Dicloxacillin Sodium (Page 2 of 2)

ADVERSE REACTIONS

Hypersensitive Reactions

The reported incidence of allergic reactions to penicillin ranges from 0.7 to 10 percent (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 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 (ie, fever, malaise, urticaria, myalgia, arthralgia, abdominal pain) and various skin rashes.

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 in 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. Cholestatic 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 pa

RECOMMENDED DOSAGES FOR DICLOXACILLIN SODIUM, USP IN MILD TO MODERATE AND SEVERE INFECTIONS
DRUG ADULTS CHILDREN
Mild to
Moderate Severe Mild to
Moderate Severe

*
Patients weighing less than 40 kg (88 lbs.)

Dicloxacillin

125 mg
every
6 hours

250 mg
every
6 hours

12.5 mg/kg/
day* in
equally
divided
doses every
6 hours

25 mg/kg/
day* in
equally
divided
doses every
6 hours

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).

renteral agent as soon as the clinical condition warrants.

HOW SUPPLIED

Dicloxacillin sodium capsules, USP

250 mg

Light blue opaque cap/body capsule printed with GG854 containing dicloxacillin sodium, USP equivalent to 250 mg dicloxacillin.
Bottle of 100 capsules NDC 0781-2248-01

500 mg

Light blue opaque cap/body capsule printed with GG855 containing dicloxacillin sodium, USP equivalent to 500 mg dicloxacillin. Bottle of 100 capsules NDC 0781-2258-01

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

REFERENCES

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.

SPL UNCLASSIFIED SECTION

12-2015M

46176893

Manufactured in Austria by Sandoz GmbH

Distributed by Sandoz Inc., Princeton, NJ 08540

500 MG LABEL

DICLOXACILLIN SODIUM dicloxacillin sodium capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67296-1205(NDC:0781-2258) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DICLOXACILLIN SODIUM (DICLOXACILLIN) DICLOXACILLIN 500 mg

Inactive Ingredients Ingredient Name Strength AMMONIA FERROSOFERRIC OXIDE GELATIN MAGNESIUM STEARATE POTASSIUM HYDROXIDE TITANIUM DIOXIDE FD&C BLUE NO. 1 PROPYLENE GLYCOL SHELLAC

Product Characteristics Color blue (light blue) Score no score Shape CAPSULE Size 22mm Flavor Imprint Code GG855 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67296-1205-4 40 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA061454 04/01/1971

Labeler — RedPharm Drug, Inc. (828374897)

Establishment
Name	Address	ID/FEI	Operations
RedPharm Drug, Inc.		828374897	repack (67296-1205)

Revised: 01/2022 RedPharm Drug, Inc.