GENERIC NAME OF MEDICINAL PRODUCT:

A. Propofol Injectable Emulsion USP 100mg/10ml
B. Propofol Injectable Emulsion USP 200mg/20ml
C. Propofol Injectable Emulsion USP 500mg/50ml
D. Propofol Injectable Emulsion USP 1g/100ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Propofol Injectable Emulsion USP 100mg/10ml
Each ml contains:
Propofol USP……………………………10mg
Soyabean Oil USP …………………….100mg
Glycerol USP ……………………….…..22.5mg
Egg Lecithin……………………………….12mg
Benzyl Alcohol USP ……………………1mg
Water for Injections USP………...…..q.s

B) Propofol Injectable Emulsion USP 200mg/20ml
Each ml contains:
Propofol USP……………………………10mg
Soyabean Oil USP …………………….100mg
Glycerol USP ……………………….…..22.5mg
Egg Lecithin……………………………….12mg
Benzyl Alcohol USP ……………………1mg
Water for Injections USP………...…..q.s


C) Propofol Injectable Emulsion USP 500mg/50ml
Each ml contains:
Propofol USP……………………………10mg
Soyabean Oil USP …………………….100mg
Glycerol USP ……………………….…..22.5mg
Egg Lecithin……………………………….12mg
Benzyl Alcohol USP ……………………1mg
Water for Injections USP………...…..q.s

D) Propofol Injectable Emulsion USP 1g/100ml
Each ml contains:
Propofol USP ……………………………10mg
Soyabean Oil USP………………………100mg
Glycerol USP……………………………………..22.5mg
Egg Lecithin……………………………….12mg
Benzyl Alcohol USP…………………….1mg
Water for Injections USP………...…...q.s

THERAPEUTIC INDICATION:

Propofol injectable emulsion has been used with a variety of agents commonly used in anesthesia such as atropine, scopolamine, glycopyrrolate, diazepam, depolarizing and nondepolarizing muscle relaxants, and opioid analgesics, as well as with inhalational and regional anesthetic agents.

DIRECTION OF USE:

For Intravenous use only.
Propofol injectable emulsion should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure.
Use strict aseptic technique.
For dosage, administration and direction for use, see package insert.

CAUTION & WARNING:

CAUTION:
• Not to be used if container is found leaking or there is evidence of separation of phases of the emulsion.
• Shake well before use.
• NOT TO BE USE IN NEWLY BORN OR PREMATURE INFANTS.
• CONTAINS BENZYL ALCOHOL, which inhibits microbial growth up to 12 hours, discard within 12 hours of opening.
• Diprikoda components and also in patients with allergies to eggs, egg product, soybeans or soy product.
• FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Warning: To sold by the retail on the prescription of a registered medical practitioner only.
Use strict aseptic technique.

STORAGE & DOSAGE:

Storage: Store at a temperature not exceeding between 20°C to 25°C.
Do not refrigerate.
Protect from light.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Dosage: As directed by the Physician.

Propofol Injectable Emulsion USP 200mg/20ml Technical Specification:

Product Name:Propofol Injectable Emulsion USP 200mg/20ml
Brand Name:Diprikoda-10
Strength:100mg/10ml, 200mg/20ml, 500mg/50ml, 1g/100ml  (10mg/ml)
Dosage Form:Liquid Injection (Emulsion) (Sterile, Non-Pyrogenic and Preservative Free)
Packing:10ml, 20ml, 50ml, 100ml
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:General anaesthetics, non-barbiturate sedative
Indication: Propofol injectable emulsion has been used with a variety of agents commonly used in anaesthesia such as atropine, as well as with inhalational and regional aesthetic agents.
Storage:Store at a temperature not exceeding between 25°C to 30°C. Do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Propofol Injectable Emulsion USP 200mg/20ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Propofol Injectable Emulsion USP 200mg/20ml
    Each ml contains:
    Propofol USP……………………………10mg
    Soyabean Oil USP …………………….100mg
    Glycerol USP ……………………….…..22.5mg
    Egg Lecithin……………………………….12mg
    Benzyl Alcohol USP ……………………1mg
    Water for Injections USP………..……q.s

THERAPEUTIC INDICATION:

Propofol injectable emulsion has been used with a variety of agents commonly used in anesthesia such as atropine, scopolamine, glycopyrrolate, diazepam, depolarizing and nondepolarizing muscle relaxants, and opioid analgesics, as well as with inhalational and regional anesthetic agents.

DIRECTION OF USE:

For Intravenous use only.
Propofol injectable emulsion should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure.
Use strict aseptic technique.
For dosage, administration and direction for use, see package insert.

CAUTION & WARNING:

CAUTION:

  • Not to be used if container is found leaking or there is evidence of separation of phases of the emulsion.
  • Shake well before use.
  • NOT TO BE USE IN NEWLY BORN OR PREMATURE INFANTS.
  • CONTAINS BENZYL ALCOHOL, which inhibits microbial growth up to 12 hours, discard within 12 hours of opening.
  • Diprikoda components and also in patients with allergies to eggs, egg product, soybeans or soy product.
  • FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Warning: To sold by the retail on the prescription of a registered medical practitioner only.
Use strict aseptic technique.

STORAGE & DOSAGE:

Storage: Store at a temperature not exceeding between 25°C to 30°C.
Protect from light.
Do not freeze.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

Dosage: As directed by the Physician.

NOTE:

Do not use if there is evidence of excessive creaming or aggregation.
If large droplets are visible, or if there are other forms of phase separation indicating that the stability of the product has been compromised.
After shaking, may be visible upon prolonged standing.

Why Taj Pharmaceuticals?

Taj Pharma is the preferred choice for Propofol Injectable Emulsion USP due to its unwavering commitment to quality, extensive pharmaceutical experience, and strong emphasis on safety. With a global reach and a patient-centric approach, Taj Pharma ensures the reliable supply of this essential medication while complying with rigorous regulatory standards. Healthcare professionals and patients alike can trust in Taj Pharma’s expertise and dedication to improving patient outcomes, making it the go-to source for Propofol Injectable Emulsion USP. Choose Taj Pharma for Propofol Injectable Emulsion USP, and experience the peace of mind that comes with a trusted pharmaceutical partner dedicated to your health and well-being.

What is Propofol Injectable Emulsion USP and its use?

Propofol Injectable Emulsion USP is a pharmaceutical product used primarily as an intravenous (IV) anesthetic agent. It is a sterile, milky-white emulsion containing the active ingredient propofol, which is a short-acting hypnotic agent. Propofol is known for its rapid onset and offset of action, making it a valuable tool for inducing and maintaining general anesthesia during surgical procedures.

Here are some key uses and applications of Propofol Injectable Emulsion USP:

  • Induction of Anesthesia: Propofol is often administered at the start of anesthesia to induce unconsciousness quickly and smoothly, allowing the patient to transition from wakefulness to a state of anesthesia without significant discomfort.
  • Maintenance of Anesthesia: It is used to maintain a controlled and deep level of anesthesia throughout surgical procedures. Anesthesia providers can adjust the dosage to keep the patient appropriately sedated and pain-free.
  • Sedation in Critical Care: Propofol can also be used in critical care settings, such as intensive care units (ICUs), to provide sedation for patients requiring mechanical ventilation or undergoing certain medical procedures.
  • Diagnostic and Therapeutic Procedures: Propofol may be utilized for sedation during various diagnostic and therapeutic procedures, such as endoscopies or minor surgeries, where patient comfort and cooperation are essential.
  • Emergency Anesthesia: In emergency situations, Propofol’s rapid action makes it a valuable choice for the induction of anesthesia when immediate surgical intervention is necessary.

Propofol Injectable Emulsion USP should be performed by trained healthcare professionals in a controlled medical environment due to its potential to cause respiratory depression and other side effects. The dosage and usage should be carefully monitored to ensure patient safety during anesthesia and sedation.

How does Propofol Injectable Emulsion USP Work?

Propofol Injectable Emulsion USP, commonly known as propofol, works by acting as a central nervous system depressant, specifically targeting the brain and spinal cord. Its primary mechanism of action is to enhance the inhibitory effects of a neurotransmitter called gamma-aminobutyric acid (GABA) in the brain.

Here’s how propofol works:

  • Enhancement of GABA: Propofol enhances the activity of GABA, which is an inhibitory neurotransmitter in the brain. GABA functions to reduce the excitability of neurons and dampen the transmission of nerve signals. When propofol interacts with GABA receptors, it increases the inhibitory effects of GABA, leading to a calming and sedative effect on the central nervous system.
  • Suppression of Neural Activity: By enhancing GABA’s inhibitory action, propofol effectively suppresses the activity of neurons in the brain. This results in a reduction in consciousness, perception of pain, and memory formation, which are essential components of general anesthesia.
  • Rapid Onset and Offset: One of the key characteristics of propofol is its rapid onset and offset of action. This makes it an ideal choice for inducing and maintaining anesthesia during surgical procedures. Patients can quickly transition into an unconscious state when propofol is administered and can awaken rapidly once the infusion is stopped.
  • Dose-Dependent Effects: The effects of propofol are dose-dependent, meaning that the depth of sedation or anesthesia can be controlled by adjusting the dosage. Lower doses may induce mild sedation, while higher doses will lead to deeper anesthesia.
  • Minimal Accumulation: Propofol has minimal accumulation in the body, which contributes to its short duration of action and rapid recovery profile. This property is particularly advantageous in ensuring that patients can wake up quickly and regain consciousness after surgery.

Benefits and Side effects of Propofol Injectable Emulsion USP:

Propofol Injectable Emulsion USP is a medication commonly used for anesthesia induction and maintenance during surgical procedures and for sedation in critical care settings. It is administered intravenously by healthcare professionals. While it is generally safe and effective when used properly, like any medication, it can have both benefits and potential side effects. It’s crucial to use propofol under the supervision of a trained medical provider. Here are some benefits and side effects:

Benefits:

  • Rapid Onset and Offset: Propofol acts quickly, inducing anesthesia or sedation within seconds. This makes it ideal for procedures where rapid changes in consciousness are necessary.
  • Smooth Recovery: Patients often wake up from anesthesia with minimal residual effects, such as grogginess or nausea, due to its short duration of action.
  • Reduced Postoperative Nausea and Vomiting (PONV): Propofol is associated with a lower incidence of PONV compared to some other anesthetic agents.
  • Amnesia: It can induce amnesia, which means patients often don’t remember the events surrounding a procedure performed under propofol.
  • Controlled Sedation: In critical care settings, propofol can be used for sedation of mechanically ventilated patients, allowing for better control of their comfort and anxiety levels.

Side Effects:

  • Hypotension: Propofol can cause a drop in blood pressure, which may be problematic for individuals with cardiovascular issues or those who are already hypotensive.
  • Respiratory Depression: It can lead to respiratory depression, especially when used at high doses or in combination with other sedatives or opioids. This can be dangerous, especially if not carefully monitored.
  • Pain on Injection: Propofol is known for causing pain and burning at the injection site. This can be minimized by administering it slowly, mixing it with lidocaine, or pre-treating with opioids or other pain-relieving medications.
  • Allergic Reactions: While rare, some individuals may experience allergic reactions to propofol, which can range from mild skin reactions to severe anaphylaxis.
  • Propofol-Related Infusion Syndrome (PRIS): In rare cases, prolonged high-dose infusions of propofol in critically ill patients have been associated with a condition known as PRIS, which can lead to metabolic acidosis, rhabdomyolysis, and organ failure.
  • Postoperative Nausea and Vomiting: Despite the reduced incidence compared to some other anesthetics, propofol can still cause PONV in some patients.
  • Infections: Contaminated propofol can potentially lead to infections, especially when used for prolonged periods or in immunocompromised patients. Proper aseptic techniques should be followed during administration.

It’s essential to discuss the benefits and risks of propofol with your healthcare provider before undergoing a procedure that requires its use. The choice of anesthesia or sedation should be tailored to the individual patient’s medical condition and the specific requirements of the procedure. Medical professionals should monitor patients closely during and after propofol administration to manage any potential side effects promptly.

Frequently asked questions (FAQs) about Propofol Injectable Emulsion USP:

  1. What is Propofol Injectable Emulsion USP used for?

Propofol is primarily used for anesthesia induction and maintenance during surgical procedures and for sedation in critical care settings.

  1. How is Propofol administered?

Propofol is administered intravenously by a healthcare professional.

  1. How quickly does Propofol work?

Propofol typically induces anesthesia or sedation within seconds of administration due to its rapid onset of action.

  1. What are the common side effects of Propofol?

Common side effects include hypotension (low blood pressure), respiratory depression, pain on injection, and postoperative nausea and vomiting (PONV).

  1. Is Propofol safe for everyone?

Propofol may not be suitable for individuals with certain medical conditions, allergies to its components, or those at risk of severe hypotension or respiratory problems. It should be administered under the guidance of a trained medical professional.

  1. Can Propofol cause allergic reactions?

While rare, some individuals may experience allergic reactions to Propofol, which can range from mild skin reactions to severe anaphylaxis.

  1. What is Propofol Related Infusion Syndrome (PRIS)?

PRIS is a rare but serious condition associated with prolonged high dose infusions of Propofol, leading to metabolic acidosis, rhabdomyolysis, and organ failure.

  1. How is pain on injection with Propofol managed?

Pain on injection can be minimized by administering Propofol slowly, mixing it with lidocaine, or pre-treating with pain relieving medications.

  1. Can Propofol be used for sedation in critically ill patients?

Yes, Propofol is often used for sedation in mechanically ventilated patients in intensive care units (ICUs) to provide controlled sedation and manage anxiety.

  1. Is Propofol associated with amnesia?

Yes, Propofol can induce amnesia, which means patients often don’t remember the events surrounding a procedure performed under Propofol.

  1. Are there any drug interactions to be aware of with Propofol?

Propofol can interact with other medications, particularly other sedatives and opioids, potentially leading to increased sedation and respiratory depression. Healthcare providers should be aware of all medications a patient is taking.

  1. Is Propofol safe during pregnancy and breastfeeding?

The safety of Propofol during pregnancy and breastfeeding is not well established, and its use in these situations should be carefully considered by healthcare providers.

  1. How is Propofol stored and handled?

Propofol should be stored as directed by the manufacturer, typically at controlled room temperature and protected from light. It should be handled aseptically to prevent contamination.

  1. Can I drive or operate heavy machinery after receiving Propofol?

No, you should not engage in activities that require alertness and coordination immediately after receiving Propofol, as it can impair cognitive and motor functions.

As Propofol Injectable Emulsion USP Exporters; We can cater to export business queries from the following geographies. We are exporting our Propofol Injectable Emulsion 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

Propofol Injectable Emulsion 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 Propofol Injectable Emulsion 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
Fax No: +91 22 2634 1274