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Etodolac 300 Mg Caps 100 By Taro Pharma.

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Etodolac 300 Mg Caps 100 By Taro Pharma.

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Etodolac 300 Mg Caps 100 By Taro Pharma. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD2973113/RXB10042499
Size : 100
Selling UoM : EA
NDC: 51672-4017-01
UPC Barcode : 351672401719
Supplier: 0050000602 TARO PHARMACEUTICALS
Supplier Material : 401701
Generic Code : 015961 ETODOLAC ORAL CAPSULE 300 MG
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : GRX Generic RX

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Product Description.:

ETO 300 MG, ETO 300 MG
capsule , pink , oblong oblong
Black ink

Lodine? (etodolac) is a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol.

The inactive ingredients in Lodine include:

-in capsules: cellulose, gelatin, iron oxides, lactose, magnesium stearate, povidone, sodium lauryl sulfate, sodium starch glycolate, and titanium dioxide.

-in tablets: cellulose, hypromellose, lactose, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, sodium starch glycolate, and titanium dioxide. The 400 mg tablets contain D&C Yellow #10, FD&C Blue #2, and FD&C Yellow #6 as color additives. The 500 mg tablets contain FD&C Blue #2 only.

INDICATIONS

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

Lodine (etodolac capsules and tablets) is indicated:

* For acute and long-term use in the management of signs and symptoms of the following:

1. Osteoarthritis
2. Rheumatoid arthritis

* For the management of acute pain

SIDE EFFECTS

In patients taking Lodine or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1-10% of patients are:

Gastrointestinal experiences including: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal), vomiting.

Other events including: abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritis, rashes, tinnitus.

Adverse-reaction information for Lodine was derived from 2,629 arthritic patients treated with Lodine (etodolac capsules and tablets) in double-blind and open-label clinical trials of 4 to 320 weeks in duration and worldwide postmarketing surveillance studies. In clinical trials, most adverse reactions were mild and transient. The discontinuation rate in controlled clinical trials, because of adverse events, was up to 10% for patients treated with Lodine.

New patient complaints (with an incidence greater than or equal to 1%) are listed below by body system. The incidences were determined from clinical trials involving 465 patients with osteoarthritis treated with 300 to 500 mg of Lodine b.i.d. (i.e., 600 to 1000 mg/day).
Incidence Greater Than Or Equal To 1%?Probably Causally Related

Body as a whole?Chills and fever.

Digestive system?Dyspepsia (10%), abdominal pain*, diarrhea*, flatulence*, nausea*, constipation, gastritis, melena, vomiting.

Nervous system?Asthenia/malaise*, dizziness*, depression, nervousness.

Skin and appendages?Pruritus, rash.

Special senses?Blurred vision, tinnitus.

Urogenital system?Dysuria, urinary frequency.

*Drug-related patient complaints occurring in 3 to 9% of patients treated with Lodine. Drug-related patient-complaints occurring in fewer than 3%, but more than 1%, are unmarked.
Incidence Less Than 1%?Probably Causally Related

(Adverse reactions reported only in worldwide postmarketing experience, not seen in clinical trials, are considered rarer and are italicized.)

Body as a whole?Allergic reaction, anaphylactic/anaphylactoid reactions (including shock).

Cardiovascular system?Hypertension, congestive heart failure, flushing, palpitations, syncope, vasculitis (including necrotizing and allergic).

Digestive system?Thirst, dry mouth, ulcerative stomatitis, anorexia, eructation, elevated liver enzymes, cholestatic hepatitis, hepatitis, cholestatic jaundice, duodenitis, jaundice, hepatic failure, liver necrosis, peptic ulcer with or without bleeding and/or perforation, intestinal ulceration, pancreatitis.

Hemic and lymphatic system?Ecchymosis, anemia, thrombocytopenia, bleeding time increased, agranulocytosis, hemolytic anemia, leukopenia, neutropenia, pancytopenia.

Metabolic and nutritional?Edema, serum creatinine increase, hyperglycemia in previously controlled diabetic patients.

Nervous system?Insomnia, somnolence.

Respiratory system?Asthma, pulmonary infiltration with eosinophilia.

Skin and appendages?Angioedema, sweating, urticaria, vesiculobullous rash, cutaneous vasculitis with purpura, Stevens-Johnson Syndrome, toxic epidermal necrolysis, hyperpigmentation, erythema multiforme.

Special senses?Photophobia, transient visual disturbances.

Urogenital system?Elevated BUN, renal failure, renal insufficiency, renal papillary necrosis.
Incidence Less Than 1%?Causal Relationship Unknown

(Medical events occurrin