Minocycline

The UK SPC in this bundle is an ACNE-ONLY modified-release product and gives no antibacterial regimen; the antibacterial regimen is US labelling and is flagged as such in the dose field. The two must not be merged — the UK acne dose is 100 mg once daily, the US infection dose is twice that daily amount. maxDose is deliberately empty: the only 24-hour ceiling in the bundle ('The total daily dosage should not exceed 200 mg in 24 hours') appears inside the US label's renal-impairment paragraph and is recorded under renalAdjustment; it is not a general ceiling, and it would in any case conflict with the label's own 200 mg + 100 mg day-1 loading regimen. ACNE COURSE LENGTH (eMC §4.2): 'Treatment of acne should be continued for a minimum of 6 weeks, and where possible limited to a maximum of six months. If, after six months, there is no satisfactory response, Acnamino MR should be discontinued and other therapies considered.' ELDERLY (eMC §4.2): 'Dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.' US INDICATION-SPECIFIC COURSES (verbatim, US label): uncomplicated gonococcal infections other than urethritis and anorectal infections in men — '200 mg initially, followed by 100 mg every 12 hours for a minimum of 4 days, with post-therapy cultures within 2 to 3 days'; uncomplicated gonococcal urethritis in men — '100 mg every 12 hours for 5 days'; syphilis — 'the usual dosage of minocycline hydrochloride should be administered over a period of 10 to 15 days'; meningococcal carrier state — '100 mg every 12 hours for 5 days'; Mycobacterium marinum — 'Although optimal doses have not been established, 100 mg every 12 hours for 6 to 8 weeks have been used successfully in a limited number of cases'; uncomplicated urethral, endocervical or rectal infection caused by Chlamydia trachomatis or Ureaplasma urealyticum — '100 mg orally, every 12 hours for at least 7 days'. The US label opens 'THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF MINOCYCLINE DIFFER FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.' KEY INTERACTIONS (US label Drug Interactions; this contract has no interactions field): tetracyclines depress plasma prothrombin activity, so anticoagulant dosage may need downward adjustment; absorption is impaired by antacids containing aluminium, calcium or magnesium and by iron-containing preparations; avoid giving tetracycline-class drugs with penicillin; concurrent use may render oral contraceptives less effective; 'Administration of isotretinoin should be avoided shortly before, during, and shortly after minocycline therapy. Each drug alone has been associated with pseudotumor cerebri'; increased risk of ergotism with ergot alkaloids. eMC §4.4 adds caution 'in conjunction with alcohol and other hepatotoxic drugs'. SOURCE LIMIT: the eMC §4.4 and §4.8 extracts and the US adverse-reactions extract are marked '[…SECTION TRUNCATED AT SOURCE-FETCH LIMIT]', so neither warnings list nor adverse-reaction list is complete.

UK SPC (Acnamino MR, eMC §4.2) verbatim: 'Children over 12 years: One 100 mg capsule every 24 hours. Children under 12 years: Minocycline should not be used in children under 12 years of age.' §4.3 contraindicates 'Children under the age of 12 years'. The UK paediatric regimen is therefore the same FIXED 100 mg adult dose, not weight-based, so dosePerKg is null and no weight calculation should be offered. CONFLICTING US LABEL, recorded as cross-check only and NOT offered as a calculator figure because it covers an age band the UK SPC contraindicates: 'For Pediatric Patients above 8 Years of Age Usual pediatric dose: 4 mg/kg initially followed by 2 mg/kg every 12 hours, not to exceed the usual adult dose'; 'Minocycline is not recommended for the use in children below 8 years of age unless the expected benefits of therapy outweigh the risks.' Verify any under-18 use against a children's formulary.