Diclofenac TR 100mg Capsule

Indications: Diclofenac TR 100mg Capsule is indicated for the relief of pain and inflammation associated with:

• Rheumatoid arthritis
• Osteoarthritis
• Ankylosing spondylitis
• General pain (including backaches, muscle aches, dental pain)
• Migraine
• Dysmenorrhea (menstrual cramps)
• Acute gout
• Inflammation (general)
• Renal colic
• Tendinitis
• Bursitis

Administration:

• Should be taken with food.
• Take immediately after meals.

Adult Dose (Oral, specifically TR Capsule):

• Extended release: 100 mg orally once daily.

Pharmacology (Mode of Action): Diclofenac, a phenylacetic acid derivative, is a prototypical Non-Steroidal Anti-Inflammatory Drug (NSAID). It has potent anti-inflammatory, analgesic (pain-relieving), and antipyretic (fever-reducing) actions. It works by reversibly inhibiting the enzyme cyclooxygenase (COX), which leads to a reduced synthesis of prostaglandin precursors. Prostaglandins are chemicals in the body that cause inflammation, pain, and fever.

Contraindications:

• Hypersensitivity to Diclofenac or any of its ingredients.
• Patients with active or suspected peptic ulcer or gastrointestinal bleeding.
• Patients in whom attacks of asthma, urticaria (hives), or acute rhinitis are triggered by aspirin or other NSAIDs that inhibit prostaglandin synthetase.
• (Due to Lidocaine, if present in other formulations, though not explicitly stated for TR 100mg capsule: Hypersensitivity to local anesthetics of the amide type; however, this incidence is very rare.)

Precautions & Warnings:

• Exercise caution in patients with a history of gastrointestinal ulceration, hematemesis (vomiting blood), melaena (black, tarry stools), ulcerative colitis, Crohn's disease, bleeding diathesis, or hematological abnormalities.
• Use with caution in patients with asthma or a history of asthma.
• Patients with severe hepatic (liver), cardiac (heart), or renal (kidney) insufficiency, or elderly individuals, should be kept under close surveillance.
• Patients with current or previous high blood pressure (hypertension) should be closely monitored.
• All patients on long-term NSAID treatment should be monitored as a precautionary measure (e.g., renal function, hepatic function, and blood counts).
• If abnormal liver function tests persist or worsen, or if clinical signs and symptoms consistent with liver disease develop, or if other manifestations occur, Diclofenac sodium should be discontinued.
• Use of Diclofenac in patients with hepatic porphyria may trigger an attack.

Side Effects: Side effects are usually mild, transient, and generally well tolerated.

• Common (especially at start): Gastrointestinal discomfort, epigastric pain, eructation (belching), nausea, diarrhea, headache.
• Occasionally: Skin rash, peripheral edema (swelling), abnormalities of serum transaminase (liver enzymes).
• Rarely: Activation of peptic ulcer, hematemesis or melena, blood dyscrasia (extensive usage).
• Isolated reports of anaphylactoid reactions (severe allergic reactions) have occurred.

Pregnancy & Lactation:

• Pregnancy:
  • Published literature reports that NSAID use after 30 weeks’ gestation increases the risk of premature closure of the fetal ductus arteriosus.
  • Data from observational studies regarding potential embryofetal risks of NSAID use (including diclofenac) in the first or second trimester are inconclusive.
  • Avoid use of NSAIDs in pregnant women starting at 30 weeks of gestation (third trimester).
• Infertility:
  • Based on its mechanism of action (prostaglandin-mediated NSAIDs), use may delay or prevent rupture of ovarian follicles, potentially leading to reversible infertility in some women.
  • Consider withdrawing NSAIDs in women experiencing difficulties conceiving or undergoing infertility investigation.
• Lactation:
  • Small amounts of diclofenac have been reported in human milk (from oral preparations).
  • There are no data on effects on the breastfed infant or on milk production.
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from treatment or underlying maternal condition.
  • Not recommended during lactation based on other available information (though this text states "Excreted in breast milk; not recommended").

Interactions:

• May increase serum levels of methotrexate.
• Concomitant use with other NSAIDs or anticoagulants (e.g., warfarin) is associated with a higher risk of GI bleeding.
• Increased risk of nephrotoxicity (kidney damage) with ciclosporin or triamterene.
• May increase the risk of developing corneal complications in patients with significant pre-existing corneal inflammation when used concomitantly with ophthalmic preparations containing corticosteroids.
• Colestyramine and colestipol reduce the bioavailability of diclofenac.
• Decreased plasma concentration when administered after sucralfate.
• Ophthalmic application of diclofenac may reduce the efficacy of ophthalmic acetylcholine and carbachol.
• May increase serum levels of lithium and digoxin.