Generic Name and Formulations:
Ketamine HCl 10mg/mL, 50mg/mL, 100mg/mL; soln for IM or IV inj.
Par Pharmaceutical, Inc.
Indications for KETALAR:
Sole anesthetic agent for diagnostic and surgical procedures not requiring skeletal muscle relaxation. Induction prior to other general anesthesia. Supplement to low-potency agents (eg, nitrous oxide).
Adults and Children:
<16yrs: not established. Pretreat with atropine, scopolamine or other drying agent prior to induction. Individualize. Give by slow IV inj over 60secs. ≥16yrs: IV induction: initial range: 1–4.5mg/kg; usually 2mg/kg to produce 5–10mins surgical anesthesia. Alternatively, 1–2mg/kg at rate of 0.5mg/kg/min may be used. In addition, diazepam 2–5mg doses given in separate syringe over 60 secs, may be used. IM induction: initial range: 6.5–13mg/kg; usually 10mg/kg to produce 12–25mins surgical anesthesia. Usual range: 9–13mg/kg IM to produce surgical anesthesia within 3–4mins following inj, with effects lasting 12–25mins. Maintenance: repeat as needed in increments of 1/2 to full induction dose; see full labeling. Supplementary to nitrous oxide/oxygen: use reduced ketamine dose with diazepam.
To be administered under the supervision of experienced clinicians. Have resuscitative equipment available. Avoid monotherapy and/or mechanical stimulation in pharynx, larynx or bronchial tree surgery/diagnostic procedures; may require muscle relaxants. Hypertensive or cardiac decompensated; monitor cardiac function. Monitor for psychological manifestations post-op. Preanesthetic elevated cerebrospinal fluid pressure. Alcoholics, drug abusers. Abuse potential. Pediatric neurotoxicity risk with repeated or prolonged use. Elderly. Labor delivery, pregnancy: not recommended.
NMDA receptor antagonist.
Concomitant barbiturates and/or narcotics may prolong recovery time.
Hyper or hypotension, bradycardia, arrhythmia, respiratory depression (may be severe; esp. with rapid IV or high-doses), apnea, laryngospasms, airway obstruction, diplopia, nystagmus, intraocular pressure, urinary tract and bladder symptoms, cystitis, hydronephrosis, reduced bladder capacity, tonic/clonic movements, anorexia, GI upset, anaphylaxis, inj site pain, exanthema, transient erythema, rash; emergence reactions (eg, pleasant dream-like states, hallucinations, delirium, confusion, excitement, irrational behavior), elevated cerebrospinal fluid pressure.
Multi-dose vials (5mL, 10mL, 20mL)—10
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