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Indications and Usage For Central Precocious Puberty
The diagnosis of central precocious puberty (CPP) is suspected when premature development of secondary sexual characteristics occurs at or before the age of 8 years in girls and 9 years in boys, and is accompanied by significant advancement of bone age and/or a poor adult height prediction. The diagnosis should be confirmed by pubertal gonadal sex steroid levels and a pubertal LH response to stimulation by native GnRH. Pelvic ultrasound assessment in girls usually reveals enlarged uterus and ovaries, the latter often with multiple cystic formations. Magnetic resonance imaging or CT-scanning of the brain is recommended to detect hypothalamic or pituitary tumors, or anatomical changes associated with increased intracranial pressure. Other causes of sexual precocity, such as congenital adrenal hyperplasia, testotoxicosis, testicular tumors and/or other autonomous feminizing or masculinizing disord ers must be excluded by proper clinical hormonal and diagnostic imaging examinations.
DOSAGE AND ADMINISTRATION
For the treatment of central precocious puberty (CPP), the recommended daily dose of SYNAREL is 1600 μg. The dose can be in creased to 1800 μg daily if adequate suppression cannot be achieved at 1600 μg/day.
The 1600 μg dose is achieved by two sprays (400 μg) into each nostril in the morning (4 sprays) and two sprays into each nostril in the evening (4 sprays), a total of 8 sprays per day. The 1800 μg dose is achieved by 3 sprays (600 μg) into alternating nostrils three times a day, a total of 9 sprays per day. The pa tient's head should be tilted back slightly, and 30 seconds should elapse between sprays.
If the prescribed therapy has been well tolerated by the patient, tr eatment of CPP with SYNAREL should continue until resumption of puberty is desired.
There appeared to be no significant effect of rhinitis, i.e., nasal congestion, on the systemic bioavailability of SYNAREL; however, if the use of a nasal decongestant for rhinitis is necessary during treatment with SYNAREL, the d econgestant should not be used until at least 2 hours following dosing with SYNAREL.
Sneezing during or immediately after dosing with SYNAREL should be avoided, if possible, since this may impair drug absorption.
At 1600 μg/day, a bottle of SYNAREL provides about a 7-day supply (about 56 sprays). If the daily dose is increased, increase the supp ly to the patient to ensure uninterrupted treatment for the duration of therapy.
Each 0.5 ounce bottle (NDC 0025-0166-08) contains 8 mL SYNAREL (nafarelin acetate) Nasal Solution 2 mg/mL (as nafarelin base), and is supplied with a metered spray pump that delivers 200 μg of nafarelin per spray. A dust cover and a leaflet of patient instructions are also included.
Store upright at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Protect from light.
Revised: January 2012. Distributed by: G.D. Searle LLc, Division of Pfizer Inc, NY, NY 10017. Revised: January 2012
Last reviewed on RxList: 1/30/2012
This monograph has been modified to include the generic and brand name in many instances.
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