Otosporin
Otosporin Uses, Dosage, Side Effects, Food Interaction and all others data.
Neomycin, an aminoglycoside with spectrum similar to gentamicin, binds to the 30S subunits of the bacterial ribosome, inhibiting protein synthesis and thereby disrupting DNA synthesis. It is active against many Gram-negative aerobes and some strains of staphylococci.
Polymixin B disrupts bacterial cell membrane and has bactericidal action against most Gram-negative bacilli. It is inactive against Gram-positive bacteria, obligate anaerobes and Neisseria spp. When used together, they are active against Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter species, Neisseria species, and Pseudomonas aeruginosa but have inadequate coverage against Serratia marcescens and streptococci, including Streptococcus pneumoniae.
Hydrocortisone is a corticosteroid used for its anti-inflammatory and immunosuppressive effects. Its anti-inflammatory action is due to the suppression of migration of polymorphonuclear leukocytes and reversal of increased capillary permeability. It may also be used as replacement therapy in adrenocortical insufficiency.
| Trade Name | Otosporin |
| Generic | Hydrocortisone + Neomycin Sulphate + Polymixin B |
| Weight | (10mg+3400units+10000units)/ml, 1%w/v, 3400iu/ml, 10000iu/ml, |
| Type | Eye/ear Drops, Ear Drops |
| Therapeutic Class | Ophthalmic steroid - antibiotic combined preparations, Ophthalmic Steroid preparations |
| Manufacturer | Glaxosmithkline |
| Available Country | Bangladesh, Pakistan, Portugal |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Acute otitis media, Ocular inflammation
Otosporin is also used to associated treatment for these conditions: Acute Gouty Arthritis, Acute Otitis Externa, Adrenal Insufficiency, Allergic Rhinitis (AR), Allergic corneal marginal ulcers, Anal Fissures, Ankylosing Spondylitis (AS), Anterior Segment Inflammation, Aspiration Pneumonitis, Asthma, Atopic Dermatitis (AD), Berylliosis, Bullous dermatitis herpetiformis, Chorioretinitis, Choroiditis, Congenital Adrenal Hyperplasia (CAH), Congenital Hypoplastic Anemia, Corneal Inflammation, Crohn's Disease (CD), Dermatitis, Dermatitis exfoliative generalised, Dermatitis, Contact, Dermatomyositis, Dermatosis, Drug hypersensitivity reaction, Epicondylitis, Erythroblastopenia, Hemorrhoids, Herpes Labialis, Hypercalcemia of Malignancy, Idiopathic Thrombocytopenic Purpura, Infection of the Fenestration Cavity, Infection of the Mastoidectomy Cavity, Iridocyclitis, Iritis, Itching caused by Hemorrhoids, Itching of the Anus, Leukemia, Acute, Leukemias, Loeffler's syndrome, Lymphomas NEC, Malignant Lymphomas, Mycosis Fungoides (MF), Ophthalmia, Sympathetic, Optic Neuritis, Pain caused by Hemorrhoids, Pemphigus, Post-traumatic Osteoarthritis, Primary adrenocortical insufficiency, Proctitis, Proteinuria, Psoriatic Arthritis, Rectal inflammations NEC, Rheumatic heart disease, unspecified, Rheumatoid Arthritis, Rheumatoid Arthritis, Juvenile, Seasonal Allergic Conjunctivitis, Secondary adrenocortical insufficiency, Secondary thrombocytopenia, Serum Sickness, Severe Seborrheic Dermatitis, Skin Diseases, Stevens-Johnson Syndrome, Synovitis, Systemic Lupus Erythematosus (SLE), Trichinosis, Tuberculous Meningitis, Ulcerative Colitis, Acquired immune hemolytic anemia, Acute Bursitis, Acute Tenosynovitis, Acute rheumatic carditis, Cryptitis, Disseminated Pulmonary Tuberculosis, Fulminating Pulmonary Tuberculosis, Itching skin, Non-suppurative Thyroiditis, Severe Erythema multiforme, Severe Psoriasis, Subacute Bursitis, Superficial infection of the external auditory canal with inflammation, Symptomatic Sarcoidosis, Systemic Dermatomyositis, Varicella-zoster virus acute retinal necrosis, Palliative
How Otosporin works
The short term effects of corticosteroids are decreased vasodilation and permeability of capillaries, as well as decreased leukocyte migration to sites of inflammation.[A187463] Corticosteroids binding to the glucocorticoid receptor mediates changes in gene expression that lead to multiple downstream effects over hours to days.[A187463]
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.[A187463]
Lower doses of corticosteroids provide an anti-inflammatory effect, while higher doses are immunosuppressive.[A187463] High doses of glucocorticoids for an extended period bind to the mineralocorticoid receptor, raising sodium levels and decreasing potassium levels.[A187463]
Dosage
Otosporin dosage
Ocular inflammation with suspected or confirmed bacterial infection:1 to 2 drops every 3-4 hourly as indicated.
Side Effects
Common side effects are irritation, increased intraocular pressure, glaucoma, posterior subcapsular cataract formation, delayed wound healing, secondary infections.
Toxicity
Data regarding acute overdoses of glucocorticoids are rare. 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
Ophthalmic: Glaucoma; monitor intraocular pressure regularly if used for >10 days.
Interaction
Additive toxicity with neurotoxic, ototoxic or nephrotoxic drugs. Increased neuromuscular blockade and possibly respiratory depression with neuromuscular blocking agents if significant amounts of neomycin absorbed significantly.
Volume of Distribution
Total hydrocortisone has a volume of distribution of 39.82L, while the free fraction has a volume of distribution of 474.38L.
Elimination Route
Oral hydrocortisone at a dose of 0.2-0.3mg/kg/day reached a mean Cmax of 32.69nmol/L with a mean AUC of 90.63h*nmol/L A 0.4-0.6mg/kg/day dose reached a mean Cmax of 70.81nmol/L with a mean AUC of 199.11h*nmol/L. However, the pharmacokinetics of hydrocortisone can vary by 10 times from patient to patient.
Topical hydrocortisone cream is 4-19% bioavailable[8546995] with a Tmax of 24h.
Hydrocortisone retention enemas are have a bioavailability of 0.810 for slow absorbers and 0.502 in rapid absorbers. Slow absorbers take up hydrocortisone at a rate of 0.361±0.255/h while fast absorbers take up hydrocortisone at a rate of 1.05±0.255/h.
A 20mg IV dose of hydrocortisone has an AUC of 1163±277ng*h/mL.
Half Life
Total hydrocortisone via the oral route has a half life of 2.15h while the free fraction has a half life of 1.39h. A 20mg IV dose of hydrocortisone has a terminal half life of 1.9±0.4h.
Clearance
Total hydrocortisone by the oral route has a mean clearance of 12.85L/h, while the free fraction has a mean clearance of 235.78L/h. A 20mg IV dose of hydrocortisone has a clearance of 18.2±4.2L/h.
Elimination Route
Corticosteroids are eliminated predominantly in the urine.[A187436] However, data regarding the exact proportion is not readily available.
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
Contraindication
Hypersensitivity to aminoglycosides and any of its components. Pre-existing nerve deafness. TB, fungal or viral infections.
Special Warning
Use in elderly patients: Clinical studies were not done in patients’ aged 65 and above. In general dose selection for an elderly patients should be cautious, usually starting at the low end of the dosing range.
Storage Condition
Store at 15-30°C.
Innovators Monograph
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