GENERIC NAME OF MEDICINAL PRODUCT:

(A) Tramadol Hydrochloride Injection 50mg/ml
(B) Tramadol Hydrochloride Injection 100mg/2ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Tramadol Hydrochloride Injection 50mg/mL
Each ml contains:
Tramadol Hydrochloride IP
Equivalent to Tramadol…………………..50mg
Water for Injection IP……………………q.s


B) Tramadol Hydrochloride Injection 100mg/2mL
Each 2ml contains:
Tramadol Hydrochloride IP
Equivalent to Tramadol…………………..100mg
Water for Injection IP……………………q.s

THERAPEUTIC INDICATION:

It helps to relieve moderate to severe pain in conditions that affect joints and muscles. It works by blocking chemical messengers in the brain that tell us we have pain. It can help relieve pain in conditions like rheumatoid arthritis and osteoarthritis.

CAUTION & WARNING:

CAUTION: Do not use if solution is not clear or has suspended matter.
WARNING:
It is dangerous to take this preparation except in accordance with medical advice.
Not to be sold by retail without the prescription of Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store Protected from moisture at a temperature below 25°C.
KEEP OUT OF REACH OF CHILDREN.
Dosage: As directed by Physician.

Tramadol Hydrochloride Injection 50mg/ml Technical Specification:

Product Name:Tramadol Hydrochloride Injection
Brand Name:Tramataj
Strength:(50mg/mL) or (100mg/2mL)
Dosage Form:Liquid Injection (Sterile)
Packing:1mL, 2mL Amp.
Route of Administration:For I.M./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:Analgesic and Anti-inflammatory Products opiate (Narcotic) Analgesics
Indication: It helps to relieve moderate to severe pain in conditions that affect joints and muscles. It works by blocking chemical messengers in the brain that tell us we have pain. It can help relieve pain in conditions like rheumatoid arthritis and osteoarthritis.
Storage:Store Protected from moisture at a temperature Below 25°C.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Tramadol Hydrochloride Injection 50mg/mL

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Tramadol Hydrochloride Injection 50mg/mL
    a) Each ml contains:
    Tramadol Hydrochloride IP
    Equivalent to Tramadol…………………..50mg
    b) Water for Injection IP……………………q.s

THERAPEUTIC INDICATION:

It helps to relieve moderate to severe pain in conditions that affect joints and muscles. It works by blocking chemical messengers in the brain that tell us we have pain. It can help relieve pain in conditions like rheumatoid arthritis and osteoarthritis.

CAUTION & WARNING:

CAUTION: Do not use if the solution is not clear or has suspended matter.

WARNING: It is dangerous to take this preparation except in accordance with medical advice. Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store Protected from moisture at a temperature Below 25°C.

KEEP OUT OF REACH OF CHILDREN.

Dosage: As directed by the Physician.

Why Taj Pharmaceuticals?

Experience the excellence of Taj Pharma’s Tramadol Hydrochloride Injection, a potent and reliable option for managing moderate to severe pain. Our commitment to patient well-being is reflected in every vial we produce. Tramadol Hydrochloride is an opioid pain medication that acts on the central nervous system to alleviate pain. It’s commonly used post-surgery, for injury-related pain, or in cases where other pain relief options may not suffice. Taj Pharma’s dedication to quality assurance means that every step of the manufacturing process adheres to strict pharmaceutical standards. We prioritize safety, efficacy, and precision to provide healthcare professionals and patients with a trusted solution for pain management. Choose Taj Pharma for Tramadol Hydrochloride Injection and take a step towards effective and compassionate pain relief. Your well-being is our priority.

What is Tramadol Hydrochloride Injection and its use?

Tramadol Hydrochloride Injection is a medication that contains the active ingredient tramadol hydrochloride. Tramadol is a synthetic opioid analgesic, meaning it is a pain reliever with properties similar to opioids, although it is considered to have a lower potential for abuse and addiction compared to some other opioids. Here’s an overview of Tramadol Hydrochloride Injection and its uses:

Use:

Tramadol Hydrochloride Injection is primarily used for the management of moderate to severe pain. It provides pain relief by acting on the central nervous system to alter the way the body perceives and responds to pain signals.

Common Indications for Use:

  • Postoperative Pain: Tramadol Hydrochloride Injection is often used in the postoperative period to manage pain following surgical procedures. It can help control acute surgical pain effectively.
  • Injury Related Pain: It can be used to alleviate pain caused by various types of injuries, including trauma and accidents.
  • Chronic Pain Conditions: In some cases, it may be prescribed for the management of chronic pain conditions when other pain relief options are not sufficient.

Important Information:

  • Tramadol Hydrochloride Injection should only be administered by healthcare professionals, typically as an intravenous (IV) or intramuscular (IM) injection.
  • The dosage and frequency of administration are determined by a healthcare provider and should be followed precisely.
  • It’s essential to inform your healthcare provider about any allergies, medical conditions, or medications you are currently taking before receiving Tramadol Hydrochloride Injection.
  • Tramadol can have side effects, including dizziness, nausea, constipation, and in some cases, more serious side effects like respiratory depression (especially in high doses).
  • It is not recommended for use in individuals with a history of substance abuse or addiction.
  • Tramadol Hydrochloride Injection should not be abruptly discontinued, as it can lead to withdrawal symptoms. The dosage should be tapered under the guidance of a healthcare provider when discontinuing the medication.

As with any medication, the use of Tramadol Hydrochloride Injection should be carefully considered by a healthcare provider, and the risks and benefits should be weighed for each individual patient. It should be used for the shortest duration and at the lowest effective dose to minimize the potential for side effects and dependence.

How does Tramadol Hydrochloride Injection work?

Tramadol Hydrochloride Injection contains the active ingredient tramadol hydrochloride, which is an opioid analgesic. Tramadol works by interacting with the central nervous system to provide pain relief. Its mechanism of action involves several components:

  • Mu-Opioid Receptor Agonism: Tramadol has a high affinity for mu-opioid receptors in the brain and spinal cord. When it binds to these receptors, it activates them. This activation results in a decrease in the perception of pain and an increased pain threshold.
  • Nor-epinephrine and Serotonin Re-uptake Inhibition: Tramadol also has a secondary mechanism of action that involves inhibiting the re uptake of nor epinephrine and serotonin in the brain. By doing so, it increases the levels of these neurotransmitters in the central nervous system. This dual mechanism, involving both opioid receptor activity and the modulation of nor epinephrine and serotonin, contributes to its pain-relieving effects.

The combination of these actions allows tramadol to provide pain relief by altering the way pain signals are transmitted and processed in the brain. It can be effective in managing moderate to severe pain, making it a valuable option for various medical conditions and situations, including postoperative pain and injury-related pain.

Benefits and Side effects of Tramadol Hydrochloride Injection:

Tramadol Hydrochloride Injection offers benefits in the management of moderate to severe pain but may also come with potential side effects. It’s important to use this medication under the supervision of a healthcare provider and be aware of its advantages and possible adverse effects. Here’s an overview:

Benefits:

  • Effective Pain Relief: Tramadol Hydrochloride Injection is a potent analgesic that can provide significant pain relief, making it valuable for managing moderate to severe pain, such as postoperative pain or injury-related pain.
  • Lower Potential for Respiratory Depression: Compared to some other opioids, tramadol is considered to have a lower risk of respiratory depression (slowed or shallow breathing). This may make it a safer option for certain patients, including those with respiratory conditions.
  • Less Euphoric Effect: Tramadol has a weaker euphoric effect compared to stronger opioids like morphine or oxycodone. This reduced potential for euphoria contributes to its lower risk of abuse and addiction.
  • Flexible Administration: Tramadol Hydrochloride Injection can be administered intravenously (IV) or intramuscularly (IM), allowing for flexibility in dosing and administration methods to suit individual patient needs.

Side Effects:

While tramadol can be effective for pain relief, it may also have side effects, including:

  • Nausea and Vomiting: These are common side effects, especially when starting tramadol. Taking it with food or as directed by your healthcare provider may help reduce these symptoms.
  • Dizziness or Drowsiness: Tramadol can cause dizziness, lightheadedness, or drowsiness, which may impair your ability to perform certain tasks, such as driving or operating heavy machinery.
  • Constipation: Opioids like tramadol can lead to constipation. Adequate hydration and dietary measures can help manage this side effect.
  • Headache: Some individuals may experience headaches as a side effect of tramadol.
  • Respiratory Depression: While tramadol has a lower risk compared to stronger opioids, it can still depress breathing in some cases, particularly when taken in high doses or in combination with other substances that depress the central nervous system.
  • Dependence and Withdrawal: Tramadol can lead to physical dependence, and abrupt discontinuation can result in withdrawal symptoms. It should be tapered off under the guidance of a healthcare provider when discontinuing the medication.
  • Seizures: Tramadol may lower the seizure threshold, increasing the risk of seizures, particularly in individuals with a history of seizures or epilepsy.
  • Serotonin Syndrome: In rare cases, tramadol can cause serotonin syndrome when used with other medications that affect serotonin levels. Symptoms may include confusion, agitation, rapid heart rate, high blood pressure, and hyperthermia.

It’s crucial to use Tramadol Hydrochloride Injection as prescribed by your healthcare provider and report any concerning side effects or adverse reactions promptly. This medication should be used cautiously in individuals with a history of substance abuse, certain medical conditions, or those taking other medications that may interact with tramadol. Your healthcare provider will assess the benefits and risks to determine if tramadol is an appropriate treatment option for your pain management.

Frequently asked questions about Tramadol Hydrochloride Injection:

Certainly, here are some frequently asked questions (FAQs) about Tramadol Hydrochloride Injection:

  1. What is Tramadol Hydrochloride Injection, and what is its primary purpose?

Tramadol Hydrochloride Injection is a medication that contains tramadol, an opioid analgesic. It is primarily used to provide pain relief, especially in cases of moderate to severe pain.

  1. How does Tramadol Hydrochloride Injection work to relieve pain?

Tramadol works by binding to opioid receptors in the central nervous system, altering the perception of pain. It also has a secondary mechanism of action involving the modulation of neurotransmitters like serotonin and nor epinephrine.

  1. When is Tramadol Hydrochloride Injection typically prescribed?

It is often prescribed for postoperative pain management, injury related pain, and other situations where significant pain relief is needed.

  1. How is Tramadol Hydrochloride Injection administered?

Tramadol Hydrochloride Injection is typically administered intravenously (IV) or intramuscularly (IM) by a healthcare professional.

  1. What are the potential side effects of Tramadol Hydrochloride Injection?

Common side effects may include nausea, vomiting, dizziness, drowsiness, constipation, headache, and in some cases, respiratory depression. Serious side effects such as seizures and serotonin syndrome are rare but possible.

  1. Is Tramadol Hydrochloride Injection habit forming or addictive?

Tramadol has a lower potential for abuse and addiction compared to some other opioids. However, it can still lead to physical dependence if used improperly or for an extended period. It should be used as prescribed by a healthcare provider.

  1. Can I drive or operate heavy machinery while taking Tramadol Hydrochloride Injection?

Tramadol can cause dizziness and drowsiness. It’s essential to avoid activities that require mental alertness until you know how the medication affects you.

  1. Are there any drug interactions I should be aware of when taking Tramadol Hydrochloride Injection?

Tramadol can interact with other medications, including other opioids, certain antidepressants, and medications that affect serotonin levels. Inform your healthcare provider about all medications you are taking to avoid potential interactions.

  1. Can Tramadol Hydrochloride Injection be used during pregnancy or breastfeeding?

It should be used during pregnancy only if the potential benefits outweigh the risks and under the guidance of a healthcare provider. It may pass into breast milk, so consult with your healthcare provider if you are breastfeeding.

  1. How should Tramadol Hydrochloride Injection be stored and disposed of safely?

Store the medication according to the manufacturer’s instructions, and dispose of unused or expired medication properly to prevent misuse.

  1. Can I abruptly stop taking Tramadol Hydrochloride Injection?

Abruptly discontinuing tramadol can lead to withdrawal symptoms. It should be tapered off under the guidance of a healthcare provider when discontinuing the medication.

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

Tramadol Hydrochloride 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 Tramadol Hydrochloride 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
Fax No: +91 22 2634 1274