Product image of Tramadol Hydrochloride 50 mg/1 (Tramadol Hydrochloride) 50 mg/1 TABLET, COATED supplied by GNH India

Tramadol Hydrochloride 50 mg/1

Active Ingredient:
Tramadol Hydrochloride
Form:
TABLET, COATED
Brand:
Tramadol Hydrochloride
Origin:
USA

Tramadol Hydrochloride 50 mg/1 (Tramadol Hydrochloride TABLET, COATED) 50 mg/1

Tramadol Hydrochloride, the active ingredient in Tramadol Hydrochloride, is an opioid analgesic presented as a 50 mg coated tablet for oral use. It is indicated for the management of moderate to moderately severe pain in adults. GNH India supplies Tramadol Hydrochloride as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies, and clinics worldwide.

Tramadol Hydrochloride is a centrally acting synthetic opioid analgesic. It is classified as a Schedule IV controlled substance due to its potential for misuse and addiction. The drug is available in various formulations, including immediate-release and extended-release tablets.

Strength

50 mg/1

Pack Size

100 BLISTER PACK in 1 CARTON (0904-7496-61) / 1 TABLET, COATED in 1 BLISTER PACK

Manufacturer / TM Owner

Major Pharmaceuticals

1
Pack/s
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Indications & Clinical Uses

Tramadol Hydrochloride is primarily used for the management of moderate to moderately severe pain in adults. It is indicated for various conditions where pain management is required.

  • Moderate to severe pain: Tramadol Hydrochloride is used to manage moderate to severe pain in adults, including postoperative pain (pain after surgery).
  • Chronic pain: It may be used for the management of chronic pain that requires around-the-clock, long-term opioid treatment.
  • Pain refractory to other medications: Tramadol Hydrochloride is restricted to cases of pain that do not respond to other non-opioid pain medications.

How It Works

  • Tramadol Hydrochloride acts as a weak μ-opioid receptor agonist and inhibits the reuptake of norepinephrine and serotonin. This dual mechanism contributes to its analgesic effects. The drug's active metabolite, M1, has a higher affinity for μ-opioid receptors, enhancing its analgesic properties. Tramadol Hydrochloride also affects the descending pain pathways in the central nervous system, providing pain relief.

Side Effects

Tramadol Hydrochloride, like other opioids, can cause a range of side effects, some of which can be serious. Common Side Effects:

  • Nausea
  • Dizziness
  • Headache
  • Constipation
  • Vomiting
  • Drowsiness
  • Serious or Rare Side Effects:
  • Respiratory depression
  • Seizures
  • Serotonin syndrome
  • Hypotension
  • Syncope
  • Orthostatic hypotension
  • Reduced respiratory drive, leading to CO2 retention and exacerbating intracranial pressure.

Precautions & Warnings

Tramadol Hydrochloride should be used with caution and under the supervision of a healthcare provider. Important precautions include:

  • Avoid use in patients with a history of seizures: Tramadol Hydrochloride may lower the seizure threshold.
  • Monitor for respiratory depression: Use cautiously in patients with respiratory conditions.
  • Avoid use in patients with severe hepatic or renal impairment: Dosage adjustments may be necessary.
  • Monitor for signs of serotonin syndrome: Especially when used with other serotonergic drugs.
  • Store at room temperature: Keep away from moisture and heat, and out of reach of children.

Avoid Interactions

Tramadol Hydrochloride can interact with various medications, which may affect its efficacy or increase the risk of adverse effects. Major Interactions (Avoid):

  • MAO inhibitors: Concurrent use can increase the risk of serotonin syndrome.
  • Serotonergic drugs: May increase the risk of serotonin syndrome.
  • CYP3A4 inhibitors: Can increase tramadol levels, leading to increased side effects.
  • Moderate Interactions (Monitor Closely):
  • CNS depressants: May enhance the sedative effects of tramadol.
  • Anticholinergics: May increase the risk of urinary retention and constipation.
  • Warfarin: May increase the risk of bleeding.

Frequently Asked Questions

Tramadol Hydrochloride is used for the management of moderate to moderately severe pain in adults. It is indicated for various conditions where pain management is required, including postoperative pain and chronic pain that requires around-the-clock, long-term opioid treatment.

Tramadol Hydrochloride acts as a weak μ-opioid receptor agonist and inhibits the reuptake of norepinephrine and serotonin. This dual mechanism contributes to its analgesic effects. The drug's active metabolite, M1, has a higher affinity for μ-opioid receptors, enhancing its analgesic properties. Tramadol Hydrochloride also affects the descending pain pathways in the central nervous system, providing pain relief.

The usual dose of Tramadol Hydrochloride is determined by a healthcare provider based on the patient's condition and response to treatment. The recommended daily dosage of immediate-release tramadol is 50 mg and 100 mg every 4 to 6 hours, with a maximum recommended dosage of 400 mg per day. For extended-release formulations, the dosage is adjusted accordingly.

The safety of Tramadol Hydrochloride during pregnancy or breastfeeding has not been established. It is important to consult with a healthcare provider before using Tramadol Hydrochloride if you are pregnant, planning to become pregnant, or breastfeeding.

To order Tramadol Hydrochloride from GNH India, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams across international markets and will ask the buyer to confirm trade or institutional credentials. The team will reply with pricing, availability, shipping, and the import paperwork.

Tramadol Hydrochloride is an opioid analgesic that is used for the management of moderate to severe pain. It is classified as a Schedule IV controlled substance due to its potential for misuse and addiction. Compared to other opioids, Tramadol Hydrochloride has a lower affinity for the μ-opioid receptor and also inhibits the reuptake of norepinephrine and serotonin, contributing to its analgesic effects.

Tramadol Hydrochloride should be stored at room temperature away from moisture and heat. It is important to keep the medication out of reach of children and to follow the storage instructions provided by the manufacturer. Do not share Tramadol Hydrochloride with others, as it is a controlled substance.

Tramadol Hydrochloride is administered orally in the form of coated tablets. The dosage and frequency of administration are determined by a healthcare provider based on the patient's condition and response to treatment. It is important to follow the prescribed dosage and administration instructions provided by the healthcare provider.

The most serious risks associated with Tramadol Hydrochloride include respiratory depression, seizures, serotonin syndrome, hypotension, and orthostatic hypotension. It is important to monitor for these adverse effects and to seek medical attention if they occur. Tramadol Hydrochloride should be used with caution and under the supervision of a healthcare provider.

Tramadol Hydrochloride should not be used by individuals who have previously demonstrated hypersensitivity to tramadol, any other component of this product, or opioids. It is also contraindicated in any situation where opioids are contraindicated, including acute intoxication with alcohol, hypnotics, narcotics, centrally acting analgesics, opioids, or psychotropic drugs. Patients with a history of seizures should use Tramadol Hydrochloride with caution.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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