Description: The instructions for naproxen sustained-release capsules were issued by the State Administration of Pharmaceutical Products on February 5, 2002 in the Notice on Publishing the Catalogue of Instructions for the Second Batch of Chemicals. The instructions published by the State Administration of Pharmaceutical Products are reference samples for revising the specifications. In case of doubt, the enterprise may propose amendments. Indications should be consistent with the original approval; Adverse reactions, drug interactions and other contents, the instructions provided by the enterprise can not be less than those listed in the sample draft. For empty or incomplete items in the sample manual, enterprises should be required to fill in according to the actual situation, such as product name and specifications.
Drug name
Generic name: naproxen sustained-release capsules
Former name:
Commodity name:
Chinese name: Naipusheng Persistence re 1 ease capsu 1 es.
Chinese pinyin: Nɑipushenɡ Hohhot Jiɑonɑnɡ
The main ingredient of this product is naproxen. Its chemical name is: (+) methoxy 6 methoxy 2 naphthylacetic acid.
Structural formula:
Molecular formula: C 14H 14O3.
Molecular weight: 230.26
Character; Role; letter
This product is a capsule with white granules.
Pharmacology and toxicology
This product is a non-steroidal anti-inflammatory drug, which has analgesic, anti-inflammatory and antipyretic effects by inhibiting prostaglandin synthesis.
pharmacokinetics
This product is absorbed slowly after oral administration, and the blood concentration changes smoothly. More than 99% of them are bound to plasma protein, and the apparent distribution volume is 0. 16L/Kg. It is mainly metabolized in the liver, and about 95% is excreted in the urine through the kidney as the original drug and metabolite. The elimination half-life T 1/2 is about 13 hours.
indicate
Suitable for relieving mild to moderate pain. Can be use for relieving systemic fever, local redness and pain cause by rheumatism and rheumatoid arthritis.
dosage
Oral. Adults take 0.5g(2 tablets) once, once a day/kloc-0 times, or as directed by the doctor.
counteraction
(1) itchy skin, shortness of breath, dyspnea, asthma, tinnitus, edema of lower limbs, heartburn, indigestion, stomachache or discomfort, constipation, dizziness, drowsiness, headache, nausea and vomiting.
(2) blurred vision or visual impairment, hearing loss, diarrhea, oral pain, palpitation and hyperhidrosis.
(3) gastrointestinal bleeding and renal damage (allergic nephritis, nephropathy, renal necrosis and renal failure, etc.). ), urticaria, allergic skin rash's disease, mental depression, muscle weakness, bleeding or granulocytopenia and liver function damage are rare.
taboo
Have a history of allergy to this product or similar drugs, and those who have asthma, rhinitis and nasal polyp syndrome caused by aspirin or other non-steroidal anti-inflammatory drugs are prohibited; Patients with active gastric ulcer and duodenal ulcer are prohibited.
Matters needing attention
(1) cross allergy. People who are allergic to aspirin or other NSAIDs are also allergic to this product.
(2) Interference with diagnosis: It can affect urine 5- hydroxyindoleacetic acid (5HIAA) and 17 ketosteroids.
(3) Use with caution in the following situations: when there is coagulation mechanism or platelet dysfunction, asthma, cardiac insufficiency or hypertension, hepatic and renal insufficiency.
(4) Long-term medication should include regular liver, renal function, hemogram and eye examination, and the dosage should be adjusted according to the patient's reaction to the drug. Generally, the lowest effective dosage should be used.
(5) Drinking and taking this product at the same time will increase the adverse reactions of gastrointestinal tract.
Medication for pregnant and lactating women
The research on the effect of banning (1) this product on fetus is not enough, because other NSAIDs can make fetal arterial duct close prematurely, and also inhibit prostaglandin synthesis, leading to dystocia or prolonged labor. (2) The concentration of this product secreted into milk is equivalent to L% of the blood drug concentration, so it is not suitable for lactating women.
Children's medication
Children under 2 years old are prohibited.
Medication for elderly patients
Use with caution for the elderly.
drug interaction
(l) When combined with other NSAIDs, gastrointestinal adverse reactions increase and there is a risk of ulcer.
(2) When combined with anticoagulants such as heparin and dicoumarin, the bleeding time will be prolonged, which may lead to bleeding tendency and gastrointestinal ulcer.
(3) This product can reduce the sodium excretion and hypotensive effect of furosemide.
(4) This product can inhibit lithium excretion with urine and increase the plasma concentration of lithium.
(5) When combined with probenecid, the blood concentration of this product increases and the T 1/2 is prolonged, which can increase the curative effect, but the toxic reaction also increases accordingly.
excessive
Excessive poisoning should be treated urgently, including vomiting or gastric lavage, oral active carbon and antacid, symptomatic support treatment and rational use of diuretics.
standard
0.25 g
store
Shading, sealing and storage.
parcel
term of validity
Registration authentication number
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