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Loratadine and pseudoephedrine: Drug information

Loratadine and pseudoephedrine: Drug information
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For additional information see "Loratadine and pseudoephedrine: Patient drug information" and "Loratadine and pseudoephedrine: Pediatric drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Alavert Allergy and Sinus [OTC] [DSC];
  • Alavert D-12 Hour Allergy and Congestion [OTC];
  • Allergy Relief-D [OTC];
  • Claritin-D 12 Hour Allergy & Congestion [OTC];
  • Claritin-D 24 Hour Allergy & Congestion [OTC];
  • Loratadine-D 12 Hour [OTC];
  • Loratadine-D 24 Hour [OTC]
Brand Names: Canada
  • Chlor-Tripolon ND;
  • Claritin Extra;
  • Claritin Liberator
Pharmacologic Category
  • Alpha-/Beta- Agonist;
  • Decongestant;
  • Histamine H1 Antagonist;
  • Histamine H1 Antagonist, Second Generation;
  • Piperidine Derivative
Dosing: Adult
Cold and allergy symptoms

Cold and allergy symptoms: Oral:

Loratadine 5 mg/pseudoephedrine 120 mg per tablet: One tablet every 12 hours (maximum: 2 tablets/day)

Loratadine 10 mg/pseudoephedrine 240 mg per tablet: One tablet daily (maximum: 1 tablet/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

Altered kidney function:

CrCl ≥30 mL/minute: No dosage adjustment necessary (Ref).

CrCl <30 mL/minute:

Loratadine 5 mg/pseudoephedrine 120 mg per tablet: One tablet every 24 hours (Ref).

Loratadine 10 mg/pseudoephedrine 240 mg per tablet: One tablet every other day (Ref).

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in manufacturer's labeling; however, hepatic impairment increases loratadine systemic exposure; use with caution and dosage adjustment should be considered. Previous FDA approved labeling recommended to avoid use in patients with hepatic impairment (Ref).

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Loratadine and pseudoephedrine: Pediatric drug information")

Allergic rhinitis, seasonal/nasal decongestion

Allergic rhinitis, seasonal/nasal decongestion: Children ≥12 years and Adolescents:

12-hour formulation (loratadine 5 mg and pseudoephedrine 120 mg/tablet): Oral: 1 tablet every 12 hours.

24-hour formulation (loratadine 10 mg and pseudoephedrine 240 mg/tablet): Oral: 1 tablet once daily.

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

Altered kidney function (Ref):

Children ≥12 years and Adolescents:

CrCl ≥30 mL/minute: No adjustment necessary.

CrCl <30 mL/minute:

12-hour formulation: 1 tablet every 24 hours.

24-hour formulation: 1 tablet every other day.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling; however, hepatic impairment increases loratadine systemic exposure; use with caution and dosage adjustment should be considered. Previous FDA approved labeling recommended to avoid use in patients with hepatic impairment (Ref).

Adverse Reactions

See individual agents.

Contraindications

OTC labeling: When used for self-medication, do not use if you are sensitive to loratadine, pseudoephedrine, or any component of the formulation; during or within 14 days of monoamine oxidase inhibitor therapy; severe hypertension or coronary heart disease.

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

Warnings/Precautions

Other warnings/precautions:

• Self-medication (OTC use): When used for self-medication (OTC), notify health care provider prior to use if you have diabetes, difficulty urinating due to an enlarged prostate, heart disease, hypertension, kidney disease, liver disease, or thyroid disease. Do not exceed the recommended doses; discontinue use and contact health care provider if symptoms do not improve within 7 days or are accompanied by fever; if nervousness, dizziness, or sleeplessness occur; or if an allergic reaction to the formulation occurs.

Warnings: Additional Pediatric Considerations

Safety and efficacy for the use of cough and cold products in pediatric patients <4 years of age is limited; the AAP warns against the use of these products for respiratory illnesses in young children. Serious adverse effects including death have been reported (in some cases, high blood concentrations of pseudoephedrine were found). Many of these products contain multiple active ingredients, increasing the risk of accidental overdose when used with other products. The FDA does not recommend OTC uses for these products in pediatric patients <2 years of age and recommends to use with caution in pediatric patients ≥2 years of age. Health care providers are reminded to ask caregivers about the use of OTC cough and cold products in order to avoid exposure to multiple medications containing the same ingredient (AAP 2018; CDC 2007; FDA 2017; FDA 2018).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, extended release:

Alavert Allergy and Sinus: Loratadine 5 mg and pseudoephedrine sulfate 120 mg [DSC]

Alavert D-12 Hour Allergy and Congestion: Loratadine 5 mg and pseudoephedrine sulfate 120 mg

Allergy Relief-D: Loratadine 10 mg and pseudoephedrine sulfate 240 mg

Claritin-D 12 Hour Allergy & Congestion: Loratadine 5 mg and pseudoephedrine sulfate 120 mg [contains calcium 30 mg/tablet]

Claritin-D 24 Hour Allergy & Congestion: Loratadine 10 mg and pseudoephedrine sulfate 240 mg [contains calcium 25 mg/tablet]

Loratadine-D 12 Hour: Loratadine 5 mg and pseudoephedrine sulfate 120 mg

Loratadine-D 24 Hour: Loratadine 10 mg and pseudoephedrine sulfate 240 mg

Generic: Loratadine 5 mg and pseudoephedrine sulfate 120 mg; Loratadine 10 mg and pseudoephedrine sulfate 240 mg

Generic Equivalent Available: US

Yes

Pricing: US

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

5-120 mg (per each): $1.23

Tablet, 24-hour (Claritin-D 24 Hour Oral)

10-240 mg (per each): $1.62

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: Do not divide, chew, crush, or dissolve tablets.

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

Administration: Pediatric

Oral: Administer without regard to meals. Swallow extended-release tablets whole; do not chew or crush; administer with a full glass of water.

Use: Labeled Indications

Cold, allergy symptoms: Temporary relief of sinus and nasal congestion, runny nose, sneezing, itching of nose or throat and itchy, watery eyes due to common cold, hay fever (allergic rhinitis), or other upper respiratory allergies or sinusitis

Medication Safety Issues
Sound-alike/look-alike issues:

Claritin-D may be confused with Claritin-D 24

Claritin-D 24 may be confused with Claritin-D

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

Amiodarone: May increase serum concentration of Loratadine. Management: Due to reported QT interval prolongation and Torsades de Pointes with this combination, consider an alternative to loratadine when possible. If concomitant use cannot be avoided, monitor QT interval and for signs of dyshythmias (eg, syncope). Risk D: Consider Therapy Modification

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

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

Ketoconazole (Systemic): May increase serum concentration of Loratadine. Risk C: Monitor

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

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

Food Interactions

See individual agents.

Pregnancy Considerations

Refer to individual monographs.

Breastfeeding Considerations

Refer to individual monographs.

Pharmacokinetics (Adult Data Unless Noted)

See individual agents.

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

  • (AE) United Arab Emirates: Lohist extra | Lorinase;
  • (AR) Argentina: Alerpriv d | Aseptobron descongestivo | Bedix d | Benadryl 24 D | Ciprocort d | Clarityne d | Lertamine d | Loisan d | Loratadina plus northia | Loremex Descongestivo | Nastizol-l | Nastizol-l-24 | Nularef-d | Vagran d;
  • (AU) Australia: Claratyne d with decongestant | Clarinase | Sinease;
  • (BD) Bangladesh: Decontin | Oradin Plus | Pretin D | Sudolor;
  • (BE) Belgium: Clarinase | Prospel;
  • (BG) Bulgaria: Clarinase;
  • (BR) Brazil: Alergaliv d | Claritin d | Claritin-d | Cloratadd d | Histadin D | Histamix d | Loradine d | Loradrina d | Loralerg d | Loranil D | Loratadina + pseudoefedrina | Loratadina + sulfato de pseudoefedrina | Loratadina sulfato de pseudoefedrina | Loratamed d | Loremix d | Loritil D;
  • (CL) Chile: Alledryl d | Clarinase | Frenaler-D | Larmax-D | Lertamine | Primorix D | Rinomex;
  • (CN) China: Bai wei qing | Clarinase | Loratadine and Pseudoephedrine Sulfate | Qi ke;
  • (CO) Colombia: Airet | Alatrin d | Alatrin d plus | Cladine d | Clarityne d | Clarityne d 24 horas | Cortaler d | Ditol | Efectine d | Loracert p | Loramine r | Valket D;
  • (CZ) Czech Republic: Clarinase;
  • (DO) Dominican Republic: Antial D | Clarinase | Clarityne d | Desolin D | Sinhistan-D | Zoman-D;
  • (EC) Ecuador: Alergin Plus | Claridex | Clarinase 24 Horas | Clarityne d | Larotin D | Lorexin D | Tricel D | Vilamax d;
  • (EE) Estonia: Clarinase;
  • (EG) Egypt: Clarinase;
  • (ES) Spain: Clarityne Plus | Narine;
  • (ET) Ethiopia: Lorinase;
  • (FI) Finland: Clarinase;
  • (GR) Greece: Clarityne d;
  • (HK) Hong Kong: Clarinase;
  • (HU) Hungary: Clarinase;
  • (ID) Indonesia: Clarinase | Cronase;
  • (IN) India: Claridin-d | Loran-d | Loratin-d | Loridin-d | Lormeg-d;
  • (KE) Kenya: Clarinase | Loratin d;
  • (KR) Korea, Republic of: Clarinase;
  • (KW) Kuwait: Lorinase;
  • (LB) Lebanon: Lorinase;
  • (LU) Luxembourg: Clarinase;
  • (LV) Latvia: Clarinase | Clarinase qd 24h;
  • (MX) Mexico: Biolodrin | Efectine d | Lovarin-p | Sensibit d | Thera flu 24 | Thera flu n12 | Thera flu n24;
  • (MY) Malaysia: Clarinase | Zoratadine P;
  • (NZ) New Zealand: Claratyne cold | Claratyne deconges;
  • (PE) Peru: Airet | Alergical lp | Alertadin d lch | Clarityne d | Disofrin NF | Nasaler plus | Rinomex;
  • (PH) Philippines: Clarinase | Rhinase;
  • (PK) Pakistan: Clarinase | Rhilor-D | Softin p;
  • (PL) Poland: Clarinase | Claritine active | Claritine Duo;
  • (PR) Puerto Rico: Allergy nasal decongestant | Allergy relief D 12 hour | Claritin-d | Loratadine D;
  • (PT) Portugal: Claridon | Claridon qd;
  • (PY) Paraguay: Alercrom d | Antialerg | Paralergim d | Rinomex;
  • (QA) Qatar: Clarinase Repetab | Lohist-Extra | Lorinase | Lorinase Syrup;
  • (RO) Romania: Clarinase;
  • (RU) Russian Federation: Clarinasa | Clarinase;
  • (SA) Saudi Arabia: Clarinase | Defonase | Fedlora | Lora s | Lorinase;
  • (SG) Singapore: Clarinase | De-Cold S.R.F.C;
  • (SI) Slovenia: Clarinase;
  • (TH) Thailand: Clarinase;
  • (TR) Turkey: Clarinase;
  • (TW) Taiwan: Clarinase | Finska LP | Lorapseudo | Minlife-P;
  • (UG) Uganda: Clarinase;
  • (UY) Uruguay: Loremex;
  • (VE) Venezuela, Bolivarian Republic of: Claridex | Fedyclar | Lokarin | Loracert | Rinaris;
  • (VN) Viet Nam: Clomistal | Papiseus;
  • (ZA) South Africa: Clarityne d | Loratyne d | Polaratyne d
  1. Alavert D-12 (loratadine and pseudoephedrine) [prescribing information]. Pfizer, Inc.
  2. American Academy of Pediatrics (AAP). Cough and cold medicines should not be prescribed, recommended or used for respiratory illnesses in young children. Updated June 12, 2018. Available at http://www.choosingwisely.org/clinician-lists/american-academy-pediatrics-cough-and-cold-medicines-for-children-under-four/
  3. Centers for Disease Control and Prevention (CDC). Infant deaths associated with cough and cold medications--two states, 2005. MMWR Morb Mortal Wkly Rep. 2007;56(1):1-4. [PubMed 17218934]
  4. Claritin-D 12-Hour extended release tablets (loratadine and pseudoephedrine) [prescribing information]. Kenilworth, NJ: Schering Corporation; May 1998.
  5. Claritin-D 24-Hour (loratadine and pseudoephedrine) [prescribing information]. Kenilworth, NJ: Schering Corporation; April 1998.
  6. Claritin-D 12 Hour extended-release tablets (loratadine and pseudoephedrine) [prescribing information]. Whippany, NJ: Bayer Healthcare LLC; April 2019.
  7. Claritin-D 24 Hour extended-release tablets (loratadine and pseudoephedrine) [prescribing information]. Whippany, NJ: Bayer Healthcare LLC; November 2019.
  8. Food and Drug Administration (FDA). Most young children with a cough or cold don't need medicines. July 18, 2017. Available at https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm422465.htm. Last accessed November 2, 2018.
  9. Food and Drug Administration (FDA). Use caution when giving cough and cold products to kids. Updated February 8, 2018. Available at https://www.fda.gov/drugs/resourcesforyou/specialfeatures/ucm263948.htm. Last accessed November 2, 2018.
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