Diclofenac Sodium
FULL PRESCRIBING INFORMATION: CONTENTS*
- BOXED WARNING
- DICLOFENAC SODIUM DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- DICLOFENAC SODIUM CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- INFORMATION FOR PATIENTS
- LABORATORY TESTS
- DRUG INTERACTIONS
- PREGNANCY
- LABOR & DELIVERY
- NURSING MOTHERS
- PEDIATRIC USE
- GERIATRIC USE
- DICLOFENAC SODIUM ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- SPL MEDGUIDE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
BOXED WARNING
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. (SeeWARNINGS.)
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● Diclofenac sodium delayed-release tablets are contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (seeWARNINGS).
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● NSAIDs cause an increased risk of serious gastrointestinal adverse events including inflammation, 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. (SeeWARNINGS).
DICLOFENAC SODIUM DESCRIPTION
CLINICAL PHARMACOLOGY
PharmacodynamicsPharmacokinetics
Absorption
Normal Healthy Adults (20-48 yrs.)PK ParameterMeanCoefficient of Mean Variation (%)Distribution
Metabolism
Excretion
Drug Interactions
Special Populations
Pediatric:
Race:
Hepatic Insufficiency:
Renal Insufficiency:
INDICATIONS & USAGE
WARNINGS-
● For relief of signs and symptoms of osteoarthritis
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● For relief of signs and symptoms of rheumatoid arthritis
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● For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis
DICLOFENAC SODIUM CONTRAINDICATIONS
WARNINGS, Anaphylactoid ReactionsPRECAUTIONS, Preexisting Asthma
WARNINGS
WARNINGS
Cardiovascular EffectsCardiovascular Thrombotic Events
CONTRAINDICATIONS
Hypertension
Congestive Heart Failure and Edema Renal Effects
Gastrointestinal (GI) EffectsRisk of GI Ulceration, Bleeding, and Perforation
Renal Effects
Advanced Renal Disease
Hepatic Effects
Anaphylactic Reactions
CONTRAINDICATIONSPRECAUTIONS, Preexisting Asthma
Skin Reactions
PRECAUTIONS
General
Hematological Effects
Preexisting Asthma
INFORMATION FOR PATIENTS
Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed.WARNINGS, Cardiovascular Effects
WARNINGS, Gastrointestinal EffectsRisk of Ulceration, Bleeding, and Perforation
WARNINGS, Anaphylactic Reactions
LABORATORY TESTS
DRUG INTERACTIONS
Aspirin:Methotrexate:
Cyclosporine:
ACE-inhibitor:
Furosemide:WARNINGS, Renal Effects
Lithium:
Warfarin:
CYP2C9 Inhibitors or Inducers:CLINICAL PHARMACOLOGY, Pharmacokinetics, Drug Interactions
PREGNANCY
Teratogenic Effects:Pregnancy Category C
Nonteratogenic Effects:
LABOR & DELIVERY
NURSING MOTHERS
PEDIATRIC USE
GERIATRIC USE
DICLOFENAC SODIUM ADVERSE REACTIONS
Body as a Whole:
Cardiovascular System:
Digestive System:
Hemic and Lymphatic System:
Metabolic and Nutritional:
Nervous System:
Respiratory System:
Skin and Appendages:
Special Senses:
Urogenital System:
Body as a Whole:
Cardiovascular System:
Digestive System:
Hemic and Lymphatic System:
Metabolic and Nutritional:
Nervous System:
Respiratory System:
Skin and Appendages:
Special Senses:
OVERDOSAGE
DOSAGE & ADMINISTRATION
WARNINGSHOW SUPPLIED
STORAGE AND HANDLING
SPL MEDGUIDE
MEDICATION GUIDE for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
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:
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● with longer use of NSAID medicines
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● in people who have heart disease
NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:
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● can happen without warning symptoms
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● may cause death
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● taking medicines calledcorticosteroidsandanticoagulants
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● longer use
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● smoking
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● drinking alcohol
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● older age
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● having poor health
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● exactly as prescribed
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● at the lowest dose possible for your treatment
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● for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
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● different types of arthritis
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● 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:
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● if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
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● for pain right before or after heart bypass surgery
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● about all your medical conditions.
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● 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.
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● if you are pregnant.NSAID medicines should not be used by pregnant women late in their pregnancy.
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● if you are breastfeeding.Talk to your doctor.
What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
Get emergency help right away if you have any of the following symptoms:
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● shortness of breath or trouble breathing
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● chest pain
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● weakness in one part or side of your body
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● slurred speech
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● swelling of the face or throat
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● nausea
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● more tired or weaker than usual
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● itching
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● your skin or eyes look yellow
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● stomach pain
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● flu-like symptoms
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● vomit blood
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● there is blood in your bowel movement or it is black and sticky like tar
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● unusual weight gain
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● skin rash or blisters with fever
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● swelling of the arms and legs, hands and feet
Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
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● 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.
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● 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.
Generic NameTradename
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
Diclofenac SodiumDiclofenac Sodium TABLET, DELAYED RELEASE
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
