Lorinose

Oval, rounded white tablet. One side has incision. Another side has the letter "L".
Each tablet contains Loratadine 10 mg.

Pharmacology: Pharmacodynamics: Mechanism of action: Long-acting tricyclic antihistamine with selective peripheral histamine H1-receptor antagonistic properties and has been referred to as a relatively "nonsedating" or second generation antihistamine.
Pharmacokinetics: Onset of action: 1-3 hours.
Peak effect: 8-12 hours.
Duration: >24 hours.
Absorption: Rapid; food increase total bioavailability (AUC) by 40% to 48%.
Distribution: V_d 119 L/kg; binds preferentially to peripheral nervous system H₁ receptors; no appreciable entry into CNS.
Protein binding: 97% to 99% (loratadine), 73% to 76% (metabolite).
Metabolism: Extensively hepatic via CYP2D6 and 3A4 to active metabolite (descarboethoxyloratadine).
Half-life elimination: 8.4 hours (range: 3 to 20 hours) (loratadine), 28 hours (range: 8.8 to 92 hours) (metabolite); hepatic impairment: 24 hours (loratadine), 37 hours (metabolite).
Time to peak, serum: Loratadine: 1.3 hours (loratadine), 2.3 hours (metabolite).
Excretion: Urine (40%) and feces (40%) as metabolites.

LORINOSE is 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.
LORINOSE is also indicated for relief of symptoms and signs of chronic urticaria and other allergic dermatologic disorders.
For allergy, not for common cold.

Recommended Dose: Adults and children 12 years of age and over: 1 tablet (10 mg) once daily.
Mode of Administration: LORINOSE is administered orally and can be administered without regard to meals.

Overdose and Treatment: In adults, drowsiness, tachycardia, and headache have been reported after overdoses (e.g., 40-180 mg) of loratadine tablets. In children, extrapyramidal manifestations and palpitations have been reported with overdoses (exceeding 10 mg) of loratadine syrup.
Treatment of loratadine overdosage generally involves symptomatic and supportive care, initiated promptly and maintained as long as necessary. In acute loratadine overdosage, the stomach should be emptied immediately by inducing emesis with ipecac syrup. Administration of activated charcoal after emesis may be useful in preventing absorption of loratadine. If induction of vomiting is unsuccessful or contraindicated (e.g., the patient is comatose, having seizure, or lacks the gag reflex), gastric lavage with a 0.9% sodium chloride solution may be performed if an endotracheal tube with cuff inflated is in place to prevent aspiration of gastric contents. Saline cathartics may be value to rapidly dilute bowel contents. Loratadine is not removed by hemodialysis. It is not known if loratadine is removed by peritoneal dialysis.

LORINOSE is contraindicated in patients who are hypersensitive to the drug or any ingredient in its formulation.

LORINOSE should be used cautiously in patients with hepatic impairment or renal insufficiency, including geriatric patients, have decreased clearance of the drug, and should be given a lower initial dose of loratadine. In adults and children 6 years of age and older with renal impairment (a glomerular filtration rate less than 30 mL/minute) or hepatic failure should be initiated at a dosage of 10 mg every other day.

Pregnancy: Loratadine may be used when a second generation antihistamine is needed. The lowest effective dose should be used.
Lactation: Loratadine and its active metabolite, desloratadine, are present in breast milk. If a breastfed infant is exposed to a second generation antihistamine via breast milk, they should be monitored for irritability, jitteriness, or drowsiness.

Central nervous system: Drowsiness (adults), fatigue (adults), headache (adults), nervousness (children), sedated state (adults).
Dermatologic: Skin rash (adults).
Gastrointestinal: Abdominal pain (children), diarrhea (children), gastritis (adults), nausea (adults), vomiting (children), xerostomia (adults).
Hypersensitivity: Hypersensitivity reaction (adults).
Neuromuscular & skeletal: Hyperkinetic muscle activity (children).
Rare but important or life-threatening: Alopecia, anaphylaxis, cough, dizziness, dry nose, hepatic insufficiency, increased appetite, palpitations, seizure, tachycardia.

Metabolism/Transport Effects: Substrate of CYP2D6 (minor), CYP3A4 (minor), P-glycoprotein/ABCB1.
Avoid Concomitant Use: Avoid concomitant use of Loratadine with any of the following: Aclidinium; Azelastine (Nasal); Bromperidol; Cimetropium; Eluxadoline; Glycopyrrolate (Oral Inhalation); Glycopyrronium (Topical); Ipratropium (Oral Inhalation); Lasmiditan; Levosulpiride; Orphenadrine; Oxatomide; Oxomemazine; Paraldehyde; Pitolisant; Potassium chloride; Potassium citrate; Revefenacin; Thalidomide; Tiotropium; Umeclidinium.
Increased Effect/Toxicity: Loratadine may increase the levels/effects of: Alcohol (Ethyl); Amezinium; Anticholinergic Agents; Azelastine (Nasal); Blonanserin; Brexanolone; Buprenorphine; Cimetropium; CNS Depressants; Eluxadoline; Flunitrazepam; Glucagon; Glycopyrrolate (Oral Inhalation); Hydrocodone; Methotrimeprazine; Metyrosine; Mirabegron; Opioid Agonists; Orphenadrine; Oxycodone; Paraldehyde; Piribedil; Potassium Chloride; Potassium citrate; Pramipexole; Ramosetron; Revefenacin; Ropinirole; Rotigotine; Selective Serotonin Reuptake Inhibitors; Suvorexant; Thalidomide; Thiazide and Thiazide-Like Diuretics; Tiotropium; Topiramate; Zolpidem.
The levels/effects of Loratadine may be increased by: Aclidinium; Alizapride; Amantadine; Amiodarone; Botulinum Toxin-Containing Products; Brimonidine (Topical); Bromopride; Bromperidol; Cannabidiol; Cannabis; Chloral Betaine; Chlormethiazole; Chlorphenesin Carbamate; Dimethindene (Topical); Doxylamine; Dronabinol; Droperidol; Erdafitinib; Esketamine; Glycopyrronium (Topical); Hydroxyzine; Ipratopium (Oral Inhalation); Kava Kava; Lasmiditan; Lemborexant; Lofexidine; Lumacaftor; Magnesium sulfate; Methotrimeprazine; Mianserin; Minocycline (Systemic); Nabilone; Oxatomide; Oxomemazine; Perampanel; P-glycoprotein/ABCB1 Inhibitors; Pramlintide; Ranolazine; Rufinamide; Sodium oxybate; Tapentadol; Tetrahydrocannabinol; Tetrahydrocannabinol and Cannabidiol; Trimeprazine; Umeclidinium.
Decreased Effect: Loratadine may decrease the levels/effects of: Acetylcholinesterase Inhibitors; Benzylpenicilloyl Polylysine; Betahistine; Gastrointestinal Agents (Prokinetic); Hyaluronidase; Itopride; Levosulpiride; Nitroglycerin; Pitolisant; Secretin.
The levels/effects of Loratadine may be decreased by: Acetylcholinesterase Inhibitors; Amphetamines; Lumacaftor; P-glycoprotein/ABCB1 Inducers.

Stored at a temperature below 30°C.

Antihistamines & Antiallergics

R06AX13 - loratadine ; Belongs to the class of other antihistamines for systemic use.

NDD