Quitapex 100 mg 30 tablets
Apex Pharma
Apex Pharma
Composition
Active ingredient
Each tablet contains 100 mg quetiapine (as quetiapine fumarate).
Excipients
Povidone, lactose monohydrate, sodium starch glycolate, Avicel PH 101, magnesium stearate, Opadry II, propylene glycol, methocel, PEG 6000, titanium dioxide, talc, FD&C Yellow No.6.
Description
Quitapex 100 mg is an atypical antipsychotic medication used to correct imbalances of neurotransmitters such as dopamine and serotonin.
It helps reduce psychotic symptoms, stabilize mood, control hyperactivity or agitation, and manage depressive or manic states in bipolar disorders.
It improves thought clarity, sleep quality, emotional stability, and reduces the risk of relapse in long-term treatment.
Indications for Use
Quitapex 100 mg is indicated for
- Treatment of schizophrenia.
- Treatment of bipolar disorder, including
- Moderate to severe manic episodes,
- Major depressive episodes,
- Prevention of recurrence in patients previously responsive to quetiapine.
Dosage and Method of Administration
Taken orally, with or without food.
Quitapex 100 mg must be swallowed whole.
Adults
- Schizophrenia:
Twice daily. Days 1-4: 50-300 mg/day.
Effective dose: 300-450 mg/day (range 150–750 mg/day).
- Manic episodes
Twice daily. Days 1-4: 100-400 mg/day.
Titrate up to 200-800 mg/day.
Usual effective dose: 400-800 mg/day.
- Bipolar depression
Once daily at bedtime.
Days 1-4: 50-300 mg/day.
Recommended dose: 300 mg.
Some patients may require 600 mg.
- Prevention of recurrence
Continue the same effective dose: 300-800 mg/day, twice daily.
Special populations
- Elderly: slower titration, lower doses may be required.
- Hepatic impairment: start with 25 mg/day and increase gradually.
Contraindications
- Hypersensitivity to quetiapine or excipients.
- Concomitant use with potent CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, nefazodone, clarithromycin, etc.).
Precautions
Use with caution in patients with
- history of severe skin reactions (SJS, TEN, DRESS);
- suicidal thoughts or behavior;
- metabolic risk factors (weight, glucose, lipids);
- cardiovascular disease or risk of QT prolongation;
- orthostatic hypotension;
- somnolence;
- seizures;
- neutropenia;
- constipation or risk of bowel obstruction;
- sleep apnea;
- elderly with dementia (increased mortality risk).
- Avoid abrupt discontinuation.
Side Effects
Very common
Elevation in serum triglyceride levels, Elevations in total cholesterol (predominantly LDL cholesterol), Decreased haemoglobin, Decreases in HDL cholesterol, Dizziness, Somnolence, Dry mouth, Headache, Extrapyramidal symptoms.
Common:
Leucopenia, Decreased neutrophil count, Eosinophils increased, Hyperprolactinemia, Decreases in total T4, Decreases in free T4, Decreases in total T3, Increases in TSH, Increased appetite, Blood glucose increased to hyperglycaemic levels, Abnormal dreams and nightmares, Suicidal ideation and suicidal behavior, Dysarthria, Tachycardia, Constipation, Dyspepsia, Vomiting, Elevations in serum alanine aminotransferase (ALT), Elevations in gamma-GT levels, Palpitations, Vision blurred, Orthostatic hypotension, Dyspnoea.
Serious
Neuroleptic malignant syndrome, Severe neutropenia/agranulocytosis, Severe skin reactions (SJS, TEN, DRESS), Pancreatitis, Seizures.
Pregnancy and Breastfeeding
Pregnancy
Use only if potential benefit justifies possible risks.
Third-trimester exposure may cause EPS or withdrawal in newborns.
Breastfeeding
Excretion into breast milk inconsistent - consider stopping breastfeeding or therapy.
Storage Conditions
Store below 30°C, in a dry place.
Keep out of reach of children
Packaging
Carton box containing 3 blisters, each with 10 film-coated tablets, plus leaflet.