Brands: Cyclomen, Danol
Androgen ( synthetic )
Pregnancy risk category X
Drug is contraindicated during pregnancy. Patient must have negative
pregnancy test immediately before therapy starts, and should use nonhormonal
contraceptive method during therapy.
patient becomes pregnant during therapy, discontinue drug and inform her of
potential fetal risk.
Drug may cause thromboembolism and thrombotic events, including
life-threatening or fatal stroke.
With long-term use, drug may cause peliosis hepatis and benign hepatic
adenoma. Use lowest dosage that provides adequate protection.
Drug has been linked to benign intracranial hypertension (pseudotumor
cerebri). Screen for early signs and symptoms, including headache, nausea,
vomiting, and visual disturbances.
axis, probably through a combination of depressed hypothalamic-pituitary
response to reduced estrogen production, altered sex hormone metabolism, and
interactions with sex hormone receptors
Capsules: 50 mg, 100 mg,
amenable to hormonal management
Adults and adolescents:
400 mg P.O. b.i.d. for up to 9 months. in milder cases, 100 to 200 mg P.O.
b.i.d. initially, with dosage adjustments based on patient response.
Fibrocystic breast disease
Adults and adolescents:
100 to 200 mg P.O. b.i.d. for 2 to 6 months
Adults adolescents: 200 mg
P.O. two to three times daily. If possible, decrease dosage by 50% or less q
1 to 3 months. If acute angioedema attack occurs, increase dosage up to 200
• Precocious puberty
• Hypersensitivity to drug
• Abnormal GU tract bleeding
• Severe hepatic, renal, or
• Pregnancy or breastfeeding
Use cautiously in:
• coronary artery disease,
conditions aggravated by edema
• mild to moderate hepatic
• Verify that patient isn't
pregnant before initiating therapy. Start therapy during menstruation.
• Don't give to female of
childbearing age unless she's willing and able to use barrier contraception
• Give with food or milk.
CNS: headache, tremor,
emotional lability, irritability, nervousness, anxiety, depression, sleep
disorders, epilepsy exacerbation, benign intracranial hypertension
CV: increased blood
pressure, palpitations, tachycardia, thrombotic events, myocardial
EENT: cataracts, blurred
vision, nasal congestion, papilledema
GI: nausea, vomiting,
constipation, indigestion, gastroenteritis, anorexia, pancreatitis
GU: hematuria; amenorrhea;
menstrual cycle disturbances (spotting, altered cycle); anovulation; vaginal
dryness; changes in breast size; clitoral enlargement; testicular atrophy;
abnormalities in semen volume, viscosity, mobility, and sperm count;
erythrocyctosis, eosinophilia, polycythemia, thrombocytosis, leukocytosis,
leukopenia, thrombocytopenia, splenic peliosis
jaundice, peliosis hepatitis, hepatic adenoma, malignant hepatic tumor
insulin requirement (in diabetic patients)
cramps, spasms, pain, or fasciculations; joint pain and swelling; joint
"lock-up"; pain in back, neck, or limbs, carpal tunnel syndrome
Skin: acne, hirsutism,
oily skin, rash, photosensitivity, yellowing of skin and sclera,
pigmentation changes, seborrhea, sweating
Other: weight gain, edema,
deepening of voice, Stevens-Johnson syndrome
Carbamazepine: increased carbamazepine blood level
increased blood levels of these drugs, increase risk of nephrotoxicity
Insulin, oral hypoglycemics:
increased blood glucose level and insulin resistance, necessitating
adjustment of insulin or oral hypoglycemic dosages
Creatine kinase, glucagon, glucose, hepatic enzymes, low-density
lipoproteins, plasma proteins, sex hormone-binding globulins: increased
Glucose tolerance, thyroid
function: altered test results
Assess for early indications of benign intracranial hypertension, such as
headache, nausea, vomiting, and visual disturbances. Screen for papilledema;
if present, refer patient to neurologist immediately.
Watch for hepatic problems. Long-term use is linked to peliosis hepatitis
and hepatic tumors, which may be silent until complicated by acute,
life-threatening intra-abdominal hemorrhage
• Monitor patient for
thromboembolism and thrombophlebitis.
• Check CBC with white cell
differential and liver and kidney function test results regularly.
• Advise female of childbearing
age to use barrier contraception, because drug causes fetal abnormalities.
• Inform female patient that drug
frequently causes amenorrhea after 6 to 8 weeks of therapy.
female patient to report masculinizing effects, such as facial hair or
deepening of voice.
• Tell male patient that drug may
cause sperm reduction during therapy.
patient to promptly report signs and symptoms of fluid retention (swelling
of ankles, feet, or hands; difficulty breathing; sudden weight gain), change
in urine or stool color, yellowing of eyes and skin, and easy bruising or
• As appropriate, review all
other significant and life-threatening adverse reactions and interactions,
especially those related to the drugs, tests, and herbs mentioned above.