Saturday, December 20, 2014
Home
Claritin D

Claritin D


View Slideshow Pictures

Claritin D Drug Description


Claritin D
(loratadine and pseudoephedrine) 12 hour and 24 hour Extended Release Tablets

Now available Over-the-Counter

DRUG DESCRIPTION

Claritin-D 12 Hour Extended Release Tablets: Claritin-D 12 hour extended release tablets contain 5 mg loratadine in the tablet coating for immediate release and 120 mg pseudoephedrine sulfate equally distributed between the tablet coating for immediate release and the barrier-coated extended release core.

The inactive ingredients are acacia, butylparaben, calcium sulfate, carnauba wax, corn starch, lactose, magnesium stearate, microcrystalline cellulose, neutral soap, oleic acid, povidone, rosin, sugar, talc, titanium dioxide, white wax, and zein.

Claritin-D 24 Hour Extended Release Tablets: Claritin-D 24 hour extended release tablets contain 10 mg loratadine in the tablet film coating for immediate release and 240 mg pseudoephedrine sulfate in the tablet core which is released slowly allowing for once-daily administration.

The inactive ingredients for oval, biconvex Claritin-D 24 hour extended release tablets are calcium phosphate, carnauba wax, ethylcellulose, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, povidone, silicon dioxide, sugar, titanium dioxide, and white wax.

Loratadine is a long-acting antihistamine having the empirical formula C22H23ClN2O2; the chemical name ethyl 4-(8-chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-1-piperidinecarboxylate.

The molecular weight of loratadine is 382.89. It is a white to off-white powder, not soluble in water, but very soluble in acetone, alcohol, and chloroform.

Pseudoephedrine sulfate is the synthetic salt of one of the naturally occurring dextrorotatory diastereomers of ephedrine and is classified as an indirect sympathomimetic amine. The empirical formula for pseudoephedrine sulfate is (C10H15NO)2H2SO4; the chemical name is a-[1-(methyl-amino) ethyl]-[S-(R*,R*)]-benzenemethanol sulfate (2:1)(salt).

The molecular weight of pseudoephedrine sulfate is 428.54. It is a white powder, freely soluble in water and methanol and sparingly soluble in chloroform.

 

What are the possible side effects of desloratadine and pseudoephedrine (Claritin-D, Claritin-D 24 Hour)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeat;
  • confusion, hallucinations, unusual thoughts or behavior;
  • severe dizziness, anxiety, restless feeling, or nervousness;
  • increased blood pressure (severe...

Read All Potential Side Effects and See Pictures of Claritin D »

 

What are the precautions when taking loratadine and pseudoephedrine (Claritin D)?

Before taking loratadine with pseudoephedrine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: glaucoma (narrow angle type), severe difficulty urinating (urinary retention), severe high blood pressure, severe heart/blood vessel disease (coronary artery disease), liver disease, experienced serious side effects with decongestants (irregular heart rhythm).

Before using this medication, tell your doctor or pharmacist your medical history,...

 

Claritin D


Claritin D Indications & Dosage


INDICATIONS

Loratadine; pseudoephedrine sulfate extended release tablets are indicated for the relief of symptoms of seasonal allergic rhinitis. Loratadine; pseudoephedrine sulfate extended release tablets should be administered when both the antihistaminic properties of loratadine and the nasal decongestant activity of pseudoephedrine are desired (see CLINICAL PHARMACOLOGY).

DOSAGE AND ADMINISTRATION

Adults and Children 12 Years of Age and Over: 12 Hour Tablet: One tablet twice a day (every 12 hours); 24 Hour Tablet: One tablet daily taken with a full glass of water (see PRECAUTIONS and ADVERSE REACTIONS). Because the doses of this fixed combination product cannot be individually titrated and hepatic insufficiency results in a reduced clearance of loratadine to a much greater extent than pseudoephedrine, loratadine; pseudoephedrine sulfate extended release tablets should generally be avoided in patients with hepatic insufficiency. Patients with renal insufficiency (GFR <30 ml/min) should be given a lower initial dose (one 12 hour tablet per day, or one 24 hour tablet every other day) because they have reduced clearance of loratadine and pseudoephedrine. Patients who have a history of difficulty in swallowing tablets or who have known upper gastrointestinal narrowing or abnormal esophageal peristalsis should not use the 24 hour tablet (see PRECAUTIONS, Information for the Patient; and ADVERSE REACTIONS).

HOW SUPPLIED

Claritin-D 12 Hour Extended Release Tablets

Claritin-D 12 hour extended release tablets contain 5 mg loratadine and 120 mg pseudoephedrine sulfate. Claritin-D 12 hour extended release tablets are white tablets branded in green with "CLARITIN-D".

Storage: Keep Unit-of-Use packaging and Unit Dose-Hospital Pack in a dry place. Store between 2-25°C (36-77°F).

Claritin-D 24 Hour Extended Release Tablets

Claritin-D 24 hour extended release tablets contain 10 mg loratadine in the tablet coating for immediate release and 240 mg pseudoephedrine sulfate in an extended-release core. Claritin-D 24 hour extended release tablets are white to off-white oval, biconvex, coated tablets branded in black with "CLARITIN-D 24 HOUR".

Storage: Protect Unit Dose-Hospital Pack from light and store in a dry place. Store between 15-25°C (59-77°F).

 

Claritin D


Claritin D Side Effects & Drug Interactions


SIDE EFFECTS

Loratadine; Pseudoephedrine Sulfate 12 Hour Extended Release Tablets

Experience from controlled and uncontrolled clinical studies involving approximately 10,000 patients who received the combination of loratadine; pseudoephedrine sulfate for a period of up to 1 month provides information on adverse reactions. The usual dose was one tablet every 12 hours for up to 28 days.

In controlled clinical trials using the recommended dose of one tablet every 12 hours, the incidence of reported adverse events was similar to those reported with placebo, with the exception of insomnia (16%) and dry mouth (14%).

TABLE 2 Reported Adverse Events with an Incidence of ³2% in Loratadine; Pseudoephedrine Sulfate 12 Hour Extended Release Tablets in Placebo-Controlled Clinical Trials
Percent of Patients Reporting
Loratadine; Pseudoephedrine Sulfate 12 Hour Loratadine Pseudoephedrine Placebo
n=1023 n=543 n=548 n=922
Headache 19 18 17 19
Insomnia 16 4 19 3
Dry Mouth 14 4 9 3
Somnolence 7 8 5 4
Nervousness 5 3 7 2
Dizziness 4 1 5 2
Fatigue 4 6 3 3
Dyspepsia 3 2 3 1
Nausea 3 2 3 2
Pharyngitis 3 3 2 3
Anorexia 2 1 2 1
Thirst 2 1 2 1

 

Adverse event rates did not appear to differ significantly based on age, sex, or race, although the number of non-white subjects was relatively small.

In addition to those adverse events reported above (³2%), the following less frequent adverse events have been reported in at least one patient treated with loratadine; pseudoephedrine sulfate 12 hour extended release tablets.

Autonomic Nervous System: Abnormal lacrimation, dehydration, flushing, hypoesthesia, increased sweating, mydriasis.

Body as a Whole: Asthenia, back pain, blurred vision, chest pain, conjunctivitis, earache, ear infection, eye pain, fever, flu-like symptoms, leg cramps, lymphadenopathy, malaise, photophobia, rigors, tinnitus, viral infection, weight gain.

Cardiovascular System: Hypertension, hypotension, palpitations, peripheral edema, syncope, tachycardia, ventricular extrasystoles.

Central and Peripheral Nervous System: Dysphonia, hyperkinesia, hypertonia, migraine, paresthesia, tremors, vertigo.

Gastrointestinal System: Abdominal distension, abdominal distress, abdominal pain, altered taste, constipation, diarrhea, eructation, flatulence, gastritis, gingival bleeding, hemorrhoids, increased appetite, stomatitis, taste loss, tongue discoloration, toothache, vomiting.

Liver and Biliary System: Hepatic function abnormal.

Musculoskeletal System: Arthralgia, myalgia, torticollis.

Psychiatric: Aggressive reaction, agitation, anxiety, apathy, confusion, decreased libido, depression, emotional lability, euphoria, impaired concentration, irritability, paroniria.

Reproductive System: Dysmenorrhea, impotence, intermenstrual bleeding, vaginitis.

Respiratory System: Bronchitis, bronchospasm, chest congestion, coughing, dry throat, dyspnea, epistaxis, halitosis, nasal congestion, nasal irritation, sinusitis, sneezing, sputum increased, upper respiratory infection, wheezing.

Skin and Appendages: Acne, bacterial skin infection, dry skin, eczema, edema, epidermal necrolysis, erythema, hematoma, pruritus, rash, urticaria.

Urinary System: Dysuria, micturition frequency, nocturia, polyuria, urinary retention.

24 Hour Extended Release Tablets

Information on adverse reactions is provided from placebo-controlled studies involving over 2000 patients, 605 of whom received loratadine; pseudoephedrine sulfate 24 hour extended release tablets once daily for up to 2 weeks. In these studies, the incidence of adverse events reported with loratadine; pseudoephedrine sulfate 24 hour extended release tablets was similar to those reported with twice-daily (q12h) 120 mg sustained-release pseudoephedrine alone.

TABLE 3 Reported Adverse Events With an Incidence of ³2% in Loratadine; Pseudoephedrine Sulfate 24 Hour Extended Release Tablets Treatment Group in Double-Blind, Randomized, Placebo-Controlled Clinical Trials
Percent of Patients Reporting
Loratadine; phedrine Sulfate 24 Hour Loratadine 10 mg Pseudoephedrine 120 mg q12h Placebo
(n = 605) (n = 449) (n = 220) (n = 605)
Dry Mouth 8 2 7 2
Somnolence 6 4 5 4
Insomnia 5 1 9 1
Pharyngitis 5 5 5 5
Dizziness 4 2 3 2
Coughing 3 2 3 1
Fatigue 3 4 1 2
Nausea 3 2 4 2
Nervousness 3 1 4 1
Anorexia 2 <1 2
Dysmenorrhea 2 2 2 1

 

Adverse events occurring in greater than or equal to 2% of loratadine; pseudoephedrine sulfate 24 hour extended release tablets-treated patients, but that were more common in the placebo-treated group, include headache.

Adverse events did not appear to significantly differ based on age, sex, or race, although the number of nonwhites was relatively small.

In addition to those adverse events reported above, the following adverse events have been reported in fewer than 2% of patients who received loratadine; pseudoephedrine sulfate 24 hour extended release tablets.

Autonomic Nervous System: Altered lacrimation, flushing, increased sweating, mydriasis, thirst.

Body as a Whole: Abnormal vision, asthenia, back pain, chest pain, conjunctivitis, earache, eye pain, facial edema, fever, flu-like symptoms, leg cramps, lymphadenopathy, malaise, rigors, tinnitus.

Cardiovascular System: Hypertension, palpitation, tachycardia.

Central and Peripheral Nervous System: Convulsions, dysphonia, hyperkinesis, hypertonia, migraine, paresthesia, tremor.

Gastrointestinal System: Abdominal distension, altered taste, constipation, diarrhea, dyspepsia, flatulence, gastritis, stomatitis, tongue ulceration, toothache, vomiting.

Liver and Biliary System: Cholelithiasis.

Musculoskeletal System: Arthralgia, musculoskeletal pain, myalgia, tendinitis.

Psychiatric: Agitation, depression, emotional lability, irritability.

Reproductive System: Vaginitis.

Resistance Mechanism: Abscess, viral infection.

Respiratory System: Bronchospasm, dyspnea, epistaxis, hemoptysis, nasal congestion, nasal irritation, pleurisy, pneumonia, sinusitis, sputum increased, wheezing.

Skin and Appendages: Acne, pruritus.

Urinary System: Oliguria, micturition frequency, urinary retention, urinary tract infection.

Additional adverse events reported with the combination of loratadine and pseudoephedrine include abnormal hepatic function, aggressive reaction, anxiety, apathy, confusion, euphoria, paroniria, postural hypotension, syncope, urticaria, vertigo, weight gain.

There have been postmarketing reports of mechanical upper gastrointestinal tract obstruction and esophageal perforation in patients taking a previously marketing formulation of loratadine; pseudoephedrine sulfate 24 hour extended release tablets. In some, but not all, of these cases, patients have had known upper gastrointestinal narrowing or abnormal esophageal peristalsis. It is not known whether this reformulation of loratadine; pseudoephedrine sulfate 24 hour extended release tablets has the potential for this adverse event (see PRECAUTIONS and DOSAGE AND ADMINISTRATION).

12 and 24 Hour Extended Release Tablets

The Following Additional Adverse Events Have Been Reported With Loratadine; Pseudoephedrine Sulfate Tablets: Alopecia, altered salivation, amnesia, anaphylaxis, angioneurotic edema, blepharospasm, breast enlargement, breast pain, dermatitis, dry hair, erythema multiforme, laryngitis, menorrhagia, nasal dryness, photosensitivity reaction, purpura, seizures, sneezing, supraventricular tachyarrhythmias, urinary discoloration. Additional Adverse Events for 24 Hour Extended Release Tablets Only: Abdominal distress, altered micturition, bronchitis, decreased libido, dry skin, hypoesthesia, impaired concentration, impotence, increased appetite, peripheral edema, rash, and upper respiratory infection.

Pseudoephedrine may cause mild CNS stimulation in hypersensitive patients. Nervousness, excitability, restlessness, dizziness, weakness, or insomnia may occur. Headache, drowsiness, tachycardia, palpitation, pressor activity, and cardiac arrhythmias have been reported. Sympathomimetic drugs have also been associated with other untoward effects, such as fear, anxiety, tenseness, tremor, hallucinations, seizures, pallor, respiratory difficulty, dysuria, and cardiovascular collapse.

DRUG ABUSE AND DEPENDENCE

There is no information to indicate that abuse or dependency occurs with loratadine. Pseudoephedrine, like other central nervous system stimulants, has been abused. At high doses, subjects commonly experience an elevation of mood, a sense of increased energy and alertness, and decreased appetite. Some individuals become anxious, irritable, and loquacious. In addition to the marked euphoria, the user experiences a sense of markedly enhanced physical strength and mental capacity. With continued use, tolerance develops, the user increases the dose, and toxic signs and symptoms appear. Depression may follow rapid withdrawal.

DRUG INTERACTIONS

No specific interaction studies have been conducted with loratadine; pseudoephedrine extended release tablets. However, loratadine (10 mg once daily) has been safely coadministered with therapeutic doses of erythromycin, cimetidine, and ketoconazole in controlled clinical pharmacology studies. 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 was no significant effects on QTc intervals, and no reports of sedation of 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. These above findings are summarized in TABLE 1.

TABLE 1 Effects on Plasma Concentrations (AUC 0-24 hrs) of Loratadine and Descarboethoxyloratadine After 10 Days of Coadministration (Loratadine 10 mg) in Normal Volunteers
Loratadine Descarboethoxyloratadine
Erythromycin (500 mg q8h) +40% +46%
Cimetidine (300 mg q.i.d.) +103% +6%
Ketoconazole (200 mg q12h) +307% +73%

 

There does not appear to be an increase in adverse events in subjects who received oral contraceptives and loratadine.

Loratadine; pseudoephedrine sulfate extended release tablets (pseudoephedrine component) are contraindicated in patients taking monoamine oxidase inhibitors and for 2 weeks after stopping use of an MAO inhibitor. The antihypertensive effects of beta-adrenergic blocking agents, methyldopa, mecamylamine, reserpine, and veratrum alkaloids may be reduced by sympathomimetics. Increased ectopic pacemaker activity can occur when pseudoephedrine is used concomitantly with digitalis.

 

Claritin D

 

Claritin D Warnings & Precautions


WARNINGS

Loratadine; pseudoephedrine sulfate extended release tablets should be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment, or prostatic hypertrophy. Central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension may be produced by sympathomimetic amines.

Use in Patients Approximately 60 Years of Age and Older: The safety and efficacy of loratadine; pseudoephedrine sulfate extended release tablets in patients greater than 60 years old have not been investigated in placebo-controlled clinical trials. The elderly are more likely to have adverse reactions to sympathomimetic amines.

PRECAUTIONS

General

Loratadine; Pseudoephedrine Sulfate 24 Hour Extended Release Tablets: Because there have been reports of esophageal obstruction and perforation in patients who have taken a previously marketed formulation of CLARITIN-D 24 HOUR Extended Release Tablets, it is recommended that patients who have a history of difficulty in swallowing tablets or who have known upper gastrointestinal narrowing or abnormal esophageal peristalsis not use this product. Furthermore, since it is not known whether this formulation of CLARITIN-D 24 HOUR Extended Release Tablets has the potential for this adverse event, it is reasonable to recommend that all patients take this product with a full glass of water (see Information for the Patient, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION).

Loratadine; Pseudoephedrine Sulfate 12 and 24 Hour Extended Release Tablets: Because the doses of this fixed combination product cannot be individually titrated and hepatic insufficiency results in a reduced clearance of loratadine to a much greater extent than pseudoephedrine, loratadine; pseudoephedrine sulfate extended release tablets should generally be avoided in patients with hepatic insufficiency. Patients with renal insufficiency (GFR <30 ml/min) should be given a lower initial dose (one 12 hour tablet per day and one 24 hour tablet every other day) because they have reduced clearance of loratadine and pseudoephedrine.

Information for the Patient

Patients Taking Loratadine; Pseudoephedrine Sulfate Extended Release Tablets Should Receive the Following Information: Loratadine; pseudoephedrine sulfate extended release tablets are prescribed for the relief of symptoms of seasonal allergic rhinitis. Patients should be instructed to take loratadine; pseudoephedrine sulfate extended release tablets only as prescribed and not to exceed the prescribed dose. Patients should also be advised against the concurrent use of loratadine; pseudoephedrine sulfate extended release tablets with over-the-counter antihistamines and decongestants.

Patients who have a history of difficulty in swallowing tablets or who have known upper gastrointestinal narrowing or abnormal esophageal peristalsis should not use the 24 hour tablet.

This product should not be used by patients who are hypersensitive to it or to any of its ingredients. Due to its pseudoephedrine component, this product should not be used by patients with narrow-angle glaucoma, urinary retention, or by patients receiving a monoamine oxidase (MAO) inhibitor or within 14 days of stopping use of an MAO inhibitor. It also should not be used by patients with severe hypertension or severe coronary artery disease.

Patients who are or may become pregnant should be told that this product should be used in pregnancy or during lactation only if the potential benefit justifies the potential risk to the fetus or nursing infant.

Patients should be instructed not to break or chew the tablet and to take the 24 hour tablet with a full glass of water (see General, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION).

Drug/Laboratory Test Interactions

The in vitro addition of pseudoephedrine to sera containing the cardiac isoenzyme MB of serum creatinine phosphokinase progressively inhibits the activity of the enzyme. The inhibition becomes complete over 6 hours.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

There are no animal or laboratory studies on the combination product loratadine and pseudoephedrine sulfate to evaluate carcinogenesis, mutagenesis, or impairment of fertility.

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 (active metabolite) times higher than a human given 10 mg/day of loratadine; pseudoephedrine sulfate 12 hour extended release tablets (for the 24 hour extended release tablets, in humans given the maximum recommended daily oral dose). Exposure of rats given 25 mg/kg of loratadine was 28 (loratadine) and 67 (active metabolite) times higher than in humans given the maximum recommended daily oral dose (for the 24 hour extended release tablets, 10 mg/day). 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 in males and females given 25 mg/kg. The clinical significance of these findings during long-term use of loratadine is not known.

Loratadine; Pseudoephedrine Sulfate 12 Hour Extended Release Tablets Only: Loratadine administration produced hepatic microsomal enzyme induction in the mouse at 40 mg/kg and rat at 25 mg/kg, but not at lower doses.

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

Loratadine; Pseudoephedrine Sulfate 24 Hour Extended Release Tablets Only: Two-year feeding studies in mice and rats conducted under the auspices of the National Toxicology Programs (NTP) uncovered no evidence of carcinogenic potential of ephedrine sulfate at doses up to 10 and 27 mg/kg, respectively (approximately 16% and 100% of the maximum recommended human daily oral dose of pseudoephedrine sulfate on a mg/m2 basis).

In mutagenicity studies with loratadine alone, 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.

Pregnancy Category B

Loratadine; Pseudoephedrine Sulfate 12 Hour Extended Release Tablets: There was no evidence of animal teratogenicity in reproduction studies performed on rats and rabbits with this combination at oral doses up to 150 mg/kg (885 mg/m2 or 5 times the recommended daily human dosage of 250 mg or 185 mg/m2), and 120 mg/kg (1416 mg/m2 or 8 times the recommended daily human dosage), respectively.

Loratadine; Pseudoephedrine Sulfate 24 Hour Extended Release Tablets: The combination product loratadine; pseudoephedrine sulfate was evaluated for teratogenicity in rats and rabbits. There was no evidence of teratogenicity in reproduction studies with this combination of the same clinical ratio (1:24) at oral doses up to 150 mg/kg (approximately 5 times the maximum recommended daily human dose on a mg/m2 basis) in rats, and 120 mg/kg (approximately 8 times the maximum recommended daily human dose on a mg/m2 basis) in rabbits. Similarly, no evidence of animal teratogenicity in rats and rabbits was reported at oral doses up to 96 mg/kg of loratadine alone (approximately 75 and 150 times, respectively, the maximum human daily oral dose on a mg/m2 basis).

Loratadine; Pseudoephedrine Sulfate 12 and 24 Hour Extended Release Tablets: There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, loratadine; pseudoephedrine sulfate extended release tablets should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known if this combination product is excreted in human milk. However, loratadine when administered alone 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 the parent and active metabolite, respectively. Following a single oral dose of 40 mg, a small amount of loratadine and metabolite was excreted into the breast milk (approximately 0.03% of 40 mg over 48 hours). Pseudoephedrine administered alone also distributes into breast milk of the lactating human female. Pseudoephedrine concentrations in milk are consistently higher than those in plasma. The total amount of drug in milk as judged by the area under the curve (AUC) is 2 to 3 times greater than in plasma. The fraction of a pseudoephedrine dose excreted in milk is estimated to be 0.4% to 0.7%. 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 loratadine; pseudoephedrine sulfate 12 and 24 hour extended release tablets are administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children below the age of 12 years have not been established.

 

Claritin D


Claritin D Overdosage & Contraindications


OVERDOSE

In the event of overdosage, general symptomatic and supportive measures should be instituted promptly and maintained for as long as necessary. Treatment of overdosage would reasonably consist of emesis (ipecac syrup), except in patients with impaired consciousness, followed by the administration of activated charcoal to absorb any remaining drug. If vomiting is unsuccessful, or contraindicated, gastric lavage should be performed with normal saline. Saline cathartics may also be of value for rapid dilution of bowel contents. Loratadine is not eliminated by hemodialysis. It is not known if loratadine is eliminated by peritoneal dialysis.

Somnolence, tachycardia, and headache have been reported with doses of 40 to 180 mg of loratadine; pseudoephedrine. In large doses, sympathomimetics may give rise to giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tenseness, anxiety, restlessness, and insomnia. Many patients can present a toxic psychosis with delusions and hallucinations. Some may develop cardiac arrhythmias, circulatory collapse, convulsions, coma, and respiratory failure.

The oral median lethal dose for the mixture of the two drugs was greater than 525 and 1839 mg/kg in mice and rats, respectively (approximately 10 and 58 times the maximum recommended human daily oral loratadine; pseudoephedrine sulfate 24 hour dose on a mg/m2 basis). The oral median lethal dose for loratadine was greater than 5000 mg/kg in rats and mice (greater than 2000 times the maximum recommended human daily oral loratadine; pseudoephedrine sulfate 24 hourdose 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.

CONTRAINDICATIONS

Loratadine; pseudoephedrine sulfate extended release tablets are contraindicated in patients who are hypersensitive to this medication or to any of its ingredients.

This product, due to its pseudoephedrine component, is contraindicated in patients with narrow-angle glaucoma or urinary retention, and in patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment (see DRUG INTERACTIONS). It is also contraindicated in patients with severe hypertension, severe coronary artery disease, and in those who have shown hypersensitivity or idiosyncrasy to its components, to adrenergic agents, or to other drugs of similar chemical structures. Manifestations of patient idiosyncrasy to adrenergic agents include: insomnia, dizziness, weakness, tremor, or arrhythmias.

 

Claritin D


Claritin D Clinical Pharmacology


CLINICAL PHARMACOLOGY

The following information is based upon studies of loratadine alone or pseudoephedrine alone, except as indicated.

Loratadine is a long-acting tricyclic antihistamine with selective peripheral histamine H1-receptor antagonistic activity.

Human histamine skin wheal studies following single and repeated oral doses of loratadine 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 developing after 28 days of dosing with loratadine.

Pharmacokinetic studies following single and multiple oral doses of loratadine in 115 volunteers showed that loratadine is rapidly absorbed and extensively metabolized to an active metabolite (descarboethoxyloratadine). Approximately 80% of the total dose administered can be found equally distributed between urine and feces in the form of metabolic products after 10 days. The mean elimination half-lives found in studies in normal adult subjects (n = 54) were 8.4 hours (range = 3 to 20 hours) for loratadine and 28 hours (range = 8.8 to 92 hours) for the major active metabolite (descarboethoxyloratadine). In nearly all patients, exposure (AUC) to the metabolite is greater than exposure to parent loratadine. Loratadine and descarboethoxyloratadine reached steady-state in most patients by approximately the fifth dosing day. The pharmacokinetics of loratadine and descarboethoxyloratadine are dose independent over the dose range of 10 to 40 mg and are not significantly altered by the duration of treatment.

In vitro studies with human liver microsomes indicate that loratadine is metabolized to descarboethoxyloratadine predominantly by P450 CYP3A4 and, to a lesser extent, by P450 CYP2D6. In the presence of a CYP3A4 inhibitor ketoconazole, loratadine is metabolized to descarboethoxyloratadine predominantly by CYP2D6. Concurrent administration of loratadine with either ketoconazole, erythromycin (both CYP3A4 inhibitors), or cimetidine (CYP2D6 and CYP3A4 inhibitor) to healthy volunteers was associated with significantly increased plasma concentrations of loratadine (see DRUG INTERACTIONS).

In a study involving 12 healthy geriatric subjects (66 to 78 years old), the AUC and peak plasma levels (Cmax) of both loratadine and descarboethoxyloratadine were significantly higher (approximately 50% increased) than in studies of younger subjects. The mean elimination half-lives for the elderly subjects were 18.2 hours (range = 6.7 to 37 hours) for loratadine and 17.5 hours (range = 11 to 38 hours) for the active metabolite.

Loratadine; Pseudoephedrine Sulfate 12 hour Extended Release Tablets Only: In the clinical efficacy studies, loratadine was administered before meals. In a single-dose study, food increased the AUC of loratadine by approximately 40% and of descarboethoxyloratadine by approximately 15%. The time of peak plasma concentration (Tmax) of loratadine and descarboethoxyloratadine was delayed by 1 hour with a meal.

In patients with chronic renal impairment (creatinine clearance £30 ml/min) both the AUC and peak plasma levels (Cmax) increased on average by approximately 73% for loratadine; and approximately by 120% for descarboethoxyloratadine, compared to individuals with normal renal function. The mean elimination half-lives of loratadine (7.6 hours) and descarboethoxyloratadine (23.9 hours) were not significantly different from that observed in normal subjects. Hemodialysis does not have an effect on the pharmacokinetics of loratadine or its active metabolite (descarboethoxyloratadine) in subjects with chronic renal impairment.

In patients with chronic alcoholic liver disease the AUC and peak plasma levels (Cmax) of loratadine were double while the pharmacokinetic profile of the active metabolite (descarboethoxyloratadine) was not significantly changed from that in normals. The elimination half-lives for loratadine and descarboethoxyloratadine were 24 hours and 37 hours, respectively, and increased with increasing severity of liver disease.

There was considerable variability in the pharmacokinetic data in all studies of loratadine, probably due to the extensive first-pass metabolism. Individual histograms of area under the curve, clearance, and volume of distribution showed a log normal distribution with a 25-fold range in distribution in healthy subjects.

Loratadine is about 97% bound to plasma proteins at the expected plasma concentrations (2.5 to 100 ng/ml) after a therapeutic dose. Loratadine does not affect the plasma protein binding of warfarin and digoxin. The metabolite descarboethoxyloratadine is 73% to 77% bound to plasma proteins (at 0.5 to 100 ng/ml).

Whole body autoradiographic studies in rats and monkeys, radiolabeled tissue distribution studies in mice and rats, and in vivo radioligand studies in mice have shown that neither loratadine nor its metabolites readily cross the blood-brain barrier. Radioligand binding studies with guinea pig pulmonary and brain H1-receptors indicate that there was preferential binding to peripheral versus central nervous system H1-receptors.

In a study in which loratadine alone was administered at four times the clinical dose for 90 days, no clinically significant increase in the QTc was seen on ECGs.

In a single-rising dose study of loratadine alone in which doses up to 160 mg (16 times the clinical dose) were administered, no clinically significnt changes on the QTc interval in the ECGs were observed.

Pseudoephedrine sulfate (d-isoephedrine sulfate) is an orally active sympathomimetic amine which exerts a decongestant action on the nasal mucosa. It is recognized as an effective agent for the relief of nasal congestion due to allergic rhinitis. Pseudoephedrine produces peripheral effects similar to those of ephedrine and central effects similar to, but less intense than, amphetamines. It has the potential for excitatory side effects.

The bioavailability of loratadine; pseudoephedrine sulfate from loratadine; pseudoephedrine sulfate 24 hour extended release tablets is similar to that achieved with separate administration of the components. Coadministration of loratadine and pseudoephedrine does not significantly affect the bioavailability of either component.

In a single-dose study, food increased the AUC of loratadine by approximately 125% and Cmax by approximately 80%. However, food did not significantly affect the pharmacokinetics of pseudoephedrine sulfate or descarboethoxyloratadine.

Loratadine; Pseudoephedrine Sulfate 12 hour Extended Release Tablets Only: The pseudoephedrine component of loratadine; pseudoephedrine sulfate 12 hour extended release tablets was absorbed at a similar rate and was equally available from the combination tablet as from a pseudoephedrine sulfate repetabs 120 mg tablet. Mean (%CV) steady-state peak plasma concentration of 464 ng/mL (22) was attained at 3.9 hours (50). The terminal half-life of pseudoephedrine from the combination tablet administered twice daily was 6.3 hours (23). The ingestion of food was found not to affect the absorption of pseudoephedrine from loratadine; pseudoephedrine sulfate 12 hour extended release tablets. Loratadine and pseudoephedrine sulfate do not influence the pharmacokinetics of each other when administered concomitantly.

CLINICAL STUDIES

12 Hour Extended Release Tablets

Clinical trials of loratadine; pseudoephedrine sulfate 12 hour extended release tablets in seasonal allergic rhinitis involved approximately 3700 patients who received either the combination product, a comparative treatment, or placebo, in double-blind, randomized controlled studies. Four of the largest studies involved approximately 1600 patients in comparisons of the combination product, loratadine (5 mg bid), pseudoephedrine sulfate (120 mg bid), and placebo. Improvement in symptoms of seasonal allergic rhinitis for patients receiving loratadine; pseudoephedrine sulfate 12 hour extended release tablets was significantly greater than the improvement in those patients who received the individual components or placebo. The combination reduced the intensity of sneezing, rhinorrhea, nasal pruritus, and eye tearing more than pseudoephedrine and reduced the intensity of nasal congestion more than loratadine, demonstrating a contribution of each of the components. The onset of antihistamine and nasal decongestant actions occurred after the first dose of loratadine; pseudoephedrine sulfate 12 hour extended release tablets. Loratadine; pseudoephedrine sulfate 12 hour extended release tablets were well tolerated, with a frequency of sedation similar to that seen with placebo, and an adverse event profile clinically similar to that of pseudoephedrine.

24 Hour Extended Release Tablets

Clinical trials of loratadine; pseudoephedrine sulfate 24 hour extended release tablets involved a total of approximately 2000 patients with seasonal allergic rhinitis. One study involved 879 patients, who received either the combination product (loratadine 10 mg and pseudoephedrine sulfate 240 mg), loratadine (10 mg once daily) or pseudoephedrine sulfate (120 mg twice daily) alone, or placebo, in a double-blind randomized design. Improvement in nasal and non-nasal symptoms of seasonal allergic rhinitis including nasal congestion in patients receiving loratadine; pseudoephedrine sulfate 24 hour extended release tablets was significantly greater than in placebo recipients, and generally greater than that achieved with loratadine or pseudoephedrine sulfate alone. In this study, loratadine; pseudoephedrine sulfate 24 hour extended release tablets were well tolerated, with a frequency of sedation similar to that seen with placebo, and a frequency of nervousness and insomnia similar to that seen with pseudoephedrine sulfate given alone.

In another study of 469 patients, once-daily administration of loratadine; pseudoephedrine sulfate 24 hour extended release tablets provided effects similar to those achieved with twice-daily administration of loratadine; pseudoephedrine sulfate 12 hour extended release tablets, a combination product containing 5 mg loratadine plus 120 mg pseudoephedrine sulfate, extended release.

The end of dosing interval efficacy of the pseudoephedrine component of loratadine; pseudoephedrine sulfate 24 hour extended release tablets on the symptom of nasal stuffiness was evaluated in a study of 695 patients who were randomized to receive loratadine; pseudoephedrine sulfate 24 hour extended release tablets, loratadine; pseudoephedrine sulfate tablets, or placebo. Patients who received loratadine; pseudoephedrine sulfate 24 hour extended release tablets had significantly more improvement in nasal stuffiness scores at the end of the dosing interval than those patients receiving loratadine; pseudoephedrine sulfate tablets or placebo throughout the course of the trial.

12 and 24 Hour Extended Release Tablets

In a 6-week, placebo-controlled study of 193 patients with seasonal allergic rhinitis and concomitant mild to moderate asthma, loratadine; pseudoephedrine sulfate 12 and 24 hour extended release tablets twice daily improved seasonal allergic rhinitis signs and symptoms with no decrease in pulmonary function or adverse effect on asthma symptoms. This supports the safety of administering loratadine; pseudoephedrine sulfate 12 and 24 hour extended release tablets to seasonal allergic rhinitis patients with asthma.

 

Claritin D


Claritin D Medication Guide


PATIENT INFORMATION

See WARNINGS, CONTRAINDICATIONS, and PRECAUTIONS.

 

Claritin D


Claritin D Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

LORATADINE/PSEUDOEPHEDRINE SUSTAINED-RELEASE - ORAL

 

(lor-AT-uh-deen/sue-doh-eff-ED-rin)

 

COMMON BRAND NAME(S): Claritin-D

 

USES: Loratadine is an antihistamine which provides relief of seasonal allergy symptoms such as watery and itching eyes, runny nose, and sneezing. Pseudoephedrine is a decongestant which helps relieve a stuffy nose, promotes sinus draining, and improves breathing.

This medication is not recommended for use in children under 12 years of age due to the high amount of pseudoephedrine.

 

HOW TO USE: Take this medication by mouth as directed by your doctor, usually twice daily (every 12 hours) with a full glass of water.

Do not crush or chew this medication. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

Do not increase your dose or take this more often than directed.

Do not take this medication for several days before allergy testing since test results can be affected. Consult your doctor or pharmacist for more information.

Claritin D


 

 

Claritin D Consumer (continued)

SIDE EFFECTS: Dry mouth, mild stomach upset, trouble sleeping, dizziness, headache, nervousness, loss of appetite, or thirst may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these serious side effects occur: fast/irregular heartbeat, uncontrolled shaking or tremor.

Tell your doctor immediately if any of these unlikely but serious side effects occur: seizures, mental/mood changes, difficulty urinating.

This medication does not usually cause drowsiness when used at recommended doses and under normal circumstances. However, this drug may make you dizzy; therefore use caution engaging in activities that require alertness such as driving or using machinery.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

PRECAUTIONS: Before taking loratadine with pseudoephedrine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: glaucoma (narrow angle type), severe difficulty urinating (urinary retention), severe high blood pressure, severe heart/blood vessel disease (coronary artery disease), liver disease, experienced serious side effects with decongestants (irregular heart rhythm).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, problems urinating (e.g., enlarged prostate), high blood pressure, diabetes, heart problems (e.g., ischemic heart disease), thyroid problems (hyperthyroidism), glaucoma (open angle type).

Limit alcoholic beverages, as it may intensify drug side effects. (See also Side Effects.)

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This medication passes into breast milk and is unlikely to cause harm to a nursing infant. Consult your doctor before breast-feeding.

 

Claritin D


Claritin D Consumer (continued)

DRUG INTERACTIONS: If you are taking this medication under your doctor's direction, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first

This drug should not be used with or within 14 days of taking MAO inhibitors (e.g., furazolidone, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, isocarboxazid, tranylcypromine).

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: adrenalin-like drugs (e.g., ephedrine, methylphenidate), certain high blood pressure drugs (e.g., guanethidine, methyldopa, reserpine, beta-blockers such as propranolol), herbal products containing ephedra.

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain additional antihistamines and decongestants that could increase your risk for side effects. Ask your pharmacist about the safe use of those products.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: irregular or unusually slow or fast heartbeat, unusual nervousness or excitement, and seizures.

 

NOTES: Do not share this medication with others.

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store between 59-77 degrees F (15-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854- 1166 (USA) or 1-800-668-1507 (Canada).

 

 

Claritin D


Claritin D Patient Information Including Side Effects

Brand Names: Claritin-D, Claritin-D 24 Hour

Generic Name: loratadine and pseudoephedrine (Pronunciation: lor AT a deen and soo doe e FED rin)

 

  • What is desloratadine and pseudoephedrine (Claritin D)?
  • What are the possible side effects of desloratadine and pseudoephedrine (Claritin D)?
  • What is the most important information I should know about desloratadine and pseudoephedrine (Claritin D)?
  • What should I discuss with my healthcare provider before taking desloratadine and pseudoephedrine (Claritin D)?
  • How should I take desloratadine and pseudoephedrine (Claritin D)?
  • What happens if I miss a dose (Claritin D)?
  • What happens if I overdose (Claritin D)?
  • What should I avoid while taking desloratadine and pseudoephedrine (Claritin D)?
  • What other drugs will affect desloratadine and pseudoephedrine (Claritin D)?
  • Where can I get more information?

 

What is desloratadine and pseudoephedrine (Claritin D)?

Desloratadine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of desloratadine and pseudoephedrine is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

Desloratadine and pseudoephedrine may also be used for purposes other than those listed in this medication guide.

Claritin-D 24 Hour

oblong, white, imprinted with CLARITIN D 24 HOUR

What are the possible side effects of desloratadine and pseudoephedrine (Claritin D)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeat;
  • confusion, hallucinations, unusual thoughts or behavior;
  • severe dizziness, anxiety, restless feeling, or nervousness;
  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
  • confusion, hallucinations, unusual thoughts or behavior;
  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
  • urinating less than usual or not at all.

Keep taking the medication and talk to your doctor if you have any of these less serious side effects:

  • blurred vision;
  • dry mouth;
  • nausea, stomach pain, constipation;
  • mild loss of appetite, stomach upset;
  • warmth, tingling, or redness under your skin;
  • sleep problems (insomnia);
  • restless or excitability (especially in children);
  • skin rash or itching;
  • dizziness, drowsiness;
  • problems with memory or concentration; or
  • ringing in your ears.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about desloratadine and pseudoephedrine (Claritin D)?

Always ask a doctor before giving a cold or allergy medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant.

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Desloratadine and pseudoephedrine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It can increase some of the side effects of this medication.

Related Drug Centers
  • Claritin D

 

Claritin D


Claritin D Patient Information including How Should I Take

In this Article

  • What is desloratadine and pseudoephedrine (Claritin D)?
  • What are the possible side effects of desloratadine and pseudoephedrine (Claritin D)?
  • What is the most important information I should know about desloratadine and pseudoephedrine (Claritin D)?
  • What should I discuss with my healthcare provider before taking desloratadine and pseudoephedrine (Claritin D)?
  • How should I take desloratadine and pseudoephedrine (Claritin D)?
  • What happens if I miss a dose (Claritin D)?
  • What happens if I overdose (Claritin D)?
  • What should I avoid while taking desloratadine and pseudoephedrine (Claritin D)?
  • What other drugs will affect desloratadine and pseudoephedrine (Claritin D)?
  • Where can I get more information?

What should I discuss with my healthcare provider before taking desloratadine and pseudoephedrine (Claritin D)?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Before taking this medication, tell your doctor if you are allergic to desloratadine, or pseudoephedrine, or if you have:

  • kidney disease;
  • diabetes;
  • glaucoma;
  • heart disease or high blood pressure;
  • diabetes;
  • a thyroid disorder;
  • an enlarged prostate; or
  • problems with urination.

If you have any of these conditions, you may not be able to use desloratadine and pseudoephedrine, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Desloratadine and pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take desloratadine and pseudoephedrine (Claritin D)?

Take this medication exactly as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Follow the directions on your prescription label. Cold medicine is usually taken only for a short time until your symptoms clear up.

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Take this medicine with a full glass of water.

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

Store the medication at room temperature away from moisture and heat.

Related Drug Centers
  • Claritin D

Claritin D


Claritin D Patient Information including If I Miss a Dose

In this Article

  • What is desloratadine and pseudoephedrine (Claritin D)?
  • What are the possible side effects of desloratadine and pseudoephedrine (Claritin D)?
  • What is the most important information I should know about desloratadine and pseudoephedrine (Claritin D)?
  • What should I discuss with my healthcare provider before taking desloratadine and pseudoephedrine (Claritin D)?
  • How should I take desloratadine and pseudoephedrine (Claritin D)?
  • What happens if I miss a dose (Claritin D)?
  • What happens if I overdose (Claritin D)?
  • What should I avoid while taking desloratadine and pseudoephedrine (Claritin D)?
  • What other drugs will affect desloratadine and pseudoephedrine (Claritin D)?
  • Where can I get more information?

What happens if I miss a dose (Claritin D)?

Since cold or allergy medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Claritin D)?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an overdose may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking desloratadine and pseudoephedrine (Claritin D)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It can increase some of the side effects of this medication.

Avoid using other medicines that make you sleepy (such as sleeping pills, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by desloratadine and pseudoephedrine.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant.

What other drugs will affect desloratadine and pseudoephedrine (Claritin D)?

Before taking this medication, tell your doctor if you are using any of the following drugs:

  • medicines to treat high blood pressure;
  • a diuretic (water pill);
  • medication to treat irritable bowel syndrome;
  • bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);
  • aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);
  • a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or
  • antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

If you are using any of these drugs, you may not be able to use desloratadine and pseudoephedrine, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect desloratadine and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist has information about desloratadine and pseudoephedrine written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2010 Cerner Multum, Inc. Version: 5.05. Revision date: 4/12/2009.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

 

Related Drug Centers
  • Claritin D

 

Share
 
Ruai Pharm Stats