Ikotref Powder for Solution for Injection

Hydrocortisone

100 mg / Vial

TABUK PHARMACEUTICAL MANUFACTURING CO

Pack size	1 Glass Vial
Dispensing mode	POM
Source	SAUDI ARABIA
Agent	AL PHAMED CO.ABUDHABI LTD.LLC
Retail Price	4.50 AED

Available as:

250 mg / Vial - Powder for Solution for Injection

Indications

Ikotref Powder for Solution for Injection is used for: Corticosteroid-responsive dermatoses, hypersensitivity reactions such as, angioedema, status asthmaticus, Soft tissue inflammation, Joint inflammations, Primary or secondary adrenocortical insufficiency, Acute adrenocortical insufficiency, Shock unresponsive to conventional therapy, Congenital adrenal hyperplasia, Hypercalcemia associated with cancer, Nonsuppurative thyroiditis, Rheumatic Disorders, Dermatologic Diseases, (Allergic States, Severe seborrheic dermatitis, Severe psoriasis, Pemphigus, Severe erythema multiforme), Control of severe or incapacitating allergic conditions, (Bronchial asthma, Contact dermatitis, Atopic dermatitis, Serum sickness, Seasonal or perennial allergic rhinitis, Drug hypersensitivity reactions, Urticarial transfusion reactions, Acute noninfectious laryngeal edema), Ophthalmic Diseases, (Herpes zoster ophthalmicus, Iritis, iridocyclitis, Chorioretinitis, Diffuse posterior uveitis and choroiditis, Optic neuritis), Gastrointestinal Diseases, Fulminating or disseminated pulmonary tuberculosis, when used concurrently with appropriate antituberculous chemotherapy, Loeffler's syndrome, Aspiration pneumonitis, Hematologic Disorders, (Acquired, autoimmune hemolytic anemia, Idiopathic thrombocytopenic purpura in adults, Secondary thrombocytopenia, Erythroblastopenia), Neoplastic Diseases, (Leukemias and lymphomas in adults, Acute leukemia of childhood), Edematous States, Acute exacerbations of multiple sclerosis

Adult Dose

Oral Replacement therapy in adrenocortical insufficiency Adult: 20-30 mg daily in 2 divided doses. Intravenous As supplement in adrenal insufficiency during minor surgery under general anaesthesia Adult: In patients taking >10 mg of prednisolone or its equivalent by mouth daily. 25-50 mg at induction. Resume with usual oral corticosteroid after surgery. As supplement in adrenal insufficiency during moderate or major surgery Adult: In patients taking >10 mg of prednisolone or its equivalent by mouth daily. Usual oral corticosteroid dose on the morning of the surgery followed by 25-50 mg at induction, then similar doses of hydrocortisone tid for 24 hr after moderate surgery or 48-72 hr after major surgery. Resume oral therapy once injections are stopped. Acute adrenocortical insufficiency Adult: 100-500 mg 3-4 times/24 hr according to the severity of the condition and patient response. Fluids and electrolytes should be administered as needed to correct any metabolic disorder. Doses may also be given via IM inj but the response may be slower. Status Asthmaticus 1-2 mg/kg IV q6hr initially for 24 hours; maintenance: 0.5-1 mg/kg q6hr Injection Soft tissue inflammation Adult: As Na phosphate or Na succinate esters: 100-200 mg as local inj. Intra-articular Joint inflammations Adult: As acetate: 5-50 mg depending on size of affected joint.

Child Dose

Oral Replacement therapy in adrenocortical insufficiency Child: 400-800 mcg/kg/day, in 2-3 divided doses. Intravenous Acute adrenocortical insufficiency Child: <1 yr: 25 mg; 1-5 yr: 50 mg; 6-12 yr: 100 mg. Fluids and electrolytes should be administered as needed to correct any metabolic disorder. Doses may also be given via IM inj but the response may be slower. Status Asthmaticus 1-2 mg/kg IV q6hr for 24 hr; not to exceed 250 mg IV Maintenance: 2 mg/kg/day IV divided q6hr

Renal Dose

Administration

Should be taken with food.

Contra Indications

Viral/fungal infections, tubercular or syphilitic lesions, bacterial infections unless used in conjunction with appropriate chemotherapy.

Precautions

CHF, hypertension, DM, epilepsy, elderly, patients on prolonged therapy. Gradual withdrawal, pregnancy and lactation. Lactation: Drug enters breast milk; use with caution

Pregnancy-Lactation

Pregnancy category: C Lactation: Drug enters breast milk; use with caution

Interactions

Thiazides may enhance hyperglycaemia and hypokalaemia caused by corticosteroids. Increased incidence of peptic ulcer or GI bleeding with concurrent NSAIDs admin. Response to anticoagulants altered. Dose of antidiabetics and antihypertensives needs to be increased. Decreases serum conc of salicylates and antimuscarinic agents. Ethanol may enhance gastric mucosal irritation. Reduced efficacy with concurrent use of carbamazepine, phenytoin, primidone, barbiturates and rifampicin. Mutual inhibition of metabolism between ciclosporin and corticosteroids increase plasma conc of both drugs. Enhanced effect in women taking oestrogens or oral contraceptives.

Adverse Effects

Side effects of Hydrocortisone : Sodium and fluid retention. Potassium and calcium depletion. Muscle wasting, weakness, osteoporosis. GI disturbances and bleeding. Increased appetite and delayed wound healing. Bruising, striae, hirsutism, acne, flushing. Raised intracranial pressure, headache, depression, psychosis, menstrual irregularities. Hyperglycaemia, glycosuria, DM, obesity, moon-face, buffalo hump. Suppression of pituitary-adrenocortical system. Growth retardation in childn (prolonged therapy). Increased susceptibility for infection. Topical use: Dermal atrophy, local irritation, folliculitis, hypertrichosis. Inhaled corticosteroids: May cause hoarseness, candidiasis of mouth and throat. Topical application to the eye: Can produce corneal ulcers, raised IOP and reduced visual function. Intralesional injection: Local hypopigmentation of deeply pigmented skin. Intra-articular injection: Joint damage, fibrosis esp in load bearing joints. Potentially Fatal: Abrupt withdrawal leading to acute adrenal insufficiency. Rapid IV Inj may cause CV collapse.

Mechanism of Action

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.

Note

Ikotref 100 mg / Vial Powder for Solution for Injection manufactured by TABUK PHARMACEUTICAL MANUFACTURING CO. Its generic name is Hydrocortisone. Ikotref is availble in United Arab Emirates. Farmaco UAE drug index information on Ikotref Powder for Solution for Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

Some other brands of Hydrocortisone :

Powder for Solution for Injection

Ikotref ^{250 mg / Vial}

TABUK PHARMACEUTICAL MANUFACTURING CO

Infusion

Hydrocortisone ^100mg

Egyptian International Pharmaceutical Industries Co. (E.I.P.I.Co.)

Tablets

Hydrocortison ^{10 mg}

ORION CORPORATION

Cream

Egocort 1% ^10mg/g

EGO PHARMACEUTICALS PTY. LTD.

Cream

Derm-Aid 0.5% ^5mg/g

EGO PHARMACEUTICALS PTY. LTD.