Drugplain

Ketalar 50 mg/mL

ketamine hydrochloride · INJECTION · Par Health USA, LLC

No Recall HistoryCurrently in Shortage
Plain English

Ketalar is a injection containing ketamine hydrochloride at 50 mg/mL, taken intramuscular. Manufactured by Par Health USA, LLC.

Key Facts

Brand Name
Ketalar
Generic Name
ketamine hydrochloride
NDC Code (Product)
42023-114
Manufacturer
Par Health USA, LLC
Strength
50 mg/mL
Dosage Form
INJECTION
Route
INTRAMUSCULAR, INTRAVENOUS
Marketing Status
DEA Schedule
Schedule III (Controlled)
Application #
NDA016812
Marketing Start
10/01/2007

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

infusion site pain685 reports
drug ineffective496 reports
off label use469 reports
nausea459 reports
infusion site erythema427 reports
headache299 reports
infusion site swelling290 reports
drug abuse287 reports
dyspnoea277 reports
diarrhoea274 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE KETALAR (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. KETALAR 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 KETALAR supplemented with diazepam can be used to produce balanced anesthesia by combination with other agents. ( 2.2 ) 2.1 Important Dosage and Administration Information KETALAR 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 KETALAR. Emergency airway equipment must be immediately available. KETALAR is …

Contraindications

4 CONTRAINDICATIONS KETALAR is contraindicated in patients for whom a significant elevation of blood pressure would constitute a serious hazard [see Warnings and Precautions ( 5.1 ) ]. KETALAR 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 KETALAR as concomitant use may lower the seizure threshold ( 7.1 ). Sympathomimetics and Vasopressin : Closely monitor vital signs when co-administered with KETALAR. 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 KETALAR and theophylline or aminophylline may lower the seizure threshold. Consider using an alternative to KETALAR 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 KETALAR and sympathomimetics or vasopressin are co-administered and consider dose adjustment individualized to the patient’s clinical situation. 7.3 Benzodiazepines, Opioid Analgesics, Or Other CNS Depressants Concomitant use of ketamine with opioid analges…

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 KETALAR 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, biliary duct stricture and/or sten…

Frequently Asked Questions

What is Ketalar used for?

Ketalar contains ketamine hydrochloride. It is a injection taken intramuscular. Consult your doctor for specific uses.

Is Ketalar a controlled substance?

Yes, Ketalar is classified as CIII under the DEA Controlled Substances Act.

What is the generic name for Ketalar?

The generic name for Ketalar is ketamine hydrochloride. There are 10 other brand versions of ketamine hydrochloride.

What is the NDC code for Ketalar 50 mg/mL?

The NDC (National Drug Code) for Ketalar 50 mg/mL is 42023-114, listed by Par Health USA, LLC.

Product NDC

42023-114

Package NDC

42023-114-10

Other Ketalar Dosages

Other Ketamine Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)