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Diclofenac (Diclofenac Potassium) - Summary

 
 



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 (see WARNINGS).
  • Diclofenac potassium tablets are contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

Gastrointestinal Risk

  • 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 (see WARNINGS).
[ 1 Throughout this package insert, the term NSAID refers to a non-aspirin non-steroidal anti-inflammatory drug.]
 

DICLOFENAC SUMMARY

DICLOFENAC POTASSIUM TABLETS, 50 mg

Rx only

Diclofenac potassium is a benzeneacetic acid derivative. Diclofenac potassium tablets, 50 mg are available as orange, film-coated tablets for oral administration.

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

See all Diclofenac indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Diclofenac

Diacerein as adjuvant to diclofenac sodium in osteoarthritis knee. [2012]
sodium in treatment of Indian patients with symptomatic osteoarthritis (OA) knee... CONCLUSION: Use of diacerein and diclofenac sodium together decreases pain and

Wound Infiltration with Bupivacaine and Intramuscular Diclofenac Reduces Postoperative Tramadol Consumption in Patients Undergoing Radical Retropubic Prostatectomy: A Prospective, Double-blind, Placebo-controlled, Randomized Study. [2011.12]
OBJECTIVES: To assess the impact of wound infiltration with bupivacaine and i.m. diclofenac administration on patient-controlled analgesia (PCA) tramadol consumptions and postoperative pain in patients who underwent radical retropubic prostatectomy (RRP) under general anesthesia. Previous studies have found only limited or no benefits of local anesthetics for postoperative opioid consumption and pain relief after RRP... CONCLUSIONS: This prospective, double-blind, placebo-controlled, randomized study demonstrated that wound infiltration with bupivacaine during surgical closure combined with i.m. diclofenac administration might decrease in 24 hours with PCA tramadol consumption in patients who underwent RRP under general anesthesia. Copyright (c) 2011 Elsevier Inc. All rights reserved.

Onset of action of diclofenac potassium liquid-filled capsules in dental surgery patients. [2011.09]
CONCLUSIONS: These results indicate that DPSGC was efficacious in providing a rapid onset of confirmed perceptible pain relief within 30 minutes of administration in these single dose postoperative dental pain studies.

Randomized, open-label, 5-way crossover study to evaluate the pharmacokinetic/pharmacodynamic interaction between furosemide and the non-steroidal anti-inflammatory drugs diclofenac and ibuprofen in healthy volunteers. [2011.08]
OBJECTIVE: Nonsteroidal anti-inflammatory drugs (NSAIDs) can induce renal complications in patients taking loop diuretics. This study investigated the pharmacokinetic/pharmacodynamic effects and safety profile of orally administered diclofenac sodium, ibuprofen and diclofenac epolamine topical patch (DETP) on furosemide in healthy adult subjects... CONCLUSIONS: Pharmacodynamic effects were seen with oral diclofenac (urine output) and ibuprofen (urine sodium excretion). Furosemide also affected plasma and urine pharmacokinetic profiles. Pharmacologic effects of DETP on furosemide were not observed under these conditions. Additional research is warranted to delineate the potential interactions of other NSAIDs with furosemide and other loop diuretics.

Comparison of topical 3% diclofenac sodium gel and 5% imiquimod cream for the treatment of actinic keratoses. [2011.07]
BACKGROUND: There is a wide spectrum of treatments available for actinic keratosis (AK). Topical diclofenac sodium and imiquimod are two topical treatments, which are noninvasive, easily applied, well-tolerated and effective. AIM: To compare the effects of topical 3% diclofenac sodium plus hyaluranon (DFS) gel, 5% imiquimod (IMQ) cream, and base cream (BC) in patients with AK... CONCLUSIONS: Although DFS and IMQ each had considerable efficacy in the treatment of AK, the efficacy of DFS seemed to decrease after cessation of treatment. (c) The Author(s). CED (c) 2011 British Association of Dermatologists.

more studies >>

Clinical Trials Related to Diclofenac

Study to Compare the Pharmacokinetics of IV Diclofenac Sodium (2 Doses)Versus Oral Diclofenac Potassium [Completed]
The purpose of this study is to assess the pharmacokinetic parameters of intravenous diclofenac sodium (DIC075V) 18. 75 mg and 37. 5 mg following single- and multiple-dose administration, as compared to oral diclofenac potassium (CataflamŽ 50 mg), the approved reference product.

Assess Platelet Function and Safety After Administration of Injectable Diclofenac Compared to Ketorolac and Aspirin in Adult Male Volunteers [Completed]
This study will assess platelet function and safety in healthy male volunteers following doses of intravenous diclofenac compared to cataflam, intravenous ketorolac and aspirin.

Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain [Active, not recruiting]
The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium patch to the skin near or over the painful area. In this study, the location being studied will be either the left or right ankle.

The secondary purpose of this study is to assess the safety and tolerability of a diclofenac patch on the skin.

Diclofenac Patch for Treatment of Mild to Moderate Tendonitis or Bursitis [Completed]
The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium patch to the skin near or over the painful area. In this study, the location being studied will be one of the following: the affected shoulder, elbow, or wrist.

The secondary purpose of this study is to assess the safety and tolerability of the diclofenac patch on the subject's skin, in the location being studied.

Efficacy and Safety of Diclofenac Sodium Gel (DSG) in Knee Osteoarthritis [Completed]
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.

more trials >>

Reports of Suspected Diclofenac Side Effects

Renal Failure Acute (27)Vomiting (25)Nausea (22)Multi-Organ Failure (18)Abdominal Pain (14)Blood Bilirubin Increased (12)Somnolence (12)Abdominal Pain Upper (12)Melaena (12)Anaemia (12)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 10 ratings/reviews, Diclofenac has an overall score of 7.20. The effectiveness score is 8 and the side effect score is 8.20. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Diclofenac review by care giver of 43 year old male patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   muscular pain - arm
Dosage & duration:   75 mg taken one tablet twice daily for the period of 30 days
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   Patient complained of muscular pain in arm, thought to be broken. Visit to physician proved otherwise. Arm imobilised and patent put on diclofenac. Thus far,no further complaint of pain, over past month increased mobility, and muscular strength.
Side effects:   Only side effect is slight drowsiness. Excepting this no other side effect has been displayed.
Comments:   Patient takes treatment one tablet bu mouth twice daily. Instructed to take with food. Warned to not take prescribes drugs containing aspirin, ibuprofent or naproxen without physicians cosent.

 

Diclofenac review by 48 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   illiotibital tibital syndrom
Dosage & duration:   50 mg taken twice per day for the period of 2 months
Other conditions:   attention deficiet disorder
Other drugs taken:   adderall
  
Reported Results
Benefits:   I had swelling and pain in my knee from itbs and in my ankle from tendenitis and it took down the swelling
Side effects:   I had gas after about 6 hours of taking it
Comments:   one tablet twice per day with food took one month to see if worked then another to continue and then as needed. marathon runner and needed it for repeat injury

 

Diclofenac review by 41 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   Knee pain/inflamation
Dosage & duration:   75 mg taken twice daily for the period of 8 days
Other conditions:   n/a
Other drugs taken:   n/a
  
Reported Results
Benefits:   Seemed to reduce some every-day pain and inflamation, although I still experienced increased pain and inflamation after physical therapy or increased activity.
Side effects:   I became very depressed. It began as crankiness and then crying and then not wanting to leave my room or continue my PT.
Comments:   After realizing that I was more than just a little upset about my condition, I began to ask questions about the depression. My pharmacist and I decided I should discontinue and contact my doctor.

See all Diclofenac reviews / ratings >>

Page last updated: 2013-02-10

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