Quellin: Product Information (Page 3 of 4)

ANIMAL SAFETY:

Laboratory studies in unanesthetized dogs and clinical field studies have demonstrated that carprofen is well tolerated in dogs after oral administration.

In target animal safety studies, carprofen was administered orally to healthy Beagle dogs at 1, 3 and 5 mg/lb twice daily (1, 3 and 5 times the recommended total daily dose) for 42 consecutive days with no significant adverse reactions.

Serum albumin for a single female dog receiving 5 mg/lb twice daily decreased to 2.1 g/dL after 2 weeks of treatment, returned to the pre-treatment value (2.6 g/dL) after 4 weeks of treatment, and was 2.3 g/dL at the final 6-week evaluation. Over the 6-week treatment period, black or bloody stools were observed in 1 dog (1 incident) treated with 1 mg/lb twice daily and in 1 dog (2 incidents) treated with 3 mg/lb twice daily. Redness of the colonic mucosa was observed in 1 male that received 3 mg/lb twice daily.

Two of 8 dogs receiving 10 mg/lb orally twice daily (10 times the recommended total daily dose) for 14 days exhibited hypoalbuminemia. The mean albumin level in the dogs receiving this dose was lower (2.38 g/dL) than each of 2 placebo control groups (2.88 and 2.93 g/dL, respectively). Three incidents of black or bloody stool were observed in 1 dog. Five of 8 dogs exhibited reddened areas of duodenal mucosa on gross pathologic examination. Histologic exam of these areas revealed no evidence of ulceration, but did show minimal congestion of the lamina propria in 2 of the 5 dogs. In separate safety studies lasting 13 and 52 weeks, respectively, dogs were administered orally up to 11.4 mg/lb/day (5.7 times the recommended total daily dose of 2 mg/lb) of carprofen. In both studies, the drug was well tolerated clinically by all of the animals. No gross or histologic changes were seen in any of the treated animals. In both studies, dogs receiving the highest doses had average increases in serum L-alanine aminotransferase (ALT) of approximately 20 IU.

In the 52-week study, minor dermatologic changes occurred in dogs in each of the treatment groups but not in the control dogs. The changes were described as slight redness or rash and were diagnosed as non-specific dermatitis. The possibility exists that these mild lesions were treatment related, but no dose relationship was observed.

Clinical field studies were conducted with 549 dogs of different breeds at the recommended oral doses for 14 days (297 dogs were included in a study evaluating 1 mg/lb twice daily and 252 dogs were included in a separate study evaluating 2 mg/lb once daily). In both studies the drug was clinically well tolerated and the incidence of clinical adverse reactions for carprofen-treated animals was no higher than placebo-treated animals (placebo contained inactive ingredients found in carprofen). For animals receiving 1 mg/lb twice daily, the mean post-treatment serum ALT values were 11 IU greater and 9 IU less than pre-treatment values for dogs receiving carprofen and placebo, respectively. Differences were not statistically significant. For animals receiving 2 mg/lb once daily, the mean post-treatment serum ALT values were 4.5 IU greater and 0.9 IU less than pre-treatment values for dogs receiving carprofen and placebo, respectively. In the latter study, 3 carprofen-treated dogs developed a 3-fold or greater increase in (ALT) and/or (AST) during the course of therapy. One placebo-treated dog had a greater than 2-fold increase in ALT.

None of these animals showed clinical signs associated with laboratory value changes. Changes in the clinical laboratory values (hematology and clinical chemistry) were not considered clinically significant. The 1 mg/lb twice daily course of therapy was repeated as needed at 2-week intervals in 244 dogs, some for as long as 5 years.

Clinical field studies were conducted in 297 dogs of different breeds undergoing orthopedic or soft tissue surgery. Dogs were administered 2 mg/lb of carprofen two hours prior to surgery then once daily, as needed for 2 days (soft tissue surgery) or 3 days (orthopedic surgery). Carprofen was well tolerated when used in conjunction with a variety of anesthetic-related drugs. The type and severity of abnormal health observation in carprofen- and placebo-treated animals were approximately equal and few in number (see Adverse Reactions). The most frequent abnormal health observation was vomiting and was observed at approximately the same frequency in carprofen- and placebotreated animals. Changes in clinicopathologic indices of hematopoietic, renal, hepatic and clotting functions were not clinically significant. The mean post-treatment serum ALT values were 7.3 IU and 2.5 IU less than pre-treatment values for dogs receiving carprofen and placebo, respectively. The mean post-treatment AST values were 3.1 IU less for dogs receiving carprofen and 0.2 IU greater for dogs receiving placebo.

STORAGE:

Store at controlled room temperature 20°–25°C (68°–77°F).

HOW SUPPLIED:

quellin soft chewable tablets are scored, and contain 25 mg, 75 mg, or 100 mg of carprofen per tablet. Each tablet size is packaged in bottles containing 30 or 120 tablets.

REFERENCES:

  1. Baruth H, et al: In Anti-Inflammatory and Anti-Rheumatic Drugs, Vol. II, Newer Anti-Inflammatory Drugs, Rainsford KD, ed. CRC Press, Boca Raton, p. 33, 1986.
  2. Vane JR, Botting RM: Mechanism of action of anti-inflammatory drugs. Scand J Rheumatol 25:102, pp. 9–21.
  3. Grossman CJ, Wiseman J, Lucas FS, et al: Inhibition of constitutive and inducible cyclooxygenase activity in human platelets and mononuclear cells by NSAIDs and COX-2 inhibitors. Inflammation Research 44:253–257, 1995.
  4. Ricketts AP, Lundy KM, Seibel SB: Evaluation of selective inhibition of canine cyclooxygenase 1 and 2 by carprofen and other nonsteroidal anti-inflammatory drugs. Am J Vet Res 59:11, pp. 1441–1446, November 1998.
  5. Ceuppens JL, et al: Non-steroidal anti-inflammatory agents inhibit the synthesis of IgM rheumatoid factor in vitro. Lancet 1:528, 1982.
  6. Ceuppens JL, et al: Endogenous prostaglandin E2 enhances polyclonal immunoglobulin production by ionically inhibiting T suppressor cell activity. Cell Immunol 70:41, 1982.
  7. Schleimer RP, et al: The effects of prostaglandin synthesis inhibition on the immune response. Immunopharmacology 3:205, 1981.
  8. Leung KH, et al: Modulation of the development of cell mediated immunity: Possible roles of the products of cyclooxygenase and lipoxygenase pathways of arachidonic acid metabolism. Int J Immunopharmacology 4:195, 1982.
  9. Veit BC: Immunoregulatory activity of cultured-induced suppressor macrophages. Cell Immunol 72:14, 1982.
  10. Schmitt M, et al: Biopharmaceutical evaluation of carprofen following single intravenous, oral, and rectal doses in dogs. Biopharm Drug Dispos 11(7):585, 1990.
  11. Kore AM: Toxicology of nonsteroidal anti-inflammatory drugs. Veterinary Clinics of North America, Small Animal Practice 20, March 1990.
  12. Binns SH: Pathogenesis and pathophysiology of ischemic injury in cases of acute renal failure. Compend for Cont Ed 16:1, January 1994.
  13. Boothe DM: Prostaglandins: Physiology and clinical implications. Compend for Cont Ed 6:11, November 1984.
  14. Rubin SI: Nonsteroidal anti-inflammatory drugs, prostaglandins, and the kidney. JAVMA 188:9, May 1986.
  15. Ko CH, Lange DN, Mandsager RE, et al: Effects of butorphanol and carprofen on the minimal alveolar concentration of isoflurane in dogs. JAVMA 217:1025–1028, 2000.

For a copy of the Safety Data Sheet (SDS) or to report adverse reactions call Elanco Veterinary Services at 1-800-422-9874. For consumer questions call 1-800-633-3796

Approved by FDA under ANADA # 200-555

Elanco US Inc
Shawnee, KS 66216
Made in Italy
© 2020 Elanco or its affiliates.
November, 2020
90197492 LV2011

TAKE TIME

OBSERVE LABEL DIRECTIONS

Elanco

Dog Owner Information about
quellin ® (carprofen) soft chewable tablets
quellin ® (pronounced “kwell-in”) for
Osteoarthritis and Post-Surgical Pain
Generic name: carprofen (“car-pro-fen”)

This summary contains important information about quellin. You should read this information before you start giving your dog quellin and review it each time the prescription is refilled. 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 if you want to know more about quellin.

What is quellin?

quellin is a nonsteroidal anti-inflammatory drug (NSAID) that is used to reduce pain and inflammation (soreness) due to osteoarthritis and pain following surgery in dogs. quellin is a prescription drug for dogs. It is available as a soft chewable tablet and is given to dogs by mouth.

Osteoarthritis (OA) is a painful condition caused by “wear and tear” of cartilage and other parts of the joints 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

To control surgical pain (e.g. for surgeries such as spays, ear procedures or orthopedic repairs) your veterinarian may administer quellin before the procedure and recommend that your dog be treated for several days after going home.

What kind of results can I expect when my dog is on quellin?

While quellin is not a cure for osteoarthritis, it can relieve the pain and inflammation of OA and improve your dog’s mobility.

  • Response varies from dog to dog but can be quite dramatic.
  • In most dogs, improvement can be seen in a matter of days.
  • If quellin is discontinued or not given as directed, your dog’s pain and inflammation may come back.

Who should not take quellin?

Your dog should not be given quellin if he/she:

  • Has had an allergic reaction to carprofen, the active ingredient of quellin.
  • Has had an allergic reaction to aspirin or other NSAIDs (for example deracoxib, etodolac, firocoxib, meloxicam, phenylbutazone or tepoxalin) such as hives, facial swelling, or red or itchy skin.

quellin should be given to dogs only. Cats should not be given quellin. Call your veterinarian immediately if your cat receives quellin. People should not take quellin. Keep quellin and all medicines out of reach of children. Call your physician immediately if you accidentally take quellin.

How to give quellin to your dog.

quellin should be given according to your veterinarian’s instructions. Your veterinarian will tell you what amount of quellin is right for your dog and for how long it should be given. Most dogs will take quellin soft chewable tablets right out of your hand or the soft chewable tablet can be placed in the mouth. quellin may be given with or without food.

What to tell/ask your veterinarian before giving quellin.

Talk to your veterinarian about:

  • The signs of OA you have observed (for example limping, stiffness).
  • The importance of weight control and exercise in the management of OA.
  • What tests might be done before quellin is prescribed.
  • How often your dog may need to be examined by your veterinarian.
  • The risks and benefits of using quellin.

Tell your veterinarian if your dog has ever had the following medical problems:

  • Experienced side effects from quellin or other NSAIDs, such as aspirin
  • Digestive upset (vomiting and/or diarrhea)
  • Liver disease
  • Kidney disease
  • A bleeding disorder (for example, Von Willebrand’s disease)

Tell your veterinarian about:

  • Any other medical problems or allergies that your dog has now or has had.
  • All medicines that you are giving your dog or plan to give your dog, including those you can get without a prescription.

Tell your veterinarian if your dog is:

  • Pregnant, nursing or if you plan to breed your dog.

What are the possible side effects that may occur in my dog during quellin therapy?

quellin, like other drugs, may cause some side effects. Serious but rare side effects have been reported in dogs taking NSAIDs, including quellin. Serious side effects can occur with or without warning and in rare situations result in death.

The most common NSAID-related side effects generally involve the stomach (such as bleeding ulcers), and liver or kidney problems. Look for the following side effects that can indicate your dog may be having a problem with quellin or may have another medical problem:

  • Decrease or increase in appetite
  • Vomiting
  • Change in bowel movements (such as diarrhea, or black, tarry or bloody stools)
  • Change in behavior (such as decreased or increased activity level, incoordination, seizure or aggression)
  • Yellowing of gums, skin, or whites of the eyes (jaundice)
  • Change in drinking habits (frequency, amount consumed)
  • Change in urination habits (frequency, color, or smell)
  • Change in skin (redness, scabs, or scratching)

It is important to stop therapy and contact your veterinarian immediately if you think your dog has a medical problem or side effect from quellin therapy. If you have additional questions about possible side effects, talk to your veterinarian.

Can quellin be given with other medicines?

quellin should not be given with other NSAIDs (for example, aspirin, deracoxib, etodolac, firocoxib, meloxicam, tepoxalin) or steroids (for example, cortisone, dexamethasone, prednisone, triamcinolone).

Tell your veterinarian about all medicines you have given your dog in the past, and any medicines that you are planning to give with quellin. This should include other medicines that you can get without a prescription. Your veterinarian may want to check that all of your dog’s medicines can be given together.

What do I do in case my dog eats more than the prescribed amount of quellin? Contact your veterinarian immediately if your dog eats more than the prescribed amount of quellin.

How to store quellin soft chewable tablets.

The soft chewable tablets are flavored.

Keep quellin soft chewable tablets in a secured storage area out of the reach of your dog and other pets. If your dog ingests more than your veterinarian prescribed, or if your other pets take quellin soft chewable tablets, contact your veterinarian right away.

What else should I know about quellin?

This sheet provides a summary of information about quellin. If you have any questions or concerns about quellin or osteoarthritis pain, or postoperative pain, talk to your veterinarian.

As with all prescribed medicines, quellin should only be given to the dog for which it was prescribed. It should be given to your dog only for the condition for which it was prescribed.

It is important to periodically discuss your dog’s response to quellin at regular check ups. Your veterinarian will best determine if your dog is responding as expected and if your dog should continue receiving quellin.

To report a suspected adverse reaction call Elanco Veterinary Services at 1-800-422-9874. For customer questions call 1-800-633-3796.

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