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Tolmetin 600 Mg 100 Tabs By Mylan Pharma.

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Tolmetin 600 Mg 100 Tabs By Mylan Pharma.

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Tolmetin 600 Mg 100 Tabs By Mylan Pharma. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXB10036208/RXD2269926/RXA301918
Size : 100
Selling UoM : EA
NDC: 00378-0313-01
UPC Barcode : 303780313019
Supplier: 0050000337 MYLAN PHARM
Supplier Material : 031301
Generic Code : 008356 TOLMETIN SODIUM ORAL TABLET 600 MG
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : GRX Generic RX

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Product Description.:

M 313
tablet , film-coated , tan , oval oblong

TOLECTIN? DS
(tolmetin sodium) Capsules

TOLECTIN? 600
(tolmetin sodium) Tablets

For Oral Administration

Cardiovascular Risk

* NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS).
* TOLECTIN is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS).

Gastrointestinal Risk

* NSAIDs cause an increased risk of serious gastrointestinal 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 are at greater risk for serious gastrointestinal events (see WARNINGS).

DRUG DESCRIPTION

TOLECTIN DS (tolmetin sodium) capsules for oral administration contain tolmetin sodium as the dihydrate in an amount equivalent to 400 mg of tolmetin. Each capsule contains 36 mg (1.568 mEq) of sodium and the following inactive ingredients: gelatin, magnesium stearate, corn starch, talc, FD&C Red No. 3, FD&C Yellow No. 6 and titanium dioxide.

TOLECTIN 600 (tolmetin sodium) tablets for oral administration contain tolmetin sodium 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: cellulose, silicon dioxide, crospovidone, hydroxypropyl methyl cellulose, magnesium stearate, polyethylene glycol, corn starch, titanium dioxide, FD&C Yellow No. 6 and D&C Yellow No. 10.

The pKa of tolmetin is 3.5 and tolmetin sodium is freely soluble in water.

INDICATIONS

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

TOLECTIN (tolmetin sodium) is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. TOLECTIN is indicated in the treatment of acute flares and the long-term management of the chronic disease.

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

SIDE EFFECTS

The adverse reactions which have been observed in clinical trials encompass observations in about 4370 patients treated with TOLECTIN (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 TOLECTIN, about 10% of patients dropped out because of adverse reactions, mostly gastrointestinal in nature.
Incidence Greater Than 1%

The following adverse reactions which occurred more frequently than 1 in 100 were reported in controlled clinical trials.

Gastrointestinal: Nausea (11%), dyspepsia,* gastrointestinal distress,* abdominal pain,* diarrhea,* flatulence,* vomiting,* constipation, gastritis, and peptic ulcer. Forty percent of the ulcer patients had a prior history of peptic ulcer disease and/or were receiving concomitant anti- inflammatory drugs including corticosteroids, which are known to produce peptic ulceration.

Body as a Whole: Headache, * asthenia, * chest pain

Cardiovascular: Elevated blood pressure, * edema*

Central Nervous System: Dizziness, * drowsiness, depression

Metabolic/Nutritional: Weight gain, * weight loss*

Dermatologic:Skin irritation

Special Senses: Tinnitus, visual disturbance

Hematologic: Small and transient decreases in hemoglobin and hematocrit not associated with gastrointestinal bleeding have occurred. These are similar to changes reported with other nonsteroidal anti- inflammatory drugs.

Urogenital: Elevated BUN, urinary tract infection

*Reactions occurring in 3% to 9% of patients treated with TOLECTIN. Reactions occurring in fewer than 3% of the patients are unmarked.
Incidence Less Than 1%

(Causal Relationship Probable)

The following adverse reactions were reported less frequently than 1 in 100 controlled clinical trials or were reported since marketing. The probability exists that there is a causal relationship between TOLECTIN and these adverse reactions.

Gastrointestinal: Gastrointestinal bleeding with or without evidence of peptic ulcer, perforation, glossitis, stomatitis, hepatitis, liver function abnormalities.

Body as a Whole: Anaphylactoid reactions, fever, lymp