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Kalmethasone Tablet, Injection

06:51
KALMETHASONE®
Dexamethasone

Composition
Each tablet contains:
Dexamethasone 0.5 mg

Each mL injection contains:
Dexamethasone Sodium Phosphate equivalent to
Dexamethasone Phosphate 4 mg or 5 mg

Pharmacology
Dexamethasone is a glucocorticoid.
Dexamethasone is practically lack of sodium retaining properties.

Indications
KALMETHASONE® is used primarily in the treatment of inflammatory and allergic conditions and other glucocorticoid-responsive diseases. It is not effective for the treatment of acute or chronic adrenocortical insufficiency in which a mineralocorticoid activity is required.
Among those conditions in which KALMETHASONE® is indicated are:
  1. The collagen and rheumatic disorders :
    • Systemic lupus erythematosus.
    • Rheumatoid arthritis .
    • Acute rheumatic carditis.
    • Post-traumatic osteoarthritis.
    • Synovitis of osteoarthritis.
    • Acute and subacute bursitis.
    • Acute gouty arthritis.
    • Psoriatic arthritis.
    • Ankylosing spondylitis.
  2. Dermatologic diseases:
    • Pemphigus.
    • Stevens Johnson syndrome.
    • Exfoliative dermatitis.
    • Severe psoriasis.
    • Bullous dermatitis herpetiformis.
  3. Neoplastic diseases:
    • Hypercalcemia associated with cancer.
    • Leukemias and Lymphomas in adults.
    • Acute leukemia in children.
  4. Allergic diseases:
    • Bronchial asthma in its various forms acute, chronic and status asthmaticus)
    • Contact dermatitis.
    • Atopic dermatitis.
    • Serum sickness.
    • Seasonal allergic rhinitis.
    • Drug hypersensitivity reactions.
    • Angioneurotic edema.
    • Anaphylactic reactions.
  5. Gastro-intestinal diseases:
    • Ulcerative colitis.
    • Regional enteritis.
  6. Hematologic disorders ;
    • Acquired hemolytic anemia.
    • Congenital hypoplastic anemia.
  7. Other life threatening conditions:
    • Tuberculous meningitis ( used concurrently with antituberculous chemotherapy).
    • Cerebral edema.
Contraindications
As with other glucocorticoid preparations KALMETHASONE® should not be used in patients with ocular herpes simplex.
It should not be used alone without concurrent administration of appropriate causal therapy in patient with pyogenic or fungal infections.

Dosage and administration
For oral administration :
Dosage requirements are variable and must be individualized on the basis of the disease and the response of the patient.
The initial dosage varies from 0.75 to 9 mg a day depending on the disease being treated. In less severe diseases doses lower than 0.75 mg may suffice, while in severe diseases doses higher than 9 mg may be required. The initial dosage should be maintained or adjusted until the patient's response is satisfactory. If satisfactory clinical response does not occur after a reasonable period of time, discontinue dexamethasone tablets and transfer the patient to other therapy. After a favorable initial response, the proper maintenance dosage should be determined by decreasing the initial dosage in small amounts to the lowest dosage that maintains an adequate clinical response. Patients should be observed closely for signs that might require dosage adjustment, including changes in clinical status resulting from remissions or exacerbations of the disease, individual drug responsiveness, and the effect of stress (e.g, surgery, infection, trauma). During stress it may be necessary to increase dosage temporarily. If the drug is to be stopped after more than a few days of treatment, it usually should be withdrawn gradually. The following milligram equivalents facilitate changing to dexamethasone from other glucocorticoids.

Warnings and precautions
Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including fever, myalgia, arthralgia, and malaise. This may occur in patients even without evidence of adrenal insufficiency. There is an enhanced effect of corticosteroids in patients with hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. The lowest possible dose of corticosteroids should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction should be gradual. Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.
Acetosal should be used cautiously in conjuction with corticosteroids in hypoprothrombinemia. Steroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending ulcerative colitis, if there is a probability of impending perforation, abscess, or other pyogenic infection, diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis and myasthenia gravis. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving large doses of corticosteroids may be minimal or absent. Fat embolism has been reported as a possible complication of hypercortisonism.
When large doses are given, should be advised that corticosteroids be taken with meals and antacids taken between meals to help to prevent peptic ulcer. Steroids may increase or decrease motility and number of spermatozoa in some patients. Phenytoin, phenobarbital, ephedrine, and rifampicin may enhance the metabolic clearance of corticosteroids, resulting in decreased blood levels and lessened physiologic activity, thus requiring adjustment in corticosteroids dosage.
These interactions may interfere with dexamethasone suppression test which should be interpreted with caution during administration of these drugs. False negative results in the dexamethasone suppressions test (DST) in patients being treated with indomethacin have been reported. Thus, results of the DST should be interpreted with caution in these patients. The prothrombin time should be checked frequently in patients who are receiving corticosteroids and coumarin anticoagulants at the same time because of reports that corticosteroids have altered the response to these anticoagulants. Studies have shown that the usual effect produced by adding corticosteroids is inhibition of response to coumarins, although there have been some conflicting reports of potentiation not substantiated by studies. When corticosteroids are administered concomitantly with potassium - depleting diuretics, patients should be observed closely for development of hypokalemia.

Information for patients
Susceptible patients who are on immunosuppressant doses or corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

Pediatric use:
Growth and development of pediatric patients on prolonged corticosteroid therapy should be carefully followed.

Adverse reactions
  1. Fluid and electrolyte disturbances :
    • Sodium retention.
    • Fluid retention.
    • Congestive heart failure in susceptible patients.
    • Potassium loss.
    • Hypokalemic alkalosis.
    • Hypertension.
  2. Musculoskeletal :
    • Muscle weakness.
    • Steroid myopathy.
    • Loss of muscle mass.
    • Osteoporosis.
    • Vertebral compression Fractures.
    • Aseptic necrosis of femoral and humeral heads.
    • Pathologic fracture of long bones.
    • Tendon rupture.
  3. Gastrointestinal:
    • Peptic ulcer with possible perforation and hemorrhage.
    • Perforation of the small and large bowel, particularly in patients with inflammatory bowel disease.
    • Pancreatitis.
    • Abdominal distention. 
    • Ulcerative esophagitis.
  4. Dermatologic:
    • Impaired wound healing.
    • Thin fragile skin.
    • Petechiae and ecchymoses.
    • Erythema.
    • Increased sweating.
    • May suppress reactions to skin tests.
    • Other cutaneous reaction, such as allergic dermatitis, urticaria, angioneurotic edema.
  5. Neurologic :
    • Convulsions.
    • Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment.
    • Vertigo.
    • Headache.
    • Psychic disturbances.
  6. Endocrine :
    • Menstrual irregularities.
    • Development of  cushingoid state.
    • Suppression of growth in children.
    • Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery, or illness.
    • Decreased carbohydrate tolerance.
    • Manifestations of latent diabetes mellitus,
    • Increased requirements for insulin or oral hypoglycemic agents in diabetics
    • Hirsutism.
  7. Opthalmic :
    • Posterior subcapsular cataracts.
    • Increased intraocular pressure.
    • Glaucoma.
    • Exophthalmos.
  8. Metabolic:
    • Negative nitrogen balance due to protein catabolism.
  9. Cardiovascular :
    • Myocardial rupture following recent myocardial infarction (see Warnings and precautions).
  10. Other:
    • Hypersensitivity.
    • Thromboembolism.
    • Weight gain. 
    • Increased appetite.
    • Nausea.
    • Malaise.
    • Hiccups.
Presentation
Box of 5 ampoules 4 mg/mL KALMETHASONE® injection
Reg. No. D. 4015597-I
Box of 10 vials of 5 mL, 4 mg/mL KALMETHASONE® injection
Reg. No. D. 4015597
Box of 5 ampoules 5 mg/mL KALMETHASONE® injection
Reg. No. D. 7813106
Box of 20 strips x 10 tablets in strips
Reg. No. DKL8311601510A1
Box of 20 blisters x 10 tablets in blisters
Reg. No. DKL8311601510A2

Store below 30°C. 
Protect from light.

ON MEDICAL PRESCRIPTION ONLY.
HARUS DENGAN RESEP DOKTER.

PT KALBE FARMA Tbk.
Bekasi - Indonesia

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