Rinoease Nasal Spray

DOSAGE FORM: Aqueous intranasal spray For use by adults and children 12 years and over.

DESCRIPTION: Mometasone aqueous nasal spray is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. The precise mechanism through which Mometasone Furoate affects rhinitis symptoms is not known.

INDICATIONS: Seasonal Allergic or Perennial Rhinitis, Nasal polyposis, Acute Rhinosinusitis, Adjunctive treatment of acute episodes of sinusitis. Mometasone Aqueous Nasal spray is indicated for the treatment of the
symptoms of seasonal and perennial allergic rhinitis in patients aged 12 years and older.

DOSAGE AND ADMINISTRATION :
Adult and Adolescents (12 years of age and older): The recommended starting dosage is 2 sprays in each nostril once daily. When the maximum benefits have been achieved and symptoms have been controlled, reducing the dosage to 1 spray in each nostril once daily may be effective in maintaining control of allergic rhinitis symptoms. Children (2 to 11 Years of Age): As advised by the physician.

ADMINISTRATION: Before administration of the first dose, shake the container well and actuate the pump 10 times (until a uniform spray is obtained). If the pump is not used for 14 days or longer, reprime the pump with 2 actuations until a uniform spray is observed before the next use.

CONTRAINDICATIONS: Mometasone Aqueous Nasal spray is contraindicated in patients with a hypersensitivity to Mometasone furoate or any of the ingredients.

WARNING AND PRECAUTIONS :

1. Use in pregnancy and lactation: Mometasone Aqueous nasal spray should be used during pregnancy only if the potential benefits justify the potential risk to the fetus.
2. Hypoadrenalism may occur in infants born to mothers receiving corticosteroids during pregnancy. Such infants should be carefully monitored. Since there is no data from controlled trials on the use of intranasal Mometasone Aqueous by nursing mothers, caution should be exercised when Mometasone Aqueous nasal spray is administered to a nursing mother.
3. Use in hepatic and renal impairment: Since Mometasone Furoate undergoes extensive first-pass metabolism by the hepatic cytochrome P450 isozyme, CYP3A4, the pharmacokinetics of Mometasone Furoate may be altered in patients with hepatic impairment. Therefore, use Mometasone Aqueous nasal spray with caution in patients with severe hepatic impairment. No dosage adjustment is required in patients with renal impairment.

UNDESIRABLE EFFECTS:
The most common adverse events reported with Mometasone Furoate use are headache, epistaxis, pharyngolaryngeal pain, nasal ulceration, back pain, pyrexia headache, epistaxis, pharyngolaryngeal pain, nasal ulceration, back pain, pyrexia and cough

PRESENTATION :
Plastic bottle with spray pump and over cap – 120 metered doses/pack.

IMPORTANT INFORMATION :

• Use your nasal spray as directed by the physician. Do not exceed the recommended dose.
• Use your nasal spray regularly and do not stop the treatment even if you feel better unless told to do so by your doctor.
• This medicine has been specially recommended by your doctor for you. Do not allow any other person to use it

SHAKE WELL BEFORE USE

• Keep out of reach of children.
• Use within 2 months of first use