Sunrise Remedies Pvt. Ltd. Generic : Diclofenac
13.15 500mg/50mg 10 Tablets
• Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) which is used to treat mild-to-moderate pain, fever, and inflammation.
• Gastrointestinal: Nausea, constipation, flatulence, pain in the abdomen, indigestion, vomiting, bleeding and ulcers in the stomach
• Cardiovascular: Heart failure, fluid accumulation, palpitations, chest pain, high blood pressure
• Central nervous system: Dizziness, headache, hallucination, drowsiness
• Respiratory: Upper respiratory infection, sinusitis, bronchitis, nasopharyngitis, shortness of breath
• Skin: Rashes, itching, increased sweating, exfoliative dermatitis, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis
• Genitourinary: Abnormal kidney function, raised concentrations of serum creatinine, urinary tract infection
• Others: Anemia, ringing sensation in the ears, raised level of liver enzymes, liver damage, prolongation in bleeding time, reduced blood counts, allergic reactions
• The recommended adult dose of diclofenac sodium or potassium is 25 mg to 50 mg three times a day after food.
• The maximum daily dose is 150 mg once daily after food.
• The dose of diclofenac sodium extended-release tablets is 100 mg once daily.
• The maximum daily dose in treating rheumatoid arthritis is 225 mg after food.
• The prescribed adult dose is 37.5 mg to be administered intravenously for every 6 to 8 hours.
• The maximum daily dose is 150 mg once daily.
• Instill 1 drop into the affected eye 4 times a day or as directed by the ophthalmologist. Do not use soft contact lenses while using diclofenac drops.
• Apply diclofenac gel or cream or spray twice daily to the affected part or as directed by the physician. Do not apply on broken skin. A diclofenac patch is also available, which should be removed while bathing.
• Diclofenac suppositories should be inserted into the rectum one to three times daily with the maximum daily dose of 150mg.
• The dose of diclofenac suppositories vary with the age but usually between 1 and 3 mg/kg body weight daily in two or three divided doses.
• Diclofenac tablets for oral use should be taken by mouth along with food to avoid gastric discomfort.
• Granules of diclofenac are taken by mixing the granules with sufficient quantity of water and swallowed immediately.
• Do not chew, crush or break the contents of enteric-coated or film-coated tablets.
Diclofenac is not recommended in patients with the following conditions-
• Allergy to diclofenac or any other related NSAID
• Asthma or breathing problems
• History of peptic ulcer or stomach bleeding
• Severe kidney or liver disease
• Reported allergic reaction after taking aspirin
• Treating pain in coronary artery bypass graft (CABG)
• Fluid retention or edema
The use of diclofenac in pregnancy should be avoided particularly in the third trimester to avoid premature closure of ductus arteriosus. Diclofenac is also not recommended during breastfeeding or during labor.
• While administering the intravenous injection, it is necessary to hydrate the patient in order to reduce the risk of adverse effects on the kidney.
• Caution is required in patients with mild liver or kidney impairment but diclofenac should not be used in moderate-or-severe damage.
• It is usually advised to start with the lowest effective dose and a treatment for a short duration if possible.
• Patients should be monitored for the signs and symptoms of stomach bleeding during diclofenac therapy because of the risk of developing a peptic ulcer.
• Monitor for the blood counts, kidney and liver function and blood pressure regularly in patients on long-term treatment with diclofenac.
• Diclofenac may increase the risk of heart attack or stroke.
• The use of another NSAID along with diclofenac is not recommended but diclofenac can be used in combination with opioids in case of severe pain or swelling.
• Alcohol intake with diclofenac is not encouraged because of the increased risk of stomach bleeding or ulcer.
• Treatment with diclofenac should be discontinued immediately and when serious skin reactions occur.
• A high injectable dose should be avoided in patients with cardiovascular disease or uncontrolled hypertension. Injectable diclofenac should also not be administered to patients with dehydration, bleeding problems or at a high risk of bleeding.
• Patients should be advised not to interchange the formulations of diclofenac for their treatment as the formulations may not be bioequivalent.
• It is recommended to report to the emergency center any signs and symptoms of allergic reactions, gastrointestinal complaints, cardiovascular events, liver toxicity, unusual weight gain or weight loss.
• Concomitant administration of diclofenac and aspirin or other NSAIDs is not advised because of the risk of increased adverse effects.
• Drugs such as methotrexate and cyclosporine should not be taken with diclofenac to avoid the potential for kidney toxicity.
• Diclofenac may decrease the antihypertensive effects of blood pressure lowering medications including ACE inhibitors such as lisinopril, enalapril, perindopril, and ramipril when taken together.
• Diclofenac may reduce the natriuretic (sodium-losing) effects of frusemide and thiazide diuretics and patients must be monitored for signs and symptoms of renal failure.
• Warfarin when taken with diclofenac results in a serious risk of gastrointestinal bleeding.
• Lithium when taken concomitantly with diclofenac results in the elevation of plasma lithium levels and reduced renal lithium clearance.
• Enzyme inducers like rifampicin may reduce the blood levels of diclofenac, while enzyme inhibitors like voriconazole may increase its level.
• Store at a controlled room temperature between 20°C and 25°C.
• Keep away from excess light and moisture.
• Keep out of the reach of children.
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