Modexa

White to off-white viscous suspension.
Each actuation contains: Mometasone furoate (as monohydrate) 50 mcg.

Pharmacology: Pharmacodynamics: Mometasone furoate is a topical glucocorticosteroid with local anti-inflammatory properties at doses that are not systemically active.
The precise mechanism of action is unknown, but it is likely that much of the mechanism for the antiallergic and anti-inflammatory effects of mometasone furoate lies in its ability to inhibit the release of mediators of allergic reactions. Mometasone furoate significantly inhibits the release of leukotrienes from leucocytes of allergic patients. In cell culture, mometasone furoate demonstrated high potency in the inhibition of synthesis and release of IL-1, IL-5, IL-6 and TNF-α. It is also a potent inhibitor of the Th₂ cytokines, IL-4, and IL-5, from human CD4+ T-cells. In mixed leukocytes from atopic patients, mometasone furoate was a more potent inhibitor of leukotriene production than beclomethasone dipropionate (BDP). Mometasone furoate has been shown to reduce the accumulation of eosinophils markedly at the site of an allergic reaction. Additionally, mometasone furoate reduced the number of lymphocytes and the levels of messenger RNA for the proallergic cytokines IL-4 and IL-5.
Pharmacokinetics: Mometasone furoate monohydrate, administered as an aqueous nasal spray, has a systemic bioavailability of <1% in plasma. Mometasone furoate nasal spray suspension is very poorly absorbed from the gastrointestinal tract, and the small amount that may be swallowed and absorbed undergoes extensive first-pass hepatic metabolism prior to excretion in urine and bile.

For use in adults, adolescents, and children between the ages of 2 and 11 years to treat the symptoms of seasonal allergic or perennial rhinitis.
In patients who have a history of moderate to severe symptoms of seasonal allergic rhinitis, prophylactic treatment with MODEXA nasal spray suspension is recommended two to four weeks prior to the anticipated start of the pollen season.
For the treatment of nasal polyps and associated symptoms including congestion and loss of smell in adult patients 18 years of age and older.
For the treatment of symptoms associated with acute rhinosinusitis in patients 12 years of age and older without signs or symptoms of severe bacterial infection.
For use in adults and adolescents 12 years of age and older as adjunctive treatment to antibiotics for acute episodes of sinusitis.

Dosage: After initial priming of the MODEXA nasal spray suspension (10 actuations, until a uniform spray is observed), each actuation delivers approximately 100 mg of mometasone furoate nasal spray suspension, containing mometasone furoate monohydrate equivalent to 50 mcg mometasone furoate. If the spray pump has not been used for 14 days or longer, it should be reprimed with 2 actuations, until a uniform spray is observed, before next use.
Shake container well before each use.
Seasonal allergic or perennial rhinitis: Adults (including geriatric patients) and adolescents: The usual recommended dose for prophylaxis and treatment is two sprays (50 mcg/spray) in each nostril once daily (total dose 200 mcg). Once symptoms are controlled, dose reduction to one spray in each nostril (total dose 100 mcg) may be effective for maintenance. If symptoms are inadequately controlled, the dose may be increased to a maximum daily dose of four sprays in each nostril once daily (total dose 400 mcg). Dose reduction is recommended following control of symptoms.
Clinically significant onset of action occurs as early as 12 hours after the first dose.
Children between the ages of 2 and 11 years: The usual recommended dose is one spray (50 mcg/spray) in each nostril once daily (total dose 100 mcg). Administration to young children should be aided by an adult.
Nasal Polyposis: Adults (including geriatric patients) and adolescents 18 years of age and older: The usual recommended dose for polyposis is two sprays (50 mcg/spray) in each nostril twice daily (total daily dose of 400 mcg). Once symptoms are adequately controlled, dose reduction to two sprays in each nostril once daily (total daily dose 200 mcg) is recommended.
Acute Rhinosinusitis: The usual recommended dose for acute rhinosinusitis is two sprays (50 mcg/spray) in each nostril twice daily (total daily dose of 400 mcg). If symptoms worsen during treatment, the patient should be advised to consult their physician.
Adjunctive treatment of acute episodes of sinusitis: Adults (including geriatric patients) and adolescents 12 years of age and older: The usual recommended dose is two sprays (50 mcg/spray) in each nostril twice daily (total dose 400 mcg). If symptoms are inadequately controlled, the dose may be increased to four sprays (50 mcg/spray) in each nostril twice daily (total dose 800 mcg).

Because the systemic bioavailability is <1% after administration of mometasone furoate, overdose is unlikely to require any therapy other than observation.

Hypersensitivity to any ingredients of MODEXA nasal spray suspension.

Mometasone furoate should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, or in untreated fungal, bacterial, systemic viral infections or ocular herpes simplex.
As with any long-term treatment, patients using mometasone furoate nasal spray suspension over several months or longer should be examined periodically for possible changes in the nasal mucosa, including the development of nasal ulcerations. If localized fungal infection of the nose or pharynx develops, discontinuance of mometasone furoate nasal spray suspension or appropriate treatment may be required.
There is no evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression following prolonged treatment with mometasone furoate nasal spray suspension. However, as with other corticosteroids, patients who are transferred from long-term administration of systemically active corticosteroids to mometasone furoate nasal spray suspension require careful attention. Systemic corticosteroid withdrawal in such patients may result in adrenal insufficiency. If these patients exhibit signs and symptoms of adrenal insufficiency or symptoms of withdrawal (e.g., joint and/or muscular pain, lassitude, and depression initially), appropriate measures should be instituted.
Patients receiving corticosteroids who are potentially immunosuppressed should be warned of the risk of exposure to certain infections (e.g., chickenpox, measles) and of the importance of obtaining medical advice if such exposure occurs.
Following the use of intranasal aerosolized corticosteroids, instances of nasal septum perforation or increased intraocular pressure have been reported very rarely.
Visual disturbances may be reported with systemic and topical (including, intranasal, inhaled, and intraocular) corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for an evaluation of possible causes of visual disturbances which may include cataract, glaucoma, or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal surgery, or trauma should not use a nasal corticosteroid until healing has occurred.
Rarely, immediate hypersensitivity reactions may occur after intranasal administration of mometasone furoate monohydrate. Very rarely, anaphylaxis and angioedema have been reported for mometasone furoate nasal spray suspension. Disturbances of taste and smell have been reported very rarely.
Acute rhinosinusitis: If signs or symptoms of severe bacterial infection are observed (such as fever, persistent severe unilateral facial/tooth pain, orbital or periorbital facial swelling, or worsening of symptoms after an initial improvement), the patient should be advised to consult their physician immediately.
Safety and efficacy of mometasone furoate nasal spray suspension for the treatment of symptoms of rhinosinusitis in children under 12 years of age have not been studied.
Safety and efficacy of mometasone furoate nasal spray suspension for the treatment of nasal polyposis in children and adolescents less than 18 years of age have not been studied.
Effect on ability to drive and use machines: There is no known information on the effect of MODEXA nasal spray suspension on the ability to drive or use machinery.

There are no adequate or well controlled studies in pregnant women and nursing mothers. As with other nasal corticosteroid preparations, MODEXA nasal spray suspension should be used in pregnant women, nursing mothers or women of childbearing age only if the potential benefit justifies the potential risk to the mother, fetus, or infant. Infants born of mothers who received corticosteroids during pregnancy should be observed carefully for hypoadrenalism.

Treatment-related local adverse events reported with mometasone furoate nasal spray suspension include headache, epistaxis (i.e., frank bleeding, blood-tinged mucus, and blood flecks), pharyngitis, nasal burning, nasal irritation, and nasal ulceration, which are typically observed with use of a corticosteroid nasal spray. Epistaxis was generally self-limiting and mild in severity.
In patients treated for acute rhinosinusitis, the overall incidence of adverse events was similar to that observed for patients with allergic rhinitis.
Nasal polyposis: In patients treated for nasal polyposis, the overall incidence of adverse events was similar to that observed for patients with allergic rhinitis.
The following additional adverse reactions have been reported in postmarketing use with mometasone furoate: vision blurred.

Mometasone furoate nasal spray suspension has been administered concomitantly with loratadine with no effect on plasma concentrations of loratadine or its major metabolite.
Mometasone furoate is metabolized by CYP3A4. Coadministration with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, cobicistat-containing products) may lead to increased plasma concentrations of corticosteroids and potentially increase the risk for systemic corticosteroid adverse effects. Consider the benefit of coadministration versus the potential risk of systemic corticosteroid effects, in which case patients should be monitored for systemic corticosteroid side effects.

On medical prescription only.
Shake well before use.
Instructions and special precautions for handling and disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Store at temperatures not exceeding 30°C.
The product should be used within 2 months of first opening.

Mode of Administration: Preparing MODEXA nasal spray suspension for use: MODEXA nasal spray suspension has a dust cap which protects the nozzle and keeps it clean. Remember to take this off before using the spray and to replace it after use.
If you are using the spray for the first time you need to 'prime' the bottle by pumping the spray 10 times until a fine mist is produced: 1. Gently shake the bottle.
2. Put your forefinger and middle finger either side of the nozzle and your thumb underneath the bottle. Do not pierce the nasal applicator.
3. Point the nozzle away from you and then press down with your fingers to pump the spray.
If you have not used the spray for 14 days or more, you need to reprime the bottle by pumping the spray 2 times until a fine mist is produced.
How to use MODEXA nasal spray: 1. Shake the bottle gently and remove the dust cap.
2. Gently blow your nose.
3. Close one nostril and put the nozzle into the other nostril. Tilt your head forward slightly, keeping the bottle upright.
4. Start to breathe in gently or slowly through your nose and whilst you are breathing in squirt a spray of fine mist into your nose by pressing down ONCE with your fingers.
5. Breathe out through your mouth. Repeat step 4 to inhale a second spray in the same nostril if applicable.
6. Remove the nozzle from this nostril and breathe out through the mouth.
7. Repeat steps 3 to 6 for the other nostril.
After using the spray, wipe the nozzle carefully with a clean handkerchief or tissue and replace the dust cap.
Cleaning MODEXA nasal spray: It is important to clean MODEXA nasal spray suspension regularly, otherwise it may not work properly.
Remove the dust cap and gently pull off the nozzle.
Wash the nozzle and dust cap in warm water and then rinse under a running tap.
Do not try to unblock the nasal applicator by inserting a pin or other sharp object as this will damage the applicator and cause you not to get the right dose of medicine.
Allow the dust cap and nozzle to dry in a warm place.
Push the nozzle back onto the bottle and replace the dust cap.
The spray will need to be primed again with 2 sprays when first used after cleaning.

Nasal Decongestants & Other Nasal Preparations

R01AD09 - mometasone ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis.

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