GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Tapentadol Extended-Release Tablets 50mg
B) Tapentadol Extended-Release Tablets 100mg
C) Tapentadol Extended-Release Tablets 150mg
D) Tapentadol Extended-Release Tablets 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Tapentadol Extended-Release Tablets 50mg
Each film coated Extended-Release tablet contains:
Tapentadol Hydrochloride
Equivalent to Tapentadol……….50mg
Excipients………………………………..q.s.
Colour: Titanium Dioxide IP

B) Tapentadol Extended-Release Tablets 100mg
Each film coated Extended-Release tablet contains:
Tapentadol Hydrochloride
Equivalent to Tapentadol………….100mg
Excipients………………………………q.s.
Colour: Lake of quinoline yellow FCF

C) Tapentadol Extended-Release Tablets 150mg
Each film coated Extended-Release tablet contains:
Tapentadol Hydrochloride
Equivalent to Tapentadol……………..150mg
Excipients………………………………………q.s.
Colour: Lake of Erythrosine

D) Tapentadol Extended-Release Tablets 200mg
Each film coated Extended-Release tablet contains:
Tapentadol Hydrochloride
Equivalent to Tapentadol………..200mg
Excipients…………………………………q.s.
Colour: Ferric oxide yellow


THERAPEUTIC INDICATIONS:

Tapentadol tablets are used to treat moderate to severe acute pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed). Tapentadol extended-release tablets are used to treat severe neuropathic pain (pain caused by nerve damage) in people who have diabetes.

CAUTION & SCHEDULE:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Read enclosed leaflet before use.
SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

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

Tapentadol Extended-Release Tablets 200mg Technical Specification:

Product Name:Tapentadol Extended-Release Tablets 200mg
Brand Name:NUCYRETA ER
Strength:50mg, 100mg, 150mg, 200mg
Dosage Form:Tablets (Film coated Extended-Release)
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, Pain killer
Indication: Tapentadol tablets are used to treat moderate to severe acute pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed).
Storage:Store below 30 °C. Protect from Light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Tapentadol Extended-Release Tablets 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Tapentadol Extended-Release Tablets 200mg
    Each film coated Extended-Release tablet contains:
    Tapentadol Hydrochloride
    Equivalent to Tapentadol……….200mg
    Excipients………………………………..q.s.
    Colour: Ferric oxide yellow

THERAPEUTIC INDICATIONS:

Tapentadol tablets are used to treat moderate to severe acute pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed). Tapentadol extended-release tablets are used to treat severe neuropathic pain (pain caused by nerve damage) in people who have diabetes.

CAUTION & SCHEDULE:

CAUTION:  SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Read enclosed leaflet before use.
SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A registered medical practitioner.
Keep medicine out of reach of children.

STORAGE & DOSAGE:

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

Why Taj Pharmaceuticals?

Taj Pharmaceuticals is a preferred choice for Tapentadol Tablets due to its commitment to high-quality pharmaceutical manufacturing, extensive industry expertise, and stringent regulatory compliance. Their global presence and distribution network ensure widespread availability of Tapentadol Tablets, enhancing patient access to essential medications. Taj Pharmaceuticals’ investment in research and development demonstrates its dedication to pharmaceutical innovation, potentially leading to advanced formulations. A reliable supply chain and competitive pricing options contribute to the accessibility and affordability of Tapentadol. Their patient-centric approach and focus on safety align seamlessly with the importance of pain management medications, reinforcing trust in their products among healthcare providers and patients. Taj Pharmaceuticals’ commitment to quality, compliance, research, affordability, and patient support positions it as a dependable supplier, benefiting healthcare providers and patients alike.

What is Tapentadol Tablets and its uses:

Tapentadol Tablets are a medication that contains the active ingredient tapentadol. Tapentadol is an opioid analgesic, which means it is used to relieve moderate to severe pain. It works by affecting certain receptors in the brain and spinal cord to reduce the perception of pain. Here are the key uses of Tapentadol Tablets:

  • Pain Management: Tapentadol Tablets are primarily prescribed to manage moderate to severe pain. They can be used in various clinical settings and conditions where pain relief is necessary. Common applications include post-surgical pain, pain due to injury or trauma, and chronic pain conditions like neuropathic pain or osteoarthritis.
  • Acute Pain: Tapentadol may be used for short-term relief of acute pain, such as that experienced after surgery, dental procedures, or injury. Its quick onset of action and effectiveness make it a valuable option for managing acute pain episodes.
  • Chronic Pain: In some cases, Tapentadol is prescribed for the management of chronic pain conditions, particularly when other pain relief medications have proven less effective or have intolerable side effects. This includes neuropathic pain conditions like diabetic neuropathy.
  • Cancer Pain: Tapentadol may also be considered for cancer-related pain management when other opioids are not suitable or when pain is not adequately controlled with other medications.
  • Nociceptive Pain: It can effectively address nociceptive pain, which results from tissue damage or inflammation. This makes it suitable for a wide range of pain types, including musculoskeletal pain.
  • Neuropathic Pain: Tapentadol has properties that make it effective in managing neuropathic pain, which arises from nerve damage or dysfunction. This is particularly relevant in conditions like diabetic neuropathy.

It’s essential to note that Tapentadol is a prescription medication and should only be used under the guidance of a healthcare provider. Due to its opioid nature, it carries a risk of dependence and addiction, so it should be used exactly as prescribed and monitored closely by healthcare professionals. Additionally, patients should be informed about potential side effects and interactions with other medications to ensure safe and effective pain management.

How Does Tapentadol Tablets work?

Tapentadol Tablets work as an analgesic (painrelieving) medication by affecting certain receptors in the brain and spinal cord. Tapentadol has a dual mechanism of action, combining two distinct modes of pain relief:

  • Mu-Opioid Receptor Agonism: Similar to traditional opioids like morphine, Tapentadol acts as a muopioid receptor agonist. It binds to and activates these receptors, which are found in various parts of the central nervous system, including the brain and spinal cord. Activation of muopioid receptors leads to several effects, including:
    Reduction of the perception of pain: Tapentadol decreases the brain’s interpretation of pain signals, making pain feel less intense.
    Altered emotional response to pain: It can induce a sense of euphoria or relaxation, which contributes to pain relief and, in some cases, can lead to a risk of misuse.
  • Norepinephrine Reuptake Inhibition: Tapentadol also inhibits the reuptake of norepinephrine, a neurotransmitter that plays a role in pain modulation. By increasing norepinephrine levels in the central nervous system, Tapentadol enhances the body’s natural paininhibiting mechanisms. This action contributes to pain relief and can help manage neuropathic pain, which often involves abnormal signaling of norepinephrine.

The dual mechanism of action of Tapentadol, combining opioid receptor agonism and norepinephrine reuptake inhibition, allows it to provide effective pain relief for a wide range of pain conditions, including nociceptive and neuropathic pain.

Benefits of Tapentadol Tablets:

  • Effective Pain Relief: Tapentadol is known for its effectiveness in providing relief from moderate to severe pain, making it valuable for various medical conditions and surgical procedures.
  • Dual Mechanism of Action: Tapentadol combines two mechanisms of action—opioid receptor agonism and norepinephrine reuptake inhibition—making it versatile in addressing different types of pain, including nociceptive and neuropathic pain.
  • Quick Onset of Action: It typically works relatively quickly, offering rapid pain relief, which can be crucial for patients experiencing acute or severe pain.
  • Lower Risk of Constipation: Compared to some other opioids, Tapentadol may have a lower tendency to cause constipation, which is a common side effect associated with opioid use.
  • Potentially Reduced Risk of Respiratory Depression: Some studies suggest that Tapentadol may have a lower risk of respiratory depression compared to traditional opioids, particularly at therapeutic doses.
  • Applicability to Various Pain Conditions: Tapentadol can be used to manage pain in a wide range of conditions, including post-operative pain, chronic pain conditions, cancer-related pain, and neuropathic pain syndromes.

Common Side Effects of Tapentadol Tablets:

  • Nausea and Vomiting: Gastrointestinal side effects like nausea and vomiting are relatively common when taking Tapentadol. These side effects often occur during the initial phase of treatment and may improve with continued use.
  • Dizziness and Drowsiness: Tapentadol can cause dizziness and drowsiness, potentially impairing coordination and cognitive function. Patients are typically advised to avoid activities that require mental alertness, such as driving or operating heavy machinery, until they understand how the medication affects them.
  • Constipation: Although Tapentadol may have a lower risk of constipation compared to some opioids, it can still cause this side effect. Adequate hydration and dietary fiber intake are recommended to manage constipation.
  • Headache: Some individuals may experience headaches while taking Tapentadol.
  • Dry Mouth: Dry mouth (xerostomia) can occur as a side effect.
  • Sweating: Excessive sweating or hyperhidrosis may be reported by some individuals.
  • Fatigue: Patients may experience fatigue or tiredness.
  • Insomnia: Difficulty falling asleep or staying asleep may occur in some cases.
  • Elevated Blood Pressure: Tapentadol can lead to increases in blood pressure, so regular monitoring is essential, especially in patients with hypertension.
  • Itching and Skin Reactions: Skin reactions, including itching or rashes, can occur in some cases.
  • Withdrawal Symptoms: Tapentadol, like other opioids, can lead to withdrawal symptoms if abruptly discontinued. Tapering the dose under medical supervision is necessary to prevent withdrawal.

Patients should discuss potential side effects with their healthcare provider and report any severe or persistent side effects promptly. It’s important for healthcare providers to assess the risks and benefits of Tapentadol for each patient and ensure safe and responsible use, considering the potential for misuse, dependence, and addiction. Patients should use Tapentadol exactly as prescribed and follow their provider’s instructions for its use.

Frequently Asked Questions About Tapentadol Tablets:

Certainly, here are some frequently asked questions (FAQs) about Tapentadol Tablets:

  1. What is Tapentadol used for?

Tapentadol is a medication used to relieve moderate to severe pain. It is prescribed for various conditions, including postsurgical pain, chronic pain conditions, neuropathic pain, and cancer related pain.

  1. How does Tapentadol work?

Tapentadol has a dual mechanism of action, combining opioid receptor agonism and norepinephrine reuptake inhibition. It reduces the perception of pain and enhances the body’s natural pain inhibiting mechanisms.

  1. Is Tapentadol safe for longterm use?

Tapentadol can be used for both shortterm and longterm pain management. However, its longterm use should be carefully monitored by a healthcare provider due to the risk of dependence and addiction.

  1. Are there alternatives to Tapentadol for pain relief?

Yes, there are other pain relief medications available, including nonopioid analgesics like acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs). Opioid alternatives and nonpharmacological approaches may also be considered based on the type and cause of pain.

  1. What should I do if I experience side effects from Tapentadol?

If you experience side effects such as nausea, dizziness, or constipation while taking Tapentadol, it’s essential to inform your healthcare provider. They can adjust the dose or recommend strategies to manage side effects effectively

  1. Can Tapentadol be taken with other medications?

Tapentadol can interact with other medications, so it’s crucial to inform your healthcare provider about all the medications, supplements, and herbal products you are taking. They will assess potential drug interactions and adjust your treatment plan accordingly.

  1. Is Tapentadol addictive?

Tapentadol, like other opioids, carries a risk of dependence and addiction if misused. It should only be used as prescribed by a healthcare provider, and patients should follow the recommended dosing instructions carefully.

  1. Can I drive or operate heavy machinery while taking Tapentadol?

Tapentadol can cause dizziness and drowsiness, which can impair your ability to drive or operate heavy machinery. It’s advisable to avoid such activities until you know how Tapentadol affects you.

  1. Can Tapentadol be used during pregnancy or breastfeeding?

Tapentadol should be used during pregnancy or breastfeeding only if the potential benefits outweigh the risks. Healthcare providers carefully assess the situation and consider alternative pain management options when necessary.

  1. How should Tapentadol be stored?

Tapentadol should be stored at room temperature, away from moisture and heat. Keep it out of reach of children and pets.

Patients should consult their healthcare provider for personalized information and guidance regarding the use of Tapentadol Tablets, including dosage, potential side effects, and interactions with other medications.

As Tapentadol Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Tapentadol Tablets 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

Tapentadol Tablets 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 Tapentadol Tablets, 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