Tendonil60 mg

Established Uses

Tendonil is a non-steroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and inflammation in the following conditions:

• Rheumatoid arthritis
• Osteoarthritis
• Ankylosing spondylitis
• Acute low back pain and acute musculoskeletal disorders (e.g. sprains, strains, soft-tissue injury)
• Post-operative pain and inflammation

Not Recommended / Off-Label

Tendonil is not established for chronic use beyond the shortest effective duration, and it is not recommended as a first-line agent for minor, self-limiting pain where paracetamol or topical agents would suffice. Any use outside the indications above should be at the physician's discretion.

Each dosage unit of Acemetacin contains Acemetacin as the active pharmaceutical ingredient, formulated as immunodifiable capsules (commonly 60 mg or 90 mg strengths in regional markets). Acemetacin is chemically the glycolic acid ester of indomethacin.

Excipients vary by manufacturer and formulation (capsule shell components, fillers, and coloring agents) and are listed on the individual product label.

Tendonil is a non-steroidal anti-inflammatory drug (NSAID) belonging to the indole acetic acid group. Structurally, Tendonil is an ester prodrug of indomethacin (the glycolic acid ester of indomethacin), and it is substantially converted to indomethacin in the body, which is largely responsible for its anti-inflammatory, analgesic, and antipyretic effects.

Tendonil is used to relieve pain, swelling, and stiffness associated with inflammatory and degenerative joint conditions as well as acute musculoskeletal and post-operative pain.

Non-steroidal anti-inflammatory drug (NSAID) — indole/indomethacin-derivative (acetic acid derivative class); Tendonil is an ester prodrug of indomethacin.

Mechanism

Acemetacin and its principal active metabolite, indomethacin, exert anti-inflammatory, analgesic, and antipyretic effects primarily through non-selective inhibition of cyclo-oxygenase (COX-1 and COX-2) enzymes, reducing the synthesis of prostaglandins that mediate pain, fever, and inflammation.

Pharmacokinetics

Acemetacin is well absorbed after oral administration and is extensively hydrolyzed to indomethacin, which undergoes further hepatic metabolism (glucuronidation, demethylation) with renal and biliary excretion of metabolites. Peak plasma concentrations of indomethacin are typically reached within a few hours of dosing, and the drug is highly protein bound.

Tendonil should be swallowed whole with a full glass of water, taken with or immediately after food or milk to minimize gastrointestinal irritation. Do not crush or chew the capsules. Doses should be spaced evenly across the day (e.g. every 8–12 hours) as directed by the prescribing physician.

Tendonil has clinically significant interactions with the following:

Adverse effects of Tendonil are generally dose- and duration-related and are consistent with the NSAID class.

Patients should seek prompt medical attention for signs of gastrointestinal bleeding (black stools, vomiting blood), unexplained bruising, chest pain, sudden weakness, or severe skin reactions.

Pregnancy

Tendonil is contraindicated in the third trimester of pregnancy because NSAIDs can cause premature closure of the fetal ductus arteriosus, fetal renal impairment, and may prolong labor. In the first and second trimesters, Tendonil should be used only if clearly needed, at the lowest effective dose for the shortest duration, and only after the potential benefit has been weighed against the potential risk to the fetus by a physician.

Lactation

NSAIDs, including Tendonil and its active metabolite, are excreted into breast milk in small amounts. Tendonil should generally be avoided during breastfeeding unless a physician determines the benefit outweighs the potential risk to the infant.

Fertility

NSAID use, including Tendonil, has been associated with reversible impairment of female fertility and should be discontinued in women having difficulty conceiving or undergoing investigation of infertility.

Cardiovascular risk: As with all NSAIDs, Tendonil may be associated with an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may increase with duration of use and in patients with existing cardiovascular risk factors or disease; cardiovascular risk should be assessed before starting Tendonil, particularly for long-term use.

Gastrointestinal risk: NSAIDs including Tendonil can cause serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can occur at any time during treatment, with or without warning symptoms. The lowest effective dose should be used for the shortest duration necessary; caution and consideration of gastroprotection is advised in elderly patients or those with a history of peptic ulcer disease, concurrent anticoagulant/corticosteroid/antiplatelet use, or other gastrointestinal risk factors.

Renal function: Tendonil can reduce renal blood flow and precipitate renal impairment, particularly in the elderly, in dehydrated patients, or in those taking diuretics, ACE inhibitors, or other nephrotoxic drugs; renal function should be monitored, especially in at-risk patients.

Fluid retention: Tendonil may cause fluid retention and edema; use with caution in patients with hypertension or heart failure.

Hepatic function: Elevated liver enzymes may occur; liver function should be monitored during prolonged treatment, and Tendonil should be discontinued if signs of liver disease develop.

Concurrent NSAID use: Avoid taking Tendonil together with other NSAIDs or high-dose aspirin, as this increases the risk of adverse effects without added benefit.

Skin reactions: Serious skin reactions, some fatal, have been reported rarely with NSAIDs; discontinue Tendonil at the first sign of rash, mucosal lesions, or other hypersensitivity.

See Contraindications for situations in which Tendonil must not be used, and Pregnancy and Lactation for use during pregnancy/breastfeeding.

Symptoms of Tendonil overdose may include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, drowsiness, disorientation, tinnitus, and, in severe cases, convulsions, acute renal failure, or liver damage.

There is no specific antidote for Tendonil overdose. If overdose is suspected, seek immediate medical attention or contact emergency services/a poison control center right away. Management is supportive and symptomatic; a physician may consider measures such as activated charcoal if given soon after ingestion, and will monitor renal and hepatic function, fluid/electrolyte status, and vital signs. Do not attempt to manage a suspected overdose at home without medical guidance.

Store below 25°C, away from light and moisture, in the original packaging. Keep out of reach and sight of children.

Elderly

Elderly patients are at higher risk of serious gastrointestinal, renal, and cardiovascular adverse effects with Tendonil. Use the lowest effective dose for the shortest duration, and monitor closely for gastrointestinal bleeding and renal function.

Renal Impairment

Tendonil is contraindicated in severe renal impairment. Use with caution and at reduced doses in mild-to-moderate renal impairment, with regular monitoring of renal function.

Hepatic Impairment

Tendonil is contraindicated in severe hepatic impairment. Use with caution in mild-to-moderate hepatic impairment, with periodic liver function monitoring.

Pediatric Use

See Pediatric Uses field.

Pregnancy and Breastfeeding

See Pregnancy and Lactation field.

Tendonil should be used for the shortest duration consistent with the treatment goal, at the lowest effective dose. For acute musculoskeletal pain and post-operative pain, short courses of a few days up to about 1–2 weeks are typical. For chronic inflammatory joint conditions such as rheumatoid arthritis, osteoarthritis, or ankylosing spondylitis, longer-term use may be necessary but requires periodic clinical review and monitoring of gastrointestinal, renal, hepatic, and cardiovascular status. Treatment duration should always be determined by the prescribing physician.

Non-steroidal anti-inflammatory drug (NSAID); acetic acid/indole derivative class; Acemetacin is an ester prodrug of indomethacin.

Acemetacin acts mainly through its principal metabolite, indomethacin, which non-selectively inhibits cyclo-oxygenase (COX-1 and COX-2) enzymes. This reduces the synthesis of prostaglandins and thromboxanes involved in pain signaling, inflammation, and fever, producing the analgesic, anti-inflammatory, and antipyretic effects of Acemetacin.

The safety and efficacy of Tendonil in children and adolescents have not been established. Tendonil is therefore not recommended for use in the pediatric population. Alternative agents with an established pediatric safety profile should be used, and any pediatric use of Tendonil should only occur under specialist medical supervision if no suitable alternative exists.