Relsec (diclofenac potassium): Uses, Dosage & Side Effects

What it's for (Indications)

Diclofenac potassium is indicated for relieving pain and inflammation.
Specific indications include: Rheumatoid arthritis, Osteoarthrosis, Lower backache, Migraine headaches (acute treatment), periarthritis (particularly frozen shoulder), tenosynovitis (inflammation of synovial sheath around tendon), tendinitis (inflammation of tendons), bursitis (inflammation of bursa), strains, sprains and dislocations, Ankylosing spondylitis, Acute Gout (very painful arthritis), Pyrophosphate arthropathy (a type of arthritis, caused by calcium pyrophosphate dihydrate accumulation) and its complications.
It is also used for pain and inflammation management following dental, orthopedic, and other minor surgeries, as well as for backache and menstrual cramps.

Dosage Information

Type	Guideline
Standard	Diclofenac potassium should be taken orally. It is crucial to use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. The dosage is dependent on the patient’s age, condition, and its severity, and should always be determined by a doctor. General Dosing: Tablets are usually prescribed two or three times a day, typically taken at the same time daily, preferably with or after meals. Some formulations may be once-daily. The tablet should be swallowed whole and not crushed. Do not alter the dose. Acute Migraine Treatment: For acute treatment of migraine, administer one packet (50 mg) of diclofenac potassium. Empty the contents into a cup containing 1 to 2 ounces or 2 to 4 tablespoons (30 to 60 mL) of water, mix well, and drink immediately. Do not use liquids other than water. Taking with food may cause a reduction in effectiveness compared to taking on an empty stomach for migraine. The safety and effectiveness of a second dose have not been established. Administration Notes: The effect of this medicine can be observed within 10-30 minutes of administration, though for conditions like Caflam, it may take up to one week, and possibly two weeks, to feel full effects. If a dose is missed, take it as soon as remembered, but do not take two doses at the same time. This formulation is not interchangeable with other diclofenac formulations.

Type

Guideline

Standard

Diclofenac potassium should be taken orally. It is crucial to use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. The dosage is dependent on the patient’s age, condition, and its severity, and should always be determined by a doctor. **General Dosing:** Tablets are usually prescribed two or three times a day, typically taken at the same time daily, preferably with or after meals. Some formulations may be once-daily. The tablet should be swallowed whole and not crushed. Do not alter the dose. **Acute Migraine Treatment:** For acute treatment of migraine, administer one packet (50 mg) of diclofenac potassium. Empty the contents into a cup containing 1 to 2 ounces or 2 to 4 tablespoons (30 to 60 mL) of water, mix well, and drink immediately. Do not use liquids other than water. Taking with food may cause a reduction in effectiveness compared to taking on an empty stomach for migraine. The safety and effectiveness of a second dose have not been established. **Administration Notes:** The effect of this medicine can be observed within 10-30 minutes of administration, though for conditions like Caflam, it may take up to one week, and possibly two weeks, to feel full effects. If a dose is missed, take it as soon as remembered, but do not take two doses at the same time. This formulation is not interchangeable with other diclofenac formulations.

Safety & Warnings

Common Side Effects

Common side effects include nausea, upset stomach, indigestion, heartburn, constipation, diarrhea, gas, headache, drowsiness, dizziness, and sleepiness.
Allergy is also a possible side effect.
Long-term use may increase the risk of severe cardiovascular and gastrointestinal events, including stroke, heart attack, ulcers, and intestinal bleeding, which are further detailed in the 'Unified Warnings and Precautions' section.

Serious Warnings

Black Box Warning: WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS **Cardiovascular Thrombotic Events:** Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Diclofenac Potassium is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. **Gastrointestinal Bleeding, Ulceration, and Perforation:** NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
Patients should use the lowest effective dose for the shortest duration consistent with treatment goals.
**Cardiovascular Risks:** NSAIDs, including diclofenac potassium, increase the risk of serious cardiovascular thrombotic events (e.
g.
, myocardial infarction, stroke), which can be fatal.
This risk may occur early in treatment and increases with duration of use.
It is not recommended for individuals with heart diseases, such as congestive heart failure, or related risk factors.
It is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
It can lead to new onset or worsening hypertension, and fluid retention and edema, requiring caution in patients with heart failure or edema.
Regular monitoring of liver function tests and blood tests is advised for patients on long-term therapy.
**Gastrointestinal Risks:** NSAIDs increase the risk of serious gastrointestinal bleeding, ulceration, and perforation, which can be fatal.
This risk can occur at any time during use without warning symptoms.
Diclofenac potassium affects platelet activity, increasing the probability of excessive bleeding.
Patients with active ulcers or a history of ulcers, or stomach bleeding should avoid this medicine.
Alcohol consumption should be avoided, as it can exacerbate diclofenac potassium-induced gastrointestinal bleeding.
Use cautiously in patients with bleeding disorders.
**Hepatic Toxicity:** Serious hepatotoxicity can occur.
Lower diclofenac potassium doses may be required in patients with liver impairment, and it is not recommended for patients with severe liver disease.
Regular monitoring of liver function tests is advised for patients on long-term therapy.
**Renal Toxicity & Hyperkalemia:** Serious renal toxicity (e.
g.
, acute renal failure, interstitial nephritis, renal papillary necrosis) can occur.
It is not recommended for patients with severe kidney disease.
Use cautiously in patients with kidney disease.
Hyperkalemia can also occur.
**Pregnancy and Lactation:** Diclofenac potassium should be avoided by pregnant and lactating females due to potential risks to the mother and infant, including toxic and possibly fatal effects as the medicine may pass to the infant.
The use of NSAIDs in late pregnancy may cause premature closure of the fetal ductus arteriosus.
Females trying to conceive should avoid this medicine as it may affect fertility.
Consult a doctor if nursing, only use if clearly needed.
**Allergic Reactions:** Inform the doctor about any allergies to the medicine's contents, aspirin, or other NSAIDs.
Serious anaphylactic reactions and serious skin reactions (e.
g.
, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)) can occur.
History of asthma, urticaria, or other allergic-type reactions to aspirin or other NSAIDs contraindicates use.
**Central Nervous System:** This medicine may cause dizziness, drowsiness, or a sudden drop in blood pressure.
Patients should avoid driving or engaging in activities requiring alertness until they know how the medicine affects them.
Medication Overuse Headache can occur.
**Hematologic Toxicity:** Anemia and inhibition of platelet aggregation can occur.
**Respiratory Disorders:** Patients with respiratory disorders should use this medicine cautiously.
**Other Precautions:** * Not to be used by patients with porphyrias or in volume depletion cases.
* Elderly patients and those on long-term therapy require regular monitoring of liver function tests and blood tests.
* Avoid taking other NSAIDs simultaneously with diclofenac potassium.
* Inform the doctor about complete medical history, especially asthma, high cholesterol, angina, high blood pressure, liver or kidney impairment, bowel problems, blood clotting disorders, and connective tissue diseases.
* Do not exceed the prescribed dose or alter the dose.

How it Works (Mechanism of Action)

Diclofenac potassium possesses analgesic, anti-inflammatory, and antipyretic properties. Its mechanism of action, similar to other NSAIDs, involves the inhibition of cyclooxygenase (COX-1 and COX-2) enzymes. This leads to a potent inhibition of prostaglandin synthesis, thereby decreasing prostaglandins in peripheral tissues, which are mediators of inflammation and pain.