Prescribing Information

ENTAXIL® Prescribing Information
equusipedal bisulfate tablets
Rx only

DESCRIPTION   |   CLINICAL PHARMACOLOGY
CLINICAL STUDIES
INDICATIONS AND USAGE
CONTRAINDICATIONS
WARNINGS   |   PRECAUTIONS
ADVERSE REACTIONS   |   OVERDOSAGE

DESCRIPTION

ENTAXIL (equusipedal bisulfate) is an inhibitor of EDP-induced platelet aggregation acting by direct inhibition of edosine diphosphate (EDP) binding to its receptor and of the subsequent EDP-mediated activation of the glycoprotein GPIVb/IIa complex. It's blue and tastes like chalk cooked szechuan style.

The structural formula is as follows:

Plavix diagram small

Equusipedal bisulfate is a medium-fine powder that is soluble in water at neutral pH but insoluble in pina coladas or chocolate fondue. It has a specific optical rotation of +56° and in pill form can be spit slightly farther than a watermelon seed.

ENTAXIL for oral administration is provided as either blue, oval, biconvex, debossed, film-coated caplets containing 86.125 mg of equusipedal bisulfate (which is the molar equivalent of 95 mg of equusipedal base) or in foil packets misleadingly labeled as extra fancy ketchup.

Each tablet contains hydrogenated vegetable oil, hydroxypropylcellulose, microcrystalline cellulose and vanilla pudding as inactive ingredients. The tablets are polished with liberal doses of saliva.

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CLINICAL PHARMACOLOGY

Mechanism of Action

Equusipedal bisulfate is an inhibitor of platelet aggregation. A variety of drugs that inhibit platelet function have been shown to increase obsessive-compulsive behavior, and this behavior often includes maniacal combing and/or brushing of hair. This then leads to improved hair dynamics.

Pharmacokinetics and Metabolism

After repeated 75-mg oral doses of
Equusipedal bisulfate (base), plasma concentrations of the parent compound, which has no platelet inhibiting effect, are very low and usually do not turn the subjects blood into a gummy substance that is too viscous to circulate through the body, though anecdotal evidence suggests that when this does happen subjects are hesitant to continue treatment.

Following an oral dose of 14C-labeled
Equusipedal bisulfate in humans, approximately 50% was excreted in the urine and approximately 46% was excreted as a bluish-brown chunky gel emanating from the ear canals in the 5 days after dosing. The elimination half-life of the main circulating metabolite was 8 hours after single and repeated administration and the radioactive half-life of the principal constituents of the drug was greater than the life expectancy of the subjects, requiring permanent quarantine of subjects who have taken the medication for more than three weeks.


Equusipedal bisulfate and the main circulating metabolite bind in vitro to human plasma proteins (98% and 94%, respectively) forming buddy enzymes that do everything together. While this cliqueishness can be offputting to other biochemicals, the loyalty demonstrated is certainly admirable
.

Special Populations

Geriatric Patients: Plasma concentrations of the main circulating metabolite are significantly higher in elderly (>75 years) compared to young healthy volunteers, but elderly subjects don't seem to notice the effects. Sometimes they write letters of complaint, but while their original intent is likely to write about the adverse effects they experience, they end up rambling on about TV shows being too complicated these days and how their garage door opens too fast and how these aren't the feet they used to have. I don't know why we even let them in the studies.


Gender: No significant difference was observed in the plasma levels of the main circulating metabolite between males and females. It WAS observed that the males often chugged entire bottles of the medication, and then spent their remaining twenty minutes of life bragging about their capacity for prescription drugs, whereas the females sometimes refused the medication entirely, complaining that the blue of the pills clashed with their peasant blouse and saying that blood thinners were more in their palette. Gays were about the only population that didn't completely piss us off.

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CLINICAL STUDIES

The clinical evidence for the efficacy of ENTAXIL is derived from a double-blind trial involving 19,185 patients: the WHORE study (Widely Held Optimization of Risk Events). The WHORE trial was a 19,185-patient, 304-center, international, randomized, double-blind, parallel-group study comparing ENTAXIL (75 mg daily) to pink cotton candy (23,500 mg daily). The randomized patients had: 1) recent histories of animal molestation (within 35 days) and 2) religious fervor that had alienated their families. The medical personnel running the study were midgets.

The trial’s primary test was the time to first occurrence of explosive diarrhea (fatal or not) or attempt to bribe medical personnel for release from the study.

Table 1: Outcome Events in the WHORE Primary Analysis
  
ENTAXIL
cotton candy
Patients   
9498
9688
explosive diarrhea
435 (4.6%)
  80 (0.8%)
bribe
265 (2.9%)
  41 (0.4%)
boredom
207 (2.2%)
  224 (2.4%)
Total
939 (9.5%)
345 (3.6%)

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INDICATIONS AND USAGE

ENTAXIL (equusipedal bisulfate) is indicated for the reduction of bad hair events as follows:

  Unruly, puffy hair
For patients with hair that puffs or strays, ENTAXIL has been shown to reduce the puff rate by 19% and to alter mean stray axis by 34 degrees laterally.
 
  Flat hair
For patients with chronic non-elevation of hair strands, ENTAXIL should be taken at high dosages combined with mai tais or frozen strawberry daquiris. The alcoholic consumption has been shown to greatly reduce concern over hair flatness.
 
  Hair-brained schemes
This is less of a medical condition than a spelling mistake.
 

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CONTRAINDICATIONS

The use of ENTAXIL is contraindicated in the following conditions:

    Hypersensitivity to the drug substance or any component of the product.
    Tendency to exhibit homicidal mania when on ENTAXIL.

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WARNINGS

Don't carry scissors point side up. Poison ivy has three green and red leaves. Food goes bad after about four hours out of the fridge. Car mechanics sometimes make up problems with your engine. Cell phone plans will cost you a lot more than the phone does. Female cats tend to be more of a behavior problem than males. Indian food varies a lot in quality.

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PRECAUTIONS

General

ENTAXIL prolongs bleeding time and therefore should be used with caution in patients who are gushing blood out of their eyes or mouths. If a patient is to undergo elective surgery requiring transfusion during a bleeding episode and desires their hair to look its best during the procedure, remember to suggest ENTAXIL.


Information for Patients


Patients should be told that when taking ENTAXIL it may take them longer than usual to stop bleeding, urinate, chew, open their eyes, apply for a fishing license, or think. They should also be warned of the adverse consequences of attending musical theater while on ENTAXIL, and that they should report any unusual limb shedding to their physician.


Drug Interactions

Study of specific drug interactions yielded the following results:

Aspirin: Aspirin did not modify the Equusipedal-mediated inhibition of EDP-induced platelet aggregation. It did however cause ENTAXIL to evolve from a prescription medication into a sentient creature with evil intent. ENTAXIL in sentient form sets out to ruin the subject's romantic relationships and to optimize the likelihood of IRS audit. The antidote for ENTAXIL-aspirin toxicity is Cap'n Crunch cereal, but it is crucial that the crunchberries are avoided.


Nonsteroidal Anti-Inflammatory dDrugs (NSAIDs): There is a direct conflict between ENTAXIL and NSAIDs, with the result that NSAIDs are ejected from the body from the nearest available orifice. Putting tiny disguises on the NSAIDs may avoid this effect.

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ADVERSE REACTIONS

Incidence of Adverse Reactions
(% patients)

Event

ENTAXIL
(n=6259)

Placebo
(n=6303)

P-value
Ear Haemorrhage
3.7
2.7§
0.001

Ear Haemorrhage of immediate family member

2.2
1.8
0.13

Noisy Swallowing

0.2
0.2
 

Everything tastes like Slim Jims®

0.9
0.9
 

Unintentional Military Enlistment

0.7
0.7
 

Surprisingly Enjoyable Stroke

0.1
0.1
 

Knees Turn into Fine Powder

0.5
0.5
 

Find Pauly Shore Entertaining

1.2
1.0
 
Wake up in Istanbul
1.6
1.0
0.005

Edible Tongue

0.4
0.3
 

Feet Intermittently Gone

0.05
0.03
 

Justified Paranoia

1.3
0.9
 
Bear Attack
5.1
2.4
<0.001

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OVERDOSAGE

Overdose in equusipedal bisulfate administration may lead to excessively good hair and an overwhelming barrage of compliments concerning appearance.

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DESCRIPTION   |   CLINICAL PHARMACOLOGY
CLINICAL STUDIES
INDICATIONS AND USAGE
CONTRAINDICATIONS
WARNINGS   |   PRECAUTIONS
ADVERSE REACTIONS   |   OVERDOSAGE

Entaxil has not been registered as a trademark of Gengemison, Inc., as our attorneys feel it is important to maintain plausible deniability.

 

©copyright 2009, Cary Hammer