Each 5ml Lorin-NSA syrup contains 5mg of loratadine.
The plasma concentration profile of descarboethoxyloratadine for the tablet and syrup is comparable. Food increases the systemic bioavailability (AUC) of loratadine and descarboethoxyloratadine by approximately 40% and 15%, respectively. The time to peak plasma concentration (Tmax) of loratadine and descarboethoxyloratadine was delayed by 1 hour. Peak plasma concentrations (Cmax) were not affected by food.
Metabolism: Loratadine is metabolized to descarboethoxyloratadine predominantly by cytochrome P450 3A4 (CYP3A4) and, to a lesser extent, by cytochrome P450 2D6 (CYP2D6). In the presence of a CYP3A4 inhibitor ketoconazole, loratadine is metabolized to descarboethoxyloratadine predominantly by CYP2D6. Concurrent administration of loratadine with either ketoconazole, erythromycin (both CYP3A4 inhibitors), or cimetidine (CYP2D6 and CYP3A4 inhibitor) to healthy volunteers was associated with substantially increased plasma concentrations of loratadine.
Elimination: Approximately 80% of the total loratadine dose administered can be found equally distributed between urine and feces in the form of metabolic products within 10 days. The mean elimination half-life is 8.4 hours for loratadine and 28 hours for descarboethoxyloratadine. Loratadine and descarboethoxyloratadine reached steady state in most patients by approximately the fifth dosing day.
Pediatric: The pharmacokinetic profile of loratadine in children in the 6 to 12 year age group is similar to that of adults. The pharmacokinetic profile of loratadine in children in the 2 to 5-year age group is similar to that of adults.
Geriatric: The mean elimination half-lives for the geriatric subjects were 18.2 hours for loratadine and 17.5 hours for descarboethoxyloratadine.
Renal Impairment: The mean elimination half-lives of loratadine (7.6 hours) and descarboethoxyloratadine (23.9 hours) were not substantially different from that observed in normal subjects. Hemodialysis does not have an effect on the pharmacokinetics of loratadine or descarboethoxyloratadine in subjects with chronic renal impairment.
Hepatic Impairment: The elimination half-lives for loratadine and descarboethoxyloratadine were 24 hours and 37 hours, respectively, and increased with increasing severity of liver disease.
Syrup: For the relief of symptoms associated with seasonal allergic rhinitis, such as sneezing, nasal discharge and itching, and ocular itching and burning, and for the relief of symptoms and signs of chronic urticaria and other allergic dermatologic disorders.
Children 2 to 5 years of age: The recommended dose of Lorin-NSA Syrup is 5 mg (1 teaspoonful) once daily.
In adults and children 6 years of age and over with liver failure or renal insufficiency (GFR < 30 mL/min):
The starting dose should be 10 mg (one tablet or two teaspoonfuls) every other day. In children 2 to 5 years of age with liver failure or renal insufficiency, the starting dose should be 5 mg (one teaspoonful) every other day.
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: 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.
- Patients with liver impairment or renal insufficiency (GFR < 30 ml/min) should be given a lower initial dose (10 mg every other day).
- Lorin-NSA lacks significant sedative effects. Patients should however be warned that a small number of individuals may experience sedation. Patients experiencing sedation or impaired concentration should be advised not to drive or perform complicated tasks. Sedation may be enhanced by the simultaneous intake of alcohol or other central nervous system depressants.
Nursing Mothers: Loratadine and its metabolite, descarboethoxyloratadine, pass easily into breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Caution should be exercised when Lorin-NSA is administered to a nursing woman.
Pediatric Use: The safety of Lorin-NSA Syrup at a daily dose of 10 mg has been demonstrated in 188 pediatric patients 6 to 12 years of age. The safety and tolerability of Lorin-NSA Syrup at a daily dose of 5 mg has been demonstrated in 60 pediatric patients 2 to 5 years of age. The safety and effectiveness of Lorin-NSA in children under 2 years of age have not been established.
Loratadine may also be used for purposes not listed in this medication guide.
Contact your doctor at once if you have a serious side effect such as:
- Fast or uneven heart rate;
- Feeling like you might pass out;
- Jaundice (yellowing of your skin or eyes); or
- Seizures (convulsions).
- Feeling tired or drowsy;
- Stomach pain, diarrhea;
- Dry mouth, sore throat hoarseness;
- Eye redness, blurred vision;
- Nosebleed; or
- Skin rash.
Store at room temperature away from moisture and heat.
Overdose symptoms may include headache, drowsiness, and fast or pounding heartbeat.