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Olopatadine (nasal): Drug information

Olopatadine (nasal): Drug information
(For additional information see "Olopatadine (nasal): Patient drug information" and see "Olopatadine (nasal): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Patanase
Pharmacologic Category
  • Histamine H1 Antagonist;
  • Histamine H1 Antagonist, Second Generation;
  • Piperidine Derivative
Dosing: Adult
Seasonal allergic rhinitis

Seasonal allergic rhinitis: Intranasal: Two sprays into each nostril twice daily.

Dosing: Kidney Impairment: Adult

No dosage adjustment necessary.

Dosing: Hepatic Impairment: Adult

No dosage adjustment necessary.

Dosing: Pediatric

(For additional information see "Olopatadine (nasal): Pediatric drug information")

Allergic rhinitis, seasonal

Allergic rhinitis, seasonal: Olopatadine 665 mcg per spray:

Children 6 to <12 years: Intranasal: 1 spray per nostril twice daily.

Children ≥12 years and Adolescents: Intranasal: 2 sprays per nostril twice daily.

Dosing: Kidney Impairment: Pediatric

Children ≥6 years and Adolescents:

Mild, moderate, or severe impairment: No dosage adjustment necessary.

Dosing: Hepatic Impairment: Pediatric

Children ≥6 years and Adolescents: No dosage adjustment necessary as metabolism of olopatadine is only a minor route of elimination.

Dosing: Older Adult

Refer to adult dosing.

Dosage Forms: US

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 (edta) disodium]

Generic: 0.6% (30.5 g)

Generic Equivalent Available: US

Yes

Dosage Forms Considerations

Patanase 30.5 g bottles contain 240 sprays.

Administration: Adult

Intranasal: For intranasal use only; do not spray in eyes. Before initial use of the nasal spray, the delivery system should be primed with 5 sprays or until a fine mist appears. If ≥7 days have elapsed since last use, the delivery system should be reprimed with 2 sprays. 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. Discard after 240 sprays (enough for 30 days of dosing) have been used, even if bottle is not completely empty.

Administration: Pediatric

Intranasal: For intranasal use only; do not spray in eyes. Before initial use of the nasal spray, the delivery system should be primed with 5 sprays or until a fine mist appears. If >7 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. Aim nasal applicator to the cheek side of the nose, away from the center of nose. Breathe in through nose. While inhaling, press pump to release spray. Breathe out through mouth. Alternate sprays between nostrils. Do not tip head back or blow nose right after use; may cause bitter taste in mouth. After each use, wipe the spray tip with a clean tissue or cloth. Discard after 240 sprays (enough for 30 days of dosing) have been used, even if bottle is not completely empty.

Use: Labeled Indications

Seasonal allergic rhinitis: Treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients ≥6 years of age.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Central nervous system: Bitter taste (13%; children: 1%)

Respiratory: Epistaxis (3% to 25%)

1% to 10%:

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

Dermatologic: Skin rash (children: 1%)

Endocrine & metabolic: Weight gain (1%)

Gastrointestinal: Xerostomia (1%)

Genitourinary: Urinary tract infection (1%)

Infection: Influenza (1%)

Neuromuscular & skeletal: Increased creatine phosphokinase (1%)

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

<1%, postmarketing, and/or case reports: Altered sense of smell, anosmia, dizziness, dysgeusia, nasal discomfort, oropharyngeal pain

Contraindications

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

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.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

CNS Depressants: Olopatadine (Nasal) may enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Pregnancy Considerations

Other agents may be preferred for the treatment of allergic rhinitis during pregnancy (BSACI [Scadding 2017]).

Breastfeeding Considerations

It is not known if olopatadine is present in breast milk following nasal administration.

According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should consider the risk of exposure to the infant and the benefits of treatment to the mother.

Monitoring Parameters

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

Mechanism of Action

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

Pharmacokinetics

Onset of action: 30 minutes in seasonal allergy patients.

Protein binding: ~55% (primarily albumin).

Metabolism: Not extensively metabolized.

Bioavailability: 57%.

Half-life elimination: 8 to 12 hours.

Time to peak, serum: 15 minutes to 2 hours.

Excretion: Urine (~70%, mostly as unchanged drug); feces (17%).

Pharmacokinetics: Additional Considerations

Sex: Cmax and AUC0 to12 were 40% and 27% higher, respectively, in females compared with males (intranasal).

Pricing: US

Solution (Olopatadine HCl Nasal)

0.6% (per gram): $3.54 - $10.25

Solution (Patanase Nasal)

0.6% (per gram): $11.96

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Aleron (BD);
  • Lopadine (BD);
  • Olopan (BD)


For country code abbreviations (show table)
  1. Patanase (olopatadine) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; June 2021.
  2. Scadding GK, Kariyawasam HH, Scadding G, et al. BSACI guideline for the diagnosis and management of allergic and non-allergic rhinitis (Revised Edition 2017; First edition 2007). Clin Exp Allergy. 2017;47(7):856‐889. doi:10.1111/cea.12953 [PubMed 30239057]
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