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Dexchlorpheniramine (Dexchlorpheniramine Maleate) - Summary

 
 



SUMMARY

DEXCHLORPHENIRAMINE MALEATE ORAL SOLUTION, USP
2 mg/5 mL

Each 5 mL (teaspoonful) contains:

Dexchlorpheniramine Maleate, USP.. .. .. .. .. .. .. . 2 mg
Alcohol. .. .. .. .. .. .. .. .. .. .. .. .. not more than 7.0%

Dexchlorpheniramine Maleate, USP, is an antihistamine agent.

Dexchlorpheniramine (Dexchlorpheniramine Maleate) is indicated for the following:

Perennial and seasonal allergic rhinitis
Vasomotor rhinitis
Allergic conjunctivitis due to inhalant allergens and foods
Mild, uncomplicated allergic skin manifestations of urticaria and angioedema
Amelioration of allergic reactions to blood or plasma
Dermographism

As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.


See all Dexchlorpheniramine indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Dexchlorpheniramine (Dexchlorpheniramine Maleate)

Repeated-dose effects of mequitazine, cetirizine and dexchlorpheniramine on driving and psychomotor performance. [2006.01]
AIMS: Previous studies have demonstrated that the antihistamines mequitazine, cetirizine and dexchlorpheniramine produce mild sedation after single doses. It is unknown, however, whether acute sedation persists after repeated dosing. Therefore, this study assessed the effects of repeated dosing of these antihistamines on driving and psychomotor performance... CONCLUSIONS: Single doses of mequitazine 10 mg and dexchlorpheniramine Repetab 6 mg cause mild driving impairment. However, when taken over several days, the impairing effect wears off, possibly as a result of tolerance.

A dose-ranging study of the effects of mequitazine on actual driving, memory and psychomotor performance as compared to dexchlorpheniramine, cetirizine and placebo. [2004.02]
BACKGROUND: Mequitazine is a so-called 'non-sedative' second-generation antihistamine even though it has never been firmly established that this drug's sedative potential actually differs from that of the 'sedative' first-generation antihistamines. OBJECTIVE: The present study compares the sedative effects of three doses of mequitazine on actual driving, psychomotor performance and memory with those of a first- and a second-generation antihistamine... CONCLUSION: It was concluded that mequitazine is mildly sedating. The effects of mequitazine are comparable to those of other second-generation antihistamines, in that it causes mild driving impairment, particularly at higher doses.

Mequitazine and dexchlorpheniramine in perennial rhinitis. A double-blind cross-over placebo-controlled study. [1990.12]
The therapeutic effect and adverse reactions of two antihistamines, mequitazine and dexchlorpheniramine were double-blindly compared both to placebo, to each other and to the pre-treatment status in 29 adult patients suffering from perennial rhinitis.In controlling perennial rhinitis symptoms mequitazine was markedly inferior to dexchlorpheniramine and only slightly better than placebo.

[Loratadine and dexchlorpheniramine in the treatment of perennial allergic rhinitis in pediatric patients] [1990.05]
The use of loratadine was compared to dexchlorpheniramine in the treatment of children affected by perennial allergic rhinitis in order to assess its clinical efficacy and tolerability. Children were randomly assigned to two groups: 15 were treated with loratadine and 16 with dexchlorpheniramine...

Antihistaminic treatment of allergic rhinitis: a double-blind study with terfenadine versus dexchlorpheniramine. [1987]
A double-blind study was carried out in 65 patients with seasonal rhinitis to compare the effectiveness and tolerance of terfenadine and dexchlorpheniramine. Patients were allocated at random to receive treatment for 1 week with either 60 mg terfenadine twice daily or 2 mg dexchlorpheniramine maleate 3-times daily...

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Clinical Trials Related to Dexchlorpheniramine (Dexchlorpheniramine Maleate)

Comparison Between Dexchlorpheniramine and Dexchlorpheniramine/Pseudoephedrine/Guaifenesin in Respiratory Infections [Not yet recruiting]
Patients with allergic rhinitis frequently present exacerbation of the atopic symptoms during viral infections of the upper respiratory tract. Also, allergic rhinitis makes the mucosa more reactive to infectious agents and potentiates mucus production.

The combination of dexchlorpheniramine, pseudoephedrine and guaifenesin elicits antihistaminic, decongestant and expectorant effects. The study hypothesizes is that this product is superior to dexchlorpheniramine alone in the relief of allergic symptoms and in promoting mucus elimination in atopic patients with viral infections of the upper respiratory tract.

Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Lotion) in the Relief of Sunburn Related Symptoms [Not yet recruiting]
Topical antihistamines can be used to promote relief of sunburn related symptoms (erythema, itch and burning sensations). Dexchlorpheniramine maleate 1% cream is a topical antihistamine formulation approved by ANVISA in Brazil for the relief of skin irritation and pruritus, including the ones caused by sunburn. The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% lotion) with the standard preparation (1% cream) for the relief of sunburn related symptoms and to demonstrate the safety of both preparations.

Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Gel) in the Relief of Sunburn Related Symptoms [Not yet recruiting]
Topical antihistamines can be used to promote relief of sunburn related symptoms (erythema, itch and burning sensations). Dexchlorpheniramine maleate 1% cream is a topical antihistamine formulation approved by ANVISA in Brazil for the relief of skin irritation and pruritus, including the ones caused by sunburn. The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% gel) with the standard preparation (1% cream) for the relief of sunburn related symptoms and to demonstrate the safety of both preparations.

Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Lotion) in the Relief of Insect Bite Related Symptoms [Not yet recruiting]
Insect bite related symptoms (pruritus and papules) are caused by the release of histamine by mast cells in the skin. Topical anti-histaminics can be used to promote relief of these symptoms. Dexchlorpheniramine maleate 1% cream is a topical anti-histaminic formulation approved by ANVISA in Brazil for the relief of skin irritation and allergies, including the ones caused by insect bites. The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% lotion) with the standard preparation (1% cream) for the relief of insect bite related symptoms and to demonstrate the safety of both preparations.

Comparative Study of Two Forms of Topical Dexchlorpheniramine Maleate (Cream Versus Gel) for Insect Bites [Not yet recruiting]
Insect bite related symptoms (pruritus and papules) are caused by the release of histamine by mast cells in the skin. Topical anti-histaminics can be used to promote relief of these symptoms. Dexchlorpheniramine maleate 1% cream is a topical anti-histaminic formulation approved by ANVISA in Brazil for the relief of skin irritation and allergies, including the ones caused by insect bites. The aim of the present study is to demonstrate non-inferiority of a new pharmacological preparation of dexchlorpheniramine maleate (1% gel) with the standard preparation (1% cream) for the relief of insect bite related symptoms and to demonstrate the safety of both preparations.

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Page last updated: 2007-02-12

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