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Zyprexa

Marketed in 59 countries across Europe, the Americas, Asia-Pacific, and parts of the Balkans, Zyprexa is a globally distributed brand of olanzapine, classified as an antipsychotic within the broader psycholeptic and psychoanaleptic categories. For an international reader — a traveller carrying an existing prescription, an expatriate trying to identify the local equivalent, or a family member helping with a relative's medication abroad — this page is a reference point rather than a clinical guide.

Olanzapine is prescribed in the management of schizophrenia and bipolar disorder, and is also indicated in certain settings for delirium and hallucinations. The structured indication list further down the page details the registered uses recognised by national regulators in the markets where Zyprexa is sold; specific approved indications can vary subtly from one country to another.

Because Zyprexa has such a broad international footprint, travellers commonly encounter it abroad — sometimes labelled as Zyprexa, sometimes as an olanzapine-containing generic. Markets where the brand is registered include China, Brazil, Canada, Australia, and Denmark, but regulatory pathways, packaging, and prescription requirements differ considerably between them. A pharmacist in the destination country can usually confirm whether an olanzapine product on a local shelf corresponds to what was prescribed at home.

Other medications in the antipsychotic class are sold worldwide under different molecules and brand names, but they are not interchangeable on the basis of class membership alone — antipsychotics differ meaningfully in their individual profiles, and substitution is a clinical decision rather than a logistical one. Anyone taking Zyprexa, evaluating it, or trying to identify a local equivalent while abroad should keep that decision firmly with a qualified healthcare provider familiar with their history.

Shelf life

ZYPREXA 2.5 mg coated tablets

2 years.

ZYPREXA 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg coated tablets

3 years.

ZYPREXA VELOTABS

3 years.

Incompatibilities

Not applicable.

List of excipients

ZYPREXA tablet

Tablet core

Lactose monohydrate

Hyprolose

Crospovidone

Microcrystalline cellulose

Magnesium stearate

Tablet coat

ZYPREXA 2.5 mg, 5 mg, 7.5 mg, and 10 mg coated tablets:

Hypromellose

Colour mixture white (hypromellose, titanium dioxide [E171], macrogol, polysorbate 80)

Carnauba wax

Edible blue ink (shellac, ethanol anhydrous, isopropyl alcohol, butyl alcohol, propylene glycol, ammonium hydroxide, indigo carmine [E132])

ZYPREXA 15 mg coated tablets:

Hypromellose

Colour mixture light blue (titanium dioxide [E171], lactose monohydrate, hypromellose, triacetin, indigo carmine [E132])

Carnauba wax

ZYPREXA 20 mg coated tablets:

Hypromellose

Colour mixture pink (titanium dioxide [E171], macrogol, lactose monohydrate, hypromellose, synthetic red iron oxide)

Carnauba wax

ZYPREXA VELOTAB

Gelatin

Mannitol (E421)

Aspartame (E951)

Sodium methyl parahydroxybenzoate (E219)

Sodium propyl parahydroxybenzoate (E217)

Preclinical safety data

Acute (single-dose) toxicity

Signs of oral toxicity in rodents were characteristic of potent neuroleptic compounds: hypoactivity, coma, tremors, clonic convulsions, salivation, and depressed weight gain. The median lethal doses were approximately 210 mg/kg (mice) and 175 mg/kg (rats). Dogs tolerated single oral doses up to 100 mg/kg without mortality. Clinical signs included sedation, ataxia, tremors, increased heart rate, laboured respiration, miosis, and anorexia. In monkeys, single oral doses up to 100 mg/kg resulted in prostration and, at higher doses, semi-consciousness.

Repeated-dose toxicity

In studies up to 3 months duration in mice and up to 1 year in rats and dogs, the predominant effects were CNS depression, anticholinergic effects, and peripheral haematological disorders. Tolerance developed to the CNS depression. Growth parameters were decreased at high doses. Reversible effects consistent with elevated prolactin in rats included decreased weights of ovaries and uterus and morphologic changes in vaginal epithelium and in mammary gland.

Haematologic toxicity

Effects on haematology parameters were found in each species, including dose-related reductions in circulating leukocytes in mice and non-specific reductions of circulating leukocytes in rats; however, no evidence of bone marrow cytotoxicity was found. Reversible neutropenia, thrombocytopenia, or anaemia developed in a few dogs treated with 8 or 10 mg/kg/day (total olanzapine exposure [area under the curve] is 12- to 15-fold greater than that of a man given a 12 mg dose). In cytopenic dogs, there were no adverse effects on progenitor and proliferating cells in the bone marrow.

Reproductive toxicity

Olanzapine had no teratogenic effects. Sedation affected mating performance of male rats. Oestrous cycles were affected at doses of 1.1 mg/kg (3-times the maximum human dose) and reproduction parameters were influenced in rats given 3 mg/kg (9-times the maximum human dose). In the offspring of rats given olanzapine, delays in foetal development and transient decreases in offspring activity levels were seen.

Mutagenicity

Olanzapine was not mutagenic or clastogenic in a full range of standard tests, which included bacterial mutation tests and in vitro and in vivo mammalian tests.

Carcinogenicity

Based on the results of studies in mice and rats, it was concluded that olanzapine is not carcinogenic.

Pharmacotherapeutic group

psycholeptics, diazepines, oxazepines, thiazepines and oxepines, ATC code N05A H03.

Date of revision of the text

23 February 2017

Marketing authorisation holder

Eli Lilly Nederland BV, Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

Special precautions for storage

ZYPREXA tablets: Store in the original package in order to protect from light and moisture.

ZYPREXA VELOTABS: Store in the original package in order to protect from light and moisture.

Nature and contents of container

ZYPREXA 2.5 mg tablets are available in cold-formed aluminium blister strips in cartons of 28, 35, 56, 70 or 98 tablets per carton.

ZYPREXA 5 mg tablets are available in cold-formed aluminium blister strips in cartons of 28, 35, 56, 70 or 98 tablets per carton.

ZYPREXA 7.5 mg tablets are available in cold-formed aluminium blister strips in cartons of 28, 35, 56, 70 or 98 tablets per carton.

ZYPREXA 10 mg tablets are available in cold-formed aluminium blister strips in cartons of 28, 35, 56, 70 or 98 tablets per carton.

ZYPREXA 15 mg tablets are available in cold-formed aluminium blister strips in cartons of 28, 35, 56, 70 or 98 tablets per carton.

ZYPREXA 20 mg tablets are available in cold-formed aluminium blister strips in cartons of 28, 35, 56, 70 or 98 tablets per carton.

ZYPREXA VELOTAB 5 mg, 10 mg, 15 mg, and 20 mg is supplied in aluminium blister strips in cartons of 28, 35, 56, 70 or 98 orodispersible tablets per carton.

Not all pack sizes may be marketed.

Marketing authorisation number(s)

EU/1/96/022/002: ZYPREXA 2.5 mg coated tablets - 28 tablets per box

EU/1/96/022/019: ZYPREXA 2.5 mg coated tablets - 56 tablets per box

EU/1/96/022/023: ZYPREXA 2.5 mg coated tablets - 35 tablets per box

EU/1/96/022/029: ZYPREXA 2.5 mg coated tablets - 70 tablets per box

EU/1/96/022/035: ZYPREXA 2.5 mg coated tablets - 98 tablets per box

EU/1/96/022/004: ZYPREXA 5 mg coated tablets - 28 tablets per box

EU/1/96/022/020: ZYPREXA 5 mg coated tablets - 56 tablets per box

EU/1/96/022/024: ZYPREXA 5 mg coated tablets - 35 tablets per box

EU/1/96/022/030: ZYPREXA 5 mg coated tablets - 70 tablets per box

EU/1/96/022/036: ZYPREXA 5 mg coated tablets - 98 tablets per box

EU/1/96/022/011: ZYPREXA 7.5 mg coated tablets - 28 tablets per box

EU/1/96/022/006: ZYPREXA 7.5 mg coated tablets - 56 tablets per box

EU/1/96/022/025: ZYPREXA 7.5 mg coated tablets - 35 tablets per box

EU/1/96/022/031: ZYPREXA 7.5 mg coated tablets - 70 tablets per box

EU/1/96/022/037: ZYPREXA 7.5 mg coated tablets - 98 tablets per box

EU/1/96/022/009: ZYPREXA 10 mg coated tablets - 28 tablets per box

EU/1/96/022/010: ZYPREXA 10 mg coated tablets - 56 tablets per box

EU/1/96/022/026: ZYPREXA 10 mg coated tablets - 35 tablets per box

EU/1/96/022/032: ZYPREXA 10 mg coated tablets - 70 tablets per box

EU/1/96/022/038: ZYPREXA 10 mg coated tablets - 98 tablets per box

EU/1/96/022/012: ZYPREXA 15 mg coated tablets - 28 tablets per box

EU/1/96/022/021: ZYPREXA 15 mg coated tablets - 56 tablets per box

EU/1/96/022/027: ZYPREXA 15 mg coated tablets - 35 tablets per box

EU/1/96/022/033: ZYPREXA 15 mg coated tablets - 70 tablets per box

EU/1/96/022/039: ZYPREXA 15 mg coated tablets - 98 tablets per box

EU/1/96/022/014: ZYPREXA 20 mg coated tablets - 28 tablets per box

EU/1/96/022/022: ZYPREXA 20 mg coated tablets - 56 tablets per box

EU/1/96/022/028: ZYPREXA 20 mg coated tablets - 35 tablets per box

EU/1/96/022/034: ZYPREXA 20 mg coated tablets - 70 tablets per box

EU/1/96/022/040: ZYPREXA 20 mg coated tablets - 98 tablets per box

EU/1/99/125/001: 5 mg x 28 Velotabs

EU/1/99/125/005: 5 mg x 56 Velotabs

EU/1/99/125/009: 5 mg x 35 Velotabs

EU/1/99/125/013: 5 mg x 70 Velotabs

EU/1/99/125/017: 5 mg x 98 Velotabs

EU/1/99/125/002: 10 mg x 28 Velotabs

EU/1/99/125/006: 10 mg x 56 Velotabs

EU/1/99/125/010: 10 mg x 35 Velotabs

EU/1/99/125/014: 10 mg x 70 Velotabs

EU/1/99/125/018: 10 mg x 98 Velotabs

EU/1/99/125/003: 15 mg x 28 Velotabs

EU/1/99/125/007: 15 mg x 56 Velotabs

EU/1/99/125/011: 15 mg x 35 Velotabs

EU/1/99/125/015: 15 mg x 70 Velotabs

EU/1/99/125/019: 15 mg x 98 Velotabs

EU/1/99/125/004: 20 mg x 28 Velotabs

EU/1/99/125/008: 20 mg x 56 Velotabs

EU/1/99/125/012: 20 mg x 35 Velotabs

EU/1/99/125/016: 20 mg x 70 Velotabs

EU/1/99/125/020: 20 mg x 98 Velotabs

Special precautions for disposal and other handling

No special requirements.

Date of first authorisation/renewal of the authorisation

2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg ZYPREXA tablets:

Date of first authorisation:

Date of latest renewal:

27 September 1996

27 September 2006

ZYPREXA VELOTABS:

Date of first authorisation:

Date of latest renewal:

3 February 2000

27 September 2006

Frequently asked questions

What conditions does Zyprexa treat?

Zyprexa is prescribed in the management of schizophrenia and bipolar disorder, and is also indicated in certain contexts for delirium and hallucinations. As an antipsychotic, it sits within the broader psycholeptic and psychoanaleptic categories of medications used in psychiatry. The full list of registered indications, which can vary slightly between national regulators, is shown in the structured data section below this introduction.

What is the active ingredient in Zyprexa?

Zyprexa contains olanzapine, classified as an antipsychotic within the wider psycholeptic category. Olanzapine is the same molecule whether sold under the Zyprexa brand or as a generic, and internationally it circulates under several commercial names — particularly in markets where the original patent has expired and multiple manufacturers produce olanzapine-containing products in parallel.

In how many countries is Zyprexa available?

Zyprexa is registered in 59 countries, with a footprint that spans Europe, the Americas, Asia, and Oceania. Examples include Australia, Brazil, China, Canada, Denmark, and Argentina. If your country does not appear in the list shown on this page, a local pharmacist can usually confirm whether olanzapine is available in that market, either as Zyprexa or under a different brand name.

Are there other medications with the same active ingredient as Zyprexa?

Olanzapine is sold under several brand names worldwide, particularly in markets where the original patent has expired and generic versions have entered the market. Other medications within the broader antipsychotic class also exist, although molecules within the class are not freely interchangeable and differ in their clinical profiles. To identify a local olanzapine product, search the active ingredient on Pill2Trip or speak with a pharmacist.

Should I consult a doctor before taking Zyprexa?

Yes. Zyprexa is a prescription medication, and antipsychotic therapy is closely calibrated to the individual patient's diagnosis, history, and concurrent medications. This is particularly relevant for travellers and people relocating between countries, since prescription rules, available brands, and generic equivalents can differ between regulatory systems. Any decision to start, stop, switch, or substitute olanzapine belongs with a treating healthcare provider.