Hydrochloride Ketarol HCL 500mg 10ml by Global Pharmaceuticals 1 Vial

Description

Brand Name:

KETAROL

Injection i.v/i.m.

(Ketamine HCL)

Composition:

Each Vial (10 ml) contains:

Ketamine………..500 mg

as Ketamine HCL B.P.

Manufactured By:

Global Pharmaceuticals

About Ketamine Hydro-chloride:

Ketamine is an anesthetic medication.

Ketamine is used as a general anesthetic to prevent pain and discomfort during certain medical tests or procedures, or minor surgery.

Ketamine may also be used for purposes other than those listed in this medication guide.

Side Effects of Ketamine (Ketamine Hydro-chloride):

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have any of these serious side effects within 24 hours after you receive Ketamine:

Composition;

Each (10 ml)contains:

Ketamine HCIBPeq. to Ketamine…………. 500 mg

Absorption and Fate;

After Intravenous bolus maladministration, Ketamine shows a bi- or-tri exponflntial pattern of elimination, the alpha phase lasts about 45 minutes with a half life of 10 to 15 minutes the first phase which represents Ketamine anesthetic action, is temiinalad by distribution from the CNS to peripheral tissues and hepatic blo transformation to an active metabolite. Other metabolic path ways include hydrolation of the cyclohexane ring and conjugation with glucagon acid the tola phase half !He Is about 25 hours Ketamine cross Bi the placenta.

Uses

General parental anesthetic. Ketamine is recommended:

1. As the sola anesthetic agent for diagnostic and surgical procedures. Although best suited for short procedures, Ketamine can be used with additional doses, for longer procedures. If skeletal muscle relaxation Is desired, a muscle relaxant should be used and respiration should be supported.
2. For the induction of anesthesia prior to the administration of other general anesthetic agents. “
3. To supplement other antithetical ag»nte, Specific areas of application or types of procedures:
4. When the intramuscular route of administration Is preferred.
5. Debridement, painful dressings, and skin grafting in burned patients, as well a other superficial surgical procedure.
6. Neurodiagnostic procedures such as pneumoencephalograms, ventriculograms, myalograms and number punctures
7. Diagnostic and operative procdure M of the eye, ear, nose, and mouth, including dental extraction. Note: eye movement may persist during epistemological procedures.
8. Anesthesia in poor-risk patient with depression of vital function or where depression of vital functions must be avoided, It all possible.
9. Orthopedic procedures such as closed reductions, manipulations, femoral pinning, amputations and biopsies,.
10. Microscopy and minor surgery of the anus and rectum, circumcision and colloidal sinus. B. Cardiac cauterization procedures.
11. Cesarean section; as an inductions agent in the absence of elevated blood pressure.
12. Anesthesia In the asthmatic patient, But to minimize the risk of an attack of bronchi spasm developing, or in the presence of bronchi spasm Where anesthesia cannot be delayed.

Dosage and Administration

Adults, elderly (over 65 years) and children: For surgery In elderly patients Ketamine has been shown to be suitable either alone or supplemented with other anesthetic agent. Preoperative preparation:

1. Ketarol has been safety used alone when the stomach was not empty. However since they need for supplemental agents and muscle relaxant cannot be predicted, when preparing tor elective surgery it is advisable that nothing be given by mouth for at least six hours prior to anesthesia.
2. Atropine, scopolamine, or other drying agents should be given at an appropriate Interval prior to Induction.
3. Minazolam, diaapam, lorazepam, or flunitrazepam used as a predicament or as an adjunct to Ketamine, have been effective In reducing the incidence of emergence reaction.

OftMl and Durations:

As with other general anesthetic agents, the Individual response to Retard injection Is some what varied depending on the dose, route of administration, age of patients, and concomitant use of dinar agents, so that dosage recommendation cannot be absolutely fixed. The dose should be titratecf against the patients requirements.

Because of rapid Induction following Intravenous Injection the patient should b« in a supported position during administration. An intravenous dose of 2 mg/kg of body’^night usually produce surgical ana«smesia within 30 seconds after infection and the anesthetic effect usually lasts 5 inlay muscular down of 10 mg/kg of body-weight usually produces surgical anesthesia within 3 to 4 minute.

Intravenous infusion: The use of Ketarol infection by continuous Infusion enables the dose to be treated more closely, thereby reducing the amount to drug administered compared with Intermittent administration. This results in a shorter recovery time and better stability of vital

signs.

A solution containing 1 mgftn! of Ketamine, in dextrose 5% or sodium chloride 0.9% is suitable for administration by infusion.

induction: An infusion corresponding to 0.5 – 2.0 mg kB tamiriBftg as total induction dose.

Maintenance of Anesthesia: Anesthesia may be maintained using a micro drip Infusion of 10-45 micro gram JkgJ min(1-3 mg/min).The rate of infusion will depend on the patient’s reaction and response to anesthesia. The dosage required may be reduced when a long acting neuro muscular blocking agent is used.

Induction

Intravenous route: The initial dose of Ketarol Injection administered intramuscular may range from 6.5 to 13 mg/kg (in terms of Ketamine base),

A low inltlai Intramuscular dose of 4 mg/kg has bean used In diagnostic man oeuvres and produces not involving intensely painful stimuli. A dose of 10 mg/kgwil! usually produce 12 to 25 minutes of surgical anesthesia.

Maintanance  of anesthesia: Lightening of anesthesia may be indicated by nystagmus, movements in response to stimulation and vocalization,

Anesthesia is maintained by the administration of additional doses of Ketamine by either the intravenous or intramuscular route.

Each additional dose from % of the full induction dose recommended above for the route selected for maintenance, regardless of the route used for induction, A-The larger the total amount of Ketamine administered, the longer will be the time to complete recovery:

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. B. Ketarol as induction agent prior to use of-other general anesthetic:

, Induction is accomplished by a full intravenous or intramuscular dose of Ketarol injection as defined above. If Ketarol has been administered intravenously and the principal anesthetic is allowed a second dose of Ketarol may be required 5 to B minutes following the Initial dose. Ketarol has been administered intramuscular and the principal anesthetic is rapid-acting, administration of the principal anesthetic may be delayed up to 15 minutes following the injection of Ketamine, C. Ketamine Hydro-chloride Injection as supplement to anesthetic agents:

Ketamine Is clinically compatible with the commonly used general and local anesthetic agents when an adequate respiratory exchange is maintained. The dose of Ketamine for use in conjunction with other anesthetic agents Is usually in the same range as the dosage stated above: however, the use of another anesthetic agent may allow a reduction In the dose of Ketamine.

Management of patients in recovery: Following the procedure the patient should be observed but left undisturbed. This does not preclude the

monitoring of viNs^iw-if i^ring lh<recovery,the patient shows any fnijiMtlonolaiMrgencydtllrium.contldtr^on may b«giv<n to uibum of

the following agento: (Umpam (5 to 10 mg i.v. in adult). A hypnotic dose of a thiobarbiturate (50 to 100 mg i.v.) may be used to tanninala severe

enMTgencerBactionl.tf any ocn of these agents li employed, fte patient may experience along a recovery period.

Contraindication: Ketarol Injection is contra-Indicated In parsons in whom an elevation of blood pressure would constitute a

serious hazard (see Adverse Reactions). Ketarol should not be used in patients with eclampsia or preeclampsia.

1. To be used only in hospital by w under ?0 supervision of experienced medically qualified anesthetists except under emergency conditions.
2. 2. As with any general anesthetic agents, resuscitation equipment should be available and ready for use.
3. Barbiturates and Ketarol, being chemically incompatible because of precipitate formation, should not be injected from the same syringe.
4. Prolonged recovery time may occur if barbiturates Andrea narcotics are used concurrently with Ketarol.
5. Emergency delirium phenomena may occur during the recovery period. The Incidence of these reactions may tn reduced if verbal and tactile

\ stimulation of the patient is minimized during the recovery period. This does not preclude the monitoring of vital signs.

6.  Because pharyngeal and laryngeal reflexes usually remain active, mechanical Stimulation of the pharynx should be avoided unless muscle relaxants, with proper attention to respiration, are used.

7. Although aspiration of contrast medium has been reported during Ketarol anesthesia under experimental conditions in clinical practice Aspiration is seldom a problem.

8. Cardiac function should be continually monitored during the procedure in patient found to have hypertension or cardiac decompensation.
9. Since an increase in cerebro spinal fluid pressure has been reported during Ketarol anesthesia. Ketarol should be used with special caution in patients with pre anesthetic elevated cerebro spinal fluid pressure.

10. Respiratory depression may occur with over dosage of Ketarol, in which ca«e supportive ventilation should be employed. Mechanical support of respiration is preferred to the administration of Analects.

11. The intravenous dose should be administered over a period of BO seconds. More rapid                                          administration may result in transient respiratory depression or apnea.

12. In surgical procedures involving visceral pain pathways. Ketarol! should be supplemented with an agent which obtund visceral pain.
13. Use with caution In the chronic alcoholic and the actually alcohol-intoxicated patient
14. When Ketarol is used in an outpatient basis, the patients should mot be released until recovery from anesthesia is complete and then should be accompanied by a responsible adult.

Cardiovascular: Temporary elevation of blood pressure and pulse rate is frequently observed following qdministnillon of Ketarol

Injection. However, hypo tension and bradycardia have been reported. Arrhythmia has also occurred.

The medium peak risk of blood pressure has ranged from 20 to 25 percent of preanaasthatic values. Depending on the condition of the patient, this elevation of blood pressure may be considered an adverse reaction a beneficial affect

Respiratory: Depression of respiration of apnea may occur following too rapid intravenous administration or high doses of Ketarol

Laryngospasm and other forms of airway obstruction have occurred during Ketamine anesthesia.

Ocular: Diplopia and mustangs may occur following Ketarol administration. A s’ifiht elevation in intramuscular pressure may also occur.

Psychological: During recovery from anesthesia the patients may experience emergency delirium, characterized by vivid dreams (Pit—ant and

often in the young (15 years of age .or less) makes Ketarol especially useful in pediatric anesthesia. These reactions are also less frequent in the elderly (over 65 years of age) patient. The incidence of emergence reactions are reduced as experience with the drug is gained. N0 residua!

Psychological effects are known to have results from the use of Ketarol.

Neurological: In some patient, enhanced skeletal muscle lone may be manifested by tonic and clonic movements some time resembling seizures.

These movements do not imply a light plane of anesthesia and are not indicative of a need for additional doses of the anesthetic.

Gastro-Intestinal: Anorexia, nausea, and vomiting have been observed, however these are not usually severe. The great majority of patients are able to take liquids by mouth shortly after regaining consciousness.

Other Local pain and anathema at the injection site have infrequently been reported. Transient erythema and/or morbid fonn rash have also been reported Increased salivation leading to respiratory difficulties may occur unless an anticoagulant is used.

Symptoms and Treatment of Over Dosage: Respiratory depression can result from an over dosage of Ketarol, Supportive ventilation should be employed. Mechanical support of respiration that will maintain adequate blood oxygen saturation carbon dioxide elimination is preferred to administration of Analects.

Ketarol has a wide margin of safety: Several instances of unintentional administration of overdoses of Ketarol (up to ID times that usually required) have been followed by prolonged but complete recovery.

Pharmaceutical Precautions;

Barbiturates and Ketarol Injection, being chemically incompatible because of precipitation formation, should not be injected from the same syringe.

Protect from light. Store at a temperature not exceeding 30’C.

A Irns’ml solution of Ketarol in dextrose 5% or sodium chloride 0.9% is stable for 24 hours.