Rabu, 17 Oktober 2012

CELESTAMINE® Tablets and Syrup


Schering-Plough

DESCRIPTION :
Each scored Celestamine® Tablet contains 0.25 mg betamethasone, a synthetic derivative of prednisolone, and 2 mg dexchlorpheniramine maleate. One teaspoonful (5 ml) of Celestamine® Syrup is equivalent to one Celestamine® Tablet.

ACTIONS:
Celestamine Tablet and Syrup combine the anti-inflammatory and antiallergic effects of the corticosteroid betamethasone with the antihistaminic activity of dexchiorpheniramine maleate.

INDICATIONS AND USAGE :
Celestamine Tablets and Syrup are recommended in the treatment of difficult cases of respiratory, dermatologic and ocular allergies, as well as ocular inflammatory disorders, where adjunctive systemic corticosteroid therapy is indicated.

DOSAGE AND ADMINISTRATION:
DOSAGE SHOULD BE INDIVIDUALIZED AND ADJUSTED ACCORDING TO THE SPECIFIC DISEASE BEING TREATED, ITS SEVERITY AND THE RESPONSE OF THE PATIENT. The recommended initial dosage of Celestamine® Tablets and Syrup adults and children over 12 years is 1 to 2 tablets (or I to 2 teaspoonfuls) four times daily, after meals and at bedtime. The dose is not to exceed 8 tablets (or 8 teaspoonfuls) per day. In younger children dosage should be adjusted according to the severity of the condition, and the response of the patient, rather than by age or body weight.
Children 6 to 12 years - The recommended dosage is 14 tablet (or '/, teaspoonful) three times a day.   If an additional daily dose is required, it should be taken preferable at bedtime. The dose is not to exceed 4 tablets "tor 4 teaspoonlUl) a dayr
Children 2 to 6 years - The initial dosage of Celestamine® Syrup is V, to K teaspoonful three times a day with adjustment of dosage according to patient response. Daily dose is not to exceed 2 teaspoonfuls.

DRUG INTERACTIONS:
Betamethasone - Concurrent use of Phenobarbital, phenytoin, rifampin or ephedrine may enhance the metabolism of corticosteroids, reducing their therapeutic effects.
Patients receiving both a corticosteroid and an estrogen should be observed for excessive corticosteroid effects. Concurrent use of corticosteroids with potassium-depleting diuretics may enhan.ce hypokalemia. Concurrent use of corticosteroids with cardiac glycosides may enhance the possibility of arrhythmias or digitalis toxicity associated with hypokalemia. Corticosteroids may enhance the potassium depletion caused by amphotericin B. In all patients taking any of these drug therapy combinations, serum electrolyte determinations, particularly potassium levels, should be monitored closely.
Concurrent use of corticosteroids with coumarin-type anticoagulants may increase or decrease the anticoagulant effects, possibly requiring adjustment in dosage.
Combined effects of non-corticosteroid anti-inflammatory drugs or alcohol with glucocorticoids may result in an increased occurrence or increased severity of gastrointestinal ulceration. "corticosteroids may decrease blood~salicylate concentralionsr Acerylsalicylic acid should be used eaTHlrmsty-in conjuction with corticosteroids in hypoprothrombinemia.
Dosage adjustments of an antidiabetic drug may be necessary when corticosteroids are given to diabetics. Concomitant glucocorticoid therapy may inhibit the response to somatotropin.
Dexchlorpheniramine Maleate - Monamine oxidase (MAO) inhibitors prolong and intensify the effects of antihistamines; severe hypotension may occur. Concomitant use of dexchlorpheniramine maleate with alcohol, tricyclic antidepressants, barbiturates or other central nervous system depressants may potentiate the sedative effect of dexchlorpheniramine. The action of oral anticoagulants may be inhibited by antihistamines. Drug/Laboratory Test Interactions- Corticosteroids may affect the nitroblue tetrazolium test for bacterial infection and produce false negative results.

ADVERSE REACTIONS:
The physician should be alerted to the possibility of any adverse effects associated with the use of corticosteroids and antihistamines, especially of the sedating type.
Betamethasone : Adverse reactions to this component, which have been the same as those reported with other corticosteroids, are related to dose and duration of therapy.   The small amount of corticosteroid in the combination makes the incidence of side-effects less likely. ~Advefse~reaciions reported tor corticosteroids includeT"
Fluid and electrolyte disturbances   sodium retention, potassium loss, hypokalemic alkalosis; fluid retention;
congestive heart failure in susceptible patients; hypertension.
Musculoskeletal: muscle weakness, corticosteroid myopathy, loss of muscle mass; aggravation of myasthenic
symptoms in myasthenia gravis; osteoporosis; vertebral compression fractures; aseptic necrosis of femoral and
humeral heads; pathologic fracture of long bones; tendon rupture.
Gastrointestinal :  peptic ulcer with possible subsequent perforation and hemorrhage; pancreatitis, abdominal
distention; ulcerative esophagitis.
DermatoloRic : impaired wound healing, skin atrophy, thin fragile skin; petechiae and ecchymoses; facial
erythema; increased sweating; suppressed reactions to skin tests; reactions such as allergic dermatitis, urticaria,
angioneurotic edema.
Neurologic: convulsions; increased intracranial pressure with papilledema (pseudotumor cerebri) usually after
treatment; vertigo; headache.
Endocrine:   menstrual irregularities; development of cushingoid state; suppression of fetal intrauterine or
childhood growth; secondary adrenocorrical and pituitary unresponsiveness, particularly in times of stress, as
in trauma, surgery or illness; decreased carbohydrate tolerance, manifestations of latent diabetes mellitus,
increased requirements of insulin or oral hypoglycemic agents in diabetics.
Ophthalmic: posterior subcapsular cataracts; increased intraocular pressure, glaucoma; exophthalmos.
Metabolic : negative nitrogen balance due to protein catabolism.
Psychiatric: euphoria, mood swings; severe depression to frank psychotic manifestations; personality changes-
hypenrritability, insomnia.
Other: anaphylactoid or hypersensitivity and hypotensive or shock-like reactions.
Dexchlorpheniramine Maleate - Adverse reactions to this component have been the same as those reported
with other conventional (sedating) antihistamines, and rarely cause toxicity. Slight to moderate drowsiness is
the most frequent side effect of dexchlorpheniramine maleate. Adverse effects of sedating antihistamines vary
in incidence and severity.   Among these are cardiovascular, hematologic (pancytopenia, thrombocytopenia
CONTRAINDICATIONS:
Celestamine® products are contraindicated in patients with systemic fungal infections, newborn and premature infants, patients receiving MAO inhibitor therapy and in those who have shown hypersensitivity or idiosyncrasy to any component of these products or drugs of similar chemical structures.

PRECAUTIONS:
Betamethasone - Dosage adjustments may be required with remission or exacerbation of the disease process, the patient's individual response to therapy and exposure of the patient to emotional or physical stress such as serious infection, surgery or injury. Monitoring may be necessary for up to one year following cessation of long-term or high-dose corticosteroid therapy.
The lowest possible dose of corticosteroid should be used to control the condition under treatment. A gradual dosage reduction is recommended.
Corticosteroid effect is enhanced in patients with hypothyroidism or in those with cirrhosis. Cautious use of corticosteroids is advised in patients with ocular herpes simplex because of possible corneal perforation.
Psychic derangements may appear with corticosteroid therapy. Existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.
Corticosteroids should be used with caution in : nonspecific ulcerative colitis, if there is a probability of - impending perforation, abscess, or other pyogenie infection; diverticulitis; fresh intestinal anastomoses; active ~ or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, and myasthenia gravis. _ Since complications of glucocorticoid treatment are dependent on dosage and duration of treatment, a risk/benefit decision must be made with each patient.
Corticosterids may mask some signs of infection and new infections may appear during use. When corticosteroids are used, decreased resistance and inability to localize infection may occur. Prolonged corticosteroid use may produce posterior subcapsular cataracts (especially in children), glaucoma with possible damage to the optic nerves, and may enhance secondary ocular infections due to fungi or viruses. Average and large doses of corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be considered. All corticosteroids increase calcium excretion.
  While on corticosteroid therapy patients should not be vaccinated against smallpox. Other immunization procedures should not be undertaken in patients receiving corticosteroids. especially high doses, because of possible hazards of neurological complications and lack of antibody response.
Treatment of Acute Overdosage: In the event of overdosage, emergency treatment should be started immediately. Consultation with a poison control center is recommended. Consider standard measures to remove any unabsorbed drug, e.g. activated charcoal, gastric lavage. Dialysis has not been found helpful. There is no specific antidote. Measures to enhance excretion (urinary acidification, hemodialysis) are not recommended. Treatment of the signs and symptoms of overdosage is symptomatic and supportive.
STORAGE : Celestamine® Syrup   : store between 2°C and 30°C, Celestamine® Tablets : store below 25°C

HARUS DENGAN RESEP DOKTER
  
Manufactured by:
PT Schering-Plough Indonesia Tbk.,

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