Semprex D
- Generic Name: acrivastine and pseudoephedrine
- Brand Name: Semprex D
Semprex D(Acrivastine and Pseudoephedrine) side effects drug center
Semprex D Side Effects Center
Semprex-D (acrivastine and pseudoephedrine) is a combination of an antihistamine and a decongestant 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. Common side effects of Semprex-D include:
- drowsiness
- dizziness
- dry mouth/nose/throat
- headache
- upset stomach
- trouble sleeping (insomnia)
- blurred vision
- constipation
- loss of appetite
- problems with memory or concentration
- flushing (warmth, tingling, or redness under your skin)
- restlessness or excitability (especially in children)
- skin rash or itching
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 breastfeeding.
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.
Semprex D Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- fever and skin redness with small pus-filled bumps;
- fast heart rate; or
- pounding heartbeats or fluttering in your chest.
Side effects such as dizziness, drowsiness, and urination problems may be more likely in older adults.
Common side effects may include:
- dizziness, drowsiness;
- dry mouth;
- sinus pain;
- nausea; or
- headache.
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)
Semprex D Professional Information
SIDE EFFECTS
Adverse Experiences
Information on the incidence of adverse events in clinical investigations conducted in the United States 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) |
Pseudoephedrine (N = 887) |
Acrivastine plus Pseudoephedrine (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 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 US 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).
Serious skin reactions, including acute generalized exanthematous pustulosis (AGEP), have been reported with pseudoephedrine-containing products.
Read the entire FDA prescribing information for Semprex D (Acrivastine and Pseudoephedrine)
&Copy; Semprex D Patient Information is supplied by Cerner Multum, Inc. and Semprex D Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.