Pilanz

Pilanz

olanzapine

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical

Marketer:

Siam Pharmaceutical
Concise Prescribing Info
Contents
Olanzapine
Indications/Uses
Acute & maintenance treatment of schizophrenia & other psychoses w/ prominent +ve &/or -ve symptoms. Moderate to severe manic episode. Prevention of recurrence in patients w/ bipolar disorder. Alleviates secondary affective symptoms commonly associated w/ schizophrenia & related disorders. Maintains clinical improvement during continuing therapy in patients who have shown an initial treatment response.
Dosage/Direction for Use
Schizophrenia Initially 10 mg once daily. Manic episode Initially 15 mg as single daily dose in monotherapy or 10 mg daily in combination therapy. Prevention of recurrence in patients w/ bipolar disorder Initially 10 mg once daily. Manic episode & recurrence prevention in bipolar disorder during treatment for schizophrenia Individualized dose. May subsequently adjust daily dose w/in 5-20 mg once daily. Patients w/ renal &/or hepatic impairment Lower starting dose: 5 mg. Moderate hepatic insufficiency (cirrhosis, Child-Pugh class A or B) Initially 5 mg.
Administration
May be taken with or without food: Take immediately after opening the blister. Place in mouth & allow to disperse before swallowing. Tab may be dispersed in a glass of water/other suitable beverage (eg, orange juice/apple juice/milk/coffee).
Contraindications
Hypersensitivity. Known risk of narrow-angle glaucoma.
Special Precautions
Discontinue treatment if hepatitis (including hepatocellular, cholestatic or mixed liver injury) occurs; at 1st signs of blood dyscrasias or ANC <1,000/mm3; signs & symptoms of NMS develop, or w/ unexplained high fever w/o additional clinical manifestations of NMS; tardive dyskinesia appears. Not recommended in patients w/ parkinsonism. Hyperglycemia, diabetes, exacerbation of pre-existing diabetes, ketoacidosis & diabetic coma. History of drug-induced bone marrow depression/toxicity, bone marrow depression caused by concomitant illness, RT or chemotherapy & hypereosinophilic conditions or myeloproliferative disease; seizures. Patients w/ decreased GI motility, urinary retention, benign prostatic hyperplasia, xerostomia, or narrow angle glaucoma; low leukocyte &/or neutrophil counts; congenital long QT syndrome, CHF, heart hyperthrophy, hypokalemia or hypomagnesaemia; acquired risk factors for VTE eg, immobilization of patients; CV disease. Frequently monitor CBC in 1st period of use. Periodically measure BP in patients >65 yr. Monitor serum lipid during treatment. Gradually taper off dose; avoid abrupt discontinuation. Combination w/ other centrally acting medicines & alcohol; medicines known to increase QTc interval. Patients w/ elevated ALT &/or AST, signs & symptoms of hepatic impairment, pre-existing conditions associated w/ limited hepatic functional reverse, & receiving potentially hepatotoxic medicines. Moderate hepatic impairment (cirrhosis, Child-Pugh class A or B). 3rd trimester of pregnancy. Avoid breastfeeding during treatment. Not recommended for elderly w/ dementia-related psychosis, cerebrovascular adverse events eg, transient ischemic stroke, stroke. Elderly ≥65 yr.
Adverse Reactions
Orthostatic hypotension, peripheral edema, venous thromboembolic effects, including pulmonary embolism & DVT, QTc prolongation, tachycardia, bradycardia; anxiety, dizziness, somnolence, lethargy, abnormal gait, akathisia, dystonia, dyskinesia, tardive dyskinesia, NMS, parkinsonism, extrapyramidal syndrome, falling, fatigue, insomnia, tremor, seizure, amnesia, hallucination; increased serum prolactin, breast changes (including discharge, enlargement, galactorrhea, gynecomastia, lactation disorder), wt gain, increased appetite, hypercholesterolemia, hypertriglyceridemia, hyperglycemia, diabetic ketoacidosis & coma, hypothermia, increased body temp; constipation, abdominal distension, nausea, vomiting, dry mouth, pancreatitis; urinary incontinence, retention & hesitation; transient, asymptomatic elevations of hepatic aminotransferase, increased serum ALT/SGPT & serum AST/SGOT, hepatic injury (cholestatic or mixed), hepatitis, increased total bilirubin, jaundice; arthralgia, rhabdomyolysis; alopecia, photosensitivity reaction, erythema; leukopenia, neutropenia, thrombocytopenia, eosinophilia, anaphylactoid reaction, angioedema, pruritus, urticaria, rash; epistaxis, pneumonia; fever, asthenia, priapism, increased creatine phosphokinase, cardiac death.
Drug Interactions
Increased clearance w/ CYP1A2 inducers eg, carbamazepine. Reduced excretion w/ CYP1A2 inhibitors eg, fluvoxamine. Antagonized effects of direct & indirect dopamine agonists of other centrally acting medicines & alcohol. Potentiated orthostatic hypotension w/ diazepam or other benzodiazepines. Reduced bioavailability w/ activated charcoal.
MIMS Class
Antipsychotics
ATC Classification
N05AH03 - olanzapine ; Belongs to the class of diazepines, oxazepines and thiazepines antipsychotics
Presentation/Packing
Form
Pilanz orodispersible tab 10 mg
Packing/Price
4 × 7's
Form
Pilanz orodispersible tab 5 mg
Packing/Price
4 × 7's
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