Description
Ingredients
The main ingredient of this product is flurbiprofen ester, whose chemical name is (±) 2 - (2-fluoro-4-biphenyl) propionic acid-1-acetoxyethyl este
Its structural formula is:
Molecular formula: C19H19FO4
Molecular weight: 330.36
Auxiliary materials: refined soybean oil, refined lecithin, concentrated glycerol, disodium hydrogen phosphate, citric acid, water for injection
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This product is a white lotion, slightly sticky, with a specific smell.
Fold and edit the indications of this paragraph
Postoperative and cancer analgesia.
Collapse and edit this specification
5ml:50mg
Collapse and edit the usage of this paragraph
Generally, adults are given 50 mg of flurbiprofen axetil intravenously each time, and the drug is administered as slowly as possible (more than 1 minute). Analgesic pump is used as needed, and can be repeated if necessary. The dosage should be increased or decreased according to age and symptoms. Generally, this product should be used when oral medicine is not available or the effect of oral medicine is not ideal.
Fold and edit the adverse reactions of this paragraph
1. Serious adverse reactions: rare shock, acute renal failure, nephrotic syndrome, gastrointestinal bleeding, convulsions with disturbance of consciousness.
2. In the study of other preparations of flurbiprofen, the following serious adverse reactions were also observed: rare aplastic anemia, toxic epidermal necrosis (Lyell syndrome), exfoliative dermatitis.
3. General adverse reactions:
(1) Injection site: occasional pain and subcutaneous hemorrhage at the injection site;
(2) Digestive system: sometimes nausea, vomiting, elevated transaminase, occasionally diarrhea, rare gastrointestinal bleeding;
(3) Mental and nervous system: sometimes there is fever, occasionally headache, fatigue, lethargy, and chills;
(4) Circulation system: occasionally seen blood pressure rise and palpitation;
(5) Skin: occasionally see itching, rash and other allergic reactions;
(6) Blood system: rare thrombocytopenia and low platelet function.
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1. Patients with peptic ulcer;
2. Patients with severe liver, kidney and blood system dysfunction;
3. Patients with severe heart failure and hypertension;
4. Patients with a history of allergy to the ingredients of this preparation;
5. Aspirin asthma, or patients with previous history;
6. Patients who are using ilofloxacin, lomefloxacin and norfloxacin.
Notes for folding and editing this paragraph
1. The following patients should use this drug with caution
(1) Patients with previous history of digestive ulcer
(2) Patients with bleeding tendency, abnormal blood system or previous history;
(3) Patients with heart, liver and kidney insufficiency or previous history and hypertension;
(4) Patients with a history of allergy;
(5) Patients with bronchial asthma.
2. Try to avoid combining with other non-steroidal anti-inflammatory drugs.
3. It can not be used for relieving fever in patients with fever and analgesia in patients with low back pain.
4. The route of administration of this product is intravenous injection, not intramuscular injection.
5. If the patients who cannot take the medicine orally can take the medicine orally, they should stop intravenous administration and change to oral administration.
6. Long-term use of this product should be avoided. When it is necessary to use it for a long time, regular monitoring of blood and urine routine and liver function should be carried out, and abnormalities should be found in time, and the drug should be reduced or stopped.
7. Pay close attention to the patient's condition during the course of medication, find adverse reactions in time and make appropriate treatment.
Fold and edit this paragraph for pregnant women and lactating women
1. The safety of application for pregnant women has not been established. Pregnant or potential pregnant women can only use it when the benefit of treatment is greater than the risk;
2. Try not to use it at the end of pregnancy (it is found in animal experiments that the use of drugs in rats at the end of pregnancy can lead to delayed delivery and contraction of fetal ductus arteriosus);
3. Avoid breastfeeding during the application of this product (it may be transferred to breast milk).
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The safety of children's use has not been determined, so children should not use it.
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Special attention should be paid to the adverse reactions of elderly patients, and the drug should be administered carefully from a small dose.
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1. It is forbidden to use with lomefloxacin, norfloxacin and enoxacin, which may lead to convulsions.
2. Be careful to use with dicoumarin anticoagulants (warfarin, etc.), methotrexate, lithium, thiazide diuretics (hydrochlorothiazide), loop diuretics (furosemide), neoquinolone antibiotics (ofloxacin, etc.), adrenocortical hormones (methylprednisolone, etc.).
Folding and editing this paragraph of drug overdose
It is not clear yet.
Fold and edit this clinical trial
A total of 200 subjects with moderate pain after surgery were enrolled in the group. A randomized double-blind trial was used to control with placebo. One intravenous injection (5ml) was slowly injected when pain occurred. The evaluation indexes were pain intensity, pain intensity difference, pain relief rate and effective rate. The analgesic effect of flurbiprofen axetil was 98%. Adverse reactions were nausea and palpitation in 2 cases.
Fold and edit the pharmacology and toxicology of this paragraph
1. Pharmacological action
This product is a non-steroidal analgesic with lipid microspheres as the drug carrier. After the drug enters the body and is targeted to the wound and tumor sites, flurbiprofen ester is released from the lipid microspheres, and is rapidly hydrolyzed to flurbiprofen under the action of carboxylesterase, which plays an analgesic role by inhibiting the synthesis of prostaglandins by flurbiprofen.
2. Toxicological study
Reproductive toxicity: the rats were given 5mg/kg/day intravenously before and at the early stage of pregnancy, and ovulation and implantation decreased; Intravenous administration during organogenesis 10 μ G/kg/day, delayed fetal development accompanied by deterioration of maternal body condition, increased fetal mortality, decreased lactation capacity and inhibition of fetal development. When rabbits were given 80mg/kg/day intravenously, miscarriage accompanied by deterioration of maternal general condition, premature delivery and fetal mortality increased.
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Healthy men were given 5ml (50mg) of this product intravenously. Flurbiprofen axetil was completely hydrolyzed into flurbiprofen within 5 minutes. After 6-7 minutes, the concentration of flurbiprofen in blood reached the highest (8.9 μ G/ml), with a half-life of 5.8 hours. After 24 hours of medication, about 50% of the product is excreted from the urine. The main metabolites are 2 - (4 '- hydroxy-2-fluoro-4-biphenyl) propionic acid and its polymer.
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Keep it in a sealed place at 0-20 ºC to avoid freezing.
Folding and editing the packaging of this section
Colorless ampoules. 5 pieces/box, 1 piece/box.
Collapse and edit the period of validity of this paragraph
18 months.
Collapse and edit the executive standard of this paragraph
National Food and Drug Administration Standard (Trial) YBH15412004
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