Generic Phenergan Syrup ( Promethazine )

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Phenergan Syrup (promethazine hydrochloride) is a first‑generation antihistamine with strong sedative, antiemetic, and anticholinergic properties. It blocks histamine H1 receptors in peripheral tissues and the brain, reducing allergic symptoms, preventing motion sickness, and suppressing the vomiting reflex.
Usual adult dose: For allergies or nausea, 12.5 mg to 25 mg (1‑2 teaspoons) every 4‑6 hours as needed. For sedation or motion sickness, 25 mg to 50 mg at bedtime or before travel. The syrup contains 6.25 mg of promethazine hydrochloride per 5 mL (teaspoon).
Dosage form: Oral syrup, 100 mL bottle, containing 6.25 mg/5 mL promethazine hydrochloride.
Onset of action: Antiemetic and antihistaminic effects begin within 20‑30 minutes after oral administration; sedative effects may be felt within an hour.
Duration of action: 4‑6 hours for most indications; sedation may persist longer, especially with higher doses.
Alcohol consumption must be strictly avoided during treatment. Alcohol potentiates the central nervous system depressant effects of promethazine and can lead to profound sedation, respiratory depression, or even coma.
Most common side effects: marked drowsiness, dizziness, dry mouth, blurred vision, and constipation.
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General Information about Phenergan Syrup

• INN (International Nonproprietary Name): Promethazine hydrochloride
• Brand names available in the USA: Phenergan® is the brand name (no longer exclusively trademarked; available under various labels). Generic promethazine syrup is manufactured by multiple FDA‑approved companies, including Tris Pharma, Inc., Pharmaceutical Associates, Inc., and others.
• ATC code: R06AD02
• Dosage forms and strengths: Syrup: 6.25 mg promethazine hydrochloride per 5 mL, supplied in 100 mL bottles. (Suppositories, tablets, and injectable forms also exist.)
• Manufacturers in USA: Tris Pharma, Inc., Pharmaceutical Associates, Inc., and various generic manufacturers.
• Registration status in USA: Approved by the U.S. Food and Drug Administration (FDA) under NDA 007993 (original approval). Generic versions are approved under ANDAs.
• OTC / Rx classification: Prescription only (Rx).

Mechanism of Action and Pharmacology

Promethazine is a phenothiazine derivative that acts as a potent, competitive antagonist of histamine at the H1 receptor. Unlike second‑generation antihistamines, it readily crosses the blood‑brain barrier and occupies central H1 receptors, producing pronounced sedation. It also possesses significant anticholinergic activity by blocking muscarinic acetylcholine receptors, which contributes to its antiemetic effect and dry mouth. Furthermore, promethazine inhibits the chemoreceptor trigger zone in the medulla oblongata, reducing nausea and vomiting. Its alpha‑adrenergic blocking properties can lead to orthostatic hypotension. After oral administration, the syrup is rapidly absorbed, with peak plasma concentrations within 2‑3 hours. It is extensively metabolized by the liver (CYP2D6 and other pathways) and excreted as metabolites in urine and feces. The elimination half‑life is approximately 10‑14 hours, but pharmacodynamic effects (especially sedation) may last longer.

Indications

• Symptomatic treatment of seasonal and perennial allergic rhinitis, conjunctivitis, and urticaria (hives).
• Prevention and treatment of nausea and vomiting, including postoperative nausea and vomiting.
• Motion sickness prophylaxis and treatment.
• Preoperative sedation and adjunct to anesthesia.
• Short‑term management of insomnia (off‑label but common).
• Adjunct to analgesics for the management of pain, particularly when sedation and antiemetic effects are desired.

Important Warnings and Precautions

Phenergan (promethazine) carries a boxed warning for the risk of respiratory depression and death in children under 2 years of age; use is absolutely contraindicated in this age group. Caution is advised in children 2 years and older; the lowest effective dose must be used, and concurrent use of other drugs with respiratory depressant effects should be avoided. Promethazine can cause severe tissue injury, including gangrene, when injected intravenously or subcutaneously; the preferred route is deep intramuscular injection. The syrup formulation avoids this risk, but excessive sedation and respiratory depression remain a danger, particularly when combined with alcohol, opioids, or other central nervous system depressants. Anticholinergic effects (dry mouth, urinary retention, constipation, blurred vision) can be problematic in the elderly. Neuroleptic malignant syndrome, a life‑threatening syndrome characterized by hyperthermia, muscle rigidity, and autonomic instability, has been reported rarely with promethazine and other phenothiazines. Use with caution in patients with asthma, sleep apnea, or compromised respiratory function. Promethazine may lower the seizure threshold; use carefully in patients with seizure disorders. It may also mask symptoms of ototoxicity from aminoglycosides or other drugs.

At‑risk groups

• Elderly: Increased sensitivity to anticholinergic and sedative effects; use the lowest effective dose. Avoid use in elderly patients with dementia due to risk of cognitive impairment and falls. Not recommended for routine sedation in this age group.
• Pregnancy: Promethazine crosses the placenta. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It has been used for nausea and vomiting of pregnancy (hyperemesis gravidarum) when other treatments fail, but only under close medical supervision. Use near delivery may cause neonatal sedation and respiratory depression.
• Breastfeeding: Promethazine is excreted into human milk. It may cause sedation, irritability, and respiratory depression in nursing infants. Breastfeeding is not recommended during treatment; a decision should be made to discontinue nursing or the drug.
• Renal impairment: Use with caution; dose reduction may be required as promethazine metabolites are renally excreted.
• Hepatic impairment: Use with caution; promethazine is extensively metabolized by the liver. Accumulation can occur, leading to excessive sedation and hepatotoxicity.
• Pediatric: Contraindicated in children under 2 years due to risk of respiratory depression. In children 2‑12 years, use the lowest effective dose; calculate by weight (0.25‑0.5 mg/kg every 4‑6 hours). Do not exceed 25 mg per dose in children under 12. Caution with concomitant use of other respiratory depressants. Not recommended for treatment of uncomplicated vomiting in children; use only when the etiology is clear.
• Respiratory conditions: Avoid or use with extreme caution in patients with asthma, COPD, or sleep apnea.

Driving and alcohol

Promethazine produces marked sedation, drowsiness, and impaired cognitive function. Patients must not drive, operate machinery, or engage in hazardous activities until they have gained sufficient experience with the drug and know how it affects them. Alcohol is strictly contraindicated during treatment; concurrent use dramatically increases the risk of profound central nervous system depression, respiratory arrest, and death. Avoid all alcoholic beverages and alcohol‑containing products (e.g., some cough syrups, mouthwashes).

Dosage Instructions

• Adults: Allergic symptoms: 12.5 mg (2 teaspoons) to 25 mg (4 teaspoons) every 4‑6 hours as needed.
• Adults: Nausea and vomiting: 12.5 mg to 25 mg every 4‑6 hours as needed.
• Adults: Motion sickness: 25 mg taken 30‑60 minutes before travel, repeated every 8‑12 hours if necessary.
• Adults: Preoperative sedation: 25 mg to 50 mg the night before surgery or 1‑2 hours before the procedure.
• Children 2‑12 years: Dose is based on body weight, usually 0.25 mg to 0.5 mg per kg every 4‑6 hours, not to exceed 25 mg per dose. Use the smallest effective dose.
• Children under 2 years: Contraindicated.
• Administration: Shake the bottle well before each use. Measure the dose using the provided dosing spoon, oral syringe, or a calibrated medicine cup. Do not use a household teaspoon. The syrup may be taken with food or milk to minimize stomach upset.
• Missed dose: If taken on a regular schedule and a dose is missed, take it as soon as remembered. If it is close to the time for the next dose, skip the missed dose. Do not double the dose.

Side Effects and Contraindications

Most common adverse reactions: Sedation, drowsiness, dizziness, dry mouth, blurred vision, constipation, and urinary retention. These anticholinergic effects are dose‑dependent and often diminish with continued use or dose reduction.
Other adverse reactions: Confusion, disorientation, nightmares, excitation (paradoxical reaction, particularly in children), photosensitivity, and weight gain.
Serious adverse reactions: Respiratory depression (especially in children and when combined with other CNS depressants), neuroleptic malignant syndrome, severe tissue injury with IV use (for syrup, risk is minimal unless overdosed), seizures, and agranulocytosis (rare).
Absolute contraindications: Known hypersensitivity to promethazine, phenothiazines, or any excipient; coma or central nervous system depression from any cause; children under 2 years of age; concomitant use of monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping them; breastfeeding mothers (due to risk of infant respiratory depression and sedation).

Drug Interactions

• Alcohol and other CNS depressants (opioids, benzodiazepines, barbiturates, sleeping pills, muscle relaxants): Additive and potentially fatal respiratory depression and profound sedation. Concomitant use is contraindicated.
• Monoamine oxidase inhibitors (MAOIs): Contraindicated; increased anticholinergic effects and possible hypertensive crisis.
• Anticholinergic drugs (tricyclic antidepressants, atropine, scopolamine, some antipsychotics): Additive anticholinergic effects, increasing risk of urinary retention, constipation, hyperthermia, and confusion.
• CYP2D6 inhibitors (fluoxetine, paroxetine, bupropion): May increase promethazine levels and risk of toxicity; monitor closely.
• Antihypertensives: Promethazine's alpha‑adrenergic blocking action may enhance the blood‑pressure‑lowering effect, leading to orthostatic hypotension.
• Epinephrine: Paradoxically, promethazine can reverse the vasopressor effect of epinephrine; if a vasopressor is needed, norepinephrine should be used instead.
• Ototoxic drugs (aminoglycosides, loop diuretics): Promethazine may mask symptoms of ototoxicity such as vertigo and tinnitus.

Practical Advice

• Take Phenergan Syrup exactly as prescribed. Do not exceed the recommended dose or frequency.
• Because this medication can cause severe drowsiness, avoid activities that require mental alertness, such as driving or operating machinery.
• Avoid all alcoholic beverages, including beer, wine, and liquor, and check labels for hidden alcohol in other products.
• Shake the syrup bottle well before measuring each dose. Use a proper measuring device, not a kitchen spoon.
• To reduce stomach upset, the syrup can be taken with food or a glass of milk.
• If you miss a dose, skip it if it is close to the time for the next scheduled dose. Do not double up.
• Store at room temperature (20‑25°C / 68‑77°F), away from light and moisture. Keep the bottle tightly capped and out of reach of children; accidental ingestion can be fatal.
• Prolonged use should be avoided; treatment is generally intended for short‑term symptom management. If symptoms persist, consult your healthcare provider.
• Never give this medication to a child under 2 years old. For children 2 years and older, measure the dose carefully based on weight and consult a doctor before use.

Alternative Medications

• Ondansetron (Zofran®): A selective serotonin 5‑HT3 receptor antagonist used for nausea and vomiting, especially postoperative and chemotherapy‑induced. Does not cause sedation or anticholinergic side effects.
• Meclizine (Antivert®, Dramamine Less Drowsy): An antihistamine used specifically for motion sickness and vertigo, with less sedation than promethazine.
• Diphenhydramine (Benadryl®): Another first‑generation antihistamine with similar sedative, antihistaminic, and antiemetic properties; available OTC.
• Dimenhydrinate (Dramamine®): Used primarily for motion sickness prevention; causes significant drowsiness.
• Prochlorperazine (Compazine®): A phenothiazine derivative with stronger antiemetic effects and less sedation than promethazine; available in tablet and suppository forms.
• Non‑sedating antihistamines (cetirizine, loratadine, fexofenadine): Effective for allergy symptoms without sedation, but without antiemetic action.

Clinical Efficacy

Promethazine has a long history of use as a sedating antihistamine and antiemetic. Clinical trials have consistently demonstrated its efficacy in reducing nausea and vomiting after surgery and in motion sickness prophylaxis. Its antihistaminic properties are comparable to diphenhydramine for urticaria and allergic rhinitis. In pediatric settings, it was once widely used for vomiting, but accumulating safety data, especially reports of fatal respiratory depression in children under 2, led to the FDA's boxed warning and restriction. For nausea and vomiting, newer agents like ondansetron have largely replaced promethazine because they do not cause sedation. However, promethazine remains a valuable option when sedation is desired, such as in preoperative settings or for nausea accompanied by severe anxiety or insomnia. Its effectiveness for sedation is well documented, and it is often used off‑label as a sleep aid, although this use should be short‑term and carefully monitored due to tolerance and dependence potential.

Important:

Phenergan Syrup (promethazine) is a prescription medication that must be used under the direct supervision of a qualified healthcare provider. It carries a boxed warning for life‑threatening respiratory depression in children under 2 years of age; do not give this medicine to any child under 2 years. Alcohol must be strictly avoided, as the combination can lead to profound sedation, coma, and death. This drug causes extreme drowsiness and impairs thinking; do not drive, operate machinery, or engage in hazardous activities while using it. Use with extreme caution in patients with breathing problems, sleep apnea, asthma, or a history of seizures. Do not combine with other sedatives, sleeping pills, or opioid pain relievers. Long‑term use is not recommended and may lead to tolerance or dependence. If you are pregnant, planning to become pregnant, or breastfeeding, discuss the risks with your healthcare provider; promethazine appears in breast milk and may harm a nursing infant. Measure each dose carefully with the provided measuring device; never use a kitchen spoon. Keep out of reach of children; accidental ingestion can be fatal. In case of an overdose (confusion, hallucinations, slow breathing, or loss of consciousness), seek emergency medical attention immediately. Never share your medication with others.

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