Promethazine injection
Other products: Promethazine
Package labels
Loading package label images…
Looking up MedlinePlus…
From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNINGS: RESPIRATORY DEPRESSION IN PEDIATRICS AND SEVERE TISSUE INJURY INCLUDING GANGRENE Respiratory Depression – Pediatrics • Promethazine hydrochloride injection 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 in pediatric patients less than 2 years of age.
Caution should be exercised when administering promethazine hydrochloride injection to pediatric patients 2 years of age and older (see WARNINGS – Respiratory Depression ) Severe Tissue Injury, Including Gangrene • Severe chemical irritation and damage to tissues regardless of the route of parenteral administration has been reported in patients treated with promethazine hydrochloride injection including gangrene, tissue necrosis, and thrombophlebitis; and in some cases, surgical intervention including fasciotomy, skin graft, and/or amputation have been required (see WARNINGS – Severe Tissue Injury, Including Gangrene .).
• The use of promethazine hydrochloride injection by the following routes of administration is CONTRAINDICATED: • Intravenous injection at concentrations greater than 1 mg/mL • Intra-arterial injection • Subcutaneous injection (see CONTRAINDICATIONS ). • The preferred route of administration is by deep intramuscular administration. • Promethazine hydrochloride injection may be administered intravenously after dilution through an intravenous catheter inserted in a large vein.
Preferably through a central venous catheter (see DOSAGE AND ADMINISTRATION ) • If pain occurs at the injection site during intravenous infusion, immediately discontinue the infusion and evaluate for possible arterial injection or perivascular extravasation, and initiate appropriate medical management.
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Injection preparation card
Loading IV preparation…
Preparation and administration
Prepare this dose
Your numbers for promethazine injection. Take vial strength, diluent, and limits from the label below.
Enter a dose to see draw volume, final concentration, and rates.
DOSAGE AND ADMINISTRATION Important Administration Information for Adult and Pediatric Patients 2 Years of Age and Older The preferred route of administration of promethazine hydrochloride injection is by deep intramuscular administration (see WARNINGS - Severe Tissue Injury, Including Gangrene ). Promethazine hydrochloride injection may be administered intravenously after dilution as recommended below (see Preparation and Administration ).
If pain occurs at the injection site during intravenous infusion, immediately discontinue the infusion, and evaluate for possible arterial injection or perivascular extravasation. Allergic Conditions The average adult dose is 25 mg. This dose may be repeated within two hours if necessary, but continued therapy, if indicated, should be via the oral route as soon as existing circumstances permit.
Preparation and Administration Instructions for Diluted Intravenous Infusion in Adults Inspect the solution for particulate matter and discoloration, before dilution, after dilution, and before administration . Discard the vial, ampule, or bag if particulates and/or discoloration are observed. Determine the recommended dose of promethazine hydrochloride injection.
Aseptically withdraw the required volume from the vial or ampule and transfer it into an infusion bag. Use a filter needle when withdrawing promethazine hydrochloride injection from the ampule. Dilute with the recommended volume of 0.9% Sodium Chloride Injection, see Table 1. Avoid mixing and/or diluting with any other drugs or solutions other than 0.9% Sodium Chloride Injection.
Gently invert the infusion bag. Check patency of the access site before administration. Administer the diluted solution through an intravenous catheter, inserted in a large vein (preferably through a central venous catheter), over 20 to 40 minutes; for maximum infusion rates, see Table 1. Do NOT administer via an intravenous catheter in the hand or wrist.
If pain occurs at the injection site during intravenous infusion, immediately discontinue the infusion and evaluate for possible arterial injection or perivascular extravasation. [See table below.] 25 mg 50 mL 2.5 mL/minute 50 mg 50 mL 2.5 mL/minute 75 mg 100 mL 5 mL/minute Preparation and Administration Instructions for Diluted Intravenous Infusion to Pediatric Patients 2 Years of Age and Older.
Inspect the solution for particulate matter and discoloration, before dilution, after dilution, and before administration. Discard the vial, ampule, syringe or bag if particulates and/or discoloration are observed. 1. Determine the recommended dose of promethazine hydrochloride injection for pediatric patients 2 years of age and older. 2.
Aseptically withdraw the required volume from the vial or ampule and transfer it into an appropriately sized syringe or bag for use with an infusion pump. Use a filter needle when withdrawing promethazine hydrochloride injection from the ampule. 3. Dilute with the recommended volume of 0.9% Sodium Chloride Injection, see Table 2.
Avoid mixing and/or diluting with any other drugs or solutions other than 0.9% Sodium Chloride Injection. 4. Gently invert the syringe or bag. 5. Check patency of the access site before administration. 6. Administer the diluted solution through an intravenous catheter, inserted in a large vein (preferably through a central venous catheter) with a maximum infusion rate of 1.25 mL/minute.
Do NOT administer via an intravenous catheter in the hand or wrist. 7. If pain occurs at the injection site during intravenous infusion, immediately discontinue the infusion and evaluate for possible arterial injection or perivascular extravasation. [See table below.] *Avoid mixing and/or diluting with any other drugs or solutions besides 0.9% Sodium Chloride Injection Storage of Diluted Promethazine Hydrochloride Injection Diluted solution may be stored up to 4 hours at room temperature, 20°C to 25°C (68°F to 77°F), or refrigerated at 2°C to 8°C (36° to 46°F), up to 24 hours.
| Dose of Promethazine Hydrochloride Injection | Volume of 0.9% Sodium Chloride Injection for Dilution | Maximum Concentration of the Diluted Promethazine Hydrochloride Injection Solution | Maximum Rate of Infusion |
| 12.5 mg | 50 mL | 1 mg/mL | 2.5 mL/minute |
| 25 mg | 50 mL | 2.5 mL/minute | |
| 50 mg | 50 mL | 2.5 mL/minute | |
| 75 mg | 100 mL | 5 mL/minute |
| Dose of Promethazine Hydrochloride Injection | Volume of 0.9% Sodium Chloride Injection for Dilution | Maximum Concentration of the Diluted Promethazine Hydrochloride Injection Solution | Maximum Rate of Infusion |
| Up to 25 mg | 25 mL | 1 mg/mL | 1.25 mL/minute |
| 25 mg to 50 mg | 50 mL |
Drug interactions
Check interactions
Add the patient's other drugs. Matches come from both FDA labels: by name, drug class, and enzyme or transporter pathway.
- Promethazine injection
Label text (3 paragraphs)
Drug Interactions CNS Depressants Promethazine hydrochloride injection may increase, prolong, or intensify the sedative action of central-nervous system depressants, such as alcohol, sedative/hypnotics (including barbiturates), general anesthetics, narcotics, narcotic analgesics, 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 injection, 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 injection 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 injection overdose. Anticholinergics Concomitant use of other agents with anticholinergic properties should be undertaken with caution.
Monoamine Oxidase (MAO) Inhibitors Drug interactions, including an increased incidence of extrapyramidal effects, have been reported when some MAO Inhibitors and phenothiazines are used concomitantly. This possibility should be considered with promethazine hydrochloride injection.
Contraindications
The use of promethazine hydrochloride injection is contraindicated: • In pediatric patients less than 2 years of age due to the risk of respiratory depression (see WARNINGS – Respiratory Depression ). • For use as an intravenous injection at concentrations greater than 1 mg/mL due to the risk of perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration (see WARNINGS - Severe Tissue Injury, Including Gangrene and DOSAGE AND ADMINISTRATION ). • For use as an intra-arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene (see WARNINGS - Severe Tissue Injury, Including Gangrene ).
• For use as a subcutaneous injection because chemical irritation and necrotic lesions have been reported (see WARNINGS - Severe Tissue Injury, Including Gangrene ). • In patients in a comatose state. • In patients who have demonstrated an idiosyncratic reaction or hypersensitivity to promethazine hydrochloride or other phenothiazines.
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
ELikelihood score E: Unlikely to be a cause of clinically apparent liver injury.
Promethazine is first generation antihistamine that belongs to the phenothiazine class and is used predominantly as an antiemetic to treat nausea and vomiting and prevent motion sickness. Despite its phenothiazine structure, promethazine has not been linked to instances of clinically apparent acute liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
Pregnancy Teratogenic Effects Teratogenic effects have not been demonstrated in rat-feeding studies at doses of 6.25 and 12.5 mg/kg (approximately 2.1 and 4.2 times the maximum recommended human daily dose) of promethazine hydrochloride injection. Daily doses of 25 mg/kg intraperitoneally have been found to produce fetal mortality in rats. There are no adequate and well-controlled studies of promethazine hydrochloride injection in pregnant women. Because animal reproduction studies are not always predictive of human response, promethazine hydrochloride injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Adequate studies to determine the action of the drug on parturition, lactation and development of the animal neonate have not been conducted. Nonteratogenic Effects Promethazine hydrochloride injection administered to a pregnant woman within two weeks of delivery may inhibit platelet aggregation in the newborn.
Lactation
Nursing Mothers It is not known whether promethazine hydrochloride injection 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 injection, 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.
Breastfeeding (LactMed)
Based on minimal excretion of other phenothiazine derivatives, it appears that occasional short-term use of promethazine for the treatment of nausea and vomiting poses little risk to the breastfed infant. With repeated doses, observe infants for excess sedation. Because promethazine can lower basal prolactin secretion, promethazine might interfere with the establishment of lactation if given during labor before lactation is well established or with a sympathomimetic such as pseudoephedrine. An antiemetic without potent histamine blocking action is preferred in nursing mothers.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.