SYNAREL*
Manufacturer Details
SYNTEX INC
Compositions:
Naferalin acetate 2mg/ml nasal solution in 10ml bottle with metered spray pump approx 200mcg/spray,
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Strength
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Rate
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Packing Style
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2mg/ml spray
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0.00
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in 10ml bottle with metered spray delivers approx 200mcg/spray
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List of Related Indications:
List Of Drugs:
- Nafarelin Acetate- @ - Gonadrotropin -Releasing Hormones- Sex Hormones
Indication Type Description:
Drug Interaction:
No pharmaceutical drug-drug- interaction studies have been conducted
Drug/lab test interactions- admin of naferalin acetate in therapeutic doses results in suppression of
the pitutiary -gondal system. Normal function is restored within 4 to 8 weeks after treatment
Indication:
Endometriosis
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Nafarelin acetate GnRH Antagonist 17-03-1999
Adverse Reaction:
Adverse reactions- as the drug lowers serum estrodiol levels the most frequently reported
adverse reactions were those related to hypoestrogenism
Less than 1% experienced
parathesia, palpitations, chloasma, maculopapular rash, eye pain,
asthenia, lactation, breast engrogement and arthalgia
Contra-Indications:
Hypersensitivity to any of the exceipients
Special Precautions-
Central Precocious Puberty- the diagnosis of central precocious puberty ( CPP ) must be
established before treatment.
Regular monitoring of CPP patients is needed to assess both patient response and compliance.
This is particularly important during the first 6 to 8 weeks of treatment to ensure that suppression
of pitutary -gonadal function is rapid
Ovarian cysts- as with other drug that stimulate the release of gonodotropins or that induce ovulation.
ovarian cysts have been reported to occur in the first two months of therapy with nefarin acetate
These cysts enlargements may resolve spontaneously generally by about 4 to 6 weeks of therapy,
but in some cases may require discontiuation of the drug and/or surgical intervention
Pregnancy- before starting treatment, pregnancy must be excluded
Lactation- naferalin acetate should not used in nursing mothers.
Children- safety and efficacy of naferalin acetate for endometriosis in patients younger than
18 years have not been established
Dosages/ Overdosage Etc:
Indication-
Endometriosis
Dosage-
Endometriosis- recommended dose of naferalin acetate is 400mcg.
This is acheived by one spray ( 200mcg ) in one nostril in the morning and into the other
nostril in the evening
Treatment should be started between days 2 and 4 of the menstrual cycle.
Patient Information:
Ref - USP PDI Vol II 17th Edition (1997)
1.Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to
nafarelin. Also tell your healthcare care professional if you are allergic
to any other substances such as foods. preservatives or dyes.
2.Pregnancy-
Naferelin is not recommended during pregnancy.
3. Breast-feeding-
It is known whether naferelin passes into breast milk.
4 Other medicines-
Tell your doctor if you are using any of the following -
Nasal decongestants - You should allow at least 30 minutes to pass before
you use a nasal decongestant spray
7. Other medical problems-
Make sure you tell your doctor if you have any other medical problems
especially-
Other conditions that increase the chance of osteoporosis - since
naferelin causes temporary thinning of the bones, your doctor
should know if you already have an increased risk of osteoporosis
Pregnancy and lactation:
Pregnancy-
Before starting treatment, pregnancy must be excluded
Lactation-
Naferalin acetate should not used in nursing mothers.
Children-
Safety and efficacy of naferalin acetate for endometriosis in patients younger than
18 years have not been established
