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The following indications for ALLERGY RELIEF (loratadine) have been approved by the FDA:
Indications:
Allergic conjunctivitis
Allergic rhinitis
Chronic idiopathic urticaria
Perennial allergic rhinitis
Seasonal allergic rhinitis
Sneezing
Professional Synonyms:
Allergy eye itch
Atopic conjunctivitis
Atopic rhinitis
Intermittent allergic rhinitis
Itchy eyes due to allergies
Non-seasonal allergic rhinitis
Ocular itching due to allergies
Periodic runny nose
Seasonal allergy
Indications:
Allergic conjunctivitis
Allergic rhinitis
Chronic idiopathic urticaria
Perennial allergic rhinitis
Seasonal allergic rhinitis
Sneezing
Professional Synonyms:
Allergy eye itch
Atopic conjunctivitis
Atopic rhinitis
Intermittent allergic rhinitis
Itchy eyes due to allergies
Non-seasonal allergic rhinitis
Ocular itching due to allergies
Periodic runny nose
Seasonal allergy
The following dosing information is available for ALLERGY RELIEF (loratadine):
In patients with chronic renal impairment (creatinine clearance of 30 mL/minute or less), both oral bioavailability and peak plasma concentrations of loratadine and desloratadine may be increased compared with individuals with normal renal function. However, elimination half-lives of the drug and its active metabolite appear to be similar to those of individuals with normal renal function. Patients with renal impairment receiving loratadine for self-medication should be advised to consult a clinician before initiating therapy, since a different dosage may be recommended.
Therapy with loratadine conventional or orally disintegrating tablets or oral solution should be initiated at a dosage of 10 mg every other day in adults and children 6 years of age and older with a glomerular filtration rate less than 30 mL/minute and at a dosage of 5 mg every other day in children 2-5 years of age with renal insufficiency. In addition, therapy with the commercially available tablets containing loratadine in fixed combination with pseudoephedrine sulfate should be initiated in adults and children 12 years of age and older with a glomerular filtration rate less than 30 mL/minute at a dosage of 5 mg once daily when the 12-hour formulation is used or at a dosage of 10 mg every other day when the 24-hour formulation is used, since clearance of both loratadine and pseudoephedrine are decreased in such patients. Hemodialysis does not appear to affect the pharmacokinetics of loratadine or desloratadine.
The pharmacokinetics of loratadine and its active metabolite also may be altered in patients with hepatic impairment and dosage adjustment may be necessary. Therefore, patients with hepatic impairment receiving loratadine for self-medication should be advised to consult a clinician before initiating therapy, since a different dosage may be recommended. Therapy with loratadine conventional or orally disintegrating tablets or oral solution should be initiated at a dosage of 10 mg every other day in adults and children 6 years of age and older with hepatic failure and at a dosage of 5 mg every other day in children 2-5 years of age with hepatic failure.
Since fixed-ratio combination preparations do not permit individual titration of dosages, and clearance of loratadine is decreased more substantially than that of pseudoephedrine sulfate in patients with hepatic impairment, the manufacturer recommends that tablets containing loratadine in fixed combination with pseudoephedrine sulfate generally not be used in such patients.
Adjustment of fexofenadine hydrochloride dosage may be necessary in The manufacturer states that patients 12 years of age or older who have impaired renal function (e.g., creatinine clearance of 11-31 mL/minute) or patients with renal impairment. Peak plasma fexofenadine concentrations hepatic impairment or who are undergoing hemodialysis (creatinine clearance increased by 87 or 111%, and elimination half-life increased by 59 or 72% in patients with mild (e.g., creatinine clearance of 41-80 mL/minute) or of less than 7 mL/minute), should receive a cetirizine hydrochloride dosage of 5 mg daily. The manufacturer also states that children 6-11 years of age severe (creatinine clearance of 11-40 mL/minute) renal impairment, respectively, when compared with those observed in healthy individuals.
In with impaired renal or hepatic function should use the lower recommended addition, peak plasma fexofenadine concentration increased by 82% and dosage (5 mg once daily). The manufacturer states that use of cetirizine elimination half-life increased by 31% in those on hemodialysis (creatinine hydrochloride in children younger than 6 years of age with impaired renal clearance of 10 mL/minute or less) compared with healthy individuals. or hepatic function is not recommended because administration of doses
smaller than 2.5 mg is difficult and not reliable, and pharmacokinetic data are lacking in this patient population. The manufacturer states that adults and children 12 years of age and older
with impaired renal function or those on hemodialysis should receive an initial fexofenadine hydrochloride dosage of 60 mg daily (either given When extended-release tablets of cetirizine hydrochloride in fixed alone or in fixed combination with 120 mg of pseudoephedrine hydrochloride combination with pseudoephedrine hydrochloride are used in patients 12 (Allegra-D(R) 12 Hour)). The fixed-combination preparation containing 180 years of age or older who have impaired renal function (i.e., creatinine clearance of 11-31 mL/minute) or hepatic impairment or who are undergoing mg of fexofenadine hydrochloride and 240 mg of pseudoephedrine hemodialysis (creatinine clearance of less than 7 mL/minute), the hydrochloride (Allegra-D(R) 24 Hour) generally should be avoided in patients with renal impairment because of a possible risk of accumulation recommended cetirizine hydrochloride dosage is 5 mg once daily.
of pseudoephedrine.
Children 6 to younger than 12 years of age with impaired renal function should receive an initial fexofenadine hydrochloride dosage of 30 mg daily.
Since the pharmacokinetics of fexofenadine do not appear to be altered in patients with hepatic impairment, the manufacturer states that dosage adjustment is not necessary in such patients. The manufacturer of Allegra-D(R) 12 Hour and Allegra-D(R) 24 Hour does not make specific recommendations for dosage adjustment in patients with hepatic impairment, although it is not known if pharmacokinetics of pseudoephedrine are altered in patients with hepatic impairment.
Therapy with loratadine conventional or orally disintegrating tablets or oral solution should be initiated at a dosage of 10 mg every other day in adults and children 6 years of age and older with a glomerular filtration rate less than 30 mL/minute and at a dosage of 5 mg every other day in children 2-5 years of age with renal insufficiency. In addition, therapy with the commercially available tablets containing loratadine in fixed combination with pseudoephedrine sulfate should be initiated in adults and children 12 years of age and older with a glomerular filtration rate less than 30 mL/minute at a dosage of 5 mg once daily when the 12-hour formulation is used or at a dosage of 10 mg every other day when the 24-hour formulation is used, since clearance of both loratadine and pseudoephedrine are decreased in such patients. Hemodialysis does not appear to affect the pharmacokinetics of loratadine or desloratadine.
The pharmacokinetics of loratadine and its active metabolite also may be altered in patients with hepatic impairment and dosage adjustment may be necessary. Therefore, patients with hepatic impairment receiving loratadine for self-medication should be advised to consult a clinician before initiating therapy, since a different dosage may be recommended. Therapy with loratadine conventional or orally disintegrating tablets or oral solution should be initiated at a dosage of 10 mg every other day in adults and children 6 years of age and older with hepatic failure and at a dosage of 5 mg every other day in children 2-5 years of age with hepatic failure.
Since fixed-ratio combination preparations do not permit individual titration of dosages, and clearance of loratadine is decreased more substantially than that of pseudoephedrine sulfate in patients with hepatic impairment, the manufacturer recommends that tablets containing loratadine in fixed combination with pseudoephedrine sulfate generally not be used in such patients.
Adjustment of fexofenadine hydrochloride dosage may be necessary in The manufacturer states that patients 12 years of age or older who have impaired renal function (e.g., creatinine clearance of 11-31 mL/minute) or patients with renal impairment. Peak plasma fexofenadine concentrations hepatic impairment or who are undergoing hemodialysis (creatinine clearance increased by 87 or 111%, and elimination half-life increased by 59 or 72% in patients with mild (e.g., creatinine clearance of 41-80 mL/minute) or of less than 7 mL/minute), should receive a cetirizine hydrochloride dosage of 5 mg daily. The manufacturer also states that children 6-11 years of age severe (creatinine clearance of 11-40 mL/minute) renal impairment, respectively, when compared with those observed in healthy individuals.
In with impaired renal or hepatic function should use the lower recommended addition, peak plasma fexofenadine concentration increased by 82% and dosage (5 mg once daily). The manufacturer states that use of cetirizine elimination half-life increased by 31% in those on hemodialysis (creatinine hydrochloride in children younger than 6 years of age with impaired renal clearance of 10 mL/minute or less) compared with healthy individuals. or hepatic function is not recommended because administration of doses
smaller than 2.5 mg is difficult and not reliable, and pharmacokinetic data are lacking in this patient population. The manufacturer states that adults and children 12 years of age and older
with impaired renal function or those on hemodialysis should receive an initial fexofenadine hydrochloride dosage of 60 mg daily (either given When extended-release tablets of cetirizine hydrochloride in fixed alone or in fixed combination with 120 mg of pseudoephedrine hydrochloride combination with pseudoephedrine hydrochloride are used in patients 12 (Allegra-D(R) 12 Hour)). The fixed-combination preparation containing 180 years of age or older who have impaired renal function (i.e., creatinine clearance of 11-31 mL/minute) or hepatic impairment or who are undergoing mg of fexofenadine hydrochloride and 240 mg of pseudoephedrine hemodialysis (creatinine clearance of less than 7 mL/minute), the hydrochloride (Allegra-D(R) 24 Hour) generally should be avoided in patients with renal impairment because of a possible risk of accumulation recommended cetirizine hydrochloride dosage is 5 mg once daily.
of pseudoephedrine.
Children 6 to younger than 12 years of age with impaired renal function should receive an initial fexofenadine hydrochloride dosage of 30 mg daily.
Since the pharmacokinetics of fexofenadine do not appear to be altered in patients with hepatic impairment, the manufacturer states that dosage adjustment is not necessary in such patients. The manufacturer of Allegra-D(R) 12 Hour and Allegra-D(R) 24 Hour does not make specific recommendations for dosage adjustment in patients with hepatic impairment, although it is not known if pharmacokinetics of pseudoephedrine are altered in patients with hepatic impairment.
Loratadine is administered orally. Loratadine conventional tablets, orally disintegrating tablets, and the commercially available tablets containing the drug in fixed combination with pseudoephedrine sulfate can be administered without regard to meals. Although the oral bioavailability of loratadine is increased when the drug is administered as the orally disintegrating tablet without water, the bioavailability of the active metabolite desloratadine (descarboethoxyloratadine) is unaffected, and the manufacturers state that the orally disintegrating tablets can be administered with or without water.
The orally disintegrating tablets are administered by placing a tablet on the tongue, where it disintegrates within a few seconds, and then subsequently swallowing with or without water. Tablets containing loratadine in fixed combination with pseudoephedrine sulfate should be swallowed intact and patients should be instructed not to break, chew, or dissolve such tablets. Patients also should be instructed to take Claritin-D(R) 24 Hour extended-release tablets with a full glass of water.
Cetirizine is administered orally. Cetirizine oral solution (syrup) should Fexofenadine hydrochloride is administered orally. The manufacturer states be administered using the measuring device (i.e., cup) provided by the that when fexofenadine hydrochloride is given alone (i.e., not in fixed combination with pseudoephedrine hydrochloride) the drug may be given manufacturer.
Cetirizine chewable tablets may be administered with or without regard to meals. Since absorption and peak plasma concentrations of without water. Tablets containing cetirizine hydrochloride in fixed combination with pseudoephedrine hydrochloride should be swallowed intact fexofenadine are decreased by concomitant administration of an aluminum and and patients should be instructed not to break or chew such tablets.
magnesium hydroxides antacid (Maalox(R)) (see Pharmacokinetics: Absorption and see Drug Interactions: Antacids), the manufacturer recommends that the drug not be taken closely in time with an antacid containing aluminum and The manufacturer states that the time of administration of cetirizine may be adjusted for individual patient requirements. Although food may decrease magnesium. Since food appears to substantially affect the rate and extent of absorption of fexofenadine hydrochloride when administered as the peak plasma concentrations of cetirizine and lengthen the time to achievement of peak plasma concentrations, the manufacturer states that extended-release tablets of the drug in fixed combination with cetirizine may be administered without regard to food because food does not pseudoephedrine hydrochloride, the manufacturer states that such affect the extent of absorption of the drug when administered as extended-release tablets should be administered on an empty stomach with conventional or chewable tablets.
water. (See Pharmacokinetics: Absorption and see Drug Interactions: Fruit Juices.) Extended-release tablets containing fexofenadine hydrochloride in fixed combination with pseudoephedrine hydrochloride should be swallowed The oral bioavailability of cetirizine hydrochloride conventional tablets intact, and patients should be instructed not to break, crush, or chew such is comparable to that of the oral solution and to that of the chewable tablets (administered with or without water). tablets.
The orally disintegrating tablets are administered by placing a tablet on the tongue, where it disintegrates within a few seconds, and then subsequently swallowing with or without water. Tablets containing loratadine in fixed combination with pseudoephedrine sulfate should be swallowed intact and patients should be instructed not to break, chew, or dissolve such tablets. Patients also should be instructed to take Claritin-D(R) 24 Hour extended-release tablets with a full glass of water.
Cetirizine is administered orally. Cetirizine oral solution (syrup) should Fexofenadine hydrochloride is administered orally. The manufacturer states be administered using the measuring device (i.e., cup) provided by the that when fexofenadine hydrochloride is given alone (i.e., not in fixed combination with pseudoephedrine hydrochloride) the drug may be given manufacturer.
Cetirizine chewable tablets may be administered with or without regard to meals. Since absorption and peak plasma concentrations of without water. Tablets containing cetirizine hydrochloride in fixed combination with pseudoephedrine hydrochloride should be swallowed intact fexofenadine are decreased by concomitant administration of an aluminum and and patients should be instructed not to break or chew such tablets.
magnesium hydroxides antacid (Maalox(R)) (see Pharmacokinetics: Absorption and see Drug Interactions: Antacids), the manufacturer recommends that the drug not be taken closely in time with an antacid containing aluminum and The manufacturer states that the time of administration of cetirizine may be adjusted for individual patient requirements. Although food may decrease magnesium. Since food appears to substantially affect the rate and extent of absorption of fexofenadine hydrochloride when administered as the peak plasma concentrations of cetirizine and lengthen the time to achievement of peak plasma concentrations, the manufacturer states that extended-release tablets of the drug in fixed combination with cetirizine may be administered without regard to food because food does not pseudoephedrine hydrochloride, the manufacturer states that such affect the extent of absorption of the drug when administered as extended-release tablets should be administered on an empty stomach with conventional or chewable tablets.
water. (See Pharmacokinetics: Absorption and see Drug Interactions: Fruit Juices.) Extended-release tablets containing fexofenadine hydrochloride in fixed combination with pseudoephedrine hydrochloride should be swallowed The oral bioavailability of cetirizine hydrochloride conventional tablets intact, and patients should be instructed not to break, crush, or chew such is comparable to that of the oral solution and to that of the chewable tablets (administered with or without water). tablets.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| PUB ALLERGY RELIEF 10 MG TAB | Maintenance | Adults take 1 tablet (10 mg) by oral route once daily |
| PUB ALLERGY RELIEF 180 MG TAB | Maintenance | Adults take 1 tablet (180 mg) by oral route once daily |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| LORATADINE 10 MG TABLET | Maintenance | Adults take 1 tablet (10 mg) by oral route once daily |
| FEXOFENADINE HCL 180 MG TABLET | Maintenance | Adults take 1 tablet (180 mg) by oral route once daily |
| CETIRIZINE HCL 10 MG TABLET | Maintenance | Adults take 1 tablet (10 mg) by oral route once daily |
| RA LORATADINE 10 MG TABLET | Maintenance | Adults take 1 tablet (10 mg) by oral route once daily |
| RA CETIRIZINE HCL 10 MG TABLET | Maintenance | Adults take 1 tablet (10 mg) by oral route once daily |
| GNP LORATADINE 10 MG TABLET | Maintenance | Adults take 1 tablet (10 mg) by oral route once daily |
| GNP FEXOFENADINE HCL 180 MG TB | Maintenance | Adults take 1 tablet (180 mg) by oral route once daily |
| HM LORATADINE 10 MG TABLET | Maintenance | Adults take 1 tablet (10 mg) by oral route once daily |
The following drug interaction information is available for ALLERGY RELIEF (loratadine):
There are 0 contraindications.
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Radioactive Iodide/Agents that Affect Iodide SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Many compounds can affect iodide protein binding and alter iodide pharmacokinetics and pharmacodynamics.(1) CLINICAL EFFECTS: Compounds that affect iodide pharmacokinetics and pharmacodynamics may impact the effectiveness of radioactive iodide.(1) PREDISPOSING FACTORS: Compounds that affect iodide pharmacokinetics and pharmacodynamics are expected to have the most impact during therapy using radioactive iodide. Diagnostic procedures would be expected to be impacted less. PATIENT MANAGEMENT: Discuss the use of agents that affect iodide pharmacokinetics and pharmacodynamics with the patient's oncologist.(1) Because indocyanine green contains sodium iodide, the iodine-binding capacity of thyroid tissue may be reduced for at least one week following administration. Do not perform radioactive iodine uptake studies for at least one week following administration of indocyanine green.(2) The manufacturer of iopamidol states administration may interfere with thyroid uptake of radioactive iodine and decrease therapeutic and diagnostic efficacy. Avoid thyroid therapy or testing for up to 6 weeks post administration of iopamidol.(3) DISCUSSION: Many agents interact with radioactive iodine. The average duration of effect is: anticoagulants - 1 week antihistamines - 1 week anti-thyroid drugs, e.g: carbimazole, methimazole, propylthiouracil - 3-5 days corticosteroids - 1 week iodide-containing medications, e.g: amiodarone - 1-6 months expectorants - 2 weeks Lugol solution - 3 weeks saturated solution of potassium iodine - 3 weeks vitamins - 10-14 days iodide-containing X-ray contrast agents - up to 1 year lithium - 4 weeks phenylbutazone - 1-2 weeks sulfonamides - 1 week thyroid hormones (natural or synthetic), e.g.: thyroxine - 4 weeks tri-iodothyronine - 2 weeks tolbutamide - 1 week topical iodide - 1-9 months (1) |
ADREVIEW, JEANATOPE, MEGATOPE, SODIUM IODIDE I-123 |
| Sodium Iodide I 131/Agents that Affect Iodide SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Many compounds can affect iodide protein binding and alter iodide pharmacokinetics and pharmacodynamics.(1,2) CLINICAL EFFECTS: Compounds that affect iodide pharmacokinetics and pharmacodynamics may impact the effectiveness of radioactive iodide.(1,2) PREDISPOSING FACTORS: Compounds that affect iodide pharmacokinetics and pharmacodynamics are expected to have the most impact during therapy using radioactive iodide. Diagnostic procedures would be expected to be impacted less. PATIENT MANAGEMENT: Discuss the use of agents that affect iodide pharmacokinetics and pharmacodynamics with the patient's oncologist.(1,2) Because indocyanine green contains sodium iodide, the iodine-binding capacity of thyroid tissue may be reduced for at least one week following administration. Do not perform radioactive iodine uptake studies for at least one week following administration of indocyanine green.(3) The manufacturer of iopamidol states administration may interfere with thyroid uptake of radioactive iodine and decrease therapeutic and diagnostic efficacy. Avoid thyroid therapy or testing for up to 6 weeks post administration of iopamidol.(4) DISCUSSION: Many agents interact with radioactive iodine. The average duration of effect is: anticoagulants - 1 week antihistamines - 1 week anti-thyroid drugs, e.g: carbimazole, methimazole, propylthiouracil - 3-5 days corticosteroids - 1 week iodide-containing medications, e.g: amiodarone - 1-6 months expectorants - 2 weeks Lugol solution - 3 weeks saturated solution of potassium iodine - 3 weeks vitamins - 10-14 days iodide-containing X-ray contrast agents - up to 1 year lithium - 4 weeks phenylbutazone - 1-2 weeks sulfonamides - 1 week thyroid hormones (natural or synthetic), e.g.: thyroxine - 4 weeks tri-iodothyronine - 2 weeks tolbutamide - 1 week topical iodide - 1-9 months (1,2) |
HICON, SODIUM IODIDE I-131 |
There are 0 moderate interactions.
The following contraindication information is available for ALLERGY RELIEF (loratadine):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 0 contraindications.
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
There are 6 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Disease of liver |
| Glaucoma |
| Hepatic failure |
| Kidney disease with reduction in glomerular filtration rate (GFr) |
| Renal disease with moderate to severe function impairment |
| Urinary retention |
The following adverse reaction information is available for ALLERGY RELIEF (loratadine):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 22 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Abnormal hepatic function tests Acute bacterial otitis media Acute generalized exanthematous pustulosis Anaphylaxis Angioedema Bronchospastic pulmonary disease Cardiac arrhythmia Cholestasis Dehydration Edema Glomerulonephritis Hearing loss Hemolytic anemia Hepatitis Hypersensitivity drug reaction Palpitations Seizure disorder Thrombocytopenic disorder Tongue swelling Tonic clonic seizure Upper respiratory infection Urticaria |
There are 91 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Drowsy Dry nose Dry throat Headache disorder Xerostomia |
Acute abdominal pain Back pain Conjunctivitis Diarrhea Dizziness Drowsy Dysmenorrhea Dyspepsia Epistaxis Fatigue Headache disorder Insomnia Myalgia Nausea Pharyngitis Sinusitis Skin rash Viral infection Vomiting Xerostomia |
| Rare/Very Rare |
|---|
|
Abdominal pain with cramps Acne vulgaris Acute cognitive impairment Aggressive behavior Agitation Alopecia Anorexia Anticholinergic toxicity Blurred vision Bronchitis Concentration difficulty Constipation Cough Cramps in legs Dizziness Dream disorder Dry nose Dry throat Dysgeusia Dyskinesia Dyspepsia Dyspnea Dysuria Earache Epistaxis Eructation Euphoria Excitement Fatigue Fever Flatulence Gastritis Hallucinations Headache disorder Hemorrhoids Hyperhidrosis Hyperkinesis Increased appetite Insomnia Malaise Memory impairment Nausea Nervousness Nightmares Pain Palpitations Parosmia Pharyngitis Pruritus of skin Sedation Skin photosensitivity Skin rash Stomatitis Syncope Tachycardia Tinnitus Tongue discoloration Tremor Unsteady gait Urinary incontinence Urinary retention Visual changes Voice change Vomiting Weight gain Xerostomia |
The following precautions are available for ALLERGY RELIEF (loratadine):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Reproduction studies in mice receiving fexofenadine doses up to 3730 mg/kg (approximately 10-15 times the maximum recommended daily oral human dosage of fexofenadine hydrochloride in adults) have not revealed evidence of adverse or teratogenic effects during gestation. Reproduction studies in rats and rabbits using oral terfenadine dosages up to 300 mg/kg resulting in fexofenadine exposure levels calculated to be about 3-4 and 25-31 times, respectively, those resulting from the maximum recommended daily oral human dosage of fexofenadine hydrochloride in adults have not revealed evidence of teratogenicity. However, in rats, oral terfenadine dosages of 150 mg/kg, resulting in fexofenadine exposure levels calculated to be about 3-4 times those resulting from the maximum recommended daily oral human dosage of fexofenadine hydrochloride in adults (based on comparison of the AUC), were associated with decreased weight gain and neonatal survival in the pups.
Reproduction studies in rats and rabbits using terfenadine and pseudoephedrine hydrochloride in a fixed-combination ratio of 1:2 at dosages of 150/300 (corresponding to fexofenadine AUCs of about 3-4 times the maximum recommended adult therapeutic value and to pseudoephedrine hydrochloride dosages about 10 times the maximum recommended human adult daily oral dosage, on a mg/m2 basis) and 100/200 mg/kg daily (corresponding to fexofenadine AUCs of about 8-10 times the maximum recommended adult therapeutic value and to pseudoephedrine hydrochloride dosages about 15 times the maximum recommended human adult daily oral dosage, on a mg/m2 basis), respectively, have revealed evidence of reduced fetal weight; delayed ossification with wavy ribs also was observed in rats receiving the drug at these dosages. There are no adequate and controlled studies to date using fexofenadine in pregnant women, and fexofenadine hydrochloride alone or in fixed combination with pseudoephedrine hydrochloride should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. An increased incidence of hypospadias in male infants born to women who received loratadine during pregnancy was reported in one study.
However, analysis of data from the National Birth Defects Prevention Study (NBDPS) indicated that use of loratadine during early pregnancy was not associated with an increased risk of second- or third-degree hypospadias. In addition, in 2 small prospective cohort studies that surveyed pregnant women who contacted a teratology information service, use of loratadine during the first trimester of pregnancy was not associated with major congenital anomalies and did not affect the rate of live birth, gestational age at birth, and birth weight. Despite these findings, it should be noted that interpretation of these results is limited by the statistical limitations of the studies (i.e., small sample size, inadequate power, reliance on patient recall of drug use, exclusion criteria).
The 2 prospective cohort studies were powered to detect statistical significance only if a substantial (i.e., approximately threefold) increase in the overall rate of major congenital anomalies was observed; the study that relied on NBDPS data excluded first-degree hypospadias because of the difficulty of detecting this mildest form in routine surveillance, making it difficult to determine the relationship between loratadine and this form of hypospadias. Thus, while these data may be useful, further study is needed to completely rule out the teratogenic risk of loratadine. Because there are no adequate and controlled studies to date using loratadine in pregnant women, loratadine alone or in fixed combination with pseudoephedrine hydrochloride should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.
Reproduction studies in rats and rabbits using loratadine dosages up to 75 and 150 times, respectively, the maximum daily human dosage on a mg/m2 basis have not revealed evidence of harm to the fetus. Reproduction studies in mice, rats, and rabbits using oral cetirizine hydrochloride dosages up to 96, 225, and 135 mg/kg daily, respectively (approximately 40, 180, and 220 times, respectively, the maximum recommended daily oral dosage in adults on a mg/m2 basis), have not revealed evidence of teratogenicity. Because there are no adequate and controlled studies to date using cetirizine in pregnant women and animal studies are not always predictive of human response, cetirizine hydrochloride should be used during pregnancy only when clearly needed.
Cetirizine hydrochloride in combination with pseudoephedrine has been shown to increase the number of fetal skeletal malformations (rib distortions) and variants (unossified sternebrae) in rats when given orally in a fixed-combination ratio at a dosage of 6/154 mg/kg (approximately 5 times the maximum recommended adult dosage on a mg/m2 basis). These effects were not observed at a dosage of 1.6/38 mg/kg (approximately the maximum recommended adult dosage on a mg/m2 basis).
Reproduction studies in rabbits using cetirizine hydrochloride and pseudoephedrine hydrochloride in a fixed-combination ratio at a dosage of up to 6/154 mg/kg (approximately 10 times the maximum recommended adult dosage on a mg/m2 basis) have not revealed evidence of harm to the fetus. There are no adequate and controlled studies to date using cetirizine hydrochloride and pseudoephedrine hydrochloride in pregnant women, and the fixed combination should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.
Reproduction studies in rats and rabbits using terfenadine and pseudoephedrine hydrochloride in a fixed-combination ratio of 1:2 at dosages of 150/300 (corresponding to fexofenadine AUCs of about 3-4 times the maximum recommended adult therapeutic value and to pseudoephedrine hydrochloride dosages about 10 times the maximum recommended human adult daily oral dosage, on a mg/m2 basis) and 100/200 mg/kg daily (corresponding to fexofenadine AUCs of about 8-10 times the maximum recommended adult therapeutic value and to pseudoephedrine hydrochloride dosages about 15 times the maximum recommended human adult daily oral dosage, on a mg/m2 basis), respectively, have revealed evidence of reduced fetal weight; delayed ossification with wavy ribs also was observed in rats receiving the drug at these dosages. There are no adequate and controlled studies to date using fexofenadine in pregnant women, and fexofenadine hydrochloride alone or in fixed combination with pseudoephedrine hydrochloride should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. An increased incidence of hypospadias in male infants born to women who received loratadine during pregnancy was reported in one study.
However, analysis of data from the National Birth Defects Prevention Study (NBDPS) indicated that use of loratadine during early pregnancy was not associated with an increased risk of second- or third-degree hypospadias. In addition, in 2 small prospective cohort studies that surveyed pregnant women who contacted a teratology information service, use of loratadine during the first trimester of pregnancy was not associated with major congenital anomalies and did not affect the rate of live birth, gestational age at birth, and birth weight. Despite these findings, it should be noted that interpretation of these results is limited by the statistical limitations of the studies (i.e., small sample size, inadequate power, reliance on patient recall of drug use, exclusion criteria).
The 2 prospective cohort studies were powered to detect statistical significance only if a substantial (i.e., approximately threefold) increase in the overall rate of major congenital anomalies was observed; the study that relied on NBDPS data excluded first-degree hypospadias because of the difficulty of detecting this mildest form in routine surveillance, making it difficult to determine the relationship between loratadine and this form of hypospadias. Thus, while these data may be useful, further study is needed to completely rule out the teratogenic risk of loratadine. Because there are no adequate and controlled studies to date using loratadine in pregnant women, loratadine alone or in fixed combination with pseudoephedrine hydrochloride should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.
Reproduction studies in rats and rabbits using loratadine dosages up to 75 and 150 times, respectively, the maximum daily human dosage on a mg/m2 basis have not revealed evidence of harm to the fetus. Reproduction studies in mice, rats, and rabbits using oral cetirizine hydrochloride dosages up to 96, 225, and 135 mg/kg daily, respectively (approximately 40, 180, and 220 times, respectively, the maximum recommended daily oral dosage in adults on a mg/m2 basis), have not revealed evidence of teratogenicity. Because there are no adequate and controlled studies to date using cetirizine in pregnant women and animal studies are not always predictive of human response, cetirizine hydrochloride should be used during pregnancy only when clearly needed.
Cetirizine hydrochloride in combination with pseudoephedrine has been shown to increase the number of fetal skeletal malformations (rib distortions) and variants (unossified sternebrae) in rats when given orally in a fixed-combination ratio at a dosage of 6/154 mg/kg (approximately 5 times the maximum recommended adult dosage on a mg/m2 basis). These effects were not observed at a dosage of 1.6/38 mg/kg (approximately the maximum recommended adult dosage on a mg/m2 basis).
Reproduction studies in rabbits using cetirizine hydrochloride and pseudoephedrine hydrochloride in a fixed-combination ratio at a dosage of up to 6/154 mg/kg (approximately 10 times the maximum recommended adult dosage on a mg/m2 basis) have not revealed evidence of harm to the fetus. There are no adequate and controlled studies to date using cetirizine hydrochloride and pseudoephedrine hydrochloride in pregnant women, and the fixed combination should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.
It is not known if fexofenadine hydrochloride is distributed into breast milk; however, pseudoephedrine hydrochloride distributes into breast milk. Since there are no adequate and controlled studies to date on the use of fexofenadine during lactation in humans and because many drugs are excreted in human milk, the manufacturer states that fexofenadine alone or in fixed combination with pseudoephedrine hydrochloride should be used with caution in nursing women, and a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman. Loratadine and desloratadine distribute readily into breast milk, achieving concentrations that are equivalent to those in plasma (i.e., a milk to plasma AUC ratio of 1.17 and 0.85, respectively).
The manufacturer states that about 0.03% of a single 40-mg dose of loratadine was distributed into breast milk as loratadine and desloratadine over 48 hours. Pseudoephedrine also distributes readily into breast milk.
Caution should be exercised when loratadine is administered alone or in fixed combination with pseudoephedrine to a nursing woman, and a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman. In lactating beagles, about 3% of a cetirizine dose was distributed in milk. In mice, cetirizine caused retarded pup weight gain during lactation when dams were receiving a cetirizine hydrochloride dosage of 96 mg/kg daily (about 40 times the maximum recommended daily dosage in adults on a mg/m2 basis).
In rats, cetirizine hydrochloride and pseudoephedrine hydrochloride caused retarded pup weight gain and decreased viability during lactation when administered orally to dams in fixed combination at a dosage of 6/154 mg/kg (approximately 5 times the maximum recommended adult dosage on a mg/m2 basis) but not when administered at a dosage of 1.6/38 mg/kg (approximately the maximum recommended adult dosage on a mg/m2 basis). Cetirizine is distributed into human milk.
Pseudoephedrine also distributes into human milk. Therefore, use of cetirizine hydrochloride alone or in combination with pseudoephedrine hydrochloride in nursing women is not recommended.
The manufacturer states that about 0.03% of a single 40-mg dose of loratadine was distributed into breast milk as loratadine and desloratadine over 48 hours. Pseudoephedrine also distributes readily into breast milk.
Caution should be exercised when loratadine is administered alone or in fixed combination with pseudoephedrine to a nursing woman, and a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman. In lactating beagles, about 3% of a cetirizine dose was distributed in milk. In mice, cetirizine caused retarded pup weight gain during lactation when dams were receiving a cetirizine hydrochloride dosage of 96 mg/kg daily (about 40 times the maximum recommended daily dosage in adults on a mg/m2 basis).
In rats, cetirizine hydrochloride and pseudoephedrine hydrochloride caused retarded pup weight gain and decreased viability during lactation when administered orally to dams in fixed combination at a dosage of 6/154 mg/kg (approximately 5 times the maximum recommended adult dosage on a mg/m2 basis) but not when administered at a dosage of 1.6/38 mg/kg (approximately the maximum recommended adult dosage on a mg/m2 basis). Cetirizine is distributed into human milk.
Pseudoephedrine also distributes into human milk. Therefore, use of cetirizine hydrochloride alone or in combination with pseudoephedrine hydrochloride in nursing women is not recommended.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for ALLERGY RELIEF (loratadine):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ALLERGY RELIEF (loratadine)'s list of indications:
| Allergic conjunctivitis | |
| H10.1 | Acute atopic conjunctivitis |
| H10.10 | Acute atopic conjunctivitis, unspecified eye |
| H10.11 | Acute atopic conjunctivitis, right eye |
| H10.12 | Acute atopic conjunctivitis, left eye |
| H10.13 | Acute atopic conjunctivitis, bilateral |
| H10.44 | Vernal conjunctivitis |
| H10.45 | Other chronic allergic conjunctivitis |
| H16.26 | Vernal keratoconjunctivitis, with limbar and corneal involvement |
| H16.261 | Vernal keratoconjunctivitis, with limbar and corneal involvement, right eye |
| H16.262 | Vernal keratoconjunctivitis, with limbar and corneal involvement, left eye |
| H16.263 | Vernal keratoconjunctivitis, with limbar and corneal involvement, bilateral |
| H16.269 | Vernal keratoconjunctivitis, with limbar and corneal involvement, unspecified eye |
| Allergic rhinitis | |
| J30.1 | Allergic rhinitis due to pollen |
| J30.2 | Other seasonal allergic rhinitis |
| J30.5 | Allergic rhinitis due to food |
| J30.8 | Other allergic rhinitis |
| J30.81 | Allergic rhinitis due to animal (cat) (dog) hair and dander |
| J30.89 | Other allergic rhinitis |
| J30.9 | Allergic rhinitis, unspecified |
| Chronic idiopathic urticaria | |
| L50.1 | Idiopathic urticaria |
| Perennial allergic rhinitis | |
| J31.0 | Chronic rhinitis |
| Seasonal allergic rhinitis | |
| J30.1 | Allergic rhinitis due to pollen |
| J30.2 | Other seasonal allergic rhinitis |
| Sneezing | |
| R06.7 | Sneezing |
Formulary Reference Tool