PROMETHAZINE HCI 50 mg/mL
PROMETHAZINE HCI · INJECTION · HF Acquisition Co. LLC, DBA HealthFirst
PROMETHAZINE HCI is a injection containing promethazine hci at 50 mg/mL, taken intramuscular. Manufactured by HF Acquisition Co. LLC, DBA HealthFirst.
Key Facts
- Brand Name
- PROMETHAZINE HCI
- Generic Name
- PROMETHAZINE HCI
- NDC Code (Product)
51662-1248- Manufacturer
- HF Acquisition Co. LLC, DBA HealthFirst
- Strength
- 50 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- ANDA083312
- Marketing Start
- 08/26/2018
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
Indications and Usage Promethazine hydrochloride injection is indicated for the following conditions: Amelioration of allergic reactions to blood or plasma. In anaphylaxis as an adjunct to epinephrine and other standard measures after the 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 from which the patient can be easily aroused. Active treatment of motion sickness. Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery. As an adjunct to analgesics for the control of postoperative pain. Preoperative, postoperative, and obstetric (during labor) sedation. 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.
Dosage & Administration
Dosage and Administration Important Notes on Administration 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 (see Warnings - Severe Tissue Injury, Including Gangrene). The preferred parenteral route of administration for promethazine hydrochloride injection is by deep intramuscular injection. 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 (see Warnings - Severe Tissue Injury, Including Gangrene). Subcutaneous injection is contraindicated as it may result in tissue necrosis. When administered intravenously, promethazine hydrochloride injection should be given in a concentration no greater than 25 mg per mL and at a rate not to exceed 25 mg per minute. It is preferable to inject through the tubing of an intravenous infusion set that is known to be functioning satisfactorily. In the event that a patient c…
Warnings
Warnings 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. 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. Other 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…
Contraindications
Contraindications 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 (see Warnings - Respiratory Depression). Comatose State Promethazine hydrochloride injection is contraindicated in comatose states. Intra-Arterial Injection 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 (see Warnings - Severe Tissue Injury, Including Gangrene). Subcutaneous Injection 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.
Adverse Reactions
Adverse Reactions Respiratory Depression Promethazine hydrochloride injection is contraindicated in pediatric patients less than 2 years of age, because of the potential for fatal respiratory depression. Promethazine hydrochloride injection should be used with caution in pediatric patients 2 years of age and older (see Warnings - Respiratory Depression). 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 reactions 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 (see Warnings - Severe Tissue Injury, Including Gangrene; and Dosage and Administration ). Central Nervous System Drowsiness is the most prominent CNS effect of this drug. Sedation, so…
Frequently Asked Questions
What is PROMETHAZINE HCI used for?
PROMETHAZINE HCI contains PROMETHAZINE HCI. It is a injection taken intramuscular. Consult your doctor for specific uses.
Is PROMETHAZINE HCI a controlled substance?
PROMETHAZINE HCI is not classified as a controlled substance by the DEA.
What is the generic name for PROMETHAZINE HCI?
The generic name for PROMETHAZINE HCI is PROMETHAZINE HCI. There are no other listed brand versions of PROMETHAZINE HCI.
What is the NDC code for PROMETHAZINE HCI 50 mg/mL?
The NDC (National Drug Code) for PROMETHAZINE HCI 50 mg/mL is 51662-1248, listed by HF Acquisition Co. LLC, DBA HealthFirst.
Other PROMETHAZINE HCI Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)