A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Mebaral Indications, Dosage, Storage, Stability - Mephobarbital
Mebaral Indications, Dosage, Storage, Stability - Mephobarbital
INDICATIONS
AND USES
MEBARAL is indicated for use as a sedative for the relief of anxiety, tension,
and apprehension, and as an anticonvulsant for the treatment of grand mal and
petit mal epilepsy.
DOSAGE AND ADMINISTRATION
Epilepsy: Average dose for adults: 400 mg to 600 mg (6 grains to 9 grains)
daily; children under 5 years: 16 mg to 32 mg ( 1 / 4 grain
to 1 / 2 grain) three or four times daily; children over
5 years: 32 mg to 64 mg ( 1 / 2 grain to 1 grain) three
or four times daily. MEBARAL is best taken at bedtime if seizures generally
occur at night, and during the day if attacks are diurnal.
Treatment should be started with a small dose which is gradually increased
over four or five days until the optimum dosage is determined. If the patient
has been taking some other antiepileptic drug, it should be tapered off as the
doses of MEBARAL are increased, to guard against the temporary marked attacks
that may occur when any treatment for epilepsy is changed abruptly. Similarly,
when the dose is to be lowered to a maintenance level or to be discontinued,
the amount should be reduced gradually over four or five days.
Special Patient Population. Dosage should be reduced in the elderly
or debilitated because these patients may be more sensitive to barbiturates.
Dosage should be reduced for patients with impaired renal function or hepatic
disease.
Combination with Other Drugs: MEBARAL may be used in combination
with phenobarbital, either in the form of alternating courses or concurrently.
When the two drugs are used at the same time, the dose should be about one-half
the amount of each used alone. The average daily dose for an adult is from 50
mg to 100 mg ( 3 / 4 grain to 1 1 / 2
grains) of phenobarbital and from 200 mg to 300 mg (3 grains to 4 1
/ 2 grains) of MEBARAL.
MEBARAL may also be used with phenytoin sodium; in some cases, combined therapy
appears to give better results than either agent used alone, since phenytoin
sodium is particularly effective for the psychomotor types of seizure but relatively
ineffective for petit mal. When the drugs are employed concurrently, a reduced
dose of phenytoin sodium is advisable, but the full
dose of MEBARAL may be given. Satisfactory results have been obtained
with an average daily dose of 230 mg (3 1 / 2 grains)
of phenytoin sodium plus about 600 mg (9 grains) of MEBARAL.
Sedation: Adults: 32 mg to 100 mg ( 1 / 2
grain to 1 1 / 2 grains) optimum dose, 50 mg (
3 / 4 grain) three to four times daily. Children: 16
mg to 32 mg ( 1 / 4 grain to 1 / 2 grain)
three to four times daily.
HOW SUPPLIED
Tablets white, round, convex and the 32 mg and 50 mg tablets are scored.
32 mg ( 1 / 2 grain), bottles of 250
(NDC 0024-1231-05)
50 mg ( 3 / 4 grain), bottles of 250
(NDC 0024-1232-05)
100 mg (1 1 / 2 grains), bottles of 250
(NDC 0024-1233-05)
Store at room temperature up to 25° C (77° F).
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