Orbidex G 0.3%+0.1% Ophthalmic Solution

Uses

This Sterile Eye Drops is used for steroid responsive ocular inflammatory conditions with involvement of bacteria like blepharitis, scleritis, episcleritis, iritis, cyclitis, iridocyclitis, choroiditis, optic neuritis and chronic anterior uveitis, disciform and interstitial keratitis, allergic corneal marginal ulcers, corneal injury from chemical radiation or thermal burns.

Orbidex G 0.3%+0.1% Ophthalmic Solution is also used to associated treatment for these conditions: Acne Rosacea, Acute Gouty Arthritis, Acute Otitis Externa, Acute Otitis Media, Adrenal cortical hypofunctions, Adrenocortical Hyperfunction, Alopecia Areata (AA), Ankylosing Spondylitis (AS), Anterior Segment Inflammation, Aspiration Pneumonitis, Asthma, Atopic Dermatitis (AD), Berylliosis, Bullous dermatitis herpetiformis, Bursitis, Chorioretinitis, Choroiditis, Congenital Adrenal Hyperplasia (CAH), Congenital Hypoplastic Anemia, Conjunctivitis, Conjunctivitis allergic, Corneal Inflammation, Cushing's Syndrome, Dermatitis, Dermatitis exfoliative generalised, Dermatitis, Contact, Diabetic Macular Edema (DME), Discoid Lupus Erythematosus (DLE), Drug hypersensitivity reaction, Edema of the cerebrum, Epicondylitis, Episcleritis, Erythroblastopenia, Eye Infections, Eye allergy, Eye swelling, Glaucoma, Hypercalcemia, Idiopathic Thrombocytopenic Purpura, Infection, Inflammation, Inflammation of the External Auditory Canal, Intraocular Inflammation, Iridocyclitis, Iritis, Keloid Scars, Leukemia, Acute, Lichen Planus (LP), Lichen simplex chronicus, Loeffler's syndrome, Macular Edema, Malignant Lymphomas, Middle ear inflammation, Mucosal Inflammation of the eye, Multiple Myeloma (MM), Muscle Inflammation caused by Cataract Surgery of the eye, Mycosis Fungoides (MF), Necrobiosis lipoidica diabeticorum, Noninfectious Posterior Uveitis, Ocular Infections, Irritations and Inflammations, Ocular Inflammation, Ocular Inflammation and Pain, Ocular Irritation, Ophthalmia, Sympathetic, Optic Neuritis, Otitis Externa, Pemphigus, Perennial Allergic Rhinitis (PAR), Phlyctenular keratoconjunctivitis, Post-traumatic Osteoarthritis, Postoperative Infections of the eyes caused by susceptible bacteria, Regional Enteritis, Rheumatoid Arthritis, Rheumatoid Arthritis, Juvenile, Sarcoidosis, Scleritis, Seasonal Allergic Conjunctivitis, Seasonal Allergic Rhinitis, Secondary thrombocytopenia, Serum Sickness, Severe Seborrheic Dermatitis, Stevens-Johnson Syndrome, Synovitis, Systemic Lupus Erythematosus (SLE), Trichinosis, Tuberculosis (TB), Tuberculosis Meningitis, Ulcerative Colitis, Uveitis, Vernal Keratoconjunctivitis, Acquired immune hemolytic anemia, Acute nonspecific tenosynovitis, Acute rheumatic carditis, Corticosteroid-responsive dermatoses, Ear infection-not otherwise specified caused by susceptible bacteria, Granuloma annulare lesions, Non-suppurative Thyroiditis, Ocular bacterial infections, Severe Psoriasis, Steroid-responsive inflammation of the eye, Varicella-zoster virus acute retinal necrosis, Watery itchy eyesBacterial Conjunctivitis, Ocular Infections, Irritations and Inflammations

How Orbidex G 0.3%+0.1% Ophthalmic Solution works

The short term effects of corticosteroids are decreased vasodilation and permeability of capillaries, as well as decreased leukocyte migration to sites of inflammation. Corticosteroids binding to the glucocorticoid receptor mediates changes in gene expression that lead to multiple downstream effects over hours to days.

Glucocorticoids inhibit neutrophil apoptosis and demargination; they inhibit phospholipase A2, which decreases the formation of arachidonic acid derivatives; they inhibit NF-Kappa B and other inflammatory transcription factors; they promote anti-inflammatory genes like interleukin-10.

Lower doses of corticosteroids provide an anti-inflammatory effect, while higher doses are immunosuppressive. High doses of glucocorticoids for an extended period bind to the mineralocorticoid receptor, raising sodium levels and decreasing potassium levels.

The bactericidal action of Gatifloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination.

Dosage

Orbidex G 0.3%+0.1% Ophthalmic Solution dosage

Instill 1-2 drops into the conjunctival sac 3 to 4 times daily.

Gatifloxacin can be administered without regard to food.

Side Effects

Mild burning, chemosis, redness may occur.

Toxicity

The oral LD₅₀ in female mice was 6.5g/kg and 794mg/kg via the intravenous route.

Overdoses are not expected with otic formulations. Chronic high doses of glucocorticoids can lead to the development of cataract, glaucoma, hypertension, water retention, hyperlipidemia, peptic ulcer, pancreatitis, myopathy, osteoporosis, mood changes, psychosis, dermal atrophy, allergy, acne, hypertrichosis, immune suppression, decreased resistance to infection, moon face, hyperglycemia, hypocalcemia, hypophosphatemia, metabolic acidosis, growth suppression, and secondary adrenal insufficiency. Overdose may be treated by adjusting the dose or stopping the corticosteroid as well as initiating symptomatic and supportive treatment.

Precaution

For ophthalmic use only. If the product is used for 10 days or more, intraocular pressure should be monitored routinely.

Interaction

Drug interaction can be occurred with following drugs:Diuretics, cardiac glycosides, antidiabetics, NSAIDs, anticoagulants, antacids etc. Besides, if patients undergo long-term therapy of glucororticoids with concomitant salicylates, any reduction in glucocorticoid dosage should be made with caution, since salicylate intoxication has been reported in such cases.

Volume of Distribution

A 1.5mg oral dose of dexamethasone has a volume of distribution of 51.0L, while a 3mg intramuscular dose has a volume of distribution of 96.0L.

Elimination Route

Absorption via the intramuscular route is slower than via the intravenous route. A 3mg intramuscular dose reaches a C_max of 34.6±6.0ng/mL with a T_max of 2.0±1.2h and an AUC of 113±38ng*h/mL. A 1.5mg oral dose reaches a C_max of 13.9±6.8ng/mL with a T_max of 2.0±0.5h and an AUC of 331±50ng*h/mL. Oral dexamethasone is approximately 70-78% bioavailable in healthy subjects.

Well absorbed from the gastrointestinal tract after oral administration with absolute bioavailability of gatifloxacin is 96%

Half Life

The mean terminal half life of a 20mg oral tablet is 4 hours. A 1.5mg oral dose of dexamethasone has a half life of 6.6±4.3h, while a 3mg intramuscular dose has a half life of 4.2±1.2h.

7-14 hours

Clearance

A 20mg oral tablet has a clearance of 15.7L/h. A 1.5mg oral dose of dexamethasone has a clearance of 15.6±4.9L/h while a 3.0mg intramuscular dose has a clearance of 9.9±1.4L/h.

Elimination Route

Corticosteroids are generally eliminated predominantly in the urine. However, dexamethasone is 15

Pregnancy & Breastfeeding use

Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Orbidex G 0.3%+0.1% Ophthalmic Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use in lactation: Caution should be exercised when Orbidex G 0.3%+0.1% Ophthalmic Solution is administered to a nursing mother.

Contraindication

This is contraindicated in epithelial herpes simplex keratitis (Dendritic keratitis), vaccinia, varicella, and in many other viral diseases of the conjunctiva and cornea. It is also contraindicated in mycobacterial infection of the eye, fungal diseases of ocular structures and in individuals hypersensitive to any of the components of the medication.

Special Warning

Use in children: Safety and effectiveness in pediatric patients have not been established.

Acute Overdose

Overdose through local administration is not known. In case of accidental oral intake, specific measures to reduce resorption should be taken. There is no specific antidote.

Storage Condition

Store at room temperature. Protect from light. Close the bottle immediately after use. Do not use for longer than one month after opening the bottle.

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