Analgesics, NDSAIDs, 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:/content/sok-wcm/en/okhca/providers/types/pharmacy/prior-authorization-pa-web

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 6^th 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).

***Dosage information obtained from label information contained on DailyMed provider of FDA label information and package inserts available at:http://dailymed.nlm.nih.gov/dailymed/index.cfm

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Analgesics, NSAIDS and Antipyretics

Cardiovascular Risk

Gastrointestinal Risk