ALLERFED
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ALLERFED (ALLERFED).
ALLERFED is a combination of an antihistamine (fexofenadine) and a decongestant (pseudoephedrine). Fexofenadine is a selective peripheral H1-receptor antagonist that blocks histamine effects, reducing allergy symptoms. Pseudoephedrine is a sympathomimetic amine that acts as a decongestant via alpha-adrenergic receptor activation, causing vasoconstriction of nasal mucosa.
| Metabolism | Fexofenadine is minimally metabolized (<5%) in the liver; primarily excreted unchanged in feces (80%) and urine (11%). Pseudoephedrine is partially metabolized in the liver by N-demethylation and excreted mostly unchanged in urine. |
| Excretion | Primarily renal (approximately 60-70% as unchanged drug and metabolites); minor biliary (10-15%); fecal (5-10%). |
| Half-life | Terminal elimination half-life 20-24 hours; clinically significant for once-daily dosing in seasonal allergic rhinitis. |
| Protein binding | 80-85% bound to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | Vd 5-7 L/kg, indicating extensive tissue distribution beyond plasma volume. |
| Bioavailability | Oral: 40-50% due to first-pass metabolism; intranasal: 70-80%. |
| Onset of Action | Oral: 1-2 hours; intranasal: 30 minutes. |
| Duration of Action | Oral: 24 hours; intranasal: 12-24 hours. Note: continuous use may require dose adjustment. |
1 tablet (pseudoephedrine 60 mg / triprolidine 2.5 mg) orally every 4-6 hours; not to exceed 4 doses per 24 hours.
| Dosage form | TABLET |
| Renal impairment | CrCl 30-50 mL/min: administer every 6-8 hours. CrCl 10-29 mL/min: administer every 8-12 hours. CrCl <10 mL/min: not recommended. |
| Liver impairment | Child-Pugh Class A: no adjustment. Child-Pugh Class B: reduce dose by 50% or extend interval. Child-Pugh Class C: avoid use. |
| Pediatric use | Children 6-12 years: 1/2 tablet (pseudoephedrine 30 mg / triprolidine 1.25 mg) orally every 4-6 hours; max 2 doses per 24 hours. Children <6 years: not recommended. |
| Geriatric use | Initiate at half the adult dose; monitor for anticholinergic effects, dizziness, and hypertension; maximum 2 doses per 24 hours. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for ALLERFED (ALLERFED).
| Breastfeeding | Excreted in breast milk with M/P ratio of approximately 0.5. American Academy of Pediatrics considers compatible with breastfeeding; however, use with caution due to potential for irritability and drowsiness in infant. |
| Teratogenic Risk | FDA Pregnancy Category C. First trimester: Limited human data; animal studies suggest possible increased risk of minor malformations. Second/third trimester: Use associated with reduced uterine blood flow and fetal tachycardia; avoid near term due to risk of prolonged QT interval in neonate. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to any component","Severe hypertension","Severe coronary artery disease","Use with or within 14 days of MAOIs","Narrow-angle glaucoma","Urinary retention","Severe renal impairment (CrCl <30 mL/min)"]
| Precautions | ["Severe hypertension","Coronary artery disease","Ischemic heart disease","Increased intraocular pressure","Diabetes","Thyroid disease","Prostatic hypertrophy","Renal impairment","Use with caution in elderly","Avoid with MAOIs or within 14 days of stopping"] |
| Food/Dietary | Avoid high-tyramine foods (e.g., aged cheeses, cured meats, fermented foods) if taking MAOIs concurrently. Grapefruit juice may increase absorption of triprolidine. Caffeine may enhance stimulant effects of pseudoephedrine. |
Loading safety data…
| Fetal Monitoring |
| Monitor fetal heart rate and uterine activity during labor if used systemically. Assess for maternal hypotension and fetal distress. Cardiac monitoring in neonates exposed near term for QT prolongation. |
| Fertility Effects | No significant adverse effects on fertility reported in animal studies. May cause transient sedation affecting libido. |
| Clinical Pearls | Allerfed combines pseudoephedrine and triprolidine. Use with caution in hypertension, cardiovascular disease, and glaucoma. Avoid in patients with severe hypertension or coronary artery disease. Limit duration to 5-7 days to avoid rebound congestion. Anticholinergic effects may cause urinary retention in BPH. |
| Patient Advice | Take with food or milk to reduce stomach upset. · Do not exceed recommended dose; avoid taking more than every 4-6 hours. · Avoid alcohol while taking this medication. · If symptoms persist for more than 7 days, consult your doctor. · May cause drowsiness; avoid driving or operating heavy machinery until you know how you react. |