GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Halothane Solution B.P. 250ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Halothane Solution B.P. 250ml
2-Bromo-2-Chloro-1,1,1
Trifluoroethane contains 0.01%w/w of Thymol.

THERAPEUTIC INDICATIONS:

Halothane is a medication previously used for induction and maintenance of general anesthesia. After its large impact on medicine and anesthesia specifically, it has since fallen out of practice due to its side effect profile.

DIRECTION OF USE:

See package insert for usual dosage.

CAUTION & WARNING:

CAUTION: Do not use the solution if it contains any foreign particulate matter.
NOT FOR INJECTION.
Keep well closed.
A change on color may occur after opening. This does not change the efficacy of the drug.
NON-FLAMMABLE
NON-EXPLOSIVE
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at the room temperature (not more than 25°C). Protect from light. Do not freeze.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.

Halothane Solution B.P. 250ml Technical Specification:

Product Name:Halothane Solution B.P.
Brand Name:Generic
Strength:250ml
Dosage Form:Liquid For Inhalation
Packing:250ml bottle
Route of Administration:For Inhalation or Oral Administration
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anesthetic
Indication: Halothane is a medication previously used for induction and maintenance of general Anesthesia.
Storage:Store at a temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

GENERIC NAME OF THE MEDICINAL PRODUCT:

  1. Halothane Solution B.P. 250ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  1. Halothane Solution B.P. 250ml
    2-Bromo-2-Chloro-1,1,1
    Trifluoroethane contains 0.01%w/w of Thymol.

THERAPEUTIC INDICATIONS:

  • Halothane is a medication previously used for induction and maintenance of general anesthesia. After its large impact on medicine and anesthesia specifically, it has since fallen out of practice due to its side effect profile.

DIRECTION OF USE:

See package insert for usual dosage.

CAUTION & Warning:

CAUTION: Do not use the solution if it contains any foreign particulate matter.

NOT FOR INJECTION.

Keep well closed.

A change on color may occur after opening. This does not change the efficacy of the drug.

NON-FLAMMABLE

NON-EXPLOSIVE

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

STORAGE & DOSAGE:

Storage: Store at the room temperature (not more than 25°C). Protect from light. Do not freeze.

Keep all medicines out of reach of children.

Dosage: As directed by the Physician.

Why Taj Pharmaceuticals?

Celebrated for our unwavering dedication to healthcare innovation, Taj Pharma continues to be a cornerstone in the pharmaceutical industry. Our Halothane Solution B.P. exemplifies our commitment to delivering top-tier anesthesia medications, adhering to stringent quality control processes, and prioritizing patient well-being. With a legacy of excellence spanning years, Taj Pharma stands as a name synonymous with trust, affordability, and a relentless pursuit of excellence in pharmaceuticals. Join the countless healthcare professionals and patients who rely on Taj Pharma for their critical healthcare needs, and experience the difference in quality and care that sets us apart.

At Taj Pharma, our legacy is built on a foundation of cutting-edge research and development, ensuring that our Halothane Solution B.P. is at the forefront of safety and efficacy in anesthesia. We understand that every patient deserves the best care, and that’s why our team of experts is dedicated to upholding the highest pharmaceutical standards. Furthermore, our commitment extends beyond quality to affordability. We believe that access to essential medications should not be a barrier to healthcare. Taj Pharma strives to make Halothane Solution B.P. and other vital pharmaceuticals accessible to individuals and healthcare institutions worldwide.

What is Halothane Solution and its use?

Halothane Solution is a pharmaceutical preparation that contains the inhalation anesthetic halothane as its active ingredient. Halothane is a volatile liquid that is used as a general anesthetic to induce and maintain unconsciousness during surgical procedures. It is administered to patients via inhalation and is typically used in a controlled and precise manner to ensure the patient’s safety and comfort during surgery or other medical procedures.

Use of Halothane Solution is as follows:

  • General Anesthesia: Halothane is primarily used to induce and maintain general anesthesia in patients undergoing various surgical procedures. It works by depressing the central nervous system, leading to loss of consciousness and pain sensation. This allows surgical interventions to be performed without causing discomfort or pain to the patient.
  • Maintenance of Anesthesia: Halothane is also used to maintain the state of anesthesia once the patient is initially induced into unconsciousness. Anesthesia providers can adjust the concentration of halothane in the patient’s breathing mixture to ensure the desired depth of anesthesia throughout the procedure.

It’s important to note that the use of halothane has declined over the years due to the development of newer and safer anesthetic agents with fewer side effects. The use of halothane carries some risks, including the potential for hepatotoxicity (liver damage), cardiac sensitization, and the need for specialized equipment to administer it safely.

Healthcare providers and anesthesia professionals make decisions regarding the choice of anesthetic agent based on the patient’s medical history, the type of surgery or procedure being performed, and other individual factors. Therefore, the use of Halothane Solution or any other anesthetic should be determined by healthcare professionals who have expertise in anesthesia management and can assess the patient’s specific needs and circumstances.

How does the Halothane Solution work?

Halothane Solution, which contains the inhalation anesthetic halothane as its active ingredient, works by depressing the central nervous system to induce and maintain a state of general anesthesia. Here’s how halothane works:

  • Inhalation Administration: Halothane is administered to the patient through inhalation. It is typically vaporized and mixed with oxygen or air before being delivered to the patient via a specialized vaporizer and breathing circuit.
  • Effect on the Central Nervous System: When a patient inhales halothane, the vaporized halothane molecules enter the lungs and are absorbed into the bloodstream. From there, they are carried to the brain and other tissues.
  • Depression of Neuronal Activity: Halothane acts as a central nervous system depressant. It affects the activity of neurons in the brain and spinal cord. Specifically, it enhances the activity of inhibitory neurotransmitters (such as gamma-aminobutyric acid or GABA) and inhibits the activity of excitatory neurotransmitters (such as glutamate).
  • Loss of Consciousness: Halothane’s primary effect is to induce loss of consciousness. It does this by reducing the excitability of neurons, leading to a decreased response to sensory stimuli. As a result, the patient becomes unconscious and unaware of their surroundings.
  • Analgesia (Pain Relief): In addition to inducing unconsciousness, halothane also provides analgesia, which means it reduces pain perception. This is important during surgery or medical procedures to ensure that the patient does not experience pain.
  • Muscle Relaxation: Halothane also has muscle-relaxant properties, which can be advantageous during surgery, as it helps to prevent involuntary muscle movements that could interfere with the procedure.
  • Maintenance of Anesthesia: Anesthesia providers can control the depth of anesthesia by adjusting the concentration of halothane in the patient’s breathing mixture. This allows them to maintain the desired level of unconsciousness throughout the surgery or procedure.

Benefits of Halothane Solution:

  • Rapid Induction: Halothane can induce anesthesia quickly, making it suitable for rapid sequence inductions in emergency situations.
  • Good Muscle Relaxation: Halothane provides good muscle relaxation, making it useful for various surgical procedures that require muscle relaxation.
  • Smooth Anesthesia Maintenance: It offers smooth and predictable anesthesia maintenance, allowing for precise control over the depth of anesthesia during surgery.
  • Low Metabolism: Halothane has low metabolism in the body, which means it can be used for longer surgical procedures without accumulating in the body.

Side Effects and Safety Concerns of Halothane Solution:

  • Hepatotoxicity: One of the most serious side effects of halothane is its potential to cause liver damage, which can be life-threatening. This is why it’s used less frequently today.
  • Arrhythmias: Halothane can cause cardiac arrhythmias (irregular heart rhythms) and may not be suitable for patients with heart conditions.
  • Sensitization: Some patients may develop sensitization to halothane, leading to allergic reactions, such as fever and hepatitis.
  • Respiratory Depression: Halothane can suppress respiratory drive, which may require mechanical ventilation during surgery.
  • Malignant Hyperthermia: Although rare, halothane has been associated with malignant hyperthermia, a life-threatening condition characterized by severe muscle rigidity, high fever, and metabolic instability.
  • Halothane Hepatitis: Halothane hepatitis is a rare but serious complication that can occur, leading to liver damage and failure.
  • Central Nervous System Effects: Halothane may cause central nervous system effects, such as excitement, delirium, or seizures, especially during induction.
  • Irritating to Airways: Halothane can be irritating to the airways, potentially causing coughing or breath-holding.
  • Slow Elimination: Halothane has a slow elimination from the body, which can prolong recovery and increase the risk of postoperative complications.

Due to these side effects and safety concerns, other inhalation anesthetics like isoflurane and sevoflurane have largely replaced halothane in clinical practice. Anesthesia providers typically consider the patient’s medical history, the type of surgery, and other factors when selecting an appropriate anesthetic agent to minimize risks and ensure patient safety. Always consult with a qualified healthcare professional for personalized advice and recommendations regarding anesthesia.

Frequently Asked Questions about Halothane Solution:

Here are some frequently asked questions (FAQs) about Halothane Solution, along with their answers:

  • What is Halothane Solution?

Halothane Solution is a volatile inhalation anesthetic that was historically used for general anesthesia during surgical procedures. It is administered through inhalation to induce and maintain anesthesia.

  • Is Halothane still used today?

Halothane is rarely used in modern anesthesia practice due to concerns about its side effects and safety profile. It has been largely replaced by newer and safer inhalation anesthetics such as isoflurane and sevoflurane.

  • What are the side effects of Halothane?

Halothane can have various side effects, including hepatotoxicity (liver damage), cardiac arrhythmias, sensitization (allergic reactions), respiratory depression, malignant hyperthermia, and central nervous system effects.

  • What is hepatotoxicity, and why is it a concern with Halothane?

Hepatotoxicity refers to liver toxicity or damage. Halothane is associated with a risk of causing liver damage, which can be severe and life-threatening in some cases. This is one of the primary reasons for its reduced use.

  • What is malignant hyperthermia, and how does it relate to Halothane?

Malignant hyperthermia is a rare but serious condition characterized by severe muscle rigidity, high fever, and metabolic instability. Halothane has been associated with triggering malignant hyperthermia in susceptible individuals.

  • Are there any alternatives to Halothane for anesthesia?

Yes, there are several alternative inhalation anesthetics, including isoflurane, sevoflurane, and desflurane, which are considered safer and are more commonly used in modern anesthesia practice.

  • Can anyone receive Halothane anesthesia?

Halothane may not be suitable for all patients, especially those with preexisting medical conditions like liver disease or heart problems. Anesthesia providers carefully assess each patient’s medical history and condition to determine the most appropriate anesthetic agent.

  • What should I discuss with my anesthesiologist regarding Halothane?

If you have concerns or questions about anesthesia, including the use of Halothane, it’s essential to discuss them with your anesthesiologist before your surgery. They can provide information specific to your case and address any concerns you may have.

  • Is Halothane available over the counter?

No, Halothane is a prescription medication and should only be administered by trained healthcare professionals in a controlled medical setting.

  • What is the current status of Halothane in medical practice?

While Halothane is still technically available, its use has declined significantly in favor of safer and more modern inhalation anesthetics. It is primarily reserved for very specific situations when other options are not suitable.

As Halothane Solution B.P. Exporters; We can cater to export business queries from the following geographies. We are exporting our Halothane Solution B.P. 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

Halothane Solution B.P. 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 Halothane Solution BP, 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