[Drug Name] Ampicillin Sodium for Injection
[Condition]sIt is suitable for respiratory infections, gastrointestinal infections, urinary tract infections, soft tissue infections, endocarditis, meningitis, sepsis, etc. caused by sensitive bacteria.
[Usage and Dosage] Adults: intramuscular injection of 2 to 4 g a day, divided into 4 doses; intravenous drip or injection dose is 4 to 8 g a day, divided into 2 to 4 times. The daily dose for severe infection patients can be increased to 12g, and the maximum daily dose is 14g. Children: intramuscular injection is administered in 4 divided doses according to body weight 50-100mg/kg per day; intravenous drip or injection is administered in 2 to 4 divided doses according to body weight per day. The maximum daily dose is 300 mg/kg based on body weight. Full-term newborns: 12.5-25 mg/kg according to body weight once, once every 12 hours on the first and second day of birth, once every 8 hours on the third day to two weeks, and once every 6 hours thereafter. Premature infants: In the first week, 1 to 4 weeks and more than 4 weeks of birth, the weight is 12.5-50 mg/kg each time, once every 12 hours, 8 hours and 6 hours, intravenously. Renal insufficiency: When the endogenous creatinine clearance rate is 10-50ml/min or less than 10ml/min, the administration interval should be extended to 6-12 hours and 12-24 hours, respectively. The higher the concentration of the ampicillin sodium solution, the worse the stability. 1% Ampicillin Sodium solution can maintain its biological potency for 7 days at 5ºC, but it is 24 hours for 5% solution. Ampicillin sodium intravenous drip with a concentration of 30mg/ml can maintain at least 90% of its potency at room temperature for 2 to 8 hours, and it can maintain 90% of its potency for 72 hours when placed in a refrigerator. Stability can be reduced due to the presence of glucose, fructose and lactic acid, and it also decreases with increasing temperature. For intramuscular injection, it can dissolve 125mg, 500mg and 1g of ampicillin sodium in 0.9~1.2ml, 1.2~1.8ml and 2.4~7.4ml sterile water for injection. The concentration of ampicillin sodium intravenous drip should not exceed 30mg/ml.
[Ingredients] Ampicillin Sodium
[Properties] This product is white or off-white powder or crystal.
[Adverse reactions] The adverse reactions of this product are similar to penicillin, and allergic reactions are more common. Skin rash is the most common reaction, which usually occurs 5 days after medication, showing urticaria or maculopapular rash; interstitial nephritis can also occur; anaphylactic shock occasionally, once it occurs, it must be rescued locally to keep the airway open. Oxygen inhalation and adrenaline, glucocorticoid and other treatment measures. Granulocytes and thrombocytopenia are occasionally seen in patients receiving ampicillin. Antibiotic-related enteritis is rare, and a small number of patients have elevated serum transaminases. Intravenous administration of large doses of ampicillin can cause neurological toxic symptoms such as convulsions. After the application of ampicillin, infants can experience increased intracranial pressure, which is manifested as pro-halogen bulge.
[Contraindications] Patients with a history of penicillin allergy or a positive penicillin skin test should not be used.
[Notes] 1. Before applying this product, a detailed history of drug allergy and penicillin skin test should be conducted. 2. Patients with infectious mononucleosis, cytomegalovirus infection, lymphocytic leukemia, and lymphoma are prone to skin rashes when using this product and should be avoided. 3. This product must be freshly prepared. [Medication for pregnant women and lactating women] There is no strict controlled trial of this product in pregnant women, so pregnant women should only use this product when really necessary. A small amount of this product is secreted from milk, and breastfeeding women should stop breastfeeding when taking the drug.
[Drug interactions] 1. Combined use with probenecid will extend the half-life of this product. 2. Ampicillin and kanamycin have a synergistic antibacterial effect on Escherichia coli and Proteus. 3. This product should be instilled separately, not in the same bottle with the following drugs: aminoglycoside drugs, clindamycin phosphate, lincomycin hydrochloride, polymyxin B, succinate, erythromycin, epinephrine , Meta-hydroxyamine, dopamine, atropine, calcium gluconate, vitamin B family, vitamin C, nutritional injections containing amino acids, and hydrocortisone succinate. 4. Allopurinol can increase the incidence of ampicillin rash reactions, especially in hyperuricemia. 5. Ampicillin can stimulate the metabolism of estrogen or reduce its hepato-intestinal circulation, thus reducing the effect of oral contraceptives.
[Pharmacological action] Ampicillin sodium is a broad-spectrum semi-synthetic penicillin. This product has a strong antibacterial effect on hemolytic streptococcus, streptococcus pneumoniae and staphylococcus without penicillinase, which is similar to or slightly inferior to penicillin. Ampicillin also has a good antibacterial effect on Streptococcus viridans, and is better than penicillin on Enterococcus and Listeria spp. This product has antibacterial activity against Corynebacterium diphtheriae, Bacillus anthracis, Actinomycetes, Haemophilus influenzae, Bordetella pertussis, Neisseria and anaerobic bacteria except Bacteroides fragilis. Some Proteus mirabilis, Escherichia coli, Salmonella and Shigella bacteria are sensitive to this product. Ampicillin exerts a bactericidal effect by inhibiting bacterial cell wall synthesis. [Pharmacokinetics] Intramuscular injection of 0.5g of this product, the peak blood concentration (Cmax) will reach 12mg/L within 0.5 to 1 hour, and the blood concentration will be 0.5mg/L within 6 hours. The blood drug concentration at 15 minutes and 4 hours after intravenous injection of 0.5 g was 17 mg/L and 0.6 mg/L, respectively. Neonates and premature infants were intramuscularly injected with 10 mg/kg and 25 mg/kg according to their body weight, and the plasma concentration reached the peak value of 20 mg/L and 60 mg/L, respectively. The blood concentration of pregnant women is significantly lower than that of non-pregnancy. This product is well distributed in the body. Patients with bacterial meningitis are intravenously injected 150mg/kg according to their body weight every day. The concentration in the cerebrospinal fluid can reach 2.9mg/L in the first 3 days, and it will decrease with the reduction of inflammation. Normal cerebrospinal fluid contains only a small amount of ampicillin. This product can penetrate the placental barrier and reach a certain concentration in the amniotic fluid. The concentration in bronchial secretions of patients with lung infection is 1/50 of the blood concentration in the same period. There are considerable amounts of this product in pleural and ascites, aqueous humor, joint effusion, and breast milk. The average concentration in the bile of typhoid fever carriers is more than three times the blood concentration, and the highest can reach 17.8 times. The serum protein binding rate of this product is 20%, the blood elimination half-life (t1/2?) is 1 to 1.5 hours, the t1/2? of newborns is 1.7 to 4 hours, and patients with renal insufficiency can be extended to 7 to 20 hours. The ampicillin excreted in the urine 24 hours after intramuscular injection and intravenous injection is 50% and 70% of the dose, respectively. A small amount is metabolized in the liver or excreted through bile. This product can be removed by hemodialysis, but peritoneal dialysis cannot remove this product.
[Storage] Keep tightly sealed and stored in a dry place.
[Condition]sIt is suitable for respiratory infections, gastrointestinal infections, urinary tract infections, soft tissue infections, endocarditis, meningitis, sepsis, etc. caused by sensitive bacteria.
[Usage and Dosage] Adults: intramuscular injection of 2 to 4 g a day, divided into 4 doses; intravenous drip or injection dose is 4 to 8 g a day, divided into 2 to 4 times. The daily dose for severe infection patients can be increased to 12g, and the maximum daily dose is 14g. Children: intramuscular injection is administered in 4 divided doses according to body weight 50-100mg/kg per day; intravenous drip or injection is administered in 2 to 4 divided doses according to body weight per day. The maximum daily dose is 300 mg/kg based on body weight. Full-term newborns: 12.5-25 mg/kg according to body weight once, once every 12 hours on the first and second day of birth, once every 8 hours on the third day to two weeks, and once every 6 hours thereafter. Premature infants: In the first week, 1 to 4 weeks and more than 4 weeks of birth, the weight is 12.5-50 mg/kg each time, once every 12 hours, 8 hours and 6 hours, intravenously. Renal insufficiency: When the endogenous creatinine clearance rate is 10-50ml/min or less than 10ml/min, the administration interval should be extended to 6-12 hours and 12-24 hours, respectively. The higher the concentration of the ampicillin sodium solution, the worse the stability. 1% Ampicillin Sodium solution can maintain its biological potency for 7 days at 5ºC, but it is 24 hours for 5% solution. Ampicillin sodium intravenous drip with a concentration of 30mg/ml can maintain at least 90% of its potency at room temperature for 2 to 8 hours, and it can maintain 90% of its potency for 72 hours when placed in a refrigerator. Stability can be reduced due to the presence of glucose, fructose and lactic acid, and it also decreases with increasing temperature. For intramuscular injection, it can dissolve 125mg, 500mg and 1g of ampicillin sodium in 0.9~1.2ml, 1.2~1.8ml and 2.4~7.4ml sterile water for injection. The concentration of ampicillin sodium intravenous drip should not exceed 30mg/ml.
[Ingredients] Ampicillin Sodium
[Properties] This product is white or off-white powder or crystal.
[Adverse reactions] The adverse reactions of this product are similar to penicillin, and allergic reactions are more common. Skin rash is the most common reaction, which usually occurs 5 days after medication, showing urticaria or maculopapular rash; interstitial nephritis can also occur; anaphylactic shock occasionally, once it occurs, it must be rescued locally to keep the airway open. Oxygen inhalation and adrenaline, glucocorticoid and other treatment measures. Granulocytes and thrombocytopenia are occasionally seen in patients receiving ampicillin. Antibiotic-related enteritis is rare, and a small number of patients have elevated serum transaminases. Intravenous administration of large doses of ampicillin can cause neurological toxic symptoms such as convulsions. After the application of ampicillin, infants can experience increased intracranial pressure, which is manifested as pro-halogen bulge.
[Contraindications] Patients with a history of penicillin allergy or a positive penicillin skin test should not be used.
[Notes] 1. Before applying this product, a detailed history of drug allergy and penicillin skin test should be conducted. 2. Patients with infectious mononucleosis, cytomegalovirus infection, lymphocytic leukemia, and lymphoma are prone to skin rashes when using this product and should be avoided. 3. This product must be freshly prepared. [Medication for pregnant women and lactating women] There is no strict controlled trial of this product in pregnant women, so pregnant women should only use this product when really necessary. A small amount of this product is secreted from milk, and breastfeeding women should stop breastfeeding when taking the drug.
[Drug interactions] 1. Combined use with probenecid will extend the half-life of this product. 2. Ampicillin and kanamycin have a synergistic antibacterial effect on Escherichia coli and Proteus. 3. This product should be instilled separately, not in the same bottle with the following drugs: aminoglycoside drugs, clindamycin phosphate, lincomycin hydrochloride, polymyxin B, succinate, erythromycin, epinephrine , Meta-hydroxyamine, dopamine, atropine, calcium gluconate, vitamin B family, vitamin C, nutritional injections containing amino acids, and hydrocortisone succinate. 4. Allopurinol can increase the incidence of ampicillin rash reactions, especially in hyperuricemia. 5. Ampicillin can stimulate the metabolism of estrogen or reduce its hepato-intestinal circulation, thus reducing the effect of oral contraceptives.
[Pharmacological action] Ampicillin sodium is a broad-spectrum semi-synthetic penicillin. This product has a strong antibacterial effect on hemolytic streptococcus, streptococcus pneumoniae and staphylococcus without penicillinase, which is similar to or slightly inferior to penicillin. Ampicillin also has a good antibacterial effect on Streptococcus viridans, and is better than penicillin on Enterococcus and Listeria spp. This product has antibacterial activity against Corynebacterium diphtheriae, Bacillus anthracis, Actinomycetes, Haemophilus influenzae, Bordetella pertussis, Neisseria and anaerobic bacteria except Bacteroides fragilis. Some Proteus mirabilis, Escherichia coli, Salmonella and Shigella bacteria are sensitive to this product. Ampicillin exerts a bactericidal effect by inhibiting bacterial cell wall synthesis. [Pharmacokinetics] Intramuscular injection of 0.5g of this product, the peak blood concentration (Cmax) will reach 12mg/L within 0.5 to 1 hour, and the blood concentration will be 0.5mg/L within 6 hours. The blood drug concentration at 15 minutes and 4 hours after intravenous injection of 0.5 g was 17 mg/L and 0.6 mg/L, respectively. Neonates and premature infants were intramuscularly injected with 10 mg/kg and 25 mg/kg according to their body weight, and the plasma concentration reached the peak value of 20 mg/L and 60 mg/L, respectively. The blood concentration of pregnant women is significantly lower than that of non-pregnancy. This product is well distributed in the body. Patients with bacterial meningitis are intravenously injected 150mg/kg according to their body weight every day. The concentration in the cerebrospinal fluid can reach 2.9mg/L in the first 3 days, and it will decrease with the reduction of inflammation. Normal cerebrospinal fluid contains only a small amount of ampicillin. This product can penetrate the placental barrier and reach a certain concentration in the amniotic fluid. The concentration in bronchial secretions of patients with lung infection is 1/50 of the blood concentration in the same period. There are considerable amounts of this product in pleural and ascites, aqueous humor, joint effusion, and breast milk. The average concentration in the bile of typhoid fever carriers is more than three times the blood concentration, and the highest can reach 17.8 times. The serum protein binding rate of this product is 20%, the blood elimination half-life (t1/2?) is 1 to 1.5 hours, the t1/2? of newborns is 1.7 to 4 hours, and patients with renal insufficiency can be extended to 7 to 20 hours. The ampicillin excreted in the urine 24 hours after intramuscular injection and intravenous injection is 50% and 70% of the dose, respectively. A small amount is metabolized in the liver or excreted through bile. This product can be removed by hemodialysis, but peritoneal dialysis cannot remove this product.
[Storage] Keep tightly sealed and stored in a dry place.