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Veterinary Drugs

 
Product and
NADA/ANADA Number
Trade Name
Ingredients
Carnidazole
139-879
Spartrix
carnidazole

                                                                   
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Summary of 
FDA Information:

Approval Date: July 31, 1989 Freedom of
Information Summary NADA 139-879 I. GENERAL INFORMATION: NADA 139-879 Sponsor: Wildlife Laboratories 1401 Duff Drive, Suite 600 Fort Collins, CO 80524 Generic Name: Carnidazole Trade Name: Spartrix Marketing Status: OTC II. INDICATIONS FOR USE Spartrix (Carnidazole) is indicated for
oral treatment of
trichomoniasis (canker) in ornamental and
homing (non-food) pigeons. III. DOSAGE A. DOSAGE FORM Tablet (Each tablet contains 10 mg of
Carnidazole). B. ROUTE OF ADMINISTRATION Oral C. RECOMMENDED DOSAGES: One (10 mg) tablet per adult pigeon. One half tablet (5 mg) per newly weaned pigeon. IV. EFFECTIVENESS A. Pivotal Studies 1. Dose Titration Study a. Name and
Address of
Investigator: Dr. D.
Thienpont Dept. of
Chemotherapy Janssen Pharmaceutica Beerse, Belgium b. General Design of
the Investigation: (1) Purpose: Determine the effective dose level of
Carnidazole in pigeons with artificially induced infections. (2)Test Animals: Species: Columba livia (3)Type of
Control: Saline treated placebo (4)Diagnosis: Artificial infections were
induced by gastric lavage with approximately 100,000 Trichomonas columbae organisms. After an incubation period of
one week, throat swabs were
examined microscopically to confirm infection. (5)Dosage Form: Pure active Carnidazole in gelatin capsules. (6)Route of
Administration: Oral (7)All birds received treatments for
only one day. (Eds. note: The following table consists of
2 columns.) Dosage Used: Number of
Birds/Group (a) 2.5 mg/kg (3 birds) (b) 5 mg/kg (11 birds) (c) 10 mg/kg (23 birds) (d) 10 mg/kg twice same day (6 birds) (e) 20 mg/kg single dose (20 birds) (f) Saline controls (19 birds) (8)Test Duration: Fourteen days (9)Pertinent Parameters Measured: Presence or
absence of
trichomonads in throat swabs on days 9 and
14, after treatment. c. Results: (Eds. note: The following table consists of
2 columns.) Dosage Used Number of
negative birds per group 2.5 mg/kg 0/3 5 mg/kg 7/11 10 mg/kg 21/23 10 mg/kg twice same day 6/6 20 mg/kg single dose 20/20 saline (controls) 0/19 These dose range studies indicated that a single oral dose of
10 mg per pigeon resulted in a 100% effectiveness in all treated birds. d. Conclusions Drawn from
the Study: The lowest effective dose rate that resulted in 100% efficacy in all treated pigeons was
a single oral dose of
10 mg/adult bird (20 mg/kg). 2. Validation Study a. Type of
Study: Validation of
the Artificial Infection Model Used for
Dose Titration. b. Name and
Address of
Investigator: Dr. Charles Hibler Department of
Parasitology College of
Veterinary Medicine Colorado State University Fort Collins, Colorado c. General Design of
the Investigation: (1) Purpose: To validate that exposure of
a pigeon to approximately 100,000 trichomonad (Trichomonas columbae ) will establish an infection. (2) Test Animals: (a) Species: Columba livia (b) Number per group: 9 (c) Number of
groups: 2 (3) Type of
Control: Negative (4) Method of
Infection: (a) All birds selected for
this study
were negative for
Trichomonas columbae organisms in crop mucus samples pretreatment. (b) Pigeons with active lesions of
trichomoniasis supplied the inoculum for
this study
. (c) Pigeons in the
treatment group were
drenched with physiological saline suspension containing 100,000 active trichomonad.
The number of
organisms in the
drench was
determined by the Stole dilution technique. (5) Route of
Exposure: Oral (6) Test Duration: Fourteen days (7) Diagnosis or
Confirmation of
Infection: Presence of
pathognomonic lesions and
/or microscopic examination of
crop mucus for
Trichomonas columbae organisms. (8) Pertinent Parameters Measured: Development of
positive mucus samples containing Trichomonas columbae and
/or active lesions. Mucus examinations were
made on days 3, 7 and
14. d. Results: All birds exposed to the infective material were
scored as having trichomonad present in the
crop by microscopic examination on day 14 of
the trial, but were
free of
clinical lesions. Eight of
nine controls (88%) were
free of
trichomoniasis and
did not have clinical lesions. e. Conclusions Drawn from
the Study: The results of
this trial confirm that exposure of
non-infected pigeons to approximately 100,000 trichomonas organisms will produce an infection.
These results validate the model used for
generation of
safety and
efficacy data by Janssen Pharmaceutica, Beerse, Belgium. 3. Field Efficacy Study a. Type of
Study: Clinical Field Efficacy Study b. Names and
Addresses of
Investigators: (1) Dr.
Thomas Angel 7640 Burington Pike Florence, Kentucky 41042 (2) Dr. David Marx 111 North Mercedes Road Norman, Oklahoma 73069 (3) Dr. John Esposito Dog, Cat & Bird Hospital 3233 North Mesa El Paso, Texas 78802 (4) Dr. Daniel S. Dohl 1220 North Julia Spokane, Washington 99202 (5) Dr. R.A. Van Ryswyk 455 West Dickman Road Battle Creek, Michigan 49015 (6) Dr. Mel Sowell 647 South Horizon El Paso, Texas 79927 (7) Dr. W.R. Lance Wildlife Laboratories, Inc. 1401 Duff Drive, Suite 600 Fort Collins, Colorado 80524 c. General Design of
the Investigation: (1) Purpose: To demonstrate the efficacy of
a single 10 mg Carnidazole tablet for
the treatment of
trichomoniasis in pigeons with natural infections. (2) Test Animals: Species - Columba livia (3) Type of
Control: Placebo (4) Diagnosis: Microscopic examination of
throat swab (5) Dosage Form: Tablets (6) Route of
Administration: Oral (7) Dosage Used: A single 10 mg tablet per bird (8) Test Duration: Seven days (9) Parameters Measured: Presence or
absence of
trichomonad in throat swabs obtained 7 days after treatment. d. Results: (Eds. note: The following table consists of
6 columns.) Summary of
Data From Multicenter Study Showing the Efficacy of
Carnidazole In Naturally Infected Pigeons and
Spontaneous Cure Rate In Placebo Treated Pigeons. ----------Treated-------- ----------Placebo---------- Investigator Treated Cured Failure Treated Spontaneous Cured Lance 5 5 0 5 0 Marx 5 4 1 5 0 Esposito 5 3 2 5 0 Dohl 4 3 1 5 0 Angel 5 3 2 5 1 Van Ryswyk 4 2 2 3 0 Sowell 5 5 0 4 2 Total 33 25 8 32 3 Efficacy = 75#37; Spontaneous Cure Rate = 9.3#37; As shown above a total of
33 birds were
treated with Carnidazole resulting in a cure rate of
75%. An equal number (32) of
birds were
included under
placebo treatment.
The spontaneous cure rate for
untreated birds was
less than 10%, which
supports the conclusion that a single 10 mg Carnidazole oral dose for
adult pigeons is efficacious against Trichomonas columbae infections. Conclusions Drawn from
the Study: A single Spartrix (Carnidazole) table was
shown to have a 75% cure rate against Trichomonas columbae infections. e. Conclusions Drawn from
the Study: A single Spartrix (Carnidazole) table was
shown to have a 75% cure rate against Trichomonas columbae infections f. Adverse Reactions: None g. Special Issues: None B. Corroborative Studies 1. Clinical Field Efficacy Study a. Type of
Study: Clinical b. Name and
Address of
Investigator: Dr. Marcel Rogiers Janssen Pharmaceutica Trunhoutseweg 30 B-2340 Beerse Belgium 41042 c. Test Animals: Species - Columba livia Number - 147 adult pigeons in 9 separate lofts. d. Type of
Control: None e. Dosage Used: Single 10 mg tablet of
Carnidazole f. Other Information: Infection was
determined by direct microscopic examination of
throat swabs. During the experiment, the
owners of
the loft were
requested to clean all the drinking vessels daily. One owner did not take these precautions in one loft of
six pigeons. g. Results and
Conclusions: Administration of
a single oral dose of
10 mg tablet of
Carnidazole resulted in a 98% cure rate when
all pigeons in the
loft were
treated under
hygienic precautions.
The data from
one loft of
six pigeons were
not included in calculating the cure rate, since the owner did not follow the protocol and
therefore his data were
considered irrelevant. 2. Clinical Field Efficacy Study a. Name and
Address of
Investigator: Dr. Marcel Rogiers Janssen Pharmaceutica Turnhoutseweg 30 B-2340 Beerse Belgium 41042 b. Test Animals: Species - Columba livia Number - 120 breeding couples, 80 of
them couples with young ones. c. Controls: None d. Dosage: Single 10 mg tablet of
Spartrix (Carnidazole) for
adult and
young unweaned pigeons older than 23 days and
half (1/2) a tablet for
young unweaned pigeons 14 to 22 days old. e. Study Design: All adult pigeons, weaned and
unweaned pigeons 14 to 22 days old were
treated with a single oral dose of
Spartrix (Carnidazole) as mentioned above. Young pigeons less than 14 days old were
left untreated.
This group of
untreated young pigeons got the medication from
their mother's crop milk. Diagnosis of
the disease was
based on the clinical signs such as listlessness and
random mucus samples for
isolation and
identification of
T. columbae . Definitive diagnosis of
the disease was
made by selective autopsies of
the birds and
postmortem examination of
dead pigeons to isolate the pathogen and
by identifying the pathognomonic lesions in the
throat, crop and
liver. f. Results: The study
demonstrated the efficacy of
Carnidazole in adult and
adult with young, under
the conditions of
use. Sixty nine (69) randomly selected adult pigeons were
negative for
organism. Six (6) adult pigeons with unweaned young ones were
positive for
T. columbae . Probably, the
adults were
reinfected while feeding the untreated young.
Three (3) weaned five (5) week old young pigeons treated with Carnidazole and
three unweaned untreated young pigeons less than five weeks old were
negative for
T. columbae in the
throat, crop and
liver, on autopsy. g. Conclusions: The study
demonstrated that 10 mg Carnidazole for
adults and
5 mg Carnidazole for
young unweaned pigeons is efficacious against T. columbae infections. V. ANIMAL SAFETY A. Pivotal Studies 1. Subacute Toxicity Study a. Name and
Address of
Investigator: Dr. Roger Harlin 7020 S. Shields Oklahoma City, Oklahoma 73149 b. General Design of
the Study: (1) Purpose of
the Study: To determine subacute toxicity of
10X the recommended dose (5 mg) of
Carnidazole (Spartrix) per newly weaned pigeon. (2) Test Animals: (a) Species - Columba livia newly weaned (b) Number per group - 5 (c) Treatment - 5 (d) Control - 5 (3) Dosage Form: Tablets (4) Dosage Used: Five 10 mg tablets (100 mg/kg) (5) Route of
Administration: Single Oral (6) Test Duration: 5 days (7) Pertinent Parameters Measured: (a) Clinical signs (b) Body weight (c) Hematology (c) Results: No mortalities or
adverse clinical signs were
seen in the
treated group.
The treated group had a net loss of
17 gms body weight and
the control group had a net loss of
16 gms body weight during the trial period. In the treated group, 3 of
5 birds lost between 2 and
28 gms. One bird had no weight change during the study
and one bird gained 22 gms. In the control group, 3 of
5 birds lost between 5 and
14 gms, one bird had no weight change and
one gained 14 gms.
There was
no difference in the
hematology results between the treated and
control groups. (d) Conclusions: Spartrix (Carnidazole) given at 10X the recommended dose (5 mg) in newly weaned pigeons is safe. 2. Acute Toxicity Study a. Name and
Address of
Investigator: Dr. Robert Marsboom Dept. of
Toxicology Janssen Pharmaceutica Beeres, Belgium b. Test Animals: Species - Columba livia c. Type of
Control: The study
was controlled by the conditions of
housing and
observations made. d. Dosage Used: 40 mg/kg, 160 mg/kg, 320 mg/kg and
640 mg/kg in a single oral dose. e. Results and
Conclusions: (Eds. note: The following table consists of
9 columns.) DATA SUMMARY Dose No. of
Mortality after hours mg/kg Animals 1 3 6 24 72 168 Observations 40 1 0 0 0 0 0 0 none 160 1 0 0 0 0 0 0 none 320 2 0 0 0 0 0 0 none 640 6 0 0 0 0 0 0 slight vomiting in 4 animals, 3 to 6 hours after dosing No drug-related adverse reactions were
observed in the
pigeons treated up to 32 times the recommended therapeutic dose. At 64 times the therapeutic dose, 4 out of
6 birds exhibited slight vomiting.
This study
supports a 32 fold margin of
safety for
Carnidazole in adult pigeons. VI. HUMAN SAFETY: A. Data on human safety pertaining to consumption of
drug residues in food are not required for
approval of this NADA.
The drug is labeled for
use in ornamental and
homing (non-food) pigeons only. B.
The human safety considerations, other than food safety: The labeling contains a statement that, in case of
accidental human ingestion, notify the physician immediately and
inform him or
her that "Spartrix Tablets each contains 10 mg of
active Carnidazole. Carnidazole is a member of
the 5 nitro-imidazole group." VII. AGENCY CONCLUSIONS: The data submitted in support of
this NADA satisfy the requirements of
Section 512 of
the Act and
Section 514.111 of
the implementing regulations.
The data demonstrate that Spartrix (Carnidazole) when
used under
its approved conditions of
use is safe and
effective.
This product is OTC (over the counter) because the pigeon fancier has adequate knowledge to accurately diagnose the disease. Pigeon flocks have mature and
young pigeons most of
the time. Adult birds are asymptomatic carriers and
rarely show typical lesions of
trichomoniasis, other than unthriftiness. Young pigeons contract the disease while feeding on crop milk and
develop pathognomonic lesions in the
throat. If untreated, the
young birds usually die in one to two days after exhibiting signs whereas older birds may die in one to two weeks.
These lesions in young pigeons are easily recognized by pigeon fanciers. OTC distribution will assist the pigeon fancier in controlling the spread of
disease by ensuring that the
entire loft will be treated when
young pigeons show the first signs of
disease. VIII. LABELING (Attached) 1. Package label 2. Package insert 3. Blister packaging sample Copies of
these labels may be obtained by writing to the: Food and
Drug Administration Freedom of
Information Staff (HFI-35) 5600 Fishers Lane Rockville, MD 20857 Or requests may be sent via fax to: (301) 443-1726. If there are problems sending a fax, call (301) 443-2414.

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