BINOTAL (Ampicillin) 500 mg 20 CAPS
In stock: 64 units
INDICATIONS: Bacterial infections of the most variable locations, severity and course of ampicillin-sensitive agents, both acute and chronic relapsing also different degrees of severity, for example:
• sepsis, endocarditis and meningitis, mostly in Haemophilus influenzae, Listeria and enterococci sensitive to ampicillin, if necessary in combination with other suitable antibiotic.
• respiratory tract infections.
• Bordetella pertussis (early treatment and prophylaxis) in childhood.
• Infections of the urinary tract.
• Infections in gynecology and obstetrics.
• biliary tract infections.
• bacterial intestinal infections by Salmonella, Shigella and E. coli.
• Treatment constant carrier-typhi Salmonella.
Serious infections, eg sepsis, endocarditis, meningitis, obstetric and gynecological infections of Salmonella carriers may initially require parenteral administration. Subsequently, oral therapy is continued.
In dentistry: Prophylaxis and treatment of infections of the oral cavity. BINOTAL ® can be administered during pregnancy.
Pharmacokinetics HUMAN BINOTAL ® is stable in presence of gastric acid so it can be administered orally.
After the housing management BINOTAL ® 1 g of 30-60% is absorbed with peak plasma concentrations after 90-120 minutes corresponding to approximately 5 ug / ml. The plasma half-life is 1-2 hours. After intramuscular administration, the peak plasma concentration is reached between 30-60 minutes, corresponding to 10-12 mg / ml after application IM 500 mg BINOTAL ®.
Ampicillin diffuses in most fluids and tissues, however, cerebrospinal fluid enters the meninges intact in only 5% relative to plasma concentration and 50% in inflamed meninges. It also crosses the placenta and is excreted in breast milk. The volume of distribution is 0.2-0.4 l / kg, ampicillin binds to plasma proteins by 10-30%. Excretion is primarily by renal excretion as unchanged, but also through the bile and feces. Aproximadamete 10-20% of the amount absorbed penicillin acid is metabolized. In bile reaches 1.5 to 12 times in serum, if there is no cholestasis.
CONTRAINDICATIONS: BINOTAL ® is contraindicated in patients with known or suspected hypersensitivity to penicillins and / or components of the formula. Should not be used in patients susceptible to cephalosporins because of the risk of cross-hypersensitivity. In patients with infectious mononucleosis and other viral diseases as well as in leukemia is also contraindicated.
PRECAUTIONS: allergic diathesis. Possibly cephalosporins cross hypersensitivity. Its use during pregnancy and / or lactation only if indicated by the treating physician. Should be avoided BINOTAL ® housing management in patients with infectious mononucleosis, other viral diseases and leukemia.
RESTRICTIONS OF USE DURING PREGNANCY AND BREASTFEEDING Ampicillin cross the placental barrier and is excreted in breast milk. No known human teratogenic effects ampicillin, so its use during pregnancy and lactation is possible if there is a justified indication. Administration of ampicillin during the first trimester of pregnancy should be done under the supervision of the attending physician.
Because ampicillin is excreted in small amounts in breast milk in infants whose mothers were treated with ampicillin, may have diarrhea and mucosal colonization by Candida. Therefore, the use of BINOTAL ® in lactating women should be supervised by a physician to monitor the reactions of the infant.
ADVERSE REACTIONS: Skin reactions (morbilliform, erythema, etc..), Gastrointestinal disorders.
Rare: Blood disorders, drug fever, interstitial nephritis and other allergic manifestations, are rare anaphylactic reactions including shock. Seizures (dose adjustment is required if renal function is compromised according to creatinine clearance). If pseudomembranous colitis is suspected (persistent severe diarrhea), discontinue the drug and institute appropriate treatment.
BINOTAL ® Injection: Reactions at the site of administration, thrombophlebitis.
DRUG INTERACTIONS AND OTHER GENDER BINOTAL ® administration in the span of two hours after administration of adsorbents such as kaolin, reduces the absorption and thus bioavailability of ampicillin. BINOTAL ® administration may temporarily decrease in plasma concentrations of estrogens and progestins, therefore, can reduce protection against pregnancy in patients treated with anovulatory.
Coadministration of probenecid leads to reduced renal clearance, with increased and prolonged blood levels of ampicillin in the serum and in the bile.
Injectable aminoglycosides and tetracycline derivatives are incompatible with BINOTAL ® solution, therefore, be administered separately.
The dextrose solutions are suitable for dilution BINOTAL ®. Simultaneous administration of food may decrease the absorption of ampicillin.
CHANGES IN RESULTS OF LABORATORY TESTS reactions may false-positive tests nilhidrina, enzymatic reactions of glucose in urine and urobilinogen tests. In rare cases can occur reversible increase of liver enzyme values as ALT, AST and ALP.
In individual cases have been observed profile changes hemático especially high doses and prolonged treatment.
These changes resolve after stopping the medication, in rare cases may appear low crystalluria intravenous administration of high doses.
PRECAUTIONS IN RELATION TO EFFECTS Carcinogenesis, Mutagenesis, Impairment of Fertility: There is no evidence to date of carcinogenicity, mutagenicity, teratogenicity or impairment of fertility.
DOSAGE AND ADMINISTRATION:
Adults and children over 14 years: 500 mg to 1 g every 6 hours, administered in any dosage forms, capsules, tablets or suspension. For smaller seeds sensitivity, the dose may be increased to 2 g every 6 hours depending on the process and after evaluation of the benefit-risk.
The recommended dose reduced in patients with impaired renal glomerular filtration rate of 30 ml / min or less. The daily dose of 500 mg every 8 hours should not be exceeded in ESRD. It should be considered that during pregnancy plasma levels are up to 50% lower, especially after oral administration. In individual cases this could mean that it requires twice the usual dose.
Children: 100-150 mg / kg / day every 6 hours.
For children up to age 14 weight recommended dose is 100 to 200 mg / kg per day divided into 4 doses (administered every 6 hours).
1-2 tablespoons c / 6 hrs.
1 Tbsp. c / 6 hrs.
1-2 Tbsp. c / 6 hrs.
1 Tbsp. c / 6 hrs.
2 caps. c / 6 hrs.
1 caps. c / 6 hrs.
1-2 caps. c / 6 hrs.
1 comp. c / 6 hrs.
Optimally oral BINOTAL ® should be taken on an empty stomach, ie ½ to 1 hour before or 2 to 3 hours after meals. BINOTAL ® should be administered for a period of not less than seven days in streptococcal infections should be administered for 10 days and salmonella infections, for 14 days.
• Sepsis, endocarditis and meningitis: 2-4 g every 6 hours.
• respiratory tract infections: 500 mg to 1 g every 6 hours.
• Urinary tract infections: 500 mg to 2 g every 6 hours.
• obstetric and gynecological infections: 1-5 g every 6 hours.
• Infections of the biliary tract: 1-2 g every 6 hours.
• Gastrointestinal infections: 1-2 g every 6 hours.
• carry salmonella: 2-4 g every 6 hours.
The daily dose can be increased as necessary depending on the clinical picture and severity of the disease. The average dose is 500 mg to 2 g every 6 hours and less sensitivity to pathogens and severe infections up to 5 or more grams every 6 hours.
The average dose is, thus, 500 mg to 2 g every 8 hours and less susceptible to pathogens and severe infections up to 5 or more grams every 8 hours.
Children: 100 to 150 mg / kg / day in 4 applications.
3 to 6 months (5 to 7 kg): 250 mg every 6 hours.
6 to 12 months (7-10 kg): 250 mg every 6 hours.
1-3 years (10-14 kg): 500 mg every 6 hours.
3-6 years (14-20 kg): 500 mg every 6 hours.
Daily doses may be increased to 200 to 400 mg / kg / day, if necessary, especially if the type and severity of the infection requires it, as in meningitis.
Premature infants: The recommended dose in the first days of life is 50 mg / kg / dose.
In severe infections, apply the same upper limits of children.
Dosage for patients with impaired renal function: In patients with creatinine clearance of 20-30 ml / min, the standard dose should be reduced to 2/3, with a clearance <20 ml / min, should be reduced by ½. As a general rule, a dose of 1 g every 8 hours BINOTAL ® should not be exceeded in ESRD.
Doses during pregnancy should be considered during pregnancy plasma levels are up to 50% lower, especially after oral administration. In individual cases, this could mean that you must not exceed the usual dose, recommended and so should not be exceeded especially with parenteral administration (which corresponds to the maximum standard dose in renal failure).
BINOTAL ® should be administered for a period of not less than seven days in streptococcal infections should be administered for 10 days and salmonella infections, for 14 days.
Mode of administration:
BINOTAL ® is usually administered as IV The powder is dissolved in the specified amount of water for injection 2 ml and 5 ml 500 mg to 1 g.
BINOTAL ® Solution is incompatible with aminoglycosides and tetracycline derivatives. The visual signs of incompatibility are sedimentation, turbidity and discoloration.
MANIFESTATIONS AND MANAGEMENT OF OVERDOSE OR ACCIDENTAL INGESTION For ampicillin and other penicillins, extremely high serum concentrations can cause neurotoxic reactions (seizures), requiring discontinuation of treatment. BINOTAL ® can hemodializarse.
BINOTAL ® Capsules:
Box with 20 capsules of 250 mg.
Box with 20 capsules of 500 mg.
BINOTAL ® Tablets:
Box with 12 tablets of 1 g.
BINOTAL ® Suspension:
Powder for suspension with ampicillin 500 mg / 5 ml.
To 90 ml bottle.
Powder for suspension with ampicillin 250 mg / 5 ml. 90-ml bottle.
Powder for suspension with ampicillin 125 mg / 5 ml. To 90 ml bottle.
BINOTAL ® Injection:
Box with vial of 500 mg and a vial of 2 ml of sterile water for injection.
Box with vial of 1 g and 5 ml vial of sterile injectable water.
BINOTAL ® Capsules: Store at room temperature not exceeding 30 ° C and dry.
Drug Name: Binotal
Comparative Brand: Binotal
Active ingredient: Ampicillin
Response time: No
Lab: Bayer de Mexico, SA de CV
Box 20 Capsules
Manufactured in: Mexico