Medical Description
Tetracosactide is a synthetic polypeptide (ACTH analogue) that stimulates the adrenal cortex to secrete adrenal steroids (including hydrocortisone, cortisone), androgenic substances, and to a lesser extent, aldosterone.
Indication & Usage
Only used for short-term therapy in:
•ULCERATIVE COLITIS
•CROHN'S DISEASE
•JUVENILE RHEUMATOID ARTHRITIS
•AS ADJUNCT THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS AND OSTEOARTHROSIS.
Active Ingredients
Tetracosactide
Dosage & Administration
Intramuscular Injection
* Adult: Alternative to corticosteroids for short-term therapy of cases in patients who are intolerant to oral glucocorticoids: As long-acting depot: Initially, 1 mg daily, or 1 mg 12 hourly (in acute cases). Once acute symptoms are controlled or adequate response is achieved, may continue treatment at reduced doses of 0.5-1 mg every 2-3 days or 1 mg once weekly.
* Child: As long-acting depot: 3-<5 years Initially, 0.25-0.5 mg daily. Maintenance: 0.25-0.5 mg every 2-8 days; 5-12 years Initially, 0.25-1 mg daily. Maintenance: 0.25-1 mg every 2-8 days.
Side Effects
* Significant: Hypersensitivity reactions (e.g. marked redness and pain at the inj site, urticaria, pruritus, severe malaise or dyspnoea, flushing), psychological disturbances (e.g. euphoria, insomnia, mood swings, personality changes, severe depression, frank psychotic manifestations); increased intraocular pressure, ocular effects with prolonged use (e.g. corneal perforation, glaucoma, cataracts); salt and water retention, activation of latent TB or amoebiasis.
* Cardiac disorders: Bradycardia, tachycardia.
* Ear and labyrinth disorders: Vertigo.
* Endocrine disorders: Adrenal haemorrhage, Cushing’s syndrome, secondary adrenocortical and pituitary unresponsiveness (particularly during stress); growth retardation in children.
* Gastrointestinal disorders: Pancreatitis, peptic ulcer with perforation and haemorrhage, oesophagitis ulcerative, abdominal distension.
* General disorders and administration site conditions: Impaired healing.
* Infections and infestations: Abscess.
* Immune system disorders: Increased infection susceptibility.
* Investigations: Increased weight.
* Metabolism and nutrition disorders: Latent diabetes mellitus, decreased carbohydrate tolerance, hyperglycaemia, hypokalaemia, Ca deficiency, increased appetite, hypokalaemic alkalosis, peripheral oedema.
Safety Advice
**Contraindications
- Allergic disorders (e.g. asthma),
- untreated infection,
-acute psychosis,
-peptic ulcer,
-refractory heart failure,
-Cushing’s syndrome; treatment of primary adrenocortical insufficiency and adrenocongenital syndrome.
**Special Precautions
- Patient with active infectious or systemic disease; latent TB or amoebiasis,
- reduced immune response,
- hypertension,
- thromboembolic tendencies,
- ocular herpes simplex,
- cataracts,
- glaucoma,
- diabetes mellitus,
- gastrointestinal disease (e.g. nonspecific ulcerative colitis, recent intestinal anastomosis, diverticulitis),
- osteoporosis,
- myasthenia gravis,
- liver cirrhosis,
- hypothyroidism.
- Patient with critical illness,
- nephrotic syndrome,
- those receiving oral contraceptives, hydrocortisone, cortisone or spironolactone, or have previously undergone operation may have an inaccurate result of plasma cortisol levels .
- Patient subjected to stress conditions (e.g. trauma, surgery, illness).
- Concomitant administration with live vaccines.
- Renal and hepatic impairment.
- Children
Storage
Store between 2-8°C and Protect from light
Drug Interactions
May enhance the hepatotoxic effects of valproate (particularly in children), phenytoin, clonazepam, nitrazepam, phenobarbital, primidone. Increased total cortisol levels with synthetic estrogens thus may diminish the diagnostic effect of tetracosactide. May potentiate the electrolyte loss with diuretics.
Pregnancy & Lactation
Pregnancy category C
Manufacture
ACDIMA INTERNATIONAL TRADING