Tramadol Domina

Tramadol Domina

COMPOSITION:

Each 1ml parenteral solution contains 50mg Tramadol hydrochloride.

Mechanism of action:

Pharmacotherapeutic Group: Opioid analgesics

Tramadol is a centrally acting analgesic which possesses opioid agonist properties. It is active as an inhibitor of noradrenalin and serotonin uptake thereby modifying the transmission of pain impulses.

Tramadol also has an antitussive action.   

Pharmacokinetic properties :

The mean bioavailability after intramuscular administration was found to be 100% and has a high tissue affinity with an apparent volume of distribution. Tramadol undergoes hepatic metabolism and is essentially excreted via the kidneys. 

Indications: Dominadol is indicated for treatment of moderate to severe pain  

Contraindications:
  • Patients who have previously shown hypersensitivity to tramadol
  • Patients suffering from acute intoxication with hypnotics, centrally acting analgesics, opioid, psychotropic drugs or alcohol.
  • Patients who are receiving monoamino oxidase inhibitors or within 2 weeks of their withdrawal.
  • Patients suffering from uncontrolled epilepsy
  • Tramadol must not be used for narcotic withdrawal treatment. 

 Warnings/Precautions:

  • On long term use tolerance, psychic and physical dependence may develop. In patients with a tendency to drug abuse or dependence, treatment should be short periods under strict medical supervision.
  • Tramadol injection is not a suitable substitute in opioid dependent patients. The product does not suppress morphine withdrawal symptoms although it is an opioid agonist.
  • Patients with a history of epilepsy or those susceptible to seizures should only be treated with tramadol if there are compelling reasons.
  • Tramadol injection should be used in cautions in who have hypersensitivity to opiates and in patients with severe renal or hepatic impairment, head injury, decreased level of consciousness, increased intracranial pressure, or patients in shock or at risk of convulsions.
  • Care should be taken when administrating tramadol injection to patients with existing respiratory depression or excessive bronchial secretion and in those patients taking concomitant CNS depressants drugs. 

Side Effects:

Very common: nausea, dizziness and vomiting.

Common: Headaches, drowsiness, constipation, dry mouth, sweating and fatigue.

Uncommon and rare: allergic reactions, changes in appetite, psychiatric disorders, blurred vision, flushing, effects on cardiovascular regulation, gastrointestinal irritation.

Drug and Food Interactions:

  • ​Tramadol may potentiate the CNS depressant effects of other centrally acting drugs (including alcohol).
  • Tramadol can induce convulsions and increase the potential for selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, tricyclic antidepressants, antipsychotics and other threshold lowering medicinal products to cause convulsions.
  • Concomitant therapeutic use of tramadol and serotonergic drugs may cause serotonin toxicity.
  • Administration of tramadol injection and carbamazepine results in markedly decreased serum concentrations of tramadol.
  • Caution should be taken during concomitant treatment with tramadol and coumarin derivatives due to reports of increased INR and ecchymoses in some patients.
  • The combination of mixed agonists/antagonists and tramadol is not recommended. 

Pregnancy and lactation:

pregnancy category (C) The product should not be used during pregnancy and lactation. 

Effects on ability to drive and use machines:

Patients should be warned not to drive or operate machinery.

DosesIndications:

- The product is indicated for parenteral administration either intramuscularly, by slow intravenous injection or by infusion.

- The dose of tramadol injection should be adjusted to the intensity of the pain and the sensitivity of the individual patients. 

  • Adults:

50 or 100mg 4-6 hourly (Intravenous injection must be given slowly over 2-3minutes).

In post operative pain, an initial bolus of 100mg is administered. For the 60minutes following this initial bolus, 50mg doses may be given every 10-20minutes up to a total dose of 250mg including the initial bolus.

Subsequent doses should be 50 or 100mg 4-6hourly up to a total daily dose of 600mg. 

A total parenteral daily dose of over 600mg should not be exceeded expect in special circumstances.

  • Elderly patients:

The dosage intervals should be carefully considered according to the patients requirements.

  • Renal and/or hepatic impairment:

Creatinine clearance <30ml/min the dosing should be increased to 12hourly intervals

Creatinine clearance <10ml/min tramadol is not recommended

  • Children: Over 12 years: dosage as for adults

                 Under 12 years: should not be used

OverdosesToxicity:

Symptoms of tramadol overdose are typical of opioid analgesics and they may include: vomiting, miosis, sedation, seizures, respiratory depression and hypotension, with circulatory failure and coma. Respiratory failure may also occur.

Treatment requires the maintenance of the airway and cardiovascular functions. 


Address

Domina Pharmaceuticals
P.O. Box : 9622
Damascus - Syria

Contacts

Email: info@dominapharm.com
Phone: +963 (11) 33 192 32
Phone: +963 (11) 33 201 04
Mobile: +963 (932) 993 304 159
Mobile: +963 (932) 993 366 254