Community Pharm PCL


Community Pharm PCL
Full Prescribing Info
Each tablet contains Loratadine (micronized) 10 mg.
Loratadine is a potent long-active tricyclic antihistamine with selective peripheral H1-receptor antagonistic activity.
For the relief of symptoms associated with allergic rhinitis, such as sneezing, nasal discharge (rhinorrhea) and itching, as well as ocular itching and burning. Nasal and ocular signs and symptoms are relieved rapidly after oral administration. For relief of symptoms and signs of chronic urticaria and other allergic dermatologic disorders.
Dosage/Direction for Use
Adults and Children 12 years of age and over: 1 tablet (10 mg) once daily.
Children 2 to 12 years of age: Body Weight >30 kg: 1 tablet (10 mg) once daily.
Body Weight ≤30 kg: ½ tablet (5 mg) once daily.
Somnolence, tachycardia and headache have been reported with overdoses. 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.
Treatment: The patient should be induced to vomit, even if emesis has occurred spontaneously. Pharmacologically-induced vomiting by the administration of ipecac syrup 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 to 360 ml of water. If emesis dose not occur within 15 minutes, the dose of ipecac should be repeated. Precautions against aspiration must be token, 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 nest 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. After emergency treatment, the patient should continue to be medically monitored.
Hypersensitivity to an ingredient of the product.
Special Precautions
Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine; an initial dose of 5 mg once daily, or 10 mg every other day is recommended. Efficacy of Carinose tablet has not been established in children younger than 2 years of age. However, the pharmacokinetic profile of loratadine in children 1 to 2 years of age after the administration of a single 2.5 mg dose of loratadine is similar to that In older children and adults, therefore. use only if the potential benefit justifies the potential risk.
Use In Pregnancy & Lactation
Products during pregnancy has not been established; therefore, use only if the potential benefit justifies the 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.
Side Effects
Has no clinically significant sedative properties at the daily recommended dose of 10 mg.
Most commonly reported side effects include fatigue, headache, somnolence, dry mouth, gastrointestinal disorders such as nausea, gastritis and also allergic symptoms like rash.
Drug Interactions
Loratadine has no potentiating effects of alcohol as measured by psychomotor performance studies. Increase 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/Laboratory Test Interactions: Products should be discontinued approximately 48 hours prior to skin testing procedures since antihistamines may prevent or diminish otherwise positive reactions to dermal reactivity indicators.
Store at room temperature (23-32°C).
ATC Classification
R06AX13 - loratadine ; Belongs to the class of other antihistamines for systemic use.
Tab 10 mg x 10 x 10's, 50 x 10's.
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