Indications and Usage for Promethazine Injection
Promethazine hydrochloride injection is indicated for the following conditions:
1. Amelioration of allergic reactions to blood or plasma.
2. In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled.
3. For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.
4. For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused.
5. Active treatment of motion sickness.
6. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.
7. As an adjunct to analgesics for the control of postoperative pain.
8. Preoperative, postoperative, and obstetric (during labor) sedation.
9. Intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia.
Children Less Than 2 Years of Age
Promethazine hydrochloride injection is contraindicated for use in pediatric patients less than two years of age due to the risk of respiratory depression.
Promethazine hydrochloride injection is contraindicated in comatose states.
Under no circumstances should promethazine hydrochloride injection be given by intra arterial injection due to the likelihood of severe arteriospasm and the possibility of resultant gangrene .
Promethazine hydrochloride injection should not be given by the subcutaneous route because evidence of chemical irritation has been noted, and necrotic lesions have resulted following subcutaneous injection. The preferred parenteral route of administration is by deep intramuscular injection.
Idiosyncratic Reaction or Hypersensitivity
Promethazine hydrochloride injection is contraindicated in patients who have demonstrated an idiosyncratic reaction or hypersensitivity to promethazine or other phenothiazines.
Promethazine hydrochloride injection should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. Post marketing cases of respiratory depression, including fatalities, have been reported with use of promethazine in pediatric patients less than 2 years of age. A wide range of weight-based doses of promethazine hydrochloride injection have resulted in respiratory depression in these patients.
Caution should be exercised when administering promethazine hydrochloride injection to pediatric patients 2 years of age and older. It is recommended that the lowest effective dose of promethazine hydrochloride injection be used in pediatric patients 2 years of age and older. Avoid concomitant administration of other drugs with respiratory depressant effects because of an association with respiratory depression, and sometimes death, in pediatric patients.
Because of the risk of potentially fatal respiratory depression, use of promethazine hydrochloride injection in patients with compromised respiratory function or patients at risk for respiratory failure (e.g. COPD, sleep apnea) should be avoided.
Severe Tissue Injury, Including Gangrene
Promethazine hydrochloride injection can cause severe chemical irritation and damage to tissues, regardless of the route of administration. Irritation and damage can result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration. Adverse event reports include burning, pain, erythema, swelling, sensory loss, palsies, paralysis, severe spasm of distal vessels, thrombophlebitis, venous thrombosis, phlebitis, abscesses, tissue necrosis, and gangrene. In some cases, surgical intervention, including fasciotomy, skin graft, and/or amputation have been required.
Because of the risks of intravenous injection, the preferred route of administration of promethazine hydrochloride injection is deep intramuscular injection .
Subcutaneous injection is contraindicated. Due to close proximity of arteries and veins in the areas most commonly used for intravenous injection, extreme care should be exercised to avoid perivascular extravasation or unintentional intra-arterial injection as pain, severe chemical irritation, severe spasm of distal vessels, and resultant gangrene requiring amputation are likely under such circumstances. Aspiration of dark blood does not preclude intra-arterial needle placement because blood is discolored upon contact with promethazine hydrochloride injection. Use of syringes with rigid plungers or small-bore needles might obscure typical arterial backflow if this is relied upon alone.
In the event that a patient complains of pain during intravenous injection of promethazine hydrochloride injection, the injection should be stopped immediately to evaluate for possible arterial injection or perivascular extravasation.
There is no proven successful management of unintentional intra-arterial injection or perivascular extravasation after it occurs. Sympathetic block and heparinization have been employed during the acute management of unintentional intra-arterial injection, because of the results of animal experiments with other known arteriolar irritants.
Promethazine hydrochloride injection 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, sedative/hypnotics (including barbiturates), general anesthetics, narcotics, narcotic analgesics, tricyclic antidepressants, and tranquilizers; therefore such agents should either be eliminated or given in reduced dosage in the presence of promethazine hydrochloride.
Lower Seizure Threshold
Promethazine hydrochloride injection may lower seizure threshold and 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.
Promethazine hydrochloride injection 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.
Promethazine hydrochloride injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthma episodes, in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
This product is light sensitive and should be inspected before use and discarded if either color or particulate is observed.
Administration of promethazine has been associated with reported cholestatic jaundice.
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.
Promethazine hydrochloride injection should be used cautiously in persons with cardiovascular disease or impairment of liver function.
Information for Patients
Patients should be advised of the risk of respiratory depression, including potentially fatal respiratory depression in children less than 2 years of age.
Patients should be advised of the risk of severe tissue injury, including gangrene. Patients should be advised to immediately report persistent or worsening pain or burning at the injection site.
Promethazine hydrochloride injection may cause marked drowsiness or impair the mental 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. The concomitant use of alcohol, sedative/hypnotics (including barbiturates), general anesthetics, narcotics, narcotic analgesics, tricyclic antidepressants, and tranquilizers may enhance impairment .
Patients should be advised to report any involuntary muscle movements .
Patients should be advised to avoid prolonged exposure to the sun
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