Acrivastine and pseudoephedrine

Name: Acrivastine and pseudoephedrine

What is the most important information I should know about acrivastine and pseudoephedrine?

You should not use this medicine if you have severe or uncontrolled high blood pressure or coronary artery disease (hardened arteries).

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.

How should I take acrivastine and pseudoephedrine?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

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 acrivastine and pseudoephedrine in the past few days.

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

What do I need to tell my doctor BEFORE I take Acrivastine and Pseudoephedrine?

  • If you have an allergy to acrivastine, pseudoephedrine, or any other part of acrivastine and pseudoephedrine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Heart disease or high blood pressure.
  • If you have kidney disease.
  • If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this medicine within 14 days of those drugs can cause very bad high blood pressure.

This is not a list of all drugs or health problems that interact with acrivastine and pseudoephedrine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How do I store and/or throw out Acrivastine and Pseudoephedrine?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Contraindications

Hypersensitivity to pseudoephedrine, acrivastine, other alkylamine antihistamines such as chlorpheniramine, or any component of the formulation; use with or within 14 days of MAO inhibitors; severe hypertension, severe coronary artery disease

Dosing Geriatric

Refer to adult dosing.

Dosing Hepatic Impairment

There are no dosage adjustments recommended in manufacturer's labeling.

Overdose

There have been no reports of overdosage with Semprex-D (acrivastine and pseudoephedrine) Capsules. In the clinical trial program and in international post-marketing experience, there have been two reported overdoses with acrivastine. Doses were 72 mg and 322 mg. Both patients recovered without sequelae. Adverse events included trembling, stridor, loss of consciousness and possible convulsions in the first patient and somnolence in the second.

Since acrivastine and pseudoephedrine have pharmacologically different actions, it is difficult to predict how an individual will respond to overdosage with SEMPREX-D (acrivastine and pseudoephedrine) Capsules. However, acute overdosage with SEMPREX-D (acrivastine and pseudoephedrine) Capsules may produce clinical signs of either CNS stimulation or depression. Overdosage of sympathomimetics has been associated with the following events: fear, anxiety, tenseness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS depression, arrhythmias, and cardiovascular collapse with hypotension. Treatment for overdosage with SEMPREX-D (acrivastine and pseudoephedrine) Capsules should follow general symptomatic and supportive principles.

In a placebo-controlled, double-blind clinical trial in 18 healthy male subjects, single doses of acrivastine up to 400 mg (50 times the recommended antihistaminic dose) produced only a weak vagolytic effect, manifested as an increase in heart rate, and did not cause cardiac repolarization delays (i.e., increased QTc). Daily doses of acrivastine up to 2400 mg (75 times the recommended antihistamine dose) in an uncontrolled study in 38 cancer patients produced a 15-beats-per-minute increase in mean heart rate and occasional episodes of nausea and vomiting. The effects of acrivastine plus pseudoephedrine at single or multiple doses higher than the recommended daily dose of SEMPREX-D (acrivastine and pseudoephedrine) Capsules (i.e., 32 mg acrivastine plus 240 mg pseudoephedrine) on heart rate and cardiac repolarization have not been investigated in clinical trials.

The mean LD50 (single, oral dose) of acrivastine is greater than 4000 mg/kg (23600 mg/m² or 1000 times the recommended human daily dose) in rats and greater than 1200 mg/kg (3600 mg/m² or 153 times the recommended human daily dose) in mice. The mean LD50 (single, oral dose) of pseudoephedrine hydrochloride is 2206 mg/kg (13015 mg/m² or 73 times the recommended human daily dose) in rats and 726 mg/kg (2178 mg/m² or 12 times the recommended human daily dose) in mice. The toxic and lethal concentrations of acrivastine and pseudoephedrine in human biologic fluids are not known. Based upon pharmacokinetic screening data from clinical trials, the maximum plasma acrivastine concentration after dosing with acrivastine 8 mg was 393 ng/mL and the maximum plasma pseudoephedrine concentration after dosing with pseudoephedrine hydrochloride 60 mg was 1308 ng/mL.

For the Consumer

Applies to acrivastine / pseudoephedrine: oral capsule

Along with its needed effects, acrivastine / pseudoephedrine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Get emergency help immediately if any of the following symptoms of overdose occur while taking acrivastine / pseudoephedrine:

Symptoms of overdose
  • Blurred vision
  • chest pain or discomfort
  • cold, clammy, or pale skin
  • confusion
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • irregular heartbeats
  • seizures
  • shortness of breath
  • slow heart rate
  • sweating
  • unusual tiredness or weakness

Some side effects of acrivastine / pseudoephedrine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Dry mouth
  • headache
  • sleepiness or unusual drowsiness
Less common
  • Acid or sour stomach
  • belching
  • body aches or pain
  • congestion
  • cough
  • dryness or soreness of the throat
  • fever
  • heartburn
  • hoarseness
  • indigestion
  • lack or loss of strength
  • nausea
  • nervousness
  • runny nose
  • stomach discomfort, upset, or pain
  • tender, swollen glands in the neck
  • trouble sleeping
  • trouble swallowing
  • voice changes

Usual Pediatric Dose for Allergic Rhinitis

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

Renal Dose Adjustments

Not recommended because acrivastine and pseudoephedrine are both eliminated by the kidneys.

Liver Dose Adjustments

Data not available

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