DIRECTIONS FOR USE

DEXAMETHASONE

This product must be prescribed by a doctor.

Dosage form: Solution for injection.

Ingredient, content:

Pharmacodynamic properties:

Dexamethasone has the main effect of glucocorticoids is anti-inflammatory, anti-allergic, immunosuppressive, has little effect on electrolyte balance. Dexamethasone has a stronger anti-inflammatory effect than hydrocortisone 30 times, prednisolone 7 times.

Dexamethasone inhibits the pituitary gland to release ACTH, causing the adrenal cortex to stop endogenous corticosteroid secretion. If long-term treatment with glucocorticoids, use the lowest dose, used as an adjunct to treatment. When stopping the drug, to reduce the dose slowly.

Pharmacokinetic properties:

After injection, dexamethasone sodium phosphate hydrolyses rapidly to dexamethasone. When intravenous dose of 20 mg, peak plasma concentrations after 5 minutes. The drug binds to plasma protenin (77%), mainly albumin. High drug absorption in the liver, kidneys, adrenal glands. Slow metabolism in the liver, excreted in the urine as unconjugated steroids. The biological half-life of dexamethasone is 36 – 54 hours.

Indications:

• Active treatment such as asthma treatment, allergic disease, reaction after blood transfusion, laryngitis.
• Prophylaxis of respiratory distress syndrome in premature child.
• Used in combination in the treatment of cerebral edema, shock.
• Adjuvant therapy in the treatment of pneumococcal meningitis.
• Local treatment: Patients with rheumatoid arthritis, osteoarthritis, periarthritis, tennis elbow.

Contraindications:

Hypersensitivity to dexamethasone or any ingredient of the drug.

Tinea corporis, localized virus infections, TB infection, gonorrhea is not under control, severely damaged joints,….

Careful:

In patients with bacterial infections, treatment with specific antibacterial agents is required first. Due to the immunosuppressive effect, Dexamethasone can cause severe infections. However, patients with bacterial meningitis need to use dexamethasone before taking specific antibacterial drugs. Should be actively monitored with patients with osteoporosis, new intestinal surgery, psychosis, peptic ulcer, diabetes, hypertension, heart failure, kidney failure, tuberculosis, …

Pregnancy period:

The drug may reduce placental weight and fetal weight.

The drug can cause adrenal suppression in the newborn if the mother takes the drug for a long time.

Lactation period:

Dexamethasone enters breast milk and is at risk for breastfed infants.

Unwanted effects:

Frequent, ADR > 1/100:

Electrolyte disorders: Hypokalemia, sodium and water retention cause edema, hypertension.

Cushing syndrome, decreased ACTH secretion, adrenal atrophy, decreased glucid tolerance, menstrual disorders.

Muscle atrophy, osteoporosis, pathological fractures, spina bifida, bone necrosis.

Peptic ulcer, acute pancreatitis, acute pancreatitis.

Skin atrophy, erythema, ecchymosis, hirsutism.

Insomnia.

Less common, 1/1000 < ADR < 1/100:

Hypersensitivity, anaphylaxis, leukocytosis, thromboembolism, weight gain, appetite, nausea, malaise, hiccups, abscess.

Symptoms and signs of drug discontinuation:

Rapid decrease in dose after prolonged treatment causes acute adrenal insufficiency, hypotension and death.

Inform your doctor unwanted effects encountered when using the drug.

Dosage and Administration:

Used for intramuscular, intravenous injection or local injection as per doctor’s prescription.

– Initial intramuscular dose in adults: 8 – 16 mg. If necessary, add dose at intervals of 1-3 weeks.

– Injection in the lesion: 0,8 – 1,6 mg/site.

– Injections in joints or soft tissue: 4 – 16 mg. If necessary, add dose at intervals of 1-3 weeks.

– Dose for children under 12 years: not determined.

– When intravenous infusion, it can be diluted in a solution of dextrose or sodium chloride.

– Intramuscular and intravenous dose depends on the disease and patient response, usually 0,5 – 24 mg/day.

– Children: 6 – 40 mcg/kg or 0,235 – 1,2 mg/m², intramuscular, intravenous injection, 1 – 2 times/day.

Shock: 1 – 6 mg/kg Dexamethasone phosphate, intravenous injection 1 time or IV 40 mg every 2 to 6 hours. Or initially intravenous 20 mg, then continuous intravenous injection of 3 mg / kg / 24 hours. High doses must be maintained until the patient is stable and usually no longer than 48-72 hours.

Cerebral edema:

Intravenous injection of 10 mg Dexamethasone phosphate, then intramuscular 4 mg every 6 hours until the symptoms of brain edema disappear. Respond well in 12 – 24 hours, reduce the dose after 2-4 days and discontinue the drug in 5-7 days. Intramuscularly can be replaced by oral Dexamethasone 1 – 3 mg / time, 3 times / day. Patients with nonoperative or recurrent brain tumors, maintenance dose of 2 mg, intramuscularly or intravenously, 2-3 times / day.

Preventive for hearing loss and neurological sequelae in H. influenzae meningitis or pneumococcal: 0,15 mg/kg Dexamethasone phosphate, Intravenous injection 4 times/day, inject together or within 20 minutes before taking the first antibiotic dose and continue for 4 days.

Respiratory distress syndrome in newborns: Intramuscularly to the mother, starting at least 24 hours or earlier (48-72 hours) before preterm labor: 6 mg every 12 hours/time, 2 day.

Allergy: Intramuscularly 4 – 8 mg in the first day, the following day orally.

Inflammatory disease: Injection in the joint: knee joints 2 – 4 mg. Small joints: 0,8 – 1 mg. Synovial fluid: 2 – 3 mg. Lymphadenopathy: 1 – 2 mg. Envelope: 0,4 – 1 mg. Soft tissue: 2 – 6 mg. Repeat injections after 3-5 days / time (synovial fluid) or 2-3 weeks / time (joint).

General principles:

The dose varies with the disease, the patient’s response. To reduce side effects, the smallest effective dose should be used.

Reduce the dose gradually after prolonged use to avoid acute adrenal insufficiency.

Drug interactions:

Barbiturate, Phenytoin, Rifampicin, Rifabutine, Carbamazepine, Ephedrine, Aminoglutethimide may increase corticosteroid excretion should reduce the therapeutic effect.

Corticosteroids antagonize the effect of agents that cause hypoglycemia (including insulin), antihypertensive drugs and diuretics. Corticosteroids increase the hypokalemic effect of acetazolamides, thiazide loop diuretics, carbanoxolones.

The effect of anticoagulant coumarins increases when taken with corticosteroids, so prothrombin time should be closely monitored to avoid spontaneous bleeding.

Salicylate elimination increases with coadministration of corticosteroids, so stopping corticosteroids is likely to be salicylate poisoning.

Hypokalemia diuretics (thiazides, furosemide) and amphotericin B increase the hypokalemic effect of glucocorticoids.

Overdose:

Glucocorticoid overdose causing acute poisoning or causing death is rare. There is no specific antidote. Symptomatic treatment should be considered if the patient is hypersensitive to corticosteroids in chronic poisoning. Anaphylactic shock treated with epinephrine, artificial respiration and aminophylin. The sick person should be kept warm and quiet.

Incompatibility:

Dexamethasone sodium phosphate incompatible with daunorubicine, doxorubicine, vancomycin, doxapram hydrochloride, glycopyrolate.

Shelf-life:

36 months since manufacture date.

Storage: Store at a dry place, temperature not exceed 30⁰C, avoid direct light.

Specification: Vietnamese pharmacopoeia.

Packaging: Box of 10 ampoules x 1 ml, box of 20 ampoules x 1 ml, box of 50 ampoules x 1 ml, box of 100 ampoules x 1 ml enclosed with instruction leaflets.