Tolectin 600

Name: Tolectin 600

Tolectin 600 Overview

Tolectin 600 is a prescription medication used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis and rheumatoid arthritis. It is also used to relieve pain associated with juvenile rheumatoid arthritis. Tolectin 600 belongs to a group of drugs called NSAIDs. These work by stopping the body's production of a substance that causes pain, fever, and inflammation.

This medication comes in tablet form and is typically taken 3 times a day.

Common side effects of Tolectin 600 include nausea, upset stomach, and stomach pain.

Uses For Tolectin 600

Tolmetin 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. This medicine does not cure arthritis and will help you only as long as you continue to take it.

This medicine is available only with your doctor's prescription.

Precautions While Using Tolectin 600

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.

This medicine may cause bleeding in your stomach or intestines. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (such as steroids or a blood thinner).

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of the skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, white spots in the mouth or on the lips, or unusual tiredness or weakness.

Possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, or lower legs; severe stomach pain; black, tarry stools; vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; unusual bleeding or bruising; or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in the chest, fast or irregular heartbeat, unusual flushing or warmth of the skin, weakness, or slurring of speech. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs.

This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs. Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure.

Tell your doctor if you have unexplained weight gain or edema (fluid retention or body swelling) with this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

For the Consumer

Applies to tolmetin: oral capsule, oral tablet

Along with its needed effects, tolmetin (the active ingredient contained in Tolectin 600) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking tolmetin:

More common
  • Abdominal or stomach pain
  • diarrhea
  • dizziness
  • headache
  • nausea
  • numbness or tingling in the arms or legs
  • swelling
  • trouble thinking, speaking, or walking
  • vomiting
  • weakness
  • weight gain
Less common
  • Black, tarry stools
  • bladder pain
  • blood in the vomit
  • bloody or cloudy urine
  • blurred or loss of vision
  • burning feeling in the chest or stomach
  • burning, itching, redness, or stinging of the skin
  • chest pain
  • difficult, burning, or painful urination
  • disturbed color perception
  • double vision
  • frequent urge to urinate
  • halos around lights
  • indigestion
  • lower back or side pain
  • night blindness
  • overbright appearance of lights
  • severe or continuing stomach pain
  • stomach upset
  • tenderness in the stomach area
  • tunnel vision
Rare
  • Back or leg pains
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • chills
  • constipation
  • cough or hoarseness
  • dark urine
  • decreased urine output
  • difficulty with breathing
  • difficulty with swallowing
  • dilated neck veins
  • extreme fatigue
  • fast, irregular heartbeat
  • feeling of discomfort
  • fever
  • general body swelling
  • heartburn
  • hives or welts
  • increased thirst
  • inflammation of the joints
  • irregular breathing
  • joint or muscle pain
  • light-colored stools
  • loss of appetite
  • muscle aches
  • nosebleeds
  • pale skin
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • severe and continuing nausea
  • shortness of breath
  • skin rash
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swelling of the face, fingers, feet, or lower legs
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • tightness in the chest
  • trouble with breathing
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal pain
  • wheezing
  • yellow eyes and skin

Some side effects of tolmetin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Acid or sour stomach
  • belching
  • bloated full feeling
  • excess air or gas in the stomach or intestines
  • lack or loss of strength
  • passing gas
  • stomach discomfort
  • weight loss
Less common
  • Continuing ringing or buzzing or other unexplained noise in the ears
  • discouragement
  • feeling sad or empty
  • hearing loss
  • irritability
  • loss of interest or pleasure
  • sleepiness
  • tiredness
  • trouble with concentrating
  • trouble with sleeping
Rare
  • Redness, swelling, or soreness of the tongue
  • swelling or inflammation of the mouth

For Healthcare Professionals

Applies to tolmetin: oral capsule, oral tablet

Gastrointestinal

Very common (10% or more): Nausea (11%)
Common (1% to 10%): Dyspepsia, gastrointestinal (GI) distress, abdominal pain, diarrhea, flatulence, vomiting, constipation, gastritis, peptic ulcer
Frequency not reported: GI bleeding, GI perforation, glossitis, stomatitis[Ref]

Hepatic

Frequency not reported: Hepatitis, liver function abnormalities[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness, drowsiness[Ref]

Hematologic

Common (1% to 10%): Hemoglobin decreased, hematocrit decreased
Frequency not reported: Lymphadenopathy, hemolytic anemia, thrombocytopenia, granulocytopenia, agranulocytosis[Ref]

Renal

Common (1% to 10%): BUN increased
Frequency not reported: Renal failure[Ref]

Hypersensitivity

Frequency not reported: Anaphylactoid reactions[Ref]

Dermatologic

Common (1% to 10%): Skin irritation
Frequency not reported: Urticaria, purpura, erythema multiforme, toxic epidermal necrolysis[Ref]

Cardiovascular

Common (1% to 10%): Blood pressure increased
Frequency not reported: Congestive heart failure[Ref]

General

The most frequently reported side effect was nausea.[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection
Frequency not reported: Hematuria, proteinuria, dysuria[Ref]

Immunologic

Frequency not reported: Serum sickness

Ocular

Common (1% to 10%): Visual disturbance
Frequency not reported: Optic neuropathy, retinal/macular changes[Ref]

Other

Common (1% to 10%): Asthenia, chest pain, edema, weight gain, weight loss, tinnitus
Frequency not reported: Fever[Ref]

Psychiatric

Common (1% to 10%): Depression[Ref]

Respiratory

Frequency not reported: Epistaxis[Ref]

Some side effects of Tolectin 600 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Renal Dose Adjustments

Advanced Renal Disease: Not recommended; if treatment is necessary, close monitoring of renal function is advised.

Dialysis

Data not available

Tolmetin Breastfeeding Warnings

Due to its short half-life and low levels expressed in breast milk, it is unlikely that this drug will cause adverse effects in the breastfed infant. However, due to lack of published clinical experience in newborns and preterm infants, other agents may be preferred.

Caution is recommended. Excreted into human milk: Yes Comment: -The manufacturer recommends to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Tolmetin Levels and Effects while Breastfeeding

Summary of Use during Lactation

Because of the low levels of tolmetin in breastmilk and its short half-life, it is unlikely to adversely affect the breastfed infant. However, because there is no published experience with breastfeeding during tolmetin use, other agents may be preferred, especially while nursing a newborn or preterm infant.

Drug Levels

Maternal Levels. Following a single 400 mg dose of tolmetin in a woman who was 2 months postpartum, peak milk levels occurred at 40 and 60 minutes after the dose in the right and left breasts, respectively, and averaged 160 mcg/L. The drug was undetectable (<30 mcg/L) in milk by 5 hours after the dose and its half-life in breastmilk was 1.54 hours.[1]

Using the peak milk level data, the estimated maximum intake of an exclusively breastfed infant would be 0.4% of the maternal weight-adjusted dosage.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Acetaminophen, Flurbiprofen, Ibuprofen, Indomethacin, Naproxen, Piroxicam

References

1. Sagraves R, Waller ES, Goehrs HR. Tolmetin in breast milk. Drug Intell Clin Pharm. 1985;19:55-6. Letter. PMID: 3967576

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