Brand Name Cotson
Type Tablet
Weight 10 mg
Generic Hydrocortisone
Manufacturer Opsonin Pharma Ltd.
Available in

Introduction

Cotson Tablet 10 mg, or cortisol, is a glucocorticoid secreted by the adrenal cortex. Cotson Tablet 10 mg is used to treat immune, inflammatory, and neoplastic conditions.

Uses

Cotson Tablet 10 mg is a glucocorticoid used to treat corticosteroid-responsive dermatoses, endocrine disorders, immune conditions, and allergic disorders.

Otic solutions are indicated for infections of the external auditory canal caused by susceptible organisms and with inflammation. Cotson Tablet 10 mg tablets are indicated for certain endocrine, rheumatic, collagen, allergic, ophthalmic, respiratory, hematologic, neoplastic, edematous, gastrointestinal, and other conditions. A hydrocortisone enema is indicated for ulcerative colitis, a topical ointment with antibiotics is indicated for corticosteroid responsive dermatoses with infections, and a topical cream with acyclovir is indicated to treat cold sores. Oral granules of hydrocortisone are used as a replacement therapy for Adrenocortical Insufficiency (AI) in children under 17 years of age.

Associated 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

Pharmacodynamics

Cotson Tablet 10 mg binds to the glucocorticoid receptor leading to downstream effects such as inhibition of phospholipase A2, NF-kappa B, other inflammatory transcription factors, and the promotion of anti-inflammatory genes.[A187463] Cotson Tablet 10 mg has a wide therapeutic index and a moderate duration of action. Patients should stop taking the medication if irritation or sensitization occurs.

Mechanism of Action

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]

Absorption

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.

Cotson Tablet 10 mg 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.

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.

Protein Binding

Corticosteroids are generally bound to corticosteroid binding globulin[A187439] and serum albumin[A187436] in plasma. Cotson Tablet 10 mg is 90.1% bound to proteins in plasma, with 56.2% bound to albumin.

Route of Elimination

Corticosteroids are eliminated predominantly in the urine.[A187436] However, data regarding the exact proportion is not readily available.

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.

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.

Food Interactions

  • Avoid alcohol.

Dosage

Tablet: The initial dosage of Cotson Tablet 10 mg Tablets may vary from 20 mg to 240 mg of hydrocortisone per day depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, Cotson Tablet 10 mg Tablets should be discontinued and the patient transferred to other appropriate therapy. 

It should be emphasized that dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patients. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response. It should be kept in mind that constant monitoring is needed in regard to drug dosage. If, after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually, rather than abruptly.

Injection:
  • Adult: By IM injection or slow IV injection or infusion. The initial dose of Cotson Tablet 10 mg sterile powder is 100 mg to 500 mg, depending on the severity of the condition. This dose may be repeated at intervals of 2, 4 or 6 hours as indicated by the patient's response and clinical condition. 
  • Children: By slow IV injection, up to 1 year 25 mg, 1-5 years 50 mg, 6-12 years 100 mg.

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Uses

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