Dextroamphetamine

Brand name: Dexedrine

 

Pharmacology
Sympathomimetic

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Indications

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Contraindications
Do not use in patients with a history of drug abuse. Do not use during or within 14
days following the administration of MAO inhibitors; hypertensive crises may result.
Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe
hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the
sympathomimetic amines, glaucoma and agitated states.

Amphetamines should not be used to combat fatigue or to replace rest.

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Precautions
The possibility of tolerance and psychological dependence should be kept in mind,
particularly with excessive use. Therefore, care should be used in the selection of
candidates for amphetamine therapy and prescription size should be limited to that
required to achieve the immediate therapeutic goal. In addition, patients should be
cautioned against increasing the recommended dosage. Should psychological
dependence occur gradual withdrawal of the medication is recommended. Abrupt
cessation following prolonged high dosage results in extreme fatigue and mental
depression; changes have also been noted on the sleep EEG. Manifestations of chronic
intoxication with amphetamines include severe dermatoses, marked insomnia,
irritability, hyperactivity, and personality changes. The most severe manifestation of
chronic intoxication is psychosis, often clinically indistinguishable from
schizophrenia.

Occupational Hazards:
Because of possible overstimulation, amphetamines may impair the ability of the
patient to perform potentially hazardous activities such as operating machinery or
driving a motor vehicle; therefore, the patient should be cautioned accordingly.

Use with caution in hypertension, even if mild.

Drug Interactions:
Insulin requirements in diabetes mellitus may be altered in association with the use of
amphetamines. Amphetamines may decrease the hypotensive effect of guanethidine.

Pregnancy:
Safe use in pregnancy has not been established. Reproduction studies in mammals at
high multiples of the human dose have suggested an embryotoxic and teratogenic
potential. Use of amphetamines by women who are or who may become pregnant, and
especially those in the first trimester of pregnancy, requires that the potential benefit
be weighed against the possible hazard to mother and child.
Lactation:
Amphetamines are excreted in human milk. Mothers taking dextroamphetamine
should be advised to refrain from nursing.

Children:
Amphetamines are not recommended for use in hyperkinetic behavior disorders in
children under 3 years of age.

Chronic administration of amphetamines may be associated with growth inhibition;

growth should be monitored during treatment.

The presence of tics or Tourette's syndrome should be ruled out before administering
amphetamines to children.

Drug Interactions:
Caution should be exercised when co-prescribing amphetamines and other drugs since
clinically significant interactions with a number of drugs have been reported. In some
instances, potentiations of CNS and cardiac effects could be life threatening. Dosages
should be closely monitored.

Known interactions with amphetamines are as follows:

Synergistic Interactions:
Tricyclic antidepressants, MAO inhibitors, meperidine, norepinephrine,
phenobarbital, phenytoin, propoxyphene, acetazolamide, thiazides, gastrointestinal
and urinary alkalinizing agents.

Antagonistic Interactions:
Adrenergic blockers, antihistamines, antihypertensives, chlorpromazine,
ethosuximide, guanethidine, haloperidol, lithium carbonate, methenamine, veratrum
alkaloids, gastrointestinal and urinary acidifying agents.

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Adverse Effects
Cardiovascular:
Palpitation, tachycardia, elevation of blood pressure. There have been isolated reports
of cardiomyopathy associated with chronic amphetamine use.

CNS:
Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor,
headache, exacerbation of tics, Tourette's syndrome and psychotic episodes (rare at
recommended doses).

Gastrointestinal:
Dryness of mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal
disturbances. Anorexia and weight loss may occur.

Allergic:
Urticaria.

Endocrine:
Impotence, changes in libido.

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Overdose
The toxic dose of amphetamine varies widely according to the degree of tolerance
present. Blood levels are, therefore, of little value in assessing the severity of the
overdose. This assessment must depend almost entirely on clinical signs.

Symptoms:
Dilated and reactive pupils, shallow rapid respiration, rhabdomyolysis, fever, chills,
sweating, hyperactive tendon reflexes. Central effects may include restlessness,
aggressiveness, anxiety, confusion, delirium, hallucinations, panic attacks and even
suicidal or homicidal tendencies. The stimulant effect is usually followed by
depression, lethargy, exhaustion. Cardiovascular effects may include anginal pain,
extrasystoles and other arrhythmias, flushing, headache, hypertension or hypotension,
pallor, palpitations, tachycardia. Circulatory collapse and syncope may occur.
Gastrointestinal effects include nausea, vomiting, diarrhea, abdominal cramps.
Fatal poisoning is usually preceded by convulsions and coma.

Treatment:
Essentially symptomatic. In addition to the usual measures (including emesis, gastric
lavage, catharsis), sedation should be given when indicated. For this purpose the
barbiturates, either orally or parenterally, are generally used. To provide a basal level
of sedation, one or more doses of sodium amobarbital may be given by mouth or, if
necessary, by i.m. injection. This may be repeated as often as necessary and in
quantities sufficient to control the symptoms. Sedation may also be accomplished with
chlorpromazine: in children 1 mg/kg body weight i.m. and in adults 100 mg i.m.,
repeated at half-hourly intervals if necessary. If the amphetamine has been taken with
a barbiturate, as is often the case, the chlorpromazine dosage should be halved.

Note:
It has been stated that the effects of amphetamines are best treated with haloperidol, a
dopamine antagonist with minimal anticholinergic side effects. Haloperidol, however,
possesses central antiemetic property; it may prolong the hypnotic action of
barbiturates and may potentiate the effects of alcohol and other CNS depressant drugs;
it may lower the convulsion threshold. In general, the hypertension which may result
from massive overdosage of dextroamphetamine sulfate does not require treatment. A
gradual drop in blood pressure will usually result when sufficient sedation has been
administered. In the presence of severe hypotension the usual procedures employed
for shock should be instituted: Elevate foot of bed, wrap patient in blankets, give i.v.
fluids.

Since much of the Spansule capsule medication is coated for gradual release, therapy
directed at reversing the effects of the ingested drug and at supporting the patient
should be continued for as long as overdosage symptoms remain. Saline cathartics are
useful for hastening evacuation of pellets that have not already released medication.
Acidification of the urine enhances excretion.

Experience with hemodialysis or peritoneal dialysis is inadequate to permit

recommendations in this regard.

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Dosage
Regardless of indication, amphetamines should be administered at the lowest effective
dosage, and dosage should be individually adjusted. Time of administration should
receive special attention particularly with the Spansule capsule form because of
possible insomnia. Late evening medication should be avoided.

Narcolepsy:
Daily dosage may range from 5 to 60 mg for optimal response. If bothersome adverse
reactions appear (e.g., insomnia or anorexia), reduce the dosage. Spansule capsules
may be used for once a day dosage wherever appropriate. With tablets, give first dose
on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.

In patients from 6 to 12 years of age, start with 5 mg daily; dosage may be raised in
increments of 5 mg at weekly intervals until optimal response is obtained. In patients
12 years of age and older, start with 10 mg daily; daily dosage may be raised in
increments of 10 mg at weekly intervals until optimal response is obtained.

Minimal brain dysfunction in children (e.g., hyperkinetic behavior disorders): 

Daily dosage may range from 2.5 mg to 40 mg, although some older children may
require more than 40 mg daily for optimal response. If bothersome adverse reactions
appear (e.g., insomnia or anorexia), dosage should be reduced. Spansule capsules may
be used for once a day dosage wherever appropriate. With tablets, give first dose on
awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.

Not recommended for this use in children under 3 years of age.

In children from 3 to 5 years of age, start with 2.5 mg daily, by tablet; daily dosage
may be raised in increments of 2.5 mg at weekly intervals until optimal response is
obtained.

In children 6 years of age or older, start with 5 mg once daily; daily dosage may be
raised in increments of 5 mg at weekly intervals until optimal response is obtained.
Only in rare cases will it be necessary to exceed a total of 40 mg/day.

Most hyperkinetic children require medication for several years, although once
symptoms have been controlled, it may be possible to reduce dosage or to interrupt
drug therapy during the summer months and at other times when the child is under
less stress. Hyperkinetic children appear to be able to tolerate comparatively high
dosages of dextroamphetamine with few adverse reactions, possibly because they
excrete the drug more rapidly than other patients.

In other indications, the physician should determine dosage after an evaluation of the
patient's condition.

Supplied
Spansule Capsules:
Each brown-capped, taper-end capsule, with three shades of orange pellets, contains:
Dextroamphetamine sulfate 10 mg (monogrammed SKF E13) or 15 mg
(monogrammed SKF E14), so prepared that a therapeutic dose is released promptly
and the remaining medication, released gradually and without interruption, sustains
the effect for 10 to 12 hours. Also contains sucrose and tartrazine. Energy: 10 mg,
3.72 kJ (0.88 kcal); 15 mg, 4.78 kJ (1.14 kcal). Gluten-free, lactose-free, parabens-
free, sodium-free and sulfites-free free. Bottles of 100.

Tablets:
Each orange, heart shaped, scored, compressed tablet, engraved SKF E19, contains:
Dextroamphetamine sulfate 5 mg. Also contains lactose 13.8 mg, sucrose and
tartrazine. Energy: 1.46 kJ (0.35 kcal). Gluten-free, parabens-free, sodium-free and
sulfites-free. Bottles of 100.

Methamphetamine
Generic Name: methamphetamine (METH am FET a meen)
Brand Names: Desoxyn, Desoxyn Gradumet

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What is methamphetamine?
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Methamphetamine is a central nervous system stimulant. It affects chemicals in the brain and nerves
that contribute to hyperactivity and impulse control.

Methamphetamine is used to treat attention deficit hyperactivity disorder (ADHD). It is also used to
treat obesity after other diets or medications have been tried without successful weight loss.

Methamphetamine may also be used for other purposes not listed in this medication guide.

Important information about methamphetamine

Do not use methamphetamine if you have used an MAO inhibitor such as isocarboxazid (Marplan),
tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam)
within the past 14 days. Serious, life-threatening side effects can occur if you take
methamphetamine before the MAO inhibitor has cleared from your body. Do not use this medication
if you are allergic to methamphetamine, or if you have hardened arteries (arteriosclerosis), heart
disease, moderate to severe high blood pressure (hypertension), overactive thyroid, glaucoma,
severe anxiety or agitation, or a history of drug or alcohol addiction. Some stimulants have caused
sudden death in children and adolescents with serious heart problems or congenital heart defects.
Before taking methamphetamine, tell your doctor if you have any type of heart problems. Do not give
this medication to a child younger than 12 years old without the advice of a doctor.

Long-term use of methamphetamine can slow a child's growth. Tell your doctor if the child using this
medication is not growing or gaining weight properly.

Methamphetamine is a drug of abuse and may be habit-forming. Keep track of how many pills have
been used from each new bottle of this medicine. You should be aware if any person in the
household is using this medicine improperly or without a prescription. Using this medication
improperly can cause death or serious side effects on the heart.

Before taking methamphetamine

Methamphetamine may be habit-forming and should be used only by the person it was prescribed
for. Methamphetamine 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. Do not use methamphetamine if you have used an MAO inhibitor such as isocarboxazid
(Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl,
Emsam) within the past 14 days. Serious, life-threatening side effects can occur if you take
methamphetamine before the MAO inhibitor has cleared from your body.

Do not use this medication if you are allergic to methamphetamine or if you have:

 heart disease or moderate to severe high blood pressure (hypertension);

 arteriosclerosis (hardening of the arteries);
 overactive thyroid;
 glaucoma;
 severe anxiety, tension, or agitation; or
 if you have a history of drug or alcohol addiction.
Some stimulants have caused sudden death in children and adolescents with serious heart
problems or congenital heart defects.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use
this medication:

 a congenital heart defect;

 high blood pressure;
 heart failure, heart rhythm disorder, or recent heart attack;
 a personal or family history of mental illness, psychotic disorder, bipolar illness,
depression, or suicide attempt;
 diabetes; or
 tics (muscle twitches) or Tourette's syndrome.
FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby.
Methamphetamine could cause premature birth, low birth weight, or withdrawal symptoms in a
newborn if the mother takes methamphetamine during pregnancy. Tell your doctor if you are
pregnant or plan to become pregnant during treatment. Methamphetamine can pass into breast milk
and may harm a nursing baby. Do not use this medication without telling your doctor if you are
breast-feeding a baby.

See also: Methamphetamine pregnancy and breastfeeding warnings (in more detail)

Long-term use of methamphetamine can slow a child's growth. Tell your doctor if the child using this
medication is not growing or gaining weight properly.

Do not give this medication to a child younger than 12 years old without the advice of a doctor.

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How should I take methamphetamine?
Take methamphetamine exactly as it was prescribed for you. Do not take the medication in larger
amounts, or take it for longer than recommended by your doctor. Follow the directions on your
prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this
medication.

Take this medication with a full glass of water.

If you are taking methamphetamine for weight loss and your appetite gradually increases, do not
take more of the medication to suppress appetite. Stop taking methamphetamine and call your
doctor.

To be sure this medication is helping your condition, your doctor will need to see you on a regular
basis. Do not miss any scheduled visits.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor
who treats you that you are using methamphetamine.

Store methamphetamine at room temperature away from moisture, heat, and light. Keep track of
how many pills have been used from each new bottle of this medicine. Methamphetamine is a drug
of abuse and you should be aware if any person in the household is using this medicine improperly
or without a prescription. Using this medication improperly can cause death or serious side effects
on the heart.

See also: Methamphetamine dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, or if it is
already evening, skip the missed dose and take the medicine the next morning. Taking this medicine
late in the day can cause sleep problems. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An
overdose of methamphetamine can be fatal.

Overdose symptoms may include restlessness, tremor, muscle twitches, rapid breathing, confusion,
hallucinations, panic, aggressiveness, unexplained muscle pain or tenderness, muscle weakness,
fever or flu symptoms, and dark colored urine. These symptoms may be followed by depression and
tiredness. Other overdose symptoms include nausea, vomiting, diarrhea, stomach pain, uneven
heartbeats, feeling light-headed, fainting, seizure (convulsions), or coma.
What should I avoid while taking methamphetamine?
Methamphetamine can cause side effects that may impair your thinking or reactions. Be careful if
you drive or do anything that requires you to be awake and alert.

Do not take methamphetamine late in the day. A dose taken too late in the day can cause sleep
problems (insomnia).

Avoid drinking fruit juices or taking vitamin C at the same time you take methamphetamine. These
can make your body absorb less of the medicine.

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Methamphetamine side effects

Get emergency medical help if you have any of these signs of an allergic reaction to
methamphetamine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop
using methamphetamine and call your doctor at once if you have any of these serious side effects:

 fast, pounding, or uneven heartbeats;

 feeling light-headed, fainting;
 dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears,
anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure); or
 tremor, restlessness, hallucinations, unusual behavior, or motor tics (muscle twitches).
Less serious methamphetamine side effects may include:

 headache or dizziness;
 sleep problems (insomnia);
 dry mouth or an unpleasant taste in your mouth;
 diarrhea, constipation;
 loss of appetite, weight loss; or
 loss of interest in sex, impotence, or difficulty having an orgasm.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice
about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Methamphetamine side effects (in more detail)

What other drugs will affect methamphetamine?

Tell your doctor about all other medications you use, especially:

 insulin;
 cold medicines (decongestants);
 phenothiazines such as chlorpromazine (Thorazine), prochlorperazine (Compazine,
Compro), promethazine (Pentazine, Phenergan, Anergan, Antinaus), thioridazine (Mellaril),
and others;
 an antidepressant such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine
(Anafranil), desipramine (Norpramin), imipramine (Tofranil), or nortriptyline (Pamelor).
This list is not complete and there may be other drugs that can interact with methamphetamine. Tell
your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal
products, and drugs prescribed by other doctors. Do not start a new medication without telling your
doctor.

Phendimetrazine Tartrate
Pronunciation: (fen-dye-ME-tra-zeen TAR-trate)
Class: Anorexiant

Trade Names:
Bontril PDM
- Tablets 35 mg

Trade Names:
Bontril Slow-Release
- Tablets 35 mg

Trade Names:
Melfiat-105 Unicelles
- Tablets 35 mg

Trade Names:
Prelu-2
- Capsules, sustained-release 105 mg

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Pharmacology
May stimulate satiety center in brain, causing appetite suppression.

Pharmacokinetics
Absorption
Phendimetrazine is readily absorbed.

Metabolism
Phendimetrazine metabolism is hepatic. Some of the drug is metabolized to phenmetrazine and
phendimetrazine-N-oxide.

Elimination
Excretion is via the kidneys and is increased by acidifying the urine. The t ½ is 1.9 h (immediate-
release) and 9.8 h (slow-release).

Duration
4 hr.

Indications and Usage

Short-term (few weeks) adjunct to diet plan to reduce weight.

Contraindications
Hypersensitivity to sympathomimetic amines; pregnancy; advanced arteriosclerosis; symptomatic
CV disease; moderate to severe hypertension; hyperthyroidism; glaucoma; agitated states; history of
drug abuse; during or within 14 days following the administration of an MAOI.

Dosage and Administration

Adults and children (12 yr of age or older)

PO Tablets or capsules: 35 mg 2 or 3 times daily before meals; sustained-release capsules: 105 mg
once daily in the morning before breakfast.

General Advice
Swallow sustained-release capsule whole. Do not crush, chew, or open capsule.

Storage/Stability
Store at controlled room temperature (59° to 86°F).
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Drug Interactions
Guanethidine

May decrease hypotensive effect of guanethidine.

MAOIs (eg, phenelzine); furazolidone

May cause hypertensive crisis and intracranial hemorrhage.

Selective serotonin reuptake inhibitors (eg, fluoxetine)

Sympathomimetic effects of phendimetrazine and risk of “serotonin syndrome” may be increased.

Laboratory Test Interactions

None well documented.

Adverse Reactions
Cardiovascular
Palpitation; tachycardia, hypertension.

CNS
Overstimulation; restlessness; dizziness; insomnia; euphoria; dysphoria; tremor; headache;
psychosis.

Dermatologic
Allergic urticaria.

GI
Dry mouth; unpleasant taste; diarrhea; constipation.

Genitourinary
Impotence; changes in libido.
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Precautions
Pregnancy
Do not use in women who are pregnant or may become pregnant.

Lactation
Undetermined.

Children
Safety and efficacy not established in children younger than 12 yr of age.

Special Risk Patients

Use with caution in patients with glaucoma, hypertension, diabetes mellitus.

Drug dependence
Psychological and physical dependence may occur with continued use; this class of drugs has been
extensively abused.

Tolerance
Tolerance to the anorectic effect usually develops within a few weeks.

Overdosage
Symptoms
Restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations,
panic states, fatigue, depression, arrhythmias, hypertension, hypotension, circulatory collapse,
nausea, vomiting, diarrhea, abdominal cramps, convulsions, coma, death.

Patient Information
 Advise patient using immediate-release tablet to take prescribed dose 1 h before meals
and to take last dose several hours before bedtime.
 Advise patient using sustained-release capsule that medication is slowly released over 12
h and to take dose in the morning. Advise patient to swallow the capsule whole and to not
crush or chew the capsule.
 Encourage patient to follow medically supervised weight reduction program. Emphasize
that this medication will only work in conjunction with a caloric restricted diet and exercise
program.
 Advise patient that medication should be taken as prescribed and to not stop taking or
change the dose unless advised to do so by the health care provider.
 Explain that appetite suppressant effects are temporary and tolerance to medication and
dependence can occur. Caution patient not to increase the dose in an effort to overcome the
tolerance when it occurs.
 Remind diabetic patient to monitor blood sugar more frequently while implementing
dietary restrictions and to notify health care provider if significant changes in blood sugar
occur.
 Caution patient that drug may impair the ability to drive or perform other tasks requiring
mental alertness.
 Advise patient to notify health care provider immediately if the following symptoms occur:
chest pain, palpitations, nervousness, dizziness.
 Advise patient to notify health care provider if experiencing any unusual or unexplained
symptoms.

Phentermine
Generic Name: phentermine (FEN ter meen)
Brand names: Adipex-P, Oby-Cap, T-Diet, Zantryl

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What is phentermine?
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Phentermine is a stimulant that is similar to an amphetamine. Phentermine is an appetite
suppressant that affects the central nervous system.
Phentermine is used togther with diet and exercise to treat obesity (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.

Important information about phentermine

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.

Phentermine may impair your thinking or reactions. Be careful if you drive or do anything that
requires you to be alert. Drinking alcohol can increase certain side effects of this medicine.

Phentermine is only part of a complete program of treatment that may also include diet, exercise,
and weight control. Follow your diet, medication, and exercise routines very closely.

Phentermine may be habit-forming and should be used only by the person it was prescribed for.
Never share phentermine with another person, especially someone with a history of drug abuse or
addiction. Keep track of the amount of medicine used from each new bottle. Phentermine is a drug
of abuse and you should be aware if anyone is using your medicine improperly or without a
prescription. Do not stop using phentermine suddenly, or you could have unpleasant withdrawal
symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using this medicine.

Before taking phentermine

Do not use phentermine if you have taken an MAO inhibitor such as furazolidone (Furoxone),
isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or
tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you
use 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 tbis medicine with any other diet medications without your doctor's advice.

You should not take phentermine if you are allergic to it, or if you have:

 coronary artery disease (hardening of the arteries);

 heart disease;
 severe or uncontrolled high blood pressure;
 overactive thyroid;
 glaucoma;
 if you have a history of drug or alcohol abuse; o
 if you are allergic to other diet pills, amphetamines, stimulants, or cold medications.
If you have any of these other conditions, you may need a phentermine dose adjustment or special
tests:
 high blood pressure;
 diabetes; or
 a thyroid disorder.
FDA pregnancy category C. It is not known whether phentermine will harm an unborn baby. Tell your
doctor if you are pregnant or plan to become pregnant while using this medication. Phentermine can
pass into breast milk and may harm a nursing baby. You should not breast-feed while taking
phentermine. Do not give this medication to a child younger than 16 years old.

See also: Phentermine pregnancy and breastfeeding warnings (in more detail)

Phentermine may be habit-forming and should be used only by the person it was prescribed for.
Never share this medicine with another person, especially someone with a history of drug abuse or
addiction. Keep the medication in a place where others cannot get to it.

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How should I take phentermine?

Take phentermine exactly as prescribed by your doctor. Do not take in larger or smaller amounts or
for longer than recommended. Follow the directions on your prescription label.

It is best to take phentermine on an empty stomach before breakfast or within 2 hours after
breakfast.

To prevent sleep problems, take this medication early in the day, no later than 6:00 pm.

Talk with your doctor if you have increased hunger or if you otherwise think the medication is not
working properly. Taking more of this medication will not make it more effective and can cause
serious, life-threatening side effects.

Phentermine should be taken only for a short time, such as a few weeks.

Do not stop taking phentermine suddenly, or you could have unpleasant withdrawal symptoms. Ask
your doctor how to avoid withdrawal symptoms when you stop using phentermine.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Phentermine is a drug of abuse
and you should be aware if anyone is using your medicine improperly or without a prescription.
See also: Phentermine dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your
next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of
phentermine can be fatal.

Overdose symptoms may include confusion, hallucinations, panic, feeling hostile or aggressive,
nausea, vomiting, diarrhea, stomach cramps, irregular heartbeat, rapid breathing, overactive
reflexes, confusion, hallucinations, seizure (convulsions), feeling light-headed, or fainting.

What should I avoid while taking phentermine?

Drinking alcohol can increase certain side effects of this medicine. Phentermine may impair your
thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

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Phentermine side effects

Get emergency medical help if you have any of these signs of an allergic reaction to phentermine:
hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you
have a serious side effect such as:

 feeling short of breath, even with mild exertion;

 chest pain, feeling like you might pass out;
 swelling in your ankles or feet;
 pounding heartbeats or fluttering in your chest;
 confusion or irritability, unusual thoughts or behavior;
 feelings of extreme happiness or sadness; 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 phentermine side effects may include:

 feeling restless or hyperactive;

 headache, dizziness, tremors;
 sleep problems (insomnia);
 dry mouth or an unpleasant taste in your mouth;
 diarrhea or constipation, upset stomach; or
 increased or decreased interest in sex, impotence.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice
about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Phentermine side effects (in more detail)

Phentermine Dosing Information

Usual Adult Phentermine Dose for Weight Loss:

Initial dose: 8 mg orally 3 times a day 30 minutes before meals.

Alternatively, phentermine hydrochloride and phentermine resin may be given as a single dose of
15-37.5 mg orally once a day before breakfast or 10-14 hours before retiring.

Usual Pediatric Phentermine Dose for Weight Loss:

Child > 12 years:

Initial dose: 8 mg orally 3 times a day 30 minutes before meals.
Alternatively, phentermine hydrochloride and phentermine resin may be given as a single dose of
15-37.5 mg orally once a day before breakfast or 10-14 hours before retiring.

What other drugs will affect phentermine?

Tell your doctor about all other medicines you use, especially:

 blood pressure medications;

 insulin or oral diabetes medication;
 guanethidine (Ismelin); or
 an antidepressant such as citalopram (Celexa), fluoxetine (Prozac, Sarafem, Symbyax),
paroxetine (Paxil), sertraline (Zoloft), and others.
This list is not complete and other drugs may interact with phentermine. Tell your doctor about all
medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do
not start a new medication without telling your doctor.
Methylphenidate Hydrochloride

DESCRIPTION

Methylphenidate Hydrochloride USP is a mild central nervous system (CNS) stimulant, available as
tablets of 5, 10, and 20 mg for oral administration; Methylphenidate Hydrochloride sustained-release
is available for oral administration as 20 mg tablets. Methylphenidate Hydrochloride is methyl α-
phenyl-2-piperidineacetate hydrochloride, and its structural formula is

Methylphenidate Hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are
acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in
chloroform and in acetone. Its molecular weight is 269.77.

Inactive Ingredients. Methylphenidate Hydrochloride tablets: D&C Yellow No. 10 (5-mg and 20-mg
tablets), FD&C Green No. 3 (10-mg tablets), lactose, magnesium stearate, polyethylene glycol,
starch (5-mg and 10-mg tablets), sucrose, talc, and tragacanth (20-mg tablets).

Methylphenidate Hydrochloride sustained-release tablets: Cellulose compounds, cetostearyl alcohol,

lactose, magnesium stearate, mineral oil, povidone, titanium dioxide, and zein.

Drug Interactions
Methylphenidate Hydrochloride should not be used in patients being treated (currently or within the
proceeding two weeks) with MAO Inhibitors (see CONTRAINDICATIONS, Monoamine Oxidase
Inhibitors). Because of possible effects on blood pressure, Methylphenidate Hydrochloride should be
used cautiously with pressor agents.

Methylphenidate may decrease the effectiveness of drugs used to treat hypertension.

Methylphenidate is metabolized primarily to ritalinic acid by de-esterification and not through
oxidative pathways.

Human pharmacologic studies have shown that racemic methylphenidate may inhibit the metabolism
of coumarin anticoagulants, anticonvulsants (e.g., phenobarbital, phenytoin, primidone), and tricyclic
drugs (e.g., imipramine, clomipramine, desipramine). Downward dose adjustments of these drugs
may be required when given concomitantly with methylphenidate. It may be necessary to adjust the
dosage and monitor plasma drug concentration (or, in case of coumarin, coagulation times), when
initiating or discontinuing methylphenidate.
Serious adverse events have been reported in concomitant use with clonidine, although no causality
for the combination has been established. The safety of using methylphenidate in combination with
clonidine or other centrally acting alpha-2-agonists has not been systematically evaluated. 

ADVERSE REACTIONS
Nervousness and insomnia are the most common adverse reactions but are usually controlled by
reducing dosage and omitting the drug in the afternoon or evening. Other reactions include
hypersensitivity (including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema
multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura);
anorexia; nausea; dizziness; palpitations; headache; dyskinesia; drowsiness; blood pressure and
pulse changes, both up and down; tachycardia; angina; cardiac arrhythmia; abdominal pain; weight
loss during prolonged therapy. There have been rare reports of Tourette’s syndrome. Toxic
psychosis has been reported. Although a definite causal relationship has not been established, the
following have been reported in patients taking this drug: instances of abnormal liver function,
ranging from transaminase elevation to hepatic coma; isolated cases of cerebral arteritis and/or
occlusion; leukopenia and/or anemia; transient depressed mood; aggressive behavior; a few
instances of scalp hair loss. Very rare reports of neuroleptic malignant syndrome (NMS) have been
received, and, in most of these, patients were concurrently receiving therapies associated with NMS.
In a single report, a ten-year-old boy who had been taking methylphenidate for approximately 18
months experienced an NMS-like event within 45 minutes of ingesting his first dose of venlafaxine. It
is uncertain whether this case represented a drug-drug interaction, a response to either drug alone,
or some other cause.

In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and
tachycardia may occur more frequently; however, any of the other adverse reactions listed above
may also occur.

Drug Dependence

Methylphenidate Hydrochloride should be given cautiously to patients with a history of drug

dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological
dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur,
especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use,
since severe depression may occur. Withdrawal following chronic therapeutic use may unmask
symptoms of the underlying disorder that may require follow-up.

PRECAUTIONS
Patients with an element of agitation may react adversely; discontinue therapy if necessary.

Periodic CBC, differential, and platelet counts are advised during prolonged therapy.

Drug treatment is not indicated in all cases of this behavioral syndrome and should be considered
only in light of the complete history and evaluation of the child. The decision to prescribe
Methylphenidate Hydrochloride should depend on the physician’s assessment of the chronicity and
severity of the child’s symptoms and their appropriateness for his/her age. Prescription should not
depend solely on the presence of one or more of the behavioral characteristics.

When these symptoms are associated with acute stress reactions, treatment with Methylphenidate
Hydrochloride is usually not indicated.

Information for Patients

Prescribers or other health professionals should inform patients, their families, and their caregivers
about the benefits and risks associated with treatment with methylphenidate and should counsel
them in its appropriate use. A patient Medication Guide is available for Methylphenidate
Hydrochloride and Methylphenidate Hydrochloride sustained-release. The prescriber or health
professional should instruct patients, their families, and their caregivers to read the Medication Guide
and should assist them in understanding its contents. Patients should be given the opportunity to
discuss the contents of the Medication Guide and to obtain answers to any questions they may
have. The complete text of the Medication Guide is reprinted at the end of this document.