MedPath

Astemizole

Generic Name
Astemizole
Drug Type
Small Molecule
Chemical Formula
C28H31FN4O
CAS Number
68844-77-9
Unique Ingredient Identifier
7HU6337315

Overview

Astemizole is a long-acting, non-sedating second generation antihistamine used in the treatment of allergy symptoms. It was withdrawn from market by the manufacturer in 1999 due to the potential to cause arrhythmias at high doses, especially when when taken with CYP inhibitors or grapefruit juice.

Indication

Astemizole was indicated for use in the relieving allergy symptoms, particularly rhinitis and conjunctivitis. It has been withdrawn from the market however due to concerns of arrhythmias.

Associated Conditions

No associated conditions information available.

Clinical Trials

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Posted
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No clinical trials found

No clinical trials found for this drug

FDA Drug Approvals

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No FDA approvals found for this drug.

EMA Drug Approvals

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No EMA approvals found for this drug.

HSA Drug Approvals

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No HSA approvals found for this drug.

NMPA Drug Approvals

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No NMPA approvals found for this drug.

PPB Drug Approvals

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No PPB approvals found for this drug.

TGA Drug Approvals

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No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
HISMANAL SUSPENSION 2MG/ML
janssen pharmaceutica, division of janssen-ortho inc.
00610070
Suspension - Oral
2 MG / ML
12/31/1984
HISMANAL TAB 10MG
janssen pharmaceutica, division of janssen-ortho inc.
00610089
Tablet - Oral
10 MG / TAB
12/31/1984
HISMANAL - TAB 10MG
johnson & johnson - merck consumer pharmaceuticals of canada
02182912
Tablet - Oral
10 MG / TAB
1/21/1997

CIMA AEMPS Drug Approvals

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Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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MA Holder
MA Number
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Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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