Diclofenac Sodium 1.5% (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

16 HOW SUPPLIED/STORAGE AND HANDLING

Diclofenac Sodium Topical Solution USP, 1.5% w/w is supplied as a clear, colorless to faintly pink orange solution containing 16.05 mg of diclofenac sodium per mL of solution, in a white high density polyethylene bottle with a white low density polyethylene dropper cap.

NDC Number and Size

5 FL.OZ. (150 mL) bottle in cartons of one NDC # 70512-038-05

Storage

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

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide) and Instructions for Use that accompanies each prescription dispensed. Inform patients, families, or their caregivers of the following information before initiating therapy with diclofenac sodium topical solution 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 diclofenac sodium topical solution 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 including DRESS

Advise patients to stop taking diclofenac sodium topical solution immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible [see WARNINGS AND PRECAUTIONS ( 5.10, 5.11)] .

Female Fertility

Advise females of reproductive potential who desire pregnancy that NSAIDs, including diclofenac sodium topical solution, 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 diclofenac sodium topical solution and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus. If treatment with diclofenac sodium topical solution is needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours [see Warnings and Precautions (5.11) and Use in Specific Populations (8.1)].

Avoid Concomitant Use of NSAIDs

Inform patients that the concomitant use of diclofenac sodium topical solution 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 diclofenac sodium topical solution until they talk to their healthcare provider [see DRUG INTERACTIONS (7)].

Eye Exposure

Instruct patients to avoid contact of diclofenac sodium topical solution with the eyes and mucosa. 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.

Prevention of Secondary Exposure

Instruct patients to avoid skin-to-skin contact between other people and the knee(s) to which diclofenac sodium topical solution was applied until the knee(s) is completely dry.

Application Site Reactions

Diclofenac sodium topical solution can cause a localized skin reaction at the application site. Advise patients to contact their physicians as soon as possible if they develop any type of localized application site rash.

Special Application Instructions

· Instruct patients not to apply diclofenac sodium topical solution to open skin wounds, infections, inflammations, or exfoliative dermatitis, as it may affect absorption and reduce tolerability of the drug.

· Instruct patients to wait until the area treated with diclofenac sodium topical solution is completely dry before applying sunscreen, insect repellant, lotion, moisturizer, cosmetics, or other topical medication.

· Instruct patients to minimize or avoid exposure of treated knee(s) to natural or artificial sunlight.

The brand(s) are trademarks of their respective owners.

Manufactured for:

SOLA Pharmaceuticals, LLC

Baton Rouge, LA 70810

March 2021 ID#: 267407

Medication Guide for Nonsterodial Anti-inflammatory Drugs (NSAIDS)

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

NSAIDs can cause serious side effects, including:

  • Increased risk of a heart attack or storke 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

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
  • longer use of NSAIDs
  • smoking
  • drinking alcohol
  • older age
  • poor health
  • advanced liver disease
  • 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 have 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. Taking NSAIDs at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor theamount of fluid in your womb around your baby. You should not take NSAIDs after 30 weeks of pregnancy.

· are breastfeeding or plan to breast feed.

Tell your healthcare provider about 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 get 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.

You may also report side effects to Sola Pharmaceuticals, LLC at 866 747-7365.

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.

G eneral 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.

Manufactured for:

SOLA Pharmaceuticals, LLC

Baton Rouge, LA 70810

March 2021

Instructions for Use

Diflofenac Sodium Topical Solution USP, 1.5% w/w

(dye-KLOE-fen-ak)

Read the Medication Guide that comes with diclofenac sodium topical solution first. Be sure that you read, understand and follow these Instructions for Use before you use diclofenac sodium topical solution for the first time.

Imporatnt: For use on the skin only (topical). Do not get diclofenac sodium topical solution in your eyes, nose or mouth.

Before you use diclofenac sodium topical solution:

  • Apply diclofenac sodium topical solution exactly as your healthcare provider tells you. Talk with your healthcare provider or pharmacist if you are not sure.
  • Only use diclofenac sodium topical solution to treat pain from osteoarthritis in your knee or knees.
  • Apply diclofenac sodium topical solution on clean, dry skin that does not have any cuts, infections, or rashes.
  • Use diclofenac sodium topical solution 4 times each day on your knee or knees as prescribed.
  • Your total dose for each knee is 40 drops of diclofenac sodium topical solution, each time you use it.
  • If you get diclofenac sodium topical solution in your eyes, rinse your eyes right away with water or saline. Call your healthcare provider if your eyes are irritated for more than one hour.

Steps for using diclofenac sodium topical solution:

Step 1. Wash your hands with soap and water before applying diclofenac sodium topical solution.

Step 2. Put 10 drops of diclofenac sodium topical solution either on your hand or directly on your knee (see Figure A).

Figure A
(click image for full-size original)

Step 3. Spread diclofenac sodium topical solution evenly on the front, back, and sides of your knee (see Figures B and C). Repeat steps 2 and 3, three times so that your knee is completely covered with a total of 40 drops of diclofenac sodium topical solution.

Figure B

Step 4. If your healthcare provider has prescribed diclofenac sodium topical solution for both knees, repeat steps 2 and 3 for the other knee.

After you use diclofenac sodium topical solution:

  • Wash your hands with soap and water right away after applying diclofenac sodium topical solution.

Do not:

  • touch the treated knee or allow another person to touch the knee treated with diclofenac sodium topical solution uinitl your knee is completely dry.
  • cover your knee with clothing until your knee is completely dry.
  • put sunscreen, insect repellant, lotion, mositurizer, cosmetics, or other topical medicines on your knee unitl it is completely dry.
  • take a shower or a bath for at least 30 minutes after you put diclofenac sodium topical solution on your knee.
  • use heating pads or cover the treated area with bandages where you have applied diclofenac sodium topical solution.
  • use sunlamps and tanning beds. Protect your treated knee from sunlight. Wear clothes that cover your skin if you have to be in sunlight.

How should I store diclofenac sodium topical solution?

  • Store diclofenac sodium topical solution 25ºC (77ºF); excursions permitted to 15 to 30ºC (59 to 86ºF) (See USP Controlled Room Temperature).

Keep diclofenac sodium topical solution and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

The brand(s) are trademarks of their respective owners.

Manufactured for:

SOLA Pharmaceuticals, LLC

Baton Rouge, LA 70810

March 2021

ID#: 267408

CARTON
(click image for full-size original)
LABEL
(click image for full-size original)

DICLOFENAC SODIUM 1.5%
diclofenac sodium topical solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70512-038
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLOFENAC SODIUM (DICLOFENAC) DICLOFENAC SODIUM 16.05 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
GLYCERIN
WATER
DIMETHYL SULFOXIDE
PROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70512-038-05 1 BOTTLE in 1 CARTON contains a BOTTLE
1 150 mL in 1 BOTTLE This package is contained within the CARTON (70512-038-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204132 06/04/2021
Labeler — SOLA Pharmaceuticals (080121345)

Revised: 07/2022 SOLA Pharmaceuticals

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