Diclofenac Potassium Tablets
Each film coated tablet contains:
Diclofenac Postssium BP 50 mg
Approved colour used.
TOPFENAC is antirheumatics (anti-inflammatory Agents). It’s chemical formula is C14H10CI2KNO2 and molecular weight 334.2.
TOPFENAC is commonly used non-steroidal, anti-inflammatory drug (NSAID’s). It has analgesic, antipyretic and anti-inflammatory action. TOPFENAC is an inhibitor of cycloxygenasealso appears to reduce intracellular concentrations of the arachidonate in leukocytes.
Lithium & Digoxin: Blood levels of lithium and digoxin increased leading to enhance efficacy and possible toxicity.
Diuretics: Inhibits diuretics but efficacy of potassium sparing diuretics enhanced.
Methotrexate: Toxicity enhanced.
Salicylates: Efficacy of salicylates reduced.
Cyclosporine: Increases nephroloxicity to both agents.
Hydantoins: Increases serum levels resulting in toxicity.
INDICATIONS & DOSAGE
Usual Adult Dose
a. For Osteoarthritis: 50 mg orally 2 to 3 times or 75 mg orally twice a day. Doses greater than 150 mg/day are not recommended for Osteoarthritis.
b. For Dysmenorrhoea: 50 mg orally 3 times a day. In some patients an initial dose of 100 mg of diclofenac potassium, followed by 50 mg doses, will provide better relief, After the first day the daily dose should generally not exceed 150 mg
c. For Pain: 50 mg orally 3 times a day. In some patients an initial dose of 100 mg of diclofenac potassium, followed by 50 mg doses, will provide better relief. After the first day, the daily dose should generally not exceed 150 mg.
d. For Rheumatoid Arthritis: 50 mg orally 3 to 4 times a day or 75 mg orally twice a day.
Doses greater than 225 mg/day are not recommended for Rheumatoid Arthritis.
USUAL PEDIATRIC DOSE FOR PAIN
Children aged 12 years and over, 2 to 3 mg/day orally in divided doses 2 to 4 times daily.
Maximum dose : 200 mg daily.
USUAL GERIATRIC DOSE
A lower dose may be used as advised by your doctor.
Not recommended or as directed by the physician.
TOPTENAC is contra-indicated in patients with known hypersensitivity to diclofenac and in patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. TOPFENAC is absolutely contra-indicated in patients with peptic ulceration or a history of such ulceration and should be used with caution in patients with renal or hepatic insufficiency. TOPFENAC is contraindicated in the test trimester.
PREGNANCY AND LACTATION
Safety of TOPFENAC in human pregnancy and lactation has not been established. Regular use of NSAID’s during the trimester of pregnancy may result in premature closure of the foetal ductus artenosus in utero and possibly in persistent pulmonary hypertension of the newborn. The onset of labour may be delayed and its duration increased. TOPFENAC should not be used during pregnancy and lactation.
TOPFENAC should be given under close medical supervision to patients prone to gastro-intestinal tract irritation particularly those with a history of peptic ulcer, diverticulosis or other inflammatory disease of the gastrointestinal tract (such as ulceractive colitis or Crohn’s disease). Medical supervision is also required for patients with pre-existing dyshematopoiesis or disorders of blood coagulation. TOPFENAC should be used with caution in patients with hepatic or renal insufficiency. Serious interactions have been reported with the concomitant use of diclofenac and methotrexate. TOPFENAC should be given in reduced dose in elderly patients.
Nausea, vomiting, epigastric discomfort, skin rash, peptic ulcer, fluid retention, oedema, impairment of hepatic function rarely.
Impairment of hepatic, renal or cardiac function. Blood coagulation disorders, Recent proctitis, Gastrointestinal disorders.
Symptoms TOPFENAC overdose are limited lethargy drowsiness, nausea, vomiting and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of TOPFENAC Management of acute poisoning with TOPENAC essentially consists of supportive and symptomatic measures. It is reasonable to take measures to reduce absorption of any recently consumed drug by forced emesis, gastric lavage and activated charcoal.
Store in cool and dry place. Protect from light.
Keep all medicines out of reach of children.
1 x 10, 1 x 12 & 10 x 10 Tablets in box.
NAFDAC REGN. NO.: B4-4541
Glow Pharma Pvt. Ltd.
Factory: Gokhiware, Vasai (E),Dist. Palghar -401 208.
Regd office: Jogeshwari (E), Mumbai – 400 060. India.
Marketed in Nigeria by
AGAPE LINK INNOVATION’S LTD.
26, Shekoni Street, Coker Village,
Orile Iganmu, Lagos State, Nigeria.