Allerhist-1

Allerhist-1 is part of the drug classes:

• Aminoalkyl ethers

• Antihistamines for topical use

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Dizziness.
• Belly pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to clemastine: oral oral solution, oral tablets

Side effects include:

Sedation, sleepiness, dizziness, disturbed coordination, epigastric distress, thickening of bronchial secretions.

< 6 years:

0.335 to 0.67 mg/day orally divided into 2 or 3 doses. Maximum daily dose is 1.34 mg.

6 to 12 years:

0.67 to 1.34 mg orally twice a day. Maximum daily dose is 4.02 mg.

> 12 years:

Initial dose: 1.34 mg orally twice a day. Dosage may be increased as required, but not to exceed 2.68 mg orally 3 times a day.

Many patients respond favorably to a single dose (clemastine 2.68 mg) which may be repeated as required, but not to exceed 3 tablets a day.

Among Michigan Medicaid recipients, 1617 exposures to clemastine were reported during the first trimester. (F. Rosa, personal communication, FDA, 1994) Birth defects were observed in 71 infants (68 expected) and included 13 cardiovascular defects, 3 oral clefts, 3 spina bifida, 4 polydactyly, 4 hypospadias, and 5 limb reductions. No evidence was found to suggest a relationship to large categories of malformations, except possibly limb reductions. A review of prenatal drug use in 3026 women with premature infants demonstrated an increased risk of retrolental fibroplasia with antihistamine use during the last two weeks of pregnancy. The dosage used or the particular antihistamine was not specified. The incidence of retrolental fibroplasia in premature infants exposed in utero to antihistamine during this time was 21% compared to 11% in premature infants not exposed.

Clemastine has been assigned to pregnancy category B by the FDA. There are no controlled data in human pregnancy. Clemastine is only recommended for use during pregnancy when benefit outweighs risk.

LactMed Record Number

71

Last Revision Date

20150310

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.