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

Palexia Retard

Active Ingredient:
Tapentadol Hydrochloride
Origin:
EU

Palexia Retard (Tapentadol Hydrochloride)

Tapentadol, the active ingredient in Palexia Retard, is an opioid analgesic presented as a prolonged‑release formulation for oral use. It is indicated for the management of moderate to severe chronic pain in adult patients when other 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 Österreich Gmbh

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Indications & Clinical Uses

Tapentadol Retard acts on the central nervous system to relieve pain associated with several chronic conditions.

  • Chronic low back pain: provides long‑lasting analgesia for patients with persistent lumbar discomfort.
  • Osteoarthritis pain: reduces pain intensity and improves functional ability in affected joints.
  • Neuropathic pain associated with diabetic peripheral neuropathy: alleviates burning and shooting sensations.
  • Cancer‑related chronic pain: contributes to overall pain control as part of a multimodal regimen.

How It Works

  • Tapentadol binds to the µ‑opioid receptor as a full agonist while simultaneously inhibiting the reuptake of norepinephrine. This dual action enhances descending inhibitory pain pathways and reduces nociceptive transmission in the spinal cord, producing analgesia without relying solely on opioid receptor activation.

Side Effects

Adverse reactions may range from mild to severe and should be monitored throughout therapy.

Common Side Effects

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

Serious or Rare Side Effects

  • Respiratory depression: slowed breathing that may be life‑threatening.
  • Seizures: convulsive episodes, particularly at high doses.
  • Severe hypotension: marked drop in blood pressure.
  • Serotonin syndrome: agitation, hyperthermia, and neuromuscular abnormalities when combined with serotonergic agents.
  • Dependence or abuse potential: risk of misuse with prolonged use.
  • Allergic reactions: rash, itching, or anaphylaxis.

Precautions & Warnings

Before initiating therapy, clinicians should evaluate patient history and monitor for specific risks.

  • Assess renal function: adjust use in severe impairment.
  • Assess hepatic function: caution in liver disease.
  • Evaluate for respiratory disorders: avoid in uncontrolled sleep‑apnea.
  • Review concomitant CNS depressants: increased sedation risk.
  • Monitor for signs of abuse: implement risk‑mitigation strategies.
  • Store below 25°C: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Tapentadol may interact with several drug classes, requiring careful review of a patient’s medication list.

Major Interactions (Avoid)

  • MAO inhibitors: risk of hypertensive crisis or serotonin syndrome.
  • CNS depressants (benzodiazepines, barbiturates): profound sedation and respiratory depression.
  • Serotonergic agents (SSRIs, SNRIs, tramadol): heightened serotonin syndrome risk.

Moderate Interactions (Monitor Closely)

  • CYP2D6 inhibitors (quinidine, fluoxetine): may increase tapentadol plasma levels.
  • CYP3A4 inducers (rifampicin, carbamazepine): may reduce analgesic effect.
  • Antihypertensives: additive hypotensive effect.
  • Alcohol: enhanced central nervous system depression.

Frequently Asked Questions

Palexia Retard is a prolonged‑release formulation of tapentadol indicated for the management of moderate to severe chronic pain, such as that arising from low back pain, osteoarthritis, diabetic neuropathy, or cancer‑related pain, when other analgesics are insufficient.

Tapentadol provides analgesia through a dual mechanism: it activates µ‑opioid receptors as an agonist and inhibits the reuptake of norepinephrine, which together strengthen descending inhibitory pathways and lower pain signal transmission in the spinal cord.

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 treatment goals. No fixed regimen is provided here.

Tapentadol is classified as a pregnancy‑category C medication in many jurisdictions, indicating that risk cannot be ruled out. It is generally advised to avoid use during pregnancy and breastfeeding unless the potential benefit justifies the potential risk, and only under specialist supervision.

To place an order, 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 a combined µ‑opioid and norepinephrine‑reuptake inhibition effect, which may result in comparable analgesia with a potentially lower incidence of certain opioid‑related side effects like constipation. Individual response varies, and choice of therapy should be guided by clinical assessment.

Palexia Retard tablets should be stored at temperatures below 25 °C, in the original packaging, protected from moisture and direct sunlight to maintain product stability throughout its shelf life.

Palexia Retard is taken orally as a whole tablet, usually once daily, with or without food. Tablets must not be split, chewed, or crushed, as this can alter the extended‑release profile and affect safety.

The most serious risks include respiratory depression, which can be life‑threatening, especially in opioid‑naïve patients or when combined with other depressants; the potential for dependence, abuse, or withdrawal; and rare events such as seizures or serotonin syndrome when used with serotonergic drugs.

Palexia Retard is contraindicated in patients with known hypersensitivity to tapentadol or any excipients, 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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