COMPOSITION :
Dexamethasone Caplet 0.5 mg, each caplet contains : Dexamethasone 0.5 mg.
DESCRIPTIONS :
Dexamethasone with active ingredient Dexamethasone is available as caplet 0.5 mg.
INDICATIONS :
- Primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia, nonsuppurative thyroiditis, hypercalcemia caused by cancer.
- Perennial rhinitis allergic, bronchial asthma, contact dermatitis, atopic dermatitis, serum sickness, drug hypersensitivity reactions.
- Eye diseases due to inflammation or allergies, and not caused by a virus.
- As adjunctive therapy for short-term administration as in : Psoriatic arthritis, rheumatoid arthritis, rheumatoid arthritis “Juvenile”.
- Systemic Lupus Erythematosus (SLE), acute rheumatic carditis.
- Pemphigus, bullous dermatitis herpetiformis, severe erythema multiforme (“Steven’s-Johnson syndrome”).
- Sarcoidosis.
- Cerebral edema.
- The effect for the type of vasogenic edema as a result of brain tumors, particularly metastases and glioblastoma.
- It may be helpful to : Idiopathic hemolytic anemia and autoimmune.
- Subacute hepatic necrosis, autoimmune chronic active hepatitis.
DOSAGE AND ADMINISTRATIONS :
Adult :
Initial dose variable : 0.75 – 9 mg/day, 2 – 4 times daily or depending on the severity of the disease.
Mild disease : < 0.75 mg.
Severe disease : > 9 mg.
CONTRAINDICATIONS :
- Systemic fungal infections.
- Ocular herpes simplex.
- Patients who are sensitive to the drug and its components.
WARNINGS AND PRECAUTIONS :
- Sensitivity with infection in patients who received corticosteroids is not specific to a particular bacterial or fungal pathogens. When an infection occur the dose is maintained or increased and best treatment should be done against the infection.
- Long-term use of corticosteroids may result in subcapsular cataract pasterior, glaucoma with possible damage of the optic nerves and may enhance the secondary ocular infections due to fungi and viruses.
- Corticosteroids is not recommended for the first trimester pregnant women because the possibility of newborn babies suffering from symptoms of hypoadrenalism.
- Not recommended use in lactating women because the possibility of corticosteroids are secreted into breast milk.
- Secondary adrenocortical insufficiency due to the use of these drugs may be reduced by lowering the dose gradually.
- Coadministration Acetosal with corticosteroids is not recommended in patients with hypoprothrombinemia.
- Administration of these drugs can suppress the clinical symptoms of an infectious disease.
- Long-term use can lower the body’s immunity to infectious diseases.
- Corticosteroids is not recommended in patients with nonspecific ulcerative colitis, if there is a tendency perforation, abscess and other pyogenic infection, diverticulitis, fresh intestinal anastomoses, peptic ulcer, renal insufficiency, hypertension, osteoporosis, myasthenia gravis.
- Not recommended for children under 6 years old, carefully observe the children and babies who use corticosteroids in the long term to the growth and development of children.
- Administration of corticosteroids in patients with hypothyroid and cirrhosis may increase corticosteroids effects.
- Use with caution of these corticosteroids in patients with diabetes, because it can increase gluconeogenesis and reduced insulin sensitivity.
DRUG INTERACTIONS :
- Antibacterial : Rifampicin accelerates corticosteroids metabolism.
- Antidiabetic : Antagonists through hypoglycemia effects.
- Antiepileptic : Carbamazepine, Phenobarbitone, Phenytoin and Pirimidone accelerate the metabolism through hypotensive effect.
- Antihipertensive : Antagonism through hypotensive effect.
- Barbiturates : Accelerate corticosteroids metabolism.
- Diuretics : Antagonism to the effects of Acetazolamide diuretics, diuretics loop and Thiazide increase the risk of hypokalemia.
- Hormone antagonists : Aminoglutetimide accelerates Dexamethasone metabolism.
- Ulcer healing drug : Carbenoxolone increase the risk of hypoglycemia.
ADVERSE REACTIONS :
- Musculoskeletal : Muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, vertebral compression fractures, pathologic fractures of long bones and osteonecrosis.
- Gastrointestinal tract : Peptic ulcer with possible perforation and hemorrhage, pancreatitis, abdominal distention and ulcerative esophagus.
- Dermatology : Impaired wound healing, thin fragile skin, facial erythema and increased sweating.
- Nervous system : Convulsions, increased intracranial pressure with papille edema (“pseudo tumor”), vertigo and headaches.
- Fluid and electrolyte disturbances : Sodium and fluid retention (edema) are rarely occur because only few have mineralocorticoid effect. This edema may occur in patients with impaired glomerular speed.
- Hypokalemia, hypertension and congenital heart failure.
- Endocrine : Menstrual irregularities, growth suppression in children of secondary adrenal insufficiency, especially in times of stress such as trauma and surgery.
- Carbohydrate and fat metabolism : This steroid use in diabetics can lead to increased gluconeogenesis and reduced sensitivity by insulin. In normal patients, carbohydrates and fats metabolism are not affected.
- Ophtalmic : Posterior subcapsular cataracts, sometimes increased intraocular pressure, glaucoma, and exophthalmos.
- Metabolic : Negative nitrogen balance due to protein catabolism.
- Hypersensitivity reactions : Anaphylactic reactions are rare.
PRESENTATIONS :
Dexamethasone Caplet 0.5 mg Box, 10 blisters @ 10 caplets Reg. No. GKL0302334010A1
STORAGE :
STORE BELOW 30°C, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
