Diclofenac Potassium - Diclofenac Potassium capsule, Liquid Filled Prescribing Information
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 [
see Warnings and Precautions (5.1)
].
●
Diclofenac Potassium Capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [
see Contraindications (4) and Warnings and Precautions (5.1)
]
.
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 [
see Warnings and Precautions
(
5.2
)].
Warnings and Precautions (5.9)
01/2025
Diclofenac Potassium Capsules are indicated for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older. (1)
Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals (2.1)
The dosage is 25 mg four times a day
Diclofenac Potassium Capsules: 25 mg
Infertility
: NSAIDs are associated with reversible infertility. Consider withdrawal of Diclofenac Potassium Capsules in women who have difficulties conceiving (8.3)
We receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available