What is Topac IM?
Topac IM 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, Topac IM does not cure osteoarthritis and will help you only as long as you continue to use it.
Topac IM 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 Topac IM helps this condition is unknown.
Topac IM topical solution is used to treat pain and swelling caused by osteoarthritis of the knees.
Topac IM topical patch is used to treat acute pain caused by minor strains, sprains, and contusions (bruises).
Topac IM is available only with your doctor's prescription.
Topac IM indications
Intramuscular
Renal colic
Adult: As Topac IM 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 Topac IM 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 Topac IM 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 Topac IM 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 Topac IM 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 Topac IM 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 Topac IM 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 Topac IM 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 Topac IM 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 Topac IM Na (0.1% soln): Instill into appropriate eye 4 times w/in 2 hr before surgery.
Ophthalmic
Post-photorefractive keratectomy pain
Adult: As Topac IM 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 Topac IM 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 Topac IM Na: 75-150 mg/day in divided doses. Max: 150 mg/day.
Oral
Migraine
Adult: As Topac IM 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 Topac IM Na: 100 mg once daily.
Topical/Cutaneous
Actinic keratoses
Adult: As Topac IM Na (3% gel): Apply bid for 60-90 days.
Topical/Cutaneous
Osteoarthritis
Adult: As Topac IM 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 Topac IM 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 Topac IM?
Use Topac IM solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Topac IM solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Topac IM solution refilled.
- Do not apply Topac IM solution to infected skin; open wounds; or red, swollen, or peeling skin.
- Wash your hands immediately before and after using Topac IM solution.
- Wash the affected area and dry completely before using Topac IM solution.
- To apply Topac IM solution, dispense 10 drops at a time onto the knee or into your hand. Spread Topac IM 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 Topac IM 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 Topac IM solution.
- If you miss a dose of Topac IM 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 Topac IM solution.
Uses of Topac IM in details
Topac IM is used to relieve pain from various conditions. This form of Topac IM is used to treat migraine headaches. Topac IM 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 Topac IM
Read the Medication Guide provided by your pharmacist before you start taking Topac IM 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 Topac IM 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.
Topac IM description
The active substance is sodium-[o[(2,6-dichlorophenyl)-amino]-phenyl]-acetate (= Topac IM sodium).
Each enteric tablet contains 25 mg or 50 mg of Topac IM sodium.
One prolonged-release tablet contains 100 mg of Topac IM 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.
Topac IM dosage
General Dosing Instructions
Carefully consider the potential benefits and risks of Topac IM and other treatment options before deciding to use Topac IM. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
The effectiveness of Topac IM when taken with food has not been studied in clinical studies. Taking Topac IM with food may cause a reduction in effectiveness compared to taking Topac IM 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 Topac IM compared to patients with normal hepatic function. As with other Topac IM products, start treatment at the lowest dose. If efficacy is not achieved with the lowest dose, discontinue use.
Non-Interchangeability with Other Formulations of Topac IM
Topac IM capsules are not interchangeable with other formulations of oral Topac IM even if the milligram strength is the same. Topac IM capsules contain Topac IM free acid whereas other Topac IM products contain a salt of Topac IM, i.e., Topac IM potassium or sodium. A 35 mg dose of Topac IM is approximately equal to 37.6 mg of sodium Topac IM or 39.5 mg of potassium Topac IM. Therefore, do not substitute similar dosing strengths of other Topac IM products without taking this into consideration.
Topac IM interactions
See also:
What other drugs will affect Topac IM?
Aspirin: Concomitant administration of Topac IM and aspirin is not recommended because Topac IM 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 Topac IM 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 Topac IM and warfarin, requires close monitoring of patients to be certain that no change in their anticoagulant dosage is required.
Digoxin, Methotrexate, Cyclosporine: Topac IM, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Ingestion of Topac IM may increase serum concentrations of digoxin and methotrexate and increase cyclosporine's nephrotoxicity. Patients who begin taking Topac IM or who increase their Topac IM 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: Topac IM decreases lithium renal clearance and increases lithium plasma levels. In patients taking Topac IM and lithium concomitantly, lithium toxicity may develop.
Oral Hypoglycemics:
Topac IM 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 Topac IM 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 Topac IM may alter a diabetic patient's response to insulin or oral hypoglycemic agents.Diuretics: Topac IM 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 Topac IM. Phenobarbital toxicity has been reported to have occurred in a patient on chronic phenobarbital treatment following the initiation of Topac IM therapy.
Topac IM side effects
See also:
What are the possible side effects of Topac IM?
There have been cases reported of Topac IM being associated with the development of symptoms resembling the syndrome of inappropriate antidiuretic hormone secretion in elderly women. A patient who had been taking Topac IM for several years and had increasingly complained of dry, gritty eyes noticed that eye irritation disappeared within 3 days when Topac IM had to be discontinued because of GI effects.
The most frequent adverse effects reported in patients given Topac IM are GI in nature. Typical reactions include epigastric pain, nausea, vomiting and diarrhoea. Rarely, peptic ulcer and GI bleeding have occurred. Topac IM 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 Topac IM. Elevations of serum aminotransferase activity and clinical hepatitis, including fetal fulminant hepatitis have occurred in patients taking Topac IM. Self-limiting skin reaction eg, rash or pruritus may occur in patients given Topac IM.
Aspirin-sensitive asthmatic patients have developed reactions (rhinorrhoea, tightness of chest, wheezing, dyspnoea) when challenged with Topac IM 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 Topac IM.
Topac IM contraindications
See also:
What is the most important information I should know about Topac IM?
Hypersensitivity to Topac IM sodium or to any of the excipients of Topac IM.
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 Topac IM (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 Topac IM (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 Topac IM 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 Topac IM may increase with dose and duration of exposure, Topac IM should always be prescribed at the lowest effective daily dose and for the shortest duration possible.
Renal Impairment: Topac IM 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 Topac IM to patients with mild to moderate renal impairment.
Hepatic Impairment: Topac IM 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 Topac IM to patients with mild to moderate hepatic impairment.
Active ingredient matches for Topac IM:
| Unit description / dosage (Manufacturer) | Price, USD |
| TOPAC IM INJECTION 1 vial / 3 ML injection each (Abbott India Ltd) | $ 0.10 |
List of Topac IM substitutes (brand and generic names): | |
| Topac Tab (India) | |
| TOPAC TAB tab 50 mg x 10's (AHPL) | $ 0.25 |
| Topalgon (Greece) | |
| Topfans (Italy) | |
| Topflam (Vietnam) | |
| Topflam 100mg TAB / 100 (Acme Pharmaceuticals) | $ 2.77 |
| Topflam 25 mg x 1 Blister x 6 Tablet (Acme Pharmaceuticals) | |
| 100 mg x 100's (Acme Pharmaceuticals) | $ 2.77 |
| Topflam 100 mg Tablet (Acme Pharmaceuticals) | $ 0.03 |
| TOPFLAM 100MG TABLET 1 strip / 10 tablets each (Acme Pharmaceuticals) | $ 0.29 |
| TOPFLAM tab 100 mg x 10's (Acme Pharmaceuticals) | $ 0.28 |
| Topflam 100mg Tablet (Acme Pharmaceuticals) | $ 0.03 |
| Toryxil (Germany) | |
| Trabona (Finland) | |
| Tratul (Austria, Romania) | |
| Tratul 50 mg (Austria) | |
| Tratul Retard (Austria) | |
| Tratul retard 100 mg (Austria) | |
| Traulen (Italy) | |
| Traumasport (Switzerland) | |
| Traumus (Chile) | |
| Travmagel (Bulgaria) | |
| Travmagel 1% (Malta) | |
| Tridic | |
| Tridic 25mg/ml INJ | |
| Tridic 30mg/ml INJ | |
| TRIDIC 50MG/325MG/250MG TABLET 1 strip / 10 tablets each (East African India Remedies Pvt Ltd) | $ 0.54 |
| Tridic 250 mg/50 mg/325 mg Tablet (East African India Remedies Pvt Ltd) | $ 0.05 |
| Trifenac (India) | |
| Trifenac 75mg x 3mL INJ / 3ml (Trigenesis Lifesciences Pvt. Ltd.) | $ 0.08 |
| 75 mg x 3 mL x 3ml (Trigenesis Lifesciences Pvt. Ltd.) | $ 0.08 |
| Trifenac 75 mg Injection (Trigenesis Lifesciences Pvt. Ltd.) | $ 0.03 |
| TRIFENAC inj 75 mg x 3 mL x 3ml (Trigenesis Lifesciences Pvt. Ltd.) | $ 0.08 |
| Trifenac-S (India) | |
| Trifenac-S Diclofenac potassium 50 mg, Serratiopeptidase 10 mg TAB / 10 (Trigenesis) | $ 0.66 |
| 10's (Trigenesis) | $ 0.66 |
| TRIFENAC-S tab 10's (Trigenesis) | $ 0.66 |
| Tripdase (India) | |
| Tripdase Diclofenac potassium 50 mg, paracetamol 500 mg. TAB / 10x10 (Novogen Captab) | $ 8.73 |
| TRIPDASE tab 10's (Novogen Captab) | $ 0.87 |
| Trips (India) | |
| Trips Diclofenac sodium 50 mg, Serratiopeptidase 10 mg. FC-TAB / 10 (Maneesh Healthcare (Maneesh Pharmaceuticals Ltd)) | $ 0.76 |
| 10's (Maneesh Healthcare (Maneesh Pharmaceuticals Ltd)) | $ 0.76 |
| Trips 50+10 Tablet (Maneesh Healthcare (Maneesh Pharmaceuticals Ltd)) | $ 0.08 |
| TRIPS 50MG/10MG TABLET 1 strip / 10 tablets each (Maneesh Healthcare (Maneesh Pharmaceuticals Ltd)) | $ 0.69 |
| TRIPS film-coated tab 10's (Maneesh Healthcare (Maneesh Pharmaceuticals Ltd)) | $ 0.76 |
| Trips 50 mg/10 mg Tablet (Maneesh Healthcare (Maneesh Pharmaceuticals Ltd)) | $ 0.07 |
| Trips-K (India) | |
| Trips-K Diclofenac potassium 50 mg, Serratiopeptidase 10 mg. FC-TAB / 10 (Maneesh Healthcare) | $ 0.73 |
| 10's (Maneesh Healthcare) | $ 0.73 |
See 7738 substitutes for Topac IM | |
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 Topac IM 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 Topac IM. 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
