Lorin-NSA | loratadine

Composition
Each Lorin-NSA 10mg tablet contains 10mg of loratadine. Each 5ml Lorin-NSA syrup contains 5mg of loratadine.
Mode of Action
Loratadine is a long-acting tricyclic antihistamine with selective peripheral histamine H1-receptor antagonistic activity. Human histamine skin wheal studies following single and repeated 10 mg oral doses of Lorin-NSA have shown that the drug exhibits an antihistaminic effect beginning within 1 to 3 hours, reaching a maximum at 8 to 12 hours, and lasting in excess of 24 hours. There was no evidence of tolerance to this effect after 28 days of dosing with Lorin-NSA. It does not readily cross the blood brain barrier.
Pharmacokinetics
Absorption: Loratadine was rapidly absorbed following oral administration of 10 mg tablets, with times to maximum concentration (Tmax) of 1.3 hours for loratadine and 2.5 hours for its major active metabolite, descarboethoxyloratadine. 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. Special Populations: 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.
Indications
Tablets: For the relief of symptoms associated with seasonal and perennial 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. 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.
Dosage & Administration
Adults and children 6 years of age and over: The recommended dose of Lorin-NSA is one 10 mg tablet or 2 teaspoonfuls (10 mg) of syrup once daily. 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.
Side Effects
The most commonly reported side-effects are fatigue, dry mouth, allergic symptoms like rash, headache, gastrointestinal disturbances (eg. gastric upsets/nausea) and somnolence. The more uncommon side-effects include alopecia, anaphylaxis and an abnormal hepatic functioning. Less frequent incidences of abnormal hepatic function including hepatitis, jaundice and hepatic necrosis have been reported.
Drug Interactions
When administered concomitantly with alcohol, loratadine has no potentiating effects 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: 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.
Precautions
General: 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. Pregnancy Category B: There was no evidence of animal teratogenicity. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Lorin-NSA should be used during pregnancy only if clearly needed. 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.
Overdose
In adults, somnolence, tachycardia, and headache have been reported with overdoses greater than 10 mg with the tablet formulation (40 mg-180 mg). Extrapyramidal signs and palpitations have been reported in children with overdoses of greater than 10 mg of Lorin-NSA Syrup. In the event of overdosage, general symptomatic and supportive measures should be instituted promptly and maintained for as long as necessary. Treatment of overdosage would reasonably consist of emesis (ipecac syrup), except in patients with impaired consciousness, followed by the administration of activated charcoal to absorb any remaining drug. If vomiting is unsuccessful, or contraindicated, gastric lavage should be performed with normal saline. Saline cathartics may also be of value for rapid dilution of bowel contents. Loratadine is not eliminated by hemodialysis. It is not known if loratadine is eliminated by peritoneal dialysis.
Contraindications
Lorin-NSA is contraindicated in patients who are hypersensitive to this medication or to any of its ingredients.
Presentation
Lorin-NSA tablet 10mg: 1x10's/pack Lorin-NSA syrup bottle: 30ml
Issued: 30-09-2009
What is loratadine (Lorin-NSA)?
Loratadine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose. Loratadine is used to treat the symptoms of allergies, such as sneezing, watery eyes, and runny nose. It is also used to treat skin hives and itching in people with chronic skin reactions. Loratadine may also be used for other purposes not listed in this medication guide.
What are the possible side effects of loratadine?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: fast or uneven heart rate; feeling like you might pass out; jaundice (yellowing of your skin or eyes); or seizures (convulsions). Less serious side effects may include: headache; nervousness; feeling tired or drowsy; stomach pain, diarrhea; dry mouth, sore throat hoarseness; eye redness, blurred vision; nosebleed; or skin rash. This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.
What is the most important information I should know about loratadine?
You should not take this medication if you are allergic to loratadine or to desloratadine. Before taking loratadine, tell your doctor if you are allergic to any drugs, or if you have liver or kidney disease. Do not give this medication to a child younger than 6 years old without the advice of a doctor.
What should I discuss with my healthcare provider before taking loratadine?
You should not take this medication if you are allergic to loratadine or to desloratadine. Before taking loratadine, tell your doctor if you are allergic to any drugs, or if you have kidney or liver disease. If you have any of these conditions, you may need a dose adjustment or special tests to safely take loratadine. FDA pregnancy category B: This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Loratadine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I take loratadine?
Take this medication as directed on the label, or as your doctor has prescribed. Do not take the medication in larger amounts or for longer than recommended. Loratadine is usually taken once per day. Follow your doctor’s instructions. Do not crush, chew, or break loratadine tablet. Swallow the pill whole. Measure liquid form of loratadine with a special dose-measuring spoon provided with the bottle. Call your doctor if your symptoms do not improve. Store loratadine at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include headache, drowsiness, and fast or pounding heartbeat.
What should I avoid while taking loratadine?
Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using loratadine.
What other drugs will affect loratadine?
There may be other drugs that can affect loratadine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
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