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tolmetin sodium
Overview
What is Tolmetin Sodium?
Each tablet for oral administration contains 738 mg of tolmetin sodium, USP as the dihydrate in an amount equivalent to 600 mg of tolmetin. Each tablet contains 54 mg (2.35 mEq) of sodium and the following inactive ingredients: black iron oxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, pregelatinized starch (corn), sodium lauryl sulfate, titanium dioxide, triacetin and yellow iron oxide.
The pKa of tolmetin is 3.5 and tolmetin sodium is freely soluble in water.
Tolmetin sodium is a nonselective nonsteroidal anti-inflammatory agent. The structural formula is:
Sodium 1-methyl-5 -toluoylpyrrole-2-acetate dihydrateMolecular Formula: CHNNaO.2HO M.W. 315.30
What does Tolmetin Sodium look like?
What are the available doses of Tolmetin Sodium?
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What should I talk to my health care provider before I take Tolmetin Sodium?
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How should I use Tolmetin Sodium?
Carefully consider the potential benefits and risks of tolmetin sodium tablets, USP and other treatment options before deciding to use tolmetin sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).
Tolmetin sodium tablets are indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. Tolmetin sodium tablets are indicated in the treatment of acute flares and the long-term management of the chronic disease.
Tolmetin sodium tablets are also indicated for treatment of juvenile rheumatoid arthritis. The safety and effectiveness of tolmetin sodium tablets have not been established in pediatric patients under 2 years of age (see and ).
Carefully consider the potential benefits and risks of tolmetin sodium tablets and other treatment options before deciding to use tolmetin sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).
After observing the response to initial therapy with tolmetin sodium tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.
For the relief of rheumatoid arthritis or 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 1 or 2 weeks. Control is usually achieved at doses of 600 mg to 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 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 tablets can be administered with antacids other than sodium bicarbonate. Tolmetin sodium 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 (see ).
What interacts with Tolmetin Sodium?
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What are the warnings of Tolmetin Sodium?
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What are the precautions of Tolmetin Sodium?
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What are the side effects of Tolmetin Sodium?
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What should I look out for while using Tolmetin Sodium?
Tolmetin sodium tablets are contraindicated in patients with known hypersensitivity to tolmetin sodium.
Tolmetin 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 (see and ).
Tolmetin is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see ).
What might happen if I take too much Tolmetin Sodium?
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How should I store and handle Tolmetin Sodium?
Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature].Dispense in a tight container as defined in the USP.Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature].Dispense in a tight container as defined in the USP.Tolmetin Sodium Tablets, USP are available containing 738 mg of tolmetin sodium, USP as the dihydrate in an amount equivalent to 600 mg of tolmetin.The 600 mg tablets are beige, film-coated, oval-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-0313-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Tolmetin Sodium Tablets, USP are available containing 738 mg of tolmetin sodium, USP as the dihydrate in an amount equivalent to 600 mg of tolmetin.The 600 mg tablets are beige, film-coated, oval-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-0313-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Tolmetin Sodium Tablets, USP are available containing 738 mg of tolmetin sodium, USP as the dihydrate in an amount equivalent to 600 mg of tolmetin.The 600 mg tablets are beige, film-coated, oval-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-0313-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Tolmetin Sodium Tablets, USP are available containing 738 mg of tolmetin sodium, USP as the dihydrate in an amount equivalent to 600 mg of tolmetin.The 600 mg tablets are beige, film-coated, oval-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-0313-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Tolmetin Sodium Tablets, USP are available containing 738 mg of tolmetin sodium, USP as the dihydrate in an amount equivalent to 600 mg of tolmetin.The 600 mg tablets are beige, film-coated, oval-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-0313-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Tolmetin Sodium Tablets, USP are available containing 738 mg of tolmetin sodium, USP as the dihydrate in an amount equivalent to 600 mg of tolmetin.The 600 mg tablets are beige, film-coated, oval-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-0313-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Tolmetin Sodium Tablets, USP are available containing 738 mg of tolmetin sodium, USP as the dihydrate in an amount equivalent to 600 mg of tolmetin.The 600 mg tablets are beige, film-coated, oval-shaped, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:NDC 0378-0313-01bottles of 100 tabletsStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Studies in animals have shown tolmetin sodium to possess anti-inflammatory, analgesic and antipyretic activity. In the rat, tolmetin prevents the development of experimentally induced polyarthritis and also decreases established inflammation.
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 due to pituitary-adrenal stimulation. Tolmetin inhibits prostaglandin synthetase and lowers the plasma level of prostaglandin E in man. This reduction in prostaglandin synthesis may be responsible for the anti-inflammatory action. Tolmetin does not appear to alter the course of the underlying disease in man.
In patients with rheumatoid arthritis and in normal volunteers, tolmetin sodium is rapidly and almost completely absorbed with peak plasma levels being reached within 30 to 60 minutes after an oral therapeutic dose. In controlled studies, the time to reach peak tolmetin plasma concentration is approximately 20 minutes longer following administration of a 600 mg tablet, compared to an equivalent dose given as 200 mg tablets. The clinical meaningfulness of this finding, if any, is unknown. Tolmetin displays a biphasic elimination from the plasma consisting of a rapid phase with a half-life of 1 to 2 hours followed by a slower phase with a half-life of about 5 hours. Peak plasma levels of approximately 40 mcg/mL are obtained with a 400 mg oral dose. Essentially all of the administered dose is recovered in the urine in 24 hours either as an inactive oxidative metabolite or as conjugates of tolmetin. An 18-day multiple-dose study demonstrated no accumulation of tolmetin when compared with a single dose.
In two fecal blood loss studies of 4 to 6 days duration involving 15 subjects each, tolmetin did not induce an increase in blood loss over that observed during a 4-day drug free control period. In the same studies, aspirin produced a greater blood loss than occurred during the drug free control period, and a greater blood loss than occurred during the tolmetin sodium treatment period. In one of the two studies, indomethacin produced a greater fecal blood loss than occurred during the drug free control period; in the second study, indomethacin did not induce a significant increase in blood loss.
Tolmetin is effective in treating both the acute flares and in the long-term management of the symptoms of rheumatoid arthritis, osteoarthritis and juvenile rheumatoid arthritis.
In patients with either rheumatoid arthritis or osteoarthritis, tolmetin is as effective as aspirin and indomethacin in controlling disease activity, but the frequency of the milder gastrointestinal adverse effects and tinnitus was less than in aspirin-treated patients, and the incidence of central nervous system adverse effects was less than in indomethacin-treated patients.
In patients with juvenile rheumatoid arthritis, tolmetin is as effective as aspirin in controlling disease activity, with a similar incidence of adverse reactions. Mean SGOT values, initially elevated in patients on previous aspirin therapy, remained elevated in the aspirin group and decreased in the tolmetin group.
Tolmetin has produced additional therapeutic benefit when added to a regimen of gold salts and, to a lesser extent, with corticosteroids. Tolmetin should not be used in conjunction with salicylates since greater benefit from the combination is not likely, but the potential for adverse reactions is increased.
Non-Clinical Toxicology
Tolmetin sodium tablets are contraindicated in patients with known hypersensitivity to tolmetin sodium.Tolmetin 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 (see and ).
Tolmetin is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see ).
Tolmetin cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.
The pharmacological activity of tolmetin in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.
The adverse reactions which have been observed in clinical trials encompass observations in about 4,370 patients treated with tolmetin sodium, over 800 of whom have undergone at least one year of therapy. These adverse reactions, reported below by body system, are among those typical of nonsteroidal anti-inflammatory drugs and, as expected, gastrointestinal complaints were most frequent. In clinical trials with tolmetin, about 10% of patients dropped out because of adverse reactions, mostly gastrointestinal in nature.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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