TRADOL-50

TRADOL-50
29 May

TRADOL-50

Analgesics, Antipyretics, Anti-Inflammatory drugs

-Tramadol is a centrally acting synthetic analgesic compound. 
 Its analgesic effects are mediated via both the stimulation of 
 μ-opioid receptors and indirect modulation of central  
 monoaminergic inhibitory pain pathways. 
- Tramadol is rapidly and almost completely absorbed after 
 oral administration and extensively metabolized. 
- Analgesic effect begins approximately within one hour after 
 administration and reaches a peak in approximately two to 
 three hours. 
- Tramadol is widely distributed, crosses the placenta , and 
 appears in small amount in breast milk. 
- Approximately 30% of the dose is excreted in the urine as 
 unchanged drug, whereas 60% of the dose is excreted as 
 metabolites.
- The elemination half-life of Tramadol  is about 6 hours after  
 oral  administration.

Indecation

 TRADOL® is indicated in management of moderate to 
 severe pain. 

Dosage & Administration

 The dosage should be adjusted to the intensity of the pain.  
 Unless otherwise prescribed, TRADOL® should be 
 administered as follow:
-Single dose for adult and adolescents over 12 years of age:
 1-2 capsules (to be taken with a little liquid) and total daily  
 dosage should not exceed 400mg (8 capsules). 
-In elderly patients (over 75 Years) and renal insufficiency
 or hepatic insufficiency: 
 It may be necessary to prolong the dosage intervals to reach 12 
 hours. 

-Children:
 TRADOL® capsules are not intended for use in children  
 weighing less than 25 kg & generally do not allow individual 
 dosing in children below the age of 12 years. Therefore more 
 suitable formulations are to be used.

- Each capsule of TRADOL®    50 contains: 
 Tramadol hydrochloride         50 mg. 

 TRADOL® is contraindicated in known hypersensitivity 
 towards Tramadol.
- in acute intoxication with alcohol, hypnotics, analgesics, 
 opioids, or other psychotropic drugs. 
- also in patients who are receiving MAO inhibitors or who have 
 taken them within the last 14 days. 

- Carbamazepine is reported to diminish the analgesic  activity of   
 Tramadol by reducing serum concentrations.  
- Tramadol inhibits reuptake of noradrenaline and serotonin and enhances serotonin release and there is the possibility that it 
 may interact with other drugs that enhance monoaminergic 
 neurotransmission including: 
 Lithium, tricyclic antidepressants and selective serotonin 
 reuptake inhibitors.
- Quinidine may increase concentrations of Tramadol and 
 lower concentrations of its active metabolite.  

-TRADOL® should not be used in pregnant women prior to or 
 during labor.
-TRADOL® is not recommended for post delivery analgesia in 
 nursing mothers because its safety in infants and newborns has 
 not been studied.  

- Frequently: nausea and dizziness. 
- Occasionally: vomiting, constipation, sweating, dry mouth, 
 headache, drowsiness. 
- Rarely: effect on  circulatory regulation (palpitations, 
 tachycardia, feeling of weakness), gastrointestinal irritation, skin 
 reactions (pruritus, rash, urticaria.) 
- Very rarely: epileptic seizures, hypertension, bradycardia, and 
 respiratory depression.

- Blister of 10 capsules, Pack of one blister.
- Hospital packs of different sizes. 

-Store in a dry place below 25oC.