Diclo Gel

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) ].

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)]
• Anaphylactic Reactions [see Warnings and Precautions ( 5.7)]
• Serious Skin Reactions [see Warnings and Precautions ( 5.9)]
• Hematologic Toxicity [see Warnings and Precautions ( 5.11)]

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 another drug and may not reflect the rates observed in practice.

During clinical development, 913 patients were exposed to VOLTAREN ® GEL in randomized, double-blind, multicenter, vehicle-controlled, parallel-group studies in osteoarthritis of the superficial joints of the extremities. Of these, 513 patients received VOLTAREN ® GEL for osteoarthritis of the knee and 400 were treated for osteoarthritis of the hand. Additionally, 583 patients were exposed to VOLTAREN ® GEL in an uncontrolled, open-label, long-term safety trial in osteoarthritis of the knee. Of these, 355 patients were treated for osteoarthritis of 1 knee and 228 were treated for osteoarthritis of both knees. Duration of exposure ranged from 8 to 12 weeks for the placebo-controlled studies, and up to 12 months for the open-label safety trial.

Short-Term Placebo-Controlled Trials:
Adverse reactions observed in at least 1% of patients treated with VOLTAREN ® GEL: Non-serious adverse reactions that were reported during the short-term placebo-controlled studies comparing VOLTAREN ® GEL and placebo (vehicle gel) over study periods of 8 to 12 weeks (16 g per day), were application site reactions. These were the only adverse reactions that occurred in >1% of treated patients with a greater frequency in the VOLTAREN ® GEL group (7%) than the placebo group (2%). 
Table 1 lists the types of application site reactions reported. Application site dermatitis was the most frequent type of application site reaction and was reported by 4% of patients treated with VOLTAREN ® GEL, compared to 1% of placebo patients.

†Preferred Term according to MedDRA 9.1.

In the placebo-controlled trials, the discontinuation rate due to adverse reactions was 5% for patients treated with VOLTAREN ® GEL, and 3% for patients in the placebo group. Application site reactions, including application site dermatitis, were the most frequent reason for treatment discontinuation. 

Long-Term Open-Label Safety Trial:
In the open-label, long-term safety study, distribution of adverse reactions was similar to that in the placebo-controlled studies. In this study, where patients were treated for up to 1 year with VOLTAREN ® GEL up to 32 g per day, application site dermatitis was observed in 11% of patients. Adverse reactions that led to the discontinuation of the study drug were experienced in 12% of patients. The most common adverse reaction that led to discontinuation of the study was application site dermatitis, which was experienced by 6% of patients.

VOLTAREN ® GEL (diclofenac sodium topical gel, 1%) is available in tubes containing 100 grams of the topical gel in each tube. Each tube contains diclofenac sodium in a gel base (10 mg of diclofenac sodium per gram of gel or 1%).

100 grams tube………………………………NDC 63481-684-47
3 Pack (3 Tubes containing 100 g each)……..NDC 63481-684-03
5 Pack (5 Tubes containing 100 g each)……..NDC 63481-684-05     

Storage

Store at room temperature 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Keep from freezing. Store the dosing card with your VOLTAREN ® GEL

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use) that accompanies each prescription dispensed. Patients, families, or their caregivers should be informed of the following information before initiating therapy with VOLTAREN ® GEL and periodically during the course of ongoing therapy.

Cardiovascular Thrombotic Events

Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately [see Warnings and Precautions ( 5.1)].

Gastrointestinal Bleeding, Ulceration, and Perforation

Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding [see Warnings and Precautions ( 5.2)].

Hepatotoxicity

Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If these occur, instruct patients to stop VOLTAREN ® GEL and seek immediate medical therapy [see Warnings and Precautions ( 5.3)].

Heart Failure and Edema

Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [see Warnings and Precautions ( 5.5)].

Anaphylactic Reactions

Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur [see Contraindications (4) and Warnings and Precautions ( 5.7)].

Serious Skin Reactions

Advise patients to stop VOLTAREN ® GEL immediately if they develop any type of rash and to contact their healthcare provider as soon as possible [see Warnings and Precautions ( 5.9)].

Female Fertility

Advise females of reproductive potential who desire pregnancy that NSAIDs, including VOLTAREN ® GEL, may be associated with a reversible delay in ovulation [see Use in Specific Populations ( 8.3)]

Fetal Toxicity

Inform pregnant women to avoid use of VOLTAREN ® GEL and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus [see Warnings and Precautions ( 5.10) and Use in Specific Populations ( 8.1)].

Avoid Concomitant Use of NSAIDs

Inform patients that the concomitant use of VOLTAREN ® GEL with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy [ see Warnings and Precautions ( 5.2) and Drug Interactions ( 7)]. Alert patients that NSAIDs may be present in "over the counter" medications for treatment of colds, fever, or insomnia.

Use of NSAIDS and Low-Dose Aspirin

Inform patients not to use low-dose aspirin concomitantly with VOLTAREN ® GEL until they talk to their healthcare provider [see Drug Interactions ( 7)].

Eye Exposure

Instruct patients to avoid contact of VOLTAREN ® GEL with the eyes and mucosa, although not studied, should be avoided. Advise patients that if eye contact occurs, immediately wash out the eye with water or saline and consult a physician if irritation persists for more than an hour  [see Warnings and Precautions ( 5.15)].

Special Application Instructions

Instruct patients how to use the dosing card to measure the proper dose of VOLTAREN ® GEL to apply.
If the patient loses their dosing card, instruct them that they can call 1-800-398-5876 to request a replacement dosing card or ask their pharmacist for a new dosing card.

Instruct patients how to correctly measure the 2.25 inches (2 g) dose or 4.5 inches (4 g) dose while waiting for a replacement dosing card [see Dosage and Administration ( 2.2)].

Instruct patients not to apply VOLTAREN ® GEL to open skin wounds, infections, inflammations, or exfoliative dermatitis, as it may affect absorption and tolerability of the drug.

Instruct patients to avoid concomitant use of VOLTAREN ® GEL with other topical products, including sunscreens, cosmetics, lotions, moisturizers, and insect repellants. Concomitant use may result in skin reactions or change the absorption of VOLTAREN ® GEL.

Instruct patients to minimize or avoid exposure of treated areas to natural or artificial sunlight [see Warnings and Precautions ( 5.14) and Dosage and Administration ( 2.4)].

Comments or Questions?

Call toll-free 1-800-398-5876

Marketed by:

Endo Pharmaceuticals Inc.

Malvern, PA 19355

Manufactured by:

• Novartis Pharma Produktions GmbH,

Wehr, Germany for

Sandoz Inc., Princeton, NJ 08540

Revised: April 2016

Medication Guide for Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

What is the most important information I should know about medicines called Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAIDs can cause serious side effects, including:

• Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:
  • with increasing doses of NSAIDs
  • with longer use of NSAIDs

Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).”

Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

• Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:
  • anytime during use
  • without warning symptoms
  • that may cause death

The risk of getting an ulcer or bleeding increases with:

• • past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
  • taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs
  • increasing doses of NSAIDs
  • older age
  • longer use of NSAID
  • poor health
  • smoking
  • advanced liver problems
  • drinking alcohol
  • bleeding problems

NSAIDs should only be used:

• • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed

What are NSAIDs?

NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain

Who should not take NSAIDs?

Do not take NSAIDs :

• if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs
• right before or after heart bypass surgery

Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you:

• have liver or kidney problems
• have high blood pressure
• have asthma
• are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy.
• Are breastfeeding or plan to breast feed

Tell your healthcare provider all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

What are the possible side effects of NSAIDs?

NSAIDs can cause serious side effects, including:

See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?”

• new or worse high blood pressure
• heart failure
• liver problems including liver failure
• kidney problems including kidney failure
• low red blood cells (anemia)
• life-threatening skin reactions
• life-threatening allergic reactions
• Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.

Get emergency help right away if you have any of the following symptoms:

• shortness of breath or trouble breathing
• slurred speech
• chest pain
• swelling of the face or throat
• weakness in one part or side of your body

Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms:

• nausea
• vomit blood
• more tired or weaker than usual
• there is blood in your bowel movement or it is black and sticky like tar
• diarrhea
• itching
• unusual weight gain
• your skin or eyes look yellow
• skin rash or blisters with fever
• indigestion or stomach pain
• swelling of the arms, legs, hands and feet
• flu-like symptoms

If you take too much of your NSAID, call your healthcare provider or get medical help right away.

These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about NSAIDs

• Aspirin is an NSAID but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
• Some NSAIDs are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

General Information about the safe and effective use of NSAIDs

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Marketed by:

• Endo Pharmaceuticals Inc., Malvern, PA 19355

Manufactured by:

Novartis Pharma Produktions GmbH,

Wehr, Germany for

Sandoz Inc., Princeton, NJ 08540

Revised: April 2016

Isopropyl Alcohol, 70% v/v

Purpose

Antiseptic

Commonly reported side effects of diclofenac topical include: increased liver enzymes. See below for a comprehensive list of adverse effects.

3% Gel:
-Apply an amount sufficient to cover each lesion twice a day and rub in gently
-Duration of therapy: 60 to 90 days; complete healing of lesions may not be evident for up to 30 days following cessation of therapy

Comments:
-Normally, 0.5 g is used on each 5 cm x 5 cm lesion site.
-Lesions that do not respond to therapy should be carefully reevaluated and management reconsidered.
-Sun exposure should be avoided during therapy.

Use: For the topical treatment of actinic keratosis

Advanced renal disease: Avoid use unless benefit is expected to outweigh risk of worsening renal function