GENERIC NAME OF THE MEDICINAL PRODUCT:

Atropine Sulphate & Pralidoxime Injection (2mg/600mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Atropine Sulphate & Pralidoxime Injection (2mg/600mg)
Each pre-filled syringe contains:
Atropine Sulphate USP………………2mg
Pralidoxime chloride……………….600mg
Water for Injection BP……………q.s.

THERAPEUTIC INDICATIONS:

Atropine Sulphate & Pralidoxime Injection is indicated for the treatment of poisoning by organophosphorus nerve agents as well as organophosphorus insecticides in adults and pediatric patients weighing more than 41 kg.
Atropine Injection belongs to a class of drugs known as ‘anticholinergics’, primarily use to treat bradycardia (slow heart rate). It also helps to restore a normal heartbeat in cardiac arrest cases.
In addition to this, it is also used to treat myopia (leads to blurry vision) and uveitis (inflammation of the eye).

DIRECTION OF USE:

Subcutaneous route, intravenous route during hemodialysis. Do not inject intramuscularly.
*Do not remove Gray Safety Release until ready to use.
Do not use later than the date of expiry.

CAUTION & WARNING:

CAUTION: The injection should be discard if any visible particle appears.
*Never touch the Tip (Needle End)
For use in Nerve agent & Insecticide poising.
Atropine reduces secretion in the mouth & respiratory passage, relieves airway construction, and may reduce centrally-mediated respiratory paralysis.
WARNING: Not to be sold by retail without the prescription of a registered Medical Practitioner.
Keep medicines out of reach of children.

STORAGE & DOSAGE:

STORAGE: Store at or below 25°C. Do not freeze prefilled syringe.
DOSAGE: As directed by Physician.
For further information see enclosed package insert.

Atropine Sulphate & Pralidoxime Injection (2mg/600mg) Technical Specification:

Product Name:Atropine Sulphate & Pralidoxime Injection
Brand Name:Generics
Strength:2mg/600mg
Dosage Form:Liquid Injection (Sterile)
Packing:1 Pre-filled Syringe (Advanced)
Route of Administration:Subcutaneous route, intravenous route during hemodialysis.
Do not inject intramuscularly.
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Cholinergic, Toxicity Antidotes
Indication: Atropine Sulphate & Pralidoxime Injection is indicated for the treatment of poisoning by organophosphorus nerve agents as well as organophosphorus insecticides in adults and pediatric patients weighing more than 41 kg.
Storage:Store at or below 25°C. Do not freeze prefilled syringe.

GENERIC NAME OF MEDICINAL PRODUCT

  • Atropine Sulphate & Pralidoxime Injection (2mg/600mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Atropine Sulphate & Pralidoxime Injection (2mg/600mg)
    Each pre-filled syringe contains:
    Atropine Sulphate USP………………2mg
    Pralidoxime chloride……………….600mg
    Water for Injection BP……………q.s.

THERAPEUTIC INDICATION:

Atropine Sulphate & Pralidoxime Injection is indicated for the treatment of poisoning by organophosphorus nerve agents as well as organophosphorus insecticides in adults and pediatric patients weighing more than 41 kg.
Atropine Injection belongs to a class of drugs known as ‘anticholinergics’, primarily use to treat bradycardia (slow heart rate). It also helps to restore a normal heartbeat in cardiac arrest cases.
In addition to this, it is also used to treat myopia (leads to blurry vision) and uveitis (inflammation of the eye).

DIRECTION OF USE:

Subcutaneous route, intravenous route during hemodialysis. Do not inject intramuscularly.
*Do not remove Gray Safety Release until ready to use.
Do not use later than the date of expiry.

CAUTION AND WARNING:

CAUTION: The injection should be discard if any visible particle appears.
*Never touch the Tip (Needle End)
For use in Nerve agent & Insecticide poising.
Atropine reduces secretion in the mouth & respiratory passage, relieves airway construction, and may reduce centrally-mediated respiratory paralysis.
WARNING: Not to be sold by retail without the prescription of a registered Medical Practitioner.
Keep medicines out of reach of children.

STORAGE AND DOSAGE:

STORAGE: Store at or below 25°C. Do not freeze prefilled syringe.
DOSAGE: As directed by Physician.
For further information see enclosed package insert.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals is the leading choice for Atropine Sulphate & Pralidoxime Injection, a critical antidote essential in countering the effects of organophosphate poisoning. With a rich legacy of pharmaceutical expertise, Taj Pharmaceuticals is synonymous with trust and reliability, ensuring that healthcare professionals and emergency responders have access to this life-saving medication. Our unwavering commitment to pharmaceutical excellence is reflected in our stringent quality control measures, ensuring the highest standards of purity and efficacy in every vial of Atropine Sulphate & Pralidoxime Injection. Whether it’s in military operations, agricultural safety, or industrial accidents, Taj Pharmaceuticals is the trusted partner of choice for those tasked with safeguarding lives. In situations where every second counts, Taj Pharmaceuticals stands as a beacon of dependability, offering healthcare providers and first responders the assurance of quality and efficacy in the face of emergencies. Choose Taj Pharmaceuticals for Atropine Sulphate & Pralidoxime Injection and experience pharmaceutical excellence dedicated to your well-being and safety.

What is Atropine Sulphate & Pralidoxime Injection and its uses?

Atropine Sulphate & Pralidoxime Injection is a medication used in the treatment of organophosphate poisoning, which can occur due to exposure to pesticides, nerve agents, or certain chemical substances. This combination injection consists of two active ingredients:

  • Atropine Sulphate: Atropine is an anticholinergic medication that works by blocking the action of the neurotransmitter acetylcholine at specific receptor sites in the body. In the context of organophosphate poisoning, it is used to counteract the excessive stimulation of acetylcholine receptors caused by the poison. This helps to alleviate symptoms such as excessive salivation, sweating, muscle tremors, and slowed heart rate, which are characteristic of organophosphate poisoning.
  • Pralidoxime: Pralidoxime, also known as 2-PAM (2-pyridine aldoxime methyl chloride), is an antidote that reactivates and restores the function of acetylcholinesterase, an enzyme that is inhibited by organophosphate compounds. Organophosphates bind to and inhibit acetylcholinesterase, leading to an accumulation of acetylcholine in nerve synapses and neuromuscular junctions. Pralidoxime helps to reverse this inhibition, allowing acetylcholinesterase to break down excess acetylcholine, which reduces the toxic effects on muscles and nerves.

Uses: Organophosphate Poisoning: Atropine Sulphate & Pralidoxime Injection is primarily used to treat organophosphate poisoning. This type of poisoning can occur through contact with agricultural pesticides, nerve agents in chemical warfare, or accidental exposure to certain chemicals. Symptoms of organophosphate poisoning include muscle weakness, paralysis, respiratory distress, excessive salivation, and altered mental status. The injection is administered as an emergency treatment to counteract the toxic effects and restore normal neuromuscular function. It’s important to note that Atropine Sulphate & Pralidoxime Injection should only be administered by trained healthcare professionals in a controlled medical setting, as it is a critical antidote for a life-threatening condition. The dosage and administration are carefully determined based on the severity of poisoning and the patient’s clinical condition.

How does Atropine Sulphate & Pralidoxime Injection Work?

Atropine Sulphate & Pralidoxime Injection works by counteracting the toxic effects of organophosphate compounds, which inhibit the normal functioning of the nervous system. Here’s how each component of the injection works:

  • Atropine Sulphate: Atropine is an anticholinergic medication. It functions by blocking the action of the neurotransmitter acetylcholine at specific receptor sites in the body. In normal circumstances, acetylcholine acts as a neurotransmitter that transmits nerve signals and regulates various bodily functions, including muscle contraction, heart rate, and secretions in the respiratory and digestive tracts.
  • Mechanism of Atropine in Organophosphate Poisoning:
    Organophosphate compounds inhibit the activity of the enzyme acetylcholinesterase. Acetylcholinesterase is responsible for breaking down acetylcholine, preventing its prolonged stimulation of nerve cells and muscles. When acetylcholinesterase is inhibited by organophosphates, acetylcholine accumulates at nerve synapses and neuromuscular junctions, leading to excessive stimulation.
    Atropine counters this excessive stimulation by blocking acetylcholine receptors, effectively reducing the effects of acetylcholine on various tissues. It helps alleviate symptoms such as excessive salivation, sweating, muscle tremors, and a slowed heart rate, all of which are characteristic of organophosphate poisoning.
  • Pralidoxime: Pralidoxime, often referred to as 2PAM (2pyridine aldoxime methyl chloride), is an antidote used in conjunction with atropine. Pralidoxime functions differently from atropine and is specifically designed to reverse the inhibition of acetylcholinesterase by organophosphates.
  • Mechanism of Pralidoxime in Organophosphate Poisoning:
    Organophosphates bind to and inhibit acetylcholinesterase. This inhibition prevents acetylcholine from being broken down, leading to excessive accumulation at nerve synapses and neuromuscular junctions.
    Pralidoxime acts by binding to the organophosphate compound itself, freeing up the acetylcholinesterase enzyme. This reactivation of acetylcholinesterase allows it to resume its normal function, breaking down acetylcholine and reducing the overstimulation of nerve cells and muscles. This helps to restore neuromuscular function and alleviate symptoms of organophosphate poisoning.

In summary, Atropine Sulphate & Pralidoxime Injection combines the anticholinergic effects of atropine with the reactivating properties of pralidoxime to counteract the toxic effects of organophosphate poisoning. The two components work together to block excessive stimulation by acetylcholine and restore normal nerve and muscle function. This treatment is administered as an emergency measure in cases of organophosphate poisoning, and its effectiveness depends on the promptness of administration and the severity of the poisoning.

Benefits of Atropine Sulphate & Pralidoxime Injection:

  • Life-Saving Treatment: The primary benefit of Atropine Sulphate & Pralidoxime Injection is its potential to save lives in cases of organophosphate poisoning. It is considered an essential antidote, especially in situations where exposure to pesticides, nerve agents, or other organophosphate compounds can lead to severe and life-threatening toxicity.
  • Rapid Symptom Relief: The injection provides rapid relief from symptoms associated with organophosphate poisoning. Symptoms such as excessive salivation, muscle twitching, respiratory distress, and altered mental status can be quickly alleviated, improving the patient’s overall condition.
  • Reactivation of Acetylcholinesterase: Pralidoxime component of the injection helps reactivate acetylcholinesterase, the enzyme that is inhibited by organophosphates. This reactivation allows the enzyme to break down excess acetylcholine, which is essential for restoring normal neuromuscular function.
  • Comprehensive Approach: The combination of atropine and pralidoxime provides a comprehensive approach to managing organophosphate poisoning. Atropine addresses the immediate symptoms by blocking the action of acetylcholine, while pralidoxime works to reverse the enzyme inhibition caused by organophosphates.

Side Effects of Atropine Sulphate & Pralidoxime Injection:

  • Dry Mouth: Atropine can cause dry mouth (xerostomia) due to its anticholinergic effects. This is a common side effect but is typically temporary.
  • Blurred Vision: Blurred vision can occur as a side effect of atropine, affecting near vision and causing difficulty with tasks such as reading.
  • Increased Heart Rate: Atropine can lead to an increased heart rate (tachycardia), which is often a desired effect in cases of organophosphate poisoning to counteract bradycardia caused by excessive stimulation of the vagus nerve.
  • Headache: Some individuals may experience headaches as a side effect of atropine.
  • Nervousness or Restlessness: Atropine can cause feelings of nervousness or restlessness in some individuals.
  • Injection Site Reactions: Injection site reactions, such as pain or redness at the injection site, can occur.

It’s important to note that the benefits of Atropine Sulphate & Pralidoxime Injection in treating organophosphate poisoning far outweigh the potential side effects. This antidote is administered in emergency situations where the risks of untreated poisoning are life-threatening. Healthcare professionals carefully assess the patient’s condition and administer the appropriate dosage to achieve the desired therapeutic effects while monitoring for side effects.

Frequently Asked Questions About Atropine Sulphate & Pralidoxime Injection:

Certainly, here are some frequently asked questions (FAQs) about Atropine Sulphate & Pralidoxime Injection:

  1. What is Atropine Sulphate & Pralidoxime Injection used for?

Atropine Sulphate & Pralidoxime Injection is primarily used as an antidote in the treatment of organophosphate poisoning. It is administered to counteract the toxic effects of exposure to pesticides, nerve agents, or other chemicals that inhibit acetylcholinesterase.

  1. How does Atropine Sulphate & Pralidoxime Injection work in organophosphate poisoning?

Atropine blocks the action of acetylcholine, alleviating symptoms such as excessive salivation and muscle twitching. Pralidoxime reactivates acetylcholinesterase, allowing it to break down excess acetylcholine, which helps restore normal neuromuscular function.

  1. Is Atropine Sulphate & Pralidoxime Injection safe for use in all types of organophosphate poisoning?

It is generally effective in treating organophosphate poisoning but should be administered under the guidance of healthcare professionals. The specific treatment approach may vary based on the type of organophosphate compound involved.

  1. Are there any contraindications for using Atropine Sulphate & Pralidoxime Injection?

It should be used with caution in individuals with certain medical conditions, such as glaucoma or heart rhythm disorders. A healthcare provider will assess the risks and benefits before administration.

  1. Can Atropine Sulphate & Pralidoxime Injection be administered outside of a medical setting?

This injection should only be administered by trained healthcare professionals in a controlled medical environment due to its critical nature and potential side effects.

  1. What are the common side effects of Atropine Sulphate & Pralidoxime Injection?

Common side effects may include dry mouth, blurred vision, increased heart rate, headache, and injection site reactions. These effects are generally temporary.

  1. Is Atropine Sulphate & Pralidoxime Injection safe during pregnancy and breastfeeding?

The use of this injection during pregnancy or breastfeeding should be carefully considered by a healthcare provider, weighing the potential benefits against any risks.

  1. How quickly should Atropine Sulphate & Pralidoxime Injection be administered in cases of organophosphate poisoning?

Timely administration is crucial. Healthcare professionals aim to administer the antidote as soon as possible after exposure to minimize the toxic effects.

  1. Can this injection be used in pediatric patients?

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

  1. Are there any long term effects or considerations after receiving Atropine Sulphate & Pralidoxime Injection?

After receiving this injection, individuals may require ongoing medical monitoring and supportive care to manage any residual effects of organophosphate poisoning.

It’s essential to follow the guidance and recommendations of healthcare professionals when administering Atropine Sulphate & Pralidoxime Injection, as it is a critical antidote for a life-threatening condition. Any questions or concerns should be discussed with healthcare providers for appropriate guidance and treatment.

As Atropine Sulphate & Pralidoxime Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Atropine Sulphate & Pralidoxime Injection 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

Atropine Sulphate & Pralidoxime Injection 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 Atropine Sulphate & Pralidoxime Injection, 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