Xtapen Injection## (strength format)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bicillin L-A and other antibacterial drugs, Bicillin L-A should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. …

• Streptococcal (Group A) Upper Respiratory Infections (for example, pharyngitis)
• Adults—a single injection of 1,200,000 units; older pediatric patients—a single injection of 900,000 units; infants and pediatric patients under 60 lbs.—300,000 to 600,000 units
• Syphilis Primary, secondary, and latent—2,400,000 units (1 dose)
• Late (tertiary and neurosyphilis)—2,400,000 units at 7-day intervals for three doses
• Congenital—under 2 years of age: 50,000 units/kg/body weight; ages 2 to 12 years: adjust dosage based on adult dosage schedule
• Yaws, Bejel, and Pinta —1,200,000 units (1 injection)
• Prophylaxis —for rheumatic fever and glomerulonephritis
• Following an acute attack, penicillin G benzathine (parenteral) may be given in doses of 1,200,000 units once a month or 600,000 units every 2 weeks
• METHOD OF ADMINISTRATION BICILLIN L-A IS INTENDED FOR INTRAMUSCULAR INJECTION ONLY
• DO NOT INJECT INTO OR NEAR AN ARTERY OR NERVE, OR INTRAVENOUSLY OR ADMIX WITH OTHER INTRAVENOUS SOLUTIONS. (SEE WARNINGS SECTION.) Administer by DEEP INTRAMUSCULAR INJECTION in the upper, outer quadrant of the buttock (dorsogluteal) or the ventrogluteal site
• In neonates, infants and small children, the midlateral aspect of the thigh may be preferable
• Administration in the anterolateral thigh is not recommended due to the adverse effects observed (see WARNINGS section), and vascularity of this region
• When doses are repeated, vary the injection site
• Because of the high concentration of suspended material in this product, the needle may be blocked if the injection is not made at a slow, steady rate. …

(See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections.)

Clinical studies of penicillin G benzathine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. …

• Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued
• Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic
• If this occurs, patients should contact their physician as soon as possible
• Patients should be counseled that antibacterial drugs including Bicillin L-A should only be used to treat bacterial infections
• They do not treat viral infections (e.g., the common cold). …

A history of a previous hypersensitivity reaction to any of the penicillins is a contraindication.

Tetracycline, a bacteriostatic antibiotic, may antagonize the bactericidal effect of penicillin, and concurrent use of these drugs should be avoided. Concurrent administration of penicillin and probenecid increases and prolongs serum penicillin levels by decreasing the apparent volume of distribution and slowing the rate of excretion by competitively inhibiting renal tubular secretion of penicillin.

WARNING NOT FOR INTRAVENOUS USE. DO NOT INJECT INTRAVENOUSLY OR ADMIX WITH OTHER INTRAVENOUS SOLUTIONS. THERE HAVE BEEN REPORTS OF INADVERTENT INTRAVENOUS ADMINISTRATION OF PENICILLIN G BENZATHINE WHICH HAS BEEN ASSOCIATED WITH CARDIORESPIRATORY ARREST AND DEATH. Prior to administration of this drug, carefully read the WARNINGS , ADVERSE REACTIONS , and DOSAGE AND ADMINISTRATION sections of the labeling. Penicillin G benzathine should only be prescribed for the indications listed in this insert. Anaphylaxis SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. …

As with other penicillins, untoward reactions of the sensitivity phenomena are likely to occur, particularly in individuals who have previously demonstrated hypersensitivity to penicillins or in those with a history of allergy, asthma, hay fever, or urticaria. As with other treatments for syphilis, the Jarisch-Herxheimer reaction has been reported. The following adverse reactions have been reported with Bicillin L-A during post-marketing experience: Skin and Appendages: Stevens-Johnson syndrome (SJS) and drug reaction with eosinophilia and systemic symptoms (DRESS). …

Pregnancy Teratogenic effects Pregnancy Reproduction studies performed in the mouse, rat, and rabbit have revealed no evidence of impaired fertility or harm to the fetus due to penicillin G. Human experience with the penicillins during pregnancy has not shown any positive evidence of adverse effects on the fetus. …

Penicillin in overdosage has the potential to cause neuromuscular hyperirritability or convulsive seizures.

Store in a refrigerator, 2° to 8°C (36° to 46°F). Keep from freezing.

Prenez-le dès que vous y pensez, sauf s'il est presque l'heure de la dose suivante. Dans ce cas, sautez la dose oubliée. Ne prenez jamais deux doses à la fois pour compenser. Vérifiez votre notice, certains médicaments font exception.