Celestamine – Complete Information About Dosage, Side Effects

What is Celestamine?

Celestamine is the brand name for a steroidal medicine usually prescribed for the treatment of Pain and Inflammatory conditions. This medicine is manufactured and marketed by Schering Plough Pharmaceuticals Limited (Under Dohme & Merck Sharp LLC). This medicine comes in the form of Tablets, and Syrup. Tablets are sold in the packaging of 10 tablets per strip while syrup is sold in the bottles of 60 and 30 ml syrup.

celestamine - side effects, uses, dosage
celestamine – side effects, uses, dosage

Uses of Celestamine

Betamethasone/Dexchlorpheniramine Maleate (CELESTAMINE) Tablet 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.
Representative conditions include severe hay fever (pollinosis), severe bronchial asthma, perennial allergic rhinitis, atopic dermatitis (eczema), contact dermatitis, drug reactions, and serum sickness.

Inflammatory ocular disorders include allergic conjunctivitis, keratitis, non-granulomatous iritis, iridocyclitis, choroiditis, chorioretinitis, and uveitis.
Betamethasone/Dexchlorpheniramine Maleate (CELESTAMINE) Tablets and Syrup control the exudative and inflammatory aspects of ocular diseases, thus helping to preserve the functional integrity of the eye while allowing treatment of the specific infection or other cause with appropriate therapy.

Dosage of Celestamine

Dosage should be individualized and adjusted according to the specific disease being treated, its severity and the response of the patient. As improvement occurs, the dosage should be reduced gradually to the minimum maintenance level and discontinued where possible. When symptoms of respiratory allergies are adequately controlled, slow withdrawal of the combination product and treatment with an antihistamine alone should be considered.

The recommended initial dosage of Celestamine Tablet and Syrup for adults and children over 12 years is 1 to 2 tablets (or 1 to 2 teaspoons) four times daily, after meals and at bedtime. The dose is not to exceed 8 tablets (or 8 teaspoons) 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 the ½ tablet (or ½ teaspoonful) three times a day. If an additional daily dose is required, it should be taken preferably at bedtime. The dose is not to exceed 4 tablets (or 4 teaspoonfuls) a day.

Children 2 to 6 Years

The initial dosage of Celestamine Syrup is ¼ to ½ teaspoonful three times a day with adjustment of dosage according to patient response. The daily dose is not to exceed 2 teaspoonfuls.

Overdosage of Celestamine

CELESTAMINE is a combination product and, therefore, the potential toxicity of each of its components must be considered. Toxicity from a single excessive dose of Celestamine results primarily from the dexchlorpheniramine component. The estimated lethal dose of the antihistamine dexchlorpheniramine maleate is 2.5 to 5.0 mg/kg.

Overdosage reactions with conventional (sedating) antihistamines may vary from central nervous system depression (sedation, apnea, diminished mental alertness, cardiovascular collapse) to stimulation (insomnia, hallucinations, tremors, convulsions) to death. Other signs and symptoms may include dizziness, tinnitus, ataxia, blurred vision and hypotension. In children, stimulation is dominant, as are atropine-like signs and symptoms (dry mouth; fixed, dilated pupils; flushing; fever and gastrointestinal symptoms). Hallucinations, incoordination, and convulsions of the tonic-clonic type may occur. In adults, a cycle consisting of depression with drowsiness and coma, and an excitement phase leading to convulsions followed by depression may occur.

A single excessive dose of betamethasone is not expected to produce acute symptoms. Except at the most extreme dosages, a few days of excessive glucocorticosteroid dosing is unlikely to produce harmful results except in patients betamethasone.

Treatment of Acute Overdosage

Immediately induce emesis (in a conscious patient) or administer gastric lavage. Dialysis has not been found helpful.
Treatment of the signs and symptoms of overdosage is symptomatic and supportive. Stimulants should not be used. Vasopressors may be used to treat hypotension. Convulsions are best treated with a short-acting depressant, such as thiopental. Maintain adequate fluid intake and monitor electrolytes in serum and urine, with particular attention to sodium and potassium balance. Treat electrolyte imbalance if necessary.

Side Effects of Celestamine

Betamethasone/Dexchlorpheniramine Maleate (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 While Using Celestamine

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 pyogenic 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.
  • Corticosteroids 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.
  • Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles, and if exposed, to obtain medical advice. This is of particular importance in children.

Dexchlorpheniramine Maleate:

  • Dexchlorpheniramine Maleate products should be used with caution in patients with narrow-angle glaucoma, stenoising peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy or bladder neck obstruction, cardiovascular disease including hypertension, in those with increased intraocular pressure or hyperthyroidism.
  • Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating appliances, machinery, etc.
  • Conventional antihistamines may cause dizziness, sedation, and hypotension in patients over 60 years of age.

Use in Children

Safety and effectiveness of Betamethasone/Dexchlorpheniramine Maleate (CELESTAMINE) products have not been established in children under 2 years of age.
Use in Elderly: Conventional antihistamines may cause dizziness, sedation, and hypotension in patients over 60 years of age.

Use In Pregnancy & Lactation

The use of Betamethasone/Dexchlorpheniramine Maleate (CELESTAMINE) products during pregnancy, in nursing mothers or in women of child-bearing age requires that the possible benefits of the drug be weighed against potential hazards to mother and fetus or infant. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.

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.

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.

Dermatologic: Impaired wound healing, skin atrophy, thin fragile skin; petechiae and ecchymoses; facial erythema; increased sweating; suppressed reactions to skin tests; reactions eg, allergic dermatitis, urticaria, angioneurotic edema.

Neurologic: Convulsions; increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment; vertigo; a headache.

Endocrine: Menstrual irregularities; development of Cushingoid state; suppression of fetal intrauterine or childhood growth; secondary adrenocortical 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; hyperirritability; insomnia.

Interactions

Betamethasone:

  • Concurrent use of phenobarbital, phenytoin, rifampicin 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 enhance 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 an adjustment in dosage.
  • Combined effects of non-corticosteroid anti-inflammatory drugs or alcohol with glucocorticosteroids may result in an increased occurrence or increased severity of gastrointestinal ulceration.
  • Corticosteroids may decrease blood salicylate concentrations. Acetylsalicylic acid should be used cautiously in conjunction 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:

  • Monoamine 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 Tests: Corticosteroids may affect the nitroblue tetrazolium test for bacterial infection and produce false negative results.

Storage

Tablet: Store below 25°C. Protect from light.
Syrup: Store below 30°C. Protect from light.

Description

Tablet: Each CELESTAMINE Tablet contains 250 mcg Betamethasone, a synthetic derivative of prednisolone, and 2 mg Dexchlorpheniramine Maleate.
Excipients/Inactive Ingredients: Cornstarch, lactose, dye FD & C red, gelatin and magnesium stearate.

Syrup: Each teaspoonful (5 mL) of Celestamine Syrup is equivalent to one tablet.
Excipients/Inactive Ingredients: Sucrose, sorbitol, propylene glycol, sodium benzoate, citric acid, sodium chloride, dye FD & C yellow, imitation strawberry flavor and purified water.

Working Mechanism of Celestamine

Celestamine Tablet and Syrup combine the anti-inflammatory and antiallergic effects of the corticosteroid betamethasone with the antihistaminic activity of dexchlorpheniramine maleate.
By using betamethasone and dexchlorpheniramine maleate in combination, comparable results usually are obtained with smaller amounts of corticosteroid than when the corticosteroid is given alone.

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