DESCRIPTION
id: 1ea1046b-83ab-5a71-e054-00144ff8d46c
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Diclofenac Sodium Delayed-release Tablets are a benzene-acetic acid derivative. Diclofenac Sodium Delayed-release Tablets are available as delayed-release (delayed-release) tablets of 25 mg or 50 mg for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C
14H
10Cl
2NNaO
2, and it has the following structural formula:
The inactive ingredients in Diclofenac Sodium Delayed-release Tablets include: lactose (monohydrate), microcrystalline cellulose, croscarmellose sodium, povidone, talc, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, opadry brown (Titanium dioxide, hypromellose, polyethylene glycol, iron oxide red, iron oxide yellow) and purified water.
INDICATIONS AND USAGE
id: 1ea0a3ac-8883-48c1-e054-00144ff8d46c
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Carefully consider the potential benefits and risks of Diclofenac Sodium Delayed-release Tablets and other treatment options before deciding to use Diclofenac Sodium Delayed-release Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
).
Diclofenac Sodium Delayed-release Tablets, are indicated:
- For relief of signs and symptoms of osteoarthritis
- For relief of signs and symptoms of rheumatoid arthritis
- For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis
CONTRAINDICATIONS
id: 1ea0a3ac-8884-48c1-e054-00144ff8d46c
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Diclofenac Sodium Delayed-release Tablets are contraindicated in patients with known hypersensitivity to Diclofenac.
Diclofenac Sodium Delayed-release 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 Sodium Delayed-Release Tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see
Warnings
).
ADVERSE REACTIONS
id: 1ea0a3ac-889f-48c1-e054-00144ff8d46c
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
In patients taking Diclofenac Sodium Delayed-release Tablets, 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) 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, fulminant hepatitis with and without jaundice, liver failure, liver necrosis, 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
To report SUSPECTED ADVERSE REACTIONS, contact Unique Pharmaceutical Laboratories toll-free at (800) 521-5340 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
OVERDOSAGE
id: 1ea0a3ac-88a0-48c1-e054-00144ff8d46c
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 a 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: 1ea0a3ac-88a1-48c1-e054-00144ff8d46c
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Carefully consider the potential benefits and risks of Diclofenac Sodium Delayed-release Tablets and other treatment options before deciding to use Diclofenac Sodium Delayed-release 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 Sodium Delayed-release Tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.
For the relief of osteoarthritis, the recommended dosage is 100-150 mg/day in divided doses (50 mg b.i.d. or t.i.d., or 75 mg b.i.d.).
For the relief of rheumatoid arthritis, the recommended dosage is 150-200 mg/day in divided doses (50 mg t.i.d. or q.i.d., or 75 mg b.i.d.).
For the relief of ankylosing spondylitis, the recommended dosage is 100-125 mg/day, administered as 25 mg q.i.d., with an extra 25-mg dose at bedtime if necessary.
Different formulations of Diclofenac (Diclofenac sodium enteric-coated tablets; Diclofenac sodium extended-release tablets, Diclofenac potassium immediate-release tablets) are not necessarily bioequivalent even if the milligram strength is the same.
HOW SUPPLIED
id: 1ea0a3ac-88a2-48c1-e054-00144ff8d46c
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Diclofenac Sodium Delayed-release Tablets, USP, for oral administration, are available as:
25 mg: round, Light brown, enteric-coated tablets P 25 imprinted on one side in black ink and plain on the reverse side are supplied as:
Bottles of 100 NDC 16571-203-10
50 mg: round, Light brown, enteric-coated tablets P 50 on one side in black ink and plain on the reverse side are supplied as:
Bottles of 60 NDC 16571-202-06
Bottles of 100 NDC 16571-202-10
Bottles of 1000 NDC 16571-202-11
75 mg: round, Light brown, enteric-coated tablets P 75 imprinted on one side in black ink and plain on the reverse side are supplied as:
Bottles of 60 NDC 16571-201-06
Bottles of 100 NDC 16571-201-10
Bottles of 500 NDC 16571-201-50
Bottles of 1000 NDC 16571-201-11
Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from moisture.
Dispense in a tight, light-resistant container.
Manufactured by:
UNIQUE PHARMACEUTICAL LABORATORIES.
(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.)
Mumbai 400 030, India.
Manufactured for:
Rising Pharmaceuticals, Inc.
Allendale, NJ 07401
1-800-521-5340
PACKAGE LABEL 50 mg container label
id: 1ea1046b-83af-5a71-e054-00144ff8d46c
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Blenheim Pharmacal, Inc.
NDC 10544-934-14
Diclofenac Sodium
Delayed-Release
Tablets, USP
50 mg
14 Tablets Rx only
