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Product
Anti-asthmatic Products (Aerocort Inhaler)
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Danogen (Danazol Capsules)
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Danogen
Danazol Capsules
Danogen-200 Capsules - Each capsule contains Danazol USP 200 mg
Description
Danogen suppresses the pituitary-ovarian axis by inhibiting output of pituitary gonadotrophins in both male and female. The only other demonstrable hormonal effect is weak androgenic activity and associated anabolic activity. Danogen depresses the output of both follicle-stimulating hormone (FSH) and luteinizing hormone (LH).
In the treatment of endometriosis, Danogen alters the normal and ectopic endometrial tissue so that it becomes inactive and atrophic. Complete resolution of endometrial lesions occurs in the majority of cases.
Indications
Endometriosis − T reatment of endometriosis where the required end-point of treatment is fertility, or for the control of symptoms when surgery is |
contraindicated or has been unsuccessful. To control pain, pelvic tenderness and other associated symptoms and to resolve or reduce the extent of endometriotic foci.
Severe Cyclical Mastalgia − With or without nodularity (fibrocystic disease), unresponsive to counselling or analgesics, to reduce pain, tenderness & nodularity.
Breast Cysts − Control of benign, multiple or recurrent breast cysts in conjunction with aspiration.
Dysfunctional Uterine Bleeding (DUB)− DUB, menorrhagia, to control excessive blood loss, to control associated dysmenorrhoea.
Symptomatic Gynaecomastia − Both idiopathic & drug induced, to reduce the size of breast, to control pain & tenderness.
Preoperative Thinning of Endometrium − Prior to hysteroscopic endometrial ablation.
Other possible uses − Idiopathic thrombocytopenic purpura (ITP), and hereditary angioneurotic edema (HAE).
Dosage And Administration
Adults
The usual dosage range is 200-800 mg daily in up to 2-3 divided doses. Danogen should be given as a continuous course, dosage being adjusted according to the patient`s response. In fertile females, Danogen should be started during menstruation, preferably on the first day, to avoid exposing a pregnancy to its possible effects. Where doubt exists, appropriate checks should be made to exclude pregnancy before starting medication. Females of childbearing age should employ nonhormonal contraception throughout the course of treatment.
Endometriosis: - I nitially 400 mg daily for 6 months, although up to 9 months may be necessary. Dosage should be increased, if normal cyclical bleeding still persists after 2 months therapy; a higher dosage may also be needed for severe disease.
Severe cyclical mastalgia :- 200-300 mg daily, for 3-6 months.
Benign breast cysts: - 300 mg daily for 3 to 6 months.
Dysfunctional uterine bleeding: - 200 mg/day for 3 months.
Gynaecomastia; - 200 mg daily in adolescents which may be increased to 400 mg daily if no response is obtained after 2 months, Adults may be given 400 mg daily for 6 months.
Preoperative thinning of the endometrium :- The usual dose is 400-800 mg daily given as a continuous course for 3-6 weeks.
Hereditary angioneurotic edema:- Longterm prophylaxis: 200-600 mg/day; Shortterm prophylaxis: 600 mg/day for 10 days before surgical trauma.
Idiopathic thrombocytopenic purpura :- 200-600 mg/day for at least two months.
Contraindications
Thromboembolic disease, Androgen dependent tumour. Abnormal vaginal bleeding, Undiagnosed ovarian/uterine masses, Past jaundice with oral contraceptives, Markedly impaired liver, renal or cardiac function, including oedema, Pelvic infection, Neoplasia of primary or secondary sexual organs, Hypertension, Known hypersensitivity to danazol, Pregnancy, Breast feeding, Porphyria .
Precautions
Drug Interactions
Anticonvulsant therapy: May reduce the plasma clearance of carbamazepine, increasing its elimination half-life plasma concentration may affect responsiveness to this agent and to phenytoin. With phenobarbitone it is likely that a similar interaction would occur.
Antidiabetic therapy: C an cause insulin resistance.
Anticoagulant therapy: Prolongation of prothrombin time occurs in patients stabilized on warfarin .
Antihypertensive therapy: D iminishes the effectiveness of antihypertensive agents .
Cyclosporin: Can increase the plasma level of cyclosporin.
Concomitant steroids: Interactions may occur with gonadal steroid therapy.
Migraine therapy: Danazol may itself provoke migraine and possibly reduce the effectiveness of medication to prevent that condition.
Ethyl alcohol: Subjective intolerance in the form of nausea & shortness of breath has been reported.
Alphacalcidol: M ay increase the calcaemic response in primary hypoparathyroidism necessitating a reduction in dosage of this agent.
Pregnancy
Danogen should not be used during pregnancy. Women of childbearing age should be advised to use an effective, nonhormonal method of contraception.
Nursing Mothers
Danogen has the theoretical potential for androgenic effects in breastfed infants and therefore either Danogen therapy or breast feeding should be discontinued.
Paediatric Use
Danogen is not recommended.
In The Elderly
Danogen is not recommended.
In Impaired Renal And Hepatic Function
No special dose requirements have been defined. Since hepatic dysfunction manifested by isolated increases in serum transaminase levels and/or jaundice has been reported in patients treated with Danogen ,periodic liver function tests and close clinical monitoring should be performed.
Others
Care should be observed when using Danogen in patients with hepatic, renal disease, hypertension or cardiovascular disease and in any state which may be exacerbated by fluid retention as well as in diabetes mellitus, polycythaemia, epilepsy, lipoprotein disorder, in those with a history of thrombosis who have shown marked or persistent androgenic reaction to previous gonadal steroid therapy. Adjustment in concomitant therapy may be called for particularly in patients with hypertension, diabetes mellitus or epilepsy, when introducing, discontinuing or during Danogen treatment.
Caution is advised in patients with migraine, and in the presence of known or suspected malignant disease. The presence of breast carcinoma should be excluded before continuing Danogen therapy if breast nodules persist or enlarge during treatment.
In the event of virilisation, Danogen should be withdrawn. Continued use is likely to cause irreversible change.
Periodic measurement of hepatic function and haematologic state should be considered.
Experience of long-term therapy with Danogen is limited. Whilst a course of therapy may need to be repeated, care should be observed. Danogen is chemically related to the 17 alkylated steroids, the long-term risks of which should be considered if used for periods longer than those normally recommended.
Side effects
The most frequent side effects are androgenic effects like acne, seborrhea, hirsutism, decrease in breast size, deepening of voice, weight gain, hair loss and oedema. Amenorrhoea occurs frequently, but disappears on discontinuation of therapy.
Presentation
Danogen-200 Strip of 10 capsuless
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