Concomitant use associated with significantly increased incidence of GI adverse reactions and increased risk of bleeding.
Source: NLP:diclofenac sodium topical gel, 1%,
Diclofenac Sodium Topical Gel, 1%, Interactions
Brand names: Diclofenac Sodium
Route: Topical
FDA 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 [ see Warnings and Precautions (5.1) ]. • Diclofenac Sodium Topical Gel, 1% is 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) ]. WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. • 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 (5.1) • Diclofenac sodium topical gel, 1% is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. (4, 5.1) • 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
Contraindications
4 CONTRAINDICATIONS Diclofenac sodium topical gel is contraindicated in the following patients: • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [see Warnings and Precautions ( 5.7 , 5.9 )] • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions ( 5.7 , 5.8)] • In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1 )] • Known hypersensitivity to diclofenac or any components of the drug product. (4) • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. (4) • In the setting of CABG surgery. (4)
Pregnancy & Breastfeeding
8.1 Pregnancy Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestation Risk Summary Use of NSAIDs, including diclofenac sodium topical gel, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including diclofenac sodium topical gel, in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequate and well-controlled studies of diclofenac sodium topical gel in pregnant women. Human and animal studies indicate that diclofenac crosses the placenta. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background rate of 2-4% for major malformations, and 15-20% for pregnancy loss. In animal reproduction studies, no evidence of teratogenicity was observed in mice, rats, or rabbits given diclofenac during the period of organogenesis at doses up to approximately 5, 5, and 10 times, respectively, the maximum recommended topical dose of diclofenac sodium topical gel, despite the presence of maternal and fetal toxicity at these doses [see Data] . Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as diclofenac, resulted in increased pre- and post-implantation loss. Clinical Considerations Labor or Delivery There are no studies on the effects of diclofenac sodium topical gel during labor or delivery. In animal studies, NSAIDS, including diclofenac, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth. Data Animal data Reproductive and developmental studies in animals demonstrated that diclofenac sodi
4 interactions on record
Synergistic effect on bleeding with increased risk of serious bleeding compared to either drug alone.
Source: NLP:diclofenac sodium topical gel, 1%,
Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. In such high risk patients, monitor for signs of worsening renal function (7) Diuretics : NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics.
Source: FDA drug label - diclofenac sodium topical gel, 1%,
NSAIDs may diminish antihypertensive effect. In elderly, volume-depleted, or renally impaired patients, may result in renal function deterioration.
Source: NLP:diclofenac sodium topical gel, 1%,