promethegan
Pharmaranks rates Promethegan 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Promethegan (Promethazine Hydrochloride) is a phenothiazine used to treat Anaphylaxis, Allergic Conjunctivitis, Motion Sickness, Nausea.
Promethazine Hydrochloride · by Cosette
Generic of Phenergan
⚠ FDA reports a current shortage of the injection form — availability differs between suppliers — see drug shortages →Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Promethazine Hydrochloride
- Drug class
- Phenothiazine
- Form
- Suppository
- Strength
- Promethazine Hydrochloride 50MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- anaphylaxis, allergic conjunctivitis, motion sickness
- Manufacturer
- Cosette
- Half-life
- about 9 to 16 hours (how long it stays in your system)
- What the pharmacy pays
- ~$1.53 for 30 — not your price
- FDA application
- ANDA087165
- FDA boxed warning
- Yes — see the boxed warning
What is Promethegan?
From the FDA label:Each rectal suppository contains 50 mg promethazine HCl with ascorbyl palmitate and polysorbate 80 in a specially blended base of saturated vegetable fatty acids. Promethazine HCl Suppositories, USP are for rectal administration only. Promethazine HCl is a racemic compound; the empirical formula is C 17 H 20 N 2 S•HCl and its molecular weight is 320.88. Promethazine HCl, a phenothiazine derivative, is designated chemically as 10 H -Phenothiazine, 10-ethanamine, N,N α -trimethyl-, monohydrochloride, (±)- with the following structural formula: Promethazine HCl occurs as a white to faint yellow, practically odorless, crystalline powder, which slowly oxidizes and turns blue on prolonged exposure to air. It is freely soluble in water and soluble in alcohol. structural formula
How to use
Promethazine HCl Rectal Suppositories are contraindicated for children under 2 years of age ( see WARNINGS–Black Box Warning and Use in Pediatric Patients). Promethazine HCl Suppositories are for rectal administration only. Allergy The average dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Single 25-mg doses at bedtime or 6.25 to 12.5 mg taken three times daily will usually suffice. After initiation of treatment in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. The administration of promethazine hydrochloride in 25-mg doses will control minor transfusion reactions of an allergic nature. Motion Sickness The average adult dose is 25 mg taken twice daily. The initial dose should be taken one-half to one hour before anticipated travel and be repeated 8 to 12 hours later, if necessary. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. For children, Promethazine HCl Rectal Suppositories, 12.5 to 25 mg, twice daily, may be administered. Nausea and Vomiting Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS– Use in Pediatric Patients ). The average effective dose of promethazine HCl for the active therapy of nausea and vomiting in children or adults is 25…
Side effects
Central Nervous System Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue, euphoria, nervousness, diplopia, insomnia, tremors, convulsive seizures, excitation, catatonic-like states, hysteria. Hallucinations have also been reported. Cardiovascular – Increased or decreased blood pressure, tachycardia, bradycardia, faintness. Dermatologic – Dermatitis, photosensitivity, urticaria. Hematologic – Leukopenia, thrombocytopenia, thrombocytopenic purpura, agranulocytosis. Gastrointestinal – Dry mouth, nausea, vomiting, jaundice. Respiratory – Asthma, nasal stuffiness, respiratory depression (potentially fatal) and apnea (potentially fatal). (See WARNINGS–Respiratory Depression ). Other – Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported (See WARNINGS–Neuroleptic Malignant Syndrome ). Paradoxical Reactions Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine HCl. Consideration should be given to the discontinuation of promethazine HCl and to the use of other drugs if these reactions occur. Respiratory depression, nightmares, delirium, and agitated behavior…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
WARNING: PROMETHAZINE HCL SUPPOSITORIES SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HCL SUPPOSITORIES IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCL SUPPOSITORIES HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCL TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HCL BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.
Who should not take Promethegan
Promethazine HCl Suppositories are contraindicated for use in pediatric patients less than two years of age. Promethazine HCl Suppositories are contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma.
Overdose — what happens if you take too much
Signs and symptoms of overdosage with promethazine HCl range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, and unconsciousness, and sudden death. Other reported reactions include hyperreflexia, hypertonia, ataxia, athetosis, and extensor-plantar reflexes (Babinski reflex). Stimulation may be evident, especially in children and geriatric patients. Convulsions may rarely occur. A paradoxical-type reaction has been reported in children receiving single doses of 75 mg to 125 mg orally, characterized by hyperexcitability and nightmares. Atropine-like signs and symptoms-dry mouth, fixed, dilated pupils, flushing, as well as gastrointestinal symptoms-may occur. Treatment Treatment of overdosage is essentially symptomatic and supportive. Only in cases of extreme overdosage or individual sensitivity do vital signs, including respiration, pulse, blood pressure, temperature, and EKG, need to be monitored. Activated charcoal orally or by lavage may be given, or sodium or magnesium sulfate orally as a cathartic. Attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. Diazepam may be used to control convulsions. Acidosis and electrolyte losses should be corrected. Note that any depressant effects…
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
CNS Depressants – Promethazine HCl Suppositories may increase, prolong, or intensify the sedative action of other central-nervous-system depressants, such as alcohol, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers; therefore, such agents should be avoided or administered in reduced dosage to patients receiving promethazine HCl. When given concomitantly with Promethazine HCl Suppositories, the dose of barbiturates should be reduced by at least one-half, and the dose of narcotics should be reduced by one-quarter to one-half. Dosage must be individualized. Excessive amounts of promethazine HCl relative to a narcotic may lead to restlessness and motor hyperactivity in the patient with pain; these symptoms usually disappear with adequate control of the pain. Epinephrine – Because of the potential for promethazine HCl to reverse epinephrine’s vasopressor effect, epinephrine should NOT be used to treat hypotension associated with Promethazine HCl Suppositories overdose. Anticholinergics – Concomitant use of other agents with anticholinergic properties should be undertaken with caution. Monoamine Oxidase Inhibitors (MAOI) – Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAOI and phenothiazines are used concomitantly. This possibility should be considered with Promethazine HCl Suppositories.
How long does Promethazine Hydrochloride stay in your body?
The elimination half-life of promethazine hydrochloride is about 9 to 16 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. Kinetics are linear (no saturable/dose-dependent behavior). The FDA label reports a plasma half-life of 9-16 hours after IV dosing and a mean of 9.8 ± 3.4 hours after IM dosing; the oral tablet label omits a numeric half-life but describes the same disposition. Duration of clinical effect (about 4-6 hours, occasionally up to 12) is shorter than the elimination half-life, so sedation can wear off well before the drug clears. Promethazine is metabolized in the liver to sulfoxides of promethazine and N-desmethylpromethazine (the main urinary metabolites); the label does not characterize these as clinically active or as outlasting the parent. Not a prodrug. Because clearance is hepatic, impaired liver function may prolong the half-life; the label gives no specific age- or kidney-based half-life values.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Promethazine Hydrochloride Injection, USP — FDA label (DailyMed).
Drug class
May treat (source: NIH RxClass)
See how Promethegan ranks — best-rated phenothiazine for:
Dosage forms
Suppository
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Promethegan treat?
- Promethegan (Promethazine Hydrochloride) may be used to treat anaphylaxis, allergic conjunctivitis, motion sickness, nausea, pain, postoperative complications, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Promethegan rated?
- pharmaranks gives Promethegan a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Promethegan cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $1.53 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Promethegan?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Promethegan. To pay less, Promethegan is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Promethegan?
- Promethegan is marketed by Cosette. You can see Cosette's full profile, rating, and other products on pharmaranks.
- Is Promethegan a brand-name or generic drug?
- Promethegan is a generic medication; its active ingredient is Promethazine Hydrochloride. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Promethegan available over the counter?
- No. Promethegan is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Promethegan come in?
- Promethegan is currently marketed as suppository, per the FDA's National Drug Code Directory.
- What class of drug is Promethegan?
- Promethegan is classified as phenothiazine, per the FDA's Established Pharmacologic Class.
- Is Promethegan FDA-registered?
- Promethegan is on record with the U.S. FDA under application number ANDA087165. You can verify this on its official FDA label.
- Has Promethegan been recalled by the FDA?
- Promethegan has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Promethegan safe?
- There's no single safe-or-not verdict. pharmaranks gives Promethegan a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Promethegan?
- Promethegan's side effects are taken directly from its FDA label. From the label: Central Nervous System Drowsiness is the most prominent CNS effect of this drug. Sedation, somnolence, blurred vision, dizziness; confusion, disorientation, and extrapyramidal symptoms such as oculogyric crisis, torticollis, and tongue protrusion; lassitude, tinnitus, incoordination, fatigue,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
Reviews
No reviews yet. Be the first to write one.
People also viewed
procomp
Prochlorperazine Maleate
perphenazine
Perphenazine
prochlorperazine edisylate
Prochlorperazine Edisylate
prochlorperazine maleate
Prochlorperazine Maleate
promethazine plain
Promethazine Hydrochloride
Compare Promethegan head-to-head
Guides for this medication
Browse medications A–Z
Research products from A to Z, compare independent ratings, and find alternatives.
promethegan
70/100