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Drugs reference index «Olopatadine Hydrochloride»

Olopatadine Hydrochloride

Pronunciation: (OH-loe-PA-ta-deen HYE-droe-KLOR-ide)Class: Antihistamine

Trade Names:Pataday- Solution, ophthalmic 0.2%

Trade Names:Patanase- Nasal Spray 0.6%

Trade Names:Patanol- Solution, ophthalmic 0.1%

Pharmacology

Inhibits release of histamine from mast cells and relatively selective histamine H 1 antagonist. Inhibits type 1 immediate hypersensitivity reactions.

Pharmacokinetics

Absorption

T max is 30 to 60 min; C max is 16 ng/mL; average absolute bioavailability is 57% (intranasal).

Distribution

Protein binding is approximately 55%.

Metabolism

Not extensively metabolized.

Elimination

Plasma elimination half-life is 3 h (ophthalmic) and 8 to 12 h (intranasal), mainly through urinary excretion.

Special Populations

Renal Function Impairment

Mean plasma AUC 0-12 is 2-fold higher. No dosage adjustment is required.

Hepatic Function Impairment

Effects have not been established.

Gender

C max and AUC were 40% and 27% higher, respectively, in women compared with men (intranasal).

Indications and Usage

Temporary relief of itching caused by allergic conjunctivitis (ophthalmic); temporary relief of symptoms of seasonal allergic rhinitis (intranasal).

Contraindications

Standard considerations.

Dosage and Administration

Adults and Children

Ophthalmic 1 to 2 drops in affected eye(s) twice daily, 6 to 8 h apart (0.1% solution). 1 drop in affected eye(s) once daily (0.2% solution). If using other topical ophthalmic drugs, separate each medication by 5 min or more.

Adults and Children 12 yr of age and older

Intranasal 2 sprays per nostril twice daily.

General Advice

  • Ophthalmic
  • Do not instill while wearing contact lenses.
  • Intranasal
  • Prime the nasal spray by releasing 5 sprays. When not in use for more than 7 days, re-prime by releasing 2 sprays.

Storage/Stability

Store between 39° and 77°F. Keep bottle tightly closed. Discard nasal spray after 240 sprays have been used.

Drug Interactions

Alcohol, CNS depressants

Avoid concurrent use (intranasal).

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Headache (7%); asthenia (5% or less); malaise (postmarketing); somnolence.

GI

Bitter taste (13%); abdominal pain, diarrhea, nausea, thirst (postmarketing); taste perversion, nausea.

Genitourinary

UTI (1%); occult blood in urine (postmarketing).

Ophthalmic

Blurred vision; burning, dry eye, foreign body sensation, hyperemia, keratitis, lid edema, pruritus, stinging (5% or less).

Lab Tests

Abnormal hepatic function, increased cholesterol, WBC disorders (postmarketing).

Respiratory

Pharyngitis (10%); pharyngolaryngeal pain (2%); cough (1%).

Special Senses

Epistaxis (19%); nasal ulceration (9%); postnasal drip (2%); rhinitis, sinusitis.

Miscellaneous

Cold syndrome, dysgeusia.

Precautions

Monitor

Preform nasal examinations periodically (intranasal)

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and effectiveness in children younger than 3 yr of age are not established (ophthalmic); safety and effectiveness in children younger than 12 yr of age not established (intranasal).

Elderly

No differences in safety or effectiveness observed; however, use caution in dose selection, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Patient Information

  • Advise patient that usual dose is 1 drop in affected eye(s) twice daily at an interval of 6 to 8 h (0.1% solution) or 1 drop once daily in the affected eye(s) (0.2% solution).
  • Teach patient proper technique for instilling eye drops: wash hands; do not allow dropper to touch eye; tilt head back, look up; pull lower eyelid down; instill prescribed number of drops; close eye for 1 to 2 min and apply gentle pressure to bridge of nose; do not rub eye.
  • Advise patients who wear contact lenses to remove their lenses before instilling this medicine and to wait at least 10 min after instilling eye drop before inserting their lenses. Also, caution these patients to not wear their lens if the eye is red.
  • Advise patient that if more than 1 topical ophthalmic drug is being used, to administer the drugs at least 5 min apart.
  • Advise patient to inform health care provider if experiencing side effects or if eye symptoms do not improve or worsen.
  • Advise patients to avoid spraying nasal spray in their eyes.
  • Advise patient to avoid engaging in hazardous occupations requiring complete mental alertness (eg, driving).

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