Acrivastine and pseudoephedrine

Name: Acrivastine and pseudoephedrine

What should I discuss with my healthcare provider before taking acrivastine and pseudoephedrine?

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.

To make sure acrivastine and pseudoephedrine is safe for you, tell your doctor if you have:

  • heart disease or high blood pressure;

  • diabetes;

  • glaucoma;

  • an ulcer or obstruction in the stomach;

  • a thyroid disorder;

  • an enlarged prostate; or

  • kidney disease.

It is not known whether acrivastine and pseudoephedrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether acrivastine and pseudoephedrine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Acrivastine and pseudoephedrine is not approved for use by anyone younger than 12 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

What happens if I miss a dose?

Since cold or allergy medicine is taken as needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Acrivastine and pseudoephedrine dosing information

Usual Adult Dose for Allergic Rhinitis:

1 capsule (8 mg-60 mg) orally 4 times a day.

Usual Adult Dose for Nasal Congestion:

1 capsule (8 mg-60 mg) orally 4 times a day.

Usual Pediatric Dose for Allergic Rhinitis:

12 years and older:
1 capsule (8 mg-60 mg) orally 4 times a day.

Usual Pediatric Dose for Nasal Congestion:

12 years and older:
1 capsule (8 mg-60 mg) orally 4 times a day.

Proper Use of acrivastine and pseudoephedrine

Use acrivastine and pseudoephedrine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.

Swallow the capsule whole. Do not crush, break, or chew it. You may take acrivastine and pseudoephedrine with or without food.

Dosing

The dose of acrivastine and pseudoephedrine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of acrivastine and pseudoephedrine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules):
    • For treatment of seasonal allergic rhinitis:
      • Adults and children 12 years of age and older—One capsule four times a day (taken every 4 to 6 hours per day).
      • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of acrivastine and pseudoephedrine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Uses of Acrivastine and Pseudoephedrine

  • It is used to treat nose stuffiness.
  • It is used to ease allergy signs.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Use Labeled Indications

Relief of symptoms associated with seasonal allergic rhinitis

Dosing Adult

Seasonal allergic rhinitis: Oral: Acrivastine 8 mg/pseudoephedrine 60 mg: One capsule every 4 to 6 hours (maximum: 4 doses/24 hours)

How supplied

SEMPREX-D (acrivastine and pseudoephedrine) Capsules (dark green opaque cap and white opaque body with a yellow band) contain acrivastine 8 mg and pseudoephedrine hydrochloride 60 mg. The cap is printed with “404” in white ink, and the body is printed with “SEMPREX-D (acrivastine and pseudoephedrine) ” in black ink.

NDC 53014-404-10 Bottle of 100's

Storage

Store at 15° to 25° C (59° to 77° F) in a dry place and protected from light.

Keep out of the reach of children.

For Medical Information, Contact: Medical Affairs Department, Phone: (866) 822-0068, Fax: (770) 970-8859. Marketed by: UCB, Inc., Smyrna, GA 30080. Manufactured by: DSM Pharmaceuticals, Inc., Greenville, NC 27834 USA. Rev. 07/2007.

Usual Adult Dose for Nasal Congestion

1 capsule (8 mg-60 mg) orally 4 times a day.

(web3)