Drug: Dynapen

Dicloxacillin sodium is a semisynthetic antibiotic substance which resists destruction by the enzyme penicillinase (beta-lactamase). It is monosodium (2S,5R,6R)-6-(3-(2,6-dichlorophenyl)5-methyl-4-isoxazolecarboxamido]-3,3-dimethyl-7-OXO-4-thia-1-azabicyclo[3.2.0] heptane-2-carboxylate monohydrate. Dicloxacillin is administered orally via capsule form or powder for reconstitution. Inactive Ingredients: Capsules: Magnesium Stearate.
  • Capsule Shell and print Constituents:
  • D& C Yellow #10 Aluminum Lake,
  • FD& C Blue #l Aluminum Lake,
  • FD& C Blue #2 Aluminum Lake,
  • FD& C Red #40 Aluminum Lake,
  • Gelatin, Pharmaceutical Glaze, Silicon Dioxide, Sodium Lauryl Sulfate, Synthetic Black Iron Oxide, Tiinium Dioxide and may contain Carboxymethylcellulose Sodium and/or Propylene Glycol.

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Body as a Whole 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, iaryngospasm, bronchospasm, hypotension, vascular collapse and death. Such immediate anaphylatic 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 Iaryngeal 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 two to four weeks after initiation of therapy. Manifestations of this type of reaction include serum sickness-like symptoms (ie, fever, malaise, urticarii, myalgia, arthralgia, abdominal pain) and various skin rashes. Nausea. vomiting, diarrhea, stomatitis, black or harry 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 the peniciilinase-resistant penicillins, especially with patients with renal insufficiency. Urogenital REACTIONS Renal tubular damage and interstitial nephritis have been associated with the administration of methicin sodium and infrequently, with the administration of nafcillin and oxacillin. Manifestations of this reacti on may include rash, fever, eosinophilia, hematuria, proteinuria and renal insufficiency. Methicillin-induced nephropathy does not appear to be dose-related and is generally reversible upon prompt discontinuation of therapy. Metabolic REACTIONS Agranulocytosis, neutropenia and bone marrow depression have been associated with the use of methicin sodium and nafcillin. Hepatotoxicity, characterized by fever, nausea and vomiting associated with abnormal liver function tests, mainly elevated SGOT levels, has been associated with the use of oxacillin. RECOMENDED DOSAGES FOR DICLOXACILLIN 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/dayb in equally divided doses every 6 hours 25 mg/kg/dayb in equally divided doses every 6 hours b Patients weighing less than 40 kg (88 Ibs.) Read the Dynapen (dicloxacillin) Side Effects Center for a complete guide to possible side effectsLearn More »

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Bacteriologic studies to determine the causative organisms and their sensitivity to the penicillinase-resistant penicillins should always be performed. Duration of therapy varies with the type and 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 penicillinase-resistant penicillins 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. The treatment of endocarditis and osteomyelitis may require a longer term of therapy. Concurrent administration of the penicillinase-resistant penicillins and probenecid increases and prolongs serum penicillin levels. Probencid 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. for Intramuscular gluteal injections, care should be taken to avoid sciatic nerve injury. With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis. NB: INFECTIONS CAUSED BY GROUP A BETA-HEMOLYTIC STREPTOCOCCI SHOULD BE TREATED FOR AT LEAST 10 DAYS TO HELP PREVENT THE OCCURRENCE OF ACUTE RHEUMATIC FEVER OR ACUTE GLOMERULONEPHRITIS.

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Tetracycline, a bacteriostatic antibiotic, may antagonize the bactercidal effect of penicillin and concurrent use of these drugs should be avoided. Read the Dynapen Drug Interactions Center for a complete guide to possible interactions Learn More »

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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 initialty to determine the causative organisms and their sensitivity to the drug. (see CLINICAL PHARMACOLOGY - Susceptibility plate Testing). Dicloxacilin 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 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 a penicillinase-resistant penicillin.

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A history of a hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication. Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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No information provided.

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Dicloxacillin Sodium Capsules, USP. 250 mg: Each capsule contains dicloxacillin sodium monohydrate equivalent to 250 mg dicloxacillin, with a light green cap and body imprinted "biocraft 02", available in bottles of 40, 100, 500 and Unit Dose cartons of 100 (10 x 10). 500 mg: Each capsule contains dicloxacillin sodium monohydrate equivalent to 500 mg dicloxacillin. with a light green cap and body imprinted "biocraft 04", available in bottles of 30, 40, 50, 100, 500 and Unit Dose cartons of 100 (10 x 10). Last reviewed on RxList: 8/21/2013
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General Dicloxacillin 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 oral route of administration should not be relied upon in patients with severe illness, or with nausea, vomiting, gastric dilatation, cardiospasm or intestinal hypermotility. Occasionally, patients will not absorb therapeutic amounts of orally administered penicillin. 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. Information for the Patient See PATIENT INFORMATION section. Laboratory Tests Bacteriologic studies to determine the causative organisms and their susceptibility to the penicillinase- resistant penicillins should be performed (see CLINICAL PHARMACOLOGY - Microbiology). In the treatment of suspected staphylococcnl 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 the penicillinase-resistant penicillins. Blood cultures white blood cell and differential cell counts should be obtained prior to initiation of therapy and at least weekly during therapy with pencillinase-resistant penicillins. Periodic urinalysis blood urea nitrogen and creatinine determinations should be performed during therapy with the penicillinase-resistant penicillins and dosage alterations should be considered if these values become elevated It 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 neurotoxin reactions (see DOSAGE AND ADMINISTRATION). SGOT and SGPT values should be obtained periodically during therapy to monitor tor possible liver function abnormalities. Drug Interactions Tetracycline. a bacteriostatic antibiotic may antagonize the bacterci dal effect of penicillin and concurrent use of these drugs should be avoided. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been conducted with these drugs Studies on reproduction (nafcillin) in rats and rabbits reveal no fetal or maternal abnormalities before conception and continuously through weaning (one generation). 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 pencillinase-resistant pencillins. Human experience with the penicillins during pregnancy has not shown any postive 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 breast milk. Caution should be exercised when penicillins are administered to a nursing woman. Pediatric Use Because of incompletely developed renal function in newborns, penicillinase-resistant penicillins (especially methicillin) may not be completely excreted, with abnormally high blood levels resulting. Frequent monitoring of blood levels is advisable in this group, with dosage adjustments when necessary. All newborns treated with penicillins should be monitored cioselv for clinical and laboratory evidence of toxic or Adverse effects (see DOSAGE AND ADMINISTRATION). Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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