AlleRx Dose Pack PE

General: AlleRx PE should be used with caution in patients with diabetes mellitus, cardiovascular disease, and hyperactivity to sympathomimetic amines. Hypertensive patients should only use with medical advice, as they may experience a change in blood pressure due to added vasoconstriction. Antihistamines may cause drowsiness, and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly. Methscopolamine nitrate should be used with caution in the elderly and all patients with autonomic neuropathy, hepatic or renal disease, or ulcerative colitis.

Drug Interactions: Monoamine oxidase (MAO) inhibitors and beta-adrenergic blockers increase the effects of sympathomimetic amines. Sympathomimetic amines may reduce the antihypertensive effects of methyldopa, guanethidine, mecamylamine, reserpine and veratrum alkaloids. Additive anticholinergic effects may result from concomitant use with antipsychotics, tricyclic antidepressants, and other drugs with anticholinergic effects. Concomitant administration with antacids may interfere with the absorption of methscopolamine nitrate.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Animal studies to assess the long-term carcinogenic and mutagenic potential or the effect on fertility in animals or humans have not been performed.

Pregnancy Category C: It is not known whether AlleRx can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. AlleRx should be given to a pregnant woman only if clearly needed.

Nursing Mothers: It is not known whether this combination drug is excreted in human milk. However, phenylephrine HCl administered alone distributes into the breast milk of lactating human females; therefore, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: The safety and effectiveness in children under 12 years of age have not been established.

Geriatric Use: The elderly (60 years and older) are more likely to experience adverse reactions to sympathomimetics. Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression, and/or death. Demonstrate safe use of a short-acting sympathomimetic amine before use of an extended-action formulation.