Claricort

Claricort

Manufacturer:

Bayer

Distributor:

Zuellig
Full Prescribing Info
Contents
Loratadine, betamethasone.
Description
Each tablet contains betamethasone 250 mcg and loratadine 5 mg.
Action
Antihistamine. Anti-inflammatory.
By using loratadine-betamethasone in combination, tablets combine the anti-inflammatory and antiallergic effect of the corticosteroid (betamethasone) with the nonsedating antihistamine (loratadine).
Loratadine is a potent long-acting tricyclic antihistamine with selective peripheral H1-receptor antagonistic activity.
Glucocorticosteroids eg, betamethasone, cause profound and varied metabolic effects and modify the body's immune response to diverse stimuli.
Betamethasone has high glucocorticosteroid activity and slight mineralocorticosteroid activity.
Indications/Uses
Relief of symptoms of atopic dermatitis, angioedema, urticaria, seasonal and perennial allergic rhinitis, food and drug allergic reaction, allergic contact dermatitis, severe seborrheic dermatitis, neurodermatitis, allergic asthma, ocular allergic manifestations eg, conjunctivitis and iridociclitis and allergic reaction to insect stings.
Dosage/Direction for Use
Adults and children ≥12 years: 1 tablet twice daily.
Dosing requirements for Claricort may vary and may need to be individualized on the basis of the specific disease, its severity and the response of the patient.
In situations of less severity, administration of the recommended dose once daily may be sufficient, treatment should be maintained until a satisfactory response is observed.
When symptoms of allergies are controlled, slow withdrawal of Claricort is recommended and treatment with an antihistamine alone should be considered if necessary.
If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued gradually.
Exposure of the patient to stressful situations unrelated to the disease under treatment may necessitate an increase in the dosage of Claricort. If the drug is to be discontinued after long-term therapy, dosage should be decreased gradually.
Overdosage
Symptoms: Somnolence, tachycardia and headache have been reported with overdoses. A single acute ingestion of 160 mg of loratadine produced no adverse effects. In the event of overdosage, treatment, which should be started immediately, is symptomatic and supportive.
Acute overdosage with glucocorticosteroids, including betamethasone, is not expected to lead to a life-threatening situation. Except at the most extreme dosages, a few days of excessive glucocorticosteroid dosing is unlikely to produce harmful results in the absence of specific contraindications eg, in patients with diabetes mellitus, glaucoma or active peptic ulcer, or in patients on medications eg, digitalis, coumarin-type anticoagulants or potassium-depleting diuretics. Maintain adequate fluid intake and monitor electrolytes in serum and urine, with particular attention to sodium and potassium balance. Treat electrolyte imbalance if necessary.
Treatment: The patient should be induced to vomit, even if emesis has occurred spontaneously. Pharmacologically-induced vomiting by the administration of ipecac solution is a preferred method. However, vomiting should not be induced in patients with impaired consciousness. The action of ipecac is facilitated by physical activity and by the administration of 240-360 mL of water. If emesis does not occur within 15 min, the dose of ipecac should be repeated. Precautions against aspiration must be taken, especially in children. Following emesis, adsorption of any drugs remaining in the stomach may be attempted by the administration of activated charcoal as a slurry with water. If vomiting is unsuccessful or contraindicated, gastric lavage should be performed. Physiologic saline solution is the lavage solution of choice, particularly in children. In adults, tap water can be used; however, as much as possible of the amount administered should be removed before the next instillation. Saline cathartics draw water into the bowel by osmosis and, therefore, may be valuable for their action in rapid dilution of bowel content. Loratadine is not cleared by hemodialysis to any appreciable extent. It is not known if loratadine is eliminated by peritoneal dialysis. After emergency treatment, the patient should continue to be medically monitored.
Otherwise, complications resulting from the metabolic effects of the corticosteroid or from deleterious effects of the basic or concomitant illness or resulting from drug interactions should be handled as appropriate.
Contraindications
Patients who have shown hypersensitivity or idiosyncrasy to the components of Claricort.
Patients with systemic fungal infections, in those with sensitivity reactions to betamethasone or to other corticosteroids or to any component of Claricort.
Special Precautions
Patients with severe liver impairment should be administered a lower dose because they may have reduced clearance of loratadine; the recommended dose should be administered initially once a day until response is established.
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 eg, serious infection, surgery or injury. Monitoring may be necessary for up to 1 year following cessation of long-term or high-dose corticosteroid therapy.
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.
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 small pox. 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. However, immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy eg, for Addison's disease.
Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to obtain medical advice. This is of particular importance in children.
Corticosteroid therapy in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management in conjunction with an appropriate antituberculous regimen.
If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary since reactivation of the disease may occur. During prolonged corticosteroid therapy, patients should receive chemoprophylaxis. If rifampin is used in a chemoprophylactic program, its enhancing effect on metabolic hepatic clearance of corticosteroids should be considered; adjustment in corticosteroid dosage may be required.
The lowest possible dose of corticosteroid should be used to control the condition under treatment; when dosage reduction is possible, it should be gradual.
Drug-induced secondary adrenocortical insufficiency may result from too rapid corticosteroid withdrawal and may be minimized by gradual dosage reduction. Such relative insufficiency may persist for months after discontinuation of therapy; therefore, if stress occurs during that period, corticotherapy should be reinstituted. If the patient is already receiving corticosteroids, dosage may have to be increased. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticosteroid should be administered concurrently.
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 glucocorticosteroid treatment are dependent on dose, size and duration of treatment, a risk/benefit decision must be made with each patient.
Corticosteroids may alter the motility and number of spermatozoa in some patients.
Use in pregnancy & lactation: Safe use of Claricort during pregnancy has not been established; therefore, use only if potential benefit justifies potential risk to fetus.
Since loratadine is excreted in breast milk and because of the increased risk of antihistamines for infants, particularly newborns and premature infants, a decision should be made whether to discontinue nursing or discontinue the drug.
Since controlled human reproduction studies have not been done with corticosteroids, the use of betamethasone during pregnancy, in nursing mothers or women of childbearing age requires that the possible benefits of the drug be weighed against potential hazards to mother and fetus or infant. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.
Use in children: Since corticosteroid administration can disturb growth rates and inhibit endogenous corticosteroid production in infants and children, the growth and development of these patients receiving prolonged therapy should be followed carefully.
Use In Pregnancy & Lactation
Safe use of Claricort during pregnancy has not been established; therefore, use only if potential benefit justifies potential risk to fetus.
Since loratadine is excreted in breast milk and because of the increased risk of antihistamines for infants, particularly newborns and premature infants, a decision should be made whether to discontinue nursing or discontinue the drug.
Since controlled human reproduction studies have not been done with corticosteroids, the use of betamethasone during pregnancy, in nursing mothers or women of childbearing age requires that the possible benefits of the drug be weighed against potential hazards to mother and fetus or infant. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.
Adverse Reactions
Claricort has no clinically significant sedative properties at the daily recommended dose (10 mg).
Most commonly reported side effects include: Fatigue, headache, somnolence, nervousness, dry mouth, gastrointestinal disorders eg, nausea, gastritis and also allergic symptoms eg, rash.
During the marketing of loratadine, alopecia, anaphylaxis and abnormal hepatic function have been reported rarely.
Adverse reactions to betamethasone which have been the same as those reported for other corticosteroids, relate both to dose and to duration of therapy. Usually, these reactions can be reversed or minimized by a reduction in dosage; this is generally preferable to withdrawal of drug treatment.
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.
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; 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.
Others: Anaphylactoid or hypersensitivity and hypotensive or shock-like reactions.
Drug Interactions
When administered concomitantly with alcohol, loratadine has no potentiating effects as measured by psychomotor performance studies.
Increase in plasma concentrations of loratadine has been reported after concomitant use with ketoconazole, erythromycin or cimetidine in controlled clinical trials, but without clinically significant changes (including electrocardiographic). Other drugs known to inhibit hepatic metabolism should be co-administered with caution until definitive interaction studies can be completed.
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 enhance hypokalemia. Concurrent use of corticosteroids with cardiac glycosides may enhance 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 NSAIDs 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 glucocorticosteroid therapy may inhibit the response to somatotropin.
Drug/Laboratory Tests: Claricort should be discontinued approximately 48 hrs prior to skin testing procedures since antihistamines may prevent or diminish otherwise positive reactions to dermal reactivity indicators.
Corticosteroids may affect the nitroblue tetrazolium test for bacterial infection and produce false-negative results.
Storage
Store at temperatures not exceeding 30°C.
ATC Classification
R06AX - Other antihistamines for systemic use ; Used as systemic antihistamines.
Presentation/Packing
Tab 100's.
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