Kop SR100 mg

Kop SR is a nonsteroidal anti-inflammatory drug (NSAID) of the propionic acid class, established for the following uses:

Established / FDA-approved uses

• Rheumatoid arthritis - relief of signs and symptoms.
• Osteoarthritis - relief of signs and symptoms of degenerative joint disease.
• Management of mild-to-moderate pain, including musculoskeletal pain, dental pain, and post-operative pain.
• Primary dysmenorrhea (menstrual cramping pain).

Guideline-supported / commonly used indications

• Acute soft-tissue conditions such as tendinitis, bursitis, and sprains/strains.
• Fever and headache, as a general analgesic-antipyretic (short-term, symptomatic use).

Kop SR is used only for symptomatic relief; it does not alter the underlying course of arthritic disease.

Each dose of Ketoprofen contains Ketoprofen as the active pharmaceutical ingredient. It is formulated as immediate-release capsules/tablets, extended-release capsules, injectable solution, or suppositories, depending on the product; inactive ingredients vary by manufacturer and dosage form.

Kop SR is a propionic-acid derivative nonsteroidal anti-inflammatory drug (NSAID) with analgesic, anti-inflammatory, and antipyretic activity. It is chemically related to other propionic acid NSAIDs such as ibuprofen and naproxen. Kop SR is available in immediate-release and extended-release oral formulations, as well as parenteral and rectal forms in some markets, and is widely used for pain and inflammatory joint conditions.

Kop SR belongs to the Nonsteroidal Anti-Inflammatory Drug (NSAID) class, specifically the propionic acid derivative subgroup.

Ketoprofen works primarily by non-selectively inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing the synthesis of prostaglandins that mediate pain, inflammation, and fever. It also has some inhibitory action on lipoxygenase and bradykinin activity, contributing to its analgesic effect.

Pharmacokinetics: Ketoprofen is rapidly and almost completely absorbed after oral administration, with peak plasma concentration reached within 0.5-2 hours (delayed with extended-release forms). It is approximately 99% bound to plasma proteins. The elimination half-life is roughly 1.1-4 hours for immediate-release forms. It is metabolized in the liver mainly via glucuronidation and excreted primarily in the urine.

Kop SR capsules/tablets should be taken orally with food or milk to minimize stomach upset. Extended-release forms must be swallowed whole. Injectable forms are administered by a healthcare professional. Do not exceed the prescribed dose or duration.

• Aspirin and other NSAIDs: Concurrent use increases the risk of gastrointestinal bleeding/ulceration and is generally not recommended; aspirin also lowers Kop SR plasma levels.
• Anticoagulants (e.g., warfarin) and antiplatelet agents: Additive bleeding risk due to combined effects on platelet function and gastric mucosa; monitor closely if co-administration is unavoidable.
• Corticosteroids: Increased risk of gastrointestinal ulceration and bleeding when combined with Kop SR.
• SSRIs/SNRIs: Increased risk of gastrointestinal bleeding when combined with Kop SR due to additive effects on platelet function.
• ACE inhibitors / ARBs / diuretics: Kop SR may reduce their antihypertensive/diuretic effect and increase the risk of renal impairment, especially in volume-depleted patients (the "triple whammy" effect).
• Lithium: Kop SR can raise plasma lithium concentrations to toxic levels; monitor lithium levels if co-administered.
• Methotrexate: Kop SR may reduce methotrexate clearance and increase its toxicity, particularly at higher methotrexate doses.
• Probenecid: Increases plasma concentrations of Kop SR; concomitant use is generally not recommended without dose adjustment.

The most common adverse effects (occurring in more than 1% of patients) include:

• Dyspepsia, nausea, abdominal pain, diarrhea, constipation, flatulence
• Headache, dizziness, drowsiness
• Rash, tinnitus, visual disturbances, fluid retention/edema

Less common but serious reactions (each fully explained under Precautions and Warnings) include gastrointestinal ulceration/bleeding/perforation, cardiovascular thrombotic events (MI, stroke), renal impairment/papillary necrosis, hepatotoxicity, serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), DRESS syndrome, anaphylactoid reactions, and blood dyscrasias. Seek prompt medical attention if any severe or unusual symptoms occur while taking Kop SR.

Pregnancy: Kop SR is contraindicated starting at approximately 30 weeks gestation (third trimester) due to the risk of premature closure of the fetal ductus arteriosus. Use between 20 and 30 weeks gestation should be avoided if possible; if needed, use the lowest effective dose for the shortest duration, as NSAID exposure in this period has been associated with fetal renal dysfunction leading to oligohydramnios. In earlier pregnancy, Kop SR should be used only if clearly needed and the potential benefit justifies the potential risk to the fetus; consult a physician before use at any stage of pregnancy.

Lactation: Use of Kop SR is not recommended in nursing mothers, as it is expected to pass into breast milk and safety data in this setting are limited. Consult a physician to weigh alternatives before use while breastfeeding.

Cardiovascular risk

Kop SR, like other NSAIDs, 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 may increase with duration of use. Use the lowest effective dose for the shortest duration possible. Kop SR is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal risk

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

Renal effects

Long-term use of Kop SR can cause renal papillary necrosis and other renal injury. Patients with pre-existing renal impairment, heart failure, liver dysfunction, or volume depletion, and the elderly, are at greatest risk of renal decompensation.

Hepatic effects

Borderline elevations of liver enzymes may occur; discontinue Kop SR if signs or symptoms of liver dysfunction develop or if abnormal liver test results persist or worsen.

Serious skin reactions

Kop SR can cause serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome, which can be fatal. Discontinue at the first appearance of skin rash or other signs of hypersensitivity.

Anaphylactoid/hypersensitivity reactions

Kop SR may cause anaphylactoid reactions even without prior exposure; patients with aspirin-sensitive asthma are at particular risk of severe bronchospasm.

Hematologic effects

Kop SR can cause anemia and inhibits platelet aggregation, increasing bleeding risk; monitor patients on anticoagulant therapy closely.

Masking of infection

The antipyretic and anti-inflammatory effects of Kop SR may reduce fever and inflammation, potentially masking signs of underlying infection.

Use in the elderly

Elderly patients are at higher risk of GI, renal, and cardiovascular adverse effects with Kop SR; use the lowest effective dose and monitor closely (see Use in Special Populations).

Symptoms of Kop SR overdose may include lethargy, drowsiness, nausea, vomiting, and epigastric pain; more severe cases can involve gastrointestinal bleeding, hypertension, acute renal failure, respiratory depression, coma, and (rarely) convulsions.

In case of suspected overdose, seek immediate medical attention or contact a poison control center right away. Treatment is supportive and symptomatic; there is no specific antidote. Do not attempt home treatment beyond seeking urgent professional care.

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

Pediatric use

Safety and effectiveness of Kop SR in patients below 18 years of age have not been established; its use in children is generally not recommended.

Geriatric use

Elderly patients (65 years and older) are more likely to have reduced renal and hepatic clearance of Kop SR and are at higher risk of GI bleeding and cardiovascular events. Use a reduced starting dose, particularly in patients over 75 years, and monitor closely.

Renal impairment

In mild renal impairment, limit Kop SR to a maximum of 150 mg/day. In moderate-to-severe impairment, limit to a maximum of 100 mg/day. Avoid use in severe or advanced renal disease.

Hepatic impairment

In patients with hypoalbuminemia (serum albumin below 3.5 g/dL) due to liver disease, limit initial dose to a maximum of 100 mg/day of Kop SR and monitor closely.

Use Kop SR for the shortest duration necessary to control symptoms, at the lowest effective dose. For acute pain or dysmenorrhea, short courses of a few days are typical; for chronic conditions such as rheumatoid arthritis or osteoarthritis, ongoing use should be periodically reassessed by a physician to weigh benefit against cumulative GI, renal, and cardiovascular risk.

Ketoprofen belongs to the Nonsteroidal Anti-Inflammatory Drug (NSAID) class, propionic acid derivative subgroup, related to ibuprofen, naproxen, and flurbiprofen.

Ketoprofen non-selectively inhibits cyclooxygenase (COX-1 and COX-2) enzymes, reducing prostaglandin synthesis responsible for pain, inflammation, and fever, and also has some inhibitory effect on lipoxygenase pathways contributing to its analgesic action.

Safety and effectiveness of Kop SR in pediatric patients (below 18 years) have not been established. Its use in children is generally not recommended; consult a pediatrician for alternative options if pain or fever management is needed in a child.