SUPREFACT NASAL
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Package:
SPRAY BOTTLE: 100 spray doses x 0.1 mg/spray.
Dosage:
Treatment for 1 week. After suppression of therapeutic injections for 7 days, nasal spray is used from 8th day. 1-2 mg daily. i.e. 1 spray into each nostril 6 x daily before and after breakfast, lunch and supper.
Prescribing Restrictions:
Indications:
Endometriosis, unless the disease primarily requires surgical treatment. Pituitary desensitization in preparation of ovulation induction, as an adjunct to gonadotrophin administration. Polycystic ovarian disease (PCOD), leyomyoma uteri, precocious puberty.
Contra-Indications:
Hypersensitivity to buserelin. Pregnancy and lactation. Undiagnosed vaginal bleeding, hypersensitivity to LHRH hormone dependent neoplasms.
Special Precautions:
Administration of an antiandrogen should be started as adjunctive therapy about 5 days before starting treatment. This therapy must be continued concomitantly with buserelin therapy for 3 t o4 weeks. After this time, testosterone levels have usually fallen to within the desired range. After the initial determination, testosterone levels should be monitored at 3-monthly intervals. If levels do not reach the therapeutic range within 4 weeks (6 weeks at the latest), the dose schedule should be checked. In hypertensive patients, blood pressure must be monitored regularly. In diabetic patients, blood sugar levels must be monitored regularly. Patients with a history of depression must be monitored carefully.
Treatment of endometriosis: Use of oral contraceptives must be discontinued before treatment is started. Pregnancy test is recommended to exclude pre-existing pregnancy.
Adjunctive use in ovulation stimulation: A pregnancy test should be performed before treatment is started. When gonadotrophins are used together with buserelin, the risk of ovarian hyperstimulation syndrome is higher than with use of gonadotrophins alone. See prescribing information for full details.
Side Effects:
At the start of treatment: Occurrence or worsening of bone pain in patients with bone metastates; signs of neurologic deficit due to tumor compression; impaired micturition, hydronephrosis or lymphostasis; thrombosis with pulmonary embolism. Hot flushes and loss of potency or libido, uterine bleeding. Withdrawal bleeding may occur during the first few weeks of treatment. Breakthrough bleeding may occur during continuing treatment. Ovarian cysts may develop in the initial phase of treatment. Treatment may lead to: increase of decrease in scalp or body hair; increase in blood pressure; hypersensitivity reactions; asthma with dyspnoea; reduction in glucose tolerance; changes in blood lipids; headaches; dizziness, tinnitus, hearing disorders, impaired vision; nausea, vomiting, increased thirst, diarrhea, constipation; back pain and pains in the limbs and joints; irritation of the mucosae of the nasal and pharyngeal cavity. See prescribing information for full details.
Drug Interactions:
Antidiabetic agents.
