ADAZIO 100/MG FC TAB 60/FC TAB

Indications

Approved Uses

Schizophrenia; Bipolar disorder (acute manic episodes and depressive episodes). Adjunctive therapy for Major Depressive Disorder applies to the extended‑release (XR) formulation (and may be jurisdiction/label dependent).

Off-Label Uses

Common off‑label uses include insomnia (not preferred due to metabolic risk), generalized anxiety disorder, PTSD, and delirium/agitation in select settings; use for Parkinson’s disease psychosis is less favored than alternatives due to limited evidence and adverse-effect burden.

Dosage & Administration

Dosing by Condition

Adults (typical labeling ranges; individualize): Schizophrenia (IR): start 25 mg twice daily, titrate to usual effective range ~300-450 mg/day in divided doses (max commonly 750 mg/day). Bipolar mania (IR): start 50 mg twice daily (or 100 mg/day divided), titrate to 400-800 mg/day (max 800 mg/day). Bipolar depression (IR): 50 mg at bedtime day 1, titrate to 300 mg at bedtime by day 4 (max commonly 300 mg/day for bipolar depression).

Initial Dose

50 mg/day (25 mg twice daily) with gradual titration as tolerated/clinically indicated

Maintenance Dose

150-300 mg/day (typical effective range; adjust based on indication and response)

Maximum Dose

800 mg/day

Children's Dosage

Approved for schizophrenia in adolescents (13-17 years) and bipolar mania in children and adolescents (10-17 years). Dosing is initiated at 25mg twice daily and titrated up to 400-800mg/day for schizophrenia or 400-600mg/day for bipolar mania.

Dose Adjustment Notes

Use lower starting doses and slower titration in elderly/debilitated patients and in hepatic impairment; monitor for hypotension/sedation. Avoid or markedly reduce dose with strong CYP3A4 inhibitors; with strong CYP3A4 inducers, higher doses may be required and dose should be reduced when the inducer is stopped (per labeling, typically over ~1-2 weeks).

How to Take

Oral use: swallow the film‑coated tablet whole with water; may be taken with or without food. For immediate‑release quetiapine tablets, doses are typically given in divided doses (usually twice daily) as prescribed.

Side Effects

Common Side Effects

Somnolence (drowsiness), dizziness, dry mouth, constipation, orthostatic hypotension, weight gain/increased appetite, fatigue/asthenia, and nasal congestion.

Side Effect Frequency

Very common (>10%): somnolence/drowsiness, dizziness, dry mouth, headache, weight gain. Common (1-10%): constipation, orthostatic hypotension, tachycardia, dyspepsia, fatigue/asthenia, increased appetite, nasal congestion, blurred vision, and metabolic/lab changes (e.g., increased triglycerides, hyperglycemia, elevated liver enzymes).

Safety & Warnings

Contraindications

Contraindication: known hypersensitivity to quetiapine or any excipients.

Warnings & Precautions

Key warnings/precautions: increased mortality in elderly with dementia-related psychosis; suicidality risk in children/adolescents/young adults; metabolic monitoring (weight, glucose, lipids); orthostatic hypotension (especially during titration); NMS; tardive dyskinesia; QT prolongation risk and caution with other QT-prolonging drugs/electrolyte abnormalities; seizure risk; cataracts/lens changes (consider eye exam if clinically indicated); leukopenia/neutropenia monitoring in at-risk patients; dysphagia/aspiration risk.

Age Restriction

Pediatric use is indication-specific: schizophrenia is approved for ages 13-17 years; bipolar I manic episodes are approved for ages 10-17 years; not approved for pediatric major depressive disorder (and not approved for children <10 years for bipolar mania or <13 years for schizophrenia).

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Major interactions: strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) markedly increase quetiapine exposure; strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, St John’s wort) decrease exposure; additive CNS depression with alcohol/benzodiazepines/opioids; additive hypotension with antihypertensives; caution with QT-prolonging drugs.

Interaction Severity

MAJOR: strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir/cobicistat) markedly increase quetiapine exposure; strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin) markedly decrease exposure. MODERATE: additive CNS depression (alcohol, opioids, benzodiazepines), additive hypotension with antihypertensives, and increased risk with other QT‑prolonging drugs (use caution/monitor).

Food Interaction

Take with or without food. If taken with food, take with a light meal. Avoid alcohol

Alcohol Interaction

Avoid

Special Populations

Children

Approved for schizophrenia in adolescents (13-17 years) and bipolar mania in children and adolescents (10-17 years). Dosing is initiated at 25mg twice daily and titrated up to 400-800mg/day for schizophrenia or 400-600mg/day for bipolar mania.

Elderly

Start at 25 mg/day, titrate slowly in increments of 25-50 mg/day; target doses are generally lower than in younger adults; monitor for orthostatic hypotension and sedation

Kidney Impairment

No renal dose adjustment is generally required; use clinical caution in severe renal impairment.

Liver Impairment

Hepatic impairment: start 25 mg/day and titrate in 25-50 mg/day increments to effect/tolerability (use extra caution in severe impairment).

Storage & Patient Advice

Overdose

Overdose: commonly causes marked sedation/CNS depression, tachycardia, hypotension; may cause QT prolongation/arrhythmias, seizures, coma. Management is supportive with airway/ventilation as needed, IV fluids/vasopressors for hypotension, ECG/cardiac monitoring; consider activated charcoal if early and airway protected; no specific antidote-seek emergency care.

Patient Counseling

Take exactly as prescribed and do not stop abruptly without medical advice. May cause drowsiness/dizziness-avoid driving until you know your response; rise slowly to reduce orthostatic symptoms; avoid alcohol and other sedatives. Monitor/mitigate weight gain (diet/activity) and keep follow-ups for weight, blood sugar and lipids; report symptoms of high blood sugar. Seek urgent care for severe muscle stiffness/fever/confusion (NMS), abnormal movements, fainting/palpitations, or signs of allergic reaction; report worsening mood/suicidal thoughts. Avoid grapefruit/grapefruit juice (CYP3A4 interaction).

Monitoring Requirements

Baseline and periodic: weight/BMI and waist circumference, blood pressure, fasting glucose or HbA1c, fasting lipid panel; assess for sedation/orthostasis and extrapyramidal symptoms/tardive dyskinesia. CBC if history of low WBC/neutropenia or clinically indicated; ECG/QTc if cardiac risk factors or QT‑prolonging co-meds; consider eye exam if long-term therapy per local practice.

Pharmacology

Mechanism of Action

Multireceptor antagonist: higher affinity for serotonin 5‑HT2A than dopamine D2 receptors, with additional antagonism at H1 and alpha‑1 (and alpha‑2) adrenergic receptors; its active metabolite (norquetiapine) contributes via norepinephrine reuptake inhibition and 5‑HT1A partial agonism.

Onset of Action

Sedation may occur within hours (often after the first dose); improvement in psychotic/mood symptoms typically begins within 1-2 weeks, with fuller therapeutic effect often taking 4-6 weeks with ongoing daily dosing.

Duration of Effect

Immediate-release: sedative effect per dose ~6-12 hours; antipsychotic/mood-stabilizing benefit requires continuous daily dosing (not a single-dose duration).

Half-Life

Approximately 6-7 hours

Bioavailability

Absolute oral bioavailability: not established/unknown; relative bioavailability of the tablet is approximately equivalent to the oral solution (near 100% relative).

Metabolism

Extensive hepatic metabolism primarily via CYP3A4; minor contribution from CYP2D6; active metabolite: norquetiapine (N-desalkylquetiapine).

Excretion

Renal ~73% and fecal ~20-21% (predominantly as metabolites); <5% excreted unchanged.

Protein Binding

Approximately 83%.

Product Information

Available Dosage Forms

For ADAZIO specifically: 100 mg film‑coated tablet (oral, blister pack). Quetiapine in general is available as immediate‑release tablets and extended‑release tablets (XR).

Composition per Dose

Each film-coated tablet: 100 mg quetiapine (as quetiapine fumarate 115.13 mg)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antipsychotic-Atypical

Controlled Substance

No

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