DEXAMETHASONE 5mg/ml Injection

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COMPOSITION :

Dexamethasone sodium phosphate Injection 5 mg/ml, each ml contains : Dexamethasone sodium phosphate equivalent to Dexamethasone 5 mg.

 

DESCRIPTIONS : 

Dexamethasone sodium phosphate with active ingredient Dexamethasone sodium phosphate (equivalent to Dexamethasone) is available in 5 mg/ml injection.

 

INDICATIONS : 

  • Endocrine disorders.
  • Rheumatoid

As a short term adjuvant therapy i.e., rheumatoid arthritis, ankylosing spondylitis.

  • Collagen diseases

During exacerbation or as maintenance therapy in systemic lupus erythematosus, acute rheumatic carditis.

  • Dermatologic disease.
  • Allergic condition

To control severe allergic condition resistant to conventional drug such as bronchial asthma and contact dermatitis.

  • Haematologic disorder.
  • Neoplastic disorder.

 

DOSAGE AND ADMINISTRATIONS : 

Dosage :

Initial dose : 0.75 – 9 mg/day, depend on the severity of the disease.

Maintenance dose : Reduced in accordance with patient condition.

Mild desease : Less than 0.75 mg/day.

Severe disease : More than 9 mg/day may be required.

Administration :

Dexamethasone sodium phosphate Injection can be administered by intravenous, subcutaneous, intramuscular and local injection, as well as by rectal drip. With intravenous administration high plasma levels can be obtained rapidly. Intravenous injections of massive doses should be given slowly, over a period of several minutes. Intra-articular injections should be given under strict aseptic conditions as glucocorticoids decrease the resistance to infection.

 

CONTRAINDICATIONS : 

For systemic therapy :

  • Gastric and duodenal ulcers.
  • Systemic fungal infections.
  • Certain viral infections, e.g., Varicella and herpes genitalis infections.
  • Glaucoma.
  • Hypersensitivity to glucocorticoids.
  • Hypersensitivity to Dexamethasone.

For local therapy :

  • Infection at the affected site, e.g., septic arthritis resulting form gonorrhea or tuberculosis.
  • Bacteraemia and systemic fungal infections.
  • Instability of the joint.
  • Hypersensitivity to glucocorticoids.

 

WARNINGS AND PRECAUTIONS : 

  • Patients with the following conditions should be monitored :
  1. Latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine, since glucocorticoids may induce fluid retention; 
  2. Osteoporosis, since glucocorticoids have a negative effect on the calcium balance;
  3. A history of psychotic illness;
  4. Latent tuberculosis, since glucocorticoids may induce reactivation;
  5. Certain parasitic infestations, in particular amoebasis;
  6. Incomplete statural growth, since glucocorticoids on prolonged administration may accelerate epiphyseal closure.
  • Glucocorticoid therapy is non-specific, suppresses the symptoms and sign of disease and decreases the resistance to infections. Appropriate antimicrobial therapy should accompany glucocorticoid therapy when necessary, e.g., in tuberculosis, and viral and fungal infections of the eye.
  • If a live vaccine is to be administered it should be borne in mind that glucocorticoids exert an immunosuppressive effect.
  • Patients on long-term glucocorticoid therapy should be regularly examined for increased intra-ocular pressure and posterior subcapsular cataracts.
  • Patients on long-term glucocorticoid therapy should be regularly examined with respect to their glucose metabolism.
  • Before, during and after stressful situations, dosage may need to be increased in patients on current or who resume glucocorticoid therapy (in patients who have undergone prolonged glucocorticoid treatment in the previous year).
  • Discontinuation of prolonged therapy should be carried out by gradual reduction of dosage (tapering off) and under strict medical supervision, since withdrawal may result in acute exacerbation of the disease and acute adrenocortical insufficiency.
  • Local injection of a glucocorticoid may produce systemic effects.
  • After parenteral administration of glucocorticoids serious anaphylactoid reactions, such as glottis oedema and bronchospasm, have occasionally occurred, particularly in patients with a history of hypersensitivity. If such an anaphylactoid reaction occurs, the following measures are recommended; immediate slow intravenous injection of 0.1 – 0.5 ml of Adrenaline 1 : 1000 (0.1 – 0.5 mg), intravenous administration of Amoniphylline and artificial respiration.
  • Corticosteroids should not be used for the management of head injury or stroke because it is unlikely to be of benefit and may even be harmful.
  • Pregnancy and lactation : Dexamethasone readily crosses the placenta. There are indications for a harmful effect of glucocorticoids on the foetus in animal experiments; they can cause abnormalities of foetal development including cleft palate or lip and effects on brain growth and development. However, in humans, there is no convincing evidence that systemic glucocorticoids cause an increased incidence of congenital abnormalities, such as cleft palate or lip. When administered for prolonged periods or repeatedly during pregnancy, systemic glucocorticoids increase the risk of intra-uterine growth retardation (IUGR). There is no evidence for an increased of IUGR following short-term treatment, such as prophylactic treatment for neonatal respiratory distress syndrome. In this case (to prevent respiratory distress syndrome), glucocorticoids are essential. Patients with normal pregnancies may be treated as though they were in non-gravid state. Patients with pre-eclampsia or fluid retention require close monitoring. There is a (theoretical) risk of adrenal suppression in the neonate following prenatal glucocorticoid exposure. However, this usually resolves spontaneously after birth and is rarely clinically important. No data are available on the transfer of Dexamethasone into breast milk. Because corticosteroids are in general excreted into breast milk, and given the lack of experience, breast feeding is discouraged during Dexamethasone sodium phosphate therapy. As with all medicines, before prescribing systemic glucocorticoids in pregnancy or during lactation, the benefits of treatment should be weighed against the potential risks to both mother and child.

 

DRUG INTERACTIONS : 

  • Patients treated concomitantly with glucocorticoids and one of the following drugs should be monitored :
  1. Diuretics and/or cardiac glucosides, since Potassium loss may be enhanced. This is a particular risk in patients using cardiac glucosides, since hypokalaemia increases the toxicity of these drugs.
  2. Antidiabetics, since glucocorticoids may impair glucose tolerance, thereby increasing the need for antidiabetic drugs.
  3. Non-steroidal anti-inflammatory drugs, since the incidence and/or severity of gastrointestinal ulceration may increase.
  4. Oral anticoagulants, since glucocorticoids may alter the need for these drugs.
  • Glucocorticoids may be less effective when used concomitantly with liver enzyme-inducing drugs, such as Rifampicin, Ephedrine, Barbiturates, Phenytoin and Pirimidone.
  • If patients undergoing long-term therapy with glucocorticoid are concomitantly given Salicylates, any reduction in glucocorticoid dosage should be made with caution, since Salicylate intoxication has been reported in such cases.

 

ADVERSE REACTIONS : 

  • Adverse reactions, associated with prolonged systemic glucocorticoid therapy, are unlikely to happen when high doses are administered over a short period of time. Nevertheless, gastric and duodenal ulceration, with possible perforation and haemorrhage, may occasionally occur.
  • The following adverse reactions have been associated with prolonged systemic glucocorticoid therapy :
  1. Endocrine and metabolic disturbances : Cushing-like syndrome, hirsutism, menstrual irregularities, premature epiphyseal closure, secondary adrenocortical and pituitary unresponsiveness, decreased glucose tolerance, negative nitrogen and calcium balance.
  2. Fluid and electrolyte disturbance : Sodium and fluid retention, hypertension, potassium loss, hypokalaemic alkalosis.
  3. Musculoskeletal effects : Myopathy, abdominal distention, osteoporosis, aseptic necrosis of femoral and humeral heads.
  4. Gastrointestinal effects : Gastric and duodenal ulceration, perforation and haemorrhage.
  5. Dermatologic effects : Impaired wound healing, skin atrophy, striae, petechiae and ecchymosis, bruising, facial erythema, increased sweating, acne.
  6. CNS effects : Psychic disturbances ranging from euphoria to frank psychotic manifestations, convulsions, in children pseudotumor cerebri (benign intracranial hypertension) with vomiting and papilloedema.
  7. Ophthalmic effects : Glaucoma, increased intraocular pressure, posterior subcapsular cataracts.
  8. Immunosuppressive effects : Increased susceptibility to infections, decreased responsiveness to vaccination and skin tests.
  • Hypersensitivity reactions may occasionally occur. 
  • A transient burning or tingling sensation, mainly in the perineal area, may occur following intravenous injection of large doses of corticosteroid phosphates.
  • Local adverse reactions include post-injection flare and painless destruction of the joint reminiscent of Charcot’s arthropathy, especially with repeated intra-articular injections.

 

PRESENTATION :

Dexamethasone sodium phosphate Injection 5 mg/ml               Box, 100 ampoules @ 1 ml      

Reg. No. GKL7802347743A1

 

STORAGE :

STORE BELOW 30°C, PROTECT FROM LIGHT

 

ON MEDICAL PRESCRIPTION ONLY

 

Manufactured by :

BERNOFARM

Sidoarjo – Indonesia

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