Momenap Nasal Spray

For the use only of a Registered Medical Practitioner, Hospital or a laboratoryMometasone Aqueous Nasal Spray BP

MOMENAP NS 0.05

FOR INTRANASAL USE ONLY

Shake well before use.

Each Spray Delivers:
Mometasone Furoate BP 50 mcg

Composition:
Mometasone Furoate BP 0.05 % w/v
Preservatives
Benzalkonium Chloride BP 0.01 % w/v
Phenyl Ethyl Alcohol USP 0.25 % w/v
Excipients q.s.

Chemistry: 9,21-Dichloro-11b-hydroxy-16a-methyl-3,20-dioxopregna-1,4-dien-17-yl furan-2- carboxylate.

Category
Mometasone furoate is a topical glucocorticosteroid with local anti-inflammatory properties

Pharmacology
Mometasone furoate is a topical gluco-corticosteroid with local anti-inflammatory properties at doses that are not systemically active.
It is likely that much of the mechanism for the anti-allergic 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.

Pharmacokinetic Actions
Mometasone furoate, administered as an aqueous nasal spray, has a negligible (<0.1%) systemic bioavailability and is generally undetectable in plasma, despite the use of a sensitive assay with a lower quantitation limit of 50 pg/ml; thus, there are no relevant pharmacokinetic data for this dosage form. Mometasone furoate 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.

Indications
• The treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis, in adults and pediatric patients 2 years of age and older.
• The prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and adolescent patients 12 years and older.
• In patients with a known seasonal allergen that precipitates nasal symptoms of seasonal allergic rhinitis, initiation of prophylaxis with Mometasone Furoate is recommended 2 to 4 weeks prior to the anticipated start of pollen season.
• The treatment of nasal polyps in patients 18 years of age and older.

Dosage and Administration
After initial priming of the Mometasone Furoate Nasal Spray pump (5 actuations, until a uniform spray is observed), each actuation delivers approximately 100 mg of mometasone furoate suspension, containing 50 micrograms 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.

Seasonal or Perennial Allergic Rhinitis
• Adults (including geriatric patients) and children 12 years of age and older.
• The usual recommended dose is two actuations (50 micrograms/actuation) in each nostril once daily (total dose 200 micrograms).
• Once symptoms are controlled, dose reduction to one actuation in each nostril (total dose 100 micrograms) may be effective for maintenance.
• If symptoms are inadequately controlled, the dose may be increased to a maximum daily dose of four actuations in each nostril once daily (total dose 400 micrograms). Dose reduction is re-commended following control of symptoms.
• Children between the ages of 6 and 11 years.
• The usual recommended dose is one actuation (50 micrograms /actuation) in each nostril once daily (total dose 100 micrograms).
• Mometasone Furoate Nasal Spray demonstrated a clinically significant onset of action within 12 hours after the first dose in some patients with seasonal allergic rhinitis; however, full benefit of treatment may not be achieved in the first 48 hours. Therefore, the patient should continue regular use to achieve full therapeutic benefit.

Nasal Polyposis
• The usual recommended starting dose for poly-posis is two actuations (50 micrograms / actuation) in each nostril once daily (total daily dose of 200 micrograms).
• If after 5 to 6 weeks symptoms are inadequately controlled, the dose may be increased to a daily dose of two sprays in each nostril twice daily (total daily dose of 400 micrograms). The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
If no improvement in symptoms is seen after
5 to 6 weeks of twice daily administration, alternative therapies should be considered.
Efficacy and Safety studies of Mometasone Furoate Nasal Spray for the treatment of nasal polyposis were four months in duration.
The bottle should be discarded after the labeled number of actuations or within 2 months of first use.
Contraindications

• Hypersensitivity to any ingredients of Mome-tasone Furoate Nasal Spray.
• Mometasone Furoate 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 warning and Precaution
• Mometasone Furoate 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.
• As with any long-term treatment, patients using Mometasone Furoate Nasal Spray over several months or longer should be examined periodically for possible changes in the nasal mucosa (Following 12 months of treatment with Mometasone Furoate 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 histological phenotype).
• If localized fungal infection of the nose or pharynx develops, discontinuance of Mometasone Furoate Nasal Spray therapy or appropriate treatment may be required.
• Persistence of nasopharyngeal irritation may be an indication for discontinuing Mometasone Furoate Nasal Spray.
• Although Mometasone Furoate will control the nasal symptoms in most patients, the concomitant use of appropriate additional therapy may provide additional relief of other symptoms, particularly ocular symptoms.

Interactions
A clinical interaction study was conducted with loratadine. No interactions were observed.

Pregnancy and Lactation
There are no adequate or well-controlled studies in pregnant women. Following intranasal administration of the maximal recommended clinical dose, mometasone plasma concentrations are not measurable; thus foetal exposure is expected to be negligible and the potential for reproductive toxicity, very low. As with other nasal corticosteroid preparations, Mometasone Furoate Nasal Spray should not be used in pregnancy or lactation unless the potential benefit to the mother justifies any potential risk to the mother, foetus or infant. Infants born of mothers who received corticosteroids during pregnancy should be observed carefully for hypoadrenalism.
Effect to Drive and use the machine
None known.

Adverse Reactions
Treatment-related adverse events reported in clinical studies for allergic rhinitis in adult and adolescent patients are shown below:
Nasal Polyposis:
• Dosage of 200 mcg once a day
Common
– Upper Respiratory Tract Infection
– Epistaxis (Epistaxis was generally
self limiting and mild in severity)
Not observed
– GI disorders like throat irritation
• Dosage of 200 mcg twice a day
Very common
– Epistaxis (Epistaxis was generally
self limiting and mild in severity)

Common
– Throat Irritation
– Un-common
– Upper Respiratory Tract Infection
Treatment-related adverse events
• Allergic Rhinitis
Common
– Epistaxis
– Pharyngitis
– Nasal Burning
– Nasal Irritation
– Nasal Ulceration
– Headache

Overdosage
Because of the negligible (<0.1%) systemic bioavailability of Mometasone Furoate, 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.

Packing
Mometasone Furoate Nasal Spray 50 mcg is supplied in an amber coloured glass bottle crimped with a spray pump and fitted with a actuator and protection cap.
Each bottle contains a net fill of 10ml / 12ml and will provide 100 / 120 actuations. Each actuation delivers 50 mcg of Mometasone furoate through the nasal adapter.
The correct amount of medication in each spray cannot be assured after 100 / 120 sprays even though the bottle is not completely empty. The bottle should be discarded when the labeled number of actuations has been used.

Storage
Store in a dry place below 300C.
Protect from light. Do not freeze.
Keep out of reach of children.
Last Update: August 2018.