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Brand Name :
INFEN-P
Synonyms :
dexketoprofen / paracetamol
Class :
NSAID
Dosage forms and strengths
INFEN-P
dexketoprofen/paracetamol (film coated tablet)
25 mg/325 mg
Not indicated
Dosage forms and strengths
INFEN-P
dexketoprofen/ paracetamol (film coated tablet)
25 mg/325 mg
The starting daily maximum dose not more than 50 mg
May consider raising the dosage to levels suggested for the common population, but only if it is well-tolerated
Actions and Spectrum:
Action:
dexketoprofen is a nonsteroidal anti-inflammatory drug (NSAID). Its primary mechanism of action is to inhibit the activity of cyclooxygenase enzymes (COX-1 and COX-2). These enzymes produce prostaglandins, chemicals in the body that mediate pain and inflammation. By inhibiting COX enzymes, dexketoprofen reduces the production of prostaglandins, thereby decreasing pain and inflammation.
paracetamol
paracetamol is thought to function by suppressing the activity of an enzyme known as cyclooxygenase (COX) within the brain. Unlike NSAIDs like dexketoprofen, paracetamol has a minimal anti-inflammatory effect and primarily acts on the central nervous system to reduce pain perception and lower fever.
Spectrum
dexketoprofen is primarily used for the treatment of acute pain, such as postoperative pain, dental pain, musculoskeletal pain, and dysmenorrhea (menstrual pain). It is more specific to pain and inflammation and is not typically used to reduce fever.
paracetamol
paracetamol is a frequently employed medication for alleviating mild to moderate discomfort, which includes conditions like headaches, dental pain, and musculoskeletal pain. Additionally, it serves to lower elevated body temperature associated with fever. It is often the preferred choice when non-steroidal anti-inflammatory drugs (NSAIDs) are contraindicated, especially in individuals with a medical history involving stomach ulcers or bleeding disorders.
Frequency not defined
Nausea/vomiting
Abdominal pain
Diarrhea
Dyspepsia
Headache
Dizziness
Flushing
Gastritis
Constipation
Dry mouth
Black Box Warning:
None
Contraindication/Caution:
Hypersensitivity: Do not use dexketoprofen or paracetamol if you have a known hypersensitivity or allergy to either of these medications or any of their components.
Severe Renal Impairment: Both dexketoprofen and paracetamol should be used with caution or avoided in individuals with severe renal impairment (kidney disease) as they may accumulate in the body and lead to toxicity.
Severe Hepatic Impairment: People with severe liver disease should also be cautious when using dexketoprofen and paracetamol, as they can affect liver function. In such cases, close monitoring and adjusted dosages may be necessary.
Active Peptic Ulcer Disease: dexketoprofen can potentially aggravate peptic ulcers or gastrointestinal bleeding. Therefore, it should not be used in individuals with active peptic ulcer disease.
Gastrointestinal Bleeding: Both medications can increase the risk of gastrointestinal bleeding. If you have a history of gastrointestinal bleeding or are currently experiencing it, avoid these medications.
Asthma: dexketoprofen and paracetamol can trigger or worsen asthma in some individuals. People with a history of asthma should use these medications cautiously and under medical supervision.
Pregnancy and Breastfeeding: The use of these medications during pregnancy and breastfeeding should be discussed with a healthcare provider. They may be contraindicated or require careful monitoring during these periods.
Pregnancy warnings:
Pregnancy category: N/A
Lactation: Excreted into human milk is unknown
Pregnancy Categories:
Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester.
Category B: There were a lack of studies on pregnant women and no evidence of risk to the fetus in animal experiments.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Pharmacology:
dexketoprofen and paracetamol are two commonly used analgesic (pain-relieving) and antipyretic (fever-reducing) medications.
Pharmacodynamics:
dexketoprofen
It inhibits by blocking the activity of the enzyme cyclooxygenase (COX), specifically targeting COX-1 and COX-2.
Inhibition of COX enzymes reduce the production of prostaglandins, which are chemicals that play a role in pain, inflammation, and fever.
paracetamol
It is believed to work primarily by inhibiting COX enzymes, but it has a stronger affinity for COX in the central nervous system than in peripheral tissues.
Unlike NSAIDs, it has minimal anti-inflammatory effects.
Pharmacokinetics:
Absorption
dexketoprofen exhibits efficient oral absorption, rapidly entering the gastrointestinal system and achieving its highest plasma levels approximately two hours following ingestion.
paracetamol is also well-absorbed from the gastrointestinal tract. It is rapidly absorbed, and peak plasma concentrations are typically reached within 30 to 60 minutes after oral administration.
Distribution
dexketoprofen has a moderate volume of distribution, indicating that it is distributed relatively evenly throughout the body.
paracetamol is distributed widely in the body, including crossing the blood-brain barrier. It is primarily distributed in the liver and kidney, where it exerts its analgesic and antipyretic effects.
Metabolism
dexketoprofen undergoes hepatic metabolism, primarily through glucuronidation and hydroxylation, with some involvement of CYP2C9 enzymes.
paracetamol undergoes its primary metabolic processes in the liver via glucuronidation and sulfation.
A small portion of it is metabolized by CYP2E1 to a highly reactive and potentially toxic intermediate, which is then detoxified by conjugation with glutathione.
Excretion and Elimination
Most of dexketoprofen and its metabolites are eliminated through the urinary system, while a smaller portion is excreted in the fecal matter.
Most of the paracetamol and its metabolites are excreted in the urine. A small portion is also excreted in the feces.
Administration:
The dosage of dexketoprofen and paracetamol can vary depending on your age, weight, medical condition, and the specific product you are using.
Follow your doctor’s or pharmacist’s recommendations carefully.
Do not exceed the recommended dosage.
Typically, these medications are taken orally with a glass of water.
Patient information leaflet
Generic Name: dexketoprofen /paracetamol
Why do we use dexketoprofen /paracetamol?
After surgical procedures, patients often experience both pain and inflammation. The combination of dexketoprofen and paracetamol can be effective in managing these symptoms, improving patient comfort, and potentially reducing the need for opioid-based pain relievers.
Dental procedures can result in both pain and inflammation. The combination of these medications may be prescribed to alleviate the discomfort associated with dental surgery or dental infections.
For conditions like sprains, strains, or muscle pain where inflammation and pain coexist, the combination of dexketoprofen and paracetamol can provide more comprehensive relief.
Some healthcare professionals may prescribe a combination of dexketoprofen and paracetamol for the treatment of migraine headaches, as this combination can target both the pain and, in some cases, the inflammation associated with migraines.