Salsalate (Page 4 of 4)

DOSAGE AND ADMINISTRATION

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 (see WARNINGS).

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.

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

HOW SUPPLIED

500 mg Tablets:
NDC 42291-755-01 100 per bottle
NDC 42291-755-50 500 per bottle

Appearance: Yellow colored, capsule-shaped, film-coated tablet, debossed “AN” over ” 512″ on one side, and plain on the other.

750 mg Tablets:
NDC 42291-756-01 100 per bottle
NDC 42291-756-50 500 per bottle

Appearance: Yellow colored, capsule-shaped, scored, film-coated, tablets debossed “AN 513″ on one side and plan on the other.

Dispense contents with a child-resistant closure (as required) and in a tight container as defined in the USP.
Store at controlled room temperature 20-25°C (68-75°F); excursions permitted to 15-30°C (59-86°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:
AvKARE Inc.
Pulaski, TN 38478
Mfg. Rev. 04/08 AV Rev. 01/14 (P)
MF#673

PRINCIPAL DISPLAY PANEL

AvKARE
NDC 42291-755-01
Salsalate Tablets, USP

500 mg
100 Tablets Rx Only

Each film-coated tablet contains:
Salsalate, USP ……………………………… 500 mg

Usual Dosage: See package outsert for dosage information.

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

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

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

Manufactured for:
AvKARE Inc.
Pulaski, TN 38478
Mfg. Rev. 08/10AV Rev. 05/13 (P)

N 3 42291 75501 7

label 500mg
(click image for full-size original)

AvKARE NDC 42291-756-01
Salsalate Tablets, USP

750 mg
100 Tablets Rx Only

Each film-coated tablet contains:
Salsalate, USP ……………………………… 750 mg

Usual Dosage: See package outsert for dosage information.

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

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

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

Manufactured for:
AvKARE Inc.
Pulaski, TN 38478
Mfg. Rev. 08/10AV Rev. 05/13 (P)

N 3 42291 75601 4

label 750mg
(click image for full-size original)
SALSALATE salsalate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-755(NDC:65162-512)
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
Cellulose, Microcrystalline
Stearic Acid
Hypromelloses
Titanium Dioxide
Polyethylene Glycols
Carnauba Wax
Silicon Dioxide
Croscarmellose Sodium
D&c Yellow No. 10
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 12mm
Flavor Imprint Code AN512
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-755-01 100 TABLET in 1 BOTTLE None
2 NDC:42291-755-50 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/17/2013
SALSALATE salsalate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-756(NDC:65162-513)
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
Cellulose, Microcrystalline
Stearic Acid
Hypromelloses
Titanium Dioxide
Polyethylene Glycols
D&c Yellow No. 10
Carnauba Wax
Croscarmellose Sodium
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code AN513
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-756-01 100 TABLET in 1 BOTTLE None
2 NDC:42291-756-50 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/17/2013
Labeler — AvKARE, Inc. (796560394)

Revised: 02/2014 AvKARE, Inc.

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