GNH USA

Europe — EMA

Ixprim

GNH USA supplies Ixprim (Tramadol Hydrochloride, Paracetamol), an opioid/non‑opioid analgesic for moderate to severe acute, post‑operative

Tramadol Hydrochloride, Paracetamol

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What is Tramadol Hydrochloride, Paracetamol?

Tramadol Hydrochloride, Paracetamol, the active ingredient in Ixprim, is an opioid analgesic and non‑opioid analgesic presented as a tablet for oral use. It treats moderate to severe acute pain, post‑operative pain and musculoskeletal pain in adult patients. It is indicated for short‑term management of pain where opioid therapy is appropriate, providing both central analgesia and antipyretic effects.

GNH USA supplies Ixprim as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality and regulatory compliance across markets.

What is Tramadol Hydrochloride, Paracetamol used for?

Ixprim combines an opioid and a non‑opioid analgesic, targeting central opioid receptors and peripheral prostaglandin pathways, to manage pain across several clinical settings. - Moderate to severe acute pain: provides rapid, effective analgesia for sudden, intense pain episodes. - Post‑operative pain: helps control pain following surgical procedures, facilitating recovery. - Musculoskeletal pain: alleviates pain associated with muscle, joint, or bone conditions, improving function. - Dental pain: offers effective relief after dental extractions or procedures. - Trauma pain: provides analgesia for pain resulting from injuries such as fractures or sprains.

What are the side effects of Tramadol Hydrochloride, Paracetamol?

Ixprim may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects: - Nausea: feeling of queasiness or urge to vomit. - Dizziness: light‑headed sensation or loss of balance. - Constipation: reduced bowel movements or hard stools. - Headache: mild to moderate head pain. - Somnolence: increased sleepiness or fatigue. - Dry mouth: reduced salivation causing throat dryness.

Serious or Rare Side Effects: - Seizures: convulsive episodes, especially at high doses or with interacting drugs. - Respiratory depression: slowed or shallow breathing that may be life‑threatening. - Serotonin syndrome: agitation, hyperthermia, tremor when combined with serotonergic agents. - Severe skin reactions: Stevens‑Johnson syndrome or toxic epidermal necrolysis. - Anaphylaxis: sudden severe allergic reaction with airway compromise. - Hepatic injury: elevated liver enzymes or jaundice.

What precautions apply to Tramadol Hydrochloride, Paracetamol?

When prescribing Ixprim, clinicians should consider several precautionary measures to ensure safe use. - Assess renal function: adjust use in patients with impaired kidney clearance. - Monitor hepatic status: use caution in liver disease and avoid excessive dosing. - Evaluate for seizure history: tramadol may lower seizure threshold. - Avoid concurrent MAO inhibitors: risk of serotonin syndrome. - Use with caution in patients with respiratory disorders: potential for respiratory depression. - Store at ambient temperature: keep tablets in original packaging, protect from moisture and heat.

What does Tramadol Hydrochloride, Paracetamol interact with?

Ixprim can interact with several medications, altering its efficacy or safety profile.

Major Interactions (Avoid): - Monoamine oxidase inhibitors (MAOIs): may cause serotonin syndrome. - Selective serotonin reuptake inhibitors (SSRIs) and SNRIs: increase risk of serotonin syndrome. - CNS depressants (benzodiazepines, alcohol): enhance sedation and respiratory depression. - CYP2D6 inhibitors (e.g., quinidine, fluoxetine): raise tramadol plasma levels, risk of toxicity. - Other opioids: additive opioid effects leading to respiratory compromise.

Moderate Interactions (Monitor Closely): - Antihypertensives: tramadol may affect blood pressure control. - Antidiabetic agents: possible alteration of glucose levels. - Warfarin: paracetamol may increase INR, requiring monitoring. - Antihistamines: may increase sedation. - Anticonvulsants: may affect seizure threshold.

Frequently asked questions

What is Ixprim used for?+
Ixprim is a prescription tablet that combines tramadol hydrochloride and paracetamol to provide analgesia for moderate to severe acute pain, post‑operative pain, and musculoskeletal pain in adult patients. It is intended for short‑term use when opioid therapy is appropriate.
How does Tramadol Hydrochloride, Paracetamol work?+
Tramadol acts as a µ‑opioid receptor agonist and inhibits the reuptake of norepinephrine and serotonin, enhancing descending pain inhibition. Paracetamol works mainly by central inhibition of cyclooxygenase enzymes, reducing prostaglandin synthesis in the brain, which contributes to analgesic and antipyretic effects. Together they provide synergistic pain relief.
What determines the dose of Ixprim?+
The dose of Ixprim is individualized by the prescribing clinician based on the severity of pain, patient age, weight, renal and hepatic function, and any concomitant medications. No fixed dosing regimen is provided here; the prescriber will set the appropriate strength and frequency.
Is Ixprim safe in pregnancy or breastfeeding?+
The pregnancy category for Ixprim is listed as unknown, and safety data are limited. It should be used only if the potential benefit justifies the potential risk to the fetus. Caution is also advised during breastfeeding, as both tramadol and paracetamol can be excreted in milk.
How do I order Ixprim from GNH USA?+
To order Ixprim, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA supplies hospitals, pharmacies and procurement teams worldwide, and will request trade or institutional credentials. The sales team will then reply with pricing, availability, shipping details and any required import documentation.
How does Ixprim compare with other analgesics?+
Compared with tramadol alone, Ixprim adds paracetamol, which can enhance pain relief while allowing lower opioid doses, potentially reducing opioid‑related side effects. Compared with paracetamol alone, the addition of tramadol provides stronger analgesia for moderate to severe pain but introduces opioid‑related risks that require monitoring.
How should Ixprim be stored and handled?+
Ixprim tablets should be stored at ambient temperature, below 25 °C, in their original packaging to protect them from moisture and light. Keep the container tightly closed and out of reach of children.
How is Ixprim administered?+
Ixprim is taken orally as a whole tablet with a glass of water. It should be swallowed whole and not crushed or chewed, unless otherwise directed by a healthcare professional.
What are the most serious risks to watch for?+
Serious risks include respiratory depression, especially in patients with compromised breathing; seizures, which may be precipitated by high doses or interacting drugs; serotonin syndrome when combined with serotonergic agents; severe skin reactions such as Stevens‑Johnson syndrome; and anaphylaxis. Immediate medical attention is required if any of these occur.
Who should not use Ixprim?+
Ixprim is contraindicated in patients with known hypersensitivity to tramadol, paracetamol, or any excipients, as well as in individuals taking monoamine oxidase inhibitors. Caution is advised in patients with severe respiratory depression, uncontrolled epilepsy, severe hepatic impairment, or those with a history of substance misuse.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Tramadol Hydrochloride, Paracetamol
Route
Oral Use
Manufacturer
Grünenthal Pharma Ltd.
Origin
EU

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