{ "schema_version": 1, "kind": "condition", "id": "bipolar-disorder-referral", "name": "Bipolar disorder (specialist referral & maintenance stabilization)", "category": "chronic", "sources": "Camcolit 400 mg controlled release lithium carbonate tablets SmPC section 4.2 (eMC product 10829): \"A low dose of 300-400 mg of lithium carbonate can be administered daily for the first seven days. A blood sample for plasma lithium estimation is then taken 12 hours after the last dose, and the dosage of Camcolit is adjusted to keep the plasma lithium level within the range\" of 0.4 to 0.8 mmol/l, with \"a plasma lithium level between 0.6 and 1.0 mmol/l 12 hours after the last dose\" for acute mania. The same SmPC states \"Camcolit should not be used in children.\" · Egyptian National Drug Formulary - Nervous System 2025 (lamotrigine monograph) · Egyptian National Drug Formulary - Nervous System Disorders 2025 · Egyptian National Drug Formulary, nervous system 2025, valproic acid monograph (printed pp. 73-74) · NICE Guideline CG185 · Quetiapine 25 mg film-coated tablets SmPC section 4.2 Posology and method of administration (eMC product 3079) · Abilify 10 mg tablets SmPC sections 4.1 and 4.2 (eMC product 7969) · LATUDA (lurasidone hydrochloride) tablets US prescribing information, boxed warning, section 1 Indications and Usage and section 2 Dosage and Administration (DailyMed SetID afad3051-9df2-4c54-9684-e8262a133af8) · Bipolar Disorder - disease-level clinical article (bipolar-disorder-referral-full.txt)", "review_status": "reviewed", "verified_against": "Camcolit 400 mg controlled release lithium carbonate tablets SmPC section 4.2 (eMC product 10829): \"A low dose of 300-400 mg of lithium carbonate can be administered daily for the first seven days. A blood sample for plasma lithium estimation is then taken 12 hours after the last dose, and the dosage of Camcolit is adjusted to keep the plasma lithium level within the range\" of 0.4 to 0.8 mmol/l, with \"a plasma lithium level between 0.6 and 1.0 mmol/l 12 hours after the last dose\" for acute mania. The same SmPC states \"Camcolit should not be used in children.\" · Egyptian National Drug Formulary - Nervous System 2025 (lamotrigine monograph) · Egyptian National Drug Formulary, nervous system 2025, valproic acid monograph (printed pp. 73-74) · Quetiapine 25 mg film-coated tablets SmPC section 4.2 Posology and method of administration (eMC product 3079) · Bipolar Disorder - disease-level clinical article (bipolar-disorder-referral-full.txt) · Risperidone 2 mg Tablets SmPC (eMC product 11872) · Olanzapine 10 mg tablets SmPC (eMC product 3070) · Abilify 10 mg tablets SmPC sections 4.1 and 4.2 (eMC product 7969) · LATUDA (lurasidone hydrochloride) tablets US prescribing information, boxed warning, section 1 Indications and Usage and section 2 Dosage and Administration (DailyMed SetID afad3051-9df2-4c54-9684-e8262a133af8)", "verified_date": "2026-08", "treatments": [ { "id": 281, "generic": "Quetiapine", "line": 1, "is_adjunct": false, "form": "oral.solid", "strength_mg": 100.0, "adult_dose": "Day 1: 50 mg twice daily; Day 2: 100 mg twice daily; Day 3: 150 mg twice daily; Day 4: 200 mg twice daily (usual target 400-800 mg daily in divided doses or at bedtime)", "adult_duration": "long-term", "dose_source": "Quetiapine 25 mg film-coated tablets SmPC section 4.2 Posology and method of administration (eMC product 3079)", "rationale": "Atypical antipsychotic used as a mood stabilizer in bipolar disorder, controlling both manic and depressive episodes through combined dopamine and serotonin receptor blockade.", "cautions": [ "Metabolic side effects include substantial weight gain, dyslipidemia, hyperglycemia, and new-onset diabetes.", "Sedation and orthostatic hypotension are common.", "Perform baseline blood glucose, lipid panel, weight, and blood pressure, then recheck periodically." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "Child/adolescent bipolar disorder requires tertiary pediatric psychiatric management", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": null, "brands": [ { "trade_name": "SPIRAQUET 100 MG 20 F.C.TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "MEDIZEN PHARMACEUTICAL INDUSTRIES", "price_egp": 70.0, "pack_count": 20, "unit_price": 3.5, "strength_mg": 100.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "QUADEL 100MG 20 F.C. TABS", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "DELTA PHARMA", "price_egp": 108.0, "pack_count": 20, "unit_price": 5.4, "strength_mg": 100.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "QUITAPEX 100 MG 30 F.C.TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "MULTI-APEX", "price_egp": 186.0, "pack_count": 30, "unit_price": 6.2, "strength_mg": 100.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "QUETIASU 100 MG 30 F.C. TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "SUN PHARMA EGYPT LIMITED", "price_egp": 210.0, "pack_count": 30, "unit_price": 7.0, "strength_mg": 100.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "QUETIAPINE 100MG 30 F.C. TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "GLOBAL NAPI PHARMACEUTICALS > FUTURE PHARMACEUTICAL INDUSTRIES (FPI)", "price_egp": 222.0, "pack_count": 30, "unit_price": 7.4, "strength_mg": 100.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "SEROQUEL 100MG 10 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ASTRA ZENECA", "price_egp": 116.5, "pack_count": 10, "unit_price": 11.65, "strength_mg": 100.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "SEROQUEL 100MG 30 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ASTRA ZENECA", "price_egp": 349.5, "pack_count": 30, "unit_price": 11.65, "strength_mg": 100.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "bipolar-disorder-referral" }, { "id": 282, "generic": "Sodium Valproate", "line": 1, "is_adjunct": false, "form": "oral.solid", "strength_mg": 500.0, "adult_dose": "750 mg daily in 2 divided doses initially, titrated to 1000-2000 mg daily (target plasma concentration 50-100 mcg/mL; never above 60 mg/kg/day)", "adult_duration": "long-term", "dose_source": "Egyptian National Drug Formulary, nervous system 2025, valproic acid monograph (printed pp. 73-74)", "rationale": "Anticonvulsant used as a mood stabilizer for bipolar disorder, with a particular role in controlling manic episodes; its teratogenic risk is severe enough that its use in women of childbearing potential is tightly restricted, as the cautions describe.", "cautions": [ "HIGHLY TERATOGENIC: strictly contraindicated in female children and women of childbearing potential unless Pregnancy Prevention Programme is fulfilled.", "There are black box warnings for fatal hepatotoxicity, pancreatitis, and teratogenicity.", "Check liver function when treatment starts and often thereafter - the first 6 months are the critical window - and take a full blood count with platelets at the start and at intervals after that. Monitoring Parameters, valproic acid monograph, Egyptian National Drug Formulary - Nervous 2025.", "The formulary's therapeutic range is 50-100 mcg/mL, not 125. It also caps the dose at 60 mg/kg/day and says anything over 250 mg a day must be split.", "Egypt's formulary restricts it further than most: under 55 years, in either sex, only when nothing else works or is tolerated. For mania the wording is the same - a last resort, not a first choice.", "Under two years the hepatotoxicity is not just a risk, it is a fatal one." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "Specialist pediatric psychiatry use only", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": null, "brands": [ { "trade_name": "LEPTOPRENOL 500 MG 20 S.R. F.C. TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ATCO PHARMA > EGYPHARMA", "price_egp": 96.0, "pack_count": null, "unit_price": null, "strength_mg": 500.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "DEKADEL CHRONO 500MG 30 E.C.TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "DELTA PHARMA", "price_egp": 131.0, "pack_count": null, "unit_price": null, "strength_mg": 500.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "DAVIKEN 250MG/5ML SYRUP 60ML", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "AMOUN", "price_egp": 8.75, "pack_count": null, "unit_price": null, "strength_mg": 250.0, "exact_strength": false, "exact_form": false, "discontinued": false, "also_contains": null }, { "trade_name": "DEPAVALPOLEM 200MG/5ML SYRUP 120 ML", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "DEBEIKY", "price_egp": 11.5, "pack_count": null, "unit_price": null, "strength_mg": 200.0, "exact_strength": false, "exact_form": false, "discontinued": false, "also_contains": null } ], "condition_id": "bipolar-disorder-referral" }, { "id": 283, "generic": "Lithium Carbonate", "line": 1, "is_adjunct": false, "form": "oral.solid", "strength_mg": 400.0, "adult_dose": "400 mg once daily at bedtime initially (or divided doses), adjusted based on 12-hour post-dose serum lithium monitoring to target 0.6-0.8 mmol/L (0.8-1.0 mmol/L for acute mania or relapse)", "adult_duration": "long-term", "dose_source": "Camcolit 400 mg controlled release lithium carbonate tablets SmPC section 4.2 (eMC product 10829): \"A low dose of 300-400 mg of lithium carbonate can be administered daily for the first seven days. A blood sample for plasma lithium estimation is then taken 12 hours after the last dose, and the dosage of Camcolit is adjusted to keep the plasma lithium level within the range\" of 0.4 to 0.8 mmol/l, with \"a plasma lithium level between 0.6 and 1.0 mmol/l 12 hours after the last dose\" for acute mania. The same SmPC states \"Camcolit should not be used in children.\"", "rationale": "Gold-standard anti-suicidal mood stabilizer; requires strict therapeutic drug monitoring", "cautions": [ "Narrow therapeutic window; toxicity (tremor, ataxia, confusion, vomiting) occurs above 1.5 mmol/L.", "Check baseline thyroid function, renal function (creatinine, eGFR), calcium, and ECG.", "Ensure adequate hydration and consistent sodium intake to avoid toxicity." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "Child >=12 years: specialist child and adolescent psychiatric supervision mandatory", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": null, "brands": [ { "trade_name": "LITHIOMOD 400 MG 30 PROLONGED REL. TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "P & C LABS > Halence Pharma", "price_egp": 147.0, "pack_count": null, "unit_price": null, "strength_mg": 400.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "PRIANIL C.R. 400MG 30 CONTROLLED REL. TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EL NILE.", "price_egp": 162.0, "pack_count": null, "unit_price": null, "strength_mg": 400.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "bipolar-disorder-referral" }, { "id": 285, "generic": "Referral & safety-netting (no drug therapy)", "line": 1, "is_adjunct": false, "form": null, "strength_mg": null, "adult_dose": null, "adult_duration": null, "dose_source": "Bipolar Disorder - disease-level clinical article (bipolar-disorder-referral-full.txt)", "rationale": "Carries the referral criteria and warning signs for this condition, which apply whichever treatment is chosen.", "cautions": [ "RED FLAG - Acute mania is a medical emergency requiring psychiatric hospitalization.", "RED FLAG - Valproate carries a contraindication and warning in women of childbearing potential, due to teratogenesis and impaired fetal intellectual development." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": null, "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": null, "brands": [], "condition_id": "bipolar-disorder-referral" }, { "id": 288, "generic": "Aripiprazole", "line": 1, "is_adjunct": false, "form": "oral.solid", "strength_mg": null, "adult_dose": "15 mg once daily to start, with or without food. SmPC verbatim: \"Manic episodes in Bipolar I Disorder: the recommended starting dose for ABILIFY is 15 mg administered on a once-a-day schedule without regard to meals as monotherapy or combination therapy\", and \"Some patients may benefit from a higher dose. The maximum daily dose should not exceed 30 mg.\" For relapse prevention the same dose continues - \"for preventing recurrence of manic episodes in patients, who have been receiving aripiprazole as monotherapy or combination therapy, continue therapy at the same dose.\"", "adult_duration": "Long-term where it is preventing recurrence; the dose is reviewed rather than left standing. SmPC verbatim: \"Adjustments of daily dosage, including dose reduction should be considered on the basis of clinical status.\"", "dose_source": "Abilify 10 mg tablets SmPC sections 4.1 and 4.2 (eMC product 7969)", "rationale": "The disease article puts it in the first-line list, verbatim: \"First-line monotherapy includes a mood stabilizer, such as lithium or valproate, or an antipsychotic, such as aripiprazole, asenapine, cariprazine, quetiapine, or risperidone.\" and names it again in combination - \"Combination treatments include lithium or valproate with either aripiprazole, asenapine, olanzapine, quetiapine, or risperidone.\" The SmPC's indication section names the disease, verbatim: \"ABILIFY is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment\". It matters in Egypt for a practical reason as well as a clinical one: valproate is barred for women of childbearing potential and lithium needs levels, and 48 aripiprazole products are on the register, from ADWIPRAZOLE 30 mg at 40 EGP upward.", "cautions": [ "Akathisia - an inner restlessness the patient may describe as anxiety rather than a side effect - is the commonest reason aripiprazole is abandoned; ask about it directly at review before concluding the mania is unresponsive.", "An antidepressant is normally tapered off and stopped once a manic phase begins - the disease article is explicit about it.", "Valproate, the alternative first-line drug, carries a hard bar in one group. It must not be given to a woman of childbearing potential: the fetal risk - teratogenesis, and impaired intellectual development - is unacceptable. That is one reason an antipsychotic is reached for first in that group.", "A manic episode with psychosis, suicidal ideation or risk to others is a same-day psychiatric problem, not a prescription problem." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "Licensed from 13 years for mania, with a titration and a stop date. SmPC verbatim: for manic episodes in Bipolar I Disorder, \"the recommended dose for ABILIFY is 10 mg/day administered on a once-a-day schedule without regard to meals. Treatment should be initiated at 2 mg (using ABILIFY oral solution 1 mg/mL) for 2 days, titrated to 5 mg for 2 additional days to reach the recommended daily dose of 10 mg. The treatment duration should be the minimum necessary for symptom control and must not exceed 12 weeks.\"", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": [ { "label": "13 years and over", "age_min_months": 156, "age_max_months": 216, "dose_text": "2 mg (as the 1 mg/mL oral solution) for 2 days, then 5 mg for 2 additional days, to the recommended 10 mg once daily. Must not exceed 12 weeks." } ], "peds_doses": null, "brands": [ { "trade_name": "APILIPEX 5 MG 30 F.C.TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "MULTI-APEX", "price_egp": 69.0, "pack_count": 30, "unit_price": 2.3, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ADWIPRAZOLE 10MG 30 F.C. TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ADWIA", "price_egp": 90.0, "pack_count": 30, "unit_price": 3.0, "strength_mg": 10.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "APILIPEX 10 MG 30 F.C.TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "MULTI-APEX", "price_egp": 90.0, "pack_count": 30, "unit_price": 3.0, "strength_mg": 10.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "CENTALIFY 10 MG 10 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "HIKMA PHARMA", "price_egp": 45.0, "pack_count": 10, "unit_price": 4.5, "strength_mg": 10.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "SCHIZOSTOP 30MG 10 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "MEMPHIS > ATM PHARMACEUTICAL INDUSTRIES", "price_egp": 54.0, "pack_count": 10, "unit_price": 5.4, "strength_mg": 30.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ARILOBE 30 MG 20 F.C. TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "MEDIZEN PHARMACEUTICAL INDUSTRIES > MEDISAVE DEVELOPED", "price_egp": 160.0, "pack_count": 20, "unit_price": 8.0, "strength_mg": 30.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "SCHIZOFY 10MG 20 SCORED F.C.TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "WESTERN PHARMACEUTICALS INDUSTRIES > WESTERN PHARMA", "price_egp": 114.0, "pack_count": null, "unit_price": null, "strength_mg": 10.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ARIPIPRAZOLE 30 MG 20 ORALLY DIS.TABLETS", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EL-OBOUR > INSPIRE PHARMACEUTICAL COMPANY", "price_egp": 126.0, "pack_count": null, "unit_price": null, "strength_mg": 30.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ARIPIPREX 1MG/ML ORAL SOL. 100 ML", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "SIGMA > ANDALOUS PHARMA", "price_egp": 44.0, "pack_count": null, "unit_price": null, "strength_mg": 1.0, "exact_strength": false, "exact_form": false, "discontinued": false, "also_contains": null }, { "trade_name": "ARIPIPRAZOLE 1MG/ML ORAL SOL. 120 ML", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ATCO PHARMA > INSPIRE PHARMACEUTICAL COMPANY", "price_egp": 46.0, "pack_count": null, "unit_price": null, "strength_mg": 1.0, "exact_strength": false, "exact_form": false, "discontinued": false, "also_contains": null } ], "condition_id": "bipolar-disorder-referral" }, { "id": 289, "generic": "Lurasidone", "line": 1, "is_adjunct": false, "form": "oral.solid", "strength_mg": null, "adult_dose": "20 mg once daily to start, taken with food. US label verbatim: \"The recommended starting dose of LATUDA is 20 mg given once daily as monotherapy or as adjunctive therapy with lithium or valproate. Initial dose titration is not required. LATUDA has been shown to be effective in a dose range of 20 mg per day to 120 mg per day as monotherapy or as adjunctive therapy with lithium or valproate. The maximum recommended dose, as monotherapy or as adjunctive therapy with lithium or valproate, is 120 mg per day. In the monotherapy study, the higher dose range (80 mg to 120 mg per day) did not provide additional efficacy, on average, compared to the lower dose range (20 to 60 mg per day)\". Food is part of the dose, not a comfort measure: \"LATUDA should be taken with food (at least 350 calories). Administration with food substantially increases the absorption of LATUDA.\" Kidney and liver cut the ceiling - in moderate or severe renal impairment and in moderate or severe hepatic impairment the label starts at 20 mg and caps at 80 mg per day.", "adult_duration": "Long enough to see the depressive episode through, then re-judged. US label verbatim: \"The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies.\" The label goes on to ask that anyone using it for extended periods re-evaluate its long-term usefulness for that individual patient at intervals.", "dose_source": "LATUDA (lurasidone hydrochloride) tablets US prescribing information, boxed warning, section 1 Indications and Usage and section 2 Dosage and Administration (DailyMed SetID afad3051-9df2-4c54-9684-e8262a133af8)", "rationale": "The disease article names it first-line for the depressive phase, verbatim: \"For patients not already taking long-term medication for BD, first-line monotherapy includes quetiapine, olanzapine, or lurasidone (has not been studied in acute bipolar mania).\" and again in combination - \"Combination treatment with olanzapine-fluoxetine, lithium plus lamotrigine, and lurasidone plus lithium or valproate may also be considered.\" The US label's indication section names the same phase of the same disease, verbatim: \"Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression)\" and \"Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression)\". The dose comes from the US label because the European SmPC for the same drug is written for schizophrenia alone and carries no bipolar regimen. Nine lurasidone products are on the Egyptian register, from ELBALURAN 20 mg at 165 EGP upward, and it matters in a country where valproate is barred for women of childbearing potential.", "cautions": [ "RED FLAG - boxed warning, suicidal thoughts and behaviours. US label verbatim: \"Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors.\" Bipolar depression is the phase in which most suicide deaths happen, so this is not a background risk.", "RED FLAG - boxed warning, elderly patients with dementia. US label verbatim: \"Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. LATUDA is not approved for the treatment of patients with dementia-related psychosis.\"", "Not a drug for mania. The US label says there is no established efficacy for lurasidone in bipolar mania, and StatPearls agrees in its own terms: no trial evidence supports its use in an acute manic episode. A patient swinging into mania needs a different drug on the card.", "Taken on an empty stomach it may not work. The label ties absorption to a meal of at least 350 calories, and states that food increases the area under the curve roughly two-fold. A patient who takes it at bedtime hours after eating is not getting the studied exposure.", "Valproate, one of the alternatives beside it, carries a hard bar in one group. It must not be given to a woman of childbearing potential: the fetal risk - teratogenesis, and impaired intellectual development - is unacceptable.", "A depressive episode with psychosis or active suicidal intent is a same-day psychiatric problem, not a prescription problem. Where a patient with bipolar disorder presents in acute depression, the disease article puts the risk of suicide and self-harm ahead of everything else in management." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "Licensed from 10 years for bipolar depression, monotherapy only. US label verbatim: \"The recommended starting dose of LATUDA is 20 mg given once daily as monotherapy. Initial dose titration is not required. The dose may be increased after one week based on clinical response. LATUDA has been shown to be effective in a dose range of 20 mg per day to 80 mg per day as monotherapy. At the end of the clinical study, most of the patients (67%) received 20 mg or 40 mg once daily. The maximum recommended dose is 80 mg per day.\"", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": 120.0, "peds_age_max_months": null, "peds_age_bands": [ { "label": "10 years and over", "age_min_months": 120, "age_max_months": 216, "dose_text": "20 mg once daily to start, no titration needed; may be raised after one week. Effective range 20 to 80 mg daily, maximum 80 mg daily. Monotherapy only." } ], "peds_doses": null, "brands": [ { "trade_name": "ELBALURAN 20 MG 30 F.C. TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "APEX PHARMA", "price_egp": 165.0, "pack_count": 30, "unit_price": 5.5, "strength_mg": 20.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ELBALURAN 40 MG 30 F.C. TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "APEX PHARMA", "price_egp": 267.0, "pack_count": 30, "unit_price": 8.9, "strength_mg": 40.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "SERODOPAMOUN 40 MG 20 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "AMOUN", "price_egp": 182.0, "pack_count": 20, "unit_price": 9.1, "strength_mg": 40.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "TUDASIDONE 40 MG 20 F.C.TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ANDALOUS PHARMA", "price_egp": 238.0, "pack_count": 20, "unit_price": 11.9, "strength_mg": 40.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ELBALURAN 80 MG 30 F.C. TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "APEX PHARMA", "price_egp": 447.0, "pack_count": 30, "unit_price": 14.9, "strength_mg": 80.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "SERODOPAMOUN 80 MG 20 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "AMOUN", "price_egp": 298.0, "pack_count": 20, "unit_price": 14.9, "strength_mg": 80.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ELBALURAN 120 MG 30 F.C. TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "APEX PHARMA", "price_egp": 580.5, "pack_count": 30, "unit_price": 19.35, "strength_mg": 120.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "TUDASIDONE 80 MG 20 F.C.TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ANDALOUS PHARMA", "price_egp": 390.0, "pack_count": 20, "unit_price": 19.5, "strength_mg": 80.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "bipolar-disorder-referral" }, { "id": 284, "generic": "Lamotrigine", "line": 2, "is_adjunct": false, "form": "oral.solid", "strength_mg": 100.0, "adult_dose": "Monotherapy or with neither valproate nor an enzyme inducer: 25 mg daily for weeks 1-2, 50 mg daily for weeks 3-4, 100 mg daily in week 5, then a target stabilisation dose of 200 mg daily. With sodium valproate: 25 mg on alternate days for weeks 1-2, 25 mg daily for weeks 3-4, 50 mg daily in week 5, target 100 mg daily (maximum 200 mg daily)", "adult_duration": "Long-term maintenance", "dose_source": "Egyptian National Drug Formulary - Nervous System 2025 (lamotrigine monograph)", "rationale": "20 live products. The formulary carries a bipolar I indication - prevention of depressive episodes in patients who predominantly have depressive episodes, and maintenance to delay recurrence of mood episodes. The three drugs already listed all target mania or general stabilisation; lamotrigine is the one that covers the depressive pole, which is where most bipolar disability sits.", "cautions": [ "SERIOUS RASH: Stevens-Johnson syndrome and toxic epidermal necrolysis. The slow titration above exists only to reduce that risk and must never be shortened. Stop at the first sign of any rash and do not rechallenge.", "Halve the titration if the patient is on the sodium valproate already listed in this condition; double it if the patient is on carbamazepine, phenytoin, phenobarbital, primidone, rifampicin or lopinavir/ritonavir.", "Lamotrigine prevents depressive relapse and is NOT effective for acute mania - do not use it alone in a manic patient.", "Combined hormonal contraceptives roughly halve lamotrigine levels; levels rebound in the pill-free week and when the contraceptive is stopped.", "If more than a few days of treatment are missed, the titration must be restarted from the beginning.", "Specialist initiation - this is a referral pathway condition and the GP role is continuation and rash vigilance." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "The bipolar indication is for adults 18 years and over only. The mg/kg schedules in the monograph are for paediatric epilepsy and must not be used for mood stabilisation.", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": null, "brands": [ { "trade_name": "LABILENO 100MG 30 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "SEDICO", "price_egp": 66.0, "pack_count": 30, "unit_price": 2.2, "strength_mg": 100.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "LAROGEN 100MG 30 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "DELTA PHARMA", "price_egp": 72.0, "pack_count": 30, "unit_price": 2.4, "strength_mg": 100.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "CONTROLEPSY 100MG 30 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "GLOBAL NAPI PHARMACEUTICALS", "price_egp": 120.0, "pack_count": 30, "unit_price": 4.0, "strength_mg": 100.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "LAMOTRINE 100MG 30 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "MULTI-APEX", "price_egp": 120.0, "pack_count": 30, "unit_price": 4.0, "strength_mg": 100.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "LAMICTAL 100MG 30 TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "GLAXO SMITHKLINE", "price_egp": 224.0, "pack_count": 30, "unit_price": 7.47, "strength_mg": 100.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "SUNLAMOTRI 100 MG 30 DISP./CHEW. TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "SUN PHARMACEUTICAL INDUSTRIES LTD.", "price_egp": 147.0, "pack_count": null, "unit_price": null, "strength_mg": 100.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "bipolar-disorder-referral" }, { "id": 286, "generic": "Risperidone", "line": 2, "is_adjunct": false, "form": "oral.solid", "strength_mg": null, "adult_dose": "Risperidone should be administered on a once daily schedule, starting with 2 mg risperidone. Dosage adjustments, if indicated, should occur at intervals of not less than 24 hours and in dosage increments of 1 mg per day. Risperidone can be administered in flexible doses over a range of 1 to 6 mg per day to optimize each patient's level of efficacy and tolerability.", "adult_duration": null, "dose_source": "Risperidone 2 mg Tablets SmPC (eMC product 11872)", "rationale": "First-line atypical antipsychotic monotherapy for acute manic episodes in bipolar disorder.", "cautions": [ "Dose-dependent extrapyramidal side effects (parkinsonism, dystonia, akathisia) and hyperprolactinaemia.", "Increased mortality and stroke risk in elderly patients with dementia-related psychosis.", "Elderly: start at 0.5 mg twice daily and step up by 0.5 mg twice daily to 1-2 mg twice daily. Not the adult 2 mg start.", "Renal or hepatic impairment: halve both the starting dose and every step after it, and titrate slower." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "Risperidone is not recommended for use in children and adolescents below age 18 with bipolar mania due to a lack of data on efficacy.", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": null, "brands": [ { "trade_name": "RISIDRONE 1MG 10 F.C. TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ADWIA", "price_egp": 10.0, "pack_count": 10, "unit_price": 1.0, "strength_mg": 1.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ITORISPERIDONE 2MG 30 F.C. TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "SIGMA > INTERNATIONAL TRADING OFFICE", "price_egp": 48.0, "pack_count": 30, "unit_price": 1.6, "strength_mg": 2.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "APEXIDONE 0.5MG 30 F.C.TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "APEX PHARMA", "price_egp": 49.5, "pack_count": 30, "unit_price": 1.65, "strength_mg": 0.5, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "APEXIDONE 1MG 20 F.C.TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "APEX PHARMA", "price_egp": 54.0, "pack_count": 20, "unit_price": 2.7, "strength_mg": 1.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "APEXIDONE 2MG 20 F.C.TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "APEX PHARMA", "price_egp": 75.0, "pack_count": 20, "unit_price": 3.75, "strength_mg": 2.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "PSYCHODAL 2MG 30 F.C.TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "DELTA PHARMA", "price_egp": 171.0, "pack_count": 30, "unit_price": 5.7, "strength_mg": 2.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "CLAVIPERDONE 2 MG 30 ORALLY DISINT. TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "NAPCO PHARMA > CLAVITA PHARMA", "price_egp": 115.5, "pack_count": null, "unit_price": null, "strength_mg": 2.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "CLAVIPERDONE 3 MG 30 ORALLY DISINT. TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "NAPCO PHARMA > CLAVITA PHARMA", "price_egp": 129.0, "pack_count": null, "unit_price": null, "strength_mg": 3.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "NEROSCHIZ 1MG/ML SYRUP 30 ML", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "DEBEIKY > PHARMACHEMIC", "price_egp": 10.5, "pack_count": null, "unit_price": null, "strength_mg": 1.0, "exact_strength": false, "exact_form": false, "discontinued": false, "also_contains": null }, { "trade_name": "SCHIZOPERDAL 1MG/ML SYRUP 30ML", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "GRAND PHARMA > DELTA GRAND PHARMA", "price_egp": 18.0, "pack_count": null, "unit_price": null, "strength_mg": 1.0, "exact_strength": false, "exact_form": false, "discontinued": false, "also_contains": null } ], "condition_id": "bipolar-disorder-referral" }, { "id": 287, "generic": "Olanzapine", "line": 2, "is_adjunct": false, "form": "oral.solid", "strength_mg": null, "adult_dose": "Manic episode: The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section 5.1).", "adult_duration": null, "dose_source": "Olanzapine 10 mg tablets SmPC (eMC product 3070)", "rationale": "First-line atypical antipsychotic for acute manic episodes and recurrence prevention in bipolar disorder.", "cautions": [ "High risk of metabolic syndrome: substantial weight gain, dyslipidemia, insulin resistance, and new-onset diabetes.", "Monitor baseline and periodic weight, fasting blood glucose, lipid profile, and blood pressure.", "Do not abruptly stop therapy due to risk of rapid psychotic relapse and severe withdrawal symptoms.", "The label starts at 10 mg a day and allows increases at intervals of not less than 24 hours, within a range of 5-20 mg. The slower start and weekly steps above are a deliberate primary-care choice, not the licence - a psychiatrist titrating an inpatient will move faster." ], "peds_mgkg_low": null, "peds_mgkg_high": null, "peds_max_mg": null, "peds_basis": null, "peds_unit": null, "peds_note": "Olanzapine is not recommended for use in children and adolescents below 18 years of age due to a lack of data on safety and efficacy.", "peds_min_weight_kg": null, "peds_max_weight_kg": null, "peds_age_min_months": null, "peds_age_max_months": null, "peds_age_bands": null, "peds_doses": null, "brands": [ { "trade_name": "INTEGROL 5 MG 30 F.C. TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "GLOBAL NAPI PHARMACEUTICALS", "price_egp": 77.25, "pack_count": 30, "unit_price": 2.58, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "BIOPREX 2.5 MG 30 F.C.TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "SAJA PHARMACEUTICALS > CLAVITA PHARMA", "price_egp": 90.0, "pack_count": 30, "unit_price": 3.0, "strength_mg": 2.5, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "OLANZA 5 MG 20 F.C. TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "EVA PHARMA", "price_egp": 60.0, "pack_count": 20, "unit_price": 3.0, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "RANXAPIN 5 MG 21 TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "FUTURE PHARMACEUTICAL INDUSTRIES (FPI) > SUN PHARMA EGYPT LIMITED", "price_egp": 115.5, "pack_count": 21, "unit_price": 5.5, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "OLAZORIX 20 MG 21 F.C.TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "MASH PREMIERE", "price_egp": 198.0, "pack_count": 21, "unit_price": 9.43, "strength_mg": 20.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ZYPREXA 5MG 7 COATED TAB.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "ELI LILLY", "price_egp": 142.0, "pack_count": null, "unit_price": null, "strength_mg": 5.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "OLANVEXA 20 MG 30 ORALLY DISINTEGRATING TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "MULTICARE", "price_egp": 327.0, "pack_count": null, "unit_price": null, "strength_mg": 20.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null }, { "trade_name": "ZYPREXA VELOTAB 10 MG 28 ORODISPERDIBLE TABS.", "scientific_name": null, "normalized_ingredient": null, "manufacturer": "CATALENT UK SWIDON ZYDIS LTD > ELI LILLY", "price_egp": 1001.0, "pack_count": null, "unit_price": null, "strength_mg": 10.0, "exact_strength": true, "exact_form": true, "discontinued": false, "also_contains": null } ], "condition_id": "bipolar-disorder-referral" } ] }