Difnac is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and other symptoms of arthritis of the joints (eg, osteoarthritis), such as inflammation, swelling, stiffness, and joint pain. However, Difnac does not cure osteoarthritis and will help you only as long as you continue to use it.
Difnac topical 3% gel is also used to treat actinic keratosis, a skin problem that may become cancerous if not treated. The exact way that topical Difnac helps this condition is unknown.
Difnac topical solution is used to treat pain and swelling caused by osteoarthritis of the knees.
Difnac topical patch is used to treat acute pain caused by minor strains, sprains, and contusions (bruises).
Difnac is available only with your doctor's prescription.
Difnac indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Intramuscular
Renal colic
Adult: As Difnac: 75 mg, may repeat once after 30 min if needed. Max: 150 mg/day. Max period: 2 days.
Intramuscular
Bursitis, Pain and inflammation associated with musculoskeletal and joint disorders, Rheumatoid arthritis, Sprains, Strains, Tendinitis, Acute gout, Dysmenorrhoea
Adult: As Difnac: 75 mg once daily, injected into the gluteal muscle, may increase to 75 mg bid in severe conditions. Max period: 2 days.
Intravenous
Postoperative pain
Adult: As Difnac: 75 mg infusion in glucose 5% or NaCl 0.9% (previously buffered w/ Na bicarbonate) given over 30-120 min or as bolus inj, may repeat after 4-6 hr if necessary. Max period: 2 days.
Intravenous
Prophylaxis of postoperative pain
Adult: As Difnac: Initially, 25-50 mg infusion given after surgery over 15-60 min followed by 5 mg/hr. Alternatively, initial dose may be given as bolus inj over 5-60 sec followed by additional inj, may repeat after 4-6 hr if necessary. Max: 150 mg/day. Max period: 2 days.
Ophthalmic
Postoperative ocular inflammation
Adult: As Difnac (0.1% soln): Instill into the appropriate eye 4 times daily starting 24 hr after surgery for up to 28 days.
Ophthalmic
Inflammation and discomfort after strabismus surgery
Adult: As Difnac (0.1% soln): Instill 1 drop 4 times daily for the 1st wk; then tid in the 2nd wk, bid in the 3rd wk, and as required for the 4th wk.
Ophthalmic
Pain and discomfort after radial keratotomy
Adult: As Difnac (0.1% soln): Instill 1 drop before surgery followed by 1 drop immediately after surgery, and then 1 drop 4 times daily for up to 2 days.
Ophthalmic
Pain after accidental trauma
Adult: As Difnac (0.1% soln): Instill 1 drop 4 times daily for up to 2 days.
Ophthalmic
Control of inflammation after argon laser trabeculoplasty
Adult: As Difnac (0.1% soln): Instill 1 drop 4 times during the 2 hr before procedure followed by 1 drop 4 times daily, up to 7 days after procedure.
Ophthalmic
Prophylaxis of intra-operative miosis
Adult: As Difnac (0.1% soln): Instill into appropriate eye 4 times w/in 2 hr before surgery.
Ophthalmic
Post-photorefractive keratectomy pain
Adult: As Difnac (0.1% soln): Instill into the affected eye twice, an hr before surgery, then 1 drop twice at 5-min intervals immediately after surgery, then every 2-5 hr while awake for up to 24 hr.
Ophthalmic
Seasonal allergic conjunctivitis
Adult: As Difnac (0.1% soln): Instill 1 drop before surgery followed by 1 drop immediately after surgery, and then 1 drop 4 times daily for up to 2 days.
Oral
Bursitis, Pain and inflammation associated with musculoskeletal and joint disorders, Rheumatoid arthritis, Sprains, Strains, Tendinitis, Acute gout, Dysmenorrhoea
Adult: As Difnac: 75-150 mg/day in divided doses. Max: 150 mg/day.
Oral
Migraine
Adult: As Difnac K: Initially, 50 mg taken at the 1st sign of an attack, an additional dose of 50 mg may be taken after 2 hr if symptoms persist. If needed, further doses of 50 mg may be taken 4-6 hrly. Max: 200 mg/day.
Rectal
Acute gout, Bursitis, Dysmenorrhoea, Pain and inflammation associated with musculoskeletal and joint disorders, Rheumatoid arthritis, Sprains, Strains, Tendinitis
Adult: As Difnac: 100 mg once daily.
Topical/Cutaneous
Actinic keratoses
Adult: As Difnac (3% gel): Apply bid for 60-90 days.
Topical/Cutaneous
Osteoarthritis
Adult: As Difnac (1.6% soln): Apply in small amounts (20 or 40 drops) onto affected area 4 times daily. As Na: (1% gel): Apply to the affected area 4 times daily. Max: 32 g/day over the affected area.
Topical/Cutaneous
Local symptomatic relief of pain and inflammation
Adult: As Difnac (1% gel): Apply onto affected area 3 or 4 times daily.
Transdermal
Acute pain
Adult: Sprains, strains, contusions: 1 patch bid.
How should I use Difnac?
Use Difnac solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Difnac solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Difnac solution refilled.
Do not apply Difnac solution to infected skin; open wounds; or red, swollen, or peeling skin.
Wash your hands immediately before and after using Difnac solution.
Wash the affected area and dry completely before using Difnac solution.
To apply Difnac solution, dispense 10 drops at a time onto the knee or into your hand. Spread Difnac solution evenly around the front, back, and sides of the knee. Repeat until you have used the whole dose.
Be sure that you cover your entire knee with your dose of Difnac solution. Do not use more than the recommended amount.
Do not apply sunscreens, cosmetics, insect repellants, other topical medicines, or any other substance to the treated area until it is completely dry.
Do not put on clothes over the treated area until it is completely dry.
Do not wrap, bandage, or apply heat to the treated area.
Let the treated skin dry before touching it or letting it touch anyone else's skin.
Do not shower, bathe, or wash the treated area for at least 30 minutes after you use Difnac solution.
If you miss a dose of Difnac solution, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Difnac solution.
Uses of Difnac in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Difnac is used to relieve pain from various conditions. This form of Difnac is used to treat migraine headaches. Difnac is a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This medication may also be used to treat gout attacks.
How to use Difnac
Read the Medication Guide provided by your pharmacist before you start taking Difnac and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth as directed by your doctor. Empty the contents of one packet into a cup containing 1 to 2 ounces (30 to 60 milliliters) of water. Mix well and drink all of it right away. Do not mix with any liquid other than water. If stomach upset occurs while taking this medication, take it with food, milk, or an antacid. However, if you take this medication with a meal high in fat, it may not work as well.
There are different brands and forms of this medication available. Because different forms do not have the same effects at equal strengths, do not switch forms of Difnac unless your doctor tells you to.
To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose. Do not increase your dose or take it more often than prescribed.
Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.
Tell your doctor if your condition persists or worsens.
Difnac description
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The active substance is sodium-[o[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (= Difnac sodium).
Each enteric tablet contains 25 mg or 50 mg of Difnac sodium.
One prolonged-release tablet contains 100 mg of Difnac sodium.
Injection: Each ampoule also contains the following excipients: Mannitol, sodium metabisulfite (E223), benzyl alcohol, propylene glycol, water for injection, sodium hydroxide.
Difnac dosage
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General Dosing Instructions
Carefully consider the potential benefits and risks of Difnac and other treatment options before deciding to use Difnac. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
The effectiveness of Difnac when taken with food has not been studied in clinical studies. Taking Difnac with food may cause a reduction in effectiveness compared to taking Difnac on an empty stomach.
Acute Pain
For management of mild to moderate acute pain, the dosage is 18 mg or 35 mg orally three times daily.
Osteoarthritis Pain
For management of osteoarthritis pain, the dosage is 35 mg orally three times daily.
Dosage Adjustments in Patients with Hepatic Impairment
Patients with hepatic disease may require reduced doses of Difnac compared to patients with normal hepatic function. As with other Difnac products, start treatment at the lowest dose. If efficacy is not achieved with the lowest dose, discontinue use.
Non-Interchangeability with Other Formulations of Difnac
Difnac capsules are not interchangeable with other formulations of oral Difnac even if the milligram strength is the same. Difnac capsules contain Difnac free acid whereas other Difnac products contain a salt of Difnac, i.e., Difnac potassium or sodium. A 35 mg dose of Difnac is approximately equal to 37.6 mg of sodium Difnac or 39.5 mg of potassium Difnac. Therefore, do not substitute similar dosing strengths of other Difnac products without taking this into consideration.
Aspirin: Concomitant administration of Difnac and aspirin is not recommended because Difnac is displaced from its binding sites during the concomitant administration of aspirin, resulting in lower plasma concentrations, peak plasma levels and AUC values.
Anticoagulants: While studies have not shown Difnac to interact with anticoagulants of the warfarin type, caution should be exercised, nonetheless, since interactions have been seen with other NSAIDs. Because prostaglandins play an important role in hemostasis and NSAIDs affect platelet function as well, concurrent therapy with all NSAIDs, including Difnac and warfarin, requires close monitoring of patients to be certain that no change in their anticoagulant dosage is required.
Digoxin, Methotrexate, Cyclosporine: Difnac, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Ingestion of Difnac may increase serum concentrations of digoxin and methotrexate and increase cyclosporine's nephrotoxicity. Patients who begin taking Difnac or who increase their Difnac dose or any other NSAID while taking digoxin, methotrexate or cyclosporine may develop toxicity characteristics for these drugs. They should be observed closely, particularly if renal function is impaired. In the case of digoxin, serum levels should be monitored.
Lithium: Difnac decreases lithium renal clearance and increases lithium plasma levels. In patients taking Difnac and lithium concomitantly, lithium toxicity may develop.
Oral Hypoglycemics:
Difnac does not alter glucose metabolism in normal subjects nor does it alter the effects of oral hypoglycemic agents. There are rare reports, however, from marketing experiences, of changes in effects of insulin or oral hypoglycemic agents in the presence of Difnac that necessitated changes in the doses of such agents. Both hypo- and hyperglycemic effects have been reported. A direct causal relationship has not been established, but physicians should consider the possibility that Difnac may alter a diabetic patient's response to insulin or oral hypoglycemic agents.
Diuretics: Difnac and other NSAIDs can inhibit the activity of diuretics. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels.
Other Drugs: In small groups of patients (7-10/interaction study), the concomitant administration of azathioprine, gold, chloroquine, D-penicillamine, prednisolone, doxycycline or digitoxin did not significantly affect the peak levels and AUC values of Difnac. Phenobarbital toxicity has been reported to have occurred in a patient on chronic phenobarbital treatment following the initiation of Difnac therapy.
There have been cases reported of Difnac being associated with the development of symptoms resembling the syndrome of inappropriate antidiuretic hormone secretion in elderly women. A patient who had been taking Difnac for several years and had increasingly complained of dry, gritty eyes noticed that eye irritation disappeared within 3 days when Difnac had to be discontinued because of GI effects.
The most frequent adverse effects reported in patients given Difnac are GI in nature. Typical reactions include epigastric pain, nausea, vomiting and diarrhoea. Rarely, peptic ulcer and GI bleeding have occurred. Difnac has also been implicated as the causative agent in colonic ulceration, small bowel perforation and pseudomembranous colitis.
Renal papillary necrosis and nephritic syndrome have been reported in patients taking Difnac. Elevations of serum aminotransferase activity and clinical hepatitis, including fetal fulminant hepatitis have occurred in patients taking Difnac. Self-limiting skin reaction eg, rash or pruritus may occur in patients given Difnac.
Aspirin-sensitive asthmatic patients have developed reactions (rhinorrhoea, tightness of chest, wheezing, dyspnoea) when challenged with Difnac in doses of 10-25 mg and the CMS in the UK have received a report of 1 aspirin-sensitive patient who died from acute asthma 4 hrs after a single 25-mg dose of Difnac.
Hypersensitivity to Difnac sodium or to any of the excipients of Difnac.
Active gastric or intestinal ulcer, bleeding or perforation.
Last trimester of pregnancy.
Hepatic, renal and severe cardiac failure.
Patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid and/or other drugs with prostaglandin-synthetase inhibitory activity.
Treatment of peri-operative pain in setting of coronary artery bypass graft (CABG) surgery.
The use of high dose Difnac (150 mg/day) for >4 weeks is contraindicated in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension.
Established Cardiovascular Disease or Significant Cardiovascular Risk Factors: The use of high dose Difnac (150mg/day) for >4 weeks is contraindicated in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension. If Difnac treatment is needed, patients with established cardiovascular disease, uncontrolled hypertension or significant cardiovascular risk factors (eg, hypertension, hyperlipidaemia, diabetes mellitus and smoking) should be treated only after careful consideration and at doses ≤100 mg daily if the treatment is for >4 weeks. As the cardiovascular risks of Difnac may increase with dose and duration of exposure, Difnac should always be prescribed at the lowest effective daily dose and for the shortest duration possible.
Renal Impairment: Difnac is contraindicated in patients with renal failure. No specific studies have been carried out in patients with renal impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering Difnac to patients with mild to moderate renal impairment.
Hepatic Impairment: Difnac is contraindicated in patients with hepatic failure. No specific studies have been carried out in patients with hepatic impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering Difnac to patients with mild to moderate hepatic impairment.
DailyMed. "DICLOFENAC EPOLAMINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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