Acrivastine and pseudoephedrine

Generic name: acrivastine and pseudoephedrine [ a-KRIV-a-steen-and-SOO-doe-ee-FED-rin ]
Brand name: Semprex-D
Dosage form: oral capsule (8 mg-60 mg)
Drug class: Upper respiratory combinations

What is acrivastine and pseudoephedrine?

Acrivastine and pseudoephedrine is a combination medicine used to treat runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies.

Acrivastine and pseudoephedrine may also be used for purposes not listed in this medication guide.

Warnings

You should not use acrivastine and pseudoephedrine if you have severe or uncontrolled high blood pressure or coronary artery disease.

Do not use acrivastine and pseudoephedrine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Before taking this medicine

You should not use this medicine if you are allergic to acrivastine or pseudoephedrine, or if:

• you have severe or uncontrolled high blood pressure;

• you have severe coronary artery disease (hardened arteries);

• you are allergic to other antihistamines such as triprolidine; or

• you are allergic to other decongestants such as phenylephrine or phenylpropanolamine.

Do not use acrivastine and pseudoephedrine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Tell your doctor if you have ever had:

• heart disease or high blood pressure;

• diabetes;

• glaucoma;

• an ulcer or obstruction in the stomach;

• a thyroid disorder;

• an enlarged prostate; or

• kidney disease.

Tell your doctor if you are pregnant or breast-feeding.

Acrivastine and pseudoephedrine is not approved for use by anyone younger than 12 years old.

How should I take acrivastine and pseudoephedrine?

Use exactly as directed on the label, or as prescribed by your doctor. Allergy medicine is only for short-term use until your symptoms clear up.

Always follow directions on the medicine label about giving acrivastine and pseudoephedrine to a child. Do not use the medicine only to make a child sleepy. Death can occur from the misuse of cold or allergy medicines in very young children.

Do not take acrivastine and pseudoephedrine for longer than 7 days in a row.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need surgery, tell the surgeon ahead of time if you have taken this medicine in the past few days.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Since acrivastine and pseudoephedrine is used when needed, you may not be on a dosing schedule. Skip any missed dose if it's almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe dizziness or drowsiness, anxiety, restlessness, tremors, hallucinations, fainting, slowed breathing, irregular heart rhythm, or seizure (convulsions).

What should I avoid while taking acrivastine and pseudoephedrine?

Avoid driving or hazardous activity until you know how acrivastine and pseudoephedrine will affect you. Your reactions could be impaired.

Drinking alcohol with this medicine can increase certain side effects.

Ask a doctor or pharmacist before using other cold or allergy medicines that may contain similar ingredients.

Acrivastine and pseudoephedrine side effects

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

Acrivastine and pseudoephedrine may cause serious side effects. 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 of acrivastine and pseudoephedrine 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.

Acrivastine and pseudoephedrine dosing information

Usual Adult Dose for Allergic Rhinitis:

1 capsule orally every 4 to 6 hours
Maximum dosing frequency: 4 times a day

Comments:
-Use when both antihistaminic activity and nasal decongestant activity are desired.
-Efficacy beyond 14 days of continuous treatment has not been studied.

Use(s): Relief of symptoms associated with seasonal allergic rhinitis such as sneezing, rhinorrhea, pruritus, lacrimation, and nasal congestion

Usual Adult Dose for Nasal Congestion:

1 capsule orally every 4 to 6 hours
Maximum dosing frequency: 4 times a day

Comments:
-Use when both antihistaminic activity and nasal decongestant activity are desired.
-Efficacy beyond 14 days of continuous treatment has not been studied.

Use(s): Relief of symptoms associated with seasonal allergic rhinitis such as sneezing, rhinorrhea, pruritus, lacrimation, and nasal congestion

Usual Pediatric Dose for Allergic Rhinitis:

12 years and older:
1 capsule orally every 4 to 6 hours
Maximum dosing frequency: 4 times a day

Comments:
-Use when both antihistaminic activity and nasal decongestant activity are desired.
-Efficacy beyond 14 days of continuous treatment has not been studied.

Use(s): Relief of symptoms associated with seasonal allergic rhinitis such as sneezing, rhinorrhea, pruritus, lacrimation, and nasal congestion

Usual Pediatric Dose for Nasal Congestion:

12 years and older:
1 capsule orally every 4 to 6 hours
Maximum dosing frequency: 4 times a day

Comments:
-Use when both antihistaminic activity and nasal decongestant activity are desired.
-Efficacy beyond 14 days of continuous treatment has not been studied.

Use(s): Relief of symptoms associated with seasonal allergic rhinitis such as sneezing, rhinorrhea, pruritus, lacrimation, and nasal congestion

What other drugs will affect acrivastine and pseudoephedrine?

Using acrivastine and pseudoephedrine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may affect acrivastine and pseudoephedrine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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