cloxacillin

REMS

Treatment of the following infections due to penicillinase-producing staphylococci:
- Respiratory tract infections,
- Sinusitis,
- Septicemia,
- Endocarditis,
- Osteomyelitis,
- Skin and skin structure infections.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Previous hypersensitivity to penicillin (cross-sensitivity exists with cephalosporins and other beta-lactam antibiotics).

Use Cautiously in:

Severe renal impairment;
Severe hepatic impairment;
OB: Safety and effectiveness not established in pregnancy;
Lactation: Safety and effectiveness not established in breastfeeding;
Pedi: Safety and effectiveness not established in premature and newborn infants.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: rash, urticaria

GI: diarrhea, epigastric distress, nausea, vomiting, CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD)

GU: interstitial nephritis

Hemat: eosinophilia, leukopenia

Neuro: SEIZURES

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND SERUM SICKNESS), superinfection

Interactions ⬆ ⬇

Drug-drug:

May ↓ effectiveness of oral contraceptive agents.
Probenecid↓ renal excretion and ↑ levels (therapy may be combined for this purpose).
May ↑ levels and risk of toxicity of methotrexate.

Drug-Food:

Food ↓ oral absorption by 50%.

Availability ⬆ ⬇

Capsules: 250 mg; 500 mg
Oral solution: 125 mg/5 mL
Lyophilized powder for injection: 250 mg/vial; 500 mg/vial; 1 g/vial; 2 g/vial

Route/Dosage ⬆ ⬇

PO (Adults ): 250—500 mg every 6 hr.
PO (Children ≥40 kg): 250—500 mg every 6 hr (max dose = 6 g/day).
PO (Children 5—<40 kg): 50 mg/kg/day divided every 6 hr (max dose = 4 g/day).
IM IV (Adults ): 1—2 g every 4—6 hr.
IM IV (Children ): 100—200 mg/kg/day in divided doses every 6 hr (max = 2 g/dose).

Action ⬆ ⬇

Bind to bacterial cell wall, leading to cell death. Not inactivated by penicillinase enzymes.

Therapeutic effects:

Bactericidal action.

Spectrum:

Active against most gram-positive aerobic cocci.
Spectrum is notable for activity against:
- Penicillinase-producing strains of Staphylococcus aureus and Staphylococcus epidermidis.
Not active against methicillin-resistant Staphylococcus aureus.

Classifications ⬆ ⬇

Therapeutic Classification: anti-infectives

Pharmacologic Classification: penicillinase resistant penicillins

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability. Moderately absorbed (50%) following oral administration.

Distribution: Widely distributed; penetration into CSF is minimal but sufficient in the presence of inflamed meninges.

Metabolism/Excretion: Some metabolism by the liver (9—22%) and some renal excretion of unchanged drug (20%).

Half-Life: 0.5—1.1 hr (↑ in severe hepatic impairment, renal impairment, and neonates).

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
PO	30 min	30—120 min	6 hr
IM	unknown	unknown	6 hr
IV	rapid	end of injection/infusion	6 hr

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy. Advise patient to take medication around the clock and to finish the drug completely as directed, even if feeling better. Missed doses should be taken as soon as remembered. Advise patient that sharing of this medication may be dangerous.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care provider before taking other medications.
Advise patient to report signs of superinfection (black, furry overgrowth on the tongue; vaginal itching or discharge; loose or foul-smelling stools) and allergy.
Advise patient to notify health care provider if fever and diarrhea develop, especially if stool contains blood, pus, or mucus. Advise patient not to treat diarrhea without consulting health care provider.
Advise patient to notify health care provider if symptoms do not improve.
Rep: Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding. Advise patient taking oral contraceptives to use an additional nonhormonal method of contraception during therapy with penicillin and until next menstrual period.

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Indications ⬇