Qutipin SR50 mg

Qutipin SR is an atypical (second-generation) antipsychotic extended-release tablet indicated for the following conditions:

Established / FDA-approved uses

• Schizophrenia in adults, for acute treatment and maintenance therapy.
• Bipolar I disorder – acute manic or mixed episodes, as monotherapy or as an adjunct to lithium or divalproex.
• Bipolar depression (depressive episodes associated with bipolar I or II disorder), as monotherapy.
• Maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex.

Adjunct use

• Major depressive disorder (MDD) as add-on therapy to antidepressants, in patients with an inadequate response to antidepressant treatment alone.

Qutipin SR is not approved for the treatment of dementia-related psychosis in elderly patients (see Precautions and Warnings).

Each extended-release tablet of Quetiapine USP Sustained Release contains quetiapine (as quetiapine fumarate) in strengths that typically range from 50 mg to 400 mg, formulated as a once-daily sustained-release (prolonged-release) matrix tablet. Strength and exact excipients vary by manufacturer; refer to the product label/pack insert for the specific strength dispensed.

Qutipin SR is the extended-release (sustained-release) formulation of quetiapine, an atypical antipsychotic belonging to the dibenzothiazepine class. Unlike the immediate-release tablet, Qutipin SR is designed to release the active drug slowly over time, allowing once-daily dosing (typically in the evening) with more stable plasma drug levels and generally improved tolerability of peak-related side effects such as sedation and dizziness.

Qutipin SR tablets must be swallowed whole with the aid of liquid and must not be crushed, chewed, or split, as this can alter the extended-release mechanism and cause rapid release of the drug.

Qutipin SR belongs to the class of atypical (second-generation) antipsychotics.

Quetiapine USP Sustained Release and its active metabolite, norquetiapine, act as antagonists at multiple neurotransmitter receptors in the brain, which is believed to underlie both its therapeutic effects and its side-effect profile.

• Dopamine D2 receptors: antagonism contributes to antipsychotic and antimanic effects, with relatively low D2 occupancy that is associated with a lower risk of extrapyramidal symptoms compared with typical antipsychotics.
• Serotonin 5-HT2A receptors: antagonism is thought to contribute to antipsychotic efficacy and to a favorable effect on mood and negative symptoms.
• Serotonin 5-HT1A receptors: partial agonism (largely via norquetiapine) is thought to contribute to antidepressant and anxiolytic effects.
• Histamine H1 receptors: antagonism contributes to sedation and weight gain.
• Alpha-1 and alpha-2 adrenergic receptors: antagonism contributes to orthostatic hypotension and dizziness.

Quetiapine USP Sustained Release has low affinity for muscarinic cholinergic and benzodiazepine receptors. Following oral administration, the extended-release formulation is absorbed gradually, reaching peak plasma concentrations later than the immediate-release form; it is extensively metabolized in the liver, primarily via the CYP3A4 enzyme.

Qutipin SR tablets should be swallowed whole with water, once daily, preferably in the evening. Tablets must not be crushed, chewed, or divided, as doing so can disrupt the extended-release mechanism and cause the entire dose to be released at once, increasing the risk of side effects. It may be taken with or without food, but a consistent pattern (either always with food or always without) is recommended, and heavy/high-fat meals should be avoided as they significantly increase drug absorption.

Qutipin SR is metabolized mainly by the CYP3A4 enzyme, so clinically significant interactions can occur with drugs that affect this pathway, as well as with other centrally-acting or QT-prolonging agents:

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir): can substantially increase quetiapine plasma levels and side effects; concurrent use should be avoided or the dose of Qutipin SR reduced.
• Strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, St. John's Wort): can markedly reduce quetiapine plasma levels and efficacy; dose of Qutipin SR may need to be increased if co-administration cannot be avoided.
• CNS depressants and alcohol: additive sedation and psychomotor impairment; concurrent use should be approached with caution.
• Antihypertensive agents: additive risk of orthostatic hypotension.
• Other drugs that prolong the QT interval (e.g., certain antiarrhythmics, other antipsychotics, some antibiotics): additive risk of QT prolongation and arrhythmia; combination should generally be avoided.

Always inform the physician or pharmacist of all other medicines being taken before starting Qutipin SR.

Common and important side effects reported with Qutipin SR include:

• Very common: somnolence/sedation, dizziness, dry mouth, weight gain.
• Common: orthostatic hypotension, tachycardia, constipation, dyspepsia, increased appetite, blurred vision, elevated blood glucose and lipids, fatigue, mild asthenia.
• Less common but clinically important: extrapyramidal symptoms (tremor, rigidity, restlessness), elevated liver enzymes, mild QT prolongation.
• Rare but serious: neuroleptic malignant syndrome, seizures, severe leukopenia/neutropenia or agranulocytosis, priapism, cataracts/lens changes with long-term use, hepatitis, severe hypersensitivity reactions.

Patients should seek prompt medical attention for high fever with muscle rigidity, unusual bleeding/bruising, severe rash, difficulty breathing, or fainting while taking Qutipin SR.

Pregnancy: Qutipin SR should be used during pregnancy only if the potential benefit clearly justifies the potential risk to the fetus, and only under medical supervision. Antipsychotics, including Qutipin SR, used during the third trimester have been associated with a risk of extrapyramidal and/or withdrawal symptoms in the neonate, ranging from mild to requiring supportive care and prolonged hospitalization. Qutipin SR does not have a current formal FDA pregnancy letter category assigned (legacy Category C); a physician should be consulted to weigh risks and benefits.

Lactation: Quetiapine is excreted in breast milk. Breastfeeding while taking Qutipin SR is not generally recommended unless the potential benefit outweighs the possible risk to the infant; consult a physician before breastfeeding.

Boxed warnings

• Increased mortality in elderly patients with dementia-related psychosis: Qutipin SR is not approved for this use and carries an increased risk of death, mostly from cardiovascular or infectious causes, in this population.
• Suicidal thinking and behavior: antidepressants and antipsychotics used for depression, including Qutipin SR, may increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults, particularly early in treatment; close monitoring is required.

Other important precautions

• Metabolic changes: weight gain, hyperglycemia/new-onset diabetes, and dyslipidemia can occur; baseline and periodic monitoring of weight, blood glucose, and lipid profile is recommended.
• Neuroleptic malignant syndrome (NMS): a rare but potentially fatal reaction presenting with high fever, muscle rigidity, altered mental status, and autonomic instability; discontinue immediately if suspected.
• QT prolongation: use with caution in patients with cardiac disease, electrolyte disturbances, or concomitant QT-prolonging drugs (see Interactions).
• Orthostatic hypotension and syncope: especially during initial dose titration, particularly in the elderly and volume-depleted patients.
• Extrapyramidal symptoms and tardive dyskinesia: less common than with typical antipsychotics but can occur.
• Leukopenia/neutropenia/agranulocytosis: blood counts should be monitored in patients with risk factors.
• Cataracts: lens changes have been reported with long-term use; periodic eye examinations are recommended.
• Sedation and cognitive/motor impairment: caution advised when driving or operating machinery.
• Qutipin SR should not be discontinued abruptly; the dose should be tapered gradually to avoid withdrawal/rebound symptoms.
• Sustained-release tablets must be swallowed whole and never crushed or chewed.

Overdose with Qutipin SR may cause exaggeration of known pharmacological effects, including drowsiness, sedation, tachycardia, hypotension, and QT-interval prolongation with risk of arrhythmia; seizures and loss of consciousness have also been reported in overdose.

There is no specific antidote for Qutipin SR overdose. Anyone suspected of having taken an overdose should seek immediate medical attention or contact a poison control center/emergency services right away. Treatment is supportive, generally with cardiac monitoring, and should be provided in a hospital setting; do not attempt to manage an overdose at home.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Elderly: use Qutipin SR with a lower starting dose and slower titration; increased risk of orthostatic hypotension and, in dementia-related psychosis, increased mortality (see Precautions and Warnings) — Qutipin SR is not approved for this use.

Hepatic impairment: reduced clearance of quetiapine; use a lower starting dose and slower titration.

Renal impairment: no dose adjustment generally required as renal elimination is minor.

Children and adolescents: see Pediatric Uses.

Pregnancy and breastfeeding: see Pregnancy and Lactation.

Duration of treatment with Qutipin SR is determined by the treating physician based on the indication and clinical response. Schizophrenia and bipolar disorder often require long-term maintenance therapy to prevent relapse, whereas adjunctive use in major depressive disorder is typically reassessed periodically. Qutipin SR should not be stopped abruptly even if symptoms improve; any change in duration or discontinuation should be done gradually and only under medical supervision.

Quetiapine USP Sustained Release is classified as an atypical (second-generation) antipsychotic of the dibenzothiazepine chemical class.

Quetiapine USP Sustained Release works primarily by antagonizing dopamine D2 and serotonin 5-HT2A receptors in the central nervous system, along with partial agonism at serotonin 5-HT1A receptors (mainly via its active metabolite, norquetiapine) and antagonism at histaminergic (H1) and adrenergic (alpha-1, alpha-2) receptors. This combined receptor activity is thought to underlie its antipsychotic, mood-stabilizing, and antidepressant-augmenting effects, while also accounting for side effects such as sedation, weight gain, and orthostatic hypotension.

C (legacy FDA pregnancy category; use only if clearly needed)

The extended-release (Qutipin SR) formulation has not been well established for use in children and adolescents in most markets, and safety and efficacy of Qutipin SR specifically in pediatric patients have not been established for routine use; the immediate-release formulation of quetiapine is approved in some regions for schizophrenia in adolescents (13–17 years) and for bipolar I manic episodes in children and adolescents (10–17 years), under close specialist supervision. Use of Qutipin SR in pediatric patients should only be undertaken by, or in consultation with, a child/adolescent psychiatrist, with close monitoring for suicidal thinking/behavior, metabolic changes, and growth/development.