Claritin® Frequently Asked Questions

What is Claritin®?

Claritin® provides effective relief from the symptoms of seasonal allergies: itchy, watery eyes; itchy palate; sneezing; and runny nose. Claritin® is also effective in relieving the symptoms of itching associated with chronic hives. Unlike all current over-the-counter and some prescription antihistamines (which can make people drowsy), Claritin® has no drowsy side effects so you feel better, not medicated! In studies, the incidence of drowsiness with Claritin® was similar to that of placebo (sugar pill) at the recommended dose. Drowsiness may occur if you take more than the recommended dose.

What is the difference between Claritin® Once-A-Day, Claritin® Reditabs and Claritin® D?

Claritin® Once-A -Day tablets contain 10 mg micronized loratadine, an antihistamine, to be administered orally. They also contain the following inactive ingredients: corn starch, lactose, and magnesium stearate. The medication provides nondrowsy effective relieve from the symptoms of seasonal allergies: itchy, watery eyes; itchy palate; sneezing and runny nose. Claritin® is also effective in relieving the symptoms of itching associated with chronic hives.  

Claritin® Reditabs (loratadine rapidly disintegrating tablets) provides the same nondrowsy allergy relief as the original Claritin®.   Each tablet contains 10 mg micronized loratadine, an antihistamine, to be administered orally. It disintegrates in the mouth within seconds after placement on the tongue, allowing its contents to be subsequently swallowed with or without water. This provides an added convenience so individuals can take the medication whenever they need to.   Claritin® Reditabs (loratadine rapidly disintegrating tablets) also contain the following inactive ingredients: citric acid, gelatin, mannitol, and mint flavor.

Claritin-D® combines the active ingredient in claritin, loaratadine, with psuedoephedrine sulfate an effective decongestant.  This combination not only relieves the symptoms of seasonal allergies: itchy, watery, eyes; sneezing and runny nose, etc., but the psuedoephedrine sulfate also relieves the nasal congestion that is associated with these symptoms.

NOTE: Individuals with any heart condition, high blood pressure, glaucoma are at increased risk with the use of any decongestant. If an individual has any of these conditions, www.onlinepills.com recommends that individuals visit their personal physician for a complete physical exam prior to taking Claritin D® that contains the psuedoephedrine sulfate.

How does Claritin® work?

Loratadine is a long-acting tricyclic antihistamine with selective peripheral histamine H1-receptor antagonistic activity.  Human histamine skin wheal studies following single and repeated 10 mg oral doses of Claritin® have shown that the drug exhibits an antihistaminic effect beginning within 1 to 3 hours, reaching a maximum at 8 to 12 hours, and lasting in excess of 24 hours. There was no evidence of tolerance to this effect after 28 days of dosing with Claritin®.

What clinical studies have been done?

Clinical trials of Claritin® tablets involved over 10,700 patients, 12 years of age and older, whom received Claritin® tablets or another antihistamine and/or placebo in double blind randomized controlled studies. In placebo-controlled trials, 10 mg once daily of Claritin® tablets was superior to placebo and similar to clemastine (1 mg tice per day) or terfenadine (60 mg twice per day) in effects on nasal and non-nasal symptoms of allergic rhinitis. In these studies somnolence occurred less frequently with Claritin® tablets than with clemastine and at about the same frequency as terfenadine or placebo. In studies with Claritin® tablets at doses 2 to 4 times higher than the recommended dose of 10 mg, a dose-related increase in the incidence of somnolence was observed. Therefore, some patients, particularly those with hepatic or renal impairment and the elderly, or those on medications that impair clearance of loratadine and its metabolites may experience somnolence. In addition, three placebo-controlled, double-blind, 2-week trials in 188 pediatric patients with seasonal allergic rhinitis aged 6 to 12 years, were conducted at doses of Claritin® syrup up to 10 mg once daily.

Clinical trials of Claritin® Reditabs (loratadine rapidly disintegrating tablets) involved over 1300 patients who received either Claritin® Reditabs (loratadine rapidly disintegrating tablets), Claritin® Tablets, or placebo. In placebo-controlled trials, one Claritin® Reditabs (loratadine rapidly disintegrating tablets) once daily was superior to placebo and similar to Claritin® tablets in effects on nasal and non-nasal symptoms of seasonal allergic rhinitis.

Among those patients involved in double blind, randomized, controlled studies of Claritin® tablets, approximately 1000 patients (age 12 and older), were enrolled in studies of chronic idiopathic urticaria. In placebo-controlled clinical trials, Claritin® tablets 10 mg once daily were superior to placebo in the management of chronic idiopathic urticaria, as demonstrated by reduction of associated itching, erythema, and hives. In these studies, the incidence of somnolence seen with Claritin® tablets was similar to that seen with placebo.

What is the appropriate dose?

Adults and children 12 years of age and over: The recommended dose of Claritin^® is 10 mg once daily. In patients with liver failure or renal insufficiency (GFR < 30 ml/min), one tablet every other day should be the starting dose.

Administration of Claritin^® Reditabs (loratadine rapidly disintegrating tablets): Place Claritin^® Reditabs (loratadine rapidly disintegrating tablets) on the tongue. Tablet disintegration occurs rapidly. Administer with or without water. .

Are there any side effects associated with Claritin^® Once A Day, Claritin^® Radiates, and Claritin^® -D 24 Hour?

Claritin^® Once-A-Day tablets have a low occurrence of side effects. The most common side effects occurred about as often as they did with placebo or sugar pill. These were headache, occurring with 12% of people; drowsiness, 8%; fatigue, 4%; and dry mouth in 3% of people.

Claritin^® Reditabs^® are well tolerated, with a low occurrence of side effects. Side effects in adults resembled those seen with Claritin^® tablets (headache, 12%; drowsiness, 8%; fatigue, 4%; and dry mouth, 3%) and were similar to those with placebo (sugar pill).

Claritin-D^® 24 Hour is safe to take as prescribed: one tablet daily. In studies, dry mouth was the most commonly reported side effect. Other side effects including drowsiness and sleeplessness occurred about as often as they did with a sugar pill.  Individuals should not take Claritin-D ^® 24 Hour with any other antihistamines and decongestants as too much pseudoephedrine sulfate can cause nervousness, sleeplessness, dizziness, and other related side effects.

Is Claritin^® safe in the pediatric population?

Pediatric Use: The safety of Claritin^® Syrup at a daily dose of 10 mg has been demonstrated in 188 pediatric patients 6-12 years of age in placebo-controlled 2-week trials. The effectiveness of Claritin for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria in this pediatric age group is based on an extrapolation of the demonstrated efficacy of Claritin® in adults in these conditions and the likelihood that the disease course, pathophysiology, and the drugâs effect are substantially similar to that of the adults. The recommended dose for the pediatric population is based on cross-study comparison of the pharmacokinetics of Claritin® in adults and pediatric subjects and on the safety profile of loratadine in both adults and pediatric patients at doses equal to or higher than the recommended doses. The safety and effectiveness of Claritin® in pediatric patients under 6 years of age have not been established.

Is Claritin safe in the elderly population aged 65 plus?

In a study involving twelve healthy geriatric subjects (66 to 78 years old), the AUC and peak plasma levels (Cmax) of both loratadine and descarboethoxyloratadine were approximately 50% greater than those observed in studies of younger subjects. The mean elimination half-lives for the geriatric subjects were 18.2 hours (range = 6.7 to 37 hours) for loratadine and 17.5 hours (range = 11 to 38 hours) for descarboethoxyloratadine.

Can renal individuals with renal impairment take Claritin?

In a study involving 12 subjects with chronic renal impairment (creatinine clearance < 30 ml/min) both AUC and Cmax increased by approximately 73% for loratadine and by 120% for descarboethoxyloratadine, as compared to 6 subjects with normal renal function (creatinine clearance > 80 ml/min). The mean elimination half-lives of loratadine (7.6 hours) and descarboethoxyloratadine (23.9 hours) were not substantially different from that observed in normal subjects. Hemodialysis does not have an effect on the pharmacokinetics of loratadine or descarboethoxyloratadine in subjects with chronic renal impairment.

How about liver disease?

In seven patients with chronic alcoholic liver disease, the AUC and Cmax of loratadine were double while the pharmacokinetic profile of descarboethoxyloratadine was not substantially different from that observed in other trials enrolling normal subjects. The elimination half-lives for loratadine and descarboethoxyloratadine was 24 hours and 37 hours, respectively, and increased with increasing severity of liver disease.

When is Claritin contraindicated?

Claritin® is contraindicated in patients who are hypersensitive to this medication or to any of its ingredients.  Additionally, patients with liver impairment or renal insufficiency (GFR < 30 ml/min) should be given a lower initial dose (10 mg every other day). 

When is Claritin-D 24 Hour contraindicated?

Some people should not take Claritin-D^® 24 Hour. If you have a history of difficulty in swallowing tablets or any medical problems associated with swallowing abnormalities, you should not take Claritin-D^® 24 Hour. Due to pseudoephedrine (the decongestant in Claritin-D^® 24 Hour tablets and many over-the-counter allergy medications), you should not take Claritin-D^® 24 Hour if you have glaucoma (abnormally high pressure in your eyes), difficulty urinating, severe high blood pressure, severe heart disease, or are taking MAO inhibitors (certain prescription medications that treat depression). Some people need to be especially careful using Claritin-D^® 24 Hour. Always take Claritin-D^® 24 Hour with a full glass of water. Also, the tablets must not be chewed or broken. Check with your healthcare provider before taking Claritin-D^® 24 HOUR if you have high blood pressure; diabetes; heart disease; increased intraocular pressure (eye pressure); thyroid, liver, or kidney problems; enlarged prostate; or if you are pregnant, planning to become pregnant, or nursing a baby. You shouldn't take Claritin-D ^® 24 Hour with any other antihistamines and decongestants as too much pseudoephedrine sulfate can cause nervousness, sleeplessness, dizziness, and other related side effects.

Are there any know drug interactions associated with Claritin?

Loratadine (10 mg once daily) has been coadministered with therapeutic doses of erythromycin, cimetidine, and ketoconazole in controlled clinical pharmacology studies in adult volunteers. Although increased plasma concentrations (AUC 0-24 hrs) of loratadine and/or descarboethoxyloratadine were observed following coadministration of loratadine with each of these drugs in normal volunteers (n = 24 in each study), there were no clinically relevant changes in the safety profile of loratadine, as assessed by electrocardiographic parameters, clinical laboratory tests, vital signs, and adverse events. There were no significant effects on QTc intervals, and no reports of sedation or syncope. No effects on plasma concentrations of cimetidine or ketoconazole were observed. Plasma concentrations (AUC 0-24 hrs) of erythromycin decreased 15% with coadministration of loratadine relative to that observed with erythromycin alone. The clinical relevance of this difference is unknown.  There does not appear to be an increase in adverse events in subjects who received oral contraceptives and loratadine.

Is there any carcinogenesis, mutagenesis, or impairment of fertility associated with Claritin?

In an 18-month carcinogenicity study in mice and a 2-year study in rats, loratadine was administered in the diet at doses up to 40 mg/kg (mice) and 25 mg/kg (rats). In the carcinogenicity studies, pharmacokinetic assessments were carried out to determine animal exposure to the drug. AUC data demonstrated that the exposure of mice given 40 mg/kg of loratadine was 3.6 (loratadine) and 18 (descarboethoxyloratadine) times higher than in humans given the maximum recommended daily oral dose. Exposure of rats given 25 mg/kg of loratadine was 28 (loratadine) and 67 (descarboethoxyloratadine) times higher than in humans given the maximum recommended daily oral dose. Male mice given 40 mg/kg had a significantly higher incidence of hepatocellular tumors (combined adenomas and carcinomas) than concurrent controls. In rats, a significantly higher incidence of hepatocellular tumors (combined adenomas and carcinomas) was observed in males given 10 mg/kg and males and females given 25 mg/kg. The clinical significance of these findings during long-term use of Claritin® is not known.

In mutagenicity studies, there was no evidence of mutagenic potential in reverse (Ames) or forward point mutation (CHO-HGPRT) assays, or in the assay for DNA damage (rat primary hepatocyte unscheduled DNA assay) or in two assays for chromosomal aberrations (human peripheral blood lymphocyte clastogenesis assay and the mouse bone marrow erythrocyte micronucleus assay). In the mouse lymphoma assay, a positive finding occurred in the nonactivated but not the activated phase of the study.

Decreased fertility in male rats, shown by lower female conception rates, occurred at an oral dose of 64 mg/kg (approximately 50 times the maximum recommended human daily oral dose on a mg/m2 basis) and was reversible with cessation of dosing. Loratadine had no effect on male or female fertility or reproduction in the rat at an oral dose of approximately 24 mg/kg (approximately 20 times the maximum recommended human daily oral dose on a mg/m2 basis).

There was no evidence of animal teratogenicity in studies performed in rats and rabbits at oral doses up to 96 mg/kg (approximately 75 times and 150 times, respectively, the maximum recommended human daily oral dose on a mg/m2 basis). There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Claritin® should be used during pregnancy only if clearly needed.

Should nursing mothers take Claritin?

Loratadine and its metabolite, descarboethoxyloratadine, pass easily into breast milk and achieve concentrations that are equivalent to plasma levels with an AUCmilk/AUCplasma ratio of 1.17 and 0.85 for loratadine and descarboethoxyloratadine, respectively. Following a single oral dose of 40 mg, a small amount of loratadine and descarboethoxyloratadine was excreted into the breast milk (approximately 0.03% of 40 mg over 48 hours). A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Caution should be exercised when Claritin® is administered to a nursing woman.

Is there a risk for drug dependence associated with Claritin?

There is no information to indicate that abuse or dependency occurs with Claritin®.

What about a drug overdose involving Claritin? 

In adults, somnolence, tachycardia, and headache have been reported with overdoses greater than 10 mg with the Tablet formulation (40 to 180 mg). Extrapyramidal signs and palpitations have been reported in children with overdoses of greater than 10 mg of Claritin® Syrup. In the event of overdosage, individuals should seek immediate medical attention.

No deaths occurred at oral doses up to 5000 mg/kg in rats and mice (greater than 2400 and 1200 times, respectively, the maximum recommended human daily oral dose on a mg/m2 basis). Single oral doses of loratadine showed no effects in rats, mice, and monkeys at doses as high as 10 times the maximum recommended human daily oral dose on a mg/m2 basis.

How is Claritin supplied?

Claritin® Tablets: 10 mg, white to off-white compressed tablets; impressed with the product identification number "458" on one side and "Claritin 10" on the other; high-density polyethylene plastic bottles of 100 (NDC 0085-0458-03) and 500 (NDC 0085-0458-06). Also available, Claritin® Unit-of-Use packages of 14 tablets (7 tablets per blister card) (NDC 0085-0458-01) and 30 tablets (10 tablets per blister card) (NDC 0085-0458-05); and 10 x 10 tablet Unit Dose-Hospital Pack (NDC 0085-0458-04).

Claritin® Reditabs (loratadine rapidly-disintegrating tablets): Claritin® Reditabs (loratadine rapidly-disintegrating tablets), 10 mg, white to off-white blister-formed tablet; Unit-of-Use polyvinyl chloride blister packages of 30 tablets (3 laminated foil pouches, each containing one blister card of 10 tablets) supplied with Patientâs Instructions for Use (NDC 0085-1128-02).

How should Claritin be stored?

Keep Claritin® in a dry place. Store between 2ˇ and 25ˇC (36ˇ and 77ˇF).  Like all medications store in a place that is secure from children.

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