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تعداد آیتم قابل مشاهده باقیمانده : 2 مورد

Desloratadine and pseudoephedrine: Drug information

Desloratadine and pseudoephedrine: Drug information
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For additional information see "Desloratadine and pseudoephedrine: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Clarinex-D 12 Hour
Pharmacologic Category
  • Alpha-/Beta- Agonist;
  • Decongestant;
  • Histamine H1 Antagonist;
  • Histamine H1 Antagonist, Second Generation;
  • Piperidine Derivative
Dosing: Adult
Allergic rhinitis, seasonal

Allergic rhinitis, seasonal: Oral: Desloratadine 2.5 mg/pseudoephedrine 120 mg per tablet: 1 tablet every 12 hours; Maximum: 2 tablets/day.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Use is not recommended.

Dosing: Liver Impairment: Adult

Use is not recommended.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric
Seasonal or allergic rhinitis

Seasonal or allergic rhinitis: Oral: Children ≥12 years of age and Adolescents: Refer to adult dosing.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Use is not recommended.

Dosing: Liver Impairment: Pediatric

Use is not recommended.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. See also individual agents. Percentages as reported with the combination products:

1% to 10%:

Central nervous system: Insomnia (10%), headache (8%), fatigue (4%), dizziness (3%), drowsiness (3%)

Gastrointestinal: Xerostomia (8%), anorexia (2%), nausea (2%)

Respiratory: Pharyngitis (3%)

<1%, postmarketing, and/or case reports: Dyspnea, palpitations, pruritus, skin rash, tachycardia

Contraindications

Hypersensitivity to loratadine, desloratadine, pseudoephedrine, or any component of the formulation; narrow-angle glaucoma; urinary retention; during or within 14 days of MAO inhibitor therapy; severe hypertension or severe coronary artery disease

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Warnings/Precautions

Concerns related to adverse effects:

• CNS stimulation: May occur due to sympathomimetic amine (pseudoephedrine); seizures have been reported.

• Hypersensitivity: Hypersensitivity reactions (including anaphylaxis) have been reported with use of desloratadine; discontinue therapy immediately with signs/symptoms of hypersensitivity.

• Tachycardia: May occur due to sympathomimetic amine (pseudoephedrine); cardiovascular collapse with hypotension may also occur.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with cardiovascular disease. Contraindicated in patients with severe hypertension or severe coronary artery disease.

• Diabetes: Use with caution in patients with diabetes mellitus.

• Hepatic impairment: Avoid use in patients with hepatic impairment.

• Increased intraocular pressure: Use with caution in patients with increased intraocular pressure.

• Prostatic hyperplasia: Use with caution in patients with prostatic hyperplasia.

• Renal impairment: Avoid use in patients with renal impairment.

• Thyroid dysfunction: Use with caution in patients with hyperthyroidism.

Special populations:

• Older adult: Use with caution in elderly patients; may be more sensitive to adverse effects.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet Extended Release 12 Hour, Oral:

Clarinex-D 12 Hour: Desloratadine 2.5 mg and pseudoephedrine sulfate 120 mg [contains corn starch, edetate (edta) disodium, fd&c blue #2 (indigo carm) aluminum lake]

Clarinex-D 12 Hour: Desloratadine 2.5 mg and pseudoephedrine sulfate 120 mg [DSC] [contains fd&c blue #2 (indigo carm) aluminum lake]

Generic Equivalent Available: US

No

Pricing: US

Tablet, 12-hour (Clarinex-D 12 Hour Oral)

2.5-120 mg (per each): $7.27

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Oral:

Administer with or without a meal. Swallow tablets whole; do not break, crush, or chew.

Bariatric surgery: Tablet, extended release: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. Switch to separate components in IR formulations.

Administration: Pediatric

Oral: Administer without regards to meals. Swallow tablets whole; do not break, crush, or chew.

Use: Labeled Indications

Seasonal allergic rhinitis: Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in adults and adolescents 12 years and older

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Alpha1-Blockers: May decrease therapeutic effects of Alpha-/Beta-Agonists. Risk C: Monitor

Amezinium: Antihistamines may increase stimulatory effects of Amezinium. Risk C: Monitor

Atomoxetine: May increase hypertensive effects of Sympathomimetics. Atomoxetine may increase tachycardic effects of Sympathomimetics. Risk C: Monitor

Benzylpenicilloyl Polylysine: Coadministration of Alpha-/Beta-Agonists and Benzylpenicilloyl Polylysine may alter diagnostic results. Management: Consider use of a histamine skin test as a positive control to assess a patient's ability to mount a wheal and flare response. Risk D: Consider Therapy Modification

Benzylpenicilloyl Polylysine: Coadministration of Antihistamines and Benzylpenicilloyl Polylysine may alter diagnostic results. Management: Suspend systemic H1 antagonists for benzylpenicilloyl-polylysine skin testing and delay testing until systemic antihistaminic effects have dissipated. A histamine skin test may be used to assess persistent antihistaminic effects. Risk D: Consider Therapy Modification

Betahistine: Antihistamines may decrease therapeutic effects of Betahistine. Betahistine may decrease therapeutic effects of Antihistamines. Risk C: Monitor

Bornaprine: Sympathomimetics may increase anticholinergic effects of Bornaprine. Risk C: Monitor

Bromocriptine: May increase hypertensive effects of Alpha-/Beta-Agonists. Management: Consider alternatives to this combination when possible. If combined, monitor for hypertension and tachycardia, and do not coadminister these agents for more than 10 days. Risk D: Consider Therapy Modification

Cannabinoid-Containing Products: May increase tachycardic effects of Sympathomimetics. Risk C: Monitor

Certoparin: Antihistamines may increase therapeutic effects of Certoparin. Risk C: Monitor

Chloroprocaine (Systemic): May increase hypertensive effects of Alpha-/Beta-Agonists. Risk C: Monitor

Cocaine (Topical): May increase hypertensive effects of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Risk D: Consider Therapy Modification

CYP2C8 Inhibitors (Moderate): May increase serum concentration of Desloratadine. Risk C: Monitor

CYP2C8 Inhibitors (Strong): May increase serum concentration of Desloratadine. Risk C: Monitor

Dihydralazine: Sympathomimetics may decrease therapeutic effects of Dihydralazine. Risk C: Monitor

Doxofylline: Sympathomimetics may increase adverse/toxic effects of Doxofylline. Risk C: Monitor

Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates): May increase vasoconstricting effects of Alpha-/Beta-Agonists. Risk X: Avoid

Esketamine (Injection): May increase adverse/toxic effects of Sympathomimetics. Specifically, the risk for elevated heart rate, hypertension, and arrhythmias may be increased. Risk C: Monitor

FentaNYL: Decongestants may decrease serum concentration of FentaNYL. Risk C: Monitor

Guanethidine: May increase hypertensive effects of Sympathomimetics. Guanethidine may increase arrhythmogenic effects of Sympathomimetics. Risk C: Monitor

Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of Haloperidol. Risk C: Monitor

Hexoprenaline: May increase adverse/toxic effects of Alpha-/Beta-Agonists. Risk X: Avoid

Hyaluronidase: Antihistamines may decrease therapeutic effects of Hyaluronidase. Risk C: Monitor

Iobenguane Radiopharmaceutical Products: Alpha-/Beta-Agonists (Indirect-Acting) may decrease therapeutic effects of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Risk X: Avoid

Kratom: May increase adverse/toxic effects of Sympathomimetics. Risk X: Avoid

Landiolol: Sympathomimetics may decrease therapeutic effects of Landiolol. Risk C: Monitor

Levothyroxine: May increase therapeutic effects of Sympathomimetics. Sympathomimetics may increase therapeutic effects of Levothyroxine. Levothyroxine may increase adverse/toxic effects of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Risk C: Monitor

Linezolid: May increase hypertensive effects of Sympathomimetics. Management: Consider initial dose reductions of sympathomimetic agents, and closely monitor for enhanced blood pressure elevations, in patients receiving linezolid. Risk D: Consider Therapy Modification

Lisuride: May increase hypertensive effects of Alpha-/Beta-Agonists. Risk X: Avoid

Lumacaftor and Ivacaftor: May decrease serum concentration of CYP2C8 Substrates (High Risk with Inhibitors or Inducers). Lumacaftor and Ivacaftor may increase serum concentration of CYP2C8 Substrates (High Risk with Inhibitors or Inducers). Risk C: Monitor

Metergoline: May increase adverse/toxic effects of Alpha-/Beta-Agonists (Indirect-Acting). Risk C: Monitor

Monoamine Oxidase Inhibitors: May increase hypertensive effects of Alpha-/Beta-Agonists (Indirect-Acting). While linezolid is expected to interact via this mechanism, management recommendations differ from other monoamine oxidase inhibitors. Refer to linezolid specific monographs for details. Risk X: Avoid

Pergolide: May increase hypertensive effects of Alpha-/Beta-Agonists. Risk C: Monitor

Pitolisant: Antihistamines may decrease therapeutic effects of Pitolisant. Risk X: Avoid

QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Reserpine: May decrease therapeutic effects of Alpha-/Beta-Agonists (Indirect-Acting). Risk C: Monitor

Serotonin/Norepinephrine Reuptake Inhibitor: May increase tachycardic effects of Alpha-/Beta-Agonists. Serotonin/Norepinephrine Reuptake Inhibitor may increase vasopressor effects of Alpha-/Beta-Agonists. Management: If possible, avoid coadministration of direct-acting alpha-/beta-agonists and serotonin/norepinephrine reuptake inhibitors. If coadministered, monitor for increased sympathomimetic effects (eg, increased blood pressure, chest pain, headache). Risk D: Consider Therapy Modification

Solriamfetol: Sympathomimetics may increase hypertensive effects of Solriamfetol. Sympathomimetics may increase tachycardic effects of Solriamfetol. Risk C: Monitor

Spironolactone: May decrease vasoconstricting effects of Alpha-/Beta-Agonists. Risk C: Monitor

Sympathomimetics: May increase adverse/toxic effects of Sympathomimetics. Risk C: Monitor

Tedizolid: May increase adverse/toxic effects of Sympathomimetics. Specifically, the risk for increased blood pressure and heart rate may be increased. Risk C: Monitor

Tranylcypromine: May increase hypertensive effects of Alpha-/Beta-Agonists (Indirect-Acting). Risk X: Avoid

Tricyclic Antidepressants: May increase vasopressor effects of Alpha-/Beta-Agonists. Management: Avoid, if possible, the use of alpha-/beta-agonists in patients receiving tricyclic antidepressants. If combined, monitor for evidence of increased pressor effects and consider reductions in initial dosages of the alpha-/beta-agonist. Risk D: Consider Therapy Modification

Pregnancy Considerations

See individual agents.

Breastfeeding Considerations

Desloratadine and pseudoephedrine are present in breast milk.

Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends a decision be made whether to discontinue breastfeeding or the drug, taking into account the importance of treatment to the mother. See individual agents.

Mechanism of Action

Desloratadine, a major active metabolite of loratadine, is a long-acting tricyclic antihistamine with selective peripheral histamine H1 receptor antagonistic activity.

Pseudoephedrine directly stimulates alpha-adrenergic receptors of respiratory mucosa causing vasoconstriction; directly stimulates beta-adrenergic receptors causing bronchial relaxation, increased heart rate and contractility.

Pharmacokinetics (Adult Data Unless Noted)

Onset: Antihistaminic activity: 1 hour

Time to peak, plasma: Desloratadine: 4-7 hours; Pseudoephedrine: 6-9 hours

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Lorinase D;
  • (AR) Argentina: Aerius D;
  • (BD) Bangladesh: D-Plus | Deslor plus | Deslorin plus | Sarinex d;
  • (BR) Brazil: Aviant efe | Desalex d12 | Esalerg d12;
  • (CL) Chile: Rinofilax D;
  • (DO) Dominican Republic: Lorax D;
  • (EC) Ecuador: Aviant D;
  • (JO) Jordan: Rina d;
  • (LB) Lebanon: Oradus p;
  • (PE) Peru: Aerius D 12 | Aviant D12;
  • (PL) Poland: Aerinase;
  • (PR) Puerto Rico: Clarinex-d 24-hour;
  • (PY) Paraguay: Lomed d | Supraler d;
  • (QA) Qatar: Aerinaze;
  • (SA) Saudi Arabia: Lorinase D;
  • (TR) Turkey: Aerius D-12;
  • (VE) Venezuela, Bolivarian Republic of: Desalex d;
  • (VN) Viet Nam: Kallitis
  1. Clarinex-D 12 Hour (desloratadine and pseudoephedrine) [prescribing information]. Jersey City, NJ: Organon LLC; June 2021.
  2. Clarinex-D 12 Hour (desloratadine and pseudoephedrine) [product monograph]. Whitby, Ontario, Canada: Patheon Inc; March 2014.
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