Tolmetin Sodium Mylan

Uses

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

Tolmetin Sodium Mylan is used for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. Tolmetin Sodium Mylan is used for the treatment of acute flares and the long-term management of the chronic disease.

Tolmetin Sodium Mylan is also used for treatment of juvenile rheumatoid arthritis. The safety and effectiveness of Tolmetin Sodium Mylan have not been established in pediatric patients under 2 years of age

Tolmetin Sodium Mylan is also used to associated treatment for these conditions: Ankylosing Spondylitis (AS), Osteoarthritis (OA), Pain, Rheumatoid Arthritis, Rheumatoid Arthritis, Juvenile, Rheumatoid arthritis flare up, Adhesive capsulitis shoulder, Radiohumeral bursitis

How Tolmetin Sodium Mylan works

The mode of action of tolmetin is not known. However, studies in laboratory animals and man have demonstrated that the anti-inflammatory action of tolmetin is not due to pituitary-adrenal stimulation. Tolmetin Sodium Mylan inhibits prostaglandin synthetase in vitro and lowers the plasma level of prostaglandin E in man. This reduction in prostaglandin synthesis may be responsible for the anti-inflammatory action. Tolmetin Sodium Mylan does not appear to alter the course of the underlying disease in man.

Dosage

Tolmetin Sodium Mylan dosage

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

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

For the relief of rheumatoidarthritisor osteoarthritis:the recommended starting dose for adults is 400 mg three times daily (1200 mg daily), preferably including a dose on arising and a dose at bedtime. To achieve optimal therapeutic effect the dose should be adjusted according to the patient's response after one or two weeks. Control is usually achieved at doses of 600-1800 mg daily in divided doses (generally t.i.d.). Doses larger than 1800 mg/day have not been studied and are not recommended.

For the relief of juvenile rheumatoid arthritis:the recommended starting dose for pediatric patients (2 years and older) is 20 mg/kg/day in divided doses (t.i.d. or q.i.d.). When control has been achieved, the usual dose ranges from 15 to 30 mg/kg/day. Doses higher than 30 mg/kg/day have not been studied, and, therefore, are not recommended.

A therapeutic response to Tolmetin Sodium Mylan can be expected in a few days to a week. Progressive improvement can be anticipated during succeeding weeks of therapy. If gastrointestinal symptoms occur, Tolmetin Sodium Mylan can be administered with antacids other than sodium bicarbonate. Tolmetin Sodium Mylan bioavailability and pharmacokinetics are not significantly affected by acute or chronic administration of magnesium and aluminum hydroxides; however, bioavailability is affected by food or milk

Side Effects

Nausea, dyspepsia, diarrhoea, flatuence, vomiting, headache, GI bleed, hypersensitivity reactions, asthenia, hypertension, oedema, dizziness, weight gain, weight loss, visual disturbances, tinnitus, abnormal liver function. Erosive oesophagitis, interstitial nephritis and nephrotic syndrome.

Toxicity

Symptoms of overdose include lethargy, drowsiness, nausea, vomiting, and epigastric pain.

Precaution

Lactation, elderly. Impaired renal and hepatic function. CV diseases, fluid retention, heart failure, history of GI bleed or gastric ulcer, dehydration, hypertension. Monitor renal function regularly.

Interaction

Decreases the efficacy of mifepristone. Increased risk of bleeding with anticoagulants, other NSAIDs, antiplatelets, LMWH. Increased risk of convulsions with quinolones. Decreased antihypertensive response to loop diuretics, β-blockers and ACE inhibitors. Coadmin increased plasma concentrations of lithium, methotrexate and cardiac glycosides. Increased risk of nephrotoxicity with ACE inhibitors, penicillamine, ciclosporin, tacrolimus or diuretics.

Food Interaction

• Avoid alcohol. Ingesting alcohol may increase the risk of developing an ulcer, or gastrointestinal bleed.
• Take with or without food. Food (or milk) can decrease oral bioavailability by 16%. Tolmetin Sodium Mylan may be taken with food to reduce gastrointestinal upset, but it may reduce tolmetin serum levels by 50%.

Tolmetin Sodium Mylan 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.

Tolmetin Sodium Mylan 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.

Tolmetin Sodium Mylan Drug Interaction

Major: naproxen, nabumetoneModerate: furosemide, clopidogrelMinor: ranitidineUnknown: ipratropium, amoxicillin / clavulanate, albuterol / ipratropium, amitriptyline, lamotrigine, pregabalin, acetaminophen, infliximab, levothyroxine, acetaminophen, cyanocobalamin, ascorbic acid, cholecalciferol, ezetimibe / simvastatin, cetirizine

Tolmetin Sodium Mylan Disease Interaction

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

Elimination Route

Rapidly and almost completely absorbed with peak plasma levels being reached within 30-60 minutes after an oral therapeutic dose.

Half Life

Biphasic elimination from the plasma consisting of a rapid phase with a half-life of one to 2 hours followed by a slower phase with a half-life of about 5 hours.

Pregnancy & Breastfeeding use

Pregnancy Category C. Reproduction studies in rats and rabbits at doses up to 50 mg/kg (1.5 times the maximum clinical dose based on a body weight of 60 kg) revealed no evidence of teratogenesis or impaired fertility due to Tolmetin Sodium Mylan. However, animal reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies in pregnant women. Tolmetin Sodium Mylan should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects: Because of the known effects of NSAIDs on the fetal cardiovascular system (closure of ductus arteriosus), use during pregnancy (particularly late pregnancy) should be avoided.

Labor and Delivery: In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. The effects of Tolmetin Sodium Mylan on labor and delivery in pregnant women are unknown.

Nursing Mothers: Tolmetin Sodium Mylan sodium has been shown to be secreted in human milk. Because of the potential for serious adverse reactions in nursing infants from tolmetin sodium, 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

Tolmetin Sodium Mylan is contraindicated in patients with known hypersensitivity to tolmetin sodium.

Tolmetin Sodium Mylan should not be given to patients who have experienced asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients Tolmetin Sodium Mylan is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery is contraindicated in patients with known hypersensitivity to tolmetin sodium.

Tolmetin Sodium Mylan should not be given to patients who have experienced asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic- like reactions to NSAIDs have been reported in such patients

Tolmetin Sodium Mylan is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery

Special Warning

Pediatric Use: Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

Geriatric Use: As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older).

Acute Overdose

In the event of overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage followed by the administration of activated charcoal.

Storage Condition

Oral: Store at 20-25°C

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