Diclo Gel 1% Pak

DICLO GEL 1% PAK- diclofenac sodium, isopropyl alcohol
Shoreline Pharmaceuticals, Inc.

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)] .
  • VOLTAREN ® GEL 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)].

1 INDICATIONS AND USAGE

VOLTAREN ® GEL is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.

  • VOLTAREN ® GEL has not been evaluated for use on the spine, hip, or shoulder.

2 DOSAGE AND ADMINISTRATION

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

2.1 Dosing Card

[See the Patient Instructions for Use]

The dosing card can be found attached to the inside of the carton.

The proper amount of VOLTAREN® GEL should be measured using the dosing card supplied in the drug product carton. The dosing card is made of clear polypropylene. The dosing card should be used for each application of drug product. The gel should be applied within the rectangular area of the dosing card up to the 2 gram or 4 gram line (2 g for each elbow, wrist, or hand, and 4 g for each knee, ankle, or foot). The 2 g line is 2.25 inches long. The 4 g line is 4.5 inches long. The dosing card containing VOLTAREN® GEL can be used to apply the gel. The hands should then be used to gently rub the gel into the skin. After using the dosing card, hold with fingertips, rinse, and dry. If treatment site is the hands, patients should wait at least one (1) hour to wash their hands.

2.2 Lower extremities, including the feet, ankles, or knees

Apply the gel (4 g) to the affected foot, ankle, or knee 4 times daily. VOLTAREN® GEL should be gently massaged into the skin ensuring application to the entire affected foot, or knee or ankle. The entire foot includes the sole, top of the foot and the toes. Do not apply more than 16 g daily to any single joint of the lower extremities.

2.3 Upper extremities including the hands, wrists, or elbows

Apply the gel (2 g) to the affected hand, wrist, or elbow 4 times daily. VOLTAREN® GEL should be gently massaged into the skin ensuring application to the entire affected hand, wrist, or elbow. The entire hand includes the palm, back of the hands, and the fingers. Do not apply more than 8 g daily to any single joint of the upper extremities.

Total dose should not exceed 32 g per day, over all affected joints.

2.4 Special Precautions

  • Avoid showering/bathing for at least 1 hour after the application. Inform patient to wash his/her hands after use, unless the hands are the treated joint. If VOLTAREN® GEL is applied to the hand(s) for treatment; inform patient not to wash the treated hand(s) for at least 1 hour after the application.
  • Do not apply VOLTAREN® GEL to open wounds.
  • Avoid contact of VOLTAREN® GEL with eyes and mucous membranes.
  • Do not apply external heat and/or occlusive dressings to treated joints.
  • Avoid exposure of the treated joint(s) to natural or artificial sunlight.
  • Avoid concomitant use of VOLTAREN® GEL on the treated skin site with other topical products, including sunscreens, cosmetics, lotions, moisturizers, insect repellants, or other topical medications.
  • Concomitant use of VOLTAREN ® GEL with oral non-steroidal anti-inflammatory drugs (NSAIDs) has not been evaluated, and may increase adverse NSAIDs effects. Do not use combination therapy with VOLTAREN ® GEL and an oral NSAID unless the benefit outweighs the risk and conduct periodic laboratory evaluations.
  • Avoid wearing of clothing or gloves for at least 10 minutes after applying VOLTAREN® GEL.

3 DOSAGE FORMS AND STRENGTHS

VOLTAREN ® GEL (diclofenac sodium topical gel), 1%

4 CONTRAINDICATIONS

VOLTAREN ® 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) ].

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 events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.

To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as diclofenac, increases the risk of serious gastrointestinal (GI) events [see Warnings and Precautions ( 5.2)] .

Status Post Coronary Artery Bypass Graft (CABG) Surgery

Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke. NSAIDs are contraindicated in the setting of CABG [see Contraindications ( 4)] .

Post-MI Patients

Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post-MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up.

Avoid the use of VOLTAREN ® GEL in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If VOLTAREN ® GEL is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

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