KETAMINE HYDROCHLORIDE

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Overview

What is KETAMINE HYDROCHLORIDE?

Ketamine

What does KETAMINE HYDROCHLORIDE look like?

What are the available doses of KETAMINE HYDROCHLORIDE?

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What should I talk to my health care provider before I take KETAMINE HYDROCHLORIDE?

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How should I use KETAMINE HYDROCHLORIDE?

Ketamine Hydrochloride Injection, USP is indicated as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. Ketamine Hydrochloride Injection, USP is best suited for short procedures but it can be used, with additional doses, for longer procedures.

Ketamine Hydrochloride Injection, USP is indicated for the induction of anesthesia prior to the administration of other general anesthetic agents.

Ketamine Hydrochloride Injection, USP is indicated to supplement low-potency agents, such as nitrous oxide.

Note:

should not

If the ketamine hydrochloride injection dose is augmented with diazepam, the two drugs must be given separately. Do not mix Ketamine hydrochloride injection and diazepam in syringe or infusion flask. For additional information on the use of diazepam, refer to the WARNINGS and DOSAGE AND ADMINISTRATION Sections of the diazepam insert.

Preoperative Preparations:

Onset and Duration:

Intramuscular doses, in a range of 9 to 13 mg/kg (4 to 6 mg/lb) usually produce surgical anesthesia within 3 to 4 minutes following injection, with the anesthetic effect usually lasting 12 to 25 minutes.

Dosage:

Induction:

Alternatively, in adult patients an induction dose of 1 mg to 2 mg/kg intravenous ketamine (base) at a rate of 0.5 mg/kg/min may be used for induction of anesthesia. In addition, diazepam in 2 mg to 5 mg doses, administered in a separate syringe over 60 seconds, may be used. In most cases, 15 mg of intravenouse diazepam will suffice. The incidence of psychological manifestations during emergence, particularly dream-like observations and emergence delirium, may be reduced by this induction dosage program.

Note: The 100 mg/mL concentration of ketamine hydrochloride injection be injected intravenously without proper dilution. It is recommended the drug be diluted with an equal volume of either Sterile Water for Injection, USP, Normal Saline, or 5% Dextrose in Water.

Maintenance of Anesthesia:

Increments of one-half to the full induction dose may be repeated as needed for maintenance of anesthesia. However, it should be noted that purposeless and tonic-clonic movements of extremities may occur during the course of anesthesia. These movements do not imply a light plane and are not indicative of the need for additional doses of the anesthetic.

It should be recognized that the larger the total dose of ketamine hydrochloride injection administered, the longer will be the time to complete recovery.

Adult patients induced with ketamine hydrochloride injection augmented with intravenous diazepam may be maintained on ketamine hydrochloride injection given by slow microdrip infusion technique at a dose of 0.1 to 0.5 mg/minute ketamine (base), augmented with diazepam 2 to 5 mg administered intravenously as needed. In many cases 20 mg or of intravenouse diazepam total for combined induction and maintenance will suffice. However, slightly more diazepam may be required depending on the nature and duration of the operation, physical status of the patient, and other factors. The incidence of psychological manifestations during emergence, particularly dream-like observations and emergence delirium, may be reduced by this maintenance dosage program.

The fluid requirements of the patient and duration of anesthesia must be considered when selecting the appropriate dilution of ketamine hydrochloride injection. If fluid restriction is required, ketamine hydrochloride injection can be added to a 250 mL infusion as described above to provide a ketamine hydrochloride injection concentration of 2 mg/mL.

Ketamine hydrochloride injection 10 mg/mL vials are not recommended for dilution.

Supplementary 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 such as nitrous oxide and oxygen.

Parenteral drug products should be inspected visually for particular matter and discoloration prior to administration, whenever solution and container permit.

What interacts with KETAMINE HYDROCHLORIDE?

Ketamine hydrochloride is contraindicated in those in whome a significant elevation of blood pressure would constitute a serious hazard and in those who have shown hypersensitivity to the drug.

Postoperative confusional states may occur during the recovery period. (See Special Note.)

Respiratory depression may occur with overdosage or too rapid a rate of administration of ketamine hydrochloride injection, in which case supportive ventilation should be employed. Mechanical support of respiration is preferred to administration of analeptics.

What are the warnings of KETAMINE HYDROCHLORIDE?

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What are the precautions of KETAMINE HYDROCHLORIDE?

General:

Because pharyngeal and laryngeal reflexes are usually active, ketamine hydrochloride injection should not be used alone in surgery or diagnostic procedures of the pharynx, larynx, or bronchial tree. Mechanical stimulation of the pharynx should be avoided, whenever possible, if ketamine hydrochloride injection is used alone. Muscle relaxants, with proper attention to respiration, may be required in both of these instances.

Resuscitative equipment should be ready for use.

The if verbal and tactile stimulation of the patient is minimized during the recovery period. This does not preclude the monitoring of vital signs (see Special Note).

The intravenous dose should be administered over a period of 60 seconds. More rapid administration may result in respiratory depression or apnea and enhanced pressor response.

In surgical procedures involving visceral pain pathways, ketamine hydrochloride injection should be supplemented with an agent wich obtunds visceral pain.

Use with caution in the chronic alcoholic and the acutely alcohol-intoxicated patient.

An increase in cerebrospinal fluid pressure has been reported following administration of ketamine hydrochloride. Use with extreme caution in patients with preanesthetic elevated cerebrospinal fluid pressure.

Information for Patients:

Drug Interactions:

Ketamine hydrochloride injection is clinically compaitlbe with the commonly used general and local anesthetic agents when an adequate respiratory exchange is maintained.

Usage in Pregnancy:

Pediatric Use:

Geriatric Use:

What are the side effects of KETAMINE HYDROCHLORIDE?

Cardiovascular:

Respiration:

Eye:

Genitourinary:

Psychological:

Neurological:

Gastrointestinal:

General:

For medical advice about your adverse reactions, contact your medical professional. To report SUSPECTED ADVERSE REACTIONS, contact Mylan Institutional at 1-877-446-3679 (1-877-4-INFO-RX) or MEDWATCH at 1-800-FDA-1088 (1-800-332-1088) or http://www.fda.gov/medwatch/.

What should I look out for while using KETAMINE HYDROCHLORIDE?

Ketamine hydrochloride is contraindicated in those in whome a significant elevation of blood pressure would constitute a serious hazard and in those who have shown hypersensitivity to the drug.

Postoperative confusional states may occur during the recovery period. (See Special Note.)

Respiratory depression may occur with overdosage or too rapid a rate of administration of ketamine hydrochloride injection, in which case supportive ventilation should be employed. Mechanical support of respiration is preferred to administration of analeptics.

What might happen if I take too much KETAMINE HYDROCHLORIDE?

Respiratory depression may occur with overdosage or too rapid rate of administration of ketamine hydrochloric injection, in which case supportive ventilation should be employed. Mechanical support of respiration is preferred to administration of analeptics.

How should I store and handle KETAMINE HYDROCHLORIDE?

Ketamine Hydrochloride Injection, USP is supplied as the hydrochloride in concentrations equivalent to ketamine base.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light. Retain in carton until time of use.Ketamine Hydrochloride Injection, USP is supplied as the hydrochloride in concentrations equivalent to ketamine base.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light. Retain in carton until time of use.Ketamine Hydrochloride Injection, USP is supplied as the hydrochloride in concentrations equivalent to ketamine base.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light. Retain in carton until time of use.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Ketamine hydrochloride injection is a rapid-acting general anesthetic producing an anesthetic state characterized by profound analgesia, normal pharyngeal-laryngeal reflexes, normal or slightly enhanced skeletal muscle tone, cardiovascular and respiratory stimulation, and occasionally a transient and minimal respiratory depression.

A patent airway is maintained partly by virtue of inumpaired pharyngeal and laryngeal reflexes. (See WARNINGS AND PRECAUTIONS Sections.)

The biotransformation of ketamine hydrochloride injection includes N-dealkylation (metabolite I), hydroxylation of the cyclohexone ring (metabolites III and IV), conjugation with glucuronic acid and dehydration of the hydroxylated metabolites to form the cyclohexene derivative (metabolite II).

Following an intravenous administration, the ketamine concentration has an initial slope (alpha phase) lasting about 45 minutes with a half-life of 10 to 15 minutes. This first phase corresponds clinically to the anesthetic effect of the drug. The anesthetic action is terminated by a combination of redistribution from the CNS to slower equilibrating peripheral tissues and by hepatic biotransformation to metabolite I. This metabolite is about 1/3 as active as ketamine in reducing halothane requirements (MAC) of the rat. The later half-life of ketamine (beta phase) is 2.5 hours.

The anesthetic state produced by ketamine hydrochloride injection as been termed "dissociative anesthesia" in that it appears to selectively interrupt association pathways of the brain before producing somatesthetic sensory blockade. It may selectively depress the thalamoneocortical system before significantly obtunding the more ancient cerebral centers and pathways (reticular-activating and limbic systems).

Elevation of blood pressure begins shortly after injection, reaches a maximum within a few minutes and usually returns to preanesthetic values within 15 minutes after injection. In the majority of cases, the systolic and diastolic blood pressure peaks from 10% to 50% above preanesthetic levels shortly after induction of anesthesia, but the elevation can be higher or longer in individual cases (see CONTRAINDICATIONS Section).

Ketamine has a wide margin of safety; several instances of unintentional administration of overdoses of ketamine hydrochloride injection (up to ten times that usually required) have been followed by prolonged by complete recovery.

Ketamine hydrochloride injection has been studied in over 12,000 operative and diagnostic procedures, involving over 10,000 patients from 105 separate studies. During the course of these studies ketamine hydrochloride injection was administered as the sole agent, as induction for other general agents, or to supplement low-potency agents.

Specific areas of application have included the following:

In these studies, the anesthesia was rated either "excellent" or "good" by the anesthesiologist and the surgeon at 90% and 93%, respectively; rated "fair" at 6% and 4%, respectively; and rated "poor" at 4% and 3%, respectively. In a second method of evaluation, the anesthesia was rated "adequate" in at least 90% and "inadequate" in 10% or less of the procedures.

Non-Clinical Toxicology

Ketamine hydrochloride is contraindicated in those in whome a significant elevation of blood pressure would constitute a serious hazard and in those who have shown hypersensitivity to the drug.

Postoperative confusional states may occur during the recovery period. (See Special Note.)

Respiratory depression may occur with overdosage or too rapid a rate of administration of ketamine hydrochloride injection, in which case supportive ventilation should be employed. Mechanical support of respiration is preferred to administration of analeptics.

CNS Drugs - Given the primary CNS effects of citalopram, caution should be used when it is taken in combination with other centrally acting drugs.

Alcohol - Although citalopram did not potentiate the cognitive and motor effects of alcohol in a clinical trial, as with other psychotropic medications, the use of alcohol by depressed patients taking citalopram is not recommended.

Monoamine Oxidase Inhibitors (MAOIs) -See , , and .

Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, Warfarin, etc.) - Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate the risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs and SNRIs are coadministered with warfarin. Patients receiving warfarin therapy should be carefully monitored when Citalopram is initiated or discontinued.

Cimetidine - In subjects who had received 21 days of 40 mg/day citalopram, combined administration of 400 mg/day cimetidine for 8 days resulted in an increase in citalopram AUC and C of 43% and 39%, respectively. The clinical significance of these findings is unknown.

Citalopram 20 mg/day is the maximum recommended dose for patients taking concomitant cimetidine because of the risk of QT prolongation (see and ).

Digoxin - In subjects who had received 21 days of 40 mg/day citalopram, combined administration of Citalopram and digoxin (single dose of 1 mg) did not significantly affect the pharmacokinetics of either citalopram or digoxin.

Lithium - Coadministration of citalopram (40 mg/day for 10 days) and lithium (30 mmol/day for 5 days) had no significant effect on the pharmacokinetics of citalopram or lithium. Nevertheless, plasma lithium levels should be monitored with appropriate adjustment to the lithium dose in accordance with standard clinical practice. Because lithium may enhance the serotonergic effects of citalopram, caution should be exercised when citalopram and lithium are coadministered.

Pimozide - In a controlled study, a single dose of pimozide 2 mg co-administered with citalopram 40 mg given once daily for 11 days was associated with a mean increase in QTc values of approximately 10 msec compared to pimozide given alone. Citalopram did not alter the mean AUC or C of pimozide. The mechanism of this pharmacodynamic interaction is not known.

Theophylline - Combined administration of citalopram (40 mg/day for 21 days) and the CYP1A2 substrate theophylline (single dose of 300 mg) did not affect the pharmacokinetics of theophylline. The effect of theophylline on the pharmacokinetics of citalopram was not evaluated.

Sumatriptan - There have been rare postmarketing reports describing patients with weakness, hyperreflexia, and incoordination following the use of a SSRI and sumatriptan. If concomitant treatment with sumatriptan and an SSRI (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram) is clinically warranted, appropriate observation of the patient is advised.

Warfarin - Administration of 40 mg/day citalopram for 21 days did not affect the pharmacokinetics of warfarin, a CYP3A4 substrate. Prothrombin time was increased by 5%, the clinical significance of which is unknown.

Carbamazepine - Combined administration of citalopram (40 mg/day for 14 days) and carbamazepine (titrated to 400 mg/day for 35 days) did not significantly affect the pharmacokinetics of carbamazepine, a CYP3A4 substrate. Although trough citalopram plasma levels were unaffected, given the enzyme inducing properties of carbamazepine, the possibility that carbamazepine might increase the clearance of citalopram should be considered if the two drugs are coadministered.

Triazolam - Combined administration of citalopram (titrated to 40 mg/day for 28 days) and the CYP3A4 substrate triazolam (single dose of 0.25 mg) did not significantly affect the pharmacokinetics of either citalopram or triazolam.

Ketoconazole - Combined administration of citalopram (40 mg) and ketoconazole (200 mg) decreased the C and AUC of ketoconazole by 21% and 10%, respectively, and did not significantly affect the pharmacokinetics of citalopram.

CYP2C19 inhibitors - Citalopram 20 mg/day is the maximum recommended dose for patients taking concomitant CYP2C19 inhibitors because of the risk of QT prolongation (see , , and ).

Metoprolol - Administration of 40 mg/day citalopram for 22 days resulted in a two-fold increase in the plasma levels of the beta-adrenergic blocker metoprolol. Increased metoprolol plasma levels have been associated with decreased cardioselectivity. Coadministration of citalopram and metoprolol had no clinically significant effects on blood pressure or heart rate.

Imipramine and Other Tricyclic Antidepressants (TCAs) - In vitro studies suggest that citalopram is a relatively weak inhibitor of CYP2D6. Coadministration of citalopram (40 mg/day for 10 days) with the TCA imipramine (single dose of 100 mg), a substrate for CYP2D6, did not significantly affect the plasma concentrations of imipramine or citalopram. However, the concentration of the imipramine metabolite desipramine was increased by approximately 50%. The clinical significance of the desipramine change is unknown. Nevertheless, caution is indicated in the coadministration of TCAs with citalopram.

Electroconvulsive Therapy (ECT) - There are no clinical studies of the combined use of electroconvulsive therapy (ECT) and citalopram.

General:

Because pharyngeal and laryngeal reflexes are usually active, ketamine hydrochloride injection should not be used alone in surgery or diagnostic procedures of the pharynx, larynx, or bronchial tree. Mechanical stimulation of the pharynx should be avoided, whenever possible, if ketamine hydrochloride injection is used alone. Muscle relaxants, with proper attention to respiration, may be required in both of these instances.

Resuscitative equipment should be ready for use.

The if verbal and tactile stimulation of the patient is minimized during the recovery period. This does not preclude the monitoring of vital signs (see Special Note).

The intravenous dose should be administered over a period of 60 seconds. More rapid administration may result in respiratory depression or apnea and enhanced pressor response.

In surgical procedures involving visceral pain pathways, ketamine hydrochloride injection should be supplemented with an agent wich obtunds visceral pain.

Use with caution in the chronic alcoholic and the acutely alcohol-intoxicated patient.

An increase in cerebrospinal fluid pressure has been reported following administration of ketamine hydrochloride. Use with extreme caution in patients with preanesthetic elevated cerebrospinal fluid pressure.

Information for Patients:

Drug Interactions:

Ketamine hydrochloride injection is clinically compaitlbe with the commonly used general and local anesthetic agents when an adequate respiratory exchange is maintained.

Usage in Pregnancy:

Pediatric Use:

Geriatric Use:

Cardiovascular:

Respiration:

Eye:

Genitourinary:

Psychological:

Neurological:

Gastrointestinal:

General:

For medical advice about your adverse reactions, contact your medical professional. To report SUSPECTED ADVERSE REACTIONS, contact Mylan Institutional at 1-877-446-3679 (1-877-4-INFO-RX) or MEDWATCH at 1-800-FDA-1088 (1-800-332-1088) or http://www.fda.gov/medwatch/.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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