Loterex-G Ophthalmic
Ophthalmic Suspension
Ibn Sina Pharmaceuticals Ltd.Generic:
Loteprednol Etabonate + GatifloxacinWeight:
0.5%+0.3%best Price:
? 250.00Generic
Loteprednol Etabonate + Gatifloxacin
Indications
This ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, and cyclitis. It is also indicated for the treatment of post-operative inflammation following ocular surgery.
Dosage Administration
Apply one or two drops of sterile ophthalmic suspension into the conjunctival sac of the affected eye(s) every four to six hours. During the initial 24 to 48 hours, the dosing maybe increased, to every one to two hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.
Contraindications
Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component or the anti-infective component, or the combination. Reactions associated with ophthalmic steroids include elevated IOP, which may be associated with infrequent optic nerve damage, visual acuity and field detects, posterior sub capsular cataract formation, delayed wound healing, and secondary ocular infections from pathogens including herpes simplex, and perforation of the globe where there is thinning of cornea or sclera. The most frequently reported adverse effects for gatifloxacin in the overall study population were conjunctival irritation, increased lacrimation, keratitis and papillary conjunctivitis. These events occurred in approximately 5-10% of patients. Other reported reactions occurring in 1-4% of patients were chemosis, conjunctival hemorrhage, dry eye, eye discharge, eye irritation, eye pain, eyelid edema, headache, red eye, reduced visual acuity and taste disturbance. Redness was the most commonly observed adverse event occurring in 6%. Itching, discharge photophobia and blurred vision were seen in less than 2% cases.
Side Effects
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this is administered to a nursing woman.
Pregnancy And Lactation
The preparation should not be injected sub conjunctively, nor should it be introduced directly into the anterior chamber of the eye. If this product is used for 10 days or longer, intraocular pressure should be monitored. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. If redness or itching becomes aggravated, the patient should be advised to consult a physician. Patients who wear soft contact lenses and whose eyes are not red, should be instructed to wait at least ten minutes after instilling it before they insert their contact lenses.
Therapeutic
Store at room temperature & protect from light. Do not touch dropper tip to any surface. It is desirable that the contents should not be used one month after first opening of the bottle. Protect from freezing.