Dicloxacillin Sodium (Page 3 of 3)
Gastrointestinal Reactions
Nausea, vomiting, diarrhea, stomatitis, black or hairy tongue and other symptoms of gastrointestinal irritation may occur, especially during oral penicillin therapy.
Pseudomembranous colitis has been reported with the use of dicloxacillin. Therefore, it is important to consider its diagnosis in patients who develop diarrhea in association with dicloxacillin use.
Reports have been received during postmarketing surveillance of esophageal burning, esophagitis, and esophageal ulceration, particularly after ingestion of dicloxacillin capsules with an insufficient quantity of water and/or before going to bed (see PRECAUTIONS and DOSAGE AND ADMINISTRATION).
Nervous System Reactions
Neurotoxic reactions similar to those observed with penicillin G (e.g., lethargy, confusion, twitching, multifocal myoclonus, localized or generalized epileptiform seizures) may occur with large intravenous doses of the penicillinase-resistant penicillins, especially with patients with renal insufficiency.
Renal Reactions
Renal tubular damage and interstitial nephritis have been associated with the administration of methicillin sodium and, infrequently, with the administration of nafcillin and oxacillin. Manifestations of this reaction 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.
Hematologic Reactions
Eosinophilia, hemolytic anemia, agranulocytosis, neutropenia, leukopenia, granulocytopenia, thrombocytopenia, and bone marrow depression have been associated with the use of penicillinase-resistant penicillins.
Hepatic Reactions
Hepatotoxicity, characterized by fever, nausea and vomiting associated with abnormal liver function tests, mainly elevated AST (SGOT) levels, has been associated with the use of oxacillin and cloxacillin. Chloestatic hepatitis has been reported rarely. Asymptomatic, transient increases in serum concentrations of alkaline phosphatase, AST (SGOT), and ALT (SGPT) have been reported.
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.
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 stomach, and should be administered at least 1 hour before or 2 hours after meals. Dicloxacillin should be taken with at least 4 fluid ounces (120 mL) of water and should not be taken in the supine position or immediately before going to bed (see PRECAUTIONS).
HOW SUPPLIED
Product: 50090-0116
NDC: 50090-0116-1 40 CAPSULE in a BOTTLE
NDC: 50090-0116-0 28 CAPSULE in a BOTTLE
NDC: 50090-0116-4 20 CAPSULE in a BOTTLE
Product: 50090-0310
Dicloxacillin Sodium
Label ImageDicloxacillin Sodium
Label Image DICLOXACILLIN SODIUM dicloxacillin sodium capsule | ||||||||||||||||||||||||||||||||
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DICLOXACILLIN SODIUM dicloxacillin sodium capsule | ||||||||||||||||||||||||||||||||
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Labeler — A-S Medication Solutions (830016429) |
Establishment | |||
Name | Address | ID/FEI | Operations |
A-S Medication Solutions | 830016429 | RELABEL (50090-0116), REPACK (50090-0116), RELABEL (50090-0310), REPACK (50090-0310) |
Revised: 12/2023 A-S Medication Solutions
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