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)
Pharmacology
Mechanism of Action
Selective histamine H1-antagonist; inhibits release of histamine from mast cells.
Pharmacokinetics/Pharmacodynamics
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)
Use in Specific Populations
Special Populations: Children
6 to 11 years of age
Mean Cmax was ~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.
Dosage and Administration
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.
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%:
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
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
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 headache, sore throat, or bad taste. Have patient report immediately to prescriber nasal sores, severe nasal irritation, noisy breathing, 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.
