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Bacitracin
Overview
What is BACiiM?
Bacitracin for Injection, USP is a sterile antibiotic for intramuscular administration. Bacitracin is derived from cultures of Bacillus subtilis (Tracey). It is a white to pale buff, hygroscopic powder, odorless or having a slight odor. It is freely soluble in water; insoluble in acetone, chloroform, and ether. While soluble in alcohol, methanol, and glacial acetic acid, there is some insoluble residue. It is precipitated from its solutions and inactivated by many of the heavy metals.
Each vial contains 50,000 units of bacitracin.
The structural formula is:
The molecular formula is: CHNOS
Bacitracin is comprised of a polypeptide complex and Bacitracin A is the major component in this complex. The molecular weight of Bacitracin A is 1422.71.
What does BACiiM look like?
What are the available doses of BACiiM?
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What should I talk to my health care provider before I take BACiiM?
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How should I use BACiiM?
In accord with the statements in the “” the use of intramuscular bacitracin 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 and other antibacterial drugs, bacitracin 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.
TO BE ADMINISTERED INTRAMUSCULARLY ONLY
Infant dose: For infants under 2500 grams – 900 units/kg/24 hours in 2 or 3 divided doses. For infants over 2500 grams – 1,000 units/kg/24 hours, in 2 or 3 divided doses. Intramuscular injections of the solution should be given in the upper outer quadrant of the buttocks, alternating right and left and avoiding multiple injections in the same region because of the transient pain following injection.
Preparation of Solutions
Diluents containing parabens should not be used to reconstitute bacitracin; cloudy solutions and precipitate formation have occurred.
Reconstitution of the 50,000 unit vial with 9.8 mL of diluent will result in a concentration of 5,000 units per mL.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
What interacts with BACiiM?
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What are the warnings of BACiiM?
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What are the precautions of BACiiM?
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What are the side effects of BACiiM?
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What should I look out for while using BACiiM?
This drug is contraindicated in those individuals with a history of previous hypersensitivity or toxic reaction to it.
Nephrotoxicity: Bacitracin in parenteral (intramuscular) therapy may cause renal failure due to tubular and glomerular necrosis. Its use should be restricted to infants with staphylococcal pneumonia and empyema when due to organisms shown to be susceptible to bacitracin. It should be used only where adequate laboratory facilities are available and when constant supervision of the patient is possible.
Renal function should be carefully determined prior to and daily during therapy. The recommended daily dose should not be exceeded and fluid intake and urinary output should be maintained at proper levels to avoid kidney toxicity. If renal toxicity occurs the drug should be discontinued. The concurrent use of other nephrotoxic drugs, particularly streptomycin, kanamycin, polymyxin B, polymyxin E (colistin), neomycin, and vancomycin, should be avoided.
What might happen if I take too much BACiiM?
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How should I store and handle BACiiM?
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Marketed/ Packaged by: Camarillo, CA 93012 USARevised: 06/12CTI-12 Rev. C Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Marketed/ Packaged by: Camarillo, CA 93012 USARevised: 06/12CTI-12 Rev. C Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Marketed/ Packaged by: Camarillo, CA 93012 USARevised: 06/12CTI-12 Rev. C Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Marketed/ Packaged by: Camarillo, CA 93012 USARevised: 06/12CTI-12 Rev. C Bacitracin for Injection, USP is available in vials containing 50,000 units.NDC 39822-0277-5. Boxes of ten vials use NDC 39822-0277-2.Store the unreconstituted product in a refrigerator 2° to 8°C (36° to 46°F). Solutions are stable for one week when stored in a refrigerator 2° to 8°C (36° to 46°F).Manufactured for:X-Gen Pharmaceuticals, Inc.Big Flats, 14814Revised June 2012BIM-P04Bacitracin for Injection, USP is available in vials containing 50,000 units.NDC 39822-0277-5. Boxes of ten vials use NDC 39822-0277-2.Store the unreconstituted product in a refrigerator 2° to 8°C (36° to 46°F). Solutions are stable for one week when stored in a refrigerator 2° to 8°C (36° to 46°F).Manufactured for:X-Gen Pharmaceuticals, Inc.Big Flats, 14814Revised June 2012BIM-P04Bacitracin for Injection, USP is available in vials containing 50,000 units.NDC 39822-0277-5. Boxes of ten vials use NDC 39822-0277-2.Store the unreconstituted product in a refrigerator 2° to 8°C (36° to 46°F). Solutions are stable for one week when stored in a refrigerator 2° to 8°C (36° to 46°F).Manufactured for:X-Gen Pharmaceuticals, Inc.Big Flats, 14814Revised June 2012BIM-P04Bacitracin for Injection, USP is available in vials containing 50,000 units.NDC 39822-0277-5. Boxes of ten vials use NDC 39822-0277-2.Store the unreconstituted product in a refrigerator 2° to 8°C (36° to 46°F). Solutions are stable for one week when stored in a refrigerator 2° to 8°C (36° to 46°F).Manufactured for:X-Gen Pharmaceuticals, Inc.Big Flats, 14814Revised June 2012BIM-P04Bacitracin for Injection, USP is available in vials containing 50,000 units.NDC 39822-0277-5. Boxes of ten vials use NDC 39822-0277-2.Store the unreconstituted product in a refrigerator 2° to 8°C (36° to 46°F). Solutions are stable for one week when stored in a refrigerator 2° to 8°C (36° to 46°F).Manufactured for:X-Gen Pharmaceuticals, Inc.Big Flats, 14814Revised June 2012BIM-P04Bacitracin for Injection, USP is available in vials containing 50,000 units.NDC 39822-0277-5. Boxes of ten vials use NDC 39822-0277-2.Store the unreconstituted product in a refrigerator 2° to 8°C (36° to 46°F). Solutions are stable for one week when stored in a refrigerator 2° to 8°C (36° to 46°F).Manufactured for:X-Gen Pharmaceuticals, Inc.Big Flats, 14814Revised June 2012BIM-P04Bacitracin for Injection, USP is available in vials containing 50,000 units.NDC 39822-0277-5. Boxes of ten vials use NDC 39822-0277-2.Store the unreconstituted product in a refrigerator 2° to 8°C (36° to 46°F). Solutions are stable for one week when stored in a refrigerator 2° to 8°C (36° to 46°F).Manufactured for:X-Gen Pharmaceuticals, Inc.Big Flats, 14814Revised June 2012BIM-P04Bacitracin for Injection, USP is available in vials containing 50,000 units.NDC 39822-0277-5. Boxes of ten vials use NDC 39822-0277-2.Store the unreconstituted product in a refrigerator 2° to 8°C (36° to 46°F). Solutions are stable for one week when stored in a refrigerator 2° to 8°C (36° to 46°F).Manufactured for:X-Gen Pharmaceuticals, Inc.Big Flats, 14814Revised June 2012BIM-P04Bacitracin for Injection, USP is available in vials containing 50,000 units.NDC 39822-0277-5. Boxes of ten vials use NDC 39822-0277-2.Store the unreconstituted product in a refrigerator 2° to 8°C (36° to 46°F). Solutions are stable for one week when stored in a refrigerator 2° to 8°C (36° to 46°F).Manufactured for:X-Gen Pharmaceuticals, Inc.Big Flats, 14814Revised June 2012BIM-P04
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Bacitracin exerts pronounced antibacterial action r against a variety of gram-positive and a few gram-negative organisms. However, among systemic diseases, only staphylococcal infections qualify for consideration of bacitracin therapy. Bacitracin is assayed against a standard and its activity is expressed in units, 1 mg having a potency of not less than 50 units.
Susceptibility plate testing: If the Kirby-Bauer method of disk susceptibility is used, a 10 unit bacitracin disk should give a zone of over 13 mm when tested against a bacitracin-susceptible strain of . Absorption of bacitracin following intramuscular injection is rapid and complete. A dose of 200 or 300 units/kg every 6 hours gives serum levels of 0.2 to 2 mcg/mL in individuals with normal renal function. The drug is excreted slowly by glomerular filtration. It is widely distributed in all body organs and is demonstrable in ascitic and pleural fluids after intramuscular injection.
Non-Clinical Toxicology
This drug is contraindicated in those individuals with a history of previous hypersensitivity or toxic reaction to it.Nephrotoxicity: Bacitracin in parenteral (intramuscular) therapy may cause renal failure due to tubular and glomerular necrosis. Its use should be restricted to infants with staphylococcal pneumonia and empyema when due to organisms shown to be susceptible to bacitracin. It should be used only where adequate laboratory facilities are available and when constant supervision of the patient is possible.
Renal function should be carefully determined prior to and daily during therapy. The recommended daily dose should not be exceeded and fluid intake and urinary output should be maintained at proper levels to avoid kidney toxicity. If renal toxicity occurs the drug should be discontinued. The concurrent use of other nephrotoxic drugs, particularly streptomycin, kanamycin, polymyxin B, polymyxin E (colistin), neomycin, and vancomycin, should be avoided.
Oral Anticoagulants:
Thyroid hormones appear to increase catabolism of vitamin K-dependent clotting factors. If oral anticoagulants are also being given, compensatory increases in clotting factor synthesis are impaired. Patients stabilized on oral anticoagulants who are found to require thyroid replacement therapy should be watched very closely when thyroid is started. If a patient is truly hypothyroid, it is likely that a reduction in anticoagulant dosage will be required. No special precautions appear to be necessary when oral anticoagulant therapy is begun in a patient already stabilized on maintenance thyroid replacement therapy.
Insulin or Oral Hypoglycemics:
Initiating thyroid replacement therapy may cause increases in insulin or oral hypoglycemic requirements. The effects seen are poorly understood and depend upon a variety of factors such as dose and type of thyroid preparations and endocrine status of the patient. Patients receiving insulin or oral hypoglycemics should be closely watched during initiation of thyroid replacement therapy.
Estrogen, Oral Contraceptives:
Estrogens tend to increase serum thyroxine-binding globulin (TBG). In a patient with a nonfunctioning thyroid gland who is receiving thyroid replacement therapy, free levothyroxine may be decreased when estrogens are started thus increasing thyroid requirements. However, if the patient’s thyroid gland has sufficient function, the decreased free thyroxine will result in a compensatory increase in thyroxine output by the thyroid. Therefore, patients without a functioning thyroid gland who are on thyroid replacement therapy may need to increase their thyroid dose if estrogens or estrogen-containing oral contraceptives are given.
Tricyclic Antidepressants:
Use of thyroid products with imipramine and other tricyclic antidepressants may increase receptor sensitivity and enhance antidepressant activity; transient cardiac arrhythmias have been observed. Thyroid hormone activity may also be enhanced.
Digitalis:
Thyroid preparations may potentiate the toxic effects of digitalis. Thyroid hormonal replacement increases metabolic rate, which requires an increase in digitalis dosage.
Ketamine:
When administered to patients on a thyroid preparation, this parenteral anesthetic may cause hypertension and tachycardia. Use with caution and be prepared to treat hypertension, if necessary.
Vasopressors:
Thyroid hormones increase the adrenergic effect of catecholamines such as epinephrine and norepinephrine. Therefore, use of vasopressors in patients receiving thyroid hormone preparations may increase the risk of precipitating coronary insufficiency, especially in patients with coronary artery disease. Therefore, use caution when administering vasopressors with liothyronine (T).
See "Warning Box"; for precautions in regard to kidney toxicity associated with intramuscular use of bacitracin.
Clostridium difficile
C. difficile
C. difficile
C. difficile
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
Adequate fluid intake should be maintained orally, or if necessary, by parenteral method.
As with other antibiotics, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be instituted.
Prescribing Bacitracin 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 the development of drug-resistant bacteria.
There have been reports of anaphylaxis and/or allergic contact dermatitis in patients exposed to Bacitracin in non-approved indications.
Nephrotoxic reactions.
Other reactions.
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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