Maxitrol Ophthalmic Solution (1 mg+3500 IU+6000 IU)/ml
Maxitrol Ophthalmic Solution (1 mg+3500 IU+6000 IU)/ml Uses, Dosage, Side Effects, Food Interaction and all others data.
Dexamethasone (Corticosteroids) suppress inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroid may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case. The anti-infective component in the combination is included to provide action against specific organisms susceptible to it.
Neomycin Sulphate is considered active against the following microorganisms: Staphylococcus aureus, Corynebacterium diphtheriae, Streptococcus Viridans, Escherichia coli,Klebsiella pneumoniae, Proteus vulgaris, Aerobacter aerogenes, and Haemophilus influenzae.
Polymyxin B Sulphate is considered active against the following microorganism: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Koch-Weeks bacillus.
When a decision to administer both a corticosteroid and an antimicrobial is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered, plus assured compatibility of ingredients when both types of drugs are in the same formulation and, particularly, that the correct volume of drug is delivered and retained.
| Trade Name | Maxitrol Ophthalmic Solution (1 mg+3500 IU+6000 IU)/ml |
| Generic | Dexamethasone + Neomycin Sulphate + Polymyxin B Sulphate |
| Weight | (1 mg+3500 IU+6000 IU)/ml |
| Type | Ophthalmic Solution |
| Therapeutic Class | Ophthalmic steroid - antibiotic combined preparations |
| Manufacturer | City Overseas Ltd. |
| Available Country | Bangladesh |
| Last Updated: | October 19, 2023 at 6:27 am |
Uses
This is used for ocular inflammation when concurrent use of an antimicrobial is judged necessary.
Maxitrol Ophthalmic Solution (1 mg+3500 IU+6000 IU)/ml 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 eyes
How Maxitrol Ophthalmic Solution (1 mg+3500 IU+6000 IU)/ml 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.
Dosage
Maxitrol Ophthalmic Solution (1 mg+3500 IU+6000 IU)/ml dosage
Eye drops: One drop topically into the conjunctival sac(s). In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used up to four to six times daily.
Eye ointment: It should be applied thinly and evenly to the conjunctival sac(s) at night (if eye drops used during the day) or 3-4 times daily (if eye ointment used alone).
Side Effects
Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available. Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitizations. The reactions due to the steroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage, posterior sub-capsular cataract formation and delayed wound healing.
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
Prolonged use may cause glaucoma, damage to the optic nerve, defects in visual acuity and fields of vision, posterior subcapsular cataract formation and increased risk of secondary ocular infections. Increased risk of perforations in diseases which can cause thinning of the cornea or sclera. Corticosteroids may mask infection or worsen existing infections in acute purulent conditions of the eye. Regular monitoring of the intraocular pressure is recommended if product is used for 10 days. Long term application of topical corticosteroids may also increase the risk of ocular fungal infections. Neomycin sulfate may cause cutaneous sensitisation. Pregnancy and lactation.
Interaction
There are no known drug interactions and none well documented.
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 Cmax of 34.6±6.0ng/mL with a Tmax of 2.0±1.2h and an AUC of 113±38ng*h/mL. A 1.5mg oral dose reaches a Cmax of 13.9±6.8ng/mL with a Tmax of 2.0±0.5h and an AUC of 331±50ng*h/mL. Oral dexamethasone is approximately 70-78% bioavailable in healthy subjects.
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.
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
Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Lactation: Unknown if excreted in breast milk; minimal systemic absorption with ophthalmic administration
Contraindication
Epithelial herpes simplex keratitis (dentritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Hypersensitivity to a component of the medication (Hypersensitivity to the antibiotic component occurs at a higher rate than other component). The use of these combinations is always contraindicated after uncomplicated removal of a corneal foreign body.
Acute Overdose
Overdose is unlikely; however, treatment of overdose is by supportive and symptomatic therapy.
Storage Condition
Store at 15-30° C.
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