NAZOL CAPSULE 200 MG [SIN03932P]

Product Info

NAZOL CAPSULE 200 MG

[SIN03932P]

INDICATIONS: Endometriosis: Danazol is indicated for use in the treatment of visually proven (eg. laparoscopy) endometriosis where the required end-point of treatment is fertility, or for the control of symptoms when surgery is contraindicated or has been unsuccessful.
Menorrhagia: Danazol is indicated for the short-term (up to 6 months) management of intractable primary menorrhagia.
Hereditary angioedema: Danazol is indicated for the prophylaxis of attacks of hereditary angioedema of a severe or life-threatening nature, in male and female patients.
Fibrocystic breast disease: Danazol is indicated for the short-term treatment (up to 6 months) of severe benign (fibrocystic) breast disease or mastalgia associated with severe symptomatic benign breast disease, in patients’ refractory to other treatments.

RECOMMENDED DOSAGE: In women of reproductive age, therapy should begin during menstruation. A sensitive test (eg. beta subunit test if available) capable of determining early pregnancy is recommended immediately prior to start of therapy. Additionally, a non-hormonal method of contraception should always be used during Danazol therapy (See Warnings – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Endometriosis: 200–800 mg danazol daily in two to four divided doses. It is recommended that treatment be initiated with a dosage of 800 mg daily in 4 divided doses. In some patients, it may be possible to maintain improvement with a reduced dosage once a satisfactory response has been obtained. Treatment should continue uninterrupted for 3 to 6 months, but may be extended to 9 months if necessary.
Menorrhagia: A course of 200–400 mg danazol daily in divided doses for up to 6 months. 200 mg is usually sufficient to reduce menstrual blood flow to acceptable limits.
Fibrocystic Breast Disease: The minimum effective dose should be used. 200 mg daily is an effective dose in the majority of patients. In some instances, 400 mg/day may be warranted.
Hereditary Angioedema: 200–600 mg danazol daily in divided doses. Dosage should be kept as low as possible with adjustment to meet individual patient requirements. Consideration should be given to interrupting treatment after an attack-free period.

CONTRAINDICATIONS: Danazol should not be administered to patients with:

1. Undiagnosed abnormal genital bleeding

2. Marked impaired liver function, renal or cardiac function, including oedema

3. Past jaundice with oral contraceptives

4. Undiagnosed ovarian / uterine masses

5. Pelvic infection

6. Neoplasia of primary or secondary sexual organs

7. Hypertension WHO II or worse

8. Known hypersensitivity to danazol

9. Pregnancy(see precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

10. Breast feeding

11. Porphyria – Danazol can induce ALA synthetase activity and hence porphyrin metabolism.

12. Androgen-dependant tumour

13. Active thrombosis, thromboembolic disease or history of such events

(see Warnings – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)