Strength200 mg
Formoral.solid
A three-day course with a double first dose. SmPC verbatim: "Acute uncomplicated cystitis: 72 hour course of 2 tablets immediately followed by 1 tablet 3 times daily to a total of 10 tablets." On 200 mg tablets that is 400 mg once, then 200 mg three times a day. For a bacteriuria that keeps returning the SmPC gives a heavier regimen: "Chronic or recurrent bacteriuria: 2 tablets three to four times daily." - Three days. SmPC verbatim: a "72 hour course" totalling ten tablets.
Paediatric doseThe SmPC doses children by weight but this is not a first move in a child. Verbatim: "Children weighing more than 40 kg" take the adult 72-hour course; "Children weighing less than 40 kg Urinary tract infections: 20-40 mg/kg body weight, daily, in 3 to 4 divided doses." No worked milligram table is printed here on purpose - a urinary infection in a small child needs the cause looked for, not a second-choice antibiotic reached for.
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 twice and says where it sits, verbatim: "Pivmecilinam may be considered when other agents cannot be used due to resistance or other factors, although it is not typically preferred for long-term use." and "Pivmecillinam is better tolerated than nitrofurantoin, and it effectively covers ESBL-producing and multiple drug-resistant strains of E coli, P mirabilis, and S saprophyticus." The SmPC's indication section names urinary tract infections and its posology names the syndrome, verbatim: "Acute uncomplicated cystitis". ESBL-producing E coli is common in Cairo and the card's existing options narrow quickly against it. Egypt registers no pivmecillinam product, so no brand and no price can be shown.
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 does not cover the gram-positive urinary organisms. The disease article does not recommend it against Pseudomonas, Acinetobacter or Enterococcus, nor against the other gram-positive urinary pathogens. A culture growing enterococcus is a reason to change, not to continue.
- Watch for antibiotic-associated colitis. SmPC verbatim: "Pseudomembranous colitis caused by Clostridium difficile may occur. If diarrhoea occurs after use, the possibility of pseudomembranous colitis should be considered".
Egyptian brandsNo Egyptian brand matched — prescribe by generic name.