Ketamine Hydrochloride 50 mg/mL
Ketamine Hydrochloride · INJECTION · Hikma Pharmaceuticals USA Inc.
Ketamine Hydrochloride is a injection containing ketamine hydrochloride at 50 mg/mL, taken intramuscular. Manufactured by Hikma Pharmaceuticals USA Inc..
Key Facts
- Brand Name
- Ketamine Hydrochloride
- Generic Name
- Ketamine Hydrochloride
- NDC Code (Product)
0143-9508- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Strength
- 50 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- DEA Schedule
- Schedule III (Controlled)
- Application #
- ANDA074524
- Marketing Start
- 07/01/1996
Recall History
Wells Pharma of Houston LLC
cGMP deviations.
Tailstorm Health INC
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
STAQ Pharma, Inc.
Labeling: Incorrect or Missing Lot and/or Exp Date
Tailstorm Health INC
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Nephron Sterile Compounding Center LLC
Lack of Assurance of Sterility
Nephron Sterile Compounding Center LLC
Lack of Assurance of Sterility
Hospira Inc.
Defective Container: There were customer complaints of cracked and leaking glass vials.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Ketamine Hydrochloride Injection is indicated: • as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. • for the induction of anesthesia prior to the administration of other general anesthetic agents. • as a supplement to other anesthetic agents. Ketamine Hydrochloride Injection is a general anesthetic indicated: • as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation ( 1 ) • for the induction of anesthesia prior to the administration of other general anesthetic agents ( 1 ) • as a supplement to other anesthetic agents. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • See Full Prescribing Information for important dosage and administration instructions. ( 2 ) • Induction of Anesthesia : -- Intravenous Route : Initially, 1 to 4.5 mg/kg administered slowly (over a period of 60 seconds). Alternatively, administer a dose of 1 to 2 mg/kg at a rate of 0.5 mg/kg/min. ( 2.2 ) -- Intramuscular Route : Initially, 6.5 to 13 mg/kg. ( 2.2 ) • Maintenance of Anesthesia : Increments of one-half to the full induction dose may be repeated as needed ( 2.2 ). Adjust the dose according to the patient's anesthetic needs and whether an additional anesthetic agent is employed. ( 2.2 ) • Supplement to Other Anesthetic Agents : The regimen of a reduced dose of Ketamine Hydrochloride Injection supplemented with diazepam can be used to produce balanced anesthesia by combination with other agents. ( 2.2 ) 2.1 Important Dosage and Administration Information Ketamine Hydrochloride Injection should be administered by or under the direction of physicians experienced in the administration of general anesthetics, maintenance of a patent airway, and oxygenation and ventilation. Continuously monitor vital signs in patients receiving Ketamine Hydrochlo…
Contraindications
4 CONTRAINDICATIONS • Ketamine Hydrochloride Injection is contraindicated in patients for whom a significant elevation of blood pressure would constitute a serious hazard [see Warnings and Precautions (5.1) ] . • Ketamine Hydrochloride Injection is contraindicated in patients with known hypersensitivity to ketamine or to any excipient [see Adverse Reactions (6) ] . • In patients for whom a significant elevation of blood pressure would be a serious hazard. ( 4 ) • Known hypersensitivity to ketamine or to any excipient. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS • Theophylline or Aminophylline : Do not co-administer with Ketamine Hydrochloride Injection as concomitant use may lower the seizure threshold. ( 7.1 ) • Sympathomimetics and Vasopressin : Closely monitor vital signs when co-administered with Ketamine Hydrochloride Injection. Consider dose adjustment individualized to the patient's clinical situation. ( 7.2 ) • Benzodiazepines, Opioid Analgesics, or Other CNS Depressants : Concomitant use may result in profound sedation, respiratory depression, coma, or death. Concomitant use of opioid analgesics may prolong recovery time. ( 7.3 ) 7.1 Theophylline or Aminophylline Concomitant administration of Ketamine Hydrochloride Injection and theophylline or aminophylline may lower the seizure threshold. Consider using an alternative to Ketamine Hydrochloride Injection in patients receiving theophylline or aminophylline. 7.2 Sympathomimetics and Vasopressin Sympathomimetics and vasopressin may enhance the sympathomimetic effects of ketamine. Closely monitor vital signs when Ketamine Hydrochloride Injection and sympathomimetics or vasopressin are co-administered and consider dose adjustment individualized to the patient's cl…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Hemodynamic Instability [see Warnings and Precautions (5.1) ] • Emergence Reactions [see Warnings and Precautions (5.2) ] • Respiratory Depression [see Warnings and Precautions (5.3) ] • Pediatric Neurotoxicity [see Warnings and Precautions (5.5) ] • Drug-Induced Liver Injury [see Warnings and Precautions (5.6) ] The following adverse reactions associated with the use of Ketamine Hydrochloride Injection were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular disorders : Elevated blood pressure, heart rate, and cardiac index; decreases in blood pressure and heart rate; arrhythmias; cardiac decompensation (in patients with suspected catecholamine depletion). Eye disorders : Diplopia, nystagmus, elevation in intraocular pressure. Gastrointestinal disorders : Anorexia, nausea, vomiting; hepatobiliary dysfunction, biliary duct dilatation, bili…
Frequently Asked Questions
What is Ketamine Hydrochloride used for?
Ketamine Hydrochloride contains Ketamine Hydrochloride. It is a injection taken intramuscular. Consult your doctor for specific uses.
Is Ketamine Hydrochloride a controlled substance?
Yes, Ketamine Hydrochloride is classified as CIII under the DEA Controlled Substances Act.
What is the generic name for Ketamine Hydrochloride?
The generic name for Ketamine Hydrochloride is Ketamine Hydrochloride. There are 8 other brand versions of Ketamine Hydrochloride.
What is the NDC code for Ketamine Hydrochloride 50 mg/mL?
The NDC (National Drug Code) for Ketamine Hydrochloride 50 mg/mL is 0143-9508, listed by Hikma Pharmaceuticals USA Inc..