ALLERGY RELIEF (chlorpheniramine maleate)

There are 0 contraindications.

There are 7 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Angle-closure glaucoma
Benign prostatic hyperplasia
Bladder outflow obstruction
Chronic idiopathic constipation
Gastrointestinal obstruction
Stenosing peptic ulcer
Urinary retention

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
Chronic obstructive pulmonary disease
Disease of liver
Hepatic failure
Hypertension
Hyperthyroidism
Renal disease with moderate to severe function impairment

There are 10 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Abnormal hepatic function tests Anaphylaxis Angioedema Blood dyscrasias Extrasystoles Hallucinations Hemolytic anemia Hypersensitivity drug reaction Hypotension Seizure disorder

There are 73 less severe adverse reactions.

More Frequent	Less Frequent
Anticholinergic toxicity Dizziness Drowsy Headache disorder Thick bronchial secretions	Acute abdominal pain Conjunctivitis Drowsy Muscle weakness Sedation

Rare/Very Rare

Abdominal distension Accidental fall Acute abdominal pain Acute cognitive impairment Agitation Alopecia Anorexia Anticholinergic toxicity Ataxia Blurred vision Bronchitis Chest discomfort Chills Concentration difficulty Constipation Cough Diarrhea Diplopia Dizziness Dream disorder Dry nose Dry throat Dyspnea Dysuria Earache Epistaxis Euphoria Excitement Fatigue Gastritis Headache disorder Hyperhidrosis Hyperkinesis Increased appetite Insomnia Irritability Maculopapular rash Malaise Migraine Nausea Nervousness Nightmares Palpitations Paresthesia Pharyngitis Pruritus of skin Sedation Skin photosensitivity Skin rash Symptoms of anxiety Tachycardia Tinnitus Tremor Urinary incontinence Urinary retention Urticaria Vertigo Visual changes Voice change Vomiting Weight gain Wheezing Xerostomia

Reproduction studies in animals using dexchlorpheniramine have not been performed to date, but reproduction studies in rabbits and rats using chlorpheniramine maleate dosages up to 50 and 85 times the usual human dosage, respectively, have not revealed evidence of harm to the fetus. Decreased postnatal survival in offspring of rats receiving 33 and 67 times the usual human dosage of chlorpheniramine maleate has been reported. There are no adequate and controlled studies to date using chlorpheniramine or dexchlorpheniramine in pregnant women, and the drugs should be used during the first 2 trimesters only when clearly needed.

In one epidemiologic study, use of chlorpheniramine was not associated with an increased risk of teratogenic effects; however, only a limited number of pregnant women received the drug in this study. Because of the risk of severe reactions (e.g., seizures) to antihistamines in neonates, chlorpheniramine or dexchlorpheniramine should not be used during the third trimester. 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.

It is not known whether chlorpheniramine or dexchlorpheniramine is distributed into milk, but other antihistamines (e.g., diphenhydramine) have been detected in milk. Because of the potential for serious adverse reactions to antihistamines in nursing infants, a decision should be made whether to discontinue nursing or chlorpheniramine or dexchlorpheniramine, 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.

No enhanced Geriatric Use information available for this drug.