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CYCLOMEN is a brand name for Danazol, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE Endometriosis: Cyclomen (danazol) is indicated for the treatment of endometriosis associated symptoms and/or to reduce the extent of endometriotic foci. Cyclomen may be used either in conjunction with surgery or, as sole hormonal therapy, in patients not responding to other treatments. Benign…
Verbatim from this product's HC label. Tap a section to expand.
Danazol is for oral administration only. Danazol should be given as a continuous course, dosage being adjusted according to the severity of the condition and the patient’s response. A reduction in dosage once a satisfactory response has been achieved may prove possible.
Therapy should begin during menstruation. Otherwise, appropriate tests should be performed to ensure that the patient is not pregnant while on Cyclomen (danazol) therapy. An effective non-hormonal method of contraception should be used during the complete course of therapy.
Regular menstrual patterns, irregular menstrual patterns and amenorrhea each occur in approximately one-third of patients treated with 100 mg of Cyclomen. Irregular menstrual patterns and amenorrhea are observed more frequently with higher doses.
The treatment course should be limited to three to six months maximum.
Endometriosis:
Clinical effectiveness has been achieved with total daily doses of Cyclomen ranging from 200 to 800 mg in two to four divided doses and administered without interruption for 3 to 6 months. If at the lower doses, an anovulatory and amenorrheic state is not achieved and if the symptomatology is not relieved in 30 to 60 days, the dose should be increased.
In patients with severe presenting symptomatology, the usual starting dose is 800 mg daily. The maximum recommended daily dose is 800 mg. It is essential that therapy continue uninterrupted for 3 to 6 months. Shorter courses of therapy have been used as adjuncts to surgery.
After termination of therapy, if symptoms recur, treatment can be reinstated.
Fibrocystic Breast Disease:
The total daily dose of Cyclomen ranges from 100 to 400 mg given in two divided doses depending upon patient response. Pain and tenderness usually respond to treatment after 30-40 days. Nodularity usually does not begin to regress until 60- 90 days after initiation of therapy.
Treatment should continue uninterrupted until complete disappearance of symptoms or for six months, whichever occurs first. Clinical studies have demonstrated that approximately 50% of patients may show evidence of recurrence of symptoms within one year.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
In this event, treatment may be reinstated. 12 STORAGE AND STABILITY Store at 15-30ºC, in a dry place.
AVAILABILITY Cyclomen (danazol) is available in blisters as follows:
Hard pink gelatin capsules containing 50 mg of danazol, with “D50" on the cap and on the body; blisters of 100. Hard bicolour (grey cap/white body) gelatin capsules containing 100 mg of danazol, with "D100" on the cap and on the body; blisters of 100.
Hard bicolour (orange cap/white body) gelatin capsules containing 200 mg of danazol with “D200” on the cap and on the body; blisters of 100. Cyclomen is a Schedule F drug. 13 CHEMISTRY Danazol is a synthetic steroid derived from ethisterone.
5 Chemical Name: 17α-pregna-2, 4-dien-20-yno[2,3,-d]-isoxazol-17-ol.
Composition: 50 mg Capsules:
Each capsule contains 50 mg danazol and as non-medicinal ingredients, maize starch, red iron oxide, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide. 100 mg Capsules: Each capsule contains 100 mg danazol and as non-medicinal ingredients, maize starch, black iron oxide, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide.
200 mg Capsules: Each capsule contains 200 mg danazol and as non-medicinal ingredients, maize starch, red iron oxide, yellow iron oxide, gelatin, lactose monohydrate, magnesium stearate, talc and titanium dioxide. 14 PHARMACOLOGY Pharmacology in Animals: Laboratory studies have shown danazol to have marked pituitary gonadotropin inhibitory activity without overt sex hormonal activity when administered orally in a variety of bio-assays.
Danazol was shown to have no estrogenic or progestational activity and to possess minimal, impeded androgenic activity. In vitro experiments have shown that danazol inhibits the biosynthesis of progesterone and estradiol-17β by cultured porcine granulosa cells and of progesterone by cultured porcine luteal cells (Tsang et al.
1979). This inhibition of steroidogenesis by danazol has further been shown to involve a step distal to gonadotropin-receptor interaction and adenosine- 3',5'-cyclic monophosphate formation (Menon et al. 1980), most likely by inhibiting enzymes involved in steroid biosynthesis (Barbieri et al.
1977, Tsang et al. 1979). Pituitary inhibitory activity has been demonstrated in female rats and rhesus monkeys and in male rats. In reproductively mature female rats, danazol given daily for 2 weeks orally, produced a dose-related reduction in ovarian weights and a reduction in the percentage of vaginal estrus days.
Subcutaneous or oral administration daily for 2 weeks inhibited compensatory ovarian hypertrophy in unilaterally ovariectomized female rats. Daily oral administration to mature, regularly cycling female rhesus monkeys beginning on day 1 of the menstrual cycle produced a dose-related reduction in the number of monkeys which menstruated and in the number of menstrual cycles which occurred during treatment.
Danazol was active orally in preventing pregnancy in mated female rats at dose levels which inhibit pituitary function and was an effective oral contraceptive in the female rhesus monkey when administered at 200 or 400 mg daily. In intact male rats, danazol reduced the weight of the testes, ventral prostate and seminal vesicles in short-term medication studies (2 weeks) and when medication was given orally up to one year.
In castrated or hypophysectomized male rats, danazol administered orally showed minimal androgenic activity. When administered concurrently with androgens or gonadotropin, danazol inhibited the stimulatory action of high dosage levels of these agents but did not inhibit the effects of lower […]