Genovate Biotechnology


Hong Wo
Full Prescribing Info
Each Genadine Tablet contains 10 mg micronized loratadine.
Chemical group: Piperidine derivative.
Pharmacology: Loratadine is a long-acting, non-sedating antihistamine with no significant sedative on antimuscarinic activity. It has a selective peripheral H1-receptor antagonistic activity.
Other actions/effects: No significant anticholinergic activity. Mild bronchodilator.
Genadine Tablets are indicated for the relief of symptoms associated with allergic rhinitis, such as sneezing, nasal discharge (rhinorrhea) and itching, as well as ocular itching and burning.
Dosage/Direction for Use
Usual adult and adolescent dose: Oral, 10 mg once a day.
Usual pediatric dose: Children 2 to 5 years of age: Oral, 5 mg once a day.
Children 6 to 12 years of age: Oral, 10 mg once a day.
Usual geriatric dose: See Usual adult and adolescent dose as previously mentioned.
Note: Geriatric patients may be more sensitive to the effects of the usual adult dose.
To date, overdosage has not occurred with loratadine. 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 milliliters of water. If emesis does not occur within 15 minutes, 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 installation. 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.
Genadine Tablets are contraindicated in patients who have shown hypersensitivity or idiosyncrasy to their components.
Special Precautions
Caution: It is dangerous to exceed the stated dose.
Use in Children: Safety and efficacy of Genadine Tablets in children younger than two years of age have not yet been established.
Use In Pregnancy & Lactation
Safe use of Genadine Tablets during pregnancy has not been established; therefore, use only if potential benefit justifies 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.
Adverse Reactions
Anticholinergic effects not likely; dose related sedation.
Drug Interactions
When administered concomitantly with alcohol, loratadine has no potentiating effects as measured by psychomotor performance studies.
Drug/Laboratory Test Interactions: Genadine Tablet should be discontinued approximately 48 hours prior to skin testing procedures since antihistamines may prevent or diminish otherwise positive reactions to dermal reactivity indicators.
Stored at room temperature below 25°C.
ATC Classification
R06AX13 - loratadine ; Belongs to the class of other antihistamines for systemic use.
Tab 10 mg x 10's, 3 x 10's, 1,000's.
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