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Simplicef 200mg (per tab)

Item# IWM032858S
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Description

Simplicef is indicated for dogs with skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus intermedius, Staphylococcus aureus, Streptococcus canis (Group G, ß-hemolytic), Escherchia coli, Pasteurella multocida, and Proteus mirabilis.

Key Benefits:

  • Ideal pharmacokinetic profile for an oral time-dependent cepholosporin.
  • Long half-life allows for once-daily dosing, which can result in increased compliance and better clinical outcomes.
  • Effective in treating skin infections (wounds and abscesses) in dogs.
  • Many large dogs can be treated with just 1 tablet.
  • Tablets are film coated, odorless and scored for easier administration.
  • Tablets can be given with or without food.

How it works

Simplicef is effective against most gram-positive and gram-negative bacteria. Cephalosporin antibiotics suppress the growth of micro-organisms such as bacteria, fungi, or protozoa.

Indication

Simplicef Chewable tablets are indicated for the teratment of skin infections (wounds and abscesses) in dogs caused by susceptible strains of Staphylococcus pseudintermedius, Staphylococcus aureus, Streptococcus canis (group G, ß hemolytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis.

Ingredients

Active Ingredients:

Cefpodoxime proxetil

Directions

View Simplicef product label.

Dose Range:

The dose range of Simplicef Chewable (cefpodoxime proxetil) tablets is 5-10 mg/kg (2.3-4.5 mg/lb) body weight, administered orally, once a day. The dose may be given with or without food. The determination of dosage for any particular patient must take into consideration such factors as the severity and nature of the infection, the susceptibility of the causative organisms, and the integrity of the patient's host defense mechanisms. Obtain a sample of the pathogenic organism for culture and sensitivity testing prior to beginning antimicrobial therapy. Once results become available, continue with appropriate therapy.

Duration:

Simplicef Chewable Tablets should be administered once daily for 5-7 days or for 2-3 days beyond the cessation of clinical signs, up to a maximum of 28 days. Treatment of acute infections should not be continued for more than 3-4 days if no response to therapy is seen.

Dosing Charts:

For daily oral administration of Simplicef Chewable at 5 mg/kg (Table 1) and 10 mg/kg (Table 2).

Table 1. Dose Table for Simplicef Chewable Tablets at 5 mg/kg Total Daily Dosage
Weight of Dog (lbs)
Daily Dose 22 44 66 88 132
No. of 100 mg tablets 0.5 1 1.5 1
No. of 200 mg tablets 1 1
Weight of Dog (kgs)
Daily Dose 10 20 30 40 60
No. of 100 mg tablets 0.5 1 1.5 1
No. of 200 mg tablets 1 1
Table 2. Dose Table for Simplicef Chewable Tablets at 10 mg/kg Total Daily Dosage
Weight of Dog (lbs)
Daily Dose 11 22 44 66 88 132
No. of 100 mg tablets 0.5 1 1
No. of 200 mg tablets 1 1 2 3
Weight of Dog (kgs)
Daily Dose 5 10 20 30 40 60
No. of 100 mg tablets 0.5 10 20 30 40 60
No. of 200 mg tablets 1 1 2 3

Caution:

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Contraindications

Cefpodoxime proxetil is contraindicated in dogs with known allergy to cepodoxime or to the ß-lactam (penicillins and cephalosporins) group of antibiotics.

Warnings:

Not for human use. Keep this and all drugs our of reach of children and pets. Antimicrobial drugs, including penicillins and cephalosporins, can cause allergic reactions in sensitized individuals. To minimize the possibility of allergic, those handling such antimicrobials, including cefpodoxime, are advised to avoid direct contact of the product with the skin and mucous membranes.

Precautions:

The safety of cefodoxime proxetil in dogs use for breeding, pregnant dogs, or lactating bitches has not been demonstrated. As with other cephalosporins, cefpodoxime proxetil may occasionally induce a positive direct Coombs' test.

Adverse Reactions

A total of 216 dogs various breeds and ages ranging from 2 months to 15 years were included in the field study safety analysis. The following table shows the number of dogs displaying each clinical observation.

Table 3. Abnormal Health Findings in the U.S. Field 1
Clinical Observation Simplicef (n=118) Active Control (n=98)
Vomiting 2 4
Diarrhea 1 1
Increased water drinking 0 2
Decreased appetite 1 1

1Dogs may have experienced more than one of the observations during the study.

To report a suspected adverse reaction call 1-888-963-8471.

To request a material safety data sheet (MSDS) for Simplicef Chewable tablets, call 1-888-963-8471.

Effectiveness

The clinical effectiveness of Simplicef (cefpodoxime proxetil) tablets was established in a multi-location (23 site) field study. In this study, 216 dogs with infected wounds or abscesses were treated with either Simplicef (n=118) once daily at 5 mg/kg (2.3 mg/lb) body weight or with an active control antibiotic (n=98) administered twice daily for 5-7 days. In this study, Simplicef was considered noninferior to the active control (88.7% versus 88.4% respectfully) in the treatment of canine skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus pseudintermedius, Staphylococcus aureus, Streptococcus canis (group G, ß hemolytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis.

Animal Safety

In target animal safety studies, cefpodoxime was well tolerated at exaggerated daily oral doses of 100 mg/kg/day (10 times the maximum label dose) for 13 weeks in adult dogs and for 28 days in puppies (18-23 days of age). Therefore, once daily administration of cefpodoxime oral tablets at the maximum labeled dose of 10 mg/kg for up to 28 days was shown to be safe in adult dogs and puppies.

Blood dyscrasia including neutropenias, may be seen following high doses of cephalosporins. Cephalosporin administration should be discontinued in such cases.

Storage:

Simplicef Chewable Tablets should be stored at controlled room temperature 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 40°C (59° to 104°F). Replace cap securely after each opening.

FAQ

Simplicef is a prescription medication FDA-approved for use in dogs. Simplicef is available as 100 mg elliptical scored tablets and 200 mg tablets that can either be elliptical, unscored tablets marked 5229 or capsule-shaped, scored tablets marked 5229. The usual dose of Simplicef in dogs is 2.3-4.5 mg/lb, given by mouth, once a day for 5 to 7 days or 2 to 3 days beyond the cessation of clinical signs, up to a maximum of 28 days. Simplicef should be given with food to increase absorption by the body. Give all of the Simplicef that is prescribed for your pet. Symptoms may begin to improve before the infection is completely treated.
Tell your veterinarian if your pet has ever had an allergic reaction to another penicillin or to a cephalosporin. Tell your veterinarian if your pet has kidney disease or stomach or intestinal disease. Tell your veterinarian if your pet is pregnant or lactating.
Give this medication exactly as directed by your veterinarian. Simplicef should be given with food to increase absorption in the body. Keep plenty of water available for your pet to drink. Do not give Simplicef at the same time as giving antacids such as Maalox or other stomach acid reducers such as Tagamet as this may decrease the absorption of Simplicef. Give all of the Simplicef even if your pet appears to be better. Symptoms may improve before the infection is completely treated. Store tablets at room temperature away from moisture or heat.
Stop giving Simplicef and seek emergency veterinary medical care in the event of an allergic reaction (shortness of breath; hives; swelling of the lips, tongue, or face; rash; or fainting), severe nausea, vomiting or diarrhea, mucus or blood in the stool, and unusual bleeding or bruising. Other, less serious side effects such as mild nausea, diarrhea, or yeast infection may be more likely to occur. Continue to give Simplicef and notify your veterinarian if these symptoms occur. Talk to your veterinarian about any side effect that seems unusual or bothersome to your pet.
Give the missed dose as soon as you remember. Do not give a double dose unless otherwise directed by your veterinarian.
Seek emergency veterinary medical treatment if an overdose is suspected. Symptoms of overdose may include nausea, vomiting, diarrhea, and abdominal cramps.
Do not give Simplicef at the same time as giving antacids such as Maalox or other stomach acid reducers such as Tagamet.
Before giving Simplicef, tell your veterinarian if your pet is being given another antibiotic (for the same or a different infection), probenecid, a loop diuretic such as furosemide, or warfarin. You may need to have the dosage adjusted. Drugs other than those listed here may also interact with Simplicef. Talk to your veterinarian or pharmacist before giving any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

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