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Semprex D

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Semprex D

Semprex D

Semprex D Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Semprex-D (acrivastine and pseudoephedrine) is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold. Acrivastine is an antihistamine and pseudoephedrine is a decongestant. Common side effects include drowsiness, dizziness, dry mouth/nose/throat, headache, upset stomach, or trouble sleeping.

The recommended dosage of Semprex-D for adults and adolescents 12 years and older is one capsule taken orally, every 4 to 6 hours, four times a day. Semprex-D may interact with medicines to treat high blood pressure, diuretics (water pills), methyldopa, medication to treat irritable bowel syndrome, bladder or urinary medications, aspirin or salicylates, beta-blockers, or antidepressants. Tell your doctor all medications you use. During pregnancy, Semprex-D should be used only when prescribed. This medication may pass into breast milk and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.

Our Semprex-D (acrivastine and pseudoephedrine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Semprex D in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

  • fast, pounding, or uneven heartbeat;
  • severe dizziness or anxiety;
  • confusion, hallucinations, unusual thoughts or behavior;
  • urinating less than usual or not at all;
  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
  • dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, anxiety, confusion, chest pain, trouble breathing, uneven heart rate, seizure).

Less serious side effects may include:

  • blurred vision;
  • dry mouth;
  • upset stomach, constipation;
  • loss of appetite;
  • dizziness, drowsiness;
  • problems with memory or concentration;
  • warmth, tingling, or redness under your skin;
  • feeling restless or excited (especially in children);
  • sleep problems (insomnia); or
  • skin rash or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Semprex D (Acrivastine and Pseudoephedrine) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Semprex D FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Adverse Experiences

Information on the incidence of adverse events in clinical investigations conducted in the U.S. was obtained from 33 controlled and 15 uncontrolled clinical studies in which 2499 patients received acrivastine and 2631 patients received acrivastine plus pseudoephedrine hydrochloride for treatment periods ranging from one day to one year. The majority of patients in clinical trials were exposed to acrivastine or acrivastine plus pseudoephedrine for less than 90 days. Acrivastine dosage ranged from 3 to 96 mg/day; 1336 patients received dosages equal to or greater than acrivastine 24 mg/day. Acrivastine plus pseudoephedrine hydrochloride dosages ranged from acrivastine 8 to 48 mg/day plus pseudoephedrine hydrochloride 60 to 240 mg/day. A total of 2335 patients received three or four daily doses of acrivastine 8 mg plus pseudoephedrine hydrochloride 60 mg.

In controlled clinical trials, only 12 spontaneously elicited adverse events were reported with frequencies greater than 1% in the acrivastine plus pseudoephedrine hydrochloride treatment group (see table).

TABLE 1: ADVERSE EVENTS REPORTED IN CLINICAL TRIALS* (PERCENT OF PATIENTS REPORTING)†

  Controlled Studies
Placebo
(n= 1767)
Acrivastine
(n= 1935)
Pseudo-ephedrine (n= 887)
Acrivastine plus Pseudo-ephedrine
(n= 1650)
CNS
   Somnolence‡ 6 12 8 12
   Headache 18 19 19 19
   Dizziness 2 3 3 3
   Nervousness‡ 1 2 4 3
   Insomnia‡ 1 1 6 4
MISCELLANEOUS
   Nausea 2 3 3 2
   Dry Mouth‡ 2 3 5 7
   Asthenia 2 3 2 2
   Dyspepsia 1 1 2 2
   Pharyngitis 2 1 1 3
   Cough Increase 1 2 1 2
   Dysmenorrhea 1 2 3 2
*Includes all events regardless of casual relationship to treatment.
†Includes all adverse events with a reported frequency of > 1% for the acrivastine plus pseudoephedrine treatment group.
‡SEMPREX-D (acrivastine and pseudoephedrine) demonstrates a statistically higher frequency of events than placebo, p ≤ 0.05.

The nature and overall frequencies of adverse events from international clinical trials (35 studies involving approximately 1600 patients) were similar to the results obtained in the U.S. studies.

Post-marketing clinical experience reports with acrivastine and acrivastine plus pseudoephedrine have included rare serious hypersensitivity reactions manifested by anaphylaxis, angioedema, bronchospasm, and erythema multiforme. No deaths associated with use of acrivastine or acrivastine plus pseudoephedrine have been reported.

Pseudoephedrine may cause ephedrine-like reactions such as tachycardia, palpitations, headache, dizziness, or nausea (see WARNINGS and OVERDOSAGE).

Read the entire FDA prescribing information for Semprex D (Acrivastine and Pseudoephedrine) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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