Important Disclaimer: This summary is for educational and informational purposes only and should not, under any circumstances, replace direct consultation with a qualified physician or pharmacist. Always refer to the product’s internal leaflet or consult a healthcare professional before use.
Drug Name: Acemetacin Stada 60 mg 20 cap.
Manufacturer:
Acemetacin Stada 60 mg 20 cap. is manufactured by **Adwia > STADA Arzneimittel AG**. The active ingredient, Acemetacin, was originally developed by **Tropon**. [1, 2]
Introduction:
Acemetacin is a prodrug non-steroidal anti-inflammatory drug (NSAID), chemically related to indomethacin. After oral administration, it is metabolized to indomethacin, which then inhibits cyclooxygenase (COX-1 and COX-2) enzymes, thus reducing prostaglandin production. Compared to indomethacin, acemetacin is generally better tolerated gastro-intestinally, providing effective relief from pain, inflammation, and fever. [2, 3]
Indications and Usage:
Acemetacin Stada is indicated for the symptomatic relief of:
* **Osteoarthritis:** Degenerative joint disease causing pain and stiffness. [2]
* **Rheumatoid Arthritis:** Chronic inflammatory disorder affecting joints. [2]
* **Ankylosing Spondylitis:** Chronic inflammatory disease primarily affecting the spine. [2]
* **Acute lower back or cervical pain.** [2]
* **Post-operative and post-traumatic musculoskeletal pain:** Including sprains and strains. [2]
* **Acute gout attacks:** Sudden and severe joint pain. [2]
* **Periarticular disorders:** Such as bursitis, tendinitis, and tenosynovitis. [2]
Characteristics:
* **Dosage Form:** Oral capsule. [1, 2]
* **Strength:** 60 mg acemetacin per capsule. [1, 2]
* **Drug Class:** NSAID (prodrug of indomethacin), specifically an indoleacetic acid derivative. [2, 3]
* **Mechanism of Action:** Acemetacin inhibits COX enzymes, leading to decreased prostaglandin synthesis. This results in its analgesic (pain-relieving), anti-inflammatory, and antipyretic (fever-reducing) effects. It also has some inhibitory effects on lysosomal enzymes, which contribute to tissue damage in inflammatory processes. [2, 3]
Dosage and Administration:
Acemetacin Stada 60 mg is administered orally as capsules.
* **Adults:** The usual recommended dose is 60 mg (1 capsule) twice daily (morning and evening). [2]
* **Severe Pain:** May be increased to 60 mg three times daily under medical supervision. [2]
* **Administration Method:** Capsules should be swallowed whole with a sufficient amount of liquid, preferably with or after food or milk to reduce gastrointestinal irritation. Do not crush the capsules. [2]
* **Maximum Dose:** Typically 180 mg/day. In acute conditions (e.g., acute gout), the dose may be increased to 120 mg 2-3 times daily for a short period, not exceeding 360 mg/day. [2]
* **Duration:** As prescribed; often 5–14 days depending on condition severity. The lowest effective dose should be used for the shortest possible duration to control symptoms. [2]
* **Pediatrics:** Not recommended for children under 12 years of age due to limited data. [2]
Contraindications:
Acemetacin should not be used in individuals with the following conditions:
* Hypersensitivity to acemetacin, indomethacin, other NSAIDs, or aspirin (especially with a history of asthma, urticaria, or angioedema). [2]
* Active or recurrent gastrointestinal ulcers, bleeding, or perforation, or a history of such events related to previous NSAID therapy. [2]
* Severe heart failure, severe renal impairment, or severe hepatic impairment. [2]
* Third trimester of pregnancy and during breastfeeding. [2]
* Established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease. [2]
* Children under 12 years of age. [2]
Warnings and Precautions:
* **General:** Use the lowest effective dose for the shortest duration to minimize risks. [2]
* **Gastrointestinal (GI) Risk:** NSAIDs can cause serious GI adverse events including ulcers, bleeding, and perforation, which can be fatal. This risk is higher in elderly patients or those with a history of ulcers. [2]
* **Cardiovascular (CV) Risk:** May increase the risk of myocardial infarction, stroke, and hypertension, particularly with long-term use or high doses. [2]
* **Renal:** Monitor kidney function in dehydrated or renal-impaired patients, and those using diuretics/ACE inhibitors, as NSAIDs can cause dose-dependent reduction in prostaglandin formation, leading to renal decompensation. [2]
* **Hepatic:** Monitor liver function; discontinue if significant elevation of liver enzymes or liver symptoms occur. [2]
* **Respiratory:** May exacerbate asthma; use with caution in patients with a history of bronchial asthma. [2]
* **Central Nervous System (CNS):** May cause dizziness, headache, vertigo, visual disturbances, or confusion. Patients should be cautioned about driving or operating machinery if affected. [2]
* **Skin Reactions:** Rare but severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported; discontinue at first sign of rash or hypersensitivity. [2]
* **Fluid Retention and Edema:** Caution is advised in patients with a history of hypertension and/or mild to moderate congestive heart failure, as fluid retention and edema have been reported. [2]
* **Blood Disorders:** Rare cases of blood dyscrasias (e.g., anemia, leukopenia, thrombocytopenia) have been reported. [2]
* **Pregnancy:** Category C (1st–2nd trimester), Category D (3rd trimester)—avoid use in the third trimester. [2]
* **Elderly Patients:** Elderly patients are at increased risk of adverse reactions, especially gastrointestinal bleeding and perforation. [2]
Pharmacokinetics:
* **Absorption:** Acemetacin is rapidly and nearly completely absorbed after oral administration. Peak plasma concentrations are typically reached within 2–4 hours. [2, 3]
* **Metabolism:** Acemetacin is extensively metabolized in the liver, primarily by hydrolysis to its active metabolite, indomethacin, and further to inactive metabolites. Liver glucuronidation also occurs. [2, 3]
* **Distribution:** It is highly protein-bound (approximately 80–90%). Acemetacin and its active metabolite (indomethacin) accumulate in inflamed tissues and distribute into synovial fluid. [2, 3]
* **Elimination:** The elimination half-life of acemetacin is approximately 4.5 hours (range 2–16 hours), while that of its active metabolite indomethacin is around 16 hours. Excretion occurs mainly via urine (about 40%) and faeces (about 50%). [2, 3]
Side Effects:
| Frequency | Reactions |
|---|---|
| **Very Common (1–10%)** | Gastrointestinal: nausea, vomiting, abdominal pain, diarrhea, blood loss (microscopic). |
| **Common** | Dyspepsia, headache, dizziness, elevated liver enzymes, rash. |
| **Uncommon** | Gastrointestinal bleeding, ulceration, hypersensitivity reactions, hair loss, abnormal liver tests. |
| **Serious/Rare** | Severe GI events (e.g., ulcer perforation), serious skin reactions (SJS/TEN), CNS effects (e.g., confusion, seizures), hematologic disorders (e.g., anemia, leukopenia, thrombocytopenia), renal failure, cardiovascular events (e.g., MI, stroke), bronchospasm, adrenal suppression, periorbital edema, tinnitus, visual disturbances. |
Drug Interactions:
Acemetacin may interact with several other medications:
* **Other NSAIDs or Corticosteroids:** Increased risk of gastrointestinal bleeding and ulceration. [2]
* **Anticoagulants (e.g., Warfarin), Antiplatelets (e.g., Clopidogrel), SSRIs:** Elevated bleeding risk. [2]
* **Diuretics, ACE inhibitors, ARBs, Ciclosporin:** May reduce antihypertensive effect and increase renal adverse effects. [2]
* **Lithium, Digoxin, Methotrexate:** Decreased clearance of these drugs, leading to increased serum levels; monitor closely. [2]
* **Quinolone Antibiotics:** Possible increased risk of convulsions. [2]
* **Potassium-sparing diuretics:** Monitor potassium levels due to risk of hyperkalemia. [2]
* **Antihypertensives:** Reduced antihypertensive effect. [2]
* **Alcohol:** Increased gastrointestinal toxicity. [2]
* **Mifepristone:** NSAIDs should not be used for 8-12 days after mifepristone administration as they can reduce its effect. [2]
* **Probenecid:** May reduce the renal excretion of acemetacin, leading to increased plasma levels. [2]
Patient Counseling:
* Take Acemetacin Stada with food or milk and a full glass of water to reduce gastrointestinal irritation. Swallow capsules whole; do not crush. [2]
* Do not exceed the prescribed dose or duration of treatment. [2]
* Avoid alcohol consumption, as it may increase the risk of gastrointestinal side effects. [2]
* Report any signs of gastrointestinal bleeding (e.g., black/tarry stools, severe abdominal pain), chest pain, shortness of breath, visual changes, rash, or swelling immediately to your doctor. [2]
* This medication may cause dizziness or visual disturbances; avoid driving or operating machinery if affected. [2]
* Inform your doctor about all other medications, supplements, and herbal products you are taking to avoid potential drug interactions. [2]
* Monitor blood pressure, renal, and liver function during prolonged use, as advised by your doctor. [2]
* Keep out of children’s reach; store below 25 °C in original packaging, protected from moisture and direct sunlight. [2]
Sources:
* Adwia Pharmaceuticals Official Website: https://www.adwia.com/ [1]
* Acemetacin 60 mg capsules - Summary of Product Characteristics (SmPC) - Medicines.org.uk: https://www.medicines.org.uk/emc/product/1000/smpc [2]
* DrugBank Online - Acemetacin: https://go.drugbank.com/drugs/DB01300 [3]
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