Diclofenac Sodium Gel 1

Contents

Label package – 20 g

This is a Phase IV clinical study on how effective diclofenac is sodium ( diclofenac sodium ) for people with tendon inflammation. This study was done by ehealthme of 7 diclofenac sodium users and is constantly being updated.

Phase IV studies are used to identify adverse drug outcomes and predict how medication will work in the real world. thanks to Honey Big Data and AI techniques, Ehealthme has run millions of Phase IV studies and generally provides cheap results. Our first study was cited in The Lancet, Mayo Clinic contailing, and over 600 medical publications spread naturally.

09 November 2022.

7 people will be studied on the use of diclofenac sodium in Tendonitis

Key Facts.

Best for lowest possible dose of diclofenac Short term to control symptoms.
Take diclofenac Tablet or capsule with meals or snacks, or immediately after meals.
Often occurring side effects are abdominal pain, feeling or pain, skin rash.
Diclofenac gel and plastic are more likely to be used twice a day to tackle pain in certain areas of the body.

Most adults have a good chance. diclofenac .

Children may be prescribed diclofenac to treat joint problems. Diclofenac pills, capsules, and dip preparations are suitable for children as young as 6 months.

Diclofenac gel is suitable for children as young as 14 years. Diclofenac plasters and plasters are suitable for 16 year olds.

Diclofenac is not suitable for some people. To make sure it is not dangerous for you, you must tell your doctor or pharmacist if you

Once had an allergic reaction to to diclofenac or another medication.
Are allergic to aspirin or another nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen or naproxen
Creaky breathing or other asthma symptoms, runny nose, skin edema (angioedema), skin rashes, etc., have been caused by NSAID use.
Ulcers in the stomach, bleeding in the stomach or intestinal tract or had a hole in the stomach.
Have high blood pressure (hypertension)
Heart deficiency, severe liver or kidney disease.
Crohn’s disease or ulcerative colitis.
Lupus.
Has a blood clotting disorder.
Is pregnant and wants to become pregnant or breastfeeding

Is being treated by a physician in connection with a non-tender disorder
Use all other medications

Avoid contact with the eyes, nose, or mouth
Thoroughly clean with water with eye contact.

Pain may worsen or last longer than 21 days.
Redness or swelling occurs in painful areas.
Fever will occur
Skin migration occurs
New signs of any kind appear. This can be a symptom of a serious condition.
You feel one of the correct symptoms of stomach bleeding
You feel faint
You have bloody or dark stools
Vomiting or diarrhea
You have stomach pain that does not get better
You have signs of heart problems or a stroke
Chest pain
difficulty breathing
Swelling of your feet
Weakness on one side or another of your body
Unclear speech

Ask your doctor before use. It is even more important not to use this product in the direction of the last 3 months of pregnancy if your doctor has not indicated this accurately.

What is diclofenac sodium used to treat?

Arthritis pain:

Knee
Ankle
Feet
Hands
wrist
Elbow

Generic Brand diclofenac sodium :

Voltaren® Contents
Store brand (e.g., Walmart Store brand “Equate” or CFS Health Store brand)

Usage

See warnings in section This medication is used to relieve joint pain for arthritis. Diclofenac belongs to a class of drugs commonly called non-steroidal anti-inflammatory drugs (NSAIDs). When treating chronic conditions such as arthritis, ask your own physician about the use of non-pharmaceuticals or other medications to treat pain.

How to use diclofenac sodium topical

Before using, read the directions for use of the drug and instructions with the pharmacist’s patient medications. diclofenac And each time you meet it again. If you have any questions, ask your doctor or pharmacist.

This medication is predetermined for use on the skin only. To measure the correct dose, use the dosing card provided with the medication. Place the dosing card on a flat surface so that you can read the pressure on the card. Squeeze a uniform amount of medication from the tube on the dosing card and use the markings on the card to measure the dose being supplied. Carefully rub the medication over the entire affected joint, usually four times a day, or as prescribed by the physician. The medication can be used with the dosing card. Do not apply to cuts, infections, or skin with rashes.

If the package leaflet indicates that the dosing card needs to be used again, you must hold the card at your fingertips each time you use it, rinse and dry. When ready to discard the dosing card, fold the card in half on the medication side and explain the card out of reach of children and pets. Wash your hands after using the medication unless you are not using the medication. Do not shower, bathe, or wash for at least one hour after using the medication. Wait at least 10 minutes before covering the treated area with gloves gloves or clothing. Do not wrap the treated area and do not apply heat (e.g., heated pillow).

Dose is based on your welfare status and healing response. use no more than 16 grams of diclofenac per day for each individual joint of the lower body (knees, ankles, feet, etc.). use no more than 8 grams of diclofenac per day for each individual joint of the upper body (hand, wrist, elbow, etc.). Do not use more than 32 grams, regardless of the number of joints you are treating. of diclofenac per day.

Discuss the risks and benefits of using this product with your physician or pharmacist. To reduce the risk of side effects, use this medication at the lowest dose in the shortest amount of time. Do not increase dosage. Do not use more frequently than directed. Do not use the medication in areas where it has not been prescribed by a physician.

Do not put the medication in your eyes, nose, or mouth. If you get the medicine in these places it has had a lot of water in it. If discomfort persists, contact a physician immediately.

For certain disorders (such as arthritis), you may use this product regularly for 2 months until you fully benefit from this product.

If this product is used on an “as needed” basis (rather than a simple schedule), remember that the drug works better than anything else if used at the first symptom of pain. If you wait until the pain worsens, the drug may not activate.

Tell your doctor if the pain persists or worsens.

*Omitted sections or subsections from the absolute prescribing information are not mentioned.

Nonsteroidal anti-inflammatory drugs (NSAIDs) increase the risk of severe cardiovascular thrombosis incidents, including myocardial infarction and heart attack, which can be fatal. This risk may occur early in the healing process and may increase with duration of use [see Warnings and Precautions (5. 1)].
Diclofenac sodium Topical gels are contraindicated in coronary artery bypass graft (CABG) operations [see Contraindications (4) and Warnings and Precautions (5. 1)].

Gastrointestinal bleeding, ulceration, and perforation

NSAIDs cause an increased risk of serious gastrointestinal (GI) side effects, including bleeding, ulcers, and perforation of the stomach or intestinal tract. These side effects have a good chance of running at any time during use and without warning signals. Elderly patients and patients with a history of peptic ulcer disease and/or gastrointestinal bleeding are at greatest risk for non-DEAD GI events [see Warnings and Precautions (5, 2)].

Diclofenac sodium Topical gel, 1%, has not been evaluated for use in the spine, hip, or upper arm.

Use the lowest effective dose for the shortest duration according to the patient’s individual treatment goals [see Warnings and Precautions (5)].

What is the implementation of Diclofenac Sodium 50 mg tablets

Diclofenac is useful when closing the following tasks

Mild to moderate pain
Rheumatoid arthritis
Ankylosing spondylitis
Arthritis
Juvenile idiopathic arthritis
Gout
DysmeLORHEA

Do not use

– if you have ever had an allergic reaction to different anesthetics or fever reducers involving stretching, twisting rain, contusions, or sports injuries. This product has not been shown to work on these types of injuries in more than one place on the body at the same time, in the eyes, nose, or mouth, immediately before or after heart surgery.

– Using anesthesia or fever reduction may have problems or serious side effects. – Use stomach bleeding warning. Suffering from asthma or had a heart attack – diuretics used – are over 18 years of age. It is not known if this product is unstable or harmless in persons under 18.

1 Carcinogenesis, mutagenesis, and fertility problems

Cancinogenes studies in mice and rats treated with diclofenac sodium As a food ingredient in the direction of up to 2 mg/kg/day for up to 2 years (thus, about 0, 5, 1 hour, the very maximum appropriate dose for the human area. of diclofenac sodium Bioavailability vs. body surface (BSA)), local gels did not significantly increase the incidence of tumors. In Katton. a diclofenac sodium Gel products in the direction of 2 years at a concentration of 0, 035%. diclofenac sodium (a 29-fold lower diclofenac sodium Subsequently, there exists a concentration in diclofenac sodium (topical gel) did not increase the incidence of neoplasia. conducted in a photocarcinogenic study in hairless mice, a diclofenac sodium Gel products with a low amount of 0.035% of diclofenac sodium (a 29-fold lower diclofenac sodium Subsequently, there exists a concentration in diclofenac sodium (topical gel) resulted in a faster mean time to tumor development. of diclofenac sodium (important gels based on bioavailability vs. BSA).

Study 1 evaluated the efficacy of of diclofenac sodium topical gel for healing osteoarthritis of the knee in a 12-week randomized, double-blind, placebo-controlled, parallel study. diclofenac sodium Topical gel was administered four times daily at a dose of 4 g in the knee (16 g per day). Patient-rated pain per week from week 12 on the Western Ontario and McMaster Institute WOMAC version (Western Ontario and McMaster Institute Osteoarthritis Index) the diclofenac sodium Topical Gel group than the placebo group. Study 2 evaluated the efficacy of of diclofenac sodium Topical gel on healing in subjects with osteoarthritis describing an 8-week randomized, double-blind, multi-chamber, placebo-controlled, parallel group. diclofenac sodium Topical gel was administered in both arms (16 g per day) at a dose of 2 g per arm, 4 times per day). motivated arm pain rated by patients at weeks 4 and 6 on a visual analog scale ranging from 0 to 100, the diclofenac sodium Topical gel group than the placebo group. Table 4: Efficacy Summary of diclofenac sodium Topical gel in Studies 1 and 2

		Diclofenac sodium topical gel, 1%	Placebo (medium)	Different indications (placebo – diclofenac) sodium topical gel, 1%)
Study 1 (knee) Women with pain *#12 weeks	Sample size	127	119
	Mean	28	37	Δ= 7† 95% confidence interval
	95% confidence interval			(1, 12)
Study 2 (poor) pain voltage #4 weeks – weeks.	Sample size	198	187
	Mean	43	50	Δ= 7‡
	95% confidence interval			(2, 12)
Test 2 (poor) pain voltage # at week 6	Sample size	198	187
	Mean	40	47	Δ= 7‡
	95% confidence interval			(1, 13)

* WOMAC = Western Ontario McMaster Osteoarthritis Index. # ranges from 0 (best) to 100 (worst). ‡ Differences were adjusted by implementation of the analysis of colleague models (ANCOVA), with major effects of starting values such as healing, central, CMC-1 joint pain index, and healing by CMC-1.

Diclofenac sodium Topical gel, 1% is an opaque, broken white gel, available in tubes with 100 grams of district gel in every tube. All tubes contain diclofenac sodium Gel base (10 mg of diclofenac sodium per G gel or 1%). 100 g tube …………………………… Prevents freezing. Store dosing card with your own dosing card diclofenac sodium topical gel.

Advise the patient to read the label approved by the FDA (Medication Guide and Instructions for Use) delivered with each dispensed recipe. Patients, their families or guardians must be informed of the correct information prior to treatment diclofenac sodium Topical gels, and occasionally during ongoing treatment. Advise the patient to watch for signs of a vascular thrombotic incident, including chest pain, respiratory, impotence or decreased speech, and report each of these signs immediately to the care provider [see Warnings and Preventive Measures (5. 1)]. Patients with gastrointestinal bleeding, ulcers, or perforations are advised to report to their care providers signs of ulcers and bleeding, upper abdominal pain, indigestion, melena, hemolysis, etc. The criteria for concurrent use of aspirin at low doses for cardiac prophylaxis inform patients of the increased risk of gastrointestinal bleeding and signs and symptoms [see Warnings and Precautions (5, 2)]. Hepatotoxicity informs patients about warning signals and symptoms of hepatotoxicity (e.g., drowsiness, fatigue, lethargy, pru urine, diarrhea, yellow und, upper right quadrant, sensitivity to “fluid-like” symptoms). If this occurs, have the patient stop diclofenac sodium Topical gel and immediately search for drug treatment [see Warnings and Precautions (5. 3)]. Cardiac insufficiency and edema advise the patient to watch for signs of congestive heart failure, including dyspnea, inexplicable weight gain or edema, and to contact a physician if these signs occur [see Warnings and Precautions (5, 5)]. An anaphylactic reaction informs the patient of the symptoms of an anaphylactic reaction (e.g., difficulty breathing, facial swelling and throat). Instruct the patient to seek emergency help if these symptoms occur [see Contraindications (4) and Warnings and Precautions (5, 7)]. Due to abnormal skin reactions, patients are advised to stop diclofenac sodium topical gel to stop immediately if they develop a skin rash pattern and contact their physician as soon as possible [see Warnings and Precautions (5. 9)]. Female fertility advises girls with reproductive potential who want to become pregnant to be included in the NSAID diclofenac sodium Topical gel may be associated with reversible delay of ovulation [see dissemination in certain population groups (8. 3)] Fetal toxicity inform pregnant women to avoid administration of diclofenac sodium Gel and other NSAIDSRs should be used beginning in the 30th month of pregnancy because of the risk of early fetal arterial occlusion [see Warnings and Precautions (5. 10 and Application in Specific Populations (8. 1)]. Warnings and Precautions (5. 10) Specific Population Coverage (8. 1)]. note concurrent use of NSAIDs. of diclofenac sodium Topical gels with other NSAIDs or salicylates (e.g., expanded, salsalate) are not recommended due to increased risk of gastrointestinal toxicity and slight increase in surgery [see Warnings and Precautions (5. 10) and Implementation by Specific Populations (8. 1). ]. Warnings and Precautions (5. 2) and Drug Interactions (7) ]]]] patients refine the fact that NSAIDs may occur with “freely available” medications for the treatment of colds, fevers, or insomnia. introduction of NSAIDs and low-dose aspirin is not They report that they diclofenac sodium topical gel until they talk to their care provider [see Interactions Between Medications (7)]. Effects on the eyes Order the patient to contact of diclofenac sodium Timely gel with eyes and mucous membranes should be ignored. If eye contact occurs, advise the patient that the eyes should be rinsed immediately with water or a physical substance and that a physician should be consulted if discomfort persists for more than 1 hour [see Warnings and Precautions (5, 15)]. The specific user manual instructs the patient how to measure the following doses using the dosing card of diclofenac sodium Topical gel to be used. If the patient loses his or her dosing card, call 1-833-285-4151 to request a replacement dosing card or indicate to the pharmacist that he or she can ask for a new dosing card. Instruct the patient to correctly measure the dose of 2.25 inches (2 g) or 4.5 inches (4 g) while waiting for the replacement dosing card [see Dosage and Administration (2. 2)]. Do not trust patient. diclofenac sodium Topical gels in open skin wounds, infections, inflammation, or exfoliative dermatitis because they may affect product absorption and tolerance. Advise patient to disregard concurrent use of diclofenac sodium Topical gels with other topical products such as solar filters, cosmetics, lotions, moisturizers, insect repellents, etc. Simultaneous use may cause skin reactions or alter absorption. of diclofenac sodium Important Gels. Instruct patient to minimize or avoid exposure to natural or non-natural sunlight in covered areas [see Warnings and Precautions (5. 14) and Dosage and Administration (2. 4)]. Comments or questions?Call Free1-833-285-4151, Prepared by Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post:Mardol, Ponda, Goa-. 403404, India, Distributed by Encube Ethicals Inc. 200 Meredith Avenue, Suite 101A, Durham, NC 27713 USA

Rev: December 2, 2019.

heart attack or increased risk of heart attack with risk of death. This risk is present at the start of healing and may increase.

Increased risk of bleeding, ulcers, and fragments (perforation) of the gastrointestinal tract (mouth tube head to stomach), stomach, and intestinal tract:
- Every time during use
- No warning symptoms
- It can cause death.
- Previous gastric ulcer or gastric or gastrointestinal bleeding due to introduction of NSAID
- Medication is taking “corticosteroids”, “anticoagulants”, “SSRIS” or “SNRIS”
- Rising dosage of NSAID o Elderly
- o Longer use of NSAID.
- Smoking o Highest liver disease
- Alcohol consumption o Bleeding problems
- As prescribed
- At lowest dose for treatment
- Short-term.
- Asthma attacks, hives, or other allergic reactions with aspirin or other NSAIDs.
- Immediately before or after a heart bypass operation.
- Has liver or kidney problems.
- Has high blood pressure.
- Asthma.
- Is pregnant or plans to become pregnant. Contact your physician if you plan to use an NSAID during pregnancy. You are not obligated to take an NSAID after 29 months of pregnancy.
- You are breastfeeding or plan to breastfeed.
- You have improved or unimproved hypertension
- Heart failure
- Liver problems, including liver failure
- Kidney problems including renal failure
- Too few red blood cells (anemia)
- Life-threatening skin reactions
- Life-threatening allergic reactions
- Other side effects of NSAIDs are abdominal pain, constipation, diarrhea, flatulence, heartburn, lightheadedness, nausea, dizziness
- Shortness of breath or hateful breathing – Unclear voice
- Chest pain – Swelling of the face or throat
- Weakness on one or both sides of your body
- Nausea – Nausea blood
- Restless or weaker than normal – Having blood in your bowel movements, or
- Diarrhea – dark and sticky as tar.
- Itching – Unusual weight gain.
- Your skin or eyes look yellowish – Skin rash or feverish blisters.
- Stomach complaints or abdominal pain – Swelling of arms, legs, hands and feet
- Symptoms of Influenza
- Aspirin is an NSAID, but does not increase the likelihood of heart attack. Aspirin can cause bleeding in the brain, stomach, and intestinal tract. Aspirin can cause stomach and intestinal ulcers.
- Some NSAIDs are sold in high doses without a prescription (over the counter); consult your own health care provider before using an NSAID without a prescription for more than 10 days.
- Use diclofenac sodium Topical gel as prescribed by your caregiver. Usage diclofenac sodium Topical gel in a different location than your doctor prescribed.
- Do not use more than 32 grams of of diclofenac sodium Topical gel on a specific day. If there is a quantity of diclofenac sodium your care provider directs, he is not obligated to provide more than 32 grams per day.
The dose for hands, wrists, or elbows is 2 grams. of diclofenac sodium Topical gel may be used at any time.
- Apply diclofenac sodium Topical gel 4 times a day (total 8 grams per day). Do not use more than 8 grams per day on any one affected hand, wrist, or elbow.
Dose for feet, ankles, and knees is 4 grams. of diclofenac sodium Topical gel may be used at any time.
- Apply diclofenac sodium Topical gel 4 times daily (16 grams per day). Do not use more than 16 grams per day on one affected foot, ankle, or knee.
Some examples of diclofenac sodium Application of topical gel includes
- If you use 2 grams of diclofenac sodium Topical gel on one side, 4 times daily, each time for a total dosage of 8 grams.
- If you use 4 grams of diclofenac sodium Topical gel on one knee, 4 times daily, each time for a total dosage of 16 grams.
- Treatment of one arm and one knee, once a day, 8 grams and 16 grams total dosage each time equals 24 grams. of diclofenac sodium topical gel.
- Remember to remove the dosing card from the box to measure your dose (see sketch A).
- Apply diclofenac sodium Topical gel on undamaged dry skin. This includes almost any cut, open wound, infection or rash.
- Do not use a heated cushion and do not apply where applied. diclofenac sodium topical gel.
- Avoid discovery of applied skin diclofenac sodium Topical gel is applied in sunlight or duty as a solar cabin.
- Do not use sunscreens, cosmetics, lotions, moisturizing creams, anti-aging preparations, or other topical medications on the same area of skin to which Topic Gel was applied. diclofenac sodium topical gel.
- Do not get diclofenac sodium Topical gel on eyes, nose, or mouth. diclofenac sodium Topic Gel may only be used on the skin (topical use). If you get diclofenac sodium Topical Gel gets into the eyes, immediately flush the eyes with water or a physical substance. If eye discomfort lasts longer than 1 hour, consult your care provider.
What happens if I skip a dose?
- If you miss a dose of diclofenac sodium Continue with the correct planned dose of Topical Gel by applying the prescribed amount of Topic Gel. of diclofenac sodium Topic Gel. Do not multiply the dose.
Apply two grams (2 g) of diclofenac sodium Topical gel on hands, wrists, or elbows:

Step 1. remove the inner dosing card of the the diclofenac sodium gel package. Use the dosing card to correctly measure the dosage. of diclofenac sodium Actual gel. Proper amount of of diclofenac sodium actual gel, place the dosing card on a flat surface so you can read the track. If pressure is backward, turn the dosing card over (see sketch A). If you lose or misplace your own dosing card, you can ask your pharmacist for a new question or call 1-833-285-4151. ask your caregiver or pharmacist to show you how to measure your dose correctly of diclofenac sodium current gel while waiting for a new dosage card.

Figure B Sketch C Sketch d

Step 2 . Squeeze diclofenac sodium Apply the measured topic gel to a 2 g portion (2, 25 inches long of gel) on the dosing card. Ensure that the gel covers the 2 g dose area (see sketch B). Place the cap back on the tube. of diclofenac sodium Topic Gel. If you have questions about how to correctly measure your dose, ask your care provider or pharmacist. of diclofenac sodium topical gel.

Step 3: Apply gel to hands, wrists, or elbows. You can apply the gel using a dosing card (see sketch C). Then carefully rub the gel onto the skin using your hands (see sketch D). Do not share the dosing card with others. Cover the entire affected arm, wrist, or elbow with gel. Remember that the hand includes the palm, upper hand, and fingers.

Step 4: After applying the Dose Card, hold the cap with fingertips, rinse and dry. Keep the dosing card until correct use. Do not apply or bathe for at least one hour after application diclofenac sodium Topic Gel. Do not wash hands covered at least 1 hour after application. the diclofenac sodium topical gel.

Step 5: After Application diclofenac sodium Topical gel, wait 10 minutes before covering treated skin with gloves or clothing.

Apply 4 grams of of diclofenac sodium Apply topical gel to feet, ankles, or knees.

Step 1. see Step 1 above.

Step 2. Squeeze diclofenac sodium Measure a 4 g portion (4, 5 inches long) of the Topic Gel on the dosing card, making sure the gel covers the 4 g dosing area (see sketch E). Place the cap back on the tube. of diclofenac sodium Topic Gel. If you have questions about how to correctly measure your dose, ask your care provider or pharmacist. of diclofenac sodium topical gel.

Step 3. Apply diclofenac sodium Important gels for feet, ankles and knees. You can apply the gel using a dosing card (see sketch F). Then carefully rub the gel into the skin using your own hands (see sketch G). Do not share your dosing card with others. Always cover the entire leg, ankle, or knee area with gel. For example, cover the skin above, below, inside and outside of the knee. Remember that the foot includes the sole of the foot, the upper lobes of the foot, and the toes.

Figure E Sketch F Sketch g

See steps 4 and 5 above. Wash hands after application. diclofenac sodium Topical gel on feet, ankles, and knees.

Which Ingredients in diclofenac sodium topical gel?

Active ingredient: diclofenac sodium

Inactive ingredients: C, cocoyl capryloclate, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, carbomer gay polymer such as strong ammonia solution.

How should I store diclofenac sodium topical gel?
- Store at 20°C to 25°C (68°F to 77°F).
- Do not freeze diclofenac sodium topical gel.
- Store the dosing card for you diclofenac sodium topical gel.
Keep diclofenac sodium topical gel, dosage, and all medications outside of the boys’ reach.

These dosing instructions and dosage memorandum are approved by the U.S. Food and Drug Administration.

Encube Ethicals Pvt. Ltd.

Plot No. C-1, Madkaim Industrial Estate, Madkaim

Submitted by Maldol, Ponda, Goa-403404,

Encube Ethicals Inc.

200 Meredith – Avenue, Suite 101A,

Durham, North Carolina 27713 USA

See drug instructions and notes for patient on inside of box.

NDC 21922-009-09 Diclofenac sodium Only for applications requiring topical gel only rx

Use the dosing card attached to the inside of the box

NDC 21922-009-09 Diclofenac sodium Only for applications requiring topical gel only rx

Dosing card 100g

NDC 21922-009-09 Diclofenac sodium topical gel 1%

Timely Application rx only

100 of.

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