Download Serex Film Coated Tablets 25-100-200-300 mg, 30 tablets

Serex
Serex Film Coated Tablets 25-100-200-300 mg, 30 tablets
COMPOSITION: Each tablet contains 28.78 mg, 115.13 mg, 230.26 mg, and 345.4 mg quetiapine fumarate equivalent to 25-100-200-300 mg base, respectively.
PHARMACOLOGICAL PROPERTIES: Quetiapine is an antipsychotic drug which is a derivative of a
new chemical group, dibenzotiazepines. It shows antagonistic effect on numerous neurotransmitter receptors (serotonin 5HT1A and 5HT2, dopamine D1 and D2, histamine H1 and adrenergic
1 and 2 receptors) Quetiapine’s affinity to muscarinic benzodiazepine receptors is negligible.
INDICATIONS: Quetiapine is indicated for treatment of schizophrenia and manic attacks accompanied by bipolar disorder, for acute (8 weeks) treatment of moderate to severe depressive attacks, and for maintenance therapy of bipolar disorder.
CONTRAINDICATIONS: Serex is contraindicated in patients known to be hypersensitive against any
of agents included as an ingredient.
WARNINGS AND PRECAUTIONS: As in with other new generation (atypical) antipsychotics, this
drug also has the potential to cause elevated risk of death because of cerebrovascular events,
infection, heart failure-dependant sudden death, etc. Long lasting QT syndrome may cause Torsades de Pointes. Signs of Neuroleptic Malign Syndrome is reported to occur sometimes in administration of antipsychotics. As in with other antipsychotics, tardive dyskinesia characterized with
involuntary dyskinetic movements may develop with quetiapine following long-term administration. Hyperglycemia cases accompanied by ketoacidosis and hyperosmolar coma and death are
sometimes reported in patients treated with atypical antipsychotics including quetiapine. Definitive diabetes mellitus diagnosed in atypical antipsychotic treatment should be monitored regularly
for deterioration in glucose table. Quetiapine may cause dizziness, tachycardia and sometimes hypotension accompanied by syncope, especially in dose increasing period at the start of treatment.
As in with other antipsychotics, quetiapine also should be used carefully in patients that have
seizures or potential to decrease the seizure threshold like Alzheimer’s disease. In clinic studies
performed with quetiapine, approximately 20 % reduction was observed in total and free thyroxin levels (T4) at the upper limit of therapeutic doses. Asymptomatic, temporary and reversible
increases were reported for serum transaminases (mainly ALT). State of depression may worsen
and/or suicide attempts or suicidality may occur in both adult and pediatric patients with major
depressive disorder (MDD) whether anti-depressant drugs are used or not. Please remember
that Serex usage is approved for bipolar depression in adults. Pregnancy category is C.
SIDE EFFECTS / ADVERSE EFFECTS: Most common (with incidence of 5 % or more) and at 2-fold
encountered compared to placebo side effects associated with the use of quetiapine are dizziness (10%), postural hypotension (7%), cotton mouth (%7) and dyspepsia (6%).
DRUG INTERACTIONS: Oral clearance of quetiapine is increased by prototype cytochrome
P450 3A4 inductive phenytoin and decrease by prototype cytochrome P450 3A4 inhibitor
ketoconazole. Co-administration of quetiapine and phenytoin increased mean oral clearance of quentiapine fivefold. Co-administation of quetiapine and divalproexine caused a
17% increase of mean maximum plasma concentration in steady-state Serex. Thioridazine
also increase oral clearence of quetiapine by 65% Co-administration of ketoconazole, a
strong P450 3A inhibitor decreased the oral clearance of quetiapine by 85% and caused
a 335% increase in peak plasma concentrations. Quetiapine should be used very carefully with other drugs and alcohol considering its effects on primary central nervous
system. Quetiapine may antagonize the effects of levodopa and dopamine antagonists. It may also increase the effect of some antihypertensive drugs as it can induce
hypotension. Alcohol use should be avoided when quetiapine is used.
Serex
DOSAGE AND ADMINISTRATION: Quetiapine may be administered 2 or 3 times a day in fasting or fed state. Schizophrenia Treatment: Treatment should start with 25 mg dose twice a
day; with 25-50 mg, 2 or 3 times a day raises according to patient’s tolerance and reach to
target dose of 300-400 mg/day divided into 2 or 3 times a day. In treatment of manic attacks
accompanying bipolar disorders: Total daily doses of in the first 4 days of treatment are; 100
mg in day 1, 200 mg in day 2, 300 mg in day 3, and 400 mg in day 4. Daily increases should not
exceed 200 mg in adjustments in order to raise the dose to 800 mg. Daily dose may vary between
200 mg and 800 mg, depending on patient’s clinical response and tolerance. Effective dose is
generally between 400 mg and 800 mg. In the acute treatment of depressive attack in bipolar
disorder, quetiapine should be administered once daily before bedtime. Total daily doses to be
administered for the first 4 days of treatment are; 50 mg for day 1, 100 mg for day 2, 200 mg for
day 3, and 300 mg for day 4. In patients receiving 600 mg, daily dose was increased to 400 for
day 5, and to 600 mg for day 8 (week 1). Concomitant use with mood stabilizers in maintenance
therapy of bipolar disorder: Quetiapine should be administered twice daily with a total daily dose
of 400 to 800 mg. During maintenance phase, patients were generally given the same dose as the
stabilizing dose they were given during the stabilization phase.
AVAILABLE FORMS: SEREX 25-100-200-300 mg, in blister pack containing 30 tablets,
NAME AND ADDRESS OF THE AUTHORISATION HOLDER: Mustafa Nevzat Ilaç Sanayii A.Ş. Prof. Dr.
Bülent Tarcan Sok., Pak Iş Merkezi No: 5/1 34349 Gayrettepe/Istanbul.
NAME AND ADDRESS OF THE MANUFACTURING COMPANY: Mustafa Nevzat Ilaç Sanayii A.Ş.
Çobançeşme Mah. Sanayi Cad. No:13 Yenibosna-Istanbul.