FLECTOR

Absorption – Adults Following a single application of the FLECTOR on the upper inner arm, peak plasma concentrations of diclofenac (range 0.7 – 6 ng/mL) were noted between 10 – 20 hours of application. Plasma concentrations of diclofenac in the range of 1.3 – 8.8 ng/mL were noted after five days with twice-a-day FLECTOR application. Systemic exposure (AUC) and maximum plasma concentrations of diclofenac, after repeated dosing for four days with FLECTOR, were lower (<1%) than after a single oral ...

14.1 Strains, Sprains, and Contusions Efficacy of FLECTOR was demonstrated in two of four studies of patients with minor strains, sprains, and contusions. Patients were randomly assigned to treatment with the FLECTOR, or a placebo identical to the FLECTOR minus the active ingredient. In the first of these two studies, patients with ankle sprains were treated once daily for a week. In the second study, patients with strains, sprains, and contusions were treated twice daily for up to two weeks. Pain was assessed over the period of treatment. Patients treated with the FLECTOR experienced a greate...

The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see Warnings and Precautions (5.1) ] GI Bleeding, Ulceration and Perforation [see Warnings and Precautions (5.2) ] Hepatotoxicity [see Warnings and Precautions (5.3) ] Hypertension [see Warnings and Precautions (5.4) ] Heart Failure and Edema [see Warnings and Precautions (5.5) ] Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.6) ] Anaphylact...

FLECTOR 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...

Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. ( 5.3 ) Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure. ( 5.4 , 7 ) Heart Failure and Edema: Avoid use of FLECTOR in patients with severe heart failure unless benefits are expected to outweigh risk...

7 DRUG INTERACTIONS See Table 2 for clinically significant drug interactions with diclofenac.

Table 2Clinically Significant Drug Interactions with Diclofenac Drugs That Interfere with Hemostasis Clinical Impact: Diclofenac and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of diclofenac and anticoagulants have an increased risk of serious bleeding comp...