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Olopatadine (Nasal)

Pronunciation

(oh la PAT a deen)

Index Terms

  • Olopatadine HCl
  • Olopatadine Hydrochloride

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Nasal:

Patanase: 0.6% (30.5 g) [contains benzalkonium chloride, edetate disodium]

Generic: 0.6% (30.5 g)

Brand Names: U.S.

  • Patanase

Pharmacologic Category

  • Histamine H1 Antagonist
  • Histamine H1 Antagonist, Second Generation
  • Piperidine Derivative

Pharmacology

Selective histamine H1-antagonist; inhibits release of histamine from mast cells.

Metabolism

Not extensively metabolized

Excretion

Urine (60% to 70%, mostly as unchanged drug); feces (17%)

Onset of Action

30 minutes in seasonal allergy patients

Time to Peak

Serum: 15 minutes to 2 hours

Half-Life Elimination

8-12 hours

Protein Binding

~55% (primarily albumin)

Special Populations: Children

6 to 11 yr of age

Mean Cmax was approximately 2-fold less when compared with adults (intranasal).

Special Populations: Gender

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

Use: Labeled Indications

Treatment of the symptoms of seasonal allergic rhinitis

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Dosing: Adult

Seasonal allergic rhinitis: Intranasal: 2 sprays into each nostril twice daily

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Seasonal allergic rhinitis: Intranasal:

Children 6-11 years: 1 spray into each nostril twice daily

Children ≥12 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

No dosage adjustment necessary.

Dosing: Hepatic Impairment

No dosage adjustment necessary.

Administration

For intranasal use only. Before initial use of the nasal spray, the delivery system should be primed with 5 sprays or until a fine mist appears. If 7 or more days have elapsed since last use, the delivery system should be reprimed with 2 sprays or until a fine mist appears. Blow nose to clear nostrils. Keep head tilted downward when spraying. Insert applicator into nostril, keeping bottle upright, and close off the other nostril. Breathe in through nose. While inhaling, press pump to release spray. Alternate sprays between nostrils. After each use, wipe the spray tip with a clean tissue or cloth.

Storage

Store at 4°C to 25°C (39°F to 77°F).

Drug Interactions

There are no known significant interactions.

Adverse Reactions

>10%:

Gastrointestinal: Bitter taste (13%; children 1%)

Respiratory: Epistaxis (3% to 25%)

1% to 10%:

Central nervous system: Depression (2%), fatigue (1%), somnolence (1%)

Dermatologic: Rash (children 1%)

Gastrointestinal: Weight gain (1%), xerostomia (1%)

Genitourinary: Urinary tract infection (1%)

Neuromuscular & skeletal: CPK increased (1%)

Respiratory: Nasal ulceration (9% to 10%), upper respiratory tract infection (children 3%), pharyngolaryngeal pain (2%), postnasal drip (2%), cough (1%), throat irritation (1%)

Miscellaneous: Influenza (1%)

<1% (Limited to important or life-threatening): Anosmia, hyposmia

Warnings/Precautions

Concerns related to adverse effects:

• CNS depression: May cause drowsiness in some patients; instruct patient to use caution when driving or operating machinery. Effects may be additive with CNS depressants and/or ethanol.

• Nasal ulcerations: Periodically examine nasal mucosa for ulceration and consider discontinuing if ulceration occurs.

Monitoring Parameters

Observe patients periodically for adverse nasal effects (eg, ulceration, perforation).

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse effects were observed in animal reproduction studies. Until additional information is available, other agents may be preferred for the treatment of rhinitis in pregnant women (Scadding 2008).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience bad taste. Have patient report immediately to prescriber nasal sores, severe nasal irritation, or severe nosebleeds (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment, in diagnosing, treating, and advising patients.

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