Triamcinolone

Brands of Triamcinolone in Kenya

Cenolone, Radiance Pharmaceuticals Limited

TESS Buccal Paste, Troikaa Pharmaceuticals Limited

Triam-Denk, Denk Pharma GmbH & Co. KG

Trinocort, Asence Pharma Private Limited

INDICATIONS

Intra-articular use: for alleviating the joint pain, swelling and stiffness associated with rheumatoid arthritis and osteoarthrosis, with an inflammatory component; also for bursitis, epicondylitis, and tenosynovitis.

Intramuscular use: Where sustained systemic corticosteroid treatment is required: Allergic states, e.g. bronchial asthma. In seasonal allergies, patients who do not respond to conventional therapy may achieve a remission of symptoms over the entire period with a single intramuscular injection : Endocrine disorders, e.g. primary or secondary adrenocortical insufficiency. Collagen disorders, e.g. during an exacerbation of maintenance therapy of selected cases of SLE or acute rheumatic carditis; Dermatological diseases, e.g. pemphigus, severe dermatitis and Stevens Johnson Syndrome; Rheumatic, Gastrointestinal or Respiratory disorders – as an adjunctive, short-term therapy; Haematological disorders, e.g. acquired (autoimmune) haemolytic anaemia; Neoplastic diseases, e.g. palliative management of leukaemia and lymphomas; Renal disease, such as acute interstitial nephritis, minimal change nephrotic syndrome or lupus nephritis.

Intradermal use: for lichen simplex chronicus (neuro-dermatitis), granuloma annulare, lichen planus, keloids, alopecia areata and hypertrophic scars.

DOSAGE AND ADMINISTRATION

Intra-Articular Injection: For intra-articular administration or injection into tendon sheaths and bursae, the dose of Triamnicolone Injection may vary from 5 mg to 10 mg (0.125 – 0.25 ml) for smaller joints and up to 40 mg (1.0 ml) for larger joints, depending on the specific disease entity being treated. Single injections into several sites for multiple joint involvement, up to a total of 80 mg, have been given without undue reactions.

It is recommended that, when injections are given into the sheaths of short tendons, (triamcinolone acetonide 10 mg/ml) should be used ).

Intramuscular Injection: To avoid the danger of subcutaneous fat atrophy, it is important to ensure that deep intramuscular injection is given into the gluteal site. The deltoid should not be used. Alternate sides should be used for subsequent injections.

Intradermal dosage is usually 2-3 mg (0.2-0.3 ml), depending on the size of the lesion. No more than 5 mg (0.5 ml) should be injected at any one site. If several sites are injected the total dosage administered should not exceed 30 mg (3 ml). The injection may be repeated if necessary, at one or two week intervals.

Adults and Children over 12 Years: The suggested initial dose is 40 mg (1.0 ml) injected deeply into the upper, outer quadrant of the gluteal muscle. Subsequent dosage depends on the patient’s response and period of relief. Patients with pollen asthma who do not respond to conventional therapy may obtain a remission of symptoms lasting throughout the pollen season after a single dose of 40-100 mg given when allergic symptoms appear .

Elderly: Treatment of elderly patients, particularly if long term, should be planned bearing in mind the more serious consequences of the common side effects of corticosteroids in old age, especially osteoporosis, diabetes, hypertension, susceptibility to infection and thinning of the skin. Close clinical supervision is required to avoid life-threatening reactions.

Children from 6-12 Years of Age: The suggested initial dose of 40 mg (1.0 ml injected deeply into the gluteal muscle should be scaled according to the severity of symptoms and the age and weight of the child. Triamnicolone is not recommended for children under six years. Growth and development of children on prolonged corticosteroid therapy should be carefully observed. Caution should be used in the event of exposure to chickenpox, measles or other communicable diseases .

Triamcinolone withdrawal: In patients who have received more than physiological doses of Triamnicolone (more than one injection during a three week period), withdrawal should not be abrupt. The dose should be reduced and the dosage interval increased until a dose of not more than 40 mg and a dosage interval of at least three weeks have been achieved as the dose of systemic corticosteroid is reduced. Clinical assessment of disease activity may be needed.

Abrupt withdrawal of short term systemic corticosteroid treatment is appropriate if it is considered that the disease is unlikely to relapse. A single dose, which is not repeated within a three week period, is unlikely to lead to clinically relevant hpa-axis suppression in the majority of patients. However, in the following patient groups, gradual withdrawal of systemic corticosteroid therapy should always be considered:

Patients who have had repeated courses of systemic corticosteroids.

When a course of Triamnicolone has been prescribed within one year of cessation of long-term therapy (months or years).

Patients who may have reasons for adrenocortical insufficiency other than exogenous corticosteroid therapy.

CONTRAINDICATIONS

Hypersensitivity to any of the ingredients.

Systemic infections unless specific anti-infective therapy is employed.

Administration by intravenous, intrathecal, epidural or intraocular injection.

DRUG INTERACTIONS:

Amphotericin B injection and potassium-depleting agents: Patients should be observed for hypokalaemia.

Anticholinesterases: Effects of anticholinesterase agent may be antagonised.

Anticoagulants, oral: Corticosteroids may potentiate or decrease anticoagulant action. Patients receiving oral anticoagulants and corticosteroids should therefore be closely monitored.

Antidiabetics: Corticosteroids may increase blood glucose; diabetic control should be monitored, especially when corticosteroids are initiated, discontinued, or changed in dosage.

Antihypertensives, including diuretics: corticosteroids antagonise the effects of antihypertensives and diuretics. The hypokalaemic effect of diuretics, including acetazolamide, is enhanced.

Anti-tubercular drugs: Isoniazid serum concentrations may be decreased.

Cyclosporin: Monitor for evidence of increased toxicity of cyclosporin when the two are used concurrently.

Digitalis glycosides: Co-administration may enhance the possibility of digitalis toxicity.

Oestrogens, including oral contraceptives: Corticosteroid half-life and concentration may be increased and clearance decreased.

Hepatic Enzyme Inducers (e.g. barbiturates, phenytoin, carbamazepine, rifampicin, primidone, aminoglutethimide): There may be increased metabolic clearance of Kenalog. Patients should be carefully observed for possible diminished effect of steroid, and the dosage should be adjusted accordingly.

Human growth hormone: The growth-promoting effect may be inhibited.

CYP 3A4 inhibitors: Triamcinolone acetonide is a substrate of CYP3A4. Co-administration with strong CYP3A4 inhibitors (eg, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with triamcinolone is not recommended because increased systemic corticosteroid adverse effects may occur . If the potential benefit of co-administration outweighs the increased risk of systemic corticosteroid side-effects, patients should be monitored for these effects. During post marketing use, there have been reports of clinically significant drug interactions in patients receiving triamcinolone acetonide and ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression .

Nondepolarising muscle relaxants: Corticosteroids may decrease or enhance the neuromuscular blocking action.

Nonsteroidal anti-inflammatory agents (NSAIDS): Corticosteroids may increase the incidence and/or severity of GI bleeding and ulceration associated with NSAIDS. Also, corticosteroids can reduce serum salicylate levels and therefore decrease their effectiveness. Conversely, discontinuing corticosteroids during high-dose salicylate therapy may result in salicylate toxicity. Aspirin should be used cautiously in conjunction with corticosteroids in patients with hypoprothrombinaemia.

Thyroid drugs: Metabolic clearance of adrenocorticoids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in adrenocorticoid dosage.

Vaccines: Neurological complications and lack of antibody response may occur when patients taking corticosteroids are vaccinated .

ADVERSE EFFECTS

System Organ Class

Frequency

MedDRA Terms

 

Infections and infestations

Common

 

Infection

Uncommon

Injection site abscess sterile, Infection masked, Tuberculosis, Candida infection, Eye infection viral, Eye infection fungal, Rhinitis, Conjunctivitis
Immune system disorders

Uncommon

Anaphylactoid reaction

Anaphylactic reaction

Anaphylactoid shock

 

Endocrine disorders

Uncommon

Cushingoid, Adrenal suppression, Secondary adrenocortical insufficiency, Hypopituitarism

 

Metabolism and nutrition disorders

Uncommon

Sodium retention, Fluid retention, Alkalosis hypokalaemic, Hyperglycaemia, Diabetes mellitus inadequate control, Calcium deficiency, Increased appetite

 

Psychiatric disorders

Uncommon

Psychiatric symptom, Depression, Euphoric mood, Mood swings, Psychotic disorder, Personality change, Insomnia, Drug dependence, Mental disorder, Irritability, Suicidal ideation, Anxiety, Cognitive disorder
Nervous system disorders

Common

Headache

 

Uncommon

Convulsion, Epilepsy, Syncope, Benign intracranial hypertension, Neuritis, Paraesthesia, Intracranial pressure increased, Dizziness

 

Eye disorders

Uncommon

Blindness, Cataract, Glaucoma, Exophthalmos, Corneal perforation, Papilloedema.

 

Not known

Vision, blurred
Ear and labyrinth disorders

Uncommon

Vertigo

 

Cardiac disorders

Uncommon

Cardiac failure congestive, Arrhythmia

 

Vascular disorders

Uncommon

Hypertension, Embolism, Thrombophlebitis, Vasculitis necrotising, Hypotension, Flushing

 

Gastrointestinal disorders

Uncommon

Peptic ulcer, Peptic ulcer perforation, Peptic ulcer haemorrhage, Pancreatitis, Abdominal distension, Oesophagitis ulcerative, Dyspepsia

 

Skin and subcutaneous tissue disorders

Uncommon

Urticaria, Rash, Skin hyperpigmentation, Skin hypopigmentation, Skin atrophy, Skin fragility, Petechiae, Ecchymosis, Erythema, Hyperhidrosis, Purpura, Skin striae, Hirsutism, Dermatitis acneiform, Cutaneous lupus erythematosus, Angioedema, Pruritus
Musculoskeletal connective tissue and bone disorders

Common

Arthralgia

 

Uncommon

Osteoporosis, Osteonecrosis, Pathological fracture, Fracture delayed union, Musculoskeletal discomfort, Muscular weakness, Myopathy, Muscle atrophy, Growth retardation, Neuropathic arthropathy, Myalgia

 

Renal and urinary disorders

Uncommon

Glycosuria

 

Reproductive system and breast disorders

Uncommon

Menstrual irregularities, Amenorrhoea and Postmenopausal vaginal bleeding

 

General disorders and administration site conditions

Common

Injection site reaction

Uncommon

Synovitis, Pain, Injection site irritation, Injection site discomfort, Fatigue, Impaired healing, Hyperthermia
Investigations

Uncommon

Blood potassium decreased, Electrocardiogram change, Carbohydrate tolerance decreased, Nitrogen balance negative, Intraocular pressure increased, Laboratory test interference, Weight decreased, Blood calcium abnormal, Protein total abnormal
Injury and poisoning

Uncommon

Spinal compression fracture

Clinical | Pharmacokinetic data


Pregnancy Category: N (Not classified yet)
Routes of Administration: By mouth, topical, intramuscular, intra-articular, intra-synovial
Bioavailability: >90%
Protein Binding: 68%
Metabolosim: Liver
Onset of Action: (2–)24(–48) hours
Elimination Half life: 200–300 minutes (plasma), up to 36 hours (total)
Excretion: Urine (75%) and faeces (25%)

Legal Status | Dosage forms & Strengths


Prescription Category:
Prescription only Medicine (POM) , ℞-only
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
This drug is not a controlled substance under Narcotic Drugs and Psychotropic Substances (Control ) Act
Dosage Forms | Strengths:


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