Synarel Nasal Solution
"Treatment approaches for endometriosis often rely on a combination of evidence-based and experience-based (“unsubstantiated” by systematic data and research) approaches. As a result, women with endometriosis may find only temporary or no relief f"...
Synarel Nasal Solution
Indications And Usage For Endometriosis
SYNAREL is indicated for management of endometriosis, including pain relief and reduction of endometriotic lesions. Experience with SYNAREL for the management of endometriosis has been limited to women 18 years of age and older treated for 6 months.
DOSAGE AND ADMINISTRATION
For the management of endometriosis, the recommended daily dose of SYNAREL is 400 μg. This is achieved by one spray (200 μg) into one nostril in the morning and one spray into the other nostril in the evening. Treatment should be started between days 2 and 4 of the menstrual cycle.
In an occasional patient, the 400 μg daily dose may not produce amenorrhea. For these patients with persistent regular menstruation after 2 months of treatment, the dose of SYNAREL may be increased to 800 μg daily. The 800 μg dose is administered as one spray into each nostril in the morning (a total of two sprays) and again in the evening.
The recommended duration of administration is six months. Retreatment cannot be recommended since safety data for retreatment are not available. If the symptoms of endometriosis recur after a course of therapy, and further treatment with SYNAREL is contemplated, it is recommended that bone density be assessed before retreatment begins to ensure that values are within normal limits.
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 decongestant 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 400 μg/day, a bottle of SYNAREL provides a 30-day (about 60 sprays) supply. If the daily dose is increased, increase the supply to the patient to ensure uninterrupted treatment for the recommended 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.
Distributed by: G.D. Searle, Division of Pfizer Inc., NY, NY 10017. Revised: August 2015.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/26/2015
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