Ozapez

Ozapez

olanzapine

Manufacturer:

Great Eastern Drug

Distributor:

Zuellig Pharma

Marketer:

Great Eastern Drug
Concise Prescribing Info
Contents
Olanzapine
Indications/Uses
Acute & maintenance treatment of schizophrenia & other psychoses where +ve symptoms (eg, delusions, hallucinations, disordered thinking, hostility, & suspiciousness) &/or -ve symptoms (eg, flattened affect, emotional & social w/drawal, poverty of speech) are prominent. Alleviates secondary affective symptoms commonly associated w/ schizophrenia & related disorder. Maintains clinical improvement during continuing therapy in patients who have shown initial treatment response. Moderate or severe manic episode. Prevention of recurrence in patients w/ bipolar disorder whose manic episode has responded to olanzapine treatment.
Dosage/Direction for Use
Adult Schizophrenia Initially 10 mg daily. Manic episode Initially 15 mg as single daily dose in monotherapy or 10 mg daily in combination therapy. Prevention of recurrent bipolar disorder Initially 10 mg daily. Continue therapy at same dose in patients receiving olanzapine for manic episode. Continue (w/ dose optimization as needed) w/ supplementary therapy to treat mood symptoms if new manic, mixed or depressive episode occurs. May adjust daily dosage w/in 5-20 mg range daily. Elderly ≥65 yr, renal & hepatic impairment Consider lower starting dose of 5 mg daily. Moderate hepatic insufficiency (cirrhosis, Child-Pugh class A or B) Initially 5 mg daily & increase w/ caution.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Dementia-related psychosis; alzheimer's disease. Patients w/ known risk of narrow-angle glaucoma. Concomitant use w/ herbal supplement or alcohol.
Special Precautions
Discontinue treatment immediately if NMS occur. Not approved for treatment of Alzheimer's disease. Increased risk of QTc-interval prolongation. Chest pain; VTE including pulmonary embolism & DVT. Metabolic changes including wt gain; peripheral edema. Galactorrhea, amenorrhea, gynecomastia & impotence; decreased bone density. DRESS. Esophageal dysmotility & aspiration pneumonia. Tardive dyskinesia. Leukopenia, neutropenia & agranulocytosis; orthostatic hypotension; hyperglycemia, sometimes severe & associated w/ ketoacidosis, hyperosmolar coma, or death. Asymptomatic elevations in serum aminotransferase conc including ALT, AST & γ-glutamyltransferase; changes in serum lipid parameters including elevated serum triglyceride & cholesterol conc; increased bilirubin serum alkaline phosphatase conc & decreased proteinemia; elevated serum prolactin conc during chronic use. Patients w/ history of seizures; conditions known to lower seizure threshold eg, dementia of Alzheimer's type; pre-existing conditions associated w/ limited hepatic functional reserve & those being treated concurrently w/ potential hepatotoxic drugs; clinically important prostatic hypertrophy, angle-closure glaucoma, or history of paralytic ileus or related conditions; known CV disease (eg, history of MI or ischemia, heart failure, conduction abnormalities), cerebrovascular disease & other conditions predisposing to HTN (eg, dehydration, hypovolemia, antihypertensive therapy). Slow metabolisers (female, elderly, non-smoking). Perform fasting blood glucose test & lipid profile determinations at start of therapy & periodically during treatment. Closely supervise patients w/ possibility of suicide attempt (schizophrenia & bipolar disease). Concurrent therapy w/ drugs that may lower seizure threshold. Avoid concomitant use w/ herbal supplement or alcohol. Hepatic impairment. Pregnancy. Not to breastfeed during treatment. Childn. Not approved for elderly w/ dementia-related psychosis.
Adverse Reactions
Abnormal gait, articulation impairment, drowsiness, extrapyramidal reaction, headache, hypertonia, insomnia, parkinsonian-like syndrome (tremor), restlessness; chest pain, HTN, orthostatic hypotension, peripheral edema; abdominal pain, constipation, diarrhea, dyspepsia, increased appetite, vomiting, xerostomia; wt gain, breast changes (enlargement, galactorrhea, gynecomastia, lactation disorder, increased γ-glutamyl transferase & uric acid), menstrual disease (amenorrhea, hypomenorrhea, delayed menstruation, oligomenorrhea); sexual disorder, urinary incontinence, UTI; decreased serum bilirubin, increased liver enzymes, serum alkaline phosphatase, ALT & AST; arthralgia, back & limb pain, dyskinesia, muscle rigidity, tremor, weakness; amblyopia, dry eyes, accommodation abnormality, mydriasis; cough, epistaxis, nasopharyngitis, pharyngitis, resp tract infection, rhinitis, sinusitis, dyspnea, hyperventilation, lung edema; alopecia, photosensitivity, anaphylactoid reaction, angioedema, pruritus, urticaria, rash, eruptive xanthomas, leukocytoclastic vasculitis.
Drug Interactions
Metabolism/transport effects w/ CYP1A2 & CYP2D6 substrates. Avoid concomitant use w/ aclidinium, amisulpride, nasal azelastine, benzodiazepines, cimetropium, eluxadoline, glucagon, glycopyrrolate, ipratropium, levosulpiride, metoclopramide, nitroglycerin, orphenadrine, oxatomide, oxomemazine, paraldehyde, piribedil, KCl, sulpiride, thalidomide, tiotropium, umeclidinium. Increased levels/effects w/ abiraterone acetate, acetylcholinesterase inhibitors, aclidinium, BP lowering agents, brimonidine, cannabis, chloral betaine, chlormethiazole, chlorphenesin, carbamate, CYP1A2 inhibitors, deferasirox, dimethindene, doxylamine, dronabinol, droperidol, fluvoxamine, hydroxyzine, ipratropium, kava kava, lamotrigine, lithium, lofexidine, Mg sulfate, methotrimeprazine, mifepristone, monocycline, nabilone, obeticholic acid, oxatomide, oxomemazine, peginterferon α-2b, perampanel, pramlintide, rufinamide, serotonin modulators, Na oxybate, tapentadol, tetrahydrocannabinol, trimeprazine, umeclidinium, vemurafenib. May increase levels/effects of abobotulinumtoxinA, ethyl alcohol, amisulpride, opioid analgesics, anticholinergics, nasal azelastine, benzodiazepines, blonanserin, buprenorphine, cimetropium, clozapine, CNS depressants, eluxadoline, glucagon, glycopyrrolate (oral inhalation), highest & moderate risk QTc-prolonging agents, hydrocodone, iohexol, iomeprol, iopamidol, mequitazine, methotrimeprazine, methylphenidate, metyrosine, mirabegron, mirtazapine, onabotulinumtoxinA, orphenadrine, oxycodone, paraldehyde, KCl, ramosetron, rimabotulinumtoxinB, SSRIs, serotonin modulators, sulpiride, suvorexant, thalidomide, thiazide & thiazide-like diuretics, tiotropium, tizanidine, topiramate, zolpidem. Decreased levels/effects w/ acetylcholinesterase inhibitors, antihepaciviral combination products, cannabis, CYP1A2 inducers, cyproterone, lithium, piribedil, ritonavir, teriflunomide, valproate products. May decrease levels/effects of acetylcholinesterase inhibitors, amphetamines, antidiabetic agents, anti-parkinson agents (dopamine agonist), prokinetic GI agents, itopride, levosulpiride, nitroglycerin, piribedil, quinagolide, secretin. May antagonize effects of levodopa & dopamine agonists. May potentiate orthostatic hypotension w/ CNS agents eg, diazepam; alcohol. May enhance effects of hypotensive agents, dopamine, epinephrine, sympathomimetic agents w/ β-agonist activity. Reduced peak plasma conc w/ activated charcoal. Lower plasma conc w/ smoking. Concomitant use w/ anticholinergics; lamotrigine.
MIMS Class
Antipsychotics
ATC Classification
N05AH03 - olanzapine ; Belongs to the class of diazepines, oxazepines and thiazepines antipsychotics
Presentation/Packing
Form
Ozapez FC tab 10 mg
Packing/Price
3 × 10's
Form
Ozapez FC tab 5 mg
Packing/Price
3 × 10's
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