Analgesics, NSAIDS and Antipyretics

Non-steroidal Anti-inflammatory Drugs (NSAIDs) Analgesics and Antipyretics – Alphabetically by Generic and Tier (Oral, Topical and Rectal)
See Tier 2, Special and Topical Prior Authorization Criteria located here:http://www.okhca.org/providers.aspx?id=1218 

PHARM-13 Statement of Medical Necessity for Quantity Limits Override

 Drug Generic Name  

 Drug Brand Name/ Common Name  

FDA Recommended Quantity Limit/ Days Supply*  

Maximum FDA Recommended Adult Daily Dose**  

Tier 1 NSAIDS   

Diclofenac ER

Voltaren XR

60/30

200 mg/day

Diclofenac potassium

Cataflam

120/30

200 mg/day

Diclofenac sodium

Voltaren

120/30

200 mg/day

Etodolac

Lodine

90/30

Not to exceed 1000 mg/day

Etodolac ER

Lodine ER

30/30

Not to exceed 1000 mg/day

Fluibiprofen

Ansaid

90/30

300 mg/day

Ibuprofen 400, 600 & 800 mg

Motrin

120/30

3200 mg/day

Ketoprofen

Orudis

90/30

300 mg/day

Ketorolac tromethamine

Toradol

21/6

40 mg/day

Meclofenamate

Meclomen

120/30

400 mg/day

Meloxicam

Mobic

30/30

15 mg/day

Nabumetone

Relafen                          

60/30

2000 mg/day

Naproxen

Naprosyn, Naprosyn EC

90/30

1500 mg/day

Naproxen sodium

Anaprox, Anaprox DS

60/30 

1500 mg day

Oxaprozin

Daypro

90/30

1800 mg (26 mg/kg)

Sulindac

Clinoril

60/30

400 mg/day

Tolmetin

Tolectin

90/30

1800 mg/day

Tier 2 NSAIDS  

Celecoxib

Celebrex

60/30

400 mg = 30/30

400 mg/day

Diclofenac sodium/misoprostol

Arthrotec

120/30

800 mcg misoprostol/day

Fenoprofen

Nalfon

120/30

3200 mg/day

Other NSAIDS   

Diflunisal

Dolobid

60/30

1500 mg/day

Salsalate

Disalcid

120/30

3000 mg/day

 Special PA NSAIDS  

Diclofenac potassium

Zipsor

Cambia

120/30

60/30 Cambia powder packets

200 mg/day

Diclofenac sub-micronized

Zorvolex

90/30

105 mg/day sub-micronized diclofenac

200 mg/day diclofenac

Esomeprazole/naproxen

Vimovo

60/30

1500 mg/day naproxen

Ibuprofen/famotidine

Duexis

90/30

3200 mg IBU/day

Indomethacin ER

Trivorbex

60/30 (extended release products)

200 mg/day

Indomethacin

Indocin

120/30 (immediate release products)

200 mg/day

Keptoprofen 200 mg XR 24 hr Pellets

Orudis SR

30/30

Max 200 mg day

Mefenamic acid

Ponstel

120/30

1000 mg/day

 

Naproxen sodium

Naprelan

90/30

1500 mg/day

Piroxicam

Feldene

30/30

20 mg/day

 Topical– Special PA*  

Diclofenac epolamine Topical

Flextor Patch*

30/15

2 patches/day

Diclofenac sodium gel

Voltaren gel**

300 GM/18 days

500  GM/30 days

4 gm

Diclofenac sodium gel – 3%

 

100 gm/30 days

N/A

Diclofenac sodium solution -  1% drops

Pennsaid**

150 mL/30 days

160 drops

 

Diclofenac sodium solution – 2%

Pennsaid**

112 gm/28 days

40 mg - topical

Lidocaine Topical

Lidoderm*

90/30

3 patches/day

Suppository    

Indomethacin Rectal Suppository

Indocin

120/30

200 mg

Miscellaneous Analgesics and Antipyretics   

Butalbital-acetaminophen

 (50-325 and 50-300 mg) Tablets-Capsules

Phrenilin, Tencon

120/30 

3250 mg/APAP+ 

The maximum daily dose of acetaminophen should not exceed 4gm (4000 mg) from ALL sources

Butalbital-acetaminophen-caffeine ) Tablets and (40-300-40 mg) Capsules

Capacet, Esgic, Fioricet Margesic,  Orbivan

120/30 

3250 mg/APAP+ 

The maximum daily dose of acetaminophen should not exceed 4gm (4000 mg) from ALL sources

Butalbital-aspirin-caffeine (50-325-40 mg) Capsules

Fiorinal, Butalbital Compound

120/30 

3250 mg/APAP+ 

The maximum daily dose of acetaminophen should not exceed 4gm (4000 mg) from ALL sources

Liquids/Suspensions**   

Butalbital-acetaminophen-caffeine (50-325-40 mg /15 mL solution

Alagesic LQ

960 mL

90 mLs/day

Choline Sal/Mag Salicylate Oral 500 Mg/5 mL Liquid             

Trilisate, Choline Magnesium Trisalicylate

720 ml

3000 mg/day

Indomethacine 25 mg/ 5 mL Oral Suspension                        

Indocin

1000 mL

200 mg/day

Meloxicam 7.5 mg/5 mL Oral Suspension                  

Mobic                 

300 mL

15 mg/day

Naproxen 125  mg/5 mL Oral Suspension                 

Naprosyn

1000 mL

1500 mg/day

* Maximum allowed amounts are currently set at 100 units or 34 days supply.  Dose optimization is required.
**Special PA or other restrictions apply
 

Source:  DailyMed, NIH US Library of Medicine, official provider of FDA label information (package inserts) located here:  http://dailymed.nlm.nih.gov/dailymed/index.cfm  

 For specific prior authorization requests or quantity limit questions, please contact Pharmacy Management Consultants at: (800) 522-0114, option 4     

Any comments, edits or suggestions for webpage content may be addressed to the following:   pharmacy@okhca.org     

Clinical Notes and Warnings: 

+Acetaminophen Hepatotoxicity 

  • Acetaminophen has been associated with severe hepatotoxicity following acute and chronic ingestion.  
  • Maximum recommended dose of acetaminophen for adults is (4) four grams/day.  
  • Be sure to consider and ask about all potential sources of acetaminophen (e.g., OTC, combination analgesics) when determining daily acetaminophen dose.  
  • Risk may increase with concurrent alcohol use, underlying liver disease, and/or the fasting state. 

[June 6th 2014] FDA recommends that health care providers consider prescribing combination drug products that contain 325 mg or less of acetaminophen. FDA also recommends that when a pharmacist receives a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit that they contact the prescriber to discuss a product with a lower dose of acetaminophen. A two tablet or two capsule dose may still be prescribed, if appropriate. In that case, the total dose of acetaminophen would be 650 mg (the amount in two 325 mg dosage units). When making individual dosing determinations, health care providers should always consider the amounts of both the acetaminophen and the opioid components in the prescription combination drug product.  Health care providers and pharmacists who have further questions are encouraged to contact the Division of Drug Information at 888.INFO.FDA (888-463-6332) or druginfo@fda.hhs.gov. 

For more information please visit the FDA Medwatch Safety Information page located here:  http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm381650.htm accessed December 2014. 

FDA reminds health care professionals to stop dispensing prescription combination drug products with more than 325 mg of acetaminophen 

[03-26-2014] FDA and industry have taken action to protect consumers from the risk of severe liver damage, which can result from taking too much acetaminophen. All manufacturers of prescription combination drug products with more than 325 milligrams (mg) of acetaminophen1 per tablet, capsule, or other dosage unit have discontinued marketing these products.  http://www.fda.gov/Drugs/DrugSafety/ucm394916.htm  

FDA Boxed Warning- NSAIDS    

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 (see WARNINGS). 
    • Most NSAIDS are contraindicated for treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS). 

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 (see WARNINGS). 

 

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