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DRUGS & SUPPLEMENTS
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Prostafilina
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Prostafilina uses
- Indications and usage
- Contraindications
- Warnings
- Precautions
- Adverse reactions
- Overdosage
- Dosage and administration
- How supplied
- References
INDICATIONS AND USAGE
Prostafilina is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug. (See CLINICAL
Pharmacology: Susceptibility Test Methods ).
Prostafilina may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. Prostafilina should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant Staphylococcus, therapy should not be continued with Prostafilina.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Prostafilina for Injection, USP and other antibacterial drugs, Prostafilina for Injection, USP 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.
CONTRAINDICATIONS
A history of a hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication.
WARNINGS
Serious and occasionally fatal hypersensitivity (anaphylactic shock with collapse) reactions have occurred in patients receiving penicillin. The incidence of anaphylactic shock in all penicillin-treated patients is between 0.015 and 0.04 percent. Anaphylactic shock resulting in death has occurred in approximately 0.002 percent of the patients treated.
When Prostafilina therapy is indicated, it should be initiated only after a comprehensive patient drug and allergy history has been obtained. If an allergic reaction occurs, Prostafilina should be discontinued and appropriate therapy instituted.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Prostafilina for injection, USP, 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.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
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.
PRECAUTIONS
General
Prostafilina should generally not be administered to patients with a history of sensitivity to any penicillin.
Penicillin should be used with caution in individuals with histories of significant allergies and/or asthma. Whenever allergic reactions occur, penicillin should be withdrawn unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to penicillin therapy.
The use of antibiotics may result in overgrowth of nonsusceptible organisms. If new infections due to bacteria or fungi occur, the drug should be discontinued and appropriate measures taken.
Prescribing Prostafilina for Injection, USP 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.
Laboratory Tests
Bacteriologic studies to determine the causative organisms and their susceptibility to Prostafilina should be performed. In the treatment of suspected staphylococcal infections, therapy should be changed to another active agent if culture tests fail to demonstrate the presence of staphylococci.
Periodic assessment of organ system function including renal, hepatic, and hematopoietic should be made during prolonged therapy with Prostafilina.
Blood cultures, white blood cell, and differential cell counts should be obtained prior to initiation of therapy and at least weekly during therapy with Prostafilina.
Periodic urinalysis, blood urea nitrogen, and creatinine determinations should be performed during therapy with Prostafilina and dosage alterations should be considered if these values become elevated. If any impairment of renal function is suspected or known to exist, a reduction in the total dosage should be considered and blood levels monitored to avoid possible neurotoxic reactions.
AST (SGOT) and ALT (SGPT) values should be obtained periodically during therapy to monitor for possible liver function abnormalities.
Drug Interactions
Tetracycline, a bacteriostatic antibiotic, may antagonize the bactericidal effect of penicillin and concurrent use of these drugs should be avoided.
Prostafilina blood levels may be increased and prolonged by concurrent administration of probenecid which blocks the renal tubular secretion of penicillins. Probenecid decreases the apparent volume of distribution and slows the rate of excretion by competitively inhibiting renal tubular secretion of penicillins.
Oxacillin-probenecid therapy should be limited to those infections where very high serum levels of Prostafilina are necessary.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been conducted with these drugs.
Studies on reproduction in rats and rabbits reveal no fetal or maternal abnormalities before conception and continuously through weaning (one generation).
Pregnancy
Teratogenic Effects
Pregnancy Category B
Reproduction studies performed in the mouse, rat, and rabbit have revealed no evidence of impaired fertility or harm to the fetus due to the penicillinase-resistant penicillins. Human experience with the penicillins during pregnancy has not shown any positive evidence of adverse effects on the fetus. There are, however, no adequate or well-controlled studies in pregnant women showing conclusively that harmful effects of these drugs on the fetus can be excluded. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers
Penicillins are excreted in human milk. Caution should be exercised when penicillins are administered to a nursing woman.
Pediatric Use
Because of incompletely developed renal function in pediatric patients, Prostafilina may not be completely excreted, with abnormally high blood levels resulting. Frequent blood levels are advisable in this group with dosage adjustments when necessary. All pediatric patients treated with penicillins should be monitored closely for clinical and laboratory evidence of toxic or adverse effects. Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Clinical studies of Prostafilina for injection did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Prostafilina for Injection contains 63.5 mg of sodium per gram of Prostafilina. At the usual recommended doses, patients would receive between 63.5 and 381 mg/day (2.8 and 16.8 mEq) of sodium. The geriatric population may respond with a blunted natriuresis to salt loading. This may be clinically important with regard to such diseases as congestive heart failure.
Information for Patients
Patients should be counseled that antibacterial drugs including Prostafilina for Injection, USP should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Prostafilina for Injection, USP 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. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Prostafilina for Injection, USP or other antibacterial drugs in the future.
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 or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
ADVERSE REACTIONS
Body as a Whole
The reported incidence of allergic reactions to penicillin ranges from 0.7 to 10 percent. Sensitization is usually the result of treatment but some individuals have had immediate reactions when first treated. In such cases, it is thought that the patients may have had prior exposure to the drug via trace amounts present in milk and vaccines.
Two types of allergic reactions to penicillins are noted clinically, immediate and delayed.
Immediate reactions usually occur within 20 minutes of administration and range in severity from urticaria and pruritus to angioneurotic edema, laryngospasm, bronchospasm, hypotension, vascular collapse, and death. Such immediate anaphylactic reactions are very rare (See WARNINGS ) and usually occur after parenteral therapy but have occurred in patients receiving oral therapy. Another type of immediate reaction, an accelerated reaction, may occur between 20 minutes and 48 hours after administration and may include urticaria, pruritus, and fever. Although laryngeal edema, laryngospasm, and hypotension occasionally occur, fatality is uncommon.
Delayed allergic reactions to penicillin therapy usually occur after 48 hours and sometimes as late as 2 to 4 weeks after initiation of therapy.
Manifestations of this type of reaction include serum sickness-like symptoms (i.e., fever, malaise, urticaria, myalgia, arthralgia, abdominal pain) and various skin rashes. Nausea, vomiting, diarrhea, stomatitis, black or hairy tongue, and other symptoms of gastrointestinal irritation may occur, especially during oral penicillin therapy.
Nervous System Reactions
Neurotoxic reactions similar to those observed with penicillin G may occur with large intravenous doses of Prostafilina especially with patients with renal insufficiency.
Urogenital Reactions
Renal tubular damage and interstitial nephritis have been associated with the administration of Prostafilina. Manifestations of this reaction may include rash, fever, eosinophilia, hematuria, proteinuria, and renal insufficiency. Nephropathy induced by penicillins does not appear to be dose-related and is generally reversible upon prompt discontinuation of therapy.
Gastrointestinal Reactions
Pseudomembranous colitis has been reported with the use of Prostafilina. The onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment.
Metabolic Reactions
Agranulocytosis, neutropenia, and bone marrow depression have been associated with the use of Prostafilina. Hepatotoxicity, characterized by fever, nausea, and vomiting associated with abnormal liver function tests, mainly elevated SGOT levels, has been associated with the use of Prostafilina.
To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
OVERDOSAGE
The signs and symptoms of Prostafilina overdosage are those described in the ADVERSE REACTIONS section. If signs or symptoms occur, discontinue use of the medication, treat symptomatically, and institute appropriate supportive measures.
DOSAGE AND ADMINISTRATION
Bacteriologic studies to determine the causative organisms and their susceptibility to Prostafilina should always be performed. Duration of therapy varies with the type of severity of infection as well as the overall condition of the patient, therefore it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with Prostafilina should be continued for at least 14 days. Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic, and cultures are negative. Treatment of endocarditis and osteomyelitis may require a longer duration of therapy.
With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.
| Drug | Adults | Infants and Children <40 kg | Other Recommendations |
|---|---|---|---|
| Prostafilina | 250 to 500 mg IM or IV every 4 to 6 hours (mild to moderate infections) | 50 mg/kg/day IM or IV in equally divided doses every 6 hours (mild to moderate infections) | |
| 1 gram IM or IV every 4 to 6 hours (severe infections) | 100 mg/kg/day IM or IV in equally divided doses every 4 to 6 hours (severe infections) | Premature and Neonates 25 mg/kg/day IM or IV |
Directions for use
For Intramuscular Use
Use Sterile Water for Injection, USP. Add 5.4 mL to the 1 gram vial and 10.6 mL to the 2 gram vial. Shake well until a clear solution is obtained. After reconstitution, vials will contain 250 mg of active drug per 1.5 mL of solution. The reconstituted solution is stable for 3 days at 70° F or for one week under refrigeration.
For Direct Intravenous Use
Use Sterile Water for Injection, USP or Sodium Chloride Injection, USP. Add 10 mL to the 1 gram vial and 20 mL to the 2 gram vial. Withdraw the entire contents and administer slowly over a period of approximately 10 minutes.
For Administration by Intravenous Drip
Reconstitute as directed above prior to diluting with Intravenous Solution.
| Concentration mg/mL | Sterile Water for Injection, USP | 0.9% Sodium Chloride Injection, USP | M/6 Molar Sodium Lactate Solution | 5% Dextrose in Water | 5% Dextrose in 0.45% Sodium Chloride | 10% Invert Sugar Injection, USP | Lactated Ringers Solution |
|---|---|---|---|---|---|---|---|
| ROOM TEMPERATURE (25°C) | |||||||
| 10 to 100 | 4 Days | 4 Days | |||||
| 10 to 30 | 24 Hrs | 24 Hrs | |||||
| 0.5 to 2 | 6 Hrs | 6 Hrs | 6 Hrs | ||||
| REFRIGERATION (4°C) | |||||||
| 10 to 100 | 7 Days | 7 Days | |||||
| 10 to 30 | 4 Days | 4 Days | 4 Days | 4 Days | 4 Days | ||
| FROZEN (-15°C) | |||||||
| 50 to 100 | 30 Days | ||||||
| 250/1.5 mL | 30 Days | ||||||
| 100 | 30 Days | ||||||
| 10 to 100 | 30 Days | 30 Days | 30 Days | 30 Days | 30 Days | ||
Stability studies on Prostafilina sodium at concentrations of 0.5 mg/mL and 2 mg/mL in various intravenous solutions listed below indicate the drug will lose less than 10% activity at room temperature (70° F) during a 6-hour period.
IV Solution
5% Dextrose in Normal Saline
10% D-Fructose in Water
10% D-Fructose in Normal Saline
Lactated Potassic Saline Injection
10% Invert Sugar in Normal Saline
10% Invert Sugar Plus 0.3% Potassium Chloride in Water
Travert 10% Electrolyte #1
Travert 10% Electrolyte #2
Travert 10% Electrolyte #3
Only those solutions listed above should be used for the intravenous infusion of Prostafilina sodium. The concentration of the antibiotic should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of Prostafilina is administered before the drug loses its stability in the solution in use.
If another agent is used in conjunction with Prostafilina therapy, it should not be physically mixed with Prostafilina but should be administered separately.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Do not add supplementary medication to Prostafilina for injection, USP.
HOW SUPPLIED
Prostafilina for Injection, USP contains Prostafilina sodium equivalent to 1 or 2 grams Prostafilina per vial.
NDC 0781-3099-95 1 gram vial packaged in 10s
NDC 0781-3101-95 2 grams vial packaged in 10s
Store dry powder at 20° to 25°C (68° to 77°F).
References
- Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard-Tenth Edition. CLSI Document M07-A10. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.
- Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fifth Informational Supplement. CLSI Document M100-S25. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.
- Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard Twelfth Edition. CLSI Document M02-A12. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.
09-2015M
46171063
Manufactured in Austria by Sandoz GmbH
for Sandoz Inc., Princeton, NJ 08540
Product of Italy
NDC 0781-3099-95 Rx only
Prostafilina
for Injection, USP
1 gram/Vial
Buffered - For IM or IV use
Mfd in Austria by Sandoz
GmbH for Sandoz Inc.,
Princeton, NJ 08540
Product of Italy
Case Qty.: 10 Vials
SANDOZ
Prostafilina 1 gram Vial
NDC 0781-3101-95 Rx only
Prostafilina
for Injection, USP
2 grams/Vial
Buffered - For IM or IV use
Mfd in Austria by Sandoz
GmbH for Sandoz Inc.,
Princeton, NJ 08540
Product of Italy
Case Qty.: 10 Vials
SANDOZ
Prostafilina 2 gram Vial
Prostafilina pharmaceutical active ingredients containing related brand and generic drugs:
Prostafilina available forms, composition, doses:
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.