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BICILLIN L-A
Overview
What is BICILLIN L-A?
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 of penicillin G. It is chemically designated as (2, 5, 6)-3,3-Dimethyl-7-oxo-6-(2-phenylacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid compound with
dibenzylethylenediamine (2:1), tetrahydrate. It occurs as a white, crystalline powder and is very slightly soluble in water and sparingly soluble in alcohol. Its chemical structure is as follows:
Bicillin L-A contains penicillin G benzathine in aqueous suspension with sodium citrate buffer and, as w/v, approximately 0.5% lecithin, 0.6% carboxymethylcellulose, 0.6% povidone, 0.1% methylparaben, and 0.01% propylparaben.
Bicillin L-A suspension in the disposable-syringe formulation is viscous and opaque. It is available in a 1 mL, 2 mL, and 4 mL sizes containing the equivalent of 600,000, 1,200,000 and 2,400,000 units respectively of penicillin G as the benzathine salt. Read , , , and sections prior to use.
What does BICILLIN L-A look like?
What are the available doses of BICILLIN L-A?
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What should I talk to my health care provider before I take BICILLIN L-A?
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How should I use BICILLIN L-A?
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.
Intramuscular penicillin G benzathine is indicated in the treatment of infections due to penicillin-G-sensitive microorganisms that are susceptible to the low and very prolonged serum levels common to this particular dosage form. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response.
The following infections will usually respond to adequate dosage of intramuscular penicillin G benzathine:
Mild-to-moderate infections of the upper-respiratory tract due to susceptible streptococci.
Venereal infections
Medical Conditions in which Penicillin G Benzathine Therapy is indicated as Prophylaxis:
Rheumatic fever and/or chorea
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
Prophylaxis
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.
What interacts with BICILLIN L-A?
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What are the warnings of BICILLIN L-A?
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What are the precautions of BICILLIN L-A?
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What are the side effects of BICILLIN L-A?
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 have been reported with parenteral penicillin G:
General:
Gastrointestinal:
Hematologic:
Neurologic:
Urogenital:
The following adverse events have been temporally associated with parenteral administration of penicillin G benzathine:
Body as a Whole:
Cardiovascular:
Gastrointestinal:
Hemic and Lymphatic:
Injection Site:
Metabolic:
Musculoskeletal:
Nervous System:
Respiratory:
Skin:
Special Senses:
Urogenital:
What should I look out for while using BICILLIN L-A?
A history of a previous hypersensitivity reaction to any of the penicillins is a contraindication.
What might happen if I take too much BICILLIN L-A?
Penicillin in overdosage has the potential to cause neuromuscular hyperirritability or convulsive seizures.
How should I store and handle BICILLIN L-A?
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAProduct: 50090-1016NDC: 50090-1016-0 2 mL in a SYRINGE NDC: 50090-1016-1 2 mL in a SYRINGE Product: 50090-1666NDC: 50090-1666-0 1 mL in a SYRINGE Product: 50090-1016NDC: 50090-1016-0 2 mL in a SYRINGE NDC: 50090-1016-1 2 mL in a SYRINGE Product: 50090-1666NDC: 50090-1666-0 1 mL in a SYRINGE Product: 50090-1016NDC: 50090-1016-0 2 mL in a SYRINGE NDC: 50090-1016-1 2 mL in a SYRINGE Product: 50090-1666NDC: 50090-1666-0 1 mL in a SYRINGE Product: 50090-1016NDC: 50090-1016-0 2 mL in a SYRINGE NDC: 50090-1016-1 2 mL in a SYRINGE Product: 50090-1666NDC: 50090-1666-0 1 mL in a SYRINGE Product: 50090-1016NDC: 50090-1016-0 2 mL in a SYRINGE NDC: 50090-1016-1 2 mL in a SYRINGE Product: 50090-1666NDC: 50090-1666-0 1 mL in a SYRINGE
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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 and slow absorption results in blood serum levels much lower but much more prolonged than other parenteral penicillins.
Intramuscular administration of 300,000 units of penicillin G benzathine in adults results in blood levels of 0.03 to 0.05 units per mL, which are maintained for 4 to 5 days. Similar blood levels may persist for 10 days following administration of 600,000 units and for 14 days following administration of 1,200,000 units. Blood concentrations of 0.003 units per mL may still be detectable 4 weeks following administration of 1,200,000 units.
Approximately 60% of penicillin G is bound to serum protein. The drug is distributed throughout the body tissues in widely varying amounts. Highest levels are found in the kidneys with lesser amounts in the liver, skin, and intestines. Penicillin G penetrates into all other tissues and the spinal fluid to a lesser degree. With normal kidney function, the drug is excreted rapidly by tubular excretion. In neonates and young infants and in individuals with impaired kidney function, excretion is considerably delayed.
Non-Clinical Toxicology
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.
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 of drug-resistant bacteria.
Penicillin should be used with caution in individuals with histories of significant allergies and/or asthma.
Care should be taken to avoid intravenous or intra-arterial administration, or injection into or near major peripheral nerves or blood vessels, since such injection may produce neurovascular damage. (See , and sections.)
Prolonged use of antibiotics may promote the overgrowth of nonsusceptible organisms, including fungi. Should superinfection occur, appropriate measures should be taken.
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 have been reported with parenteral penicillin G:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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