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Promethazine Injection (promethazine hydrochloride)

BOXED WARNING

Do not use in pediatric patients <2 yrs of age; potential for fatal respiratory depression. Caution when administering to pediatric patients ≥2 yrs of age. May cause severe chemical irritation and damage to tissue regardless of the route of administration. Irritation and damage may result from perivascular extravasation, unintentional intra-arterial inj, and intraneuronal/perineuronal infiltration; surgical intervention may be required. Preferred route of administration is deep IM inj. SQ inj is contraindicated.

OTHER BRAND NAMES

Phenergan (Discontinued)

THERAPEUTIC CLASS

Phenothiazine derivative

DEA CLASS

RX

INDICATIONS

Amelioration of allergic reactions to blood or plasma. Adjunct to epinephrine and other standard measures in anaphylaxis after acute symptoms have been controlled. For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated. For sedation and relief of apprehension and to produce light sleep. Active treatment of motion sickness. Prevention and control of N/V associated with certain types of anesthesia and surgery. Adjunct to analgesics for the control of postop pain. Preop, postop, and obstetric sedation. IV in special surgical situations (eg, repeated bronchoscopy, ophthalmic surgery, poor-risk patients) with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia.

ADULT DOSAGE

Allergic Reactions

25mg; may repeat w/in 2 hrs if necessary; adjust to smallest amount adequate to relieve symptoms

Continued therapy, if indicated, should be via oral route as soon as existing circumstances permit

Sedation

Nighttime Sedation in Hospitalized Patients:
25-50mg

Nausea/Vomiting

Usual: 12.5-25mg, not to be repeated more frequently than q4h

Pre- and Postoperative Use

25-50mg; may be combined w/ appropriately reduced doses of analgesics and atropine-like drugs as desired

Obstetrics

Early Stages of Labor:
50mg

Established Labor:
25-75mg; may be given w/ an appropriately reduced dose of any desired narcotic. If necessary, may repeat once or twice at 4-hr intervals in the course of a normal labor
Max: 100mg/24 hrs

Other Indications

Amelioration of allergic reactions to blood/plasma

Adjunct to epinephrine and other standard measures in anaphylaxis after acute symptoms have been controlled

For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated

For sedation and relief of apprehension and to produce light sleep

Active treatment of motion sickness

Prevention and control of N/V associated w/ certain types of anesthesia and surgery

Adjunct to analgesics for the control of postop pain

Preop, postop, and obstetric sedation

IV in special surgical situations (eg, repeated bronchoscopy, ophthalmic surgery, poor-risk patients) w/ reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia

PEDIATRIC DOSAGE

General Dosing

≥2 Years:
Dose should not exceed 1/2 of suggested adult dose; use lowest effective dose

Premedication Adjunct:
Usual: 1.1mg/kg in combination w/ an appropriately reduced dose of narcotic or barbiturate and appropriate dose of an atropine-like drug

DOSING CONSIDERATIONS

Elderly
≥60 Years:
Reduce dose

ADMINISTRATION

Deep IM/IV route

The preferred parenteral route of administration is by deep IM inj
When administered IV, give in a concentration no greater than 25mg/mL and at a rate not to exceed 25mg/min; preferable to inject through the tubing of IV infusion set that is known to be functioning satisfactorily

HOW SUPPLIED

Inj: 25mg/mL, 50mg/mL

CONTRAINDICATIONS

Children <2 yrs of age, comatose states, intra-arterial or SQ inj.

WARNINGS/PRECAUTIONS

If pain occurs during IV inj, d/c immediately to evaluate for possible arterial inj or perivascular extravasation. Not recommended for uncomplicated vomiting in pediatric patients; should be limited to prolonged vomiting of known etiology. May lead to potentially fatal respiratory depression; avoid with compromised respiratory function or in patients at risk of respiratory failure (eg, chronic obstructive pulmonary disease, sleep apnea). May impair physical/mental abilities and lower seizure threshold. Caution with bone marrow depression; leukopenia and agranulocytosis reported. Neuroleptic malignant syndrome (NMS) reported alone and in combination with antipsychotics; d/c immediately and monitor. Contains sodium metabisulfite, which may cause allergic-type reactions. Cholestatic jaundice reported. Caution with narrow-angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, bladder-neck or pyloroduodenal obstruction, cardiovascular disease, and hepatic dysfunction. Avoid in pediatric patients whose signs/symptoms may suggest Reye's syndrome or other hepatic diseases. Hallucinations and convulsions may occur in pediatric patients. Increased susceptibility to dystonias in acutely ill pediatric patients. Lab test interactions may occur. Caution in elderly.

ADVERSE REACTIONS

Respiratory depression, severe tissue injury, drowsiness, dizziness, tinnitus, blurred vision, dry mouth, increased/decreased BP, urticaria, N/V, tachycardia, photosensitivity, gangrene.

DRUG INTERACTIONS

Avoid concomitant use of other drugs with respiratory depressant effects in pediatric patients. May increase, prolong, or intensify sedative action of CNS depressants (eg, alcohol, sedative/hypnotics, narcotics, TCAs); avoid concomitant use or reduce dose of such agents. Reduce dose of barbiturates by at least 50% if given concomitantly. Reduce dose of narcotics by 25-50% if given concomitantly. Caution with drugs that alter seizure threshold (eg, narcotics, local anesthetics). Leukopenia and agranulocytosis reported when used with other known marrow-toxic agents. May reverse vasopressor effect of epinephrine; do not use to treat promethazine overdose. Caution with anticholinergics. May increase incidence of extrapyramidal effects with MAOIs.

PREGNANCY AND LACTATION

Category C, not for use in nursing.

MECHANISM OF ACTION

Phenothiazine derivative; H1 receptor antagonist (does not block release of histamine). Possesses antihistaminic, sedative, antimotion-sickness, antiemetic, and anticholinergic effects.

PHARMACOKINETICS

Metabolism: Liver; sulfoxides, N-desmethylpromethazine (metabolites). Elimination: Urine; T1/2=9-16 hrs (IV), 9.8 hrs (IM).

ASSESSMENT

Assess for drug hypersensitivity or idiosyncratic reaction to phenothiazines, bone marrow depression, sulfite sensitivity, seizure disorders, pregnancy/nursing status, possible drug interactions, or any other conditions where treatment is contraindicated or cautioned. Assess for signs/symptoms of Reye's syndrome or hepatic diseases in pediatric patients.

MONITORING

Monitor for signs/symptoms of CNS/respiratory depression, seizures, leukopenia, NMS, cholestatic jaundice, and other adverse reactions. Monitor for hallucinations, convulsions, extrapyramidal symptoms, respiratory depression, and dystonias in pediatric patients.

PATIENT COUNSELING

Advise of the risk of respiratory depression and severe tissue injury. Instruct to immediately report persistent/worsening pain or burning at the inj site. Inform that drowsiness or impairment of mental/physical abilities may occur. Counsel to report any involuntary muscle movements. Instruct to avoid alcohol use, prolonged sun exposure, and concomitant use of other CNS depressants.

STORAGE

20-25°C (68-77°F). Protect from light.

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