ANADROL-50- oxymetholone tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OXYMETHOLONE (UNII: L76T0ZCA8K) (OXYMETHOLONE - UNII:L76T0ZCA8K)

Available from:

Alaven Pharmaceutical LLC

INN (International Name):

OXYMETHOLONE

Composition:

OXYMETHOLONE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Anadrol® -50 Tablets is indicated in the treatment of anemias caused by deficient red cell production. Acquired aplastic anemia, congenital aplastic anemia, myelofibrosis and the hypoplastic anemias due to the administration of myelotoxic drugs often respond. Anadrol® -50 Tablets should not replace other supportive measures such as transfusion, correction of iron, folic acid, vitamin B12 or pyridoxine deficiency, antibacterial therapy and the appropriate use of corticosteroids. Controlled Substance: ANADROL®-50 Tablets is considered to be a controlled substance and is listed in Schedule III.

Product summary:

ANADROL®-50 (oxymetholone) Tablets is supplied in bottles of 100 (NDC 68220-055-10) white scored tablets embossed with 0055 and ALAVEN. Keep out of reach of children. Dispense in a tight, light-resistant container.

Authorization status:

New Drug Application

Summary of Product characteristics

ANADROL-50- OXYMETHOLONE TABLET
ALAVEN PHARMACEUTICAL
----------
ANADROL
-50 (OXYMETHOLONE) 50 MG TABLETS
RX ONLY CIII
DESCRIPTION
Anadrol
-50 (oxymetholone) Tablets for oral administration each contain 50 mg
of the steroid
oxymetholone, a potent anabolic and androgenic drug.
The chemical name for oxymetholone is
17β-hydroxy-2-(hydroxymethylene)-17-methyl-5α-androstan-3-
one. The structural formula is:
Inactive Ingredients- lactose, magnesium stearate, povidone, starch
CLINICAL PHARMACOLOGY
Anabolic steroids are synthetic derivatives of testosterone. Nitrogen
balance is improved with anabolic
agents but only when there is sufficient intake of calories and
protein. Whether this positive nitrogen
balance is of primary benefit in the utilization of protein-building
dietary substances has not been
established. Oxymetholone enhances the production and urinary
excretion of erythropoietin in patients
with anemias due to bone marrow failure and often stimulates
erythropoiesis in anemias due to deficient
red cell production.
Certain clinical effects and adverse reactions demonstrate the
androgenic properties of this class of
drugs. Complete dissociation of anabolic and androgenic effects has
not been achieved. The actions of
anabolic steroids are therefore similar to those of male sex hormones
with the possibility of causing
serious disturbances of growth and sexual development if given to
young children. They suppress the
gonadotropic functions of the pituitary and may exert a direct effect
upon the testes.
INDICATIONS AND USAGE
Anadrol
-50 Tablets is indicated in the treatment of anemias caused by
deficient red cell production.
Acquired aplastic anemia, congenital aplastic anemia, myelofibrosis
and the hypoplastic anemias due to
the administration of myelotoxic drugs often respond. Anadrol
-50 Tablets should not replace other
supportive measures such as transfusion, correction of iron, folic
acid, vitamin B
or pyridoxine
deficiency, antibacterial therapy and the appropriate use of
corticosteroids.
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