Product Information

Loratidine + Betamethasone (Claricort®) 

Indication(s): Loratadine + Betamethasone (Claricort®) Tablets are recommended when adjunctive systemic corticosteroid therapy is indicated for the relief of severe symptoms of atopic dermatitis , angioedema , urticaria , seasonal and perennial allergic rhinitis , food and drug allergic reactions, allergic contact dermatitis, seborrheic dermatitis, neurodermatitis, allergic asthma, ocular allergic manifestations such as conjunctivitis and iridociclitis, and allergic reaction to insect stings.

Dosage Regimen:
Adults and Children 12 years of age and over:
One tablet twice a day.
Dosing requirements 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 satistactory response is observed.

When symptoms of allergies are controlled, slow withdrawal of Loratadine + Betamethasone (Claricort®) is recommended and treatment with an antihistamine alone should be considered if necessary. If a period of spontaneous remissions occurs in a chronic condition, treatment should be discontinued gradually. Exposure of the patient to stressful situations unrelated to the disease under treatment may necessitates an increase in the dosage. If the drug is to be discontinued after long-term, dosage should be decreased gradually.

Contraindications: 
Hypersensitivity to the active substances, metabolites or to any of the excipients.
Betamethasone is contraindicated

• In patients with systemic fungal infections
• In those with sensitivity reactions to betamethasone or to other corticosteroids, or to any component of this product.

Special warnings and precautions for use:

The product should be administered with caution in patients with severe hepatic impairment (see section 4.2). 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. Corticosteroids may mask some signs of infection, and new infections may appear during use. When corticosteroids are used, decreased resistance and inability to localize may occur. Prolonged corticosteroid use may produce posterior subcapsular cataract (especially in children), glaucoma with possible damage to the optic nerves, and may enhance secondary ocular intections due to fungi or viruses. Average and large doses of corticosteroids can cause elevation of blood pressure, salt and water retention, and increase 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 therav. patients should not be vaccinated adainst smalloox. 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 patient who are receiving corțicosteroids as replacement therapy, e.g., for Addison disease. Patients who are 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. † 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. It rifampicin 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 corticosteroids 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 receiving corticosteroids already, dosage may have to be increased. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid 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. Paraded yeer with corticosteroid therapy. Existing emotional instability or psychotic tendencies may be Corticosteroids should be used with caution in: nonspecițic ulcerative colitis, if there is a probability of impending perforation, abscess, or other pyogenic infection; diverticulitis, fresh intestinal anastomoses; active of latent peptic ulcer; renal insufficiency; hypertension; osteoporosis; and myasthenia gravis. Since complications of glucocorticosteroid treatment are depended on dose, size and duration of treatment, a risk/benefit decision must be made with each patient. 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 Safe use of Loratadine + Betamethasone (Claricort®) during pregnancy has not been established. Therefore, Loratadine + Betamethasone (Claricort ®) combination product is not recommended for use during pregnancy. Infants born of mothers who have eceived substantial doses of corticosteroids during pregnancy should be observed carefully for signs for hypoadrenalism Since loratadine and betamethasone are excreted in breast milk, infant risk cannot be ruled out. Therefore, this product is not recommended for use in breastfeeding women.

Visual disturbance
Cataract, glaucoma or rare disease such as central serous chorioretinopathy (CSCK) have been reported with corticosteroid use. f a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be referred to an ophthalmologist for evaluation.

Summary of the safety profile:
Loratadine + Betamethasone (Claricort®) has no clinically significant sedative properties at the daily dose (10 mg). Most commonly reported side effects include fatigue, headache, somnolence, nervousness, dry mouth, gastrointestinal disorders such as nausea, gastritis, and also allergic symptoms like rash. During the marketing of loratadine, alopecia, anaphylaxis (including angioedema), abnormal hepatic function, dizziness, and seizures 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 preterable to withdrawal of drug treatment.

Fluid and electrolyte disturbance:
sodium retention, potassium loss, hypokalemic alkalosis; fluid retention; congestive hear failure insusceptible 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; suppressant 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 adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness; decreased carbohydrate tolerance, manifestations of latent diabetes mellitus, increase 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.

Other:
anaphylactoid or hypersensitıvity and hypotensive or shock-like reactions. The following adverse reaction has been identified during post-approval use, or have been cited in medical literature (unknown frequency) and is considered possible with corticosteroid use: blurred vision.

Disclaimer: Full prescribing information is available upon request.