Ketamine
Product Name:
Ketamine Hydrochloride Injection, USP 500 mg per 10 mL (50 mg/mL)
Product Overview
Ketamine Hydrochloride Injection, USP 500 mg per 10 mL (50 mg/mL) vial is a potent and versatile anesthetic widely used in medical, veterinary, and emergency settings. Designed for parenteral administration, ketamine hydrochloride offers effective dissociative anesthesia and analgesic properties. Recognized for its unique pharmacological profile, ketamine can provide rapid sedation, pain management, and in certain cases, serve as an adjunct for mental health treatments under strict medical supervision. This product is intended strictly for professional use in hospital, surgical, and other controlled environments where qualified personnel can administer, monitor, and evaluate its effects.
Composition
Each vial contains:
- Ketamine Hydrochloride, USP: 500 mg per 10 mL (50 mg/mL)
- Sodium Chloride: for isotonicity
- Water for Injection: q.s. to 10 mL
Pharmacology and Mechanism of Action
Ketamine hydrochloride is a derivative of phencyclidine (PCP) and functions as an NMDA receptor antagonist. When administered, it blocks excitatory neurotransmitter glutamate at the NMDA receptors in the brain, inducing a dissociative state. This dissociation leads to a unique type of anesthesia in which the patient is both conscious and unaware of pain, offering a distinct advantage in specific clinical scenarios. Unlike many sedative-hypnotic agents, ketamine does not suppress respiratory function, making it safer than many traditional anesthetics in emergency situations.
Clinical Applications and Uses
1. Anesthesia for Short and Minor Procedures Ketamine hydrochloride’s primary indication is as an anesthetic agent for short surgical or diagnostic procedures. Its rapid onset and reliable duration of action make it ideal for minor operations, endoscopic examinations, and radiologic procedures, especially in outpatient settings. Ketamine can be administered alone or in combination with other anesthetics to provide effective anesthesia while maintaining hemodynamic stability.
2. Emergency and Battlefield Medicine Ketamine is frequently used in emergency medicine and battlefield settings due to its unique combination of analgesic and anesthetic properties, as well as its minimal impact on respiratory and cardiovascular function. In trauma patients, ketamine helps manage pain without the risk of respiratory depression, making it valuable in pre-hospital and transport scenarios.
3. Pain Management in Chronic and Acute Cases Besides its use as an anesthetic, ketamine is known for its potent analgesic effects, even at sub-anesthetic doses. In acute cases, such as post-operative pain management, ketamine is often administered in low doses to control pain. It has also shown promise in managing chronic pain conditions, such as complex regional pain syndrome (CRPS) and fibromyalgia, by modulating pain pathways.
4. Adjunct Treatment for Mental Health Conditions In recent years, ketamine has gained recognition for its potential in treating specific mental health conditions, particularly treatment-resistant depression (TRD) and major depressive disorder (MDD). Low-dose ketamine therapy, often administered intravenously in controlled environments, has been found to offer rapid antidepressant effects. The therapeutic effects are believed to stem from ketamine’s ability to enhance neuroplasticity, leading to quick improvements in mood and cognitive function. However, this application remains highly regulated and should be administered only by licensed professionals in appropriate settings.
Product Benefits
- Rapid Onset and Reliable Duration: Ketamine hydrochloride has a rapid onset (30 seconds to 1 minute for IV and 2-5 minutes for IM) and reliable duration of action, allowing for quick induction and emergence.
- Respiratory and Hemodynamic Stability: Unlike many other anesthetics, ketamine does not significantly depress respiratory function, making it particularly useful in emergency settings where respiratory compromise is a concern.
- Pain Management: Beyond its anesthetic uses, ketamine provides significant analgesic benefits, even in small doses, helping manage both acute and chronic pain.
- Versatile Administration: The 500 mg per 10 mL (50 mg/mL) concentration allows for flexible dosing and administration via intravenous (IV) or intramuscular (IM) routes, offering versatility in different medical settings.
Usage Instructions
Administration: Ketamine hydrochloride is suitable for both IV and IM administration. Dosage and route of administration depend on the type of procedure, patient condition, and intended use.
- Induction of Anesthesia:
- IV: Administer as a slow bolus over 60 seconds.
- IM: Inject into a large muscle, typically the deltoid or gluteus, ensuring that the full dose is delivered.
- Maintenance of Anesthesia:
- Can be maintained with repeated doses or by continuous infusion. The dose and rate should be titrated to the patient’s needs and responses.
- Pain Management (Sub-Anesthetic Doses):
- Administer lower doses either by infusion or bolus depending on the level of analgesia required. This approach is generally applied in post-operative pain and palliative care settings.
- Psychiatric Indications (under professional guidance only):
- Low-dose infusion protocols are followed under controlled environments for treating severe mental health disorders. Administration should only be conducted in accredited healthcare settings with professional oversight.
Safety and Precautions
- Professional Supervision Required: This product is intended for use by qualified medical professionals only. Due to ketamine’s dissociative effects and potential for misuse, it should not be administered without proper supervision.
- Contraindications: Contraindicated in patients with hypersensitivity to ketamine, those with a history of severe hypertension, and in individuals with specific psychotic disorders due to the risk of exacerbating symptoms.
- Potential Side Effects: Common side effects include dizziness, nausea, increased blood pressure, and emergence reactions, which may involve vivid dreams or hallucinations. These effects are typically transient and manageable with appropriate measures.
- Controlled Substance: As a Schedule III controlled substance, ketamine should be handled, stored, and disposed of following local regulatory guidelines. Access should be strictly limited to authorized personnel.
Storage and Handling
- Storage: Store at controlled room temperature (20–25°C). Protect from light and avoid freezing.
- Packaging: Each vial is sealed for single-use. Discard any unused portions following administration. Proper disposal is crucial, given the controlled nature of the drug.
Conclusion
Ketamine Hydrochloride Injection, USP 500 mg per 10 mL (50 mg/mL) offers a unique and valuable solution for a range of medical applications. Its robust safety profile, versatile application, and rapid onset make it an essential tool in anesthetic and pain management protocols across various clinical settings. With emerging research supporting its potential benefits in mental health treatment, ketamine stands out as a multifaceted medication. However, strict adherence to professional guidelines and controlled administration are essential to ensure safe and effective use.
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