Proxym

Uses

Carefully consider the potential benefits and risks of etodolac capsules and other treatment options before deciding to use etodolac capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.Proxym are used:1. For acute and long-term use in the management of signs and symptoms of the following:

• Osteoarthritis
• Rheumatoid arthritis

2. For the management of acute pain

Proxym is also used to associated treatment for these conditions: Chronic Back Pain, Extra-Articular Rheumatism, Juvenile Idiopathic Arthritis (JIA), Muscle Spasms, Nonspecific Pain Post Traumatic Injury, Osteoarthritis (OA), Pain, Acute, Postoperative pain, Rheumatoid Arthritis, Spinal Disorders

How Proxym works

Similar to other NSAIDs, the anti-inflammatory effects of etodolac result from inhibition of the enzyme cycooxygenase (COX). This decreases the synthesis of peripheral prostaglandins involved in mediating inflammation. Proxym binds to the upper portion of the COX enzyme active site and prevents its substrate, arachidonic acid, from entering the active site. Proxym was previously thought to be a non-selective COX inhibitor, but it is now known to be 5 – 50 times more selective for COX-2 than COX-1. Antipyresis may occur by central action on the hypothalamus, resulting in peripheral dilation, increased cutaneous blood flow, and subsequent heat loss.

Dosage

Proxym dosage

Carefully consider the potential benefits and risks of Proxym and other treatment options before deciding to use Proxym capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

After observing the response to initial therapy with Proxym capsules, the dose and frequency should be adjusted to suit an individual patient's needs.

Dosage adjustment of Proxym is generally not required in patients with mild to moderate renal impairment. Proxym should be used with caution in such patients, because, as with otherNSAIDs, they may further decrease renal function in some patients with impaired renal function.

Analgesia: The recommended total daily dose of Proxym for acute pain is up to 1000 mg, given as 200 to 400 mg every 6 to 8 hours. Doses of Proxym greater than 1000 mg/day have not been adequately evaluated in well-controlled clinical trials.

Osteoarthritis and Rheumatoid Arthritis: The recommended starting dose is 300 mg b.i.d., t.i.d., or 400 mg b.i.d., or 500 mgb.i.d.A lower dose of 600 mg/day may suffice for long-term administration. Physicians should be aware that doses above 1000 mg/day have not been adequately evaluated in well-controlled clinical trials.

In chronic conditions, a therapeutic response to therapy with Proxym is sometimes seen within one week of therapy, but most often is observed by two weeks. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required.

Side Effects

The common side effects of Proxym involve the gastrointestinal system. It can cause abdominal pain, constipation, diarrhea, dyspepsia, flatulence, heartburn, nausea, GI ulcers, vomiting. Other events including abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritis, rashes, tinnitus etc.

Toxicity

Selective COX-2 inhibitors have been associated with increased risk of serious cardiovascular events (e.g. myocardial infarction, stroke) in some patients. Current data is insufficient to assess the cardiovascular risk of etodolac. Proxym may increase blood pressure and/or cause fluid retention and edema. Risk of GI toxicity including bleeding, ulceration and perforation. Risk of direct renal injury, including renal papillary necrosis. Anaphylactoid and serious skin reactions (e.g. exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported. Common adverse events include abdominal pain, constipation, diarrhea, dyspepsia, flatulence, GI bleeding, GI perforation, nausea, peptic ulcer, vomiting, renal function abnormalities, anemia, dizziness, edema, liver function test abnormalities, headache, prolonged bleeding time, pruritus, rash, tinnitus. Symptoms of overdose include lethargy, drowsiness, nausea, vomiting, and epigastric pain.

Precaution

Proxym should be given with caution in patients with severe hepatic reactions, pre-existing asthma, fluid retention, hypertension or heart failure. If clinical sings and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g. eosinophilia, rash etc.), it should be discontinued.

Interaction

Since Proxym is extensively protein-bound, it may be necessary to modify the dosage of other highly protein-bound drugs. The concomitant administration of Warfarin and Proxym should not require a dosage adjustment of either drug, however it has rarely led to prolonged prothrombin times, therefore caution should be exercised when Proxym is administered with Warfarin. Concomitant use of Ciclosporin, Methotrexate, Digoxin, or Lithium with NSAIDs may cause an increase in serum levels of these compounds and associated toxicities. Care should also be taken in patients treated with any of the following drugs as interactions have been reported in some patients: Anti-hypertensives, Mifepristone, other Analgesics, Corticosteroids and Quinolone Antibiotics.

Food Interaction

• Avoid alcohol.
• Take with food. Food reduces irritation.

Proxym Alcohol interaction

[Moderate] GENERALLY AVOID:

The concurrent use of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) and ethanol may lead to gastrointestinal (GI) blood loss.

The mechanism may be due to a combined local effect as well as inhibition of prostaglandins leading to decreased integrity of the GI lining.

Patients should be counseled on this potential interaction and advised to refrain from alcohol consumption while taking aspirin or NSAIDs.

Proxym Hypertension interaction

[Major] Fluid retention and edema have been reported in association with the use of nonsteroidal anti-inflammatory drugs (NSAIDs).

Therapy with NSAIDs should be administered cautiously in patients with preexisting fluid retention, hypertension, or a history of heart failure.

Blood pressure and cardiovascular status should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.

[Moderate] Nonsteroidal anti-inflammatory drugs (NSAIDs), including topicals, can lead to new onset of hypertension or worsening of preexisting hypertension, either of which can contribute to the increased incidence of cardiovascular events.

NSAIDs should be used with caution in patients with hypertension.

Blood pressure should be monitored closely during the initiation of NSAID therapy and throughout the course of therapy.

Proxym Drug Interaction

Moderate: aspirin, aspirin, duloxetine, duloxetine, omega-3 polyunsaturated fatty acids, omega-3 polyunsaturated fatty acidsUnknown: cyclobenzaprine, cyclobenzaprine, pregabalin, pregabalin, acetaminophen / hydrocodone, acetaminophen / hydrocodone, cyanocobalamin, cyanocobalamin, ascorbic acid, ascorbic acid, cholecalciferol, cholecalciferol, cetirizine, cetirizine

Proxym Disease Interaction

Major: asthma, fluid retention, GI toxicity, rash, renal toxicities, thrombosisModerate: anemia, heart failure, hepatotoxicity, hyperkalemia, hypertension, platelet aggregation inhibition

Volume of Distribution

• 390 mL/kg

Elimination Route

Based on mass balance studies, the systemic bioavailability of etodolac from either the tablet or capsule formulation is at least 80%.

Half Life

Terminal t_1/2, 7.3 ± 4.0 hours. Distribution t_1/2, 0.71 ± 0.50 hours

Clearance

• Oral cl=49.1 mL/h/kg [Normal healthy adults]
• Oral cl=49.4 mL/h/kg [Healthy males (18-65 years)]
• Oral cl=35.7 mL/h/kg [Healthy females (27-65 years)]
• Oral cl=45.7 mL/h/kg [Eldery (>65 years)]
• Oral cl=58.3 mL/h/kg [Renal impairement (46-73 years)]
• Oral cl=42.0 mL/h/kg [Hepatic impairement (34-60 years)]

Elimination Route

It is not known whether etodolac is excreted in human milk; however, based on its physical-chemical properties, excretion into breast milk is expected. Proxym is extensively metabolized in the liver. The hydroxylated-etodolac metabolites undergo further glucuronidation followed by renal excretion and partial elimination in the feces (16% of dose). Approximately 1% of a etodolac dose is excreted unchanged in the urine with 72% of the dose excreted into urine as parent drug plus metabolite.

Pregnancy & Breastfeeding use

Pregnancy: There are no adequate and well-controlled studies in pregnant women. It should be use in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation: It is not known whether Proxym is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother.

Contraindication

Proxym is contraindicated in patients with known hypersensitivity to Proxym. Proxym should not be given to patients who have experienced asthma, urticaria or other allergic-type reactions after taking Aspirin or other NSAIDs.

Acute Overdose

Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain which are generally reversible with supportive care.

Storage Condition

Store at a cool and dry place protected from light & moisture. Keep out of reach of children.

Innovators Monograph

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