Dicloxacillin Sodium (Page 3 of 3)

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 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 (i.e., 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 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.

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 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

Dicloxacillin Sodium Capsules USP are available as follows:

250 mg: Each capsule contains dicloxacillin sodium monohydrate equivalent to 250 mg dicloxacillin (anhydrous), with green colored cap and light green colored body, imprinted “TEVA” on the cap and “3123” on the body, available in:

NDC 55289-592-10 Bottles of 10 capsules

NDC 55289-592-20 Bottles of 20 capsules

NDC 55289-592-28 Bottles of 28 capsules

NDC 55289-592-40 Bottles of 40 capsules

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

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Package/Label Display Panel

Dicloxacillin
Sodium
Capsules USP
250 mg*

55289592 Label
(click image for full-size original)
DICLOXACILLIN SODIUM
dicloxacillin sodium capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55289-592(NDC:0093-3123)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLOXACILLIN SODIUM (DICLOXACILLIN) DICLOXACILLIN 250 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
D&C YELLOW NO. 10 ALUMINUM LAKE
FD&C BLUE NO. 1 ALUMINUM LAKE
FD&C BLUE NO. 1
FD&C BLUE NO. 2–ALUMINUM LAKE
FD&C RED NO. 40
D&C YELLOW NO. 10
GELATIN
SHELLAC
SODIUM LAURYL SULFATE
SORBITAN MONOLAURATE
FERROSOFERRIC OXIDE
TITANIUM DIOXIDE
PROPYLENE GLYCOL
Product Characteristics
Color green (light green) , green Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code TEVA;3123
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55289-592-10 10 CAPSULE in 1 BOTTLE, PLASTIC None
2 NDC:55289-592-20 20 CAPSULE in 1 BOTTLE, PLASTIC None
3 NDC:55289-592-28 28 CAPSULE in 1 BOTTLE, PLASTIC None
4 NDC:55289-592-40 40 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062286 09/30/1990
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (55289-592)

Revised: 07/2022 PD-Rx Pharmaceuticals, Inc.

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