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- Pharmacology For Diclofenac Sodium + Misoprostol
Diclofenac Sodium + Misoprostol Pharmacology
Diclofenac Sodium + MisoprostolAbout Diclofenac Sodium + MisoprostolN/AMechanism of Action of Diclofenac Sodium + MisoprostolDiclofenac: Inhibits cyclooxygenase-1 (COX-1) & -2 (COX-2), thereby inhibiting prostaglandin synthesis.
Misoprostol: inhibits NSAID-induced ulcers
Pharmacokinets of Diclofenac Sodium + MisoprostolN/AOnset of Action for Diclofenac Sodium + MisoprostolN/ADuration of Action for Diclofenac Sodium + MisoprostolN/AHalf Life of Diclofenac Sodium + MisoprostolN/ASide Effects of Diclofenac Sodium + Misoprostol1.Diarrhea
3.Gas or heartburn
5.Menstrual irregularity or cramps
6.Stomach pain or cramps
Contra-indications of Diclofenac Sodium + MisoprostolN/ASpecial Precautions while taking Diclofenac Sodium + MisoprostolN/APregnancy Related InformationContraindicatedOld Age Related InformationUse with cautionBreast Feeding Related InformationContraindicatedChildren Related InformationContraindicatedIndications for Diclofenac Sodium + MisoprostolTreatment of signs and symptoms of osteoarthritis and rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications.Interactions for Diclofenac Sodium + MisoprostolN/ATypical Dosage for Diclofenac Sodium + MisoprostolOsteoarthritis:50 mg/200 mcg (diclofenac/misoprostol; 1 tablet) PO TID
If patient intolerant to TID dosing, reduce to 1 tablet BID
Rheumatoid Arthritis:50 mg/200 mcg (diclo/miso; 1 tablet) PO TID-QID
If patient intolerant to TID dosing, reduce to 1 tablet BID
Schedule of Diclofenac Sodium + MisoprostolN/AStorage Requirements for Diclofenac Sodium + MisoprostolThe tablets should be kept at room temperature, 15-30 C.Effects of Missed Dosage of Diclofenac Sodium + MisoprostolN/AEffects of Overdose of Diclofenac Sodium + MisoprostolN/A
Diclofenac SodiumAbout Diclofenac SodiumN/AMechanism of Action of Diclofenac SodiumDiclofenac possess analgesic, anti-inflammatory and antipyretic action. It inhibits the enzyme cyclo-oxygenase and there by inhibits the synthesis of Prostaglandins (PGs). It is more potent against cyclo-oxygenase-2 enzyme as compared to other NSAIDs like Indomethacin, Naproxen etc. It reduces intracellular concentrations of free arachidonic acid in leukocyte by altering its release or uptake. .Pharmacokinets of Diclofenac SodiumAbsorption: Diclofenac sodium is rapidly absorbed after oral administration. It undergoes first pass metabolism and its bioavailability is 50 % only. Distribution: It is distributed in highly protein bound form. Metabolism: Diclofenac sodium is metabolised in the liver. Excretion: Drug and metabolites are primarily excreted in urine and some amount in the bile.Onset of Action for Diclofenac Sodium1- 4.5 hoursDuration of Action for Diclofenac SodiumHoursHalf Life of Diclofenac Sodium2 hoursSide Effects of Diclofenac Sodium1.Nausea
9.Ulceration of the stomach or intestine
Contra-indications of Diclofenac Sodium1.Hypersensitivity to Indomethacin and other Non steroidal anti inflammatory drugs(NSAID)
Special Precautions while taking Diclofenac Sodium1.Hepatic impairment
4.Blood clotting disorders
8.Cautioned against driving, operating or activities requiring concentration
Pregnancy Related InformationContraindicatedOld Age Related InformationUse with cautionBreast Feeding Related InformationContraindicatedChildren Related InformationUse with caution
CHILDREN below 14: contraindicatedIndications for Diclofenac Sodium1.Ankylosing spondylitis
3.Joint disorders e.g. inflammatory disease in joints, crystal deposition in the joints
5.For the relief of pain and inflammation in dental minor surgery and orthopedic
7.Juvenile chronic arthritis
Interactions for Diclofenac SodiumLithium & Digoxin : Blood levels of lithium and digoxin increased leading to enhanced efficacy and posible toxicity.
Diuretics : Inhibits diuretics but efficacy of potassium sparing diuretics enhanced.
Methotrexate : Toxicity enhanced.
Salicylates : Efficacy of salicylates reduced.
Cyclosporine : Increases nephrotoxicity of both agents.
Hydantoins : Increases serum levels resulting in toxicity.
Typical Dosage for Diclofenac SodiumAdult: 100 - 150 mg / day in 2 - 3 divided doses.
For the relief of pain, Migraine, Dysmenorrhoea: 150 mg / day in 3 divided doses.
Osteoarthritis: 50 mg 2 - 3 times daily
Rheumatoid arthritis: 150 - 200 mg / day in 3 - 4 divided doses.
Ankylosing spondylitis: 25 mg 4 times daily give an extra dose of 25 mg at bed time if necessary.
Children Juvenile rheumatoid arthritis: 0.5 - 2 mg / kg body weight / day in divided doses.
Maximum dose: 3 mg / kg body weight / day in divided doses
Schedule of Diclofenac SodiumHStorage Requirements for Diclofenac SodiumStore Diclofenac sodium at room temperature in a tightly closed light resistant container.Effects of Missed Dosage of Diclofenac SodiumTake the missed dose as soon as noticed and if it is the time for next dose then skip the missed dose. Continue the regular schedule. Do not double the dose.Effects of Overdose of Diclofenac SodiumGive supportive measures and symptomatic treatment. Drug can be removed from the body by gastric lavage or by inducing emesis. Absorption of the drug can be reduced by administration of activated charcoal.
MisoprostolAbout MisoprostolA synthetic prostaglandin E1 (PGE1) analogue, Anti ulcer(antisecretory and protective),Abortifacient.Mechanism of Action of MisoprostolMisoprostol is a synthetic Prostaglandin E1 analog. It binds to the EP3 receptor on the basolateral membrane of the parietal cells and stimulates the inhibitory G protein (Gi) receptors. This will leads to decrease in intracellular cyclic AMP level and inhibits proton pump (H+K+ATPase) which exchange the extracellular K+ for intracellular H+ ion. By inhibiting the proton pump Misoprostol decreases gastric acid secretion. Misoprostol also binds to the EP3 receptor on the superficial epithelial cells of the lumen and stimulates the mucin and bicarbonate secretion and decreases nocturnal, basal and stimulated gastric acid secretion.Pharmacokinets of MisoprostolAbsorption: Misoprostol is well absorbed after oral administration. Distribution: It is distributed in the body in protein bound form. Metabolism: Misoprostol is rapidly undergoes de-esterification and form active metabolite Misoprostol acid. Excretion: Metabolite is excreted mainly in the urine and small amount in the faeces.Onset of Action for Misoprostol30 minutesDuration of Action for Misoprostol3 hoursHalf Life of Misoprostol20 - 40 minutesSide Effects of Misoprostol1.Nausea
Contra-indications of Misoprostol1.Hypersensitivity to Misoprostol and other ProstaglandinsSpecial Precautions while taking Misoprostol1.Cardiovascular disease
Pregnancy Related InformationContraindicatedOld Age Related InformationUse with cautionBreast Feeding Related InformationContraindicatedChildren Related InformationContraindicated
Indications for Misoprostol1.NSAID induced ulcer
Interactions for MisoprostolAnalgesics: Increased risk of CNS toxicity with phenylbutazone.
Typical Dosage for MisoprostolAdult: NSAID induced ulcer: 200mcg 4 times daily with meals and at bed time for atleast1 month and up to 2 month.
Duodenal ulcer, Gastric ulcer: 400 - 800 mcg/ day in 4 divided doses with meals and at bed time for 1 - 2 month.
Children: not recommended
Schedule of MisoprostolN/AStorage Requirements for MisoprostolStore at 15 - 30 degree C in a tightly closed container. Protect from light.Effects of Missed Dosage of MisoprostolTake the missed dose as soon as noticed and if it is the time for next dose then skip the missed dose. Continue the regular schedule. Do not double the dose.Effects of Overdose of MisoprostolGive supportive measures and symptomatic treatment.
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