Diclofen K Tablet

Diclofen K Tablet is used for: Rheumatoid arthritis, Osteoarthritis, Ankylosing spondylitis, Pain, Migraine, Allergic conjunctivitis, Dysmenorrhea, Muscle aches, Acute gout, Inflammation, Renal colic, Miosis, Tendinitis, Actinic keratosis, Backaches, Dental pain, Menstrual cramps, Bursitis

Oral Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis, Mild-to-Moderate Acute Pain Adult: 50 mg PO 8-12 hourly. Migraine Adult: As diclofenac K: Initially, 50 mg taken at the 1st sign of an attack, an additional dose of 50 mg may be taken after 2 hr if symptoms persist. If needed, further doses of 50 mg may be taken 4-6 hourly. Max: 200 mg/day. Dysmenorrhea In primary dysmenorrhea, the daily dose should be individually adjusted and is generally 50 to 150 mg. 50 mg PO 8 hourly PRN.

Renal impairment Patients with renal impairment had AUC values and elimination rates that were comparable to healthy patients

May be taken with food to decrease GI distress

It is contraindicated for those patients who are hypersensitive to Diclofenac. In patients with active or suspected peptic ulcer or gastrointestinal bleeding, or for those patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other NSAIDs possessing prostaglandin synthetase inhibitinig activity, it is also contraindicated.

Cardiovascular risk Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal Risk may increase with duration of use Patients with existing cardiovascular disease or risk factors for such disease may be at greater risk Use of COX-2 selective NSAID for pain treatment in the first 10­14 days following CABG surgery increased incidence of MI and stroke; use of NSAIDS is contraindicated for perioperative pain in setting of coronary artery bypass graft (CABG) surgery Gastrointestinal risk NSAIDs can increase risk of serious GI adverse events, including bleeding, ulceration, and gastric or intestinal perforation, which can be fatal May occur at any time during use and without warning symptoms Patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events Use caution in patients with bronchospasm, cardiac disease, CHF, hepatic porphyria, hypertension, fluid retention, severe renal impairment, smoking, systemic lupus erythematosus Platelet aggregation and adhesion may be decreased; may prolong bleeding time Use caution in blood dyscrasias or bone marrow depression; also with thrombocytopenia, agranulocytosis, and aplastic anemia Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include elderly individuals, those with impaired renal function, hypovolemia, heart failure, liver dysfunction, or salt depletion, and those taking diuretics, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers Increase risk of hyperkalemia may occur, especially in renal disease, diabetics, the elderly, and concomitant use of agents that may induce hyperkalemia; monitor potassium closely May cause dizziness blurred vision and neurologic effects that may impair physical and mental abilities Persistent urinary symptoms, including bladder pain and dysuria, hematuria or cystitis may occur after initiating therapy; discontinue therapy with symptom onset and evaluate cause May increase risk of aseptic meningitis (rare), especially in patients with systemic lupus erythrmatosus, and mixed connective tissue disorders Use caution if patient dehydrated before initiating therapy; rehydrate patient before initiating therapy and monitor renal function closely Avoid use of NSAIDs in pregnant women at about >30 weeks gestation Use of NSAIDs at about >20 weeks gestation in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment Serious Skin Reactions NSAIDs, including this drug, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal Gastrointestinal bleeding, ulceration, perforation Risk factors for GI bleeding, ulceration, and perforation Hepatoxicity Increase in transaminase levels reported within 2 months of therapy; may occur at any time Monitor transaminase levels periodically beginning 4-8 weeks after initiation of therapy Hypertension NSAIDs can lead to new onset of hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events.

Pregnancy There are no studies on effects of drug during labor or delivery Premature closure of fetal ductus arteriosus Use of NSAIDs can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment Limit dose and duration of use to ~20-30 weeks of gestation; avoid use at about 30 weeks of gestation and later in pregnancy Use of NSAIDs at >30 weeks gestation in pregnancy increases risk of premature closure of fetal ductus arteriosus Oligohydramnios/neonatal renal impairment Use of NSAIDs at about >20 weeks gestation in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment Data from observational studies regarding other potential embryofetal risks of NSAID use in women in first or second trimesters of pregnancy are inconclusive Avoid use of NSAIDs in women at about 30 weeks gestation in pregnancy, because NSAIDs can cause premature closure of fetal ductus arteriosus If an NSAID is necessary at about >20 weeks gestation in pregnancy, limit use to lowest dose and shortest duration possible; if treatment extends beyond 48 hr, consider monitoring with ultrasound for oligohydramnios If oligohydramnios occurs, discontinue therapy, and follow up according to clinical practice Animal data NSAIDS, including diclofenac, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth Infertility Females Based on mechanism of action, use of prostaglandin-mediated NSAIDs may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation Consider withdrawal of NSAIDs in women who have difficulties conceiving or who are undergoing investigation of infertility Animal data In published studies, administration of clinically relevant doses of diclofenac to pregnant rats produced adverse effects on brain, kidney, and testicular development Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization Administration of prostaglandin synthesis inhibitors such as diclofenac, resulted in increased pre-and post-implantation loss; prostaglandins also have been shown to have an important role in fetal kidney development Prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses Lactation Data from published literature reports with oral preparations of diclofenac indicate the presence of diclofenac in small amounts human milk There are no data on effects on breastfed infant, or on milk production

Drugs that interfere with hemostasis Monitor for bleeding Diclofenac and anticoagulants such as warfarin have a synergistic effect on bleeding. Use with anticoagulants have an increased risk of serious bleeding Serotonin release by platelets plays an important role in hemostasis Monitor for signs of bleeding in patients concomitantly using anticoagulants (eg, warfarin), antiplatelet agents (eg, aspirin), selective serotonin reuptake inhibitors, and serotonin norepinephrine reuptake inhibitors Salicylates Not generally recommended Diclofenac with other NSAIDs or salicylates (eg, diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy ACE inhibitors, angiotensin receptor blockers (ARBs), beta-blockers H5 Monitor for signs of worsening renal function in high-risk patients (eg, elderly patients, volume depleted, renal impaired patients) NSAIDs may diminish the antihypertensive effect of ACE inhibitors, ARBs, or beta-blockers Diuretics Monitor patients to assure diuretic efficacy including antihypertensive effects NSAIDs can reduce natriuretic effect of loop and thiazide diuretics Digoxin Monitor serum digoxin level Diclofenac can increase serum concentration and prolong half-life of digoxin Pemetrexed Monitor for myelosuppression, renal, and GI toxicity during coadministration of NSAIDS with pemetrexed in renally impaired patients (CrCl 45-79 mL/min) Avoid NSAIDs with short elimination half-lives (eg, diclofenac, indomethacin) for a period of 2 days before, the day of, and 2 days following administration of pemetrexed Interrupt dosing of NSAIDs with longer half-lives (eg, meloxicam, nabumetone) for at least 5 days before, during, and 2 days following pemetrexed administration Diclofenac may increase the risk of pemetrexed­-associated myelosuppression, renal, and GI toxicity CYP2C9 inhibitors Consider increasing duration of diclofenac doses for subsequent migraine attacks CYP2C9 inhibitors may affect the pharmacokinetics of diclofenac Cyclosporine Monitor for signs of worsening renal function Diclofenac may increase cyclosporine nephrotoxicity Methotrexate Monitor for methotrexate toxicity NSAIDS may increase the risk for methotrexate toxicity (eg, neutropenia, thrombocytopenia, renal dysfunction) Lithium Monitor for signs of lithium toxicity NSAIDs elevated plasma lithium levels and reduced renal lithium clearance Contraindicated (0) Serious (23) aminolevulinic acid oral aminolevulinic acid topical apixaban benazepril captopril enalapril fosinopril ivosidenib ketorolac ketorolac intranasal lisinopril lonafarnib methotrexate methyl aminolevulinate moexipril pemetrexed perindopril pexidartinib pirfenidone quinapril ramipril tacrolimus trandolapril

Side effects of Diclofenac Potassium : 1-10% Abdominal pain Constipation Diarrhea Dyspepsia Flatulence Gross bleeding/perforation Heartburn Nausea GI ulcers (gastric/duodenal) Vomiting Abnormal renal function Anemia Dizziness Edema Elevated liver enzymes Headaches Increased bleeding time Pruritus Rashes Tinnitus

Diclofenac, a phenylacetic acid derivative is a prototypical NSAID. It has potent anti-inflammatory, analgesic and antipyretic actions. It reversibly inhibits the enzyme, cyclooxygenase, thus resulting in reduced synthesis of prostaglandin precursors.

Diclofen K 50mg Tablet manufactured by Opsonin Pharma Limited. Its generic name is Diclofenac Potassium. Diclofen K is availble in Bangladesh. Farmaco BD drug index information on Diclofen K Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.