ALPRAZOLAM- alprazolam tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

ALPRAZOLAM (UNII: YU55MQ3IZY) (ALPRAZOLAM - UNII:YU55MQ3IZY)

Verfügbar ab:

Lake Erie Medical DBA Quality Care Products LLC

INN (Internationale Bezeichnung):

ALPRAZOLAM

Zusammensetzung:

ALPRAZOLAM 0.5 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Alprazolam tablets are contraindicated in patients with known sensitivity to this drug or other benzodiazepines. Alprazolam may be used in patients with open angle glaucoma who are receiving appropriate therapy, but is contraindicated in patients with acute narrow angle glaucoma. Alprazolam is contraindicated with ketoconazole and itraconazole, since these medications significantly impair the oxidative metabolism mediated by cytochrome P450 3A (CYP3A) (see  WARNINGS and  PRECAUTIONS:  Drug Interactions).

Produktbesonderheiten:

Alprazolam tablets, USP for oral administration are available as: 0.25 mg:  Oval, white tablets debossed GG 256 on one side and scored on the reverse side and supplied as: 0.5 mg: Oval, peach tablets debossed GG 257 on one side and scored on the reverse side and supplied as: 49999-039-30 49999-039-60 49999-039-90 1 mg: Oval, blue tablets debossed GG 258 on one side and scored on the reverse side and supplied as:

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

ALPRAZOLAM - ALPRAZOLAM TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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DESCRIPTION SECTION
DESCRIPTION
Alprazolam is a triazolo analog of the 1,4 benzodiazepine class of
central nervous
system-active compounds. The chemical name of alprazolam is
8-Chloro-1-methyl-6-
phenyl-4_H_-_s_-triazolo [4,3-α] [1,4] benzodiazepine.
Alprazolam is a white to off-white crystalline powder, which is
soluble in alcohol but
which has no appreciable solubility in water at physiological pH.
Each alprazolam tablet, for oral administration, contains 0.25, 0.5,
or 1 mg of
alprazolam. Inactive ingredients: docusate sodium, lactose
monohydrate, magnesium
stearate, microcrystalline cellulose, pregelatinized starch, and
sodium benzoate.
Additionally, the 0.5 MG also contains FD and C Yellow #6 Aluminum
Lake, and the 1
MG also contains FD and C Blue #2 Aluminum Lake.
Alprazolam tablets are contraindicated in patients with known
sensitivity to this drug or
other benzodiazepines. Alprazolam may be used in patients with open
angle glaucoma
who are receiving appropriate therapy, but is contraindicated in
patients with acute
narrow angle glaucoma.
Alprazolam is contraindicated with ketoconazole and itraconazole,
since these
medications significantly impair the oxidative metabolism mediated by
cytochrome P450
3A (CYP3A) (see WARNINGS and PRECAUTIONS: Drug Interactions).
Side effects to alprazolam tablets, if they occur, are generally
observed at the beginning
of therapy and usually disappear upon continued medication. In the
usual patient, the
most frequent side effects are likely to be an extension of the
pharmacological activity of
alprazolam, eg, drowsiness or light-headedness.
The data cited in the two tables below are estimates of untoward
clinical event incidence
among patients who participated under the following clinical
conditions: relatively short
duration (ie, four weeks) placebo-controlled clinical studies with
dosages up to 4 mg/day
of alprazolam (for the management of anxiety disorders or for the
short-term relief