Atropine Sulphate Injection USP 1mg Technical Specification:

Product Name:Atropine Sulphate Injection USP 1mg
Brand Name:Generics
Strength:0.25mg, 0.5mg, 1mg
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 Sulfate Injection, USP, is indicated for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an anti-vagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat brady systolic cardiac arrest.
Storage:Store at or below 25°C. Do not freeze prefilled syringe.

GENERIC NAME OF MEDICINAL PRODUCT

  • Atropine Sulphate Injection USP ( 1mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Atropine Sulphate Injection USP ( 1mg)
    Each pre-filled syringe contains:
    Atropine Sulphate USP……………… 1mg
    Water for Injection BP……………q.s.

THERAPEUTIC INDICATION:

Atropine Sulfate Injection, USP, is indicated for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an anti-vagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat brady systolic cardiac arrest.

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 leads the way in providing Atropine Sulphate Injection, a vital medication with a wide range of medical applications. With our unwavering dedication to quality, safety, and innovation, we ensure that every vial of Atropine Sulphate meets the highest global standards. For decades, Taj Pharmaceuticals has been a symbol of trust in the pharmaceutical industry, delivering life-saving medications to healthcare professionals and patients worldwide. Our commitment to accessibility ensures that individuals in need have access to top-quality pharmaceuticals, including Atropine Sulphate. Our state-of-the-art manufacturing facilities adhere to the most rigorous quality control protocols, guaranteeing the purity and efficacy of every dose. Whether it’s in emergency situations, ophthalmic procedures, or cardiac care, healthcare providers trust Taj Pharmaceuticals for reliable and effective medications. Choose Taj Pharmaceuticals for Atropine Sulphate Injection and experience pharmaceutical excellence that prioritizes your health and well-being. We are here to support healthcare providers and patients, providing the quality and reliability you deserve in various medical applications.

What is Atropine Sulphate Injection and its uses?

Atropine Sulphate Injection is a medication that contains the active ingredient atropine sulfate. It is used in various medical situations and has several important applications. Here are the key uses of Atropine Sulphate Injection:

  • Cardiac Care:
    Atropine Sulphate Injection is often used in cardiac care settings. It can be administered intravenously to treat bradycardia, a condition characterized by an abnormally slow heart rate. By blocking the action of the vagus nerve, which can slow down the heart rate, atropine increases the heart rate and improves cardiac output in emergency situations.
  • Ophthalmic Procedures:
    In ophthalmology, atropine sulfate is used as a mydriatic and cycloplegic agent. When applied as eye drops or during ophthalmic examinations, it causes pupil dilation (mydriasis) and temporary paralysis of the ciliary muscles (cycloplegia). These effects help eye care professionals examine the eye’s internal structures and provide certain treatments.
  • Antispasmodic:
    Atropine Sulphate can be used as an antispasmodic agent to reduce smooth muscle spasms in the gastrointestinal (GI) tract. It can help alleviate symptoms associated with GI disorders, such as irritable bowel syndrome.
  • Poisoning and Toxicity:
    Atropine Sulphate may be used as an antidote in cases of organophosphate poisoning or cholinergic toxicity. Organophosphates are chemicals found in pesticides and nerve agents, and atropine can counteract some of their toxic effects by blocking excessive stimulation of the cholinergic system.
  • Pre-Anesthetic Medication:
    In anesthesia, atropine sulfate can be administered prior to surgery to reduce salivation and respiratory tract secretions. This helps maintain clear airways during anesthesia.
  • Parkinson’s Disease:
    Atropine Sulphate is occasionally used as an adjunctive therapy in the management of Parkinson’s disease to reduce tremors and drooling.

It’s important to note that the use of Atropine Sulphate Injection should be under the guidance and supervision of a qualified healthcare professional. The dosage and administration method may vary depending on the specific medical condition being treated and the patient’s individual needs. Atropine Sulphate is a potent medication, and its use should be carefully monitored to minimize potential side effects or adverse reactions.

How Does Atropine Sulphate Injection Work?

Atropine Sulphate Injection works by blocking the action of a neurotransmitter called acetylcholine at specific receptor sites in the body. Acetylcholine is a neurotransmitter that plays a crucial role in transmitting nerve signals in the parasympathetic nervous system, which is responsible for controlling involuntary bodily functions like heart rate, smooth muscle contraction, and glandular secretions.

Here’s how Atropine Sulphate Injection works:

  • Blockade of Muscarinic Receptors: Atropine sulfate is an anticholinergic agent that primarily acts by binding to and blocking the activity of muscarinic acetylcholine receptors. These receptors are found in various tissues throughout the body, including the heart, smooth muscles, and glands.
  • Inhibition of Parasympathetic Nervous System: By inhibiting muscarinic receptors, Atropine Sulphate effectively inhibits the parasympathetic nervous system’s activity. This system is responsible for “rest and digest” functions, such as slowing the heart rate, promoting digestion, and causing smooth muscle contractions in the digestive tract.
  • Increased Heart Rate: In cardiac care, one of the primary effects of Atropine Sulphate is to increase heart rate. This occurs because atropine blocks the action of acetylcholine on the heart’s muscarinic receptors, leading to decreased vagal (parasympathetic) stimulation. As a result, the heart rate accelerates, which can be beneficial in the treatment of bradycardia (slow heart rate).
  • Relaxation of Smooth Muscles: Atropine’s action on smooth muscle cells leads to relaxation, particularly in the gastrointestinal tract. This can help alleviate spasms and reduce GI motility.
  • Pupil Dilation and Cycloplegia: In ophthalmic use, Atropine Sulphate causes pupil dilation (mydriasis) and paralysis of the ciliary muscles (cycloplegia). These effects are achieved by blocking muscarinic receptors in the eye’s iris and ciliary body, allowing eye care professionals to examine the eye’s internal structures.
  • Reduction in Salivation and Secretions: In preanesthetic medication and certain medical procedures, Atropine Sulphate reduces salivation and respiratory tract secretions. This can help maintain clear airways during anesthesia.

It’s important to note that Atropine Sulphate Injection should be administered by trained healthcare professionals and under appropriate medical supervision. The dosage and administration are carefully determined based on the specific medical condition being treated and the patient’s individual needs.

Benefits of Atropine Sulphate Injection:

  • Cardiac Support: Atropine Sulphate is used to treat bradycardia (slow heart rate) and certain heart rhythm disturbances. By increasing the heart rate, it can help improve cardiac output in emergency situations.
  • Ophthalmic Use: It is valuable in ophthalmology for dilating the pupil (mydriasis) and causing cycloplegia (paralysis of the ciliary muscles). These effects are essential for eye examinations and some eye treatments.
  • Reduced Salivation: In pre-anesthetic medication and surgical procedures, Atropine Sulphate reduces salivation and respiratory tract secretions, helping maintain clear airways during anesthesia.
  • Gastrointestinal Relief: Atropine can be used to alleviate smooth muscle spasms in the gastrointestinal tract, making it useful in treating conditions like irritable bowel syndrome.
  • Antidote for Toxicity: It serves as an antidote in cases of organophosphate poisoning or cholinergic toxicity by counteracting the toxic effects of excessive acetylcholine.

Side Effects of Atropine Sulphate Injection:

  • Dry Mouth and Throat: Atropine commonly causes dry mouth (xerostomia) and a dry throat due to its anticholinergic effects.
  • Blurred Vision: In ophthalmic use, temporary blurred vision can occur due to pupil dilation. This effect subsides as the drug wears off.
  • Increased Heart Rate: While increasing the heart rate is a therapeutic effect, excessive use can lead to tachycardia (excessively rapid heart rate).
  • Constipation: Atropine can slow down GI motility, leading to constipation in some individuals.
  • Urinary Retention: It may cause difficulty in urination or urinary retention in some patients.
  • Sensitivity to Light: Dilated pupils can result in increased sensitivity to light (photophobia).
  • Confusion and Delirium: In high doses or sensitive individuals, atropine can lead to confusion, agitation, or delirium.
  • Increased Intraocular Pressure: In rare cases, Atropine can raise intraocular pressure, potentially affecting individuals with glaucoma.
  • Allergic Reactions: Some individuals may experience allergic reactions, such as skin rash or itching.
  • Increased Body Temperature: Atropine can interfere with the body’s ability to sweat, potentially leading to increased body temperature, especially in hot environments.

It’s important to use Atropine Sulphate Injection under the guidance and supervision of a healthcare professional. The dosage and administration should be carefully determined based on the specific medical condition being treated. The benefits of using Atropine should outweigh the potential side effects, and healthcare providers monitor patients for any adverse reactions during treatment.

Frequently Asked Questions About Atropine Sulphate Injection:

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

  • What is Atropine Sulphate Injection used for?
    Atropine Sulphate Injection is used for various purposes, including treating bradycardia (slow heart rate), dilating the pupil for eye examinations, reducing salivation during anesthesia, and alleviating smooth muscle spasms in the gastrointestinal tract.
  • How does Atropine Sulphate Injection increase the heart rate?
    Atropine Sulphate blocks the action of the vagus nerve, which normally slows down the heart rate. By inhibiting the vagus nerve’s effects, it increases the heart rate in cases of bradycardia.
  • Is Atropine Sulphate an antidote for poisoning?
    Yes, Atropine Sulphate can act as an antidote in cases of organophosphate poisoning or cholinergic toxicity. It counteracts the toxic effects of excessive acetylcholine.
  • Can Atropine Sulphate be used in children and infants?
    Atropine Sulphate can be used in pediatric patients under the guidance of healthcare professionals, but the dosage is carefully adjusted based on the child’s age and weight.
  • Are there any contraindications for using Atropine Sulphate?
    Atropine Sulphate should be used with caution or avoided in individuals with certain medical conditions, such as glaucoma, urinary retention, and hypersensitivity to the drug. It should also be used carefully in the elderly.
  • What should I do if I experience side effects like dry mouth or blurred vision after receiving Atropine Sulphate?
    Side effects like dry mouth and blurred vision are common and usually temporary. If they persist or worsen, consult your healthcare provider. In the case of severe side effects, seek immediate medical attention.
  • How is Atropine Sulphate Injection administered?
    Atropine Sulphate is typically administered as an intravenous (IV) or intramuscular (IM) injection by healthcare professionals. The specific dosage and administration method depend on the medical condition being treated.
  • Can Atropine Sulphate affect my ability to drive or operate machinery?
    Atropine Sulphate may cause drowsiness or blurred vision, which can impair your ability to drive or operate heavy machinery. It is advisable to avoid such activities until you are sure about your individual response to the medication.
  • Is Atropine Sulphate safe to use during pregnancy and breastfeeding?
    The use of Atropine Sulphate during pregnancy or breastfeeding should be discussed with a healthcare provider. The potential benefits and risks should be carefully considered.
  • Can Atropine Sulphate be used as a long-term treatment?
    Atropine Sulphate is typically used for short-term treatments or specific medical procedures. The duration of use depends on the medical condition and the healthcare provider’s recommendations.

It’s essential to communicate openly with your healthcare provider regarding any questions or concerns you may have about Atropine Sulphate Injection to ensure safe and effective use.

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

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Atropine Sulphate Injection USP (0.25mg)
B. Atropine Sulphate Injection USP (0.5mg)
C. Atropine Sulphate Injection USP (1mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Atropine Sulphate Injection USP (0.25mg)
Each pre-filled syringe contains:
Atropine Sulphate USP………………0.25mg
Water for Injection BP……………q.s.

B. Atropine Sulphate Injection USP (0.5mg)
Each pre-filled syringe contains:
Atropine Sulphate USP………………0.5mg
Water for Injection BP……………q.s.

C. Atropine Sulphate Injection USP (1mg)
Each pre-filled syringe contains:
Atropine Sulphate USP………………1mg
Water for Injection BP……………q.s.


THERAPEUTIC INDICATIONS:

Atropine Sulfate Injection, USP, is indicated for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an anti-vagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat brady systolic cardiac arrest.
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.