Nasal Decongestant (triprolidine HCl/pseudoephedrine HCl)

Dosage of triprolidine hydrochloride should be individualized according to the patient's response and tolerance.

When triprolidine hydrochloride is used in fixed combination with pseudoephedrine hydrochloride, dosage recommendations for adults and children are the same as when the drug is used as a single agent.

For self-medication in adults and children 12 years of age and older, the usual dosage of triprolidine hydrochloride is 2.5 mg every 4-6 hours, not to exceed 10 mg in 24 hours. For self-medication in children 6 to younger than 12 years of age, the usual dosage is 1.25 mg every 4-6 hours, not to exceed 5 mg in 24 hours. Therapy should be discontinued if symptoms persist for more than 7 days or are accompanied by fever.

Under the direction of a physician, children 4 to younger than 6 years of age may receive 0.938 mg every 4-6 hours, not to exceed 3.744 mg in 24 hours; children 2 to younger than 4 years of age may receive 0.625 mg every 4-6 hours, not to exceed 2.5 mg in 24 hours; and children 4 months to younger than 2 years of age may receive 0.313 mg every 4-6 hours, not to exceed 1.252 mg in 24 hours. (See Cautions: Pediatric Precautions.)

For further information on chemistry, pharmacology, pharmacokinetics, uses, cautions, acute toxicity, drug interactions, laboratory test interferences, and dosage and administration of triprolidine, see the Antihistamines General Statement 4:00.

Triprolidine hydrochloride preparations are administered orally.

Pseudoephedrine hydrochloride and sulfate are administered orally.

Pseudoephedrine hydrochloride 240-mg extended-release tablets should be administered orally once daily and swallowed whole with water; the extended-release tablets should not be divided, crushed, chewed, or dissolved. Patients should be advised that the tablet does not completely dissolve and may be passed in the stool.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

No enhanced messaging available.

There is inadequate experience with use of triprolidine in pregnant women to determine whether the potential for harm to the fetus exists. Reproduction studies in rats and rabbits using dosages up to 70 times the usual human dosage of the fixed-dose combination of triprolidine and pseudoephedrine (Actifed(R)) have not revealed evidence of harm to the fetus. In an epidemiologic study in pregnant women, there was no evidence of increased risk of teratogenicity associated with use of triprolidine in fixed combination with pseudoephedrine during the first trimester, although a modest association could not be ruled out. There are no adequate and controlled studies to date using triprolidine in pregnant women, and the drug should be used during pregnancy only when clearly needed.

Triprolidine is distributed into milk. Because of the potential for serious adverse reactions to antihistamines in nursing infants, some manufacturers state that a decision should be made whether to discontinue nursing or triprolidine, taking into account the importance of the drug to the woman. However, the American Academy of Pediatrics (AAP) considers triprolidine to be compatible with breast-feeding.

No enhanced messaging available.