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Generic Name: Phenobarbital (fee-noe-BAR-bih-tal)
Brand Name: CROPRAM
Phenobarbital is used for:
Treating and preventing seizures, and treating sleep
disorders. It may also be used for other conditions as determined
by your doctor. Phenobarbital is a barbiturate. It works by
depressing the central nervous system or brain. In low doses, it
causes mild sedation. As the dose increases, it can cause sleep
and even coma. As it causes the brain to relax, it also decreases
seizure activity.
Do NOT use Phenobarbital if:
you are allergic to any ingredient in Phenobarbital
you have a history of the blood disorder porphyria
you are taking methoxyflurane, sodium oxybate (GHB), or
voriconazole
you consume alcohol
you have liver problems or lung disease with breathing problems
Contact your doctor or health care
provider right away if any of these apply to you.
Before using Phenobarbital:
Some medical conditions may interact with Phenobarbital. Tell your
doctor or pharmacist if
you have any medical conditions, especially if any of the
following apply to you:
if you are pregnant, planning to become pregnant, or are
breast-feeding
if you are taking any prescription or nonprescription medicine,
herbal preparation, or dietary
supplement
if you have allergies to medicines, foods, or other substances
if you have depression, pain, breathing problems, suicidal
tendencies, or are in shock
if you have a history of substance abuse or dependence
Some MEDICINES MAY INTERACT with Phenobarbital. Tell your
health care provider if you are taking any other medicines,
especially any of the following:
Ethanol , MAO inhibitors (eg, phenelzine), quinine, sodium oxybate
(GHB), stiripentol, or valproic acid because side effects such as
increased sedation and difficulty breathing may occur
Ethanol, methoxyflurane, orsodium oxybate because the risk of
their side effects may be increased by PhenobarbitalAnticoagulants
(eg, warfarin), beta-blockers (eg, propranolol), clozapine,
corticosteroids (eg, hydrocortisone), cyclosporine, doxorubicin,
doxycycline, estrogens (eg, estradiol), imatinib, metronidazole,
steroidal contraceptives (eg, birth control pills), theophylline,
or voriconazole because their effectiveness may be decreased by
Phenobarbital.
This may not be a complete list of all interactions that may
occur. Ask your health care provider if Phenobarbital may interact
with other medicines that you take. Check with your health care
provider before you start, stop, or change the dose of any
medicine.
Why is this medication prescribed?
Phenobarbital, a barbiturate, is used to control epilepsy
(seizures) and as a sedative to relieve anxiety. It is also used
for short-term treatment of insomnia to help you fall asleep.This medication is sometimes prescribed for other uses; ask your
doctor or pharmacist for more information.
How to use Phenobarbital:
Use Phenobarbital as directed by your doctor. Check the label on
the medicine for exact
dosing instructions. Take Phenobarbital by mouth with or without
food.Do not suddenly stop taking Phenobarbital or change the dose
without checking with your
doctor. If you miss a dose of Phenobarbital, take it as soon as
possible. If it is almost time for your
next dose, skip the missed dose and go back to your regular dosing
schedule. Do not take 2
doses at once.
ASK YOUR HEALTH CARE PROVIDER ANY
QUESTIONS YOU MAY HAVE ABOUT HOW
TO USE PHENOBARBITAL. IMPORTANT SAFETY INFORMATION:
Side effects from Phenobarbital may occur and include:
drowsiness
headache
dizziness
depression
excitement (especially in children)
upset stomach
omitting

OTHER DETAIL INFORMATION :
Phenobarbital, a long-acting barbiturate, is a central nervous
system depressant. In ordinary doses, the drug acts as a sedative
and anticonvulsant. Its onset of action occurs within 30 minutes,
and the duration of action ranges from 5 to 6 hours. It is
detoxified in the liver.
Phenobarbital is indicated for use as a sedative or
anticonvulsant.
Phenobarbital is contraindicated in patients who are
hypersensitive to barbiturates. In such patients, severe hepatic
damage can occur from ordinary doses and is usually associated
with dermatitis and involvement of parenchymatous organs. A
personal or familial history of acute intermittent porphyria
represents one of the few absolute contraindications to the use of
barbiturates. Phenobarbital is also contraindicated in patients
with marked impairment of liver function, or respiratory disease
in which dyspnea or obstruction is evident. It should not be
administered to persons with known previous addiction to the
sedative/hypnotic group, since ordinary doses may be ineffectual
and may contribute to further addiction.
IN SMALL DOSES, THE BARBITURATES MAY
INCREASE THE REACTION TO PAINFUL STIMULI. TAKEN BY THEMSELVES, THE
BARBITURATES CANNOT BE RELIED UPON TO RELIEVE PAIN OR EVEN TO
PRODUCE SEDATION OR SLEEP IN THE PRESENCE OF SEVERE PAIN.
Barbiturates induce liver microsomal enzyme activity. This
accelerates the biotransformation of various drugs and is probably
part of the mechanism of the tolerance encountered with
barbiturates. Phenobarbital, therefore, should be used with
caution in patients with decreased liver function. This drug
should also be administered cautiously to patients with a history
of drug dependence or abuse (see DRUG ABUSE AND DEPENDENCE ).
Oral Sedative Dose, Adults – 30 to 120 mg daily in 2 or 3 divided
doses. Children – 6 mg/kg of body weight daily in 3 divided doses.
Oral Hypnotic Dose, Adults – 100 to 320 mg.
Oral Anticonvulsant Dose, Adults – 50 to 100 mg 2 or 3 times
daily.
Children – 15 to 50 mg 2 or 3 times daily.
Phenobarbital Tablets USP 15 mg: White, round, unscored,
compressed tablet imprinted “West- ward 445”.
Bottles of 1000 tablets.
Phenobarbital Tablets USP 30 mg: White, round, scored, compressed
tablet imprinted “West- ward 450”.
Bottles of 1000 tablets.
Bottles of 5000 tablets.
Phenobarbital Tablets USP 60 mg: White, round, unscored,
compressed tablet imprinted “WW- 455”.
Bottles of 100 tablets. Bottles of 1000 tablets.
Phenobarbital Tablets USP 100 mg: White, round, scored, compressed
tablet imprinted “WW- 458”.
Bottles of 100 tablets. Bottles of 1000 tablets.
Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature].
Protect from light and moisture.
Dispense in a tight, light-resistant container as defined in the
USP using a child-resistant closure
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