Trepoxicam-7.5 (Page 5 of 5)

14.1 Osteoarthritis and Rheumatoid Arthritis 14.2 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course

14 CLINICAL STUDIES

14.1 Osteoarthritis and Rheumatoid Arthritis The use of MOBIC for the treatment of the signs and symptoms of osteoarthritis of the knee and hip was evaluated in a 12-week, double-blind, controlled trial. MOBIC (3.75 mg, 7.5 mg, and 15 mg daily) was compared to placebo. The four primary endpoints were investigator’s global assessment, patient global assessment, patient pain assessment, and total WOMAC score (a self-administered questionnaire addressing pain, function, and stiffness). Patients on MOBIC 7.5 mg daily and MOBIC 15 mg daily showed significant improvement in each of these endpoints compared with placebo. The use of MOBIC for the management of signs and symptoms of osteoarthritis was evaluated in six double-blind, active-controlled trials outside the U.S. ranging from 4 weeks’ to 6 months’ duration. In these trials, the efficacy of MOBIC, in doses of 7.5 mg/day and 15 mg/day, was comparable to piroxicam 20 mg/day and diclofenac SR 100 mg/day and consistent with the efficacy seen in the U.S. trial. The use of MOBIC for the treatment of the signs and symptoms of rheumatoid arthritis was evaluated in a 12-week, double-blind, controlled multinational trial. MOBIC (7.5 mg, 15 mg, and 22.5 mg daily) was compared to placebo. The primary endpoint in this study was the ACR20 response rate, a composite measure of clinical, laboratory, and functional measures of RA response. Patients receiving MOBIC 7.5 mg and 15 mg daily showed significant improvement in the primary endpoint compared with placebo. No incremental benefit was observed with the 22.5 mg dose compared to the 15 mg dose. 14.2 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course The use of MOBIC for the treatment of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older was evaluated in two 12-week, double-blind, parallel-arm, active-controlled trials. Both studies included three arms: naproxen and two doses of meloxicam. In both studies, meloxicam dosing began at 0.125 mg/kg/day (7.5 mg maximum) or 0.25 mg/kg/day (15 mg maximum), and naproxen dosing began at 10 mg/kg/day. One study used these doses throughout the 12-week dosing period, while the other incorporated a titration after 4 weeks to doses of 0.25 mg/kg/day and 0.375 mg/ kg/day (22.5 mg maximum) of meloxicam and 15 mg/kg/day of naproxen. The efficacy analysis used the ACR Pediatric 30 responder definition, a composite of parent and investigator assessments, counts of active joints and joints with limited range of motion, and erythrocyte sedimentation rate. The proportion of responders were similar in all three groups in both studies, and no difference was observed between the meloxicam dose groups.

16 HOW SUPPLIED/STORAGE AND HANDLING MOBIC is available as a pastel yellow, round, biconvex, uncoated tablet containing meloxicam 7.5 mg or as a pastel yellow, oblong, biconvex, uncoated tablet containing meloxicam 15 mg. The 7.5 mg tablet is impressed with the Boehringer Ingelheim logo on one side, and on the other side, the letter “M”. The 15 mg tablet is impressed with the tablet code “15” on one side and the letter “M” on the other. MOBIC is also available as a yellowish green tinged viscous oral suspension containing 7.5 mg meloxicam in 5 mL. MOBIC tablets 7.5 mg: NDC 0597-0029-01; Bottles of 100 MOBIC tablets 15 mg: NDC 0597-0030-01; Bottles of 100 MOBIC oral suspension 7.5 mg/5 mL: NDC 0597-0034-01; Bottles of 100 mL

Storage Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F). Keep MOBIC tablets in a dry place. Dispense tablets in a tight container. Keep oral suspension container tightly closed. Keep this and all medications out of the reach of children.

17 PATIENT COUNSELING INFORMATION 17.8 Effects During Pregnancy

17 PATIENT COUNSELING INFORMATION See FDA-approved Medication Guide Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. 17.1 Medication Guide Inform patients of the availability of a Medication Guide for NSAIDs that accompanies each prescription dispensed, and instruct them to read the Medication Guide prior to using MOBIC.

17.2 Cardiovascular Effects NSAIDs including MOBIC may cause serious CV side effects, such as MI or stroke, which may result in hospitalization and even death. Although serious CV events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up [see Warnings and Precautions (5.1)].

17.3 Gastrointestinal Effects NSAIDs including MOBIC, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of this follow-up [see Warnings and Precautions (5.2)].

17.4 Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and “flu like” symptoms). If these occur, instruct patients to stop therapy and seek immediate medical therapy [see Warnings and Precautions (5.3)].

17.5 Adverse Skin Reactions NSAIDs including MOBIC, can cause serious skin side effects such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which may result in hospitalization and even death. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and should ask for medical advice when observing any indicative signs or symptoms. Advise patients to stop the drug immediately if they develop any type of rash and contact their physicians as soon as possible [see Warnings and Precautions (5.8)].

17.6 Weight Gain and Edema Advise patients to promptly report signs or symptoms of unexplained weight gain or edema to their physicians [see Warnings and Precautions (5.5)].

17.7 Anaphylactoid Reactions Inform patients of the signs of an anaphylactoid reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients seek immediate emergency help [see Warnings and Precautions (5.7)].

17.8 Effects During Pregnancy Starting at 30 weeks gestation, MOBIC should be avoided as premature closure of the ductus arteriosus in the fetus may occur [see Warnings and Precautions (5.9) and Use in Specific Populations (8.1)]. Please address medical inquiries to (800) 542-6257 or (800) 459-9906 TTY. Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA Licensed from: Boehringer Ingelheim International GmbH ©Copyright 2010 Boehringer Ingelheim International GmbH ALL RIGHTS RESERVED 10003990/06 OT1400GD2810 090340141-7 OT1407E

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (See the end of this Medication Guide for a list of prescription NSAID medicines.) What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases: — with longer use of NSAID medicines — in people who have heart disease NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).” NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding: — can happen without warning symptoms — may cause death The chance of a person getting an ulcer or bleeding increases with: — taking medicines called “corticosteroids” and “anticoagulants” — longer use — smoking — drinking alcohol — older age — having poor health NSAID medicines should only be used: — exactly as prescribed — at the lowest dose possible for your treatment — for the shortest time needed What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as: — different types of arthritis — menstrual cramps and other types of short-term pain Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine: — if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine — for pain right before or after heart bypass surgery Tell your healthcare provider: — about all of your medical conditions. — about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist. — if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy. — if you are breastfeeding. Talk to your doctor. What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? Serious side effects include: — heart attack — stroke — high blood pressure — heart failure from body swelling (fluid retention) — kidney problems including kidney failure — bleeding and ulcers in the stomach and intestine — low red blood cells (anemia) — life-threatening skin reactions — life-threatening allergic reactions — liver problems including liver failure — asthma attacks in people who have asthma Other side effects include: — stomach pain — constipation — diarrhea — gas — heartburn — nausea — vomiting — dizziness Get emergency help right away if you have any of the following symptoms: — shortness of breath or trouble breathing — chest pain — weakness in one part or side of your body — slurred speech — swelling of the face or throat Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms: — nausea — more tired or weaker than usual — itching — your skin or eyes look yellow — stomach pain — flu-like symptoms — vomit blood — there is blood in your bowel movement or it is black and sticky like tar — unusual weight gain — skin rash or blisters with fever — swelling of the arms and legs, hands and feet These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) — Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines. — Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

NSAID medicines that need a prescription
Generic Name Tradename
Celecoxib Celebrex
Diclofenac Cataflam, Voltaren, Arthrotec (combined with misoprostol)
Diflunisal Dolobid
Etodolac Lodine, Lodine XL
Fenoprofen Nalfon, Nalfon 200
Flurbiprofen Ansaid
Ibuprofen Motrin, Tab-Profen, Vicoprofen* (combined with hydrocodone), Combunox (combined with oxycodone)
Indomethacin Indocin, Indocin SR, Indo-Lemmon, Indomethagan
Ketoprofen Oruvail
Ketorolac Toradol
Mefenamic Acid Ponstel
Meloxicam Mobic
Nabumetone Relafen
Naproxen Naprosyn, Anaprox, Anaprox DS, EC-Naprosyn, Naprelan, Naprapac (copackaged with lansoprazole)
Oxaprozin Daypro
Piroxicam Feldene
Sulindac Clinoril
Tolmetin Tolectin, Tolectin DS, Tolectin 600

Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke. This Medication Guide has been approved by the U.S. Food and Drug Administration.

NDC 0597-0029-01 ATTENTION DISPENSER: Disperse with separately provided Medication Guide. Mobic (meloxicam) tablets 7.5 mg 100 tablets Dosage: Read accompanying prescribing information. RX only Boehringer Ingelheim EXP. LOT

Store at 25 degree C (77 degree F); excursions permitted to 15 degree — 30 degree C (59 degree — 86 degree F.) Dispense in a tight container.Keep in a dry place. Keep out of reach of children. Mfd. by: Boehringer Ingelheim (BI) Promeco, S.A de C.V. Mexico City,Mexico Lic. from: BI Int’l GmbH Mkd. by: BI Pharmaceuticals, Inc. Ridgefield, CT 06877 USA C2009 BI Int’l GmbH L1411A

Trepadone (U.S. patent pending) capsules by oral administration. A specially formulated Medical Food product, consisting of a proprietary blend of amino acids, glucosamine, chondroitin sulfate, fish oil, and polyphenol ingredients in specific proportions, for the dietary management of the metabolic processes associated with pain disorders and inflammatory conditions. (PD) (IC), particularly diseases associated with joint pain. Must be administered under physician supervision.
Medical Foods
Medical Food products are often used in hospitals (e.g., for burn victims or kidney dialysis patients) and outside of a hospital setting under a physician’s care for the dietary management of diseases in patients with particular medical or metabolic needs due to their disease or condition. Congress defined “Medical Food” in the Orphan Drug Act and Amendments of 1988 as “a food which is formulated to be consumed or administered enterally [or orally] under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” Medical Foods are complex formulated products, requiring sophisticated and exacting technology. Trepadone has been developed, manufactured, and labeled in accordance with both the statutory and the FDA regulatory definition of a Medical Food. Trepadone must be used while the patient is under the ongoing care of a physician.

PAIN DISORDERS (PD) INFLAMMATORY CONDITIONS (IC)
PD and IC as a Metabolic Deficiency Disease
A critical component of the definition of a Medical Food is the requirement for a distinctive nutritional deficiency. FDA scientists have proposed a physiologic definition of a distinctive nutritional deficiency as follows: “the dietary management of patients with specific diseases requires, in some instances, the ability to meet nutritional requirements that differ substantially from the needs of healthy persons. For example, in establishing the recommended dietary allowances for general, healthy population, the Food and Nutrition Board of the Institute of Medicine National Academy of Sciences, recognized that different or distinctive physiologic requirements may exist for certain persons with “special nutritional needs arising from metabolic disorders, chronic diseases, injuries, premature birth, other medical conditions and drug therapies. Thus, the distinctive nutritional needs associated with a disease reflects the total amount needed by a healthy person to support life or maintain homeostasis, adjusted for the distinctive changes in the nutritional needs of the patient as a result of the effects of the disease process on absorption, metabolism and excretion.” It was also proposed that in patients with certain disease states who respond to nutritional therapies, a physiologic deficiency of the nutrient is assumed to exist. For example, if a patient with pain disorders responds to a tryptophan formulation by decreasing perceived pain, a deficiency of tryptophan is assumed to exist.
Patients with pain disorders and inflammatory conditions are known to have nutritional deficiencies of tryptophan, choline, arginine, GABA, flavonoids, and certain antioxidants. Patients with pain disorders and inflammatory conditions frequently exhibit reduced plasma levels of tryptophan and GABA and have been shown to respond to oral administration of GABA, arginine, tryptophan, or a 5-hydoxytryptophan formulation. Research has shown that tryptophan, arginine or GABA reduced diets result in a fall of circulating tryptophan, arginine, and/or GABA. Patients with pain disorders frequently exhibit activation of the degradation pathways that increases the turnover of GABA, arginine and/or tryptophan leading to a reduced level of production of serotonin, GABA or nitric oxide for a given precursor blood level. Patients with pain disorders and inflammatory conditions are known to have nutritional deficiencies of glucosamine and chondroitin sulfate. Patients with pain disorders and inflammatory conditions frequently exhibit reduced plasma levels of glucosamine and chondroitin sulfate and have been shown to respond to oral administration of glucosamine and chondroitin sulfate formulation. Patients with pain disorders and inflammatory conditions are known to have nutritional deficiencies of prostaglandin precursors such as omega-3 free fatty acids. Patients with pain disorders and inflammatory conditions frequently exhibit reduced plasma levels of prostaglandin precursors and have been shown to respond to oral administration of prostaglandin precursors, such as the Omega-3 free fatty acids, particularly in the form of fish oils. Research has also shown that a genetic predisposition to accelerated degradation of prostaglandins can lead to increased precursor requirements in certain patients with pain disorders and inflammatory conditions.
Choline is required to fully potentiate acetylcholine synthesis by brain neurons. A deficiency of choline leads to reduced acetylcholine production by the neurons. Flavonoids potentiate the production of acetylcholine by the neurons thereby reducing pain. Diets deficient in flavonoid rich foods and choline result in inadequate flavonoid concentrations, impeding acetylcholine production in certain patients with pain disorders and/or inflammatory conditions. Acetylcholine in pre-synaptic ganglia is necessary for the production of serotonin and nitric oxide in post-synaptic ganglia. Provision of tryptophan, arginine, GABA, choline and flavonoids with antioxidants, in specific proportions can restore the production of beneficial serotonin, nitric oxide, and acetylcholine, thereby reducing the perception of pain and reducing inflammation. L-Histidine is known to produce brain histamine that stimulates production of ACTH.


PRODUCT DESCRIPTION
Primary Ingredients
Trepadone consists of a proprietary blend of amino acids, prostaglandin precursors in the form of omega-3 free fatty acids, glucosamine, chondroitin sulfate, cocoa, caffeine, cinnamon, and flavonoids in specific proportions. These ingredients fall into the category of Generally Regarded as Safe” (GRAS) as defined by the Food and Drug Administration (FDA) (Sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act). A GRAS substance is distinguished from a food additive on the basis of the common knowledge about the safety of the substance for its intended use. The standard for an ingredient to achieve GRAS status requires not only technical demonstration of non-toxicity and safety, but also general recognition of safety through widespread usage and agreement of that safety by experts in the field. Many ingredients have been determined by the U.S. Food and Drug Administration (FDA) to be GRAS, and are listed as such by regulation, in Volume 21 Code of Federal Regulations (CFR) Sections 182, 184, and 186.
Amino Acids
Amino Acids are the building blocks of protein. All amino acids are GRAS listed as they have been ingested by humans for many thousands of years. The doses of the amino acids in Trepadone are equivalent to those found in the usual human diet. Patients with pain disorders may require an increased amount of certain amino acids that cannot be obtained from normal diet alone. Tryptophan, for example, is an obligatory amino acid. The body cannot make tryptophan and must obtain tryptophan from the diet. Tryptophan is needed to produce serotonin. Serotonin is required to reduce pain. Patients with pain disorders and inflammatory conditions have altered serotonin metabolism. Some patients with pain disorders and inflammatory conditions have a resistance to the use of tryptophan that is similar to the mechanism found in insulin resistance. Patients with pain disorders and inflammatory conditions cannot acquire sufficient tryptophan from the diet to alter the perception of pain and the inflammatory process without ingesting a prohibitively large amount of calories, particularly calories from protein.
Chondroitin Sulfate and Glucosamine
Chondroitin sulfate and glucosamine are the building blocks of joint cartilage and are GRAS listed as they have been ingested by humans for thousands of years. The doses of the chondroitin sulfate and glucosamine in Trepadone are equivalent to those found in the usual human diet. Patients with pain disorders, particularly of the joints, may require an increased amount of chondroitin sulfate and glucosamine that cannot be obtained from normal diet alone. Patients with pain disorders and inflammatory conditions, particularly of the joints have altered chondroitin sulfate and glucosamine metabolism. Some patients with pain disorders and inflammatory conditions of the joints have a resistance to the use of chondroitin sulfate and glucosamine. Patients with pain disorders and inflammatory conditions of the joints cannot acquire sufficient chondroitin sulfate and glucosamine from the diet to alter the pain and the inflammatory process of the joint without ingesting a prohibitively large amount of calories, particularly calories from protein.
Omega-3 Free Fatty Acids in the Form of Fish Oil
Omega-3 Free Fatty Acids in the Form of Fish Oil are the building blocks of prostaglandin precursors that control the inflammatory process. Omega-3 Free Fatty Acids in the Form of Fish Oil are GRAS listed as they have been ingested by humans for thousands of years. The doses of the Omega-3 Free Fatty Acids in the Form of Fish Oil in Trepadone are equivalent to those found in the usual human diet. Patients with pain disorders, particularly of the joints, may require an increased amount of Omega-3 Free Fatty Acids in the Form of Fish Oil that cannot be obtained from normal diet alone. Patients with pain disorders and inflammatory conditions, particularly of the joints have altered prostaglandin metabolism. Some patients with pain disorders and inflammatory conditions exhibit a resistance to the use of Omega-3 Free Fatty Acids in the Form of Fish Oil. Patients with pain disorders and inflammatory conditions of the joints cannot acquire sufficient Omega-3 Free Fatty Acids in the Form of Fish Oil from the diet to alter the pain and the inflammatory process of the joint without ingesting a prohibitively large amount of calories.
Flavonoids
Flavonoids are a group of phytochemical compounds found in all vascular plants including fruits and vegetables. They are a part of a larger class of compounds known as polyphenols. Many of the therapeutic or health benefits of colored fruits and vegetables, cocoa, red wine, and green tea are directly related to their flavonoid content. The specially formulated flavonoids found in Trepadone cannot be obtained from conventional foods in the necessary proportions to elicit a therapeutic response.
Other Ingredients
Trepadone contains the following inactive or other ingredients, as fillers, excipients, and colorings: magnesium stearate, microcrystalline cellulose, Maltodextrin NF, gelatin (as the capsule material).
Physical Description
Trepadone is a yellow to light brown powder. Trepadone contains L-Glutamine, L-Arginine, L-Histidine, and L-Serine, 5-Hydroxytryptophan as Griffonia Seed Extract, GABA, Choline Bitartrate, Cinnamon, Cocoa, Hydrolyzed Whey Protein, and Grape Seed Extract.

CLINICAL PHARMACOLOGY
Mechanism of Action
Trepadone acts by restoring and maintaining the balance of the neurotransmitters; GABA, nitric oxide, serotonin, and acetylcholine that are associated with pain disorders and inflammatory conditions. Trepadone stimulates the production ACTH to reduce inflammation. Trepadone stimulates the production prostaglandins to reduce inflammation. Trepadone stimulates the production joint cartilage.
Metabolism
The amino acids in Trepadone are primarily absorbed by the stomach and small intestines. All cells metabolize the amino acids in Trepadone. Circulating tryptophan, arginine and choline blood levels determine the production of serotonin, nitric oxide, and acetylcholine. The Omega-3 free fatty acids in Trepadone are primarily absorbed by the stomach and small intestines. Inflammatory cells metabolize the free fatty acids in Trepadone.
Excretion
Trepadone is not an inhibitor of cytochrome P450 1A2, 2C9, 2C19, 2D6, or 3A4. These isoenzymes are principally responsible for 95% of all detoxification of drugs, with CYP3A4 being responsible for detoxification of roughly 50% of drugs. Amino acids do not appear to have an effect on drug metabolizing enzymes. Free fatty acids, glucosamine, and chondroitin sulfate do not appear to have an effect on drug metabolizing enzymes


INDICATIONS FOR USE
Trepadone is intended for the clinical dietary management of the metabolic processes of pain disorders and inflammatory conditions, particularly those associated with joint pain.
CLINICAL EXPERIENCE
Administration of Trepadone has demonstrated significant reduction in symptoms of pain and inflammation in patients with acute and chronic pain when used for the dietary management of the metabolic processes associated with pain disorders and inflammatory conditions. Administration of Trepadone results in the induction and maintenance of pain relief in patients with pain disorders and inflammatory conditions associated with joint pain.

PRECAUTIONS AND CONTRAINDICATIONS
Trepadone is contraindicated in an extremely small number of patients with hypersensitivity to any of the nutritional components of Trepadone.

ADVERSE REACTIONS
Oral supplementation with L-tryptophan, L-arginine or choline at high doses up to 15 grams daily is generally well tolerated. The most common adverse reactions of higher doses — from 15 to 30 grams daily — are nausea, abdominal cramps, and diarrhea. Some patients may experience these symptoms at lower doses. The total combined amount of amino acids in each Trepadone capsule does not exceed 400 mg. The doses of chondroitin sulfate, glucosamine, and omega-3 free fatty acids are well tolerated. Large doses of free fatty acids can be associated with bleeding disorders.

DRUG INTERACTIONS
Trepadone does not directly influence the pharmacokinetics of prescription drugs. Clinical experience has shown that administration of Trepadone may allow for lowering the dose of coadministered drugs under physician supervision.

OVERDOSE
There is a negligible risk of overdose with Trepadone as the total dosage of amino acids in a one month supply (90 capsules) is less than 36 grams. Overdose symptoms may include diarrhea, weakness, and nausea. There is a negligible risk of overdose with Trepadone as the total dosage of glucosamine, chondroitin sulfate, and omega-3 free fatty acids in a one month supply (90 capsules) is less than 10 grams. Overdose symptoms may include diarrhea, weakness, and nausea.
POST-MARKETING SURVEILLANCE
Post-marketing surveillance has shown no serious adverse reactions. Reported cases of mild rash and itching may have been associated with allergies to Trepadone flavonoid ingredients, including cinnamon, cocoa, and chocolate. These reactions were transient in nature and subsided within 24 hours.

DOSAGE AND ADMINISTRATION
Recommended Administration
For the dietary management of the metabolic processes associated with pain disorders and inflammatory conditions, particularly joint pain. Take (2) capsules up to four times per day times daily or as directed by physician. As with most amino acid formulations Trepadone should be taken without food to increase the absorption of key ingredients.

How Supplied
Trepadone is supplied in green and yellow, size 0 capsules in bottles of 90 capsules.
Physician Supervision
Trepadone is a Medical Food product available by prescription only and must be used while the patient is under ongoing physician supervision.
U.S. patents pending.
Manufactured by Arizona Nutritional Supplements, Inc. Chandler AZ 85225
Distributed by Physician Therapeutics LLC, Los Angeles, CA 90077. www.ptlcentral.com
© Copyright 2003-2006, Physician Therapeutics LLC, all rights reserved
NDC # 68405-1003-02
NDC: 68405-1016-03

Storage
Store at room temperature, 59-86oF (15-30oC) Protect from light and moisture. Trepadone is supplied to physicians in a recyclable plastic bottle with a child-resistant cap.

PHYSICIAN THERAPEUTICS TREPADONE Medical Food Rx only 90 Capsules Directions for use: Must be administered under medical supervision. For adults only. As a Medical Food, take two (2) capsules four times daily in between meals. For the dietary management of osteoarthritis, tendonitis, and joint pain. Contains no added sugar, starch, wheat, yeast, preservatives, or flavor. Storage: Keep tightly closed in a cool dry place 8-32 Degree Centigrade (45-90 Degree F), relative humidity, below 50%. Warning: Keep this product out of the reach of children. NDC#68405-1016-03 Ingredients: Each serving (per 2 capsules) contains: Proprietary Amino Acid Blend L-Histadine, GABA, Hydrolyzed Whey Protein Glucosamine Omega — 3 FFA from Tuna Oil Chondroitin Sulfate Grape Seed Extract Cocoa (6% Theobromine) (fruit) Other indgredients: Gelatin. tricalcium phosphate, magnesium stearate, silicon dioxide, microcrystalline cellulose, FD and C yello #5, FD and C yellow #6, chlorophyllin copper complex, titanium dioxide. Distributed by: Physician Therapeutics LLC, Los Angeles, CA 90077 www.ptlcentral.com Patent Pending

For the Dietary Management of Joint Disorder.
Two capsules up to four times daily or as directed by physician. See product label and insert.
Trepadone Medical Food
PHYSICIAN THERAPEUTICS
Trepadone Meloxicam 7.5 mg
A Convenience Packed Medical Food and Drug
Trepoxicam — 7.5
PHYSICIAN THERAPEUTICS
Trepadone 90 Capsules
Meloxicam 7.5 mg 30 Tablets
No Refills Without Physician Authorization
Rx only
NDC# 68405-036-36 of this co-pack
As prescribed by physician. See product label and product information insert.
Meloxicam 7.5 mg
Rx Drug
Manufactured and Distributed by Physician Therapeutics, A Division of Targeted Medical Pharma Inc. Los Angeles, CA 90077 www.ptlcentral.com
B-NDC# 68405-8036-36

Trepadone 90 Label
(click image for full-size original)

Meloxicam
(click image for full-size original)

Meloxicam Image Outer
(click image for full-size original)

TREPOXICAM-7.5 meloxicam, histidine kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68405-036
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68405-036-36 1 KIT (KIT) in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 BOTTLE 30
Part 2 1 BOTTLE 90
Part 1 of 2
MOBIC meloxicam tablet
Product Information
Item Code (Source) NDC:52959-856(NDC:0597-0029)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MELOXICAM (SILICON DIOXIDE) MELOXICAM 7.5 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
TRISODIUM CITRATE DIHYDRATE
Product Characteristics
Color yellow (YELLOW) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code Company;symbol;M
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52959-856-30 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020938 01/31/2011
Part 2 of 2
TREPADONE 90 histidine capsule
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HISTIDINE (HISTIDINE) HISTIDINE 50 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
MALTODEXTRIN
GELATIN
Product Characteristics
Color green (GREEN YELLOW) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code ;
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 90 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Medical Food 02/02/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/31/2011
Labeler — Physician Therapeutics LLC (931940964)
Establishment
Name Address ID/FEI Operations
Boehringer Ingelheim Pharma GmbH and Co. KG 551147440 manufacture
Establishment
Name Address ID/FEI Operations
H.J. Harkins Company, Inc. 147681894 repack
Establishment
Name Address ID/FEI Operations
Targeted Medical Pharma Inc. 126962740 manufacture

Revised: 08/2011 Physician Therapeutics LLC

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