Benzathine benzylpenicillin/procaine benzylpenicillin

What is Benzathine benzylpenicillin/procaine benzylpenicillin?

• Benzathine benzylpenicillin/procaine benzylpenicillin (Bicillin CR) contains equal amounts of the benzathine and procaine salts of penicillin G is an antibiotic medication.

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Benzathine benzylpenicillin

What are the uses of this medicine?

Benzathine benzylpenicillin/procaine benzylpenicillin (Bicillin CR) is indicated in the treatment of the following in adults and pediatric patients:

• Moderately severe to severe infections of the upper-respiratory tract, scarlet fever, erysipelas, and skin and soft-tissue infections due to susceptible streptococci.
• Moderately severe pneumonia and otitis media due to susceptible pneumococci.

Limitations of use:

• This drug should not be used in the treatment of venereal diseases, including syphilis, gonorrhea, yaws, bejel, and pinta.
• Antibiotics such as penicillin G benzathine and penicillin G procaine injection will not work for colds, flu, or other viral infections.
• Penicillin G benzathine and penicillin G procaine injection should not be used to treat sexually transmitted diseases (STD) or early in the treatment of certain serious infections.

How does this medicine work?

• Penicillin G benzathine and penicillin G procaine have a low solubility and, thus, the drugs are slowly released from intramuscular injection sites.
• The drugs are hydrolyzed to penicillin G.
• This combination of hydrolysis and slow absorption results in blood serum levels much lower but more prolonged than other parenteral penicillins.
• Penicillin G exerts a bactericidal action against penicillin-susceptible microorganisms during the stage of active multiplication.
• It acts through the inhibition of biosynthesis of cell-wall mucopeptide.
• It is not active against the penicillinase-producing bacteria, which include many strains of staphylococci.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• hypersensitivity reaction to any penicillin or to procaine

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention the following:

• probenecid (Probalan) and tetracycline (Achromycin)

Is this medicine FDA approved?

• Yes, it was FDA aprroved.

How should this medicine be used?

Recommended dosage: Streptococcal Infections Group A (Infections of the upper-respiratory tract, skin and soft-tissue infections, scarlet fever, and erysipelas):

• Adults and pediatric patients over 60 lbs. in weight: 2,400,000 units.
• Pediatric patients from 30 to 60 lbs: 900,000 units to 1,200,000 units.
• Pediatric patients under 30 lbs: 600,000 units.

Pneumococcal Infections (except pneumococcal meningitis):

• 600,000 units in pediatric patients and 1,200,000 units in adults, repeated every 2 or 3 days until the temperature is normal for 48 hours.

Administration:

• Bicillin C-R is intended for Intramuscular Injection ONLY.
• Do not inject into or near an artery or nerve, or intravenously or admix with other intravenous solutions.
• Penicillin G benzathine and penicillin G procaine injection comes as a suspension (liquid) in a prefilled syringe to inject into the muscles of the buttocks or thigh by a doctor or nurse in a medical facility.
• Penicillin G benzathine and penicillin G procaine injection may be given as a single dose or divided into 2 doses given 2 days apart.
• In some cases, you may need to receive additional doses spaced 2 to 3 days apart.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As penicillin G benzathine and penicillin G procaine injectable suspension

This medicine is available in fallowing brand namesː

• Bicillin CR
• Bicillin CR 900/300

What side effects can this medication cause?

The most adverse effects of this medicine include:

• Hypersensitivity reactions
• Cardiac arrest
• hypotension
• tachycardia
• palpitations
• pulmonary hypertension
• pulmonary embolism
• vasodilation
• vasovagal reaction
• cerebrovascular accident
• syncope
• Nausea
• vomiting
• blood in stool
• intestinal necrosis
• Lymphadenopathy
• Injection site reactions including pain, inflammation
• Joint disorder, periostitis
• exacerbation of arthritis
• myoglobinuria
• rhabdomyolysis
• Nervousness
• tremors
• dizziness
• somnolence
• confusion
• anxiety
• euphoria
• transverse myelitis
• seizures
• coma
• Hypoxia
• apnea
• dyspnea
• Diaphoresis
• Blurred vision
• blindness
• Neurogenic bladder
• hematuria
• proteinuria
• renal failure
• impotence
• priapism

What special precautions should I follow?

• Clostridium difficile associated with diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Bicillin C-R, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
• Do not inject into or near an artery or nerve. Injection into or near a nerve may result in permanent neurological damage.
• 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.
• Prescribing Bicillin C-R 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.
• The use of antibiotics may result in overgrowth of non susceptible organisms. Constant observation of the patient is essential. If new infections due to bacteria or fungi appear during therapy, the drug should be discontinued and appropriate measures taken.
• 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 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 C-R should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).
• When Bicillin C-R is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.
• Caution should be exercised when penicillin G benzathine and penicillin G procaine are administered to a nursing woman.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• neuromuscular hyperirritability or convulsive seizures

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Pregnancy Category B.
• There are, however, no adequate and well-controlled studies in pregnant women showing conclusively that harmful effects of these drugs on the fetus can be excluded.
• This drug should be used during pregnancy only if clearly needed.

Can this medicine be used in children?

• The safety and effectiveness of Bicillin C-R in pediatric patients have been established.

What are the active and inactive ingredients in this medicine?

Active:

• PENICILLIN G BENZATHINE
• PENICILLIN G PROCAINE

Inactives:

• none

Who manufactures and distributes this medicine?

• Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN

What should I know about storage and disposal of this medication?

• Store in a refrigerator, 2º to 8º (36º to 46ºF).
• Keep from freezing.

• Dailymed label info on Benzathine benzylpenicillin/procaine benzylpenicillin
• FDA Benzathine benzylpenicillin/procaine benzylpenicillin

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