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TARO-LORATADINE is a brand name for Loratadine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Adverse Drug Reaction Overview Adverse experiences reported with loratadine in adults during clinical trials were mild and consisted of fatigue, headache, dry mouth, sedation, gastrointestinal disorders such as nausea, gastritis, and also allergic symptoms like rash.
Nervousness and hyperkinesia were among the reported adverse experiences in pediatric patients. Gastrointestinal adverse reactions reported during pediatric trials may have been slightly more frequent in the younger patients (less than or equal to 30 kg).
During the marketing of loratadine, alopecia, anaphylaxis, abnormal hepatic function, dizziness, palpitations and tachycardia have been reported rarely. Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Table 1 - Loratadine Tablets, 10 mg Once Daily vs. Placebo and Comparatives Number (%) of Adult Patients Reporting Frequently Occurring (>2% of loratadine treated patients) Adverse Experiences in Adults Possibly or Probably Related to Treatment: Patients Treated with Loratadine, Placebo and Comparatives Adverse Experience Loratadine 10 mg OD Placebo Clemastine 1 mg BID Terfenadine 60 mg BID Astemizole 10 mg OD n = 1241 n = 1652 n = 687 n = 506 n = 342 Fatigue 54 (4) 62 (4) 62 (9) 17 (3) 22 (6) Headache 97 (8) 104 (6) 32 (5) 40 (8) 26 (7) Dry Mouth 49 (4) 32 (2) 22 (3) 15 (3) 2 (1) Dryness in nose 9(<1) - 6(<1) 3(<1) - Sedation* 99 (8) 101 (6) 151 (22) 41 (8) 50 (15) *Reported as somnolence, sleepiness, drowsiness, lethargy, slow or "drugged feeling".
Adverse experience reported with loratadine tablets in adults during the clinical trials were mild and consisted of fatigue, headache, dry mouth, sedation, gastrointestinal disorders such as nausea, gastritis, and also allergic symptoms like rash.
01) from clemastine. Less Common Clinical Trial Adverse Drug Reactions (<1%) In addition to those listed in Table 1, the following were reported less frequently (less than 1%): appetite increased, coughing, dizziness and palpitations.
Patients who are hypersensitive to this drug, including its metabolite, Descarboethoxy- loratadine or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph.
WARNINGS AND PRECAUTIONS Hepatic/Biliary/Pancreatic In patients with chronic alcoholic liver disease, the AUC and peak plasma levels (Cmax) of loratadine were double while the pharmacokinetic profile of the active metabolite was not significantly changed from that in patients with normal liver function.
The elimination half-lives for loratadine and its active metabolite were 24 hours and 37 hours, respectively, and increased with increasing severity of liver disease. Dosing adjustment is therefore recommended in patients with severe liver disease.
Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine. (See DOSAGE AND ADMINISTRATION, Dosing Considerations). Renal In patients with chronic renal impairment, both the AUC and peak plasma levels (Cmax) increased for loratadine and its metabolite as compared to the AUCs and peak plasma levels (Cmax) of patients with normal renal function.
The mean elimination half-lives of loratadine and its metabolite were not significantly different from that observed in normal subjects. Haemodialysis does not have an effect on the pharmacokinetics of loratadine or its active metabolite in subjects with chronic renal impairment.
Therefore, no dosage adjustments are required in patients with renal insufficiency. In the case of severe renal insufficiency, loratadine should be used with caution.
Special Populations Pregnant Women:
The safe use of loratadine during pregnancy has not been established and is therefore not recommended.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Abnormal Hematologic and Clinical Chemistry Findings Not applicable. Post-Market Adverse Drug Reactions During the marketing of loratadine, in addition to the adverse events reported during clinical trials, alopecia, anaphylaxis (including angioedema), abnormal hepatic function, dizziness, palpitations and tachycardia have been reported rarely.
Convulsions and seizures have been reported very rarely. DRUG INTERACTIONS Overview When administered concomitantly with alcohol, loratadine has no potentiating effects as measured by psychomotor performance studies (see DETAILED PHARMACOLOGY/Human Pharmacology).
Drug-Drug Interactions Increases in plasma concentrations of loratadine have 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 coadministered with caution until definitive interaction studies can be completed. Drug-Food Interactions See ACTION AND CLINICAL PHARMACOLOGY/Pharmacokinetics/Absorption. Drug-Herb Interactions Interactions with herbs have not been established.
Drug-Laboratory Interactions Loratadine should be discontinued approximately 48 hours prior to skin testing procedures since antihistamines may prevent or diminish otherwise positive reactions to dermal reactivity indicators. Serious Drug Interactions None to report.
Taro-Loratadine Page 7 of 22 Drug-Lifestyle Interactions Interactions with lifestyle have not been established. DOSAGE AND ADMINISTRATION Dosing Considerations Patients with severe liver impairment: an initial dose of 5 mg once daily or 10 mg every other day is recommended for adults and children weighing more than 30kg, and for children weighing 30 kg or less, 5 mg is recommended every other day.
No dosage adjustments are required in patients with renal insufficiency (See WARNINGS AND PRECAUTIONS, Renal). Recommended Dose and Dosage Adjustment Adults and Children 12 years of age and over: One TARO-LORATADINE tablet, 10 mg, once daily.
OVERDOSAGE Somnolence, tachycardia and headache have been reported with overdoses of the conventional loratadine formulation. A single acute ingestion of 160 mg produced no adverse effects. In the event of overdosage, treatment, which should be started immediately, is symptomatic and supportive.
Consider standard measures to remove any unabsorbed drug in the stomach, such as adsorption by activated charcoal administered as a slurry with water. The administration of gastric lavage should be considered. 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 removed by peritoneal dialysis. For management of a suspected drug overdose, contact your regional Poison Control Centre. Taro-Loratadine Page 8 of
Nursing Women:
The safe use of loratadine during lactation has not been established and is therefore not recommended (see DETAILED PHARMACOLOGY/Human Pharmacology for information on secretion into breast milk).
Pediatrics (2 - 12 years of age):
The safety and efficacy of loratadine in children younger than 2 years of age have not been established. Long-term safety and efficacy of loratadine in children between the ages of 2 and 12 has not been demonstrated. Therefore, it is desirable that loratadine not be administered to children between the ages of 2 and 12 for longer than 14 days, unless recommended by a physician.
Taro-Loratadine Page 5 of 22 ADVERSE REACTIONS Adverse Drug Reaction Overview Adverse experiences reported with loratadine in adults during clinical trials were mild and consisted of fatigue, headache, dry mouth, sedation, gastrointestinal disorders such as nausea, gastritis, and also allergic symptoms like rash.
Nervousness and hyperkinesia were among the reported adverse experiences in pediatric patients. Gastrointestinal adverse reactions reported during pediatric trials may have been slightly more frequent in the younger patients (less than or equal to 30 kg).
During the marketing of loratadine, alopecia, anaphylaxis, abnormal hepatic function, dizziness, palpitations and tachycardia have been reported rarely. Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Table 1 - Loratadine Tablets, 10 mg Once Daily vs. Placebo and Comparatives Number (%) of Adult Patients Reporting Frequently Occurring (>2% of loratadine treated patients) Adverse Experiences in Adults Possibly or Probably Related to Treatment: Patients Treated with Loratadine, Placebo and Comparatives Adverse Experience Loratadine 10 mg OD Placebo Clemastine 1 mg BID Terfenadine 60 mg BID Astemizole 10 mg OD n = 1241 n = 1652 n = 687 n = 506 n = 342 Fatigue 54 (4) 62 (4) 62 (9) 17 (3) 22 (6) Headache 97 (8) 104 (6) 32 (5) 40 (8) 26 (7) Dry Mouth 49 (4) 32 (2) 22 (3) 15 (3) 2 (1) Dryness in nose 9(<1) - 6(<1) 3(<1) - Sedation* 99 (8) 101 (6) 151 (22) 41 (8) 50 (15) *Reported as somnolence, sleepiness, drowsiness, lethargy, slow or "drugged feeling".
Adverse experience reported with loratadine tablets in adults during the clinical trials were mild and consisted of fatigue, headache, dry mouth, sedation, gastrointestinal disorders such as nausea, gastritis, and also allergic symptoms like rash.
01) from clemastine. Less Common Clinical Trial Adverse Drug Reactions (<1%) In addition to those listed in Table 1, the following were reported less frequently (less than 1%): appetite increased, coughing, dizziness and palpitations.
Abnormal Hematologic and Clinical Chemistry Findings Not applicable. Post-Market Adverse Drug Reactions During the marketing of loratadine, in addition to the adverse events reported during clinical trials, alopecia, anaphylaxis (including angioedema), abnormal hepatic function, dizziness, palpitations and tachycardia have been reported rarely.
Convulsions and seizures have been reported very rarely. DRUG INTERACTIONS Overview When administered concomitantly with alcohol, loratadine has no potentiating effects as measured by psychomotor performance studies (see DETAILED PHARMACOLOGY/Human Pharmacology).
Drug-Drug Interactions Increases in plasma concentrations of loratadine have 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 coadministered with […]