A-Phedrin

Name: A-Phedrin

A-Phedrin Drug Class

A-Phedrin is part of the drug classes:

  • Other antihistamines for systemic use

  • Sympathomimetics

What are some other side effects of this drug?

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:

  • Dizziness.
  • Feeling nervous and excitable.
  • Not able to sleep.
  • Feeling sleepy.

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.

Usual Adult Dose for Allergic Rhinitis

Tablets:
Pseudoephedrine-triprolidine 60 mg-2.5 mg
1 tablet orally every 4-6 hours; do not exceed 4 doses in 24 hours.

Syrup:
Pseudoephedrine-triprolidine 30 mg-1.25 mg/mL oral liquid
10 mL orally every 4-6 hours; do not exceed 4 doses in 24 hours.

Liquid:
Pseudoephedrine-triprolidine 10 mg-0.938 mg/mL oral liquid:
2.67 mL orally every 6 hours. Do not take more than 4 doses in 24 hours.
Pseudoephedrine-triprolidine 45 mg-2.5 mg/5 mL oral liquid:
5 to 10 mL orally every 4 to 6 hours. (maximum pseudoephedrine: 240 mg/24 hours).

Liver Dose Adjustments

Data not available

Pseudoephedrine / triprolidine Pregnancy Warnings

Pseudoephedrine-triprolidine has not been formally assigned to a pregnancy category by the FDA. There are no controlled data in human pregnancy. Pseudoephedrine-triprolidine is only recommended for use during pregnancy when benefit outweighs risk. Pseudoephedrine has not been formally assigned to a pregnancy category by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Based on available data, pseudoephedrine is not thought to be teratogenic. Triprolidine has been assigned to pregnancy category C by the FDA. There are no controlled data in human pregnancy.

A case-controlled surveillance study reported an elevated relative risk (3.2) of gastroschisis with first-trimester pseudoephedrine use in 76 cases. Relative risks for other drugs were 1.6 for salicylates, 1.7 for acetaminophen, 1.3 for ibuprofen, and 1.5 for phenylpropanolamine (not significant). The authors hypothesized vascular disruption was the etiology of gastroschisis. A second group of 416 infants with heterogeneous defects suspected to have a vascular etiology were reviewed. There was no increased risk associated with salicylates, ibuprofen, pseudoephedrine, phenylpropanolamine or other decongestants. These data require independent confirmation. In a review of 229,101 deliveries to Michigan Medicaid patients, 940 first-trimester exposures to pseudoephedrine were recorded and 1919 exposures anytime during pregnancy. A total of 37 birth defects were reported with first trimester exposure (40 expected) and included (observed/expected) 3/9 cardiovascular defects, 2 oral clefts, and 3/2 polydactyly. These researchers reviewed nine cases of abdominal wall defects in the 1980-1983 Medicaid data. Seven of the nine cases occurred in 3752 woman who had taken pseudoephedrine for a relative risk of 1.8. Only one of these cases was a surgically treated abdominal wall defect. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). The Collaborative Perinatal Project monitored 50,282 mother-child pairs. Only 39 first-trimester exposures to pseudoephedrine were recorded, with one birth defect observed. For use anytime during pregnancy, 194 exposures were recorded with 3 birth defects observed (3.22 expected). The effect of pseudoephedrine on uterine and fetal blood was studied in 12 healthy pregnant women between 26 and 40 weeks gestation. Following a single 60 mg dose of pseudoephedrine, no significant effect was seen on fetal heart rate, uterine blood flow, or fetal aortic blood flow.

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