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Disalcid

Disalcid

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Disalcid Drug Description


Disalcid
(salsalate) Tablets and Capsules

DRUG DESCRIPTION

DISALCID (salsalate) is a nonsteroidal anti-inflammatory agent for oral administration. Chemically, salsalate (salicylsalicylic acid or 2-hydroxybenzoE acid, 2carboxyphenyl ester) is a dimer of salicylic acid; its structural formula is shown below.

Each DISALCID capsule contains 500 mg salsalate and also contains colloidal silicon dioxide, gelatin, magnesium stearate, pregelatinited starch, corn starch, titanium dioxide, FD& C blue #l, and D& C yellow #l0. Each DISALCI D tablet contains 500 or 750 mg salsalate and also contains croscarmellose sodium, hydroxypropyl methylcellulose, magnesium stearate, microcryst, alline cellulose, polyethylene glycol, polysorbate 80, propylene glycol, talc, titanium dioxide, FD& C blue #l, and D& C yellow #l0. (See HOW SUPPLIED)

 

What are the possible side effects of salsalate (Disalcid, Salsitab)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • chest pain, severe dizziness, shortness of breath, slurred speech, problems with vision or balance;
  • sudden numbness or weakness, especially on one side of the body;
  • feeling like you might pass out;
  • black, bloody, or tarry...

 

 

Disalcid


Disalcid Indications & Dosage


INDICATIONS

DISALCID (salsalate) is indicated for relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis and related rheumatic disorders.

DOSAGE AND ADMINISTRATION

Adults

The usual dosage is 3000 mg daily, given in divided doses as follows: 1) two doses of two 750 mg tablets: 2) two doses of three 500 mg tablets/capsules; or 3) three doses of two 500 mg tablets/capsules. Some patients, e.g., the elderly, may require a lower dosage to achieve therapeutic blood concentrations and to avoid the more common side effects such as auditory.

Alleviation of symptoms is gradual, and full benefit may not be evident for 3 to 4 days, when plasma salicylate levels have achieved steady state. There is no evidence for development of tissue tolerance (tachyphylaxis) but salicylate therapy may induce increased activity of metabolizing liver enzymes, causing a greater rate of salicyluric acid production and excretion, with a resultant increase in dosage requirement for maintenance of therapeutic serum salicylate levels.

Children

Dosage recommendations and indications for DISALCID (salsalate) use in children have not been established.

HOW SUPPLIED

Each DISALCID (salsalate) 500 mg aqua/white capsule printed with Disalcid (salsalate) /3M is available in:
Bottles of 100 (NDC #0089-0148-10)

Each DISALCID (salsalate) 500 mg aqua, film coated, round, bisected tablet embossed with DISALCID (salsalate) on one side and 3M on the other side is available in:
Bottles of 100 (NDC #0089-0149-10)
Bottles of 500 (NDC #0089-0149-50)

Each DISALCID (salsalate) 750 mg aqua, film coated, capsule shaped, bisected tablet embossed with DISALCID (salsalate) 750 on one side and 3M on the other side is available in:
Bottles of 100 (NDC #0089-0151-10)
Bottles of 500 (NDC #0089-0151-50)

Store at controlled room temperature 15°-30°C (59°-86°F).
Rx only

JUNE 1998

3M Pharmaceuticals
Northridge, CA 91324

 

 

Disalcid


 

Disalcid Side Effects & Drug Interactions


SIDE EFFECTS

In two well-controlled clinical trials (n= 280 patients), the following reversible adverse experiences characteristic of salicylates were most commonly reported with DISALCID (salsalate) , listed in descending order of frequency: tinnitus, nausea, hearing impairment, rash, and vertigo. These common symptoms of salicylates, i.e., tinnitus or reversible hearing impairment, are often used as a guide to therapy.

Although cause-and-effect relationships have not been established, spontaneous reports over a ten-year period have included the following additional medically significant adverse experiences: abdominal pain, abnormal hepatic function, anaphylactic shock, angioedema, bronchospasm, decreased creatinine dearance, diarrhea, G.I. bleeding, hepatitis, hypotension, nephritis and urticaria.

DRUG ABUSE AND DEPENDENCE

Drug abuse and dependence have not been reported with DISALCID (salsalate) .

DRUG INTERACTIONS

Salicylates antagonize the uricosuric action of . drugs used to treat gout. ASPIRIN AND OTHER SALICYLATE DRUGS WILL BE ADDITIVE TO DISALCID (salsalate) AND MAY INCREASE PLASMA CONCENTRATIONS OF SALICYLIC ACID TO TOXIC LEVELS. Drugs and foods that raise urine pH will increase renal clearance and urinary excretion of salicylic acid, thus lowering plasma levels; acidifying drugs or foods will decrease urinary excretion and increase plasma levels. Salicylates given concomitantly with anticoagulant drugs may predispose to systemic bleeding. Salicylates may enhance the hypoglycemic effect of oral antidiabetic drugs of the sulfonylurea class. Salicylate competes with a number of drugs for protein binding sites, notably penicillin, thiopental, thyroxine, triiodothyronine, phenytoin, sulfinpyrazone, naproxen, warfarin, methotrexate, and possibly corticosteroids.

Drug/ Laboratory Test Interactions

Salicylate competes with thyroid hormone for binding to plasma proteins, which may be reflected in a depressed plasma T4 value in some patients; thyroid function and basal metabolism are unaffected.

 

Disalcid


Disalcid Warnings & Precautions


WARNINGS

Reye's Syndrome may develop in individuals who have chicken pox, influenza, or flu symptoms. Some studies suggest a possible association between the development of Reye's Syndrome and the use of medicines containing salicylate or aspirin. DISALCID (salsalate) contains a salicylate and therefore is not recommended for use in patients with chicken pox, influenza, or flu symptoms.

PRECAUTIONS

General

Patients on treatment with DISALCID (salsalate) should be warned not to take other salicylates so as to avoid potentially toxic concentrations. Great care should be exercised when DISALCID (salsalate) is prescribed in the presence of chronic renal insufficiency or peptic ulcer disease. Protein binding of salicylic acid can be influenced by nutritional status, competitive binding of other drugs, and fluctuations in serum proteins caused by disease (rheumatoid arthritis, etc.).

Although cross reactivity, induding bronchospasm, has been reported occasionally with non- acetylated salicylates, including salsalate, in aspirin-sensitive patients,8,9 salsalate is less likely than aspirin to induce asthma in such patients.10

Laboratory Tests

Plasma salicylic acid concentrations should be periodically monitored during longterm treatment with DISALCID (salsalate) to aid maintenance of therapeutically effective levels: 10 to 30 mg/100 ml. Toxic manifestations are not usually seen until plasma concentrations exceed 30 mg/l00 ml (see OVERDOSAGE). Urinary pH should also be regularly monitored: sudden acidification, as from pH 6.5 to 5.5, can double the plasma level, resulting in toxicity.

Carcinogenesis

No long-term animal studies have been performed with DISALCID (salsalate) to evaluate its carcinogenic potential.

Use in Pregnancy

Pregnancy Category C: Salsalate and salicylic acid have been shown to be teratogenic and embryocidal in rats when given in doses 4 to 5 times the usual human dose. The effects were not observed at doses twice as great as the usual human dose. There are no adequate and well-controlled studies in pregnant women. DISALCID (salsalate) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Labor and Delivery

There exist no adequate and well-controlled studies in pregnant women. Although adverse effects on mother or infant have not been reported with DISALCID (salsalate) use during labor, caution is advised when anti-inflammatory dosage is involved. However, other salicylates have been associated with prolonged gestation and labor, maternal and neonatal bleeding sequelae, potentiation of narcotic and barbiturate effects (respiratory or cardiac arrest in the mother), delivery problems and stillbirth.

Nursing Mothers

It is not known whether salsalate per se is excreted in human milk; salicylic acid, the primary metabolite of DISALCID (salsalate) , has been shown to appear in human milk in concentrations approximating the maternal blood level. Thus, the infant of a mother on DISALCID (salsalate) therapy might ingest in mother†s milk 30 to 80% as much salicylate per kg body weight as the mother is taking. Accordingly, caution should be exercised when DISALCID (salsalate) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. (See WARNINGS)

 

Disalcid


 

Disalcid Overdosage & Contraindications


OVERDOSE

Death has followed ingestion of 10 to 30 g of salicylates in adults, but much larger amounts have been ingested without fatal outcome.

Symptoms

The usual symptoms of salicylism - tinnitus, vertigo, headache, confusion, drowsiness, sweating, hyperventilation, vomiting and diarrhea - will occur. More severe intoxication will lead to disruption of electrolyte balance and blood pH, and hyperthermia and dehydration.

Treatment

Further absorption of DISALCID (salsalate) from the G.I. tract should be prevented by emesis (syrup of ipecac) and if necessary, by gastric lavage.

Fluid and electrolyte imbalance should be corrected by the administration of appropriate I.V. therapy. Adequate renal function should be maintained. Hemodialysis or peritoneal dialysis may be required in extreme cases.

CONTRAINDICATIONS

DISALCID is contraindicated in patients hypersensitive to salsalate.

 

Disalcid


Disalcid Clinical Pharmacology


CLINICAL PHARMACOLOGY

DISALCID (salsalate) is insoluble in acid gastric fluids (< 0.1 mg/ml at pH 1.0), but readily soluble in the small intestine where it is partially hydrolyzed to two molecules of salicylic acid. A significant portion of the parent compound is absorbed unchanged and undergoes rapid esterase hydrolysis in the body; its half-life is about one hour. About 13% is excreted through the kidneys as a glucuronide conjugate of the parent compound, the remainder as salicylic acid and its metabolites. Thus, the amount of salicylic acid available from DISALCID (salsalate) is about 15% less than from aspirin, when the two drugs are administered on a salicylic acid molar equivalent basis (3.6 g salsalate/5 g aspirin).

Salicylic acid biotransformation is saturated at anti-inflammatory doses of DISALCID (salsalate) . Such capacity limited biotransformation results in an increase in the half-life of salicylic acid from 3.5 to 16 or more hours. Thus, dosing with DISALCID (salsalate) twice a day will satisfactorily maintain blood levels within the desired therapeutic range (10 to 30 mg/100 ml) throughout the 12-hour intervals. Therapeutic blood levels continue for up to 16 hours after the last dose. The parent compound does not show capacity-limited biotransformation, nor does it accumulate in the plasma on multiple dosing. Food slows the absorption of all salicylates including DISALCID (salsalate) .

The mode of anti-inflammatory action of DISALCID (salsalate) and other nonsteroidal anti-inflammatory drugs is not fully defined. Although salicylic acid (the primary metabolite of DISALCID (salsalate) ) is a weak inhibitor of prostaglandin synthesis in vitro, DISALCID (salsalate) appears to selectively inhibit prostaglandin synthesis in vivo, providing anti-inflammatory activity equivalent to aspirin and indomethacin. Unlike aspirin, DISALCID (salsalate) does not inhibit platelet aggregation.

The usefulness of salicylic acid, the active in vivo product of DISALCID (salsalate) , in the treatment of arthritic disorders has been established. In contrast to aspirin, DISALCID (salsalate) causes no greater fecal gastrointestinal blood loss than placebo.

 

Disalcid


 

Disalcid Medication Guide


PATIENT INFORMATION

See WARNINGS, CONTRAINDICATIONS, and PRECAUTIONS.

 

 

Disalcid


Disalcid Patient Information Including Side Effects

Brand Names: Disalcid, Salsitab

Generic Name: salsalate (Pronunciation: SAL sa late)

 

  • What is salsalate (Disalcid)?
  • What are the possible side effects of salsalate (Disalcid)?
  • What is the most important information I should know about salsalate (Disalcid)?
  • What should I discuss with my healthcare provider before taking salsalate (Disalcid)?
  • How should I take salsalate (Disalcid)?
  • What happens if I miss a dose (Disalcid)?
  • What happens if I overdose (Disalcid)?
  • What should I avoid while taking salsalate (Disalcid)?
  • What other drugs will affect salsalate (Disalcid)?
  • Where can I get more information?

 

What is salsalate (Disalcid)?

Salsalate is a non-steroidal anti-inflammatory drug (NSAID) in a group of drugs called salicylates (sa-LIS-il-ates). This medicine works by reducing substances in the body that cause pain, fever, and inflammation.

Salsalate is used to reduce pain, swelling, and joint stiffness caused by arthritis.

Salsalate may also be used for other purposes not listed in this medication guide.

Salsalate 750 mg-SID

oblong, yellow, imprinted with SL 391

What are the possible side effects of salsalate (Disalcid)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • chest pain, severe dizziness, shortness of breath, slurred speech, problems with vision or balance;
  • sudden numbness or weakness, especially on one side of the body;
  • feeling like you might pass out;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • hearing problems, ringing in your ears;
  • swelling in your hands or feet, rapid weight gain;
  • fast or pounding heartbeats;
  • easy bruising or bleeding, fever, chills, sore throat, flu symptoms;
  • urinating more or less than usual;
  • severe stomach pain, ongoing nausea or vomiting;
  • dark urine, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • upset stomach, heartburn; or
  • mild dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about salsalate (Disalcid)?

You should not use this medication if you are allergic to aspirin or to an NSAID (non-steroidal anti-inflammatory drug).

Before taking salsalate, tell your doctor if you have asthma, heart disease, high blood pressure, stomach or intestinal bleeding, diabetes, anemia, a bleeding disorder, liver or kidney disease, nasal polyps, a genetic enzyme deficiency, or if you are dehydrated.

Salsalate may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use salsalate just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, severe dizziness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking salsalate, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

This medication should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Salicylates can cause a serious and sometimes fatal condition called Reye's syndrome in children.

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  • Disalcid

 

 

Disalcid


Disalcid Patient Information including How Should I Take

In this Article

  • What is salsalate (Disalcid)?
  • What are the possible side effects of salsalate (Disalcid)?
  • What is the most important information I should know about salsalate (Disalcid)?
  • What should I discuss with my healthcare provider before taking salsalate (Disalcid)?
  • How should I take salsalate (Disalcid)?
  • What happens if I miss a dose (Disalcid)?
  • What happens if I overdose (Disalcid)?
  • What should I avoid while taking salsalate (Disalcid)?
  • What other drugs will affect salsalate (Disalcid)?
  • Where can I get more information?

What should I discuss with my healthcare provider before taking salsalate (Disalcid)?

Salicylates may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use salsalate just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Salicylates may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking salsalate, especially in older adults.

You should not use this medication if you are allergic to aspirin or to an NSAID (non-steroidal anti-inflammatory drug).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take this medication:

  • asthma;
  • heart disease, high blood pressure, congestive heart failure;
  • a history of stroke or heart attack;
  • a stomach ulcer or intestinal bleeding;
  • a bleeding or blood clotting disorder;
  • diabetes;
  • swelling or fluid retention;
  • anemia (a lack of red blood cells);
  • liver disease;
  • kidney disease;
  • an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD);
  • nasal polyps; or
  • if you are dehydrated.

FDA pregnancy category C. Salsalate may be harmful to an unborn baby if the mother takes the medication during the last 3 months of pregnancy. Do not take this medication without telling your doctor if you are pregnant or plan to become pregnant during treatment.

Salsalate can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

This medication should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Salicylates can cause a serious and sometimes fatal condition called Reye's syndrome in children.

Older adults may be more likely to have side effects from salsalate.

How should I take salsalate (Disalcid)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Salsalate may be taken up to 3 times per day. Follow your doctor's instructions.

Take the medicine with a full glass of water.

Take salsalate with food, milk, or an antacid if it upsets your stomach. To prevent stomach upset, do not lie down for at least 30 minutes after taking salsalate.

It may take up to 2 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not start to improve after 2 weeks of treatment.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using salsalate.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using salsalate. You may need to stop using the medicine for a short time.

Store salsalate at room temperature away from moisture and heat.

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  • Disalcid

Disalcid


 

Disalcid Patient Information including If I Miss a Dose

In this Article

  • What is salsalate (Disalcid)?
  • What are the possible side effects of salsalate (Disalcid)?
  • What is the most important information I should know about salsalate (Disalcid)?
  • What should I discuss with my healthcare provider before taking salsalate (Disalcid)?
  • How should I take salsalate (Disalcid)?
  • What happens if I miss a dose (Disalcid)?
  • What happens if I overdose (Disalcid)?
  • What should I avoid while taking salsalate (Disalcid)?
  • What other drugs will affect salsalate (Disalcid)?
  • Where can I get more information?

What happens if I miss a dose (Disalcid)?

Since salsalate is often used as needed, you may not be on a dosing schedule. If you are using the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Disalcid)?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include ringing in your ears, severe dizziness or drowsiness, sweating, fast breathing, severe vomiting or diarrhea, confusion, or seizure (convulsions).

What should I avoid while taking salsalate (Disalcid)?

Salsalate can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Do not use any other over-the-counter medication without first asking your doctor or pharmacist. Salicylates and non-steroidal anti-inflammatory drugs (NSAIDs) are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, naproxen, ketoprofen, magnesium salicylate, or similar medicines.

If you are also taking low-dose aspirin because your doctor has prescribed it to prevent heart attack or stroke, do not stop taking it or change your dose without your doctor's advice. Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

Avoid alcohol or use it in moderation while taking salsalate. If you drink more than three alcoholic beverages a day, the risk of stomach bleeding may increase.

Avoid smoking while you are taking this medication. Smoking can also increase your risk of stomach bleeding.

What other drugs will affect salsalate (Disalcid)?

Many drugs can interact with salsalate. Below is just a partial list. Tell your doctor if you are using:

  • acetazolamide (Diamox);
  • cyclosporine (Gengraf, Neoral, Sandimmune);
  • lithium (Eskalith, LithoBid);
  • methotrexate (Rheumatrex, Trexall);
  • pemetrexed (Alimta);
  • tenofovir (Viread);
  • an antidepressant such as fluoxetine (Prozac) or sertraline (Zoloft);
  • a blood thinner such as warfarin (Coumadin);
  • diabetes medication you take by mouth;
  • a diuretic (water pill);
  • gout medication such as probenecid (Benemid);
  • heart or blood pressure medication such as atenolol (Tenormin), captopril (Capoten), lisinopril (Prinivil, Zestril), losartan (Cozaar, Hyzaar), metoprolol (Lopressor, Toprol), and others;
  • medication used to prevent blood clots, such as cilostazol (Pletal) or clopidogrel (Plavix);
  • medicine to treat or prevent osteoporosis, such as alendronate (Fosamax), ibandronate (Boniva), risedronate (Actonel), and others;
  • sodium bicarbonate, potassium citrate (K-Lyte, Urocit-K), sodium citrate and citric acid (Bicitra, Oracit), or sodium citrate and potassium (Citrolith, Polycitra);
  • seizure medication such as phenytoin (Dilantin), phenobarbital (Solfoton), valproic acid (Depakene); or
  • steroid medicine (prednisone and others).

This list is not complete and there are many other medicines that can interact with salsalate. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about salsalate.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only f or the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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