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 HIGHLIGHTSMedia Articles Related to Semprex-D (Acrivastine / Pseudoephedrine)
Nonallergic Rhinitis Symptoms More Severe Than Allergic Rhinitis
Source: Allergy News From Medical News Today [2009.10.06]
A comparison of symptoms in patients with allergic rhinitis (AR) and non-allergic rhinitis (NAR) revealed that those with the NAR experienced worse symptoms. The findings are according to new research presented at the 2009 American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) Annual Meeting & OTO EXPO, in San Diego, CA.
Patients With Allergic Rhinitis And Obstructive Sleep Apnea Plagued By Stress, Fatigue
Source: Allergy News From Medical News Today [2009.10.06]
Patients who suffer from both allergic rhinitis and obstructive sleep apnea (OSA) may experience escalated symptoms of stress and fatigue. In a paper presented at the 2009 American Academy of Otolaryngology - Head and Neck Surgery Foundation (AAO-HNSF) Annual Meeting & OTO EXPO in San Diego, researchers studied 34 people who were diagnosed with obstructive sleep apnea. Among them, 12 people were classified in the allergic rhinitis group and 22 people in the control group.
Botox Sponge Treats Intrinsic Rhinitis Without Needles
Source: Ear, Nose and Throat News From Medical News Today [2009.10.16]
Injecting botulinum toxin (botox) to treat intrinsic or allergic rhinitis may be a thing of the past as researchers have now shown that sponges soaked in botox are equally effective in treating the condition. The research published in BioMed Central's open access journal Head & Face Medicine offers a potential needle-free treatment to the millions of people who suffer from rhinitis.
STALLERGENES: Immunotherapy Tablet Containing Recombinant Allergen (rBet V 1) Of Birch Pollen: Positive Results For A Phase IIb/III Trial
Source: Allergy News From Medical News Today [2009.09.17]
Stallergenes S.A. has announced the first results of a new phase IIb/III clinical trial (VO59.08) conducted in allergic rhinitis caused by birch pollen and concerning the development of a sublingual immunotherapy tablet containing the recombinant allergen of this pollen, rBet v 1. This study is the first ever to use a recombinant allergen as an active substance. To Stallergenes' knowledge, the use of a recombinant protein in dry form is also a world first. The VO59.
Chlorinated Pools Increase Risk Of Allergic Diseases
Source: Allergy News From Medical News Today [2009.09.15]
Chlorine is effective at killing pathogens in swimming pools, but it also irritates the skin, eyes and upper respiratory tract of swimmers. Recent research has found swimming in outdoor or indoor chlorinated pools can increase asthma risks. The study, "Impact of Chlorinated Swimming Pool Attendance on the Respiratory Health of Adolescents" found that children who swam in chlorinated pools had a higher risk of asthma, as well as other allergic diseases such as hay fever and allergic rhinitis.
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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