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Nasonex®
(mometasone furoate monohydrate) Nasal Spray, 50
µg*
FOR INTRANASAL USE ONLY
*calculated
on the anhydrousb basis
Drug Uses
Nasonex is a nasal allergy spray for the
treatment of seasonal and perennial allergy symptoms. Nasonex helps relieve
itchy, runny noses, sneezing and congestion caused by dust mites, pet dander and
tree and grass pollen. Nasonex Nasal Spray is a corticosteroid demonstrating
anti-inflammatory properties. The Corticosteroids have been shown to have a wide
range of effects on multiple cell types.
How Taken
Shake Nasonex well before each use. Prime
the spray pump as instructed by your pharmacist. Use as directed generally two
sprays in each nostril daily. Do not use this drug more often or longer than
prescribed. Use Nasonex regularly during the prescribed treatment period for
full benefit. If the drug is used for seasonal allergy, therapy is best started
2-4 weeks before the season. Improvement in symptoms occurs generally within 2
days and full benefit occurs after 1-2 weeks of use.
Warnings/Precautions
Before using Nasonex, tell your doctor and
pharmacist if you have a viral, bacterial, or fungal infection of any kind. The
absorption of this drug into your system can inhibit your body's ability to
fight off infections. You may not be able to use Nasonex if you have an
infection. Before using Nasonex, tell your doctor if you have a nasal septum
ulcer, recently had nasal surgery, or nasal damage. You may not be able to use
Nasonex, or you may require a dosage adjustment or special monitoring during
your treatment. Nasonex is in the FDA pregnancy category C. This means that it
is not known whether Nasonex will harm an unborn baby. Do not use this
medication without first talking to your doctor if you are pregnant. It is
unknown whether Nasonex passes into breast milk. Do not use Nasonex without
first talking to your doctor if you are breast feeding a baby. Nasonex is not
approved for children use younger than 3 years of age.
Missed Dose
If you miss a dose of Nasonex, use it as
soon as you remember. If it is near the time of the next dose, skip the missed
dose and resume your usual dosing schedule. Do not "double-up" the dose to catch
up.
Possible Side Effects
Headache or sore throat might occur. If
these effects persist or worsen, notify your doctor promptly. Very unlikely but
report promptly: vision changes, unusual nasal bleeding or irritation/pain,
blood-tinged mucus/phlegm, unusual increase in thirst or urination, nausea,
weakness, weight loss. In the unlikely event you have an allergic reaction to
Nasonex, seek immediate medical attention. Symptoms of an allergic reaction
include: rash, itching, swelling, dizziness, trouble breathing. If you notice
other effects not listed above, contact your doctor or pharmacist.
Storage
Store at 25°C (77°F); excursions permitted
to 15-30°C (59-86°F). Protect from light. When Nasonex Nasal Spray, 50 mcg is
removed from its cardboard container, prolonged exposure of the product to
direct light should be avoided. Brief exposure to light, as with normal use, is
acceptable.
Overdose
An overdose of this medication is not
likely to occur. If you do think that an overdose has occurred, call an
emergency room or poison control left.
More Information
Avoid items or activities that you know
are allergens for you if they make your symptoms worse. Clean areas where dust
or pet fur may aggravate your condition. Avoid exposing yourself to known
sources of infection. Stay away from people with chicken pox, measles, or any
other type of infectious disease. Your immune system may not be strong enough to
fight off an infection while you are using Nasonex.
Mometasone furoate monohydrate, the active component of NASONEX Nasal Spray, 50
µg, is an anti- inflammatory corticosteroid having the chemical name:
9,21-Dichloro-11ß, 17-dihydroxy-16a
-methylpregna-1, 4-diene-3,20-dione 17-(2-furoate) monohydrate.
Mometasone furoate monohydrate is a white powder, with an empirical formula of
C27H30Cl2O6 H2O and a molecular weight of 539.45. It is practically insoluble in
water; slightly soluble in methanol, ethanol, and isopropanol; soluble in
acetone and chloroform; and freely soluble in tetrahydrofuran. Its partition
coefficient between octanol and water is greater than 5000.
NASONEX Nasal Spray, 50 µg is a metered-dose, manual pump spray unit containing
an aqueous suspension of mometa- sone furoate monohydrate equivalent to 0.05%
w/w mometasone furoate calculated on the anhydrous basis; in an aqueous medium
containing glycerin, microcrystalline cellulose and carboxymethylcellulose
sodium, sodium citrate, 0.25% w/w phenylethyl alcohol, citric acid, benzalkonium
chloride, and polysorbate 80. The pH is between 4.3 and 4.9.
After initial priming (10 actuations), each actuation of the pump delivers a
metered spray containing 100 mg of suspension containing mometasone furoate
monohydrate equivalent to 50 µg of mometasone furoate calculated on the
anhydrous basis. Each bottle of NASONEX Nasal Spray, 50 µg provides 120 sprays.
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