Model:7501349022942
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Bencilpenicilina Sodica Cristalina 1,000,000U INJ SOL 1 AMP Penicillin
Dosage form:
Each bottle contains powder ampoule:
Crystalline sodium penicillin .............................. 1,000,000 U
The vial with diluent containing 2 ml.
Each bottle contains powder ampoule:
Crystalline sodium penicillin .............................. 5,000,000 U
The vial with diluent containing 2 ml.
INDICATIONS: BENZYLPENICILLIN CRYSTAL SODIUM is a useful antibiotic in the treatment of diseases caused by susceptible microorganisms such as actinomycosis, Anthrax, gonococcal arthritis, and pneumococcal bacteremia sensitive streptococci; clostridial infections, active prevention of diphtheria carrier state; pneumococcal empyema, bacterial endocarditis, gonorrhea, Listeria infections, meningitis and strep sensitive pneumococci; Pasteurella infections, pneumococcal pericarditis, strep throat, pneumonia, rat bite fever, staphylococcal and streptococcal infections and syphilis and gonorrhea and periodontitis.
It has been used in conditions such as anaerobic infections, Behçet disease prophylaxis in burn wounds and other, dog bite, bacterial endophthalmitis, infection by Fusobacterium, preservation of organs for transplantation, leptospirosis, stomatitis Leptotrichia, Lyme disease prevention and treatment of ocular diseases, osteomyelitis, premature rupture of membranes, rheumatic fever prophylaxis, prophylaxis of group B streptococcus prophylaxis in surgery and Whipple's disease; however, its usefulness is limited.
Contraindications Penicillin is totally contraindicated in persons with a history or past incidents of allergic reactions including anaphylaxis, serum sickness, etc. It should also be exercised in patients with a history of atopy, renal failure or epilepsy.
WARNINGS: Caution should be exercised in individuals with a history of allergies, especially to cephalosporins or other antibiotics, the penicillin type.
RESTRICTIONS OF USE DURING PREGNANCY AND BREASTFEEDING
Risk Category B: Because BENZYLPENICILLIN CRYSTAL SODIUM crosses the placenta should evaluate the utility of their use against the likely risks to the product.
ADVERSE REACTIONS: The administration of BENZYLPENICILLIN CRYSTAL SODIUM can cause hemolytic anemia, massive intravascular hemolysis, eosinophilia, granulocytopenia, leukopenia, neutropenia, agranulocytosis, and coagulation defects.
Cardiovascular: in patients allergic to penicillin, has observed the development of myocardial infarction, heart failure, asystole and ventricular fibrillation, allergic myocarditis and periarteritis nodosa.
Central Nervous System: With IV administration, have been reported muscle twitching, myoclonic twitching, and convulsions. Rarely has also been reported neuromuscular blockade associated with headache and papilledema, pseudotumor cerebri, and neuropathy, and myelitis.
Endocrine disorders: CRYSTAL SODIUM BENZYLPENICILLIN may induce hypokalemia, hypernatremia, porphyria and elevation in the secretion of growth hormone.
Gastrointestinal: Using BENZYLPENICILLIN CRYSTAL SODIUM has been associated with abdominal pain, cramping, pseudomembranous colitis and tongue discoloration.
Respiratory: Use of BENZYLPENICILLIN CRYSTAL SODIUM has been associated with the occurrence of pneumonitis.
Genitourinary: In some patients have been reported cases of development of acute interstitial nephritis. Infertility has also been observed, especially in men.
Liver: BENZYLPENICILLIN CRYSTAL SODIUM can cause cholestatic hepatitis with or without hepatitis, lupoid hepatitis and jaundice.
Skin: CRYSTAL SODIUM BENZYLPENICILLIN can induce the onset of rash, urticaria, Stevens-Johnson syndrome, Dermografía, loose skin, tissue necrosis and pemphigus.
Other adverse effects include anaphylaxis, crossed with penicillamine sensitivity, hypersensitivity reactions and serum sickness.
DRUG INTERACTIONS: Co-administration of BENZYLPENICILLIN CRYSTAL SODIUM with aminoglycosides can lead to inactivation of the latter; acetylcysteine ​​reduces the effectiveness of the penicillin.
Chloramphenicol and tetracyclines have an antagonistic effect on the action of penicillin, while the latter enhances the toxicity of methotrexate.
Altering the balance of intestinal flora leads to the modification of the enterohepatic circulation of oral contraceptives.
Penicillin removal decreases with administration of probenecid. BENZYLPENICILLIN crystalline sodium can be administered in combination with parenteral nutrition, dextran solutions, dextrose and saline.
PRECAUTIONS IN RELATION TO EFFECTS Carcinogenesis, Mutagenesis, Impairment of Fertility: Caution should be used in people with a history of allergies, especially to cephalosporins or other antibiotics.
No alterations have been reported carcinogenicity, mutagenicity, teratogenicity or fertility.
DOSAGE AND ADMINISTRATION: I. M. and I.V.
Penicillin is dosed in International Units (IU). One unit of activity is equivalent to 0.6 mcg of pure sodium penicillin.
Adults: The dose for the IV, varies according to the type of organism, its sensitivity, the severity of the infection and its localization. The usual doses are 1 to 4 million IU every 4 to 6 hours.
In severe infections may be administered every 2 to 3 hours. For severe infections, such as bacterial meningitis can be used higher doses, reaching 2 to 3 million every 3 hours.
children:
For premature and up to one week of age: 30 mg / kg every 12 hours is recommended.
For children 2 to 4 weeks: 30 mg / kg every 8 hours is recommended.
In children under 12 years: The recommended dose of CRYSTAL SODIUM BENZYLPENICILLIN are 25.000 to 400.000 IU / kg per day, administered every 4 to 6 hours.
In over 12 years are recommended 25,000 to 400,000 IU / kg per day every 4-6 hours. The maximum recommended pediatric dose is 500,000 IU / kg / day.
MANIFESTATIONS AND MANAGEMENT OF OVERDOSE OR ACCIDENTAL INGESTION: Low toxicity of penicillin allows use in a very wide margin.
RECOMMENDED STORAGE: Store at room temperature to no more than 30 ° C and dry temperature.
