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ZYPREXA(Olanzapine coated tablets)
2016-03-21 09:03:10 来源: 作者: 【 】 浏览:647次 评论:0
Zyprexa 2.5mg, 5mg, 7.5mg, 10mg, 15mg, and 20mg coated tablets. Zyprexa Velotab 5mg, 10mg, 15mg, and 20mg orodispersible tablets 
1. Name of the medicinal product

ZYPREXA* 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg coated tablets.

ZYPREXA VELOTAB* 5 mg, 10 mg, 15 mg, and 20 mg orodispersible tablets.

2. Qualitative and quantitative composition

Each coated tablet contains 2.5 mg olanzapine.

Excipient with known effect: Each coated tablet contains 102 mg lactose monohydrate.

Each coated tablet contains 5 mg olanzapine.

Excipient with known effect: Each coated tablet contains 156 mg lactose monohydrate.

Each coated tablet contains 7.5 mg olanzapine.

Excipient with known effect: Each coated tablet contains 234 mg lactose monohydrate.

Each coated tablet contains 10 mg olanzapine.

Excipient with known effect: Each coated tablet contains 312 mg lactose monohydrate.

Each coated tablet contains 15 mg olanzapine.

Excipient with known effect: Each coated tablet contains 178 mg lactose monohydrate.

Each coated tablet contains 20 mg olanzapine.

Excipient with known effect: Each coated tablet contains 238 mg lactose monohydrate.

Each orodispersible tablet contains 5 mg olanzapine.

Excipients with known effect: Each orodispersible tablet contains

0.60 mg aspartame

0.1125 mg sodium methyl parahydroxybenzoate

0.0375 mg sodium propyl parahydroxybenzoate

Each orodispersible tablet contains 10 mg olanzapine.

Excipients with known effect: Each orodispersible tablet contains

0.80 mg aspartame

0.15 mg sodium methyl parahydroxybenzoate

0.05 mg sodium propyl parahydroxybenzoate

Each orodispersible tablet contains 15 mg olanzapine.

Excipients with known effect: Each orodispersible tablet contains

1.20 mg aspartame

0.225 mg sodium methyl parahydroxybenzoate

0.075 mg sodium propyl parahydroxybenzoate

Each orodispersible tablet contains 20 mg olanzapine.

Excipients with known effect: Each orodispersible tablet contains

1.60 mg aspartame

0.30 mg sodium methyl parahydroxybenzoate

0.10 mg sodium propyl parahydroxybenzoate

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Coated Tablets

ZYPREXA 2.5 mg tablets: Round, white, coated tablets imprinted with 'LILLY' and a numeric identicode '4112'.

ZYPREXA 5 mg tablets: Round, white, coated tablets imprinted with 'LILLY' and a numeric identicode '4115'.

ZYPREXA 7.5 mg tablets: Round, white, coated tablets imprinted with 'LILLY' and a numeric identicode '4116'.

ZYPREXA 10 mg tablets: Round, white, coated tablets imprinted with 'LILLY' and a numeric identicode '4117'.

ZYPREXA 15 mg tablets: Elliptical, blue, coated tablets debossed with 'LILLY' and a numeric identicode '4415'.

ZYPREXA 20 mg tablets: Pink, elliptical, coated tablets debossed with 'LILLY' and a numeric identicode '4420'.

Orodispersible Tablets

ZYPREXA VELOTAB 5 mg, 10 mg, 15 mg, and 20 mg orodispersible tablet is a yellow, round, freeze-dried, rapid-dispersing preparation to be placed in the mouth or alternatively to be dispersed in water or other suitable beverage for administration.

4. Clinical particulars
 
4.1 Therapeutic indications

Adults

Olanzapine is indicated for the treatment of schizophrenia.

Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.

Olanzapine is indicated for the treatment of moderate to severe manic episode.

In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder (see section 5.1).

4.2 Posology and method of administration

Adults

Schizophrenia: The recommended starting dose for olanzapine is 10 mg/day.

Manic episode: The starting dose is 15 mg as a single daily dose in monotherapy or 10 mg daily in combination therapy (see section 5.1).

Preventing recurrence in bipolar disorder: The recommended starting dose is 10 mg/day. For patients who have been receiving olanzapine for treatment of manic episode, continue therapy for preventing recurrence at the same dose. If a new manic, mixed, or depressive episode occurs, olanzapine treatment should be continued (with dose optimisation as needed), with supplementary therapy to treat mood symptoms, as clinically indicated.

During treatment for schizophrenia, manic episode, and recurrence prevention in bipolar disorder, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5-20 mg/day. An increase to a dose greater than the recommended starting dose is advised only after appropriate clinical reassessment and should generally occur at intervals of not less than 24 hours.

Olanzapine can be given without regard for meals, as absorption is not affected by food. Gradual tapering of the dose should be considered when discontinuing olanzapine.

ZYPREXA VELOTAB orodispersible tablet should be placed in the mouth, where it will rapidly disperse in saliva, so it can be easily swallowed. Removal of the intact orod

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