Desloratadine 5 mg Tablet, Film Coated, 100-count
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Histamine-1 Receptor Antagonist class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 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 ↗- Desloratadine is used to relieve allergy symptoms — think sneezing, runny nose, itchy eyes — from both seasonal allergies (like hay fever) and year-round allergies. It also helps w...
- Desloratadine is far less likely to cause drowsiness than older antihistamines because it doesn't readily cross into the brain. That said, drowsiness was still reported in some pat...
- Some medications — including the antifungal ketoconazole, the antibiotics erythromycin and azithromycin, the antidepressant fluoxetine, and the acid-reducer cimetidine — can raise...
- Can I take this with my other medications?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Desloratadine — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 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.
-
UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
-
UNII 70097M6I30
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.
-
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
-
UNII 532B59J990
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
-
UNII ETJ7Z6XBU4
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.
-
UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
-
UNII O8232NY3SJ
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.
-
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
-
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.
10 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.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.4652 | $46.52 / 100 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Desloratadine 5 mg 68180-0153-01 | Lupin | 100 tablets | $0.255 | AB | Availability likely | — |
| Desloratadine 5 mg 69452-0363-20 | Bionpharma | 100 tablets | $0.255 | AB | Availability likely | — |
| Desloratadine 5 mg 69543-0107-10 | Virtus | 100 tablets | $0.255 | AB | Availability likely | — |
| Clarinex 5 mg 78206-0188-01 | Organon | 100 tablets | $8.848 | AB | Availability likely | — |
| 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 mgthis 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?
⏳ 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?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 69339-0194-01 You're viewing this | 100 TABLET, FILM COATED in 1 BOTTLE (69339-194-01) | 2026-04-01 | Active |
| 69339-0194-05 | 500 TABLET, FILM COATED in 1 BOTTLE (69339-194-05) | 2026-04-01 | Active |
You're viewing the smallest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 69339-0194-01?
What is the difference between NDC 69339-0194-01 and NDC 69339-0194-05?
What NDC number is used to bill for this package of Desloratadine 5 mg Tablet, Film Coated?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
Why is there no price listed?
Is the NDC printed on the package the same as the 11-digit billing NDC?
What do the three segments of this NDC mean?
Is this package still being marketed?
Does this product come in other package sizes?
Who lists this product with the FDA?
Do I need a prescription for this product?
Where does this data come from?
📄 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. Dosage (by age): 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 available containing 5 mg of desloratadine, USP. The 5 mg tablets are red, film-coated, round, biconvex, beveled edge tablet debossed with “D5” on one side of the tablet and “N” on the other side. Desloratadine tablets - 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 tablets 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 Natco Pharma USA LLC at 1-201-786-6500 or FDA at 1-800-FDA-1088 orwww.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% 2.0% Nervous System Disorders Somnolence 2.1% 1.8% Gastrointestinal Disorders Dry Mouth 3.0% 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 1.0 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 Oral…
🔄 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 H2-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 F1pups at the summed AUC-based exposures of desloratadine and its metabolite approximately 70 times or greater than that at the RHD [seeData] . 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 2-4% and 15-20%, 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 F1 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 F1 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 F0 dams. F1 offspring were subsequently mated and there was no developmental toxicity for F2 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 and its metabol…
🤰 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 F1pups at the summed AUC-based exposures of desloratadine and its metabolite approximately 70 times or greater than that at the RHD [seeData] . 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 2-4% and 15-20%, 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 F1 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 F1 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 F0 dams. F1 offspring were subsequently mated and there was no developmental toxicity for F2 pups observed.
🧒 Pediatric Use ▾
8.4Pediatric Use The recommended dose of Desloratadine Oral Solution in the pediatric population is based on cross-study comparison of the plasma concentration of desloratadine in adults and pediatric subjects. The safety of Desloratadine Oral Solution has been established in 246 pediatric subjects aged 6 months to 11 years in three placebo-controlled clinical studies. Since the course of seasonal and perennial allergic rhinitis and chronic idiopathic urticaria and the effects of desloratadine are sufficiently similar in the pediatric and adult populations, it allows extrapolation from the adult efficacy data to pediatric patients.
The effectiveness of desloratadine Oral Solution in these age groups is supported by evidence from adequate and well-controlled studies of desloratadine tablets in adults. The safety and effectiveness of desloratadine tablets or Desloratadine Oral Solution have not been demonstrated in pediatric patients less than 6 months of age. [See C linical Pharmacology (12.3) .] The Desloratadine RediTabs® 2.5-mg tablet has not been evaluated in pediatric patients. Bioequivalence of the Desloratadine RediTabs Tablet and the previously marketed RediTabs Tablet was established in adults.
In conjunction with the dose-finding studies in pediatrics described, the pharmacokinetic data for desloratadine RediTabs supports the use of the 2.5 mg dose strength in pediatric patients 6 to 11 years of age.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of desloratadine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. [See Clinical Pharmacology (12.3) .]
🆘 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 H1-receptor histamine antagonist activity. Receptor binding data indicates that at a concentration of 2-3 ng/mL (7 nanomolar), desloratadine shows significant interaction with the human histamine H1-receptor. Desloratadine inhibited histamine release from human mast cells in vitro .
Results of a radiolabeled tissue distribution study in rats and a radioligand H1-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 1 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 QTc 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 (QTc) by both the Bazett and Fridericia methods. Using the QTc (Bazett) there was a mean increase of 8.1 msec in desloratadine-treated subjects relative to placebo. Using QTc (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 tablet. Food had no effect on the bioavailability (AUC and C max ) of desloratadine Oral Solution. The pharmacokinetic profile of desloratadine RediTabs tablets was evaluated in a three-way crossover study in 24 adult volunteers.
A single desloratadine RediTabs tablet containing 5 mg of desloratadine was bioequivalent to a single 5-mg desloratadine RediTabs Tablet (original formulation) for both desloratadine and 3-hydroxydesloratadine. Food and water had no effect on the bioavailability (AUC and C max ) of desloratadine RediTabs Tablets. 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 s…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Desloratadine is a long-acting tricyclic histamine antagonist with selective H1-receptor histamine antagonist activity. Receptor binding data indicates that at a concentration of 2-3 ng/mL (7 nanomolar), desloratadine shows significant interaction with the human histamine H1-receptor. Desloratadine inhibited histamine release from human mast cells in vitro .
Results of a radiolabeled tissue distribution study in rats and a radioligand H1-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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Desloratadine Tablets, USP are available containing 5 mg of desloratadine, USP. The 5 mg tablets are red film coated, round, biconvex, beveled edge tablet debossed with “D5” on one side of the tablet and “N” on the other side. They are available as follows: NDC 69339-194-01 bottles of 100 tablets NDC 69339-194-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Heat sensitive.
Avoid exposure at or above 30ºC (86ºF). Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
📋 Description ▾
11 DESCRIPTION Desloratadine tablets, USP are red film coated, round, biconvex, beveled edge tablet debossed with “D5” on one side of the tablet and “N” on the other side containing 5 mg of desloratadine, an antihistamine, to be administered orally. Desloratadine tablets also contain the following excipients: colloidal silicon dioxide, FD&C Red No. 40 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch (corn), sodium lauryl sulfate, talc and titanium dioxide.
Desloratadine, USP is a white to off-white powder that is slightly soluble in water, but very soluble in ethanol and propylene glycol. 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-(piperidin-4-ylidene)- 5H benzo[5,6]cyclohepta[1,2-b]pyridine and has the following structure: 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. Desloratadine Tablets, USP (des′′ lor a′ ta deen) 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 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 many desloratadine tablets, 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: o rash o itching o hives o swelling of your lips, tongue, face, and throat o 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 rhiniti…