Difelene Uses

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What is Difelene?

Difelene 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, Difelene does not cure osteoarthritis and will help you only as long as you continue to use it.

Difelene 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 Difelene helps this condition is unknown.

Difelene topical solution is used to treat pain and swelling caused by osteoarthritis of the knees.

Difelene topical patch is used to treat acute pain caused by minor strains, sprains, and contusions (bruises).

Difelene is available only with your doctor's prescription.

Difelene 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 Difelene Na: 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 Difelene Na: 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 Difelene Na: 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 Difelene Na: 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 Difelene Na (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 Difelene Na (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 Difelene Na (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 Difelene Na (0.1% soln): Instill 1 drop 4 times daily for up to 2 days.

Ophthalmic

Control of inflammation after argon laser trabeculoplasty

Adult: As Difelene Na (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 Difelene Na (0.1% soln): Instill into appropriate eye 4 times w/in 2 hr before surgery.

Ophthalmic

Post-photorefractive keratectomy pain

Adult: As Difelene Na (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 Difelene Na (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 Difelene Na: 75-150 mg/day in divided doses. Max: 150 mg/day.

Oral

Migraine

Adult: As Difelene 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 Difelene Na: 100 mg once daily.

Topical/Cutaneous

Actinic keratoses

Adult: As Difelene Na (3% gel): Apply bid for 60-90 days.

Topical/Cutaneous

Osteoarthritis

Adult: As Difelene Na (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 Difelene Na (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 Difelene?

Use Difelene solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Difelene solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Difelene solution refilled.
  • Do not apply Difelene solution to infected skin; open wounds; or red, swollen, or peeling skin.
  • Wash your hands immediately before and after using Difelene solution.
  • Wash the affected area and dry completely before using Difelene solution.
  • To apply Difelene solution, dispense 10 drops at a time onto the knee or into your hand. Spread Difelene 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 Difelene 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 Difelene solution.
  • If you miss a dose of Difelene 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 Difelene solution.

Uses of Difelene 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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Difelene is used to relieve pain from various conditions. This form of Difelene is used to treat migraine headaches. Difelene 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 Difelene

Read the Medication Guide provided by your pharmacist before you start taking Difelene 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 Difelene 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.

Difelene description

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The active substance is sodium-[o[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (= Difelene).

Each enteric tablet contains 25 mg or 50 mg of Difelene.

One prolonged-release tablet contains 100 mg of Difelene.

Excipients/Inactive Ingredients: Gastro-Resistant Tablet: Core for 25 mg and 50 mg: Cellulose microcrystalline; lactose monohydrate; magnesium stearate; maize starch; povidone; silica, colloidal anhydrous; sodium starch glycolate (type A).

Coating for 25 mg and 50 mg: Hypromellose; iron oxide yellow (E172); macrogoglycerol hydroxystearate; methacrylic acid-ethyl acrylate copolymer; macrogol 8000; talc; titanium dioxide (E171); simeticone; alpha-octadecyl-omega-hydroxy-polyglykolether; sorbic acid.

Coating for 50 mg: Iron oxide red (E172).

SR Tablet: Tablet Core: Cetyl alcohol; magnesium stearate; povidone; silica; colloidal anhydrous; sucrose.

Tablet Coating: Hypromellose; iron oxide red (E172); macrogol 8000; polysorbate 80; sucrose; talc; titanium dioxide (E171). Printing Ink: Carbon black, shellac, ammonium hydroxide, simethicone.

Injection: Each ampoule also contains the following excipients: Mannitol, sodium metabisulfite (E223), benzyl alcohol, propylene glycol, water for injection, sodium hydroxide.

Difelene dosage

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Difelene Dosage

Generic name: Difelene 18mg

Dosage form: capsule

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

General Dosing Instructions

Carefully consider the potential benefits and risks of Difelene and other treatment options before deciding to use Difelene. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.

The effectiveness of Difelene when taken with food has not been studied in clinical studies. Taking Difelene with food may cause a reduction in effectiveness compared to taking Difelene 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 Difelene compared to patients with normal hepatic function. As with other Difelene products, start treatment at the lowest dose. If efficacy is not achieved with the lowest dose, discontinue use.

Non-Interchangeability with Other Formulations of Difelene

Difelene capsules are not interchangeable with other formulations of oral Difelene even if the milligram strength is the same. Difelene capsules contain Difelene free acid whereas other Difelene products contain a salt of Difelene, i.e., Difelene potassium or sodium. A 35 mg dose of Difelene is approximately equal to 37.6 mg of sodium Difelene or 39.5 mg of potassium Difelene. Therefore, do not substitute similar dosing strengths of other Difelene products without taking this into consideration.

More about Difelene (Difelene)

  • Side Effects
  • During Pregnancy or Breastfeeding
  • Dosage Information
  • Drug Images
  • Drug Interactions
  • Support Group
  • Pricing & Coupons
  • En Espanol
  • 12 Reviews - Add your own review/rating

Consumer resources

  • Difelene
  • Difelene (Advanced Reading)
  • Other brands: Difelene, Cataflam, Difelene, Zipsor, More (2) »

Professional resources

  • Difelene (FDA)
  • Difelene epolamine (AHFS Monograph)

Related treatment guides

  • Osteoarthritis
  • Pain

Difelene interactions

See also:
What other drugs will affect Difelene?

Aspirin: Concomitant administration of Difelene and aspirin is not recommended because Difelene 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 Difelene 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 Difelene and warfarin, requires close monitoring of patients to be certain that no change in their anticoagulant dosage is required.

Digoxin, Methotrexate, Cyclosporine: Difelene, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Ingestion of Difelene may increase serum concentrations of digoxin and methotrexate and increase cyclosporine's nephrotoxicity. Patients who begin taking Difelene or who increase their Difelene 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: Difelene decreases lithium renal clearance and increases lithium plasma levels. In patients taking Difelene and lithium concomitantly, lithium toxicity may develop.

Oral Hypoglycemics:

Difelene 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 Difelene 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 Difelene may alter a diabetic patient's response to insulin or oral hypoglycemic agents.

Diuretics: Difelene 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 Difelene. Phenobarbital toxicity has been reported to have occurred in a patient on chronic phenobarbital treatment following the initiation of Difelene therapy.

Difelene side effects

See also:
What are the possible side effects of Difelene?

Fluid Retention and Edema: Fluid retention and edema have been observed in some patients taking Difelene. Therefore, as with other NSAIDs, Difelene should be used with caution in patients with history of cardiac decompensation, hypertension or other conditions predisposing to fluid retention.

Hematological Effects: Anemia is sometimes seen in patients receiving Difelene or other NSAIDs. This may be due to fluid retention, GI blood loss or an incompletely described effect upon erythropoiesis.

Renal Effects: As a class, NSAIDs have been associated with renal papillary necrosis and other abnormal renal pathology in long-term administration to animals. In patients treated with Difelene, rare cases of interstitial nephritis and papillary necrosis have been reported. A second form of renal toxicity, generally associated with NSAIDs, is seen in patients with conditions leading to a reduction in renal blood flow or blood volume, where renal prostaglandins have a supported role in the maintenance of renal perfusion. In these patients, administration of an NSAID results in a dose-dependent decrease in prostaglandin synthesis and secondarily, in a reduction of renal blood flow, which may precipitate over the renal failure. Patients at greater risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and the elderly.

Porphyria: The use of Difelene in patients with hepatic porphyria should be avoided.

Aseptic Meningitis: As with other NSAIDs, aseptic meningitis with fever and coma has been observed in rare occasions in patients on Difelene therapy. Although it is probably more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has been reported in patients who do not have an underlying chronic disease. If signs or symptoms of meningitis develop in a patient on Difelene, the possibility of it being related to Difelene should be considered.

There may be pain and occasionally tissue damage at the site of injection when given IM.

Difelene contraindications

See also:
What is the most important information I should know about Difelene?

Hypersensitivity to Difelene or to any of the excipients of Difelene.

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 Difelene (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 Difelene (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 Difelene 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 Difelene may increase with dose and duration of exposure, Difelene should always be prescribed at the lowest effective daily dose and for the shortest duration possible.

Renal Impairment: Difelene 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 Difelene to patients with mild to moderate renal impairment.

Hepatic Impairment: Difelene 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 Difelene to patients with mild to moderate hepatic impairment.



Active ingredient matches for Difelene:

Diclofenac in Thailand, Vietnam.

Diclofenac Na in Thailand.

Diclofenac Sodium

Diclofenac diethylamine or diclofenac sodium in Thailand.


Unit description / dosage (Manufacturer)Price, USD
Difelene 25 mg x 24 x 10's
Difelene 50 mg x 24 x 10's

List of Difelene substitutes (brand and generic names):

Difelene Gel 1 % x 15 g
Difelene Gel 1 % x 30 g
Difelene Gel 1 % x 60 g
DIFEN INJECTION 1 vial / 30 ML injection each (McW Healthcare)$ 0.13
Drops; Ophthalmic; Diclofenac Sodium 0.1%
Difena 25 mg x 1000's (Standard)
Difena 50 mg x 1000's (Standard)
Difena 50 mg x 100 x 10's (Standard)
Difena 25 mg/1 mL x 3 mL x 100's (Standard)
Difena 12.5 mg x 100's (Standard)
Difena 25 mg x 100's (Standard)
50 mg x 10's (Intermed)$ 0.17
Difenac 25 mg x 100 x 10's (Intermed)
Difenac 25 mg x 1, 000's (Intermed)
Difenac 50 mg x 50 x 10's (Intermed)
Difenac 50 mg x 500's (Intermed)
Difenac 75 mg/3 mL x 5's (Intermed)
Difenac 75 mg/3 mL x 50's (Intermed)
Difenac 50mg TAB / 10 (Intermed)$ 0.17
Difenac 25 mg x 10 x 10 x 10's (Intermed)
Difenac 50 mg x 10 x 10 x 10's (Intermed)
Tablets, Enteric Coated; Oral; Diclofenac Sodium 25 mg (Intermed)
Tablets, Enteric Coated; Oral; Diclofenac Sodium 50 mg (Intermed)
Difenac 25 mg x 1000's (Intermed)
Difenac 50 mg x 1000's (Intermed)
Difenac 50 mg Tablet (Intermed)$ 0.02
Difenac enteric-coated tab 25 mg 10 x 10 x 10's (Intermed)
Difenac enteric-coated tab 50 mg 10 x 10 x 10's (Intermed)
DIFENAC tab 50 mg x 10's (Intermed)$ 0.27
Difenac DHA 25 mg x 10 Box x 10 Blister x 10 Tablet
Difenac Gel Diclofenac diethylamine 1.16%, Linseed oil 3 %, methylsalicylate 10 %, Menthol 5 %. GEL / 30g (Intermed)$ 0.68
30g (Intermed)$ 0.68
Difenac Gel 30 gm Gel (Intermed)$ 0.68

References

  1. 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).
  2. PubChem. "diclofenac". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "diclofenac". http://www.drugbank.ca/drugs/DB00586 (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Difelene are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Difelene. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

1 consumer reported useful

Was the Difelene drug useful in terms of decreasing the symptom or the disease?
According to the reports released by ndrugs.com website users, the below mentioned percentages of users say the drug is useful / not useful to them in decreasing their symptoms/disease. The usefulness of the drug depends on many factors, like severity of the disease, perception of symptom, or disease by the patient, brand name used [matters only to a certain extent], other associated conditions of the patient. If the drug is not effective or useful in your case, you need to meet the doctor to get re-evaluated about your symptoms/disease, and he will prescribe an alternative drug.
Users%
Useful1
100.0%


2 consumers reported price estimates

Was the price you paid to purchase the drug reasonable? Did you feel it was expensive?
The below mentioned numbers have been reported by ndrugs.com website users about whether the Difelene drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.
Users%
Expensive1
50.0%
Not expensive1
50.0%


4 consumers reported time for results

To what extent do I have to use Difelene before I begin to see changes in my health conditions?
As part of the reports released by ndrugs.com website users, it takes 3 month and a few days before you notice an improvement in your health conditions.
Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Difelene. To get the time effectiveness of using Difelene drug by other patients, please click here.
Users%
3 month1
25.0%
1 week1
25.0%
1 month1
25.0%
3 days1
25.0%


17 consumers reported age

Users%
> 605
29.4%
30-455
29.4%
16-294
23.5%
46-603
17.6%


Consumer reviews


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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