Promethazine Hydrochloride 25 mg Tablet, 100-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Phenothiazine class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Promethazine is used to relieve the symptoms of allergic reactions such as allergic rhinitis (runny nose and watery eyes caused by allergy to pollen, mold or dust), allergic conjunctivitis (red, watery eyes caused by allergies), allergic skin reactions, and allergic reactions to blood or plasma products. Promethazine is used with other medications to treat anaphylaxis (sudden, severe allergic reactions) and the symptoms of the common cold such as sneezing, cough, and runny nose. Promethazine is also used to relax and sedate patients before and after surgery, during labor, and at other times. P...
Read the full MedlinePlus article ↗- Promethazine has several uses. It's most commonly used for allergy symptoms like hay fever, hives, and itchy or watery eyes. It's also used to prevent or treat nausea and vomiting...
- Yes — drowsiness is the most common and expected side effect. You should avoid driving, operating machinery, or doing anything that requires sharp focus until you know how it affec...
- Will promethazine make me really drowsy?
- Promethazine is strictly off-limits for children under 2 years old — it can slow or stop breathing, and there have been fatalities reported in this age group. For children 2 and ol...
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII RFW2ET671P
Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 2165RE0K14
A plant-based thickener made from cellulose that helps control how quickly the medicine dissolves and releases its active ingredient. It also binds ingredients together and improves the tablet's texture and handling during manufacturing.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
4 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.045 | $4.54 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.2411 | $24.11 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.1075 | $10.75 / 100 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Promethazine Hydrochloride 25 mg 00591-5307-01 | Actavis | 100 tablets | $0.045 | — | Availability likely | — |
| Promethazine Hydrochloride 25 mg 00904-7304-61 | Major | 100 tablets | $0.045 | AB | Availability likely | — |
| Promethazine Hydrochloride 25 mg 10702-0003-01 | KVK-Tech, | 100 tablets | $0.045 | AB | Availability likely | — |
| Promethazine Hydrochloride 25 mg 53746-0521-01 | Amneal | 100 tablets | $0.045 | AB | Availability likely | — |
| Promethazine Hydrochloride 25 mg 65162-0521-10 | Amneal | 100 tablets | $0.045 | AB | Availability likely | — |
| Promethazine Hydrochloride 25 mgthis 68001-0162-00 | BluePoint | 100 tablets | $0.045 | AB | Availability likely | — |
| Promethazine Hydrochloride 25 mg 68084-0155-01 | American | 100 tablets | $0.045 | AB | Availability likely | — |
| Promethazine Hydrochloride 25 mg 68382-0041-01 | Zydus | 100 tablets | $0.045 | AB | Availability likely | — |
| Promethazine Hydrochloride 25 mg 00615-8154-39 | NCS | 30 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 43063-0405-01 | PD-Rx | 1 tablet | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 43063-0874-01 | PD-Rx | 100 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 50090-4452-00 | A-S | 5 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 50090-4453-00 | A-S | 12 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 50090-4608-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 50090-4750-00 | A-S | 12 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 50090-4811-00 | A-S | 5 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 50090-4812-00 | A-S | 90 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 50090-4813-00 | A-S | 12 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 50090-4875-00 | A-S | 12 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 51655-0085-20 | Northwind | 20 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 51655-0140-52 | Northwind | 30 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 51655-0462-27 | Northwind | 12 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 51655-0758-20 | Northwind | 20 tablets | — | AB | FDA listed | — |
| Promethazine 25 mg 54348-0117-00 | PharmPak, | 1 tablet | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 55154-3373-00 | Cardinal | 10 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 63187-0829-10 | Proficient | 10 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 65841-0041-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 68071-4424-01 | NuCare | 10 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 68071-4544-02 | NuCare | 12 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 68071-4686-01 | NuCare | 10 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 68071-4737-03 | NuCare | 30 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 68071-4809-02 | NuCare | 20 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 68071-4865-04 | NuCare | 4 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 68788-7886-01 | Preferred | 10 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 70518-1306-01 | REMEDYREPACK | 6 tablets | — | AB | Discontinued | — |
| Promethazine Hydrochloride 25 mg 70518-4419-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 71205-0126-10 | Proficient | 10 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 71205-0658-10 | Proficient | 10 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 71205-0805-15 | Proficient | 15 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 71335-1139-00 | Bryant | 14 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 71335-1359-00 | Bryant | 14 tablets | — | AB | Discontinued | — |
| Promethazine Hydrochloride 25 mg 72189-0176-10 | DIRECT | 10 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 76420-0679-01 | Asclemed | 100 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 80425-0265-01 | Advanced | 20 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 85766-0109-00 | Sportpharm | 1000 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 87063-0015-00 | ASCLEMED | 1000 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 67046-1043-03 | Coupler | 30 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 87441-0070-01 | Unit | 30 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 82868-0115-20 | Northwind | 20 tablets | — | AB | FDA listed | — |
| Promethazine Hydrochloride 25 mg 67296-0198-04 | Redpharm | 10 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 68001-0162-00 You're viewing this | 100 TABLET in 1 BOTTLE (68001-162-00) | $0.0454 / ea | $4.54 | 2014-01-13 | Active |
| 68001-0162-08 | 1000 TABLET in 1 BOTTLE (68001-162-08) | $0.0517 / ea | $51.67 | 2014-01-13 | Discontinued by firm |
| 68001-0162-03 | 500 TABLET in 1 BOTTLE (68001-162-03) | $0.0454 / ea | $22.72 | 2023-07-27 | Active |
You're viewing the smallest of 3 pack sizes for this product.
This pack has the lowest per-ea cost of the 3 priced pack sizes ($0.0454 NADAC).
This pack accounts for about 34% of this product's recent Medicaid fills; most go to the 500 tablets pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 68001-0162-00?
What is the difference between NDC 68001-0162-00 and NDC 68001-0162-03?
What NDC number is used to bill for this package of Promethazine Hydrochloride 25 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
PROMETHAZINE HYDROCHLORIDE TABLETS, USP 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 HYDROCHLORIDE TABLETS, USP IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE TABLETS, USP HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS.
CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE TABLETS, USP TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HYDROCHLORIDE BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Promethazine Hydrochloride, is useful orally for: Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods.
Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Dermographism.
Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled. Preoperative, postoperative, or obstetric sedation. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.
Therapy adjunctive to meperidine or other analgesics for control of post-operative pain. Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused. Active and prophylactic treatment of motion sickness.
Antiemetic therapy in postoperative patients.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Promethazine hydrochloride tablets, USP are contraindicated for children under 2 years of age (see WARNINGS-Black Box Warning and Use in Pediatric Patients ). Allergy The average oral 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 hydrochloride tablets, USP, 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 hydrochloride for the active therapy of nausea and vomiting in children or adults is 25 mg. When oral medication cannot be tolerated, the dose should be given parenterally (cf.
Promethazine hydrochloride Injection). 12.5- to 25-mg doses may be repeated, as necessary, at 4- to 6-hour intervals. For nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the dose should be adjusted to the age and weight of the patient and the severity of the condition being treated.
For prophylaxis of nausea and vomiting, as during surgery and the postoperative period, the average dose is 25 mg repeated at 4- to 6-hour intervals, as necessary. Sedation This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Administration of 12.5 to 25 mg promethazine hydrochloride by the oral route or by rectal suppository at bedtime will provide sedation in children.
Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation. Pre- and Postoperative Use Promethazine hydrochloride in 12.5- to 25-mg doses for children and 50-mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep. For preoperative medication, children require doses of 0.5 mg per pound of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug.
Usual adult dosage is 50 mg promethazine hydrochloride with an appropriately reduced dose of narcotic or barbiturate and the required amount of a belladonna alkaloid. Postoperative sedation and adjunctive use with analgesics may be obtained by the administration of 12.5 to 25 mg in children and 25- to 50-mg doses in adults. Promethazine hydrochloride tablets, USP are contraindicated for children under 2 years of age.
⛔ Contraindications ▾
CONTRAINDICATIONS Promethazine hydrochloride tablets, USP are contraindicated for use in pediatric patients less than two years of age. Promethazine hydrochloride tablets, USP 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.
⚠️ Warnings ▾
WARNINGS PROMETHAZINE HYDROCHLORIDE TABLETS, USP 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 HYDROCHLORIDE TABLETS, USP IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE TABLETS, USP HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS.
CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE TABLETS, USP TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HYDROCHLORIDE BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED. CNS Depression Promethazine hydrochloride tablets, USP may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery.
The impairment may be amplified by concomitant use 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 either be eliminated or given in reduced dosage in the presence of promethazine hydrochloride (see PRECAUTIONS Information for Patients and Drug Interactions ). Respiratory Depression Promethazine hydrochloride tablets, USP may lead to potentially fatal respiratory depression.
Use of promethazine hydrochloride tablets, USP in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Lower Seizure Threshold Promethazine hydrochloride tablets, USP may lower seizure threshold. It should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold.
Bone-Marrow Depression Promethazine hydrochloride tablets, USP should be used with caution in patients with bone-marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine hydrochloride has been used in association with other known marrow-toxic agents. Neuroleptic Malignant Syndrome A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine hydrochloride alone or in combination with antipsychotic drugs.
Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS).
Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology. The management of NMS should include 1) immediate discontinuation of promethazine hydrochloride, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available.
There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine hydrochloride should be carefully considered. Use in Pediatric Patients PROMETHAZINE HYDROCHLORIDE TABLETS, USP ARE CONTRAIN…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS 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 hydrochloride. Consideration should be given to the discontinuation of promethazine hydrochloride and to the use of other drugs if these reactions occur.
Respiratory depression, nightmares, delirium, and agitated behavior have also been reported in some of these patients.
🔄 Drug Interactions ▾
Drug Interactions CNS Depressants - Promethazine hydrochloride tablets, USP 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 hydrochloride. When given concomitantly with promethazine hydrochloride tablets, USP 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 hydrochloride 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 hydrochloride to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine hydrochloride tablets, USP 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 hydrochloride tablets, USP.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine hydrochloride. These doses are from approximately 2.1 to 4.2 times the maximum recommended total daily dose of promethazine for a 50-kg subject, depending upon the indication for which the drug is prescribed. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats.
Specific studies to test the action of the drug on parturition, lactation, and development of the animal neonate were not done, but a general preliminary study in rats indicated no effect on these parameters. Although antihistamines have been found to produce fetal mortality in rodents, the pharmacological effects of histamine in the rodent do not parallel those in man. There are no adequate and well-controlled studies of promethazine hydrochloride tablets, USP in pregnant women.
Promethazine hydrochloride tablets, USP should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects Promethazine hydrochloride tablets, USP administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn.
🧒 Pediatric Use ▾
Pediatric Use PROMETHAZINE HYDROCHLORIDE TABLETS, USP ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE (see WARNINGS-BLACK BOX Warning and Use in Pediatric Patients ). Promethazine hydrochloride tablets, USP should be used with caution in pediatric patients 2 years of age and older (see WARNINGS-Use in Pediatric Patients ).
🧓 Geriatric Use ▾
Geriatric Use Clinical studies of promethazine hydrochloride formulations did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of promethazine hydrochloride tablets, USP and observed closely.
🆘 Overdosage ▾
OVERDOSAGE Signs and symptoms of overdosage with promethazine hydrochloride range from mild depression of the central nervous system and cardiovascular system to profound hypotension, respiratory depression, 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 of promethazine hydrochloride are not reversed by naloxone. Avoid analeptics which may cause convulsions. The treatment of choice for resulting hypotension is administration of intravenous fluids, accompanied by repositioning if indicated.
In the event that vasopressors are considered for the management of severe hypotension which does not respond to intravenous fluids and repositioning, the administration of norepinephrine or phenylephrine should be considered. EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. Extrapyramidal reactions may be treated with anticholinergic antiparkinsonian agents, diphenhydramine, or barbiturates.
Oxygen may also be administered. Limited experience with dialysis indicates that it is not helpful.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Promethazine is a phenothiazine derivative which differs structurally from the antipsychotic phenothiazines by the presence of a branched side chain and no ring substitution. It is thought that this configuration is responsible for its relative lack (1/10 that of chlorpromazine) of dopamine antagonist properties. Promethazine is an H 1 receptor blocking agent.
In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects. Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours.
Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Promethazine hydrochloride tablets USP, 12.5 mg are, white to off-white, round shape, biconvex, uncoated tablets debossed with the logo of "ZC", "01" and bisect on one side and plain on the other side and are supplied as follows: NDC 68001-161-00 in bottle of 100 tablets Promethazine hydrochloride tablets USP, 25 mg are, white to off-white, round shape, biconvex, uncoated tablets debossed with the quadrisect and the logo of "Z", "C", "0" and "2" on one side and plain on the other side and are supplied as follows: NDC 68001-162-00 in bottle of 100 tablets NDC 68001-162-03 in bottle of 500 tablets NDC 68001-162-08 in bottle of 1000 tablets Promethazine hydrochloride tablets USP, 50 mg are, white to off-white, round shape, biconvex, uncoated tablets debossed with the logo of "ZC03" on one side and plain on the other side and are supplied as follows: NDC 68001-163-00 in bottle of 100 tablets Keep tightly closed.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in light-resistant, tight container.
Manufactured by: Zydus Lifesciences Ltd., India. For BluePoint Laboratories Rev.: 11/22
📋 Description ▾
DESCRIPTION Each tablet of promethazine hydrochloride contains 12.5 mg, 25 mg, or 50 mg promethazine hydrochloride. The inactive ingredients present are hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose and magnesium stearate. Promethazine hydrochloride is a racemic compound; the molecular formula is C 17 H 20 N 2 S·HCl and its molecular weight is 320.88.
Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10H -Phenothiazine-10-ethanamine, N , N ,α-trimethyl-, monohydrochloride, (±)- with the following structural formula: Promethazine hydrochloride 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, in hot dehydrated alcohol, and in chloroform; practically insoluble in ether, in acetone and in ethyl acetate. Structured product formula for Promethazine
💬 Information for Patients ▾
Information for Patients Promethazine hydrochloride tablets, USP may cause marked drowsiness or impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The use of alcohol or other central-nervous-system depressants such as sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, tricyclic antidepressants, and tranquilizers, may enhance impairment ( see WARNINGS-CNS Depression and PRECAUTIONS-Drug Interactions ).
Pediatric patients should be supervised to avoid potential harm in bike riding or in other hazardous activities. Patients should be advised to report any involuntary muscle movements. Avoid prolonged exposure to the sun.
💬 Medication Guide ▾
Patient Information Leaflet Promethazine Hydrochloride Tablets, USP (proe meth’ a zeen hye’ droe klor’ ide) Tablets, USP This is a summary of the most important information about promethazine. For details, talk to your healthcare professional. What Is Promethazine?
Promethazine is an antihistamine which can be taken by mouth as a tablet or syrup, rectally as a suppository, or by injection. It can be used for: "hay fever," or, a stuffy runny nose from allergy watery, itchy eyes due to inhaled allergies and foods mild allergic skin reactions with itching and swelling allergic reactions to blood or plasma dermographism, a form of hives known as "skin writing" serious allergic reactions along with epinephrine and other treatments sedation before or after surgery, or during childbirth prevention and control of nausea and vomiting after surgery along with meperidine (demerol) or other pain medicines sedation, relief of anxiety, and production of light sleep from which the patient can be easily aroused treatment and prevention of motion sickness Who Should Not Use Promethazine?
Promethazine should not be given to: children under two years of age patients who are unconscious patients who are allergic to promethazine, any of the ingredients in promethazine, or to other phenothiazines patients with lung symptoms including asthma children who are vomiting unless the vomiting is prolonged and there is a known cause What Are The Risks? The following are the major potential risks and side effects of promethazine therapy. However, this list is not complete.
Severe drowsiness and reduced mental alertness. Promethazine may cause drowsiness which may impair your ability to ride a bike, drive a car, or operate machinery. This may be worsened if taken with alcohol or other drugs that also cause central nervous system (CNS) slowing such as sedatives, pain medicines, tranquilizers or certain drugs for depression.
Serious breathing problems. Promethazine should not be used in patients with poor lung function such as chronic obstructive lung disease or breathing problems while sleeping (sleep apnea). Increased risk of seizures.
Promethazine should be used with caution in patients with seizures or who are on other medicines which may also increase the risk of seizures. Bone-marrow problems and blood cell production. Promethazine should not be used in patients with bone-marrow problems or used with other drugs that affect the bone marrow’s production of blood cells.
Neuroleptic malignant syndrome. This potentially deadly syndrome includes symptoms such as fever, muscle rigidity, mental changes, changes in pulse or blood pressure, fast heartbeat, increased sweating or irregular heart rhythm. The most common side effects are drowsiness, changes in blood pressure, skin reactions, blood cell changes and breathing problems.
Increased excitability or abnormal movements may occur after one dose of promethazine. If they do, consult your doctor about using another medicine. What Should I Tell My Healthcare Professional?
Before you start taking promethazine, tell your healthcare professional if you: have narrow-angle glaucoma have an enlarged prostate have a stomach ulcer have an intestinal blockage have a bladder blockage have heart problems have liver problems have breathing or lung problems have sleep apnea (breathing problems when sleeping) have seizures drink alcohol are trying to become pregnant, are already pregnant, or are breast-feeding Can Other Medicines Or Food Affect Promethazine? Promethazine and certain other medicines can interact with each other.
Tell your healthcare professional about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how promethazine works or promethazine may affect how your other medicines work. Know the medicines you take.
Keep a list of them with you to show your healthcare professional. Especially tell your healthcare professional if…