The Greatest Conspiracy of All Time -
Marijuana
By: Rev. Frank Paul Jones aka Apostle Paul Castellano bka Jesus Christ
I am about to unveil the greatest conspiracy of modern age. The pharmaceutical industry sole mission is to kill people. Under the order of the Illuminati, the German Reich or who we have come to know as the Nazi party and their goal is to cause people of color to suffer, sometimes slowly, but they do not want people to feel good. At the same time controlling the world's healthcare system.
The conspiracy is behind marijuana believe it or not. Long ago the pharmaceutical industry discovered marijuana is a miracle drug, that would revolutionize medical science and thereby drastically reducing the cost of healthcare and therefore their power and influence over the world.
The controlled substance act of 1970 was signed by President Richard Nixon. Giving the Attorney General the authority to create scheduling for drugs based on certain guidelines. However without any real evidence or any study, they made marijuana a schedule one drug, meaning it had no medial use, was basically poison to be kept out of Americans hands at all cost to protect our people.
In June 1971 President Nixon declared a war on drugs.
The DEA was formed by executive order of President Richard Nixon in July 1973, whose mission was to carryout the war on drugs based marijuana which was determined to be a schedule one drug without research or empirical data. This was unconstitutional at best.
Today over 1.5 million people are in prison, 13% of black men have been disenfranchised and cannot vote.
In 2013: $26.6 Billions was spent on drug control. With one third spent of treatment and about a little more on law enforcement. While the DEA handles law enforcement, the medical profession handle the treatment areas, led by non profit organizations. And rehabilitation is often based on just believing in any higher power? We call this non religious practices s to say there really isn't a living God?
The DEA job is to run a drug operation, while making these Mexican farmers seem like sophisticated drug smugglers digging all types of tunnels Americans are supposed to believe is done without surveillance from satellites. And the DEA control all asset held by Cartel leaders, because even if they have accounts in different identities, they can always be killed, put in prison and accounts can be closed at a moments notice and they have no one to complain to. Can they tell the President about their situation? While in reality the Americans controlled tunnels are used by the DEA to go in and out as well. In fact it is the DEA that allowed the Cartels to gain access to bring drug in. This is why only drugs go through and it is not a national security concern.
Meanwhile the non profit sector controls homeless shelters, rehab centers, mental health facilities and any the treatments paid for by Medicaid and Medicare. While the mental health profession is loyal to the pharmaceutical industry, the DEA is really our drug distributors, while the Cartels are farmers and other lower level employees. And black's go to jail and are made unemployable, based on these laws of the DEA or should we say the Attorney General. This is the job you inherit and most not conceal. Because the enemy is within, he is the desire for white supremacy. He is the Nazi's, he is the German Reich and his headquarters our the headquarters of
The weakness of both systems of extortion is that the DEA is a government agency and therefore certain lifestyles and holdings must meet their pay grades. There will be a money trial, And undercover operations requiring lots of money to maintain lifestyles must meet its cost with arrest results. But mostly poor blacks go to jail.
The Attorney General today is Eric Holder a black man.
Under: Title 21
The Attorney General shall, before initiating proceedings under subsection (a) of this section to control a drug or other substance or to remove a drug or other substance entirely from the schedules, and after gathering the necessary data, request from the Secretary a scientific and medical evaluation, and his recommendations, as to whether such drug or other substance should be so controlled or removed as a controlled substance.
Factors determinative of control or removal from schedules
In
making any finding under subsection (a) of this section or under subsection (b)
of section 812 of this title, the Attorney General shall consider the following
factors with respect to each
drug or other substance proposed to be
controlled or removed from the schedules:
(1) Its actual or
relative potential for abuse.
(2) Scientific
evidence of its pharmacological effect, if known.
(3) The state of
current scientific knowledge regarding the drug or other substance.
(4) Its history and
current pattern of abuse.
(5) The scope,
duration, and significance of abuse.
(6) What, if any,
risk there is to the public health.
(7) Its psychic or
physiological dependence liability.
(8) Whether the
substance is an immediate precursor of a substance already controlled under
this subchapter.
Rev Sep 2004 MARINOL®
In 2004, a clinical research was done that was approved by the FDA, Therefore even though the DEA improperly scheduled marijuana as a schedule one drug in 1970 it was proven to be effective for the intent of the research to help people with AIDS and cancer eat, but also unintentional they discovered that its the best possible sedative they have available, it is non addictive and you cannot die from an extreme overdose.
The Drug Cartels work for the DEA, who works for Eric Holder and Eric Holder works for President Barack Obama. While the non profit is extorting Medicaid and Medicare? Eric Holder has raise the scheduling of marijuana based on this research to at least 4. Based on these facts, the Federal Government is going to have to release and/or overturn at least all non violent marijuana convictions since September 2004. The DEA must be dismantled and Eric Holder might have to take the fall to protect President Barack Obama. This conspiracy called the war on drugs and could reach the White House.
The Proof:
500012 Rev Sep 2004
MARINOL® 
DESCRIPTION
Dronabinol is a cannabinoid designated chemically as (6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9- trimethyl-3-pentyl-6H-dibenzo[b,d]pyran-1-ol. Dronabinol has the following empirical and structural formulas:
Dronabinol, the active ingredient in MARINOL®
Capsules, is synthetic delta-9- tetrahydrocannabinol (delta-9-THC). Delta-9-tetrahydrocannabinol
is also a naturally occurring component of Cannabis sativa L. (Marijuana).
Dronabinol is a light yellow resinous
oil that is sticky at room temperature and hardens upon refrigeration. Dronabinol is insoluble
in water and is formulated in sesame
oil. It has a pKa of 10.6 and an octanol-water partition coefficient: 6,000:1 at pH 7.
Capsules for oral administration: MARINOL®
Capsules is supplied
as round, soft gelatin capsules
containing either 2.5 mg, 5 mg, or 10 mg dronabinol. Each MARINOL® Capsule
is formulated with the following
inactive ingredients: FD&C Blue No. 1 (5 mg), FD&C
Red No. 40 (5 mg), FD&C Yellow
No. 6 (5 mg and 10 mg), gelatin, glycerin,
methylparaben, propylparaben, sesame oil, and titanium
dioxide.
CLINICAL PHARMACOLOGY
Dronabinol is an orally active cannabinoid which, like other cannabinoids, has complex effects on the central nervous system (CNS), including central sympathomimetic activity. Cannabinoid receptors have been discovered in neural tissues. These receptors may play a role in mediating the effects of dronabinol and other cannabinoids.
Pharmacodynamics
Dronabinol-induced sympathomimetic activity
may result in tachycardia and/or
conjunctival injection. Its effects on blood pressure are inconsistent, but occasional subjects have experienced orthostatic hypotension and/or syncope upon abrupt standing.
Dronabinol also demonstrates reversible effects
on appetite, mood,
cognition, memory,
and perception. These phenomena
appear to be dose-related, increasing in frequency with higher dosages,
and subject to great interpatient variability.
After oral administration, dronabinol has an onset of action of approximately 0.5 to 1 hours and peak effect
at 2 to 4 hours.
Duration of action
for psychoactive effects
is 4 to 6 hours,
but the appetite stimulant
effect of dronabinol may continue
for 24 hours or longer
after administration.
Tachyphylaxis and tolerance develop
to some of the pharmacologic effects of dronabinol and other cannabinoids with chronic use, suggesting an indirect effect
on sympathetic neurons. In a study of the pharmacodynamics of chronic dronabinol exposure, healthy
male volunteers (N = 12) received
210 mg/day dronabinol, administered orally
in divided doses, for 16 days. An initial tachycardia induced by dronabinol was replaced successively by normal sinus rhythm
and then bradycardia. A decrease in supine blood pressure, made worse by standing, was also observed initially. These volunteers developed tolerance to the cardiovascular and subjective adverse CNS effects of dronabinol within
12 days of treatment
initiation.
Tachyphylaxis and tolerance do not, however,
appear to develop
to the appetite stimulant
effect of MARINOL®
Capsules. In studies
involving patients with Acquired Immune
Deficiency Syndrome
(AIDS), the appetite
stimulant effect of MARINOL® Capsules
has been sustained
for up to five months
in clinical trials,
at dosages ranging
from 2.5 mg/day to 20 mg/day.
Pharmacokinetics
Absorption and Distribution: MARINOL® (Dronabinol) Capsules
is almost completely absorbed (90 to 95%) after single
oral doses. Due to the combined
effects of first
pass hepatic metabolism and high lipid solubility, only 10 to 20% of the administered dose reaches the systemic
circulation. Dronabinol has a large apparent volume of distribution, approximately 10 L/kg, because of its lipid solubility. The plasma protein binding
of dronabinol and its metabolites is approximately 97%.
The elimination phase of dronabinol can be described using a two compartment model with an initial
(alpha) half-life of about 4 hours and a terminal
(beta) half-life of 25 to 36 hours. Because
of its large volume of distribution, dronabinol and its metabolites may be excreted at low levels for prolonged periods of time.
The pharmacokinetics of dronabinol after single doses (2.5, 5, and 10 mg) and multiple
doses (2.5, 5, and 10 mg given twice a day; BID) have been studied
in healthy women and men.
Summary of Multiple-Dose Pharmacokinetic Parameters of Dronabinol in Healthy Volunteers (n=34; 20-45 years) under Fasted
Conditions
Mean (SD) PK Parameter Values
|
|||
BID
Dose
|
Cmax
ng/mL
|
Median Tmax (range), hr
|
AUC(0-12)
ng•hr/mL
|
2.5 mg
|
1.32 (0.62)
|
1.00 (0.50-4.00)
|
2.88 (1.57)
|
5 mg
|
2.96 (1.81)
|
2.50 (0.50-4.00)
|
6.16 (1.85)
|
10 mg
|
7.88 (4.54)
|
1.50 (0.50-3.50)
|
15.2 (5.52)
|
A slight increase in dose proportionality on mean Cmax and AUC (0-12) of dronabinol was observed with increasing dose over the dose range studied.
Metabolism: Dronabinol undergoes extensive
first-pass hepatic metabolism, primarily by microsomal hydroxylation, yielding both active and inactive metabolites. Dronabinol and its principal
active metabolite, 11-OH-delta-9-THC, are present in approximately equal concentrations in plasma.
Concentrations of both parent drug and metabolite peak at approximately 0.5 to 4 hours after oral dosing
and decline over several days. Values for clearance average
about 0.2 L/kg-hr,
but are highly
variable due to the complexity of cannabinoid distribution.
Elimination: Dronabinol and its biotransformation products
are excreted in both feces and urine.
Biliary excretion is the major route of elimination with about half of a radio-labeled oral dose being recovered from the feces
within 72 hours as contrasted with 10 to 15% recovered from urine. Less than 5% of an oral dose is recovered
unchanged in the feces.
Following single
dose administration, low levels of dronabinol metabolites have been detected
for more than 5 weeks in the urine and feces.
In a study of MARINOL® Capsules
involving AIDS patients, urinary
cannabinoid/creatinine concentration ratios were studied
bi-weekly over a six week period.
The urinary cannabinoid/creatinine ratio was closely correlated with dose. No increase
in the cannabinoid/creatinine
ratio was observed after the first two weeks of treatment, indicating that steady- state cannabinoid levels
had been reached.
This conclusion is consistent with predictions based on the observed terminal half-life of dronabinol.
Special Populations: The pharmacokinetic profile
of MARINOL® Capsules has not been investigated in either pediatric or geriatric patients.
Clinical Trials
Appetite Stimulation: The appetite stimulant effect of MARINOL®
(Dronabinol) Capsules in the treatment of AIDS-related anorexia
associated with weight
loss was studied
in a randomized, double-
blind, placebo-controlled study
involving 139 patients. The initial dosage
of MARINOL® Capsules
in all patients was 5 mg/day,
administered in doses of 2.5 mg one hour before
lunch and one hour before
supper. In pilot studies, early
morning administration of MARINOL® Capsules
appeared to have been associated with an increased frequency of adverse experiences, as compared
to dosing later in the day. The effect
of MARINOL® Capsules
on appetite, weight,
mood, and nausea was measured
at scheduled intervals during the six-week
treatment period. Side effects (feeling
high, dizziness, confusion, somnolence) occurred
in 13 of 72 patients
(18%) at this dosage level and the dosage
was reduced to
2.5 mg/day, administered as a single dose at supper or bedtime.
As compared
to placebo, MARINOL® Capsules
treatment resulted
in a statistically significant improvement in appetite as measured
by visual analog
scale (see figure).
Trends toward improved body weight and mood, and decreases in nausea were also seen.
After completing the 6-week study,
patients were allowed
to continue treatment with MARINOL®
Capsules in an open-label study, in which there was a sustained improvement in appetite.
Capsules in an open-label study, in which there was a sustained improvement in appetite.
Antiemetic: MARINOL®
(Dronabinol) Capsules treatment of chemotherapy-induced emesis was evaluated in 454 patients with cancer,
who received a total of 750 courses
of treatment of various malignancies. The antiemetic efficacy of MARINOL®
Capsules was greatest in patients receiving cytotoxic therapy with MOPP for Hodgkin’s
and non-Hodgkin’s lymphomas. MARINOL®
Capsules dosages ranged from 2.5 mg/day to 40 mg/day, administered in equally divided
doses every four to six hours (four times daily). As indicated in the following
table, escalating the MARINOL® Capsules
dose above 7 mg/m2 increased the frequency of adverse experiences, with no additional antiemetic benefit.
MARINOL®
Capsules Dose: Response
Frequency and Adverse
Experiences*
(N = 750 treatment
courses)
MARINOL® Capsules Dose
<7 mg/m2
>7 mg/m2
|
Response Frequency (%)
|
Adverse Events Frequency (%)
|
||||
Complete
|
Partial
|
Poor
|
None
|
Nondysphoric
|
Dysphoric
|
|
36
|
32
|
32
|
23
|
65
|
12
|
|
33
|
31
|
36
|
13
|
58
|
28
|
|
*Nondysphoric events consisted of drowsiness, tachycardia, etc.
Combination antiemetic therapy with MARINOL®
Capsules and a phenothiazine (prochlorperazine) may result
in synergistic or additive
antiemetic effects and attenuate
the toxicities associated with each of the agents.
INDIVIDUALIZATION OF DOSAGES
The pharmacologic effects
of MARINOL® (Dronabinol) Capsules
are dose-related and subject to considerable interpatient variability. Therefore, dosage individualization is critical
in achieving the maximum
benefit of MARINOL®
Capsules treatment.
Appetite Stimulation: In the clinical
trials, the majority
of patients were treated
with 5 mg/day MARINOL®
Capsules, although the dosages ranged
from 2.5 to 20 mg/day. For an adult:
·
Begin with 2.5 mg before
lunch and 2.5 mg before supper.
If CNS symptoms (feeling
high, dizziness, confusion, somnolence) do occur, they usually
resolve in 1 to 3 days with continued
dosage.
·
If CNS symptoms
are severe or persistent, reduce
the dose to 2.5 mg before
supper. If symptoms continue
to be a problem, taking the single dose in the evening or at bedtime may reduce
their severity.
· When adverse effects are absent or minimal and further therapeutic effect is desired, increase the dose to 2.5 mg before lunch and 5 mg before supper or 5 and 5 mg. Although most patients respond to 2.5 mg twice daily, 10 mg twice daily has been tolerated in about half of the patients in appetite stimulation studies.
The pharmacologic effects
of MARINOL® Capsules
are reversible upon treatment
cessation.
Antiemetic: Most patients respond
to 5 mg three or four times daily. Dosage
may be escalated during
a chemotherapy cycle or at subsequent cycles, based upon initial results.
Therapy should be initiated at the lowest
recommended dosage and titrated to clinical response. Administration of MARINOL® Capsules
with phenothiazines, such as prochlorperazine, has resulted in improved efficacy
as compared to either drug alone,
without additional toxicity.
Pediatrics: MARINOL® Capsules is not recommended for AIDS-related anorexia
in pediatric patients
because it has not been studied in this population. The pediatric dosage
for the treatment of chemotherapy-induced emesis is the same as in adults.
Caution is recommended in prescribing MARINOL®
Capsules for children
because of the psychoactive effects.
Geriatrics: Caution is advised
in prescribing MARINOL® Capsules
in elderly patients
because they are generally more sensitive to the psychoactive effects
of drugs. In antiemetic studies, no difference in tolerance or efficacy was apparent
in patients >55 years old.
INDICATIONS AND USAGE
MARINOL® (Dronabinol) Capsules is indicated for the treatment
of:
·
anorexia associated with weight loss in patients
with AIDS; and
·
nausea and vomiting
associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.
CONTRAINDICATIONS
MARINOL® (Dronabinol) Capsules is contraindicated in any patient who has a history of hypersensitivity to any cannabinoid or sesame oil.
WARNINGS
Patients receiving treatment with MARINOL®
Capsules should
be specifically warned
not to drive, operate
machinery, or engage in any hazardous activity until it is established that they are able to tolerate
the drug and to perform
such tasks safely.
PRECAUTIONS
General: The risk/benefit ratio of MARINOL® (Dronabinol) Capsules
use should be carefully evaluated in patients
with the following medical conditions because
of individual variation in response and tolerance
to the effects of MARINOL® Capsules.
MARINOL® Capsules
should be used with caution in patients
with cardiac disorders because
of occasional hypotension, possible hypertension, syncope, or tachycardia (see CLINICAL PHARMACOLOGY).
MARINOL® Capsules
should be used with caution
in patients with a history
of substance abuse, including alcohol
abuse or dependence, because
they may be more prone to abuse MARINOL®
Capsules as well. Multiple substance
abuse is common and marijuana, which contains the same active compound, is a frequently abused substance.
MARINOL® Capsules
should be used with caution
and careful psychiatric monitoring in patients with mania,
depression, or schizophrenia because MARINOL® Capsules
may exacerbate these illnesses.
MARINOL® Capsules
should be used with caution
in patients receiving concomitant therapy
with sedatives, hypnotics or other
psychoactive drugs because
of the potential for additive
or synergistic CNS effects.
MARINOL® Capsules
should be used with caution
in pregnant patients, nursing mothers,
or pediatric patients because it has not been studied
in these patient
populations.
Information for Patients: Patients receiving treatment with MARINOL® (Dronabinol) Capsules should be alerted to the potential
for additive central
nervous system depression if MARINOL® Capsules
is used concomitantly with alcohol or other CNS depressants such as benzodiazepines and barbiturates.
Patients receiving treatment with MARINOL® Capsules
should be specifically warned not to drive,
operate machinery, or engage in any hazardous activity
until it is established that they are able to tolerate
the drug and to perform
such tasks safely.
Patients using MARINOL® Capsules
should be advised
of possible changes
in mood and other
adverse behavioral effects of the drug so as to avoid panic
in the event of such manifestations. Patients should remain under the supervision of a responsible adult during initial
use of MARINOL® Capsules and following dosage
adjustments.
Drug Interactions: In studies
involving patients with AIDS and/or cancer, MARINOL®
(Dronabinol) Capsules has been co-administered with a variety of medications (e.g., cytotoxic agents,
anti-infective agents,
sedatives, or opioid analgesics) without resulting in any clinically significant drug/drug interactions. Although no drug/drug interactions were discovered during
the clinical trials of MARINOL®
Capsules, cannabinoids may interact
with other medications through
both metabolic and pharmacodynamic mechanisms. Dronabinol is highly protein
bound to plasma proteins,
and therefore, might displace
other protein-bound drugs. Although this displacement has not been confirmed
in vivo, practitioners should monitor
patients for a change
in dosage requirements when administering dronabinol to patients
receiving other highly
protein-bound drugs.
Published reports of drug/drug interactions involving cannabinoids are summarized in the following
table.
CONCOMITANT DRUG
|
CLINICAL EFFECT(S)
|
Amphetamines, cocaine, other
sympathomimetic agents
|
Additive hypertension, tachycardia, possibly cardiotoxicity
|
Atropine, scopolamine, antihistamines, other
anticholinergic agents
|
Additive or super-additive tachycardia, drowsiness
|
Amitriptyline, amoxapine, desipramine, other tricyclic antidepressants
|
Additive tachycardia, hypertension, drowsiness
|
Barbiturates, benzodiazepines, ethanol, lithium, opioids, buspirone, antihistamines, muscle
relaxants, other CNS depressants
|
Additive drowsiness and
CNS depression
|
Disulfiram
|
A reversible hypomanic reaction was reported in a 28 y/o man who
smoked marijuana; confirmed by dechallenge and
rechallenge
|
Fluoxetine
|
A 21 y/o female with
depression and bulimia receiving 20 mg/day
fluoxetine X 4 wks became hypomanic after smoking marijuana; symptoms resolved after 4 days
|
Antipyrine, barbiturates
|
Decreased clearance of these agents, presumably via competitive inhibition of metabolism
|
Theophylline
|
Increased theophylline metabolism reported with smoking
of marijuana; effect similar to that following smoking tobacco
|
Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenicity studies in mice and rats have been conducted under the US National Toxicology Program (NTP). In the 2-year
carcinogenicity study in rats,
there was no evidence of carcinogenicity at doses up to 50 mg/kg/day, about 20 times the maximum
recommended human dose on a body surface area basis. In the 2-year
carcinogenicity study in mice, treatment
with dronabinol at 125 mg/kg/day, about 25 times the maximum
recommended human dose on a body surface area basis, produced
thyroid follicular cell adenoma
in both male and female
mice but not at 250 or 500 mg/kg/day.
Dronabinol was not genotoxic in the Ames
In a long-term study (77 days) in rats, oral administration of dronabinol at doses of 30 to 150 mg/m2, equivalent to 0.3 to 1.5 times maximum recommended human dose (MRHD) of 90 mg/m2/day in cancer patients or 2 to 10 times MRHD of 15 mg/m2/day in AIDS patients, reduced
ventral prostate, seminal vesicle
and epididymal weights and caused a decrease
in seminal fluid volume.
Decreases in spermatogenesis, number of developing germ cells, and number of Leydig cells in the testis were also observed. However, sperm count, mating success
and testosterone levels
were not affected.
The significance of these animal findings
in humans is not known.
Pregnancy: Pregnancy Category C. Reproduction studies
with dronabinol have been performed
in mice at 15 to 450 mg/m2, equivalent to 0.2 to 5 times maximum
recommended human dose (MRHD)
of 90 mg/m2/day in cancer patients or 1 to 30 times MRHD of 15 mg/m2/day in AIDS patients,
and in rats at 74 to 295 mg/m2 (equivalent to 0.8 to 3 times MRHD of 90 mg/m2 in cancer patients or 5 to 20 times MRHD of 15 mg/m2/day in AIDS patients). These studies
have revealed no evidence
of teratogenicity due to dronabinol. At these dosages in mice and rats, dronabinol decreased
maternal weight
gain and number of viable pups and increased
fetal mortality and early resorptions. Such effects were dose dependent
and less apparent
at lower doses
which produced less maternal
toxicity. There are no adequate
and well-controlled studies in pregnant women. Dronabinol should be used only if the potential benefit justifies the potential
risk to the fetus.
Nursing Mothers:
Use of MARINOL® Capsules
is not recommended in nursing mothers
since, in addition
to the secretion of HIV virus in breast milk, dronabinol is concentrated in and secreted
in human breast milk and is absorbed
by the nursing baby.
Geriatric Use: Clinical studies
of MARINOL® (Dronabinol) Capsules
in AIDS and cancer patients
did not include the sufficient numbers of subjects aged 65 and over to determine
whether they respond
differently from younger
subjects. Other reported
clinical experience has not identified differences in responses between the elderly
and younger patients. In general, dose selection for an elderly
patient should be cautious
usually starting at the low end of the dosing
range, reflecting the greater frequency
of decreased hepatic,
renal, or cardiac
function, increased sensitivity to psychoactive effects and of concomitant disease
or other drug therapy.
ADVERSE REACTIONS
Adverse experiences information summarized in the tables below was derived from well-controlled clinical trials conducted in the US
A cannabinoid dose-related “high” (easy
laughing, elation and heightened awareness) has been reported
by patients receiving MARINOL® Capsules in both the antiemetic (24%) and the lower dose appetite
stimulant clinical
trials (8%) (see Clinical Trials).
The most frequently reported adverse experiences in patients with AIDS during placebo-controlled clinical
trials involved the CNS and were reported
by 33% of patients receiving
MARINOL® Capsules. About 25% of patients
reported a minor CNS adverse event during the first 2 weeks and about 4% reported such an event each week for the next 6 weeks thereafter.
PROBABLY CAUSALLY
RELATED: Incidence greater
than 1%.
Rates derived
from clinical trials
in AIDS-related anorexia
(N=157) and chemotherapy-related nausea
(N=317). Rates were generally higher in the anti-emetic use (given in parentheses).
Body as a whole:
Asthenia.
Cardiovascular: Palpitations, tachycardia, vasodilation/facial flush.
Digestive: Abdominal pain*, nausea*, vomiting*.
Nervous system:
(Amnesia), anxiety/nervousness, (ataxia), confusion, depersonalization, dizziness*, euphoria*, (hallucination), paranoid
reaction*, somnolence*, thinking abnormal*.
*Incidence of events 3% to 10%
PROBABLY CAUSALLY
RELATED: Incidence less than 1%.
Event rates derived
from clinical trials
in AIDS-related anorexia
(N=157) and chemotherapy-related nausea
(N=317).
Cardiovascular: Conjunctivitis*,
hypotension*.
Digestive: Diarrhea*, fecal incontinence.
Musculoskeletal: Myalgias.
Nervous system:
Depression, nightmares, speech difficulties, tinnitus.
Skin and Appendages: Flushing *.
Special senses:
Vision difficulties.
*Incidence of events
0.3% to 1%
CAUSAL RELATIONSHIP UNKNOWN: Incidence less than 1%.
The clinical significance of the association of these events with MARINOL® Capsules
treatment is unknown, but they are reported as alerting
information for the clinician.
Body as a whole:
Chills, headache, malaise. Digestive: Anorexia, hepatic
enzyme elevation. Respiratory: Cough, rhinitis, sinusitis.
Skin and Appendages: Sweating.
DRUG ABUSE AND DEPENDENCE
MARINOL® (Dronabinol) Capsules is one of the psychoactive compounds present
in cannabis, and is abusable
and controlled [Schedule III (CIII)] under the Controlled Substances Act. Both psychological and physiological dependence have been noted
in healthy individuals receiving dronabinol, but addiction is uncommon and has only been seen after prolonged
high dose administration.
Chronic abuse of cannabis
has been associated with decrements in motivation, cognition, judgement, and perception. The etiology
of these impairments is unknown,
but may be associated with the complex process
of addiction rather than an isolated
effect of the drug. No such decrements in psychological, social
or neurological status have been associated with the administration of MARINOL® Capsules
for therapeutic purposes.
In an open-label study in patients
with AIDS who received
MARINOL® Capsules for up to five months,
no abuse, diversion or systematic change in personality or social functioning were observed despite
the inclusion of a substantial number of patients with a past history of drug abuse.
An abstinence syndrome has been reported
after the abrupt
discontinuation of dronabinol in volunteers receiving dosages
of 210 mg/day for 12 to 16 consecutive days. Within 12 hours
after discontinuation, these volunteers manifested symptoms such as irritability, insomnia, and restlessness. By approximately 24 hours post-dronabinol discontinuation, withdrawal symptoms intensified to include “hot flashes”, sweating, rhinorrhea, loose stools, hiccoughs
and anorexia.
These withdrawal symptoms gradually
dissipated over the next 48 hours. Electroencephalographic changes
consistent with the effects of drug withdrawal (hyperexcitation) were recorded
in patients after abrupt dechallenge. Patients
also complained of disturbed
sleep for several
weeks after discontinuing therapy with high dosages of dronabinol.
OVERDOSAGE
Signs and symptoms
following MILD MARINOL®
(Dronabinol) Capsules intoxication include drowsiness, euphoria, heightened sensory awareness, altered time perception, reddened
conjunctiva, dry mouth and tachycardia; following MODERATE intoxication include memory impairment, depersonalization, mood alteration, urinary
retention, and reduced bowel motility; and following SEVERE
intoxication include decreased
motor coordination, lethargy, slurred
speech, and postural
hypotension. Apprehensive patients
may experience panic reactions and seizures may occur in patients
with existing seizure
disorders.
The estimated lethal
human dose of intravenous dronabinol is 30 mg/kg (2100 mg/ 70 kg).
Significant CNS symptoms in antiemetic studies followed
oral doses of 0.4 mg/kg (28 mg/70 kg) of MARINOL® Capsules.
Management: A potentially serious
oral ingestion, if recent,
should be managed with gut decontamination. In unconscious patients
with a secure airway, instill
activated charcoal
(30 to 100 g in adults, 1 to 2 g/kg in infants) via a nasogastric tube. A saline
cathartic or sorbitol may be added to the first dose of activated charcoal.
Patients experiencing depressive, hallucinatory or psychotic
reactions should
be placed in a quiet area and offered
reassurance. Benzodiazepines (5 to 10 mg diazepam po) may be used for treatment of extreme
agitation. Hypotension usually
responds to Trendelenburg position and IV fluids. Pressors
are rarely required.
DOSAGE AND ADMINISTRATION
Appetite Stimulation: Initially, 2.5 mg MARINOL®
(Dronabinol) Capsules
should be administered orally
twice daily (b.i.d.),
before lunch and supper. For patients unable to tolerate
this 5 mg/day dosage of MARINOL®
Capsules, the dosage can be reduced
to 2.5 mg/day, administered as a single dose in the evening or at bedtime.
If clinically indicated and in the absence of significant adverse
effects, the dosage may be gradually increased to a maximum
of 20 mg/day MARINOL®
Capsules, administered in divided oral doses. Caution
should be exercised in escalating the dosage
of MARINOL® Capsules
because of the increased frequency
of dose-related adverse experiences at higher dosages
(see PRECAUTIONS).
Antiemetic: MARINOL®
Capsules is best administered at an initial dose of 5 mg/m2, given 1 to 3 hours prior to the administration of chemotherapy, then every
2 to 4 hours after chemotherapy is given, for a total of 4 to 6 doses/day. Should the 5 mg/m2 dose prove to be ineffective, and in the absence
of significant side effects, the dose may be escalated by 2.5 mg/m2 increments to a maximum of 15
mg/m2 per dose. Caution should be exercised in dose escalation, however, as the incidence of disturbing psychiatric symptoms increases significantly at maximum
dose (see PRECAUTIONS).
STORAGE CONDITIONS
MARINOL® (Dronabinol) Capsules should be packaged in a well-closed container and stored in a cool environment between 8° and 15°C (46° and 59°F) and alternatively could
be stored in a refrigerator. Protect
from freezing.
HOW SUPPLIED
MARINOL® Capsules
(dronabinol solution in sesame oil in soft gelatin capsules)
2.5 mg white capsules (Identified UM or RL).
NDC 0051-0021-21 (Bottle of 60 capsules).
5 mg dark brown capsules (Identified UM or RL).
NDC 0051-0022-11 (Bottle of 25 capsules).
10 mg orange capsules
(Identified UM or RL).
NDC 0051-0023-21 (Bottle of 60 capsules).
MARINOL® is a registered trademark of Unimed Pharmaceuticals, Inc. and is Manufactured by Banner Pharmacaps, Inc.
© 2004 Solvay Pharmaceuticals, Inc.
A Solvay
Pharmaceuticals, Inc. Company
Marietta , GA 30062
Rev. Frank Paul Jones aka Apostle Paul Castellano bka Jesus Christ
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