DESLORATADINE 5 mg Tablet, Film Coated, 1,000-count
Past resolved recalls for this product (1)
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Histamine-1 Receptor Antagonist class.
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🏭 Manufacturer & labeler
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🩺 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?
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Supplement & herbal interactions
Some supplements/herbs that may interact with Desloratadine — tap one for details:
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💊 What it looks like
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🧪 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.
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💲 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 · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| 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 68180-0153-03 | Lupin | 1000 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 | — |
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⏳ 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?
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 68180-0153-01 | 100 TABLET, FILM COATED in 1 BOTTLE (68180-153-01) | $0.2553 / ea | $25.53 | 2013-02-25 | Active |
| 68180-0153-02 | 500 TABLET, FILM COATED in 1 BOTTLE (68180-153-02) | $0.2553 / ea | $127.63 | 2013-02-25 | Active |
| 68180-0153-03 You're viewing this | 1000 TABLET, FILM COATED in 1 BOTTLE (68180-153-03) | — | — | 2013-02-25 | Active |
| 68180-0153-06 | 30 TABLET, FILM COATED in 1 BOTTLE (68180-153-06) | — | — | 2013-02-25 | Active |
| 68180-0153-12 | 3 BLISTER PACK in 1 CARTON (68180-153-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68180-153-11) | — | — | 2013-02-25 | Active |
| 68180-0153-13 | 10 BLISTER PACK in 1 CARTON (68180-153-13) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68180-153-11) | — | — | 2013-02-25 | Active |
This pack shows little to no recent Medicaid volume — the 100 tablets pack carries most fills. See all packs ↓
Pack size FAQ
What quantity is in NDC 68180-0153-03?
What is the difference between NDC 68180-0153-03 and NDC 68180-0153-06?
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.
🧭 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) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Desloratadine tablets are 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 )
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.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Dosage (by age): Adults and Adolescents 12 Years of Age and Over: Desloratadine Tablets - one 5 mg tablet once daily Desloratadine tablets may be taken without regard to meals.
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 - 5 mg ( 3 ) Desloratadine tablets USP, 5 mg are light blue, circular, biconvex, film-coated tablets, debossed "LU" on one side and "S71" on other side.
⛔ Contraindications ▾
4 CONTRAINDICATIONS Hypersensitivity ( 4 , 6.2 ) 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 )].
⚠️ 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 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 Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following adverse reactions are discussed in greater detail in other sections of the label: Hypersensitivity reactions. [See WARNINGS AND PRECAUTIONS ( 5.1 ).]
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. 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 solution and at a frequency greater than placebo were fever (16.9%, 12.9%), diarrhea (15.4%, 11.3%), upper respiratory tract infections (10.8%, 9.7%), coughing (10.8%, 6.5%), appetite increased (3.1%, 1.6%), emotional lability (3.1%, 0%), epistaxis (3.1%, 0%), parasitic infection (3.1%, 0%), pharyngitis (3.1%, 0%), rash maculopapular (3.1%, 0%).
In subjects 6 months to 11 months 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…
🔄 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 F1 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 peri- natal (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…
🤰 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 F1 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 peri- natal (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 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 CLINICAL PHARMACOLOGY ( 12.3 )].
🧓 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 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 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 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 (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. 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 1196 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 Caucasians (2%…
🧬 Mechanism of Action ▾
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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Desloratadine tablets USP, 5 mg are light blue, circular, biconvex, film-coated tablets, debossed "LU" on one side and "S71" on other side. They are supplied as follows: NDC 68180-153-01 Bottles of 100 NDC 68180-153-02 Bottles of 500 Storage: Store at 25°C (77°F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature]. Heat Sensitive.
Avoid exposure at or above 30°C (86°F). Dispense in tight, light-resistant container as defined in the USP using a child-resistant closure.
📋 Description ▾
11 DESCRIPTION Desloratadine tablets USP, 5 mg are light blue, circular, biconvex, film-coated tablets debossed "LU" on one side and "S71" on other side, containing 5 mg desloratadine, an antihistamine, to be administered orally. Desloratadine tablets USP also contain the following excipients: anhydrous lactose, colloidal silicon dioxide, FD&C Blue#2/Indigo Carmine Aluminium Lake, hydrogenated vegetable oil, hypromellose, microcrystalline cellulose, polyethylene glycol, pregelatinised starch and titanium dioxide. Desloratadine is a white to off-white crystalline powder that is freely soluble in dichloromethane and in methanol.
It has an empirical 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-piperdinylidene)-5 H -benzo[5,6]cyclohepta[1,2- b ]pyridine and has the following structure: 1
💬 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.
The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products. LUPIN and the are registered trademarks of Lupin Pharmaceuticals, Inc.
Manufactured for: Lupin Pharmaceuticals, Inc. Naples, FL 34108 United States Manufactured by: Lupin Limited Goa 403 722 INDIA Revised: August 2025 Image