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Siverol

Tramadol hydrochloride




Brand Name, Dosage Format and Strength
Siverol  50mg/mL Solution for Injection

Therapeutic Category
Central Nervous System

Class
Opioid, Non-Opioids, NSAID, Anticonvulsant, Antiepileptic, Antidepressant, SSRI, Antipsychotic, Anti-Vertigo, CNS Stimulant, Neuroprotective Agent, Sedative, Hypnotic


DOSAGE AND ADMINISTRATION

Like any other analgesic drug, the dosing of tramadol should be adjusted according to the severity of pain and patient’s clinical response.

The lowest effective analgesic dose should be given.

Strict aseptic technique should be observed when drawing up the contents of tramadol ampule.  If injection ampules become contaminated, they have the potential to become a source of infection to patients     

Adults and children over 12 yrs old:

DOSAGE FORM

PAIN SEVERITY

RECOMMENDED DOSE

FOR ORAL ADMINISTRATION:

 

Tramadol 50 mg Cap

 

 

Moderate Pain

  • Initial Dose: Orally, 50 mg (1 cap) administered BID or TID.
  • May be increased to       100 mg (2 caps) BID or TID.

Moderate to Severe Pain

  • Orally, 50 mg to 100 mg

     (1 to 2 caps) as needed,

     every 4 to 6 hrs.

  • The 100 mg dose is usually more effective as the initial dose for more severe pain.
  • Maximum Dose:

     400 mg/day

FOR PARENTERAL ADMINISTRATION:

IV or IM injection  

 

Tramadol 50 mg/1 mL Solution for Injection or

Tramadol 100 mg/2 mL  Solution for Injection

Postoperative pain

  • Initial bolus of 100 mg should be administered.
  • During the 60 mins after the bolus, additional doses of  50 mg may be given every 10 to 20 mins up to a total dose of 250 mg (including the bolus dose).
  • Subsequent doses of 50 mg or 100 mg every 4 to 6 hrs may be given, up to a total daily dose of 600 mg. A total parenteral daily dose of 600 mg should not be exceeded except in special circumstances.

Less severe pain

  • 50 mg or 100 mg administered every 4 to 6 hrs not to exceed 400 mg/day.

IV injection should be given slowly over 2 to 3 mins.

Or, as prescribed by a physician

SPECIAL POPULATION:
Patients with Renal Impairment/Renal Dialysis

  • Impaired renal function results in a decreased rate and extent of excretion of tramadol and M1. The usual initial adult doses should be employed, but the dosage interval should be adjusted.
  • Creatinine clearance <30 mL/min: Dose interval should be increased to 12 hrs.
  • Creatinine clearance <10 mL/min (severe renal impairment):   Tramadol HCl is not recommended.
  • Dialysis patients can receive their regular dose on the day of dialysis since only 7% of an administered dose is removed by hemodialysis.
  • Tramadol is removed very slowly by hemodialysis or hemofiltration and therefore postdialysis dosing to maintain analgesia is usually unnecessary.

Patients with Hepatic Impairment

  • An initial dose of 50 mg is given. Depending on the severity of the impairment and individual clinical response, the recommended dosage interval of 4 to 6 hrs may need to be extended, and/or the dose level titrated as required.  
  • Severe hepatic impairment: Elimination of tramadol may be prolonged in severe hepatic impairment including liver cirrhosis. Although the usual initial adult doses can be used, dosing should be at 12 hourly intervals. 

Elderly patients

  • Changes in renal and/or hepatic function in the elderly may require dose adjustment. Daily doses of 300 mg are not recommended in patients over 75 yrs. 

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