Clofenac DT50 mg

Clofenac DT is a nonsteroidal anti-inflammatory drug (NSAID) formulated using fine-particle (submicronized) technology to enhance dissolution and absorption, allowing effective pain relief at lower milligram doses than conventional diclofenac salts.

Established/FDA-Approved Uses (Adults)

• Management of osteoarthritis (OA) pain
• Management of mild-to-moderate acute pain

Notes on Formulation-Specific Use

Clofenac DT capsules are not interchangeable on a milligram-for-milligram basis with other diclofenac products (such as diclofenac sodium or diclofenac potassium), because the fine-particle formulation achieves comparable effect at reduced doses. Clofenac DT is indicated for short-term, symptomatic relief only; it does not alter the underlying disease process in osteoarthritis.

Clofenac DT is not approved for use in children, and is not intended for chronic use beyond what is clinically necessary.

Each capsule contains Diclofenac Free Acid (submicronized, as the free acid rather than a sodium or potassium salt) in strengths of 18 mg or 35 mg, formulated with fine-particle technology to improve dissolution. Exact strengths, excipients, and available pack sizes may vary by manufacturer and market.

Clofenac DT is a phenylacetic acid derivative NSAID supplied in its unsalted (free acid) chemical form and manufactured as submicronized particles to improve solubility and the rate of absorption compared with conventional diclofenac sodium or diclofenac potassium salts. This allows Clofenac DT capsules to provide analgesic and anti-inflammatory effects at lower doses. Clofenac DT is used for osteoarthritis pain and for mild-to-moderate acute pain in adults.

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

Pharmacodynamics

Diclofenac Free Acid non-selectively inhibits cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes, reducing the synthesis of prostaglandins that mediate pain, inflammation, and fever. Its mechanism of anti-inflammatory, analgesic, and antipyretic action is the same as that of other diclofenac salts; the free-acid, submicronized formulation differs only in its dissolution and absorption characteristics, not its receptor-level activity.

Pharmacokinetics

• Absorption: The submicronized free-acid particles dissolve rapidly, giving faster and more consistent absorption than standard-particle diclofenac salts, permitting lower effective doses; food delays and reduces peak absorption.
• Distribution: Highly bound to plasma proteins (greater than 99%, mainly albumin).
• Metabolism: Extensively metabolized in the liver, mainly via CYP2C9, to hydroxylated metabolites that are further conjugated.
• Elimination: Eliminated mainly via urine (as glucuronide/sulfate conjugates) and bile; elimination half-life is approximately 1.5-2 hours.

Clofenac DT capsules should be swallowed whole with a glass of water. Do not crush, chew, or open the capsule, as the submicronized particle formulation is designed to be taken intact. Capsules may be taken with or without food; taking with food may reduce stomach upset but can slightly delay onset of pain relief. See Dosage and Administration for complete dosing schedules.

Clofenac DT has clinically significant interactions with the following medicines:

Common

• Headache
• Nausea, diarrhea, dyspepsia, abdominal pain
• Constipation, flatulence
• Elevated liver enzymes
• Dizziness

Uncommon

• Vomiting
• Fluid retention/edema
• Increased blood pressure
• Rash, pruritus
• Tinnitus

Rare/Serious

• Gastrointestinal ulceration, bleeding, or perforation
• Cardiovascular thrombotic events (myocardial infarction, stroke) - see Precautions and Warnings
• Severe hepatotoxicity, including hepatitis and liver failure (rare but reported with diclofenac specifically)
• Acute renal failure
• Severe hypersensitivity reactions, including anaphylaxis and angioedema
• Serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) - rare
• Bronchospasm in 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

Clofenac DT is contraindicated during the third trimester of pregnancy because NSAIDs can cause premature closure of the fetal ductus arteriosus. In addition, use of NSAIDs, including Clofenac DT, at or after 20 weeks of pregnancy may cause fetal renal dysfunction leading to low amniotic fluid (oligohydramnios), and should generally be avoided from that point onward unless clearly necessary. Use earlier in pregnancy is not recommended unless the potential benefit justifies the potential risk to the fetus, and only under medical supervision at the lowest effective dose for the shortest duration; consult a physician before use.

Lactation

Diclofenac (including the free-acid form) passes into breast milk in small amounts. Use of Clofenac DT while breastfeeding is generally not recommended unless a physician determines the benefit outweighs the potential risk to the nursing infant; if used, the lowest effective dose for the shortest duration should be chosen and the infant monitored.

Boxed Warning: Cardiovascular Risk

Clofenac DT, like other NSAIDs, can increase the risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use and in patients with existing cardiovascular disease or risk factors. Clofenac DT is contraindicated for the treatment of perioperative pain in the setting of CABG surgery.

Boxed Warning: Gastrointestinal Risk

Clofenac DT can cause serious gastrointestinal adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal; these events can occur at any time during use and without warning symptoms. Elderly patients and those with a prior history of peptic ulcer disease or GI bleeding are at greater risk.

Hepatotoxicity

Elevations of liver enzymes and, rarely, severe hepatic reactions (including liver failure) have been reported specifically with diclofenac products. Monitor liver function periodically with prolonged use, and discontinue if abnormal liver test results persist or worsen, or if clinical signs/symptoms of liver disease develop.

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, particularly with prolonged use.

Fluid Retention and Hypertension

Clofenac DT can cause new-onset hypertension or worsening of pre-existing hypertension, and fluid retention/edema; use with caution in patients with heart failure or hypertension.

Other Precautions

• Use the lowest effective dose for the shortest duration necessary, particularly in patients with GI or cardiovascular risk factors; consider gastroprotection if risk factors are present.
• 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 dizziness; use caution when driving or operating machinery.
• Anaphylactoid reactions may occur even without prior exposure to Clofenac DT.

Symptoms of Clofenac DT overdose may include drowsiness, dizziness, nausea, vomiting, and epigastric pain, and in more severe cases gastrointestinal bleeding, hypertension, acute kidney injury, respiratory depression, coma, and seizures. There is no specific antidote for Clofenac DT overdose.

If an overdose of Clofenac DT 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 the lowest effective dose with close monitoring in mild-to-moderate renal impairment; contraindicated in severe renal impairment (see Contraindications).

Hepatic Impairment

Use the lowest effective dose with close monitoring in mild-to-moderate hepatic impairment; contraindicated in severe hepatic impairment.

Elderly

Start at the lowest recommended dose and monitor closely, as elderly patients have a higher risk of GI, renal, and cardiovascular adverse effects with Clofenac DT.

Pregnancy and Lactation

See Pregnancy and Lactation section for full details.

Children

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; contraindicated in the perioperative period of CABG surgery.

Clofenac DT should be used for the shortest duration necessary to control symptoms. For acute pain, treatment is typically limited to the period the pain persists, generally reassessed if needed beyond a few days. For osteoarthritis, periodic reassessment by a physician is recommended to confirm continued need and to monitor for cardiovascular, renal, GI, and hepatic effects. Prolonged use increases the risk of these adverse effects.

Diclofenac Free Acid belongs to the Non-Steroidal Anti-Inflammatory Drug (NSAID) class, within the phenylacetic acid derivative subgroup, alongside other diclofenac salt forms such as diclofenac sodium and diclofenac potassium.

Diclofenac Free Acid works by non-selectively inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, thereby blocking synthesis of the prostaglandins responsible for pain, inflammation, and fever. Its submicronized, unsalted (free acid) particle formulation improves dissolution and absorption compared with conventional diclofenac salts, allowing effective relief at lower doses. See Pharmacology for full pharmacodynamic and pharmacokinetic details.

The safety and efficacy of Clofenac DT in pediatric patients have not been established, and its use in children is not recommended. Clofenac DT should only be used in pediatric patients if specifically directed and supervised by a physician; no established pediatric dosing regimen exists.