BICILLIN L-A Suspension for injection (2021)

Βιβλιογραφική αναφορά

Συγγραφείς

Pfizer Laboratories Div Pfizer Inc

Λέξεις κλειδιά

60793-700 60793-701 60793-702

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BOXED WARNING SECTION

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 ...

1. Description

Bicillin L-A (penicillin G benzathine injectable suspension) is available for deep intramuscular injection. Penicillin G benzathine is prepared by the reaction of dibenzylethylene diamine with two molecules ...

2. Clinical Pharmacology

General Penicillin G benzathine has an extremely low solubility and, thus, the drug is slowly released from intramuscular injection sites. The drug is hydrolyzed to penicillin G. This combination of hydrolysis ...

3. Indications and Usage

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 ...

4. Contraindications

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

5. Warnings

6.1. General

Prescribing Bicillin L-A in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of a development ...

6.2. Information for 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 ...

6.3. Laboratory Tests

In streptococcal infections, therapy must be sufficient to eliminate the organism; otherwise, the sequelae of streptococcal disease may occur. Cultures should be taken following completion of treatment ...

6.4. Drug Interactions

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 ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been conducted with this drug.

6.7. 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 ...

6.9. Nursing Mothers

Soluble penicillin G is excreted in breast milk. Caution should be exercised when penicillin G benzathine is administered to a nursing woman.

6.10. Pediatric Use

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

6.11. Geriatric Use

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 ...

7. Adverse Reactions

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 ...

9. Overdosage

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

10. Dosage and Administration

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 ...

11. How Supplied

Bicillin L-A (penicillin G benzathine injectable suspension) is supplied in packages of 10 disposable syringes as follows: 1 mL size, containing 600,000 units per syringe, (21 gauge, thin-wall 1 inch needle ...

12. Storage and Handling

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

14. References

SHAW, E.: Transverse myelitis from injection of penicillin. Am. J. Dis. Child., 111:548, 1966. KNOWLES, J.: Accidental intra-arterial injection of penicillin. Am. J. Dis. Child., 111: ...