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Aceclofenac dispersible tablets are indicated for the treatment of pain and inflammation caused by osteoarthritis, rheumatoid arthritis, ankylosing spondylitis.

Drug Name: Aceclofenac Dispersible Tablets

Drug type: Prescription drugs, medicines for medical workers' injuries
Use classification: Carboxylic acids

Aceclofenac Dispersible Tablets Ingredients

The main ingredient of this product is aceclofenac.

Chemical name: 2-[(2.6-dichlorophenyl) amino] phenylacetoxyacetic acid

Molecular formula: C ₁₆ H ₁₃ Cl ₂ NO ₄

Molecular weight: 354.19

Aceclofenac Dispersible Tablets Properties

This product is white or off-white film.

Indications of Aceclofenac Dispersible Tablets

Symptom treatment of pain and inflammation caused by osteoarthritis, rheumatoid arthritis, ankylosing spondylitis.

Aceclofenac dispersible tablets

After dispersing in warm water, or take it directly orally, take it with at least half a glass of water and take it with food. Adults take 1 tablet (100mg) twice daily or as directed by a doctor. The recommended maximum daily dose is 4 tablets.

Adverse reactions of aceclofenac dispersible tablets

According to foreign research data: Gastrointestinal adverse reactions (indigestion, abdominal pain, nausea, and diarrhea) occur. The most common are indigestion (7.5%) and abdominal pain (6.2%). 1. Common (> 1/100) Gastrointestinal disorders: indigestion, abdominal pain, nausea, and diarrhea. Liver and Gall: Liver enzymes are elevated. 2. Occasionally (1/100 1/1000) General: Dizziness. Gastrointestinal system: flatulence, gastritis, constipation, vomiting, ulcerative oral mucositis. Skin: itching, rash, and dermatitis. Metabolism and nutrition: elevated urea nitrogen and creatinine. 3. Rare (<1/1000) General: headache, fatigue, facial swelling, allergic reactions, weight gain. Blood: anemia, granulocytopenia, thrombocytopenia, neutropenia. Cardiovascular: Edema, palpitation, gastrocnemius spasm, flushing, purpura. Central and peripheral nervous system: sensory disturbances, tremors. Gastrointestinal system disorders: gastrointestinal bleeding and ulcers, hemorrhagic diarrhea, hepatitis or pancreatitis, tar-like stools, inflammation of the oral mucosa. Urinary system disorders: interstitial nephritis. Skin: Eczema. Metabolism and nutrition: elevated alkaline phosphatase, hyperkalemia. Psychiatry: depression, dreaming, lethargy, insomnia. Eyes: abnormal vision. Others: taste inversion, vasculitis. Like other NSAIDs, severe skin and mucous membrane hypersensitivity reactions may occur.

Aceclofenac dispersible tablets contraindications

People who are allergic to aceclofenac and other nonsteroidal drugs are contraindicated. Patients taking drugs with a similar mechanism of action (such as aspirin or other non-steroidal anti-inflammatory drugs) cause asthma, bronchospasm, acute rhinitis or urticaria or those who are known to be allergic to this class of drugs. Patients with or suspected of having gastric or duodenal ulcers, or patients with a history of recurrence of gastric or duodenal ulcers, are not allowed in patients with gastrointestinal bleeding or other bleeding or coagulopathy. Those with severe heart failure and liver and kidney dysfunction are disabled. Pregnant women are disabled during the third trimester of pregnancy.

Precautions for Aceclofenac Dispersible Tablets

Patients with a history of gastrointestinal tract disease and patients with a history of peptic ulcer, cerebrovascular hemorrhage, ulcerative colitis, Crohn's disease, systemic lupus erythematosus (SLE), porphyria and hematopoietic and coagulopathy should be used with caution or closely monitored Use. Mild to moderate liver, kidney, and heart dysfunction and patients with a tendency to retain fluid should be used with caution. The use of NSAIDs in these patients can lead to renal failure and fluid retention. Treatment with diuretics or other patients who are also at risk for hypovolemia should also be used with caution. Elderly patients are more likely to have side effects and should be used with caution. During the treatment, many times the patient has no aura symptoms or obvious medical history, resulting in severe gastrointestinal bleeding and / or perforation. Elderly patients are more likely to cause kidney, cardiovascular, and liver damage. Patients treated with long-term NSAIDs should be checked regularly for prevention (eg, liver, kidney function, and blood cell count). Patients who experience dizziness and other central nervous system disorders after taking NSAIDs should avoid driving and engaging in mechanical operations.

Aceclofenac dispersible tablets for children

The safety and effectiveness of medicinal drugs for children have not been determined, so it is not recommended for children.

Aceclofenac dispersible tablets for elderly patients

There is generally no need to reduce the dose, but the following conditions should be noted: Elderly patients are more likely to have side effects and should be used with caution. During the treatment, many times the patient has no aura symptoms or obvious medical history, resulting in severe gastrointestinal bleeding and / or perforation. Elderly patients are more likely to cause kidney, cardiovascular, and liver damage.

Aceclofenac dispersible tablets for pregnant and lactating women

Several cases of anti-inflammatory drugs have been reported to affect the fetus, possibly by inhibiting prostaglandin synthesis. Anti-inflammatory drugs can block uterine contractions and delay childbirth. They can cause contraction and occlusion of intrauterine arterial catheters, leading to pulmonary hypertension and respiratory insufficiency in newborns. Anti-inflammatory drugs can reduce fetal platelet function and inhibit fetal kidney function, which can lead to oligohydramnios and neonatal anuria. Anti-inflammatory drugs are disabled for three months after pregnancy. Whether aceclofenac is secreted into human milk is unclear. Therefore, aceclofenac should not be used during breastfeeding unless the doctor considers it necessary.

Aceclofenac dispersible tablets drug interactions

1. Avoid combination with the following drugs: NSAIDs inhibit methotrexate secretion in the renal tubules, which may have slight metabolic interactions, resulting in reduced methotrexate clearance. Therefore, NSAID medication should always be avoided during high-dose methotrexate treatment. Certain NSAID drugs can inhibit the elimination of lithium salts in the kidney, resulting in an increase in serum lithium concentration. Unless serum lithium levels can be measured frequently, they should be avoided in combination with lithium salts. NSAIDs inhibit platelet aggregation and damage the gastrointestinal mucosa, increase the activity of anticoagulants, and increase the risk of gastrointestinal bleeding in patients using anticoagulants. Unless close monitoring is possible, aceclofenac should be avoided in combination with coumarin oral anticoagulants, ticlopidine, thrombolytic agents, and heparin. 2. The following combination drugs need to adjust the dose or pay attention: When using low-dose methotrexate, attention should also be paid to the possibility of drug interactions between NSAIDs and methotrexate, especially in patients with renal insufficiency. Caution should be exercised if NSAIDs and methotrexate are used concurrently within 24 hours, as methotrexate plasma concentrations may increase and lead to increased toxicity. NSAIDs are used in combination with cyclosporine or tachylide, and kidney kidney function should be closely monitored during combination therapy due to reduced renal prostaglandin synthesis and increased risk of nephrotoxicity. Taking aspirin and other non-steroidal anti-inflammatory drugs at the same time will increase the incidence of side effects and should be warned. Non-steroidal anti-inflammatory drugs can weaken the diuretic effects of furanilic acid (diuretics) and bupropionic acid (bumettanib, diuretics). The possible mechanism of action is to inhibit prostaglandin synthesis. They also reduce the antihypertensive effect of thiazide drugs (diuretics). Concurrent use with potassium-sparing diuretics can increase potassium levels, so blood potassium should be monitored. The simultaneous use of non-steroidal anti-inflammatory drugs and ACE (angiotensin-converting enzyme) inhibitors will increase the risk of acute renal failure in patients with fluid loss. Although the interaction with other antihypertensive drugs, such as -receptor antagonists, cannot be ruled out, the combination of aceclofenac and benzfluthiazine (diuretic and antihypertensive drugs) has not been found to affect its control of blood pressure. Others Possible interactions have been reported on hypoglycemic and hypoglycemic effects. Aceclofenac may cause hypoglycemia, and the dose of hypoglycemic drugs should be adjusted when using. No clinically significant differences in pharmacokinetics were observed in patients with mild to moderate renal insufficiency after a single dose. 3. Aceclofenac is metabolized mainly by cytochrome P450 2C9, so it may be related to phenytoin, digoxin, cimetidine, tolbutamide, butazone, amiodarone, miconazole, and sulfamethoxazole. Risk of drug interactions. Like other drugs in the NSAID class, there is also a risk of drug interactions with drugs eliminated by renal excretion, such as methotrexate and lithium salts. Aceclofenac is actually completely bound to plasma proteins, and it will then displace with other high-protein binding drugs, which must be paid attention to.

Aceclofenac dispersible tablets overdose

There are no data on the overdose of aceclofenac in humans. Possible symptoms after overdose are: nausea, vomiting, stomach pain, dizziness, drowsiness, and headache. Treatment: if necessary, gastric lavage, repeated administration of activated carbon, if necessary, antacids or other symptomatic treatments.

Aceclofenac Dispersible Tablets Pharmacology and Toxicology

1. Pharmacological effect: This product is a non-steroidal anti-inflammatory drug with anti-inflammatory and analgesic effects. Its mechanism of action may be mainly through the inhibition of cyclooxygenase activity, thereby reducing prostaglandin synthesis. 2. Toxicology study: Repeated administration toxicity: Wistar rats were administered orally continuously for 1 month at doses of 15, 50, and 100 mg / kg / day. As a result, only 100 mg / kg / day group experienced animal death and accompanied stool. Occult blood. Histopathological examination revealed gastric or intestinal mucosal irritation in this group of animals. Similar to other non-steroidal anti-inflammatory drugs, test animals are less tolerant to this product. In addition, the difference in pharmacokinetics between animals and humans makes its potential toxicity difficult to judge, but rats (capable of aceclofenac to diclofenac) and monkeys (some of which are unmetabolized prototype drugs) are given at maximum tolerated dose The toxicological test results of the drug show that this product has not seen other toxic effects than the common toxicity of non-steroidal anti-inflammatory drugs. Genotoxicity: The result of this product is negative. Reproductive toxicity: It is reported that the effects of anti-inflammatory drugs on the inhibition of prostaglandin synthesis may lead to severe embryo toxicity. Can inhibit uterine contraction, leading to delay in childbirth; can cause narrowing or closing of fetal arterial blood ducts in the uterus, resulting in neonatal pulmonary hypertension and respiratory insufficiency. Anti-inflammatory drugs can also inhibit fetal platelet function and affect its renal function, resulting in oligohydramnios and neonatal anuria. Therefore, anti-inflammatory drugs are prohibited in the last 3 months of pregnancy. However, there are reports in the literature that in the middle and early stages of pregnancy, this product will also affect fetal development. It is unclear whether this product is excreted by human milk, so women should not use this product unless they are deemed necessary by a doctor. Carcinogenicity: This product has not been shown to have a carcinogenic effect in mice and rats.

Pharmacokinetics of Aceclofenac Dispersible Tablets

According to foreign literature reports: 1. Absorption: Aceclofenac is quickly and completely absorbed after oral administration, and its bioavailability is almost 100%. The peak drug concentration time was 1.25 to 3 hours after the administration. With food, the peak time is extended, but absorption is not affected by food. 2. Distribution: Aceclofenac has a high protein binding rate (> 99.7%). Aceclofenac penetrates into the synovial fluid and its concentration reaches 60% of the plasma drug concentration. The distribution volume is nearly 30L. 3. Excretion: The average plasma elimination half-life is 4 to 4.3 hours, and the clearance rate is about 5L / h. Nearly two-thirds of the drug is mainly excreted through the urine in the form of hydroxylated metabolites in combination, and the prototype drug only accounts for 1% of the drug dose. Aceclofenac is likely to be metabolized to 4-OH aceclofenac by CYP2C9, and its clinical activity is minimal. Diclofenac and 4-OH diclofenac have been detected in many metabolites. 4. Characteristics in patients: No change in the pharmacokinetic characteristics of aceclofenac was detected in the elderly. A slower clearance of aceclofenac was detected in patients with decreased liver function after a single dose of aceclofenac. Pharmacokinetic parameters of patients with mild to moderate liver cirrhosis were not different from those of normal people. ^[1]