Carbinoxamine

Overview

Carbinoxamine is a first generation antihistamine that competes with free histamine for binding at HA-receptor sites. This antagonizes the effects of histamine on HA-receptors, leading to a reduction of the negative symptoms brought on by histamine HA-receptor binding. The product label for carbinoxamine as an over the counter cough and cold medicine is being modified to state "do not use" in children under 4 years of age in order to prevent and reduce misuse, as many unapproved carbinoxamine-containing preparations contained inappropriate labeling, which promoted unapproved uses (including management of congestion, cough, the common cold, and the use in children under 2 years of age), which can potentially cause serious health risks.

Indication

For symptomatic relief of seasonal and perennial allergic rhinitis and vasomotor rhinitis, as well as allergic conjunctivitis caused by foods and inhaled allergens. Also for the relief of allergic reactions to blood or plasma, and the symptomatic management of mild, uncomplicated allergic skin manifestations of urticaria and angioedema.

Associated Conditions

Allergic Conjunctivitis (AC)
Allergic Reaction
Allergic Rhinitis (AR)
Anaphylaxis
Angioedema
Urticaria
Vasomotor Rhinitis
Dermatographism

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor

No clinical trials found

No clinical trials found for this drug

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Karbinal ER	Aytu Therapeutics, LLC	23594-101	ORAL	4 mg in 5 mL	1/5/2023
Carbinoxamine Maleate	Biocomp Pharma, Inc.	44523-825	ORAL	4 mg in 1 1	3/6/2024
Carbinoxamine Maleate	Breckenridge Pharmaceutical, Inc.	51991-334	ORAL	4 mg in 5 mL	9/23/2022
Carbinoxamine Maleate	Genus Lifesciences Inc.	64950-211	ORAL	4 mg in 1 1	3/11/2024
RyVent	Carwin Pharmaceutical Associates, LLC	15370-130	ORAL	6 mg in 1 1	1/9/2024
Carbinoxamine Maleate	Foxland Pharmaceuticals, Inc.	69067-240	ORAL	6 mg in 1 1	3/26/2024
Carbinoxamine Maleate	Breckenridge Pharmaceutical, Inc.	51991-333	ORAL	4 mg in 1 1	9/23/2022
Carbinoxamine Maleate	Genus Lifesciences Inc.	64950-243	ORAL	4 mg in 5 mL	3/11/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
BECAME TABLET	Y S P INDUSTRIES (M) SDN BHD	SIN07964P	TABLET	4 mg	12/15/1994

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
BECAME TAB	N/A	PT. YUNG SHIN PHARMACEUTICAL INDONESIA	N/A	N/A	1/8/1991

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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

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