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Cheminova ketamine injection

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CHEMINOVA KETAMINE

Cheminova Ketamine HCL is a quick-acting anesthetic that can be used legally on both people and animals (as a sedative for minor surgery) (as a tranquilizer).
dosage of the drug ketamine, This medication is administered
under a doctor’s guidance.
Ketamine’s initial intravenous (IV) doses can range from 1 mg/kg to 4.5 mg/kg.

DRUG DESCRIPTION

Cheminova ketamine hydrochloride injection,  for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic. Ketamine hydrochloride,  is a white crystalline powder and has a molecular formula of C13H16ClNO•HCl and a molecular weight of 274.19. The chemical name for ketamine hydrochloride is dl-2-(o-Chlorophenyl)-2-(methylamino) cyclohexanone hydrochloride. The chemical structure of ketamine hydrochloride is:

Strengths and Dosage Forms

Cheminova ketamine hydrochloride injection, is a clear, colorless solution that is safe to use. It comes in multiple-dose vials that contain either 10 mg of ketamine base (equivalent to 11.53 mg of ketamine hydrochloride), 50 mg of ketamine base (equivalent to 57.67 mg of ketamine hydrochloride), or 100 mg of ketamine base (equivalent to 115.33 mg ketamine hydrochloride).

20 mL of 200 mg (10 mg/mL)

(50 mg/mL) 500 mg in 10 mL

100 mg/mL (1,000 mg/10mL)

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.

DOSAGE AND ADMINISTRATION

Important Dosage and Administration Information

Cheminova 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 hydrochloride injection.

Emergency airway equipment must be immediately available.

Do not administer the 100 mg/mL concentration of ketamine hydrochloride injection intravenously without proper dilution and also must be used immediately after dilution.

While some degree of airway protection may be afforded due to active laryngeal-pharyngeal reflexes, vomiting and aspiration may occur with cheminova ketamine hydrochloride injection. Ketamine hydrochloride injection is not recommended for use in patients who have not followed nil per os guidelines.

Due to the potential for salivation during ketamine hydrochloride injection administration, administer an antisialagogue prior to induction of anesthesia.

In individuals with a history of chronic ketamine use for off-label indications, there have been case reports of genitourinary pain that may be related to the ketamine treatment, not the underlying condition [see Adverse Reactions (6)]. Consider cessation of ketamine if genitourinary pain continues in the setting of other genitourinary symptoms.

Recommended Dosage and Administration

The ketamine hydrochloride injection dosage must be individualized and titrated to the desired clinical effect.

If a longer duration of effect is desired, additional increments can be administered intravenously or intramuscularly to maintain anesthesia. However, a higher total dose will result in a longer time to complete recovery.

Induction of Anesthesia

Intravenous Route:
The initial dose of ketamine hydrochloride injection administered intravenously may range from 1 mg/kg to 4.5 mg/kg.         The average amount required to produce 5 to 10 minutes of surgical anesthesia within 30 seconds following injection is 2 mg/kg. Administer ketamine hydrochloride injection slowly (i.e., over a period of 60 seconds).                                                                                                  Rapid administration may result in respiratory depression and enhanced vasopressor response.

Intramuscular Route
: The initial dose of ketamine hydrochloride injection administered intramuscularly may range from 6.5 to 13 mg/kg. A dose of 9 to 13 mg/kg usually produces surgical anesthesia within 3 to 4 minutes following injection, with the anesthetic effect usually lasting 12 to 25 minutes.                                                                                           Administer a benzodiazepine, if clinically indicated, for the prevention of neuropsychological manifestations during emergence from anesthesia.

Maintenance of Anesthesia

Adjust the maintenance dose according to the patient’s anesthetic needs and whether an additional anesthetic agent is administered.

Repeat increments of one-half to the full induction dose as needed for maintenance of anesthesia. Purposeless and tonic-clonic movements of extremities may occur during the course of ketamine anesthesia. These movements do not imply a light plane and are not indicative of the need for additional doses of the anesthetic.

Ketamine hydrochloride injection given by slow microdrip infusion technique at a dose of 0.1 to 0.5 mg/minute will maintain general anesthesia in adult patients induced with ketamine hydrochloride injection. Augment ketamine hydrochloride injection with an intravenous benzodiazepine for the prevention of neuropsychological manifestations during emergence.

Supplement to Other Anesthetic Agents

Cheminova ketamine hydrochloride injection can be administered to supplement other general and local anesthetic agents. Continuously monitor patients for changes in respiratory and hemodynamic parameters.

A reduced dose of ketamine hydrochloride injection can be used to produce balanced anesthesia when used in combination with other anesthetic agents.

Preparation of Dilution

Ketamine hydrochloride injection is a clear, colorless sterile solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if product is discolored or contains particulate matter.

Induction of Anesthesia
: Do not intravenously inject the 100 mg/mL concentration of ketamine hydrochloride injection without proper dilution. Dilute ketamine hydrochloride injection with an equal volume of either Sterile Water for injection, USP, 0.9% Sodium Chloride Injection, USP (Normal Saline), or 5% Dextrose in Water. Use immediately after dilution.

Dosage Forms and Strengths

Cheminova ketamine hydrochloride injection,  is a clear, colorless, sterile solution available in multiple-dose vials containing either 10 mg ketamine base (equivalent to 11.53 mg ketamine hydrochloride), 50 mg ketamine base (equivalent to 57.67 mg ketamine hydrochloride) or 100 mg ketamine base (equivalent to 115.33 mg ketamine hydrochloride).

  • 200 mg/20 mL (10 mg/mL)
  • 500 mg/10 mL (50 mg/mL)
  • 1,000 mg/10 mL (100 mg/mL)

Warnings and Precautions

Hemodynamic Instability

Transient increases in blood pressure, heart rate, and cardiac index are frequently observed following administration of ketamine hydrochloride. Decreases in blood pressure and heart rate, arrhythmias, and cardiac decompensation have also been observed. Monitor vital signs and cardiac function during ketamine hydrochloride administration. Ketamine hydrochloride is contraindicated in patients for whom a significant elevation of blood pressure would constitute a serious hazard

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