In late pregnancy, as with other NSAIDs, Flodin tablets should be avoided because it may cause premature closure of the ductus arteriosus.
Flodin Tablets, USP 7.5 mg is available as light yellow colored, oval shaped uncoated tablet engraved S 160 on one side and plain on other side.
Flodin Tablets, USP 15 mg is available as yellow colored, oval shaped uncoated tablet engraved S 161 on one side and plain on other side.
Flodin Tablets, USP 7.5 mg are available as follows:
Bottles of 100 NDC: 60505-3578-1 Bottles of 500 NDC: 60505-3578-5
Flodin Tablets, USP 15 mg are available as follows:
Bottles of 100 NDC: 60505-3579-1 Bottles of 500 NDC: 60505-3579-5
Store at 20° to 25° C (68° to 77° F) . Keep Flodin Tablets, USP in a dry place. Dispense tablets in a tight container.
Keep this and all medications out of the reach of children.
manufactured by: Strides Arcolab Ltd.Bangalore-560 076, India. Manufactured for: Apotex Corp., Weston, Florida 33326. Revised: January 2010
It's important to take this and other medication as prescribed. If you feel you have taken too much get emergency help immediately.
Signs of overdose may include asthma-like symptoms, nausea, vomiting, gastritis, and upper abdominal pain or burning sensation.
2.6 Headache 2.4 2.7 3.6 2.6 Hematologic Anemia 0.1 0.0 4.1 2.9 Musculoskeletal Arthralgia 0.5 0.0 5.3 1.3 Back pain 0.5 0.4 3.0 0.7 Psychiatric Insomnia 0.4 0.0 3.6 1.6 Respiratory Coughing 0.2 0.8 2.4 1.0 Upper respiratory tract infection 0.2
Skin Pruritus 0.4 1.2 2.4 0.0 Rash† 0.3 1.2 3.0 1.3 Urinary Micturition frequency 0.1 0.4 2.4 1.3 Urinary tract infection 0.3
Higher doses of Flodin (22.5 mg and greater) have been associated with an increased risk of serious GI events; therefore, the daily dose of Flodin should not exceed 15 mg.
Pauciarticular and Polyarticular Course Juvenile Rheumatoid Arthritis (JRA) Three hundred and eighty-seven patients with pauciarticular and polyarticular course JRA were exposed to Flodin with doses ranging from 0.125 to 0.375 mg/kg per day in three clinical trials. These studies consisted of two 12-week multicenter, double-blind, 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 Flodin were similar in nature to the adult clinical trial experience, 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 the pediatric than in the adult trials. Rash was reported in seven ( Body as a Whole allergic reaction, face edema, fatigue, fever, hot flushes, malaise, syncope, weight decrease, weight increase Cardiovascular angina pectoris, cardiac failure, hypertension, hypotension, myocardial infarction, vasculitis Central and Peripheral Nervous System convulsions, paresthesia, tremor, vertigo Gastrointestinal colitis, dry mouth, duodenal ulcer, eructation, esophagitis, gastric ulcer, gastritis, gastroesophageal reflux, gastrointestinal hemorrhage, hematemesis, hemorrhagic duodenal ulcer, hemorrhagic gastric ulcer, intestinal perforation, melena, pancreatitis, perforated duodenal ulcer, perforated gastric ulcer, stomatitis ulcerative Heart Rate and Rhythm arrhythmia, palpitation, tachycardia Hematologic leukopenia, purpura, thrombocytopenia Liver and Biliary System ALT increased, AST increased, bilirubinemia, GGT increased, hepatitis Metabolic and Nutritional dehydration Psychiatric abnormal dreaming , anxiety, appetite increased, confusion, depression, nervousness, somnolence Respiratory asthma, bronchospasm, dyspnea Skin and Appendages alopecia, angioedema, bullous eruption, photosensitivity reaction, pruritus, sweating increased, urticaria Special Senses abnormal vision, conjunctivitis, taste perversion, tinnitus Urinary System albuminuria, BUN increased, creatinine increased, hematuria, renal failure
Flodin has been associated with anaphylactic reactions in patients with and without known hypersensitivity to Flodin and in patients with aspirin-sensitive asthma .
Seek emergency help if an anaphylactic reaction occurs.
Mechanism of Action
Flodin has analgesic, anti-inflammatory, and antipyretic properties.
The mechanism of action of Flodin, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).
Flodin is a potent inhibitor of prostaglandin synthesis in vitro . Flodin concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because Flodin is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.
Blood pressure warning
This medication may increase or worsen your blood pressure. This can increase your risk of heart attack or stroke. Your doctor may check your blood pressure while you’re taking Flodin. Some medicines for high blood pressure may not work as well as they should when you’re taking Flodin.
Gastrointestinal Bleeding, Ulceration, and Perforation
NSAIDs, including Flodin, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occurred in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. However, even short-term NSAID therapy is not without risk.
Risk Factors for GI Bleeding, Ulceration, and Perforation
Patients with a prior history of peptic ulcer disease and/or GI bleeding who used NSAIDs had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors. Other factors that increase the risk of GI bleeding in patients treated with NSAIDs include longer duration of NSAID therapy; concomitant use of oral corticosteroids, aspirin, anticoagulants, or selective serotonin reuptake inhibitors (SSRIs); smoking; use of alcohol; older age; and poor general health status. Most postmarketing reports of fatal GI events occurred in elderly or debilitated patients. Additionally, patients with advanced liver disease and/or coagulopathy are at increased risk for GI bleeding.
Strategies to Minimize the GI Risks in NSAID-treated patients :
- Use the lowest effective dosage for the shortest possible duration.
- Avo >see Drug Interactions (7) ].
Uses of Flodin / How to use Flodin?
Study the Medication Guidelines provided by the doctor before start using Flodin 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 Flodin conveys different measures of prescription than the tablet and solution forms. Try not to switch between the capsule and different forms of Flodin 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.
Not Addictive but Dangerous to Misuse
Flodin does not alter the brain’s reward pathways the way most drugs do, so it is not considered an addictive drug. People who develop a psychological dependence on Mobic and who discontinue their intake will likely not experience the severity of withdrawal symptoms that come from attempting to quit opioids or alcohol. Nonetheless, people who are in chronic pain or who have serious cases of inflammation and arthritis, and who have been abusing Flodin to manage that pain, will likely experience an increase in their pain symptoms if they stop their Flodin consumption. Patients in this situation should immediately consult with their primary care physician about the best way to moderate their Flodin consumption, so as to not depend on it as much as they did without leaving their pain unmanaged.
Despite Flodin not being addictive, it is still dangerous; and patients who struggle with their use of Mobic (or its various formulations) should seek medical help immediately to avoid the danger of harming their bodies as a result of excessive exposure to the NSAID. There is also the psychological element that has to be addressed. Even though Flodin does not have any addictive properties, the abuse of it suggests the presence a substance use disorder, and if that disorder is not treated, then the patient is likely to continue using other, more dangerous, drugs and medications.
Flodin and other nonsteroidal anti-inflammatory drugs are unlikely to be as intricately linked with addiction as opioids, but there are still question marks surrounding whether these drugs will offer a way out from the shadow of the prescription overdose epidemic. Psychology Today notes that the risk of gastrointestinal and cardiovascular complications that can arise from the use of NSAIDs mean that while that category of drug is worth talking about as an alternative to opioid prescriptions, doctors should nonetheless be hypervigilant about their patients’ medical histories, risk factors, and the possibility of adverse health reactions when putting people on Flodin prescriptions.