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Ionamin is used for:

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Reducing weight in obese patients when used short-term and combined with exercise, diet, and behavioral modification. Ionamin is an appetite suppressant. It works by helping to release certain chemicals in the brain that control appetite.

Do NOT use Ionamin if:

you are allergic to any ingredient in Ionamin or other sympathomimetics (eg, pseudoephedrine) you are taking dexfenfluramine, fenfluramine, furazolidone, guanadrel, guanethidine, or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) in the last 14 days you have moderate to severe or uncontrolled high blood pressure, an overactive thyroid, glaucoma, heart or blood vessel disease, or severe narrowing of the blood vessels you have high blood pressure in the lungs

you are in an agitated state, or have a history of substance abuse

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ionamin:

Some medical conditions may interact with Ionamin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have a brain or spinal cord disorder, hardening of the arteries, high blood pressure, diabetes, or high cholesterol or lipid levels Some MEDICINES MAY INTERACT with Ionamin. Tell your health care provider if you are taking any other medicines, especially any of the following:

Dexfenfluramine, fenfluramine, furazolidone, or MAOIs (eg, phenelzine) because the risk of serious side effects, such as increasing headache, high blood pressure, slow heart rate, elevated temperature, or possibly fatal lung problems, may be increased Serotonin specific reuptake inhibitors (eg, fluoxetine) because the risk of their side effects may be increased by Ionamin Guanadrel or guanethidine because their effectiveness may be decreased by Ionamin Ask your health care provider if Ionamin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
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How to use Ionamin:

Use Ionamin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Ionamin by mouth before breakfast or 10 to 14 hours before bedtime unless directed otherwise by your doctor. Swallow Ionamin whole. Do not break, crush, or chew before swallowing. If you miss a dose of Ionamin, take it as soon as possible. If it is after 12 pm, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Ask your health care provider any questions you may have about how to use Ionamin.

Important safety information:

Ionamin may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Ionamin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Doing so may increase the risk of serious side effects. Tell your doctor immediately if you are not able to exercise as well as you could before you started taking Ionamin. Before you have any medical or dental treatments, emergency care, or surgery, tell your doctor or dentist that you are using Ionamin. Avoid drinking alcohol with Ionamin. Diabetes patients-Ionamin may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Use Ionamin with caution in the ELDERLY; they may be more sensitive to its effects. Ionamin is not recommended for use in CHILDREN younger than 16 years old; safety and effectiveness in this age group have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ionamin while you are pregnant. It is not known if Ionamin is found in breast milk. Do not breast-feed while taking Ionamin. After you have taken Ionamin for a few weeks, it will usually not work as well as when you began taking it. This is known at TOLERANCE. Talk with your doctor if Ionamin stops working well. Do not take more medicine than prescribed. Some people who use Ionamin for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Ionamin suddenly, you may have WITHDRAWAL symptoms. These may include extreme tiredness, mental depression, trouble sleeping, irritability, or mental, mood, or personality changes.

Possible side effects of Ionamin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome: Bad taste in mouth; constipation; diarrhea; difficulty sleeping; dizziness; dry mouth; exaggerated sense of well being; headache; nervousness; overstimulation; restlessness; sleeplessness; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; changes in sex drive; chest pain; decreased sexual ability; fainting; fast or irregular heartbeat; mental or mood changes; pounding in the chest; shortness of breath; swelling of the legs and feet; tremor. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA. See also: Ionamin side effects (in more detail)
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If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include aggressive behavior; confusion; depression; exaggerated reflexes; hallucinations; irregular heartbeat; nausea; panic; rapid breathing; severe or persistent dizziness, diarrhea, or restlessness; severe tiredness; stomach cramps; tremor; vomiting. Proper storage of Ionamin: Store Ionamin at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ionamin out of the reach of children and away from pets.

General information:

If you have any questions about Ionamin, please talk with your doctor, pharmacist, or other health care provider. Ionamin is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Ionamin. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider. Issue Date: September 7, 2011 Database Edition 11.3.1.003 Copyright 2011 Wolters Kluwer Health, Inc.

Ionamin Description
Ionamin 15 and Ionamin 30 contain 15 mg and 30 mg respectively of phentermine as the cationic exchange resin complex. Phentermine is , -dimethyl phenethylamine (phenyl-tertiary-butylamine). Inactive Ingredients: D&C Yellow No. 10, dibasic calcium phosphate, FD&C Yellow No. 6, gelatin, iron oxides (15 mg capsules only), lactose, magnesium stearate, titanium dioxide.

ACTIONS
Ionamin is a sympathomimetic amine with pharmacologic activity similar to the prototype drug of this class used in obesity, amphetamine (d- and dl-amphetamine). 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 these phenomena have been looked for. Drugs of this class used in obesity are commonly known as anorectics or anorexigenics. It has not been established, however, 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. Adult obese subjects instructed in dietary management and treated with anorectic drugs, lose more weight on the average than those treated with placebo and diet, as determined in relatively short-term clinical trials. The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an anorectic drug varies from trial to trial, and the increased weight loss

appears to be related in part to variables other than the drugs prescribed, such as the physicianinvestigator, the population treated, and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss. The natural history of obesity is measured in years, whereas the studies cited are restricted to a few weeks or months duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited. The bioavailability of Ionamin has been studied in humans in which blood levels of phentermine were measured by a gas chromatography method. Blood levels obtained with the 15 mg and 30 mg resin complex formulations indicated slower absorption with a reduced but prolonged peak concentration and without a significant difference in prolongation of blood levels when compared with the same doses of phentermine hydrochloride. The clinical significance of these differences is not known. In clinical trials establishing the efficacy of Ionamin, a single daily dose produced an effect comparable to that produced by other regimens of anorectic drug therapy.

INDICATION
Ionamin Capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification, and caloric restriction in the management of exogenous obesity for patients with an initial body mass index 30 kg/m2, or 27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia). Below is a chart of Body Mass Index (BMI) based on various heights and weights. BMI is calculated by taking the patients weight, in kilograms (kg), divided by the patients height, in meters (m), squared. Metric conversions are as follows: pounds 2.2 = kg; inches x 0.0254 = meters. BODY MASS INDEX (BMI), kg/m2

Height (feet, inches)

Weight (pounds)

50

53

56

59

60

63

140

27

25

23

21

19

18

150

29

27

24

22

20

19

BODY MASS INDEX (BMI), kg/m2

Height (feet, inches)

160

31

28

26

24

22

20

170

33

30

28

25

23

21

180

35

32

29

27

25

23

190

37

34

31

28

26

24

200

39

36

32

30

27

25

210

41

37

34

31

29

26

220

43

39

36

33

30

28

230

45

41

37

34

31

29

240

47

43

39

36

33

30

250

49

44

40

37

34

31

The limited usefulness of agents of this class (see ACTIONS) should be measured against possible risk factors inherent in their use such as those described below.
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Contraindications
Advanced arteriosclerosis, cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity, or idiosyncrasy to the sympathomimetic amines, glaucoma. Agitated states. Patients with a history of drug abuse. During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).

Warnings
Ionamin 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, the 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. 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.

If tolerance to the anorectic effect develops, the recommended dose should not be exceeded in an attempt to increase the effect: rather, the drug should be discontinued. Ionamin 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. When using CNS active agents, consideration must always be given to the possibility of adverse interactions with alcohol.

Drug Dependence
Ionamin is related chemically and pharmacologically to amphetamine (d- and dl-amphetamine) and other stimulant drugs that have been extensively abused. The possibility of abuse of Ionamin should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. Abuse of amphetamine (d- and dl-amphetamine) and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage of some of these drugs 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.

Usage in Pregnancy
Safe use in pregnancy has not been established. Use of Ionamin by women who are or may become pregnant requires that the potential benefit be weighed against the possible hazard to mother and infant.

Pediatric Use
Ionamin Capsules (phentermine resin) are not recommended for use in pediatric patients under 16 years of age.

Precautions
Caution is to be exercised in prescribing Ionamin for patients with even mild hypertension. Insulin requirements in diabetes mellitus may be altered in association with the use of Ionamin and the concomitant dietary regimen. Ionamin may decrease the hypotensive effect of adrenergic neuron blocking drugs. The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Geriatric Use
Clinical studies of Ionamin did not include sufficient numbers of subjects aged 65 or 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, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Adverse Reactions
Cardiovascular
Primary pulmonary hypertension (see WARNINGS), palpitation, tachycardia, elevation of blood pressure.

Central Nervous System

Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache; rarely psychotic episodes at recommended doses with some drugs in this class.

Gastrointestinal
Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances.

Allergic
Urticaria.

Endocrine
Impotence, changes in libido.
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Ionamin Dosage and Administration

One capsule daily, before breakfast or 10-14 hours before retiring. For individuals exhibiting greater drug responsiveness, Ionamin 15 will usually suffice. Ionamin 30 is recommended for less responsive patients. Ionamin is not recommended for use in pediatric patients under 16 years of age. Ionamin Capsules should be swallowed whole.

Overdosage
Manifestations of acute overdosage may 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. Overdosage of pharmacologically similar compounds has resulted in fatal poisoning, usually terminating in convulsions and coma. Management of acute Ionamin intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendation in this regard. Intravenous phentolamine (Regitine) has been suggested on pharmacologic grounds for possible acute, severe hypertension, if this complicates overdosage.

How is Ionamin Supplied

Ionamin Capsules (phentermine resin) are available in two strengths: 15 mg, yellow/grey capsules, imprinted with Ionamin 15. NDC 53014-903-71 Bottle of 100s NDC 53014-903-84 Bottle of 400s

30 mg, yellow/yellow capsules, imprinted with Ionamin 30. NDC 53014-904-71 Bottle of 100s NDC 53014-904-84 Bottle of 400s Dispense in a tight container. Store at 25C (77F); excursions permitted to 15-30C (59-86F) [See USP Controlled Room Temperature]. Keep out of the reach of children. Celltech Pharmaceuticals, Inc. Rochester, NY 14623 USA 2003, Celltech Pharmaceuticals, Inc. All rights reserved. Celltech Manufacturing, Inc. Rev. 3/03 R523A

Ionamin phentermine capsule

Product Information

Product Type

HUMAN PRESCRIPTION DRUG

NDC Product Code (Source)

53014-903

Route of Administration

ORAL

DEA Schedule

CIV

INGREDIENTS

Name (Active Moiety)

Type

Strength

phentermine (phentermine)

Active

15 MILLIGRAM In 1 CAPSULE

D&C Yellow No. 10

Inactive

dibasic calcium phosphate

Inactive

FD&C Yellow No. 6

Inactive

gelatin

Inactive

iron oxides

Inactive

lactose

Inactive

magnesium stearate

Inactive

titanium dioxide

Inactive

Product Characteristics

Color

YELLOW (yellow) , GRAY (gray)

Score

no score

Shape

CAPSULE (CAPSULE)

Size

16MM

Flavor

Imprint Code

Ionamin;15

Contains

Coating

false

Symbol

false

Packaging

# NDC

Package Description

Multilevel Packaging

1 53014-903-71

100 CAPSULE In 1 BOTTLE, PLASTIC

None

2 53014-903-84

400 CAPSULE In 1 BOTTLE, PLASTIC

None

Ionamin phentermine capsule

Product Information

Product Type

HUMAN PRESCRIPTION DRUG

NDC Product Code (Source)

53014-904

Route of Administration

ORAL

DEA Schedule

CIV

INGREDIENTS

Name (Active Moiety)

Type

Strength

phentermine (phentermine)

Active

30 MILLIGRAM In 1 CAPSULE

D&C Yellow No. 10

Inactive

dibasic calcium phosphate

Inactive

FD&C Yellow No. 6

Inactive

gelatin

Inactive

lactose

Inactive

magnesium stearate

Inactive

titanium dioxide

Inactive

Product Characteristics

Color

YELLOW (yellow)

Score

no score

Shape

CAPSULE (CAPSULE)

Size

16MM

Flavor

Imprint Code

Ionamin;30

Contains

Coating

false

Symbol

false

Packaging

# NDC

Package Description

Multilevel Packaging

1 53014-904-71

100 CAPSULE In 1 BOTTLE, PLASTIC

None

2 53014-904-84

400 CAPSULE In 1 BOTTLE, PLASTIC

None

Revised: 07/2006Celltech Pharmaceuticals, Inc.