FLECTOR Patch (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Pfizer, Inc.

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

BOXED WARNING SECTION

WARNING: RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious ...

1. Indications and Usage

FLECTOR PATCH is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.

2. Dosage and Administration

2.1 General Dosing Instructions Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)]. The recommended ...

3. Dosage Forms and Strengths

FLECTOR (diclofenac epolamine) Patch (10 × 14 cm) containing 180 mg of diclofenac epolamine, embossed with FLECTOR PATCH <DICLOFENAC EPOLAMINE TOPICAL PATCH> 1.3%.

4. Contraindications

FLECTOR PATCH 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 ...

5. Warnings and Precautions

5.1 Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic ...

6. Adverse Reactions

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 ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of ...

7. Drug Interactions

See Table 2 for clinically significant drug interactions with diclofenac. Table 2. Clinically Significant Drug Interactions with Diclofenac: Drugs That Interfere with Hemostasis Clinical Impact: ...

8.1. Pregnancy

Risk Summary Published literature reports that use of NSAIDs, including FLECTOR PATCH, after 30 weeks' gestation increases the risk of premature closure of the fetal ductus arteriosus. Data from observational ...

8.2. Lactation

Risk Summary Data from published literature reports with oral preparations of diclofenac indicate the presence of small amounts of diclofenac in human milk (see Data). There are no data on the ...

8.3. Females and Males of Reproductive Potential

Infertility Females Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including FLECTOR PATCH may delay or prevent rupture of ovarian follicles, which has been associated with ...

8.4. Pediatric Use

The safety and effectiveness of FLECTOR PATCH in pediatric patients have not been established.

8.5. Geriatric Use

Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions. If the anticipated benefit for the elderly ...

10. Overdosage

Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal ...

11. Description

FLECTOR PATCH (diclofenac epolamine patch) is a nonsteroidal anti-inflammatory drug, available for topical application. FLECTOR PATCH is a 10 cm × 14 cm patch comprised of an adhesive material containing ...

12.1. Mechanism of Action

Diclofenac has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of diclofenac, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase ...

12.2. Pharmacodynamics

FLECTOR PATCH applied to intact skin provides local analgesia by releasing diclofenac epolamine from the patch into the skin.

12.3. Pharmacokinetics

Absorption Following a single application of the FLECTOR PATCH 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 ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Long-term studies in animals have not been performed to evaluate the carcinogenic potential of either diclofenac epolamine or FLECTOR PATCH. Mutagenesis Diclofenac epolamine is not mutagenic ...

14. Clinical Studies

14.1 Ankle Sprains Efficacy of FLECTOR PATCH was demonstrated in two of four studies of patients with minor sprains, strains, and contusions. Patients were randomly assigned to treatment with the FLECTOR ...

16.1. How Supplied

The FLECTOR PATCHis supplied in resealable envelopes, each containing 5 patches (10 cm × 14 cm), with 6 envelopes per box (NDC 60793-411-30). Each individual patch is embossed with FLECTOR PATCH <DICLOFENAC ...

16.2. Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed, as well as the Directions for Use on the product packaging. Inform patients, ...