COMPOSITION :
Loratadine Caplet 10 mg, each caplet contains : Loratadine 10 mg.
DESCRIPTIONS :
Loratadine containing Loratadine is available in caplet 10 mg.
INDICATIONS :
Relief of symptoms associated with allergic rhinitis, such as sneezing, rhinorrhea, itchy nose, ocular itching and burning.
Relief of signs and symptoms of chronic urticaria and other allergic dermatological disorder.
DOSAGE AND ADMINISTRATIONS :
Adult, elderly, children at age 12 years old or more : 10 mg a day.
Children at age 2-12 years :
BW > 30 kg : 10 mg a day.
BW ≤ 30 kg : 5 mg a day.
Safety and efficacy in children less than 2 years old have not been established.
CONTRAINDICATION :
Patients showing hypersensitivity or idiosyncrasy to drug components.
WARNINGS AND PRECAUTIONS :
Patients with severe hepatic disorder should be given a lower initial dose, because it can affect Loratadine clearance, an initial dose of 5 mg a day or 10 mg every 2 day is adviced.
Safety and efficacy in children under 2 years old have not been established.
Safety of Loratadine usage during pregnancy has not been established, administer only if the benefit potential is bigger than the risk to the fetus.
Should be given with care in nursing women, because Loratadine excreted to the breast milk.
DRUG INTERACTIONS :
If administered together with alcohol, Loratadine did not have potentiation effect as measured with psycomotor study.
Loratadine increasing plasma level has been reported in concomitant use with Ketoconazole, Erythromycin or Cimetidine in a controlled clinical trial, but no significant clinical change (including electrocardiographic).
Caution should be given when administered with drugs that inhibit liver metabolism.
Antihistamine administration must be stopped ± 48 hours before skin test procedure, because this drug can prevent or lower positive reaction to dermal reactivity indicator.
ADVERSE REACTIONS :
Loratadine shows no clinically significant sedative effect with dosage administration of 10 mg a day.
Reported adverse reactions : fatigue, headache, somnolence, dry mouth, indigestion, nausea, gastritis, and rash-like allergic symptoms.
It was reported the occurrence of alopecia, anaphylaxis, abnormal liver function and tachyarrhythmias supraventikuler although rarely.
PRESENTATION :
Loratadine Caplet 10 mg Box, 10 blisters @ 10 caplets Reg. No. GKL0402335904A1
STORAGE :
STORE BELOW 30°C
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
