Modexa

Modexa

mometasone

Manufacturer:

Dexa Medica
Full Prescribing Info
Contents
Mometasone furoate.
Description
Each spray contains: Mometasone furoate monohydrate equivalent to mometasone furoate 50 mcg.
Action
Pharmacotherapeutic group: decongestants and other nasal preparations for topical use-corticosteroids.
Pharmacology: Mometasone furoate is a topical glucocorticosteroid with local anti-inflammatory properties at doses that are not systemically active.
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.
Mometasone furoate demonstrated potency in inhibition of synthesis and release of IL-1, IL-5, IL-6 and TNFα. It is also a potent inhibitor of leukotriene production. In addition, it is an inhibitor of the production of the Th 2 cytokines, IL-4 and IL-5, from human CD4+ T-cells.
Indications/Uses
MODEXA nasal spray is indicated for use in adults, adolescents and children between the age of 2 and 11 years to treat the symptoms of seasonal or perennial rhinitis, especially in moderate to severe persistent allergy.
MODEXA nasal spray is also indicated for the treatment of nasal polyps in adults 18 years of age and older.
MODEXA nasal spray is indicated for the treatment of symptoms associated with mild to moderate uncomplicated acute rhinosinusitis in adults and children 12 years of age and older where signs or symptoms of bacterial infection are not present.
Dosage/Direction for Use
Seasonal allergic or perennial rhinitis: After initial priming of the MODEXA nasal spray (usually 10 sprays, until a uniform spray is released), each spray delivers approximately 100 mg of mometasone furoate suspension, containing mometasone furoate monohydrate equivalent to 50 mcg mometasone furoate. Prior to administration of the first dose, shake container well and actuate pump well before each use. If the product has not been used for 7 days or longer, it should be reprimed before next use.
Adults (including geriatric patients) and children 12 years of age and older: The usual recommended dose for prophylaxis and treatment is 2 sprays (50 mcg/spray) in each nostril once daily (total dose 200 mcg). Once symptoms are controlled, dose reduction to 1 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 4 sprays in each nostril once daily (total dose 400 mcg). Dose reduction is recommended following control of symptoms.
Children between the ages of 2 through 11 years: The usual recommended dose is 1 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 starting dose for polyposis is 2 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. Efficacy and safety of MODEXA nasal spray for the treatment of nasal polyps were four months in duration.
Treatment of mild to moderate uncomplicated 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.
Patients should not use MODEXA nasal spray without an antibiotic if bacterial infection of the sinuses is present or suspected.
If signs or symptoms of severe bacterial infection are observed during treatment (such as fever, persistent severe unilateral facial/tooth pain, orbital or peri-orbital facial swelling, or worsening of symptoms after an initial improvement), the patient should be advised to consult their physician immediately, at which time the physician may advise the patient to stop using MODEXA nasal spray. Safety and efficacy of MODEXA nasal spray in the treatment of symptoms associated with mild to moderate uncomplicated acute rhinosinusitis beyond 15 days have not been evaluated.
The therapeutic effects of corticosteroids, unlike those of decongestants, are not immediate. Since the effect of MODEXA nasal spray depends on its regular use, patients should be instructed to take the nasal inhalation at regular intervals and not, as with other nasal sprays, as they feel necessary.
In the presence of excessive nasal mucous secretion or edema of the nasal mucosa, the drug may fail to reach the site of action. In such cases, it is adviseable to use a nasal vasoconstrictor for 2 to 3 days prior to starting treatment with MODEXA nasal spray. Patients should be instructed on the correct method of use, which is to blow the nose, then insert the nozzle carefully into the nostril, compress the opposite nostril and actuate the spray while inspiring through the nose, with the mouth closed.
Overdosage
Because of the negligible systemic bioavailability of MODEXA nasal spray, overdose is unlikely to require any therapy other than observation, followed by initiation of the appropriate prescribed dosage. Inhalation or oral administration of excessive doses of corticosteroids may lead to suppression of HPA axis function.
Contraindications
Hypersensitivity to any ingredients of MODEXA nasal spray.
MODEXA nasal spray should not be used in the presence of untreated localized infection involving the nasal mucosa.
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.
Special Precautions
MODEXA nasal spray should not be used in the presence of untreated localized infection involving the nasal mucosa.
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.
Following 12 months of treatment with MODEXA nasal spray there was no evidence of atrophy of the nasal mucosa; also, mometasone furoate tended to reverse the nasal mucosa closer to a normal histologic phenotype. As with any long-term treatment, patients using MODEXA nasal spray over several months or longer should be examined periodically for possible changes in the nasal mucosa. If localized fungal infection of the nose or pharynx develops, discontinuance of MODEXA nasal spray therapy or appropriate treatment may be required. Persistence of nasopharyngeal irritation may be an indication for discontinuing MODEXA nasal spray.
MODEXA nasal spray 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.
There is no evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression following prolonged treatment with MODEXA nasal spray. However, patients who are transferred from long-term administration of systemically active corticosteroids to MODEXA nasal spray require careful attention. Systemic corticosteroid withdrawal in such patients may result in adrenal insufficiency for a number of months until recovery of HPA axis function. If these patients exhibit signs and symptoms of adrenal insufficiency, systemic corticosteroid administration should be resumed and other modes of therapy and appropriate measures instituted.
During transfer from systemic corticosteroids to MODEXA nasal spray some patients may experience symptoms of withdrawal from systemically active corticosteroids (e.g., joint and/or muscular pain, lassitude, and depression initially) despite relief from nasal symptoms and will require encouragement to continue MODEXA nasal spray therapy. Such transfer may also unmask pre-existing allergic conditions, such as allergic conjunctivitis and eczema, previously suppressed by systemic corticosteroid therapy.
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 corticosteroids, instances of nasal septum perforation or increased intraocular pressure have been reported very rarely.
Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. Growth retardation has been reported in children receiving nasal corticosteroids at licensed doses.
It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid if possible, to the lowest dose at which effective control of symptoms is maintained. In addition, consideration should be given to referring the patient to a pediatric specialist.
Treatment with higher than recommended doses may result in clinically significant adrenal suppression. If there is evidence for higher than recommended doses being used, then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
If signs or symptoms of severe bacterial infection are observed (such as fever, persistent severe unilateral facial/tooth pain, orbital or peri-orbital facial swelling, or worsening of symptoms after an initial improvement), the patient should be advised to consult their physician immediately.
Safety and efficacy of MODEXA nasal spray for the treatment of symptoms of rhinosinusitis in children under 12 years of age have not been studied.
The safety and efficacy of MODEXA nasal spray has not been studied for use in the treatment of unilateral polyps, polyps associated with cystic fibrosis, or polyps that completely obstruct the nasal cavities.
Unilateral polyps that are unusual or irregular in appearance, especially if ulcerating or bleeding, should be further evaluated.
Safety and efficacy of MODEXA nasal spray for the treatment of nasal polyposis in children and adolescents under 18 years of age have not been studied.
Use in Pregnancy & Lactation: There are no adequate or well-controlled studies in pregnant women. As with other nasal corticosteroid preparations, MODEXA nasal spray should not be used in pregnant women, nursing mothers or women of childbearing age unless the potential benefit justifies any potential risk to the mother, fetus or infant. Infants born of mothers who received corticosteroids during pregnancy should be observed carefully for hypoadrenalism.
Use In Pregnancy & Lactation
There are no adequate or well-controlled studies in pregnant women. As with other nasal corticosteroid preparations, MODEXA nasal spray should not be used in pregnant women, nursing mothers or women of childbearing age unless the potential benefit justifies any potential risk to the mother, fetus or infant. Infants born of mothers who received corticosteroids during pregnancy should be observed carefully for hypoadrenalism.
Adverse Reactions
Seasonal allergic or perennial rhinitis: treatment-related local adverse events include: headache, epistaxis, 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 the pediatric population, the incidence of adverse effects e.g., headache, epistaxis, nasal irritation and sneezing.
Rarely, immediate hypersensitivity reactions (e.g., bronchospasm, dyspnea) may occur after intranasal administration of mometasone furoate monohydrate.
Very rarely, anaphylaxis and angioedema have been reported.
Disturbances of taste and smell have been reported very rarely.
Nasal polyposis: in patients treated for nasal polyposis, the overall incidence of adverse events similar to that observed for patients with allergic rhinitis.
Acute rhinosinusitis: in patients treated for mild to moderate acute rhinosinusitis, the overall incidence of adverse events similar to that observed for patients with allergic rhinitis.
Drug Interactions
Loratadine: A clinical interaction study was conducted with loratadine. No interactions were observed.
Inhibitors of cytochrome P450 3A4: Mometasone furoate is primarily and extensively metabolized in the liver to multiple metabolites. In vitro studies have confirmed the primary role of cytochrome CYP 3A4 in the metabolism of this compound. Co-administration with ketoconazole, a potent CYP 3A4 inhibitor, may increase the plasma concentrations of mometasone furoate.
Caution For Usage
Instructions for use of MODEXA nasal spray: 1. Shake the bottle gently and remove the dust cap.
2. Gently blow the nose.
3. Close one nostril and put the nozzle into the other nostril. Tilt the head forward slightly, keeping the bottle upright.
4. Start to breathe in gently or slowly through the nose and whilst breathing in, squirt a spray of fine mist into the nose by pressing down ONCE with the fingers.
5. Breathe out through the 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.
Storage
Store at temperature below 30°C.
Do not freeze.
Protect from light.
ATC Classification
R01AD09 - mometasone ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis.
Presentation/Packing
Nasal spray 50 mcg/spray x 60 sprays x 1's.
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