Hydroxyzine

The selected hydrochloride tablets/solution and pamoate capsules are labeled for symptomatic anxiety/tension associated with the conditions described in their labels, allergic or histamine-mediated pruritus, and sedation before or following general anesthesia. Long-term antianxiety effectiveness beyond 4 months has not been systematically assessed; reassess continued usefulness.

This reference covers oral hydrochloride and pamoate products. Intramuscular hydroxyzine is a separate formulation requiring its own label, dose, and administration precautions; oral solution is not injectable. European national indications differ, and EMA QT-risk restrictions are identified separately rather than portrayed as U.S. labeling.

The selected U.S. labels describe anxiety dosing of 50–100 mg four times daily (200–400 mg/day); this is a label range, not a default target or a universally safe maximum. Allergic pruritus: 25 mg three or four times daily. Peri-anesthetic sedation: 50–100 mg in adults under clinical supervision. Adjust to response, sedation, QT risks, and interacting medicines; European restrictions below are substantially lower.

The oral labels state 50 mg/day in divided doses for children under 6 and 50–100 mg/day in divided doses for children over 6, for anxiety or pruritus; peri-anesthetic sedation is 0.6 mg/kg. Their “under 6” and “over 6” wording leaves exactly age 6 unspecified: confirm a pediatric regimen with the prescriber rather than invent a boundary. These legacy age-only ranges need individualized review and are not weight-based European maxima. PAI solution is 10 mg/5 mL (2 mg/mL); use an accurate oral measuring device.

EMA measures call for short-duration treatment at the lowest effective dose, an adult maximum of 100 mg/day, and avoidance in older adults when possible; if necessary, the older-adult maximum is 50 mg/day. Where pediatric use is authorized, children up to 40 kg have a maximum of 2 mg/kg/day, and those over 40 kg use the adult maximum. Follow the jurisdiction’s current product label; these European limits are not the U.S. dosing table.

Selected U.S. labels contraindicate prolonged QT, early pregnancy, and hypersensitivity to hydroxyzine/product ingredients, cetirizine, or levocetirizine. EMA additionally contraindicates use with known QT-risk factors such as cardiovascular disease, significant electrolyte imbalance, family sudden-death history, significant bradycardia, or concomitant QT/TdP-producing medicines. These regional classifications should remain distinct.

These selected oral U.S. labels do not contain a boxed warning. That does not remove their contraindications or clinically important QT and sedation risks.

Dry mouth and drowsiness are common reported effects. Rare tremor/convulsions, hallucinations, hypersensitivity, severe skin reactions, QT prolongation, and TdP are reported. Overdose can produce profound sedation, stupor, seizures, and arrhythmia; get emergency/poison-center assessment and ECG/vital-sign monitoring. There is no specific antidote and dialysis benefit is doubtful. Do not attempt home decontamination.

Opioids, barbiturates, other sedatives, and alcohol can add to impairment. The labels call for reducing concomitant CNS-depressant doses as appropriate under supervision. Avoid alcohol and unsafe driving/operating machinery until effects are known.

Review antiarrhythmics, antipsychotics, antidepressants, macrolide/fluoroquinolone antibiotics, methadone, ondansetron, and other QT-prolonging drugs. U.S. labels caution with these combinations; EMA prohibits QT/TdP-producing combinations and advises care with drugs causing bradycardia or low potassium, and potent alcohol-dehydrogenase or CYP3A4/5 inhibitors.

Early pregnancy is contraindicated in the selected U.S. labels because human safety data are inadequate. Their nursing warning says not to give hydroxyzine to breastfeeding mothers. LactMed is more nuanced: occasional small doses are unlikely to harm, but larger/prolonged use may sedate an infant or reduce milk supply, and alternatives are preferred for newborns/preterm infants. This difference requires a clinician’s individualized discussion rather than a blanket safe-use claim.

Confirm the pediatric product, age wording, weight, and regional limit before prescribing; no infant or exact-age-6 regimen is supplied here. U.S. labels advise low cautious starting doses and close observation in older adults because of sedation and diminished organ function. EMA discourages older-adult use and imposes its lower limit when unavoidable.

The selected U.S. labels do not supply a validated numerical renal/hepatic adjustment or a full organ-impairment PK model. They emphasize cautious selection when hepatic, renal, or cardiac function is reduced, particularly in older patients. Review local formulation guidance and clinical risk rather than assuming no adjustment is needed.

Oral labels describe antihistaminic effects and CNS actions involving subcortical regions, although a precise modern antianxiety mechanism is not established there. Oral clinical effects are generally noted within 15–30 minutes. Pamoate capsule strengths are expressed as hydrochloride-equivalent doses.

The selected U.S. oral labels do not quantify a reliable half-life or complete renal/hepatic disposition, so none is invented. EMA describes reduced elimination in older adults and cardiac-channel effects, including hERG inhibition, underlying its QT-risk restrictions.

Assess benefit, duration, sedation, cognition, falls risk, and interacting medicines. Review QT history and electrolyte/cardiac risk; select ECG/electrolyte assessment according to those risks rather than an invented universal schedule. Reassess chronic anxiety therapy because effectiveness beyond 4 months is unstudied.

Verify the exact salt and oral strength. Measure liquid accurately; do not use oral solution as an injection. Avoid alcohol, sharing medication, and hazardous activity while sedated. Stop and obtain prompt assessment for a rash or worsening skin reaction; fainting, marked palpitations, seizure, severe allergy, or profound sleepiness needs urgent help.

American Health Packaging’s Aurobindo-source 50-mg hydrochloride tablet is purple, round, marked 7, in 100 unit doses (NDC 60687-875-01; source NDC 59651-501). PAI’s clear-to-slightly-yellow 10 mg/5 mL solution is a 473-mL bottle, NDC 0121-1034-16. Teva’s 25-mg pamoate capsule is yellow/pink, marked barr 323 / 25 (100-count NDC 0555-0323-02). Generic appearances vary.

The hydrochloride tablet label describes 10/25/50 mg, with the selected repackaged presentation specifically 50 mg. The selected solution is 10 mg/5 mL and contains sucrose and 0.5% alcohol by volume. Teva pamoate capsules contain hydrochloride-equivalent 25/50/100 mg. IM products are outside this oral dosing reference.

Selected oral products store at 20–25°C. PAI liquid requires protection from freezing and light in a tight, light-resistant container with child-resistant closure. Teva capsules also require a tight, light-resistant container and child-resistant closure. Do not use a torn/broken unit-dose blister; keep all medicines out of children’s reach.