WHAT IS KETAMINE ROTEXMEDICA?

Ketamine Rotexmedica injection is used alone or together with other medicines to produce loss of consciousness before and during surgery or a medical procedure. It belongs to the group of medicines called general anesthetics.

Ketamine Rotexmedica is given only by or under the immediate supervision of a medical doctor trained to use it. If you will be receiving Ketamine Rotexmedica during surgery, your doctor or anesthesiologist will give you the medicine and closely follow your progress.

KETAMINE ROTEXMEDICA INDICATIONS

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

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As an anaesthetic agent for diagnostic and surgical procedures. When used by IV or IM injection, Ketamine Rotexmedica is best suited for short procedures. With additional doses or by IV infusion, Ketamine Rotexmedica can be used for longer procedures. If skeletal muscle relaxation is desired, a muscle relaxant should be used and respiration should be supported.

For the induction of anaesthesia prior to the administration of other general anaesthetic agents.

To supplement other anaesthetic agents.

Specific areas of application or types of procedures: When the IM route of administration is preferred.

Debridement, painful dressings and skin grafting in burned patients, as well as other superficial surgical procedures.

Neurodiagnostic procedures eg, pneumoencephalograms, ventriculograms, myelograms and lumbar punctures.

Diagnostic and operative procedures of the eye, ear, nose and mouth, including dental extractions.

Note: Eye movements may persist during ophthalmological procedures.

Anaesthesia in poor-risk patients with depression of vital functions or where depression of vital functions must be avoided, if at all possible.

Orthopaedic procedures eg, closed reductions, manipulations, femoral pinning, amputations and biopsies.

Sigmoidoscopy and minor surgery of the anus and rectum, circumcision and pilonidal sinus.

Cardiac catheterization procedures.

Caesarian section; as an induction agent in the absence of elevated blood pressure.

Anaesthesia in the asthmatic patient, either to minimise the risks of an attack of bronchospasm developing, or in the presence of bronchospasm where anaesthesia cannot be delayed.

HOW SHOULD I USE KETAMINE ROTEXMEDICA?

Use Ketamine Rotexmedica as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ketamine Rotexmedica is usually administered as an injection at your doctor's office, hospital, or clinic by those experienced in administering general anesthetics, in maintaining an airway, and in controlling respiration.
Do not use Ketamine Rotexmedica if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
If you miss a dose of Ketamine Rotexmedica, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Ketamine Rotexmedica.

USES OF KETAMINE ROTEXMEDICA IN DETAILS

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.

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Use: Labeled Indications

Anesthesia: Induction and maintenance of general anesthesia

Off Label Uses

Agitation, severe

Data from a limited number of patients in open-label, prospective clinical trials suggest that Ketamine Rotexmedica may be beneficial for the treatment of severe agitation and violent behavior. However, the dosage range varies considerably and an optimal dosage has not been established. Additional data is necessary to further define the role of Ketamine Rotexmedica in this condition. Since there is limited data on the safety and efficacy of Ketamine Rotexmedica in this setting, the Neurocritical Care Society recommends reservation of Ketamine Rotexmedica for patients who do not respond to more frequently recommended antiepileptic drug treatment.

KETAMINE ROTEXMEDICA DESCRIPTION

Ketamine Rotexmedica contains Ketamine HCl equivalent to Ketamine Rotexmedica base per mL. It also contains benzethonium chloride and water for injection. Additionally, the 10-mg/mL vial also contains sodium chloride.

KETAMINE ROTEXMEDICA DOSAGE

Note: Barbiturates and Ketamine Rotexmedica, being chemically incompatible because of precipitate formation, should not be injected from the same syringe.

If the Ketamine Rotexmedica dose is augmented with diazepam, the two drugs must be given separately. Do not mix Ketamine Rotexmedica 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:

•: While vomiting has been reported following Ketamine Rotexmedica administration, some airway protection may be afforded because of active laryngeal-pharyngeal reflexes. However, since aspiration may occur with Ketamine Rotexmedica and since protective reflexes may also be diminished by supplementary anesthetics and muscle relaxants, the possibility of aspiration must be considered. Ketamine Rotexmedica is recommended for use in the patient whose stomach is not empty when, in the judgment of the practitioner, the benefits of the drug outweigh the possible risks.
•: Atropine, scopolamine, or another drying agent should be given at an appropriate interval prior to induction.

Onset and Duration:

Because of rapid induction following the initial intravenous injection, the patient should be in a supported position during administration.

The onset of action of Ketamine Rotexmedica is rapid; an intravenous dose of 2 mg/kg (1 mg/lb) of body weight usually produces surgical anesthesia within 30 seconds after injection, with the anesthetic effect usually lasting five to ten minutes. If a longer effect is desired, additional increments can be administered intravenously or intramuscularly to maintain anesthesia without producing significant cumulative effects.

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:

As with other general anesthetic agents, the individual response to Ketamine Rotexmedica is somewhat varied depending on the dose, route of administration, and age of patient, so that dosage recommendation cannot be absolutely fixed. The drug should be titrated against the patient's requirements.

Induction:

Intravenous Route:

The initial dose of Ketamine Rotexmedica administered intravenously may range from 1 mg/kg to 4.5 mg/kg (0.5 to 2 mg/lb). The average amount required to produce five to ten minutes of surgical anesthesia has been 2 mg/kg (1 mg/lb).

Alternatively, in adult patients an induction dose of 1 mg to 2 mg/kg intravenous Ketamine Rotexmedica 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 intravenous diazepam or less 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 Rotexmedica should not 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.

Rate of Administration:

It is recommended that Ketamine Rotexmedica be administered slowly (over a period of 60 seconds). More rapid administration may result in respiratory depression and enhanced pressor response.

Intramuscular Route:

The initial dose of Ketamine Rotexmedica administered intramuscularly may range from 6.5 to 13 mg/kg (3 to 6 mg/lb). A dose of 10 mg/kg (5 mg/lb) will usually produce 12 to 25 minutes of surgical anesthesia.

Maintenance of Anesthesia:

The maintenance dose should be adjusted according to the patient's anesthetic needs and whether an additional anesthetic agent is employed.

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 Rotexmedica administered, the longer will be the time to complete recovery.

Adult patients induced with Ketamine Rotexmedica augmented with intravenous diazepam may be maintained on Ketamine Rotexmedica given by slow microdrip infusion technique at a dose of 0.1 to 0.5 mg/minute, augmented with diazepam 2 to 5 mg administered intravenously as needed. In many cases 20 mg or less of intravenous 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.

Dilution:

To prepare a dilute solution containing 1 mg of Ketamine Rotexmedica per mL, aseptically transfer 10 mL from a 50 mg per mL vial or 5 mL from a 100 mg per mL vial to 500 mL of 5% Dextrose Injection, USP or Sodium Chloride (0.9%) Injection, USP (Normal Saline) and mix well. The resultant solution will contain 1 mg of Ketamine Rotexmedica per mL.

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

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

Supplementary Agents:

Ketamine Rotexmedica is clinically compatible with the commonly used general and local anesthetic agents when an adequate respiratory exchange is maintained.

The regimen of a reduced dose of Ketamine Rotexmedica supplemented with diazepam can be used to produce balanced anesthesia by combination with other agents such as nitrous oxide and oxygen.

KETAMINE ROTEXMEDICA INTERACTIONS

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Prolonged recovery time may occur if barbiturates and/or narcotics are used concurrently with Ketamine Rotexmedica.

Ketamine Rotexmedica is chemically incompatible with barbiturates and diazepam because of precipitate formation. Therefore, these should not be mixed in the same syringe or infusion fluid.

Ketamine Rotexmedica may potentiate the neuromuscular-blocking effects of atracurium and tubocurarine including respiratory depression with apnoea.

The use of halogenated anaesthetics concomitantly with Ketamine Rotexmedica can lengthen the elimination half-life of Ketamine Rotexmedica and delay recovery from anaesthesia. Concurrent use of Ketamine Rotexmedica (especially in high doses or when rapidly administered) with halogenated anaesthetics can increase the risk of developing bradycardia, hypotension or decreased cardiac output.

The use of Ketamine Rotexmedica with other CNS depressants (eg, ethanol, phenothiazines, sedating H₁-blockers or skeletal muscle relaxants) can potentiate CNS depression and/or increase risk of developing respiratory depression. Reduced doses of Ketamine Rotexmedica may be required with concurrent administration of other anxiolytics, sedatives and hypnotics.

Ketamine Rotexmedica has been reported to antagonise the hypnotic effect of thiopental.

Patients taking thyroid hormones have an increased risk of developing hypertension and tachycardia when given Ketamine Rotexmedica.

Concomitant use of antihypertensive agents and Ketamine Rotexmedica increases the risk of developing hypotension.

When Ketamine Rotexmedica and theophylline are given concurrently, a clinically significant reduction in the seizure threshold is observed. Unpredictable extensor-type seizures have been reported with concurrent administration of these agents.

Incompatibilities: Ketamine Rotexmedica is chemically incompatible with barbiturates and diazepam because of precipitate formation. Therefore, these should not be mixed in the same syringe or infusion fluid.

KETAMINE ROTEXMEDICA SIDE EFFECTS

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Applies to Ketamine Rotexmedica: injection solution

In addition to its needed effects, some unwanted effects may be caused by Ketamine Rotexmedica. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking Ketamine Rotexmedica, check with your doctor or nurse immediately:

Incidence not known:

Bloody or cloudy urine
bluish lips or skin
blurred vision
chest pain or discomfort
confusion
confusion as to time, place, or person
convulsions
cough
difficult or troubled breathing
difficult, burning, or painful urination
difficulty with swallowing
dizziness
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
fainting
fast, slow, or irregular heartbeat
frequent urge to urinate
hives
holding false beliefs that cannot be changed by fact
irregular, fast or slow, or shallow breathing
itching
not breathing
pale or blue lips, fingernails, or skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
seeing, hearing, or feeling things that are not there
shortness of breath
skin rash
sweating
tightness in the chest
unusual excitement, nervousness, or restlessness
unusual tiredness or weakness

Minor Side Effects

Some of the side effects that can occur with Ketamine Rotexmedica may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Incidence not known:

Double vision
dream-like state
flushing or redness of the skin
loss of appetite
nausea
pain at the injection site
seeing double
uncontrolled eye movements
unusually warm skin
vomiting
weight loss

KETAMINE ROTEXMEDICA CONTRAINDICATIONS

Hypersensitivity to Ketamine Rotexmedica or any component of the formulation; conditions in which an increase in blood pressure would be hazardous

Note: When used for procedural sedation and analgesia in the emergency department, the following additional absolute contraindications according to the American College of Emergency Physicians have been asserted (ACEP [Green 2011]): Infants <3 months of age; known or suspected schizophrenia (even if currently stable or controlled with medications)

Canadian labeling: Additional contraindications (not in US labeling): History of cerebrovascular accident; severe cardiac decompensation; surgery of the pharynx, larynx, or bronchial tree unless adequate muscle relaxants are used

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