Oxymetazoline hydrochloride.
Each ml of Oxymetazoline Hydrochloride (ClariClear) Nasal Spray contains 0.5 mg (0.05%) oxymetazoline hydrochloride. Benzalkonium chloride is used as a preservative.
Excipients/Inactive Ingredients: Other inactive ingredients include benzalkonium chloride, sodium biphosphate, disodium edetate, propylene glycol, hydrochloric acid and purified water.
The sympathomimetic action of oxymetazoline hydrochloride constricts the arteriolar network within the nasal mucosa producing a prolonged decongestant effect.
0.05% Oxymetazoline HCl nasal spray is indicated in adults and children aged 6 years and over for symptomatic relief of nasal congestion due to conditions such as the common cold, sinusitis, hay fever or other upper respiratory allergies, and may also be useful in the adjunctive treatment of a middle ear infection.
Method of administration: Spray the dose of the medicine into each nostril by squeezing the bottle rapidly and strongly.
Keep the bottle vertical.
Dosage regimen: Adults and children over 10 years: 2 sprays into each nostril.
Do not repeat at intervals less than 12 hours.
Duration of treatment should not exceed 7 days, unless prescribed by a doctor.
Additional information on special populations: Pediatric patients: Children aged 6-10 years: 1 spray into each nostril.
Do not repeat at intervals less than 12 hours.
Duration of treatment should not exceed 7 days, unless prescribed by a doctor.
What Should Be Done If the Patient Missed a Dose: Consult a physician.
A nonselective alphalytic such as phentolamine may be administered to depress the increased blood pressure. Intubation and artificial respiration may be necessary in serious cases.
In the case of moderate or severe inadvertent oral consumption, standard methods to remove unabsorbed drugs are indicated. Further treatment is supportive and symptomatic.
Signs And Symptoms of Overdose: Symptoms of moderate or severe overdose can be mydriasis, nausea, cyanosis, fever, spasms, tachycardia, cardiac arrhythmia, cardiac arrest, hypertension, edema of the lungs, dyspnea, psychic disturbance. The inhibition of functions of the central nervous system such as somnolence, lowering of the body temperature, bradycardia, shock like hypotension, apnea and loss of consciousness is also possible.
Pediatric population: Clinical manifestation includes CNS signs and symptoms: convulsion and coma, hallucinations, bradycardia, apnea, hypertension changing into hypotension.
Oxymetazoline-containing nasal sprays should not be used: in patients with known hypersensitivity to oxymetazoline or other adrenergic agents, or to any component of the medicinal product; in patients taking monoamine oxidase inhibitors (MAOIs) or in patients who have taken MAOIs in the previous two weeks; in patients with narrow-angle glaucoma; in patients after trans-sphenoidal hypophysectomy; where there is inflammation of the skin and mucosa of the nasal vestibule and encrustation (rhinitis sicca); in patients with acute cardiovascular disease or cardiac asthma; in patients with severe high blood pressure.
Do not exceed the recommended dosage. The product may cause rebound congestion if used for longer than three days. This product should not be used by patients who have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland without careful clinical consideration. In such patients, a physician should be consulted before use. Prolonged use may result in rebound congestion.
Duration of treatment should not exceed 7 days, unless prescribed by a doctor. Use of the product by more than one person may spread infection. This product is not recommended for use in children under six years of age.
Effects On Ability to Drive or Use Machines: Oxymetazoline has no or negligible influence on the ability to drive and use machines.
Pregnancy: Oxymetazoline has not been associated with adverse pregnancy outcome. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. Caution should be exercised in patients with hypertension or signs of reduced placental perfusion. Frequent or prolonged use of high doses may reduce placental perfusion.
Oxymetazoline can be used in pregnant women if recommended by a physician.
Lactation: It is not known if oxymetazoline is excreted into breast milk. In view of this lack of data, oxymetazoline should not be used during breast feeding.
Fertility: There are no data available on male and female fertility.
Oxymetazoline Hydrochloride (ClariClear) Nasal Spray is generally well tolerated and side effects, should they occur, are usually mild and transient. They include burning, stinging, sneezing or increased nasal discharge.
Tabulated list of adverse reactions: The listed adverse drug reactions (ADRs) are based on spontaneous postmarketing reports or literature, thus an organization according to CIOMS III categories of frequency is not pertinent. (See table.)
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Concomitant use of tricyclic antidepressants, maprotiline, other vasoconstrictive drugs or monoamine oxidase inhibitors (MAOIs), may potentiate the pressor effects of Oxymetazoline.
R01AA05 - oxymetazoline ; Belongs to the class of topical sympathomimetic agents used as nasal decongestants.
ClariClear nasal spray 500 mcg/mL (0.05% w/v)
15 mL x 1's
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