What are the primary uses of Salsalate 500 mg. How should patients take this medication safely. What are the potential side effects and interactions of Salsalate. When should patients seek immediate medical attention while using Salsalate.

Understanding Salsalate: An Overview of the Medication

Salsalate is a nonsteroidal anti-inflammatory drug (NSAID) primarily used to treat arthritis. It’s available in oral tablet form, typically in 500 mg and 750 mg strengths. The brand name for this medication is Disalcid, though it’s also available as a generic drug. Salsalate works by reducing inflammation and pain in the body, making it an effective treatment for various forms of arthritis.

Is Salsalate suitable for all types of arthritis? While it’s commonly prescribed for osteoarthritis and rheumatoid arthritis, the effectiveness may vary depending on the specific type and severity of the condition. Always consult with a healthcare provider to determine if Salsalate is the right choice for your particular situation.

Proper Administration and Dosage Guidelines

Taking Salsalate correctly is crucial for its effectiveness and to minimize potential side effects. Here are the key guidelines for proper administration:

• Take the medication with 250 mL (1 cup) of water
• Remain upright (sitting or standing) for 10 minutes after taking the medicine
• Consider taking it with food to prevent stomach upset
• Store at room temperature away from heat, light, and moisture
• Drink plenty of water while on this medicine

How often should Salsalate be taken? The dosage frequency depends on the prescribed regimen, but it’s typically taken multiple times a day. It’s important to maintain a consistent schedule and not skip doses, even if you’re feeling better.

Missed Dose Protocol

If you forget to take a dose, take it as soon as you remember. However, if it’s almost time for your next scheduled dose, skip the missed one and return to your regular schedule. Never take a double dose to make up for a missed one.

Potential Side Effects and Risks of Salsalate

While Salsalate can be effective in managing arthritis symptoms, it’s important to be aware of potential side effects. Common side effects include:

• Dizziness
• High blood pressure
• Stomach upset or abdominal pain

Are there more serious side effects to watch out for? Yes, some patients may experience more severe reactions that require immediate medical attention. These include:

1. Bleeding or bruising
2. Chest or jaw pain
3. Confusion
4. Coughing up blood or vomit that looks like coffee grounds
5. Swelling of the legs, feet, and hands
6. Severe or persistent headaches
7. Signs of kidney or liver damage
8. Shortness of breath
9. Severe stomach or bowel pain
10. Dark, tarry stools
11. Symptoms of stroke (such as one-sided weakness, slurred speech, confusion)

Drug Interactions and Precautions

Salsalate can interact with other medications, potentially altering their effectiveness or increasing the risk of side effects. It’s crucial to inform your healthcare provider about all medications you’re taking, including over-the-counter drugs, vitamins, and herbal supplements.

Can Salsalate be taken with blood thinners? This combination can be particularly risky, as Salsalate may increase the risk of serious bleeding problems in patients taking blood thinners. Close monitoring and careful dosage adjustment may be necessary if these medications must be used together.

Special Precautions for Specific Groups

• Children and teenagers should not use Salsalate for cold, flu symptoms, or chickenpox
• Patients with heart conditions may experience worsening symptoms
• Pregnant women should consult their doctor, as Salsalate can potentially harm the fetus
• Breastfeeding is not recommended while taking Salsalate

Cardiovascular Risks Associated with Salsalate

Like other NSAIDs, Salsalate is associated with an increased risk of serious cardiovascular events, including heart attack and stroke. This risk may be higher for patients with existing cardiovascular conditions or risk factors.

Does the cardiovascular risk increase with long-term use? While the risk can increase with prolonged use, it’s important to note that cardiovascular events can occur even with short-term use. Regular monitoring and discussion with your healthcare provider about your individual risk factors is crucial.

Signs of Cardiovascular Complications

Patients should be aware of the following symptoms that may indicate a serious cardiovascular event:

• Chest pain or pressure
• Shortness of breath
• Weakness on one side of the body
• Slurred speech
• Sudden severe headache

Gastrointestinal Risks and Bleeding Concerns

Salsalate, like other NSAIDs, can cause serious gastrointestinal (GI) adverse events, including inflammation, bleeding, ulceration, and perforation of the stomach or intestines. These events can occur at any time during treatment and without warning symptoms.

Who is at higher risk for GI complications? Elderly patients, those with a history of peptic ulcer disease or GI bleeding, and patients using certain medications (such as corticosteroids or anticoagulants) may be at increased risk for developing these complications.

Recognizing Signs of GI Bleeding

Patients should be alert to the following signs of GI bleeding:

• Black, tarry stools
• Vomiting blood or material that looks like coffee grounds
• Severe abdominal pain
• Weakness or dizziness

Monitoring and Follow-up While on Salsalate

Regular monitoring is essential when taking Salsalate to ensure its effectiveness and to catch any potential complications early. This may include:

• Periodic blood tests to check kidney and liver function
• Blood pressure monitoring
• Assessment of cardiovascular risk factors
• Evaluation of gastrointestinal health

How often should patients have follow-up appointments? The frequency of follow-up visits will depend on individual factors such as age, overall health, and the presence of other medical conditions. Your healthcare provider will determine the appropriate schedule for your situation.

Self-Monitoring Tips

In addition to regular medical check-ups, patients can monitor themselves for potential issues:

• Keep track of any new or worsening symptoms
• Monitor for signs of bleeding or bruising
• Be aware of changes in urination patterns or urine color
• Note any unexplained weight gain or swelling

Lifestyle Considerations While Taking Salsalate

Certain lifestyle factors can impact the safety and effectiveness of Salsalate treatment. Patients should be aware of the following considerations:

Alcohol Consumption

Alcohol can increase the risk of stomach bleeding when combined with Salsalate. Patients should consult their healthcare provider about safe alcohol consumption while on this medication.

Smoking

Smoking can increase the risk of cardiovascular events, which is already a concern with Salsalate use. Quitting smoking or reducing tobacco use can help mitigate this risk.

Physical Activity

While Salsalate can help manage arthritis pain, allowing for increased physical activity, patients should be cautious about overexertion. Gradual increases in activity levels are often recommended.

Diet

A healthy, balanced diet can support overall health and potentially reduce inflammation. Some patients may benefit from following an anti-inflammatory diet while taking Salsalate.

Can dietary changes enhance the effectiveness of Salsalate? While no specific diet is proven to directly enhance Salsalate’s effectiveness, a healthy diet rich in fruits, vegetables, and omega-3 fatty acids may complement the anti-inflammatory effects of the medication.

Alternative and Complementary Therapies

While Salsalate can be effective in managing arthritis symptoms, some patients may explore complementary therapies to enhance their treatment plan. These may include:

• Physical therapy
• Occupational therapy
• Acupuncture
• Massage therapy
• Yoga or tai chi
• Heat and cold therapy

Is it safe to use complementary therapies alongside Salsalate? Many complementary therapies can be safely used in conjunction with Salsalate, but it’s important to discuss any additional treatments with your healthcare provider to ensure they don’t interfere with your medication or overall treatment plan.

Herbal Supplements and Salsalate

Some patients may consider using herbal supplements to manage their arthritis symptoms. However, it’s crucial to exercise caution:

• Some herbs can interact with Salsalate or affect its effectiveness
• Certain supplements may increase the risk of bleeding when combined with Salsalate
• The quality and purity of herbal supplements can vary widely

Always consult with your healthcare provider before adding any herbal supplements to your regimen while taking Salsalate.

Long-term Outlook and Management of Arthritis with Salsalate

While Salsalate can be an effective tool in managing arthritis symptoms, it’s important to view it as part of a comprehensive treatment plan. Long-term management of arthritis often involves a multi-faceted approach:

• Regular medication management and adjustments as needed
• Ongoing physical therapy or exercise programs
• Weight management to reduce stress on joints
• Occupational therapy to improve daily functioning
• Psychological support to cope with chronic pain

Can Salsalate slow the progression of arthritis? While Salsalate can effectively manage symptoms, it’s not known to significantly alter the course of the disease. However, by reducing inflammation and pain, it may help patients maintain better joint function and quality of life.

Periodic Reassessment of Treatment

Regular evaluation of the treatment plan is crucial for optimal management of arthritis with Salsalate:

• Assess the continued effectiveness of the medication
• Evaluate for any developing side effects or complications
• Consider adjustments to dosage or alternative treatments if necessary
• Review overall arthritis management strategies

How often should treatment plans be reassessed? The frequency of reassessment can vary based on individual factors, but typically, a comprehensive review should occur at least annually or more frequently if there are significant changes in symptoms or overall health status.

Patient Education and Self-Management Strategies

Empowering patients with knowledge and self-management skills is crucial for the successful long-term use of Salsalate and overall arthritis management. Key areas of focus include:

Medication Adherence

Understanding the importance of taking Salsalate as prescribed and developing strategies to maintain consistency in medication use.

Symptom Tracking

Keeping a journal of arthritis symptoms, pain levels, and any potential side effects can help in discussions with healthcare providers and in making informed treatment decisions.

Lifestyle Modifications

Learning about and implementing lifestyle changes that can complement medication therapy, such as proper nutrition, stress management, and appropriate exercise routines.

Emergency Preparedness

Knowing when and how to seek immediate medical attention if serious side effects or complications occur.

What resources are available for patient education on Salsalate use? Many healthcare providers offer educational materials, and reputable online sources such as arthritis foundations and medical institutions provide valuable information. Additionally, support groups can offer practical tips and emotional support for managing arthritis with medications like Salsalate.

Future Directions in Arthritis Treatment

While Salsalate remains an important tool in managing arthritis, ongoing research continues to explore new treatment options and refine existing therapies. Some areas of development include:

• Targeted biologic therapies
• Gene therapy approaches
• Regenerative medicine techniques
• Improved drug delivery methods
• Personalized medicine strategies

How might future treatments impact the use of Salsalate? As new therapies emerge, the role of traditional NSAIDs like Salsalate may evolve. However, given its established efficacy and relatively low cost, Salsalate is likely to remain an important option in the arthritis treatment arsenal for the foreseeable future.

Participating in Clinical Trials

For patients interested in contributing to the advancement of arthritis treatment, participation in clinical trials may be an option. Benefits of participating in trials can include:

• Access to cutting-edge treatments
• Close monitoring by healthcare professionals
• Contributing to medical research
• Potential for improved symptom management

Patients should discuss the possibility of clinical trial participation with their healthcare providers to determine if it’s an appropriate option for their individual situation.

What is Salsalate Oral Tablet 500 mg, 750 mg?

For arthritis.

Brand Name(s): Disalcid

Generic Name: Salsalate

Instructions

Take the medicine with 250 mL (1 cup) of water.

Sit or stand upright for 10 minutes after taking the medicine. Do not lie down.

You may take with food to prevent stomach upset.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Drink plenty of water while on this medicine.

If you are using this medicine regularly, it is important to take each dose of medicine on time. Keep taking the medicine even if you feel well.

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Return to your normal schedule. Do not take 2 doses at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Talk to your doctor before taking other medicines, including aspirins and ibuprofen containing products. Speak to your doctor about which medicines are safe to use while you are on this medicine.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

IMPORTANT: Children and teenagers should not use this medicine if they have cold and flu symptoms or chickenpox.

This medicine may cause serious bleeding problems in patients taking blood thinner medications. Follow your doctor’s instructions carefully to monitor your blood lab tests if you are on blood thinners.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients with weak hearts may have worsening of symptoms. If you notice difficulty breathing, weight gain, or swelling of your legs or ankles, let your doctor know right away.

Some patients taking this medicine have experienced serious side effects. Please speak with your doctor to understand the risks and benefits associated with this medicine.

This medicine is associated with an increased risk of serious heart problems, heart attack, and stroke. Please speak with your doctor about the risks and benefits of using this medicine. Contact your doctor immediately if you experience chest pain or difficulty breathing.

This medicine may cause serious bleeding from the stomach or bowels. Stop this medicine and call your doctor immediately if you see any signs of bleeding. Bleeding can cause pain in the stomach, vomiting up liquid that looks like coffee grounds, and red or dark tarry stools.

Do not use the medication any more than instructed.

Your ability to stay alert or to react quickly may be impaired by this medicine. Do not drive or operate machinery until you know how this medicine will affect you.

Speak with your doctor before taking any medicine with aspirin.

Please check with your doctor before drinking alcohol while on this medicine.

Avoid smoking while on this medicine. Smoking may increase your risk for stroke, heart attack, blood clots, high blood pressure, and other diseases of the heart and blood vessels.

Contact your doctor if you notice a change in the amount or darkening of your urine.

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or breastfeeding.

Do not breastfeed while on this medicine.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Call your doctor right away if you notice any unusual bleeding or bruising.

Do not share this medicine with anyone who has not been prescribed this medicine.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• dizziness
• high blood pressure
• stomach upset or abdominal pain

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• bleeding or bruising
• chest or jaw pain
• confusion
• coughing up blood or vomit that looks like coffee grounds
• swelling of the legs, feet, and hands
• fainting
• severe or persistent headache
• signs of kidney damage (such as change in urine color or bubbly urine)
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• shortness of breath
• severe stomach or bowel pain
• dark, tarry stool
• symptoms of stroke (such as one-sided weakness, slurred speech, confusion)
• difficulty swallowing
• sweating
• urinating less often
• blurring or changes of vision
• severe or persistent vomiting
• sudden or unexplained weight gain

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.

IMPORTANT NOTE: This document tells you briefly how to take your medicine, but it does not tell you all there is to know about it. Your doctor or pharmacist may give you other documents about your medicine. Please talk to them if you have any questions. Always follow their advice.

There is a more complete description of this medicine available in English. Scan this code on your smartphone or tablet or use the web address below. You can also ask your pharmacist for a printout. If you have any questions, please ask your pharmacist.

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Selected from data included with permission and copyright by First DataBank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

Conditions of Use: The information in this database is intended to supplement, not substitute for the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. The display and use of this drug information is subject to express Terms of Use.

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Salsalate – wikidoc

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Black Box Warning

Overview

Salsalate is an analgesic that is FDA approved for the treatment of relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis and related rheumatic disorder. There is a Black Box Warning for this drug as shown here. Common adverse reactions include rash, nausea, vertigo, hearing disorder, tinnitus.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Carefully consider the potential benefits and risks of Salsalate tablets, USP and other treatment options before deciding to use Salsalate tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
• Salsalate is indicated for relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis and related rheumatic disorder.

Carefully consider the potential benefits and risks of Salsalate tablet, USP and other treatment options before deciding to use Salsalate tablet, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

• After observing the response to initial therapy with Salsalate tablet, USP, the dose and frequency should be adjusted to suit an individual patient’s needs.
• Salsalate is indicated for relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis and related rheumatic disorder.
• 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; or 3) three doses of two 500 mg tablets. 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.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Salsalate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Salsalate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Salsalate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Salsalate in pediatric patients.

Contraindications

• Salsalate tablet, USP is contraindicated in patients with known hypersensitivity to salsalate.
• Salsalate tablet, USP should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients.
• Salsalate tablet, USP is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

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. Salsalate contains a salicylate and therefore is not recommended for use in patients with chicken pox, influenza, or flu symptoms.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Salsalate in the drug label.

Postmarketing Experience

• In two well-controlled clinical trials, the following reversible adverse experiences characteristic of salicylates were most commonly reported with salsalate (n-280 pts; 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 clearance, diarrhea, G.I. bleeding, hepatitis, hypotension, nephritis and urticaria.

Drug Interactions

There is limited information regarding Salsalate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

• Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. However, animal reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies in pregnant women.

Nonteratogenic Effects

• Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during pregnancy (particularly late pregnancy) should be avoided.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Salsalate in women who are pregnant.

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 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.
• In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. The effects of Salsalate tablet, USP on labor and delivery in pregnant women are unknown.

Nursing Mothers

• It is not known whether salsalate per se is excreted in human milk; salicylic acid, the primary metabolite of salsalate, has been shown to appear in human milk in concentrations approximating the maternal blood level. Thus, the infant of a mother on 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 salsalate is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of salsalate use in children have not been established.

Geriatic Use

As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older).

Gender

There is no FDA guidance on the use of Salsalate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Salsalate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Salsalate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Salsalate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Salsalate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Salsalate in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral.

• Intravenous.

Monitoring

• Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.
• If Salsalate tablet, USP therapy must be initiated, close monitoring of the patient’s renal function is advisable
• Patients receiving Salsalate tablet, USP, who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.

IV Compatibility

There is limited information regarding IV Compatibility of Salsalate in the drug label.

Overdosage

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 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.

Pharmacology

Mechanism of Action

• Salsalate is a nonsteroidal anti-inflammatory drug (NSAID). The anti-inflammatory property may be attributed to its ability to inhibit prostaglandin synthesis.

Structure

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

This image is provided by the National Library of Medicine.

Each tablet, for oral administration contains 500 mg or 750 mg of salsalate, USP. In addition each tablet contains the following inactive ingredients: Microcrystalline Cellulose, Sodium Starch Glycolate, Povidone, and Stearic Acid. Also contains: Hydroxypropyl Methylcellulose, Polydextrose, Titanium Dioxide, Triacetin, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake and Polyethylene Glycol.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Salsalate in the drug label.

Pharmacokinetics

• 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 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 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 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 salsalate.
• The mode of anti-inflammatory action of salsalate and other nonsteroidal anti-inflammatory drugs is not fully defined. Although salicylic acid (the primary metabolite of salsalate) is a weak inhibitor of prostaglandin synthesis in vitro, salsalate appears to selectively inhibit prostaglandin synthesis in vivo1, providing anti-inflammatory activity equivalent to aspirin2 and indomethacin3. Unlike aspirin, salsalate does not inhibit platelet aggregation4.
• The usefulness of salicylic acid, the active in vivo product of salsalate, in the treatment of arthritic disorders has been established 5,6. In contrast to aspirin, salsalate causes no greater fecal gastrointestinal blood loss than placebo.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Salsalate in the drug label.

Clinical Studies

There is limited information regarding Salsalate Clinical Studies in the drug label.

How Supplied

• 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 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 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 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 salsalate.
• The mode of anti-inflammatory action of salsalate and other nonsteroidal anti-inflammatory drugs is not fully defined. Although salicylic acid (the primary metabolite of salsalate) is a weak inhibitor of prostaglandin synthesis in vitro, salsalate appears to selectively inhibit prostaglandin synthesis in vivo, providing anti-inflammatory activity equivalent to aspirin2 and indomethacin3. Unlike aspirin, salsalate does not inhibit platelet aggregation.
• The usefulness of salicylic acid, the active in vivo product of salsalate, in the treatment of arthritic disorders has been established. In contrast to aspirin, salsalate causes no greater fecal gastrointestinal blood loss than placebo.

Storage

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

Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Salsalate Patient Counseling Information in the drug label.

Precautions with Alcohol

• Alcohol-Salsalate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• SALSALATE ®^[1]

Look-Alike Drug Names

There is limited information regarding Salsalate Look-Alike Drug Names in the drug label.

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

1. ↑ “SALSALATE – salsalate tablet”.

instructions for use, dosages, composition, analogues, side effects / Pillintrip

Page reviewed by pharmacist Kovalenko Svetlana Olegovna Last update 2022-04-06

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Name of medicine

Description The name of the medicine Salsalate is an automatic translation from the original language.
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Salsalat

Composition

Description Composition Salsalate is an automatic translation from the original language.
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Salsalat

Forms

Description Forms Salsalate is an automatic translation from the original language.
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Tablet

Therapeutic indications

Description Therapeutic indications Salsalate is an automatic translation from the original language.
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Disalcid (salsalate) is indicated for the relief of the signs and symptoms of rheumatoid arthritis, arthrosis and related rheumatic disorders.

Dosage and administration

Description Dosage and administration of Salsalate is an automatic translation from the original language.
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Adults

The usual dose is 3000 mg per day, in divided doses as follows: 1) two doses of two 750 mg tablets: 2) two doses of three 500 mg tablets / capsule ; or 3) three doses of two 500 mg tablets/capsules. Some patients, for example. older people may need a lower dose to achieve therapeutic blood levels and prevent more common side effects such as hearing loss.

Symptoms gradually decrease and full use may not be evident until 3-4 days when plasma salicylate levels have reached steady state. There is no evidence for the development of tissue tolerance (tachyphylaxis), but salicylate therapy may cause increased activity in the metabolism of liver enzymes, resulting in a higher rate of production and excretion of salicyluric acid, which increases the need for dosing to maintain therapeutic serum levels of salicylate.

Children

Dosage recommendations and indications for the use of disalcid (salsalat) in children have not been established.

Contraindications

Description Contraindications Salsalate is an automatic translation from the original language.
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Disalcid is contraindicated in patients with hypersensitivity to salsalat.

Special Warnings and Precautions

Description Special Warnings and Precautions Salsalate is an automatic translation from the original language.
Do not use this information for any medical prescription or manipulation under any circumstances.
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This description may contain numerous errors due to automatic translation!
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WARNINGS

Reye’s syndrome can develop in people with chickenpox, the flu, or the flu. Some studies point to a possible link between the development of Reye’s syndrome and the use of medicines containing salicylate or aspirin. Disalcid (salsalate) contains salicylate and is therefore not recommended for use in patients with symptoms of chickenpox, flu, or influenza.

PRECAUTIONS

general

Patients receiving DISALCID (salsalate) should be warned not to take any other salicylates to avoid potentially toxic concentrations. Great care should be taken if LIMIT (salsalat) is prescribed for chronic renal failure or stomach ulcers. Protein binding to salicylic acid may be due to nutritional status, competitive binding of other drugs and diseases (rheumatoid arthritis, etc.) caused by fluctuations in serum proteins are influenced.).

Although cross-reactivity, including bronchospasm, has occasionally been reported with nonacetylated salicylates, including salsalate, in aspirin-sensitive patients _8.9 salsalate is less likely to cause asthma in these patients than aspirin. ₁₀

Laboratory tests

Plasma salicylic acid concentrations should be regularly monitored during long-term treatment with disalcid (salsalat) to maintain maintenance of therapeutically effective levels: 10 to 30 mg/100 ml. Toxic manifestations usually only occur when plasma concentrations exceed 30 mg/l/ml (see TRANSLATION ). Urinary pH should also be regularly monitored: sudden acidification from 6.5 to 5.5 can double plasma levels, leading to toxicity.

Carcinogenesis

Long-term animal studies with DISALCID (salsalate) have not been conducted 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 administered at doses 4-5 times the usual human dose. Effects were not observed at doses twice the usual human dose. There are no adequate and well-controlled studies in pregnant women. DISALCID (salsalat) should only be used during pregnancy if the potential use justifies the potential risk to the fetus.

Work and delivery

There are no adequate and well-controlled studies in pregnant women. Although no adverse effects on the mother or baby have been reported when taking DZALCIDA (salsalat) during childbirth, caution should be exercised when using an anti-inflammatory agent. However, other salicylates have been associated with prolonged pregnancy and childbirth, maternal and neonatal bleeding, increased narcotic and barbitural effects (maternal respiratory or cardiac arrest), labor problems, and stillbirth.

Nursing mothers

It is not known if salsalate is excreted in breast milk as such; Salicylic acid, the main metabolite of disalcid (salsalate), has been shown to be present in breast milk at concentrations close to maternal blood levels. Thus, a mother’s child receiving LIMIT therapy (salsalat) can take 30% more salicylate per kg of body weight from the mother than the mother takes milk. Accordingly, caution should be exercised when LIMIT (salsalat) is given to a breastfeeding woman.

Pediatric use

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

Side Effects

Description Side Effects Salsalate is an automatic translation from the original language.
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In two well-controlled clinical trials (n = 280 patients), the following salicylate-specific reversible side effects were most commonly reported with DISALCID (salsalate), listed in descending order of frequency: tinnitus, nausea , hearing impairment, rash and dizziness. These common symptoms of salicylate, tinnitus, or reversible hearing loss are often used as a guide to therapy.

Although no causal relationship was found, spontaneous reports over a ten-year period included the following additional medically significant side effects: abdominal pain, liver dysfunction, anaphylactic shock, angioedema, bronchospasm, decreased creatinine deficiency, diarrhea, G.I. Bleeding, hepatitis, hypotension, nephritis and urticaria.

DRUG EVIL and DEPENDENCE

No drug abuse or dependence has been reported with DISALCID (salsalat).

Overdose

Description Overdose Salsalate is an automatic translation from the original language.
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Death was followed by withdrawal of 10 to 30 g of salicylates in adults, but much larger amounts were taken without death.

Symptoms

Common symptoms of salicylism are tinnitus, dizziness, headache, confusion, drowsiness, sweating, hyperventilation, vomiting and diarrhea. Severe intoxication leads to electrolyte imbalance and blood pH, as well as hyperthermia and dehydration.

Treatment

Further absorption of disalcid (salsalate) from the G.I tract. should be prevented by vomiting (ipecac syrup) and possibly gastric lavage.

Fluid and electrolyte imbalance must be corrected by administration of the appropriate I.V. therapy. Adequate kidney function must be maintained. In extreme cases, hemodialysis or peritoneal dialysis may be required.

Sources:

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• https://www.rxlist.com/disalcid-drug.htm

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Disalcid (salsalat): use, dosage, side effects, interactions, warning

• Generic Name: Salsalat
• Brand Name: Disalcid

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• Product description
• Indications and dosage
• Side effects
• Drug interactions
• Warnings and precautions
• Overdose and contraindications
• Clinical pharmacology
• Medication guide

Product description

Disalcid
(salsalat) Tablets and capsules

DESCRIPTION

DISALCIDE (salsalate) is a non-steroidal anti-inflammatory agent for oral administration. From a chemical point of view, salsalate (salicylsalicylic acid or 2-hydroxybenzoester acid, 2-carboxyphenyl ester) is a dimer of salicylic acid; its structural formula is shown below.

Each DISALCID capsule contains 500 mg of salsalate, plus colloidal silicon dioxide, gelatin, magnesium stearate, pregelatinized starch, corn starch, titanium dioxide, FD&C blue #l and D&C yellow #l0. Each DISALCI D tablet contains 500 or 750 mg of salsalate, as well as croscarmellose sodium, hydroxypropyl methylcellulose, magnesium stearate, microcrystals, allic cellulose, polyethylene glycol, polysorbate 80, propylene glycol, talc, titanium dioxide, blue #1 FD&C and D&C. yellow #l0. (See HOW SUPPLIED )

Indications and Dosage

INDICATIONS

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

DOSAGE AND ADMINISTRATION

Adults

The usual dose is 3000 mg per day, which is distributed 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, such as the elderly, may require a lower dosage to achieve therapeutic blood levels and to avoid more common side effects such as hearing loss.

Relief of symptoms is gradual and full improvement may not occur until 3-4 days when plasma salicylate levels have reached a steady state. There is no evidence for the development of tissue tolerance (tachyphylaxis), but salicylate therapy can induce increased activity of liver metabolizing enzymes, causing a higher rate of production and excretion of salicyluric acid, which leads to an increase in dosage requirements to maintain therapeutic salicylate serum levels.

what allegrade is used for

Children

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

HOW SUPPLIED

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

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

Each DISALCID (salsalat) tablet 750 mg aqua, film-coated, capsule form, halved tablet, embossed with DISALCID ( salsalate) 750 on one side and 3M on the other side available in:
Bottles of 100 (NDC No. 0089-0151-10)
Bottles of 500 (NDC No. 0089-0151-50)

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

JUNE 1998

3M Pharmaceuticals
Northridge, CA 91324

Side effects total reported with DISALCID (salsalat), listed in descending order of frequency: tinnitus, nausea, hearing loss, rash, and dizziness. . These common symptoms of salicylates, i.e. tinnitus or reversible hearing loss, are often used as a guide to therapy.

Although a causal relationship has not been established, spontaneous reports over a ten-year period have included the following additional medically considered adverse events: abdominal pain, hepatic impairment, anaphylactic shock, angioedema, bronchospasm, creatinine reduction, diarrhea, GI bleeding, hepatitis , arterial hypotension, nephritis and urticaria.

DRUG ABUSE AND DEPENDENCE

There have been no reports of drug abuse and dependence on DISALCID (salsalat).

Drug interactions

DRUG INTERACTIONS

Salicylates counteract uricosuric action. drugs used to treat gout. ASPIRIN AND OTHER SLICYLATE MEDICATIONS WILL BE ADDED TO DYSALCIDE (salsalate) AND MAY INCREASE THE PLASMA CONCENTRATION OF SLICYLIC ACID TO TOXIC LEVEL. Drugs and products that increase urinary pH increase renal clearance and urinary excretion of salicylic acid, thereby lowering plasma levels; acidifying drugs or foods decrease urinary excretion and increase plasma levels. Salicylates given concomitantly with anticoagulants 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, especially penicillin, thiopental, thyroxine, triiodothyronine, phenytoin, sulfinpyrazone, naproxen, warfarin, methotrexate, and possibly corticosteroids.

Drug Interactions / Lab Tests

Salicylate competes with thyroid hormone for plasma protein binding, which may result in decreased plasma T levels. ₄ useful in some patients; thyroid function and basal metabolism are not disturbed.

Warnings and Precautions

WARNINGS

Reye’s syndrome can develop in people who have symptoms of chickenpox, influenza, or influenza. Some research suggests a possible link between the development of Reye’s syndrome and the use of medications containing salicylate or aspirin. DISALCID (salsalate) contains salicylate and is therefore not recommended for the treatment of patients with chickenpox, flu, or flu-like symptoms.

PRECAUTIONS

General

Patients treated with DISALCIDE (salsalate) should be warned against other salicylates to avoid potentially toxic concentrations. Special care should be taken when prescribing DISALCIDE (salsalat) in the presence of chronic renal failure or peptic ulcer disease. Protein binding of salicylic acid can be affected by nutritional status, competitive binding of other drugs, and fluctuations in serum proteins caused by disease (rheumatoid arthritis, etc. ).

Although cross-reactivity inducing bronchospasm has occasionally been reported with non-acetylated salicylates, including salsalate, in aspirin-sensitive patients, ^8.9 Salsalate is less likely than aspirin to cause asthma in these patients. ¹⁰

Laboratory Tests

During long-term treatment with DISALCID (salsalat), plasma concentrations of salicylic acid should be monitored periodically to maintain therapeutically effective levels: 10 to 30 mg/100 ml. Toxic manifestations are usually not observed until the plasma concentration exceeds 30 mg/100 ml (see OVERDOSE ). Urinary pH should also be monitored regularly: sudden acidification from 6.5 to 5.5 can double plasma levels, leading to toxicity.

Carcinogenesis

what promethazine syrup is used for

Long-term animal studies of DISALCID (salsalate) have not been conducted to evaluate its carcinogenic potential.

Pregnancy use

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

Work and delivery

There are no adequate and well-controlled studies in pregnant women. Although there have been no reported adverse effects of DISALCIDE (salsalate) use during labor on either the mother or the baby, caution should be exercised when using anti-inflammatory doses. However, other salicylates have been associated with prolongation of pregnancy and childbirth, consequences of bleeding in the mother and newborn, potentiation of narcotic and barbiturate effects (maternal respiratory or cardiac arrest), problems with childbirth and stillbirth.

Breastfeeding mothers

It is not known whether salsalate per se is excreted in breast milk; salicylic acid, the main metabolite of DISALCID (salsalate), is found in human milk at concentrations approaching maternal blood levels. Thus, the child of a mother receiving therapy with DISALCIDE (salsalate) can swallow with mother’s milk 30-80% more salicylate per kilogram of body weight than the mother takes. Accordingly, caution should be exercised when prescribing DISALCIDE (salsalat) to a nursing woman.

Pediatric use

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

Overdose and contraindications

OVERDOSAGE

Death has occurred after ingestion of 10 to 30 g of salicylates by adults, but much larger amounts have been taken without fatal outcome.

Symptoms

The usual symptoms of salicylism will appear – tinnitus, dizziness, headache, confusion, drowsiness, sweating, hyperventilation, vomiting and diarrhea. More severe intoxication will lead to electrolyte imbalance and blood pH, hyperthermia and dehydration.

Care

Further absorption of DISALCIDE (salsalate) from G.I. Prevent vomiting (ipecac syrup) and, if necessary, gastric lavage.

Fluid and electrolyte imbalance should be corrected by appropriate intravenous injections. therapy. Adequate renal function should be maintained. In extreme cases, hemodialysis or peritoneal dialysis may be required.

CONTRAINDICATIONS

DISALCID is contraindicated in patients with hypersensitivity to salsalat.

Clinical Pharmacology

CLINICAL PHARMACOLOGY

DISALCID (salsalate) does not dissolve in acidic gastric fluid (

Biotransformation of salicylic acid saturates at anti-inflammatory doses of DISALCID (salsalate). This limited ability to bio transformation leads to an increase in the half-life of salicylic acid from 3, 5 to 16 hours or more.Thus, taking DISALCID (salsalate) twice daily satisfactorily maintains blood levels in the desired therapeutic range (10 to 30mg/100mL) over 12-hour intervals.Therapeutic blood levels are maintained up to 16 hours after the last dose.The parent compound does not exhibit limited biotransformation and does not accumulate in plasma with repeated administration.