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Semprex-D (Acrivastine / Pseudoephedrine Hydrochloride) - Summary

 
 



SEMPREX-D SUMMARY

SEMPREX-D Capsules (acrivastine and pseudoephedrine hydrochloride) are a fixed combination product formulated for oral administration. Acrivastine is an antihistamine and pseudoephedrine is a decongestant.

SEMPREX-D Capsules are indicated for relief of symptoms associated with seasonal allergic rhinitis such as sneezing, rhinorrhea, pruritus, lacrimation, and nasal congestion. SEMPREX-D Capsules should be administered when both the antihistaminic activity of acrivastine and the nasal decongestant activity of pseudoephedrine are desired (see CLINICAL PHARMACOLOGY). The efficacy of SEMPREX-D Capsules beyond 14 days of continuous treatment in patients with seasonal allergic rhinitis has not been adequately investigated in clinical trials.

SEMPREX-D Capsules have not been adequately studied for effectiveness in relieving the symptoms of the common cold.


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NEWS HIGHLIGHTS

Media Articles Related to Semprex-D (Acrivastine / Pseudoephedrine)

ICD-10 Follies: Allergic Rhinitis Due to Pollen
Source: MedPage Today Allergy & Immunology [2014.03.22]
(MedPage Today) -- Yes, there's a code for that. To mark the forthcoming move to the ICD-10 coding system, MedPage Today is spotlighting some of those thousands of new codes that might just be getting a bit too granular.

FDA OKs Sublingual Grastek for Timothy Grass Pollen Allergy
Source: Medscape Allergy & Clinical Immunology Headlines [2014.04.14]
The FDA approved a grass pollen allergen extract for the treatment of Timothy grass pollen-induced allergic rhinitis, with or without conjunctivitis, in individuals aged 5 to 65 years.
FDA Approvals

FDA approves first sublingual allergen extract for the treatment of certain grass pollen allergies
Source: Allergy News From Medical News Today [2014.04.04]
The U.S. Food and Drug Administration recently approved Oralair to treat allergic rhinitis (hay fever) with or without conjunctivitis (eye inflammation) that is induced by certain grass pollens in...

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Published Studies Related to Semprex-D (Acrivastine / Pseudoephedrine)

Efficacy of acrivastine plus pseudoephedrine for symptomatic relief of seasonal allergic rhinitis due to mountain cedar. [1996.05]
BACKGROUND: Acrivastine is a second-generation H1-antagonist chemically related to triprolidine, but more polar and with less central nervous system penetration than triprolidine. OBJECTIVE: The efficacy of the antihistamine-decongestant combination product (Semprex-D capsules) containing acrivastine 8 mg plus pseudoephedrine HCl 60 mg was evaluated for the treatment of seasonal allergic rhinitis symptoms... CONCLUSION: These findings in a large clinical trial demonstrate (1) the efficacy of acrivastine and (2) that each component of the combination of acrivastine 8 mg plus pseudoephedrine HCl 60 mg contributes to the overall efficacy, thereby supporting the conclusion that the combination is rational, safe, and effective for the treatment of allergic rhinitis.

Effects of semprex-D and diphenhydramine on learning in young adults with seasonal allergic rhinitis. [1996.03]
OBJECTIVES: The purpose of this study was to test the hypothesis that learning ability is impaired in patients with seasonal allergic rhinitis relative to untreated individuals and to evaluate a combination compound (acrivastine 8 mg + pseudoephedrine 60 mg) for attenuation of the learning impairment in these patients. BACKGROUND: In a previous study employing the same method it was shown that young children (10 to 12 yrs) suffering from seasonal allergic rhinitis performed significantly worse on tests of learning and using knowledge after acute treatment with a sedating antihistamine (diphenhydramine 50 mg) or placebo as compared with nontreated healthy controls. This effect was partially reversed by treatment with loratadine... CONCLUSION: The study supports our previous finding that allergy symptoms reduce learning ability which is further reduced learning ability which is further reduced by diphenhydramine. Atopic subjects with allergies treated with acrivastine + pseudoephedrine learned as well as normal subjects.

Efficacy of acrivastine with pseudoephedrine in treatment of allergic rhinitis due to ragweed. [1996.02]
BACKGROUND: Semprex-D capsules contain acrivastine 8 mg (a second generation H1-antagonist) plus pseudoephedrine HCl 60 mg and were developed to satisfy the needs of allergy suffers who prefer combination products designed to provide broader symptom relief. Approval of combination products by the US Food and Drug Administration requires demonstration that each component contributes to the overall effectiveness. OBJECTIVE: The objective of the study was to demonstrate that both acrivastine and pseudoephedrine share in the efficacy of the combination in relieving allergy symptoms in patients sensitive to ragweed pollen... CONCLUSIONS: These findings in a large clinical trial demonstrate that each component of the combination of acrivastine 8 mg plus pseudoephedrine HCl 60 mg contributes to the overall efficacy, thereby supporting the conclusion that the combination is rational, safe, and effective for the treatment of allergic rhinitis.

Acrivastine, terfenadine and diphenhydramine effects on driving performance as a function of dose and time after dosing. [1994]
The study was conducted according to a nine-way, observer- and subject-blind, cross-over design. Its purpose was to compare the single-dose effects of the following drugs on driving performance: acrivastine (8, 16 and 24 mg); the combination of acrivastine (8 mg) with pseudoephedrine (60 mg); terfenadine (60, 120 and 180 mg); diphenhydramine-HCl (50 mg); and placebo...

A cross-over comparison of acrivastine, pseudoephedrine and their combination in seasonal allergic rhinitis. [1990.03]
In a four period, double-blind cross-over study, forty patients with moderate to severe symptoms of seasonal allergic rhinitis received in randomised order 8 mg acrivastine, 60 mg pseudoephedrine, 8 mg acrivastine plus 60 mg pseudoephedrine and placebo... There was no significant difference in the number of adverse experiences reported in either of these two groups compared to the number of adverse experiences reported in the placebo group.

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Page last updated: 2014-04-14

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