Consists of bacitracin zinc, neomycin sulphate, polymyxin B sulphate
What is Bacitracin zinc?
Bacitracin zinc injection is an antibiotic that treats staph infection caused by a bacteria called staphylococcus (STAF-il-oh-KOK-us).
Bacitracin zinc injection is used in infants to treat pneumonia. It is also used to treat an infection that causes pus to build up between the lungs and the membrane that covers them.
Bacitracin zinc injection may also be used for purposes other than those listed in this medication guide.
Bacitracin zinc indications
In accordance with the statements in the “WARNING BOX”, the use of intramuscular Bacitracin zinc is limited to the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bacitracin zinc and other antibacterial drugs, Bacitracin zinc 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.
How should I use Bacitracin zinc?
Use Bacitracin zinc as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Bacitracin zinc may be used around the eye or in the eye. To use Bacitracin zinc in the eye, first, wash your hands. Using your index finger, pull the lower eyelid away from your eye to form a pouch. Squeeze a thin strip of ointment into the pouch. After using Bacitracin zinc, gently close your eyes for 1 to 2 minutes. Wash your hands to remove any medicine that may be on them. Wipe the applicator tip with a clean, dry tissue.
- To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
- Wash your hands before using Bacitracin zinc. To use Bacitracin zinc, pull the lower eyelid away from your eye to form a pouch. Squeeze a thin strip of ointment into the pouch. After using the medicine, gently close your eyes and keep them closed for 1 to 2 minutes. Wash your hands to remove any medicine that may be on them. Wipe the applicator tip with a clean, dry tissue.
- Ask your doctor how to use your contact lenses while using Bacitracin zinc.
- Bacitracin zinc works best if it is used at the same time each day.
- To clear up your infection completely, use Bacitracin zinc for the full course of treatment. Keep using it even if you feel better in a few days.
- To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
- If you miss a dose of Bacitracin zinc, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Bacitracin zinc.
Uses of Bacitracin zinc in details
This medication is used to prevent minor skin infections caused by small cuts, scrapes, or burns. Bacitracin zinc works by stopping the growth of certain bacteria. It belongs to a class of drugs known as antibiotics.
This antibiotic only prevents bacterial infections. It will not work for virus or fungus infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.
Do not use this product over large areas of the body. Do not use it for serious skin infections. Ask your doctor first before using this product for serious skin injuries (such as deep or puncture wounds, animal bites, serious burns). A different treatment may be necessary for these types of conditions. Consult your doctor for more information.
If you are self-treating with this medication, it is important to read the package instructions carefully before you start using this product to be sure it is right for you.
How to use Bacitracin zinc zinc topical
This medication is for use on the skin only. If you are self-treating, follow all directions on the product package. If you are uncertain about any of the information, ask your doctor or pharmacist.
Wash your hands before using. Clean and dry the affected area. Then gently apply a small amount of medication (no more than can fit on your finger tip) in a thin layer, usually 1 to 3 times a day or as directed by your doctor. If you are using the spray form, shake the bottle well before each use. You may cover the area with a sterile bandage. Wash your hands after use.
Avoid getting this medication in your eyes, nose, or mouth. If this occurs, wipe off the medication and rinse thoroughly with water.
Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day. Do not apply large amounts of this medication, use it more often, or use it for longer than directed. Your condition will not improve any faster, and your risk of side effects may increase. Do not use this product for longer than 1 week unless directed by your doctor.
Stop using this medication and tell your doctor right away if your condition persists after a few days, or if it worsens, or if you develop a rash or an allergic reaction. If you think you may have a serious medical problem, seek immediate medical attention.
Bacitracin zinc description
Bacitracin zinc is a mixture of related cyclic polypeptides produced by organisms of the licheniformis group of Bacillus subtilis var Tracy. Its unique name derives from the fact that the bacillus producing it was first isolated in 1943 from a knee scrape from a girl named Margaret Tracy. As a toxic and difficult-to-use antibiotic, Bacitracin zinc doesn't work well orally. However, it is very effective topically. Bacitracin zinc is synthesised via the so-called nonribosomal peptide synthetases (NRPSs), which means that ribosomes are not involved in its synthesis.
Bacitracin zinc dosage
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution Reconstituted,
Intramuscular:
BACiiM: 50,000 units (1 ea)
Generic: 50,000 units (1 ea [DSC])
Solution Reconstituted,
Intramuscular [preservative free]:
BACiiM: 50,000 units (1 ea [DSC])
Generic: 50,000 units (1 ea)
Dosing: Pediatric
Note: In February 2020, the FDA requested that all current manufacturers of Bacitracin zinc for injection voluntarily withdraw their product from the market because other effective FDA-approved treatments are available that do not have the same serious risks as Bacitracin zinc, including nephrotoxicity, anaphylactic reactions, and the need for repeated IM injections. This requested voluntary withdrawal does not impact approved topical or ophthalmic drugs that contain Bacitracin zinc. Further information may be found at https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-Bacitracin zinc-injection-market.
Pneumonia and empyema; staphylococcal: Note: Due to toxicity risks, systemic use of Bacitracin zinc should be limited to situations where less toxic alternatives would not be effective; systemic use in pediatric patients is rare. Do not administer IV:
Infants: IM:
≤2.5 kg: 900 units/kg/day in 2 to 3 divided doses.
>2.5 kg: 1,000 units/kg/day in 2 to 3 divided doses.
Bacitracin zinc interactions
See also:
What other drugs will affect Bacitracin zinc?
The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.
To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.
Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.
Bacitracin zinc side effects
See also:
What are the possible side effects of Bacitracin zinc?
This medication usually has no side effects. If you have any unusual effects, contact your doctor or pharmacist promptly.
If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Rarely, use of this medication for prolonged or repeated periods may result in other types of skin infections (such as fungal or other bacterial infections). Contact your doctor if you notice any unusual skin symptoms or if your condition does not improve.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Bacitracin zinc contraindications
See also:
What is the most important information I should know about Bacitracin zinc?
Before your child receives Bacitracin zinc injection, tell the doctor if the child has a history of kidney disease.
Many other drugs can damage the kidneys and should not be used together with Bacitracin zinc. Tell your doctor if your child is receiving chemotherapy, medicines used to treat a bowel disorder, medications to prevent organ transplant rejection, antiviral medications, or any other injected antibiotics.
Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of the face, lips, tongue, or throat.
Serious side effects of Bacitracin zinc injection include urinating less than usual or not at all, blood in the urine, lower back pain, or painful urination.
Make sure your child receives this medication for the entire length of time prescribed by the doctor. Your child's symptoms may get better before the infection is completely treated. Bacitracin zinc injection will not treat a viral infection such as the common cold or flu.
What is Neomycin sulphate?
Neomycin sulphate is an antibiotic that fights bacteria in the body.
Neomycin sulphate is used to reduce the risk of infection during surgery of your intestines. Neomycin sulphate is also used to reduce the symptoms of hepatic coma.
Neomycin sulphate may also be used for purposes not listed in this medication guide.
Neomycin sulphate indications
Local skin & mucous membrane infections
How should I use Neomycin sulphate?
Use Neomycin sulphate as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Neomycin sulphate by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Take Neomycin sulphate with plenty of water to avoid dehydration.
- Do not take Neomycin sulphate for more than 2 weeks unless advised to do so by your health care provider.
- Take Neomycin sulphate on a regular schedule to get the most benefit from it.
- To clear up your infection completely, use Neomycin sulphate for the full course of treatment. Keep using it even if you feel better in a few days.
- If you miss a dose of Neomycin sulphate, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If more than one dose is missed, contact your health care provider.
Ask your health care provider any questions you may have about how to use Neomycin sulphate.
Uses of Neomycin sulphate in details
Oral Neomycin sulphate is used before the operation of the gut to kill the bacteria which normally live in the gut that may cause a serious infection and in treatment of patients with coma due to liver disease (hepatic coma).
Neomycin sulphate description
A component of Neomycin sulphate that is produced by Streptomyces fradiae. On hydrolysis it yields neamine and neobiosamine B. (From Merck Index, 11th ed). Neomycin sulphate is a bactericidal aminoglycoside antibiotic that binds to the 30S ribosome of susceptible organisms. Binding interferes with mRNA binding and acceptor tRNA sites and results in the production of non-functional or toxic peptides.
Neomycin sulphate dosage
Usual Adult Dose for Bowel Preparation:
1 g orally every hour for 4 doses followed by 1 g every 4 hours for 5 doses
Alternate dosing: 6 g/day orally divided every 4 hours for 2 to 3 days
Usual Adult Dose for Hepatic Encephalopathy:
4 to 12 g/day orally divided every 4 to 6 hours for 5 to 6 days
Usual Adult Dose for Hepatic Coma:
4 to 12 g/day orally divided every 4 to 6 hours for 5 to 6 days
Usual Adult Dose for Diarrhea:
3 g/day orally in 4 divided doses
Usual Pediatric Dose for Bowel Preparation:
The safety and efficacy of Neomycin sulphate in children less than 18 years of age has not been established. However, the use of Neomycin sulphate may be appropriate is some situations.
Less than 1 month: 50 mg/kg/day orally divided every 6 hours
1 year to 18 years: 50 to 100 mg/kg/day orally divided every 6 hours
Usual Pediatric Dose for Hepatic Encephalopathy:
The safety and efficacy of Neomycin sulphate in children less than 18 years of age has not been established. However, the use of Neomycin sulphate may be appropriate is some situations.
1 month to 18 years: 50 to 100 mg/kg/day orally divided every 6 to 8 hours for 5 to 6 days
Usual Pediatric Dose for Hepatic Coma:
The safety and efficacy of Neomycin sulphate in children less than 18 years of age has not been established. However, the use of Neomycin sulphate may be appropriate is some situations.
1 month to 18 years: 50 to 100 mg/kg/day orally divided every 6 to 8 hours for 5 to 6 days
Usual Pediatric Dose for Diarrhea:
The safety and efficacy of Neomycin sulphate in children less than 18 years of age has not been established. However, the use of Neomycin sulphate may be appropriate is some situations.
Less than 1 month: 50 mg/kg/day orally divided every 6 hours
1 year to 18 years: 50 mg/kg/day orally divided every 6 hours for 2 to 3 days
Neomycin sulphate interactions
See also:
What other drugs will affect Neomycin sulphate?
none known
Neomycin sulphate side effects
See also:
What are the possible side effects of Neomycin sulphate?
Hypersensitivity reactions, oedema, itching of palpebra, erythema of conjunctiva (discontinue use). Local sensitization
Neomycin sulphate contraindications
See also:
What is the most important information I should know about Neomycin sulphate?
Hypersensitivity.
What is Polymyxin B sulphate?
Polymyxin B sulphate injection is used to treat bacterial infections in many different parts of the body.
Polymyxin B sulphate belongs to the group of medicines known as antibiotics. It works by killing bacteria or preventing their growth. However, Polymyxin B sulphate will not work for colds, flu, or other virus infections.
Polymyxin B sulphate is to be given only by or under the direct supervision of a doctor.
Polymyxin B sulphate indications
Acute Infections Caused by Susceptible Strains of Pseudomonas aeruginosa.
Polymyxin B sulphate (Polymyxin B sulphate sulfate) sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of Ps. aeruginosa. It may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of Ps. aeruginosa.
It may be indicated in serious infections caused by susceptible strains of the following organisms, when less potentially toxic drugs are ineffective or contraindicated: H influenzae, specifically meningeal infections. Escherichia coli, specifically urinary tract infections. Aerobacter aerogenes, specifically bacteremia. Klebsiella pneumoniae, specifically bacteremia.
NOTE: IN MENINGEAL INFECTIONS, POLYMYX-IN B SULFATE SHOULD BE ADMINISTERED ONLY BY THE INTRATHECAL ROUTE.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Polymyxin B sulphate (Polymyxin B sulphate sulfate) and other antibacterial drugs, Polymyxin B sulphate (Polymyxin B sulphate sulfate) 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.
Uses of Polymyxin B sulphate in details
Use: Labeled Indications
Infections, acute:
Pseudomonal infections: Treatment of infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of Pseudomonas aeruginosa
Serious infections: Treatment of serious infections caused by susceptible strains of the following organisms, when less potentially toxic drugs are ineffective or contraindicated: H. influenzae, specifically meningeal infections; Escherichia coli, specifically urinary tract infections; Aerobacter aerogenes, specifically bacteremia; Klebsiella pneumoniae, specifically bacteremia
In meningeal infections, Polymyxin B sulphate sulfate should be administered only by the intrathecal route.
Polymyxin B sulphate description
Polymyxin B sulphate sulfate is a mixture of polymyxins B1 and B2, obtained from Bacillus polymyxa strains. They are basic polypeptides of about eight amino acids and have cationic detergent action on cell membranes. Polymyxin B sulphate is used for infections with gram-negative organisms, but may be neurotoxic and nephrotoxic. All gram-positive bacteria, fungi, and the gram-negative cocci, N. gonorrhea and N. menigitidis, are resistant. It is appropriate for treatment of infections of the urinary tract, meninges, and blood stream, caused by susceptible strains of Pseudomonas aeruginosa.
Polymyxin B sulphate dosage
Parenteral:
Intravenous:
Dissolve 500,000 Polymyxin B sulphate (Polymyxin B sulphate sulfate) units in 300 to 500 mL solutions for parenteral dextrose injection 5% for continuous drip.
Adults and children: 15,000 to 25,000 units/kg body weight/day in individuals with normal kidney function. This amount should be reduced from 15,000 units/kg downward for individuals with kidney impairment. Infusions may be given every 12 hours; however, the total daily dose must not exceed 25,000 units/kg/day.
Infants: Infants with normal kidney function may receive up to 40,000 units/kg/day without adverse effects.
Intramuscular:
Not recommended routinely because of severe pain at injection sites, particularly in infants and children. Dissolve 500,000 Polymyxin B sulphate units in 2 mL sterile water for injection or sodium chloride injection or procaine hydrochloride injection 1%.
Adults and children: 25,000 to 30,000 units/kg/day. This should be reduced in the presence of renal impairment. The dosage may be divided and given at either 4 or 6 hour intervals.
Infants: Infants with normal kidney function may receive up to 40,000 units/kg/day without adverse effects.
Note: Doses as high as 45,000 units/kg/day have been used in limited clinical studies in treating prematures and newborn infants for sepsis caused by Ps aeruginosa.
Intrathecal: A treatment of choice for Ps aeruginosameningitis. Dissolve 500,000 Polymyxin B sulphate (Polymyxin B sulphate sulfate) units in 10 mL sodium chloride injection USP for 50,000 units per mL dosage unit.
Adults and children over 2 years of age: Dosage is 50,000 units once daily intrathecally for 3 to 4 days, then 50,000 units once every other day for at least 2 weeks after cultures of the cerebrospinal fluid are negative and sugar content has returned to normal.
Children under 2 years of age: 20,000 units once daily, intrathecally for 3 to 4 days or 25,000 units once every other day. Continue with a dose of 25,000 units once every other day for at least 2 weeks after cultures of the cerebrospinal fluid are negative and sugar content has returned to normal.
IN THE INTEREST OF SAFETY, SOLUTIONS OF PARENTERAL USE SHOULD BE STORED UNDER REFRIGERATION, AND ANY UNUSED PORTIONS SHOULD BE DISCARDED AFTER 72 HOURS.
Topical:
Ophthalmic:
Dissolve 500,000 Polymyxin B sulphate (Polymyxin B sulphate sulfate) units in 20 to 50 mL sterile water for injection or sodium chloride injection USP for a 10,000 to 25,000 units per mL concentration.
For the treatment of Ps aeruginosa infections of the eye, a concentration of 0.1 percent to 0.25 percent (10,000 units to 25,000 units per mL) is administered 1 to 3 drops every hour, increasing the intervals as response indicates.
Subconjunctival injection of up to 100,000 units/day may be used for the treatment of Ps aeruginosa infections of the cornea and conjunctiva.
Note: Avoid total systemic and ophthalmic instillation over 25,000 units/kg/day.
How supplied
Polymyxin B sulphate for Injection (Polymyxin B sulphate (Polymyxin B sulphate sulfate) sulfate), 500,000 Polymyxin B sulphate (Polymyxin B sulphate sulfate) units per vial is supplied in rubber-stoppered glass vial with flip off cap, carton of 10, NDC 55390-139-10.
Storage recommendations
Before reconstitution: Store at controlled room temperature 15° to 30°C (59° to 86°F).
Protect from light. Retain in carton until time of use.
After reconstitution: Product must be stored under refrigeration, between 2° to 8°C (36° to 46°F) and any unused portion should be discarded after 72 hours.
Manufactured for: Bedford Laboratories™, Bedford, OH 44146. Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146. February 2004. FDA Rev date: 5/15/2002
Polymyxin B sulphate interactions
Polymyxin B sulphate (Systemic): Polymyxin B sulphate may enhance the nephrotoxic effect of Polymyxin B sulphate (Systemic). Avoid combination
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy
Capreomycin: May enhance the neuromuscular-blocking effect of Polymyxin B sulphate. Monitor therapy
Cefazedone: May enhance the nephrotoxic effect of Polymyxin B sulphate. Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Avoid combination
Colistimethate: Polymyxin B sulphate may enhance the neuromuscular-blocking effect of Colistimethate. Monitor therapy
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy
Mecamylamine: Polymyxin B sulphate may enhance the neuromuscular-blocking effect of Mecamylamine. Avoid combination
Methoxyflurane: May enhance the nephrotoxic effect of Polymyxin B sulphate. Avoid combination
Neuromuscular-Blocking Agents: Polymyxin B sulphate may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Management: If possible, avoid concomitant use of neuromuscular-blocking agents and Polymyxin B sulphate. If concomitant use cannot be avoided, monitor for deeper, prolonged neuromuscular-blocking effects (eg, respiratory paralysis) in patients receiving this combination. Consider therapy modification
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification
Polymyxin B sulphate side effects
See also:
What are the possible side effects of Polymyxin B sulphate?
Nephrotoxic reactions: Albuminuria, cylin-duria, azotemia, and rising blood levels without any increase in dosage.
Neurotoxic reactions: Facial flushing, dizziness progressing to ataxia, drowsiness, peripheral paresthesias (circumoral and stocking glove), apnea due to concurrent use of curariform muscle relaxants, other neurotoxic drugs or inadvertent overdosage, and signs of meningeal irritation with intrathecal administration, e.g., fever, headache, stiff neck and increased cell count and protein cerebrospinal fluid.
Other reactions occasionally reported: Drug fever, urticarial rash, pain (severe) at intramuscular injection sites, and thrombophlebitis at intravenous injection sites.
Polymyxin B sulphate contraindications
Hypersensitivity to Polymyxin B sulphate or any component of the formulation
Active ingredient matches for Bacitracin zinc/neomycin sulphate/polymyxin B sulphate:
Bacitracin zinc/neomycin sulphate/polymyxin B sulphate
References
- DailyMed. "HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "neomycin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "neomycin". http://www.drugbank.ca/drugs/DB00452 (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology