Keto-D25 mg

Keto-D is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the symptomatic relief of mild-to-moderate acute pain. Its use should be limited to short-term treatment.

Established/Approved Uses

• Musculoskeletal pain (e.g., muscle strains, sprains, low back pain)
• Primary dysmenorrhea (menstrual pain)
• Dental pain (e.g., post-extraction pain)
• Post-operative pain (injectable formulation, in hospital settings, usually as part of a multimodal analgesia regimen)

Other Uses (Guideline-Supported/Limited Availability)

• Renal colic (adjunct, injectable formulation, in some countries)

Keto-D is not approved by the US FDA and is not intended for long-term or chronic pain management; it treats the symptom of pain and does not address the underlying cause.

Each tablet of Dexketoprofen typically contains Dexketoprofen 12.5 mg or 25 mg (as dexketoprofen trometamol). An injectable solution containing Dexketoprofen 50 mg/2 mL (as dexketoprofen trometamol) is also available for intramuscular or intravenous use in hospital settings. Exact strength and available dosage forms may vary by manufacturer and market.

Keto-D is the pharmacologically active dextrorotatory (S-(+)) enantiomer of the racemic NSAID ketoprofen. It belongs to the arylpropionic acid class of NSAIDs and provides analgesic, anti-inflammatory, and antipyretic effects by inhibiting cyclooxygenase (COX) enzymes. Keto-D is used for short-term relief of mild-to-moderate acute pain and is available as oral tablets and, in hospital settings, as an injectable solution.

Keto-D belongs to the Non-Steroidal Anti-Inflammatory Drug (NSAID) class, specifically the arylpropionic acid (propionic acid) derivative group of non-selective cyclooxygenase (COX-1 and COX-2) inhibitors.

Pharmacodynamics

Dexketoprofen non-selectively inhibits cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes, reducing synthesis of prostaglandins that mediate pain, inflammation, and fever. As the active enantiomer of ketoprofen, Dexketoprofen provides comparable analgesic and anti-inflammatory activity at approximately half the dose of racemic ketoprofen.

Pharmacokinetics

• Absorption: Rapidly absorbed after oral administration; peak plasma concentration reached within about 15-45 minutes.
• Distribution: Highly bound to plasma proteins (approximately 99%).
• Metabolism: Primarily metabolized in the liver via glucuronidation.
• Elimination: Mainly excreted via the kidneys; elimination half-life is approximately 1-2.5 hours.

Keto-D tablets should be swallowed whole with water, preferably about 30 minutes before meals for a faster onset of action; they may be taken with food if gastric irritation occurs. Do not crush or chew the tablet. The injectable form of Keto-D must be administered by a healthcare professional via slow intravenous or deep intramuscular injection. See Dosage and Administration for complete dosing schedules.

Keto-D has clinically significant interactions with the following medicines:

Common

• Nausea, vomiting
• Abdominal pain, dyspepsia, diarrhea
• Headache, dizziness
• Somnolence

Uncommon

• Insomnia, anxiety
• Palpitations, flushing
• Dry mouth
• Elevated liver enzymes
• Pruritus, rash
• Fatigue

Rare/Serious

• Gastrointestinal ulceration, bleeding, or perforation
• Cardiovascular thrombotic events (myocardial infarction, stroke) - see Precautions and Warnings
• Severe hypersensitivity reactions, including anaphylaxis and angioedema
• Serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) - rare
• Acute renal failure, hepatitis
• Bronchospasm in susceptible (aspirin/NSAID-sensitive) patients

Patients should seek prompt medical attention for signs of a severe allergic reaction, black or bloody stools, unexplained bruising/bleeding, or yellowing of the skin or eyes.

Pregnancy

Keto-D is contraindicated during the third trimester of pregnancy due to risk of premature closure of the fetal ductus arteriosus, fetal renal impairment, and reduced amniotic fluid (oligohydramnios). Use during the first and second trimesters is not recommended unless clearly necessary; if used, the lowest effective dose for the shortest duration should be given, only if the potential benefit justifies the potential risk to the fetus, and only under medical supervision. NSAID use early in pregnancy has been associated with an increased risk of miscarriage in some studies.

Lactation

It is not known with certainty whether Keto-D passes into human breast milk in clinically significant amounts; because of the potential for adverse effects in a nursing infant, use of Keto-D during breastfeeding is not recommended. A physician should be consulted and an alternative analgesic considered before use while breastfeeding.

Cardiovascular Risk

NSAIDs as a class, including Keto-D, may increase the risk of serious cardiovascular thrombotic events such as myocardial infarction and stroke; this risk may increase with duration of use and in patients with existing cardiovascular risk factors or disease. Keto-D is intended for short-term use only.

Gastrointestinal Risk

NSAIDs, including Keto-D, carry a risk of serious GI adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can occur without warning symptoms. Use the lowest effective dose for the shortest duration, particularly in elderly patients or those with a history of GI disease.

Renal Function

Use with caution in patients who are dehydrated, elderly, or taking concurrent nephrotoxic drugs, diuretics, or ACE inhibitors/ARBs; renal function should be monitored.

Fluid Retention

Fluid retention and edema have been reported; use with caution in patients with hypertension or heart failure.

Hepatic Function

Use with caution in patients with pre-existing liver disease; discontinue if signs of liver dysfunction develop.

Short-Term Use Only

Keto-D is indicated only for short-term treatment of acute pain and is not intended for chronic or long-term use, given its acute-pain indication and NSAID-class risks.

Other Precautions

• Avoid concurrent use with other NSAIDs or aspirin (including low-dose aspirin) unless specifically directed by a physician.
• May mask signs of infection (fever, inflammation).
• May cause drowsiness or dizziness; use caution when driving or operating machinery.
• Use with caution in patients with known hypersensitivity to other NSAIDs.

Symptoms of Keto-D overdose may include nausea, vomiting, abdominal pain, drowsiness, lethargy, headache, and, in more severe cases, gastrointestinal bleeding, hypertension, acute kidney injury, respiratory depression, and, rarely, hypotension or coma. There is no specific antidote for Keto-D overdose.

If an overdose of Keto-D is suspected, seek immediate medical attention or contact a poison control center/emergency services right away. Treatment is generally supportive and symptomatic and should be provided by trained medical personnel; do not attempt specific home treatment.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Renal Impairment

Use with caution and at reduced doses in mild-to-moderate renal impairment; contraindicated in severe renal impairment (see Contraindications).

Hepatic Impairment

Use with caution and at reduced doses in mild-to-moderate hepatic impairment; contraindicated in severe hepatic impairment.

Elderly

Start at the lower end of the dosing range and monitor closely, as elderly patients have a higher risk of GI, renal, and cardiovascular adverse effects with Keto-D.

Pregnancy and Lactation

See Pregnancy and Lactation section for full details.

Children and Adolescents

See Pediatric Uses section for full details.

Cardiovascular Disease

Use with caution and only after cardiovascular risk assessment in patients with pre-existing cardiovascular disease or risk factors.

Keto-D should be used for the shortest duration necessary to control symptoms. Oral treatment is generally not recommended beyond 5 days without medical reassessment, and injectable Keto-D is generally limited to short-term hospital use (commonly up to 2 days). Prolonged use increases the risk of gastrointestinal, renal, and cardiovascular adverse effects. A physician should be consulted if pain persists beyond the recommended duration.

Dexketoprofen belongs to the Non-Steroidal Anti-Inflammatory Drug (NSAID) class, within the arylpropionic acid derivative subgroup, alongside drugs such as ketoprofen and ibuprofen.

Dexketoprofen works by non-selectively inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, thereby blocking synthesis of the prostaglandins responsible for pain, inflammation, and fever. See Pharmacology for full pharmacodynamic and pharmacokinetic details.

The safety and efficacy of Keto-D in children and adolescents under 18 years of age have not been established, and its use in this age group is generally not recommended. Keto-D should only be used in pediatric patients if specifically directed and supervised by a physician; no established pediatric dosing regimen exists.