Ketipinor Special Precautions

Cardiovascular: Ketipinor should be used with caution in patients with known cardiovascular disease or family history of QT prolongation, cerebrovascular disease, or other conditions predisposing to hypotension. Ketipinor may induce orthostatic hypotension, especially during the initial dose-titration period and therefore dose reduction or more gradual-titration should be considered if this occurs.
Seizures: As with other antipsychotics, caution is recommended when treating patients with a history of seizures.
Extrapyramidal symptoms: Clinical experience thus far indicates that the incidence of extrapyramidal symptoms was no different from that of placebo across the recommended therapeutic dose range.
Tardive dyskinesia: If signs and symptoms of tardive dyskinesia appear, dose reduction or discontinuation of Ketipinor should be considered (see Adverse Reactions).
Neuroleptic malignant syndrome: Neuroleptic malignant syndrome has been associated with antipsychotic treatment, including quetiapine (see also Adverse Reactions). Clinical manifestations include hyperthermia, altered mental status, muscular rigidity, autonomic instability, and increased creatine phosphokinase. In such an event, Ketipinor should be discontinued and appropriate medical treatment given.
Acute withdrawal reactions: Acute withdrawal symptoms including nausea, vomiting and insomnia have very rarely been described after abrupt cessation of high doses of antipsychotic drugs. Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported. Therefore, gradual withdrawal is advisable.
Elderly patients with dementia-related psychosis: Quetiapine is not approved for the treatment of patients with dementia-related psychosis. Increased risk of cerebrovascular adverse events has been reported in the dementia population with some atypical antipsychotics. The mechanism for this increased risk is not known. An increased risk cannot be excluded for other antipsychotics or other patient populations. Ketipinor should be used with caution in patients with risk factors for stroke.
It has also been reported that elderly patients with dementia-related psychosis are at increased risk of death when treated with quetiapine although the causal relationship between quetiapine treatment and death in these elderly patients with dementia has not been established.
Interactions: See also Interactions.
Concomitant use of quetiapine with a strong hepatic enzyme inducer such as carbamazepine or phenytoin substantially decreases quetiapine plasma concentrations, which could affect the efficacy of quetiapine therapy. In patients receiving a hepatic enzyme inducer, initiation of Ketipinor treatment should only occur if the physician considers that the benefits of quetiapine outweigh the risks of removing the hepatic enzyme inducer. It is important that any change in the inducer is gradual, and if required, replaced with a non-inducer (e.g. sodium valproate).
Hyperglycemia and Diabetes Mellitus: Hyperglycemia in some cases, extreme, and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Given this confounders, the relationship between atypical antipsychotic use and hyperglycemiarelated adverse events is not completely understood. However, epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-related events in patients treated with the atypical antipsychotics. Precise risk estimates for hyperglycemia-related adverse events in patients treated with atypical antipsychotics are not available.
Patients with an established diagnosis of diabetes mellitus who are started on antipsychotics should be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.
QT prolongation: QT prolongation has been observed in cases of overdose with quetiapine. As with other antipsychotics, caution should be exercised when quetiapine is prescribed with medicines known to increase the QTc interval, especially in the elderly, in patients with congenital long QT syndrome, congestive heart failure, heart hypertrophy, hypokalaemia and hypomagnesaemia. Concomitant use of quetiapine with other neuroleptics should be avoided.
Additional information: Use of quetiapine in combination with divalproex or lithium in moderate to severe manic episodes is limited; however, combination therapy was well tolerated (see Adverse Reactions and Pharmacology: Pharmacodynamics under Actions).
Ketipinor 100 mg and 200 mg tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Effects on ability to drive and use machines: Given its primary central nervous system effects, quetiapine may interfere with activities requiring mental alertness. Therefore, patients should be advised not to drive or operate machinery, until individual susceptibility to this is known.