COMPOSITION :
Klinset® Caplet 10 mg, each caplet contains : Loratadine 10 mg.
DESCRIPTIONS :
Klinset® 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 symptoms with signs of chronic urticaria and other allergic dermatological disorder.
DOSAGE AND ADMINISTRATIONS :
- Adult, elderly, children at age 12 years old or more : 1 caplet (10 mg) daily.
- 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.
OVERDOSAGE :
Somnolence, tachycardia and headache in adult and extrapyramidal symptoms, palpitation in children at dose > 10 mg/day has been reported. In case of over dosage, an immediate symptomatic treatment must be done to the patients :
- Patients must be induced to vomit, even if spontaneous vomit has happened.
- Vomit can be induced pharmacologically with administration of ipecac syrup unless in patient with disturbed consciousness. If the vomit didn’t happen in 15 minutes, ipecac must be re-administered, after vomit, drug absorption that left in the stomach can be given activated charcoal with water. If the vomit didn’t happen, or vomit is contraindicated, a gastric lavage must be done using physiological saline solution (especially for children) and water (for adult).
- Loratadine can’t be removed by hemodialysis in adequate amount. After emergency treatment, patients must be monitored medically.
CONTRAINDICATIONS :
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 days 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 didn’t have potentiation effect as measured with psychomotor 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 decrease 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 hepatic function and supraventricular tachyarrhythmias, athough rarely.
PRESENTATION :
Klinset® Caplet 10 mg Box, 3 strips @ 10 caplets Reg. No. DKL9602322304A1
STORAGE :
STORE BELOW 30°C
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
