CLINICAL PHARMACOLOGY
Phentermine is a
sympathomimetic amine with pharmacologic activity similar to the prototype
drugs of this class used in obesity, the amphetamines. Actions include
central nervous system stimulation and elevation of blood pressure. Tachyphylaxis
and tolerance have been demonstrated with all drugs of this class in which
the sephenomena have been looked for.
-
Drugs of this class
used in obesity are commonly known as anorecticsor anorexigenics It has
not been established that the action of such drugs in treating obesity
is primarily one of appetite suppression. Other central nervous system
actions, or metabolic effects, may be involved, for example. Adult obese
subjects instructed in dietary management and treated with anorecticdrugs
lose more weight on the average than those treated with placebo and diet,
as determined in relatively short-term clinical trials.
USES
Oral
phentermine hydrochloride is used as an appetite suppressant used for short-term
treatment of exogenous obesity,It is used in conjunction with an overall
diet plan to reduce weight.
-
--
HOW IT WORKS
It works by stimulating
a gland, called the hypothalamus, and affecting certain neurotransmitters
to decrease appetite. Because phentermine hydrochloride is similar chemically
to amphetamines, it has the potential for psychological dependency; it
should be used with caution
HOW TO TAKE
THIS MEDICATION
This
medication is best taken on an empty stomach one half-hour before breakfast.
Because this medication may cause sleeplessness, avoid taking a dose late
in the day. Take this medication as prescribed. Do not take it more often
or longer than directed.
SIDE EFFECTS
Dry
mouth, sleeplessness, irritability, stomach upset or constipation may occur
the first few days as your body adjusts to the medication. If these effects
persist or become bothersome, inform your doctor.
DOSAGE
Adults Under
60
Capsules:15
to 37.5 mg every morning before breakfast or 1 to 2
hours after breakfast.
Tablets:15
to 37.5 mg every morning before breakfast or 1 to 2
hours after breakfast.
Alternatively, take 15 to 37.5 mg in divided
doses one-half hour
before meals.
-
Adults 60 and
Over
Reduced dosage may
be necessary. Consult your physician.
-
Infants and Children
Use is not recommended.
-
Maximum Dosage
Recommendations
Do not exceed the
recommended doses, unless deemed necessary by your doctor.
-
If You Miss a
Dose
Take as soon as
possible. If close to the next dose, skip and take the next dose. Do not
double the dose.
PRECAUTIONS
Tell
your doctor your complete medical history especially if you have high blood
pressure, an over-active thyroid, glaucoma, diabetes or emotional problems.
Consult with your doctor if you think you are pregnant or before breast-feeding.
Alcohol can increase unwanted side effects of dizziness. Limit alcohol
use. This drug is not recommended for use in children. Consult your doctor
or pharmacist for further information.
-
DRUG INTERACTIONS
Inform
your doctor about all the medicines you use, (prescription and nonprescription)
especially if you take high blood pressure medicine or MAO inhibitors (e.g.,
furazolidone, phenelzine, selegiline, tranylcypromine) or any other weight
loss medicine. Decongestants are commonly found in over-the-counter cough
and cold medicine.
-
DRUG ABUSE
AND DEPENDENCE
Phentermine is related chemically and
pharmacologically to the amphetamines.
Amphetamines and related stimulant drugs
have been extensively abused, and the possibility of abuse of Phentermine
should be kept in mind when evaluating the desirability of including a
drug as part of a weight reduction program.
-
Abuse of amphetamines and related drugs
may be associated with intense psychological dependence and severe social
dysfunction. There are reports of patients who have increased the dosage
to many times that recommended. Abrupt cessation following prolonged high
dosage administration results in extreme fatigue and mental depression;
changes are also noted on the sleep EEG.
-
Manifestations of chronic intoxication
with anorectic drugs include severe dermatoses, marked insomnia, irritability,
hyperactivity and personality changes. The most severe manifestation of
chronic intoxications is psychosis, often clinically indistinguishable
from schizophrenia.
--
WARNINGS
Tolerance to the anorectic effect usually
develops within a few weeks. When this occurs, the recommended dose should
not be exceeded in an attempt to increase the effect; rather, the drug
should be discontinued. Phentermine hydrochloride may impair the
ability of the patient to engage in potentially hazardous activities such
as
operating machinery or driving a motor vehicle; the patient should therefore
be cautioned accordingly.
Usage in Pregnancy: Safe
use in pregnancy has not been established. Use of phentermine hydrochloride
by women who are or who may become pregnant, and those in the first trimester
of pregnancy, requires that the potential benefit be weighed against the
possible hazard to mother and infant.
Usage in Children: Phentermine
hydrochloride is not recommended for use in children under 12 years of
age.
OVERDOSAGE
Manifestations of acute overdosage with
phentermine include restlessness, tremor, hyperreflexia, rapid respiration,
confusion, assaultiveness, hallucinations, panic states. Fatigue and depression
usually follow the central stimulation. Cardiovascular effects include
arrhythmias, hypertension or hypotension, and circulatory collapse. Gastrointestinal
symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Fatal
poisoning usually terminates in convulsions and coma.
Management of acute phentermine intoxication
is largely symptomatic and includes lavage and sedation with a barbiturate.
Experience with hemodialysis or peritoneal dialysis is inadequate to permit
recommendations in this regard. Acidification of the urine increases phentermine
excretion. Intravenous phentolamine (REGITINE) has been suggested for possible
acute, severe hypertension, if this complicates phentermine overdosage.
NOTES
Appetite
suppressants are not a substitute for proper diet. For maximum effects,
this must be used in conjunction with a diet and exercise program. Do not
share this medication with others.
-
-
STORAGE
Store
at room temperature away from sunlight and moisture. Keep this and all
medications out of the reach of children.
-
|