pivmecillinam

Absorption: Well absorbed and subsequently rapidly hydrolyzed to mecillinam (the active antibacterial agent). Bioavailability of mecillinam = 25–35%.

Distribution: Well distributed to tissues.

Metabolism/Excretion: Mecillinam undergoes minimal metabolism. Primarily excreted in urine as mecillinam.

Half-Life: 1 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	90 min	8 hr

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Serious hypersensitivity to penicillins or cephalosporins;
Primary or secondary carnitine deficiency resulting from inherited disorders of mitochondrial fatty acid oxidation and carnitine metabolism, and other inborn errors of metabolism;
Porphyria.

Use Cautiously in:

OB: May cause a false-positive test for isovaleric acidemia during newborn screening if administered shortly before delivery;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: ACUTE GENERALIZED EXANTHEMATOUS PUSTULOSIS (AGEP), DRUG REACTIONS WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), STEVENS-JOHNSON SYNDROME (SJS), TOXIC EPIDERMAL NECROLYSIS (TEN)

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

GU: genital pruritus, vulvovaginal candidiasis

Neuro: headache

Misc: carnitine deficiency, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), porphyria

Interactions ⬆ ⬇

Drug-drug:

Valproic acid orvalproate may ↑ risk of carnitine deficiency; avoid concurrent use.
May ↑ levels and risk of toxicity of methotrexate.

Route/Dosage ⬆ ⬇

PO (Adults ): 185 mg 3 times daily for 3–7 days.

Availability ⬆ ⬇

Film-coated tablets: 185 mg

Assessment ⬆ ⬇

Assess for hypersensitivity reactions (anaphylaxis), discontinue treatment and institute appropriate therapy. Obtain history of hypersensitivity to beta-lactams (penicillins, cephalosporins, carbapenems) or multiple allergens.
Monitor for AGEP, DRESS, SJS, and TEN; discontinue at the 1st sign/symptom of these adverse reactions.
Monitor for CDAD, pseudomembranous colitis, and other superinfections: Evaluate if diarrhea occurs. May persist up to 3 mo after antibiotic treatment.
Monitor for signs/symptoms of acute porphyria (anxiety, confusion, limb or abdominal pain, hyponatremia, seizures, and muscle weakness).

Lab Test Considerations:

May ↓ plasma carnitine. Monitor for hypoglycemia, muscle aches, fatigue, and confusion.
May cause a false-positive test for isovaleric acidemia in the newborn as part of newborn screening. Prompt follow-up of a positive newborn screening result for isovaleric acidemia is recommended.

Implementation ⬆ ⬇

PO: Administer with or without food and with adequate fluids to avoid esophageal ulceration.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy. If a dose is missed, advise to take the dose as soon as possible. Do not double the dose.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care provider before taking other medications.
Advise patient that antibacterial drugs should only be used to treat bacterial infections. These drugs do not treat viral infections (common cold). Advise patient to complete the entire course of therapy as prescribed even if feeling better. Skipping doses or not completing the full course may ↓ effectiveness of the immediate treatment and ↑ likelihood of bacteria resistance and infection that will not be treatable by antibacterial drugs in the future.
Advise patient to notify health care provider immediately if new rash, urticaria, drug eruptions, swelling of the face, difficulty in breathing, or other symptoms of allergic reactions occur and to seek immediate medical attention if indicated.
Advise patient to discontinue therapy if any type of skin rash, mucosal lesions, or any other sign of hypersensitivity develops and to seek immediate medical attention.
Advise patient to avoid use of valproic acid, valproate, or other pivalate-generating drugs due to ↑ risk of carnitine depletion.
Advise patient after starting treatment with antibacterial drugs that watery and bloody stools (with or without stomach cramps and fever) can develop even as late as >2 mo after taking the last dose of the drug. Advise patient to seek medical attention as soon as possible if symptoms occur.
Rep: Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding. Advise pregnant patient if treatment is used before delivery, there may be a false-positive test for isovaleric acidemia in the newborn as part of newborn screening and follow-up of a positive result is recommended.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇