Bipolar disorder (specialist referral & maintenance stabilization)

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) - long-term

Child/adolescent bipolar disorder requires tertiary pediatric psychiatric management

Quetiapine 25 mg film-coated tablets SmPC section 4.2 Posology and method of administration (eMC product 3079)

Atypical antipsychotic used as a mood stabilizer in bipolar disorder, controlling both manic and depressive episodes through combined dopamine and serotonin receptor blockade.

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) - long-term

Specialist pediatric psychiatry use only

Egyptian National Drug Formulary, nervous system 2025, valproic acid monograph (printed pp. 73-74)

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.

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) - long-term

Alternatives, all specialist-initiated. NICE CG185 names lithium first-line for long-term management of bipolar disorder. Sodium valproate must not be used in a woman who could become pregnant.

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."

Gold-standard anti-suicidal mood stabilizer; requires strict therapeutic drug monitoring

Bipolar Disorder - disease-level clinical article (bipolar-disorder-referral-full.txt)

Carries the referral criteria and warning signs for this condition, which apply whichever treatment is chosen.

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." - 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."

(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.")

Abilify 10 mg tablets SmPC sections 4.1 and 4.2 (eMC product 7969)

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.

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. - 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.

Age restriction: minimum 120 months

(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.")

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)

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.

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) - Long-term maintenance

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.

Egyptian National Drug Formulary - Nervous System 2025 (lamotrigine monograph)

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.

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.

Risperidone is not recommended for use in children and adolescents below age 18 with bipolar mania due to a lack of data on efficacy.

Risperidone 2 mg Tablets SmPC (eMC product 11872)

First-line atypical antipsychotic monotherapy for acute manic episodes in bipolar disorder.

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).

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.

Olanzapine 10 mg tablets SmPC (eMC product 3070)

First-line atypical antipsychotic for acute manic episodes and recurrence prevention in bipolar disorder.