Loratadine Sustained-Release Tablets

This product is a compound preparation of acetaminophen, loratadine and pseudoephedrine sulfate. Among them, acetaminophen is an oral acetanilide antipyretic analgesic, which may produce antipyretic and analgesic effects mainly by inhibiting the synthesis of prostaglandins. Loratadine is a long-acting tricyclic antihistamine that can relieve nasal or non-nasal symptoms of seasonal allergic rhinitis by selectively antagonizing peripheral H1 receptors. Pseudoephedrine sulfate is an adrenergic mimetic that can constrict nasal mucosal blood vessels and relieve nasal congestion and runny nose symptoms. Toxicological studies: Loratadine. Genetic toxicity: In the Ames test, forward point mutation test, and DNA damage test, no mutagenic effect of loratadine was found. In the mouse lymphoma test, positive results appeared in the inactive state and negative results in the activated state. Reproductive toxicity: When male rats were given loratadine at a dose of 64 mg/kg (about 50 times the clinically recommended maximum daily oral dose based on body surface area), fertility decreased, as manifested by a decrease in the pregnancy rate of female rats. Oral administration of loratadine at a dose of 24 mg/kg (about 20 times the clinically recommended maximum daily dose based on body surface area weight) had no effect on the fertility of male and female rats. When rats and rabbits were given loratadine orally at a dose of 96 mg/kg (about 75 and 150 times the clinically recommended maximum oral dose based on body area weight), no teratogenic effects were observed. Carcinogenicity: When mice were given loratadine orally for 18 consecutive months, the incidence of hepatoma (including adenomas and cancers) in male mice increased significantly at a dose of 40 mg/kg; when rats were given loratadine orally for 2 consecutive years, the incidence of hepatoma (including adenomas and cancers) in male mice at a dose of 10 mg/kg and in male and female rats at a dose of 25 mg/kg increased significantly. The clinical significance of the above findings is unclear when humans take loratadine for a long time.

This product is a compound preparation, its components are: acetaminophen, pseudoephedrine sulfate, and loratadine.

This product is white or off-white oval tablets.

Used for symptoms such as sneezing, runny nose, nasal congestion, throat discomfort, fatigue, fever, muscle aches, headache, etc. caused by colds and seasonal allergic rhinitis.

Oral administration: Adults and children over 12 years old take 1 to 2 tablets every 12 hours.

Loratadine: Common adverse reactions reported with loratadine include fatigue, headache, drowsiness, dry mouth, gastrointestinal disorders such as ambition and stomach pain, and allergic symptoms such as rash. During the marketing period of loratadine tablets, hair loss, allergic reactions and liver dysfunction were rare. Pseudoephedrine sulfate: Patients who are particularly sensitive to sympathomimetic drugs may have mild irritation reactions: nausea, headache, drowsiness, weakness, dizziness, tachycardia, palpitations, insomnia, nervousness, excitement, restlessness, and mydriasis have also been reported. In addition, acetaminophen: The adverse reactions of acetaminophen at the recommended dose are generally weak. Hematological reactions and rashes have been reported. There are reports of nephrotoxic effects caused by long-term use.

This product is contraindicated for patients who are allergic to any ingredient of this product or adrenergic drugs; patients who are taking or have taken monoamine oxidase inhibitors within 14 days are contraindicated for this product; patients with angle-closure glaucoma, urinary retention, severe hypertension, severe coronary artery disease and hyperthyroidism are also contraindicated for this product.

Loratadine: 1. Clinical trials have shown that taking ketoconazole, erythromycin or cimetidine at the same time will increase the blood concentration of loratadine, but there are no significant clinical symptoms (including electrocardiogram); 2. Unless a confirmed drug interaction is completed, other drugs known to have a resistant effect on liver metabolism should be taken with caution; 3. This product should be discontinued at least 48 hours before skin testing. The antihistamine loratadine drug may inhibit or eliminate the symptoms of positive skin reactions. Pseudoephedrine sulfate: 1. Patients who are receiving monoamine oxidase (MAO) inhibitors and taking sympathomimetics, such as pseudoephedrine sulfate, at the same time may experience hypertensive reactions, including hypertensive crisis; 2. When compound antihypertensive tablets, methyldopa tablets, reserpine and Veratrum alkaloids are used in combination with sympathomimetics, the antihypertensive effect of the former may be reduced; 3. beta-adrenergic blockade may interact with sympathomimetics; 4. Simultaneous use of pseudoephedrine and digitalis may increase the activity of ectopic pacemakers; 5. Antacids can increase the absorption of pseudoephedrine sulfate; kaolin reduces the absorption rate of pseudoephedrine sulfate. Acetaminophen: 1. Acetaminophen increases the anticoagulant activity of coumadin; 2. Taking acetaminophen with enzyme-linked drugs such as barbiturates or drinking alcohol may accelerate the metabolism of acetaminophen and increase the risk of liver necrosis caused by acetaminophen overdose; 3. When used in combination with chloramphenicol, acetaminophen can prolong the half-life of chloramphenicol and enhance its toxicity; 4. When used in combination with aspirin and other non-steroidal anti-inflammatory drugs for a long time and in large quantities, acetaminophen has a significant risk of increasing renal toxicity.

Store in a sealed container at 2°C to 30°C, shielded from light. The shelf life is tentatively 24 months.

Each tablet contains 5mg of loratadine and 120mg of pseudoephedrine sulfate

Tentative 24 months

Beijing Honglin Pharmaceutical Co., Ltd.

• Founded in:

  1993-12-07

• Address:

  Yanqi Industrial Development Zone, Huairou District, Beijing

• Tax NO.:

  91110000621702873B

• Registered Funds:

  $15.8 million

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