The optimum times for making the first and subsequent transaminase measurements are not known. The 2 g line is 2.25 inches long. No: 10816015000084 |, /wp-content/uploads/2016/08/2016-10-27-AUDIO-00000011.mp3" autoplay="on" ]'); Once after its application on the painful skin area, it gets easily absorbed into the skin & starts its effective pain-relieving action by blocking inflammation. 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• chest pain• weakness in one part or side of your body• slurred speech• swelling of the face or throatStop taking your NSAID and call your health care provider right away if you get any of the following symptoms:• nausea• more tired or weaker than usual• diarrhea• itching• your skin or eyes look yellow indigestion or stomach painflu-like symptoms• vomit blood• there is blood in your bowel movement or it is black and sticky like tar• unusual weight gain• skin rash or blisters with fever• swelling of the arms, legs, hands, and feetIf you take too much of your NSAID, call your health care provider or get medical help right away. You may have an increased risk of another heart. Keep all regular medical and laboratory appointments. If you have any questions, ask your doctor or pharmacist. Talk to your pharmacist for more details. Laboratory and/or medical tests (such as blood pressure, complete blood count, liver and kidney function tests) should be performed periodically to monitor your progress or check for side effects. For example, cover the skin above, below, inside and outside the knee cap. No overall differences in effectiveness or safety were observed between these subjects and younger subjects, but greater sensitivity to the effect of NSAIDs in some older individuals cannot be ruled out. Before using this medication, tell your doctor or pharmacist your medical history, especially of: Kidney problems can sometimes occur with the use of NSAID medications, including diclofenac. (2), --------------DOSAGE FORM AND STRENGTH-----------• Diclofenac sodium topical gel, 1% (3), ----------------------CONTRAINDICATIONS--------------------• Known hypersensitivity to diclofenac or any components of the drug product. Amneal Pharmaceuticals LLC (5.2), To report SUSPECTED ADVERSE REACTIONS, contact, Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-, See 17 for PATIENT COUNSELING INFORMATION, FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS, 5.8 Exacerbation of Asthma Related to Aspirin Sensitivity, 5.10 Premature Closure of Fetal Ductus Arteriosus. Risk SummaryBased on available data, diclofenac may be present in human milk. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. Keep all medications away from children and pets. Additionally, patients with advanced liver disease and/or coagulopathy are at increased risk for GI bleeding. Events, 8.3 Females and Males of Reproductive Potential. To report SUSPECTED ADVERSE REACTIONS, contact To measure the right dose, use the dosing card(s) provided with the medication. Stop taking your NSAID and call your health care provider right away if you get any of the following symptoms:• nausea• more tired or weaker than usual• diarrhea• itching• your skin or eyes look yellow indigestion or stomach painflu-like symptoms• vomit blood• there is blood in your bowel movement or it is black and sticky like tar• unusual weight gain• skin rash or blisters with fever• swelling of the arms, legs, hands, and feet General information about the safe and effective use of NSAIDs Remember that the hand includes the palm of your hand, the top of your hand, and your fingers. InfertilityFemalesBased on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including diclofenac sodium topical gel, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. Do not double the dose to catch up. You may have an increased risk of another heartattack if you take NSAIDs after a recent heart attack. This risk may occur early in treatment and may increase with duration of use, Diclofenac sodium topical gel is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. CarcinogenesisCarcinogenicity studies in mice and rats administered diclofenac sodium as a dietary constituent for 2 years at doses up to 2 mg/kg/day (approximately 0.5 and 1 times, respectively, the maximum recommended human topical dose of diclofenac sodium topical gel based on bioavailability and body surface area (BSA) comparison) resulted in no significant increases in tumor. Otherwise, call a poison control center right away. There has been no experience of overdose with diclofenac sodium topical gel. If it is near the time of the next dose, skip the missed dose. Do not share your dosing card withanother person. Female FertilityAdvise females of reproductive potential who desire pregnancy that NSAIDs, including diclofenac sodium topical gel, may be associated with a reversible delay in ovulation [see Use in Specific Populations (8.3)]. If this effect persists or worsens, tell your doctor or pharmacist promptly. See full prescribing information for DICLOFENAC SODIUM TOPICAL GEL. If you wait until the pain has worsened, the medication may not work as well. Diclofenac sodium, USP is a benzeneacetic acid derivative. Tell your doctor if your pain persists or worsens. Do not get the medication in the eyes, nose, or mouth. These events can occur at any time during use and without DICLOTAL-FORTE Gel is contraindicated in the following: Known or suspected hypersensitivity to diclofenac or aspirin or other NSAIDs, linseed oil, methyl salicylate, menthol, capsaicin or to any other component of the formulation. Squeeze diclofenac sodium topical gel onto the dosing card evenly up to the 4 g line (a 4.5 inch lengthof gel), making sure the gel covers the 4 g area of the dosing card (see Figure E). (4, 5.1), NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or, fatal.