prior to [1.005):<0.0009) dose-dependent trend toward increased levels of blood urea nitrogen (BUN). Mean BUN values remained within historical normal limits at the label dose. No effects on other clinical chemistry values associated with renal function were reported. There was no evidence of renal, gastrointestinal, hepatic or biliary lesions noted during gross necropsy. Renal histopathology revealed trace amounts of tubular degeneration/regeneration in all dose groups including placebo, but no clear dose relationship could be determined. There was no histopathologic evidence of gastrointestinal, hepatic or biliary lesions. In another study, micronized deracoxib in gelatin capsules was administered once daily to healthy young dogs at doses of 10, 25, 50, and 100 mg/kg body weight for periods up to 14 consecutive days. Food was withheld prior to dosing. Non-linear elimination kinetics occurred at all doses. At doses of 25, 50, and 100 mg/kg, reduced body weight, vomiting, and melena occurred. Necropsy revealed gross gastrointestinal lesions in dogs from all dose groups. The frequency and severity of the lesions increased with escalating doses. At 10 mg/kg, moderate diffuse congestion of gut associated lymphoid tissues (GALT) and erosions/ulcers in the jejunum occurred. At 100 mg/kg, all dogs exhibited gastric ulcers and erosions/ulcerations of the small intestines. There were no hepatic or renal lesions reported at any dose in this study. In a 13-week study, deracoxib in gelatin capsules was administered to healthy dogs at doses of 0, 2, 4, and 8 mg/kg/day. No test-article related changes were identified in clinical observations, physical exams, or any of the other parameters measured. One dog in the 8 mg/kg dose group died from bacterial septicemia secondary to a renal abscess. The relationship between deracoxib administration and the renal abscess is not clear. Palatability: Deramaxx tablets were evaluated for palatability in 100 client-owned dogs of a variety of breeds and sizes. Dogs received two doses of Deramaxx tablets, one on each of two consecutive days. Deramaxx tablets were accepted by 94% of dogs on the first day of dosing and by 92% of dogs on the second day of dosing. Effectiveness: Deramaxx tablets were evaluated in masked, placebo-controlled multi-site field studies involving client-owned animals to determine effectiveness. Postoperative Orthopedic Pain and Inflammation Field Study: In this study, 207 dogs admitted to veterinary hospitals for repair of a cranial cruciate injury were randomly administered Deramaxx tablets or a placebo. Drug administration started the evening before surgery and continued once daily for 6 days postoperatively. Effectiveness was evaluated in 119 dogs and safety was evaluated in 207 dogs. Statistically significant differences in favor of Deramaxx tablets were found for lameness at walk and trot, and pain on palpation values at all post-surgical time points. The results of this field study demonstrate that Deramaxx tablets, when administered daily for 7 days are effective for the control of postoperative pain and inflammation associated with orthopedic surgery. Adverse Reactions: A total of 207 dogs of forty three (43) different breeds, 1-15 years old, weighing 7-141 lbs were included in the field safety analysis. The following table shows the number of dogs displaying each clinical observation. Abnormal Health Findings in The Postoperative Orthopedic Pain Field Study 1 Clinical Observation Deramaxx ( deracoxib ) tablets N = 105 Placebo N = 102 Vomiting 11 6 Diarrhea 6 7 Hematochezia 4 0 Melena 0 1 Anorexia 0 4 Incision site lesion (drainage, oozing) 11 6 Non-incision skin lesions (moist dermatitis, pyoderma) 2 0 Otitis externa 2 0 Positive joint culture 1 0 Phlebitis 1 0 Hematuria 2 0 Conjunctivitis 1 2 Splenomegaly 1 0 Hepatomegaly 1 0 Death 0 1 1 Dogs may have experienced more than one of the observations during the study. This table does not include one dog that was dosed at 16.92 mg/kg/day for the study duration. Beginning on the last day of treatment, this dog experienced vomiting, diarrhea, increased water intake and decreased appetite. Hematology and clinical chemistry values were unremarkable. The dog recovered uneventfully within 3 days of cessation of dosing. Incisional drainage was most prevalent in dogs enrolled at a single study site. There were no statistically significant changes in the mean values for hepatic or renal clinical pathology indices between Deramaxx tablet- and placebo-treated dogs. Four Deramaxx tablet-treated dogs and two placebo-treated dogs exhibited elevated bilirubin during the dosing phase. One Deramaxx tablet-treated dog exhibited elevated ALT, BUN and total bilirubin and a single vomiting event. None of the changes in clinical pathology values were considered clinically significant. The results of this clinical study demonstrate that Deramaxx tablets, when administered daily for 7 days to control postoperative orthopedic pain and inflammation in dogs, are well tolerated. Osteoarthritis Pain and Inflammation Field Study: Two hundred and nine (209) client-owned dogs with clinical and radiographic signs of osteoarthritis of at least one appendicular joint were enrolled in this study. A total of 194 dogs were included in the safety evaluation and a total of 181 dogs were included in the effectiveness evaluation. The effectiveness of Deramaxx tablets in the control of pain and inflammation associated with osteoarthritis was demonstrated in a placebo-controlled, masked study evaluating the anti-inflammatory and analgesic effects of Deramaxx tablets. Tablets were administered by the owner at approximately 1-2 mg/kg/day for forty-three (43) consecutive days. In general, statistically significant (p 0.05) differences in favor of Deramaxx were seen for force plate parameters (vertical impulse area, peak vertical force) and owner evaluations (quality of life, lameness and overall level of activity). The results of this field study demonstrate that Deramaxx tablets, when administered at 1-2 mg/kg/day for 43 days, are effective for the control of pain and inflammation associated with osteoarthritis. Adverse Reactions: Deramaxx was well tolerated and the incidence of clinical adverse reactions was comparable in Deramaxx and placebo-treated animals. A total of 209 dogs of 41 breeds, 1-14 years old, weighing 17-177 lbs were included in the field safety analysis. The following table shows the number of dogs displaying each clinical observation. Abnormal Health Findings in The Osteoarthritis Field Study 1 Clinical Observation Deramaxx ( deracoxib ) tablets N = 105 Placebo N = 10 4 Vomiting 3 4 Diarrhea/soft stool 3 2 Weight loss 1 0 Abdominal pain (splinting) 0 1 Seizure 1 0 Lethargy 0 1 Pyoderma/Dermatitis 2 0 Unilateral conjunctivitis 1 0 Scleral injection 0 1 Hematuria/UTI 1 0 Splenomegaly* 1 0 Grade II murmur systolic 1 0 1 Dogs may have experienced more than one of the observations during the study. *This dog was less active and eating less on enrollment, with elevated WBC, amylase, and AST and died 1 month after exiting the study. The dog was withdrawn from the study on Day 17 with anorexia, lethargy and a suspicion of diarrhea. Follow-up laboratory analyses revealed hypoalbuminemia, hyperphosphatemia, elevated AST and decreased BUN. Follow-up treatment included other anti-inflammatories and antibiotics. Complete blood count, serum chemistry, and buccal bleeding time analysis were conducted at the beginning and end of the trial. Mean values of all CBC and chemistry results for both Deramaxx and placebo-treated dogs were within normal limits. There was no statistically significant difference in the buccal bleeding time between Deramaxx and placebo-treated dogs before or after the study, and all results remained within normal limits (less than 5 minutes). The results of this field study demonstrate that Deramaxx is safe and effective for the control of pain and inflammation associated with osteoarthritis in dogs. During this trial, dogs were safely treated with a variety of commonly used medications, including antibiotics, anti-parasiticides, topical flea adulticides and thyroid supplements. The results of this field study demonstrate that Deramaxx tablets are well tolerated when administered at 1-2 mg/kg/day for up to 43 days for the control of pain and inflammation associated with osteoarthritis. Post Approval Experience: The following adverse reactions are based on voluntary post-approval reporting. The categories are listed in decreasing order of frequency by body system. Gastrointestinal: Vomiting, anorexia, diarrhea, melena, inappetence, hematemesis, hematochezia, weight loss, nausea, gastrointestinal ulceration, gastrointestinal perforation, salivation. Hematological: Anemia, thrombocytopenia. Hepatic: Hepatic enzyme elevations, decreased or increased total protein and globulin, decreased albumin, decreased BUN, hyperbilirubinemia, icterus, ascites, pancreatitis. Neurological: Lethargy, weakness, seizure, ataxia, tremor, nystagmus, mydriasis. Sensory: Vestibular signs, glazed eyes, uveitis. Behavioral: Aggression, apprehension. Urinary: Azotemia, polydipsia, polyuria, hematuria, low specific gravity, urinary incontinence, urinary tract infection, renal failure. Cardiovascular: Bradycardia. Respiratory: Tachypnea, coughing. Dermatological/Immunological: Fever, edema, facial/muzzle edema, pruritis, urticaria, moist dermatitis, erythema, dermal ulceration/necrosis. In rare situations, death has been reported as an outcome of the adverse events listed above. For technical assistance or to report suspected adverse events, call 1-800-332-2761. Information for Dog Owners: Deramaxx, like other drugs of its class, is not free from adverse reactions. Owners should be advised of the potential for adverse reactions and be informed of the clinical signs associated with drug intolerance. Adverse reactions may include vomiting, diarrhea, decreased appetite, dark or tarry stools, increase water consumption, increased urination, anemia, yellowing of gums, skin or white of the eye due to jaundice, lethargy, incoordination, seizure, or behavioral changes. Serious adverse reaction s associated with this drug class can occur without warning and in rare situations result in death (see Warnings, Post-Approval Experience and Adverse Reactions) . Owners should be advised to discontinue Deramaxx therapy and contact their veterinarian immediately if signs of intolerance are observed. The vast majority of patients with drug related adverse reactions have recovered when the signs are recognized, the drug is withdrawn, and veterinary care, if appropriate, is initiated. Owners should be advised of the importance of periodic follow up for all dogs during administration of any NSAID. Storage Conditions: Deramaxx tablets should be stored at room temperature between 59 and 86 F (15-30 C). Keep this and all medications out of reach of children. How Supplied: Deramaxx tablets are available as 25 mg, 50mg, 75 mg and 100 mg round, brownish, half-scored tablets in 7, 30, and 90 count bottles. Manufactured for: Novartis Animal Health US, Inc. Greensboro, NC 27408 USA Deramaxx Chewable Tablets are under the following U.S. patent numbers: U.S. Patent Number Date of Expiration 5,521,207 November 30, 2013 5,756,529 September 29, 2015 5,892,053 May 25, 2015 5,910,597 May 25, 2015 References: Data on File Data on File Smith, et al.: Pharmacological Analysis of Cyclo-oxygenase -1 in Inflammation, Proc. Natl. Acad. Sci. USA (October 1998) 95: 13313-13318, Pharmacology. Zhang, et al.: Inhibition of Cyclo-oxygenase -2 Rapidly Reverses Inflammatory Hyperalgesia and Prostaglandin E2 Production, JPET , (1997) 283: 1069-1075. Verburg, KM et al. Cox-2 Specific Inhibitors: Definition of a New Therapeutic Concept. Amer J of Therapeutics 8, 49-64, 2001. Data on File NADA # 141-203, Approved by FDA 2008 Novartis Animal Health US, Inc. NAH/DXB-T/PI/6 07/08 INFORMATION FOR DOG OWNERS Deramaxx Chewable Tablets are for the control of pain and inflammation due to osteoarthritis or following orthopedic surgery. This summary contains important information about Deramaxx tablets. You should read this information before starting your dog on Deramaxx tablets. This sheet is provided only as a summary and does not take the place of instructions from your veterinarian. Talk to your veterinarian if you do not understand any of this information or you want to know more about Deramaxx tablets. What is Deramaxx ? Deramaxx tablets are a prescription non-steroidal anti-inflammatory drug (NSAID) of the coxib class. They are indicated for the control of postoperative pain and inflammation associated with orthopedic (bone) surgery in dogs and for the control of pain and inflammation (soreness) associated with osteoarthritis in dogs. The tablets are flavored to make administration more convenient. What kind of results can I expect when my dog takes Deramaxx tablets for postoperative orthopedic pain and inflammation? Deramaxx tablets allow your dog to recover more comfortably by controlling pain and inflammation that follow orthopedic surgery. Control of pain and inflammation may vary from dog to dog. If Deramaxx tablets are not given according to your veterinarian's directions, your dog's pain may return. Consult your veterinarian if your dog appears to be uncomfortable. What kind of results can I expect when my dog takes Deramaxx tablets for pain and inflammation due to osteoarthritis? Osteoarthritis is a painful condition caused by damage to cartilage and other parts of the joint that may result in the following changes or signs in your dog: Limping or lameness Decreased activity or exercise (reluctance to stand, climb stairs, jump or run, or difficulty in performing these activities) Stiffness or decreased movement of joints While Deramaxx is not a cure for osteoarthritis, it can control the pain and inflammation of osteoarthritis and improve your dog's mobility. Response may vary from dog to dog but can be quite dramatic. Deramaxx tablets may need to be given on a periodic basis for the animal's lifetime. Use the lowest dose to provide adequate relief. Always consult with your veterinarian before altering the dose. What dogs should not take Deramaxx tablets? Your dog should not be given Deramaxx tablets if s/he: Has had an allergic reaction to deracoxib, the active ingredient in Deramaxx tablets Has had an allergic reaction (such as hives, facial swelling, or red or itchy skin) to aspirin or other NSAIDs Is presently taking aspirin, other NSAIDs, or corticosteroids (unless directed by your veterinarian) Has bloody stool or vomit Has a pre-existing kidney or liver condition Has any condition predisposing to dehydration Is anorexic (loss of appetite) Deramaxx tablets should only be given to dogs. People should not take Deramaxx tablets. Keep Deramaxx tablets and all medication out of reach of children. Call your physician immediately if you accidentally take Deramaxx tablets. What to discuss with your veterinarian before giving Deramaxx tablets? Tell your veterinarian about: Any side effects your dog has experienced from Deramaxx tablets or other NSAIDs Any digestive upset (vomiting or diarrhea) your dog has had Any kidney disease your dog has had Any other medical problems or allergies that your dog has now or has had in the past All medications that you are giving your dog or plan to give your dog, including those you can get without prescription and any dietary supplements If you plan to breed your dog, or if your dog is pregnant or nursing Talk to your veterinarian about: The orthopedic surgery your dog will undergo What tests might be done before surgery is performed or Deramaxx tablets are prescribed The signs of pain or inflammation that may occur after surgery Normal events that can be expected after your dog undergoes surgery The proper amount of exercise after surgery to aid recovery The signs of osteoarthritis you have observed (for example, limping or stiffness) The importance of weight control, physical therapy and exercise in the management of osteoarthritis How often your dog may need to be examined by your veterinarian The risks and benefits of using Deramaxx tablets How to give Deramaxx tablets to your dog. Deramaxx tablets should be given according to your veterinarian's instructions. Your veterinarian will tell you what amount of Deramaxx tablets is right for your dog and for how long they should be given. Do not change the way you give Deramaxx tablets to your dog without first speaking with your veterinarian. Deramaxx tablets should be given by mouth and may be given with or without food, although with food is preferable. What are the possible side effects that may occur in my dog during therapy with Deramaxx tablets? Deramaxx tablets, like all other drugs, may cause some side effects in individual dogs. These are normally mild, but rare serious side effects have been reported in dogs taking non-steroidal anti-inflammatory drugs (NSAIDs) including Deramaxx. Serious side effects can, in rare situations, result in death. It is important to stop the medication and contact your veterinarian immediately if you think your dog may have a medical problem or side effect while on Deramaxx tablets. If you have additional questions about possible side effects, talk with your veterinarian or call 1-800-332-2761. Look for the following side effects that may indicate that your dog is having a problem with Deramaxx tablets or may have another medical problem: Vomiting Change in bowel movements such as diarrhea or change in stool color Change in drinking or urination Decrease in appetite Change in behavior, such as depression or restlessness Can Deramaxx tablets be given with other medications? Deramaxx tablets should not be given with other non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids (for example, aspirin, carprofen, etodolac, prednisone). Tell your veterinarian about all medications that you have given your dog in the past, and any medications that you are planning to give with Deramaxx tablets. This should include any medications that you can get without a prescription and any dietary supplements. Your veterinarian may want to evaluate the potential for any drug interactions and to assure drug compatability. What can I do in case my dog eats more than the prescribed amount of Deramaxx tablets? Contact your veterinarian immediately if your dog eats more than the prescribed amount of Deramaxx tablets. What else should I know about Deramaxx tablets? This sheet provides a summary of information about Deramaxx tablets. If you have any questions or concerns about Deramaxx tablets, postoperative orthopedic pain and inflammation, or osteoarthritis, talk to your veterinarian. As with all prescribed medications, Deramaxx tablets should only be given to the dog for which they are prescribed. They should be given to your dog only for the condition for which they were prescribed, at the prescribed dose, as directed by your veterinarian. It is important to periodically discuss your dog's response to Deramaxx tablets at regular checkups. Your veterinarian will best determine if your dog is responding as expected and if your dog should continue receiving Deramaxx tablets. NADA 141-203, Approved by FDA 2008 Novartis Animal Health US, Inc. PRINCIPAL DISPLAY PANEL Package Label 25 mg Deramaxx (deracoxib) 7 chewable tablets A coxib-class NSAID For Use in Dogs Only Caution: Federal Law (U.S.) restricts this drug to use by or on the order of a licensed veterinarian. NADA#141-203, Approved by FDA. Made in Canada. Manufactured for Novartis Animal Health US, Inc. Greensboro, NC 27408 NOVARTIS 25 mg PRINCIPAL DISPLAY PANEL Package Label 7 5 mg Deramaxx (deracoxib) 7 chewable tablets A coxib-class NSAID For Use in Dogs Only Caution: Federal Law (U.S.) restricts this drug to use by or on the order of a licensed veterinarian. NADA#141-203, Approved by FDA. Made in Canada. Manufactured for Novartis Animal Health US, Inc. Greensboro, NC 27408 NOVARTIS 75 mg ANIMAL HEALTH PRINCIPAL DISPLAY PANEL Package Label 100 mg Deramaxx (deracoxib) 7 chewable tablets A coxib-class NSAID For Use in Dogs Only Caution: Federal Law (U.S.) restricts this drug to use by or on the order of a licensed veterinarian. NADA#141-203, Approved by FDA. Made in Canada. Manufactured for Novartis Animal Health US, Inc. Greensboro, NC 27408 NOVARTIS 100 mg PRINCIPAL DISPLAY PANEL BULK PRODUCT Bulk Product 40 KILOGRAM DRUM DERACOXIB MICRO. NOA 448123 B PROD. NO. 80025 CAS-NO 169590-41-4 DANGEROUS FOR THE ENVIRONMENT HARMFUL NEW ANIMAL DRUG NADA 141-203 ISSUED BY U.S. FDA, CENTER FOR VETERINARY MEDICINE U.S. CONSIGNEE NOVARTIS ANIMAL HEALTH US, INC. GREENSBORO, NC REGULATORY AFFAIRS 336-387-1000 THIS PRODUCT IS REGULATED BY FDA. IN THE EVENT THAT U.S. CUSTOMS REQUIRES SAMPLING OR CONTAINER INSPECTION, CONTACT CONSIGNEE IMMEDIATELY. Manufactured by DOTTIKON EXCLUSIVE SYNTHESIS AG CH-5605 Dottikon Switzerland Milled by Micro-Macinazione SA CH-6995 Molinazzo di Monteggio Switzerland IN EMERGENCY DIAL CH 4161-696-3333 US 1-800-424-9300 602374/NAH/DER/BULK/03/08 Deramaxx deracoxib tablet, chewable Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:58198-5215 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DERACOXIB (DERACOXIB) DERACOXIB 25 mg Product Characteristics Color BROWN (speckled with white, brown or tan) Score 2 pieces Shape ROUND (biconvex) Size 11mm Flavor MEAT Imprint Code NA;AF Contains Packaging # Item Code Package Description 1 NDC:58198-5215-2 7 TABLET, CHEWABLE (7 TABLET) in 1 BOTTLE 2 NDC:58198-5215-3 30 TABLET, CHEWABLE (30 TABLET) in 1 BOTTLE 3 NDC:58198-5215-4 90 TABLET, CHEWABLE (90 TABLET) in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141203 08/21/2008 Deramaxx deracoxib tablet, chewable Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:58198-5217 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DERACOXIB (DERACOXIB) DERACOXIB 75 mg Product Characteristics Color BROWN (speckled with white, brown or tan) Score 2 pieces Shape ROUND (biconvex) Size 16mm Flavor MEAT Imprint Code NA;DH Contains Packaging # Item Code Package Description 1 NDC:58198-5217-2 7 TABLET, CHEWABLE (7 TABLET) in 1 BOTTLE 2 NDC:58198-5217-3 30 TABLET, CHEWABLE (30 TABLET) in 1 BOTTLE 3 NDC:58198-5217-4 90 TABLET, CHEWABLE (90 TABLET) in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141203 06/13/2007 Deramaxx deracoxib tablet, chewable Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:58198-5216 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DERACOXIB (DERACOXIB) DERACOXIB 100 mg Product Characteristics Color BROWN (speckled with white, brown or tan) Score 2 pieces Shape ROUND (biconvex) Size 17mm Flavor MEAT Imprint Code NA;BD Contains Packaging # Item Code Package Description 1 NDC:58198-5216-2 7 TABLET, CHEWABLE (7 TABLET) in 1 BOTTLE 2 NDC:58198-5216-3 30 TABLET, CHEWABLE (30 TABLET) in 1 BOTTLE 3 NDC:58198-5216-4 90 TABLET, CHEWABLE (90 TABLET) in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141203 08/21/2002 DERACOXIB deracoxib powder Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:58198-2106 Route of Administration NOT APPLICABLE DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DERACOXIB (DERACOXIB) DERACOXIB 1 kg in 1 kg Product Characteristics Color WHITE (white to off-white including light pink to light yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description 1 NDC:58198-2106-3 40 kg in 1 DRUM Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141203 08/21/2002 Labeler - Novartis Animal Health US, Inc. (966985624) Revised: 12/2009 Novartis Animal Health US, Inc. Print this page> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Recently Approved Lonhala Magnair Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for... Ozempic Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog administered once-weekly for the... Ogivri Ogivri (trastuzumab-dkst) is a HER2 / neu receptor antagonist biosimilar to Herceptin indicated for... Sublocade Sublocade (buprenorphine) is a once-monthly injectable partial opioid agonist formulation for the... More} } per chance
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