CLARITIN LIQUID is a brand name for Loratadine, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE................................................................................. 3 CONTRAINDICATIONS ...................................................................................................... 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations Patients with severe liver impairment: a dose of 10 mg every other day is recommended. 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 CLARITIN LIQUID CAPSULE, 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. ACTION AND CLINICAL PHARMACOLOGY Mechanis m of Action Loratadine is a long-acting tricyclic antihistamine with selective peripheral H1 receptor antagonistic activity.
It exhibits a dose-related inhibition of the histamine-induced skin wheal and flare response in humans which is rapid in onset, is apparent at two hours and persists throughout the 24 hour observation period. Single oral doses up to 160 mg and repeat daily doses of 40 mg for up to 13 weeks were well tolerated with the incidence of sedation and dry mouth being no different from placebo.
Loratadine is well absorbed by all species studied and is almost totally metabolized (See DETAILED PHARMACOLOGY / Pharmacokinetics and Metabolism). Pharmacodynamics Loratadine has a lower affinity for central receptors than for peripheral receptors, and it does not readily penetrate into the brain tissue.
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(See DETAILED PHARMACOLOGY / Animal Pharmacology).
CLARITIN LIQUID CAPSULES Page 8 of 22 Wheal and Flare:
The antihistaminic activity and dose-response profile of loratadine were evaluated in three clinical pharmacologic studies using a histamine-induced skin wheal suppression model in healthy male volunteers. All doses were significantly more effective than placebo in suppressing the formation of histamine- induced skin wheals (See DETAILED PHARMACOLOGY / Human Pharmacology).
Alcohol:
The ability of healthy male volunteers to concentrate was not impaired by loratadine in combination with alcohol. Loratadine did not potentiate the effects of alcohol on driving performance (See DETAILED PHARMACOLOGY / Human Pharmacology).
3 hours for the 10, 20 and 40 mg dose, respectively. 0 hours. 0 hours after a dose of 10, 20 and 40 mg, respectively. Its T -1/2 ranged from 17 to 24 hours. The accumulation indices, calculated by Cmax and the area under the curve (AUC) ratios did not change after the 5th day, indicating little or no accumulation of either loratadine or its metabolite after a multiple once per day dosage regimen.
7 hours, respectively, similar to that reported following a single oral dose.
Excretion:
Approximately 82% of the 14C-loratadine dose is excreted in the urine (40%) and faeces (42%) over a 10-day period. Approximately 27% of the dose, eliminated during the first 24 hours is present only in trace quantities in the urine.
6% of the administered loratadine dose.
Special Populations and Conditions Geriatrics:
The pharmacokinetic parameters of loratadine and its major metabolite are comparable in healthy adult volunteers and healthy geriatric volunteers. (See DETAILED PHARMACOLOGY / Pharmacokinetics and Metabolism) STORAGE AND STABILITY Temperature and Moisture Store at room temperature 15° to 30°C.
Protect from exposure to excessive moisture. Others Keep in a safe place out of reach of children. SPECIAL HANDLING INSTRUCTIONS None CLARITIN LIQUID CAPSULES Page 9 of