Pharken

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Pharken uses



NADA 141-331, Approved by FDA

Dopamine receptor agonist for oral use in horses only

Caution

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

Description

Pharken Tablets are rectangular light red colored, half-scored tablets containing 1 mg Pharken, as Pharken mesylate. Pharken mesylate is a synthetic ergot derivative and is a potent dopamine receptor agonist. The chemical name of Pharken mesylate is 8β-[(Methylthio) methyl]-6-propylergoline monomethanesulfonate.

The chemical structure is:

Picture of chemical structure.

Indication

For the control of clinical signs associated with Pituitary Pars Intermedia Dysfunction (Equine Cushing’s Disease) in horses.

Dosage and Administration

Administer orally at a starting dose of 2 mcg/kg once daily. Dosage may be adjusted to effect, not to exceed 4 mcg/kg daily. It has been reported that Pharken tablets may cause eye irritation, an irritating smell, or headache when Pharken Tablets are split or crushed. Pharken Tablets should not be crushed due to the potential for increased human exposure and care should be taken to minimize exposure when splitting tablets.

The tablets are scored and the calculated dosage should be provided to the nearest one-half tablet increment.


Dosage


Dosage


Body weight


2 mcg/kg


4 mcg/kg


136 - 340 kg

(300 - 749 lb)


0.5 tablet


1 tablet


341 - 567 kg

750 - 1,249 lb)


1 tablet


2 tablets


568 - 795 kg

(1,250 - 1,749 lb)


1.5 tablets


3 tablets


796 - 1,022 kg

(1,750 - 2,249 lb)


2 tablets


4 tablets


Dosing should be titrated according to individual response to therapy to achieve the lowest effective dose. Dose titration is based on improvement in clinical signs associated with Pituitary Pars Intermedia Dysfunction (PPID) and/or improvement or normalization of endocrine tests (for example, dexamethasone suppression test or endogenous ACTH test). If signs of dose intolerance develop, the dose should be decreased by half for 3 to 5 days and then titrated back up in 2 mcg/kg increments every 2 weeks until the desired effect is achieved.

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Contraindications

Pharken is contraindicated in horses with hypersensitivity to Pharken mesylate or other ergot derivatives.

Warnings

Do not use in horses intended for human consumption.

Human Warnings

Not for use in humans. Keep this and all medications out of the reach of children. Pharken should not be administered by persons who have had adverse reactions to ergotamine or other ergot derivatives. Pregnant or lactating women should wear gloves when administering this product. It has been reported that Pharken tablets may cause eye irritation, an irritating smell, or headache when Pharken Tablets are split or crushed. Pharken Tablets should not be crushed due to the potential for increased human exposure and care should be taken to minimize exposure when splitting tablets. Consult a physician in case of accidental ingestion by humans.

Precautions

Treatment with Pharken may cause inappetance.

The use of Pharken in breeding, pregnant, or lactating horses has not been evaluated. The effects of Pharken mesylate on breeding, pregnant, or lactating horses are not known; however, the pharmacologic action of Pharken mesylate suggests that it may interfere with reproductive functions such as lactation.

Pharken is approximately 90% associated with plasma proteins. Use caution if administering Pharken with other drugs that affect protein binding. Dopamine antagonists, such as neuroleptics (phenothiazines, domperidone) or metoclopramide, ordinarily should not be administered concurrently with Pharken (a dopamine agonist) since these agents may diminish the effectiveness of Pharken.

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Adverse Reactions

A total of 122 horses treated with Pharken Tablets for six months were included in a field study safety analysis.


Clinical Sign


# Cases


Cases (%)


Decreased appetite


40


32.8


Lameness


22


18.0


Diarrhea/Loose stool


12


9.8


Colic


12


9.8


Lethargy


12


9.8


Abnormal Weight Loss


11


9.0


Laminitis*


10


8.2


Heart murmur


10


8.2


Death


8


6.6


Tooth disorder


8


6.6


Skin abscess


7


5.7


Musculoskeletal pain


6


4.9


Behavior change


6


4.9


*Three new cases and 7 pre-existing, recurring cases

Inappetance or decreased appetite occurred at one or more meals in 40 of 122 horses treated with Pharken. At the baseline evaluation 1.6% of owners reported a history of inappetance or decreased appetite as compared to the 32.8% of horses that experienced inappetance or decreased appetite during the study. Most cases of inappetance were transient and occurred during the first month of treatment; however, some horses experienced sporadic inappetance throughout the study. Two horses required a temporary reduction in dose due to inappetance during the first month of the study. Both horses returned to their original dose within 30 days.

Weight loss occurred in more than half of the horses in this study; however, weight loss that was considered abnormal was only reported in 11 horses.

Lethargy was reported in 9.8% of horses during the study, and was not reported in any horses at the baseline evaluation.

Behavioral changes were noted in 6 horses including aggression, kicking, agitation, nervous behavior and increased activity. One horse required a temporary reduction in dose due to energetic behavior during the first month of the study.

Eight horses died or were euthanized during the study due to worsening of pre-existing conditions (laminitis, dental disease, septic tenosynovitis) or colic (strangulating lipomas, large colon volvulus).

One mare was inadvertently enrolled in the study while pregnant and experienced dystocia resulting in the death of the foal.

To report suspected adverse reactions, to obtain a Material Safety Data Sheet (MSDS), or for technical assistance, call 1-866-638-2226.

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Clinical Pharmacology

Pharken mesylate is a synthetic ergot derivative and is a potent dopamine receptor agonist. As with other dopamine agonists, Pharken inhibits the release of prolactin which suggests that it may interfere with lactation. In horses with PPID, Pharken is believed to exert its therapeutic effect by stimulating dopamine receptors, and has been shown to decrease the plasma levels of adrenocorticotropic hormone (ACTH), melanocyte stimulating hormone (MSH), and other pro-opiomelanocortin peptides.1

Pharmacokinetic information in the horse is based on a study using single oral doses of 10 mcg/kg in six healthy mares between 3 and 17 years of age.2 Pharken was rapidly absorbed; the mean maximum concentration (Cmax) was 4.05±2.02 ng/mL with the median time to maximum concentration (Tmax) being 0.415 hours.

The area under the curve (AUC) was 14.08±7.46 hr∙ng/mL. The mean half life (T1/2) was 5.86±3.42 hours; the mean apparent oral clearance (CL/F) was 1204 mL/kg/hr; and the mean apparent volume of distribution (V/F) was 3082±1354 mL/kg.

Effectiveness

An open-label, historical control, field study evaluated the effectiveness of Pharken for the control of clinical signs of PPID. A total of 122 horses with PPID were enrolled in the study, 113 of which were included in effectiveness evaluations. The success of each horse was based on results of endocrinology testing (dexamethasone suppression test or endogenous ACTH test) and/or improvement in clinical signs related to PPID (hirsutism, hyperhidrosis, polyuria/polydypsia, abnormal fat distribution, and/or muscle wasting) on the Day 180 evaluation. Based on endocrine testing and investigators' clinical assessment scores, 86 (76.1%) of the 113 evaluable cases were treatment successes.


Percent Success


Lower bound: one-sided 95% confidence interval


76.1% (86/113)


68.6%


Enrolled horses were diagnosed with PPID based on the presence of hirsutism and an abnormal pre-study endocrine test result. All horses were treated with 2 mcg/kg Pharken (to the nearest one-half tablet) orally once daily for the first three months. If the endocrine test result on Day 90 was normal or adequately improved, the horse continued on the same dose through Day 180. If the endocrine test result on Day 90 was abnormal, the dose increased to 4 mcg/kg given once daily through Day 180. Forty-seven (41.6%) of the 113 horses included in the effectiveness database required a dose increase at Day 90.

Improvement was noted in scores for all clinical sign categories and in mean results for endocrine tests.


Clinical Sign


Day 90±7 (%)


Day 180±7 (%)


Hirsutism


32.7%


89.2%


Hyperhidrosis


27.4%


42.3%


Polyuria/polydypsia


31.0%


34.2%


Abnormal fat distribution


21.2%


33.3%


Muscle wasting


36.3%


46.0%


Test


# Animals


Baseline


Day 90


Day 180


ACTH

(pg/mL)


20


73.53


51.12


45.08


DST**

(mcg/dL)


93


3.12


1.39


1.47


*Dexamethasone suppression test: Post dexamethasone cortisol concentration

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Animal Safety

In a six month target animal safety study healthy adult horses received Pharken administered orally, once daily, at doses of either 0 mcg/kg, 4 mcg/kg, 6 mcg/kg, or 8 mcg/kg (0X, 1X, 1.5X, or 2X the maximum recommended dose). There were eight healthy horses (four males and four females) in each treatment group. Doses were prepared by dissolving tablets in approximately 10 mL of a 50% sugar water solution.

Pharken treated groups had lower mean heart rates and higher mean temperatures than the control group. Horses in all treatment groups had minimum heart rates within the normal range and maximum temperatures below 101.5°F. One 1.5X horse experienced a mild episode of spasmodic colic on Day 3 that resolved after treatment with flunixin meglumine.

Mean red blood cell counts and hemoglobin values were lower in Pharken treated groups as compared to the control group. Other hematology parameters including hematocrit, white blood cells, absolute neutrophils, and absolute lymphocytes exhibited mild, transient decreases as compared to the control group. The hematology parameters generally decreased over the first 30 to 60 days after treatment initiation and then returned to values similar to pre-treatment levels. No treatment related alterations were identified on histopathology evaluation of bone marrow.

Storage

Store at or below 25°C (77°F).

How Supplied

Pharken Tablets are available in 1 mg strength – packaged 10 tablets per blister and 60 or 160 tablets per carton.

NDC 0010-4489-01 – 60 tablets

NDC 0010-4489-02 – 160 tablets

References

1 Orth, D.N., Holscher, M.A., Wilson, M.G., et al. (1982) Equine Cushing’s Disease: Plasma Immunoreactive Proopiolipomelanocortin Peptide and Cortisol Levels Basally and in Response to Diagnostic Tests. Endocrinology. 110(4):1430-41

2 Wright A, Gehring R, Coetzee H (2008.) Pharmacokinetics of Pharken in normal mares. American College of Veterinary Internal Medicine Forum, Abstract #36, San Antonio, TX.

Manufactured for:

Boehringer Ingelheim Vetmedica, Inc.

St. Joseph, MO 64506 U.S.A.

Made in Japan and packaged in Germany.

Pharken is a registered trademark of Boehringer Ingelheim Vetmedica GmbH used under license.

© 2016 Boehringer Ingelheim Vetmedica, Inc. All Rights Reserved.

448901-01

Revised 07/2016

10 – Tablet Blister Pack

Picture of 10 - Tablet Blister Pack

60 – Tablet Display Carton

Picture of 60 - Tablet Display Carton

Pharken pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Pharken available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Pharken destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Pharken Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Pharken pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. "pergolide". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  2. "pergolide". http://www.drugbank.ca/drugs/DB0118... (accessed August 28, 2018).
  3. "24MJ822NZ9: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Dat... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Pharken?

Depending on the reaction of the Pharken after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Pharken not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Pharken addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Pharken, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Pharken consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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