Diclofenac Sodium description, usages, side effects, indications, overdosage, supplying and lots more!

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Diclofenac Sodium

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




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).
  • ●     Diclofenac sodium extended-release is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (seeWARNINGS).
Gastrointestinal Risk
  • ●     NSAIDs cause an increased risk of serious gastrointestinal adverse events including inflammation, bleeding, inflammation, 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


Diclofenac Sodium



CLINICAL PHARMACOLOGY

Pharmacodynamics


Pharmacokinetics

Absorption


Normal Healthy Adults (18-48 yrs.)
Distribution



Metabolism



Excretion


Special Populations





INDICATIONS & USAGE

WARNINGS




DICLOFENAC SODIUM CONTRAINDICATIONS


WARNINGS, Anaphylactoid ReactionsPRECAUTIONS, Preexisting Asthma
WARNINGS

WARNINGS

Cardiovascular Effects

Cardiovascular Thrombotic Events

WARNINGS, GI Effects
CONTRAINDICATIONS

Hypertension


Congestive Heart Failure and Edema


Gastrointestinal (GI) Effects - Risk of GI Ulceration, Bleeding, and Perforation




Renal Effects



Advanced Renal Disease


Hepatic Effects









Anaphylactoid Reactions
CONTRAINDICATIONSPRECAUTIONS, Preexisting Asthma

Skin Reactions


Pregnancy


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 Effects-Risk of Ulceration, Bleeding, and Perforation).


WARNINGS, Hepatic Effects
WARNINGS




LABORATORY TESTS



DRUG INTERACTIONS





WARNINGS, Renal Effects



PREGNANCY





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

WARNINGS





HOW SUPPLIED




STORAGE AND HANDLING




SPL MEDGUIDE

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.


  • ●     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 calledcorticosteroidsandanticoagulants
  • ●     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)?

  • ●     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 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)?



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


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Diclofenac Sodium

Diclofenac Sodium

Diclofenac Sodium TABLET, EXTENDED RELEASE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-939(NDC:0228-2717)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DICLOFENAC SODIUM DICLOFENAC 100 mg

Inactive Ingredients

Ingredient Name Strength
carnauba wax
CETYL ALCOHOL
SILICON DIOXIDE
HYPROMELLOSES
lactose monohydrate
MAGNESIUM STEARATE
povidone
talc
titanium dioxide
triacetin

Product Characteristics

Color Size Imprint Code Shape
yellow 9 mm 717 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-939-08 10 in 1 VIAL

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075910 2012-03-28


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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