Semprex D

DRUG DESCRIPTION

SEMPREX-D Capsules (acrivastine and pseudoephedrine hydrochloride) are a fixed combination product formulated for oral administration. Acrivastine is an antihistamine and pseudoephedrine is a decongestant. Each capsule contains 8 mg acrivastine and 60 mg pseudoephedrine hydrochloride and the inactive ingredients: lactose, magnesium stearate and sodium starch glycolate. The green and white capsule shell consists of gelatin, D&C Yellow No. 10, FD&C Green No. 3, and titanium dioxide. The yellow band around the capsule consists of gelatin and D&C Yellow No. 10. The capsules may contain one or more parabens and are printed with edible black and white inks.

The chemical name of acrivastine is (E,E)-3-[6-[1-(4-methylphenyl)-3-(1-pyrrolidinyl)-1-propenyl]-2-pyridinyl]-2-propenoic acid; the molecular formula is C22H24N2O2. As an analog of triprolidine hydrochloride, acrivastine is classified as an alkylamine antihistamine. Acrivastine is an odorless, white to pale cream crystalline powder that is soluble in chloroform and alcohol and slightly soluble in water.

The chemical name of pseudoephedrine hydrochloride is [S-(R*,R*)]-?-[1-(methylamino)ethyl]benzenemethanol hydrochloride; the molecular formula is C10H15NO•HCl. Pseudoephedrine is one of the naturally occurring dextrorotatory diastereoisomers of ephedrine and is classified as an indirect sympathomimetic amine. Pseudoephedrine hydrochloride occurs as odorless, fine white to off-white crystals or powder; the drug is soluble in water, alcohol and chloroform.

Structural formulae for the active ingredients of SEMPREX-D (acrivastine and pseudoephedrine) Capsules are as follows:

Acrivastine Structural Formula Illustration

(a) Acrivastine (Molecular Weight = 348.44)


(b) Pseudo ephedrine hydrochloride (Molecular Weight = 201.70)

What are the possible side effects of acrivastine and pseudoephedrine (Semprex-D)?

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 medication and call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeat;
  • confusion, hallucinations, unusual thoughts or behavior;
  • severe dizziness, anxiety, restless feeling, or nervousness;
  • increased blood pressure (severe headache, blurred...

Read All Potential Side Effects and See Pictures of Semprex D »

What are the precautions when taking acrivastine and pseudoephedrine (Semprex D)?

Before taking this product, tell your doctor or pharmacist if you are allergic to any of its ingredients; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, emphysema), diabetes, glaucoma, heart problems, high blood pressure, kidney problems, liver disease, seizures, stomach/intestinal problems (such as ulcers, blockage), overactive thyroid (hyperthyroidism), difficulty urinating (such as due to enlarged prostate).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires...

Read All Potential Precautions of Semprex D »


Semprex D Consumer (continued)

SIDE EFFECTS: Drowsiness, dizziness, dry mouth/nose/throat, headache, upset stomach, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has directed you to use this product, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using the product do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as confusion, hallucinations), ringing in the ears, difficulty urinating, vision changes (such as blurred/double vision).

Seek immediate medical attention if any of these rare but very serious side effects occur: fast/irregular heartbeat, seizure.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to any of its ingredients; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, emphysema), diabetes, glaucoma, heart problems, high blood pressure, kidney problems, liver disease, seizures, stomach/intestinal problems (such as ulcers, blockage), overactive thyroid (hyperthyroidism), difficulty urinating (such as due to enlarged prostate).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Liquid products, chewable tablets, or dissolving tablets/strips may contain sugar or aspartame. Liquid products may also contain alcohol. Caution is advised if you have diabetes, alcohol dependence, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be more sensitive to the side effects of this product, especially excitation and agitation.

Older adults may be more sensitive to the side effects of this product, especially dizziness, drowsiness, or urination problems.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication may pass into breast milk and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.


Semprex D Patient Information Including Side Effects

Brand Names: Semprex-D

Generic Name: acrivastine and pseudoephedrine (Pronunciation: a KRIV as teen and soo doe e FED rin)

  • What is acrivastine and pseudoephedrine (Semprex D)?
  • What are the possible side effects of acrivastine and pseudoephedrine (Semprex D)?
  • What is the most important information I should know about acrivastine and pseudoephedrine (Semprex D)?
  • What should I discuss with my healthcare provider before taking acrivastine and pseudoephedrine (Semprex D)?
  • How should I take acrivastine and pseudoephedrine (Semprex D)?
  • What happens if I miss a dose (Semprex D)?
  • What happens if I overdose (Semprex D)?
  • What should I avoid while taking acrivastine and pseudoephedrine (Semprex D)?
  • What other drugs will affect acrivastine and pseudoephedrine (Semprex D)?
  • Where can I get more information?

What is acrivastine and pseudoephedrine (Semprex D)?

Acrivastine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of 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 and pseudoephedrine may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of acrivastine and pseudoephedrine (Semprex D)?

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 medication and call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeat;
  • confusion, hallucinations, unusual thoughts or behavior;
  • severe dizziness, anxiety, restless feeling, or nervousness;
  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
  • urinating less than usual or not at all.

Keep taking the medication and talk to your doctor if you have any of these less serious side effects:

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

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about acrivastine and pseudoephedrine (Semprex D)?

Always ask a doctor before giving a cold or allergy medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant.

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Acrivastine and pseudoephedrine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It can increase some of the side effects of this medication.

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