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

Palexia Retard

Active Ingredient:
Tapentadol Hydrochloride
Origin:
EU

Palexia Retard (Tapentadol Hydrochloride)

Tapentadol Hydrochloride, the active ingredient in Palexia Retard, is an opioid analgesic presented as a prolonged‑release oral formulation for oral 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 S.A.

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Indications & Clinical Uses

Palexia Retard is an opioid analgesic that acts on the central nervous system to relieve pain. It is prescribed for several recognized pain‑related conditions:

  • Chronic low back pain: provides sustained relief of moderate to severe pain.
  • Osteoarthritis pain: improves functional ability and reduces pain intensity.
  • Neuropathic pain associated with diabetic peripheral neuropathy: alleviates burning and shooting sensations.
  • Cancer‑related chronic pain: contributes to overall pain control as part of multimodal therapy.
  • Post‑surgical chronic pain (when pain persists beyond the usual healing period): helps manage lingering moderate to severe pain.

How It Works

  • Tapentadol Hydrochloride exerts its analgesic effect through a dual mechanism: it is a μ‑opioid receptor agonist that activates inhibitory pathways in the central nervous system, and it inhibits the reuptake of norepinephrine, enhancing descending pain‑modulating pathways. This combined action reduces the perception of pain without requiring high opioid receptor occupancy.

Side Effects

Adverse reactions may occur with Palexia Retard and should be monitored during therapy.

Common Side Effects

  • Nausea: mild to moderate upset stomach.
  • Constipation: reduced bowel movements.
  • Dizziness: feeling light‑headed or unsteady.
  • Somnolence: increased sleepiness.
  • Headache: mild to moderate head pain.
  • Dry mouth: reduced salivation.

Serious or Rare Side Effects

  • Respiratory depression: slowed or shallow breathing.
  • 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

When prescribing Palexia Retard, clinicians should consider several safety aspects:

  • Assess renal function: dose adjustment may be needed in severe impairment.
  • Evaluate hepatic function: monitor for accumulation in liver disease.
  • Screen for respiratory disorders: patients with COPD or sleep apnea are at higher risk of respiratory depression.
  • Review concomitant CNS depressants: avoid additive sedation with benzodiazepines or alcohol.
  • Pregnancy and lactation: use only if clearly needed; discuss risks with the patient.
  • Store at ambient temperature: keep below 25°C, retain original packaging, and protect from moisture.

Avoid Interactions

Palexia Retard can interact with other medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

  • Monoamine oxidase inhibitors (MAOIs): risk of hypertensive crisis or serotonin syndrome.
  • CNS depressants (e.g., benzodiazepines, barbiturates): additive respiratory depression.
  • CYP2D6 inhibitors (e.g., quinidine, fluoxetine): increased tapentadol plasma levels.

Moderate Interactions (Monitor Closely)

  • Serotonergic agents (e.g., tramadol, SSRIs): potential for serotonin syndrome.
  • Antihistamines with sedative properties: enhanced drowsiness.
  • Diuretics: may exacerbate hypotension.
  • Anticonvulsants: possible reduction in seizure‑threshold protection.
  • Alcohol: increased risk of sedation and respiratory depression.

Frequently Asked Questions

Palexia Retard is prescribed for the management of moderate to severe chronic pain, including conditions such as chronic low back pain, osteoarthritis, diabetic neuropathy, cancer‑related pain, and persistent post‑surgical pain when other therapies are insufficient.

Tapentadol combines μ‑opioid receptor agonism with norepinephrine reuptake inhibition. The opioid activity activates inhibitory pathways in the brain and spinal cord, while the norepinephrine effect enhances descending pain‑modulating circuits, together lowering the perception of pain.

The dosage of Palexia Retard is individualized; a qualified prescriber determines the appropriate strength and dosing schedule based on the patient’s pain severity, prior opioid exposure, and clinical condition.

Palexia Retard should be used in pregnancy or while breastfeeding only if the potential benefit justifies the potential risk to the fetus or infant. Clinicians must evaluate risks and discuss them with the patient before prescribing.

To 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, confirming trade or institutional credentials before providing pricing, availability, shipping details and any necessary import documentation.

Palexia Retard’s dual mechanism provides analgesia with potentially lower opioid‑related side effects compared with pure μ‑opioid agonists. Its extended‑release formulation offers once‑daily dosing, which can improve adherence relative to immediate‑release opioids that require multiple daily doses.

Store Palexia Retard at ambient temperature, below 25 °C, in its original packaging and protected from moisture. Do not expose the tablets to excessive heat or humidity to maintain potency.

Palexia Retard is taken orally as a whole tablet, usually once daily. Tablets should not be split, crushed, or chewed, as this can alter the extended‑release profile and increase the risk of adverse effects.

The most serious risks include respiratory depression, severe hypotension, seizures, dependence or abuse potential, and rare allergic reactions such as anaphylaxis. Patients should be monitored closely, especially during treatment initiation and dose adjustments.

Palexia Retard is contraindicated in patients with known hypersensitivity to tapentadol or any formulation component, those with severe respiratory depression, acute or severe asthma, and individuals taking mono‑amine oxidase inhibitors within 14 days.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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