acrivastine/pseudoephedrine (Rx)

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Brand and Other Names:Semprex-D

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

acrivastine/pseudoephedrine

capsule

  • 8mg/60mg
more...

Seasonal Allergic Rhinitis or Nasal Congestion

8 mg/60 mg (1 capsule) PO q4-6h

>14 days continuous treatment efficacy not adequately investigated

Renal Impairment

CrCl>48mL/min: Dose adjustment not necessary

CrCl <48mL/min: Not recommended

Hepatic Impairment

Not studied

Dosage Forms & Strengths

acrivastine/pseudoephedrine

capsule

  • 8mg/60mg
more...

Seasonal Allergic Rhinitis or Nasal Congestion  

<12 years: Safety and efficacy not established

>12 years: 8 mg/60 mg (1 capsule) PO q4-6h

>14 days continuous treatment efficacy not adequately investigated    

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Interactions

Interaction Checker

and acrivastine/pseudoephedrine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Somnolence

            Nervousness

            Insomnia

            Dry mouth

            <1%

            Headache

            Dizziness

            Asthenia

            Nausea

            Dyspepsia

            Pharyngitis

            Cough increase

            Dysmenorrhea

            Postmarketing Reports

            Rare serious hypersensitivity reactions manifested by anaphylaxis, angioedema, bronchospasm, and erythema multiforme

            Pseudoephedrine

            • Tachycardia
            • Palpitations
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            Warnings

            Contraindications

            Hypersensitivity to acrivastine or other alkylamine antihistamines

            Hypersensitivity to pseudoephedrine or other sympathomimetic amines

            Severe hypertension

            Severe coronary artery disease

            Patients taking monoamine oxidase (MAO) inhibitors and for 14 days after stopping use of an MAO inhibitor

            Cautions

            Due to potential for sedation, assess individual responses before engaging in any activity requiring mental alertness, such as driving a motor vehicle or operating machinery

            Concurrent use with alcohol or other CNS depressants may cause additional reductions in alertness and impairment of CNS performance and should be avoided

            Not adequately studied for relieving common cold symptoms  

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            Pregnancy & Lactation

            Pregnancy Category: B

            Lactation: Unknown whether acrivastine is distributed in breast milk, caution advised ; pseudoephedrine is excreted in human milk, caution advised

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Acrivastine exhibits H1-antihistaminic receptor activity, which prevents histamine from binding to its receptor in target cells

            Pseudoephedrine:  Indirect sympathomimetic agent, releases norepinephrine from adrenergic nerves

            Half-Life

            Acrivastine 1.9-3.5 hr; propionic acid metabolite 3.8 hrs

            Pseudoephedrine 5-8 hr

            Absorption

            Rapid and complete

            Vd

            Acrivastine 0.46 L/kg

            Pseudoephedrine 3 L/kg

            Peak Plasma Time

            Acrivastine 1.1 hr

            Pseudoephedrine 1.97 hr

            Peak Plasma Concentration

            Acrivastine 227 ng/ml

            Pseudoephedrine 422 ng/ml

            Protein Bound

            Acrivastine 50%

            Pseudoephedrine minimal

            Metabolism

            Acrivastine 11% to propionic acid metabolite

            Clearance

            Acrivastine 2.9 mL/min/kg

            Pseudoephedrine 5.9 mL/min/kg

            Excretion

            Acrivastine: feces (13%) urine (84%)

            Pseudoephedrine: 55-75% renal (dependent on urine pH)

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • View the formulary and any restrictions for each plan.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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