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
Dalmane Indications, Dosage, Storage, Stability - Flurazepam
Dalmane Indications, Dosage, Storage, Stability - Flurazepam
INDICATIONS
Flurazepam hydrochloride
is a hypnotic agent
useful for the treatment of insomnia
characterized by difficulty in failing asleep, frequent nocturnal
awakenings, and/or early morning awakening. Flurazepam hydrochloride
can be used effectively in patients with recurring insomnia
or p.o. sleeping habits,
and in acute or chronic
medical situations requiring
restful sleep. Sleep laboratory
studies have objectively determined that flurazepam hydrochloride
is effective for at least 28 consecutive nights of drug
administration. Since insomnia
is often transient
and intermittent,
short term use is usually
sufficient. Prolonged use of hypnotics is usually not indicated
and should only be undertaken concomitantly with appropriate
evaluation of the
patient.
DOSAGE AND ADMINISTRATION
Dosage should be individualized for maximal beneficial effects.
The usual adult dosage
is 30 mg before retiring.
In some patients, 15 mg
may suffice. In elderly and/or
debilitated patients, 15 mg
is usually sufficient for a therapeutic
response and it is
therefore recommended that therapy be initiated with this dosage.
HOW SUPPLIED
Dalmane (flurazepam hydrochloride) Capsules are available in the following presentations:
15 mg hard gelatin capsules in bottles of 100 (NDC 0187-4051-10), with ICN logo imprinted on the opaque orange cap and DalmaneŽ 15 imprinted on the opaque ivory body.
30 mg hard gelatin capsules in bottles of 100 (NDC 0187-4052-10), with ICN logo imprinted on the opaque red cap and almaneŽ 30 imprinted on the opaque ivory body.
Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F).
REFERENCE
1. Greenblatt DJ, Divoll M, Harmatz JS, MacLauglin DS, Shader RI: Kinetics and clinical effects of flurazepam in young and elderly noninsomniacs. Clin Pharmacol Ther 30:475-486, 1981.
Valeant Pharmaceuticals International, 3300 Hyland Avenue Costa Mesa, California 92626, Tel. 714-545-0100
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