Tramazac

Description

Tramazac Injection (Tramadol Hydrochloride)

Tramazac 100mg Injection, manufactured by Zydus Pharmaceuticals, is available in Nepal. Its generic name is Tramadol Hydrochloride.

Indications

Tramazac Injection is prescribed for managing moderate to severe pain, including postoperative pain.

Dosage Information

Important: Dosage must be tailored to individual patient needs and response.

Adult Dosing

• Parenteral (IM/IV):
  • Moderate to Severe Pain: 50-100 mg intramuscularly (IM) or intravenously (IV) every 4-6 hours, administered over 2-3 minutes.
  • Postoperative Pain:
    • Initial: 100 mg.
    • Follow-up: 50 mg every 10-20 minutes if required, up to a total of 250 mg in the first hour (including the initial dose).
    • Maintenance: Thereafter, 50-100 mg every 4-6 hours, up to a total daily dose of 600 mg.
• Oral (Immediate Release – Note: This section refers to general Tramadol oral forms, not specifically Tramazac Injection):
  • Chronic Pain: Begin with 25 mg orally (PO) every morning. The dose can be increased by 25-50 mg/day every 3 days, up to 50-100 mg PO every 4-6 hours as needed. Do not exceed 400 mg/day.
  • Acute Pain: Take 50-100 mg PO every 4-6 hours as needed. Do not exceed 400 mg/day.
• Oral (Extended Release – Note: This section refers to general Tramadol oral forms, not specifically Tramazac Injection):
  • Start with 100 mg PO once daily. Increase by 100 mg/day every 5 days as needed. Do not exceed 300 mg/day.

Special Populations

• Elderly (>75 years): The dosing interval may need to be extended.
• Severe Hepatic Impairment:
  • Immediate Release (Oral): 50 mg PO every 12 hours.
  • Extended Release (Oral): Not recommended.

Pediatric Dosing

• Immediate Release (for Moderate-to-Severe Pain – Note: This section refers to general Tramadol oral forms):
  • <17 years: Safety and efficacy have not been established.
  • >17 years (Acute Pain): 50-100 mg PO every 4-6 hours as needed. Do not exceed 400 mg/day.
  • >17 years (Chronic Pain): Begin with 25 mg PO every morning. Increase by 25-50 mg/day every 3 days as separate doses, up to 50-100 mg PO every 4-6 hours as needed. Do not exceed 400 mg/day.
• Extended Release (Note: This section refers to general Tramadol oral forms):
  • <18 years: Safety and efficacy have not been established.

Renal Impairment

• Creatinine Clearance (CrCl) 10-30 mL/min: Increase the dosing interval to every 12 hours.
• CrCl <10 mL/min: Contraindicated.

Administration

While the product is an injection, general Tramadol information states it may be taken with or without food (relevant for oral forms).

Contraindications

Do not use Tramazac Injection in patients who are:

• Suicidal
• Experiencing acute alcoholism
• Suffering from head injuries
• Having raised intracranial pressure
• With severe renal impairment
• Lactating (breastfeeding)

Precautions

Use Tramazac Injection with caution in patients with:

• Emotional disturbance or depression
• A history of epilepsy or risk of seizures
• Head injury
• Increased intracranial pressure
• Renal or hepatic impairment
• Elderly patients
• Pregnancy and lactation (refer to the detailed section below)

Patient Counseling: This medication may impair your ability to drive or operate machinery.

Monitoring Parameters: Your healthcare provider will monitor your pain relief, respiratory rate, blood pressure, pulse rate, and watch for signs of tolerance, abuse, or suicidal ideation.

Pregnancy and Lactation

• Lactation: Tramadol is found in high concentrations in breast milk and is not recommended for breastfeeding mothers.
• Pregnancy: Use with caution.

Drug Interactions

• Increased Risk of Convulsions or Serotonin Syndrome: This risk increases when Tramazac is used with SSRIs, serotonin-norepinephrine reuptake inhibitors (SNRIs), TCAs, and other seizure-threshold-lowering drugs (e.g., bupropion, mirtazapine, tetrahydrocannabinol).
• Decreased Serum Concentrations: When taken with carbamazepine.
• Potentiation of Antidepressant Effect: May enhance the effect of norepinephrine, 5-HT agonists, or lithium.
• Increased INR and Ecchymoses: When used with coumarin derivatives (e.g., warfarin).
• Potentially Fatal: There is an increased risk of seizure and serotonin syndrome when used with MAOIs.

Adverse Effects

Very Common (>10%): Constipation, nausea, dizziness, vertigo, headache, somnolence, vomiting, agitation, anxiety, emotional lability, euphoria, hallucinations, nervousness, spasticity, dyspepsia, asthenia, pruritus.

Common (1-10%): Diarrhea, dry mouth, sweating, hypertonia, malaise, menopausal symptoms, rash, urinary frequency, urinary retention, vasodilation, visual disturbance.

Less Common (<1%): Abnormal gait, amnesia, cognitive dysfunction, depression, difficulty in concentration, dysphoria, dysuria, fatigue, menstrual disorder, motor system weakness, orthostatic hypotension, paresthesia, seizures, suicidal tendencies, syncope, tachycardia, tremor.

Frequency Not Defined: Abnormal electrocardiogram (ECG), angioedema, bronchospasm, flushing, hypertension, hypotension, myocardial ischemia, palpitation, urticaria, withdrawal syndrome.

Potentially Fatal: Respiratory depression.

Mechanism of Action

Tramadol works by inhibiting the reuptake of norepinephrine and serotonin, and by enhancing serotonin release. It alters your perception and response to pain by binding to mu-opioid receptors in the central nervous system (CNS).

Disclaimer: This information is for general knowledge and is not intended for diagnosis, medical advice, or treatment. It is not a substitute for professional medical judgment. Always consult with a healthcare professional for any medical concerns