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Claricort Full Prescribing Information, Dosage & Side Effects | MIMS Philippines - |
Loratadine-betamethasone: uses & side-effects | PatientsLikeMe.
Manufacturer: Bayer. Distributor: Zuellig. Full Prescribing Info. Each tablet contains betamethasone mcg and loratadine 5 mg. 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 H 1 -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. 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.
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. Symptoms: Somnolence, tachycardia and headache have been reported with overdoses.
A single acute ingestion of 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 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.
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 childrenglaucoma 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. 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.
Corticosteroids may alter the motility and number of spermatozoa in some patients. 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.
Safe use of Claricort during pregnancy has not been established; therefore, use only if potential benefit justifies potential risk to fetus. 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.
What is loratadine betamethasone -
What is loratadine betamethasone.
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. Symptoms: Somnolence, tachycardia and headache have been reported with overdoses. A single acute ingestion of 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 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.
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.
Avoid excessive usage of cream in children Consult your doctor about the intended route of administration of this drug Cream is for external use only Do not drive or operate machinery Do not take this drug at least 48 hours before skin tests Do not use cream across large areas of the body Do not use the cream on your face for more than 5 days Have severe liver impairment or rare hereditary problems of sugar intolerance.
This may increase your risk for side-effects or cause your drug not to work properly. Tell your doctor about all the drugs, vitamins, and herbal supplements you are using, so that you doctor can help you prevent or manage drug interactions. Breastfeeding Children below the age of 2 years Hypersensitivity Idiopathic thrombocytopenic purpura Pregnant.
Loratadine: No Betamethasone: Please consult with your doctor for case-specific recommendations. Loratadine: No Betamethasone: Please discuss the risks and benefits with your doctor.
One should not drive a vehicle if using the medicine makes you drowsy, dizzy or lowers your blood-pressure extensively. Pharmacists also advise patients not to drink alcohol with medicines as alcohol intensifies drowsiness side-effects. Always consult with your doctor for recommendations specific to your body and health conditions.
Most medicines don't come with a potential for addiction or abuse. Usually, the government's categorizes medicines that can be addictive as controlled substances. Please consult the product package to make sure that the medicine does not belong to such special categorizations of medicines. Lastly, do not self-medicate and increase your body's dependence to medicines without the advice of a doctor.
Can i stop using this product immediately or do I have to slowly wean off the use? The aim of this study was to investigate the effect of low-dose oral betamethasone alone and in combination with loratadine in a group of patients with allergic rhinitis with clinically significant obstruction.
Methods: In this parallel, double-blind, active controlled multicentre study, patients with severe allergic rhinitis were randomly allocated to either betamethasone 1.
Total symptom scores, nasal obstruction, and doctor and patient perception of improvement were measured as markers of disease severity. Individual symptoms score 0 to 3 points were: Sneezing or nasal pruritus, eye reddening or pruritus, nasal congestion, wet nose or with secretion sniffing , secretion sensation at pharynx post-nasal dripping. Number of symptoms: At least three. Co-existence of acute sinusitis or some chronic condition different from asthma or atopic dermatitis.
Presence of systemic fungal infections. Conscience or behavioral disturbances. Current oral or parenteral steroid treatment. Concomitant use of Phenobarbital, rifampicin, diphenylhydantoin or ephedrine. Known hypersensitivity to any of the study pharmacological combination components. Contacts and Locations. More Information.
Clinical efficacy and safety of a combined loratadine-betamethasone oral solution in the treatment of severe pediatric perennial allergic rhinitis.
World Allergy Organ J.
Study record managers: refer to the Data Element Definitions if submitting registration or results information. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
We're building a better ClinicalTrials. Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Last Update Posted : April 21, Study Description.
This study attempts to document the therapeutic value of combining loratadine antihistamine action no sedative with anti-inflammatory effects of betamethasone at low doses, which may facilitate treatment adherence by patients whereas providing an effective and rapid perennial allergic rhinitis PAR symptoms relief.
FDA Resources. Arms and Interventions. Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Clinical diagnosis of perennial allergic rhinitis.
Patients in good general conditions, without any other relevant clinical condition except for perennial allergic rhinitis. Individual symptoms score 0 to 3 points were: Sneezing or nasal pruritus, eye reddening or pruritus, nasal congestion, wet nose or with secretion sniffingsecretion sensation at pharynx post-nasal dripping. Number of symptoms: At least three. Co-existence of acute sinusitis or some chronic condition different from asthma or atopic dermatitis.
Presence of systemic fungal infections. Conscience or behavioral disturbances. Current oral or parenteral steroid treatment. Concomitant use of Phenobarbital, rifampicin, diphenylhydantoin or ephedrine. Known hypersensitivity to any of the study pharmacological combination components. Contacts and Locations.
More Information. Clinical efficacy and safety of a combined loratadine-betamethasone oral solution in the treatment of severe pediatric perennial allergic rhinitis. World Allergy Organ J. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Drug: Loratadine Drug: Betamethasone. Phase 4. Study Type :. Interventional Clinical Trial.
Actual Enrollment :. Study Start Date :. Actual Primary Completion Date :. Actual Study Completion Date :. August 21, Key Record Dates.
Combination treatment with betamethasone mg and loratadine 10mg was significantly better in relieving symptoms of hayfever as experienced by patients. This. Combination loratadine-betamethasone in an oral solution (1 mg/ mg/1 mL) was a safe, well-tolerated, and effective initial, short-term. Combination loratadine-betamethasone in an oral solution (1 mg/ mg/1 mL) was a safe, well-tolerated, and effective initial, short-term. Loratadine is a potent long-acting tricyclic antihistamine with selective peripheral H1-receptor antagonistic activity. Glucocorticosteroids eg, betamethasone. This study attempts to document the therapeutic value of combining loratadine antihistamine action (no sedative) with anti-inflammatory effects of betamethasone. Avoid excessive usage of cream in children Consult your doctor about the intended route of administration of this drug Cream is for external use only Do not drive or operate machinery Do not take this drug at least 48 hours before skin tests Do not use cream across large areas of the body Do not use the cream on your face for more than 5 days Have severe liver impairment or rare hereditary problems of sugar intolerance. This may increase your risk for side-effects or cause your drug not to work properly. Dosage is based on your condition.This salt combination may also be used for purposes not listed in this medication guide. Report your Use ». Learn more: Uses. This is not a comprehensive list.
These side-effects are possible, but do not always occur. Some of the side-effects may be rare but serious. Consult your doctor if you observe any of the following side-effects, especially if they do not go away. If you notice other side-effects not listed above, contact your doctor for medical advice.
You may also report side-effects to your local food and drug administration authority. Report Side-effects ». Some health conditions may make you more susceptible to the side-effects of the drug. Take as directed by your doctor or follow the direction printed on the product insert. Dosage is based on your condition. Tell your doctor if your condition persists or worsens. Important counseling points are listed below.
Avoid excessive usage of cream in children Consult your doctor about the intended route of administration of this drug Cream is for external use only Do not drive or operate machinery Do not take this drug at least 48 hours before skin tests Do not use cream across large areas of the body Do not use the cream on your face for more than 5 days Have severe liver impairment or rare hereditary problems of sugar intolerance.
This may increase your risk for side-effects or cause your drug not to work properly. Tell your doctor about all the drugs, vitamins, and herbal supplements you are using, so that you doctor can help you prevent or manage drug interactions. Breastfeeding Children below the age of 2 years Hypersensitivity Idiopathic thrombocytopenic purpura Pregnant. Loratadine: No Betamethasone: Please consult with your doctor for case-specific recommendations.
Loratadine: No Betamethasone: Please discuss the risks and benefits with your doctor. One should not drive a vehicle if using the medicine makes you drowsy, dizzy or lowers your blood-pressure extensively.
Pharmacists also advise patients not to drink alcohol with medicines as alcohol intensifies drowsiness side-effects. Always consult with your doctor for recommendations specific to your body and health conditions.
Most medicines don't come with a potential for addiction or abuse. Usually, the government's categorizes medicines that can be addictive as controlled substances.
Please consult the product package to make sure that the medicine does not belong to such special categorizations of medicines. Lastly, do not self-medicate and increase your body's dependence to medicines without the advice of a doctor. Can i stop using this product immediately or do I have to slowly wean off the use? Some medicines need to be tapered or cannot be stopped immediately because of rebound effects.
Please consult with your doctor for recommendations specific to your body, health and other medications that you may be using. If it is close to the time of your next dose, skip the missed dose and resume your dosing schedule.
Do not use extra dose to make up for a missed dose. If you are regularly missing doses, consider setting an alarm or asking a family member to remind you. Please consult your doctor to discuss changes in your dosing schedule or a new schedule to make up for missed doses, if you have missed too many doses recently. Taking more medication will not improve your symptoms; rather they may cause poisoning or serious side-effects. Bring a medicine box, container, or label with you to help doctors with necessary information.
Do not give your medicines to other people even if you know that they have the same condition or it seems that they may have similar condition s.
This may lead to overdosage. Please consult your physician or pharmacist or product package for more information.
Do not freeze medicines unless required by package insert. Keep medicines away from children and pets. Do not flush medications down the toilet or pour them into drainage unless instructed to do so. Medication discarded in this manner may contaminate the environment. However, please discuss with your primary health provider or pharmacist for proper advice or if you feel unwell or sick.
Expired drug may become ineffective in treating your prescribed conditions. To be on the safe side, it is important not to use expired drugs. If you have a chronic illness that requires taking medicine constantly such as heart condition, seizures, and life-threatening allergies, you are much safer keeping in touch with your primary health care provider so that you can have a fresh supply of unexpired medications.
Dosage Information Please consult your physician or pharmacist or refer to the product package. Cite this page Page URL. Accessed October 17, Ataxia Telangiectasia. Sign Up. Continue with Email. Invite your friends to TabletWise learning marketplace. Share with Google Contacts.
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