Desloratadine 5 mg Tablet, Film Coated, 100-count — NDC 69452-363-20 (Billing 69452-0363-20)
This is a package of 100 tablets of Desloratadine 5 mg Tablet, Film Coated from Bionpharma Inc., marketed since Nov 2023 and currently FDA-listed; retail pharmacies pay about $0.2576 per tablet (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 69452-363-20 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 69452 labeler · 363 product · 20 package
- Package marketed since
- Nov 28, 2023
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 100 EA per package
- Barcode (UPC-A, from the NDC)
- 3 6945236320 1
- Medicaid fills, this package
- 4,599 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 047763
- GCN: 12762
- GPI-14 (Medi-Span): 41550021000320
- HICL (First Databank): 021934
- AHFS class code: 04:08.00.00
- RxCUI (RxNorm): 349420
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Histamine-1 Receptor Antagonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Desloratadine is used to treat allergy symptoms: sneezing runny nose itching of the nose or throat red, itchy, or watery eyes. It is also used to treat urticaria (hives) to reduce itching and the number and size of the hives. Desloratadine is in a class of medications called antihistamines. It works by blocking histamine, a substance in the body that causes allergic symptoms.
Read the full MedlinePlus article ↗- It relieves allergy symptoms from seasonal and year-round allergic rhinitis, like nasal and non-nasal symptoms. It also helps with chronic idiopathic urticaria, which means long-la...
- Take it by mouth once a day, with or without food. If you use the dissolving tablet, put it on your tongue and let it melt right after opening the blister. For liquid, use a droppe...
- Most people have few problems. Some get a sore throat, dry mouth, muscle aches, tiredness or sleepiness. People treated for hives also reported headache, nausea and dizziness.
- Stop the medicine and get help right away if you get a rash, hives, swelling or trouble breathing. Also call about a racing heartbeat, seizures, unusual movements or signs of liver...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Desloratadine — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.258 | $25.76 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.5390 | $53.90 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.4652 | $46.52 / 100 tablets |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 69452-0363-20 You're viewing this Main listing | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | $0.2576 / ea | $25.76 | 2023-11-28 | — | Active |
| 69452-0363-30 69452-363-30 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | $0.2576 / ea | $128.78 | 2023-11-28 | — | Active |
You're viewing the smallest of 2 pack sizes for this product.
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.2576 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 90% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 69452-0363-30?
What NDC number is used to bill for this package of Desloratadine 5 mg Tablet, Film Coated?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Desloratadine 5 mg 69543-0107-10 | Virtus | 100 tablets | $0.255 | AB | Availability likely | save 1% |
| Desloratadine 5 mg 68180-0153-01 | Lupin | 100 tablets | $0.258 | AB | Availability likely | — |
| Desloratadine 5 mgthis 69452-0363-20 | Bionpharma | 100 tablets | $0.258 | AB | Availability likely | — |
| Clarinex 5 mg 78206-0188-01 | Organon | 100 tablets | $8.848 | AB | Availability likely | +3335% |
| Desloratadine 5 mg 50090-3975-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Desloratadine 5 mg 50090-4794-01 | A-S | 30 tablets | — | AB | Discontinued | — |
| Desloratadine 5 mg 50090-6724-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Desloratadine 5 mg 69339-0194-01 | Natco | 100 tablets | — | AB | FDA listed | — |
| Desloratadine 5 mg 71335-1000-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Desloratadine 5 mg 72162-2308-01 | Bryant | 100 tablets | — | AB | FDA listed | — |
| Clarinex 5 mg 78206-0119-01 | Organon | 100 tablets | — | AB | FDA listed | — |
| Desloratadine 5 mg 87717-0001-01 | Morepen | 100 tablets | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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Betadex is a modified sugar molecule derived from starch. It acts as a solubilizer and stabilizer in medicines, helping dissolve poorly soluble drugs and keep them stable during storage.
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Butylated hydroxyanisole is a synthetic preservative that prevents oils and fats in medicines from spoiling or becoming rancid. It keeps the medicine stable and extends its shelf life.
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Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
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A plant-based thickener made from cellulose that helps control how quickly the medicine dissolves and releases its active ingredient. It also binds ingredients together and improves the tablet's texture and handling during manufacturing.
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Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
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Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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Polyethylene glycol 6000 is a synthetic polymer made from ethylene glycol units. It acts as a binder, filler, and solubilizer in medicines to help hold ingredients together, add bulk, and improve how well active drugs dissolve and absorb.
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Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
12 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
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Manufacturer & labeler
More NDCs from Bionpharma Inc. labeler code 69452
- Ropinirole .5 mg Tablet, Film Coated NDC 69452-357-20
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- Ropinirole 4 mg Tablet, Film Coated NDC 69452-361-20
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- Zaleplon 5 mg Capsule NDC 69452-364-20
- Zaleplon 10 mg Capsule NDC 69452-365-20
- cool and heat pain relieving liquid Menthol 16 mg/100mL Liquid NDC 69452-375-96
- A Health Itch Relief Gel 2 mg/100mL Gel NDC 69452-376-55
- ear drops Carbamide Peroxide 6.5% .065 mg/mL Liquid NDC 69452-377-75
- Ibandronate Sodium 150 mg Tablet NDC 69452-378-74
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Desloratadine tablets are a histamine-1 (H1) receptor antagonist indicated for: Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 12 years of age and older. (1.1) Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 12 years of age and older. (1.2) Chronic Idiopathic Urticaria: symptomatic relief of pruritus, reduction in the number of hives, and size of hives in patients 12 years of age and older.
(1.3)
1.1Seasonal Allergic Rhinitis Desloratadine tablets are indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 12 years of age and older.
1.2Perennial Allergic Rhinitis Desloratadine tablets are indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 12 years of age and older.
1.3Chronic Idiopathic Urticaria Desloratadine tablets are indicated for the symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria 12 years of age and older.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Desloratadine tablets may be taken without regard to meals. Adults and Adolescents 12 Years of Age and Over: Desloratadine tablets - one 5 mg tablet once daily.
2.1Adults and Adolescents 12 Years of Age and Over The recommended dose of desloratadine tablets is one 5 mg tablet once daily.
2.5Adults with Hepatic or Renal Impairment In adult patients with liver or renal impairment, a starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data. Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data [see Clinical Pharmacology ( 12.3 )].
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Desloratadine tablets, USP are light blue colored, film coated, circular, biconvex tablets debossed with “D” on one side and plain on the other side containing 5 mg desloratadine, USP. Desloratadine tablets, USP - 5 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Desloratadine tablets are contraindicated in patients who are hypersensitive to this medication or to any of its ingredients or to loratadine [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.2 )]. Hypersensitivity ( 4 , 6.2 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions including rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis have been reported. In such cases, stop desloratadine at once and consider alternative treatments. ( 5.1 )
5.1Hypersensitivity Reactions Hypersensitivity reactions including rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis have been reported after administration of desloratadine. If such a reaction occurs, therapy with desloratadine should be stopped and alternative treatment should be considered. [see Adverse Reactions ( 6.2 ).]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: Hypersensitivity reactions. [see Warnings and Precautions ( 5.1 ).] The most common adverse reactions (reported in ≥ 2% of adult and adolescent patients with allergic rhinitis and greater than placebo) were pharyngitis, dry mouth, myalgia, fatigue, somnolence, dysmenorrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bionpharma Inc. at 1-888-235-BION or 1-888-235-2466 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adults and Adolescents Allergic Rhinitis: In multiple-dose placebo-controlled trials, 2834 patients ages 12 years or older received desloratadine tablets at doses of 2.5 mg to 20 mg daily, of whom 1655 patients received the recommended daily dose of 5 mg.
In patients receiving 5 mg daily, the rate of adverse events was similar between desloratadine and placebo-treated patients. The percent of patients who withdrew prematurely due to adverse events was 2.4% in the desloratadine group and 2.6% in the placebo group. There were no serious adverse events in these trials in patients receiving desloratadine.
All adverse events that were reported by greater than or equal to 2% of patients who received the recommended daily dose of desloratadine tablets (5 mg once daily), and that were more common with desloratadine tablets than placebo, are listed in Table 1. Table 1: Incidence of Adverse Events Reported by ≥ 2% of Adult and Adolescent Allergic Rhinitis Patients Receiving Desloratadine Tablets Adverse Event Desloratadine Tablets 5 mg (n=1655) Placebo (n=1652) Infections and Infestations Pharyngitis 4.1% 2% Nervous System Disorders Somnolence 2.1% 1.8% Gastrointestinal Disorders Dry Mouth 3% 1.9% Musculoskeletal and Connective Tissue Disorders Myalgia 2.1% 1.8% Reproductive System and Breast Disorders Dysmenorrhea 2.1% 1.6% General Disorders and Administration Site Conditions Fatigue 2.1% 1.2% The frequency and magnitude of laboratory and electrocardiographic abnormalities were similar in desloratadine and placebo-treated patients.
There were no differences in adverse events for subgroups of patients as defined by gender, age, or race. Chronic Idiopathic Urticaria: In multiple-dose, placebo-controlled trials of chronic idiopathic urticaria, 211 patients ages 12 years or older received desloratadine tablets and 205 received placebo. Adverse events that were reported by greater than or equal to 2% of patients who received desloratadine tablets and that were more common with desloratadine than placebo were (rates for desloratadine and placebo, respectively): headache (14%, 13%), nausea (5%, 2%), fatigue (5%, 1%), dizziness (4%, 3%), pharyngitis (3%, 2%), dyspepsia (3%, 1%), and myalgia (3%, 1%).
Pediatrics Two hundred and forty-six pediatric subjects 6 months to 11 years of age received desloratadine oral solution for 15 days in three placebo-controlled clinical trials. Pediatric subjects aged 6 to 11 years received 2.5 mg once a day, subjects aged 1 to 5 years received 1.25 mg once a day, and subjects 6 to 11 months of age received 1 mg once a day. In subjects 6 to 11 years of age, no individual adverse event was reported by 2 percent or more of the subjects.
In subjects 2 to 5 years of age, adverse events reported for desloratadine and placebo in at least 2 percent of subjects receiving desloratadine oral solution and at a frequency greater than placebo were fever (5.5%, 5.4%), urinary tract infection (3.6%, 0%) and varicella (3.6%, 0%). In subjects 12 months to 23 months of age, adverse events reported for the desloratadine product and placebo in at least 2 percent of subjects receiving desloratadine… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS
7.1Inhibitors of Cytochrome P450 3A4 In controlled clinical studies co-administration of desloratadine with ketoconazole, erythromycin, or azithromycin resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine. [see Clinical Pharmacology ( 12.3 ).]
7.2Fluoxetine In controlled clinical studies co-administration of desloratadine with fluoxetine, a selective serotonin reuptake inhibitor (SSRI), resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine. [see Clinical Pharmacology ( 12.3 ).]
7.3Cimetidine In controlled clinical studies co-administration of desloratadine with cimetidine, a histamine H 2 -receptor antagonist, resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine. [see Clinical Pharmacology ( 12.3 ).]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Renal impairment: dosage adjustment is recommended ( 2.5 , 8.6 , 12.3 ) Hepatic impairment: dosage adjustment is recommended ( 2.5 , 8.7 , 12.3 )
8.1Pregnancy Risk Summary The limited available data with desloratadine in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There are no adequate and well-controlled studies in pregnant women. Desloratadine given during organogenesis to pregnant rats was not teratogenic at the summed area under the concentration-time curve (AUC)-based exposures of desloratadine and its metabolite approximately 320 times that at the recommended human daily oral dose (RHD) of 5 mg/day.
Desloratadine given during organogenesis to pregnant rabbits was not teratogenic at the AUC-based exposures of desloratadine approximately 230 times that at the RHD. Desloratadine given to pregnant rats during organogenesis through lactation resulted in reduced body weight and slow righting reflex of F 1 pups at the summed AUC-based exposures of desloratadine and its metabolite approximately 70 times or greater than that at the RHD [see Data] . The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Desloratadine was given orally during organogenesis to pregnant rats at doses of 6, 24 and 48 mg/kg/day (approximately 50, 200 and 320 times the summed AUC-based exposure of desloratadine and its metabolite at the RHD). No fetal malformations were present.
Reduced fetal weights and skeletal variations noted at doses of 24 and 48 mg/kg/day were likely secondary to the maternal toxicities of reduced body weight gain and food consumption observed at the same doses. Desloratadine was also given orally during organogenesis to pregnant rabbits at doses of 15, 30 and 60 mg/kg/day (approximately 30, 70 and 230 times the AUC-based exposure of desloratadine at the RHD). No adverse effects to the fetus were noted.
Reduced maternal body weight gain was noted in rabbits at 60 mg/kg/day. In a peri- and post-natal development study, desloratadine was given to rats orally during the perinatal (Gestation Day 6) through lactation periods (Postpartum Day 21) at doses of 3, 9 and 18 mg/kg/day. Reduced body weight and slow righting reflex were reported in F 1 pups at doses of 9 mg/kg/day or greater (approximately 70 times or greater than the summed AUC-based exposure of desloratadine and its metabolite at the RHD).
Desloratadine had no effect on F 1 pup development at 3 mg/kg/day (approximately 10 times the summed AUC-based exposure of desloratadine and its metabolite at the RHD). Maternal toxicities including reduced body weight gain and food consumption were noted at 18 mg/kg/day for F 0 dams. F 1 offspring were subsequently mated and there was no developmental toxicity for F 2 pups observed.
8.2Lactation Risk Summary Desloratadine passes into breast milk. There are not sufficient data on the effects of desloratadine on the breastfed infant or the effects of desloratadine on milk production. The decision should be made whether to discontinue nursing or to discontinue desloratadine, taking into account the developmental and health benefits of breastfeeding, the nursing mother’s clinical need, and any potential adverse effects on the breastfed infant from desloratadine or from the underlying maternal condition.
8.3Females and Males of Reproductive Potential Infertility There are no data available on human infertility associated with desloratadine. There were no clinically relevant effects of desloratadine on female fertility in rats. A male specific decrease in fertility occurred at an oral desloratadine dose of 12 mg/kg or greater in rats (approximately 65 times the summed AUC-based exposure of desloratadine a… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary The limited available data with desloratadine in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There are no adequate and well-controlled studies in pregnant women. Desloratadine given during organogenesis to pregnant rats was not teratogenic at the summed area under the concentration-time curve (AUC)-based exposures of desloratadine and its metabolite approximately 320 times that at the recommended human daily oral dose (RHD) of 5 mg/day.
Desloratadine given during organogenesis to pregnant rabbits was not teratogenic at the AUC-based exposures of desloratadine approximately 230 times that at the RHD. Desloratadine given to pregnant rats during organogenesis through lactation resulted in reduced body weight and slow righting reflex of F 1 pups at the summed AUC-based exposures of desloratadine and its metabolite approximately 70 times or greater than that at the RHD [see Data] . The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Desloratadine was given orally during organogenesis to pregnant rats at doses of 6, 24 and 48 mg/kg/day (approximately 50, 200 and 320 times the summed AUC-based exposure of desloratadine and its metabolite at the RHD). No fetal malformations were present.
Reduced fetal weights and skeletal variations noted at doses of 24 and 48 mg/kg/day were likely secondary to the maternal toxicities of reduced body weight gain and food consumption observed at the same doses. Desloratadine was also given orally during organogenesis to pregnant rabbits at doses of 15, 30 and 60 mg/kg/day (approximately 30, 70 and 230 times the AUC-based exposure of desloratadine at the RHD). No adverse effects to the fetus were noted.
Reduced maternal body weight gain was noted in rabbits at 60 mg/kg/day. In a peri- and post-natal development study, desloratadine was given to rats orally during the perinatal (Gestation Day 6) through lactation periods (Postpartum Day 21) at doses of 3, 9 and 18 mg/kg/day. Reduced body weight and slow righting reflex were reported in F 1 pups at doses of 9 mg/kg/day or greater (approximately 70 times or greater than the summed AUC-based exposure of desloratadine and its metabolite at the RHD).
Desloratadine had no effect on F 1 pup development at 3 mg/kg/day (approximately 10 times the summed AUC-based exposure of desloratadine and its metabolite at the RHD). Maternal toxicities including reduced body weight gain and food consumption were noted at 18 mg/kg/day for F 0 dams. F 1 offspring were subsequently mated and there was no developmental toxicity for F 2 pups observed.
🆘 Overdosage ▾
10 OVERDOSAGE In the event of overdose, consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Desloratadine and 3-hydroxydesloratadine are not eliminated by hemodialysis.
Information regarding acute overdosage is limited to experience from post-marketing adverse event reports and from clinical trials conducted during the development of the desloratadine product. In a dose-ranging trial, at doses of 10 mg and 20 mg/day somnolence was reported. In another study, no clinically relevant adverse events were reported in normal male and female volunteers who were given single daily doses of desloratadine 45 mg for 10 days [see Clinical Pharmacology ( 12.2 )].
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Desloratadine is a long-acting tricyclic histamine antagonist with selective H 1 -receptor histamine antagonist activity. Receptor binding data indicates that at a concentration of 2 to 3 ng/mL (7 nanomolar), desloratadine shows significant interaction with the human histamine H 1 -receptor. Desloratadine inhibited histamine release from human mast cells in vitro .
Results of a radiolabeled tissue distribution study in rats and a radioligand H 1 -receptor binding study in guinea pigs showed that desloratadine did not readily cross the blood brain barrier. The clinical significance of this finding is unknown.
12.2Pharmacodynamics Wheal and Flare: Human histamine skin wheal studies following single and repeated 5 mg doses of desloratadine have shown that the drug exhibits an antihistaminic effect by one hour; this activity may persist for as long as 24 hours. There was no evidence of histamine-induced skin wheal tachyphylaxis within the desloratadine 5 mg group over the 28 day treatment period. The clinical relevance of histamine wheal skin testing is unknown.
Effects on QT c : Single daily doses of 45 mg were given to normal male and female volunteers for 10 days. All ECGs obtained in this study were manually read in a blinded fashion by a cardiologist. In desloratadine-treated subjects, there was an increase in mean heart rate of 9.2 bpm relative to placebo.
The QT interval was corrected for heart rate (QT c ) by both the Bazett and Fridericia methods. Using the QT c (Bazett) there was a mean increase of 8.1 msec in desloratadine-treated subjects relative to placebo. Using QT c (Fridericia) there was a mean increase of 0.4 msec in desloratadine-treated subjects relative to placebo.
No clinically relevant adverse events were reported.
12.3Pharmacokinetics Absorption Following oral administration of a desloratadine 5 mg tablet once daily for 10 days to normal healthy volunteers, the mean time to maximum plasma concentrations (T max ) occurred at approximately 3 hours post dose and mean steady state peak plasma concentrations (C max ) and AUC of 4 ng/mL and 56.9 ng·hr/mL were observed, respectively. Neither food nor grapefruit juice had an effect on the bioavailability (C max and AUC) of desloratadine. The pharmacokinetic profile of desloratadine oral solution was evaluated in a three-way crossover study in 30 adult volunteers.
A single dose of 10 mL of desloratadine oral solution containing 5 mg of desloratadine was bioequivalent to a single dose of 5 mg desloratadine tablets. Food had no effect on the bioavailability (AUC and C max ) of desloratadine oral solution. Distribution Desloratadine and 3-hydroxydesloratadine are approximately 82% to 87% and 85% to 89% bound to plasma proteins, respectively.
Protein binding of desloratadine and 3-hydroxydesloratadine was unaltered in subjects with impaired renal function. Metabolism Desloratadine (a major metabolite of loratadine) is extensively metabolized to 3-hydroxydesloratadine, an active metabolite, which is subsequently glucuronidated. The enzyme(s) responsible for the formation of 3-hydroxydesloratadine have not been identified.
Data from clinical trials indicate that a subset of the general population has a decreased ability to form 3-hydroxydesloratadine, and are poor metabolizers of desloratadine. In pharmacokinetic studies (n=3748), approximately 6% of subjects were poor metabolizers of desloratadine (defined as a subject with an AUC ratio of 3-hydroxydesloratadine to desloratadine less than 0.1, or a subject with a desloratadine half-life exceeding 50 hours). These pharmacokinetic studies included subjects between the ages of 2 and 70 years, including 977 subjects aged 2 to 5 years, 1575 subjects aged 6 to 11 years, and 1,196 subjects aged 12 to 70 years.
There was no difference in the prevalence of poor metabolizers across age groups. The frequency of poor metabolizers was higher in Blacks (17%, n=988) as compared to Cau… [Excerpted — this section continues on DailyMed.]
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Desloratadine Tablets, USP: Light blue colored, film coated, circular, biconvex tablets debossed with “D” on one side and plain on the other side are supplied as follows: Bottles of 100 NDC 69452-363-20, with a child-resistant closure. Bottles of 500 NDC 69452-363-30, with a child-resistant closure. Storage: Desloratadine Tablets, USP: Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature].
Heat sensitive. Avoid exposure at or above 30°C (86°F). Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
📋 Description ▾
11 DESCRIPTION Desloratadine tablets, USP are light blue, circular, film-coated tablets containing 5 mg desloratadine USP, an antihistamine, to be administered orally. It also contains the following excipients: corn starch, low substituted hydroxypropyl cellulose, colloidal silicon dioxide, betadex, butylated hydroxyanisole, croscarmellose sodium, magnesium stearate and opadry blue. The components of opadry blue are hypromellose, titanium dioxide, polyethylene glycol 6000, F D&C Blue # 2 and polysorbate 80.
Desloratadine, USP is a pale yellow powder that is freely soluble in dichloromethane. It has a molecular formula: C 19 H 19 ClN 2 and a molecular weight of 310.8. The chemical name is 8-chloro-6,11-dihydro-11-(4-piperidinylidene)-5 H -benzo[5,6]cyclohepta[1,2- b ]pyridine and has the following structure: FDA approved dissolution test specifications differ from USP. structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information).
17.1Information for Patients Patients should be instructed to use desloratadine tablets as directed. As there are no food effects on bioavailability, patients can be instructed that desloratadine tablets may be taken without regard to meals. Patients should be advised not to increase the dose or dosing frequency as studies have not demonstrated increased effectiveness at higher doses and somnolence may occur.
Distributed by: Bionpharma Inc. Princeton, NJ 08540 MADE IN INDIA 948026776 Revised: 5/2023
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Seasonal Allergic Rhinitis The clinical efficacy and safety of desloratadine tablets were evaluated in over 2300 patients 12 to 75 years of age with seasonal allergic rhinitis. A total of 1838 patients received 2.5 to 20 mg/day of desloratadine in four double-blind, randomized, placebo-controlled clinical trials of 2 to 4 weeks' duration conducted in the United States. The results of these studies demonstrated the efficacy and safety of desloratadine 5 mg in the treatment of adult and adolescent patients with seasonal allergic rhinitis.
In a dose-ranging trial, desloratadine 2.5 to 20 mg/day was studied. Doses of 5, 7.5, 10, and 20 mg/day were superior to placebo; and no additional benefit was seen at doses above 5 mg. In the same study, an increase in the incidence of somnolence was observed at doses of 10 mg/day and 20 mg/day (5.2% and 7.6%, respectively), compared to placebo (2.3%).
In two 4 week studies of 924 patients (aged 15 to 75 years) with seasonal allergic rhinitis and concomitant asthma, desloratadine tablets 5 mg once daily improved rhinitis symptoms, with no decrease in pulmonary function. This supports the safety of administering desloratadine tablets to adult patients with seasonal allergic rhinitis with mild to moderate asthma. Desloratadine tablets 5 mg once daily significantly reduced the Total Symptom Score (the sum of individual scores of nasal and non-nasal symptoms) in patients with seasonal allergic rhinitis.
See Table 3. Table 3:TOTAL SYMPTOM SCORE (TSS) Changes in a 2 Week Clinical Trial in Patients with Seasonal Allergic Rhinitis Treatment Group (n) Mean Baseline * ( SEM) Change from Baseline† (SEM) Placebo Comparison ( P - value) Desloratadine 5 mg (171) 14.2 (0.3) -4.3 (0.3) P <0.01 Placebo (173) 13.7 (0.3) -2.5 (0.3) SEM=Standard Error of the Mean *At baseline, a total nasal symptom score (sum of 4 individual symptoms) of at least 6 and a total non-nasal symptom score (sum of 4 individual symptoms) of at least 5 (each symptom scored 0 to 3 where 0=no symptom and 3=severe symptoms) was required for trial eligibility.
TSS ranges from 0=no symptoms to 24=maximal symptoms. †Mean reduction in TSS averaged over the 2 week treatment period. There were no significant differences in the effectiveness of desloratadine tablets 5 mg across subgroups of patients defined by gender, age, or race.
14.2Perennial Allergic Rhinitis The clinical efficacy and safety of desloratadine tablets 5 mg were evaluated in over 1300 patients 12 to 80 years of age with perennial allergic rhinitis. A total of 685 patients received 5 mg/day of desloratadine in two double-blind, randomized, placebo-controlled clinical trials of 4 weeks' duration conducted in the United States and internationally. In one of these studies desloratadine tablets 5 mg once daily was shown to significantly reduce the Total Symptom Score in patients with perennial allergic rhinitis (Table 4).
Table 4: TOTAL SYMPTOM SCORE (TSS) Changes in a 4 Week Clinical Trial in Patients with Perennial Allergic Rhinitis Treatment Group (n) Mean Baseline* (SEM) Change from Baseline† (SEM) Placebo Comparison ( P - value) Desloratadine 5 mg (337) 12.37 (0.18) -4.06 (0.21) P =0.01 Placebo (337) 12.30 (0.18) -3.27 (0.21) SEM=Standard Error of the Mean *At baseline, average of total symptom score (sum of 5 individual nasal symptoms and 3 non-nasal symptoms, each symptom scored 0 to 3 where 0=no symptom and 3=severe symptoms) of at least 10 was required for trial eligibility.
TSS ranges from 0=no symptoms to 24=maximal symptoms. †Mean reduction in TSS averaged over the 4 week treatment period.
14.3Chronic Idiopathic Urticaria The efficacy and safety of desloratadine tablets 5 mg once daily was studied in 416 chronic idiopathic urticaria patients 12 to 84 years of age, of whom 211 received desloratadine. In two double-blind, placebo-controlled, randomized clinical trials of six weeks duration, at the pre-specified one-week primary time point evaluatio… [Excerpted — this section continues on DailyMed.]
🔒 Drug Abuse and Dependence ▾
9 DRUG ABUSE AND DEPENDENCE There is no information to indicate that abuse or dependency occurs with desloratadine tablets.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity Studies The carcinogenic potential of desloratadine was assessed using a loratadine study in rats and a desloratadine study in mice. In a 2 year study in rats, loratadine was administered in the diet at doses up to 25 mg/kg/day (approximately 45 times the summed AUC-based exposure of desloratadine and its metabolite at the RHD). A significantly higher incidence of hepatocellular tumors (combined adenomas and carcinomas) was observed in males given 10 mg/kg/day of loratadine (approximately 10 times the summed AUC-based exposure of desloratadine and its metabolite at the RHD) and in males and females given 25 mg/kg/day of loratadine.
The clinical significance of these findings during long-term use of desloratadine is not known. In a 2 year dietary study in mice, males and females given up to 16 mg/kg/day and 32 mg/kg/day desloratadine, respectively (approximately 30 and 70 times the summed AUC-based exposure of desloratadine and its metabolite at the RHD, respectively), did not show significant increases in the incidence of any tumors. Genotoxicity Studies In genotoxicity studies with desloratadine, there was no evidence of genotoxic potential in a reverse mutation assay ( Salmonella/E. coli mammalian microsome bacterial mutagenicity assay) or in 2 assays for chromosomal aberrations (human peripheral blood lymphocyte clastogenicity assay and mouse bone marrow micronucleus assay).
Impairment of Fertility In a female fertility study, desloratadine was given to female rats orally 14 days prior to and throughout mating until Gestation Day 7 at doses of 6, 12 and 24 mg/kg/day. An increase in preimplantation loss and a decrease in number of implantations and fetuses noted at 24 mg/kg (approximately 200 times the summed AUC-based exposure of desloratadine and its metabolite at the RHD) was likely due to maternal toxicities including reduced body weight gain and food consumption. In a male fertility study in rats, desloratadine was given orally to male rats for 70 days prior to mating and throughout the mating period (total dosing period 106 to 108 days) at doses of 3, 12 and 40 mg/kg/day.
Reduced body weight gain, food consumption, and absolute organ weights of testes, epididymis, and cauda epididymis were noted at 40 mg/kg/day. A male-specific decrease in fertility, demonstrated by reduced female conception rates, decreased sperm numbers and motility, and histopathologic changes in testes and epididymis, occurred at a dose of 12 mg/kg or greater (approximately 65 times or greater than the summed AUC-based exposure of desloratadine and its metabolite at the RHD). Desloratadine had no effect on male fertility in rats at 3 mg/kg/day (approximately 10 times the summed AUC-based exposure of desloratadine and its metabolite at the RHD).
📄 Patient Package Insert ▾
PATIENT INFORMATION Desloratadine (dess-lor-AT-ah-deen) Tablets, USP Read the Patient Information that comes with desloratadine tablets before you start taking them and each time you get a refill. There may be new information. This leaflet is a summary of the information for patients.
Your doctor or pharmacist can give you additional information. This leaflet does not take the place of talking to your doctor about your medical condition or treatment. What are desloratadine tablets?
Desloratadine tablets are a prescription medicine that contains the medicine desloratadine (an antihistamine). Desloratadine tablets are used to help control the symptoms of: seasonal allergic rhinitis (sneezing, stuffy nose, runny nose and itching of the nose) in people 12 years of age and older. perennial allergic rhinitis (sneezing, stuffy nose, runny nose and itching of the nose) in people 12 years of age and older. chronic idiopathic urticaria (long-term itching) and to reduce the number and size of hives in people 12 years of age and older.
Who should not take desloratadine tablets? Do not take desloratadine tablets if you: are allergic to desloratadine or any of the ingredients in desloratadine tablets. See the end of this leaflet for a complete list of ingredients. are allergic to loratadine (Alavert, Claritin).
Talk to your doctor before taking this medicine if you have any questions about whether or not to take this medicine. What should I tell my doctor before taking desloratadine tablets? Before you take desloratadine tablets, tell your doctor if you: have liver or kidney problems. have any other medical conditions. are pregnant or plan to become pregnant.
It is not known if desloratadine tablets will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. are breast-feeding or plan to breast-feed. Desloratadine can pass into your breast milk .
Talk to your doctor about the best way to feed your baby if you take desloratadine tablets. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Desloratadine tablets may affect the way other medicines work, and other medicines may affect how desloratadine tablets work.
Especially tell your doctor if you take: ketoconazole (Nizoral) erythromycin (Ery-tab, Eryc, PCE) azithromycin (Zithromax, Zmax) antihistamines fluoxetine (Prozac) cimetidine (Tagamet) Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine. How should I take desloratadine tablets?
Take desloratadine tablets exactly as your doctor tells you to take them. Do not change your dose of desloratadine tablets or take more often than prescribed. Desloratadine tablets can be taken with or without food.
If you take too much desloratadine, call your doctor or get medical attention right away. What are the possible side effects of desloratadine tablets? Desloratadine tablets may cause serious side effects, including: Allergic reactions.
Stop taking desloratadine tablets and call your doctor right away or get emergency help if you have any of these symptoms: rash itching hives swelling of your lips, tongue, face, and throat shortness of breath or trouble breathing The most common side effects of desloratadine tablets in adults and children 12 years of age and older with allergic rhinitis include: sore throat dry mouth muscle pain tiredness sleepiness menstrual pain Increased sleepiness or tiredness can happen if you take more desloratadine tablets than your doctor prescribed to you.
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of desloratadine tablets. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store desloratadine tablets?
Store deslor… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 69452- 363 -20 Desloratadine Tablets, USP 5 mg PHARMACIST: Dispense the patient information leaflet provided separately to each patient. Rx Only 100 Tablets BIONPHARMA label