DESCRIPTION
id: 6bbaf5ab-6d1b-4763-8b7a-20f7f9730ce0
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Diclofenac potassium tablets are a benzeneacetic acid derivative. Diclofenac potassium tablets, 50 mg are available as orange, film-coated tablets for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monopotassium salt. The structural formula is:
C14H10Cl2KNO2 M.W. 334.25
Diclofenac potassium is a faintly yellowish white to light beige, virtually odorless, slightly hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol and water, and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. It has a single dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water.
Each tablet, for oral administration, contains 50 mg of diclofenac potassium. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, FD&C Blue No. 2, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 4000, povidone, sodium starch glycolate, titanium dioxide, and tricalcium phosphate.
INDICATIONS AND USAGE
id: 931ef847-a318-458c-9ebe-693f3724282a
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Diclofenac potassium tablets are indicated:
- For treatment of primary dysmenorrhea
- For relief of mild to moderate pain
- For relief of the signs and symptoms of osteoarthritis
- For relief of the signs and symptoms of rheumatoid arthritis
CONTRAINDICATIONS
id: ad7ba791-00ec-47a2-b24a-03d76d423039
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Diclofenac potassium tablets are contraindicated in patients with known hypersensitivity to diclofenac.
Diclofenac potassium tablets should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions and PRECAUTIONS, Preexisting Asthma).
Diclofenac potassium tablets are contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
ADVERSE REACTIONS
id: a10f3832-f53c-4a41-af0c-6f8589bb6eae
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
In 718 patients treated for shorter periods, i.e., 2 weeks or less, with diclofenac potassium tablets, adverse reactions were reported one-half to one-tenth as frequently as by patients treated for longer periods. In a 6 month, double-blind trial comparing diclofenac potassium tablets (N = 196) versus diclofenac sodium delayed-release tablets (N = 197) versus ibuprofen (N = 197), adverse reactions were similar in nature and frequency.
In patients taking diclofenac potassium tablets or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1% to 10% of patients are:
Gastrointestinal experiences including: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal), and vomiting.
Abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes, and tinnitus.
Additional adverse experiences reported occasionally include:
Body as a Whole
:
fever, infection, sepsis
Cardiovascular System
:
congestive heart failure, hypertension, tachycardia, syncope
Digestive System
:
dry mouth, esophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice
Hemic and Lymphatic System:
ecchymosis, eosinophilia, leukopenia, melena, purpura, rectal bleeding, stomatitis, thrombocytopenia
Metabolic and Nutritional
:
weight changes
Nervous System:
anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo
Respiratory System:
asthma, dyspnea
Skin and Appendages:
alopecia, photosensitivity, sweating increased
Special Senses:
blurred vision
Urogenital System:
cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure
Other adverse reactions, which occur rarely are:
Body as a Whole:
anaphylactic reactions, appetite changes, death
Cardiovascular System:
arrhythmia, hypotension, myocardial infarction, palpitations, vasculitis
Digestive System:
colitis, eructation, liver failure, pancreatitis
Hemic and Lymphatic System:
agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia
Metabolic and Nutritional:
hyperglycemia
Nervous System:
convulsions, coma, hallucinations, meningitis
Respiratory System:
respiratory depression, pneumonia
Skin and Appendages:
angioedema, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, urticaria
Special Senses:
conjunctivitis, hearing impairment
OVERDOSAGE
id: 5d952758-c6e7-46f5-8dfb-e9e09dfa5f99
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression, and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.
Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
DOSAGE AND ADMINISTRATION
id: d10b7596-deea-483b-b1bb-343255731d96
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with diclofenac potassium tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.
For treatment of pain or primary dysmenorrhea the recommended dosage is 50 mg t.i.d. With experience, physicians may find that in some patients an initial dose of 100 mg of diclofenac potassium tablets, followed by 50 mg doses, will provide better relief.
For the relief of osteoarthritis the recommended dosage is 100 to 150 mg/day in divided doses, 50 mg b.i.d. or t.i.d.
For the relief of rheumatoid arthritis the recommended dosage is 150 to 200 mg/day in divided doses, 50 mg t.i.d. or q.i.d.
Different formulations of diclofenac [diclofenac sodium enteric-coated tablets; diclofenac sodium extended-release tablets; diclofenac potassium tablets] are not necessarily bioequivalent even if the milligram strength is the same.
HOW SUPPLIED
id: 30e9102f-626a-4aba-a685-1fdabe4f9c58
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Diclofenac potassium tablets USP, 50 mg are available as orange, round, unscored, biconvex, film- coated tablets debossed with the numbers “93” and “948” on one face of the tablet and plain on the other, in
| Bottles of 30
|
NDC 54868-5437-1
|
| Bottles of 60
|
NDC 54868-5437-2
|
| Bottles of 90
|
NDC 54868-5437-0
|
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Manufactured In Israel By:
TEVA PHARMACEUTICAL IND. LTD.
Jerusalem, 91010, Israel
Manufactured For:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. I 7/2009
Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK 74146
CONTAINER LABELS
id: 60ae6627-cc2d-4141-9801-e0fa4a5ec45c
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
