Olopatadine Hydrochloride (Nasal Spray)

Olopatadine Nasal Spray is an H1 receptor antagonist indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and children 6 years of age and older.

Olopatadine, an antihistamine, works by blocking the action of histamine in the body, which reduces allergy symptoms. Olopatadine Hydrochloride treats sneezing, itching, runny nose, and other nasal symptoms of allergies. Olopatadine Nasal Spray contains 0.6% w/v Olopatadine (base) in a nonsterile aqueous solution with pH of approximately 3.7. After initial priming (5 sprays), each metered spray from the nasal applicator delivers 100 microliters of the aqueous solution containing 665 mcg of olopatadine Hydrochloride, which is equivalent to 600 mcg of Olopatadine (base). Olopatadine Nasal Spray also contains benzalkonium chloride (0.01%), dibasic sodium phosphate, edetate disodium, sodium chloride, hydrochloric acid and/or sodium hydroxide (to adjust pH), and purified water.

Adults and Adolescents 12 years of age and older: Two sprays per nostril twice daily.

Children 6 to 11 years of age: One spray per nostril twice daily.

Administer Olopatadine Nasal Spray by the intranasal route only.

Administration

How to use the Nasal Spray-

• Shake the bottle gently and remove the dust cover.
• Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
• Gently blow the nose to clear the nostrils.
• Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
• Breathe out through your mouth.
• Repeat the above steps in the same/ other nostril for consecutive doses.

Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-

• Remove the dust cover.
• Gently pull off the nasal applicator.
• Wash the applicator and dust cover in warm water.
• Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
• Gently push the applicator back on the top of the bottle and re-fix the dust cover.

Interaction with other medications have not been investigated.

A bitter taste in the mouth, nosebleeds, or irritation/soreness in the nose may occur. Drowsiness may rarely occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Pregnancy Category C. No adequate and well-controlled studies in pregnant women have been conducted. Olopatadine Nasal Spray should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.

Lactation: It is not known whether topical nasal administration could result in sufficient systemic absorption to produce detectable quantities in human breast milk. Olopatadine Nasal Spray should be used by nursing mothers only if the potential benefit to the patient outweighs the potential risks to the infant.

Before initial use, Olopatadine Nasal Spray by releasing 5 sprays or until a fine mist appears. When Olopatadine Nasal Spray has not been used for more than 7 days, re-prime by releasing 2 sprays. Avoid spraying Olopatadine Nasal Spray into the eyes. Patients should be informed to avoid spraying Olopatadine Nasal Spray in their eyes.

There have been no reported overdoses with Olopatadine Nasal Spray.

Nasal Anti-histamine preparations

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.