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Salsalate 500 mg: Salsalate Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Содержание

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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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

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Black Box Warning

Boxed Warning

See full prescribing information for complete Boxed Warning.

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.
  • Salsalate tablets, USP is contraindicated for the treatment of perioperative 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.

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

Boxed Warning

See full prescribing information for complete Boxed Warning.

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.
  • Salsalate tablets, USP is contraindicated for the treatment of perioperative 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.
  • 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

Drug 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

Name of the drug

Therapeutic indications
Dosage and administration
Contraindications
Special warnings and precautions
Side effects
Overdose

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

Attention!
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The information is collected from open sources and may contain significant errors!
Be careful and double-check all the information on this page!

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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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This description may contain numerous errors due to automatic translation!
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Salsalat

Composition

Description Composition Salsalate is an automatic translation from the original language.
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This description may contain numerous errors due to automatic translation!
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Salsalat

Forms

Description Forms 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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Tablet

Therapeutic indications

Description Therapeutic indications 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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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.
Do not use this information for any medical prescription or manipulation under any circumstances.
Be sure to read the original instructions for the medicine from the package.
This description may contain numerous errors due to automatic translation!
Keep this in mind and do not use this description!

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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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This description may contain numerous errors due to automatic translation!
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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.
Be sure to read the original instructions for the medicine from the package.
This description may contain numerous errors due to automatic translation!
Keep this in mind and do not use this description!

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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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This description may contain numerous errors due to automatic translation!
Keep this in mind and do not use this description!

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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:

  • https://www.drugs.com/search.php?searchterm=salsalate
  • https://www.rxlist.com/disalcid-drug.htm

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

9 0007

Drug name
Composition
Therapeutic indications
Dosage and administration
Contraindications
Special warnings and precautions
Interactions with other drugs
Side effects
Overdose

Page reviewed by pharmacist Milityan Inessa Mesropovna Last update 2022-03-20

Attention!
The information on this page is for healthcare professionals only!
The information is collected from open sources and may contain significant errors!
Be careful and double-check all the information on this page!

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Name of the medicine

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

Composition

Description Composition Disalcid is an automatic translation from the original language.
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Each DISALCID (salsalate) 500 mg aqua/white capsule printed with Disalcid (salsalate) /3M is available in:
Bottles of 100 (NDC #0089-0148-10)

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

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

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

June 1998

3M Pharmaceuticals
Northridge, CA 91324

Therapeutic indications

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

Dosage and Administration

Description Dosage and Administration Disalcid is an automatic translation from the original language.
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Adults

The usual dose is 3000 mg per day given in divided doses as follows: 1) two doses of two 750 mg tablets: 2) two doses of three 500 mg tablets per day capsules or 3) three doses of two tablets of 500 mg/capsule. 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 benefit may not be apparent until 3-4 days after plasma salicylate reaches steady state. There are no data on the development of tissue tolerance (tachyphylaxis), but salicylate therapy can induce increased activity of metabolizing liver enzymes, causing a greater rate of production and excretion of salicylic acid, which leads to an increase in the need for dosage to maintain therapeutic salicylate serum levels.

Children

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

Contraindications

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

Special Warnings and Precautions

Description Special Warnings and Precautions Disalcid is an automatic translation from the original language.
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WARNINGS

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

PRECAUTIONS

General

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

Although bronchospasm-inducing cross-reactivity has been occasionally 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

Plasma salicylic acid concentration should be monitored periodically during long-term treatment with DISALCIDE (salsalat) to maintain a therapeutically effective level: 10 to 30 mg/100 ml. Toxic manifestations are usually not observed until the plasma concentration exceeds 30 mg/l00 ml (see OVERDOSE Urinary pH should also be monitored regularly: sudden acidification starting from pH 6.5 to 5.5 can double plasma levels, leading to toxicity.

Carcinogenesis

No long-term animal studies have been conducted with DISALCIDE (salsalate) 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 y. 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 benefit justifies the potential risk to the fetus.

Labor and delivery

There are no adequate and well-controlled studies in pregnant women. Although no adverse effects on mother or child have been reported with the use of DISALCIDE (salsalate) during childbirth, caution is advised when using anti-inflammatory drugs. However, other salicylates have been associated with prolonged pregnancy and childbirth, sequelae of maternal and neonatal bleeding, potentiation of narcotic and barbiturate effects (maternal respiratory or cardiac arrest), labor problems, and stillbirth.

Nursing Mothers

It is not known if salsalate is excreted per se in human milk, but salicylic acid, the main metabolite of DISALCIDE (salsalate), has been shown to appear in human milk at concentrations approaching maternal blood levels. Thus, the child of a mother receiving disalcid (salsalat) therapy can ingest in breast milk from 30 to 80% of salicylate per kg of body weight, as much as the mother takes. Accordingly, caution should be exercised when administering DISALCIDE (salsalat) to a nursing woman.

Pediatric

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

Interactions with other drugs

Description Interactions with other drugs Disalcid is an automatic translation from the original language.
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SIDE EFFECTS

In two well-controlled clinical trials (n= 280 patients), the most commonly reported reversible adverse reactions associated with salicylates with disalcid (salsalat) are listed in descending order of frequency: murmur in ears, 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 causal relationships have not been established, spontaneous reports over a ten-year period included the following additional clinically significant side effects: abdominal pain, liver dysfunction, anaphylactic shock, angioedema, bronchospasm, decreased creatinine, diarrhea, gastrointestinal 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 effect of drugs used to treat gout. ASPIRIN AND OTHER SALICYLATE MEDICINES WILL BE ADDITIVE TO DISALCIDE (salsalate) AND MAY INCREASE SALICYLIC ACID PLASMA CONCENTRATION TO TOXIC LEVEL. Drugs and products that increase urinary pH increase renal clearance and urinary excretion of salicylic acid, thereby reducing plasma levels, acidifying drugs or products 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 range of drugs for protein binding, including penicillin, thiopental, thyroxine, triiodothyronine, phenytoin, sulfinpyrazone, naproxen, warfarin, methotrexate, and possibly corticosteroids.

Drug Interactions and Lab Tests

Salicylate competes with thyroid hormone for plasma protein binding, which may result in a decrease in plasma T levels. 4 in some patients, thyroid function and basal metabolism remain unchanged.

Side effects

Description Side effects Disalcid is an automatic translation from the original language.
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This description may contain numerous errors due to automatic translation!
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In two well-controlled clinical trials (n= 280 patients), the most frequently reported reversible adverse reactions associated with salicylates with disalcid (salsalat) were reported 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 no causal relationship has been established, spontaneous reports over a ten-year period included the following additional clinically significant side effects: abdominal pain, hepatic dysfunction, anaphylactic shock, angioedema, bronchospasm, decreased creatinine, diarrhea, gastrointestinal bleeding , hepatitis, hypotension, nephritis and urticaria.

DRUG ABUSE AND DEPENDENCE

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

Overdose

Description Overdose Disalcid is an automatic translation from the original language.
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Be sure to read the original instructions for the medicine from the package.
This description may contain numerous errors due to automatic translation!
Keep this in mind and do not use this description!

more…

Death has occurred after ingestion of 10 to 30 g of salicylates in adults, but much larger amounts have been swallowed without death.

Symptoms

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

Treatment

Further absorption of disalcid (salsalate) from the gastrointestinal tract must be prevented by vomiting (ipecac syrup) and if necessary by gastric lavage.

Fluid and electrolyte imbalances should be corrected by appropriate intravenous therapy. Adequate renal function should be maintained.