Aceclofenac

Aceclofenac is used for:
Indicated for the relief of pain and inflammation in both acute and chronic pain like, osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, dental pain, post-traumatic pain, low back pain, gynaecological pain.

Adult: PO Ankylosing spondylitis; Osteoarthritis; Rheumatoid arthritis
100 mg twice daily.

SR Tablet: The recommended dose is 200 mg, once daily.

Safety & Efficacy not established.

Avoid if possible or use with caution; avoid in moderate to severe impairment.
Dose adjustments: The lowest effective dose should be used for the shortest possible duration.

Monitoring In renal impairment monitor renal function; sodium and water retention may occur and renal function may deteriorate, possibly leading to renal failure.

Should be taken with food. Take w/ or immediately after meals.

Known hypersensitivity to aspirin or NSAIDs or any components of the drug product.
History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
In the setting of CABG surgery.
Moderate to severe renal impairment; pregnancy (3rd trimester); history of peptic ulceration or GI bleed; patients with infections.

Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased 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.
Aceclofenac is contraindicated in the setting of coronary artery bypass graft (CABG) surgery
NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events

Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.
Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs.
Monitor blood pressure
Heart Failure and Edema: Avoid use of Aceclofenac in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.
Renal Toxicity: Avoid use of Aceclofenac in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function.
Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.
Exacerbation of Asthma Related to Aspirin Sensitivity: Aceclofenac is contraindicated in patients with aspirin-sensitive asthma.
Serious Skin Reactions: Discontinue Aceclofenac at first appearance of skin rash or other signs of hypersensitivity.
Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnant women starting at 30 weeks gestation.
Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.

Monitoring Parameters
Monitor blood pressure.
Monitor patients with preexisting asthma (without aspirin sensitivity).
Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia.

Side effects of Aceclofenac :
Gastrointestinal disorders (dyspepsia, abdominal pain, nausea and diarrhoea) and occasional occurance of dizziness. Dermatological side effects including pruritus and rash. Abnormal hepatic enzyme levels and raised serum creatinine have occasionally been reported.

Potentially Fatal: Severe GI bleeding; nephrotoxicity; blood dyscrasias.

Pregnancy: Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of
NSAIDs in pregnant women starting at 30 weeks gestation.

There are no adequate and well-controlled studies of Aceclofenac in pregnant women.
Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive.

Labor or Delivery
There are no studies on the effects of Aceclofenac during labor or delivery. In animal studies, NSAIDs, including diclofenac, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth.

Lactation
Risk Summary
Based on available data, diclofenac may be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Aceclofenac and any potential adverse effects on the breastfed infant from the Aceclofenac or from the underlying maternal condition.

Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of Aceclofenac in women who have difficulties conceiving.

Abaloparatide caused a dose-dependent increase in the incidence of osteosarcoma (a malignant bone tumor) in male and female rats. The effect was observed at systemic exposures to abaloparatide ranging from 4 to 28 times the exposure in humans receiving the 80 mcg dose. It is unknown if Abaloparatide will cause osteosarcoma in humans.
The use of Abaloparatide is not recommended in patients at increased risk of osteosarcoma including those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, open epiphyses, bone metastases or skeletal malignancies, hereditary disorders predisposing to osteosarcoma, or prior external beam or implant radiation therapy involving the skeleton.
Cumulative use of Abaloparatide and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient’s lifetime is not recommended.

keep in a dry place away from light and heat. Keep out of the reach of children.