Promethazine Hydrochloride 25 mg Tablet, 100-count
🆔 Identity & classification
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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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🧪 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 O7TSZ97GEP
A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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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.
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UNII 5856J3G2A2
A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
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UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
5 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 | $0.1847 | $18.47 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.1075 | $10.75 / 100 tablets |
| Medicare Part B allowsASP · Q0169 | No ASP payment limit on file for Q0169 this quarter. | |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Promethazine Hydrochloride 25 mgthis 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 mg 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 | — |
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⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
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 |
|---|---|---|---|---|---|
| 00591-5307-01 You're viewing this | 100 TABLET in 1 BOTTLE, PLASTIC (0591-5307-01) | $0.0454 / ea | $4.54 | 1973-09-19 | Active |
| 00591-5307-10 | 1000 TABLET in 1 BOTTLE, PLASTIC (0591-5307-10) | $0.0454 / ea | $45.44 | 1973-09-19 | Active |
| 00591-5307-00 | 50000 TABLET in 1 BAG (0591-5307-00) | — | — | — | Active |
| 00591-5307-77 | 60000 TABLET in 1 CONTAINER (0591-5307-77) | — | — | — | Active |
You're viewing the smallest of 4 pack sizes for this product.
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0454 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 63% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 00591-5307-01?
What is the difference between NDC 00591-5307-01 and NDC 00591-5307-10?
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.
🧭 About this NDC listing & data coverage
What "drug for further processing" means
FDA lists this package under the "drug for further processing" marketing category: Actavis Pharma, Inc. supplies it to other companies for further processing or repackaging (blister cards that are later repackaged or co-packaged are a common example). The units themselves are a finished dosage form — which is why pricing or Medicaid data can still appear — but this exact package code may not be the presentation a retail pharmacy dispenses.
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | ✓ Available |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
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📄 Full FDA label FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Promethazine hydrochloride tablets are useful 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 HCl 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, syrup, or 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 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 Injection) or by rectal suppository. 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 HCl 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 are contraindicated for children under 2 years of age.
⛔ Contraindications ▾
CONTRAINDICATIONS Promethazine hydrochloride tablets are contraindicated for use in pediatric patients less than two years of age. Promethazine hydrochloride tablets 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 IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS.
CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE 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 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 HCl (see PRECAUTIONS-Information for Patients and Drug Interactions ). Respiratory Depression Promethazine hydrochloride tablets may lead to potentially fatal respiratory depression.
Use of promethazine hydrochloride tablets in patients with compromised respiratory function (e.g., COPD, sleep apnea) should be avoided. Lower Seizure Threshold Promethazine hydrochloride tablets may lower seizure threshold. They 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 should be used with caution in patients with bone-marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl 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 HCl 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 HCl, 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 HCl should be carefully considered. Use in Pediatric Patients PROMETHAZINE HYDROCHLORIDE TABLETS USP ARE CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PR…
🤒 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 WARNINGSRespiratory 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 have also been reported in some of these patients.
🔄 Drug Interactions ▾
Drug Interactions CNS Depressants - Promethazine hydrochloride tablets 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 hydrochloride tablets, 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 to reverse epinephrine’s vasopressor effect, epinephrine should NOT be used to treat hypotension associated with promethazine hydrochloride tablets 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.
🔄 Drug / Laboratory Test Interactions ▾
Drug/Laboratory Test Interactions The following laboratory tests may be affected in patients who are receiving therapy with promethazine hydrochloride: Pregnancy Tests Diagnostic pregnancy tests based on immunological reactions between HCG and anti-HCG may result in false-negative or falsepositive interpretations. Glucose Tolerance Test An increase in blood glucose has been reported in patients receiving promethazine HCl.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects-Pregnancy Category C Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg of promethazine HCl. 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 in pregnant women.
Promethazine hydrochloride tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects Promethazine hydrochloride tablets 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 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 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 and observed closely.
🆘 Overdosage ▾
OVERDOSAGE 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, 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 HCl 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, 25 mg are scored, round, white tablets imprinted DAN DAN and 5307 supplied in bottles of 100 and 1000. Promethazine Hydrochloride Tablets USP, 50 mg are unscored, round, white tablets imprinted DAN and 5319 supplied in bottles of 100. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.
Keep tightly closed. Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Protect from light. Manufactured by: Watson Pharma Private Ltd.
Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: December 2016 190824-1
📋 Description ▾
DESCRIPTION Promethazine hydrochloride is a racemic compound. Promethazine hydrochloride, a phenothiazine derivative, is designated chemically as 10 H -Phenothiazine-10-ethanamine, N, N ,α-trimethyl-, monohydrochloride, (±)- with the following structural formula: C 17 H 20 N 2 S•HCl M.W. 320.88 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 soluble in water and freely soluble in alcohol. Each tablet, for oral administration, contains 25 mg or 50 mg of promethazine hydrochloride. In addition each tablet contains the following inactive ingredients: dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and stearic acid.
Promethazine Hydrochloride Tablets USP, 50 mg also contain anhydrous lactose. Promethazine HCl Structural Formula
💬 Information for Patients ▾
Information for Patients Promethazine hydrochloride tablets 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.