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Basic Drug Info
Drug Name:Ketalar
Manufacturer:King Pharmaceuticals, Inc.
Other Info:

Reproduction: Male and female rats, when given five times the average human intravenous dose of Ketalar for three consecutive days about one week before mating, had a reproductive performance equivalent to that of saline-injected controls. When given to pregnant rats and rabbits intramuscularly at twice the average human intramuscular dose during the respective periods of organogenesis, the litter characteristics were equivalent to those of saline-injected controls. A small group of rabbits was given a single large dose (six times the average human dose) of Ketalar on Day 6 of pregnancy to simulate the effect of an excessive clinical dose around the period of nidation.

The outcome of pregnancy was equivalent in control and treated groups.

To determine the effect of Ketalar on the perinatal and postnatal period, pregnant rats were given twice the average human intramuscular dose during Days 18 to 21 of pregnancy.

Litter characteristics at birth and through the weaning period were equivalent to those of the control animals.

There was a slight increase in incidence of delayed parturition by one day in treated dams of this group.

Three groups each of mated beagle bitches were given 2.5 times the average human intramuscular dose twice weekly for the three weeks of the first, second, and third trimesters of pregnancy, respectively, without the development of adverse effects in the pups.

Prescribing Information as of April 2004.

Distributed for: Monarch Pharmaceuticals, Inc., Bristol, TN 37620Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620Manufactured by: Parkedale Pharmaceuticals, Inc., Rochester, MI 48307



Clinical Trials:


Indications and Usage

Ketalar is indicated as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation.

Ketalar is best suited for short procedures but it can be used, with additional doses, for longer procedures.

Ketalar is indicated for the induction of anesthesia prior to the administration of other general anesthetic agents.

Ketalar is indicated to supplement low-potency agents, such as nitrous oxide.

Specific areas of application are described in the CLINICAL PHARMACOLOGY Section.
Vitelliform dystrophy --

Absence of sensation --

Contraindications
Ketamine hydrochloride is contraindicated in those in whom a significant elevation of blood pressure would constitute a serious hazard and in those who have shown hypersensitivity to the drug.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Cardiac function should be continually monitored during the procedure in patients found to have hypertension or cardiac decompensation.

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 Ketalar, in which case supportive ventilation should be employed.

Mechanical support of respiration is preferred to administration of analeptics.

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