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Synarel Generic Name & Formulations
Legal Class
Rx
General Description
Nafarelin (as acetate) 200mcg/spray; intranasal soln.
Pharmacological Class
GnRH analogue.
How Supplied
Nasal spray—8mL (60 sprays)
Manufacturer
Generic Availability
NO
Synarel Indications
Indications
Endometriosis.
Synarel Dosage and Administration
Adult
≥18yrs: Start between days 2 and 4 of menstrual cycle. 400mcg daily as 1 spray in one nostril in AM and repeat in other nostril in PM. If menstruation continues after 2 months of therapy, increase to 800mcg daily as 1 spray each nostril AM and PM. Max therapy 6 months.
Children
<18yrs: not established.
Synarel Contraindications
Contraindications
Undiagnosed abnormal vaginal bleeding. Pregnancy. Nursing mothers.
Synarel Boxed Warnings
Not Applicable
Synarel Warnings/Precautions
Warnings/Precautions
Exclude pregnancy before treatment; use nonhormonal contraception during therapy; discontinue immediately if pregnancy occurs. Patients should adhere to regimen carefully. Missing successive doses may lead to breakthrough bleeding or ovulation. Risk factors for decreased bone mineral density (eg, chronic alcohol or tobacco abuse, family history of osteoporosis, chronic corticosteroids or anticonvulsants). Avoid sneezing during or immediately after dosing.
Synarel Pharmacokinetics
See Literature
Synarel Interactions
Interactions
Avoid nasal decongestants until at least 2hrs after dosing. Possible convulsions if concomitant with bupropion or SSRIs.
Synarel Adverse Reactions
Adverse Reactions
Hypoestrogenic: hot flashes, decreased libido, vaginal dryness, headache, emotional lability, insomnia, bone density loss. Androgenic: acne, myalgia, breast size reduction, edema, seborrhea, weight gain, hirsutism, increased libido. Ovarian cysts. Nasal irritation.
Synarel Clinical Trials
See Literature
Synarel Note
Not Applicable
Synarel Patient Counseling
See Literature
Synarel Generic Name & Formulations
Legal Class
Rx
General Description
Nafarelin (as acetate) 200mcg/spray; intranasal soln.
Pharmacological Class
GnRH analogue.
How Supplied
Nasal spray—8mL (60 sprays)
Manufacturer
Generic Availability
NO
Synarel Indications
Indications
Central precocious puberty.
Synarel Dosage and Administration
Adult
Not applicable.
Children
1600mcg daily as 2 sprays into each nostril in the AM and PM (total: 8 sprays/day); may increase to 1800mcg daily as 3 sprays into alternating nostrils 3 times daily (total: 9 sprays/day). Allow 30 secs to elapse between sprays. Discontinue when resumption of puberty is desired.
Synarel Contraindications
Contraindications
Undiagnosed abnormal vaginal bleeding. Pregnancy. Nursing mothers.
Synarel Boxed Warnings
Not Applicable
Synarel Warnings/Precautions
Warnings/Precautions
Exclude pregnancy before treatment. Confirm diagnosis. Monitor LH and sex steroid levels during the first 6–8 weeks. Assess growth velocity and bone age velocity within 3–6 months after treatment initiation. Monitor for pseudotumor cerebri or psychiatric symptoms. History of seizures/epilepsy, cerebrovascular disorders, CNS anomalies or tumors: risk of convulsions. Avoid sneezing during or immediately after dosing.
Synarel Pharmacokinetics
See Literature
Synarel Interactions
Interactions
Avoid nasal decongestants until at least 2hrs after dosing. Possible convulsions if concomitant with bupropion or SSRIs.
Synarel Adverse Reactions
Adverse Reactions
Acne, transient breast enlargement, vaginal bleeding or discharge, emotional lability, transient increase in pubic hair, body odor, seborrhea, hot flashes, rhinitis; occasional pituitary gland morphological changes.
Synarel Clinical Trials
See Literature
Synarel Note
Not Applicable
Synarel Patient Counseling
See Literature
