Indication:
LIST OF DRUGS DURING 2006
Sr.No- 137
Name of the Drug- Epinastine Hcl (0.05%0 Ophthalmic solution Pharmacological Classification- For allergic conjunctivitis
Date of Approval- 22-09-2006
Approved by U.S.FDA on 30-12-2006 (Ref- FDA approved List)
Allergic conjuntivitis
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Epinastine Hcl 0.05% 22-09-2006
ophthalmic solution
For allergic conjuntivitis
Adverse Reaction:
Most frequently reported ocular adverse reactions occuring in approximately 1% to 10% of patients were - burning sensation in the eye, folliculitis,hyperermia and pruritus
Most frequently reported non- ocular adverse reactions were-
infection ( cold symptoms and upper respiratory infection ) seen in approx 8% and
headache, rhinitis, sinusitis, increased cough, and pharynginitis in approx 2% of cases
Contra-Indications:
Hypersensitivity to epinastine or any other components
Special Precautions/ Warning-
Administration- Epinastine Hydrochoride is for topical ophthalmic use only and not for
injection or oral use.
Contact lenses- advice patients not to wear a contact lenses if their eyes are red.
Do not use epinastine to treat contact lenses related irritation
Contact lenses should be removed prior to instillation and may be reinserted after
10 minutes following its administration.
Administration- instruct patients to avoid the tip of the dispensing container to contact the eye, surrounding strictures , fingers or any other surface to prevent contamination of the solution by common bacteria to cause ocular infections
Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions
Pregnancy - epinastine ophthalmic solution should be used during pregnancy only if the
potential justifies the potential risk to the fetus.
Lactation- caution should be excercised when epinastine ophthalmic solution is administered to a nursing woman
Children- safety and effectiveness in pediatric younger than the age of 3 years have not been established
Elderly - No overall differences in safety or effectiveness have been observed between elderly and younger patients
Dosages/ Overdosage Etc:
Indication-
Allergic conjuntivitis
Dosage-
Recommended dose is 1 drop in each eye twice a day
Store - at 15 to 25C ( 59 to 77F ). Keep out of reach of children
Patient Information:
1. Epinastine Hydrochoride is for topical ophthalmic use only and not for
injection or oral use.
2. Advice patients not to wear a contact lenses if their eyes are red.
Do not use epinastine to treat contact lenses related irritation
3. Contact lenses should be removed prior to instillation and may be reinserted after
10 minutes following its administration.
4. Instruct patients to avoid the tip of the dispensing container to contact the eye,
surrounding strictures , fingers or any other surface to prevent contamination of the solution by common bacteria to cause ocular infections
5. Serious damage to the eye and suscequent loss of vision may result from using contaminated solutions
6. Keep bottle tightly closed when not in use.
Pregnancy and lactation:
Pregnancy -
Epinastine ophthalmic solution should be used during pregnancy only if the
potential justifies the potential risk to the fetus.
Lactation-
Caution should be excercised when epinastine ophthalmic solution is administered
to a nursing woman
Children-
Safety and effectiveness in pediatric patients younger than the age of 3 years have not been
established
Elderly -
No overall differences in safety or effectiveness have been observed between elderly
and younger patients
Manufacturer Details