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Patanase (Olopatadine Hydrochloride Nasal) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Formal drug-drug interaction studies were not conducted for PATANASE Nasal Spray. Drug interactions with inhibitors of liver enzymes are not anticipated because olopatadine is eliminated predominantly by renal excretion. Drug interactions involving P450 inhibition and plasma protein binding are also not expected. [See Clinical Pharmacology ].

OVERDOSAGE

There have been no reported overdosages with PATANASE Nasal Spray.

Acute overdosage with this dosage form is unlikely due to the configuration of the primary container closure system. However, symptoms of antihistamine overdose may include drowsiness in adults and, initially, agitation and restlessness, followed by drowsiness in children. There is no known specific antidote to PATANASE Nasal Spray. Should overdose occur, symptomatic or supportive treatment is recommended, taking into account any concomitantly ingested medications.

No mortality was observed in rats at an intranasal dose of 3.6 mg/kg (approximately 6 times the MRHD for adults and adolescents ≥12 years of age and 7 times the MRHD for children 6-11 years of age on a mg/m2 basis), or in dogs at an oral dose of 5 g/kg (approximately 28,000 times the MRHD for adults and adolescents ≥12 years of age and 33,000 the MRHD for children 6-11 years of age on a mg/m2 basis). The oral median lethal dose (MLD) in mice and rats were 1,490 mg/kg and 3,870 mg/kg respectively (approximately 1,200 times and 6,500 times the MRHD for adults and adolescents ≥12 years of age and 1,500 times and 7,700 times the MRHD for children 6-11 years of age, on a mg/m2 basis, respectively).

For additional information about overdose treatment, call a poison control center (1-800-222-1222).

CONTRAINDICATIONS

None.

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