packing

Price in kr.

Price DDD

195.50

13.03

248.60

4.97

325.60

3.26

strengthen
(A)

Tablets 15 mg

085,260 100
pieces.

(A)

Tablets 50 mg

085,269 100
pieces.

(A)

Tablets 100 mg

085,278 100
pieces.

See generally grant

See generally on extradition
See generally on price DDD

Identication and image

Tablets 15 mg

Tablets 50 mg

100 mg Tablets

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Phenobarbital"DLF"

revision Date
2015-05-11. However, prices are valid as. Monday, June 6, 2016
There may be dierences between the preparation description and summary of product and / or package insert.
This is because pro.medicin.dk may have supplemented the Danish Medicines Agency and the manufacturer's
prescribing information with other sources. Pro.medicin.dk has full responsibility for preparation descriptions.

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