What is Rofenac SR?
Rofenac SR 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, Rofenac SR does not cure osteoarthritis and will help you only as long as you continue to use it.
Rofenac SR 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 Rofenac SR helps this condition is unknown.
Rofenac SR topical solution is used to treat pain and swelling caused by osteoarthritis of the knees.
Rofenac SR topical patch is used to treat acute pain caused by minor strains, sprains, and contusions (bruises).
Rofenac SR is available only with your doctor's prescription.
Rofenac SR indications
Intramuscular
Renal colic
Adult: As Rofenac SR 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 Rofenac SR 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 Rofenac SR 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 Rofenac SR 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 Rofenac SR 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 Rofenac SR 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 Rofenac SR 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 Rofenac SR 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 Rofenac SR 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 Rofenac SR Na (0.1% soln): Instill into appropriate eye 4 times w/in 2 hr before surgery.
Ophthalmic
Post-photorefractive keratectomy pain
Adult: As Rofenac SR 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 Rofenac SR 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 Rofenac SR Na: 75-150 mg/day in divided doses. Max: 150 mg/day.
Oral
Migraine
Adult: As Rofenac SR 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 Rofenac SR Na: 100 mg once daily.
Topical/Cutaneous
Actinic keratoses
Adult: As Rofenac SR Na (3% gel): Apply bid for 60-90 days.
Topical/Cutaneous
Osteoarthritis
Adult: As Rofenac SR 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 Rofenac SR 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 Rofenac SR?
Use Rofenac SR solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Rofenac SR solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Rofenac SR solution refilled.
- Do not apply Rofenac SR solution to infected skin; open wounds; or red, swollen, or peeling skin.
- Wash your hands immediately before and after using Rofenac SR solution.
- Wash the affected area and dry completely before using Rofenac SR solution.
- To apply Rofenac SR solution, dispense 10 drops at a time onto the knee or into your hand. Spread Rofenac SR 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 Rofenac SR 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 Rofenac SR solution.
- If you miss a dose of Rofenac SR 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 Rofenac SR solution.
Uses of Rofenac SR in details
Rofenac SR is used to relieve pain from various conditions. This form of Rofenac SR is used to treat migraine headaches. Rofenac SR 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 Rofenac SR
Read the Medication Guide provided by your pharmacist before you start taking Rofenac SR 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 Rofenac SR 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.
Rofenac SR description
The active substance is sodium-[o[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (= Rofenac SR sodium).
Each enteric tablet contains 25 mg or 50 mg of Rofenac SR sodium.
One prolonged-release tablet contains 100 mg of Rofenac SR sodium.
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.
Rofenac SR dosage
General Dosing Instructions
Carefully consider the potential benefits and risks of Rofenac SR and other treatment options before deciding to use Rofenac SR. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
The effectiveness of Rofenac SR when taken with food has not been studied in clinical studies. Taking Rofenac SR with food may cause a reduction in effectiveness compared to taking Rofenac SR 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 Rofenac SR compared to patients with normal hepatic function. As with other Rofenac SR products, start treatment at the lowest dose. If efficacy is not achieved with the lowest dose, discontinue use.
Non-Interchangeability with Other Formulations of Rofenac SR
Rofenac SR capsules are not interchangeable with other formulations of oral Rofenac SR even if the milligram strength is the same. Rofenac SR capsules contain Rofenac SR free acid whereas other Rofenac SR products contain a salt of Rofenac SR, i.e., Rofenac SR potassium or sodium. A 35 mg dose of Rofenac SR is approximately equal to 37.6 mg of sodium Rofenac SR or 39.5 mg of potassium Rofenac SR. Therefore, do not substitute similar dosing strengths of other Rofenac SR products without taking this into consideration.
Rofenac SR interactions
See also:
What other drugs will affect Rofenac SR?
Aspirin: Concomitant administration of Rofenac SR and aspirin is not recommended because Rofenac SR 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 Rofenac SR 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 Rofenac SR and warfarin, requires close monitoring of patients to be certain that no change in their anticoagulant dosage is required.
Digoxin, Methotrexate, Cyclosporine: Rofenac SR, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Ingestion of Rofenac SR may increase serum concentrations of digoxin and methotrexate and increase cyclosporine's nephrotoxicity. Patients who begin taking Rofenac SR or who increase their Rofenac SR 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: Rofenac SR decreases lithium renal clearance and increases lithium plasma levels. In patients taking Rofenac SR and lithium concomitantly, lithium toxicity may develop.
Oral Hypoglycemics:
Rofenac SR 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 Rofenac SR 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 Rofenac SR may alter a diabetic patient's response to insulin or oral hypoglycemic agents.Diuretics: Rofenac SR 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 Rofenac SR. Phenobarbital toxicity has been reported to have occurred in a patient on chronic phenobarbital treatment following the initiation of Rofenac SR therapy.
Rofenac SR side effects
See also:
What are the possible side effects of Rofenac SR?
There have been cases reported of Rofenac SR being associated with the development of symptoms resembling the syndrome of inappropriate antidiuretic hormone secretion in elderly women. A patient who had been taking Rofenac SR for several years and had increasingly complained of dry, gritty eyes noticed that eye irritation disappeared within 3 days when Rofenac SR had to be discontinued because of GI effects.
The most frequent adverse effects reported in patients given Rofenac SR are GI in nature. Typical reactions include epigastric pain, nausea, vomiting and diarrhoea. Rarely, peptic ulcer and GI bleeding have occurred. Rofenac SR 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 Rofenac SR. Elevations of serum aminotransferase activity and clinical hepatitis, including fetal fulminant hepatitis have occurred in patients taking Rofenac SR. Self-limiting skin reaction eg, rash or pruritus may occur in patients given Rofenac SR.
Aspirin-sensitive asthmatic patients have developed reactions (rhinorrhoea, tightness of chest, wheezing, dyspnoea) when challenged with Rofenac SR 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 Rofenac SR.
Rofenac SR contraindications
See also:
What is the most important information I should know about Rofenac SR?
Hypersensitivity to Rofenac SR sodium or to any of the excipients of Rofenac SR.
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 Rofenac SR (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 Rofenac SR (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 Rofenac SR 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 Rofenac SR may increase with dose and duration of exposure, Rofenac SR should always be prescribed at the lowest effective daily dose and for the shortest duration possible.
Renal Impairment: Rofenac SR 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 Rofenac SR to patients with mild to moderate renal impairment.
Hepatic Impairment: Rofenac SR 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 Rofenac SR to patients with mild to moderate hepatic impairment.
Active ingredient matches for Rofenac SR:
Diclofenac in Lebanon.
List of Rofenac SR substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| Rofenac D 50mg (Oman) | |
| Roitonin (Taiwan) | |
| Roitonin 25 mg x 100's | |
| Roitonin 25 mg x 500's | |
| Roitonin 25 mg x 1000's | |
| ROLOD K | |
| ROLOD K 50MG TABLET 1 strip / 10 tablets each (Tidal Laboratories Pvt Ltd) | $ 0.23 |
| Romafen 1% (Egypt) | |
| Romalex (Oman) | |
| Romalex 0.1% (Egypt) | |
| Romatim (Turkey) | |
| Ronac INJ (India) | |
| Ronac INJ 75mg INJ / 3ml (Rouzel) | |
| 75 mg x 3ml (Rouzel) | |
| RONAC INJ inj 75 mg x 3ml (Rouzel) | |
| Ronac-S (India) | |
| Ronac-S Diclofenac potassium 50 mg, Serratiopeptidase 15 mg. TAB / 10 (Rouzel) | |
| 10's (Rouzel) | |
| RONAC-S tab 10's (Rouzel) | |
| Ronac-TR (Bangladesh) | |
| Rozadin (India) | |
| Rozadin Diclofenac diethylammonium, Linseed oil, methylsalicylate, menthol 5 %. GEL / 30g (Hi-Tec) | $ 0.54 |
| 30g (Hi-Tec) | $ 0.54 |
| ROZADIN topical gel 30g (Hi-Tec) | $ 0.54 |
| Rubex Gel (India) | |
| Rubex Gel Diclofenac diethylammonium1.16 %, Methyl salicylate 10%, Menthol 2 %, Linseed oil 3%, Benzyl alcohol 1 % w/w. GEL / 30g (Rapross) | $ 0.58 |
| 30g (Rapross) | $ 0.58 |
| RUBEX GEL topical gel 30g (Rapross) | $ 0.58 |
| Rubigel (India) | |
| Rubigel Diclofenac diethylammonium1.16 % w/w, Methyl salicylate10 % w/w, Menthol 5 % w/w. GEL / 30g (Galantica) | |
| 30g (Galantica) | |
| RUBIGEL topical gel 30g (Galantica) | |
| Rubwel (India) | |
| Rubwel Diclofenac sodium 1 % w/w, Methyl salicylate 10 % w/w, menthol 5 % w/w. GEL / 30g (Acme Pharma (Optima)) | $ 0.48 |
| 30g (Acme Pharma (Optima)) | $ 0.48 |
| RUBWEL topical gel 30g (Acme Pharma (Optima)) | $ 0.48 |
| Rui Pei En (China) | |
| Rumafen (Oman) | |
| Rumafen 1% (Oman) | |
| Rumafen 25mg (Oman) | |
| Rumafen 50mg (Oman) | |
| Rumatab (Thailand) | |
| RUMATAB 100 MG/500 MG TABLET 1 strip / 10 tablets each (Pharmaland) | $ 0.39 |
| Rumatab 100 mg/500 mg Tablet (Pharmaland) | $ 0.04 |
| Runac (India, Serbia) | |
| RUNAC Modified Release Capsule/ Tablet / 100mg / 10 units (Sun) | $ 0.13 |
| RUNAC Capsule/ Tablet / 50mg / 10 units (Sun) | $ 0.07 |
| RUNAC Injection / 25mg per ml / 3ml units (Sun) | $ 0.04 |
| Runac 50mg TAB / 10 (Sun) | $ 0.07 |
| Runac - INJ / 3ml (Sun) | $ 0.19 |
| 50 mg x 10's (Sun) | $ 0.07 |
| 100 mg x 10's (Sun) | $ 0.13 |
See 7738 substitutes for Rofenac SR | |
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 Rofenac SR 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 Rofenac SR. 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
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Information checked by Dr. Sachin Kumar, MD Pharmacology
