GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Acetaminophen and Tramadol Hydrochloride Tablets USP (325mg+37.5mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A)Acetaminophen and Tramadol Hydrochloride Tablets USP (325mg+37.5mg)
Each film-coated tablet contains:
Acetaminophen IP………………………325mg
Tramadol Hydrochloride IP………….37.5mg
Excipients……………………………………q. s
Colour: Titanium Dioxide IP

THERAPEUTIC INDICATIONS:

Tramadol and acetaminophen combination is used to relieve acute pain severe enough to require an opioid treatment and when other pain medicines did not work well enough or cannot be tolerated. When used together, the combination provides better pain relief than either medicine used alone.

CAUTION & SCHEDULE:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
PRESERVE IN TIGHT CONTAINER.
TRAMADOL HYDROCHLORIDE SHOULD BE USED FOR SEVERE ACUTE PAIN ONLY FOR A PERIOD NOT EXCEEDING 5 DAYS.
WARNING: Taking more than daily dose may cause serious liver damage or allergic reactions (e.g., swelling of the face, mouth and throat, difficulty in breathing, itching or rash); in case of overdose, get medical help right away. Quick medical attention is critical even if you do not notice any sign or symptoms.
SCHEDULE: SCHEDULE H1: PRESCRIPTION DRUG CAUTION- IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT IN ACCORDANCE WITH THE MEDICAL ADVICE.
NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.

STORAGE & DOSAGE:

Storage: Store below 30°C.
Protect from Light and moisture.
Dosage: As directed by the Physician.

Acetaminophen and Tramadol Hydrochloride Tablets USP (325mg+37.5mg) Technical Specification:

Product Name:Acetaminophen and Tramadol Hydrochloride Tablets USP
Brand Name:Tramataj A
Strength:(325mg+37.5mg)
Dosage Form:Tablets(film-coated)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Opioid Analgesic
Indication: Tramadol and acetaminophen combination is used to relieve acute pain severe enough to require an opioid treatment and when other pain medicines did not work well enough or cannot be tolerated. When used together, the combination provides better pain relief than either medicine used alone.
Storage:Store below 30°C. Protect from Light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Acetaminophen and Tramadol Hydrochloride Tablets USP (325mg+37.5mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Acetaminophen and Tramadol Hydrochloride Tablets USP (325mg+37.5mg)
    Each film-coated tablet contains:
    Acetaminophen IP………………………325mg
    Tramadol Hydrochloride IP………….37.5mg
    Excipients……………………………………q. s
    Colour: Titanium Dioxide IP

THERAPEUTIC INDICATIONS:

Tramadol and acetaminophen combination is used to relieve acute pain severe enough to require an opioid treatment and when other pain medicines did not work well enough or cannot be tolerated. When used together, the combination provides better pain relief than either medicine used alone.

CAUTION & SCHEDULE:

CAUTION:  SWALLOW WHOLE DO NOT CHEW OR CRUSH
Read enclosed leaflet before use.
Keep medicine out of reach of children.
Preserve in tight container.tramadol Hydrochloride should be used for severe acute pain only for a period not exceeding 5 days.
SCHEDULE: Taking more than daily dose may cause serious liver damage or allergic reactions (e.g., swelling of the face, mouth and throat, difficulty in breathing, itching or rash); in case of overdose, get medical help right away. Quick medical attention is critical even if you do not notice any sign or symptoms.|
SCHEDULE: SCHEDULE H1: PRESCRIPTION DRUG CAUTION- It is dangerous to take this preparation except in accordance with the medical advice.
NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.

STORAGE & DOSAGE:

Storage: Store below 30°C.
Protect from Light and moisture.
Dosage: As directed by the Physician.

Why Taj Pharmaceuticals?

Why Taj Pharmaceuticals is your trusted choice for Acetaminophen and Tramadol Hydrochloride Tablets USP. With a legacy of pharmaceutical excellence, Taj Pharmaceuticals is dedicated to producing Acetaminophen and Tramadol Hydrochloride Tablets USP of the highest quality. Our state-of-the-art facilities and stringent quality control measures ensure that you receive medications that meet the most rigorous industry standards. At Taj Pharmaceuticals, we prioritize patient well-being and understand the importance of effective pain management. Our Acetaminophen and Tramadol Hydrochloride Tablets USP are designed to provide reliable and compassionate solutions for pain relief. Trust in Taj Pharmaceuticals for your healthcare needs and experience a commitment to excellence that sets us apart.

What is Acetaminophen and Tramadol Hydrochloride Tablets USP and its use?

Acetaminophen and Tramadol Hydrochloride Tablets USP is a combination medication that contains two active ingredients: acetaminophen and tramadol hydrochloride. Each of these components serves a specific purpose:

  • Acetaminophen (also known as Paracetamol): Acetaminophen is a widely used over-the-counter pain reliever and fever reducer. It is commonly employed for the treatment of mild to moderate pain and for reducing fever. Acetaminophen works by affecting the brain’s temperature-regulating center and inhibiting the production of certain chemicals called prostaglandins, which are responsible for pain and fever.
  • Tramadol Hydrochloride: Tramadol is an opioid analgesic that acts on the central nervous system to relieve pain. It is prescribed for moderate to severe pain management. Tramadol works by binding to opioid receptors in the brain and spinal cord, altering the perception and response to pain.

The combination of acetaminophen and tramadol in one tablet provides a dual mechanism of action, making it particularly effective for the relief of moderate to severe pain. This medication is often used in various medical conditions where pain control is necessary, such as post-surgical pain, dental procedures, and certain chronic pain conditions.

How does Acetaminophen and Tramadol Hydrochloride Tablets USP Work?

Acetaminophen and Tramadol Hydrochloride Tablets USP work through the combined action of their two active ingredients, acetaminophen and tramadol hydrochloride. Each component has a distinct mechanism of action:

Acetaminophen (Paracetamol):

Acetaminophen primarily works by affecting the brain’s hypothalamus, which is responsible for regulating body temperature. While its exact mechanism isn’t fully understood, it is believed to reduce the production of prostaglandins in the brain. Prostaglandins are responsible for raising the body’s temperature (fever) and increasing the perception of pain. Acetaminophen’s actions include:

  • Pain Relief: Acetaminophen helps reduce pain perception by acting on the central nervous system, particularly in the brain.
  • Fever Reduction: It lowers fever by reducing the hypothalamus’s temperature setpoint, which leads to the body cooling down.

Tramadol Hydrochloride:

Tramadol is an opioid analgesic that works in a different way. It binds to specific receptors in the central nervous system, including muopioid receptors. Tramadol also inhibits the reuptake of certain neurotransmitters, such as serotonin and norepinephrine. Its actions include:

  • Pain Relief: Tramadol modifies the perception and response to pain by binding to opioid receptors. It can provide significant pain relief, especially for moderate to severe pain.
  • Altered Pain Signals: Tramadol changes how pain signals are transmitted and perceived in the brain and spinal cord, resulting in pain relief.

The combination of acetaminophen and tramadol in one tablet provides a synergistic effect, offering both effective pain relief (through tramadol) and fever reduction and additional pain relief (through acetaminophen). This makes Acetaminophen and Tramadol Hydrochloride Tablets USP particularly valuable for the management of moderate to severe pain, such as that experienced after surgery, dental procedures, or in certain chronic pain conditions.

Benefits and Side Effects of Acetaminophen and Tramadol Hydrochloride Tablets USP:

Acetaminophen and Tramadol Hydrochloride Tablets USP offer several benefits when used under the supervision and prescription of a healthcare professional, primarily for their pain-relieving properties. However, like any medication, they also come with potential side effects. Here’s an overview of the benefits and possible side effects:

Benefits:

  • Effective Pain Relief: These tablets are particularly effective in providing pain relief, especially for moderate to severe pain. The combination of acetaminophen and tramadol offers a dual mechanism of action for better pain management.
  • Fever Reduction: Acetaminophen component helps lower fever, making it suitable for febrile illnesses and reducing discomfort associated with high body temperature.
  • Enhanced Pain Control: Tramadol is an opioid analgesic that can offer stronger pain relief than over-the-counter medications, making it valuable for post-surgical pain, dental procedures, and certain chronic pain conditions.
  • Combination Convenience: The combination of acetaminophen and tramadol in a single tablet simplifies medication management for individuals who require both pain relief and fever reduction.

Side Effects:

It’s important to note that not everyone will experience these side effects, and many people tolerate Acetaminophen and Tramadol Hydrochloride Tablets USP well. However, potential side effects can include:

  • Nausea and Vomiting: Nausea is a common side effect, and vomiting may occur in some individuals. Taking the medication with food can help reduce these symptoms.
  • Dizziness and Drowsiness: Tramadol can cause dizziness and drowsiness, which can impair your ability to operate machinery or drive safely.
  • Constipation: Opioid medications like tramadol often lead to constipation. Maintaining proper hydration and dietary fiber intake can help manage this side effect.
  • Headache: Some individuals may experience headaches as a side effect of these tablets.
  • Dry Mouth: Dry mouth can occur, and staying hydrated can alleviate this symptom.
  • Allergic Reactions: While rare, some individuals may experience allergic reactions, including skin rashes, itching, swelling, or difficulty breathing. Seek immediate medical attention if you experience these symptoms.
  • Respiratory Depression: Tramadol, being an opioid, can suppress breathing at high doses or when misused. It’s essential to use this medication as prescribed to avoid serious respiratory side effects.
  • Dependency and Withdrawal: Long-term use of tramadol can lead to physical dependency, and sudden discontinuation may result in withdrawal symptoms. It should be used cautiously and under medical supervision, especially if taken for an extended period.
  • Serotonin Syndrome: In rare cases, the use of tramadol in combination with certain other medications can lead to serotonin syndrome, which is a potentially life-threatening condition. It requires immediate medical attention and includes symptoms like agitation, hallucinations, rapid heart rate, high blood pressure, fever, muscle stiffness, and loss of coordination.

Frequently asked questions about Acetaminophen and Tramadol Hydrochloride Tablets USP:

  1. What are Acetaminophen and Tramadol Hydrochloride Tablets USP used for?

These tablets are typically prescribed for the management of moderate to severe pain, such as post-surgical pain, dental procedures, and certain chronic pain conditions.

  1. How do Acetaminophen and Tramadol Hydrochloride Tablets USP work?

Acetaminophen (paracetamol) reduces pain and fever by affecting the brain’s temperature-regulating center. Tramadol, an opioid analgesic, modifies pain perception and response by binding to opioid receptors in the central nervous system.

  1. Are these tablets available over-the-counter (OTC) or by prescription only?

Acetaminophen and Tramadol Hydrochloride Tablets USP typically require a prescription due to the opioid component (tramadol), which carries potential risks and side effects.

  1. What is the recommended dosage for Acetaminophen and Tramadol Hydrochloride Tablets USP?

The dosage can vary based on individual factors, such as the severity of pain and the patient’s medical condition. It’s crucial to follow the dosage instructions provided by your healthcare provider.

  1. Can I take these tablets with other medications?

It’s essential to inform your healthcare provider about all medications, supplements, and herbal products you are taking, as there can be interactions with other drugs.

  1. What are the common side effects of Acetaminophen and Tramadol Hydrochloride Tablets USP?

Common side effects may include nausea, vomiting, dizziness, drowsiness, constipation, and dry mouth. However, not everyone will experience these side effects.

  1. Can these tablets be taken during pregnancy or while breastfeeding?

It’s crucial to consult your healthcare provider before taking these tablets if you are pregnant, planning to become pregnant, or breastfeeding. They can provide guidance on the safety of the medication in your specific situation.

  1. Is there a risk of dependence or addiction with tramadol in these tablets?

Tramadol is an opioid medication and has the potential for dependence, especially with prolonged use or misuse. It should be used as prescribed and under medical supervision.

  1. How should I store Acetaminophen and Tramadol Hydrochloride Tablets USP?

Store the medication at room temperature, away from light and moisture. Keep it out of reach of children and pets.

  1. What should I do if I miss a dose?

If you miss a dose, take it as soon as you remember. However, if it’s close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one.

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

Acetaminophen and Tramadol Hydrochloride Tablets 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 Acetaminophen and Tramadol Hydrochloride Tablets 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