Tolanz 5/Tolanz 10

Tolanz 5/Tolanz 10

olanzapine

Manufacturer:

Torrent

Distributor:

Torrent
Concise Prescribing Info
Contents
Olanzapine
Indications/Uses
Management of schizophrenia & treatment of moderate to severe mania associated w/ bipolar disorder.
Dosage/Direction for Use
Schizophrenia Initially 10 mg daily. Acute manic episodes Initially 10-15 mg daily as monotherapy or 10 mg in combination therapy; dose adjustments of 5 mg may subsequently be made at intervals of not <24 hr if necessary w/in the range of 5-20 mg daily. Prevention of recurrence Patient whose manic episodes have responded previously to olanzapine Initially 10 mg daily. All indications Patient w/ renal impairment, moderate hepatic insufficiency Initially 5 mg daily. Female, elderly or non-smoking patient Lower initial dose (eg, 5 mg daily) & more gradual dose escalation should be considered.
Administration
May be taken with or without food: Place in the mouth where it will rapidly disperse in saliva & can be easily swallowed. Alternatively, disperse in a full glass of water or other beverages (orange juice/apple juice/milk/coffee) immediately before administration.
Contraindications
Hypersensitivity. Patients w/ known risk for narrow-angle glaucoma.
Special Precautions
Discontinue treatment in case of clinical manifestations of NMS or presence of high fever w/o clinical manifestations of NMS; hepatitis. Monitor regularly for worsening of glucose control in patients w/ established diagnosis of DM; for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, & weakness. Reports of acute symptoms eg, sweating, insomnia, tremor, anxiety, nausea, or vomiting when treatment is stopped abruptly (very rare); hepatitis (rare); cholestatic or mixed liver injury (very rare); seizures (rare). Caution in patients w/ prostatic hypertrophy, or paralytic ileus & related conditions; w/ elevated ALT &/or AST, w/ signs & symptoms of hepatic impairment, w/ preexisting conditions associated w/ limited hepatic functional reserve, & who are being treated w/ potentially hepatotoxic drugs; w/ low leukocyte &/or neutrophil counts for any reason, w/ history of drug-induced bone marrow depression/toxicity, those receiving medicines known to cause neutropenia in patients w/ bone marrow depression caused by concomitant illness, RT or chemotherapy, & w/ hypereosinophilic conditions or w/ myeloproliferative disease; who have history of seizures or are subject to factors which may lower seizure threshold. Not recommended in treatment of dopamine agonist associated psychosis in patients w/ Parkinson's disease. Occasionally, transient, asymptomatic elevations of hepatic transaminases, ALT, AST especially in early treatment. Patients w/ risk factors for DM (eg, obesity, family history of diabetes) who are starting treatment should undergo fasting blood glucose testing at baseline & periodically during treatment. Gradually reduce dose when discontinuing treatment. Consider follow-up & dose reduction in the event of elevated ALT &/or AST during treatment. Limited data on co-medication w/ lithium & valproate. No clinical data on co-therapy w/ carbamazepine. Caution in combination w/ other centrally acting drugs & alcohol. May antagonize effects of direct & indirect dopamine agonists. May affect performance of skilled tasks eg, driving. Should be used in pregnancy only if the potential benefit justifies the potential risk to fetus. Very rare spontaneous reports of tremor, hypertonia, lethargy & sleepiness in infants born to mothers treated during 3rd trimester. Do not breastfeed during treatment. Increased risk of stroke & all-cause mortality in elderly patients w/ dementia-related psychosis; risk should be considered relevant to any patient w/ history of stroke or transient ischemic attack or other risk factors for cerebrovascular disease including HTN, diabetes, current smoking or atrial fibrillation. Periodically measure BP in patients >65 yr.
Adverse Reactions
Somnolence, wt gain; hyperprolactinemia. Increased appetite, dizziness, elevated plasma glucose, triglyceride & liver enzyme values, eosinophilia, edema, orthostatic hypotension, mild transient antimuscarinic effects eg, constipation & dry mouth. Speech difficulty.
Drug Interactions
May enhance central effects of other CNS depressants including alcohol. May antagonize actions of dopaminergics. Neutropenia may be more common w/ valproate. Theoretical risk of QT prolongation w/ other drugs known to cause QT prolongation. Plasma conc may be affected by CYP1A2 inhibitors, inducers or substrates. Significantly inhibited metabolism w/ CYP1A2 inhibitor fluvoxamine. Increased clearance by tobacco smoking & carbamazepine.
MIMS Class
Antipsychotics
ATC Classification
N05AH03 - olanzapine ; Belongs to the class of diazepines, oxazepines and thiazepines antipsychotics
Presentation/Packing
Form
Tolanz 10 orodispersible tab 10 mg
Packing/Price
30's (P3,937.5/box)
Form
Tolanz 5 orodispersible tab 5 mg
Packing/Price
30's (P2,199/box)