Cataflam50 mg

Cataflam is a fast-acting, non-steroidal anti-inflammatory drug (NSAID) formulated as a potassium salt for rapid dissolution and onset of action. It is indicated for the following:

Established / approved uses

• Mild to moderate acute pain, including post-traumatic and post-operative pain.
• Primary dysmenorrhea (painful menstrual cramps).
• Signs and symptoms of osteoarthritis.
• Signs and symptoms of rheumatoid arthritis.

Guideline-supported / commonly accepted uses

• Acute migraine attack (with or without aura), used as an abortive analgesic.
• Acute pain associated with minor surgery, dental procedures, and soft-tissue injuries.

Cataflam is intended for short-term, symptomatic relief; it does not alter the underlying course of chronic inflammatory disease. The lowest effective dose should be used for the shortest duration consistent with individual treatment goals.

Each tablet contains Diclofenac Potassium as the active pharmaceutical ingredient, commonly available in strengths of 25 mg and 50 mg, together with standard pharmaceutical excipients that permit rapid disintegration and dissolution for fast-onset pain relief.

Cataflam is the potassium salt of diclofenac, a phenylacetic acid derivative belonging to the non-steroidal anti-inflammatory drug (NSAID) class. Compared with diclofenac sodium, the potassium salt formulation is more water-soluble and is designed for faster disintegration and absorption, making it suitable for the rapid relief of acute pain and inflammation.

Cataflam possesses analgesic, anti-inflammatory, and antipyretic properties, and is used both as a stand-alone analgesic and as part of the management of musculoskeletal inflammatory disorders.

Cataflam 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.

Diclofenac Potassium exerts its analgesic, anti-inflammatory, and antipyretic effects primarily through non-selective inhibition of the cyclooxygenase (COX-1 and COX-2) enzymes, which reduces the synthesis of prostaglandins involved in pain, inflammation, and fever.

Pharmacokinetics

• Absorption: Rapidly and almost completely absorbed after oral administration; peak plasma concentration is reached in about 20–60 minutes in the fasting state, faster than diclofenac sodium.
• Bioavailability: Approximately 50–60% due to first-pass hepatic metabolism.
• Protein binding: Greater than 99%, mainly to albumin.
• Metabolism: Extensively metabolized in the liver via CYP2C9, primarily to 4′-hydroxydiclofenac and other hydroxylated metabolites.
• Elimination half-life: Approximately 1–2 hours.
• Excretion: Roughly 65% renally and 35% via bile/feces, mostly as metabolites.

Cataflam tablets are for oral use only. Swallow the tablet whole with a full glass of water. For fastest onset of pain relief, it may be taken on an empty stomach; if stomach upset occurs, it may be taken with food or milk, which may slightly delay onset. Do not crush or chew the tablet unless specifically directed.

Cataflam has the following well-documented, clinically significant drug interactions:

• Anticoagulants (e.g., warfarin) and antiplatelet agents (e.g., aspirin, clopidogrel): Increased risk of serious gastrointestinal bleeding.
• Other NSAIDs or aspirin: Concomitant use increases the risk of GI ulceration and bleeding without added therapeutic benefit; avoid combination.
• ACE inhibitors, angiotensin receptor blockers (ARBs), and diuretics: Cataflam may reduce their antihypertensive/diuretic effect and increase the risk of acute kidney injury, especially in volume-depleted patients.
• Lithium: Reduces renal clearance of lithium, increasing plasma lithium levels and risk of toxicity; monitor lithium levels.
• Methotrexate: Reduces renal clearance of methotrexate, increasing the risk of methotrexate toxicity, particularly at higher methotrexate doses.
• Cyclosporine: Increased risk of nephrotoxicity.
• Corticosteroids: Increased risk of GI ulceration and bleeding.
• Selective serotonin reuptake inhibitors (SSRIs): Increased risk of GI bleeding due to additive effects on platelet function.

The following adverse effects have been reported with Cataflam:

Common (occur in roughly 1–10% of patients)

• Abdominal pain, dyspepsia, nausea, diarrhea
• Headache, dizziness
• Elevated liver enzymes
• Skin rash

Less common / serious

• Gastrointestinal ulceration, bleeding, or perforation
• Cardiovascular thrombotic events (myocardial infarction, stroke) — see Precautions and Warnings
• Hepatotoxicity, including rare fulminant hepatitis
• Renal impairment or acute kidney injury
• Fluid retention, edema, or worsening hypertension
• Serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) — rare
• Hypersensitivity reactions, including anaphylaxis and bronchospasm — rare

Patients should seek prompt medical attention for signs of GI bleeding (black stools, vomiting blood), chest pain, sudden weakness or slurred speech, unusual bruising/bleeding, jaundice, or severe skin reactions.

Pregnancy: Cataflam should be avoided during pregnancy unless clearly necessary and only if the potential benefit justifies the potential risk to the fetus; use should be discussed with a physician. Use of NSAIDs, including Cataflam, is contraindicated starting at 30 weeks gestation (third trimester) because of the risk of premature closure of the fetal ductus arteriosus. Use between approximately 20 and 30 weeks gestation should be limited to the lowest effective dose for the shortest possible duration, as it may cause fetal renal dysfunction leading to oligohydramnios; if use beyond 48 hours is needed, ultrasound monitoring of amniotic fluid may be considered.

Lactation: Diclofenac passes into breast milk in small amounts. Cataflam should be used during breastfeeding only if clearly needed, with the infant monitored for potential adverse effects; consult a physician before use while breastfeeding.

Boxed warnings (class warnings for NSAIDs)

• Cardiovascular thrombotic risk: Cataflam may 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 increases with duration of use, dose, and in patients with existing cardiovascular disease or risk factors. Cataflam is contraindicated for perioperative pain in CABG surgery.
• Gastrointestinal risk: Cataflam increases the risk of serious GI adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can occur at any time during use and without warning symptoms, and can be fatal. Risk is higher in the elderly, in patients with a prior history of peptic ulcer disease or GI bleeding, and with concomitant use of anticoagulants, corticosteroids, other NSAIDs, aspirin, or SSRIs, and with alcohol use, smoking, or longer duration of therapy.

Other precautions

• Hepatotoxicity: Elevations of liver enzymes may occur; monitor liver function periodically, particularly during the first months of therapy, and discontinue if signs of liver dysfunction develop.
• Renal effects: May reduce renal blood flow and precipitate renal failure in patients with pre-existing renal impairment, volume depletion, heart failure, or in the elderly; use with caution and monitor renal function.
• Hypertension and fluid retention: May cause new-onset hypertension or worsening of pre-existing hypertension, and fluid retention/edema; use with caution in patients with heart failure.
• Hematologic effects: May inhibit platelet aggregation and prolong bleeding time.
• Skin reactions: Rare but serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) can occur, sometimes without warning; discontinue at the first appearance of a skin rash or hypersensitivity signs.
• Asthma-related exacerbation: Caution in patients with pre-existing asthma, as NSAIDs may precipitate bronchospasm in a subset of patients.
• Masking of infection signs: May reduce fever and inflammation, which can mask signs of an underlying infection.
• Use the lowest effective dose for the shortest duration consistent with individual treatment goals.

Overdose of Cataflam may cause lethargy, drowsiness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, and, in severe cases, hypertension, acute kidney injury, respiratory depression, or coma. There is no specific antidote.

In case of suspected overdose, seek immediate medical attention or contact a poison control center / emergency services right away. Management is supportive and may include measures such as activated charcoal if given soon after ingestion, under medical supervision; do not attempt to induce vomiting or manage a suspected overdose at home without professional guidance.

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

• Elderly: Higher risk of serious GI, cardiovascular, and renal adverse effects with Cataflam; use the lowest effective dose and monitor closely.
• Renal impairment: Use with caution; not recommended in severe renal impairment. Monitor renal function during treatment.
• Hepatic impairment: Use the lowest effective dose and monitor liver function, since diclofenac is extensively metabolized by the liver.
• Pediatric patients: Safety and efficacy have not been established for most age groups and indications; use only under specialist supervision where locally approved (see Pediatric Uses).
• Pregnancy and lactation: See Pregnancy and Lactation section.
• Cardiovascular disease/risk factors: Use with particular caution; contraindicated for CABG perioperative pain.

Cataflam is generally intended for short-term use for acute pain, dysmenorrhea, or migraine (typically a few days). For chronic conditions such as osteoarthritis or rheumatoid arthritis, it may be used longer under regular medical supervision, with periodic reassessment of the need for continued therapy, monitoring for GI, renal, hepatic, and cardiovascular safety, and use of the lowest effective dose for the shortest duration consistent with treatment goals.

Diclofenac Potassium belongs to the following drug classification groups:

• Non-steroidal anti-inflammatory drug (NSAID)
• Phenylacetic acid derivative
• Non-selective cyclooxygenase (COX-1 and COX-2) inhibitor

Diclofenac Potassium works by non-selectively inhibiting the cyclooxygenase enzymes COX-1 and COX-2, which are responsible for converting arachidonic acid into prostaglandins and thromboxanes. By reducing prostaglandin synthesis, Diclofenac Potassium decreases inflammation, pain sensitization, and fever. Its potassium salt form allows for faster dissolution and gastric absorption compared with diclofenac sodium, giving it a quicker onset of analgesic action.

Category C (Category D from approximately 30 weeks gestation / the third trimester)

The safety and efficacy of Cataflam have not been established in pediatric patients for most indications in major regulatory labeling. In some countries, Cataflam is used in adolescents older than 14 years at doses up to 75 mg/day in divided doses for short-term pain relief, but only under medical supervision. Cataflam should not be used in children below this age unless specifically directed by a pediatrician, given the lack of established safety data and the potential for the same GI, renal, and hepatic risks seen in adults.