Ethisterone
Generic medicine reference
Not yet clinically reviewed
This entry was migrated from the earlier Pharmapedia app bundle and has not been reviewed by a named clinician on this site. It is provided for educational reference only — verify dosage and safety information against current, authoritative sources and a qualified healthcare professional before any clinical use.
Overview
Ethisterone is a progestogen, the first orally hormone active progestin. Female sex hormone administered in cases of progestrone deficiency also called hydrohydroxy-progestron, pregneninolone.
Indications
Ethisterone is primarily indicated in conditions like Endometriosis, Gynaecomastia, Menorrhagia.
Contraindications
Ethisterone
Side Effects
The following events have been reported in association with the use of danazol capsules:
Androgen like effects include weight gain, acne and seborrhea. Mild hirsutism, edema, hair loss, voice change, which may take the form of hoarseness, sore throat or of instability or deepening of pitch, may occur and may persist after cessation of therapy. Hypertrophy of the clitoris is rare.
Other possible endocrine effects are menstrual disturbances including spotting, alteration of the timing of the cycle and amenorrhea. Although cyclical bleeding and ovulation usually return within 60-90 days after discontinuation of therapy with danazol capsules, persistent amenorrhea has occasionally been reported.
Flushing, sweating, vaginal dryness and irritation and reduction in breast size, may reflect lowering of estrogen. Nervousness and emotional lability have been reported. In the male a modest reduction in spermatogenesis may be evident during treatment. Abnormalities in semen volume, viscosity, sperm count, and motility may occur in patients receiving long-term therapy.
Hepatic dysfunction, as evidenced by reversible elevated serum enzymes and/or jaundice, has been reported in patients receiving a daily dosage of danazol capsules of 400 mg or more. It is recommended that patients receiving danazol capsules be monitored for hepatic dysfunction by laboratory tests and clinical observation. Serious hepatic toxicity including cholestatic jaundice, peliosis hepatis, hepatic adenoma, hepatocellular injury, hepatocellular jaundice and hepatic failure have been reported (see WARNINGS and PRECAUTIONS ).
Abnormalities in laboratory tests may occur during therapy with danazol capsules including CPK, glucose tolerance, glucagon, thyroid binding globulin, sex hormone binding globulin, other plasma proteins, lipids and lipoproteins.
The following reactions have been reported, a causal relationship to the administration of danazol capsules has neither been confirmed nor refuted; allergic: urticaria, pruritus and rarely, nasal congestion; CNS effects: headache, nervousness and emotional lability, dizziness and fainting, depression, fatigue, sleep disorders, tremor, paresthesias, weakness, visual disturbances, and rarely, benign intracranial hypertension, anxiety, changes in appetite, chills, and rarely convulsions, Guillain-Barre syndrome; gastrointestinal: gastroenteritis, nausea, vomiting, constipation, and rarely, pancreatitis and splenic peliosis; musculoskeletal: muscle cramps or spasms, or pains, joint pain, joint lockup, joint swelling, pain in back, neck, or extremities, and rarely, carpal tunnel syndrome which may be secondary to fluid retention; genitourinary: hematuria, prolonged posttherapy amenorrhea; hematologic: an increase in red cell and platelet count. Reversible erythrocytosis, leukocytosis or polycythemia may be provoked. Eosinophilia, leukopenia and thrombocytopenia have also been noted. Skin: rashes (maculopapular, vesicular, papular, purpuric, petechial), and rarely, sun sensitivity, Stevens-Johnson syndrome and erythema multiforme; other: increased insulin requirements in diabetic patients, change in libido, myocardial infarction, palpitation, tachycardia, elevation in blood pressure, interstitial pneumonitis, and rarely, cataracts, bleeding gums, fever, pelvic pain, nipple discharge. Malignant liver tumors have been reported in rare instances, after long-term use.
Warnings
Ethisterone should be used with caution in conditions which may be adversely affected by fluid retention, such as in cardiovascular, hepatic and renal disorder, migraine and epilepsy, it is should be avoided in marked cardiac, hepatic or renal dysfunction. Should used with care in diabets mellitas should not be given to patients with undiagnosed gential bleeding or androgen dependent tumors.
High Risk Groups
Drug should not be given to Pregnant Mothers, Cardiac / Hypertensive Patients, patients suffering from Kidney dysfunction, and patients suffering from Liver Malfunction.If prescribing authority justifies the benefits of the drug against the possible damages he/she should reevaluate them and consult the reference material and previous studies.
Adult Dosage
Scraped Dose — Endometriosis. In moderate to severe disease, or in patients infertile due to endometriosis, a starting dose of 800 mg given in two divided doses is recommended. Amenorrhea and rapid response to painful symptoms is best achieved at this dosage level. Gradual downward titration to a dose sufficient to maintain amenorrhea may be considered depending upon patient response. For mild cases, an initial daily dose of 200 mg to 400 mg given in two divided doses is recommended and may be adjusted depending on patient response. Therapy should begin during menstruation. Otherwise, appropriate tests should be performed to ensure that the patient is not pregnant while on therapy with danazol capsules (see CONTRAINDICATIONS and WARNINGS ). It is essential that therapy continue uninterrupted for 3 to 6 months but may be extended to 9 months if necessary. After termination of therapy, if symptoms recur, treatment can be reinstituted.
Hereditary Angioedema. The dosage requirements for continuous treatment of hereditary angioedema with danazol capsules should be individualized on the basis of the clinical response of the patient. It is recommended that the patient be started on 200 mg, two or three times a day. After a favorable initial response is obtained in terms of prevention of episodes of edematous attacks, the proper continuing dosage should be determined by decreasing the dosage by 50% or less at intervals of one to three months or longer if frequency of attacks prior to treatment dictates. If an attack occurs, the daily dosage may be increased by up to 200 mg. During the dose adjusting phase, close monitoring of the patient's response is indicated, particularly if the patient has a history of airway involvement.
Child Dosage
No child dosage information is recorded for this medicine yet.
Neonatal Dosage
No neonatal dosage information is recorded for this medicine yet.
Drug Interactions
No data regarding the interactions of Ethisterone was found.
Storage
No storage information is recorded for this medicine yet.
Available Brands in Pakistan
No brands are recorded for this generic.
