Indications
Quiet 25 Tablet is used for:
Schizophrenia, Bipolar disorder, Major depressive disorder
Adult Dose
Oral
Schizophrenia
Immediate release
Day 1: 50 mg/day PO divided q12hr
Days 2-3: Dose increased daily in increments of 25-50 mg q8-12hr to 300-400 mg by day 4; further adjustments can be made in increments of 25-50 mg q12hr at intervals >2 days
Dosage range: 150-750 mg/day
Extended release
Day 1: 300 mg/day PO; subsequently, may be increased by up to 300 mg/day at intervals >1 day
Maintenance (monotherapy): 400-800 mg/day
Patients who have discontinued therapy for >1 week should have their dose retitrated following initiation of therapy; patients may reinitiate at their previous maintenance dose if discontinued therapy <1 week
Bipolar I Disorder, Mania
Administered as monotherapy or as adjunct to lithium or divalproex
Immediate release
Day 1: 100 mg/day PO divided q12hr
Day 2: 200 mg/day PO divided q12hr
Day 3: 300 mg/day PO divided q12hr
Day 4: 400 mg/day PO divided q12hr
Further dosage adjustments, up to 800 mg/day by day 6, should be in increments <200 mg/day
Dosage range: 400-800 mg/day; not to exceed 800 mg/day
Extended release
Day 1: 300 mg PO once daily
Day 2: 600 mg PO once daily
Maintenance (day 3 onward): 400-800 mg/day PO
Bipolar Disorder, Depressive Episodes
Either immediate-release or extended-release tablets may be given; dosage titrated upward over 4 days
Day 1: 50 mg PO at bedtime
Day 2: 100 mg PO at bedtime
Day 3: 200 mg PO at bedtime
Maintenance (day 4 onward): 300 mg PO at bedtime
Bipolar I Disorder, Maintenance
Administered as adjunct to lithium or divalproex
Immediate release: 400-800 mg/day PO divided q12hr
Extended release: 400-800 mg/day PO in single dose
Generally, in maintenance phase, patients continue to receive same dosage on which they were stabilized
Major Depressive Disorder
Extended-release formulation administered as adjunct to antidepressants
Days 1 and 2: 50 mg PO in evening
Day 3: May be increased to 150 mg PO in evening
Dosage range: 150-300 mg/day
Elderly: Slower rate of dose titration and lower daily therapeutic dose.
Hepatic impairment: Initially, 25 mg daily. May increase in increments of 25-50 mg daily until effective dose, according to response and tolerability is achieved.
Child Dose
Schizophrenia
<12 year
Safety and efficacy not established
>12 years (monotherapy, immediate release)
Day 1: 50 mg/day PO divided q12hr
Day 2: 100 mg/day PO divided q12hr
Day 3: 200 mg/day PO divided q12hr
Day 4: 300 mg/day PO divided q12hr
Day 5: 400 mg/day PO divided q12hr; further adjustments should be in increments ?100 mg/day
Dosage range: 400-800 mg/day
Depending on response and tolerance, daily dose may be divided q8hr
>12 years (monotherapy, extended release)
Day 1: 50 mg/day PO once daily
Day 2: 100 mg/day PO once daily
Day 3: 200 mg/day PO once daily
Day 4: 300 mg/day PO once daily
Day 5: 400 mg/day PO once daily; further adjustments should be in increments ?100 mg/day
Bipolar I Disorder, Mania
<10 years
Safety and efficacy not established
>10 years (monotherapy, immediate release)
Day 1: 50 mg/day PO divided q12hr
Day 2: 100 mg/day PO divided q12hr
Day 3: 200 mg/day PO divided q12hr
Day 4: 300 mg/day PO divided q12hr
Day 5: 400 mg/day PO divided q12hr; further adjustments should be in increments ?100 mg/day
Dosage range: 400-600 mg/day
Depending on response and tolerance, daily dose may be divided q8hr
>10 years (monotherapy, extended release)
Day 1: 50 mg/day PO once daily
Day 2: 100 mg/day PO once daily
Day 3: 200 mg/day PO once daily
Day 4: 300 mg/day PO once daily
Day 5: 400 mg/day PO once daily; further adjustments should be in increments ?100 mg/day
Dosage range: 400-600 mg once daily
Renal Dose
Administration
Extended-release: Should be taken on an empty stomach. Take w/o food or w/ a light meal. Swallow whole, do not chew/crush.
May be taken with or without food.
Contra Indications
Quetiapine is contraindicated in individuals with a known hypersensitivity to this medication or any of its ingredients. Severe CNS depression, bone marrow suppression, coma.
Precautions
Patient w/ CV and cerebrovascular disease, conditions predisposing to hypotension, history of seizures or conditions that lower the seizure threshold, conditions that may increase risk of QT prolongation. Avoid abrupt withdrawal. Elderly w/ dementia-related psychosis. Hepatic or renal impairment. Pregnancy and lactation.
Patient Counselling This drug may cause somnolence and impair judgement, thinking or motor skills, if affected, avoid driving, operating machinery or performing hazardous tasks.
Monitoring Parameters Closely monitor for worsening of glucose control in patients w/ pre-existing DM. Monitor for possible worsening of depression, suicidal thoughts or unusual changes in behaviour. Measure BP at the beginning of, and periodically during treatment. It is recommended that patients should have an eye examination to detect cataract formation when starting therapy and 6 mthly during treatment.
Lactation: Drug excreted in breast milk; breastfeeding not recommended
Pregnancy-Lactation
Pregnancy
Neonates exposed during third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery; overall available data from published epidemiologic studies of pregnant women exposed to drug have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; there are risks to the mother associated with untreated schizophrenia, bipolar I, or major depressive disorder, and with exposure to drug during pregnancy
There is a risk to the mother from untreated schizophrenia, or bipolar I disorder, including increased risk of relapse, hospitalization, and suicide; schizophrenia and bipolar I disorder are associated with increased adverse perinatal outcomes, including preterm birth; it is not known if this is a direct result of the illness or other comorbid factors
Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder reported in neonates exposed to drug, during third trimester of pregnancy; symptoms varied in severity; monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately; some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization
Based on pharmacologic action of drug, treatment may result in an increase in serum prolactin levels, which may lead to a reversible reduction in fertility in females of reproductive potential
Lactation
Limited data from published literature report the presence of drug in human breast milk at relative infant dose of <1% of maternal weight-adjusted dosage; there are no consistent adverse events reported in infants exposed to quetiapine through breast milk; there is no information on effects of quetiapine on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from mother’s underlying condition
Interactions
Increased risk of drowsiness and postural hypotension when used with alcohol. CYP3A4 inducers eg. phenytoin and carbamazepine may decrease plasma levels of quetiapine while CYP3A4 inhibitors eg. ketoconazole and erythromycin may increase its plasma levels.
Side Effects
Side effects of Quetiapine :
>10%
Dizziness (1-18%), Fatigue (3-14%), Extrapyramidal symptoms (1-13%), Increased diastolic blood pressure (41%), Increased triglycerides (8-22%), Increased total cholesterol (7-18%), Increased appetite (2-12%), Constipation (6-11%), Dry mouth (9-44%), Headache (7-21), Somnolence (18-57%)
1-10%
Abdominal pain (4-7%; dose related), Dyspepsia (2-7%; dose related, Tremor (2-8%), Back pain (3-5%), Postural hypotension (2-7%), Tachycardia (1-6%), Pharyngitis (4-6%), Rhinitis (3-4%), Rash (4%), Blurred vision (1-4%), Arthralgia (1-4%), Myalgia (2%), Neck pain (2%), Dyskinesia (4%), Neutropenia (2%), Hemorrhage (1%)
< 1%
Priapism, Cardiomyopathy, myocarditis, QTc prolongation, Night mares, Pancreatitis, Rhabdomyolysis, Palpitation, Leukocytosis, Epistaxis, Exfoliative dermatitis
Mode of Action
Quetiapine is an antagonist at multiple neurotransmitter receptors in the brain: Serotonin 5-HT1A and 5-HT2, dopamine D1 and D2, histamine H1 and adrenergic a1 and a2 receptors. It is used in the treatment of schizophrenia and bipolar disorder.
Note
Quiet 25 25mg Tablet generic name is Quetiapine. Quiet 25 25mg Tablet is manufactured by Incepta Pharmaceuticals Ltd.Quiet 25 is availble in all over Bangladesh.
Mes BD drug index information on Quiet 25 Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.