ALLERGY RELIEF-NASAL DECONGEST (loratadine/pseudoephedrine sulfate)

There are 3 contraindications. Absolute contraindication.

Contraindication List
Severe coronary artery disease
Severe uncontrolled hypertension
Urinary retention

There are 6 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Angle-closure glaucoma
Benign prostatic hyperplasia
Diabetes mellitus
Hypertension
Hyperthyroidism
Pheochromocytoma

There are 5 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
Hepatic failure
Kidney disease with reduction in glomerular filtration rate (GFr)
Renal disease with moderate to severe function impairment
Severe hepatic disease

There are 12 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Abnormal hepatic function tests Acute generalized exanthematous pustulosis Anaphylaxis Angioedema Dyspnea Hallucinations Hypertension Ischemic colitis Posterior reversible encephalopathy syndrome Reversible cerebral vasoconstriction syndrome Seizure disorder Vomiting

There are 58 less severe adverse reactions.

More Frequent	Less Frequent
Headache disorder Insomnia	Acute abdominal pain Agitation Anorexia Conjunctivitis Dizziness Drowsy Dysuria General weakness Nausea Nervousness Pallor Tachycardia Tremor

Rare/Very Rare

Abdominal pain with cramps Acute cognitive impairment Alopecia Anticholinergic toxicity Blurred vision Bronchitis Cardiac arrhythmia Chest tightness Concentration difficulty Cough Dizziness Dream disorder Dry nose Dry throat Dyspepsia Dyspnea Earache Epistaxis Excitement Fatigue Gastritis Hyperhidrosis Hyperkinesis Increased appetite Insomnia Malaise Nausea Nervousness Palpitations Pharyngitis Sedation Skin photosensitivity Skin rash Symptoms of anxiety Syncope Tachycardia Tinnitus Urinary incontinence Urinary retention Visual changes Voice change Weight gain Xerostomia

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.

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.

No enhanced Geriatric Use information available for this drug.