Dicloxacillin Sodium 250 mg/1
Dicloxacillin Sodium · CAPSULE · PD-Rx Pharmaceuticals, Inc.
Dicloxacillin Sodium is a capsule containing dicloxacillin sodium at 250 mg/1, taken oral. Manufactured by PD-Rx Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Dicloxacillin Sodium
- Generic Name
- Dicloxacillin Sodium
- NDC Code (Product)
55289-592- Manufacturer
- PD-Rx Pharmaceuticals, Inc.
- Strength
- 250 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA062286
- Marketing Start
- 09/30/1990
Recall History
Sandoz, Inc
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Sandoz, Inc
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of dicloxacillin sodium capsules and other antibacterial drugs, dicloxacillin sodium capsules 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. Dicloxacillin 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 organisms and their sensitivity to the drug (see CLINICAL PHARMACOLOGY – Susceptibility Testing ) . Dicloxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of laboratory test results. The penicillinase-resistant penicillins should not be used in infections caused by organisms susceptible…
Dosage & Administration
DOSAGE AND ADMINISTRATION Concurrent administration of the penicillinase-resistant penicillins and probenecid increases and prolongs serum penicillin levels. Probenecid decreases the apparent volume of distribution and slows the rate of excretion by competitively inhibiting renal tubular secretion of penicillin. Penicillin-probenecid therapy is generally limited to those infections where very high serum levels of penicillin are necessary. Oral preparations of the penicillinase-resistant penicillins should not be used as initial therapy in serious, life-threatening infections (see PRECAUTIONS - General ). Oral therapy with the penicillinase-resistant penicillins may be used to follow up the previous use of a parenteral agent as soon as the clinical condition warrants. RECOMMENDED DOSAGES FOR DICLOXACILLIN SODIUM IN MILD TO MODERATE AND SEVERE INFECTIONS DRUG ADULTS CHILDREN Mild to Moderate Severe Mild to Moderate Severe Dicloxacillin 125 mg every 6 hours 250 mg every 6 hours 12.5 mg/kg/day 1 in equally divided doses every 6 hours 25 mg/kg/day 1 in equally divided doses every 6 hours 1 . Patients weighing less than 40 kg (88 lbs) Dicloxacillin is best absorbed when taken on an empty…
Warnings
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%. Anaphylactic shock resulting in death has occurred in approximately 0.002% of the patients treated. Although anaphylaxis is more frequent following a parenteral administration, it has occurred in patients receiving oral penicillins. When penicillin therapy is indicated, it should be initiated only after a comprehensive patient drug and allergy history has been obtained. If an allergic reaction occurs, dicloxacillin should be discontinued and appropriate therapy instituted. Individuals with a history of penicillin hypersensitivity may also experience allergic reactions when treated with a cephalosporin. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including dicloxacillin sodium, 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 produce…
Contraindications
CONTRAINDICATIONS Dicloxacillin sodium is contraindicated in persons who have shown hypersensitivity to any of the penicillins or any component of the formulations.
Drug Interactions
Drug Interactions Tetracycline, a bacteriostatic antibiotic, may antagonize the bactericidal effect of penicillin and concurrent use of these drugs should be avoided. Probenecid administered concomitantly with penicillins increases and prolongs serum penicillin levels (see DOSAGE AND ADMINISTRATION ). Penicillinase-resistant penicillins, like other penicillins, are physically and/or chemically incompatible with aminoglycosides and can inactivate the drugs in vitro. In vitro mixing of penicillins and aminoglycosides should be avoided during concomitant therapy and the drugs should be administered separately. Penicillins can inactivate aminoglycosides in vitro in serum samples from patients receiving both drugs, which could produce falsely decreased results in serum aminoglycoside assays of the serum samples. Dicloxacillin may reduce the anticoagulant response to dicumarol and warfarin. Careful monitoring of prothrombin times is suggested during concomitant therapy, and dosage of the anticoagulant should be adjusted as required. The mechanism of this possible interaction is unclear, but may be due to hepatic enzyme induction.
Adverse Reactions
ADVERSE REACTIONS Hypersensitive Reactions The reported incidence of allergic reactions to penicillin ranges from 0.7% to 10% (see WARNINGS ). Sensitization is usually the result of treatment, but some individuals have had immediate reactions to penicillin 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 penicillin 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 …
Frequently Asked Questions
What is Dicloxacillin Sodium used for?
Dicloxacillin Sodium contains Dicloxacillin Sodium. It is a capsule taken oral. Consult your doctor for specific uses.
Is Dicloxacillin Sodium a controlled substance?
Dicloxacillin Sodium is not classified as a controlled substance by the DEA.
What is the generic name for Dicloxacillin Sodium?
The generic name for Dicloxacillin Sodium is Dicloxacillin Sodium. There are 2 other brand versions of Dicloxacillin Sodium.
What is the NDC code for Dicloxacillin Sodium 250 mg/1?
The NDC (National Drug Code) for Dicloxacillin Sodium 250 mg/1 is 55289-592, listed by PD-Rx Pharmaceuticals, Inc..