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Pronunciation |
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(floo
oks i MES te
rone) |
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U.S. Brand
Names |
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Halotestin® |
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Generic
Available |
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Yes |
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Pharmacological Index |
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Androgen |
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Use |
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Replacement of endogenous testicular hormone; in females, used as palliative
treatment of breast cancer; stimulation of erythropoiesis, angioneurotic edema,
postpartum breast engorgement |
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Restrictions |
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C-III |
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Pregnancy Risk
Factor |
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X |
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Contraindications |
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Serious cardiac disease, liver or kidney disease, hypersensitivity to
fluoxymesterone or any component; pregnancy |
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Warnings/Precautions |
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May accelerate bone maturation without producing compensatory gain in linear
growth in children; in prepubertal children perform radiographic examination of
the hand and wrist every 6 months to determine the rate of bone maturation and
to assess the effect of treatment on the epiphyseal centers |
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Adverse
Reactions |
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>10%:
Males: Priapism
Females: Menstrual problems (amenorrhea), virilism, breast soreness
Cardiovascular: Edema
Dermatologic: Acne
1% to 10%:
Males: Prostatic carcinoma, hirsutism (increase in pubic hair growth),
impotence, testicular atrophy
Cardiovascular: Edema
Gastrointestinal: GI irritation, nausea, vomiting
Genitourinary: Prostatic hypertrophy
Hepatic: Hepatic dysfunction
<1%:
Males: Gynecomastia
Females: Amenorrhea
Hypercalcemia, leukopenia, polycythemia, hepatic necrosis, cholestatic
hepatitis, hypersensitivity reactions |
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Overdosage/Toxicology |
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Symptoms of overdose include abnormal liver function tests, water
retention |
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Drug
Interactions |
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Decreased effect:
Fluphenazine effectiveness with anticholinergics
Barbiturate levels and decreased fluphenazine effectiveness when given
together
Increased toxicity:
Anticoagulants: Fluoxymesterone may suppress clotting factors II, V, VII, and
X; therefore, bleeding may occur in patients on anticoagulant therapy
Cyclosporine: May elevate cyclosporine serum levels
Insulin: May enhance hypoglycemic effect of insulin therapy
May decrease blood glucose concentrations and insulin requirements in
patients with diabetes
With ethanol, effects of both drugs may increase
EPSEs and other CNS effects may increase when coadministered with lithium
May potentiate the effects of narcotics including respiratory depression
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Stability |
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Protect from light |
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Mechanism of
Action |
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Synthetic androgenic anabolic hormone responsible for the normal growth and
development of male sex hormones and development of male sex organs and
maintenance of secondary sex characteristics; synthetic testosterone derivative
with significant androgen activity; stimulates RNA polymerase activity resulting
in an increase in protein production; increases bone
development |
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Pharmacodynamics/Kinetics |
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Absorption: Oral: Rapid
Protein binding: 98%
Metabolism: In the liver
Half-life: 10-100 minutes
Elimination: Enterohepatic circulation and urinary excretion (90%)
Halogenated derivative of testosterone with up to 5 times the activity of
methyltestosterone |
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Usual Dosage |
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Adults: Oral:
Hypogonadism: 5-20 mg/day
Delayed puberty: 2.5-20 mg/day for 4-6 months
Female:
Inoperable breast carcinoma: 10-40 mg/day in divided doses for 1-3 months
Breast engorgement: 2.5 mg after delivery, 5-10 mg/day in divided doses for
4-5 days |
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Monitoring
Parameters |
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In prepubertal children, perform radiographic examination of the head and
wrist every 6 months |
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Test
Interactions |
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Decreased levels of thyroxine-binding globulin; decreased total T4
serum levels; increased resin uptake of T3 and
T4 |
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Mental Health: Effects
on Mental Status |
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None reported |
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Mental Health:
Effects on Psychiatric
Treatment |
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May cause leukopenia; use caution with clozapine and
carbamazepine |
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Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
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No information available to require special precautions |
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Dental Health:
Effects on Dental Treatment |
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No effects or complications reported |
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Patient
Information |
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Take as directed; do not discontinue without consulting prescriber. Diabetics
should monitor serum glucose closely and notify prescriber of changes; this
medication can alter hypoglycemic requirements. You may experience acne, growth
of body hair, loss of libido, impotence, or menstrual irregularity (usually
reversible); nausea or vomiting (small frequent meals, frequent mouth care,
sucking lozenges, or chewing gum may help). Report changes in menstrual pattern;
deepening of voice or unusual growth of body hair; fluid retention (swelling of
ankles, feet, or hands, difficulty breathing, or sudden weight gain); change in
color of urine or stool; yellowing of eyes or skin; unusual bruising or
bleeding; or other adverse reactions. Pregnancy/breast-feeding
precautions: Inform prescriber if you are pregnant and do not get pregnant
during or for 1 month following therapy. Consult prescriber for instruction on
appropriate barrier contraceptive measures. This drug may cause severe fetal
defects. Do not breast-feed. |
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Nursing
Implications |
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In prepubertal children, perform radiographic examination of the head and
wrist every 6 months |
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Dosage Forms |
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Tablet: 2 mg, 5 mg, 10 mg |
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