Tetracosactide

Registered South African indications:

• Glucocorticoid-responsive conditions
• Diagnosis of adrenocortical insufficiency

Contraindications

• Hypersensitivity to the active ingredient or to any of its excipients
• Asthma
• Allergic conditions
• Acute psychosis
• Infectious diseases
• Cushing's syndrome
• Peptic ulcer
• Refractory cardiac failure
• Treatment of primary adrenocortical insufficiency
• Adrenogenital syndrome
• Premature babies
• Neonates
• Intravenous use

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Ulcerative colitis
• Diverticulitis
• Recent intestinal anastomosis
• Hypertension
• Thromboembolic tendencies
• Osteoporosis
• Myasthenia gravis
• Ocular herpes simplex
• Latent amoebiasis
• Latent tuberculosis
• Diabetes mellitus
• Hypothyroidism
• Cirrhosis
• Nephrotic syndrome
• Prolonged use

Forms avail. in SA and covered in this monograph: inj

Rheumatoid diseases
Ulcerative colitis
Steroid responsive skin conditions
Nephrotic syndrome
Multiple sclerosis
Retrobulbar neuritis

• IM: Initial: 1mg, dly; Once acute manifestation has subsided, can reduce dose; Maintenance: 0.5-1mg, every 2-3 days OR 1mg, weekly

Diagnosis of adrenocortical insufficiency

• IM: 1mg, as a single dose; Cortisol level to be measured immediately before and 0.5,1,2,3,4 and 5hrs after injection

Paed. forms avail. in SA and covered in this monograph: inj

Rheumatoid diseases
Ulcerative colitis
Steroid responsive skin conditions
Nephrotic syndrome
Multiple sclerosis
Retrobulbar neuritis

Younger than 3 years

• Not established for use

Between 3-5 years

• IM: Initial: 0.25-0.5mg, dly; Once acute manifestation has subsided, can reduce dose; Maintenance: 0.25-0.5mg, every 2-8 days

Between 5-12 years

• IM: Initial: 0.25-1mg, dly; Once acute manifestation has subsided, can reduce dose; Maintenance: 0.25-1mg, every 2-8 days

Older than 12 years

• See adult dosage

Pregnancy

• Caution; not recommended
• There is a limited amount of data on the use of tetracosactide in pregnant patients. Data from animal studies are insufficient with respect to reproductive toxicity
• Tetracosactide should be used during pregnancy only if the expected benefit outweighs the potential risk to the foetus

Breastfeeding

• Caution

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Central Nervous System Disorders

• Seizures
• Benign increased intracranial pressure with papilloedema 
• Vertigo
• Headache

Cardiovascular Disorders

• Congestive cardiac failure
• Reversible cardiac hypertrophy 
• Necrotising vasculitis
• Thromboembolism
• Hypertension

Gastrointestinal Disorders

• Pancreatitis
• Peptic ulcer
• Ulcerative oesophagitis
• Abdominal distension

Endocrine and Metabolic Disorders

• Adrenal haemorrhage
• Cushing's syndrome
• Secondary adrenocortical and pituitary unresponsiveness
• Irregular menstruation 
• Decreased carbohydrate tolerance 
• Hyperglycaemia
• Manifestations of latent diabetes mellitus
• Hirsutism
• Hypokalaemia
• Calcium deficiency
• Sodium retention
• Fluid retention
• Increased appetite
• Hypokalaemic alkalosis

Musculoskeletal Disorders

• Aseptic necrosis of femoral and humeral heads
• Spinal compression fractures
• Muscle atrophy
• Myopathy
• Osteoporosis
• Muscular weakness
• Pathological fracture of long bones
• Tendon rupture
• Growth retardation
• Impaired healing

Skin and Subcutaneous Tissue Disorders

• Skin atrophy
• Petechiae
• Ecchymosis
• Erythema
• Hyperhidrosis
• Acne
• Skin hyperpigmentation

Immune, Blood and Lymphatic System Disorders

• Leukocytosis
• Hypersenstivity
• Abscess
• Increased susceptibility to infection

Sensory Disorders

• Increased intraocular pressure
• Glaucoma
• Posterior subcapsular cataracts
• Exophthalmos

• Anticonvulsants
• Endogenous and synthetic oestrogens
• Agents used for diabetes mellitus
• Antihypertensive agents
• Oral contraceptives

None routine. Specific cases may require

• Blood pressure
• Weight
• Height (children)
• Bone mass density (children)
• Urinalysis
• Blood glucose
• Electrolytes
• Ophthalmic examination
• ECG

• Tetracosactide Depot is intended for intramuscular injection. The ampoule should be shaken before use

Tetracosactide acetate consists of the first 24 amino acids occurring in the natural corticotropic hormone sequence and displays the same physiological properties as adrenocorticotropic hormone (ACTH). In the adrenal cortex, it stimulates the biosynthesis of glucocorticoids, mineralocorticoids, and, to a lesser extent, androgens, which explains its therapeutic effect in conditions responsive to glucocorticoid treatment. The site of action of ACTH is the plasma membrane of the adrenocortical cells, where it binds to a specific receptor. The hormone-receptor complex activates adenylate cyclase, stimulating the production of cyclic adenosine monophosphate and so promoting the synthesis of pregnenolone from cholesterol. From pregnenolone the various corticosteroids are produced via different enzymatic pathways.

Injection (per 1ml) 1mg

• Synacthen (Novartis) originator