The action of the drug on the human body is called Pharmacodynamics in Medical terminology. To produce its effect and to change the pathological process that is happening the body and to reduce the symptom or cure the disease, the medicine has to function in a specific way. The changes it does to the body at cellular level gives the desired result of treating a disease. Drugs act by stimulating or inhibiting a receptor or an enzyme or a protein most of the times. Medications are produced in such a way that the ingredients target the specific site and bring about chemical changes in the body that can stop or reverse the chemical reaction which is causing the disease.
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Pharmacology: Pharmacodynamics: Dexketo care trometamol is the tromethamine salt of S-(+)-2-(3-benzoylphenyl) propionic acid, an analgesic, anti-inflammatory and antipyretic drug, which belongs to the nonsteroidal anti-inflammatory group of drugs (M01AE).
The mechanism of action of NSAIDs is related to the reduction of prostaglandin synthesis by the inhibition of cyclooxygenase pathway. Specifically, there is an inhibition of the transformation of arachidonic acid into cyclic endoperoxides, PGG2 and PGH2, which produce prostaglandins PGE1, PGE2, PGF2α and PGD2 and also prostacyclin PGI2 and thromboxanes (TxA2 and TxB2). Furthermore, the inhibition of the synthesis of prostaglandins could affect other inflammation mediators eg, kinins, causing an indirect action which would be additional to the direct action.
Dexketo care has been demonstrated to be an inhibitor for COX-1 and COX-2 activities in experimental animals and humans.
Clinical studies performed on several pain models demonstrated effective analgesic activity of Dexketo care trometamol.
Tablet: The onset of the analgesic activity was obtained in some studies at 30 min post-administration. The analgesic effect persists for 4-6 hrs.
Injection: The analgesic efficacy of IM and IV Dexketo care trometamol in the management of moderate to severe pain was investigated in several surgical pain models (orthopedic and gynecologic/abdominal surgery) as well as in musculoskeletal pain (acute low back pain model) and renal colic. In the studies performed, the onset of analgesic effect was rapid, and within the first 45 min the peak analgesic effect occurred. Duration of analgesic effect after the administration of Dexketo care 50 mg is usually 8 hrs.
Clinical studies in postoperative pain management have demonstrated that Dexketo care solution for injection or concentrate for solution for infusion when used in combination with opioids significantly reduced opioid consumption. In the postoperative pain studies where patients received morphine by a patient controlled analgesia device, patients treated with Dexketo care required significantly less morphine (between 30-45% less) than patients in the placebo group.
Pharmacokinetics:Tablet: After oral administration of Dexketo care trometamol to humans, the Cmax is reached at 30 min (range 15-60 min).
The distribution t½ and elimination t½ values of Dexketo care trometamol are 0.35 hrs and 1.65 hrs, respectively. As with other drugs with a high plasma protein-binding (99%), its volume of distribution has a mean value <0.25 L/kg. The main elimination route for Dexketo care is glucuronide conjugation followed by renal excretion.
After administration of Dexketo care trometamol only the S-(+) enantiomer is obtained in urine, demonstrating that no conversion to the R-(-) enantiomer occurs in humans.
In multiple-dose pharmacokinetic studies, it was observed that the AUC after the last administration is not different from that obtained following a single dose, indicating that no drug accumulation occurs.
When administered concomitantly with food, the AUC does not change, however the Cmax of Dexketo care trometamol decreases and its absorption rate is delayed (increased tmax).
Injection: After IM administration of Dexketo care trometamol to humans, the peak concentrations are reached at 20 min (range 10-45 min). For 25-50 mg single doses, the AUC has been shown to be dose proportional after both IM and IV administration.
In multiple-dose pharmacokinetic studies, it was observed that Cmax and AUC after the last IM or IV administration were not different from that obtained following a single dose, indicating that no drug accumulation occurs.
As with other medicinal products with a high plasma-protein binding (99%), the volume of distribution has a mean value <0.25 L/kg. The distribution t½ was approximately 0.35 hrs and the elimination t½ ranged between 1-2.7 hrs. The main elimination route for Dexketo care is glucuronide conjugation followed by renal excretion.
After administration of Dexketo care trometamol only the S-(+) enantiomer is obtained in urine, demonstrating that no conversion to the R-(-) enantiomer occurs in humans.
In healthy elderly subjects (≥65 yrs), exposure was significantly higher than in young volunteers after single and repeated oral doses (up to 55%) whereas there was no statistically significant difference in peak concentrations and time to reach peak concentration. The mean elimination t½ was prolonged after single and repeated doses (up to 48%), and the apparent total clearance was reduced.
Toxicology: Preclinical Safety Data: Preclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated-dose toxicity, genotoxicity, toxicity to reproduction and immunopharmacology. The chronic toxicity studies carried out in mice and monkeys gave a No Observed Adverse Effect Level (NOAEL) of 3 mg/kg/day. The main adverse effect observed at high doses was gastrointestinal erosions and ulcers that developed dose-dependently.
As it has been recognized for the whole pharmacological class of NSAIDs, Dexketo care trometamol may cause changes of embryo-fetal survival in animal models, both indirectly, through the gastrointestinal toxicity on the pregnant mothers, and directly upon the development of the fetus.
Dexketo care administration
Administration of drug is important to know because the drug absorption and action varies depending on the route and time of administration of the drug. A medicine is prescribed before meals or after meals or along with meals. The specific timing of the drug intake about food is to increase its absorption and thus its efficacy. Few work well when taken in empty stomach and few medications need to be taken 1 or 2 hrs after the meal. A drug can be in the form of a tablet, a capsule which is the oral route of administration and the same can be in IV form which is used in specific cases. Other forms of drug administration can be a suppository in anal route or an inhalation route.
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Should be taken on an empty stomach. Take 30 min before meals, esp for quick relief of acute pain.
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