Praziquantel: what the FDA reviewed for dog products
9 Freedom of Information summaries from the FDA Center for Veterinary Medicine for products containing Praziquantel, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Cats; Dogs; Dogs (4 weeks of age and greater) and cats (6 weeks of age and greater); Dogs and cats; Dogs and puppies; Dogs and puppies; cats and kittens.
Products
- Droncit® Canine Cestocide Tablets Droncit® Feline Cestocide Tablets Praziquantel 34 (Rx) Tapeworm Dewormer for Cats (OTC) Tapeworm Dewormer for Dogs (OTC) (NADA/ANADA 111-798)
- Droncit™ 5.68% Injectible Solution (NADA/ANADA 111-607)
- Prazi-C Tablets (OTC) Praziquantel Tablets (Rx) (NADA/ANADA 200-265)
- Praziquantel Injection (NADA/ANADA 200-501)
- Praziquantel Tablets (NADA/ANADA 200-734)
- Prazitech™ (NADA/ANADA 200-176)
Prazi-C Tablets (OTC) Praziquantel Tablets (Rx) NADA 200-265, Original approval, August 28, 2003; sponsor Cronus Pharma Specialities India Private Ltd.; species: Dogs and puppies; foi_id 1023; FDA PDF
Indication
Removal of Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus, and removal and control of Echinococcus multilocularis.
Dose regimen
5 lbs. & under: 0.5 tablet; 6-10 lbs: 1 tablet; 11-15 lbs: 1.5 tablets; 16-30 lbs: 2 tablets; 31-45 lbs: 3 tablets; 46-60 lbs: 4 tablets; over 60 lbs: 5 tablets max, Oral (directly per os or crumbled and mixed with feed), Single treatment, 34 mg praziquantel per tablet; not intended for puppies less than 4 weeks of age; fasting neither necessary nor recommended
5 lbs. & under 0.5 tablet 6-10 lbs. 1 tablet 11-15 lbs. 1.5 tablets 16-30 lbs. 2 tablets 31-45 lbs. 3 tablets 46-60 lbs. 4 tablets Over 60 lbs. 5 tablets max
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | Loge(AUC) mean 7.452 (generic) vs 7.449 (pioneer); confidence limits -7.5% to 8.76% | Serum bioequivalence, two-period crossover, single oral dose of three 34 mg tablets (102 mg), 24 dogs; table columns: Phoenix mean, Bayer mean, lower, upper | Loge (Area under Curve) 7.452 7.449 -7.5% 8.76% |
| cmax | Loge(Cmax) mean 6.33 (generic) vs 6.22 (pioneer); confidence limits -0.09% to 25.42% | Serum bioequivalence, two-period crossover, single oral dose of three 34 mg tablets (102 mg), 24 dogs; table columns: Phoenix mean, Bayer mean, lower, upper | Loge (Maximum Concentration) 6.33 6.22 -0.09% 25.42% |
Effectiveness
Bioequivalence study (generic ANADA): two-period crossover serum bioequivalence of generic vs pioneer (DRONCIT) 34 mg tablets in healthy mixed-breed dogs; single oral dose of three 34 mg tablets (102 mg), 48-hour washout, 17 serum samples over 24 h per period, HPLC-UV assay, analysis per the 1996 Bioequivalence Guideline.; n = twenty-four (12 male, 12 female); primary endpoint: Log AUC and log Cmax bioequivalence criteria; result: Both log AUC and log Cmax satisfied the bioequivalence criteria; generic and pioneer tablets bioequivalent.
This study used twenty-four, 12 male and 12 female, healthy mixed breed dogs, between 1 and 3 years of age at the time of selection for the study and weighing from 31 to 45 lb.
Extraction notes: Generic (ANADA) approval: the only study is the serum bioequivalence study, recorded under effectiveness with its AUC/Cmax statistics as PK entries (values are log-transformed means, not absolute exposures). No target animal safety or adverse reaction data. Dose table quoted as flattened text (weight band, tablets).
Droncit® Canine Cestocide Tablets Droncit® Feline Cestocide Tablets Praziquantel 34 (Rx) Tapeworm Dewormer for Cats (OTC) Tapeworm Dewormer for Dogs (OTC) NADA 111-798, Supplemental approval, January 11, 1993; sponsor Elanco US Inc.; species: Cats; foi_id 1608; FDA PDF
Indication
Removal of the feline cestodes Dipylidium caninum and Taenia taeniaeformis (unchanged); supplement adds an 11.5 mg tablet for cats 4 pounds and under.
Dose regimen
11.5 mg tablet (cats 4 pounds and under), Oral, Single treatment, Half the strength of the previously approved 23 mg tablet
The 11.5 mg tablet is administered orally to cats 4 pounds and under.
Extraction notes: Feline summary (catalogued under a dog application). Category II supplement for a new tablet size: 'The approval of the 11.5 mg tablet did not require safety and effectiveness data.' Approval was based on environmental assessment, labeling and manufacturing/dissolution/stability information; no PK, safety, effectiveness or adverse reaction content exists.
Praziquantel Tablets NADA 200-734, Original approval, January 12, 2023; sponsor Felix Pharmaceuticals Pvt. Ltd.; species: Dogs; foi_id 13377; FDA PDF
Indication
Removal of canine cestodes Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus and removal and control of Echinococcus multilocularis.
Dose regimen
½ tablet (5 lbs and under) up to 5 tablets maximum (over 60 lbs), by body-weight schedule, Oral, not stated, Administer directly by mouth or crumbled and mixed with the feed; not intended for use in puppies less than 4 weeks of age. Each chewable tablet contains 34 mg praziquantel.
5 lbs and under ½ tablet 6-10 lbs 1 tablet 11-15 lbs 1 ½ tablets 16-30 lbs 2 tablets 31-45 lbs 3 tablets 46-60 lbs 4 tablets Over 60 lbs 5 tablets maximum
Pharmacokinetics
| Parameter | Value | Conditions | Quote |
|---|---|---|---|
| auc | 1990 (ng/mL)*hour (generic, geometric mean) | Single oral dose of two 34 mg tablets, 24 fasted intact male Beagle dogs, two-period crossover; Table II.1 columns: generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI (geometric means) | AUC (ng/mL)*hour 1990† 2138† 0.93 0.85 1.01 |
| auc | 2138 (ng/mL)*hour (RLNAD Droncit, geometric mean) | Single oral dose of two 34 mg tablets, 24 fasted intact male Beagle dogs, two-period crossover; Table II.1 columns: generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI (geometric means) | AUC (ng/mL)*hour 1990† 2138† 0.93 0.85 1.01 |
| cmax | 652 ng/mL (generic, geometric mean) | Single oral dose of two 34 mg tablets, 24 fasted intact male Beagle dogs, two-period crossover; Table II.1 columns: generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI (geometric means) | CMAX (ng/mL) 652† 682† 0.96 0.82 1.12 |
| cmax | 682 ng/mL (RLNAD Droncit, geometric mean) | Single oral dose of two 34 mg tablets, 24 fasted intact male Beagle dogs, two-period crossover; Table II.1 columns: generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI (geometric means) | CMAX (ng/mL) 652† 682† 0.96 0.82 1.12 |
| tmax | 1.01 (0.45) hours (generic, arithmetic mean (SD)) | Single oral dose of two 34 mg tablets, 24 fasted intact male Beagle dogs, two-period crossover; Table II.1 columns: generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI (geometric means) | TMAX (hours) (SD)‡ 1.01 (0.45)‡ 1.26 (0.61)‡ NE NE NE |
| tmax | 1.26 (0.61) hours (RLNAD Droncit, arithmetic mean (SD)) | Single oral dose of two 34 mg tablets, 24 fasted intact male Beagle dogs, two-period crossover; Table II.1 columns: generic mean, RLNAD mean, ratio, lower 90% CI, upper 90% CI (geometric means) | TMAX (hours) (SD)‡ 1.01 (0.45)‡ 1.26 (0.61)‡ NE NE NE |
Effectiveness
Pivotal blood-level bioequivalence study (Study No. 080-BC-2319): randomized, masked, two-period, two-sequence, single-dose crossover in healthy fasted intact male Beagles, generic chewable tablet vs RLNAD Droncit 34 mg tablets, 7-day washout.; n = 24; primary endpoint: CMAX and AUC (90% CI of geometric mean ratio within 0.80-1.25); result: Bioequivalence demonstrated: AUC ratio 0.93 (90% CI 0.85-1.01), CMAX ratio 0.96 (90% CI 0.82-1.12).
The in vivo blood-level study was conducted in 24 healthy, fasted dogs.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Serious adverse events (bioequivalence study) | There were no serious adverse events reported during the study. |
Extraction notes: Generic ANADA (dosage form changed to chewable tablet via suitability petition). The bioequivalence study is recorded as effectiveness; no target animal safety or field studies were required. PK values are geometric means from Table II.1 as flattened by PDF extraction.
Droncit® Canine Cestocide Tablets Droncit® Feline Cestocide Tablets Praziquantel 34 (Rx) Tapeworm Dewormer for Cats (OTC) Tapeworm Dewormer for Dogs (OTC) NADA 111-798, Supplemental approval, January 18, 1990; sponsor Elanco US Inc.; species: Dogs and puppies; cats and kittens; foi_id 1325; FDA PDF
Indication
OTC removal of the common tapeworms Dipylidium caninum and Taenia pisiformis from dogs and puppies (and D. caninum and Taenia taeniaeformis from cats and kittens).
Dose regimen
Label dosage schedule (weight-based; minimum effective dose related to body surface area, body weight raised to the three-quarter power); no mg/kg figure tabulated in this summary, Oral (tablets, directly or in food), Single treatment, Small dogs (less than 25 lbs) require a larger mg/kg dosage
Dr. Kruckenberg than related the minimum effective dosage to the surface area of the animal utilizing a formula in which the body weight is raised to the three-quarter power and then multiplied by a constant. Utilizing this formula as a basis, the dosage schedule was then achieved.
Target-animal safety
dose multiples 2X, 5X, 10X; duration Two treatments at a 14 day interval (up to 147.8 mg/kg); animals eight.
Dr. Shmidl treated eight dogs twice at 14 day intervals with 5X or 10X the labeled tablet dose. Their weight range was five to 95 lb and the dosage rate was up to 147.8 mg/kg.
| Finding | Quote |
|---|---|
| 5X/10X twice at 14-day intervals: vomiting and diarrhea only; no effects on temperature, cholinesterase, body weight, clinical pathology or histopathology | Vomiting and diarrhea were the only clinical signs with no significant effects on body temperature, cholinesterase values, body weights, clinical pathology or histopathology. |
| 100 or 200 mg/kg twice at 14-day intervals in eight dogs: vomition the only sign of toxicity | Dr. Shmidl administered two tablet treatments at 14-day intervals to eight dogs with either 100 or 200 mg/kg doses. Vomition was the only sign of toxicity. |
| Puppies 4.5-5 weeks old, two 5X treatments: no effects | Four puppies (4 1/2 to 5 weeks of age) received two 5X tablet treatment at 14 day intervals by Dr. Shmidl. No effects were observed as to clinical signs, body weights, gross- or histopathology. |
| Reproductive safety up to 26.8 mg/kg: no effects on fertility, conception, fetal development or pregnancy | Nine dogs (male and female) received tablet treatments up to 26.8 mg/kg during critical stages of reproduction by Dr. M. Barth of Mt. Horeb, Wisconsin. No effects occurred on fertility, conception, fetal development or pregnancy. |
| Safety factor at least 5X the label rate at 14-day intervals in puppies four weeks and older | The safety factor is at least 5X the label rate when the product is administered at 14 day intervals to puppies four weeks of age and older. |
Effectiveness
Twenty-five well-controlled critical (necropsy) anthelmintic studies with the final tablet formulation in dogs and cats with natural or experimental tapeworm infections, plus well-controlled field trials by 12 investigators (279 dogs, 173 cats) using bunamidine hydrochloride as positive control, with proglottid checks 10-14 days post-treatment.; n = 100 treated dogs and 80 untreated control dogs (laboratory studies); primary endpoint: 100% elimination of tapeworms (post-mortem counts); field: absence of proglottids and investigator rating; result: Praziquantel tablets were 100% effective against Taenia pisiformis, Taenia taeniaeformis and Dipylidium caninum (one underdosed animal not cleared); field efficacy rated excellent to good in 97% of cases.
157 (100 dogs and 57 cats) were treated with praziquantel tablets orally or in food and 135 (80 dogs and 55 cats) served as untreated controls.
Adverse reactions
| Term | Treated | Control | Quote |
|---|---|---|---|
| Vomiting, anorexia, lethargy or diarrhea (dogs, field trials; seven instances, non-significant) | 3.2% | The tablet formulation was administered to 218 dogs (eight weeks to 16 years of age and 1.5 to 122 lb) in clinical field trials. Seven instances (3.2%) of either vomiting, anorexia, lethargy or diarrhea were reported and were rated as non-significant. | |
| Diarrhea and vomiting (bunamidine hydrochloride positive-control dogs) | 8.2% (Five of 61) | Five of 61 dogs (8.2%) receiving the positive control drug hydrochloride were observed with side effects of diarrhea and vomiting following the administration of clinically recommended dose. | |
| Diarrhea or salivation (cats, field trials) | 1.5% (2/135) | The tablet formulation was further administered to 135 cats (eight weeks to 13 years of age and two to 19 lb) in clinical field trials. One instance of diarrhea and one of salivation (total = 2, 1.5%) were reported and were rated as non-significant. |
Extraction notes: Supplement providing OTC marketing; summary recaps the original preclinical and field data for dogs and cats. No PK data. The label dosage table is not reproduced in this summary, so dose is descriptive only. Treated-dog field adverse reaction rate is given as 3.2% (seven of 218; 'Seven' is spelled out so the count is not placed in the treated field).
Praziquantel Injection NADA 200-501, Original approval, July 01, 2016; sponsor Bimeda Animal Health Ltd.; species: Dogs (4 weeks of age and greater) and cats (6 weeks of age and greater); foi_id 1203; FDA PDF
Indication
Removal of canine cestodes Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus and removal and control of Echinococcus multilocularis; removal of feline cestodes Taenia taeniaeformis and Dipylidium caninum.
Dose regimen
Dogs: 5 lbs and under 0.3 mL; 6-10 lbs 0.5 mL; 11-25 lbs 1.0 mL; over 25 lbs 0.2 mL per 5 lbs to a maximum of 3 mL, Injection (subcutaneous or intramuscular), not stated, Not intended for use in puppies less than four weeks of age. Solution strength 56.8 mg/mL. Cats: under 5 lbs 0.2 mL; 5-10 lbs 0.4 mL; 11 lbs and over 0.6 mL maximum.
DOGS AND PUPPIES† Dogs: 5 lbs. and under— 0.3 mL 6-10 lbs.— 0.5 mL 11-25 lbs.— 1.0 mL Over 25 lbs.— 0.2 mL/5 lbs. body weight to a maximum of 3 mL
Effectiveness
Generic (ANADA) approval with a bioequivalence waiver based on formulation characteristics (injectable solution, same active ingredient, concentration and dosage form as the RLNAD DRONCIT 5.68% Injectable Solution); no effectiveness or target animal safety studies were required.; result: Waiver from demonstrating bioequivalence granted.
Based on the formulation characteristics of the generic product, Cross Vetpharm Group Ltd. was granted a waiver from the requirement to demonstrate bioequivalence for the generic product, Praziquantel Injection.
Extraction notes: ANADA with bioequivalence waiver; summary states 'CVM did not require effectiveness studies for this approval' and 'CVM did not require target animal safety studies for this approval'. The effectiveness field records the waiver rather than a study.
Droncit™ 5.68% Injectible Solution NADA 111-607, Supplemental approval, July 16, 1993; sponsor Elanco US Inc.; species: Dogs; foi_id 369; FDA PDF
Indication
Dogs: removal of Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus, and removal and control of Echinococcus multilocularis (supplement adds E. multilocularis).
Dose regimen
5 lbs and under: 0.3 mL; 6-10 lbs: 0.5 mL; 11-25 lbs: 1.0 mL; over 25 lbs: 0.2 mL/5 lbs body weight to a maximum of 3.0 mL, Subcutaneous or intramuscular injection, Single treatment (monthly repeat dosing used in the Alaska field program), 5.68% praziquantel solution; not intended for use in puppies less than 4 weeks of age
5 lbs and under 0.3 mL 6-10 lbs. 0.5 mL 11-25 lbs. 1.0 mL over 25 lbs. 0.2 mL/5 lbs. body weight to a maximum of 3.0 mL
Target-animal safety
dose multiples 1X; duration Seven years of continuous dosing at 30 day intervals (Alaska field program); animals 80-90.
This was a seven year study in which 80-90 dogs were dosed at the label recommended rate at 30 day intervals continuously.
| Finding | Quote |
|---|---|
| No adverse effects with repeated monthly dosing over seven years | No adverse effects were reported by the investigators. Multiple dosing with praziquantel tablets over an extended time was safe for the treated animals. |
| Original approval: wide margin of safety demonstrated in laboratory and clinical evaluations | The safety data include both laboratory and clinical evaluations conducted in accordance with existing FDA guidelines and a wide margin of safety was demonstrated for the praziquantel formulation. |
| No adverse clinical signs in the E. multilocularis laboratory trial | No adverse clinical signs or reactions related to either the experimental infection or praziquantel treatment were observed. |
Effectiveness
Controlled, blinded laboratory anthelmintic trial (K.R. Kazacos, West Lafayette, IN) per CVM Canine/Feline Anthelmintic Guidelines in adult mixed-breed dogs experimentally infected with at least 100,000 E. multilocularis protoscolices; label dose (4.8-7.0 mg/kg) of the 5.68% injectable solution given IM 21 days post-infection, necropsy at 28 days; plus an 8-dog immature-infection trial and a 10-year Alaska field program with the tablet formulation.; n = 12 treated, 12 untreated controls; primary endpoint: Post-mortem E. multilocularis counts vs untreated controls; result: 100% elimination: all treated dogs negative; controls averaged 41,492 adult E. multilocularis. Immature-infection trial also 100% elimination (controls averaged 46,317). Alaska program: vole infection rate fell from 29% to 1% by the third year of dosing (average 83% reduction over 7 years).
All 12 control dogs were infected with an average of 41,492 adult E. multilocularis. By comparison, all treated dogs (12 with the injectable solution), were completely negative for E. multilocularis (and as well for other cestodes), i.e. 100% elimination. No adverse clinical signs or reactions related to either the experimental infection or praziquantel treatment were observed.
Extraction notes: Supplemental approval adding E. multilocularis; laboratory studies and a 10-year Alaska field program (tablet formulation, 80-90 dogs) support effectiveness and safety. No PK data and no dose-multiple study in this summary (safety cross-referenced to the original NADA 111-607 FOI). No adverse reactions were reported in any study, so adverse_reactions is empty. The dose table is quoted as flattened text (weight band, volume).
Droncit® Canine Cestocide Tablets Droncit® Feline Cestocide Tablets Praziquantel 34 (Rx) Tapeworm Dewormer for Cats (OTC) Tapeworm Dewormer for Dogs (OTC) NADA 111-798, Supplemental approval, July 16, 1993; sponsor Elanco US Inc.; species: Dogs; foi_id 1611; FDA PDF
Indication
Dogs: removal of Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus, and removal and control of Echinococcus multilocularis (supplement adds E. multilocularis).
Dose regimen
5 lbs and under: 0.5 tablet; 6-10 lbs: 1 tablet; 11-15 lbs: 1.5 tablets; 16-30 lbs: 2 tablets; 31-45 lbs: 3 tablets; 46-60 lbs: 4 tablets; over 60 lbs: 5 tablets max, Oral (directly per os or crumbled and mixed with feed), Single treatment (monthly repeat dosing used in the Alaska field program), 34 mg praziquantel tablets; not intended for use in puppies less than 4 weeks of age
Dogs and Puppies* Tablets 5 Lbs and Under 0.5 Tablet 6 - 10 Lbs 1 Tablet 11 – 15 Lbs 1.5 Tablets 16 – 30 Lbs 2 Tablets 31 – 45 Lbs 3 Tablets 46 – 60 Lbs 4 Tablets Over 60 Lbs 5 Tablets Max
Target-animal safety
dose multiples 1X; duration Seven years of continuous dosing at 30 day intervals (Alaska field program); animals 80-90.
This was a seven year study in which 80-90 dogs were dosed at the label recommended rate at 30 day intervals continuously.
| Finding | Quote |
|---|---|
| No adverse effects with repeated monthly dosing over seven years | No adverse effects were reported by the investigators. Multiple dosing with praziquantel tablets over an extended time was safe for the treated animals. |
| Original approval: wide margin of safety demonstrated | The safety data include both laboratory and clinical evaluations conducted in accordance with existing FDA guidelines and a wide margin of safety was demonstrated for the praziquantel formulation. |
Effectiveness
Controlled, blinded laboratory anthelmintic trial (K.R. Kazacos, West Lafayette, IN) per CVM Canine/Feline Anthelmintic Guidelines in adult mixed-breed dogs (13.2 to 22.7 kg) experimentally infected with at least 100,000 E. multilocularis protoscolices; label dose (4.8-7.0 mg/kg) of the 34 mg tablets orally 21 days post-infection, necropsy at 28 days; supported by an 8-dog immature-infection trial and a 10-year Alaska field program.; n = 12 treated, 12 untreated controls; primary endpoint: Post-mortem E. multilocularis counts vs untreated controls; result: 100% elimination: all treated dogs negative; controls averaged 41,492 adult E. multilocularis. Immature-infection trial 100% elimination (controls averaged 46,317). Alaska program: vole infection rate fell from 29% to 1% by the third year of dosing (average 83% reduction over 7 years).
All 12 control dogs were infected with an average of 41,492 adult E. multilocularis. By comparison, all treated dogs, 12 with tablets, were completely negative for E. multilocularis ( and as well for other cestodes), i.e. 100% elimination.
Extraction notes: Supplemental approval adding E. multilocularis for the tablet; same study set as the injectable supplement (foi 369). No PK data; no dose-multiple study (safety cross-referenced to the original NADA 111-798 FOI). No adverse reactions reported in any study, so adverse_reactions is empty. Dose table quoted as flattened text (weight band, number of tablets).
Prazitech™ NADA 200-176, Original approval, October 16, 2002; sponsor Bimeda Animal Health Ltd.; species: Dogs and cats; foi_id 991; FDA PDF
Indication
Removal of canine cestodes (Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus, Echinococcus multilocularis) and feline cestodes (Taenia taeniaeformis, Dipylidium caninum).
Dose regimen
Dogs: 5 lbs. and under 0.3 mL; 6-10 lbs 0.5 mL, IM or SC injection, Single treatment, 56.8 mg/mL solution; the 11-25 lb (1.0 mL) dog row and the cat rows (under 5 lb 0.2 mL, 5-10 lb 0.4 mL, 11 lb and over 0.6 mL maximum) are garbled in the extracted text
Dogs: 5 lbs. and under-0.3 mL 6-10 lbs-0.5 mL
Effectiveness
Generic (ANADA) approval: in vivo bioequivalence study waived on formulation grounds (solution with the same active and inactive ingredients in the same concentrations as the pioneer Droncit® Injectable, NADA 111-607).; result: No new safety or effectiveness data; bioequivalence waiver granted.
Based upon the formulation characteristics of the generic product, Phoenix Scientific, Inc. was granted a waiver from conducting an in vivo bioequivalence study for PRAZITECH
Extraction notes: Generic injectable praziquantel; no studies, PK, target animal safety or adverse reaction data (bioequivalence waiver). Effectiveness entry records the waiver only. Dose table is partly garbled by PDF extraction (character-spaced), so only the first two dog weight bands are quoted.
Prazi-C Tablets (OTC) Praziquantel Tablets (Rx) NADA 200-265, Supplemental approval, September 15, 2004; sponsor Cronus Pharma Specialities India Private Ltd.; species: Dogs and puppies; foi_id 1024; FDA PDF
Indication
Removal of the tapeworms Dipylidium caninum and Taenia pisiformis in dogs and puppies (OTC).
Dose regimen
0.5 tablet (5 lbs and under) up to 5 tablets max (over 60 lbs), by body-weight band, Oral (per os or crumbled and mixed with feed), not stated, Not intended for use in puppies less than 4 weeks of age; fasting is neither necessary nor recommended. Each tablet contains 34 mg praziquantel.
Recommended Dosage: Tablets may be administered directly per os or crumbled and mixed with feed: --------------------------------------- 5 lbs. & under 0.5 tablet 6-10 lbs. 1 tablet 11-15 lbs. 1.5 tablets 16-30 lbs. 2 tablets 31-45 lbs. 3 tablets 46-60 lbs. 4 tablets Over 60 lbs. 5 tablets max
Effectiveness
Generic (ANADA) approval: in vivo blood-level bioequivalence study of generic vs pioneer praziquantel tablets (details in the original FOI Summary dated August 28, 2003); no new safety or effectiveness studies.; primary endpoint: Serum (blood-level) bioequivalence; result: Bioequivalence to the pioneer praziquantel tablets was demonstrated.
To show that this generic product is safe and effective for its intended use, an in vivo blood level bioequivalence study was conducted. The study objective to determine the bioequivalence of generic and pioneer praziquantel tablets by serum bioequivalence was achieved.
Extraction notes: Supplemental ANADA providing for OTC marketing in 5, 10 and 50-tablet containers; contains no study data beyond a reference to the bioequivalence study in the original 2003 FOI Summary. Tablet strength 34 mg praziquantel per tablet (from General Information).
Reproduce: foi_structured_search(query="Praziquantel") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).