ALOVENT
Manufacturer DetailsSANOFI AVENTIS
SANOFI INDIA LTD SANOFI HOUSE, CTS NO 117-B L&T BUSINESS PARK SAKI VIHAR ROAD, POWAI ANDHERI EAST, MUMBAI 400072
Compositions:
Olopatadine 5mg tabs,
Olopatadine 5mg tabs,
| Strength | Rate | Packing Style |
|---|---|---|
| 5mg | 68.50 | 10s tablets |
List of Related Indications:
- Allergic rhinitis
- Urticaria
List Of Drugs:
- Olopatadine - Anti-allergic drug- (June 2006)
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
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.
