Advanced Consumer Information

Tolectin DS

Generic Name: tolmetin (Oral route)

TOLE-met-in

Oral routeTabletCapsule

CARDIOVASCULAR RISK
- NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk

Tolmetin sodium is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery .

GASTROINTESTINAL RISK
- NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events .

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Tolmetin is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Commonly used brand name(s):

In the U.S.

Tolectin 600
Tolectin DS

Available Dosage Forms:

Tablet
Capsule

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Acetic Acid (class)

Uses For Tolectin DS

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 .

Before Using Tolectin DS

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of tolmetin in children below 2 years of age. Safety and efficacy have not been established .

Geriatric

No information is available on the relationship of age to the effects of tolmetin in geriatric patients. However, elderly patients may be more sensitive to the effects of tolmetin than younger adults, and are more likely to have age-related kidney problems, which may require adjustment of dosage in patients receiving tolmetin .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Ketorolac

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Ardeparin
Beta Glucan
Certoparin
Dalteparin
Danaparoid
Enoxaparin
Ginkgo
Methotrexate
Nadroparin
Parnaparin
Pemetrexed
Reviparin
Tacrolimus
Tinzaparin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acenocoumarol
Acetohexamide
Alacepril
Amiloride
Azosemide
Bemetizide
Benazepril
Bendroflumethiazide
Benzthiazide
Bumetanide
Buthiazide
Candesartan Cilexetil
Canrenoate
Captopril
Chlorothiazide
Chlorpropamide
Chlorthalidone
Cilazapril
Citalopram
Clopamide
Clopidogrel
Clovoxamine
Cyclopenthiazide
Cyclosporine
Cyclothiazide
Delapril
Desvenlafaxine
Dicumarol
Duloxetine
Enalaprilat
Enalapril Maleate
Eprosartan
Escitalopram
Ethacrynic Acid
Femoxetine
Flesinoxan
Fluoxetine
Fluvoxamine
Fosinopril
Furosemide
Gliclazide
Glimepiride
Glipizide
Gliquidone
Glyburide
Hydrochlorothiazide
Hydroflumethiazide
Imidapril
Indapamide
Irbesartan
Lisinopril
Lithium
Losartan
Methyclothiazide
Metolazone
Milnacipran
Moexipril
Nefazodone
Olmesartan Medoxomil
Paroxetine
Pentopril
Perindopril
Phenprocoumon
Piretanide
Polythiazide
Quinapril
Quinethazone
Ramipril
Sertraline
Spirapril
Spironolactone
Tasosartan
Telmisartan
Temocapril
Tolazamide
Tolbutamide
Torsemide
Trandolapril
Triamterene
Trichlormethiazide
Valsartan
Venlafaxine
Xipamide
Zimeldine
Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of tolmetin

This section provides information on the proper use of a number of products that contain tolmetin. It may not be specific to Tolectin DS. Please read with care.

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients .

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine .

It is best to take this medicine on an empty stomach. However, if it upsets your stomach, you may take this medicine with an antacid that does not contain sodium bicarbonate .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage forms (capsules or tablets):
- For osteoarthritis and rheumatoid arthritis:
  - Adults—At first, 400 milligrams (mg) three times a day. Your doctor may increase the dose, if necessary, up to a total of 1800 mg a day. After your condition improves, your doctor may direct you to take a lower dose.
  - Children 2 years of age and older—The dose is based on body weight. At first, 20 mg per kilogram (kg) (about 9 mg per pound) of body weight a day, divided into smaller amounts that are taken three or four times a day. Your doctor may increase the dose, if necessary, up to 30 mg per kg (about 13.5 mg per pound) of body weight a day. After your condition improves, your doctor may direct you to take a lower dose.
  - Children up to 2 years of age—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Tolectin DS

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. These problems 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 old, if you are in poor health, or if you are using certain other medicines (a steroid 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 skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, white spots in mouth or on 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, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; unusual bleeding or bruising; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, unusual flushing or warmth of 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 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 .

Tolectin DS Side Effects

Along with its needed effects, a medicine 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:

More common

Abdominal or stomach pain
diarrhea
dizziness
headache
nausea
numbness or tingling in arms or legs
swelling
trouble thinking, speaking, or walking
vomiting
weakness
weight gain

Less common

Black, tarry stools
bladder pain
blood in vomit
bloody or cloudy urine
blurred or loss of vision
burning feeling in chest or stomach
burning, itching, redness, or stinging of 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 stomach area
tunnel vision

Rare

Back or leg pains
bleeding gums
blistering, peeling, loosening of skin
chills
constipation
cough or hoarseness
dark urine
decreased urine output
difficulty breathing
difficulty swallowing
dilated neck veins
extreme fatigue
fast, irregular heartbeat
feeling of discomfort
fever
general body swelling
heartburn
hives or welts
increased thirst
inflammation of joints
irregular breathing
joint or muscle pain
light-colored stools
loss of appetite
muscle aches
nosebleeds
pale skin
pinpoint red spots on 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 lips or in mouth
swelling of face, fingers, feet, or lower legs
swollen, painful, or tender lymph glands in neck, armpit, or groin
tightness in chest
trouble breathing
unusual bleeding or bruising
unusual tiredness or weakness
upper right abdominal pain
wheezing
yellow eyes and skin

Some side effects 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 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 ears
discouragement
feeling sad or empty
hearing loss
irritability
loss of interest or pleasure
sleepiness
tiredness
trouble concentrating
trouble sleeping

Rare

Redness, swelling, or soreness of tongue
swelling or inflammation of the mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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