Hot Felanorm (methimazole) Oral Solution 5 mg/mL

What is Felanorm (methimazole) Oral Solution 5 mg/mL?

Felanorm® (methimazole) Oral Solution 5 mg/mL for cats is an easy-to-administer, honey-flavored treatment for feline hyperthyroidism that allows pet owners to avoid many health and safety risks associated with transdermal gels, as well as the challenges involved in getting a cat to take a pill.

Suitable for:

Cats with Hyperthyroidism

Benefits:

• The first FDA-approved oral solution for feline hyperthyroidism
• Honey Flavored Solution
• Easy to give (International Society of Feline Medicine approved)
• Flexible, accurate dosing
• Proven track record (over 100 million doses in UK)
• Bioequivalent to the FDA-approved tablets containing methimazole

How does Felanorm (methimazole) Oral Solution 5 mg/mL work?

No Gels. No Pills. The New Normal: Felanorm® allows pet owners to avoid the health and safety risks associated with transdermal gels, as well as the challenges involved in getting a cat to take a pill. Methimazole is an antithyroid drug that acts by blocking the biosynthesis of thyroid hormone in vivo. The primary action is to inhibit binding of iodide to the enzyme thyroid peroxidase, thereby preventing the catalyzed iodination of thyroglobulin and T3 and T4 synthesis. Methimazole is well absorbed following oral administration. Maximum plasma concentrations are achieved within 1-1 1/2 hours after dosing and methimazole is rapidly eliminated from the blood (T1/2 is approximately 3 hours). Administration of methimazole in a fasted state enhances absorption.

Caution:

As with all drugs, side effects may occur. The most commonly reported side effects are anorexia, vomiting, head/facial pruritus or edema, depression/lethargy, weight loss, anemia, elevated liver enzymes, skin lesions, elevated BUN, diarrhea, and thrombocytopenia. Felanorm® Oral Solution is not for use in pregnant or lactating queens, or cats with renal, hepactic, or hematological disorders. In some reported cases, the patients recovered after adverse signs were recognized, the drug was withdrawn, and veterinary care was applied. In some cases, death (or euthanasia) has been reported as an outcome of the adverse reactions listed above. Methimazole has anti-vitamin K activity and may induce bleeding diathesis without evidence of thrombocytopenia. Refer to the prescribing information for complete details. Methimazole has anti-vitamin K activity and may induce bleeding diathesis without evidence of thrombocytopenia. See ADVERSE REACTIONS. Keep Felanorm in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

How should I store this product?

Store at controlled room temperature 25°C (77°F) with excursions between 15°-30°C (59°-86°F) permitted. Keep the container tightly closed.

What is the most important information I should know about Felanorm (methimazole) Oral Solution 5 mg/mL?

Do not use in cats with hypersensitivity to methimazole, carbimazole or the excipient, polyethylene glycol. Do not use in cats with primary liver disease or renal failure. Do not use in cats with autoimmune disease. See ADVERSE REACTIONS.Do not use in cats with hematological disorders (such as anemia, neutropenia, lymphopenia, or thrombocytopenia) or coagulopathies. See ADVERSE REACTIONS. Do not use in pregnant or lactating queens. Laboratory studies in rats and mice have shown evidence of teratogenic and embryotoxic effects of methimazole.

What should I discuss with my veterinarian before giving Felanorm (methimazole) Oral Solution 5 mg/mL to my pet?

Talk to your Veterinarian About:Any serious disease or health conditions your cat has had.Any previous treatments for hyperthyroidism, including methimazole treatment or radioactive iodine, and any side effects related to those treatments.Any allergies that your cat has now or has had.All medications that you are giving your cat or plan to give your cat, including those you can get without prescription (over-the-counter) and any dietary supplements.If you plan to breed your cat, or if your cat is pregnant or nursing.What tests might be done before Felanorm is prescribed.The potential side effects your cat may experience while taking Felanorm.How often your cat may need to be examined by your veterinarian .The risks and benefits of using Felanorm, including human user safety risks.

How should Felanorm (methimazole) Oral Solution 5 mg/mL be given/administered?

The starting dose of Felanorm is 2.5 mg administered every 12 hours. Following 3 weeks of treatment, the dose should be titrated to effect based on individual serum total T4 (TT4) levels and clinical response. Dose adjustments should be made in 2.5 mg increments. The maximum total dosage is 20 mg per day divided, not to exceed 10 mg as a single administration. Hematology, biochemistry, and TT4 should be evaluated prior to initiating treatment and monitored after 3 weeks and 6 weeks of treatment. Thereafter, bloodwork should be monitored every 3 months and the dose adjusted as necessary. Cats receiving doses greater than 10 mg per day should be monitored more frequently. The product should be administered orally usingthe enclosed graduated dosing syringe. The syringe has measurements representing the mg dose of the product. Rinse/clean the oral dosing syringe between uses. (See the Instructions for Preparing a Dose of Felanorm (methimazole) Oral Solution).

What are the potential side effects of Felanorm (methimazole) Oral Solution 5 mg/mL?

Felanorm, like all other drugs, may cause side effects in individual cats. These are normally mild, but serious side effects have been reported in cats taking methimazole. 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 cat may have a medical problem or side effects while on Felanorm. Possible side effects include loss of appetite, lethargy, vomiting, diarrhea/loose stool, head and facial itchiness or swelling, skin lesions, weight loss, elevated liver enzymes, elevated kidney enzymes, abnormal vocalization, and low counts of red cells, white cells, and platelets. Methimazole may cause your cat to bleed or bruise more easily. In some cases, patients recovered after side effects from methimazole were recognized, methimazole was withdrawn, and veterinary care was administered. In some cases, death (or euthanasia) was the outcome of the side effects. To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Norbrook at 1-866-591-5777. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

What happens if I miss giving a dose of Felanorm (methimazole) Oral Solution 5 mg/mL?

Give the missed dose as soon as you remember. * If it’s almost time for the next dose, skip the missed dose and continue with the regular schedule. Never give a double dose to make up for a missed one.

What happens if I overdose my pet on Felanorm (methimazole) Oral Solution 5 mg/mL?

Contact your veterinarian immediately if your cat gets more than the prescribed amount of Felanorm.

What special precautions are there?

Special precautions to be taken when administering Felanorm. Methimazole can cause or increase the risk of birth defects in human babies. Always wear protective single use, impermeable (e.g., latex or nitrile) gloves when administering elanorm or to prevent direct contact with litter, feces, urine, or vomit of treated cats. Wash your hands with soap and water after administration of Felanorm or after contact with the litter of treated cats to avoid exposure to Felanorm. This is especiallyimportant if you are pregnant, become pregnant, are nursing, or have an endocrine disorder that could be impacted by Felanorm. Avoid skin and oral exposure, including hand-to-mouth contact. Wash any spillages eat, drink, smoke/vape, or use smokeless tobacco while handling the product or used litter. In the event of accidental ingestion, seek medical advice immediately and show the product label to the physician. Felanorm may cause skin or eye irritation. Avoid eye contact, including hand-to-eye contact. In case of accidental eye contact, rinse eyes immediately with clean running water. If irritation develops, seek medical advice.

What should I avoid while giving Felanorm (methimazole) Oral Solution 5 mg/mL to my pet?

What kind of results can I expect when my cat takes Felanorm for the control of hyperthyroidism? Felanorm controls hyperthyroidism but does not cure the disease. It may take several weeks for the medication to normalize the thyroid hormone levels. Improvement in signs may include: weight gain or cessation of weight loss, a decrease in excessive appetite, water consumption, and urination, and a decrease in vomiting, diarrhea, and hyperactivity. Your veterinarian will evaluate your cat several weeks after starting treatment and on a regular basis thereafter to determine if dose adjustments are needed. Dose adjustment should only be carried out in consultation with your veterinarian.

What other drugs will affect Felanorm (methimazole) Oral Solution 5 mg/mL?

Interactions with certain medications are possible. Always tell your veterinarian about all medications, including those you can get without a prescription (over-the-counter), that you have given your cat in the past and all medications that you are planning to give with Felanorm.

Felanorm (methimazole) Oral Solution 5 mg/mL Directions:

• Instructions for Preparing a Dose of Felanorm (methimazole) Oral Solution: To draw up a dose, carefully follow these instructions. Prior to preparing a dose, carefully read the Special precautions to be aken when administering Felanorm in the Information for Cat Owners.
• Always wear protective single use, impermeable (e.g., latex or nitrile) gloves when preparing and administering the cat’s dose of this medicine.
• Push and turn the screw cap to open the bottle. Attach the dosing syringe to the bottle by gently pushing the end onto the top of the bottle. ( Note: Always cap the bottle after use.)
• Check that the plunger of the oral dosing syringe (included with the product bottle) is pushed all the way down.
• Turn the bottle/syringe upside down. Pull the plunger back/down until the oral dosing syringe fills with medicine.
• Carefully expel any large bubbles by pushing and pulling the plunger a few times with the bottle upside down. The presence of a few tiny bubbles is not important for dosing accuracy.
• Fill the syringe with the dose of medicine prescribed by your veterinarian by pulling the plunger back/down slowly. The scale on the oral dosing syringe corresponds to the milligram (mg) dose. The end of plunger nearest the tip of the syringe should be level with the measurement (line) corresponding to the correct mg dose.
• Turn the bottle right way up and with a twisting movement, separate the dosing syringe from the bottle. Note: If the prescribed dose is more than one syringe-full (5 mg or 1 milliliter (mL) of solution), you will need to reload the syringe with additional medication to provide the full dose. In this case, the total dose will need to be given via multiple fillings of the dosing syringe. For instance, if the dose is 7.5 mg, then you will need to give one syringe-full (5 mg) plus an additional 2.5 mg to provide the full dose.
• The product should be administered slowly and gently, allowing the cat to swallow the product. The product is administered by pushing it out of the syringe with the syringe plunger. Following administration, any residual product remaining on the tip of the dosing syringe should be wiped clean with a disposable item (napkin, paper towel, or tissue). The contaminated item (napkin, paper towel, or tissue) should be disposed of immediately in a trash receptacle. To avoid contamination of the
• product bottle, the dosing syringe should be rinsed externally, cleaned, and dried between doses and between individual fillings (when multiple fillings of the dosing syringe are needed to provide a single dose). The bottle cap should be screwed back on the product bottle tightly, and the dosing syringe should be stored with the product bottle in the original carton. Wash your hands with soap and water after administration to avoid exposure to the drug.
• Push the plunger to empty the content of the syringe directly in the cat’s mouth.