ADAZIO 25/MG FC TAB 30/FC TAB

Indications

Approved Uses

Schizophrenia; Bipolar I disorder (acute manic episodes and bipolar depression; maintenance as adjunct to lithium/valproate).

Off-Label Uses

Common off‑label uses include insomnia (not recommended as routine first‑line), generalized anxiety disorder, PTSD, and OCD augmentation; use in Parkinson’s disease psychosis is generally not preferred compared with agents with better evidence/safety (e.g., pimavanserin/clozapine).

Dosage & Administration

Dosing by Condition

Schizophrenia (adults, IR): start 25 mg twice daily; titrate over several days to usual effective range ~300-450 mg/day in divided doses (max commonly 750 mg/day per some labels). Bipolar mania (adults, IR): start 50 mg twice daily; titrate to 400-800 mg/day (max 800 mg/day). Bipolar depression (adults, IR): 50 mg at bedtime day 1, then 100 mg day 2, 200 mg day 3, 300 mg day 4; target 300 mg nightly (some labels allow up to 600 mg/day).

Initial Dose

25 mg twice daily (schizophrenia); 50 mg twice daily (bipolar mania); 50 mg once daily at bedtime (bipolar depression)

Maintenance Dose

150-300 mg/day (schizophrenia); 400-800 mg/day (bipolar mania); 300 mg/day (bipolar depression)

Maximum Dose

800mg/day for Schizophrenia and Bipolar Mania; 600mg/day for Bipolar Depression.

Children's Dosage

Schizophrenia (13-17 years): Initial 25 mg twice daily, titrate by 25-50 mg/day increments, target 400-800 mg/day, max 800 mg/day. Bipolar mania (10-17 years): Initial 25 mg twice daily, titrate to 400-600 mg/day, max 600 mg/day. Not approved under 10 years.

Dose Adjustment Notes

Use lower starting doses and slower titration in elderly/frail patients and in hepatic impairment; avoid or markedly reduce dose with strong CYP3A4 inhibitors; with strong CYP3A4 inducers, higher doses may be required and should be reduced when the inducer is stopped.

How to Take

Swallow the film‑coated tablet whole with water; may be taken with or without food; for immediate‑release quetiapine, doses are typically given twice daily (or as prescribed) and taken consistently at the same times each day.

Side Effects

Common Side Effects

Somnolence (drowsiness), dizziness, dry mouth, constipation, orthostatic hypotension, weight gain/increased appetite, fatigue; nasal congestion and dyspepsia can also occur.

Side Effect Frequency

Very common (>10%): somnolence/drowsiness, dizziness, dry mouth, headache; metabolic effects such as weight gain and lipid changes can occur. Common (1-10%): constipation/dyspepsia, orthostatic hypotension, tachycardia, fatigue, increased appetite.

Safety & Warnings

Contraindications

Contraindication: hypersensitivity to quetiapine or any excipients; avoid coadministration with strong CYP3A4 inhibitors (contraindicated in many product labels).

Warnings & Precautions

Key warnings/precautions: dementia-related psychosis mortality risk; suicidality risk in children/adolescents/young adults; metabolic changes (hyperglycemia, dyslipidemia, weight gain); orthostatic hypotension/syncope (esp. during titration); NMS; tardive dyskinesia; QT prolongation/cardiac risk; cataracts (consider eye exam per labeling); seizure risk; thyroid changes; dysphagia/aspiration risk; withdrawal symptoms if abruptly stopped.

Age Restriction

Not approved for schizophrenia in patients <13 years; not approved for bipolar mania in patients <10 years (and not approved for bipolar depression in patients <10 years).

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Major: strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) ↑ quetiapine; strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, St John’s wort) ↓ quetiapine. Additive effects: CNS depressants/alcohol ↑ sedation; antihypertensives ↑ orthostasis; QT‑prolonging drugs ↑ arrhythmia risk; dopamine agonists/levodopa may have reduced effect.

Interaction Severity

MAJOR: Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir) and strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampicin) due to large exposure changes; QT‑prolonging drugs are clinically significant (use caution/avoid in high‑risk patients). MODERATE: CNS depressants (alcohol, opioids, benzodiazepines) and antihypertensives (additive sedation/hypotension).

Food Interaction

No restriction

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Children

Schizophrenia (13-17 years): Initial 25 mg twice daily, titrate by 25-50 mg/day increments, target 400-800 mg/day, max 800 mg/day. Bipolar mania (10-17 years): Initial 25 mg twice daily, titrate to 400-600 mg/day, max 600 mg/day. Not approved under 10 years.

Elderly

Initiate at 25 mg/day, titrate slowly in increments of 25-50 mg/day. Use lowest effective dose. Monitor closely for orthostatic hypotension, sedation, and metabolic effects. Not approved for dementia-related psychosis.

Liver Impairment

Hepatic impairment: start 25 mg/day and increase by 25-50 mg/day based on response/tolerability; titrate more cautiously in severe impairment.

Storage & Patient Advice

Overdose

Overdose may cause marked sedation, tachycardia, hypotension, anticholinergic effects, and possible QT prolongation/arrhythmias; management is supportive with airway protection, ECG/cardiovascular monitoring, and decontamination (activated charcoal) when appropriate-no specific antidote.

Patient Counseling

Take exactly as prescribed and do not stop abruptly; may cause marked drowsiness/dizziness-avoid driving until effects are known and rise slowly to reduce orthostasis; avoid alcohol and check with a clinician before new medicines (major CYP3A4 interactions) and avoid grapefruit products; report severe rash, fever/rigidity/confusion (NMS), abnormal movements, fainting/palpitations, or signs of high blood sugar; attend metabolic monitoring (weight, glucose, lipids) and store below 30°C.

Monitoring Requirements

Monitor weight/BMI and waist circumference, blood pressure, fasting glucose or HbA1c, and fasting lipids at baseline and periodically; assess for EPS/tardive dyskinesia, sedation/orthostasis and falls risk, and suicidality/mood changes; consider CBC if history of low WBC/neutropenia and ECG/QTc in patients with cardiac risk factors or on QT‑prolonging drugs.

Pharmacology

Mechanism of Action

Multireceptor antagonist: serotonin 5‑HT2A and dopamine D2 antagonism (key for antipsychotic effect) with additional activity at H1 and α1/α2 adrenergic receptors; its active metabolite (norquetiapine) contributes via norepinephrine reuptake inhibition and 5‑HT1A partial agonism.

Onset of Action

Sedation can occur within hours of a dose; antipsychotic/mood symptom improvement typically begins over 1-2 weeks with fuller effect over several weeks; pharmacokinetic peak (Tmax) for IR is about 1-2 hours.

Duration of Effect

Immediate‑release quetiapine has a clinical dosing interval typically requiring 2-3 divided doses per day (often BID), consistent with an elimination half‑life of ~6 hours; extended‑release formulations are designed for once‑daily dosing.

Half-Life

Quetiapine terminal half-life is approximately 6-7 hours (norquetiapine ~9-12 hours).

Bioavailability

Absolute oral bioavailability is not well established; quetiapine undergoes extensive first‑pass metabolism with low systemic availability (often cited around ~9%).

Metabolism

Extensive hepatic metabolism primarily via CYP3A4; minor contribution from other pathways (e.g., CYP2D6); major active metabolite is norquetiapine.

Protein Binding

Approximately 83%.

Product Information

Available Dosage Forms

Film‑coated tablet (immediate‑release) for this product (ADAZIO 25 mg).

Composition per Dose

Each film-coated tablet: 25 mg quetiapine (as quetiapine fumarate 28.78 mg)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antipsychotic-Atypical

Controlled Substance

No

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