Ionamin

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to phentermine.

Do not let anyone else take your medication. Phenteramine is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Drinking alcohol can increase certain side effects of phentermine.

Phentermine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Use of phentermine is not recommended in children 16 years of age and younger. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of phentermine in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving phentermine.

Pregnancy

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Moclobemide
• Nialamide
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Sibutramine
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Fenfluramine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Agitated state (very nervous or anxious) or
• Arrhythmias (abnormal heart rhythms), history of or
• Arteriosclerosis (hardening of the arteries), serious or
• Congestive heart failure, history of or
• Drug abuse or dependence, history of or
• Glaucoma or
• Heart or blood vessel disease (eg, coronary artery disease), history of or
• Hypertension (high blood pressure) that is not controlled, history of or
• Hyperthyroidism (overactive thyroid) or
• Stroke, history of—Should not be used in patients with these conditions.

• Allergy to tartrazine—Suprenza™ contains tartrazine. Patients with this condition may have an allergic reaction.

• Heart valve disease or
• Hypertension (high blood pressure) or
• Pulmonary hypertension (elevated pressure in the lungs)—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

This section provides information on the proper use of a number of products that contain phentermine. It may not be specific to Ionamin. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If you take too much of this medicine, it may become habit-forming (causing mental or physical dependence).

This medicine is available in four forms: capsules, disintegrating tablets, extended-release capsules, and tablets. Carefully follow the dosing instructions for the form you are using.

Swallow the extended-release capsule whole. Do not crush, break, or chew it.

Take the disintegrating tablet with or without food. Make sure your hands are dry before touching the tablet. Place the tablet on the top of your tongue right after removing it from the bottle. It should melt quickly. After the tablet has melted, swallow or take a sip of water.

Swallow the tablet whole. Do not crush, break, or chew it.

Carefully follow your doctor's instructions for a reduced-calorie diet plan and regular exercise. Talk with your doctor before starting an exercise program.

To avoid trouble with sleeping, take the last dose of the day about 4 to 6 hours before bedtime, unless your doctor tells you otherwise.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For treatment of obesity:
  • For oral dosage form (capsules):
    • Adults and children 17 years of age and older—15 to 30 milligrams (mg) once a day, taken at approximately 2 hours after breakfast.
    • Children 16 years of age and younger—Use is not recommended.
  • For oral dosage form (disintegrating tablets):
    • Adults and children 17 years of age and older—One tablet once a day, taken in the morning.
    • Children 16 years of age and younger—Use is not recommended.
  • For oral dosage form (extended-release capsules):
    • Adults and children 16 years of age and older—One capsule once a day, taken before breakfast or 10 to 14 hours before sleeping.
    • Children 15 years of age and younger—Use is not recommended.
  • For oral dosage form (tablets):
    • Adults and children 17 years of age and older—
      • Lomaira™: One tablet three times a day, taken 30 minutes before meals.
      • Phentermine: 18.75 to 37.5 milligrams (mg) once a day, taken before breakfast or 1 to 2 hours after breakfast.
    • Children 16 years of age and younger—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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).

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.

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.

Ionamin Capsules (phentermine resin) are available in two strengths:

15 mg, yellow/grey capsules, imprinted with “Ionamin 15.”
 NDC 53014-903-71 Bottle of 100’s
 NDC 53014-903-84 Bottle of 400’s

30 mg, yellow/yellow capsules, imprinted with “Ionamin 30.”
 NDC 53014-904-71 Bottle of 100’s
 NDC 53014-904-84 Bottle of 400’s

Dispense in a tight container. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [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

Applies to phentermine: oral capsule, oral capsule extended release, oral tablet, oral tablet disintegrating

Along with its needed effects, phentermine (the active ingredient contained in Ionamin) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking phentermine:

• Seeing, hearing, or feeling things that are not there
• severe mental changes

• Chest pain
• decreased ability to exercise
• dizziness
• fainting
• fast, irregular, pounding, or racing heartbeat or pulse
• headache
• numbness or tingling in the arms or legs
• swelling of the feet or lower legs
• trembling or shaking of the legs, arms, hands, or feet
• trouble breathing
• trouble with thinking, speaking, or walking
• weakness

Some side effects of phentermine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Decreased interest in sexual intercourse
• difficulty having a bowel movement (stool)
• dry mouth
• false or unusual sense of well-being
• hives or welts, itching, or skin rash
• inability to have or keep an erection
• increased in sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• loss in sexual ability, desire, drive, or performance
• redness of the skin
• unpleasant taste