Olopatadine HCl Tablets 5mg

Nonproprietary name: Olopatadine Hydrochloride
Chemical name:
(Z)-11-(3-Dimethylaminopropylidene)-6,11-dihydrodibenz [b,e]oxepine-2acetic acid monohydrochloride
Description: Olopatadine hydrochloride occurs as a white crystal or crystalline powder. It is odorless and has a bitter taste.
Solubility: It is very soluble in formic acid, sparingly soluble in water and very slightly soluble in ethanol (99.5).
INDICATIONS
Allergic rhinitis, urticaria, itching resulting from skin diseases (eczema/dermatitis, prurigo, pruritus cutaneous, psoriasis vulgaris, multiform exudative erythema)
DOSAGE AND ADMINISTRATION
Usually, for adults, administer 5 mg as olopatadine hydrochloride twice a day orally in the morning and at bedtime. The dose may be increased or decreased according to age and symptoms.
PRECAUTIONS
1. Careful Administration (OLOPATAINE should be administered with care in the following patients.)
(1) Patients with impaired renal function [There is a possibility of persistently elevated blood concentrations.]
(2)Since elderly patients often have reduced physiological function and are more likely to develop adverse reactions, OLOPATADINE should be administered cautiously by starting at a low dose while monitoring the patient’s condition.
(3) Patients with hepatic dysfunction [Hepatic dysfunction may be aggravated.]
2. Important Precautions
(1) Since OLOPATADINE may induce drowsiness, patients should be cautioned against engaging in potentially hazardous activities requiring alertness such as operating machinery or driving a car.
(2) In case OLOPATADINE is administered in the patients who have been under chronic treatment with a steroid, dose reduction of the steroid should be made gradually under careful supervision.
(3) In case OLOPATADINE is administered in the patients with seasonal diseases, it is recommended to initiate administration immediately before the typical season to be continued until the end of the season.
(4) If OLOPATADINE dose not exhibit effect, administration should not be continued aimlessly for a prolonged time.
STORAGE:
Store below 30°C (86°F), protected from light.