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PATANASE

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Overview

What is PATANASE?

PATANASE (olopatadine hydrochloride) Nasal Spray, 665 micrograms (mcg) is a metered-spray solution for intranasal administration. Olopatadine hydrochloride, the active component of PATANASE Nasal Spray, is a white, water-soluble crystalline powder. The chemical name for olopatadine hydrochloride is (Z)-11-[3-(dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid hydrochloride. It has a molecular weight of 373.88, and its molecular formula is CHNO • HCl with the following chemical structure:

PATANASE Nasal Spray contains 0.6% w/v olopatadine (base) in a nonsterile aqueous solution with pH of approximately 3.7. After initial priming (5 sprays), each metered spray from the nasal applicator delivers 100 microliters of the aqueous solution containing 665 mcg of olopatadine hydrochloride, which is equivalent to 600 mcg of olopatadine (base) [. PATANASE Nasal Spray also contains benzalkonium chloride (0.01%), dibasic sodium phosphate, edetate disodium, sodium chloride, hydrochloric acid and/or sodium hydroxide (to adjust pH), and purified water.



What does PATANASE look like?



What are the available doses of PATANASE?

Nasal spray 0.6%: 665 mcg of olopatadine hydrochloride in each 100- microliter spray. Supplied as a 30.5 g bottle containing 240 sprays.

What should I talk to my health care provider before I take PATANASE?

How should I use PATANASE?

PATANASE Nasal Spray is an H receptor antagonist indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and children 6 years of age and older.

Administer PATANASE Nasal Spray by the intranasal route only.


What interacts with PATANASE?

Sorry No Records found


What are the warnings of PATANASE?

Sorry No Records found


What are the precautions of PATANASE?

Sorry No Records found


What are the side effects of PATANASE?

Sorry No records found


What should I look out for while using PATANASE?

None.


What might happen if I take too much PATANASE?

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/m 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/m 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/m basis, respectively).

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


How should I store and handle PATANASE?

Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).See Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).See Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).See Product: 50090-1568NDC: 50090-1568-0 90 TABLET in a BOTTLENDC: 50090-1568-1 21 TABLET in a BOTTLEProduct: 50090-1568NDC: 50090-1568-0 90 TABLET in a BOTTLENDC: 50090-1568-1 21 TABLET in a BOTTLEProduct: 50090-1568NDC: 50090-1568-0 90 TABLET in a BOTTLENDC: 50090-1568-1 21 TABLET in a BOTTLE


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Olopatadine is a histamine H -receptor antagonist. The antihistaminic activity of olopatadine has been documented in isolated tissues, animal models, and humans.

Non-Clinical Toxicology
None.

































Epistaxis and Nasal Ulceration

Nasal Septal Perforation

Three placebo (vehicle nasal spray)-controlled long term (12 months) safety trials were conducted. In the first safety trial, patients were treated with an investigational formulation of PATANASE Nasal Spray containing povidone (not the commercially marketed formulation) or a vehicle nasal spray containing povidone. Nasal septal perforations were reported in one patient treated with the investigational formulation of PATANASE Nasal Spray and 2 patients treated with the vehicle nasal spray. In the second safety trial with PATANASE Nasal Spray, which does not contain povidone, there were no reports of nasal septal perforation.  In the third safety trial, one patient exposed to the 3.7 pH vehicle nasal spray (containing no povidone) reported a nasal septal perforation [].

Before starting PATANASE Nasal Spray, conduct a nasal examination to ensure that patients are free of nasal disease other than allergic rhinitis. Perform nasal examinations periodically for signs of adverse effects on the nasal mucosa and consider stopping PATANASE Nasal Spray if patients develop nasal ulcerations.

The most clinically significant adverse reactions described in other sections of labeling include;

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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