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Induced diuresis may be beneficial because diclofenac and misoprostol metabolites are excreted in the urine, provided that the patient does not develop renal failure at diclofenac overdose. In co-administration studies in animals, the addition of misoprostol did not enhance the toxic effects of diclofenac. AST elevations were observed in 3. Management of acute poisoning with NSAIDs essentially consists of supportive and symptomatic measures.
To bookmark a medicine you must be a registered user. It is prudent to start with the lowest dose of Arthrotec 75 and to monitor closely for signs of toxicity. Arthrotec 75 in common with other NSAIDs, may decrease platelet aggregation and prolong bleeding time. Concomitant use of a systemic NSAID and another NSAID may increase frequency of gastrointestinal ulcers and bleeding.
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Because of their effect on renal prostaglandins, NSAIDs such as diclofenac may increase the nephrotoxicity of ciclosporin. Patients who experience dizziness or other central nervous system disturbances while taking NSAIDs should refrain from driving or operating machinery. The combination was also shown not to be teratogenic or mutagenic.
GI bleeding or other active bleedings e. Physicians and patients should remain alert for the development of such events, even in the absence of previous cardiovascular symptoms. One tablet to be taken with food, two times daily. Single and multiple dose studies have been conducted comparing the pharmacokinetics of Arthrotec 75 with the diclofenac 75 mg and misoprostol 200 micrograms components administered separately.
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Because of decreased platelet aggregation caution is advised when using Arthrotec 75 with anti-coagulants. NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone. This activity is due to the presence of diclofenac, which has been shown to have anti-inflammatory and analgesic properties.
Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions. Arthrotec 75 is presented in cold-formed aluminium blisters in pack sizes of 10, 20, 30, 60, 90, 100 and 140 tablets. The toxic dose of Arthrotec 75 has not been determined and there is no experience of overdosage.
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2 Diarrhoea is usually mild to moderate and transient and can be minimised by taking Arthrotec 75 with food and by avoiding the use of predominantly magnesium-containing antacids. NSAIDs inhibit the synthesis of renal prostaglandin which plays a supportive role in the maintenance of renal perfusion in patients whose renal blood flow and blood volume are decreased. Patients appear to be at highest risk for these events early in the course of therapy, the onset of the event occurring in the majority of cases within the first month of treatment. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www. The most commonly observed adverse events are gastrointestinal in nature.
No accumulation of misoprostol acid was found in multiple-dose studies, and plasma steady state was achieved within 2 days. Patients with a known hypersensitivity to diclofenac, acetylsalicylic acid, other NSAIDs, misoprostol, other prostaglandins, or any other ingredient of the product. Extra supervision is recommended in haematopoietic disorders or in conditions with defective coagulation or in patients with a history of cerebrovascular bleeding. Inhibition of prostaglandin synthesis might adversely affect pregnancy. For the full list of excipients, see section 6. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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Cases of hypo and hyperglycaemia have been reported when diclofenac was associated with antidiabetic agents. No adjustment of dosage is necessary in the elderly or in patients with hepatic impairment or mild to moderate renal impairment as pharmacokinetics are not altered to any clinically relevant extent. Under fed conditions diclofenac Tmax is increased to 4 hours. Additionally, adverse drug reactions reported during post-marketing surviellance are whose frequency cannot be estimated from the available data, such as spontaneous reports, have been listed at frequency ‘unknown’. In the steady state comparisons under fasted conditions bioequivalence was demonstrable in terms of AUC. NSAIDs can reduce the efficacy of diuretics and other antihypertensive drugs, including ACE inhibitors, AIIA and beta-blockers.
Arthrotec 75 is indicated for patients who require the non-steroidal anti-inflammatory drug diclofenac together with misoprostol. Arthrotec 75 is contraindicated in pregnant women and in women planning a pregnancy because misoprostol induces uterine contractions and is associated with abortion, premature birth, and fetal death. In general, the potential effects on the infant from any exposure to misoprostol and its metabolites via breast feeding are unknown. Each tablet consists of a gastro-resistant core containing 75 mg diclofenac sodium surrounded by an outer mantle containing 200 micrograms misoprostol. There is a possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus. White, round, biconvex tablets marked ‘SEARLE’ over ‘1421’ on one side, and four times ‘A’ around the circumference with ’75’ in the centre on the reverse side.
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Concomitant use with other NSAIDs or with corticosteroids may increase the frequency of gastrointestinal ulceration or bleeding and of side effects generally. Intensification of the pharmacological effects may occur with overdosage. Pharmacodynamic studies with diclofenac have shown no potentiation of oral hypoglycaemic and anticoagulant drugs. The diclofenac component of Arthrotec 75 is indicated for the symptomatic treatment of osteoarthritis and rheumatoid arthritis. Under steady state conditions food decreases the misoprostol Cmax after Arthrotec 75 administration and slightly delays absorption, but the AUC is equivalent. In the table below the incidence of adverse drug reactions reported in controlled clinical studies where Arthrotec was administered to more than 2000 patients are listed.
In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss. Use of misoprostol has been associated with birth defects. As with other NSAIDs, metabolites of which are excreted by the kidney, patients with significantly impaired renal function should be more closely monitored. When diclofenac was administered with acetylsalicylic acid, the protein binding of diclofenac was reduced, although the clearance of the free diclofenac was not altered. The patient’s need for symptomatic relief and response to therapy should be re-evaluated periodically. Data from epidemiological studies suggest an increased risk of spontaneous abortion after use of prostaglandin synthesis inhibitors in early pregnancy.
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This characteristic response to E-series prostaglandins reverts to normal on discontinuation of the compound. Arthrotec may mask fever and thus an underlying infection. 200 micrograms given tds, both regimens providing a total daily dose of 150 mg diclofenac. Tablets should be swallowed whole, not chewed. NSAIDs may precipitate bronchospasm in patients suffering from, or with a history of bronchial asthma or allergic disease.
To email a medicine you must be a registered user. In the following conditions Arthrotec 75 should be used only in exceptional circumstances and with close clinical monitoring: advanced liver disease, severe dehydration. Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Magnesium-containing antacids have been shown to exacerbate misoprostol-associated diarrhoea. However, diarrhoea is a recognised side effect of misoprostol and could occur in infants of nursing mothers.
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Patients in whom, attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or other non-steroidal anti-inflammatory agents. There are no pharmacokinetic interactions between the two components, apart from a slight decrease in diclofenac sodium Cmax when administered concomitantly with misoprostol. When co-administered with ciclosporin, there is a two-fold increase in diclofenac systemic exposure. The safety and efficacy of Arthrotec 75 in children under 18 years has not been established.
Misoprostol in multiples of the recommended therapeutic dose in animals has produced gastric mucosal hyperplasia. Not all pack sizes may be marketed. Misoprostol is rapidly metabolised in the mother to misoprostol acid, which is biologically active and is excreted in breast milk.
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Arthrotec 75 is a non-steroidal, anti-inflammatory drug, which is effective in treating the signs and symptoms of arthritic conditions. Clinical signs that may indicate misoprostol overdose are sedation, tremor, convulsions, dyspnoea, abdominal pain, diarrhoea, fever, palpitations, hypotension, or bradycardia. The extent to which the metabolites may accumulate in patients with renal failure has not been studied. Steady state plasma lithium and digoxin levels may be increased and ketoconazole levels may be decreased. The label will state: ‘Not for use in pre-menopausal women unless using effective contraception’. Patients with severe renal and hepatic failure.
NSAIDs may attenuate the natriuretic efficacy of diuretics due to inhibition of intrarenal synthesis of prostaglandins. The terminal half-life is approximately 2 hours. Diclofenac is excreted in breast milk in very small quantities. If pregnancy is suspected, use of the product should be discontinued. Antacids may delay the absorption of diclofenac. In clinical trials, hepatitis has been observed in patients who received diclofenac, and in postmarketing experience, other hepatic reactions have been reported, including jaundice and hepatic failure.
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Reporting suspected adverse reactions after authorization of the medicinal product is important. With respect to administration of misoprostol, bioequivalence was demonstrated after a single dose of Arthrotec 75 or misoprostol administered alone. Also diclofenac may cause premature closure of the ductus arteriosus. The individual components show no evidence of carcinogenic potential.
Diclofenac metabolism is predominantly mediated via cytochrome P450 CYP2C9 in the liver. The misoprostol component of Arthrotec 75 is indicated for patients with a special need for the prophylaxis of NSAID-induced gastric and duodenal ulceration. AST elevations usually occur within 1-6 months. The pharmacokinetic profiles following oral administration of a single dose or multiple doses of diclofenac sodium and misoprostol administered as Arthrotec 75 are similar to the profiles when the two drugs are administered as separate tablets.