Drixoral Nasal Solution (Oxymetazoline HCl)

DRIXORAL® NASAL SOLUTION

Schering

Oxymetazoline HCl

Nasal Decongestant

Indications And Clinical Uses: The relief of congestion of the nasopharyngeal mucous membranes in a variety of allergic and infectious disorders of the upper respiratory tract, including acute rhinitis and nasopharyngitis; acute and chronic sinusitis; acute and chronic vasomotor rhinitis; perennial allergic rhinitis and seasonal allergic rhinitis (hay fever).

Contra-Indications: Narrow angle glaucoma, rhinitis sicca. Concurrent therapy with MAO inhibitors. Hypersensitivity to any component. Sensitivity to even small doses of adrenergic substances as manifested by sleeplessness, dizziness, lightheadedness, weakness, tremulousness, or cardiac arrhythmias. Do not use for irrigation or displacement after sinus operations in which the dura may have been entered.

Precautions: To be used only in adults and children over 6 years of age. Do not exceed the recommended dose.

Systemic effects from the use of topical decongestants can occur due to rapid absorption from the nasal mucous membrane, especially when it is inflamed, and from gastrointestinal absorption if given in excess so that the nasally applied solution is swallowed. Such reactions are most likely to occur in infants, young children and the elderly.

Because of the possibility of generalized vasoconstriction and tachycardia, use sympathomimetic amines very cautiously in patients with hypertension, heart disease, including angina, hyperthyroidism, diabetes mellitus, advanced arteriosclerotic conditions and those patients receiving tricyclic antidepressants.

Overdosage in children may produce profound CNS depression, possibly requiring intensive supportive treatment.

Pregnancy: Clinical data are inadequate to establish conditions for safe use in pregnancy or in women of childbearing potential.

To help prevent contamination from nasal secretions, rinse spray tips in hot water after each use. No more than one person should use the same nasal spray or pump.

Adverse Reactions: The following adverse effects may occur with topical nasal decongestants: burning, stinging, dryness of the nasal mucosa, sneezing, palpitations, headache, lightheadedness, insomnia. Prolonged or excessive use may cause rebound congestion.

Dosage: Adults or children over 6 years old. Spray 2 or 3 strokes into each nostril 2 times a day every 12 hours.

Availability And Storage: Each spray or pump bottle contains: oxymetazoline HCl 0.05% in aqueous solution. Nonmedicinal ingredients: benzalkonium chloride, edetate disodium, propylene glycol, water and pH adjusted with hydrochloric acid or sodium hydroxide. Conventional spray bottles of 20 mL and metered pump sprays of 25 mL.

DRIXORAL® NASAL SOLUTION Schering Oxymetazoline HCl Nasal Decongestant

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