Drug Information

Drug Interaction:

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.

Indication:

U.S.FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08

Drug name Indication Date of Approval

171. Olapatidine Nasal Spray (0.6%) 05-08-08

For the relief of the symptoms of seasonal allergic

in rhinitis in patients in patiients in patients 12 years

of age and older

PATANASE (olopatadine hydrochloride) Nasal Spray

Initial U.S. Approval: 1996

U.S.FDA APPROVED DRUGS DURING 2006

64. Olopatadine Ophthalmic solution (0.1%) 08-06-2006 For allergic conjunctivitis

U.S.FDA APPROVED DRUGS DURING 2007

26. Olapatadine HCL tablet 2.5mg/5mg 26-02-07

Allergic nasal inflammation, hives, itching

with skin diseases

59. Olopatadime Opththalmic solution (0.2%) 24-04-07

( addl.stgth)

As approved

New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing

(Ref- IDMA Publication)

Name of Drug Indication Date of Approval

1.Olapatadime Ophthalmic soln. 24-04-2007

0.2% - Addl.Stgth

As approved

2.Olapatadime Hcl Nasal spray 10-02-2010

0.6 %w/w - Addl.Indn

For the relief of symptoms of seasonal allergic rhinitis in patients

6 years of age and older

3.Olapataime Hcl Tablet 2.5mg/5mg 26-02-2007

Allergic nasal inflammation Hives,itching with skin diseases

4.Olapatadine Nasal Spray 0.6% 05-08-2008

For the relief of symptoms of seasonal allergic rhinitis in patients

12 years of age and older

5.Olapatadine Ophthalmic soln 0.1% 08-06-2006

For allergic conjuntivitis

6.Olapatamine 05-03-2010

+ Amboxol 30mg tablets

For the management of Cough in adult patients only

Allergic conjunctivitis

Adverse Reaction:

Opthalmic -

Headache, asthnenia, Cold syndrome, Pharyngitis, rhinitis, sinusitis, Dysgeusia , Ocular burning or stinging Dry eye, foreign body sensation Keratitis Blurred vision Nasal - Nasal ulceration Bitter taste, Epistaxis Drowsiness

Contra-Indications:

Hypersensitivity Ophthalmic-

Children < 3 yr Nasal children < 12 yr

Special precaution-

Pregnancy Lactation Ophthalmic- Remove contact lenses prior to eye admin. Reinsert soft contact lenses 10 min after admin

Dosages/ Overdosage Etc:

Indication-

Allergic conjunctivitis

Dosage-

As 0.1% soln or 1 or 2 drops in the affected eye(s) bid at an interval of 6-8 hr

INDICATIONS AND USAGE

PATANASE Nasal Spray is an H1 receptor antagonist indicated for the relief

of the symptoms of seasonal allergic rhinitis in adults and children

6 years of age and older.

DOSAGE AND ADMINISTRATION

For intranasal use only.

Recommended dosages:

Adults and adolescents . 12years: Two sprays per nostril twice daily.

Children 6 to 11 years: One spray per nostril twice daily.

Priming Information:

Prime PATANASE Nasal Spray before initial use and

when PATANASE Nasal Spray has not been used for more than 7 days.

DOSAGE FORMS AND STRENGTHS

Nasal spray 0.6%: 665 mcg of olopatadine hydrochloride in each

100- microliter spray.

Supplied as a 30.5 g bottle containing 240 sprays.

Patient Information:

PATIENT COUNSELING INFORMATION

See FDA-approved Patient Labeling accompanying the product.

1. Local Nasal Effects and Other Common Adverse Reactions

Patients should be informed that treatment with PATANASE Nasal Spray may lead

to adverse reactions, which include epistaxis and nasal ulcerations.

Other common adverse reactions reported with use of PATANASE Nasal Spray

include bitter taste, headache, and pharyngolaryngeal pain, ].

2. Activities Requiring Mental Alertness

Somnolence has been reported in some patients taking PATANASE Nasal Spray.

Patients should be cautioned against engaging in hazardous occupations requirin

complete mental alertness and motor coordination such as driving or operating

machinery after administration of PATANASE Nasal Spray

.3 Concurrent Use of Alcohol and other Central Nervous System Depressants

Concurrent use of PATANASE Nasal Spray with alcohol or other central nervous

system depressants should be avoided because additional reductions

in alertness and additional impairment of central nervous system performance

may occur

4. Keep Spray Out of Eyes

Patients should be informed to avoid spraying PATANASE Nasal Spray in their eyes.

Mfd for:

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

Mfd by:

ALCON CUSI, S.A.

08320 El Masnou-Barcelona

Spain

Pharmacology/ Pharmacokinetics:

CLINICAL PHARMACOLOGY

1. Mechanism of Action

Olopatadine is a histamine H1 -receptor antagonist. The antihistaminic activity of

olopatadine has been documented in isolated tissues, animal models, and humans.

2. Pharmacokinetics

The pharmacokinetic properties of olopatadine were studied after administration

by the nasal, oral, intravenous, and topical ocular routes. Olopatadine exhibited

linear pharmacokinetics across the routes studied over a large dose range

Pregnancy and lactation:

USE IN SPECIFIC POPULATIONS

1. Pregnancy

Pregnancy Category C: No adequate and well-controlled studies in pregnant women

have been conducted. Animal reproductive studies in rats and rabbits revealed

treatment-related effects on fetuses or pups. Because animal studies are not

always predictive of human responses,

PATANASE Nasal Spray should be used in pregnant women only if the potential

benefit to the mother justifies the potential risk to the embryo or fetus

2. Nursing Mothers

Olopatadine has been identified in the milk of nursing rats following oral

administration. It is not known whether topical nasal administration could

result in sufficient systemic absorption to produce detectable quantities

in human breast milk. PATANASE Nasal Spray should be used by nursing

mothers only if the potential benefit to the patient outweighs the potential

risks to the infant.

3. Pediatric Use

The safety and effectiveness of PATANASE Nasal Spray has not been

established for patients under 6 years of age.

The safety of olopatadine nasal spray was evaluated in 3 vehicle-controlled

2-week studies in 870 patients 6 to 11 years of age

In this study, the incidence of epistaxis with PATANASE treatment

was 5.7%, compared to 3.2% seen in adult and adolescent studies.

This study also evaluated the effectiveness of PATANASE Nasal Spray in

patients 6 through 11 years of age with seasonal allergic rhinitis .

4. Geriatric Use

Clinical studies of PATANASE Nasal Spray did not include sufficient numbers

of patients aged 65 years and older to determine whether they respond

differently from younger patients.

Other reported clinical experience has not identified differences in responses

between the elderly and younger patients. In general, dose selection

for an elderly patient should be cautious, reflecting the greater frequency

of decreased hepatic, renal, or cardiac function and of concomitan

disease or other drug therapy.

Olopatadine - Anti-allergic drug- (June 2006)

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pharmacology/ Pharmacokinetics

Pregnancy and lactation