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BTG PHARMACEUTICALS
OXANDRIN3
oxandrolone tablets
Revised. May 1996
tS
DESCRIPTION
Oxandrin" oral tablets contain 2 5 mg ol the anabolic steroid
oxandrolone Oxandrolone is 17|l-hydroxy-l7*(-methyl-2-oxa-5a-
androslan-3-one
Inactive ingredients include cornstarch, lactose, magnesium
siearale. and hydroxypropyl melhylcellulose
CLINICAL PHARMACOLOGY
Cerlain clinical eflects and adverse reac
androgenic properties ol litis class of drugs. Compute dissociation ol anabolic and androgenic eflects has nol been achieved
The actions ol anabolic steroids are therefore similar to those ol
wrth and sexual development it given lo young
children. Anabolic steroids suppress the gonadotropic functions
ol lhe pHurtary and may exert a direct elfecl jpon the lestes.
During exogenous administration of anabolic androgens,
endogenous lestosterone release is inhibited through inhibition
ol ptluitary luteinizing hormone (LH) Al large doses, spermatogenesis may Be suppressed through feedback inhibition ol pituitary follicle-stimulating hormone (FSH)
Anabolic steroids have been reported to increase low-density
lipoproteins and decrease high-density lipoproteins. These levels revert lo normal on discontinuation ot Ireatmenl
INDICATIONS AND USAGE
Oxandrin is indicated as adjunctive therapy to promote weight
gam alter weight loss following extensive surgery, chronic infections, or severe trauma, and in some palients who without deli-
nite pathophysiologic reasons fait to gain or to maintain normal
weight, le offset the protein calabolism associated with prolonged administration ol corticosteroids, and lor Ihe relief of the
bone pain frequently accompanying osteoporosis (See
DOSAGE AND ADMINISTRATION)
DRUG ABUSE AND DEPENDENCE
Oxandrolone is dassllied as a controlled substance under the
Anabolic Steroids Control Act ol 1990 and has been assigned
lo Schedule III (non-narcotic)
CONTRAINDICATIONS
1. Known or suspected carcinoma ot lhe prostate or the
3 Pregnancy. Because ol possible masculiniiation ol the
lelus Oxandnn has been shown to cause embryotox icily,
letotoxicity. infertility, and masculmudlion oi lemale
animal oltspnng when given in doses 9 limes the human
4 Nephrosis, lhe nephrotic phase ol nephritis
5. Hypercalcemia
WARNINGS
PEL/OS'S HEPATIS. A CONDITION IN WHICH LIVER AND
SOMETIMES SPLENIC TISSUE IS REPLACED WITH
BLOOD-FILLED CYSTS. HAS BEEN REPORTED IN
PATIENTS RECEIVING ANDROGENIC ANABOLIC
STEROID THERAPY THESE CYSTS ARE SOMETIMES
PRESENT WITH MINIMAL HEPATIC DYSFUNCTION. BUT
AT OTHER TIMES THEY HAVE BEEN ASSOCIATED
WITH LIVER FAILURE THEY ARE OFTEN NOT RECOGNIZED UNTIL LIFE-THREATENING LIVER FAILURE OR
INTRAABDOMINAL HEMORRHAGE DEVELOPS WITHDRAWAL OF DRUG USUALLY RESULTS IN COMPLETE
DISAPPEARANCE OF LESIONS
LIVER CELL TUMORS ARE ALSO REPORTED MOST
OFTEN THESE TUMORS ARE BENIGN AND ANDRO-
GEN-DEPENDENT. BUT FATAL MALIGNANT TUMORS
HAVE BEEN REPORTED WITHDRAWAL OF DRUG
OFTEN RESULTS IN REGRESSION OR CESSATION OF
PROGRESSION OF THE TUMOR HOWEVER. HEPATIC
TUMORS ASSOCIATED WITH ANDROGENS OH ANABOLIC STEROIDS ARE MUCH MORE VASCULAR THAN
OTHER HEPATIC TUMORS AND MAY BE SILENT UNTIL
LIFE-THREATENING INTRA-ABDOMINAL HEMOR
RHACE DEVELOPS BLOOD LIPID CHANGES THAT ABE
KNOWN TO BE ASSOCIATED WITH INCREASED RISK
OF ATHEROSCLEROSIS ARE SEEN IN PATIENTS
TREATED WITH ANDROGENS OR ANABOLIC
STEROIDS. THESE CHANGES INCLUDE DECREASED
HIGH-DENSITY LIPOPROTEINS AND SOMETIMES
INCREASED LOW-DENSITY LIPOPROTEINS THE
CHANGES MAY BE VERY MARKED AND COULD HAVE
A SERIOUS IMPACT ON THE RISK OF ATHEROSCLEROSIS AND CORONARY ARTERY DISEASE
Cholestatic hepatitis and jaundice may occur with 17-alpha-
alkylated androgens al a relatively low dose If cholestalic hepatitis with jaundice appears or if liver function tests Become
abnormal, oxandrolone should be discontinued and fhe etiology
should be determined. Drug-induced jaundice is reversible when
In patients with Breasl cancer, anabolic steroid therapy may
cause hypercalcemia by stimulating osteolysis. Oxandrolone
therapy should Be discontinued if hypercalcemia occurs.
Edema wilh or without congestive head failure may be a serious complication in patienis with preexisting cardiac, renal, or
hepatic disease. Concomitant adminislration ol adrenal cortical
steroid or ACTH may increase the edema
In children, androgen therapy may accelerate Bone maturation wilhoul producing compensatory gam in linear growth. This
adverse effect results in compromisea aduH height The younger
Ihe child, the greater the risk ol compromising final mature
height The effect on Bone maturation should be monitored By
assessing Bone age ot Ihe tell wrist and hand every 6 months
i See PRECAUTIONS: Laboratory tests)
Geriatric patienis trealed wilh androgenic anabolic sleroids
may be al an increased risk for the development ol prostatic
hypertrophy and prostatic carcinoma.
ANABOLIC STEROIDS HAVE NOT BEEN SHOWN TO
ENHANCE ATHLETIC ABILITY.
PRECAUTIONS
Women should be observed lor signs ol viriWalion (deepening
ol the voice, hirsutism, acne, clitoromegaly). Discontinualion ol
drug therapy at the time of evidence ol mild virilism is necessary
to prevenl irreversible virilization Some virilizing changes in
therapy and are nol prevented by concomitant use ol estrogens.
Menstrual irregularities may also occur.
Anabolic sleroids may cause suppression ol dotting factors II.
V, VII, and X, and an increase in prothrombin time.
Information lor patient*:
The physician should instruct patienis to report any ol Ihe following side eftects ol androgens:
Males: Too frequenf or persisleni erections of Ihe penis.
appearance or aggravation ol acne.
I, changes in menstrual periods.
All palients: Nausea, vomiting, changes in skin color, or ankle
h'Cw
quent determination ot urine and serum calcium levels during
the course ol therapy (See WARNINGS)
Because of the hepatotoxicity associated with Ihe use of 17-
alpha-alkylated androgens, liver function tests should be
obtained periodically.
Periodic (every 6 months) x-ray examinations ol bone age
should be mate during treatment ol children ti
the epiphyseal centers.
Serum lipids and high-density lipoprotein cholesterol determinations should be done periodically as androgenic anabolic
steroids have been reported to increase low-densily lipoproteins.
Serum cholesterol levels may increase during therapy Therefore,
caution is required when administering these agents to palients
with a history ol myocardial infarction or coronary artery disease
Serial determinations of serum cholesterol should be made and
therapy adiusted accordingly
Hemoglobin and hematocrit should be checked periodically lor
polycythemia in palients who are receiving high doses ol ana-
D| goi t'yiK-qlytornic
Anabolic sleroids may increase sensitivity to oral antKoagulants
Dosage of the anticoagulant may have lo be decreased in order
lo maintain desired prothrombin time Patients receiving oral anb-
coagulanl therapy require close monitoring, especially when
anabolic sleroids are started or stopped
Oral hypoglycemic agents:
Oxandrolone may inhibit lh<
Adrenal steroids or ACTH:
In patients with edema, conr*omrtant administration with adrenal
cortical steroids or ACTH may increase the edema
Drugtaboralory test interactions:
Anabolic steroids may decrease levels ol thyroxine-binding globulin, resulting in decreased total T, serum levels and increased
resin uptake ol T3 and T,. Free thyroid hormone levels remain
unchanged In addition, a decrease m PBi and radioactive iodine
uptake may occur
Carcinogenesis, mutagenesis, impairment ol fertility
Oxandrolone has not been tested in laboratory ami
cmogenic or mutagenic effecis In 2-year chrome I
ies. a dose-related reduction ol speri
organ weights (testes, prostate,
uterus, adrenals, and pituitary) wen
Liver cell tumors have been reported in patients receiving long-
term therapy with androgenic anabolic steroids in high doses
(See WARNINGS) Withdrawal ol the drugs did not lead to
regression ol Ihe tumors in al cases.
Geriatric patients trealed wilh androgenic anabolic sleroids
may be al an increased risk tor the development ot proslalic
hypertrophy and prostatic carcinoma.
milk Because of the potential ol senous adverse reactions in
nursing mtanis Irom oxandrolone. a decision should be made
whether to discontinue nuising oi lo discontinue the drug, taking into account the importance ol the drug to the mother
Pediatric use:
Anabolic agents may accelerate epiphyseal maturation more
rapidly than linear growth in children and the effect may continue
lor 6 months alter the drug has been stopped Therefore, therapy
should be moniiored by x-ray studies at 6-rnonlh intervals in
order to avoid the risk ol compromising adult heighl Androgenic
anabolic steroid therapy should be usasd very cautiously in children and only by specialists who are aware ol the etfects on
bone maturation (See WARNINGS)
ADVERSE REACTIONS
The following adverse reactions have been associated with use
ot anabolic steroids:
Hepatic: Cholestatic laundice with, rarely, hepalic necrosis and
death Hepatocellular neoplasms and poliosis hepatis with long-
term therapy (See WARNINGS) Reversible changes in liver
function tests also occur including increased bromsulfophihatom
(BSP) reiention, and increases in serum bilirubin, aspartate
aminotransferase (AST, SGOT) and aid
Prepubertal: Phalhc enlargement and increased frequency or
PostptJMHlal IrJutHtioii ol testicular lunclion. ti
and oligospermia, impotence, chronic priapis
and bladder imiability
Hematologic. Bleeding in pi
...,.„;l.r:
Breasl: Gynecomastia
Larynx Deepening of the voice in females.
Hair. Hirsutism and male pattern baldness in females.
Skin: Acne (especially in females and prepubertal males).
Skeletal: Premature closure of epiphyses in children (See PRECAUTIONS: Pediatric use)
Fluid and electrotyles Edema, retention of serum electrolytes
(sodium chloride, potassium, phosphale, calcium)
Metabolic/Endocrine: Decreased glucose tolerance (See PRECAUTIONS: Laboratory tests), increased creatinine excretion,
increased serum levels ot creatinine phosphoklnase (CPK)
Masculinr-ration ol the lelus Inhibition ol gonadotropin secretion
No symptoms or signs
OVERDOSAGE
is known, but gaslhc lavage
DOSAGE ANO ADMINISTRATION
Therapy with anabolic steroids is adjunctive to and not a replace
men! lor conventional therapy. The duration of therapy wilh
Oxandrin (oxandrolone) will depend on Ihe response ol the
patient and Ihe possible appearance ol adverse reactions.
Therapy should be intermittent
*4oUtts:The usual adult dosage ol Oxandrin is one 2 5-mg tablet
2 to 4 times daitv However, the response ol indMduals lo ana-
o< as title as 2.5 mg or
B 2(1 m
if therapy ol 2 lo 4
response. /
adequate. This may tn
Children: For cnildren the total daily dosage ol Oxandrin is
SO.! mg per kilogram body weight or - o 045 mg per pound of
body we#it. This may be repeated intermittently as indfoaled
d scored with BTG
>t the scoredne on the other
side, bottles ol 100 (NDC 54396-1 11-11)
Caution: Federal law prohibits dispensing without presenption
Manufactured fee BTG Pharmaceuticals try:
G.D Searle S Co.
Chicago. IL 60680
Address mettcal inquiries fo
BTG Pharmaceuticals
Medical Attairs
BTG PHARMACEUTICALS
OIN960411-0401
BTG PHARMACEUTICALS
OXANDRIN"
oxandrolone tablets
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