Diclofenac Sodium Topical Gel 1

These maximum factors do not include all the information needed to use sodium gel temporarily in a harmless and effective manner. For timely sodium, see the complete line information on Diclofenac Sodium Gel.

DICLOFENAC SODIUM topical gel, 1% for topical use only

Original American Encouragement: 1988

• Nonsteroidal anti-inflammatory drugs (NSAIDs) increase the risk of nonvigorous cardiovascular thrombotic incidents, including myocardial infarction and heart attack, which could be fatal. This risk may occur early in treatment and may increase with duration of use (5. 1).
• Diclofenac sodium topical Gel, 1% is contraindicated by coronary artery bypass graft (CABG) surgery criteria. (4, 5. 1)
• 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 gastric ulceration

Diclofenac sodium topical This gel is considered a non-steroidal inflammatory product that has been shown to relieve pain in joint osteoarthritis. to topical For example, treatment of knees and hands.

• Diclofenac sodium topical The gel has not been evaluated for use in spinal, leg, or shoulder joints. (14.1)

• Use the lowest effective dose for the shortest duration according to the individual patient’s therapeutic goals (2. 1).
• Lower extremities: Apply the gel (4 g) to the affected area 4 times daily. Do not use more than 16 g per day on affected joints of the lower extremities. (2. 2)
• Upper limb: Apply gel (2 g) to the affected area 4 times daily. Do not use more than 8 g per day on affected joints of the upper extremity (2. 3)
• Total dosage may not exceed 32 g per day in all affected joints. (2. 3) diclofenac sodium topical Gel is measured in closed dosing cards to the correct sign of 2 g or 4 g (2.)

• Diclofenac significant sodium gel, 1%, (3)

• Well-known hypersensitivity to diclofenac for various components of the drug product. (4)
• History of asthma, ur measles, or other allergic reactions after using aspirin or other NSAIDs. (4)
• History of CABG operations. (4)

• Hepatotoxicity: Inform patient of warning signals and symptoms of hepatotoxicity. (5, 3) Stop if abnormal liver tests are maintained or worsened, or if clinical signs or symptoms of liver disease occur
• Hypertension: patients using certain blood pressure lowering agents may well not comply with these curative measures when using NSAIDs. Be aware of blood pressure (5, 4, 7).
• Heart deficiency and edema: use caution when using of diclofenac sodium topical Gel in difficult cardiac deficiency patients (5, 5) unless superior quality is assumed to outweigh the risk of a downward shift in cardiac deficiency
• Nephrotoxicity: renal or hepatic dysfunction, cardiac deficiency, dehydration or hemopenia patient renal function prognosis. Caution should be exercised when using of diclofenac sodium topical Gel in patients with advanced renal disease unless the benefit is expected to outweigh the risk of deterioration of renal function (5, 6).
• Anaphylactic reactions: seek help from critical care if anaphylactic reactions occur (5. 7)
• Asthma finding related to aspirin sensitivity: diclofenac sodium topical gel is contraindicated in patients with aspirin-sensitive asthma. Prognosis in patients with pre-existing asthma (no sensitivity to aspirin) (5, 8)
• Severe skin reactions: stop diclofenac sodium topical Gel from first occurrence of skin rash or other symptoms of hypersensitivity (5, 9)
• Non-occlusive closure of fetal ductus arteriosus: use with caution in pregnant women in the first 30 months of gestation. (5. 10, 8. 1)
• Hematologic toxicity: control of hemoglobin or hematocrit in patients with anemia or signs of anemia (5, 11, 7)

Most common adverse reactions (incidence >2% of patients treated diclofenac sodium topical (over gel and placebo) are considered use room, including dermatitis. (6. 1)

To report an adverse reaction, contact Enicals Private Limited at 1-833-285-4151 or 1-800-FDA-1088 O RW FDA and contact FDA.Gov/Medwatch.

• Medications that do not cause hemostasis (e.g., warfarin, aspirin, SSRIS/SNRIS): at the same time confirm with the patient the presence of bleeding diclofenac sodium topical gel with medications that do not cause hemostasis. Simultaneous use of diclofenac sodium topical aspirin gel and analgesic doses of aspirin is generally not recommended (7)
• ACE inhibitors, angiotensin-dependent blockers (ARBs) or beta-blockers: concurrent doses with gel are not recommended. diclofenac sodium topical Gels can reduce the antihypertensive effects of these substances. Keep blood pressure under control (7)
• ACE inhibitors and ARBs: concurrent administration diclofenac sodium topical Elderly gels, weakened in size, or with impaired renal function can lead to an increase in adverse trends in renal function. In patients at highest risk for this, check for symptoms of worsening renal function (7)
• Diuretics: NSAIDs may reduce the natriuretic effect of furosemide and thiazide diuretics. Patient prognosis to ensure efficacy of bridging with antihypertensive effect (7)
• Digoxin: simultaneous application. diclofenac sodium topical Gel can build up serum concentrations and extend the half-life of digoxin. Prediction of digoxin levels in serum (7)

Pregnancy: administration of NSAIDs in the third trimester of pregnancy increases the risk of premature occlusion of fetal intramammary arteries. Beware of using NSAIDs in pregnant women from 30 months gestation (5, 10, 8, 1)

Infertility: NSAIDs have been associated with reversible infertility. Look at cancellations. of diclofenac sodium topical Gel with women with problems (8. 3)

See 17 for patient advice and drug bureau.

2. one dosing card [see package leaflet for use].

2. 2 lower extremities regarding foot, ankle, knee

2. 3 upper extremities covered by hands, wrists and elbows

2. 4 special precautions

5. 1 mental vascular thrombotic accidents

5. 2 gastrointestinal bleeding, ulcer, perforation

5. 3 Revelatoxic

5. 4 Hypertension

5. 5 Cardiac Infelelithiasis and Edema

5. 6 Nephrotoxicity and hyperkalemia

5. 7 Anaphylactoid reaction

5. 8 Asthmatic factor degradation related to sensitivity to aspirin

5. 9 Non-crystalline skin reactions

5. 10 Premature closure of arterioles

5. 11 Hematologic toxicity

5. 12 Inflammation and Fever Conspiracy

5. 13 Lab check

5. 14 Sun.

5. 15 Eye Exposure

5. 16 Oral Nonsteroidal Anti-inflammatory Drugs

6. 1 Clinical experience control

8. 1 Pregnancy

8. 2 Lactation

8.3 Reproductive Potential of Women and Gentlemen

8.4 Pediatric Use

8. 5 Geriatric use

12. 1 Action devices

12. 3 Pharmacokinetics

13. 1 Carcinogenesis, mutagenesis, fertility issues

14. 1 Most important studies on osteoarthritis of superficial joints of the extremities

Cardiovascular thrombotic accidents

• Nonsteroidal anti-inflammatory drugs (NSAIDs) increase the risk of nonfatty cardiovascular thrombotic incidents, including potentially fatal myocardial infarctions and heart attacks. This risk may occur early during treatment and may increase with duration of use [see Warnings and Precautions (5. 1)].
• Diclofenac Topical Sodium Gel 1% is contraindicated in coronary artery bypass graft (CABG) operations [see Contraindications (4) and Warnings and Precautions (5. 1)].

Gastrointestinal bleeding, ulceration, 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 to run at any time during use and without warning signals. Elderly patients and patients with a history of gastric ulcer and/or gastrointestinal bleeding are at greatest risk for non-fatal GI incidents [see Warnings and Precautions (5, 2)].

Diclofenac sodium topical Gel is indicated for the illumination of osteoarthritis amanda joint pain. to topical For example, treatment of knees and hands.

• Diclofenac sodium topical Gel is not rated for use in the spine, hip, or shoulder.

Use the lowest effective dose in the direction of the shortest duration to work with the individual patient’s healing goals [see Warnings and Precautions (5)].

2. one dosing card [see package leaflet for use].

The dosing card is attached to the inside of the box. Subsequent quantities of diclofenac sodium topical Gels are measured using the dosing card supplied in the medicine box. The dosing card is made of Illusiepolypropylene. The dosing card must be used for use with pharmaceutical products. Gel should be used in the rectangular area of the dosing card, up to 2 g or 4 g (2 g at each elbow, wrist or hand, 4 g per knee, ankle or leg). 2 g track length is 2.25 inches. 4 g trail length is 4.5 inches. Dosing table included. diclofenac sodium topical Gel can be used with gel. Carefully rub the gel across the legs and into the skin. After applying the dosing card, free the tops of the fingers, rinse and dry. If the healing area is the hands, the patient should wait at least 1 hour to wash hands.

2. two lower extremities covering the feet, ankles, and knees

Apply gel (4 g) 4 times a day to the affected leg, ankle or knee. Diclofenac. sodium topical The gel should be carefully massaged into the skin. This should ensure that it is used over the entire affected base, knee, or ankle. The entire sole includes the sole of the foot, the top of the foot, and the toes. Do not use more than 16 g per day at any single joint of the lower extremity.

2. three upper extremities, including hands, wrists, and elbows

Apply gel (2 g) 4 times daily to affected hands, wrists, or elbows. Diclofenac. sodium topical The gel should be carefully massaged into the skin and used over the entire affected arm, wrist, or elbow. The entire arm includes the palm, back of the hand, and fingers. Do not use more than 8 g per day on a single joint of the upper extremity.

Total dosage may not exceed 32 g per day at all affected joints.

2. 4 Special precautions

• Avoid showering/bathing for at least 1 hour after use. If hands are not considered treated joints, inform patient to wash hands after application. If diclofenac sodium topical Gel is used on hands for treatment. Advise patient not to wash treated hands for at least 1 hour after use.
• Do not apply diclofenac sodium topical gel to open wounds.
• Avoid contact of diclofenac sodium topical Gel on eyes and mucous membranes.
• Do not use external heat or occlusive connections to covered joints.
• Avoid exposure of treated joints to natural or non-natural sunlight.
• Avoid simultaneous use of of diclofenac sodium topical gel on the treated skin with others. topical products such as solar filters, cosmetics, lotions, moisturizing methods, insect resistant agents or other products. topical medications
• Concomitant use of diclofenac sodium topical Gels containing oral nonsteroidal anti-inflammatory products (NSAID) have not been evaluated and may enhance NSAID side effects. Do not use concomitant therapy diclofenac sodium topical gel and oral NSAID unless repeated laboratory evaluations are performed, unless the benefit outweighs the risk.
• Do not wear clothing or gloves for at least 10 minutes after application. diclofenac sodium topical gel

Diclofenac sodium topical gel, 1%

Diclofenac sodium topical Gels are contraindicated in emerging patients:

• Known hypersensitivity (e.g., anaphylactic reactions or nonsensitive skin reactions) to diclofenac or all different components of the pharmaceutical product [see Warnings and Precautions (5, 7, 5, 9)].
• History of asthma, ur measles, or other allergic reactions to aspirin or other NSAIDs; fatal anaphylactic reactions to NSAIDs have been reported in these patients [see Warnings and Precautions (5, 7, 5, 8)].
• Patients undergoing coronary artery bypass graft (CABG) operations [see Warnings and Precautions (5. 1)].

5. 1 Vaso-thrombotic effects

Clinical studies of various selective and nonselective NSAIDs with lifetimes of up to 3 years have shown an increased risk of nonfatty cardiovascular (CV) thrombotic incidents, including myocardial infarction (MI) and heart attack. Fatal to fatal. Based on inexpensive data, it is unclear whether the risk of CV thrombotic incidents for all NSAIDs is the same; with the introduction of NSAIDs, the conditional increase in fatty central heating condensible incidents compared to original levels is similar to those without popular CV disease or CV disease risk points This appears to be the case. Nevertheless, patients with popular CV disease or risk factors had a higher incidence of unqualified unnecessary nonappropriate CV thrombotic accidents due to increased output frequency. Several observational studies have shown that this increased risk of central heating thrombotic thrombotic accidents began in the first few weeks of treatment. the increased risk of CV-thrombotic accidents was observed at higher doses and with more alternatives.

To minimize the potential risk of adverse central heating effects in patients treated with NSAIDs, the lowest effective dose should be used for the shortest time. Physicians and patients are obligated to remain vigilant to the formation of these measures during the entire treatment if there are no signs of CV in the past. The patient must be informed of the signs of a central heating event and of the measures to be taken if one occurs.

There is no consistent evidence that concurrent use of aspirin increases the risk of a non-vigorous thrombotic central heating event associated with NSAID use. Concurrent Aspirin and NSAID Use as diclofenac Increases risk of non-vigorous gastrointestinal (GI) incidents [see Warnings and Precautions (5. 2)].

Status after bypass coloneal bypass graft (CABG)

Two major clinical studies on COX-2 selective NSAIDs for pain relief 10-14 days after CABG operations show an increased incidence of myocardial infarction and heart attack; NSAIDs are contraindicated in CABG [see Contraindications (4)].

An observational study of the Danish National Registry showed that patients treated with NSAIDs at stages after MI have updated exposure, central heating-related mortality, and risk of all-cause mortality from the first week of treatment. Similarly, the incidence of death in patients treated with an MI 20 per 100 patients treated with an NSAID compared to 12 per 100 patients exposed to an NSAID. However, after the first year after MI, the ineligible mortality rate declined slightly, but the explosive comparative risk of death in NSAID users remained during at least 4 years of follow-up studies.

Avoid the use of diclofenac sodium topical Unless the gel in recent MI patients is expected to outweigh the risk of recurrent central heating condensing accidents superior quality. If diclofenac sodium topical When using gel in patients with recent MI, patients should be checked for the presence of symptoms of cardiac ischemia.

5. 2 Tour bleeding, ulceration, perforation

NSAIDs, including diclofenac NSAIDs cause serious gastrointestinal (GI) side effects, including inflammation, bleeding, ulcers, perforation of the GI tract, stomach, small intestine or colon. These serious side effects can occur at any time in patients treated with NSAIDs, with or without warning signals. only every 5 patients who develop significant side effects in the upper GI during NSAID therapy, this is considered an indication. upper GI caused by an NSAID, bleeding, or perforation occurred in about 1% of patients treated for 3 to 6 months and in about 2 to 4% of patients treated for 1 year. However, even short-term treatment with NSAIDS is not without risk.

Risk Factors for Gastric Bleeding, Ulcers, and Perforation

Patients with a history of gastric ulcers and/or gastrointestinal bleeding that NSAIDs used 10 or more times the risk of gastrointestinal bleeding compared to patients without these risk factors.Other points that increase the risk of gastrointestinal bleeding in patients treated with NSAIDs include longer duration of NSAID therapy, oral corticosteroids, aspirin, anticoagulants, or selective serotonin reshoot inhibitors (SSRIs), concurrent use of smoking, cigarette smoking, alcohol use, older age, and General health with advancing age. The majority of mail marketing notifications of fatal GI events occurred in older or weakened patients. In addition, patients with advanced liver disease and/or coagulopathy are at increased risk for gastrointestinal bleeding.

Strategies to minimize GI risk in patients treated with NSAIDs:

• Use the lowest effective dose for the most likely maximum duration.
• Avoid administering more than 1 NSAID at the same time.
• Avoid use in patients at increased risk unless there is an opinion that the benefit does not outweigh the increased risk of bleeding. In these patients and in patients with severe gastrointestinal bleeding, alternative therapy to NSAID.
• Pay attention to the draw and symptoms of gastrointestinal ulcers and bleeding during NSAID therapy.
• If significant unwanted GI is anticipated, immediately reinforce evaluation and healing, diclofenac sodium topical gel until significant adverse GI is ruled out.
• Under the criteria for concurrent use of aspirin at low doses for cardiac prophylaxis, patients should be checked more closely for the presence of indications of gastrointestinal bleeding [see Drug Interactions (7)].

5. 3 Hepatotoxicity.

In laboratory testing of products containing oral diclofenac, a significant increase in AST (SGOT) (i.e., >3 times the ULN) was observed in approximately 2% of an estimated 5700 patients during treatment (ALT was not measured in patients at increased risk of one (hepatotoxicity). diclofenac treatment (ALT was not measured in all studies).

A large, open-label, controlled study of 3700 patients who received oral medications diclofenac sodium At 26 months follow-up, patients were checked for the first time after 8 months and again after 24 weeks for 1200 patients. significant increases in ALTO and/or AST occurred in about 4% of the 3700 patients and included a clear increase (≥8 ULN) in about 1% of the 3700 patients The ALTOs were not included in the study. This publicly produced brand name survey indicates that a borderline high percentage (less than 3 times ULN) and small (38 times ULN) (ULN greater than 38) (ULN greater than 8) were observed in patients with increased ALT or AST. Resources addressed. diclofenac compared to other NSAIDs. Elevated transaminases were observed more frequently in patients with osteoarthritis than in patients with rheumatoid arthritis.

Almost all significant increases in transaminases were found before patients became symptomatic. Abnormal studies occurred in the direction of the first two months of treatment diclofenac 42 out of 51 patients in all studies who developed transaminase race shown.

Hepatotoxicity caused by the drug is reported in the first month and in the post marketing report for the first two months of treatment, but may run at any time during healing. diclofenac Field post-marketing surveillance reports cases of liver toxicity, including necrosis of the liver, yellow und, fi prolonged hepatitis with or without yellow und, and poor delivery. Some of these reported cases resulted in fatal final or liver transplantation.

European retrospective, control population level, 10 cases of diclofenac Drug-related liver injury from current and unused applications of diclofenac was associated with a statistically significant 4-fold higher odds ratio of adaptation to liver injury. This final study is based on a total of 10 liver injuries associated with diclofenac Adapted odds ratios were further increased for female gender, doses greater than 150 mg, and duration of use greater than 90 days.

Physicians should measure transaminases at the first value, sometimes in patients being treated with the drug. diclofenac This is because hepatotoxicity can develop without the product of different symptoms. The appropriate time for initial and further transaminase measurements has not yet been established. Based on laboratory data and post-marketing skills, transaminase levels should be kept under control for 4 to 8 months after starting treatment with FieldThem. diclofenac Nevertheless, a delivery response can be made at any time during treatment diclofenac .

If abnormal liver tests persist or worsen, if clinical signs or symptoms corresponding to liver disease develop, or if systemic symptoms occur (e.g., eosinophilia, skin rash, abdominal pain, diarrhea, black urine) diclofenac sodium topical Gel should be stopped immediately.

Point the patient to warning signals and symptoms of hepatotoxicity (e.g., nausea, lethargy, diarrhea, pruritus, yellow und, sensitivity in the right upper quadrant, and “flu-like” symptoms). If clinical signs or symptoms corresponding to liver disease occur, or if systemic symptoms occur (e.g., eosinophilia, skin rash, etc.), stop immediately diclofenac sodium topical Stop the gel immediately and evaluate the patient clinically.

Likely risk of liver-related side effects in patients treated with diclofenac sodium topical gel, use the lowest effective dose in the direction of the shortest possible duration. Use caution when prescribing diclofenac sodium topical gels with concurrent use of products known to be hepatotoxic (e.g., acetaminophen, medications, antiepileptic).

5. 4 Hypertension

NSAIDs, including diclofenac sodium topical Gels may lead to an increase in newly created hypertension or an adverse trend in pre-existing hypertension, which may contribute to an increased incidence of CV events. Patients using angiotensin-converting enzyme (ACE) inhibitors, thiazide diuretics, or diuretics may not respond to these therapies if they acquire an NSAID [see Drug Interactions (7)].

Check blood pressure (BP) at the start of NSAID therapy and during the entire treatment.

5. 5 Cardiac Infelelithiasis and Edema

A meta-analysis of Coxib and classical NSAID trials combined with randomized controlled trials showed an approximately two-fold increase in heart failure hospitalizations in patients treated with Cox-2 selective and nonselective NSAIDs compared to patients treated with placeotolide. A Danish study of a public registry of heart failure patients reported an increased risk of myocardial infarction, heart failure hospitalization, and death with NSAID use.

In addition, fluid retention and edema were observed in some patients receiving NSAIDs. Dosage of of diclofenac some therapeutic agents used to treat these conditions (e.g., diuretics, ACE inhibitors, angiotensin receptor blockers [ARBS]) may decrease the CV effect. [See Drug Interactions (7)].

Avoid the use of diclofenac sodium topical Use gel in patients with refractory heart failure if the superior properties are not expected to outweigh the risk of downward migration of heart failure. If diclofenac sodium topical Gel is used in patients with severe heart failure to monitor for symptoms of worse heart failure bias.

5. 6 Nephrotoxicity and hyperkalemia

Prolonged administration of nephrotoxic NSAIDs can cause renal papillary necrosis and other renal injuries. Nephrotoxicity has also been observed in patients in whom renal prostaglandins play a compensatory role in maintaining renal perfusion. In these patients, the introduction of NSAIDs may cause a dose-dependent decrease in prostaglandin production, which in turn causes a decrease in renal blood flow and may lead to apparent renal compensatory failure. Patients at higher risk for this reaction are those with renal dysfunction, dehydration, decreased blood volume, heart failure, hepatic dysfunction, patients taking diuretics, ACE inhibitors or ARBs, and the elderly. discontinuation of NSAID therapy usually results in return to a state of readiness. There is no information on its use in controlled clinical research articles. of diclofenac sodium topical Gel for patients with advanced renal disease. Effects on the kidneys. of diclofenac sodium topical Gel may accelerate the progression of renal dysfunction in patients with pre-existing renal disease.

Correct sizing status in patients with dehydration or pre-existing blood loss diclofenac sodium topical Gel. Prognosis for renal function in patients with renal dysfunction, hepatic dysfunction, heart failure, dehydration, or pre-existing blood loss during use of diclofenac sodium topical Gel [see Drug Interactions (7)]. Caution should be exercised when using this product. of diclofenac sodium topical Gel in patients with advanced renal disease unless superior properties are deemed to outweigh the risk of renal function loss. If diclofenac sodium topical When gels are used in patients with advanced kidney disease, patients should be monitored for the presence of symptoms of renal function deterioration.

Even in some patients without renal dysfunction, increased serum calendar concentrations, including hypercalcemia, have been reported with the use of NSAIDS. In patients with normal renal function, these effects were associated with hypovolemic hippordesteronism.

5.7 Anaphylactoid Reactions

Diclofenac has been associated with anaphylactic reactions in patients with and without known hypersensitivity. to diclofenac Patients with aspirin-sensitive asthma [see Contraindications (4) and Warnings and Precautions (5, 8)].

If an anaphylactic reaction occurs, seek help from the emergency department.

5. 8 8 Asthma Factor Breakdown Related to Sensitivity to Aspirin

A subpopulation of asthmatics may suffer from aspirin-sensitive asthma, which consists of a stroke inflammation complicated by nasal polyps. Difficult and possibly fatal bronchospasm. and/or intolerance to aspirin and other NSAIDs. Because cross-reactivity between aspirin and other NSAIDs has been reported in these aspirin-sensitive patients, diclofenac sodium topical gel is contraindicated in patients with this form of aspirin sensitivity [see Contraindications (4)]. When diclofenac sodium topical gel is used in patients with pre-existing asthma (no known sensitivity to aspirin), the presence of asthma symptoms and symptom changes should be confirmed in the patient.

5. 9 Non-gravitational skin reactions

NSAIDs, including diclofenac Aspirin can cause severe skin side effects, including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrosis (10). These nonsense actions have the chance to occur without warning. Report symptoms and signs of non-energetic skin reactions to the patient and discontinue use. of diclofenac sodium topical gel at the first occurrence of a skin rash or other symptoms of hypersensitivity. diclofenac sodium topical Gel is contraindicated in patients with previous non-vigorous skin reactions to NSAIDs [see contraindications (4)].

5. 10 Premature closure of the ductus arteriosus.

Diclofenac may cause premature closure of the fetal ductus arteriosus. Caution should be exercised in the use of NSAIDs containing diclofenac sodium topical ger, in pregnant women in the 30th month of pregnancy (third trimester) [see Specific Populations Referral (8. 1)].

5. 11 Hematologic Toxicity

Anemia has occurred in patients receiving NSAIDs. This may be due to occult or hard blood, water retention, or effects not fully accounted for on erythropoiesis. In the treated patient diclofenac sodium topical Ger symptoms or signs of anemia include controlled hemoglobin levels or hematocrit.

NSAIDs, including diclofenac sodium topical Gels can increase the risk of bleeding. Coagulopathy, concurrent use of warfarin, other anticoagulants, anticoagulants (e.g., aspirin), serotonin re-recording inhibitors (SSRIs), serotonin noradrenalin re-recording inhibitors (SNRIS), and other common disorders. Check these patients for the presence of bleeding symptoms [see Drug Interactions (7)].

5. 12 Consistency of inflammation and fever

Pharmacologic Activity of diclofenac sodium topical Reduce inflammation and possibly fever gels may reduce the usefulness of lab symptoms in detecting infection.

5. 13 Lab Checks.

The prognostic probability of patients with long-term NSAID regimens should be differentiated from CBC and chemical profiles because significant gastrointestinal bleeding, hepatotoxicity, and kidney damage all have the opportunity to occur without signs or warning symptoms [see Warnings and Precautions (5, 2, 5, 3, 5, 5, 6)].

5. 14 Sun.

Patients should minimize or ignore the effects of natural or artificial sunlight in the treatment area because animal studies show that topical diclofenac treatment has resulted in earlier initiation of UV-induced skin tumors. Possible Effects. of diclofenac sodium topical gel on skin response to UV damage in humans is unknown.

5. 15 eye exposure.

Contact of diclofenac sodium topical Gel with eyes and mucous membranes, but not investigated, footprints are ignored. Patients should be told that if eye contact occurs, they should immediately flush their eyes with water or a physical substance and consult a physician if discomfort persists for more than 1 hour.

5. 16 Oral Nonsteroidal Anti-inflammatory Drugs

Concurrent administration of oral and topical NSAIDs have every opportunity to lead to higher rates of bleeding and more abnormally abnormal creatinine, urea, and hemoglobin. Do not use concomitant therapy diclofenac sodium topical gel and oral NSAID unless the benefit outweighs the risk.

The following side effects are described in more detail in other labeling segments

• Cardiovascular thrombotic effects [see Warnings and Precautions (5. 1)].
• Bleeding, ulceration, perforation [see Warnings and Precautions (5. 2)].
• Hepatotoxicity [see Warnings and Precautions (5. 3)].
• Hypertension [see Warnings and Precautions (5. 4)].
• Cardiac 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)].
• Severe skin reactions [see Warnings and Precautions (5. 9)].
• Hematologic toxicity [see Warnings and Precautions (5.11)].

6.1 clinical skills check

Because clinical testing is performed to very different standards, the incidence of adverse reactions observed during clinical testing of one product cannot be directly related to the incidence during clinical testing of another product and may not reflect the incidence observed in practice.

During medical development, 913 patients were exposed to the effects of to diclofenac sodium topical gels in a randomized, double-blind, multicentric, controlled study in parallel groups for osteoarthritis of the superficial joints of the extremities. of 513 patients. diclofenac sodium topical knees and 400 with osteoarthritis gel treated for osteoarthritis. Of these, 583 patients were exposed to to diclofenac sodium topical gels in an uncontrolled open-label study of long-term protection for osteoarthritis of the knee. Of these, 355 patients were treated for 1 knee osteoarthritis and 228 for osteoarthritis of both knees. Impact times varied from 8 to 12 months in the placebo-controlled study and up to 12 months in the public protection study.

Short-term placebo-controlled studies:

Adverse effects were observed as minimal in 1% of patients who used the product. diclofenac sodium topical GEL: Non-energetic side effects reported in placebo-controlled short-term studies diclofenac sodium topical 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 patients treated, the diclofenac sodium topical GEL group (7%) and placebo group (2%).

Table 1 outlines the species of reactions reported in the application zones. Dermatitis of the skin upon application was reported by 4% of patients who received the product, with a low frequency of skin reactions upon application. diclofenac sodium topical compared to 1% of patients who received placebo.

Table 1. Non-energetic side effects when applying (≥ 1% of diclofenac sodium topical gel patients) – Short-term controlled study

Preferred term according to †Meddra 9. 1.

In placebo-controlled studies, incidence of stopping treatment due to side effects, 5% of patients used the product. diclofenac sodium topical Gel in patients in the placebo group. Responses in the application zone, including dermatitis in the application zone, were more uncommon conditions to stop healing.

Long-term protection study:

In the published long-term prevention study, the distribution of adverse events was similar to that in the placebo-controlled study. In this study, patients were treated for up to one year. diclofenac sodium topical With up to 32 g of gel per day, dermatitis at the site of use was observed in 11% of patients. Adverse events leading to discontinuation of the study drug were observed in 12% of patients. The most common adverse reaction leading to discontinuation of study drug was site dermatitis, observed in 6% of patients.

See Table 2 for clinically significant pharmacological interactions. diclofenac .

Table 2: Clinically Important Pharmacologic Interactions with Diclofenac

• Diclofenac and anticoagulants such as warfarin have a synergistic effect on bleeding. Simultaneous use of diclofenac anticoagulants also increases the risk of major bleeding compared to the use of either drug.
• Serotonin release by platelets plays an important role in hemostasis. Epidemiologic case-control and cohort studies have shown that concomitant use of NSAIDs with drugs that inhibit serotonin reuptake may increase the risk of bleeding more than NSAIDs alone.

• Patients should be adequately hydrated when these drugs are administered concurrently. Monitor renal function at the beginning of concurrent therapy and occasionally thereafter.

Repetitive NSAIDs with short half-lives (e.g., indomethacin diclofenac indomethacin) should be ignored for up to 2 days, 1 day, and 2 days after PemetRexed entry.

8. 1 Pregnancy

Pregnancy Category C up to 30 months gestation. Category D at 30 months gestation.

Use of NSAIDs, including diclofenac sodium topical gels in late pregnancy increases the risk of early fetal arterial occlusion. Caution should be exercised in the use of NSAIDs, including the following diclofenac sodium topical Gels for pregnant women after the 30th month of pregnancy (second trimester).

There are no adequate and fully controlled studies on it of diclofenac sodium topical Gel for pregnant women. In human and animal studies, diclofenac Passage through the placenta. Data from observational studies on the risks to the fetus of NSAID use in women in the first or second trimester of pregnancy are inconclusive. For the combined U.S. population, all clinically observed pregnancies have background rates of 2-4% for major malformations and 15-20% for pregnancy costs, independent of product effects. In animal reproduction studies, virtually no signs of teratogenicity have been observed in mice, rats, or rabbits. diclofenac In accordance with this, the very maximum recommended in the direction of the organogenesis period, at doses of up to about 5, 5, 10 topical dose of diclofenac sodium topical gels, the presence of maternal and fetal toxicity with these doses is not considered [see data]. Based on animal data, prostaglandins have been shown to play an important role in endometrial vascular permeability, blastocyst implantation, and desmoplasia. In animal studies, the introduction of inhibitors of prostaglandin synthesis, and inhibitors of prostaglandin synthesis, resulted in increased prostaglandin loss as diclofenac and increased loss before and after transplantation.

Labor or delivery

There are no studies on the effects of of diclofenac sodium topical gel during delivery.NSAIDs have animal studies involving diclofenac synthesis of prostaglandins, delayed pregnancies, and increased rates of stillbirths.

Animal reproductive and developmental studies show that diclofenac sodium Dosing during organogenesis did not cause induction of maternal and fetal toxicity in mice during oral administration of up to 20 mg/kg/day (about 5 A more than the matching dose in humans (MRD)). of diclofenac sodium topical (Approximately 5 and 10 MRHD based on bioavailability and body surface (BSA) comparisons, but approximately 5 and 10 MRHD based on organic availability and BSA comparisons) in rats and rabbits at the 10 mg/kg/day maximum dose.

In studies in which pregnant rats were orally dosed at 2 or 4 mg/kg diclofenac (approximately 1 and 2 times the MRHD based on bioavailability vs. BSA), significant maternal toxicity (peritoneal inflammation, death) was observed from day 15 of gestation to day 21 of lactation. Maternal doses of these toxicities were associated with dystocia, prolonged gestation, decreased fetal weight, lift, and decreased fetal survival.

8. 2 Lactation

Based on inexpensive data, diclofenac may occur in breast milk. Along with the medical needs of mothers for cataphlam, the adverse effects of cataphlam on breastfed babies, or as a result of primary maternal disorders, should be considered superior qualities for the creation and well being of the breastfeeding well from the mother.

1 woman treated orally a diclofenac had salt, 150 mcg/day, milk diclofenac A level of 100 µg/L corresponds to a pediatric dose within 0, 03 mg/kg/day. Diclofenac was not found in the milk of 12 women diclofenac (100 mg/day post oral for 7 days with 50 mg intramuscularly administered during the specific postpartum period)

8. 3 women and a gentleman with reproductive potential

women based on mechanism of action, prostaglandin-mediated NSAID induction, diclofenac sodium topical The gel has the potential to prevent or arrest follicle rupture, which is associated with reversible infertility in some women. Animal studies have shown that the introduction of prostaglandin synthesis inhibitors may interfere with prostaglandin-mediated follicle rupture, which is important for ovulation; small studies in women treated with NSAIDs continue to show reversible ovulation delays. Evaluate the possibility of discontinuing NSAIDs. diclofenac sodium topical Gel for women suffering from or considering infertility.

8.4 Pediatric Use

Safety and efficacy in pediatric patients have not been established.

8. 5 Use in the Elderly.

Elderly patients are at greatest risk for serious non-serious cardiovascular, gastrointestinal, and renal reactions associated with NSAIDs compared to younger patients. If the expected benefit to older patients outweighs these possible risks, start dosing at the lower end of the dose range and monitor patients for one or two adverse reactions [see Warnings and Precautions (5, 1, 5, 2), 5, 5, 3, 5, 5, 6, 5, 13)].

Of the total number of subjects treated diclofenac sodium topical gels in clinical trials included 498 subjects over the age of 65. Although virtually no cumulative differences in performance or protection were observed between these subjects and younger subjects, the dramatic effects of NSAIDs in some older subjects cannot be excluded.

Diclofenac, like all NSAIDs, is extensively excreted by the kidneys and is known to carry a high risk of toxic reactions. to diclofenac sodium topical Gel use may be more common in patients with impaired renal function. Because older patients are more likely to have impaired renal function, their use raises a number of concerns. diclofenac sodium topical Gels for the elderly. This may be healthier for renal function prognosis.

Symptoms after acute administration of NSAIDs are generally limited to lethargy, somnolence, nausea, vomiting, and bothersome pain in the pericardial area and usually resolve with assistance. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred but were rare [see Warnings and Precautions (5, 1, 5, 2, 5, 4, 5, 6)].

After an NSAID overdose, treat patients with symptomatic and supportive care. There is no special antidote. Due to high protein binding, forced diuresis, urinalysis, hemodialysis, or hemoperfusion may not be necessary.

For more information on overdose treatment, contact the Center for Addiction Management at 1-800-222-1222.

Diclofenac sodium topical Gel, 1% is considered a nonsteroidal anti-inflammatory product. for topical Use only. Chemical name is 2-[(2,6-dichlorophenyl)amino]benzolic acid, monosodium salt. Molecular formula is 318, 14. The molecular formula is C 14 H 10 CL 2 NNAO 2 and contains the correct chemical structure.

Active components are, diclofenac sodium Opaque white gel base. Diclofenac. sodium A snow white, slightly yellowish crystalline powder. Diclofenac. sodium A derivative of benzoic acid. Inactive ingredients in diclofenac sodium topical The gel contains homopolymeric carbomers such as C, cocoyl capryloclate, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearate, propylene glycol, purified water and strong ammonia solution.

12. 1 Mechanism of Action

Diclofenac has analgesic, anti-inflammatory, and antifunctional properties. Mechanism. of diclofenac sodium topical Like other NSAIDs, it involves inhibition of cyclooxygenase (COX-1 and COX-2), although the gel has not been fully investigated. Diclofenac is considered a large inhibitor of prostaglandin synthesis in vitro. Diclofenac concentrations achieved during treatment cause in vivo effects. Prostaglandins grow congenital nerves and increase the effect of bradykinin on pain recovery in animal models. Prostaglandins are considered an inflammatory medium. Therefore. diclofenac inhibitor of prostaglandin synthesis, his mechanism of action may be related to the reduction of prostaglandins in peripheral tissues.

12. 3 Pharmacokinetics

The pharmacokinetics of diclofenac sodium topical The gel was observed among healthy volunteers after repeated applications in the direction of 7 days of diclofenac sodium topical 1 knee (4 x 4 g per day) or 2 knees and 2 hands (4 x 12 g per day) gel vs. appropriate oral administration of diclofenac sodium treatment of osteoarthritis (3 x 50 mg per day). Table 2 contains a summary of pharmacokinetic characteristics.

Table 3: Pharmacokinetic Characteristics and Comparison of diclofenac sodium topical Gel containing oral diclofenac sodium tablets reintroduced

c max = final plasma concentration, t max = time cmax. auc0-24 = surface under the concentration-time curve. SD = normal deviation. CI = confidence interval.

Systemic effects (area under the concentration curve) and maximum plasma concentration of diclofenac It is important in diclofenac sodium topical Gel with equivalent oral treatment of diclofenac sodium .

Systemic effects with correct use of of diclofenac sodium topical gel (4 x 4 g per day used on knees), average 17 a lower than oral treatment (base: treatment) diclofenac sodium topical 1 piece of knee gel, 4 times a day, compared to 50 mg 3 times a day of Orel diclofenac tablet.) Quantity of diclofenac sodium Systematically absorbed diclofenac sodium topical Average 6% gel for systemic exposure for oral dosage forms of diclofenac sodium .

Average peak plasma concentration for recommended use of diclofenac sodium topical Gel (4 x 4 g per day, used up to the knees) is 158 than oral treatment.

The pharmacokinetics of diclofenac sodium topical Gels were tested with the criteria of low fire (applying heat position in the direction of 15 minutes prior to gel use) and low effort (20 minutes of exertion on a treadmill after first applying the gel). No clinically important differences in systemic absorption and tolerance were found between applications of diclofenac sodium topical gel (4 x 4 g per day) with and under the tested criteria. Pharmacokinetics of the of diclofenac sodium topical gel was not tested with the criterion of using gel followed by heat. Simultaneous use of the of diclofenac sodium topical gel and warmth is not recommended.

Drug interaction studies

Aspirin: When NSAID was administered with aspirin, protein binding of NSAID was reduced, but clearance of free NSAID was not altered. The clinical significance of this interaction is not popular; see Table 2 for clinically important drug interactions between NSAIDs and aspirin [see Drug Interactions (7)].

13.1 Carcinogenesis, Mutagenesis, and Fertility Issues

Carcinogenicity studies in mice and rats administered diclofenac sodium as a food ingredient in the direction of up to 2 mg/kg/day for 2 years (about 0, 5, and in accordance with this, once in the very largest appropriate person) topical dose of diclofenac sodium topical Gel based on a comparison of bioavailability and body surface (BSA)) did not significantly increase the incidence of tumors.

In the cuton topical applications of a diclofenac sodium Gel products in the direction of 2-jr at concentrations up to 035% of diclofenac sodium (a 29-fold lower diclofenac sodium Concentration is current. in diclofenac sodium topical (Gel) did not increase the incidence of neoplasia.

In the picture, in a par sciatic membranous study performed on white-footed mice, topical application of a diclofenac sodium The gel product at the time of administration is a concentration of 0.035% of diclofenac sodium (a 29-fold lower diclofenac sodium Concentration is current. in diclofenac sodium topical (GEL) resulted in a faster mean time to tumor development.

Diclofenac reeks genotoxiciteitsStudies, waaronder debacteriëleomzetmutatietest, de muriene puntmutatietest, van murien lymfoom, chromosoomafwijkingen in beenmergcellen in vitr o-chromosomal aberrations in vitro chromosomes in vitro chromosomes in vitro – in vone chromosomal aberrations in myeloid cells – in vone chromosomal aberrations in myeloid cells

Limitations

Diclofenac did not affect fertility in male or female rats at doses up to 4 mg/kg/day

(approximately twice as much as the highest human dose. topical dose of diclofenac sodium topical gel based on bioavailability and BSA comparisons).

14. 1 The most important study on osteoarthritis of the superficial joints of the extremities

Study 1 evaluated the efficacy of of diclofenac sodium topical gel for healing osteoarthritis of the knee in a 12-week randomized, double-blind, multi-chamber, 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). Pain assessed by patients weekly from week 12 on a version of the Western Ontario and McMaster Institute Osteoarthritis Index (WOMAC) the diclofenac sodium topical gel group, then the placebo group.

Study 2 evaluated the efficacy of of diclofenac sodium topical healing osteoarthritis gel in osteoarthritis subjects in an 8-week randomized, double-blind, multicentric, placebo-controlled parallel study. diclofenac sodium topical The 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 the patients at weeks 4 and 6 on a visual analog scale ranging from 0 to 100, the diclofenac sodium topical gel group, then the placebo group.

Table 4: Efficacy summary of the of diclofenac sodium topical Gels in Studies 1 and 2

* WOMAC = Western Ontario McMaster Osteoarthritis Index.

# ranges from 0 (best) to 100 (worst).

† Differences are corrected by application of the analysis of covariate models (ANCOVA) with the main effects of healing and central and base line covariates.

‡ Differences are corrected by the introduction of the analysis of the covariate model (ANCOVA) with the main effects of healing and central and pain pointers for CMC-1 joints and baseline healing as covariates by CMC-1.

Diclofenac sodium topical Gel, 1% is an opaque off-white gel, available in 100 gram tubes. the topical Each tube contains gel. Each tube contains diclofenac sodium Gel base (10 mg) of diclofenac sodium (per gram of gel or 1%).

Packaging: 1 piece per box, 100 g per tube, photo 0

Store at room temperature 20°C to 25°C (68°F to 77°F) [see USP – Room Temperature Control].

Protect from freezing. Always carry the dosage card with you diclofenac sodium topical gel.

Repackage and distribute:.

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625 Dr. Colter Suite #4 Indiana, PA 1-724-465-8762

Advise the ill patient to read the FDA-approved Sick Patient Label (Drug Guide and Instructions for Use) that accompanies each prescription dispensed. Patients, relatives, or their parents should be informed of the correct information before treatment is initiated. diclofenac sodium topical Apply gel occasionally while continuing treatment.

Cardiovascular thrombotic accidents

Watch for signs of cardiovascular thrombotic events, including chest pain, dyspnea, impotence, or silence, and advise the patient to report any of these signs promptly to the health care provider [see Warnings and Preventive Measures (5. 1)].

Gastrointestinal bleeding, ulceration, perforation

Advise patient to report any signs of ulceration or bleeding to health care provider, including cardiac pain, indigestion, melena, and hematemesis. Under the concomitant criteria for low-dose aspirin for cardiac prophylaxis, inform the patient of the increased risk and signs and symptoms of gastrointestinal bleeding [see Warnings and Precautions (5, 2)].

Advise patient of warning signs and symptoms of hepatotoxicity (e.g., drowsiness, fatigue, lethargy, teeth, diarrhea, jaundice, tenderness in the right upper quadrant, signs of “flu”). If this occurs, have the patient discontinue diclofenac sodium topical gel and seek immediate drug treatment [see Warnings and Precautions (5. 3)].

Cardiac deficiency and edema

Watch for signs of congestive heart failure such as dyspnea, unexplained weight gain, and edema and advise the patient to contact a health care professional if these signs develop [see Warnings and Precautions (5, 5)].

Inform the patient of any symptoms of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). If these symptoms occur, advise the patient to seek emergency medical attention immediately [see Contraindications (4) and Warnings and Precautions (5. 7)].

Severe skin reactions

Advise patient to slow down. diclofenac sodium topical Immediately, if they develop a skin rash pattern and confuse with their care provider as soon as possible [see Warnings and Precautions (5. 9)].

Advise girls with reproductive potential who want to conceive to include NSAID

diclofenac sodium topical gel may be associated with reversible delay of ovulation [see application in certain populations (8. 3)].

Advise use in pregnant girls of diclofenac sodium topical Gel and other NSAIDs during the first 30 months of pregnancy [see Warnings and Precautions (8. 3)] because of the risk of premature closure of the fetal ductus arteriosus. Warnings and Precautions (5. 10) and specific population applications (8. 1)].

Avoid concurrent use of NSAIDs

Properly advise patients to use concurrently 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)]. Warnings and Precautions (5. 2) and Drug Interactions (7)]. It is important to know that NSAIDs may occur with “freely available” medications for the treatment of colds, fevers, or insomnia.

Use of NSAID and low-dose aspirin

Advise patients not to use low-dose aspirin at the same time diclofenac sodium topical gel until they have spoken with their care provider [see Interactions Between Medications (7)].

Instruct patient to ignore contact of diclofenac sodium topical Ignore as well as do not examine the gel with the eyes and mucous membranes. If discomfort persists for more than 1 hour, if eye contact, advise patient to wash eyes with water or physical substance and advise physician to physician [see Warnings and Precautions (5, 15)].

Specific Administration Notes

Instruct the patient how to apply the dosing card to measure the correct dose of diclofenac sodium topical gel to apply.

If the patient loses his/her dosing card, call 1-833-285-4151 to request a replacement dosing card or indicate to the pharmacist that he/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 instruct anyone in the patient to diclofenac sodium topical Open skin wounds, infection, inflammation, or exfoliative dermatitis because the gel may affect product absorption and tolerance.

Instruct patient to use at the same time of diclofenac sodium topical gel with other topical products such as solar filters, cosmetics, lotions, moisturizing creams, and anti-aging agents. If used at the same time, they may cause skin reactions or alter absorption. of diclofenac sodium topical gel.

Instruct patient to minimize or avoid exposure to natural or non-natural sunlight in covered areas [see Warnings and Precautions (5. 14) and Dosing and Administration (2. 4)].

Comments or questions?

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• Increased risk of heart attack or heart attack. This can be fatal. This risk can occur at the start of treatment and can increase

o To use NSAIDs longer

Do not take NSAIDs immediately before or after a cardiac procedure called a “coronary artery bypass graft (CABG).”

• Risk of bleeding, ulcers, and fractions (perforations) in the gastrointestinal tract (tube running from mouth to stomach), stomach, and intestinal tract:
  • Every time
  • No Warning Symptoms.
  • May cause death.
  • Risk of gastric ulcer or bleeding is as follows
    • History of gastric ulcers or stomach or gastrointestinal bleeding when using NSAID
    • Medication is taking “corticosteroids”, “anticoagulants”, “SSRIS” or “SNRIS”
    • Rising doses of NSAID o Elderly
    • o Longer use of NSAID.
    • Smoking o Highest liver disease
    • Drink o Difficulty bleeding
    • As prescribed
    • o Lowest dose of treatment
    • Short-term
    • Asthma attacks, hives, or other allergic reactions with aspirin or other NSAIDs.
    • Immediately before or after heart bypass operation.
    • Has liver or kidney problems.
    • Has high blood pressure.
    • Asthma.
    • Is pregnant or plans to become pregnant. If you plan to use an NSAID during pregnancy, consult your own supplier of health care suggestions. You are not obligated to take an NSAID after 29 months of pregnancy.
    • You are breastfeeding or plan to breastfeed.

    NSAIDs can cause serious side effects.

    • Improved or unimproved hypertension
    • Heart failure
    • Liver problems, including liver failure
    • Kidney problems, including renal failure
    • Low red blood cell count (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
    • Aspirin is an NSAID but does not increase the likelihood of a 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 health care provider before using an NSAID without a prescription for more than 10 days.

    Medications may be prescribed for purposes other than those listed in the Drug Guide. Do not use an NSAID for a condition for which it is not prescribed. Do not give an NSAID to another person, even if they have the same symptoms as you. This may cause them harm.

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    Diclofenac sodium topical gel, 1%

    IMPORTANT: Use a dosing card. the diclofenac sodium topical Gel package for correct measurement of any dose. Dose cards are reusable. Do not throw away doses. Before you use diclofenac sodium topical caregiver or pharmacist must first be shown how to correctly measure your dose with the dosing tool.

    Read these instructions before use diclofenac sodium topical each time you get a gel and refill. Include current information. This information is not a substitute for an interview with your health care provider about your condition or treatment.

    Your care provider will have you diclofenac sodium topical Gel formulated to illuminate arthritis in some of your joints. diclofenac sodium topical Gel can be used to help arthritis pain in the hands (arms, wrists, elbows) and feet (legs, ankles, knees). It is unknown. if diclofenac sodium topical Gel is harmless and effective when applied to the back, hips, and shoulders.

    • Use diclofenac sodium topical Literally gel as your caregiver stipulates. Bring. diclofenac sodium topical Apply gel only where prescribed by your doctor.
    • Do not use more than 32 grams of of diclofenac sodium topical gel one day. If there is a quantity of diclofenac sodium topical as prescribed by your care provider, he is not obligated to dose more than 32 grams per day.

    The dose for the hand, wrist, or elbow is 2 grams of diclofenac sodium topical Use at any time.

    • Apply diclofenac sodium topical Gel four times a day (8 grams per total). Do not use more than 8 grams per day on one of the affected hands, wrists, or elbows.

    Dose for feet, ankles, and knees is 4 grams of gel per day. of diclofenac sodium topical Use at any time.

    • Apply diclofenac sodium topical Use 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 topical GEL applications include

    • Apply diclofenac sodium topical GEL on impure dry skin with little or no amputations, open wounds, ulcers or rashes.
    • Do not use heating cushions and do not apply where applied. diclofenac sodium topical gel.
    • Avoid skin exposure where you are diclofenac sodium topical Gel, do not expose gel to sunlight or duty such as solar cabins.
    • Do not use sunscreen, cosmetics, lotions, moisturizing methods, insect resistant agents, etc. topical Medication on the same area of skin where you are diclofenac sodium topical gel.
    • Do not get diclofenac sodium topical Gel on your eyes, nose, or mouth. diclofenac sodium topical Gel may only be used on the skin ( topical use). If you get diclofenac sodium topical If the gel gets into your eyes, immediately flush your eyes with water or a physical substance. If eye discomfort persists for more than 1 hour, contact a physician.

    What if I skip a dose?

    • If you miss a dose of diclofenac sodium topical Continue with the correct planned dose of gel, then through the prescribed quantity of of diclofenac sodium topical Gel. Do not multiply the dose.

    Apply 2 grams (2 g) of diclofenac sodium topical Gel on the hand, wrist, or elbow:

    Step 1. Remove the inner dosing card of the the diclofenac sodium topical gel package. Using the dosing card, of diclofenac sodium topical gel. Measure the appropriate amount of of diclofenac sodium topical 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 Schedule A). If you have lost or misplaced your own dosing card, you can ask your pharmacist for a new question or call 1-833-285-4151. ask your care provider or pharmacist to show you how to measure your dose correctly. of diclofenac sodium topical While waiting for the gel new dosage card.

    Figure B Sketch C Sketch d

    Step 2 . Squeeze diclofenac sodium topical Apply gel to the dosing card to make a 2 g portion (2, 25 in. long gel). Make sure the gel covers the area of the 2 g portion (see sketch B). Place the cap back on the tube of of diclofenac sodium topical Gel. Ask your care provider or pharmacist if you have questions about how to correctly correct your dosage. 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 it is ready for correct use. Do not swim or bathe for at least 1 hour after applying diclofenac sodium topical Gel. Do not wash covered hands 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 topical Gel on feet, ankles and knees:

    Step 1. see Step 1 above.

    Step 2. Squeeze diclofenac sodium topical Measure the gel on the pipette card into a 4 g piece (4, 5 inch long gel), making sure the gel covers the area of the 4 g dose (see sketch E). Place the cap back on the tube of diclofenac sodium topical Gel. Ask your care provider or pharmacist if you have questions about how to correctly correct your dosage. of diclofenac sodium topical gel.

    Step 3. Apply diclofenac sodium topical Gel on feet, ankles, and knees. Gel can be used by applying a dosing card (see sketch F). Then carefully rub the gel onto the skin using your own hand (see Sketch G). Do not share your dosing card with another dosing card. 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 the feet, ankles, and knees.

    Which Ingredient 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, strong ammonia solution, or other carbomer gaylod.

    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 dosage card with you diclofenac sodium topical gel.

    Keep diclofenac sodium topical gel, dosage, and all medications outside the reach of children.

    This medication instruction and dosage card has been approved by the FDA.

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