Flexiver (Flexiver) is a non-steroidal anti-inflammatory drug (NSAID) that works by reducing hormones that cause inflammation and pain in the body. It is used to treat pain or inflammation caused by rheumatoid arthritis and osteoarthritis in adults and also to treat juvenile rheumatoid arthritis in children who are at least 2 years old. This article will detail the uses, side effects and recommended dosage of this medication as well as the indications for its use.

Flexiver: Uses

  • Osteoarthritis (OA)
    Flexiver is indicated for the relief of the signs and symptoms of osteoarthritis.
  • Rheumatoid Arthritis (RA)
    Flexiver is indicated for the relief of the signs and symptoms of rheumatoid arthritis.
  • Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course Flexiver
    is indicated for the relief of signs and symptoms of the pauciarticular or polyarticular course. Juvenile rheumatoid arthritis in patients 2 years of age and older.

How should I use flexiver?

Use Flexiver suspension as directed by your doctor. Check the medicine label for exact dosing instructions. The Flexiver suspension comes with an additional patient information sheet called a Medication Guide . Please read it carefully and read it again each time you refill the Flexiver suspension. Take Flexiver suspension by mouth.

The suspension can be taken with food if it upsets your stomach, although it may not reduce the risk of stomach or intestinal problems (eg, bleeding, ulcers).

Use a marked measuring device for medication dosing. Ask your pharmacist for help if you are not sure how to measure your dose.

Shake gently before each use.

Take Flexiver suspension with a full glass of water as directed by your doctor.

If you take cholestyramine, ask your doctor or pharmacist how to take it with Flexiver suspension.

If you miss a dose of Flexiver suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at the same time. Consult your healthcare provider if you have any questions about how to use Flexiver suspension.

Flexiver: Description

Flexiver is a non-steroidal anti-inflammatory drug (NSAID) that is used to relieve the symptoms of arthritis, primary dysmenorrhea, fever; and as an analgesic, especially where there is an inflammatory component. It is closely related to piroxicam. In Europe it is marketed under the brands Movalis, Melox and Recoxa. In North America, it is generally marketed under the brand name Flexiver. In Latin America, the drug is marketed as Tenaron.

Flexiver: Recommended dosage

Carefully consider the potential benefits and risks of Flexiver and other treatment options before deciding to use Flexiver. Use the lowest effective dose for the shortest duration compatible with the patient’s individual treatment goals. After observing the response to initial therapy with Flexiver, adjust the dose to meet the needs of an individual patient.

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In adults, the maximum recommended daily oral dose of Flexiver is 15 mg, regardless of the formulation. However, it may vary depending on the condition you have

  • In hemodialysis patients , a maximum daily dose of 7.5 mg is recommended. Flexiver can be taken regardless of the timing of meals.
  • For the relief of the signs and symptoms of osteoarthritis, the recommended oral starting and maintenance dose of Flexiver is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once a day.
  • To relieve the signs and symptoms of rheumatoid arthritis , the recommended oral starting and maintenance dose of Flexiver is 7.5 mg once a day. Some patients may receive additional benefit by increasing the dose to 15 mg once a day.
  • For the treatment of juvenile rheumatoid arthritis , the recommended oral dose of Flexiver is 7.5 mg once a day in children weighing more than 60 kg. No additional benefit was shown when increasing the dose above 7.5 mg in clinical trials. Flexiver tablets should not be used in children weighing less than 60 kg.

The use of Flexiver is not recommended in subjects with severe renal impairment.

Flexiver: side effects

The following adverse reactions are discussed in more detail in other sections of the labeling:

  • Cardiovascular thrombotic events
  • Gastrointestinal bleeding, ulceration, and perforation.
  • Hepatotoxicidad
  • Hypertension
  • Heart failure and edema
  • Renal toxicity and hyperkalemia
  • Anaphylactic reactions
  • Severe skin reactions
  • haematological toxicity

Flexiver clinical trial experience

Because clinical trials are conducted under widely varying conditions, the rates of adverse reactions seen in clinical trials of one drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates. observed in practice.

In adults

Osteoarthritis and rheumatoid arthriti
The Flexiver clinical trial database includes 10,122 osteoarthritis patients and 1012 rheumatoid arthritis patients treated with Flexiver 7.5 mg / day; and 3505 patients with osteoarthritis and 1351 patients with rheumatoid arthritis treated with Flexiver 15 mg / day. Flexiver at these doses was administered to 661 patients for at least 6 months and 312 patients for at least one year. Approximately 10,500 of these patients were treated in ten placebo-controlled and / or activated osteoarthritis trials and 2363 of these patients were treated in ten placebo-controlled and / or activated rheumatoid arthritis trials. Gastrointestinal (GI) adverse events were the most frequently reported adverse events in all treatment groups in the Flexiver trials.

A 12-week multicenter randomized trial was conducted in patients with osteoarthritis of the knee or hip to compare the efficacy and safety of Flexiver with placebo and with an active control. Cases of abdominal pain, diarrhea, dyspepsia, flatulence and nausea were recorded even with the use of placebo alone. Gastrointestinal events were greater at a dose of 7.5 mg / day than at a dose of 15 mg / day but increased dramatically, exceeding 15 mg / day. It was concluded that higher doses of Flexiver (22.5 mg and higher) have been associated with an increased risk of serious gastrointestinal events; therefore, the daily dose of Flexiver should not exceed 15 mg.

In children

Polyarticular and pauciarticular juvenile rheumatoid arthritis

Three hundred and eighty-seven patients with polyarticular and pauciarticular juvenile rheumatoid arthritis were exposed to Flexiver at doses ranging from 0.125 to 0.375 mg / kg per day in three clinical trials. These studies consisted of two 12-week multicenter randomized trials (one with a 12-week open-label extension and one with a 40-week extension) and one 1-year open-label PK study. The adverse events observed in these pediatric studies with Flexiver were similar in nature to the experience in adult clinical trials, although there were differences in frequency. In particular, the following most common adverse events, abdominal pain, vomiting, diarrhea, headache, and pyrexia were more common in pediatric trials than in adults. Rash was reported in seven patients who received Flexiver. No unexpected adverse events were identified during the course of the trials. Adverse events did not demonstrate an age or gender specific subgroup effect.

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Dr. Samantha Robson ( CRN: 0510146-5) is a nutritionist and website content reviewer related to her area of ​​expertise. With a postgraduate degree in Nutrition from The University of Arizona, she is a specialist in Sports Nutrition from Oxford University and is also a member of the International Society of Sports Nutrition.

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