Betamethasone, dexchlorpheniramine maleate.
Each tab and each 5 mL syrup contains betamethasone 0.25 mg and dexchlorpheniramine maleate 2 mg.
Pharmacology: Betamethasone is a synthetic glucocorticoid with an anti-inflammatory and immunosuppressant effect. Its use for adrenocortical insufficiency should be combined with a mineralocorticosteroid since its natrium effect (mineralocorticosteroid nature) is very low.
The anti-inflammatory effect consists of stabilizing lysosomal leucocyte, preventing acid-destructing hydrolase release from leucocyte, preventing macrophage accumulation on inflammation site, decreasing leucocyte adherence capacity on endothelium capillary, decreasing capillary wall permeability and edema, bearing against histamine activity kinin release from substrate, decreasing fibroblast proliferation, precipitating collagen and other mechanisms. Duration of anti-inflammatory activity is in line with duration of hypothalamic-pituitary-adrenal (HPA) axis pressing. Colergis can decrease lymphatic activity and volume, produce lymphocytopenia, decrease antigen-antibody interaction tissue reactivity immunology concentration in such a way that suppresses immune response.
Betamethasone also stimulates erythroid cells in bone marrow, elongating erythrocyte and blood platelet lifespan, bringing on neutrophilia and eosinopenia, increasing protein catabolism, gluconeogenesis and lipid redistribution from peripheral to central part of the body, as well as decreasing intestinal absorption and increasing renal excretion of calcium.
Dexchlorpheniramine maleate is a propylamine derivative antihistamine. Dexchlorpheniramine competitively inhibits histamine pharmacologic action (receptor H1 histamine antagonist).
Allergic conditions that need corticosteroid therapy.
Tablet: Adults and children ≥12 years: 1 tab or 1 teaspoonful every 4-6 hrs, not more than 6 tabs/day.
Children 6-12 years: ½ tab or ½ teaspoonful every 4-6 hrs, not more than 3 tabs/day; 2-6 years: ¼ tab or ¼ teaspoonful every 4-6 hrs, not more than 1.5 tab/day.
Syrup: Adults and children ≥12 years: 1 teaspoonful every 4-6 hrs, not more than 6 teaspoonful/day.
Children 6-12 years: ½ teaspoonful every 4-6 hrs, not more than 3 teaspoonful/day; 2-6 years: ¼ teaspoonful every 4-6 hrs, not more than 1.5 teaspoonful/day.
For infants and children, dose will be more accurate when based on response and degree of illness rather than age, weight or area of body surface. Drug should be administered simultaneously with food or milk to alleviate gastrointestinal side effects.
Dose depends on patients' condition and response, when appropriate reaction is reached, dose should be tapered off until the lowest dose, giving sufficient permanent clinical response.
Administration should be stopped as soon as possible. Patients should always be monitored toward signs of the need of dose-adjustment, as severity of illness or stress (surgery, infection, trauma).
In long-term therapy, administration should be gradually reduced. Before long-term therapy, patients should first undergo ECG, blood pressure, chest and spinal radiography, sugar test and HPA axis function, as well as gastrointestinal radiography for patients who are susceptible to gastrointestinal disturbance. During long-term therapy, periodic evaluation should be done on height, weight of chest and spinal radiography, hematopoietic, electrolyte, glucose tolerance, blood pressure and ocular pressure.
Hypersensitivity to betamethasone and sulphites. Patients taking monoamine oxidase inhibitor (MAOI) therapy. Neonates and premature infants. Systemic fungal infection. Patients taking immunization. Peptic ulcer.
Use in pregnancy & lactation: Administration in pregnancy can cause fetal damage. Lactating woman taking betamethasone should not breastfeed her baby. Betamethasone may cause false negative result on tetrazolium nitroblue test of systemic bacterial infection and suppresses the reaction of skin test and complicate thyroiditis medicine therapy response. Administration should be done carefully in closed-angle glaucoma, pyloroduodenal obstruction, prostate hypertrophy or bladder neck obstruction, diabetes mellitus, steroid myopathy and epilepsy. Administration of Colergis may suppress clinical symptoms of an infection. Long-term use can suppress immune system against infection. In long-term use, avoid sudden discontinuation. Long-term use of corticosteroids may cause posterior subcapsular cataract, glaucoma with possibility of optical nerve destruction and may increase fungal and viral secondary ocular infection. Be careful in congestive heart failure patients since Colergis can cause fluid retention.
Patients should be instructed to tell the doctor about progression of infection, signs of infection (fever, sore throat, urinary tract pain, muscle ache) and wound during therapy or 12 months after the therapy has been stopped in order to adjust the dose and if re-administration is needed. Administration should be done carefully in the elderly, debilitated, patients with hypothyroidism/cirrhosis, myocardial infarction, asthma, psychosis, hypertension; liver function failure, myasthenia gravis patients taking anticholinesterase, thromboembolic disturbance, renal insufficiency, osteoporosis, ocular herpes simplex infection, increased intraocular pressure and seizure disturbance. There is a tendency for osteoporosis, therefore, administration in menopausal patients should be done carefully. Colergis should not be used in patients with peptic ulcer except in a very serious situation; also, be careful in patients with diverticulitis, colitis ulcer and intestinal anastomosis. It should not be administered in viral/bacterial infection that cannot be controlled by antibiotics unless in a very critical situation. Chemoprophylaxis should be included in managing patients with active tuberculosis history.
Effects on the Ability to Drive or Operate Machinery: May impair ability to drive or operate machinery (drowsiness, dizziness, weakness).
Use in children: If possible, long-term high-dose use in children should be avoided, since Colergis can decelerate bone growth; if long-term therapy is really needed, monitor on infants and children's growth and development should always be done. High-dose in children also causes acute pancreatitis, furthermore, it causes destruction of pancreas.
When administered in long-term therapy, it can bring adverse reactions eg, general protein catabolism; adrenocortical atrophy and secondary adrenocortical insufficiency; infection sensitivity augmentation especially in high dose; edema eg, natrium retention, potassium loss, hypokalemic alkalosis and hypertension, as well as hypocalcemia; bringing on posterior subcapsular cataract especially in children, exopthalmos and increased intraocular pressure in such a way that it leads to glaucoma; occasionally, eye nerve destruction; endocrinal disturbance including hypercortism and amenorrhea or other menstrual disturbance; decrease glucose tolerance, hyperglycemia and exacerbating diabetes mellitus; gastrointestinal effects (nausea, vomiting, anorexia causing weight reduction, increases appetite causing weight gain, diarrhea, constipation, abdominal distention, pancreatitis, gastric irritation and esophageal ulcer); neurological effects (dizziness, vertigo, insomnia, uneasiness, depression and anxiety); the most common side effects of dexchlorpheniramine maleate: Drowsiness, headache, dryness of the mouth, nose and throat, dizziness, weakness, gastrointestinal disturbance (anorexia, nausea, vomiting, constipation, diarrhea); disturbance of fluid and electrolyte equilibrium, suppression of HPA axis, glaucoma, mental disturbance, myopathy, muscle mass loss.
Barbiturates, phenytoin and rifampin (drugs that induce liver enzymes) can increase betamethasone metabolism, therefore dose adjustment needs to be done if these therapy are given simultaneously. Concomitant administration with ulcerogenic drugs eg, indomethacin can decrease peptic/intestinal ulcer risk. Also, co-administration with aspirin in hypoprothrombinemia patients should be done carefully. In polyarthritis patients, concomitant administration with salicylates should be done carefully, adverse effects should always be monitored. Diuretics (thiazides, furosemide, ethacrynic acid) and other drugs which promotes potassium loss causes excessive betamethasone effect on potassium, therefore serum potassium should always be monitored. In myasthenia gravis patients, anticholinesterase drugs should be stopped at least 24 hrs before betamethasone administration is initiated. Immunization in patients taking betamethasone needs serological test to assure appropriate antibody response and vaccine/toxoid dose may increase. Central nervous system depression may be exacerbated when given simultaneously with other depressants eg, barbiturates, tranquilizers and alcohol; physicians should not give these drugs to avoid overdose and patients should be informed not to consume alcohol. MAOI can elongate and magnify antihistamine effect.
Store in a dry place, under 30°C. Protect from light.
R06AB52 - dexchlorpheniramine, combinations ; Belongs to the class of substituted alkylamines used as systemic antihistamines.
Tab 10 x 10's. Syr 60 mL x 1's.