Details About Generic Salt ::  Diclofe1

Main Medicine Class:: Analgesic,Non-narcotic analgesic combination   

(die-KLOE-fen-ak SO-dee-uhm my-so-PRAHST-ole)
Arthrotec
Class: Analgesic/Non-narcotic analgesic combination

 

Drugs Class ::

 Action Diclofenac, a non-steroidal anti-inflammatory drug, decreases inflammation, pain, and fever, probably through inhibition of cyclooxygenase activity and prostaglandin synthesis. Misoprostol, a GI mucosal protective prostaglandin E1 analog, provides gastric antisecretory and mucosal protective properties.

Indications for Drugs ::

 Indications Treatment 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.

Drug Dose ::

 Route/Dosage

Osteoarthritis

ADULTS: PO 50/200 (50 mg diclofenac/200 mg misoprostol) tid, or 50/200 bid or 75/200 (75 mg diclofenac/200 mg misoprostol) bid for patients experiencing intolerance. Take with meals.

Rheumatoid Arthritis

ADULTS PO 50/200 tid, qid, or 50/200 bid or 75/200 bid for patients experiencing intolerance. Take with meals.

Contraindication ::

 Contraindications Pregnancy; sensitivity to aspirin or any NSAID; sensitivity to misoprostol or other prostaglandins; history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.

Drug Precautions ::

 Precautions

Pregnancy: Category X. Lactation: Diclofenac — Excreted in breast milk. Misoprostol — Undetermined. Children: Safety and efficacy in children < 18 not established. Women of childbearing potential: Contraindicated in pregnant women because of abortifacient properties. Avoid in women of childbearing potential unless patient requires NSAIDs and is at high risk of complications from gastric ulcers associated with use of NSAIDs. If used in women of childbearing potential, patient should be capable of complying with effective contraceptive measures; have received oral and written warnings of the hazards of misoprostol, risk of possible contraception failure and danger to other women of childbearing potential should drug be taken by mistake; have a negative serum pregnancy test within 2 wks prior to starting therapy; and will begin therapy only on the second or third day of the next menstrual period. Elderly: Increased risk of adverse reactions. GI effects: NSAIDs may cause serious GI toxicity (eg, bleeding, ulceration, perforation) which can occur at any time, with or without warning symptoms. Renal effects: NSAIDs may cause further decrease in renal function in patients with preexisitng renal impairment. Use is not recommended in patients with advanced kidney disease. Hepatic effects: Diclofenac can cause hepatitis, usually within the first 2 months of therapy. Monitor liver enzymes within 4 to 8 wks after initiating treatment. Asthma: NSAIDs may precipitate bronchospasm in some patients with asthma. Hematologic disorders: NSAIDs interfere with platelet function and vascular response to bleeding; use with caution in patients with coagulation disorders or receiving anticoagulants. Fluid retention: NSAIDs may cause fluid retention and edema; use with caution in patients with fluid retention, hypertension, or heart failure.

PATIENT CARE CONSIDERATIONS


Drug Side Effects ::

 Adverse Reactions

GI: Abdominal pain; diarrhea; dyspepsia; nausea; flatulence. GU: Postmenopausal vaginal bleeding (misoprostol).

Drug Mode of Action ::  

 Action Diclofenac, a non-steroidal anti-inflammatory drug, decreases inflammation, pain, and fever, probably through inhibition of cyclooxygenase activity and prostaglandin synthesis. Misoprostol, a GI mucosal protective prostaglandin E1 analog, provides gastric antisecretory and mucosal protective properties.

Drug Interactions ::

 Interactions

Antihypertensive agents: May inhibit activity of antihypertensives. Aspirin: May reduce serum diclofenac concentrations. Cyclosporine: May increase nephrotoxicity. Digoxin: May increase serum digoxin concentrations. Lithium: May decrease lithium clearance, increasing lithium concentrations. Magnesium-containing antacids: May increase incidence of diarrhea. Methotrexate: May increase methotrexate levels. Warfarin: May increase risk of gastric erosion and bleeding.

Drug Assesment ::

 Assessment/Interventions

  • Review patient history, including drug history.
  • If patient is female and of childbearing age, determine the following: if the patient is willing and able to comply with effective contraceptive measures; if the patient has had a negative serum pregnancy test within two wks, prior to beginning treatment; if the patient has received both written and oral warnings of the hazards of misoprostol, risk of possible contraception failure, and danger to other women of childbearing age if the medicine is taken by mistake; if the patient will begin therapy on the second or third day of her next normal menstrual period.
  • Note possible drug interactions and take appropriate action.
  • Do not administer if patient is allergic to NSAIDs or aspirin.
  • Do not administer to patients with aspirin-sensitive asthma or hepatic porphyria. Administer with caution to patients with preexisting asthma.
  • Assess hydration status of patient, rehydrate before beginning therapy.
  • Assess patients for signs and symptoms of decreased renal blood flow (eg, decreased urine output, increased serum creatine), which might precipitate renal decompensation. Patients at greater risk include those with impaired renal function, heart failure, impaired liver function, those taking diuretics and ACE inhibitors, and the elderly.
  • Monitor chemistry profile and CBC of patients on long-term therapy.
  • Assess patient on long-term therapy for anemia. If symptoms are present, hemoglobin and hematocrit should be checked and appropriate therapy instituted.
  • Carefully monitor patients with coagulation disorders or those on anticoagulants for signs of bleeding or bruising.
  • Administer with caution to any patient with a history of cardiac decompensation, hypertension, or other conditions predisposing to fluid retention. Assess patient for signs of edema or fluid retention (eg, pulmonary rales, dyspnea, weight gain, swelling).
OVERDOSAGE: SIGNS & SYMPTOMS
  Diclofenac — Acute renal failure, drowsiness, nausea, vomiting. Misoprostol — Abdominal pain, bradycardia, diarrhea, dyspnea, fever, hypotension, palpitations, sedation, seizure, tremor.

Drug Storage/Management ::

 Administration/Storage

  • Administer tablet whole; do not crush or dissolve.
  • Administer with meals.
  • Do not coadminister with magnesium-containing antacids to minimize incidence of diarrhea.
  • Do not give to pregnant or nursing women. Should not be used routinely in women of childbearing age, unless benefits outweigh the risks.
  • Store tablets at room temperature. Protect from moisture.

Drug Notes ::

 Patient/Family Education

  • Provide patient information pamphlet.
  • Caution female patients not to take this medicine if they are pregnant and to take measures to prevent pregnancy while they are on this drug. If a patient suspects she is pregnant, she should stop taking the drug and contact her primary care giver immediately.
  • Instruct patient to report any signs or symptoms of GI ulceration or bleeding, skin rash, weight gain, or swelling.
  • Instruct patient not to take drug and seek immediate medical attention if signs of liver toxicity occur, including nausea, fatigue, lethargy, itching, jaundice, right upper quadrant tenderness, or flu-like symptoms.
  • Caution nursing mothers to discontinue breastfeeding due to potential harm to the baby.
  • Tell patient that diarrhea, abdominal pain, upset stomach, and nausea may develop during first few wks of therapy and usually stop after about a wk of continued treatment. To minimize diarrhea, take with meals and avoid antacids containing magnesium. If difficulty persists for > 7 days or if symptoms become severe, patient should notify primary care giver.
  • Instruct patients to swallow pill whole; do not crush, chew, or dissolve.

Disclaimer ::

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