Brand name:
Phentermine
Generic Name: phentermine (FEN ter meen)
Brand names: Adipex-P, Ionamin, Obenix, Oby-Cap, Teramine, Zantryl
Phentermine Description : What is phentermine.
Phentermine is a stimulant that is similar to an amphetamine. It is
an appetite suppressant that affects the central nervous system.
Phentermine is used togther with diet, exercise and behavioral modification
to treat obesity (excessively overweight) in people with risk factors
such as high blood pressure, high cholesterol, or diabetes.Phentermine
may also be used for other purposes not listed in this medication guide.Phentermine
hydrochloride, USP has the chemical name of a,a-Dimethylphenethylamine
hydrochloride. The structural formula is as follows:
Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline
powder which is soluble in water and lower alcohols, slightly soluble
in chloroform and insoluble in ether.Phentermine hydrochloride, an
anorectic agent for oral administration, is available as a capsule
containing 15 mg, 30 mg or 37.5 mg of Phentermine
hydrochloride (equivalent to 12 mg, 24 mg and 30 mg respectively of
Phentermine base) and as a tablet containing 37.5 mg of Phentermine
hydrochloride (equivalent to 30 mg of Phentermine base).Phentermine
hydrochloride capsules 15 mg contain the inactive ingredients D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C
Red #3, FD&C Red #40 Aluminum Lake, Gelatin, Lactose Monohydrate,
Magnesium Stearate, Talc and Titanium Dioxide.
Phentermine hydrochloride capsules 30 mg and 37.5 mg contain the inactive
ingredients D&C Red #33 (in 37.5 mg only), D&C Yellow #10 Aluminum
Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake,
FD&C Red #3 (in 30 mg only), FD&C Red #40 Aluminum Lake, Gelatin,
Lactose Monohydrate, Magnesium Stearate, Pharmaceutical Glaze, Propylene
Glycol, Silicon Dioxide, Sodium Lauryl Sulfate, Synthetic Black Iron
Oxide, Talc and Titanium Dioxide.
Phentermine hydrochloride capsules 30 mg (Seed Formulation) contain
the inactive ingredients D&C Red #28, FD&C Blue #1, FD&C
Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, D&C Yellow
#10 Aluminum Lake, Gelatin, n-Butyl alcohol, Pharmaceutical Glaze,
Propylene Glycol, Povidone, Starch, Sucrose, Synthetic Black Iron Oxide
and Talc.
Phentermine hydrochloride tablets 37.5 mg contain the inactive ingredients
Anhydrous Lactose, Colloidal Silicon Dioxide, Corn Starch, FD&C
Yellow #6 Aluminum Lake, FD&C Blue #1, Magnesium Stearate, Microcrystalline
Cellulose, Pregelatinized Starch, Stearic Acid and Sucrose.
Warnings
Phentermine hydrochloride tablets and capsules are indicated only
as short-term monotherapy for the management of exogenous obesity.
The safety and efficacy of combination therapy with Phentermine and
any other drug products for weight loss, including selective serotonin
reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine),
have not been established. Therefore, coadministration of these drug
products for weight loss is not recommended.
Primary Pulmonary Hypertension (PPH) – a rare, frequently fatal
disease of the lungs – has been reported to occur in patients
receiving a combination of Phentermine with fenfluramine or dexfenfluramine.
The possibility of an association between PPH and the use of Phentermine
alone cannot be ruled out; there have been rare cases of PPH in patients
who reportedly have taken Phentermine alone. The initial symptom of
PPH is usually dyspnea. Other initial symptoms include: angina pectoris,
syncope or lower extremity edema. Patients should be advised to report
immediately any deterioration in exercise tolerance. Treatment should
be discontinued in patients who develop new, unexplained symptoms of
dyspnea, angina pectoris, syncope or lower extremity edema.
Valvular Heart Disease: Serious regurgitant cardiac valvular disease,
primarily affecting the mitral, aortic and/or tricuspid valves, has
been reported in otherwise healthy persons who had taken a combination
of Phentermine with fenfluramine or dexfenfluramine for weight loss.
The etiology of these valvulopathies has not been established and their
course in individuals after the drugs are stopped is not known. The
possibility of an association between valvular heart disease and the
use of Phentermine alone cannot be ruled out; there have been rare
cases of valvular heart disease in patients who reportedly have taken
Phentermine alone.
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 with Alcohol: Concomitant use of alcohol with Phentermine hydrochloride
may result in an adverse drug interaction.
Pregnancy
Teratogenic Effects
Pregnancy Category C. Animal reproduction studies have not been conducted
with Phentermine hydrochloride. It is also not known whether Phentermine
hydrochloride can cause fetal harm when administered to a pregnant
woman or can affect reproductive capacity. Phentermine hydrochloride
should be given to a pregnant woman only if clearly needed.
Nursing Mothers :
Because of the potential for serious adverse reactions in nursing
infants, a decision should be made whether to discontinue nursing or
to discontinue the drug, taking into account the importance of the
drug to the mother.
Pediatric Use phentermine without
Rx/Prescriptions
Safety and effectiveness in pediatric patients have not been established.
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 has been suggested for possible acute, severe
hypertension, if this complicates Phentermine overdosage.
Before taking phentermine
Do not take phentermine if you have used an MAO inhibitor such as isocarboxazid
(Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline
(Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14
days. Serious, life-threatening side effects can occur if you take
phentermine before the MAO inhibitor has cleared from your body.
Taking phentermine together with other diet medications such as fenfluramine
(Phen-Fen) or dexfenfluramine (Redux) can cause a rare fatal lung disorder
called pulmonary hypertension. Do not take phentermine with any other
diet medications without your doctor's advice.
Do not take this medication if you are allergic to phentermine or other
stimulants, or if you have:
heart disease or high blood pressure;
arteriosclerosis (hardening of the arteries); an overactive thyroid;
glaucoma;if you are in an agitated state; or
if you have a history of drug or alcohol abuse.Before taking phentermine, tell
your doctor if you are allergic to any drugs, or if you have: a thyroid disorder;
anxiety disorder; diabetes; or epilepsy or another seizure disorder.
Phentermine side effects
Get emergency medical help if you have any of these signs of an allergic
reaction: hives; difficulty breathing; swelling of your face, lips,
tongue, or throat. Stop using phentermine and call your doctor at
once if you have any of these serious side effects:feeling short of breath,
even with mild exertion;
swelling, rapid weight gain;
chest pain, fast or uneven heartbeat, feeling like you might pass
out;
unusual thoughts or behavior, feeling restless or confused; or
dangerously high blood pressure (severe headache, blurred vision,
buzzing in your ears, anxiety, confusion, chest pain, shortness of
breath, uneven heartbeats, seizure).
Less serious side effects may include:
feeling nervous or anxious;
headache, dizziness, tremors;
trouble sleeping (insomnia);
dry mouth or an unpleasant taste in your mouth;
diarrhea or constipation; or
itching.
This is not a complete list of side effects and others may occur.
Tell your doctor about any unusual or bothersome side effect.
If you have any of these conditions, you may need a dose adjustment
or special tests during treatment.
It is not known whether phentermine will harm an unborn baby. Do not
take phentermine without telling your doctor if you are pregnant. It
is also not known whether phentermine passes into breast milk or if
it could harm a nursing baby. Do not take phentermine without telling
your doctor if you are breast-feeding a baby. Do not give this medication
to anyone younger than 16 years old without the advice of a doctor.
Phentermine may be habit-forming and should be used only by the person
it was prescribed for. Phentermine should never be shared with another
person, especially someone who has a history of drug abuse or addiction.
Keep the medication in a secure place where others cannot get to it.