Amsapen 500mg INJECTABLE SOL, Ampicillin
Ampicillin is indicated in the treatment of various acute, chronic or recurrent caused by organisms susceptible to ampicillin.
- Genitourinary tract infections, such as gonorrhea and other infections of upper and lower urinary tract.
- Respiratory tract infections such as acute otitis media, sinusitis, pharyngitis, bronchitis and pneumonia.
- Gastrointestinal tract infections like typhoid and paratyphoid Salmonella and Shigella.
- Bordetella pertussis Infections
- Infections of skin and soft tissue.
- Infections of the biliary tract.
- Infections ginecoobstétricas.
Besides being useful in treating infections such as septicemia, meningitis and endocarditis.
Pharmacokinetics HUMAN: Ampicillin is a broad-spectrum semisynthetic penicillin, which can be used orally and parenterally.
Absorption of ampicillin not altered gastric acid medium, after oral administration are absorbed in 30-60% and the blood levels are reached after 90 to 120 minutes.
It has a plasma half life of 1 to 2 hours.
Ampicillin penetrates tissues, crosses the placental barrier and is excreted in breast milk.
Ampicillin binds to plasma proteins by 10-30%, spreading rapidly to all body fluids and tissues, reaching high concentrations in urine and bile.
In the cerebrospinal fluid and in the intact meninges reached only 5% of the plasmatic levels, however, in cases where the meninges are inflamed can increase to 50% of plasma levels.
Excretion is primarily by the kidney as unchanged ampicillin, and 10 to 20% of the amount absorbed (or of an injected dose) is metabolized to penicillin acid, then excreted in the bile and feces. Also crosses the placental barrier and can be excreted through breast milk.
Following a 500 mg dose, serum levels are 45 mg / ml, within the first 5 minutes after being administered intravenously and 8 ug / ml within one hour, when administered intramuscularly.
Ampicillin is effective against Gram-positive and Gram-negative. Is active in vitro against Haemophilus influenzae, Bordetella pertussis, Neisseria gonorrhoeae, N. meningitidis, Salmonella typhi, Proteus mirabilis not producing penicillinase, Shigella, Escherichia coli, some strains of Klebsiella, Streptococcus faecalis and Listeria monocytogenes.
CONTRAINDICATIONS: Ampicillin is contraindicated in patients with known hypersensitivity to any penicillin or cephalosporin, since cross-sensitivity may occur between them.
PRECAUTIONS crops is recommended to determine the susceptibility and causative pathogen and its sensitivity to ampicillin.
Patients with infectious mononucleosis can often develop skin rashes when using ampicillin.
Antibiotic therapy with high doses and over time may develop superinfections by fungi and bacteria.
Ampicillin should be taken preferably in fasting (empty stomach) and with water (a glass of 250 ml), to ensure maximum absorption and promote optimal plasma and urinary concentrations.
In beta hemolytic streptococcus infections in group B, treatment with ampicillin should be continued at least for 10 days to prevent the risk of rheumatic fever.
The doctor will make chronic treatment it deems relevant.
RESTRICTIONS OF USE DURING PREGNANCY AND BREASTFEEDING Ampicillin cross the placental barrier and is excreted in breast milk, so infants whose mothers are treated with this medicine, may have diarrhea and blastomycetes colonization of mucosal so that treatment with ampicillin in nursing mothers should be supervised by a doctor. Not The safety of ampicillin during pregnancy, so its use is under the responsibility of the treating physician, who has assessed that the benefits outweigh the risks.
ADVERSE REACTIONS: Ampicillin is generally well tolerated, so that adverse reactions are mild, but like any other penicillin, can cause hypersensitivity reactions can be mild to severe. They may appear in order of decreasing frequency the following manifestations: maculopapular rash or rash, erythema and sometimes gastrointestinal disorders, blood disorders, urticaria, drug fever, interstitial nephritis and other allergies with bronchospasm, vasculitis, serum sickness, exfoliative dermatitis , Stevens-Johnson syndrome. Rarely, anaphylaxis and shock, if this occurs, to reduce its severity and avoid fatal consequences, it is necessary to go to the emergency room of a hospital and emergency treatment measures such as the use of epinephrine, steroids, intravenous fluids, oxygen and including endotracheal intubation, depending on the severity of the case.
It has been shown that there is cross-allergenicity with other beta-lactam antibiotics and carbapenems.
In rare cases has been associated with ampicillin renal tubular damage and interstitial nephritis, and eosinophilia, hemolytic anemia and abnormal liver enzymes SGOT and SGPT. If renal function is restricted, the dose should be reduced according to creatinine clearance.
There is a possibility of occurrence of pseudomembranous colitis, in such a case should be discontinued immediately ampicillin.
Locally thrombophlebitis can occasionally after or during infusion and local pain at the site of intramuscular injection.
DRUG INTERACTIONS AND OTHER GENDER: Oral administration with food decreases the bioavailability of ampicillin absorption. His administration has been associated with a temporary reduction in plasma levels of estrogen during treatment with oral contraceptives (anovulatory).
Probenecid increases and prolongs blood levels, reducing the time of excretion of ampicillin. The administration of ampicillin to patients who are taking allopurinol increases the incidence of rashes.
Aminoglycosides and tetracycline derivatives injectable are not chemically compatible with ampicillin solution in simultaneous administration in a single solution for infusion, therefore, be administered separately.
CHANGES IN RESULTS OF LABORATORY TESTS glycosuria may occur false-positive, false positive reactions nilhidrina tests as well as tests of urobilinogen.
There may be isolated cases with elevated SGOT, SGPT, alkaline phosphatase once or several times at once.
In case of prolonged treatment with high doses, it has been observed hemático profile modification, these changes disappear after discontinuing treatment.
During intravenous treatment with high doses crystalluria may occur.
PRECAUTIONS IN RELATION TO EFFECTS Carcinogenesis, Mutagenesis, Impairment of Fertility: To date there is no documented effects of carcinogenicity, mutagenicity, teratogenicity or fertility with the use of ampicillin.
DOSAGE AND ADMINISTRATION:
When deciding ampicillin orally (tablets):
Children: Up to 14 years of age, the recommended dose is 100 to 200 mg / kg, divided into 4 doses (one every 6 hours) for a period of not less than 7 days.
Adults: 500 mg to 1 g orally every 6 hours for 7 to 10 days depending on the type of infection and the severity of the disease.
Gonorrhea: 3.5 g of ampicillin simultaneously with 1 g probenecid, both orally as a single dose.
If the decision of the physician is to use intravenous ampicillin:
Mixing the powder with the diluent should be used within the first 60 minutes after reconstitution, also the solution for injection should be visually inspected to determine the possible presence of particles or change in color, among others.
Children: 25 to 50 mg / kg every 6 to 8 hours, intramuscularly or intravenously.
Adults: 500 mg to 1 g every 6 to 8 hours by intramuscular injection or intravenous slow for a period of 3 to 5 minutes to a vial of 500 mg, and up to 10 minutes or more for the dosage of 1 g , or you can install an IV.
Rapid administration can cause seizures.
For administration by intravenous drip powder is reconstituted continuous intravenous infusion, dissolving the contents of the vial of 500 mg in 2 ml and 1 g in 5 ml water for injection. Once the mixture is transferred directly to the corresponding intravenous fluids.
In case of Neisseria gonorrhoeae urethritis sufficient dose of 500 mg administered IM one every 12 hours, for the treatment of gonococcal urethritis complications as prostatitis and epididymitis, prolonged treatment is recommended.
Infections in adults with seeds relatively insensitive, the dose may be increased up to 15 g by infusion.
MANIFESTATIONS AND MANAGEMENT OF OVERDOSE AND ACCIDENTAL INGESTION: Discontinue drug overdoses and instituting giving symptomatic supportive measures as required.
High doses may cause cramps and convulsions.
In cases of renal impairment or intoxication, ampicillin can be removed by hemodialysis but not peritoneal dialysis.
For the content of parenteral ampicillin sodium, electrolytes should be monitored to avoid the presence of relatively hypernatremia.
Drug Name: Ampicillin
Comparable patent medicine: PENTREXYL
Active Ingredients: Ampicillin
Presentation: Solution injectable
Prolonged release tablets: No
Laboratory: Laboratory PISA
Box with vial with powder and diluent vial with 2ml
Made in Mexico