
KETAKAR 10 MG ML
Generic Name/API: ketamine hydrochloride
Manufacturer: Par Pharmaceutical
Dosage Forms & Strength & Pack Size:
Injection: 200 mg/20 mL (10 mg/mL), 500 mg/10 mL (50 mg/mL), and 500 mg/5 mL (100 mg/mL) multiple-dose vials (3).
Storage:
KETALAR injection should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light.
- INDICATION
- IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE
KETALAR (ketamine hydrochloride) injection is indicated:
- as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation.
- for the induction of anesthesia prior to the administration of other general anesthetic agents.
- as a supplement to other anesthetic agents.
Important Dosage and Administration Information
KETALAR should be administered by or under the direction of physicians experienced in the administration of general anesthetics, maintenance of a patent airway, and oxygenation and ventilation. Continuously monitor vital signs in patients receiving KETALAR.
Emergency airway equipment must be immediately available.
Do not administer the 100 mg/mL concentration of KETALAR intravenously without proper dilution [see Dosage and Administration (2.3)]. Must be used immediately after dilution.
While some degree of airway protection may be afforded due to active laryngealpharyngeal reflexes, vomiting and aspiration may occur with KETALAR. KETALAR is not recommended for use in patients who have not followed nil per os guidelines.
Due to the potential for salivation during KETALAR administration, administer an antisialagogue prior to induction of anesthesia.
In individuals with a history of chronic ketamine use for off-label indications, there have been case reports of genitourinary pain that may be related to the ketamine treatment, not the underlying condition [see Adverse Reactions (6)]. Consider cessation of ketamine if genitourinary pain continues in the setting of other genitourinary symptoms.
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