Salsalate (Page 4 of 4)

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 tablets, 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 (see WARNINGS section).

Geriatric Use

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

ADVERSE REACTIONS

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.

To report SUSPECTED ADVERSE REACTIONS, contact Westminster Pharmaceuticals, LLC at 1-844-221-7294 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG ABUSE AND DEPENDENCE

Drug abuse and dependence have not been reported with salsalate.

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.

DOSAGE AND ADMINISTRATION

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 (see WARNINGS).

After observing the response to initial therapy with Salsalate tablets, USP, the dose and frequency should be adjusted to suit an individual patient’s needs. Salsalate, USP 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.

Children

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

HOW SUPPLIED

500 mg Tablets: Supplied in bottles of 100ct (NDC 69367-615-01)

Appearance: Yellow, round, Biconvex tablet, debossed “615” on one side and plain on the other side.

750 mg Tablets: Supplied in bottles of 100ct (NDC 69367-616-01)

Appearance: Yellow, capsule-shaped, Biconvex tablet, debossed “616” on one side and plain on the other side.

Dispense contents with a child-resistant closure (as required) and in a tight container as defined in the USP.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Rx only

REFERENCES

1.
Morris HG, Sherman NA, McQuain C, et al: Effects of Salsalate (Non- Acetylated Salicylate) and Aspirin (ASA) on Serum Prostaglandins in Humans. Ther. Drug Monit. 7:435-438, 1985.
2.
April PA, Curran NJ, Ekohlm BP, et al: Multicenter Comparative Study of Salsalate (SSA) vs Aspirin (ASA) in Rheumatoid Arthritis (RA), Arthritis Rheumatism 30 (4 supplement):S93, 1987.
3.
Deodhar SD, McLeod MM, Dick WC, et al: A Short-Term Comparative Trial of Salsalate and Indomethacin in Rheumatoid Arthritis. Curr. Med. Res. Opin., 5:185-188, 1977.
4.
Estes D, Kaplan K: Lack of Platelet Effect With the Aspirin Analog, Salsalate, Arthritis and Rheumatism, 23:1303-1307, 1980.
5.
Dick C, Dick PH, Nuki G, et al: Effect of Anti-inflammatory Drug Therapy on Clearance of 133Xe from Knee Joints of Patients with Rheumatoid Arthritis. British Med. J. 3:278-280, 1969.
6.
Dick WC, Grayson MF, Woodburn A, et al: Indices of Inflammatory Activity. Ann. of the Rheum. Dis. 29:643-648, 1970.
7.
Cohen A: Fecal Blood Loss and Plasma Salicylate Study of Salicylsalicylic Acid and Aspirin. J. Clin. Pharmacol. 19:242-247, 1979.
8.
Chudwin DS, Strub M. Golden HE, et al: Sensitivity to Non-Acetylated Salicylates in a Patient with Asthma, Nasal Polyps, and Rheumatoid Arthritis. Annals of Allergy 57:133-134, 1986.
9.
Spector SL, Wangaard CH, Farr RS: Aspirin and Concomitant Idiosyncrasies in Adult Asthmatic Patients. J. Allergy Clin. Immunol 64:500-506, 1979.
10.
Stevenson DD, Schrank PJ, Hougham AJ, et al: Salsalate Cross Sensitivity in Aspirin-Sensitive Asthmatics. J. Allergy Clin. Immunol 81:181, 1988.

Manufactured for:
Westminster Pharmaceuticals, LLC
Nashville, TN 37217
Rev. 1/2024

PRINCIPAL DISPLAY PANEL — 500 mg Tablet Bottle Label

NDC 69367-615-01
Rx Only

Salsalate
Tablets, USP
500 mg

100 Tablets

Westminster
Pharmaceuticals

PRINCIPAL DISPLAY PANEL -- 500 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 750 mg Tablet Bottle Label

NDC 69367-616-01
Rx Only

Salsalate
Tablets, USP
750 mg

100 Tablets

Westminster
Pharmaceuticals

PRINCIPAL DISPLAY PANEL -- 750 mg Tablet Bottle Label
(click image for full-size original)
SALSALATE
salsalate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-615
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALSALATE (SALSALATE) SALSALATE 500 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
D&C YELLOW NO. 10
HYPROMELLOSE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A
STEARIC ACID
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 11mm
Flavor Imprint Code 615
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-615-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 11/15/2023
SALSALATE
salsalate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-616
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALSALATE (SALSALATE) SALSALATE 750 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
D&C YELLOW NO. 10
HYPROMELLOSE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A
STEARIC ACID
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 19mm
Flavor Imprint Code 616
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-616-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 11/15/2023
Labeler — Westminster Pharmaceuticals, LLC (079516651)

Revised: 02/2024 Westminster Pharmaceuticals, LLC

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