|Your Health is our Priority|
Each tablet contains 0.25 mg betamethasone and 2 mg dexchlorpheniramine maleate.
Celestik is a combination of the corticosteroid betamethasone and the antihistamine dexchlorpheniramine maleate with anti
inflammatory , anti allergic properties .
Treatment of difficult cases of respiratory , dermatologic and ocular allergies and ocular inflammatory disorders where systemic
corticosteroid therapy is indicated.
Dosage and administration
Dose should be individualized and adjusted according to condition treated and response obtained.
Adults and children > 12 years :
4 x 1 – 2 tabs / day , after meals and at bed time .
Do not exceed 8 tabs / day.
Children 6- 12 years: 3 x ½ tab / day . Do not exceed 4 tabs / day.
Children 2 – 6 years: 3 x ¼ - ½ tab / day .
As improvement occurs , dosage should be reduced gradually to the minimum maintenance level and discontinued
Dosage adjustment may be required for remissions or exacerbations of disease , patient’s individual response to therapy and
exposure of patient to emotional and physical stress. Following cessation of long term or high dose therapy , monitoring may
be necessary for up to 1 year.
Drug induced secondary adrenocortical insufficiency may result from too rapid withdrawal and may be minimized by gradual
dose reduction . Corticosteroid effect is enhanced in patients with hypothyroidism or cirrhosis . Use with caution in patients with
ocular herpes simplex , non specific ulcerative colitis , abscess or other pyogenic infection diverticulitis , fresh intestinal
anastomoses , active or latent peptic ulcer , renal insufficiency , hypertension, osteoporosis , myasthenia gravis.
Corticosteroid may aggravate existing emotional instability or psychotic tendencies .
Corticosteroid may mask signs of infection . Prolonged used may produce posterior subcapsular cataracts , glaucoma with
possible damage to the optic nerves and may enhance the establishment of secondary ocular infections due to fungi or viruses.
With corticosteroid therapy , dietary salt restriction and potassium supplementation may be considered , all corticosteroid s
increase calcium excretion .
Do not immunize patients undergoing corticosteroid therapy .
Patients undergoing corticosteroid with immunosupresan dose, should be told to avoid the exposure of chicken pox or measles
, and if expose , give the medical treatment , especially for the children .
In active tuberculosis patients , corticosteroid therapy should be restricted to cases of fulminating or disseminated tuberculosis
in which concomitant appropriate anti tuberculous regimen is used. Reactivation of latent tuberculosis may occur , these
patients should receive chemoprophylaxis during prolonged corticosteroid therapy .
Carefully monitor growth and development of infants and children on prolonged therapy .
Corticosteroid may alter the motility and number of spermatozoa .
Concurrent use of Phenobarbital , rifampicin, phenytoin or ephedrine may enhance corticosteroid metabolism . Excessive
corticosteroid effects may occur in patients concurrently receiving an estrogen.
Concurrent corticosteroid use with potassium - depleting diuretics may enhance hypokalemia . Concurrent corticosteroid use
with cardiac glycosides may enhance the possibility of arrhythmias or digitalis toxicity associated with hypokalemia .
Corticosteroids may enhance potassium depletion caused by amphotericin B . In patients receiving any of these drug therapy
combinations , monitor serum electrolyte determinations closely .
Concurrent corticosteroid use with coumarin – type anticoagulants may increase or decrease anticoagulant effects possibly
requiring adjustment in dosage .
Combined effects of non corticosteroid anti inflammatory drugs or alcohol with glucocorticoids may result in increased
occurrence or severity of gastrointestinal ulceration .
Corticosteroid may decrease blood salicylate concentrations, use acetylsalicylic acid cautiously in conjunction with corticosteroid
in hypoprothrombinemia .
When corticosteroids are given to diabetics , dosage adjustments of anti diabetic drugs may be necessary .
Concomitant glucocorticoid therapy may inhibit the response to somatotropin.
Corticosteroid may affect the nitro blue tetrazolium test for bacterial infection and produce false negative results .
Use with caution in patients with narrow angle glaucoma , stenosing peptic ulcer , pyloroduodenal obstruction , prostatic
hypertrophy or bladder neck obstruction , cardiovascular disease including hypertension , increased intraocular pressure or
Caution patients against engaging in activities requiring mental alertness.
In patients > 60 years , antihistamine may cause sedation , dizziness and hypotension.
MAO inhibitors prolong and intensify the effects of antihistamine , severe hypotension may occur .
Concomitant use with alcohol , tricyclic anti depressant , barbiturates or other CNS depressants may potentiate the sedative
effect of dexchlorpheniramine. Action of oral anticoagulant may be inhibited by antihistamine.
Safety and effectiveness in children < 2 years have not ben established .
Use during pregnancy and in lactating women and women of childbearing potential requires that risk / benefit ratio be
considered for both mother and child . Infants born of women who have received substantial corticosteroid doses during
pregnancy should be carefully observed for signs of hypoadrenalism .
Because it is a combination product , so the potential toxicity from each component must be considered. The toxicity of single
drug over dose mainly from dexchlorpheniramine . The lethal dose anti histamine dexchlorpheniramine maleate is about 2,5
– 5 mg / kg.
The overdose reactions with conventional antihistamine ( sedative ) vary from CNS depression ( sedation , apnea , decreased
mental alertness , cardiovascular collapse ), stimulation ( insomnia , hallucination , tremor , convulsion ) until death . The
other signs and symptoms are vertigo , tinnitus , ataxia , sight decreased and hypotension .
In children , the stimulation is dominant , like atropine symptoms ( dry mouth , pupil dilatation , hot burn sensation , fever
and gastrointestinal symptoms ) , hallucination , in coordination , tonic clonic convulsion .
In adults , depression with drowsiness and coma , and a stimulate phase to convulsion followed by depression .
Single over dose from betamethasone is predicted not caused the acute symptoms . Except the most extreme dose , the over
dose of glucocorticosteroid for some days doesn’t cause dangerous , but for the patients with certain risks because of their
condition or drug interaction with betamethasone.
The overdose treatment
Symptomatic and supportive .
Induced emesis / vomiting / gastric lavage for patient with normal consciousness. Dialysis doesn’t really help . Don’t use
stimulant . Vasopressor could be used for treatment of hypotension . The best treatment for convulsion is short acting
depressant , eg thiopental . Adequate fluid should be maintained and control electrolyte level in urine and serum , especially
sodium and potassium .
Increased fluid and electrolyte , musculosceletal , gastrointestinal , dermatologic , neurologic , endocrine , opthalmic ,
metabolic and psychiatric distrurbances .However , the small amount of corticosteroid in this combination makes the incidence
of side effects less likely .
Most frequent adverse effect is slight to moderate drowsiness . Other possible adverse effects of antihistamines include
cardiovascular , hematologic , neurologic , gastrointestinal , dermato-venerologic , respiratory reactions . General adverse
effects , eg urticaria , drug rash , anaphylactic shock , photosensitivity , excessive perspiration , chills , dryness of mouth ,
nose and throat have been reported .
Hypersensitive , neonate , premature , patients with systemic fungal infections , patients receiving MAOI therapy .
Box @ 10 x 10 tab ,