What is Surgam® (tiaprofenic acid) used for?
Surgam® is a non-steroidal anti-inflammatory drug (NSAIDs), which is commonly used for these health conditions, such as:
- Rheumatoid arthritis
- Ankylosing spondylitis
- Low back pain
- Musculoskeletal disorders such as fibrositis, capsulitis, epicondylitis and other soft-tissue inflammatory conditions
- Sprains and strains
- Post-operative inflammation and pain
- Other soft tissue injuries
How should I take Surgam® (tiaprofenic acid)?
This drug is taken by mouth. Swallow it whole. It can be taken preferably with or after food.
How do I store Surgam® (tiaprofenic acid)?
Surgam® is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Surgam® in the bathroom or the freezer. There may be different brands of Surgam® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.
You should not flush Surgam® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.
Precautions & warnings
What should I know before using Surgam® (tiaprofenic acid)?
Before using this drug, there is some important safe information that you may notice:
- This medicine can sometimes cause severe cystitis. For this reason, if you experience any symptoms of this, such needing to go to the toilet more frequently, a sense of urgency to urinate, pain on passing urine, or blood in your urine, you should stop taking this medicine and consult a doctor promptly.
- Your doctor will prescribe you the lowest effective dose of this medicine for the shortest possible time necessary to relieve your symptoms. This is to minimize the chances of any side effects, particularly those mentioned below. It is important not to exceed the prescribed dose.
- NSAIDs can occasionally cause serious side effects on the gut, such as ulceration, bleeding or perforation of the stomach or intestinal lining. This type of side effect is more likely to occur in elderly people and in people taking high doses of the medicine. The risk can also be increased by taking certain other medicines. It is important that these people, as well as people with a history of disorders affecting the stomach or intestines, are closely monitored by a doctor while taking this medicine. If your doctor thinks you are at high risk of side effects on the gut, you may be prescribed an additional medicine to help protect your gut. All people having treatment with this medicine should stop taking it and consult their doctor immediately if they experience any sign of bleeding from the stomach or intestine, for example vomiting blood and/or passing black/tarry/bloodstained stools.
- Studies have suggested that use of some NSAIDs may be associated with a small increase in the risk of heart attacks and stroke (particularly if used in high doses or for long periods of time). If you have risk factors for heart disease or stroke, such as diabetes, high blood pressure, high cholesterol or smoking, your doctor will need to assess the overall benefits and risks before deciding if this medicine is suitable for you. You should tell your doctor if you experience shortness of breath, chest pains or ankle swelling while taking the medicine. Ask your doctor or pharmacist for further information.
- Very rarely, NSAIDS may cause serious blistering or peeling skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis). For this reason, you should stop taking this medicine and consult your doctor if you get a skin rash or sores inside your mouth while taking this medicine. This side effect is very rare, but if it occurs, is most likely to happen in the first month of treatment.
- If you have heart failure, liver disease or kidney disease, or you are taking diuretic medicines, your kidney function should be assessed before starting and regularly throughout treatment with this medicine.
- During long-term treatment with this medicine you should have regular check-ups with your doctor so that you can be monitored for possible side effects of the medicine. This might include routine blood tests to monitor your kidney function, liver function and levels of blood components, particularly if you are elderly.
Is it safe during pregnancy or breastfeeding?
There isn’t enough information about the safety of using this medication during pregnancy and breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking this medication.
What side effects can occur from Surgam® (tiaprofenic acid)?
Reported reactions include dyspepsia, nausea, vomiting, abdominal/upper abdominal pain, melena, hematemesis, anorexia, indigestion, heartburn, disorders of intestinal transit (flatulence, diarrhea, constipation), gastritis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease. Pancreatitis has been reported very rarely.
Peptic ulcers, occult or active gastrointestinal hemorrhage and perforation have occasionally been reported, particularly in the elderly, and in exceptional case may have been associated with fatalities.
Skin and subcutaneous tissue disorders:
Rash, urticaria, pruritus, purpura, alopecia and erythema multiforme and dermatitis bullous (Stevens-Johnson Syndrome or toxic epidermal necrolysis), photosensitivity reactions have been reported.
Immune system disorders:
Hypersensitivity reactions have been reported following treatment with NSAIDs.
Non-specific allergic reactions, asthma, especially in subjects allergic to aspirin and other NSAIDs, bronchospasm, dyspnoea, angioedema, anaphylactic shock has also been reported.
Blood and lymphatic system disorders:
Thrombocytopenia, prolonged bleeding time anemia due to bleeding may occur.
Ear and labyrinth disorders:
Vertigo, dizziness, tinnitus and drowsiness have been reported.
Nervous system disorders:
Headaches have been reported.
Renal and urinary disorders:
These may include:
- Bladder pain
- Sodium and water retention
After continuous, prolonged treatment with tiaprofenic acid in presence of urinary symptoms, inflammatory changes to the urinary tract, sometimes severe, have been observed.
NSAIDs have been reported to cause nephrotoxicity in various forms. As with other NSAIDs, isolated cases of interstitial nephritis, nephrotic syndrome and renal failure have also been reported with tiaprofenic acid.
Hepatitis, jaundice have been reported.
These may include:
- Nervous system disorders
- Optic neuritis
- Eye disorders: visual disturbances
- Musculoskeletal and connective tissue disorders: paraesthesia
- Psychiatric disorders: depression, confusion, hallucinations
- General disorders and administration site conditions: fatigue, malaise
- Blood and lymphatic system disorders: neutropenia, agranulocytosis, aplastic anemia, haemolytic anemia
Vascular and cardiac disorders:
Edema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.
Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.
What drugs may interact with Surgam® (tiaprofenic acid)?
Surgam® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.
Does food or alcohol interact with Surgam® (tiaprofenic acid)?
Surgam® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.
What health conditions may interact with Surgam® (tiaprofenic acid)?
Surgam® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.
Products may interact with this drug, such as:
- Chronic renal insufficiency (particularly careful monitoring of renal function is required)
- Arterial hypertension
- Heart failure
- A history of hepatic insufficiency
The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Surgam® (tiaprofenic acid).
What is the dose of Surgam® (tiaprofenic acid) for an adult?
The recommended dose is 600 mg daily in divided doses, 300mg twice a day or 200mg three times a day.
The dose is same as for adults. NSAIDs should be used with particular caution in older patients who are at increased risk of the serious consequences of adverse reactions.
In cases of renal, cardiac or hepatic impairment, the dosage should be kept as low as possible. It is suggested that in such cases, the dosage be reduced to 200 mg twice daily.
If an NSAID is considered necessary, elderly patients should receive the lowest effective dose for the shortest possible duration and be monitored regularly for gastrointestinal bleeding for following initiation of NSAID therapy
What is the dose of Surgam® (tiaprofenic acid) for a child?
The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.
How is Surgam® (tiaprofenic acid) available?
Surgam® is available in the following dosage forms and strengths:
- Surgam® Tablets 300 mg
What should I do in case of an emergency or overdose?
In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.
What should I do if I miss a dose?
If you miss a dose of Surgam®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.
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