Branded Medicine

 
FLAMICORT injeksi 40 mg

Intramuscular Injection

 
:: COMPOSITION ::

FLAMICORT 40 mg

Each ml contains:

Triamcinolone acetonide 40 mg

Preservative:

Benzyl alcohol 1.5%

 

 
:: PHARMACOLOGY ::

Flamicort provides a synthetic corticosteroid with marked anti-infalmmatory action and anti allergic actions.

Naturally occurring gluococorticoid (hydrocortisone), which also have salt retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogues are primarily used for their potent anti-inflammatory effects in disorder of many organ systems.

Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimul.

Triamcinole acetonide injection 40 mg/ml has an extended duration of effect which may be permanent, or sustained over a period of several weeks.

 
:: PHARMACOKINETICS ::

Triamcinolone acetonide may be absorbed into systemic circulation from synovial spaces. However clinically significant systemic levels after intraarticular injection are unlikely to occur except perhaps following treatment of large joints with high doses.

Systemic effects do not ordinarily occur with intraarticular injections when the proper techniques of administration and the recommended dosage regiments are observed. Triamcinolone acetonide is absorbed slowly, though almost completely, following depot administration by deep intramuscular injection; biologically active levels are achieved systemically for prolonged periods (weeks to months). In common with other corticosteroids, triamcinolone is metabolised largely but also by the kidney and is excreted in urine. The main metabolic route is 6-beta-hydroxylation; no significant hydrolytic cleavage of the acetonide occurs.

In view of the hepatic metabolism and renal excretion of triamcinolone acetonide, functional impairments of the liver kidney may affect the pharmacokinetics of the drug.

 
:: INDICATIONS ::

Intramuscular

Where oral therapy is not feasible or is temporarily undesirable in the judgement of the physician, Flamicort injection 40 mg/ml is indicated for intramuscular use as follows:

  • Allergic diseases
     
  • Rheumatic disorders
    As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: post-traumatic osteoarthritis, synovitis of osteoarthritis, rheumatoid arthritis, acute and subacute bursitis, epicondylitis, acute non-specific tenosynovitis, acute gouty arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile rheumatoid arthritis.
     
  • Collagen diseases
    During an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus, acute rheumatic carditis.
     
  • Dermatologic diseases
    Pemphigus, severe erythema multiforma (Stevens-johnson syndrome), exfoliative dermatitis, bullous dermatitis herpetiformis, severe seborrheic dermatitis, severe psoriasis.
     
  • Edematous state
    To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.
 
:: CONTRAINDICATIONS ::
Corticosteroids are contraindicated in patients with systemic fungal infections. Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.
 
:: DOSAGE and ADMINISTRATION ::

General :

The initial dose of Flamicort intramuscular injection may vary from 2.5 to 60 mg per day depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice while in selected patients higher initial doses may be required. Usually the parenteral dosage ranges are one-third to one-half the oral dose given every 12 hours. However, in certain overwhelming, acute, life-threating situations, administration of dosage exceeding the usual dosages may be justified and may be in multiples of the oral dosages.

The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response. Flamicort intramuscular injection should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increaments at appropriate time intervals until the lowesr dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage.

Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbation in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of Flamicort intramuscular injection for a period of time consistent with patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawal gradually rather than abruptly.

Dosage :

Systemic

Although Flamicort intramuscular injection may be administered intramuscularly for initial therapy, most physicians prefer to adjust the dose orally until adequate control is attained. Intramuscular administration provides a sustained or depot action which can be used to supplement or replace initial oral therapy. With intramuscular therapy, greater supervision of the amount of steroid used is made possible in the patient who is inconsistent in following an oral dosage schedule in maintenance therapy, the patient-to-patient response is not uniform and therefore the dose must be individualized for optimal control.

For adults and children over 12 years of age, the suggested initial dose is 60 mg, injected deeply into the gluteal muscle. Subcutaneous fat atrophy may occur if care is not taken to inject the preparation intramuscularly. Dosage is usually adjusted within the range of 40 - 80 mg, depending upon patient response and duration of relief. However, some patients may be well controlled on dosages as low as 20 mg or less. Patients with has fever or pollen asthma who are responding to pollen administration and other conventional therapy may obtain a remission of symptoms throughout the pollen season after one injection of 40 to 100 mg.

For children from 6 to 12 years of age, the suggested initial dose is 40 mg, although dosage depends more on the severity of symptoms than on age or weight. There is insufficient clinical experience with Flamicort intramuscular injection to recommended its use in children under six years of age.

Administration :

  • General
    Shake the vial before use to insure a uniform suspension. Prior to withdrawal, inspect suspension for clumping or glanular appearance 9agglomeration). An agglomerated product results from exposure to freezing temperatures should not be used. After withdrawal, inject without delay to prevent settling in the syringe. Careful technique should be employed to avoid the possibility of entering a blood vessel or introducing infection.
  • Systemic
    For systemic therapy, injection should be made deeply into the gluteal muscle yo insure intramuscular delivery (see warnings). For adults, a minimum needle length of 1� inches is recommended. In obese patients, a longer needle may be required. Use alternative sites for subsequent injections.
 
:: SIDE EFFECT and ADVERSE REACTIONS ::

The side-effects associated with the use of corticosteroids (such as triamcinolone acetonide) in the large dose, often necessary to produce a therapeutic response, result from excessive action on electrolyte balance, excessive action on other aspects of metabolism including gluconeogenesis, the action on tissue repair and healing, and an inhibitory effect on the secretion of corticotrophin by the anterior lobe of the pituitary gland.

Triamcinolone acetonide exhibits little disturbance of electrolyte balance.

Large doses of corticosteroid (e.g. triamcinolone acetonide) may produce symptoms typical of hyperactivity of the adrenal cortex, with moon-face, sometimes with hirtsuttism, buffalo hump, flushing, increased bruising stnae, and acne, sometimes leading to fully developed Cushing's Syndrome. If administration is discontinued these symptoms are usually reversed, but sudden cessation is dangerous.

Other adverse effects include amenorrhoea, hyperhidrosis, mental and neurological disturbances, intracranial hypertension, acute pancreatitis and aseptic necrosis of bone. Muscular weakness is an occasional side-effect of most corticosteroids, particulary when they are taken in large doses, and it is most evident with triamcinolone acetonide.

Prolonged use of glucocorticoids may result in postenor subcapsular cataracts (particularly in children), exophthalmus or increased intraocular pressure which may result in glaucoma or may occasionally damage the optic nerve.

Corticosteroids may cause adverse GI effects such as pancreatitis, gastric imitation and ulcerative esophagitis.

Hypercholesterolemia, arthrosclerosis, thrombosis, thromboembolism, fat embolism and thrombophlebitis have been observed in a few patients following prolonged high dose glucocorticoid therapy.

 
:: WARNING and PRECAUTIONS ::

Corticosteroids (including triamcinolone acetonide) should be used only with great caution in the presence of congestive heart failure or hypertension, in patients with diabetes mellitus infections, chronic renal failure, and uraemia, and in elderly persons. Patients with active or doubtfully quiescent tuberculosis should not be given corticosteroids except, very rarely, as adjuncts to treatment with antitubercular drugs.

Patients who receiving corticosteroids are more susceptible to infection.

Patients on corticosteroid therapy should not be vaccinated against smallpox while on corticosteroid therapy. Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially on high dose, because of possible hazards of neurological complications and lack of antibody response.

Children are at special risk of infection and may require prophylaxis with immunoglobulin.

Response to anticoagulants may be reduce and, on some occasions, enhanced by corticosteroids.

Long term administration of glucocorticoids to children should be avoided if possible since the drugs may retard bone growth.

Use in pregnancy :

Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers, or woman of child-bearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and the embryo, fetus or nursing infant. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

 
:: DRUGS INTERACTIONS ::

Triamcinolone acetonide has demonstrated an interaction with the following drugs:

  • Alcuronium: decrease alcuronium effetiveness; prolonged muscle weakness and myopathy.
  • Aldesleukin: reduced antitumor effectiveness.
  • Amphotericin b liposome: an increased risk of hypokalemia.
  • Anthrax vaccine adsorbed: an inadequate immunological response to the vaccine.
  • Aspirin: an increased risk of gastrointestinal ulceration and subtherapeutic aspirin serum concentrations.
  • Atracurium/cisatracurium/doxacurium/haxafluorenium: decreased effectiveness; prolonged muscle weakness and myopathy.
  • Echinacea: decreased effectiveness of corticosteroids.
  • Fluoroquinolones: an increased risk for tendon rupture.
  • Fosphenytoin: decreased triamcinolone effectiveness.
  • Gallamine: decreased gallamine effectiveness; prolonged muscle weakness and myopathy.
  • Human growth hormone: decreased efficacy of the growth hormone.
  • Hydrochlorothiazide: hypokalemia and subsequent cardiac arrythmias.
  • Insulin/Insulin Lispro, Human: corticosteroid therapy tends to increase blood glucose in diabetic patients and higher doses of insulin may be required.
  • Itraconazole: increased corticosteroid plasma concentrations and an increased risk of corticosteroid side effects (myopathy, glucose intolerance, Cushing's syndrome).
  • Phenobarbital: decreased corticosteroid effectiveness.
  • Phenytoin: decreased triamcinolone effectiveness.
  • Vaccines: an inadequate immunological response to the vaccine.
  • Concurrent administration of barbiturates, phenytoin, or rifampicin may enhance the metabolism and reduce the effects of corticosteroids.
  • Concurrent administration of corticosteroids with potassium-depleting diuretics such as thiazides or furosemide may cause excessive potassium loss.
 
:: SYMPTOMS and TREATMENT for OVERDOSAGE and ANTIDOTE (s) ::

The adverse effects of corticosteroids are nearly always due to their use in excess of normal physiological requirements. They should be treated symptomatically where possible the dosage being reduced or the drug slowly withdrawn. Sudden withdrawal or reduction in dosage may precipitate acute adrenal insufficiency. Symptoms of adrenal insufficiency include malaise, muscular weakness, mental changes, muscle and joint pain, desquamation of the skin, dyspnea, anorexia, nausea and vomiting, fever, hypoglycaemia, hypotension, and dehydration.

In primary adrenal insufficiency, such as Addison's disease or after adrenal-ectomy, both mineralocorticoid and glucocortucoid replacement (in physiological doses) is needed. Hydrocortisone may be given by mouth, usually in association with fludrocortisone.

In secondary adrenal insufficiency, associated with adequate corticotrophin sectrion, glucocorticoid replacement is usually adequate.

The emergency treatment of adrenal insufficiency usually involves the intravenous administration of hydrocortisone sodium succinate, together with infusions of sodium chloride and glucose to correct electrolyte disturbances.

 
:: PRESENTATION and REGISTRATION NUMBER ::

FLAMICORT 40 mg; Dus, vial @ 1 ml, DKI0619700143B1

ON MEDICAL PRESCRIPTION ONLY

STORE IN A COOL 15-25oC DRY PLACE, PROTECT FROM LIGHT

AVOID FREEZING