Non-Interchangeability with Other Formulations of Flexocam
Flexocam tablets have not shown equivalent systemic exposure to other approved formulations of oral Flexocam. Therefore, Flexocam tablets are not interchangeable with other formulations of oral Flexocam product even if the total milligram strength is the same. Do not substitute similar dose strengths of Flexocam tablets with other formulations of oral Flexocam product.
Flexocam side effects
Get emergency medical help if you have signs of an allergic reaction to Flexocam: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.
Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.
Stop using Flexocam and call your doctor at once if you have:
the first sign of any skin rash, no matter how mild;
shortness of breath (even with mild exertion);
swelling or rapid weight gain;
signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
liver problems - nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
kidney problems - little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;
low red blood cells (anemia) - pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Common Flexocam side effects may include:
upset stomach, nausea, vomiting, heartburn;
diarrhea, constipation, gas;
cold symptoms, flu symptoms.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Rated Flexocam for Osteoarthritis Report
Side effects of severe drowsiness, ears ringing, dizziness and worsened depression. Minimal to zero improvement in pain.
What Are NSAIDs and Flexocam?
Nonsteroidal anti-inflammatory drugs have many other drugs under their umbrella: ibuprofen, nabumetone, and indomethacin, to name a few. They address problems caused by prostaglandins, chemical compounds in the body that contribute to inflammation in bone joints. The inflammation leads to the recognizable symptoms of pain, such as the swelling and tenderness that sufferers of arthritis are familiar with.
When a patient takes Flexocam, the chemicals in the drug block the enzymes that produce prostaglandins and reduce the overall level of those chemical compounds. This results in a decrease in inflammation and the pain symptoms they cause.
For this reason, Flexocam is prescribed for the treatment of rheumatoid arthritis, osteoarthritis, and juvenile rheumatoid arthritis. The brand-name formulation of Flexocam is Mobic. The drug is administered in capsule, tablet, or liquid forms. The average dose is 5-7.5 mg once a day, with room for adjustment.
Flexocam tablets are indicated for relief of the signs and symptoms of osteoarthritis .
Flexocam Side Effects
As with any other drug, Flexocam has side effects. What sets it apart is that it is a high-dose NSAID, and it can cause significant issues in patients who have heart and gastrointestinal conditions. Some patients are allergic to nonsteroidal anti-inflammatory drugs in general, so taking Flexocam will exacerbate negative reactions, such as being short of breath. As a result of this, people with asthma will be at a higher risk for triggering their allergies if they take Flexocam or any other NSAID.
Patients may also experience hypertension (high blood pressure or an increase thereof) if they have certain health conditions while they take Flexocam, and they might also experience fluid retention and swelling. Patients at risk for heart failure should take Flexocam very carefully, and never without a physician’s approval and supervision.
1 MedDRA high level term (preferred terms): dyspeptic signs and symptoms (dyspepsia, dyspepsia aggravated, eructation, gastrointestinal irritation), upper respiratory tract infections-pathogen unspecified (laryngitis NOS, pharyngitis NOS, sinusitis NOS), joint related signs and symptoms (arthralgia, arthralgia aggravated, joint crepitation, joint effusion, joint swelling)
2 MedDRA preferred term: nausea, abdominal pain NOS, influenza-like illness, headaches NOS, and rash NOS
No . of Patients 469 481 477 Gastrointestinal Disorders 14.1 18.9 16.8 Abdominal pain NOS 2 0.6 2.9 2.3 Dyspeptic signs and symptoms 1 3.8 5.8 4.0 Nausea 2 2.6 3.3 3.8 General Disorders and Administration Site Conditions Influenza-like illness 2 2.1 2.9 2.3 Infection and Infestations Upper respiratory tract infections-pathogen >1 4.1 7.0 6.5 Musculoskeletal and Connective Tissue Disorders Joint related signs and symptoms 1 1.9 1.5 2.3 Nervous System Disorders Headaches NOS 2 6.4 6.4 5.5 Skin and Subcutaneous Tissue Disorders Rash NOS 2 1.7 1.0 2.1
The adverse events that occurred with Flexocam in ≥2% of patients treated short-term (4 to 6 weeks) and long-term (6 months) in active-controlled osteoarthritis trials are presented in Table 2
Rated Flexocam for Osteoarthritis Report
I have had both knees and my right hip replaced, from sport related wear. I'm 63 years old and have been using anti inflammatories since mid 30's. I won't name the actual ones I used, but the two I initially used caused issues, I was then prescribed Flexocam and had no more problems I guess it depends on the individual, but i found they agreed with me. Now that I have had the joints replaced, I still use the anti inflammatory if I know I'm going to have a problem. like today when I cycled under a tree and nearly took my head off. Home two panadol oestio's and a Flexocam, i will see how my neck feels tommorrow.lol
Flexocam is not a substitute for low dose aspirin for cardiovascular protection. ACE Inhibitors , Angiotensin Receptor Blockers , or Beta - Blockers Clinical Impact :
NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Intervention :
During concomitant use of Flexocam and ACE inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. During concomitant use of Flexocam and ACE inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function . When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter. Diuretics
Clinical Impact :
Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis. However, studies with furosemide agents and Flexocam have not demonstrated a reduction in natriuretic effect. Furosemide single and multiple dose pharmacodynamics and pharmacokinetics are not affected by multiple doses of Flexocam. Intervention :
During concomitant use of Flexocam with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects . Lithium Clinical Impact :
NSA >see Clinical Pharmacology ( 12 . 3 )]. Intervention :
During concomitant use of Flexocam and lithium, monitor patients for signs of lithium toxicity. Methotrexate Clinical Impact : Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). Intervention : During concomitant use of Flexocam and methotrexate, monitor patients for methotrexate toxicity. Cyclosporine
Clinical Impact : Concomitant use of Flexocam and cyclosporine may increase cyclosporine’s nephrotoxicity. Intervention : During concomitant use of Flexocam and cyclosporine, monitor patients for signs of worsening renal function. NSAIDs and Salicylates
Clinical Impact : Concomitant use of Flexocam with other NSA >see Warnings and Precautions ( 5 . 2 )]. Intervention : The concomitant use of Flexocam with other NSAIDs or salicylates is not recommended. Pemetrexed
Clinical Impact : Concomitant use of Flexocam and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information). Intervention : During concomitant use of Flexocam and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. Patients taking Flexocam should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration. In patients with creatinine clearance below 45 mL/min, the concomitant administration of Flexocam with pemetrexed is not recommended.
- This drug has a black box warning. This is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients about drug effects that may be dangerous.
- Heart risk warning: This drug may increase your risk of developing a blood clot, heart attack, or stroke, which can be fatal. Your risk may be higher if you’re taking it long term, at high doses, or if you already have heart problems or risk factors for heart disease, such as high blood pressure. You shouldn’t take Flexocam for pain before, during, or after coronary artery bypass graft surgery. This can increase your risk for a heart attack or stroke.
- Stomach problems warning: This medication may increase your risk of developing stomach and intestinal problems. These include bleeding, ulcers, and holes in your stomach or intestines, which can be fatal. These effects can occur any time while you’re taking this drug. They may happen without any signs or symptoms. Adults aged 65 years and older are at higher risk of these stomach or intestinal problems.
Taking warfarin with Flexocam increases your risk of stomach bleeding.
Other uses for this medicine
Flexocam is also used sometimes to treat ankylosing spondylitis (arthritis that mainly affects the spine). Talk to your doctor about the possible risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Flexocam 15 mg once daily for 7 days did not alter the plasma concentration profile of digoxin after β- acetyldigoxin administration for 7 days at clinical doses. In vitro testing found no protein binding drug interaction between digoxin and Flexocam.
Juvenile Rheumato > The use of Flexocam for the treatment of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older was evaluated in two 12-week, double-blind, parallel-arm, active-controlled trials.
Both studies included three arms: naproxen and two doses of Flexocam. In both studies, Flexocam dosing began at 0.125 mg/kg/day (7.5 mg maximum) or 0.25 mg/kg/day (15 mg maximum), and naproxen dosing began at 10 mg/kg/day. One study used these doses throughout the 12-week dosing period, while the other incorporated a titration after 4 weeks to doses of 0.25 mg/kg/day and 0.375 mg/kg/day (22.5 mg maximum) of Flexocam and 15 mg/kg/day of naproxen.
The efficacy analysis used the ACR Pediatric 30 responder definition, a composite of parent and investigator assessments, counts of active joints and joints with limited range of motion, and erythrocyte sedimentation rate. The proportion of responders were similar in all three groups in both studies, and no difference was observed between the Flexocam dose groups.
Uses of Flexocam / How to use Flexocam?
Study the Medication Guidelines provided by the doctor before start using Flexocam and every time you get a renewal. If you have any confusion regarding uses, feel free to consult your doctor or pharmacist.
Take the dosages by mouth as prescribed by your doctor, usually one time daily. Drink a full glass of water (8 ounces/240 milliliters) with it except if your doctor tells you otherwise. Try not to rests for somewhere around 10 minutes after taking this medication.
On the off chance that you are taking the fluid type of this drug, shake the bottle delicately before each dose. Cautiously measure the dose utilizing an estimating gadget/spoon. Try not to use a household spoon since you may not get the right proportion of the dosage.
If stomach upset happens while taking this drug, take it with some food, milk, or an acid neutralizer. The dosage depends on your ailment and reaction to treatment. The lowest effective dosage ought to dependably be used and just for the recommended period of time. Try not to take a greater amount of this medicine than recommended in light of the fact that higher portions increment the possibility of stomach ulcers/bleeding.
The capsule form of Flexocam conveys different measures of prescription than the tablet and solution forms. Try not to switch between the capsule and different forms of Flexocam without your specialist’s consent and directions.
It might take as long as about fourteen days before you get the full advantage of this medication. Utilize this prescription properly to get the most benefit of it. Make sure to utilize it in the meantime every day.
Consult your doctor if your condition worsens.