OCUCLEAR®
Schering
Oxymetazoline HCl
Topical Decongestant
Action And Clinical Pharmacology: Oxymetazoline elicits relief of conjunctival hyperemia by causing vasoconstriction of superficial conjunctival blood vessels. The drug’s action has been demonstrated in acute allergic conjunctivitis and in chemical (chloride) conjunctivitis. Oxymetazoline has a lesser tendency to dilate the pupils than 0.12% phenylephrine. There are no clinical data available on the degree and rate of systemic absorption of oxymetazoline when used topically in the eye, although no measurable effects are seen in blood pressure.
Indications And Clinical Uses: For the symptomatic relief of conjunctival hyperemia and edema associated with superficial ocular inflammatory conditions such as acute allergic conjunctivitis and non-infectious conjunctivitis. The usual duration of action is 6 hours.
Contra-Indications: Hypersensitivity to any of the components, in patients with untreated angle closure glaucoma and in the presence of infection.
Manufacturers’ Warnings In Clinical States: As with all sympathomimetic amines, oxymetazoline should be used with extreme caution in patients who are receiving MAO inhibitors and b-receptor blocking drugs, as severe hypertensive crises may ensue.
Precautions: Should be used with caution in patients with hypertension, coronary artery disease, hyperthyroidism or diabetes mellitus.
Pregnancy and Lactation: The safety of the use of oxymetazoline during pregnancy has not been established. Secretions of oxymetazoline into human breast milk has not been demonstrated, however, because many drugs are excreted in this manner, caution should be exercised when oxymetazoline is administered to a nursing mother.
Children: Safety and effectiveness of oxymetazoline to children below the age of 6 years have not been established.
Adverse Reactions: Ocular irritation and eyelid retraction have occasionally been observed. Hypertension, cardiac arrhythmia and hyperglycemia may occur following systemic absorption of large quantities of drugs in this category.
Symptoms And Treatment Of Overdose: Symptoms: Overdosage with oxymetazoline may result in ocular irritation, dryness, mydriasis and increase in intraocular pressure among susceptible individuals. No data are available on the specific dose frequency at which the above signs and symptoms are expected to occur.
Treatment: Discontinue the drug.
Dosage And Administration: Adults and children 6 years of age and older: Instill 1 or 2 drops into the conjunctival sac 3 to 4 times daily. The usual duration of treatment is 7 to 10 days. Noticeable improvement should be evident within 3 days and treatment should be continued until the condition is cleared, however, if irritation persists, the diagnosis should be reviewed.
To circumvent bacterial contamination of the solution, do not allow the dropper tip to touch the eye or external surfaces of the dropper bottle. The use of the dispenser by more than one person may contribute to contamination and spread infection. Patients with contact lenses should remove the lenses while using oxymetazoline.
Availability And Storage: Each mL contains oxymetazoline hydrochloride USP, 0.25 mg (0.025%) in a clear, sterile isotonic, buffered aqueous solution. Nonmedicinal ingredients: sodium chloride, disodium edetate, boric acid and benzalkonium chloride. The pH is adjusted to approximately 6.4 with sodium hydroxide or hydrochloric acid. Plastic squeeze bottles of 15 mL with dropper tip. Store between 2 and 30°C.
OCUCLEAR® Schering Oxymetazoline HCl Topical Decongestant
Posted by RxMed