What is Serataur-D10?
Serataur-D10 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, Serataur-D10 does not cure osteoarthritis and will help you only as long as you continue to use it.
Serataur-D10 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 Serataur-D10 helps this condition is unknown.
Serataur-D10 topical solution is used to treat pain and swelling caused by osteoarthritis of the knees.
Serataur-D10 topical patch is used to treat acute pain caused by minor strains, sprains, and contusions (bruises).
Serataur-D10 is available only with your doctor's prescription.
Serataur-D10 indications
Intramuscular
Renal colic
Adult: As Serataur-D10 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 Serataur-D10 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 Serataur-D10 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 Serataur-D10 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 Serataur-D10 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 Serataur-D10 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 Serataur-D10 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 Serataur-D10 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 Serataur-D10 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 Serataur-D10 Na (0.1% soln): Instill into appropriate eye 4 times w/in 2 hr before surgery.
Ophthalmic
Post-photorefractive keratectomy pain
Adult: As Serataur-D10 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 Serataur-D10 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 Serataur-D10 Na: 75-150 mg/day in divided doses. Max: 150 mg/day.
Oral
Migraine
Adult: As Serataur-D10 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 Serataur-D10 Na: 100 mg once daily.
Topical/Cutaneous
Actinic keratoses
Adult: As Serataur-D10 Na (3% gel): Apply bid for 60-90 days.
Topical/Cutaneous
Osteoarthritis
Adult: As Serataur-D10 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 Serataur-D10 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 Serataur-D10?
Use Serataur-D10 solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Serataur-D10 solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Serataur-D10 solution refilled.
- Do not apply Serataur-D10 solution to infected skin; open wounds; or red, swollen, or peeling skin.
- Wash your hands immediately before and after using Serataur-D10 solution.
- Wash the affected area and dry completely before using Serataur-D10 solution.
- To apply Serataur-D10 solution, dispense 10 drops at a time onto the knee or into your hand. Spread Serataur-D10 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 Serataur-D10 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 Serataur-D10 solution.
- If you miss a dose of Serataur-D10 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 Serataur-D10 solution.
Uses of Serataur-D10 in details
Serataur-D10 is used to relieve pain from various conditions. This form of Serataur-D10 is used to treat migraine headaches. Serataur-D10 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 Serataur-D10
Read the Medication Guide provided by your pharmacist before you start taking Serataur-D10 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 Serataur-D10 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.
Serataur-D10 description
The active substance is sodium-[o[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (= Serataur-D10 sodium).
Each enteric tablet contains 25 mg or 50 mg of Serataur-D10 sodium.
One prolonged-release tablet contains 100 mg of Serataur-D10 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.
Serataur-D10 dosage
General Dosing Instructions
Carefully consider the potential benefits and risks of Serataur-D10 and other treatment options before deciding to use Serataur-D10. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
The effectiveness of Serataur-D10 when taken with food has not been studied in clinical studies. Taking Serataur-D10 with food may cause a reduction in effectiveness compared to taking Serataur-D10 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 Serataur-D10 compared to patients with normal hepatic function. As with other Serataur-D10 products, start treatment at the lowest dose. If efficacy is not achieved with the lowest dose, discontinue use.
Non-Interchangeability with Other Formulations of Serataur-D10
Serataur-D10 capsules are not interchangeable with other formulations of oral Serataur-D10 even if the milligram strength is the same. Serataur-D10 capsules contain Serataur-D10 free acid whereas other Serataur-D10 products contain a salt of Serataur-D10, i.e., Serataur-D10 potassium or sodium. A 35 mg dose of Serataur-D10 is approximately equal to 37.6 mg of sodium Serataur-D10 or 39.5 mg of potassium Serataur-D10. Therefore, do not substitute similar dosing strengths of other Serataur-D10 products without taking this into consideration.
Serataur-D10 interactions
See also:
What other drugs will affect Serataur-D10?
Aspirin: Concomitant administration of Serataur-D10 and aspirin is not recommended because Serataur-D10 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 Serataur-D10 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 Serataur-D10 and warfarin, requires close monitoring of patients to be certain that no change in their anticoagulant dosage is required.
Digoxin, Methotrexate, Cyclosporine: Serataur-D10, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Ingestion of Serataur-D10 may increase serum concentrations of digoxin and methotrexate and increase cyclosporine's nephrotoxicity. Patients who begin taking Serataur-D10 or who increase their Serataur-D10 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: Serataur-D10 decreases lithium renal clearance and increases lithium plasma levels. In patients taking Serataur-D10 and lithium concomitantly, lithium toxicity may develop.
Oral Hypoglycemics:
Serataur-D10 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 Serataur-D10 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 Serataur-D10 may alter a diabetic patient's response to insulin or oral hypoglycemic agents.Diuretics: Serataur-D10 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 Serataur-D10. Phenobarbital toxicity has been reported to have occurred in a patient on chronic phenobarbital treatment following the initiation of Serataur-D10 therapy.
Serataur-D10 side effects
See also:
What are the possible side effects of Serataur-D10?
There have been cases reported of Serataur-D10 being associated with the development of symptoms resembling the syndrome of inappropriate antidiuretic hormone secretion in elderly women. A patient who had been taking Serataur-D10 for several years and had increasingly complained of dry, gritty eyes noticed that eye irritation disappeared within 3 days when Serataur-D10 had to be discontinued because of GI effects.
The most frequent adverse effects reported in patients given Serataur-D10 are GI in nature. Typical reactions include epigastric pain, nausea, vomiting and diarrhoea. Rarely, peptic ulcer and GI bleeding have occurred. Serataur-D10 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 Serataur-D10. Elevations of serum aminotransferase activity and clinical hepatitis, including fetal fulminant hepatitis have occurred in patients taking Serataur-D10. Self-limiting skin reaction eg, rash or pruritus may occur in patients given Serataur-D10.
Aspirin-sensitive asthmatic patients have developed reactions (rhinorrhoea, tightness of chest, wheezing, dyspnoea) when challenged with Serataur-D10 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 Serataur-D10.
Serataur-D10 contraindications
See also:
What is the most important information I should know about Serataur-D10?
Hypersensitivity to Serataur-D10 sodium or to any of the excipients of Serataur-D10.
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 Serataur-D10 (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 Serataur-D10 (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 Serataur-D10 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 Serataur-D10 may increase with dose and duration of exposure, Serataur-D10 should always be prescribed at the lowest effective daily dose and for the shortest duration possible.
Renal Impairment: Serataur-D10 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 Serataur-D10 to patients with mild to moderate renal impairment.
Hepatic Impairment: Serataur-D10 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 Serataur-D10 to patients with mild to moderate hepatic impairment.
Active ingredient matches for Serataur-D10:
Diclofenac in India.
Diclofenac sodium/serratiopeptidase in India.
| Unit description / dosage (Manufacturer) | Price, USD |
| Serataur-D10 Diclofenac sodium 50 mg, Serratiopeptidase 10 mg. TAB / 10 | $ 0.60 |
| 10's | $ 0.60 |
| SERATAUR-D10 tab 10's (Taurus Labs) | $ 0.60 |
List of Serataur-D10 substitutes (brand and generic names): | |
| Seranavi (India) | |
| Seranavi 50 mg/10 mg Tablet (Speciality Meditech Pvt. Ltd.) | $ 0.06 |
| Serazyme-DP (India) | |
| Serazyme-DP Diclofenac potassium 50 mg, Serratiopeptidase 10 mg. TAB / 10 (Saga Lab) | $ 0.54 |
| 10's (Saga Lab) | $ 0.54 |
| SERAZYME-DP tab 10's (Saga Lab) | $ 0.54 |
| Seren-DP (India) | |
| Seren-DP Diclofenac potassium 50 mg, serratiopeptidase 10 mg, paracetamol 500 mg. TAB / 10 (Active HC) | $ 0.71 |
| SEREN-DP tab 10's (Active HC) | $ 0.71 |
| Serflam D (India) | |
| Serflam D Diclofenac potassium 50 mg, Serratiopeptidase / ER 15 mg. FC-TAB / 100 (Burgeon Pharmaceuticals Pvt. Ltd.) | $ 6.27 |
| 100's (Burgeon Pharmaceuticals Pvt. Ltd.) | $ 6.27 |
| Serflam D 50+15 Burgeon Pharma Tablet (Burgeon Pharmaceuticals Pvt. Ltd.) | $ 0.06 |
| Serflam D 50+15 Tablet (Burgeon Pharmaceuticals Pvt. Ltd.) | $ 0.06 |
| SERFLAM D TABLET 1 strip / 10 tablets each (Burgeon Pharmaceuticals Pvt. Ltd.) | $ 0.60 |
| Serflam D Tablet (Burgeon Pharmaceuticals Pvt. Ltd.) | $ 0.06 |
| Seriz-D (India) | |
| Seriz-D Serratiopeptidase 10 mg, Diclofenac 50 mg. TAB / 10 (Ritz Pharma) | $ 0.70 |
| 10's (Ritz Pharma) | $ 0.70 |
| SERIZ-D tab 10's (Ritz Pharma) | $ 0.70 |
| Serofin (India) | |
| Serofin 50mg INJ / 3ml (Globus Remedies Ltd) | $ 0.08 |
| 50 mg x 3ml (Globus Remedies Ltd) | $ 0.08 |
| Serofin 75 mg Injection (Globus Remedies Ltd) | $ 0.03 |
| SEROFIN inj 25 mg x 1 mL x 3ml (Globus Remedies Ltd) | $ 0.08 |
| Serofin Plus (India) | |
| Serofin Plus Diclofenac potassium 50 mg, Serratiopeptidase 10 mg. TAB / 100 (Globus Remedies Ltd) | $ 6.63 |
| 100's (Globus Remedies Ltd) | $ 6.63 |
| Serofin Plus 50+10 Tablet (Globus Remedies Ltd) | $ 0.07 |
| SEROFIN PLUS tab 10's (Globus Remedies Ltd) | $ 0.66 |
| Seros-D (India) | |
| Seros-D Diclofenac sodium 50 mg, Serratiopeptidase 10 mg. TAB / 10 (DWD) | |
| 10's (DWD) | |
| SEROS-D tab 10's (DWD) | |
| Serous-D (India) | |
| Serous-D Diclofenac potassium 50 mg, Serratiopeptidase 10 mg. TAB / 10 (Zenon) | $ 0.68 |
| 10's (Zenon) | $ 0.68 |
| SEROUS-D tab 10's (Zenon) | $ 0.68 |
| Serra-D (India) | |
| Serra-D Diclofenac potassium 50 mg, Serratiopeptidase 10 mg. TAB / 10 (Kamron) | $ 0.73 |
| 10's (Kamron) | $ 0.73 |
| SERRA-D tab 10's (Kamron) | $ 0.73 |
| Serranic-D (India) | |
| 10's (Medihealth) | $ 0.63 |
| Serranic-D Serratiopeptidase 10 mg, diclofenac sodium 50 mg. TAB / 10 (Medihealth) | $ 0.63 |
| SERRANIC-D tab 10's (Medihealth) | $ 0.63 |
| Serras-D (India) | |
| Serras-D Serratiopeptidase 10 mg, Diclofenac potassium 50 mg. TAB / 100 (Shreshtha) | $ 5.18 |
| 100's (Shreshtha) | $ 5.18 |
| SERRAS-D tab 10's (Shreshtha) | $ 0.52 |
| Serrinova (India) | |
| Serrinova Diclofenac potassium 50 mg, Serratiopeptidase 10 mg. TAB / 10 (Daffohils) | |
| 10's (Daffohils) | |
| SERRINOVA tab 10's (Daffohils) | |
| Serrint-D (India) | |
| Serrint-D Diclofenac potassium 50 mg, Serratiopeptidase 10 mg. TAB / 10 (Intag) | |
See 7758 substitutes for Serataur-D10 | |
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
