DICLOGEN Diclofenac Sodium 25mg/ mL (75mg / 3mL) Solution for IM Injection 3mL 5's
RXDRUG-DRP-5697
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Features
Brand
Diclogen
Full Details
Dosage Strength
25 mg / ml ( 75 mg / 3 ml)
Drug Ingredients
- Diclofenac
Drug Packaging
Solution for Injection (I.M.) 3ml x 5's
Generic Name
Diclofenac Sodium
Dosage Form
Solution for Injection (I.M.)
Registration Number
DRP-5697
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
Relief of signs and symptoms of acute and chronic rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. Painful posttraumatic and postoperative inflammation and swelling. Pain following dental surgery. Acute attacks of gout. Painful gynecological conditions.
Dosage/Direction for Use
Tablet: Adults: Moderate to Severe Acute Pain: 100-150 mg in 2-3 divided doses.
Injection: Recommended Dose: 1 ampule once daily or, if required in severe cases, twice daily, injected deep intragluteally. It should not be mixed with other solutions for injection. It should not be given >2 days.
Elderly: The usual adult dosage may be used.
Injection: Recommended Dose: 1 ampule once daily or, if required in severe cases, twice daily, injected deep intragluteally. It should not be mixed with other solutions for injection. It should not be given >2 days.
Elderly: The usual adult dosage may be used.
Administration
Should be taken with food: Take immediately after meals.
Contraindications
Hypersensitivity to diclofenac sodium and to other components of Diclogen. Patients in whom drugs eg, aspirin and other NSAIDs precipitate attacks of asthma, urticaria or acute rhinitis. Tablet: Gastric or intestinal ulcer. Patients w/ hemorrhagic diathesis. Injection: It should not be given to patients with peptic ulcer.
Special Precautions
Tablet: History of cardiac decompensation, hypertension or other conditions predisposing to fluid retention. Injection: Strict accuracy of diagnosis and close medical surveillance are imperative in patients with symptoms indicative of gastrointestinal disorder, with a history suggestive of gastrointestinal ulceration with ulcerative colitis or with Crohn's disease and in patients suffering from impairment of hepatic function. If peptic ulceration or gastrointestinal bleeding occur in patients receiving Diclogen solution for injection, treatment should be withdrawn.
Adverse Reactions
Gastric ulcer, gastrointestinal hemorrhage, headache. Tablet: Epigastric pain, nausea, diarrhea & slight dizziness. Injection: Blood dyscrasias, gastrointestinal disturbances and bleeding, peptic ulcer, hepatic and renal abnormalities, dizziness, rash, pruritus, peripheral edema.
Storage
Store at temperatures not exceeding 30°C.
Shelf-Life: 36 months.
Shelf-Life: 36 months.
Action
Pharmacology: Pharmacodynamics: Diclofenac sodium has analgesic, anti-inflammatory, antirheumatic and antipyretic activities. It is a nonsteroidal cyclooxygenase inhibitor. Diclofenac is metabolized in the liver to 4-hydroxy-diclofenac and other hydroxylated forms after glucuronidation and sulphation the metabolites are excreted in the urine (65%) and bile (5%).
Pharmacokinetics: Injection: Peak plasma concentration attained 10-22 min after a dose of Diclogen solution for injection. The mean terminal elimination t½ of the unchanged medicine is 1-2 hrs. Approximately 65% of the dose administered is excreted via the kidneys in the form of metabolites, and <1% in unchanged form. About 35% of the dose is excreted in metabolized form in the feces.
Pharmacokinetics: Injection: Peak plasma concentration attained 10-22 min after a dose of Diclogen solution for injection. The mean terminal elimination t½ of the unchanged medicine is 1-2 hrs. Approximately 65% of the dose administered is excreted via the kidneys in the form of metabolites, and <1% in unchanged form. About 35% of the dose is excreted in metabolized form in the feces.
MedsGo Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
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