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Highly Regulated (List I)

HYCOSONE

10MG/Scored Tablet/HYDROCORTISONE
GEOPHARM
ManufacturerVerified lab

GEOPHARM

Public retail price
N/ADZD

Identification

Active ingredient (INN)
HYDROCORTISONE
Internal code
09 H 028
Country of Origin
Algeria
Pharmaceutical form
Scored Tablet
Prescription List
Highly Regulated (List I)
Packaging
B/20
HYCOSONE
Clinical View
Highly Regulated (List I)

DAWA Clinical Workbench v2.0

Information may not be accurate. Always consult a physician, pharmacist, or specialist before acting on any data shown here.

Description

Hydrocortisone, or cortisol, is a glucocorticoid secreted by the adrenal cortex.

Hydrocortisone is used to treat immune, inflammatory, and neoplastic conditions. 14, 15, 16, 17, 18, 19 It was discovered in the 1930s by Edward Kendall and named Compound F, or 17-hydroxycorticosterone.

Hydrocortisone was granted

FDA approval on 5 August 1952.

Indications

Otic solutions are indicated for infections of the external auditory canal caused by susceptible organisms and with inflammation. 14, 15 Hydrocortisone 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, 17 a topical ointment with antibiotics is indicated for corticosteroid responsive dermatoses with infections, 18 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.

Pharmacodynamics

Hydrocortisone 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.

Hydrocortisone has a wide therapeutic index and a moderate duration of action. 1, 6 Patients should stop taking the medication if irritation or sensitization occurs. 14, 15, 16, 17, 18, 19.

Absorption

The pharmacokinetics of hydrocortisone can vary by 10 times from patient to patient.

Following the oral administration of hydrocortisone at a dose of 0.2-0.3 mg/kg/day, the mean C max and AUC of plasma free cortisol were 32.69 nmol/L and 90.63 h x nmol/L, respectively.

The mean C max and

AUC of plasma total cortisol were 514.47 nmol/L and 1743.93 h x nmol/L, respectively.

Following the dose of 0.4-0.6 mg/kg/day, the mean C max and AUC of plasma free cortisol were 70.81 nmol/L and 199.11 h x nmol/L.

AUC of plasma total cortisol were 754.94 nmol/L and 2533.02 h x nmol/L, respectively.

Topical hydrocortisone cream is 4-19% bioavailable with a T max of 24h.

Hydrocortisone retention enemas have a bioavailability of 0.810 for slow absorbers and 0.502 for 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 20 mg Intravenous dose of hydrocortisone has an AUC of 1163±277ng*h/mL.

Volume of Distribution

Total hydrocortisone has a volume of distribution of 39.82 L, while the free fraction has a volume of distribution of 474.38 L.

Metabolism

Hydrocortisone is metabolised to 6-beta hydrocortisol via CYP3A, 5-beta tetrahydrocortisol via 3-oxo-5-beta-steroid 4-dehydrogenase, 5-alpha tetrahydrocortisol via 3-oxo-5-alpha-steroid 4-dehydrogenase 2, cortisone via Corticosteroid 11-beta-dehydrogenase isozyme and Corticosteroid 11-beta-dehydrogenase isozyme 2, and glucuronide products.

Cortisone is further metabolized to tetrahydrocortisone and dihydrocortisol.

Hover over products below to view reaction partners Hydrocortisone 6-beta-hydrocortisol 5-beta Tetrahydrocortisol 5-alpha Tetrahydrocortisol Cortisone Dihydrocortisol Tetrahydrocortisone Tetrahydrocortisol Glucuronide 1 + Tetrahydrocortisol Glucuronide 2 + Tetrahydrocortisone Glucuronide 1 + Tetrahydrocortisone Glucuronide 2.

Route of Elimination

Corticosteroids are eliminated predominantly in the urine.

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 20 mg Intravenous 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 12.85 L/h, while the free fraction has a mean clearance of 235.78 L/h.

A 20 mg Intravenous dose of hydrocortisone has a clearance of 18.2±4.2 L/h.

Adverse Effects

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Toxicity

Data regarding acute overdoses of glucocorticoids are rare. 14, 15, 16, 17, 18, 19 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.

Warnings

For external use only

Do not use.

  • in the genital area if you have a vaginal discharge.

Consult a doctor.

  • for the treatment of diaper rash.

When using this product.

  • avoid contact with the eyes.
  • do not use more than directed unless told to do so by a doctor.
  • do not put directly into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if.
  • condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor.
  • rectal bleeding occurs Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • adults and children 2 years of age and older: apply to affected area not more than to 4 times daily.
  • children under 2 years of age: do not use, ask a doctor.
  • when practical, clean the affected area with mild soap and warm water and rinse thoroughly.
  • gently dry by patting or blotting with toilet tissue or a soft cloth before applying.
  • apply to affected area not more than to 4 times daily.
  • children under 12 years of age: ask a doctor.

Storage & Handling

Other information.

  • store at 20-25°C (68-77°F).

Alternatives