Product Overview
【Drug Name】
Generic Name: Loratadine Tablets
Brand Name: Hismanal Loratadine Tablets 10mg*12 tablets
Pinyin Code: XiSiMin LvLeiTaDingPian 10MG*12Pian
【Main Ingredients】
Each tablet contains 10 mg of loratadine. Excipients include: sodium lauryl sulfate, starch, microcrystalline cellulose, povidone K30, sodium carboxymethyl starch, talc, and magnesium stearate.
【Appearance】
This product is a white or off-white tablet.
【Indications/Main Functions】
Used to relieve symptoms associated with allergic rhinitis, such as sneezing, runny nose, nasal itching, nasal congestion, and itchy and burning eyes. After oral administration, nasal and ocular symptoms and signs are rapidly relieved. Also suitable for relieving symptoms and signs of chronic urticaria, pruritic dermatitis, and other allergic skin diseases.
【Specifications】
10mg*12 tablets
【Dosage and Administration】
Oral administration.
Adults and children over 12 years of age: One tablet (10 mg) once daily.
Children aged 2–12 years: Weight > 30 kg: One tablet (10 mg) once daily.
Weight ≤ 30 kg: Half a tablet (5 mg) once daily.
【Adverse Reactions】
At the recommended daily dose of 10 mg, this product has not shown significant sedative effects.
Common adverse reactions include fatigue, headache, drowsiness, dry mouth, gastrointestinal discomfort including nausea, gastritis, and rash. Rare adverse reactions include hair loss, allergic reactions, abnormal liver function, tachycardia, and palpitations.
In a clinical trial involving approximately 90,000 patients, the following adverse reactions also occurred, with an incidence of less than 2%:
Autonomic nervous system: lacrimation, salivation, flushing, hypoesthesia, impotence, hyperhidrosis;
General condition: angioedema, weakness, back pain, blurred vision, chest pain, ear pain, eye pain, leg cramps, depression, chills, tinnitus, viral infection, weight gain;
Cardiovascular system: hypertension, hypotension, supraventricular tachyarrhythmia, syncope;
Central and peripheral nervous system: blepharospasm, dizziness, paresthesia, tremor;
Gastrointestinal system: indigestion, bloating, altered taste, decreased appetite, constipation, diarrhea, hiccups, increased appetite, toothache, vomiting Musculoskeletal System: Arthritis, myalgia;
Nervous System: Agitation, forgetfulness, anxiety, mental confusion, decreased libido, depression, poor concentration, insomnia, irritability;
Reproductive System: Breast pain, dysmenorrhea, menorrhagia, vaginitis;
Respiratory System: Bronchitis, bronchospasm, cough, dyspnea, epistaxis, hemoptysis, laryngitis, dry nose, pharyngitis, sinusitis, sneezing;
Skin and Appendages: Dermatitis, dry hair, dry skin, photosensitivity, pruritus, purpura, urticaria;
Urinary System: Frequent urination, changes in urine appearance and color, urinary incontinence, urinary retention;
Additionally, this product may occasionally cause breast hyperplasia, erythema multiforme, peripheral edema, and epilepsy.
【Contraindications】
This product is contraindicated in patients with known hypersensitivity to any of its ingredients.
【Precautions】
1. Patients with severe hepatic impairment should use this product under the guidance of a physician.
2. Use with caution during pregnancy and lactation.
3. Discontinue use approximately 48 hours before a skin test, as antihistamines can prevent or reduce a positive skin test reaction.
4. Contraindicated in patients with known hypersensitivity to this product; use with caution in patients with allergic constitution.
5. Do not use if the product's appearance changes.
6. Keep out of reach of children.
7. Children must use this product under adult supervision.
8. Consult a physician or pharmacist before using this product if you are currently using other medications.
9. The safety and efficacy of this product in children under 6 years of age have not been established; please consult a physician or pharmacist.
10. Patients with hepatic or renal insufficiency should reduce the dosage; a dose of 10 mg every two days is recommended, or use under the guidance of a physician.
11. Because plasma concentrations are higher in elderly patients than in healthy individuals, close monitoring for adverse reactions is necessary when elderly patients use this product long-term.
12. Overdose of this product in adults (40-180 mg) may cause drowsiness, arrhythmia, and headache. If these symptoms occur, immediate symptomatic and supportive therapy should be administered. Treatment includes inducing vomiting, followed by administration of activated charcoal to absorb unabsorbed drug. If vomiting is unsuccessful, gastric lavage with normal saline and catharsis should be administered to dilute the drug concentration in the intestines. Hemodialysis cannot remove loratadine, and it is not yet determined whether peritoneal dialysis can remove this product.
【Drug Interactions】
1. Concomitant use with ketoconazole, macrolide antibiotics, cimetidine, theophylline, etc., may increase the plasma concentration of loratadine and should be used with caution. Other drugs known to inhibit hepatic metabolism should be used with caution until their interaction with loratadine is clearly established.
2. Drug interactions may occur when used with other medications; please consult your doctor or pharmacist for details.
【Pediatric Use】
As directed by your doctor.
【Geriatric Use】
As directed by your doctor.
【Use in Pregnant and Lactating Women】
Not yet clear.
【Overdosage】
Not yet clear.
【Pharmacology and Toxicology】
This product is a highly effective, long-lasting tricyclic antihistamine and a selective peripheral H1 receptor antagonist. It can relieve various symptoms caused by allergic reactions.
【Pharmacokinetics】
Not yet clear.
【Storage】
Protect from light and store in a sealed container.
【Packaging】
Aluminum-plastic packaging, 6 tablets/blister/box, 2*6 tablets/blister/box
【Shelf Life】
48 months
【Approval Number】
National Drug Approval Number H20070030
【Manufacturer】
Xi'an Janssen Pharmaceutical Co., Ltd.
