Diclofenac potassium

What is Diclofenac potassium?

• Diclofenac potassium (Cataflam) is a benzeneacetic acid derivative having analgesic, anti-inflammatory, and antipyretic properties.

Diclofenac

Diclofenac 3D

What are the uses of this medicine?

Diclofenac potassium (Cataflam) is used:

• 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

How does this medicine work?

• Diclofenac has analgesic, anti-inflammatory, and antipyretic properties.
• The mechanism of action of CATAFLAM, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).
• Diclofenac is a potent inhibitor of prostaglandin synthesis in vitro.
• Prostaglandins are mediators of inflammation.
• Because diclofenac is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product.
• History of asthma, urticaria, or allergic type reactions after taking aspirin or other NSAIDs.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking.

Be sure to mention any of the following:

• Voriconazole
• Aspirin

Is this medicine FDA approved?

• It came into medical use in the United States in 1988.
• It is available as a generic medication.
• In 2020, it was the 72nd most commonly prescribed medication in the United States, with more than 9 million prescriptions.

How should this medicine be used?

Recommended dosage:

• For treatment of pain or primary dysmenorrhea the recommended dosage is 50 mg three times a day. With experience, physicians may find that in some patients an initial dose of 100 mg of CATAFLAM, followed by 50 mg doses, will provide better relief.
• For the relief of osteoarthritis, the recommended dosage is 100-150 mg/day in divided doses, 50 mg twice a day or three times a day.
• For the relief of rheumatoid arthritis, the recommended dosage is 150-200 mg/day in divided doses, 50 mg three times a day or four times a day.

Administration:

• Diclofenac tablets and diclofenac delayed-release tablets are usually taken 2, 3, or 4 times a day.
• Diclofenac solution is taken without food as a one dose treatment to relieve the pain of migraine headaches.
• If you were told to take diclofenac on a regular basis, take it at around the same time(s) every day.
• Only take the diclofenac product prescribed by your doctor and do not switch to a different diclofenac product unless your doctor says that you should.
• Your doctor may adjust the dose of your medication during your treatment depending on your response to the medication.
• Talk to your doctor about how you are feeling during your treatment with diclofenac.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As tablets of 50 mg (light brown) for oral administration.

This medicine is available in fallowing brand namesː

• Cataflam

What side effects can this medication cause?

The most common side effects of this medicine include:

• 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

NSAIDs can cause serious side effects, including:

• Increased risk of a heart attack or stroke that can lead to death
• Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus
• new or worse high blood pressure
• heart failure
• liver problems including liver failure
• kidney problems including kidney failure
• low red blood cells (anemia)
• life-threatening skin reactions
• life-threatening allergic reactions

What special precautions should I follow?

• CATAFLAM (diclofenac potassium tablets, USP) cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation.
• Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids and the patient should be observed closely for any evidence of adverse effects.
• Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately.
• Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their healthcare provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for the signs and symptoms of GI bleeding.
• Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right upper quadrant tenderness, and "flu-like" symptoms).
• Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur.
• Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur.
• Advise patients to stop taking CATAFLAM immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible.
• Advise females of reproductive potential who desire pregnancy that NSAIDs, including VOLTAREN®, may be associated with a reversible delay in ovulation.
• Inform pregnant women to avoid use of CATAFLAM and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus. If treatment with diclofenac potassium tablets is needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours.
• Inform patients that the concomitant use of CATAFLAM with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended.
• Inform patients not to use low-dose aspirin concomitantly with CATAFLAM until they talk to their healthcare provider.
• The pharmacological activity of CATAFLAM in reducing fever and inflammation, and possibly fever, may diminish the utility of these diagnostic signs in detecting infections.
• Based on available data, diclofenac may be present in human milk.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• lethargy
• drowsiness
• nausea
• vomiting
• epigastric pain
• Gastrointestinal
• Hypertension
• acute renal failure
• respiratory depression
• coma

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Manage patients with symptomatic and supportive care following an NSAID overdosage.
• There are no specific antidotes.
• Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion in patients with a large overdose (5 to 10 times the recommended dosage).
• Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

Can this medicine be used in pregnancy?

• Use of NSAIDs, including CATAFLAM, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.
• Because of these risks, limit dose and duration of CATAFLAM use between about 20 and 30 weeks of gestation and avoid CATAFLAM use at about 30 weeks of gestation and later in pregnancy.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• DICLOFENAC POTASSIUM

Inactive ingredients:

• SILICON DIOXIDE
• HYDROXYETHYL CELLULOSE, UNSPECIFIED
• FERRIC OXIDE RED
• MAGNESIUM STEARATE
• METHYL ALCOHOL
• POLYETHYLENE GLYCOL, UNSPECIFIED
• POVIDONE, UNSPECIFIED
• sodium bicarbonate
• titanium dioxide
• FERRIC OXIDE YELLOW

Who manufactures and distributes this medicine?

Manufactured for:

• Blucrest Pharmaceuticals, LLC.
• Hazlet, NJ

What should I know about storage and disposal of this medication?

• Dispense in a tight, light-resistant container as defined in the USP using a child resistant closure.
• Keep container tightly closed.
• Store at 20° to 25°C (68° to 77°F).
• Protect from moisture.

• Dailymed label info on Diclofenac potassium
• FDA Diclofenac potassium

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