Promethazine hydrochloride tablets (Phenergan)

Generic name: promethazine hydrochloride · Brand names: Phenergan

Quick facts

Drug class
Label: a phenothiazine derivative; an H1 receptor blocking agent (Description; Clinical Pharmacology). openFDA EPC not checked.
Rx or otc
Rx (DailyMed: HUMAN PRESCRIPTION DRUG)
Forms and strengths
  • Tablets for oral administration: 12.5 mg, 25 mg or 50 mg (Description). Syrup, suppository and injection forms exist as separate labels and are NOT covered.
Generic available
Yes: generic tablets, Marketing Category ANDA (ANDA040712) on the KVK-Tech label.
Common use one line
Antihistamine used for allergy symptoms, motion sickness, nausea and vomiting, and sedation (Indications and Usage).

What it is used for

Promethazine tablets treat year-round and seasonal allergies, runny nose, allergic eye and skin symptoms, and allergic reactions to blood or plasma. They are also used with epinephrine after anaphylaxis is controlled, for sedation before or after surgery or during childbirth, to prevent and control nausea and vomiting with surgery, with pain medicine after surgery, and for motion sickness.
Section
INDICATIONS AND USAGE
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Confidence
high
Source text (exact source wording)
Promethazine hydrochloride tablet is 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 postoperative 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.

How it works

Promethazine blocks H1 histamine receptors, and it also causes sedation and eases nausea. After a tablet, effects start within 20 minutes and usually last four to six hours, though they may last as long as 12 hours.
Section
CLINICAL PHARMACOLOGY
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Confidence
high
Source text (exact source wording)
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 H1 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.

Dosage: adults

Tablets are taken by mouth only. For allergy the average dose is 25 mg at bedtime, or 12.5 mg before meals and at bedtime if needed; the smallest dose that relieves symptoms is used. For motion sickness it is 25 mg twice daily, first dose one-half to one hour before travel. For nausea and vomiting it is 25 mg, and 12.5 to 25 mg may be repeated every 4 to 6 hours. For sedation adults usually need 25 to 50 mg.
Section
DOSAGE AND ADMINISTRATION
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Confidence
high
Source text (exact source wording)
Promethazine hydrochloride tablets are for oral administration only. 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 mg 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. 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. Nausea and Vomiting: The average effective dose of promethazine hydrochloride for the active therapy of nausea and vomiting in children or adults is 25 mg. 12.5 to 25 mg doses may be repeated, as necessary, at 4 to 6 hour intervals. 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: Adults usually require 25 to 50 mg for nighttime, presurgical, or obstetrical sedation. Pre- and Postoperative Use: ...50 mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep. 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 ...25 to 50 mg doses in adults.

Dosage: children

Never for children under 2 years. In older children, motion sickness is 12.5 mg to 25 mg twice daily; nausea and vomiting is usually 0.5 mg per pound of body weight; bedtime sedation is 12.5 to 25 mg. Antiemetics should not be used for vomiting of unknown cause in children.
Section
DOSAGE AND ADMINISTRATION
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Confidence
high
Source text (exact source wording)
Promethazine hydrochloride tablets are contraindicated for children under 2 years of age. Motion Sickness: For children, promethazine hydrochloride tablets 12.5 mg 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. 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. Sedation: Administration of 12.5 to 25 mg promethazine hydrochloride orally at bedtime will provide sedation in children. Pre- and Postoperative Use: Promethazine hydrochloride in 12.5 to 25 mg doses for children ... 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. Postoperative sedation and adjunctive use with analgesics may be obtained by the administration of 12.5 to 25 mg in children.

Dosage adjustments

Drug interaction caps
With promethazine, barbiturate doses should be cut by at least one-half and narcotic doses by one-quarter to one-half.
Section
PRECAUTIONS: Drug Interactions
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Confidence
high
Source text (exact source wording)
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.
Kidney
Confidence
high
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Liver
Use with caution in people with impaired liver function. No specific dose change is given.
Section
PRECAUTIONS: General
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Confidence
high
Source text (exact source wording)
Promethazine hydrochloride tablets should be used cautiously in persons with cardiovascular disease or with impairment of liver function.
Elderly
Older adults start at the low end of the dosing range and are watched closely because sedation can cause confusion and over-sedation.
Section
PRECAUTIONS: Geriatric Use
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Confidence
high
Source text (exact source wording)
Clinical studies of promethazine hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. ... In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range... 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.

Missed dose

Confidence
high
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a

Overdose

Overdose can cause anything from mild drowsiness to very low blood pressure, slowed breathing, unconsciousness and sudden death. Children and older adults may become stimulated and have convulsions. Treatment is supportive, naloxone does not reverse it, and epinephrine should not be used. Call poison control at 1-800-222-1222.
Section
OVERDOSAGE
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Confidence
high
Source text (exact source wording)
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. ... Note that any depressant effects of promethazine hydrochloride are not reversed by naloxone. ... EPINEPHRINE SHOULD NOT BE USED, since its use in patients with partial adrenergic blockade may further lower the blood pressure. ... Limited experience with dialysis indicates that it is not helpful.

Storage

Store at 20° to 25°C (excursions 15° to 30°C allowed), protected from light.
Section
HOW SUPPLIED (KVK-Tech labeler-specific)
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Confidence
high
Source text (exact source wording)
Store at 20° to 25°C with excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. (as required).

Boxed warning

Promethazine tablets must not be used in children under 2 years of age because of the risk of fatal slowed breathing (respiratory depression). In children 2 and older, use the lowest effective dose and avoid other medicines that slow breathing.
Section
WARNINGS (first paragraphs). The label text elsewhere refers to 'WARNINGS: Black Box Warning'.
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Confidence
medium
Note
The extracted page text had no separate 'BOXED WARNING' heading; this text is the opening of the WARNINGS section, which the label cross-references as the Black Box Warning. Needs human check against the rendered label. The injection-specific boxed warning (severe tissue injury, gangrene) belongs to the injection label and was NOT read.
Source text (exact source wording)
Promethazine hydrochloride 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.

Contraindications

Do not give to children under two.
Section
CONTRAINDICATIONS
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Confidence
high
Source text (exact source wording)
Promethazine hydrochloride tablets are contraindicated for use in pediatric patients less than two years of age.
Do not use in a coma or with a known allergy or unusual reaction to promethazine or other phenothiazines.
Section
CONTRAINDICATIONS
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Confidence
high
Source text (exact source wording)
Promethazine is contraindicated in comatose states, and in individuals known to be hypersensitive or to have had an idiosyncratic reaction to promethazine or to other phenothiazines.
Not for lower respiratory tract symptoms, including asthma.
Section
CONTRAINDICATIONS
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Confidence
high
Source text (exact source wording)
Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms including asthma.

Warnings and precautions

It can impair driving and machinery use, and alcohol and other sedating drugs can make this worse.
Heading
CNS Depression
Section
WARNINGS
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Confidence
high
Source text (exact source wording)
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 hydrochloride.
Can cause potentially fatal slowed breathing; avoid in people with COPD or sleep apnea.
Heading
Respiratory Depression
Section
WARNINGS
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Confidence
high
Source text (exact source wording)
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.
May lower the seizure threshold; use caution with seizure disorders.
Heading
Lower Seizure Threshold
Section
WARNINGS
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Confidence
high
Source text (exact source wording)
Promethazine hydrochloride tablets 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.
Use with caution with bone-marrow depression; leukopenia and agranulocytosis have been reported.
Heading
Bone-Marrow Depression
Section
WARNINGS
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Confidence
high
Source text (exact source wording)
Promethazine hydrochloride tablets, should be used with caution in patients with bone-marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine hydrochloride have been used in association with other known marrow-toxic agents.
A potentially fatal reaction with high fever, muscle rigidity, altered mental status and unstable pulse or blood pressure has been reported.
Heading
Neuroleptic Malignant Syndrome
Section
WARNINGS
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Confidence
high
Source text (exact source wording)
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).
In children, slowed breathing and apnea have occurred regardless of weight-based dosing. Avoid in suspected Reye's syndrome; large doses may cause sudden death; hallucinations and convulsions have occurred.
Heading
Use in Pediatric Patients
Section
WARNINGS
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Confidence
high
Source text (exact source wording)
Respiratory depression and apnea, sometimes associated with death, are strongly associated with promethazine products and are not directly related to individualized weight-based dosing, which might otherwise permit safe administration. Antiemetics are not recommended for treatment of uncomplicated vomiting in pediatric patients, and their use should be limited to prolonged vomiting of known etiology. The use of promethazine hydrochloride tablets should be avoided in pediatric patients whose signs and symptoms may suggest Reye’s syndrome or other hepatic diseases. Excessively large dosages of antihistamines, including promethazine hydrochloride tablets, in pediatric patients may cause sudden death. Hallucinations and convulsions have occurred with therapeutic doses and overdoses of promethazine hydrochloride in pediatric patients.
Jaundice has been reported. Use caution with glaucoma, enlarged prostate, ulcer or bladder-neck blockage. Report involuntary muscle movements and avoid prolonged sun exposure.
Heading
Other (cholestatic jaundice; anticholinergic cautions; sun)
Section
WARNINGS; PRECAUTIONS
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Confidence
high
Source text (exact source wording)
Administration of promethazine hydrochloride has been associated with reported cholestatic jaundice. (WARNINGS: Other Considerations) Drugs having anticholinergic properties should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, and bladder-neck obstruction. (PRECAUTIONS: General) Patients should be advised to report any involuntary muscle movements. Avoid prolonged exposure to the sun. (PRECAUTIONS: Information for Patients)

Pregnancy and breastfeeding

No adequate studies in pregnant women; use only if the benefit justifies the risk. Use within two weeks of delivery may affect platelets in the newborn. It is not known whether it passes into breast milk; a decision is made to stop nursing or the drug.
Section
PRECAUTIONS: Pregnancy; Nursing Mothers
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Confidence
high
Source text (exact source wording)
Teratogenic Effects - Pregnancy Category C: ...There are no adequate and well-controlled studies of promethazine 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 administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn. Nursing Mothers: It is not known whether promethazine hydrochloride is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from promethazine hydrochloride tablets, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Side effects

Common
The label gives no percentages. Drowsiness is the most prominent central nervous system effect.
Section
ADVERSE REACTIONS
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Confidence
high
Threshold
none stated by label
Less common
Confidence
high
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Serious
Label
The label lists reactions by body system (see source text), without separating serious from other ones. Potentially fatal: respiratory depression, apnea, neuroleptic malignant syndrome. Others include seizures, blood count problems (leukopenia, agranulocytosis), jaundice, and angioneurotic edema.
Section
ADVERSE REACTIONS
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Confidence
high
Source text (exact source wording)
Central Nervous System: 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). Other: Angioneurotic edema. Neuroleptic malignant syndrome (potentially fatal) has also been reported. Paradoxical Reactions: Hyperexcitability and abnormal movements have been reported in patients following a single administration of promethazine hydrochloride.
Led to discontinuation
Confidence
high
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a

Interactions

Drugs
Increases sedation from other sedating drugs. Barbiturate doses should be cut by at least one-half, and narcotic doses by one-quarter to one-half.
Name
CNS depressants (alcohol, sedatives/hypnotics incl. barbiturates, narcotics, general anesthetics, tricyclic antidepressants, tranquilizers)
Section
PRECAUTIONS: Drug Interactions
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Source text (exact source wording)
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 hydrochloride. 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.
Epinephrine should not be used to treat low blood pressure from a promethazine overdose.
Name
Epinephrine
Section
PRECAUTIONS: Drug Interactions
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Source text (exact source wording)
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 overdose.
Use caution with other anticholinergic drugs.
Name
Anticholinergics
Section
PRECAUTIONS: Drug Interactions
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Source text (exact source wording)
Concomitant use of other agents with anticholinergic properties should be undertaken with caution.
Movement-related side effects may be more common with some MAO inhibitors.
Name
MAO inhibitors
Section
PRECAUTIONS: Drug Interactions
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Source text (exact source wording)
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.
Food and alcohol
Name
Alcohol
Section
PRECAUTIONS: Information for Patients
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Source text (exact source wording)
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.
Other
May cause false pregnancy test results and raise blood glucose on a glucose tolerance test.
Name
Laboratory tests
Section
PRECAUTIONS: Drug/Laboratory Test Interactions
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Source text (exact source wording)
Pregnancy Tests: Diagnostic pregnancy tests based on immunological reactions between HCG and anti- HCG may result in false-negative or false-positive interpretations. Glucose Tolerance Test: An increase in blood glucose has been reported in patients receiving promethazine hydrochloride.

Patient tips

Label information for patients
It can cause marked drowsiness, so be careful driving or using machinery, and supervise children on bikes. Report involuntary muscle movements and avoid prolonged sun.
Section
PRECAUTIONS: Information for Patients
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Source text (exact source wording)
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. ... 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.

Alternatives

Class source
Label: a phenothiazine derivative; H1 receptor blocking agent. openFDA EPC not checked.

Frequently asked questions

Question
What is promethazine used for?
Answer
It treats allergy symptoms such as allergic rhinitis, allergic conjunctivitis and hives, and is used for motion sickness, preventing and controlling nausea and vomiting with surgery, and sedation.
Source section
INDICATIONS AND USAGE
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Question
Can children take it?
Answer
Not children under 2 years of age because of the potential for fatal respiratory depression. In children 2 and older, the lowest effective dose is recommended and other drugs that slow breathing should be avoided.
Source section
Boxed text / CONTRAINDICATIONS
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Question
Will it make me drowsy?
Answer
Drowsiness is the most prominent CNS effect. It may impair driving or machinery use, and alcohol can make impairment worse.
Source section
ADVERSE REACTIONS; WARNINGS
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Question
Can I drink alcohol with it?
Answer
Alcohol and other sedating drugs can increase or prolong sedation and enhance impairment, so they should be avoided or the dose reduced.
Source section
PRECAUTIONS
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Question
How is it taken for motion sickness?
Answer
The average adult dose is 25 mg twice daily, with the first dose one-half to one hour before travel and repeated 8 to 12 hours later if needed.
Source section
DOSAGE AND ADMINISTRATION
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Question
Is it safe in pregnancy or breastfeeding?
Answer
There are no adequate studies in pregnant women, so it is used only if the benefit justifies the risk. It is not known whether it passes into breast milk.
Source section
PRECAUTIONS
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Question
Who should avoid it?
Answer
People in a coma, people allergic to promethazine or other phenothiazines, and children under two. It is not for lower respiratory tract symptoms including asthma.
Source section
CONTRAINDICATIONS
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a
Question
What if someone takes too much?
Answer
Overdose can cause slowed breathing, very low blood pressure, unconsciousness and sudden death; naloxone does not reverse it. Call poison control at 1-800-222-1222.
Source section
OVERDOSAGE
Source
DailyMed printer-friendly label, KVK-Tech, Inc. promethazine hydrochloride tablets USP, set ID 7a137adf-39b7-4b14-80da-c3cac9ad562a

Sources

Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug