ATX code: R01AB06
INSTRUCTIONS FOR USE
RHINITIS AND Z XI
RHINITEASE XI
Trade name of the drug: RINITIZ XI
Active ingredients (INN): xylometazoline/ipratropium bromide
Dosage form : metered dose nasal spray
Compound:
active ingredients : xylometazoline 0.51 mg and ipratropium bromide 0.612 mg ;
excipients: benzalkonium chloride 0.105 mg, disodium edetate 0.50 mg, sodium chloride 3.42 mg, anhydrous disodium hydrogen phosphate 5.00 mg, hydrochloric acid
5.10 mg, dexpanthenol 50.00 mg, liquid sorbitol (non-crystallizing) 30 .00 mg, sufficient amount of water for injection.
Description: white suspension.
Pharmacotherapeutic group: Nasal drugs. Sympathomimetics, in combination with other drugs (except corticosteroids).
ATC code: R01AB06.
Pharmacological properties
Xylometazoline is an alpha-adrenergic agonist, a vasoconstrictor for topical use in ENT practice. When applied to the mucous membranes, it causes vasoconstriction, as a result of which local hyperemia and swelling are reduced. For rhinitis, it facilitates nasal breathing. The vasoconstrictor effect of xylometazoline develops within 5-10 minutes and lasts for 6-8 hours.
Ipratropium bromide is a blocker of m-cholinergic receptors, has a bronchodilator effect, reduces the secretion of glands (including bronchial and digestive). When applied topically, it reduces nasal congestion through competitive blockade of cholinergic receptors in the nasal epithelium.
Pharmacokinetics
When applied topically, xylometazoline and ipratropium bromide are practically not absorbed; plasma concentrations are so low that they cannot be determined by modern analytical methods.
Indications for use
Nasal congestion with runny nose (rhinorrhea) due to a cold, acute allergic rhinitis, chronic rhinitis with hypersecretion, sinusitis, hay fever, otitis media (to reduce swelling of the nasopharyngeal mucosa), preparing the patient for diagnostic procedures in the nasal passages.
Directions for use and doses
Adults: 1 injection into each nasal passage 3 times a day. The interval between doses should be at least 6 hours. The duration of treatment should not exceed 7 days, since long-term use, due to increased sensitivity in the cells, can cause the development of swelling of the mucous membrane and nasal congestion (rhinitis medicamentosa).
Side effects
With frequent and/or long-term use: irritation of the mucous membrane, burning, tingling, sneezing, cough, nosebleeds, dry nasal mucosa, hypersecretion, allergic reactions in the form of itching, rash, urticaria.
Rarely: swelling of the nasal mucosa (more often with long-term use), palpitations, tachycardia, heart rhythm disturbances, increased blood pressure, headache, vomiting, sleep disorders, insomnia, visual disturbances.
With long-term use in high doses: depressive state.
Contraindications
Angle-closure glaucoma, atrophic rhinitis, arterial hypertension, tachycardia, severe atherosclerosis, hyperthyroidism, surgical interventions on the meninges (history), hypersensitivity to xylometazoline and ipratropium bromide, as well as excipients of the drug, children and adolescents under 18 years of age.
The drug should be used with caution for cardiovascular diseases, diabetes mellitus, prostate hypertrophy, bladder sphincter stenosis, pheochromocytoma, and hypersensitivity to adrenergic substances.
Drug interactions
Incompatible with MAO inhibitors and tricyclic antidepressants.
Concomitant use of other anticholinergic drugs may increase the anticholinergic effect of the drug.
special instructions
Avoid contact of the drug with the eyes. If the drug accidentally gets into your eyes, you should quickly and thoroughly rinse them with cold running water.
Should not be used for a long time, for example, chronic rhinitis. For colds, in cases where crusts form in the nose, it is preferable to administer it in the form of a gel.
Rhinitis XI nasal spray contains benzalkonium chloride as a preservative, which can cause bronchospasm.
Pregnancy and lactation.
During pregnancy and lactation, the drug should be used only after a thorough assessment of the risk-benefit ratio for the mother, fetus and child; recommended doses should not be exceeded.
Influence on the ability to drive vehicles and operate machinery.
Considering the possibility of the drug affecting visual acuity, during treatment you should be careful when driving a car and operating machinery.
The drug should be stored out of the reach of children and should not be used after the expiration date.
Overdose
When applied topically, the risk of overdose is unlikely. Signs of a drug overdose are dry mouth, headache, vomiting, tachycardia. In case of overdose, it is recommended to discontinue use of the drug and symptomatic treatment.
Release form
Metered-dose nasal spray 70 mcg/84 mcg dose (70 measured doses) 10 ml in polypropylene bottles with a dosing device and a protective cap.
1 bottle along with instructions for use is placed in a cardboard box.
Storage conditions
Store no higher than 30 o C in a place protected from light. Do not freeze.
Keep out of the reach of children.
Best before date
2 years. After opening the bottle, the drug must be used within 3 months.
Conditions for dispensing from pharmacies
Available without a prescription.
Manufacturer
Coral Laboratories Ltd.
At: 5,6, Khokhani Ind. complex no. 2,
Near Sai Temple, Sativali, Vasai (E),
Dist. Thane – 401208, INDIA.
E-mail: exports@corallab.com
Website: www.corallab.com
