| 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:

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
|