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Medically reviewed by Oliinyk Elizabeth Ivanovna, PharmD. Last updated on 23.03.2022
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To reduce the development of drug-resistant bacteria and maintain the effectiveness of Benzatina Bencilpenicilina V Potassium and other antibacterial drugs, Benzatina Bencilpenicilina V Potassium should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible 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.
Benzatina Bencilpenicilina V Potassium tablets are indicated in the treatment of mild to moderately severe infections due to Benzatina Bencilpenicilina G-sensitive microorganisms. Therapy should be guided by bacteriologic studies (including sensitivity tests) and by clinical response.
NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with Benzatina Bencilpenicilina V during the acute stage. Indicated surgical procedures should be performed.
The following infections will usually respond to adequate dosage of Benzatina Bencilpenicilina V.
Streptococcal Infections (without bacteremia)
Mild-to-moderate infections of the upper respiratory tract, scarlet fever, and mild erysipelas.
NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to Benzatina Bencilpenicilina. Other groups, including group D (enterococcus), are resistant.
Pneumococcal Infections
Mild to moderately severe infections of the respiratory tract.
Staphylococcal infections – Benzatina Bencilpenicilina G-sensitive
Mild infections of the skin and soft tissues.
NOTE: Reports indicate an increasing number of strains of staphylococci resistant to Benzatina Bencilpenicilina G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections.
Fusospirochetosis (Vincent’s gingivitis and pharyngitis)
Mild to moderately severe infections of the oropharynx usually respond to therapy with oral Benzatina Bencilpenicilina.
NOTE: Necessary dental care should be accomplished in infections involving the gum tissue.
Medical conditions in which oral Benzatina Bencilpenicilina therapy is indicated as prophylaxis: For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral Benzatina Bencilpenicilina on a continuing basis has proven effective in preventing recurrence of these conditions.
Although no controlled clinical efficacy studies have been conducted, Benzatina Bencilpenicilina V has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract1.
Oral Benzatina Bencilpenicilina should not be used in those patients at particularly high risk for endocarditis (e.g., those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Benzatina Bencilpenicilina V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha hemolytic streptococci relatively resistant to Benzatina Bencilpenicilina may be found when patients are receiving continuous oral Benzatina Bencilpenicilina for secondary prevention of rheumatic fever, prophylactic agents other than Benzatina Bencilpenicilina may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen.
NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association1.
Penicillins are used to treat infections caused by bacteria. They work by killing the bacteria or preventing their growth.
There are several different kinds of penicillins. Each is used to treat different kinds of infections. One kind of Benzatina Bencilpenicilina usually may not be used in place of another. In addition, penicillins are used to treat bacterial infections in many different parts of the body. They are sometimes given with other antibacterial medicines (antibiotics). Some of the penicillins may also be used for other problems as determined by your doctor. However, none of the penicillins will work for colds, flu, or other virus infections.
Penicillins are available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, penicillins are used in certain patients with the following medical conditions:
- Chlamydia infections in pregnant women—Amoxicillin and ampicillin
- Gas gangrene—Benzatina Bencilpenicilina G
- Helicobacter pylori-associated gastritis or peptic ulcer disease—Amoxicillin
- Leptospirosis—Ampicillin and Benzatina Bencilpenicilina G
- Lyme disease—Amoxicillin and Benzatina Bencilpenicilina V
- Typhoid fever—Amoxicillin and ampicillin
Usual Adult Dose for Bacterial Infection
Mild to moderate infections: 125 to 500 mg orally every 6 to 8 hours
Usual Adult Dose for Streptococcal Infection
Mild to moderate infections of the upper respiratory tract and including scarlet fever and erysipelas: 125 to 250 mg orally every 6 to 8 hours for 10 days
Usual Adult Dose for Upper Respiratory Tract Infection
Mild to moderate streptococcal infections of the upper respiratory tract: 125 to 250 mg orally every 6 to 8 hours for 10 days
Mild to moderate pneumococcal infections of the respiratory tract, including otitis media: 250 to 500 mg orally every 6 hours until the patient has been afebrile for at least 2 days
Usual Adult Dose for Skin or Soft Tissue Infection
Mild staphylococcal infections (Benzatina Bencilpenicilina G-sensitive): 250 to 500 mg orally every 6 to 8 hours
Usual Adult Dose for Fusospirochetosis
Mild to moderate infections of the oropharynx: 250 to 500 mg orally every 6 to 8 hours
Usual Adult Dose for Tonsillitis/Pharyngitis
Streptococcal tonsillopharyngitis (primary prevention of rheumatic fever): 500 mg orally 2 to 3 times a day for 10 days
Usual Adult Dose for Rheumatic Fever Prophylaxis
Secondary prevention of rheumatic fever (prevention of recurrence): 250 mg orally twice a day on a continuing basis
The manufacturer recommends 125 to 250 mg orally twice a day on a continuing basis for the prevention of recurrence following rheumatic fever and/or chorea.
For high-risk patients, Benzatina Bencilpenicilina G benzathine given every 3 weeks may be more effective and is recommended.
Oral Benzatina Bencilpenicilina can be used for prevention in lower risk patients whose compliance can be ensured.
Usual Adult Dose for Otitis Media
Mild to moderate pneumococcal infections: 250 to 500 mg orally every 6 hours until the patient has been afebrile for at least 2 days
Usual Adult Dose for Pneumonia
Mild to moderate infections: 250 to 500 mg orally every 6 hours
Usual Adult Dose for Cutaneous Bacillus anthracis
Treatment of mild, uncomplicated cutaneous anthrax (IV therapy not considered necessary): 200 to 500 mg orally 4 times a day
Duration: 5 to 10 days for naturally occurring or endemic exposures to anthrax; therapy should be continued for 60 days if cutaneous anthrax occurred as result of exposure to aerosolized B anthracis spores
Usual Adult Dose for Clostridial Infection
Wound botulism: 250 to 500 mg orally every 6 hours once the patient improves after treatment with aqueous Benzatina Bencilpenicilina G and debridement
Usual Adult Dose for Lyme Disease - Erythema Chronicum Migrans
250 to 500 mg orally every 6 hours for 14 to 21 days
Amoxicillin and doxycycline are considered the oral drugs of choice.
Usual Adult Dose for Rat-bite Fever
Mild infection: 500 mg orally every 6 hours
Duration: 10 to 14 days
Usual Pediatric Dose for Bacterial Infection
Mild to moderate infections:
Greater than 1 month to less than 12 years: 25 to 50 mg/kg per day orally in divided doses every 6 to 8 hours
Maximum dose: 3 g/day
12 years or older: 125 to 500 mg orally every 6 to 8 hours
Usual Pediatric Dose for Streptococcal Infection
Mild to moderate infections of the upper respiratory tract and including scarlet fever and erysipelas:
12 years or older: 125 to 250 mg orally every 6 to 8 hours for 10 days
Usual Pediatric Dose for Upper Respiratory Tract Infection
Mild to moderate streptococcal infections of the upper respiratory tract:
12 years or older: 125 to 250 mg orally every 6 to 8 hours for 10 days
Mild to moderate pneumococcal infections of the respiratory tract, including otitis media:
12 years or older: 250 to 500 mg orally every 6 hours until the patient has been afebrile for at least 2 days
Usual Pediatric Dose for Skin or Soft Tissue Infection
Mild staphylococcal infections (Benzatina Bencilpenicilina G-sensitive):
12 years or older: 250 to 500 mg orally every 6 to 8 hours
Usual Pediatric Dose for Fusospirochetosis
Mild to moderate infections of the oropharynx:
12 years or older: 250 to 500 mg orally every 6 to 8 hours
Usual Pediatric Dose for Tonsillitis/Pharyngitis
Streptococcal tonsillopharyngitis (primary prevention of rheumatic fever):
Children 27 kg or less: 250 mg orally 2 to 3 times a day
Children greater than 27 kg and adolescents: 500 mg orally 2 to 3 times a day
Duration: 10 days
Usual Pediatric Dose for Rheumatic Fever Prophylaxis
Secondary prevention of rheumatic fever (prevention of recurrence): 250 mg orally twice a day on a continuing basis
The manufacturer recommends 125 to 250 mg orally twice a day on a continuing basis for the prevention of recurrence following rheumatic fever and/or chorea.
For high-risk patients, Benzatina Bencilpenicilina G benzathine given every 3 weeks may be more effective and is recommended.
Oral Benzatina Bencilpenicilina can be used for prevention in lower risk patients whose compliance can be ensured.
Usual Pediatric Dose for Otitis Media
Mild to moderate pneumococcal infections:
12 years or older: 250 to 500 mg orally every 6 hours until the patient has been afebrile for at least 2 days
Usual Pediatric Dose for Pneumonia
Mild to moderate infections:
12 years or older: 250 to 500 mg orally every 6 hours
Usual Pediatric Dose for Cutaneous Bacillus anthracis
Treatment of mild, uncomplicated cutaneous anthrax (IV therapy not considered necessary):
Less than 12 years: 25 to 50 mg/kg/day orally in 2 to 4 divided doses
12 years or older: 200 to 500 mg orally 4 times a day
Duration: 5 to 10 days for naturally occurring or endemic exposures to anthrax; therapy should be continued for 60 days if cutaneous anthrax occurred as result of exposure to aerosolized B anthracis spores
Initial therapy should be IV for young children (i.e., less than 2 years of age) and combination therapy should be considered since it is unknown if infants and young children are at greater risk of systemic dissemination of cutaneous anthrax.
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Precautions
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported with antibiotics. The drug should be discontinued immediately at the first appearance of a skin rash or other signs of hypersensitivity. Severe, acute hypersensitivity reactions may require treatment with epinephrine and other resuscitative measures including oxygen, intravenous fluids, antihistamines, corticosteroids, cardiovascular support and airway management as clinically indicated.
Clostridium difficile associated diarrhea (CDAD) has been reported with almost all antibiotics and may potentially be life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea following Benzatina Bencilpenicilina therapy. Mild cases generally improve with discontinuation of the drug, while severe cases may require supportive therapy and treatment with an antimicrobial agent effective against C difficile. Hypertoxin producing strains of C difficile cause increased morbidity and mortality; these infections can be resistant to antimicrobial treatment and may necessitate colectomy.
Caution is recommended in patients with histories of significant allergies and/or asthma.
Periodic monitoring of renal, hepatic, and hematologic function is recommended during high-dose or prolonged therapy because the risk of neutropenia and serum sickness-like reactions may be increased.
Use of antibiotics may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if superinfection occurs.
In patients with streptococcal infections, clinicians should take measure to ascertain that therapy is sufficient to eradicate the organism and to prevent streptococcal sequelae.
To reduce the risk of development of drug-resistant organisms, antibiotics should only be used to treat or prevent proven or suspected infections caused by bacteria. Culture and susceptibility information should be considered when selecting treatment or, if no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy. Ambulatory patients should be advised to avoid missing doses and to complete the entire course of therapy.
Dialysis
Data not available
Other Comments
Oral Benzatina Bencilpenicilina should be taken on an empty stomach 1 hour before or 2 hours after meals.
Oral Benzatina Bencilpenicilina should not be used for the treatment of patients with severe infections, or with nausea, vomiting, gastric dilatation, cardiospasm, or intestinal hypermotility.
Benzatina Bencilpenicilina V potassium: 250 mg = 400,000 units; 500 mg = 800,000 units
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What is the most important information I should know about Benzatina Bencilpenicilina?
A previous hypersensitivity reaction to any Benzatina Bencilpenicilina is a contraindication.
Benzatina Bencilpenicilina is injected into a muscle or into a vein through an IV. You may be shown how to use an injection at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.
Benzatina Bencilpenicilina may also be injected into the membrane surrounding the lungs, or into the fluid surrounding the spinal cord. A healthcare provider will give you this type of injection.
Benzatina Bencilpenicilina is a powder medicine that must be mixed with a liquid (solvent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.
Store the powder at room temperature away from moisture and heat.
After mixing the powder with a liquid, store in the refrigerator and use it within 7 days. Do not freeze.
Benzatina Bencilpenicilina that is supplied as a frozen solution should be stored in a deep freezer at a temperature of 4 degrees below 0 (F).
Thaw the solution either in a refrigerator or at room temperature. Do not heat the medicine to thaw it more quickly. Once the solution has been thawed, it should look clear.
Benzatina Bencilpenicilina that is thawed in the refrigerator should be used within 14 days. If you have thawed the medicine at room temperature, you must use it within 24 hours. Do not refreeze.
Do not use Benzatina Bencilpenicilina if it has changed colors or has particles in it. Call your pharmacist for new medication.
Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.
This medicine can cause false results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using Benzatina Bencilpenicilina.
If you use this medicine long-term, your blood may need to be tested to make sure the medicine is not causing harmful effects. Your kidney or liver function may also need to be tested.
Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Benzatina Bencilpenicilina will not treat a viral infection such as the flu or a common cold.
After you have finished your treatment with Benzatina Bencilpenicilina, your doctor may want to do tests to make sure your infection has completely cleared up.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled Indications
Fusospirochetosis (Vincent gingivitis and pharyngitis): Treatment of fusospirochetosis (Vincent gingivitis and pharyngitis), in conjunction with dental care for infections involving gum tissue.
Pneumococcal infections: Treatment of mild to moderately severe pneumococcal respiratory tract infections, including otitis media.
Rheumatic fever and/or chorea prophylaxis: Prophylaxis (chronic, secondary) of rheumatic fever and/or chorea.
Staphylococcal infections (Benzatina Bencilpenicilina G-sensitive): Treatment of mild infections of the skin and soft tissues.
Streptococcal infections (without bacteremia): Treatment of mild to moderate streptococcal infections of the upper respiratory tract, scarlet fever, and mild erysipelas.
Off Label Uses
Actinomycosis
Data from a limited number of clinical studies suggest that Benzatina Bencilpenicilina V potassium may be beneficial for the treatment of actinomycosis after initial surgical intervention and IV therapy with Benzatina Bencilpenicilina G (if clinically indicated).
Streptococcus (group A) chronic carrier
Based on the Infectious Diseases Society of America (IDSA) Clinical Practice Guideline for the Diagnosis and Management of Group A Streptococcal Pharyngitis, Benzatina Bencilpenicilina V potassium given to chronic carriers of group A streptococcal is effective and recommended in the management of this condition.
See also:
What other drugs will affect Benzatina Bencilpenicilina?
Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin.
Chloramphenicol, macrolides, sulfonamides, and tetracy-clines may interfere with the bactericidal effects of Benzatina Bencilpenicilina. This has been demonstrated in vitro; however, the clinical significance of this interaction is not well documented.
Drug/Laboratory Test Interactions: High urine concentrations of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST®, Benedictís Solution, or Fehlingís Solution. Since this effect may also occur with amoxicillin, it is recommended that glucose tests based on enzymatic glucose oxi-dase reactions (such as CLINISTIX®) be used.
Following administration of ampicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted. This effect may also occur with amoxicillin.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to detect mutagenic potential of amoxicillin alone have not been conducted; however, the following information is available from tests on a 4:1 mixture of amoxicillin and potassium clavulanate (AUGMENTIN). AUGMENTIN was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. AUGMENTIN was weakly positive in the mouse lymphoma assay, but the trend toward increased mutation frequencies in this assay occurred at doses that were also associated with decreased cell survival. AUGMENTIN was negative in the mouse micronucleus test, and in the dominant lethal assay in mice. Potassium clavulanate alone was tested in the Ames bacterial mutation assay and in the mouse micronucleus test, and was negative in each of these assays. In a multi-generation reproduction study in rats, no impairment of fertility or other adverse reproductive effects were seen at doses up to 500 mg/kg (approximately 3 times the human dose in mg/m2).
Pregnancy: Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 10 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to amoxicillin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Labor and Delivery:
Oral ampicillin-class antibiotics are poorly absorbed during labor. Studies in guinea pigs showed that intravenous administration of ampicillin slightly decreased the uterine tone and frequency of contractions but moderately increased the height and duration of contractions. However, it is not known whether use of amoxicillin in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary.
Nursing Mothers: Penicillins have been shown to be excreted in human milk. Benzatina Bencilpenicilina use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin is administered to a nursing woman.
Pediatric Use: Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed. Dosing of AMOXIL should be modified in pediatric patients 12 weeks or younger (£3 months). (See DOSAGE AND ADMINISTRATIONñNeonates and infants.)
See also:
What are the possible side effects of Benzatina Bencilpenicilina?
Applies to Benzatina Bencilpenicilina v potassium: capsule, powder for solution, powder for suspension, solution, suspension, syrup, tablet, tablet for suspension, tablet chewable, tablet extended release
As well as its needed effects, Benzatina Bencilpenicilina v potassium may cause unwanted side effects that require medical attention.
Stop taking Benzatina Bencilpenicilina v potassium and get emergency help immediately if any of the following effects occur:
Less common:
- Fast or irregular breathing
- fever
- joint pain
- lightheadedness or fainting (sudden)
- puffiness or swelling around the face
- red, scaly skin
- shortness of breath
- skin rash, hives, itching
Major Side Effects
If any of the following side effects occur while taking Benzatina Bencilpenicilina v potassium, check with your doctor immediately:
Rare
- Abdominal or stomach cramps and pain (severe)
- abdominal tenderness
- convulsions (seizures)
- decreased amount of urine
- diarrhea (watery and severe), which may also be bloody
- mental depression
- nausea and vomiting
- pain at place of injection
- sore throat and fever
- unusual bleeding or bruising
- yellow eyes or skin
- Agitation or combativeness
- anxiety
- confusion
- fear of impending death
- feeling, hearing, or seeing things that are not real
Minor Side Effects
Some Benzatina Bencilpenicilina v potassium side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:
More common:
- Diarrhea (mild)
- headache
- sore mouth or tongue
- vaginal itching and discharge
- white patches in the mouth and/or on the tongue
Benzatina Bencilpenicilina (Benzatina Bencilpenicilina G) is narrow spectrum antibiotic used to treat infections caused by susceptible bacteria. It is a natural Benzatina Bencilpenicilina antibiotic that is administered intravenously or intramuscularly due to poor oral absorption. Benzatina Bencilpenicilina G may also be used in some cases as prophylaxis against susceptible organisms. Natural penicillins are considered the drugs of choice for several infections caused by susceptible gram positive aerobic organisms, such as Streptococcus pneumoniae, groups A, B, C and G streptococci, nonenterococcal group D streptococci, viridans group streptococci, and non-penicillinase producing staphylococcus. Aminoglycosides may be added for synergy against group B streptococcus (S. agalactiae), S. viridans, and Enterococcus faecalis. The natural penicillins may also be used as first or second line agents against susceptible gram positive aerobic bacilli such as Bacillus anthracis, Corynebacterium diphtheriae, and Erysipelothrix rhusiopathiae. Natural penicillins have limited activity against gram negative organisms; however, they may be used in some cases to treat infections caused by Neisseria meningitidis and Pasteurella. They are not generally used to treat anaerobic infections. Resistance patterns, susceptibility and treatment guidelines vary across regions.