What is Grofenac Retard 100mg?
Grofenac Retard 100mg 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, Grofenac Retard 100mg does not cure osteoarthritis and will help you only as long as you continue to use it.
Grofenac Retard 100mg 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 Grofenac Retard 100mg helps this condition is unknown.
Grofenac Retard 100mg topical solution is used to treat pain and swelling caused by osteoarthritis of the knees.
Grofenac Retard 100mg topical patch is used to treat acute pain caused by minor strains, sprains, and contusions (bruises).
Grofenac Retard 100mg is available only with your doctor's prescription.
Grofenac Retard 100mg indications
Intramuscular
Renal colic
Adult: As Grofenac Retard 100mg 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 Grofenac Retard 100mg 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 Grofenac Retard 100mg 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 Grofenac Retard 100mg 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 Grofenac Retard 100mg 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 Grofenac Retard 100mg 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 Grofenac Retard 100mg 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 Grofenac Retard 100mg 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 Grofenac Retard 100mg 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 Grofenac Retard 100mg Na (0.1% soln): Instill into appropriate eye 4 times w/in 2 hr before surgery.
Ophthalmic
Post-photorefractive keratectomy pain
Adult: As Grofenac Retard 100mg 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 Grofenac Retard 100mg 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 Grofenac Retard 100mg Na: 75-150 mg/day in divided doses. Max: 150 mg/day.
Oral
Migraine
Adult: As Grofenac Retard 100mg 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 Grofenac Retard 100mg Na: 100 mg once daily.
Topical/Cutaneous
Actinic keratoses
Adult: As Grofenac Retard 100mg Na (3% gel): Apply bid for 60-90 days.
Topical/Cutaneous
Osteoarthritis
Adult: As Grofenac Retard 100mg 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 Grofenac Retard 100mg 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 Grofenac Retard 100mg?
Use Grofenac Retard 100mg solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Grofenac Retard 100mg solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Grofenac Retard 100mg solution refilled.
- Do not apply Grofenac Retard 100mg solution to infected skin; open wounds; or red, swollen, or peeling skin.
- Wash your hands immediately before and after using Grofenac Retard 100mg solution.
- Wash the affected area and dry completely before using Grofenac Retard 100mg solution.
- To apply Grofenac Retard 100mg solution, dispense 10 drops at a time onto the knee or into your hand. Spread Grofenac Retard 100mg 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 Grofenac Retard 100mg 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 Grofenac Retard 100mg solution.
- If you miss a dose of Grofenac Retard 100mg 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 Grofenac Retard 100mg solution.
Uses of Grofenac Retard 100mg in details
Grofenac Retard 100mg is used to relieve pain from various conditions. This form of Grofenac Retard 100mg is used to treat migraine headaches. Grofenac Retard 100mg 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 Grofenac Retard 100mg
Read the Medication Guide provided by your pharmacist before you start taking Grofenac Retard 100mg 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 Grofenac Retard 100mg 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.
Grofenac Retard 100mg description
The active substance is sodium-[o[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (= Grofenac Retard 100mg sodium).
Each enteric tablet contains 25 mg or 50 mg of Grofenac Retard 100mg sodium.
One prolonged-release tablet contains 100 mg of Grofenac Retard 100mg 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.
Grofenac Retard 100mg dosage
General Dosing Instructions
Carefully consider the potential benefits and risks of Grofenac Retard 100mg and other treatment options before deciding to use Grofenac Retard 100mg. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
The effectiveness of Grofenac Retard 100mg when taken with food has not been studied in clinical studies. Taking Grofenac Retard 100mg with food may cause a reduction in effectiveness compared to taking Grofenac Retard 100mg 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 Grofenac Retard 100mg compared to patients with normal hepatic function. As with other Grofenac Retard 100mg products, start treatment at the lowest dose. If efficacy is not achieved with the lowest dose, discontinue use.
Non-Interchangeability with Other Formulations of Grofenac Retard 100mg
Grofenac Retard 100mg capsules are not interchangeable with other formulations of oral Grofenac Retard 100mg even if the milligram strength is the same. Grofenac Retard 100mg capsules contain Grofenac Retard 100mg free acid whereas other Grofenac Retard 100mg products contain a salt of Grofenac Retard 100mg, i.e., Grofenac Retard 100mg potassium or sodium. A 35 mg dose of Grofenac Retard 100mg is approximately equal to 37.6 mg of sodium Grofenac Retard 100mg or 39.5 mg of potassium Grofenac Retard 100mg. Therefore, do not substitute similar dosing strengths of other Grofenac Retard 100mg products without taking this into consideration.
Grofenac Retard 100mg interactions
See also:
What other drugs will affect Grofenac Retard 100mg?
Aspirin: Concomitant administration of Grofenac Retard 100mg and aspirin is not recommended because Grofenac Retard 100mg 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 Grofenac Retard 100mg 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 Grofenac Retard 100mg and warfarin, requires close monitoring of patients to be certain that no change in their anticoagulant dosage is required.
Digoxin, Methotrexate, Cyclosporine: Grofenac Retard 100mg, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Ingestion of Grofenac Retard 100mg may increase serum concentrations of digoxin and methotrexate and increase cyclosporine's nephrotoxicity. Patients who begin taking Grofenac Retard 100mg or who increase their Grofenac Retard 100mg 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: Grofenac Retard 100mg decreases lithium renal clearance and increases lithium plasma levels. In patients taking Grofenac Retard 100mg and lithium concomitantly, lithium toxicity may develop.
Oral Hypoglycemics:
Grofenac Retard 100mg 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 Grofenac Retard 100mg 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 Grofenac Retard 100mg may alter a diabetic patient's response to insulin or oral hypoglycemic agents.Diuretics: Grofenac Retard 100mg 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 Grofenac Retard 100mg. Phenobarbital toxicity has been reported to have occurred in a patient on chronic phenobarbital treatment following the initiation of Grofenac Retard 100mg therapy.
Grofenac Retard 100mg side effects
See also:
What are the possible side effects of Grofenac Retard 100mg?
There have been cases reported of Grofenac Retard 100mg being associated with the development of symptoms resembling the syndrome of inappropriate antidiuretic hormone secretion in elderly women. A patient who had been taking Grofenac Retard 100mg for several years and had increasingly complained of dry, gritty eyes noticed that eye irritation disappeared within 3 days when Grofenac Retard 100mg had to be discontinued because of GI effects.
The most frequent adverse effects reported in patients given Grofenac Retard 100mg are GI in nature. Typical reactions include epigastric pain, nausea, vomiting and diarrhoea. Rarely, peptic ulcer and GI bleeding have occurred. Grofenac Retard 100mg 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 Grofenac Retard 100mg. Elevations of serum aminotransferase activity and clinical hepatitis, including fetal fulminant hepatitis have occurred in patients taking Grofenac Retard 100mg. Self-limiting skin reaction eg, rash or pruritus may occur in patients given Grofenac Retard 100mg.
Aspirin-sensitive asthmatic patients have developed reactions (rhinorrhoea, tightness of chest, wheezing, dyspnoea) when challenged with Grofenac Retard 100mg 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 Grofenac Retard 100mg.
Grofenac Retard 100mg contraindications
See also:
What is the most important information I should know about Grofenac Retard 100mg?
Hypersensitivity to Grofenac Retard 100mg sodium or to any of the excipients of Grofenac Retard 100mg.
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 Grofenac Retard 100mg (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 Grofenac Retard 100mg (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 Grofenac Retard 100mg 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 Grofenac Retard 100mg may increase with dose and duration of exposure, Grofenac Retard 100mg should always be prescribed at the lowest effective daily dose and for the shortest duration possible.
Renal Impairment: Grofenac Retard 100mg 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 Grofenac Retard 100mg to patients with mild to moderate renal impairment.
Hepatic Impairment: Grofenac Retard 100mg 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 Grofenac Retard 100mg to patients with mild to moderate hepatic impairment.
Active ingredient matches for Grofenac Retard 100mg:
Diclofenac in Oman, Switzerland.
List of Grofenac Retard 100mg substitutes (brand and generic names) | Sort by popularity |
Unit description / dosage (Manufacturer) | Price, USD |
Grofenac Retard (Switzerland) | |
Tablets, Retard; Oral; Diclofenac Sodium 100 mg | |
Gronac | |
Gronac 25mg INJ / 3ml (Multilax Pharmaceuticals Pvt Ltd) | $ 0.11 |
Gronac 75 mg Injection (Multilax Pharmaceuticals Pvt Ltd) | $ 0.03 |
Haloran SR | |
Haloran SR 100 mg Tablet (Hindustan Antibiotics Ltd.) | $ 0.01 |
Healpil (India) | |
Healpil Diclofenac potassium 50 mg, Serratiopeptidase 10 mg. TAB / 100 (Biosync Pharmaceuticals Pvt Ltd) | $ 7.11 |
100's (Biosync Pharmaceuticals Pvt Ltd) | $ 7.11 |
Healpil 50+10 Tablet (Biosync Pharmaceuticals Pvt Ltd) | $ 0.07 |
HEALPIL tab 10's (Biosync Pharmaceuticals Pvt Ltd) | $ 0.71 |
Heclow-N (India) | |
Heclow-N 25mg INJ / 3ml (Hecures) | |
25 mg x 3ml (Hecures) | |
HECLOW-N inj 25 mg x 3ml (Hecures) | |
Heclow-S (India) | |
Heclow-S Diclofenac potassium 50 mg, Serratiopeptidase 15 mg. TAB / 10 (Hecures) | |
10's (Hecures) | |
HECLOW-S tab 10's (Hecures) | |
Helini (India) | |
Helini Linseed oil 3 % w/w, Diclofenac diethylamine 1 %w/w, Methyl salicylate 10 %w/w, Menthol 5 % w/w. GEL / 1 (Hecures) | |
1's (Hecures) | |
HELINI topical gel 30g (Hecures) | |
Heumatic (Pakistan) | |
Hexal Diclac | |
Gel; Topical; Diclofenac Sodium 1% | |
Tablet, Enteric Coated; Oral; Diclofenac Sodium 25 mg | |
Tablets, Enteric Coated; Oral; Diclofenac Sodium 25 mg | |
Hexal Diclac Anti-Inflammatory Gel | |
Gel; Topical; Diclofenac Sodium 1% | |
Hexal Diclac Anti-Inflammatory Tablets | |
Tablet, Enteric Coated; Oral; Diclofenac Sodium 25 mg | |
Tablets, Enteric Coated; Oral; Diclofenac Sodium 25 mg | |
Hi-nil (Pakistan) | |
Hidiclodase (India) | |
Hidiclodase Diclofenac potassium 50 mg, Serratiopeptidase 10 mg. TAB / 10 (Hiral Labs Ltd.) | $ 0.60 |
10's (Hiral Labs Ltd.) | $ 0.60 |
Hidiclodase 50+10 Tablet (Hiral Labs Ltd.) | $ 0.06 |
HIDICLODASE tab 10's (Hiral Labs Ltd.) | $ 0.60 |
Hifenac (Bangladesh) | |
Hifenac 100mg TAB / 10 (Intas Pharmaceuticals Ltd.) | $ 0.30 |
Hifenac 200mg TAB / 10 (Intas Pharmaceuticals Ltd.) | $ 0.40 |
Hifenac 150mg AMP / 1mlx5 (Intas Pharmaceuticals Ltd.) | $ 0.18 |
100 mg x 10's (Intas Pharmaceuticals Ltd.) | $ 0.30 |
200 mg x 10's (Intas Pharmaceuticals Ltd.) | $ 0.40 |
150 mg x 1 mL x 1ml (Intas Pharmaceuticals Ltd.) | $ 0.17 |
Hifenac 150 mg Injection (Intas Pharmaceuticals Ltd.) | $ 0.18 |
Hifenac 100 mg Tablet (Intas Pharmaceuticals Ltd.) | $ 0.03 |
Hifenac 200 mg Tablet (Intas Pharmaceuticals Ltd.) | $ 0.04 |
Hifenac 150mg x 1mL AMP / 1ml (Intas Pharmaceuticals Ltd.) | $ 0.17 |
HIFENAC 100 MG TABLET 1 strip / 10 tablets each (Intas Pharmaceuticals Ltd.) | $ 0.41 |
HIFENAC 200 MG TABLET SR 1 strip / 10 tablet srs each (Intas Pharmaceuticals Ltd.) | $ 0.64 |
HIFENAC GEL 1 tube / 30 GM gel each (Intas Pharmaceuticals Ltd.) | $ 0.81 |
See 7738 substitutes for Grofenac Retard 100mg |
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).
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Information checked by Dr. Sachin Kumar, MD Pharmacology