Uses

Nasal Congestion

Self-medication for temporary relief of nasal congestion associated with the common cold, hay fever, or other upper respiratory allergies.

As effective as other topical vasoconstrictors.

Labeled and has been used for self-medication for temporary relief of nasal congestion associated with sinusitis; however, efficacy data are lacking and/or controversial. In October 2005, FDA issued final rule to remove this indication from labeling of OTC nasal decongestants. Compliance date for preparations with annual sales <$25,000 is October 11, 2007; compliance date for all other preparations is April 11, 2007.

Conjunctival Congestion

Self-medication for temporary relief of ocular redness due to minor irritation.

Otitic Barotrauma

Has been used for self-medication for symptomatic prevention of otitic barotrauma† (aerotitis [barotitis] media); however, no more effective than placebo.

Dosage and Administration

Administration

Administer topically to nasal mucosa or conjunctiva.

Intranasal Administration

Administer nasal solution intranasally as drops, sprays, or nasal pumps. Nasal sprays may be preferable to drops due to decreased risk of swallowing of drug and resultant systemic absorption.

Prior to initial use of metered sprays, prime nasal inhaler by depressing the pump firmly several times.

Apply drops to dependent (lower) nostril while in a lateral, head-low position. Remain in the same position for 5 minutes, then apply drops to the other nostril in a similar manner. Alternatively, instill drops while in a reclining position, with head tilted back as far as possible.

Administer nasal spray or pump into each nostril while head is erect.

Ophthalmic Administration

Administer ophthalmic solution topically to the conjunctiva.

Avoid contamination of the dropper tip.

Remove contact lenses before administering ophthalmic solution.

Do not administer discolored or cloudy solutions.

Dosage

Available as oxymetazoline hydrochloride; dosage expressed in terms of the salt.

Pediatric Patients

Nasal Congestion

Intranasal

For self-medication in children ≥6 years of age: 2 or 3 drops or sprays of a 0.05% nasal solution in each nostril every 10–12 hours (usually in the morning and evening), up to 2 times daily.

Conjunctival Congestion

Ophthalmic

For self-medication in children ≥6 years of age: 1 or 2 drops of a 0.025% ophthalmic solution in the affected eye(s) every 6 hours as needed.

Adults

Nasal Congestion

Intranasal

For self-medication: 2 or 3 drops or sprays of a 0.05% nasal solution in each nostril every 10–12 hours (usually in the morning and evening), up to 2 times daily.

Conjunctival Congestion

Ophthalmic

For self-medication: 1 or 2 drops of a 0.025% ophthalmic solution in the affected eye(s) every 6 hours as needed.

Prescribing Limits

Pediatric Patients

Nasal Congestion

Intranasal

Self-medication in children ≥6 years of age: Maximum of 2 times (2 doses) in a 24-hour period. (See Advice to Patients.)

Adults

Nasal Congestion

Intranasal

Self-medication: Maximum of 2 times (2 doses) in a 24-hour period. (See Advice to Patients.)