RHINITEASE-P

INSTRUCTIONS FOR USE

RINITIZ-P

RHINITEASE — P

Trade name of the drug: RINITIZ-P.

International nonproprietary name : Fluticasone propionate.

Dosage form: dosed nasal spray.

Compound

1 ml spray contains:

Active substance : fouticasone propionate 0.55 mg;

Excipients: microcrystalline cellulose and sodium carboxymethylcellulose 11.00, anhydrous disodium hydrogen phosphate 4.60 mg, citric acid monohydrate 0.80 mg, anhydrous dextrose 45.00 mg, polysorbate 80 1.00, phenylethyl alcohol 2.5 mg, benzalkonium chloride 0.10 mg, sufficient quantity of water for injection.

Pharmacotherapeutic group: Local glucocorticosteroids.

ATC code: R01AD08.

Pharmacological properties

Fluticasone trifluoride glucocorticosteroid for topical use, when administered intranasally, inhaled, or locally, has a pronounced anti-inflammatory, antiallergic, antipruritic effect and does not have any specific systemic effect.

Indication

RINITIZ-P nasal spray is used for the prevention and treatment of seasonal allergic rhinitis (including hay fever) and persistent rhinitis.

Directions for use and dosage

In adults and children over 12 years of age, the nasal spray is administered by two sprays into each nasal passage once a day, preferably in the morning. In some cases, two sprays into each nostril twice a day may be necessary. After suppressing the signs of the disease, you can proceed to use once a day. It is necessary to use the minimum dose that provides effective control of signs of the disease. The maximum daily dose should not exceed four sprays into each nasal passage.

For children aged 4 to 12 years, the nasal spray is administered by one spray into each nasal passage once a day, preferably in the morning. It is necessary to use the minimum dose that provides effective control of signs of the disease. The maximum daily dose should not exceed two sprays into each nasal passage. To achieve a good therapeutic effect, regular use of the drug is important.

Side effects

When using the drug RINITIZ-P nasal spray, side effects may be observed in the form of nosebleeds, dryness and irritation of the nasal mucosa, dryness and irritation of the throat, headache, unpleasant taste, unpleasant odor, very rarely skin allergic reactions, Quincke’s edema, respiratory symptoms ( bronchospasm), anaphylactic reactions, increased intraocular pressure, in isolated cases — especially with a history of surgical interventions in the nasal cavity, perforation of the nasal septum.

Contraindications

Hypersensitivity to fluticasone or any of the excipients of the drug.

Pregnancy and lactation

During pregnancy and lactation, the drug can be used only after a thorough assessment of the risk-benefit ratio for the mother, fetus and child; recommended doses must not be exceeded.

Overdose

There is no data on drug overdose.

Drug interactions

Since fluticasone propionate is practically not absorbed systemically when applied topically and has a high “first pass” metabolism, its clinically significant interactions with other drugs are unlikely.

When studying the interaction of simultaneous use of 100 mg of ritonavir (a powerful inhibitor of cytochrome P450 3A4) and intranasal fluticasone propionate in healthy volunteers, there was an increase in the plasma concentration of fluticasone propionate several times, leading to a noticeable decrease in serum cortisol concentration. It is recommended to avoid this combination.

When used simultaneously with such potent CYP3A4 inhibitors as ketoconazole, itraconazole, the risk of developing systemic effects and side effects of fluticasone propionate increases. Concomitant use of fluticasone propionate and strong CYP3A4 inhibitors is not recommended.

special instructions

In case of infection of the nasal air tract, appropriate treatment is necessary, but this is not a contraindication to treatment with RINITIZ-P nasal spray. When transferring patients from treatment with systemic glucocorticosteroids to RINITIZ-P nasal spray, care must be taken

Although RINITIZ-P nasal spray in most cases allows to control seasonal allergic rhinitis, in some severe cases it requires appropriate additional treatment.

Systemic effects of nasal corticosteroids can occur when they are used for a long time, and especially at high doses. Potential systemic effects may include Cushing’s syndrome, adrenal suppression, growth retardation in children and adolescents, cataracts, glaucoma and, more rarely, a range of psychological or behavioral effects including psychomotor hyperactivity, sleep disturbance, anxiety, depression or aggression (especially in children).

Growth retardation has been reported in children receiving recommended doses of some nasal corticosteroids. Regular growth checks are recommended in children undergoing long-term treatment with nasal corticosteroids. If growth is slowed, treatment should be considered with a view to reducing the dose of nasal corticosteroid, if possible, to the lowest dose that provides effective control of symptoms.

RINITIZ-P nasal spray in the form of a preserved product contains benzalkonium chloride, which can cause bronchospasm.

It is necessary to avoid getting RINITIZ-P nasal spray into the eyes. In case of accidental contact with eyes, rinse quickly and thoroughly with running water.

Impact on driving vehicles and operating machinery

No data available.

Release form​

Metered-dose nasal spray 50 mcg (100 measured doses) 15 ml in polypropylene bottles with a dosing device and a protective cap.

1 bottle along with instructions for medical use is placed in a cardboard box.

Storage conditions

Store in a dry place, protected from light, at a temperature below 30 ^o C.

Keep out of the reach of children.

Best before date

2 years. After opening the bottle, the drug must be used within 3 months.

Do not use the drug after the expiration date.

Conditions for dispensing from pharmacies

Available without a prescription.

Manufacturer

CORAL LABORATORIES LIMITED

503, Dalamal House, 5th floor J.B. Road, Nariman Point,

Mumbai 400021, India

Phone: + 91-22-2287 3635, 2287 3745, 2287 3698.

Fax: +01-22-2287 3694

Email: exports@corallab.com