Composition: Tablets: Each tablet contains : Loratadine 10 mg Inactive ingredients: Calcium phosphate dihydrate, lactose monohydrate, a vicel PH 102, povidone XL (crospovidone), povidone k 30, magnesium stearate, talc purified, aerosil 200 Syrup|: Each teaspoonful ( 5 ml ) contains : Loratadine 5 mg Inactive ingredients: Propylene glycol, tween 80, sucrose, citric acid monohydrate, benzoic acide, saccharine sodium, veltol plus, strawberry flavour, alcohol, purified water
Indications And Usage: Mosedin® is indicated for the relief of nasal and non-nasal symptoms of seasonal allergic rhinitis and for the treatment of chronic idiopathic urticaria in patients 2 years of age or older.
Contraindications: Mosedin® is contraindicated in patients who are hypersensitive to this medication or to any of its ingredients. 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).
Adverse Reactions: Mosedin® Tablets: Reported adverse events with an incidence of more than 2% in allergic rhinitis patients & chronic idiopathic urticaria. 12 years of age and older are: headache, somnolence ,fatigue , dry mouth Mosedin® Syrup: Adverse events in these pediatric patients were observed to occur with type and frequency similar to those seen in the adult population. The rate of premature discontinuance due to adverse events among pediatric patients receiving loratadine 10 mg daily was less than 1%. Adverse events occurring with a frequency of ≥>_ 2% in loratadine syrup-treated patients (6 to 12 years old) are: Nervousness, wheezing, fatigue, hyperkinesia , abdominal pain, conjunctivitis, dysphonia, malaise, upper respiratory tract infection In pediatric patients 2 to 5 years of age received 5 mg loratadine once daily for a period of 14 days. No unexpected adverse events were seen given the known safety profile of loratadine and likely adverse reactions for this patient population. The following adverse events occurred with a frequency of 2 to 3 percent in the loratadine syrup-treated patients (2 to 5 years old) : diarrhea, epistaxis, pharyngitis, influenza-like symptoms, fatigue, stomatitis, tooth disorder, earache, viral infection, and rash. In addition to those adverse events reported above (≥>_ 2%), the following adverse events have been reported in at least one patient in loratidine clinical trials in adult and pediatric patients: Autonomic Nervous System: altered lacrimation, altered salivation, flushing, hypoesthesia, impotence, increased sweating, thirst. Body as a Whole: angioneurotic edema, asthenia, back pain, blurred vision, chest pain, earache, eye pain, fever, leg cramps, malaise, rigors, tinnitus, weight gain. Cardiovascular System: hypertension, hypotension, palpitations, supraventricular tachyarrhythmias, syncope, tachycardia. Central and Peripheral Nervous System: blepharospasm, dizziness, dysphonia, hypertonia, migraine, paresthesia, tremor, vertigo. Gastrointestinal System: altered taste, anorexia, constipation, diarrhea, dyspepsia, flatulence, gastritis, hiccup, increased appetite, loose stools, nausea, vomiting. Musculoskeletal System: arthralgia, myalgia. Psychiatric: agitation, amnesia, anxiety, confusion, decreased libido, depression, impaired concentration, insomnia, irritability, paroniria. Reproductive System: breast pain, dysmenorrhea, menorrhagia, vaginitis. Respiratory System: bronchitis, bronchospasm, coughing, dyspnea, hemoptysis, laryngitis, nasal dryness, sinusitis, sneezing. Skin and Appendages: dermatitis, dry hair, dry skin, photosensitivity reaction, pruritus, purpura, urticaria. Urinary System: altered micturition, urinary discoloration, urinary incontinence, urinary retention. In addition, the following spontaneous adverse events have been reported rarely during the marketing of loratadine: abnormal hepatic function, including jaundice, hepatitis, and hepatic necrosis; alopecia; anaphylaxis; breast enlargement; erythema multiforme; peripheral edema; thrombocytopenia; and seizures.
Dosage & Administration: Adults and children 6 years of age and over: The recommended dose of Mosedin® 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 Mosedin® 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. Never to be used for children less than 2 years In case of children less than 6 years, it should be prescribed by the physician
Drug Interactions: Loratadine (10 mg once daily) has been coadministered with therapeutic doses of erythromycin, cimetidine, and ketoconazole in controlled clinical pharmacology studies in adult volunteers. Although increased plasma concentrations (AUC 0-24 hrs) of loratadine and/or descarboethoxyloratadine were observed following coadministration of loratadine with each of these drugs in normal volunteers, there were no clinically relevant changes in the safety profile of loratadine, as assessed by electrocardiographic parameters, clinical laboratory tests, vital signs, and adverse events. There were no significant effects on QTc intervals, and no reports of sedation or syncope. No effects on plasma concentrations of cimetidine or ketoconazole were observed. Plasma concentrations (AUC 0-24 hrs) of erythromycin decreased 15% with coadministration of loratadine relative to that observed with erythromycin alone. The clinical relevance of this difference is unknown. There does not appear to be an increase in adverse events in subjects who received oral contraceptives and loratadine. Pregnancy Category B: Mosedin® should be used during pregnancy only if clearly needed. Nursing Mothers: Loratadine and its metabolite, descarboethoxyloratadine, pass easily into breast milk and achieve concentrations that are equivalent to plasma levels with an AUCmilk/AUCplasma ratio of 1.17 and 0.85 for loratadine and descarboethoxyloratadine, respectively. 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 Mosedin® is administered to a nursing woman. Pediatric Use: The safety of Mosedin® Syrup at a daily dose of 10 mg has been demonstrated in pediatric patients 6 to 12 years of age. The safety and tolerability of Mosedine® Syrup at a daily dose of 5 mg has been demonstrated in pediatric patients 2 to 5 years of age . The effectiveness of Mosedin® for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria in children aged 2 to 12 years is based on an extrapolation of the demonstrated efficacy of Mosedin® in adults in these conditions and the likelihood that the disease course, pathophysiology, and the drug’s effect are substantially similar to that of the adults. The recommended dose for the pediatric population is based on cross-study comparison of the pharmacokinetics of Mosedin® in adults and pediatric subjects and on the safety profile of loratadine in both adults and pediatric patients at doses equal to or higher than the recommended doses. The safety and effectiveness of Mosedin® in children under 2 years of age have not been established.
How Supplied: Tablets: Carton box containing 1, 2, 3 strips each of 10 tablets. Syrup: Bottles of 60 ml with graduated spoon.
Clinical Pharmacology In Adults: Loratadine is a long-acting tricyclic antihistamine with selective peripheral histamine H1-receptor antagonistic activity. Mosedin® 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 Mosedin®. Neither loratadine nor its metabolites readily cross the bloodbrain barrier. Mosedin® has preferential binding to peripheral versus central nervous system H1-receptors.
Pharmacokinetics: Absorption: Loratadine was rapidly absorbed following oral administration with maximum concentration (Tmax) of 1.3 hours for loratadine and 2.5 hours for its major active metabolite, descarboethoxyloratadine. The pharmacokinetics of loratadine and descarboethoxyloratadine are independent of dose over the dose range of 10 mg to 40 mg and are not altered by the duration of treatment. 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. In nearly all patients, exposure (AUC) to the metabolite is greater than to the parent loratadine. The mean elimination half-lives in normal adult subjects were 8.4 hours (range = 3 to 20 hours) for loratadine and 28 hours (range = 8.8 to 92 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: In healthy geriatric subjects (66 to 78 years old), the AUC and peak plasma levels (Cmax) of both loratadine and descarboethoxyloratadine were approximately 50% greater than those observed in studies of younger subjects. The mean elimination half-lives for the geriatric subjects were 18.2 hours (range = 6.7 to 37 hours) for loratadine and 17.5 hours (range = 11 to 38 hours) for descarboethoxyloratadine. Renal Impairment: In subjects with chronic renal impairment (creatinine clearance _ 80 mL/min). 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: In patients with chronic alcoholic liver disease, the AUC and Cmax of loratadine were double while the pharmacokinetic profile of descarboethoxyloratadine was not substantially different from that observed in other trials enrolling normal subjects. The elimination half-lives for loratadine and descarboethoxyloratadine were 24 hours and 37 hours, respectively, and increased with increasing severity of liver disease.
Storage: Store at temperature not exceeding 30 ˚