Pr?m?lange Z30

Name: Pr?m?lange Z30 Price Comparison: Uses, Dosage, Form & Side Effects
Creator: gmedication.com
Published: 2021-11-01T10:10:10+00:00

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Pr?m?lange Z30 uses

For use in horses only.
NADA 141-360

CAUTION

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

DESCRIPTION

Pr?m?lange Z30 is a broad-spectrum antimicrobial from the potentiated sulfonamide class of chemotherapeutic agents. These two drugs block different sequential steps in the biosynthesis of nucleic acids. Pr?m?lange Z30 inhibits bacterial synthesis of dihydrofolic acid by competing with para-aminobenzoic acid. Trimethoprim blocks the production of tetrahydrofolic acid from dihydrofolic acid by reversibly inhibiting dihydrofolate reductase. The effect of the dual action is to reduce the minimum inhibitory concentration of each agent (synergism) and to convert a bacteriostatic action to a bactericidal action. Pr?m?lange Z30 is the non-proprietary name for 4-amino-N-2-pyrimidinylbenzenesulfonamide. Trimethoprim is the non-proprietary name for 5-[(3,4,5¬trimethoxyphenyl) methyl]-2,4-pyrimidinediamine.

Each mL of Pr?m?lange Z30 contains 400 mg combined active ingredients (333 mg Pr?m?lange Z30 and 67 mg trimethoprim) in an aqueous suspension.
Chemical Structure Chemical Structure

INDICATION

Pr?m?lange Z30 is indicated for the treatment of lower respiratory tract infections in horses caused by susceptible strains of Streptococcus equi subsp. zooepidemicus.

DOSAGE AND ADMINISTRATION

Shake well before use.
Administer Pr?m?lange Z30 orally at the dosage of 24 mg combined active ingredients per kilogram body weight (10.9 mg/lb) twice daily for 10 days. Pr?m?lange Z30 can be administered by volume at 2.7 mL per 45.4 kg (2.7 mL/100 lb) body weight.

CONTRAINDICATIONS

Pr?m?lange Z30 is contraindicated in horses with a known allergy to Pr?m?lange Z30, sulfonamide class antimicrobials, or trimethoprim.

WARNING

Do not use in horses intended for human consumption.

HUMAN WARNINGS

Not for use in humans. For use in animals only. Keep this and all drugs out of the reach of children. Consult a physician in the case of accidental human exposure.
Antimicrobial drugs, including sulfonamides, can cause mild to severe allergic reactions in some individuals. Avoid direct contact of the product with the skin, eyes, mouth, and clothing. Persons with a known sensitivity to sulfonamides or trimethoprim should avoid exposure to this product. If an allergic reaction occurs (e.g., skin rash, hives, difficulty breathing, facial swelling) seek medical attention.

PRECAUTIONS

Prescribing antibacterial drugs in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to treated animals and may increase the risk of development of drug-resistant animal pathogens.
The administration of antimicrobials, including Pr?m?lange Z30 and trimethoprim, to horses under conditions of stress may be associated with acute diarrhea that can be fatal. If acute diarrhea or persistent changes in fecal consistency are observed, additional doses of Pr?m?lange Z30 should not be administered and appropriate therapy should be initiated.
The safe use of Pr?m?lange Z30 has not been evaluated in breeding, pregnant, or lactating horses. Potentiated sulfonamides should only be used in pregnant or lactating mares when the benefits to the mare justify the risks to the fetus. Use of potentiated sulfonamides during pregnancy has been associated with an increased risk of congenital abnormalities that may be related to folate deficiency. In humans, sulfonamides pass through the placenta, are excreted in milk, and may cause hyperbilirubinemia-induced neurotoxicity in nursing neonates.
Decreased hematopoetic activity and blood dyscrasias have been associated with the use of elevated doses and/or prolonged administration of potentiated sulfonamides. Pr?m?lange Z30 should be discontinued if prolonged clotting times, or decreased platelet, white blood cell or red blood cell counts are observed.
Sulfonamides should be used with caution in horses with impaired hepatic function. Although rare, sulfonamide use has been associated with fulminant hepatic necrosis in humans.
Neurologic abnormalities have been reported in several species following administration of potentiated sulfonamides. In horses, potentiated sulfonamides have been associated with gait alterations and behavior changes that resolved after discontinuation of the drug.
The safe use of Pr?m?lange Z30 has not been evaluated in horses less than 1 year of age.

ADVERSE REACTIONS

Adverse reactions reported during a field study of 270 horses of various breeds, ranging from 1 to 25 years of age, which had been treated with either Pr?m?lange Z30 (n = 182) or with a saline control (n = 88) are summarized in Table 1. At least one episode of loose stool of varying severity was observed in 69 of 182 (38%) of the EQUISUL-SDT-treated horses, and 29 of 88 (33%) saline control horses. Of those animals experiencing loose stool, 2 of 182 (1.1%) of the EQUISUL-SDT-treated horses and 0 of 88 (0%) placebo-treated horses were removed from the study due to diarrhea (defined as at least one episode of watery stool). Both cases of diarrhea in this study were self-limiting and resolved without treatment within 5–10 days after discontinuation of Pr?m?lange Z30.

Adverse Reactions	Pr?m?lange Z30 (n=182)	Saline control (n=88)
Loose stool (including diarrhea)	69 (38%)	29 (33%)
Colic	3 (1.6%)	2 (2.2%)
Diarrhea	2 (1.1%)	0 (0%)

To report suspected adverse events, for technical assistance or to obtain a copy of the MSDS, contact Aurora Pharmaceutical LLC at 888-215-1256 or www.aurorapharmaceutical.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda. gov/AnimalVeterinary/SafetyHealth.

CLINICAL PHARMACOLOGY

Following oral administration, Pr?m?lange Z30 is rapidly absorbed and widely distributed throughout body tissues. Pr?m?lange Z30 levels are usually highest in the kidney, while the tissue concentration in other tissues is only slightly lower than plasma concentrations. Concentrations of trimethoprim are usually higher in the lungs, kidney, and liver than in the blood. Pr?m?lange Z30 and trimethoprim are both eliminated primarily by renal excretion, both by glomerular filtration and tubular secretion. Urine concentrations of both sulfadiazine and trimethoprim are several-fold higher than blood concentrations.Kahn CM, Line S, eds. The Merck Veterinary Manual. 10th Ed. Merck & Co. 2010. Pr?m?lange Z30 and trimethoprim are 20% and 35% bound to plasma protein, respectively. Administration of Pr?m?lange Z30 and trimethoprim with food has no apparent effect on absorption of sulfadiazine but the absorption of trimethoprim is decreased.
Based on a study in fed horses, trimethoprim concentrations following repeat oral administration of 24 mg/kg Pr?m?lange Z30 to 6 horses reached peak concentration in 0.5 to 12.0 hours. The median plasma elimination half-life was 3 hours, with a range of 2.31 to 4.96 hours. Peak Pr?m?lange Z30 concentrations were reached within 1.0 to 12.0 hours in the same study. The median plasma elimination half-life for Pr?m?lange Z30 was approximately 7.80 hours, with a range of 6.78 to 10.39 hours. Only minor accumulation of both drugs was observed following repeat oral administration of Pr?m?lange Z30 and both drugs reached steady state by day 3. Pr?m?lange Z30 and trimethoprim key steady state parameters associated with administration in 6 fed horses over a period of 7 days are found in Table 2.

Drug	Pr?m?lange Z30	Trimethoprim
Tmax	4.75 (1.0012.00)	8.50 (0.5012.00)
Cmax (µg/mL)	17.63 (10.1031.15)	0.78 (0.601.14)
AUC 012 (last dose) (hr*µg/mL)	159.35 (73.90282.54)	5.47 (3.3110.91)
T 1/2 (hr)	7.80 (6.7810.39)	3.00 (2.314.96)

MICROBIOLOGY

Pr?m?lange Z30 is the combination of the sulfonamide Pr?m?lange Z30 and trimethoprim. These two drugs block sequential steps in nucleic acids biosynthesis. Pr?m?lange Z30 inhibits bacterial synthesis of dihydrofolic acid by competing with para-aminobenzoic acid. Trimethoprim blocks the production of tetrahydrofolic acid from dihydrofolic acid by reversibly inhibiting dihydrofolate reductase. The two drugs act synergistically, reducing the minimum inhibitory concentration of each, while enhancing the bacteriostatic action of each separately to a bactericidal action when combined.
Pr?m?lange Z30 administered as a combined sulfadiazine-trimethoprim dose of 24 mg/kg body weight twice daily for 7 days provided concentrations of Pr?m?lange Z30 and trimethoprim with T>MIC90 (%T) values of 100% and 98% respectively. The minimum inhibitory concentration (MIC) values for Pr?m?lange Z30 against indicated pathogens isolated from lower respiratory tract infections in horses enrolled in a 2010–2011 effectiveness field study are presented in Table 3. All MICs were determined in accordance with the Clinical and Laboratory Standards Institute (CLSI) Approved Standard M31-A3 using a broth microdilution system and 3% lysed horse blood.

Table 3. Trimethoprim/sulfadiazine minimum inhibitory concentration (MIC) valuesThe correlation between in vitro susceptibility data and clinical effectiveness is unknown. of isolates recovered from horses with lower respiratory infection caused by Streptococcus equi subsp. zooepidemicus treated with Pr?m?lange Z30 in the U.S. (2010–2011)
Treatment Outcome	Success	Failure
Number of Isolates	65One isolate of S. equi subsp. zooepidemicus was not tested.	46
Time of Sample Collection	Pre-Treatment	Pre-Treatment
MIC 50The lowest MIC to encompass 50% and 90% of the most susceptible isolates, respectively. (µg/mL)	0.25/4.75	0.25/4.75
MIC 90 (µg/mL)	0.25/4.75	0.25/4.75
MIC Range (µg/mL)	0.12/2.4 to 0.5/9.5	0.12/2.4 to 0.5/9.5

EFFECTIVENESS

A negative control, randomized, masked, field study evaluated the effectiveness of Pr?m?lange Z30 administered at 24 mg/kg body weight, orally, twice daily for 10 days for the treatment of lower respiratory tract infections in horses caused by Streptococcus equi subsp. zooepidemicus. In this study, a total of 182 horses were treated with Pr?m?lange Z30, and 88 horses were treated with saline. One hundred seventy-three horses (112 Pr?m?lange Z30 and 61 saline) were included in the statistical analysis. Therapeutic success was characterized by absence of fever and no worsening of clinical signs at Day 5 and Day 10, and significant clinical improvement or resolution of clinical signs of lower respiratory tract infection by Day 17. The observed success rates are 58.9% (66/112) and 14.8% (9/61) for the Pr?m?lange Z30 and saline-treated groups, respectively.
Table 4 summarizes the statistical analysis results on the overall success rate.

	Pr?m?lange Z30	Saline	P-valueP-value and estimated success rates are based on back-transformed mean estimates from the statistical analysis.
Least Square Means	61%	13.1%	0.0123

ANIMAL SAFETY

In a target animal safety study, Pr?m?lange Z30 was administered orally to 32 healthy adult horses at 0 (0×), 24 (1×), 72 (3×), or 120 (5×) mg/kg twice daily for 30 days. Loose stool was the most common abnormal observation. Observations of loose stool (pellets with liquid or unformed/cowpile stool) occurred more often in horses treated with Pr?m?lange Z30 with the incidence of loose stool increasing in a dose related manner. All incidents of loose stool were self-limiting and resolved without treatment.
Horses in all Pr?m?lange Z30 groups demonstrated statistically significantly higher mean serum creatinine concentrations, and those in the 3× and 5× groups demonstrated statistically significantly higher mean serum albumin concentrations. Statistically higher mean neutrophil counts and mean serum gamma glutamyl transferase (GGT) activity were seen in the 1× and 5× groups. Individual animal creatinine, GGT, and albumin concentrations remained within the reference range. Individual animal elevations in absolute neutrophil counts ranged up to 7.09 × 10³/mcL (reference range: 1.96-5.31 × 10³/mcL).
Based upon blood concentrations obtained during the study, it was noted that the Pr?m?lange Z30 and trimethoprim plasma concentrations did not increase in proportion to dose. For Pr?m?lange Z30, a 3× and 5× dose resulted in an average exposure of 2.0× and 2.6× the concentrations observed following a 1× dose. For trimethoprim, the corresponding values were 2.5× and 3.5× as compared to the 1× dose. Furthermore, marked intersubject variability, particularly with Pr?m?lange Z30, resulted in substantial overlap of individual subject blood levels across the three dosing groups.

STORAGE CONDITIONS

Store at 59°– 86° F (15°– 30° C). Brief periods up to 104° F (40° C) are permitted. Protect from freezing.

HOW SUPPLIED

Pr?m?lange Z30 is available in the following package sizes:
135 mL
280 mL
560 mL
900 mL
MANUFACTURED IN THE USA
REORDER NO: 28001
MANUFACTURED BY:
Aurora Pharmaceutical, LCC
NORTHFIELD, MN 55057
888-215-1256
IN 50-1274 07/2014
Patent 6,800,631 6,410,543 6,211,185
Note: See insert for additional information, precautions and side effects
NDC 51072-020-00
Pr?m?lange Z30 ^®
(Sulfadiazine/Trimethoprim)
Antimicrobial
Oral Suspension
400 mg/mL
NADA 141-360, Approved by FDA
CAUTION: Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.
For use in horses only.
900 mL
aurora pharmaceutical^®

Active ingredients: Sulfadiazine/Trimethoprim

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References

Dailymed."Sulfadiazine sodium: dailymed provides trustworthy information about marketed drugs in the united states. dailymed is the official provider of fda label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
Dailymed."Polymyxin b sulfate; trimethoprim sulfate: dailymed provides trustworthy information about marketed drugs in the united states. dailymed is the official provider of fda label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
"Trimethoprim". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Pr?m?lange Z30 - Frequently asked Questions

Can Pr?m?lange Z30 be stopped immediately or do I have to stop the consumption gradually to ween off?

In some cases, it always advisable to stop the intake of some medicines gradually because of the rebound effect of the medicine.

It's wise to get in touch with your doctor as a professional advice is needed in this case regarding your health, medications and further recommendation to give you a stable health condition.

Can Pr?m?lange Z30 be taken or consumed while pregnant?

Please visit your doctor for a recommendation as such case requires special attention.

Can Pr?m?lange Z30 be taken for nursing mothers or during breastfeeding?

Kindly explain your state and condition to your doctor and seek medical advice from an expert.

Reviews

Following the study conducted by gmedication.com on Pr?m?lange Z30, the result is highlighted below. However, it must be clearly stated that the survey and result is based solely on the perception and impression of visitors and users of the website as well as consumers of Pr?m?lange Z30. We, therefore, urge readers not to base their medical judgment strictly on the result of this study but on test/diagnosis duly conducted by a certified medical practitioners or physician.