Etomidate Injection USP 20mg/10ml Technical Specification:

Product Name:Etomidate Injection USP
Brand Name:Generic
Strength:20mg/10ml,  40mg/20ml
Dosage Form:Liquid Injection (Sterile and Nonpyrogenic)
Packing:2mg/ml- 10ml Single Dose Vial/Ampoule
2mg/ml- 20ml Single Dose Vial/Ampoule
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Sedative-hypnotics(Non-barbiturate) , Induction Agent
Indication: Etomidate is indicated for sedation, during maintenance of anaesthesia, and for short operative procedures such as reducing dislocated joints, tracheal intubation, cardioversion, dilation and curettage, or cervical conization.
Storage:Store at 20°C to 25°C (68° to 77°F). Protect from light. Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Etomidate Injection USP 20mg/10ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Etomidate Injection USP 20mg/10ml
    Each ml contains:
    Etomidate USP……….2mg
    Propylene glycol…….35%W/V
    Water for Injections USP……..q.s

THERAPEUTIC INDICATIONS:

Etomidate is indicated for sedation, during maintenance of anaesthesia, and for short operative procedures such as reducing dislocated joints, tracheal intubation, cardioversion, dilation and curettage, or cervical conization.

DIRECTION OF USE:

For Intravenous use only
Refer package insert for full prescribing information.

CAUTION & Warning:

CAUTION: Do not use the injection if the foreign particulate matter is visible.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
Discard unused portions.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° to 77°F).
Protect from light.
Do not freeze.
Dosage: As directed by the Physician.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals is your dependable supplier of Etomidate Injection USP, a crucial medication used in anesthesia. Our unwavering commitment to pharmaceutical excellence, stringent quality assurance, and patient-centered care sets us apart as a trusted provider of healthcare solutions. With a strong track record in pharmaceutical manufacturing and distribution, Taj Pharmaceuticals ensures that Etomidate Injection USP adheres to the highest international standards of safety and efficacy. We prioritize accessibility to essential medications, ensuring that healthcare providers have access to reliable anesthetics when needed most. At Taj Pharmaceuticals, we understand the critical role that Etomidate plays in anesthesia and patient comfort. Our commitment to patient well-being drives us to provide high-quality medications that healthcare professionals can rely on for safe and effective anesthesia administration. Choose Taj Pharmaceuticals for Etomidate Injection USP, and experience pharmaceutical expertise that prioritizes your health and the well-being of your patients. We are dedicated to contributing to improved healthcare outcomes by delivering quality medications that make a difference in medical procedures and patient care. Trust Taj Pharmaceuticals for all your pharmaceutical needs and partner with us in your journey to better health.

What is Etomidate Injection USP and its uses:

Etomidate Injection USP is a medication used primarily in anaesthesia for its sedative and hypnotic properties. It is administered intravenously and is valued for its rapid onset of action and short duration, making it suitable for various medical procedures. Here are its uses:

  • Induction of General Anaesthesia: Etomidate is often used to induce general anaesthesia at the beginning of surgical procedures. Its fast onset and smooth induction make it a preferred choice for aesthetic management.
  • Sedation for Medical Procedures: In addition to general anaesthesia, Etomidate can be used for sedation during certain medical procedures that do not require full anaesthesia. This includes procedures such as endoscopy and minor surgeries.
  • ICU Sedation: Etomidate may be used in intensive care units (ICUs) for sedating critically ill patients who require intubation and mechanical ventilation. Its rapid onset and short duration are advantageous in these situations.
  • Status Epilepticus: In emergency situations, Etomidate can be used to control prolonged seizures, known as status epilepticus, when other medications are not effective.
  • Hemodynamically Stable Patients: Etomidate is sometimes preferred for induction in patients who are hemodynamically stable or those with compromised cardiac function because it typically has minimal effects on blood pressure and heart rate.
  • Trauma Patients: It is occasionally used for rapid sequence induction in trauma patients requiring immediate intubation in the emergency department.
  • Elderly or High-risk Patients: Etomidate may be considered for elderly patients or those with significant coexisting medical conditions, as it tends to have fewer cardiovascular and respiratory effects compared to some other aesthetic agents.

It’s important to note that while Etomidate is effective for induction and sedation, it may not provide pain relief. Therefore, it is often used in conjunction with analgesic medications when needed. The choice of anesthetic agent, including Etomidate, is made by anaesthesiologists and healthcare providers based on the patient’s individual characteristics, the nature of the procedure, and the desired level of anesthesia or sedation.

How does Etomidate Injection USP Work?

Etomidate Injection USP works as a short acting intravenous anesthetic agent that produces a rapid onset of sedation and hypnosis. Its mechanism of action involves its interaction with gamma aminobutyric acid (GABA) receptors in the central nervous system. Here’s how it works:

  • GABAergic Effects: Etomidate enhances the inhibitory effects of the neurotransmitter GABA in the brain. GABA is an inhibitory neurotransmitter that reduces the activity of neurons, leading to a calming and sedative effect.
  • Activation of GABA Receptors: Etomidate binds to specific receptors on the surface of neurons known as GABA receptors. These receptors are part of the GABAergic inhibitory system in the brain.
  • Hyperpolarization of Neurons: When Etomidate binds to GABA receptors, it enhances the inhibitory actions of GABA. This results in the hyperpolarization of neurons, making them less likely to fire and transmit signals.
  • Sedation and Hypnosis: The hyperpolarization of neurons in various regions of the brain, including the cortex and thalamus, leads to sedation and hypnosis. Patients become unconscious and lose awareness of their surroundings.
  • Minimal Cardiovascular Effects: One of the advantages of Etomidate is its relatively minimal impact on the cardiovascular system. It tends to have less effect on heart rate and blood pressure compared to some other anesthetic agents.
  • Rapid Onset and Short Duration: Etomidate is valued for its rapid onset of action, typically within seconds after intravenous administration. Its effects are also relatively short-lived, which can be advantageous for procedures where a shorter duration of anesthesia is required.
  • Metabolism and Elimination: Etomidate is metabolized in the liver and eliminated from the body primarily through urine. Its short duration of action allows for a relatively quick recovery of consciousness and cognitive function.

It’s important to note that while Etomidate provides sedation and hypnosis, it does not provide pain relief. Therefore, it is often used in combination with analgesic medications when pain control is needed during medical procedures or surgeries. The dosage and administration of Etomidate are carefully monitored by anesthesia professionals to ensure safe and effective anesthesia for patients undergoing various medical interventions.

Benefits of Etomidate Injection USP:

  • Rapid Onset: Etomidate is known for its exceptionally fast onset of action, typically within seconds after intravenous administration. This makes it valuable in situations where rapid induction of anesthesia or sedation is required.
  • Short Duration: It has a relatively short duration of action, allowing for a quick and predictable recovery of consciousness. This can be advantageous in procedures where a shorter period of anesthesia or sedation is needed.
  • Minimal Cardiovascular Effects: Etomidate tends to have minimal impact on heart rate and blood pressure, making it suitable for patients with cardiovascular concerns or those who require hemodynamic stability during anesthesia.
  • Minimal Respiratory Depression: It is associated with fewer respiratory depressant effects compared to some other anesthetic agents, reducing the risk of respiratory complications.
  • Predictable Pharmacokinetics: The pharmacokinetics of Etomidate are well-characterized, allowing for precise dosing and titration based on the patient’s needs.
  • Suitable for Elderly and High-Risk Patients: Due to its cardiovascular stability and reduced risk of respiratory depression, Etomidate may be preferred for elderly patients or those with coexisting medical conditions.

Side Effects of Etomidate Injection USP:

  • Adrenal Suppression: Etomidate can suppress the adrenal glands’ production of cortisol, a hormone crucial for the body’s stress response. This effect is more pronounced with prolonged or high-dose administration.
  • Myoclonus: Some patients may experience involuntary muscle movements or myoclonus during induction with Etomidate. This can be distressing but is generally harmless.
  • Pain at Injection Site: Pain or discomfort at the site of injection is a common side effect of Etomidate. It is usually mild and transient.
  • Nausea and Vomiting: Nausea and vomiting may occur, although less frequently than with some other anesthetics.
  • Suppression of Cortisol Response: Etomidate may blunt the body’s cortisol response to stress during surgery or trauma, which can be a concern in critically ill patients.
  • Hiccups: Hiccups have been reported as a side effect of Etomidate administration.
  • Allergic Reactions: While rare, allergic reactions to Etomidate can occur and may include rash, itching, or swelling.
  • Post-Operative Nausea and Vomiting (PONV): Some patients may experience nausea and vomiting after the procedure, particularly if other medications or factors contribute to PONV.
  • Respiratory Depression: While Etomidate is associated with less respiratory depression compared to other anesthetics, it can still lead to respiratory depression, especially when used in combination with other medications.

It’s important to note that the choice of anesthetic agent, including Etomidate, is made by anesthesia professionals based on the patient’s medical history, the nature of the procedure, and the desired level of anesthesia. The potential side effects and benefits are carefully considered to provide safe and effective anesthesia care. Patients should discuss any concerns or questions with their healthcare providers before undergoing anesthesia.

Frequently Asked Questions About Etomidate Injection USP:

Certainly, here are some frequently asked questions (FAQs) about Etomidate Injection USP:

  1. What is Etomidate Injection USP used for?

Etomidate is primarily used for the induction of general anesthesia at the beginning of surgical procedures. It is also used for sedation during certain medical procedures.

  1. How is Etomidate Injection administered?

Etomidate is administered intravenously (IV) by healthcare professionals. The dosage is carefully calculated based on the patient’s weight and medical condition.

  1. How quickly does Etomidate work?

Etomidate is known for its rapid onset of action, typically inducing sedation or anesthesia within seconds of administration.

  1. How long does the sedative effect of Etomidate last?

The sedative effect of Etomidate is relatively shortlived, with a duration of action typically lasting a few minutes. Patients usually regain consciousness quickly after the IV infusion is stopped.

  1. Is Etomidate safe for all patients?

Etomidate may not be suitable for patients with certain medical conditions, such as those with severe adrenal insufficiency. Anesthesia professionals carefully assess each patient’s medical history to determine its suitability.

  1. Does Etomidate provide pain relief during surgery?

Etomidate primarily induces sedation and hypnosis but does not provide pain relief. Additional analgesic medications may be administered as needed to control pain during surgery.

  1. What are the potential side effects of Etomidate?

Common side effects of Etomidate may include pain at the injection site, nausea, vomiting, and myoclonus (involuntary muscle movements). Rare side effects can include adrenal suppression and allergic reactions.

  1. Can Etomidate be used for pediatric patients?

Yes, Etomidate can be used for pediatric patients, but the dosage is adjusted based on the child’s weight and age.

  1. Is there a risk of postoperative nausea and vomiting (PONV) with Etomidate?

PONV is possible but occurs less frequently with Etomidate compared to some other anesthetics. However, it can still occur, especially if other factors contribute to PONV.

  1. Can I drink alcohol before or after receiving Etomidate?

It is generally recommended to avoid alcohol before and after receiving Etomidate, as it can interact with the medication and affect its effectiveness.

  1. What should I discuss with my healthcare provider before receiving Etomidate?

It’s important to discuss any allergies, medical conditions, and medications you are taking with your healthcare provider. They will also provide instructions on fasting before the procedure.

  1. How long does it take to recover from the effects of Etomidate?

The effects of Etomidate wear off quickly, and patients typically regain consciousness within minutes after the IV infusion is stopped. However, full recovery may vary depending on the individual and the specific procedure.

Always consult with your healthcare provider or anesthesia team if you have any questions or concerns about Etomidate Injection USP or the anesthesia process for your upcoming procedure. They can provide personalized guidance and address any uncertainties you may have.

As Etomidate Injection USP Exporters; We can cater to export business queries from the following geographies. We are exporting our Etomidate Injection USP product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Etomidate Injection USP Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Etomidate Injection USP, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Etomidate Injection USP 20mg/10ml(2mg/ml)
B. Etomidate Injection USP 40mg/20ml(2mg/ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Etomidate Injection USP 20mg/10ml(2mg/ml)
Each ml contains:
Etomidate USP……….2mg
Propylene glycol…….35%W/V
Water for Injections USP……..q.s

2. Etomidate Injection USP 40mg/20ml(2mg/ml)
Each ml contains:
Etomidate USP………2mg
Propylene glycol……35%W/V
Water for Injections USP……..q.s

THERAPEUTIC INDICATIONS:

Etomidate is indicated for sedation, during maintenance of anesthesia, and for short operative procedures such as reducing dislocated joints, tracheal intubation, cardioversion, dilation and curettage, or cervical conization.

DIRECTION OF USE:

For Intravenous use only.
See package inserts for full information.

CAUTION & WARNING:

CAUTION: Do not use the injection if the foreign particulate matter is visible.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
Discard unused portion.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° to 77°F) [see USP controlled room temperature.]
Protect from light.
Do not freeze.
Dosage: See package inserts.