Strength200 mg
Formoral.solid
The SmPC writes a separate pregnancy regimen, and it is the one to follow. Verbatim, under Pregnant women: "Acute cystitis: 7 day course of 2 tablets immediately followed by 1 tablet 3 times daily to a total of 22 tablets." On 200 mg tablets that is 400 mg as the first dose, then 200 mg three times a day for seven days. The disease article gives a heavier regimen for the same seven days - "pivmecillinam 400 mg 3 times a day for 7 days for uncomplicated cystitis" - and the two are printed side by side because they genuinely differ; the label's own pregnancy schedule leads. - Seven days, which is the pregnancy course rather than the three-day course used outside pregnancy. The SmPC's non-pregnant regimen is a "72 hour course"; the pregnancy entry is a "7 day course", and the disease article agrees on seven.
Paediatric doseNot applicable to pregnancy entry - the patient is a pregnant adult. Any weight-based child dose for this drug belongs on the paediatric urinary tract infection entry.
Dose sourceSelexid 200 mg Film-coated Tablets (pivmecillinam hydrochloride) SmPC sections 4.1, 4.2, 4.3, 4.4 and 4.6 (eMC product 3799)
WhyThe disease article names the drug and puts it among the alternative regimens, verbatim: "Multiple randomized trials support the use of a newer antibiotic, pivmecillinam 400 mg 3 times a day for 7 days for uncomplicated cystitis. Routine use for upper urinary tract infection is not yet recommended." The SmPC's indication section names urinary tract infections, and its pregnancy section names the disease and the patient together, verbatim: "A large amount of data on pregnant women (more than 40 000 pregnancy outcomes) indicate no malformative nor feto/neonatal toxicity of pivmecillinam. Selexid can be used for treatment of acute uncomplicated cystitis during pregnancy, if clinically needed." It earns a place because resistance is the reason the card needs depth - the article's own point about pivmecillinam elsewhere is that it covers ESBL-producing organisms. Egypt registers no pivmecillinam product, so no brand and no price can be shown; the row exists so a regimen started abroad can be recognised and continued.
Cautions- Contraindicated in more than the obvious group. SmPC verbatim: "Hypersensitivity to penicillins and/or cephalosporins. Any conditions resulting in impaired transit through the oesophagus." and "Genetic metabolism anomalies known to be leading to severe carnitine deficiency, such as carnitine transporter defect, methylmalonic aciduria or propionic acidaemia."
- Take it upright, with fluid and food. SmPC verbatim: "The tablets must be taken with at least half a glass of fluid, and preferably taken with or immediately after a meal." The oesophageal contraindication above is the reason this instruction carries weight.
- Severe skin reactions end the course. SmPC verbatim: "Severe cutaneous adverse reactions (SCAR) such as acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been reported in relation to beta-lactam treatment, including Selexid. When SCAR is suspected, Selexid should be discontinued immediately".
- It depletes carnitine, and valproate makes that worse. SmPC verbatim: "Selexid tablets should be used with caution for long-term or frequently-repeated treatment, due to the possibility of carnitine depletion. Symptoms of carnitine depletion include muscle aches, fatigue, and confusion." and "Concurrent treatment with valproic acid, valproate or other medication liberating pivalic acid should be avoided due to increased risk of carnitine depletion."
- Caution in porphyria. SmPC verbatim: "Selexid tablets should be used with caution in patients with porphyria since pivmecillinam has been associated with acute attacks of porphyria."
- It can trip the newborn screen. SmPC verbatim: "The intake of pivmecillinam shortly before delivery may cause a false positive test for isovaleric acidaemia in the newborn as part of neonatal screening. This may be due to the formation of pivaloylcarnitine simulating the presence of isovalerylcarnitine." If it was given near term, say so when the baby is screened.
- Breastfeeding is not a reason to withhold it. SmPC verbatim: "Mecillinam is excreted in human milk, but at therapeutic doses of Selexid no effects on the breast-fed newborns/infants are anticipated. Selexid can be used during breast-feeding."
- Not for a kidney infection. The disease article is explicit that it is not yet recommended for routine use in an upper urinary tract infection - fever, flank pain or vomiting in a pregnant patient is a different pathway.
Egyptian brandsNo Egyptian brand matched — prescribe by generic name.