What is Indofen?
Indofen 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, Indofen does not cure osteoarthritis and will help you only as long as you continue to use it.
Indofen 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 Indofen helps this condition is unknown.
Indofen topical solution is used to treat pain and swelling caused by osteoarthritis of the knees.
Indofen topical patch is used to treat acute pain caused by minor strains, sprains, and contusions (bruises).
Indofen is available only with your doctor's prescription.
Indofen indications
Carefully consider the potential benefits and risks of Indofen delayed-release tablets and other treatment options before deciding to use Indofen delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
Indofen delayed-release tablets are indicated:
- •
- For relief of the signs and symptoms of osteoarthritis
- •
- For relief of the signs and symptoms of rheumatoid arthritis
- •
- For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis
How should I use Indofen?
Use Indofen solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Indofen solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Indofen solution refilled.
- Do not apply Indofen solution to infected skin; open wounds; or red, swollen, or peeling skin.
- Wash your hands immediately before and after using Indofen solution.
- Wash the affected area and dry completely before using Indofen solution.
- To apply Indofen solution, dispense 10 drops at a time onto the knee or into your hand. Spread Indofen 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 Indofen 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 Indofen solution.
- If you miss a dose of Indofen 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 Indofen solution.
Uses of Indofen in details
Use: Labeled Indications
Ankylosing spondylitis (delayed-release tablets only): Acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.
Dysmenorrhea (immediate-release tablets only): Treatment of primary dysmenorrhea.
Migraine (powder for oral solution only): Acute treatment of migraine attacks with or without aura in adults.
Osteoarthritis (immediate-release, extended-release, and delayed-release tablets; capsules [Zorvolex]; and suppositories [Canadian product] only): Relief of signs and symptoms of osteoarthritis.
Pain
Capsules/immediate-release tablets only: Relief of mild to moderate acute pain.
Injection only: Management of mild to moderate pain and moderate to severe pain (alone or in combination with opioid analgesics) in adults.
Rheumatoid arthritis (immediate-release, extended-release, and delayed-release tablets; and suppositories [Canadian product] only): Relief of signs and symptoms of rheumatoid arthritis.
Off Label Uses
Gout, treatment (acute flares)
Data from a limited number of trials support the efficacy of Indofen in the treatment of acute gout flares.
Based on the 2012 American College of Rheumatology guidelines for management of gout, nonsteroidal anti-inflammatory drugs are effective and recommended agents in the treatment of acute gout flares.
Indofen description
A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.
Indofen dosage
Carefully consider the potential benefits and risks of Indofen extended-release tablets, and other treatment options before deciding to use Indofen extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
After observing the response to initial therapy with Indofen extended-release tablets the dose and frequency should be adjusted to suit an individual patient’s needs.
For the relief of osteoarthritis, the recommended dosage is 100 mg daily.
For the relief of rheumatoid arthritis, the recommended dosage is 100 mg daily. In the rare patient where Indofen extended-release tablets 100 mg/day is unsatisfactory, the dose may be increased to 100 mg twice a day if the benefits outweigh the clinical risks of increased side effects.
Different formulations of Indofen (Indofen enteric-coated tablets; Indofen extended-release tablets; Indofen potassium immediate-release tablets) are not necessarily bioequivalent even if the milligram strength is the same.
Indofen interactions
See also:
What other drugs will affect Indofen?
Aspirin: Concomitant administration of Indofen and aspirin is not recommended because Indofen 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 Indofen 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 Indofen, and warfarin requires close monitoring of patients to be certain that no change in their anticoagulant dosage is required.
Digoxin, Methotrexate, Cyclosporine: Indofen, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Ingestion of Indofen may increase serum concentrations of digoxin and methotrexate and increase cyclosporineís nephrotoxicity. Patients who begin taking Indofen or who increase their Indofen 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: Indofen decreases lithium renal clearance and increases lithium plasma levels. In patients taking Indofen and lithium concomitantly, lithium toxicity may develop.
Oral Hypoglycemics:
Indofen 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 Indofen 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 Indofen may alter a diabetic patientís response to insulin or oral hypoglycemic agents.
Diuretics: Indofen 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 Indofen. Phenobarbital toxicity has been reported to have occurred in a patient on chronic phenobarbital treatment following the initiation of Indofen therapy.
Protein Binding
In vitro, Indofen interferes minimally or not at all with the protein binding of salicylic acid (20% decrease in binding), tolbutamide, prednisolone (10% decrease in binding), or warfarin. Benzylpenicillin, ampicillin, oxacillin, chlortetracycline, doxycycline, cephalothin, erythromycin, and sulfamethoxazole have no influence in vitro on the protein binding of Indofen in human serum.
Drug/Laboratory Test Interactions
Effect on Blood Coagulation: Indofen increases platelet aggregation time but does not affect bleeding time, plasma thrombin clotting time, plasma fibrinogen, or factors V and VII to XII. Statistically significant changes in prothrombin and partial thromboplastin times have been reported in normal volunteers. The mean changes were observed to be less than 1 second in both instances, however, and are unlikely to be clinically important. Indofen is a prostaglandin synthetase inhibitor, however, and all drugs that inhibit prostaglandin synthesis interfere with platelet function to some degree; therefore, patients who may be adversely affected by such an action should be carefully observed.
Indofen side effects
See also:
What are the possible side effects of Indofen?
Ocular
Transient burning and stinging were reported in approximately 15% of patients across studies with the use of Indofen ophthalmic solution, 0.1%. In cataract surgery studies, keratitis was reported in up to 28% of patients using Indofen ophthalmic solution, 0.1%, although in many of these cases keratitis was initially noted prior to the initiation of treatment. Elevated intraocular pressure following cataract surgery was reported in approximately 15% of patients undergoing cataract surgery. Lacrimation complaints were reported in approximately 30% of case studies undergoing incisional refractive surgery. The following adverse reactions were reported in approximately 10% or less of the patients: abnormal vision, acute elevated IOP, blurred vision, conjunctivitis, corneal deposits, corneal edema, corneal opacity, corneal lesions, discharge, eyelid swelling, eye pain, injection (redness), iritis, irritation, itching, lacrimation disorder, and ocular allergy.
Systemic
The following adverse reactions were reported in 3% or less of the patients: abdominal pain, asthenia, chills, dizziness, facial edema, fever, headache, insomnia, nausea, pain, rhinitis, viral infection and vomiting.
Clinical Practice
The following reactions have been identified during postmarketing use of topical Indofen ophthalmic solution, 0.1% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical Indofen ophthalmic solution, 0.1%, or a combination of these factors, include corneal erosion, corneal infiltrates, corneal perforation, corneal thinning, corneal ulceration and epithelilal breakdown.
TO REPORT SUSPECTED ADVERSE REACTIONS, contact Altaire Pharmaceuticals, Inc., at 1-800-258-2471 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Indofen contraindications
See also:
What is the most important information I should know about Indofen?
Indofen in all formulations, Cataflam, Voltaren, and Voltaren-XR, is contraindicated in patients with known hypersensitivity to Indofen and Indofen-containing products. Indofen should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to Indofen have been reported in such patients.
Active ingredient matches for Indofen:
Diclofenac sodium in India.
| Unit description / dosage (Manufacturer) | Price, USD |
| 25 mg x 10's | $ 0.09 |
| Indofen 25mg AMP / 10 | $ 0.09 |
| Indofen 25 mg Injection | $ 0.09 |
| INDOFEN inj 25 mg x 1ml (Adley) | $ 0.09 |
| Indofen 25mg AMP / 10 | $ 0.09 |
List of Indofen substitutes (brand and generic names): | |
| Indicam (Italy) | |
| Indofen E | |
| Indofen E Eye 5 ml Drop (Adley Formulation) | $ 0.04 |
| Indofen-E (India) | |
| Indofen-E 0.1% w/v EYE-DPS / 5ml (Adley) | $ 0.19 |
| 0.1 % w/v x 5ml (Adley) | $ 0.19 |
| INDOFEN-E eye drops 0.1 % w/v x 5ml (Adley) | $ 0.19 |
| Indofen-SR (India) | |
| Indofen-SR 100mg TAB / 10 (Adley) | |
| 100 mg x 10's (Adley) | |
| INDOFEN-SR tab 100 mg x 10's (Adley) | |
| Indonac | |
| Indonac 75 mg Injection (Indoss Life Sciences (Oscar Remedies Pvt. Ltd)) | $ 0.03 |
| INFADIC (India) | |
| INFADIC inj 75 mg x 1 mL x 5ml (Agron Rem.) | |
| Infla SR | |
| Infla SR 100 mg Tablet (Bajaj Pharmaceuticals) | $ 0.04 |
| Infla-Ban (Bahrain, Iraq, Jordan, Kuwait, Lebanon, Libya, Nigeria, Oman, Qatar, Saudi Arabia, South Africa, Sudan, Syria, United Arab Emirates, Yemen) | |
| Infla-Ban 100mg (Oman) | |
| Infla-Ban 1mg/g (Oman) | |
| Infla-Ban 50mg (Oman) | |
| Infla-Ban 75mg (Oman) | |
| Infla-Ban 75mg/3ml (Oman) | |
| Infla-ban Sr | |
| Infla-eze | |
| Infla-SR | |
| Infla-SR 100mg TAB / 10x10 | $ 4.46 |
| Inflaban (Pakistan) | |
| Inflacord (Mexico) | |
| Infladex (Brazil) | |
| Infladoren (Brazil) | |
| Inflaforte (Greece) | |
| Inflaforte 1.5% (Greece) | |
| Inflahit (India) | |
| Inflahit Diclofenac diethylamine 1.16%, Methylsalicylate 10 %, Menthol 5 %, linseed oil 3 %. GEL / 30g (Aurel Biolife) | $ 0.60 |
| 30g (Aurel Biolife) | $ 0.60 |
| Inflahit 30 gm Gel (Aurel Biolife) | $ 0.60 |
| INFLAHIT topical gel 30g (Aurel Biolife) | $ 0.78 |
| Inflakod (India) | |
| Inflakod Serratiopeptidase 10 mg, Diclofenac potassium 50 mg. TAB / 10 (Plus India) | $ 0.59 |
| 10's (Plus India) | $ 0.59 |
| INFLAKOD tab 10's (Plus India) | $ 0.59 |
| Inflamac (Czech Republic, Estonia, Latvia, Lithuania, Switzerland) | |
| Capsule; Oral; Diclofenac Sodium 25 mg (Spirig) | |
| Capsule; Oral; Diclofenac Sodium 50 mg (Spirig) | |
| Injectable; Injection; Diclofenac Sodium 25 mg / ml (Spirig) | |
| Suppositories; Rectal; Diclofenac Sodium 100 mg (Spirig) | |
| Suppositories; Rectal; Diclofenac Sodium 12.5 mg (Spirig) | |
| Suppositories; Rectal; Diclofenac Sodium 50 mg (Spirig) | |
| Capsules; Oral; Diclofenac Sodium 25 mg (Spirig) | |
| Capsules; Oral; Diclofenac Sodium 50 mg (Spirig) | |
| Inflamac 1% (Switzerland) | |
See 8654 substitutes for Indofen | |
References
- 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).
- PubChem. "diclofenac". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "diclofenac". http://www.drugbank.ca/drugs/DB00586 (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Indofen 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 Indofen. 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
Consumer reported useful
No survey data has been collected yetConsumer reported price estimates
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Information checked by Dr. Sachin Kumar, MD Pharmacology
