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Medically reviewed by Kovalenko Svetlana Olegovna, PharmD. Last updated on 17.04.2022
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Carefully consider the potential benefits and risks of Tolectin 600 (Tolectin 600 sodium) and other treatment options before deciding to use Tolectin 600 (Tolectin 600 sodium). Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
Tolectin 600 (Tolectin 600 sodium) is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. Tolectin 600 (Tolectin 600 sodium) is indicated in the treatment of acute flares and the long-term management of the chronic disease.
Tolectin 600 (Tolectin 600 sodium) is also indicated for treatment of juvenile rheumatoid arthritis. The safety and effectiveness of Tolectin 600 (Tolectin 600 sodium) have not been established in pediatric patients under 2 years of age.
Tolectin 600 is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, or juvenile arthritis) such as inflammation, swelling, stiffness, and joint pain. Tolectin 600 does not cure arthritis and will help you only as long as you continue to take it.
Tolectin 600 is available only with your doctor's prescription.
Carefully consider the potential benefits and risks of Tolectin 600 (Tolectin 600 sodium) and other treatment options before deciding to use Tolectin 600 (Tolectin 600 sodium). Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
After observing the response to initial therapy with Tolectin 600 (Tolectin 600 sodium), the dose and frequency should be adjusted to suit an individual patient's needs.
For the relief of rheumatoid arthritis or osteoarthritis, the recommended starting dose for adults is 400 mg three times daily (1200 mg daily), preferably including a dose on arising and a dose at bedtime. To achieve optimal therapeutic effect the dose should be adjusted according to the patient's response after one or two weeks. Control is usually achieved at doses of 600-1800 mg daily in divided doses (generally t.i.d.). Doses larger than 1800 mg/day have not been studied and are not recommended.
For the relief of juvenile rheumatoid arthritis, the recommended starting dose for pediatric patients (2 years and older) is 20 mg/kg/day in divided doses (t.i.d. or q.i.d.). When control has been achieved, the usual dose ranges from 15 to 30 mg/kg/day. Doses higher than 30 mg/kg/day have not been studied, and, therefore, are not recommended.
A therapeutic response to Tolectin 600 (Tolectin 600 sodium) can be expected in a few days to a week. Progressive improvement can be anticipated during succeeding weeks of therapy. If gastrointestinal symptoms occur, Tolectin 600 (Tolectin 600 sodium) can be administered with antacids other than sodium bicarbonate. Tolectin 600 (Tolectin 600 sodium) bioavailability and pharmacokinetics are not significantly affected by acute or chronic administration of magnesium and aluminum hydroxides; however, bioavailability is affected by food or milk.
How supplied
Tolectin 600
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What is the most important information I should know about Tolectin 600?
This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use Tolectin 600. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).
Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.
This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal. These gastrointestinal effects can occur without warning at any time while you are taking Tolectin 600. Older adults may have an even greater risk of these serious gastrointestinal side effects.
Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.
Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to Tolectin 600 (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen.
Do not drink alcohol while taking Tolectin 600. Alcohol can increase the risk of stomach bleeding caused by Tolectin 600.
Use Tolectin 600 600 as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Tolectin 600 600 comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Tolectin 600 600 refilled.
- Take Tolectin 600 600 by mouth. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.
- If Tolectin 600 600 upsets your stomach, you may take it with an antacid. Do not take it with sodium bicarbonate.
- Take Tolectin 600 600 with a full glass of water (8 oz/240 mL) as directed by your doctor.
- If you miss a dose of Tolectin 600 600 and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Tolectin 600 600.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Tolectin 600 is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by breakdown of the lining of the joints), rheumatoid arthritis (arthritis caused due to destruction of the lining of the joints by the body’s own immune system), and juvenile rheumatoid arthritis (rheumatoid arthritis seen in children 2 years of age and older).
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What other drugs will affect Tolectin 600?
ACE-inhibitors
Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE- inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE- inhibitors.
Aspirin
As with other NSAIDs, concomitant administration of Tolectin 600 sodium and aspirin is not generally recommended because of the potential of increased adverse effects.
Diuretics
Clinical studies, as well as post- marketing observations, have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure, as well as to assure diuretic efficacy.
Lithium
NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.
Methotrexate
NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.
Warfarin
The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.
The in vitro binding of warfarin to human plasma proteins is unaffected by Tolectin 600, and Tolectin 600 does not alter the prothrombin time of normal volunteers. However, increased prothrombin time and bleeding have been reported in patients on concomitant Tolectin 600 (Tolectin 600 sodium) and warfarin therapy. Therefore, caution should be exercised when administering Tolectin 600 (Tolectin 600 sodium) to patients on anticoagulants.
Hypoglycemic Agents
In adult diabetic patients under treatment with either sulfonylureas or insulin there is no change in the clinical effects of either Tolectin 600 (Tolectin 600 sodium) or the hypoglycemic agents.
Drug/Laboratory Test Interactions
The metabolites of Tolectin 600 sodium in urine have been found to give positive tests for proteinuria using tests which rely on acid precipitation as their endpoint (e.g., sulfosalicylic acid). No interference is seen in the tests for proteinuria using dye- impregnated commercially available reagent strips (e.g., Albustix®, Uristix®, etc.).
Drug-Food Interactions
In a controlled single-dose study, administration of Tolectin 600 (Tolectin 600 sodium) with milk had no effect on peak plasma Tolectin 600 concentrations, but decreased total Tolectin 600 bioavailability by 16%. When Tolectin 600 (Tolectin 600 sodium) was taken immediately after a meal, peak plasma Tolectin 600 concentrations were reduced by 50% while total bioavailability was again decreased by 16%.
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What are the possible side effects of Tolectin 600?
The adverse reactions which have been observed in clinical trials encompass observations in about 4370 patients treated with Tolectin 600 (Tolectin 600 sodium), over 800 of whom have undergone at least one year of therapy. These adverse reactions, reported below by body system, are among those typical of nonsteroidal anti- inflammatory drugs and, as expected, gastrointestinal complaints were most frequent. In clinical trials with Tolectin 600 (Tolectin 600 sodium), about 10% of patients dropped out because of adverse reactions, mostly gastrointestinal in nature.
Incidence Greater Than 1%
The following adverse reactions which occurred more frequently than 1 in 100 were reported in controlled clinical trials.
Gastrointestinal: Nausea (11%), dyspepsia,* gastrointestinal distress,* abdominal pain,* diarrhea,* flatulence,* vomiting,* constipation, gastritis, and peptic ulcer. Forty percent of the ulcer patients had a prior history of peptic ulcer disease and/or were receiving concomitant anti- inflammatory drugs including corticosteroids, which are known to produce peptic ulceration.
Body as a Whole: Headache, * asthenia, * chest pain
Cardiovascular: Elevated blood pressure, * edema*
Central Nervous System: Dizziness, * drowsiness, depression
Metabolic/Nutritional: Weight gain, * weight loss*
Dermatologic:Skin irritation
Special Senses: Tinnitus, visual disturbance
Hematologic: Small and transient decreases in hemoglobin and hematocrit not associated with gastrointestinal bleeding have occurred. These are similar to changes reported with other nonsteroidal anti- inflammatory drugs.
Urogenital: Elevated BUN, urinary tract infection
*Reactions occurring in 3% to 9% of patients treated with Tolectin 600 (Tolectin 600 sodium). Reactions occurring in fewer than 3% of the patients are unmarked.
Incidence Less Than 1%
(Causal Relationship Probable)
The following adverse reactions were reported less frequently than 1 in 100 controlled clinical trials or were reported since marketing. The probability exists that there is a causal relationship between Tolectin 600 (Tolectin 600 sodium) and these adverse reactions.
Gastrointestinal: Gastrointestinal bleeding with or without evidence of peptic ulcer, perforation, glossitis, stomatitis, hepatitis, liver function abnormalities.
Body as a Whole: Anaphylactoid reactions, fever, lymphadenopathy, serum sickness
Hematologic: Hemolytic anemia, thrombocytopenia, granulocytopenia, agranulocytosis
Cardiovascular: Congestive heart failure in patients with marginal cardiac function.
Dermatologic: Urticaria, purpura, erythema multiforme, toxic epidermal necrolysis
Urogenital: Hematuria, proteinuria, dysuria, renal failure
Incidence Less Than 1%
(Causal Relationship Unknown)
Other adverse reactions were reported less frequently than 1 in 100 in controlled clinical trials or were reported since marketing, but a causal relationship between Tolectin 600 (Tolectin 600 sodium) and the reaction could not be determined. These rarely reported reactions are being listed as alerting information for the physician since the possibility of a causal relationship cannot be excluded.
Body as a Whole: Epistaxis
Special Senses: Optic neuropathy, retinal and macular changes
A non-steroidal anti-inflammatory agent (anti-inflammatory agents, NON-steroidal) similar in mode of action to indomethacin. [PubChem]