Chapter I General Principles
Article 1 In order to standardize the administration of drug instructions and labels, these Provisions are formulated in accordance with the Drug Administration Law of People's Republic of China (PRC) and the Regulations for the Implementation of the Drug Administration Law of People's Republic of China (PRC).
Article 2 The instructions and labels of drugs listed and sold in People's Republic of China (PRC) shall meet the requirements of these Provisions.
Article 3 Drug instructions and labels shall be approved by the US Food and Drug Administration.
Drug labels shall be subject to the instructions, and their contents shall not exceed the scope of the instructions, and shall not be printed with words and labels suggesting curative effect, misleading use and improper promotion of products.
Article 4 Pharmaceutical packaging must be printed or labeled in accordance with regulations, and shall not contain other words, videos and other materials that introduce or publicize products and enterprises.
The minimum package produced by a pharmaceutical manufacturer for marketing must be accompanied by instructions.
Article 5 The written expression of drug instructions and labels shall be scientific, standardized and accurate. Instructions for over-the-counter drugs should also be expressed in easy-to-understand words, so that patients can judge, choose and use them themselves.
Article 6 The words in drug instructions and labels shall be legible, and the labels shall be clear and eye-catching, and there shall be no phenomena such as printing shedding or poor pasting, and no modification or supplement shall be made by pasting, cutting or altering.
Article 7 The standardized Chinese characters published by the State Language Committee shall be used for drug instructions and labels. If other characters are added for comparison, the Chinese characters shall prevail.
Article 8 In order to protect public health and guide the correct and rational use of drugs, pharmaceutical production enterprises may take the initiative to mark warnings on drug instructions or labels, and the State Food and Drug Administration of the United States may also require pharmaceutical production enterprises to mark warnings on drug instructions or labels.
Chapter II Drug Instructions
Article 9 The drug instructions shall contain important scientific data, conclusions and information about the safety and effectiveness of drugs, so as to guide the safe and rational use of drugs. The specific format, content and writing requirements of drug instructions are formulated and published by the State Food and Drug Administration.
Article 10 The description of disease names, pharmaceutical technical terms, drug names, clinical trial names and results in drug instructions shall be in the special language uniformly promulgated or standardized by the state, and the unit of measurement shall conform to the provisions of national standards.
Article 11 The drug instructions shall list all active ingredients or all traditional Chinese medicines in the prescription. Injections and over-the-counter drugs should also list the names of all excipients used.
If the drug prescription contains ingredients or auxiliary materials that may cause serious adverse reactions, it shall be explained.
Article 12 After a drug is put on the market, the pharmaceutical production enterprise shall actively track the safety and effectiveness of the drug, and if it is necessary to modify the drug instructions, it shall apply in time.
According to the monitoring of adverse drug reactions, the results of drug re-evaluation, and other information, the State Food and Drug Administration of the United States can also require pharmaceutical manufacturers to modify the drug instructions.
Article 13 After the drug instructions are approved to be revised, the drug production enterprise shall immediately notify the relevant drug trading enterprises, users and other departments of the revised contents, and use the revised instructions and labels in a timely manner as required.
Article 14 The drug instructions shall fully record the information of adverse drug reactions and explain the adverse drug reactions in detail. If a pharmaceutical manufacturer fails to modify the instructions in time according to the safety and effectiveness of the drug after listing, or fails to fully explain the adverse drug reactions in the instructions, the adverse consequences arising therefrom shall be borne by the manufacturer.
Article 15 The drug instructions shall clearly indicate the date of approval and the date of revision.
Chapter III Drug Labeling
Article 16 Drug labels refer to the contents printed or pasted on drug packages, which are divided into internal labels and external labels. The internal label of a drug refers to the label that directly contacts the drug package, and the external label refers to the label of other packages except the internal label.
Article 17 The internal label of a drug shall include the generic name, indications or functional indications, specifications, usage and dosage, production date, product batch number, expiration date, manufacturer, etc.
If the package size is too small to fully indicate the above contents, at least the generic name, specifications, product batch number, expiration date and other contents of the drug shall be indicated.
Article 18 The external label of a drug shall indicate the general name, ingredients, properties, indications or functional indications, specifications, usage and dosage, adverse reactions, contraindications, precautions, storage, production date, product batch number, expiration date, approval number, production enterprise, etc. If indications or functional indications, usage and dosage, adverse reactions, contraindications and precautions cannot all be indicated, the main contents shall be indicated, and the words "see the instructions for details" shall be indicated.
Article 19 The packaging label used for transportation and storage shall at least indicate the generic name, specifications, storage, production date, product batch number, expiration date, approval number and production enterprise of the drug, and may also indicate the necessary contents such as packaging quantity, transportation precautions or other signs as required.
Article 20 The label of an API shall indicate the drug name, storage, production date, product batch number, expiration date, implementation standard, approval number, manufacturer, packaging quantity, transportation precautions and other necessary contents.
Article 21 If the specifications and packaging specifications of the same drug produced by the same pharmaceutical manufacturer are the same, the contents, formats and colors of the labels must be the same; If the drug specifications or packaging specifications are different, the labels shall clearly distinguish or indicate the specifications.
If the same drug produced by the same pharmaceutical manufacturer is managed according to prescription drugs and over-the-counter drugs respectively, the packaging colors of the two drugs should be obviously different.
Article 22 Drugs with special storage requirements shall be indicated on the labels.
Article 23 The expiration date in the drug label shall be marked in the order of year, month and day, with the year being represented by four digits and the month and day being represented by two digits. Its specific labeling format is "valid until XX" or "valid until XX"; It can also be expressed by numbers and other symbols as "valid until XXXX". XX "or" valid until XXXX/XX/XX "and so on.
The expiration date of preventive biological products shall be marked according to the registration standards approved by the US Food and Drug Administration. The expiration date of therapeutic biological products shall be calculated from the date of packaging, and the expiration date of other drugs shall be calculated from the date of production.
If the validity period is marked on day, it is the day before the month corresponding to the start date, and if it is marked on month, it is the month before the month corresponding to the start month.
Chapter IV Use of Drug Names and Registered Trademarks
Article 24 The names of drugs marked in drug instructions and labels must conform to the naming principles of general names of drugs and commodity names promulgated by the State Food and Drug Administration of the United States, and be consistent with the corresponding contents of drug approval numbers.
Article 25 The generic names of drugs shall be eye-catching and prominent, and the font, size and color must be consistent, and meet the following requirements:
(a) For the horizontal label, it must be marked in a prominent position within the upper third; For vertical labels, they must be marked in a prominent position within the right third;
(two) do not use cursive script, seal script and other illegible fonts, do not use italics, hollowing out, shading and other forms to modify fonts;
(three) the font color should be black or white, in sharp contrast with the corresponding light or dark background;
(four) except for the size limit of the package, it cannot be written in the same line, nor is it allowed to be written in the branch.
Article 26 The trade name of a drug shall not be written with a generic name, its font and color shall not be more prominent and obvious than the generic name, and its font shall not be more than half of the font used in the generic name in terms of the area of a single word.
Article 27 It is prohibited to use unregistered trademarks and other drug names that have not been approved by the US Food and Drug Administration in drug instructions and labels.
Where a registered trademark is used on a drug label, it shall be printed on the corner of the drug label. If there are characters, the font shall not be larger than a quarter of the font used in the common name, based on the area of a single character.
Chapter V Other Provisions
Twenty-eighth narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, drugs for external use and over-the-counter drugs have special labels prescribed by the state, and their instructions and labels must be printed with the prescribed labels.
Where the state has special provisions on drug instructions and labels, those provisions shall prevail.
Article 29 The regulations on the label management of Chinese herbal medicines and Chinese herbal pieces shall be formulated separately by the State Food and Drug Administration of the United States.
Thirtieth drug instructions and labels do not meet these provisions, shall be punished in accordance with the relevant provisions of the "Drug Administration Law of People's Republic of China (PRC)".
Chapter VI Supplementary Provisions
Thirty-first these Provisions shall come into force as of June 6, 2006. The Provisions on the Administration of Drug Packaging, Labeling and Instructions (Provisional) issued by the State Pharmaceutical Products Supervision and Administration on June 5, 2000 shall be abolished at the same time.
This is necessary.
Amoxicillin sodium for injection
standard light sources
Drug name
Generic Name: Amoxicillin Sodium Injection Product Name: English Name: AmoxicillinSodiumforInjection Chinese Pinyin: ZhusheyongAmoxilingna The main component of this product is Amoxicillin Sodium, and its chemical name is (2S, 5R, 6R)-3,3-dimethyl -6-[(R)-(-)-2- amino -2-(4-) Its structural formula is: molecular formula: C 16H 18N3NaO5S molecular weight: 387.40.
composition
Character; Role; letter
This product is white or white-like powder or crystal.
Functional category
Pharmacology and toxicology
Amoxicillin is a penicillin antibiotic, which has good antibacterial activity against aerobic gram-positive cocci such as Streptococcus pneumoniae and Streptococcus hemolyticus, Escherichia coli, Proteus mirabilis, Salmonella, Haemophilus influenzae, Neisseria gonorrhoeae and other aerobic gram-negative bacteria and Helicobacter pylori. By inhibiting the synthesis of bacterial cell wall, amoxicillin can make bacteria quickly become spheroids, dissolve and rupture, thus playing a role in sterilization.
pharmacokinetics
After intramuscular injection of 0.5g amoxicillin sodium, the peak time was 65438 0 hours, and the peak blood concentration (Cmax) was 65438 0.4 mg/L, which was similar to that after oral administration of the same dose of amoxicillin. The blood concentration of this product was 42.6mg/L 5 minutes after intravenous injection of 0.5g and 1mg/L 5 hours later. The product is well distributed in most tissues and body fluids. After intravenous injection of 2g of this product, the drug concentration in cerebrospinal fluid is 2.9 ~ 40.0mg/L1.5h.. This product can pass through the placenta, and its concentration in umbilical cord blood is 1/4 ~ 1/3 of the maternal blood concentration, and it also contains trace amounts in milk, sweat and tears. The protein binding rate of amoxicillin is 17% ~ 20%. Blood elimination half-life of this product (t 1/2? ) is 1.08 hours, more than 60% of drugs are excreted in urine, about 24% of drugs are metabolized in the liver, and a small amount is excreted through biliary tract. The serum half-life of patients with severe renal insufficiency can be extended to 7 hours. Hemodialysis can remove this product, while peritoneal dialysis has no effect.
indicate
Amoxicillin is suitable for patients with the following infections caused by sensitive bacteria (strains that do not produce β -lactamase) that are seriously ill and need hospitalization or cannot be taken orally. 1. Upper respiratory tract infections caused by hemolytic streptococcus, streptococcus pneumoniae, staphylococcus or Haemophilus influenzae, such as otitis media, sinusitis, pharyngitis and tonsillitis. 2. Urogenital tract infection caused by Escherichia coli, Proteus mirabilis or Enterococcus faecalis. 3. Skin and soft tissue infections caused by hemolytic streptococcus, staphylococcus or Escherichia coli. 4. Lower respiratory tract infections, such as acute bronchitis and pneumonia caused by hemolytic streptococcus, streptococcus pneumoniae, staphylococcus or Haemophilus influenzae. 5. This product can be used to treat typhoid and leptospirosis.
dosage
Intramuscular injection or intravenous drip after dilution. 0.5 ~ 1g for adults once, every 6 ~ 8 hours 1 time. The daily dose for children is 50 ~ 100 mg/kg, taken in 3 ~ 4 times. The dosage should be adjusted for patients with severe renal function damage, in which the clearance rate of endogenous creatinine is 10 ~ 30 ml/min, 0.25 ~ 0.5 g per 12 hour; Patients with endogenous creatinine clearance rate less than 10ml/ min, 0.25~0.5g every 24 hours. Hemodialysis can remove this product, and amoxicillin 1g should be given after each hemodialysis.
counteraction
1. Gastrointestinal reactions such as nausea, vomiting, diarrhea and pseudomembranous enteritis. 2. Allergic reactions such as rash, drug fever and asthma. 3. Anemia, thrombocytopenia and eosinophilia. 4. Serum transaminase can be slightly increased. 5. Double infection caused by candida or drug-resistant bacteria. 6. Occasionally, symptoms of the central nervous system such as excitement, anxiety, insomnia, dizziness and abnormal behavior can be seen.
taboo
People who are allergic to penicillin and those who are positive for penicillin skin test are prohibited.
Matters needing attention
1. Penicillins occasionally cause anaphylactic shock, especially in patients with allergic history to penicillin or cephalosporins. Be sure to ask about the history of drug allergy in detail and do a penicillin skin test before taking the medicine. If anaphylactic shock occurs, first aid should be given on the spot, and the airway should be kept clear, oxygen should be inhaled, and adrenaline and glucocorticoid should be used. 2. Patients with infectious mononucleosis are prone to rash when using this product, and should avoid using it. 3. Patients with a long course of treatment should check their liver, renal function and blood routine. 4. Amoxicillin can lead to false positive of urine glucose test with Benedit or Fehling reagent. 5. Use with caution in the following situations: (1) Those with a history of allergic diseases such as asthma, eczema, hay fever and urticaria. (2) The elderly and severely impaired renal function may need to adjust the dosage.
Medication for pregnant and lactating women
Animal reproduction test showed that 10 times the human dose of amoxicillin did not harm the fertility of rats and mice and the fetus. However, there are not enough human controlled studies. In view of the fact that animal reproduction tests can not completely predict human reactions, pregnant women should only use this product when it is really necessary. Because a small amount of amoxicillin can be secreted in milk, breastfeeding mothers may cause baby allergies after taking it.
Children's medication
Medication for elderly patients
drug interaction
1. probenecid competitively reduces the renal tubular secretion of this product, and the simultaneous application of both can increase the blood concentration of amoxicillin and prolong the half-life; 2. Chloramphenicol, macrolides, sulfonamides and tetracyclines interfere with the antibacterial effect of amoxicillin in vitro, but their clinical significance is unknown.
excessive
A prospective study involving 5/kloc-0 children showed that when the dose was less than 250mg/Kg, amoxicillin would not cause obvious clinical symptoms. It is reported that a small number of patients have renal insufficiency and oliguria due to amoxicillin overdose, but the renal function damage can be reversed after drug withdrawal.
standard
Calculate 0.5g according to C 16H 19N3O5S.
store
Shading sealed storage.
parcel
term of validity