Product image of Palexia Retard (Tapentadol Hydrochloride) supplied by GNH India

Palexia Retard

Active Ingredient:
Tapentadol Hydrochloride
Origin:
EU

Palexia Retard (Tapentadol Hydrochloride)

International sale not permitted. Listed for the domestic market and B2B only.

Tapentadol hydrochloride, the active ingredient in Palexia Retard, is an opioid analgesic presented as a prolonged‑release oral tablet for systemic use. It is indicated for the management of moderate to severe chronic pain in adult patients when alternative treatments are inadequate.
GNH India supplies Palexia Retard as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Grünenthal Gmbh

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Indications & Clinical Uses

Palexia Retard is an opioid analgesic that acts on the central nervous system to relieve persistent pain conditions.

  • Chronic low back pain: provides long‑lasting relief of moderate to severe pain when other analgesics are insufficient.
  • Osteoarthritis pain: reduces pain intensity and improves functional ability in adults with severe joint degeneration.
  • Neuropathic pain associated with diabetic peripheral neuropathy: alleviates burning and shooting pain where first‑line agents are ineffective.

How It Works

  • Tapentadol hydrochloride exerts analgesia through a dual mechanism: it is a μ‑opioid receptor agonist that inhibits nociceptive transmission and a norepinephrine reuptake inhibitor that enhances descending inhibitory pain pathways. This combined action reduces the perception of pain at spinal and supraspinal levels.

Side Effects

Tapentadol may cause a range of adverse reactions, from mild to potentially life‑threatening.

Common Side Effects

  • Nausea: mild to moderate upset stomach.
  • Constipation: reduced bowel movements.
  • Dizziness: sensation of light‑headedness.
  • Somnolence: increased sleepiness.
  • Headache: mild throbbing pain.
  • Dry mouth: reduced salivation.

Serious or Rare Side Effects

  • Respiratory depression: slowed breathing that may be fatal.
  • Seizures: convulsive episodes, especially at high doses.
  • Severe hypotension: marked drop in blood pressure.
  • Allergic reactions: rash, itching, swelling, or anaphylaxis.
  • Dependence or abuse potential: risk of misuse with prolonged use.
  • Adrenal insufficiency: rare hormonal imbalance affecting stress response.

Precautions & Warnings

Before prescribing Palexia Retard, clinicians should evaluate patient history and monitor for specific safety concerns.

  • Assess renal function: dose adjustment may be required in severe impairment.
  • Assess hepatic function: caution in patients with liver disease.
  • Evaluate for respiratory disorders: avoid in uncontrolled asthma or COPD.
  • Review concomitant CNS depressants: increased risk of sedation and respiratory depression.
  • Monitor for signs of addiction: watch for misuse or craving behaviors.
  • Store at ambient temperature: keep below 25°C in the original container, protected from moisture and direct sunlight.

Avoid Interactions

Tapentadol interacts with several drug classes; careful review of a patient’s medication list is essential.

Major Interactions (Avoid)

  • Benzodiazepines: additive central nervous system depression.
  • Barbiturates: heightened risk of respiratory depression.
  • Monoamine oxidase inhibitors (MAOIs): may precipitate hypertensive crisis.
  • CNS depressants (e.g., alcohol, opioids): synergistic sedation.
  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): increased tapentadol plasma levels.

Moderate Interactions (Monitor Closely)

  • Serotonergic agents (e.g., tramadol, SSRIs): risk of serotonin syndrome.
  • Antihistamines: enhanced drowsiness.
  • Antihypertensives: possible additive hypotensive effect.
  • Diuretics: may intensify orthostatic hypotension.
  • Anticonvulsants: potential alteration of seizure threshold.

Frequently Asked Questions

Palexia Retard is a prolonged‑release formulation of tapentadol hydrochloride indicated for the management of moderate to severe chronic pain, such as persistent low‑back pain, severe osteoarthritis, or neuropathic pain when other analgesics are insufficient.

Tapentadol combines μ‑opioid receptor agonism with norepinephrine reuptake inhibition. The opioid action blocks pain signals in the spinal cord, while the norepinephrine effect strengthens descending inhibitory pathways, together providing effective analgesia.

The dose of Palexia Retard is individualized by the prescribing clinician based on the patient’s pain severity, prior opioid exposure, renal and hepatic function, and overall safety profile. No fixed regimen is provided here.

Tapentadol is classified as a pregnancy‑category C medication; it should only be used if the potential benefit justifies the potential risk to the fetus. It is excreted in breast milk, so breastfeeding is not recommended while taking this drug.

Submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Compared with traditional opioids such as morphine, tapentadol offers dual‑mechanism analgesia, which may provide effective pain relief at lower opioid‑related side‑effect burden. However, it retains similar risks of respiratory depression, dependence and constipation, requiring comparable monitoring.

Store the tablets at ambient temperature, below 25 °C, in the original packaging. Protect them from moisture, heat and direct sunlight to maintain potency throughout the shelf‑life.

Palexia Retard is taken orally as a whole tablet, usually once daily, with or without food. The tablet should not be split, crushed, or chewed, as this can alter the intended prolonged‑release profile.

The most serious risks include respiratory depression, which can be fatal, severe hypotension, seizures, and the potential for dependence, abuse, or accidental overdose. Immediate medical attention is required if any of these occur.

Palexia Retard is contraindicated in patients with known hypersensitivity to tapentadol or other opioids, those with severe respiratory depression, acute or severe asthma, and individuals who have taken monoamine oxidase inhibitors within the past 14 days.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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International sale not permitted. Listed for the domestic market and B2B only.

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