Diclofenac Sodium Delayed-Release Tablets USP

/Diclofenac Sodium Delayed-Release Tablets USP
Diclofenac Sodium Delayed-Release Tablets USP2018-09-06T09:12:40+00:00

Prescription Drug Name:

Diclofenac Sodium Delayed-Release Tablets USP

ID:

6324e226-ecf0-6a3d-e053-2a91aa0a0dac

Code:

34391-3

DESCRIPTION


id: 6324a782-d90a-0635-e053-2a91aa0aef7e
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Diclofenac, as the sodium salt, is a benzene-acetic acid derivative.. 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
2NaO
2, and it has the following structural formula
Each enteric-coated tablet for oral administration contains 25mg, 50 mg or 75 mg of diclofenac sodium. In addition, each tablet contains the following inactive ingredients; black iron oxide, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, microcrystalline cellulose, pharmaceutical glaze, polyethylene glycol, povidone, sodium starch glycolate, talc, titanium dioxide, triethyl citrate.

INDICATIONS AND USAGE


id: 6324a782-d90f-0635-e053-2a91aa0aef7e
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Carefully consider the potential benefits and risks of diclofenac 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 is 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: 6324a782-d910-0635-e053-2a91aa0aef7e
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Diclofenac sodium delayed-release tablets are contraindicated in patients with known hypersensitivity to diclofenac. Diclofenac 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 are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see
WARNINGS ).

ADVERSE REACTIONS


id: 6324a782-d92b-0635-e053-2a91aa0aef7e
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, 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

To report SUSPECTED ADVERSE REACTIONS contact AvKARE, Inc. at 1-855-361-3993; email drugsafety@avkare.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE


id: 6324a782-d92c-0635-e053-2a91aa0aef7e
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: 6324a782-d92d-0635-e053-2a91aa0aef7e
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. 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, 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 delayed-release 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: 6324a782-d92e-0635-e053-2a91aa0aef7e
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Diclofenac sodium delayed-release tablets 25 mg – white to off-white, biconvex, round-shaped, unscored (imprinted  “CT1 101” on the side)

50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted “CTI 102” on one side), supplied in bottles of 180 NDC 42291-230-18 and 1000 NDC 42291-230-10 75 mg – white to off-white, biconvex, round shaped, unscored (imprinted “CTI 103” on one side), supplied in bottles of 60 NDC 42291-231-60, bottles of 180 NDC 42291-231-18 and 1000 NDC 42291-231-10 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. Manufactured for:

AvKARE Inc.

Pulaski, TN 38478

Mfg. Rev. 08/13

AV Rev. 03/15 (P)

MEDICATION GUIDE for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)


id: 6324a782-d92f-0635-e053-2a91aa0aef7e
displayName: SPL MEDGUIDE SECTION
FDA Article Code: 42231-1

(See the end of this Medication Guide for a list of prescription NSAID medicines.) What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (
NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.

This chance increases:

    • with longer use of NSAID medicines

    • in people who have heart disease  

NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”

  NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers

  and bleeding:


    • can happen without warning symptoms

    • may cause death     The chance of a person getting an ulcer or bleeding increases with:

      • taking medicines called “corticosteroids” and “anticoagulants”

      • longer use

      • smoking

      • drinking alcohol

      • older age

      • having poor health   NSAID medicines should only be used:

    • exactly as prescribed

    • at the lowest dose possible for your treatment

    • for the shortest time needed What are Non-Steroidal Anti-Inflammatory Drugs (
NSAIDs)
?

NSAID medicines are use to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

  • different types of arthritis

  • menstrual cramps and other types of short-term pain Who should not take a Non-Steroidal Anti-Inflammatory Drug (
NSAID)?

Do not take an NSAID medicine:

  • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine

  • for pain right before or after heart bypass surgery

  Tell your healthcare provider:

  • about all of your medical conditions.

  • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side

    effects.
Keep a list of your medicines to show to your healthcare provider and pharmacist.

  • if you are pregnant.
NSAID medicines should not be used by pregnant women late in their pregnancy.

  • if you are breastfeeding.
Talk to your doctor. What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (
NSAIDs)
?


Serious side effects include:

• heart attack

• stroke

• high blood pressure

• heart failure from body swelling (fluid retention)

• kidney problems including kidney failure

• bleeding and ulcers in the stomach and intestine

• low red blood cells (anemia)

• life-threatening skin reactions

• life-threatening allergic reactions

• liver problems including liver failure

• asthma attacks in people who have asthma Other side effects include:

• stomach pain

• constipation

• diarrhea

• gas

• heartburn

• nausea

• vomiting

• dizziness Get emergency help right away if you have any of the following symptoms:

  • shortness of breath or trouble breathing

  • chest pain

  • weakness in one part or side of your body

  • slurred speech

  • swelling of the face or throat Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

  • nausea

  • more tired or weaker than usual

  • itching

  • your skin or eyes look yellow

  • stomach pain

  • flu-like symptoms

  • vomit blood

  • there is blood in your bowel movement or it is black and stickylike tar

  • unusual weight gain

  • skin rash or blisters with fever

  • swelling of the arms and legs, hands and feet These are not all the side effects with NSAID medicines. Talk to your health care provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about the side effects. You may report side effects to FDA at 1-800-FDA-1088. Other information about Non-Steroidal Anti-Inflammatory Drugs (
NSAIDs)

• Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, 

   stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.

• Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider

   before using over-the-counter NSAIDs for more than 10 days.

NSAID medicines that need a prescription
 Generic Name  Tradename
Celecoxib Celebrex
Diclofenac Cataflam, Voltaren, Arthrotec (combined with misoprostol)
Diflunisal Dolobid
Etodalac Lodine, Lodine XL
Fenoprofen Nalfon, Nalfon 200
Flurbiprofen Ansaid
Ibuprofen Motrin, Tab-Profen, Vicoprofen* (combined with hydrocodone), Combunox (combined with oxycodone)
Indomethacin Indocin, Indocin SR, Indo-Lemmon, Indomethagan
Ketoprofen Oruvail
Ketorolac Toradol
Mefenamic Acid Ponstel
Meloxicam Mobic
Nabumetone Relafen
Naproxen Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Naprelan, Naprapac (copackaged with lansoprazole)
Oxaprozin Daypro
Piroxicam Feldene
Sulindac Clinoril
Tolmetin Tolectin, Tolectin DS, Tolectin 600
*Vicoprofen contains the same dose of ibuprofen as over-thecounter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke. This Medication Guide has been approved by the U.S. Food and Drug Administration.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


id: 6324a782-d930-0635-e053-2a91aa0aef7e
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

AvKARE

NDC 42291-230-18 Diclofenac Sodium

Delayed-Release Tablets USP

PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE 50 mg

180 Tablets     Rx Only Each delayed-release tablet contains: Diclofenac Sodium USP, 50 mg Usual dosage: See insert for full prescribing information. Dispense in a tight, light-resistant container as defined in the USP. Store at 20
o to 25
oC (68
o to 77
oF) [See USP Controlled Room Temperature]. Protect from moisture.
Keep this and all medication out of the reach of children.

Manufactured for:

AvKARE Inc.

Pulaski, TN 38478

Mfg. Rev. 02/10          AV Rev. 04/13 (P)
N

3   42291 23018  
7
Lot No.:

Exp. Date: AvKARE

NDC 42291-231-10 Diclofenac Sodium

Delayed-Release Tablets USP

PHARMACIST: PLEASE DISPENSE WITH MEDICATION GUIDE 75 mg

1000 Tablets     Rx Only Each delayed-release tablet contains: Diclofenac Sodium USP, 75 mg Usual dosage: See insert for full prescribing information. Dispense in a tight, light-resistant container as defined in the USP. Store at 20
o to 25
oC (68
o to 77
oF) [See USP Controlled Room Temperature]. Protect from moisture.
Keep this and all medication out of the reach of children.

Manufactured for:

AvKARE Inc.

Pulaski, TN 38478

Mfg. Rev. 02/10          AV Rev. 05/14 (P)
N

3   42291 23110  
8
Lot No.:

Exp. Date: