{ "schema_version": 1, "kind": "condition", "id": "familial-mediterranean-fever", "name": "Familial Mediterranean Fever", "category": "chronic", "sources": "EULAR/PReS Recommendations for Familial Mediterranean Fever (FMF) 2024 · Colchicine 500 microgram tablets SmPC sections 4.1 and 4.2, Paediatric population - Familial Mediterranean fever (eMC product 100968): \"Colchicine is indicated in Familial Mediterranean Fever for prophylaxis of attacks and prevention of amyloidosis\", with starting doses \"0.5 mg / day in children less than 5 years of age (1 tablet); 1 mg / day in children from 5 to 10 years of age (2 tablets); 1.5 mg / day in children over 10 years (3 tablets)\" and \"increased in a stepwise fashion (e.g., 0.25mg/step) up to a maximum of 2mg/day (four tablets a day)\". This label carries the familial Mediterranean fever indication for children only and states no adult regimen; the adult 1 to 1.5 mg daily rising to 3 mg is from the EULAR/PReS 2024 recommendations, which are not held in this corpus. · Ibuprofen 400 mg film-coated tablets (POM) SmPC section 4.2 (eMC product 7020)", "review_status": "reviewed", "verified_against": "EULAR/PReS Recommendations for Familial Mediterranean Fever (FMF) 2024 · Colchicine 500 microgram tablets SmPC sections 4.1 and 4.2, Paediatric population - Familial Mediterranean fever (eMC product 100968): \"Colchicine is indicated in Familial Mediterranean Fever for prophylaxis of attacks and prevention of amyloidosis\", with starting doses \"0.5 mg / day in children less than 5 years of age (1 tablet); 1 mg / day in children from 5 to 10 years of age (2 tablets); 1.5 mg / day in children over 10 years (3 tablets)\" and \"increased in a stepwise fashion (e.g., 0.25mg/step) up to a maximum of 2mg/day (four tablets a day)\". This label carries the familial Mediterranean fever indication for children only and states no adult regimen; the adult 1 to 1.5 mg daily rising to 3 mg is from the EULAR/PReS 2024 recommendations, which are not held in this corpus. · Ibuprofen 400 mg film-coated tablets (POM) SmPC section 4.2 (eMC product 7020)", "verified_date": "2026-08", "treatments": [ { "id": 730, "generic": "Colchicine", "line": 1, "is_adjunct": false, "form": "oral.solid", "strength_mg": 0.5, "adult_dose": "1-1.5 mg daily in 1-2 divided doses; increase in steps of 0.5 mg if attacks continue, to a maximum of 3 mg daily", "adult_duration": "continuous, lifelong prophylaxis - not just during attacks", "dose_source": "Colchicine 500 microgram tablets SmPC sections 4.1 and 4.2, Paediatric population - Familial Mediterranean fever (eMC product 100968): \"Colchicine is indicated in Familial Mediterranean Fever for prophylaxis of attacks and prevention of amyloidosis\", with starting doses \"0.5 mg / day in children less than 5 years of age (1 tablet); 1 mg / day in children from 5 to 10 years of age (2 tablets); 1.5 mg / day in children over 10 years (3 tablets)\" and \"increased in a stepwise fashion (e.g., 0.25mg/step) up to a maximum of 2mg/day (four tablets a day)\". This label carries the familial Mediterranean fever indication for children only and states no adult regimen; the adult 1 to 1.5 mg daily rising to 3 mg is from the EULAR/PReS 2024 recommendations, which are not held in this corpus.", "rationale": "Colchicine is the mainstay of FMF: daily continuous dosing prevents both attacks and the amyloidosis that untreated FMF can cause, unlike its short 3-day course use in gout. EULAR/PReS 2024 states colchicine should be continued through conception, pregnancy, and lactation - stopping risks a flare and amyloidosis, and current evidence does not show the fetal risk that older general drug-labelling contraindications assume for colchicine's other indications", "cautions": [ "Narrow therapeutic index - diarrhoea or vomiting is an early sign of toxicity; do not exceed the recommended dose.", "Reduce dose in renal or hepatic impairment; avoid combining with strong CYP3A4 or P-glycoprotein inhibitors (e.g. clarithromycin, ciclosporin) - risk of life-threatening toxicity.", "Do not stop colchicine in pregnancy without discussing with the treating specialist - see rationale.", "During an acute attack, keep the dose unchanged; do not increase colchicine to control attack pain.", "Numbers for the dose reductions: in mild to moderate renal or hepatic impairment an adult goes to 0.5 mg a day and a child's dose halves. A strong CYP3A4 or P-gp inhibitor needs a four-fold reduction and a moderate CYP3A4 inhibitor a two-fold one - and in renal or hepatic impairment those combinations are contraindicated outright, not merely reduced." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "EULAR/PReS 2024 age-band starting doses (not weight-based): under 5 years, up to 0.5 mg/day; 5-10 years, 0.5-1 mg/day; over 10 years, 1-1.5 mg/day (same as adult). Maximum 2 mg/day in children versus 3 mg/day in adults. Titrate under specialist guidance", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": [ { "label": "Under 5 years", "age_min_months": 0, "age_max_months": 59, "dose_text": "Up to 0.5 mg daily" }, { "label": "5 to 10 years", "age_min_months": 60, "age_max_months": 119, "dose_text": "0.5 to 1 mg daily" }, { "label": "Over 10 years", "age_min_months": 120, "age_max_months": 216, "dose_text": "1 to 1.5 mg daily, as for an adult. Maximum 2 mg daily in a child." } ], "peds_doses": null, "brands": [ { "trade_name": "COLCHICINE 500 MCG 100 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EL NASR", "price_egp": 190.0, "pack_count": 100, "unit_price": 1.9, "strength_mg": 0.5, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "COLMEDITEN 0.5 MG 100 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "KAHIRA", "price_egp": 190.0, "pack_count": 100, "unit_price": 1.9, "strength_mg": 0.5, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "GOURYST 0.5 MG 100 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "PHAROPHARMA", "price_egp": 190.0, "pack_count": 100, "unit_price": 1.9, "strength_mg": 0.5, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "familial-mediterranean-fever" }, { "id": 731, "generic": "Ibuprofen", "line": 1, "is_adjunct": true, "form": "oral.solid", "strength_mg": 400.0, "adult_dose": "400-800 mg three times daily with food during an acute attack, alongside the usual unchanged colchicine dose", "adult_duration": "duration of the acute attack, typically 1-3 days", "dose_source": "Ibuprofen 400 mg film-coated tablets (POM) SmPC section 4.2 (eMC product 7020)", "rationale": "EULAR/PReS 2024 recommends NSAIDs for symptomatic relief during attacks; glucocorticoids and opioids are advised against, and the colchicine dose itself should not be increased for an attack", "cautions": [ "Avoid in peptic ulcer disease, severe heart failure, or CKD.", "Take with food or gastroprotection.", "Do not use opioids or increase the colchicine dose to manage attack pain - EULAR/PReS 2024 recommends against both.", "Contraindicated in the third trimester of pregnancy.", "2400 mg a day is the ceiling and the label allows it only as a temporary increase in acute severe conditions - which an FMF attack is. The usual range is 1200-1800 mg daily, no single dose above 800 mg, and it comes back down when the attack settles." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "Specialist-guided in paediatric FMF attacks. No document held here gives a paediatric dose for FMF specifically. The ibuprofen label behind the adult dose above (Ibuprofen 400 mg SmPC, eMC 7020) gives, under the same Rheumatic diseases heading: \"Adolescents from 15 to 17 years of age: The recommended dose should be adjusted by weight: 20 mg/kg to a maximum of 40 mg/kg body weight daily (max 2400 mg daily) in 3 to 4 divided doses.\" Below 15 years that label gives weight bands for pain and fever only, not for rheumatic disease, and it states: \"Ibuprofen is contraindicated in children below 20 kg body weight or younger than 6 years of age.\"", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": [ { "label": "15 to 17 years", "age_min_months": 180, "age_max_months": 215, "dose_text": "20 mg/kg daily, up to a maximum of 40 mg/kg daily (maximum 2400 mg daily), in 3 to 4 divided doses. Below 15 years the label gives weight bands for pain and fever only, not for rheumatic disease." } ], "peds_doses": null, "brands": [ { "trade_name": "DAJUANOFEN 400 MG 20 F.C. TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "COPAD PHARMA", "price_egp": 5.0, "pack_count": 20, "unit_price": 0.25, "strength_mg": 400.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "FLABU 400MG 10 F.C.TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "DELTA PHARMA", "price_egp": 3.75, "pack_count": 10, "unit_price": 0.38, "strength_mg": 400.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "NOVA-PROFEN 400MG 30 F.C. TABLETS", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "SANOFI", "price_egp": 12.75, "pack_count": 30, "unit_price": 0.42, "strength_mg": 400.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "IBUPROFEN 400 MG 10 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "SEDICO", "price_egp": 6.0, "pack_count": 10, "unit_price": 0.6, "strength_mg": 400.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "MAFO 400 MG 30 F.C.TABS", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EIPICO", "price_egp": 42.0, "pack_count": 30, "unit_price": 1.4, "strength_mg": 400.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "BRUFEN 400 MG 30 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "KAHIRA > ABBOTT LABORATORIES", "price_egp": 78.0, "pack_count": 30, "unit_price": 2.6, "strength_mg": 400.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "PROFUSOL 400MG 20 S.G CAPS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EUROPEAN EGYPTIAN PHARM. IND.", "price_egp": 31.0, "pack_count": null, "unit_price": null, "strength_mg": 400.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ANALGIPROF 400 MG 25 SACHETS", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EVA PHARMA", "price_egp": 37.5, "pack_count": null, "unit_price": null, "strength_mg": 400.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "NOVA-PROFEN 100MG/5ML ORAL SUSP. 100ML", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "SANOFI", "price_egp": 2.25, "pack_count": null, "unit_price": null, "strength_mg": 100.0, "exact_strength": false, "exact_form": false, "discontinued": false, "also_contains": null }, { "trade_name": "BRUFEMOL-N SUSP. 60 ML", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ARAB DRUG COMPANY (ADCO)", "price_egp": 4.5, "pack_count": null, "unit_price": null, "strength_mg": null, "exact_strength": false, "exact_form": false, "discontinued": false, "also_contains": null } ], "condition_id": "familial-mediterranean-fever" } ] }