Loratadine Oral Solution USP 5mg /5 ml
Loratadine Tablets USP 10mg
Loratadine is a white to off-white powder not soluble in water, but very soluble in acetone, alcohol, and chloroform. Molecular weight of 382.89(C22H23C1N2O2).
Chemical name is ethyl4-(8-chloro-5,6-dihydro-11H-benzo(5,6)cyclohepta[ I ,2-b]pyridin–11-ylidene)-1- piperidinecarboxylate.
Each uncoated tablet contains:
Loratadine USP 10mg
Each 5m1 contains:
Loratadine USP 5mg.
MODE OF ACTION
Loratadine is a long-acting tricyctic ANTIHISTAMINE with selective peripheral histamine H1-receptor antagonistic activity.
Loratadine is indicated for the relief of nasal and non nasal symptoms of seasonal allergic rhinitis and for the treatment of chronic diopathic urticaria in patients 2 years of age or older. 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 10mg (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 5mg (one teaspoonful) every other day.
DOSAGE AND ADMINISTRATION
Adults and children 6 years of age and over: Recommended dose of ATADYN 10mg tablet or 2 teaspoonfuls (10mg) of syrup once daily.
Children 2 to5years of age: Recommended dose of ATADYN Syrup is 5mg (1 teaspoonful) once daily.
Angioneurotic edema, asthenia, back pain, blurred vision, chest pain, earache, eye pain, fever, leg cramps, malaise, rigors, tinnitus, viral infection, weight gain, abnormal hepatic function, including jaundice, hepatitis, and hepatic necrosis; alopecia; anaphylaxis; breast enlargement; erythema multiforme; peripheral edema; and seizures.
ANS: Altered lacrimation, altered salivation, flushing, hypoesthesia, impotence, increased sweating, thirst.
CVS: Hypertension, hypotension, palpitations, supraventricular tachyarrhythmias, syncope, tachycardia.
CNS & PNS: Blepharospasm, dizziness, dysphonia, hypertonia, migraine, parenthesia, tremor, vertigo.
Gastrointestinal System: Altered taste, anorexia, constipation, diarrhea, dyspepsia, flatulence, gastritis, hiccup, increased appetite, nausea, stomatitis, toothache, vomiting.
Musculoskeletal Sysfem: Arthralgia, myalgia.
Psychiatric: Agitation, amnesia, anxiety, confusion, decreased libido, depression, impaired concentration, insomnia, irritability paroniria.
Reproductive System: Breast pain, dysmenorrhea, menorrhagia, vagintis.
Skis and Appendages: Dermatitis, dry hair, dry skin, photosensitivity reaction, pruritus, purpura, rash, urticaria.
Urinary System: Altered micturition, urinary discoloration, urinary incontinence, urinary retention.
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.
Patients with liver impairment or renal insufficiency (GFR <30 ml/min) should be given a lower initial dose (10mg every other day).
Loratadine should be used during pregnancy only if clearly needed.
Caution should be exercised when loratadine is administered to a nursing woman.
The safety of loratadine syrup or tablet at a daily dose of 10mg has been demonstrated in pediatric patients 6 to 12 years of age in placebo-controlled. The effectiveness of loratadine for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria.
In adults, somnolence, tachycardia, and headache have been reported. Extrapyramidal signs and palpitations have been reported in children.
Loratadine is contraindicated in patients who are hypersensitive to this medication or to any of its ingredients.
Store in a cool, dry and dark place.
10 TABLETS pack in blister pack.
100ml SYRUP pack in Bottles.
Manufactured in India by
STALLION LABORATORIES PVT. LTD.
C-1B, 305/2 & 3, G.I.D.C. Kerala (Bavia), Dist.: Ahmedabad-382 220. Gujarat.