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Ionamin (Phentermine Capsules) Side Effects, Interactions, Warning

9.22.2017 | Jennifer Bargeman
Ionamin (Phentermine Capsules) Side Effects, Interactions, Warning

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

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

Intravenous phentolamine (Regitine) has been suggested on pharmacologic grounds for possible acute, severe hypertension, if this complicates overdosage. 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.

oblong, white, imprinted with P 316.

Manifestations of acute overdosage may include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states.

Patients with a history of drug abuse.

30 mg, yellow/yellow capsules, imprinted with “IONAMIN 30.”

Other initial symptoms include: angina pectoris, syncope, or lower extremity edema. Patients should be advised to report immediay any deterioration in exercise tolerance. 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. Treatment should be discontinued in patients who develop new, unexplained symptoms of dyspnea, angina pectoris, syncope, or lower extremity edema. The initial symptom of PPH is usually dyspnea. The possibility of an association between PPH and the use of phentermine alone cannot be ruled out.

capsule, gray/yellow, imprinted with barr 15 mg, 1112.

IONAMIN '15' and IONAMIN '30' contain 15 mg and 30 mg respectively of phentermine as the cationic exchange resin complex. Phentermine is a, a-dimethyl phenethylamine (phenyl-tertiary-butylamine).

In a single-dose study comparing the exposures after oral administration of a combination capsule of 15 mg phentermine and 92 mg topiramate to the exposures after oral administration of a 15 mg phentermine capsule or a 92 mg topiramate capsule, there is no significant topiramate exposure change in the presence of phentermine. However in the presence of topiramate, phentermine Cmax and AUC increase 13% and 42% respectively.

Therefore, the coadministration of these drug products for weight loss is not recommended. 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.

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

IONAMIN Capsules should be swallowed whole.

The etiology of these valvulopathies has not been established and their course in individuals after the drugs are stopped is not known. 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.

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capsule, gray, imprinted with E882.

The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia. 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. There are reports of patients who have increased the dosage of some of these drugs to many times that recommended. IONAMIN is related chemically and pharmacologically to amphetamine (d- and dl-amphetamine) and other stimulant drugs that have been extensively abused. Abuse of amphetamine (d- and dl-amphetamine) and related drugs may be associated with intense psychological dependence and severe social dysfunction. 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.

Call your doctor at once if you have a serious side effect such as:

Endocrine: Impotence, changes in libido.

oval, white, imprinted with MP 273.

NDC Bottle of 100's NDC Bottle of 400's.

home drugs a-z list side effects drug center ionamin (phentermine capsules) drug.

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.

IONAMIN may decrease the hypotensive effect of adrenergic neuron blocking drugs.

When using CNS active agents, consideration must always be given to the possibility of adverse interactions with alcohol.

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 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 physician-investigator, the population treated, and the diet prescribed. The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The possible origins of the increased weight loss due to the various drug effects are not established. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.

Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for. 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.

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. Safe use in pregnancy has not been established.

Other central nervous system actions, or metabolic effects may be involved. 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.

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.

Overdosage of pharmacologically similar compounds has resulted in fatal poisoning, usually terminating in convulsions and coma. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Cardiovascular effects include arrhythmias, hypertension, or hypotension and circulatory collapse.

BODY MASS INDEX (BMI), kg/m² Height (feet, inches) Weight (pounds) 5'0” 5'3” 5'6” 5'9” 6'0” 6'3” 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 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.

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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.

oval, blue/white, imprinted with ADIPEX-P, 9 9.

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.

Agitated states. Advanced arteriosclerosis, cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity, or idiosyncrasy to the sympathomimetic amines, glaucoma.

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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. 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.

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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.

blue/white, capsule, imprinted with ADIPEX-P 37.5.

Below is a chart of Body Mass Index ( BMI ) based on various heights and weights.

Metric conversions are as follows: pounds 2.2 = kg; inches x 0.0254 = meters. BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared.

Fatigue and depression usually follow the central stimulation.

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.

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

capsule, yellow, imprinted with MUTUAL 274.

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

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Dispense in a tight container. Keep out of the reach of children.

oval, white, imprinted with A 159.

capsule, yellow, imprinted with barr 30 mg, 1113.

blue/clear, imprinted with E 5000.

Ionamin (phentermine resin) Capsules.

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The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

12/2012. Rev. Manufactured for: UCB, Inc., Smyrna, GA 30080 USA.

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. The clinical significance of these differences is not known. 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 level when compared with the same doses of phentermine hydrochloride.

NDC Bottle of 100's NDC Bottle of 400's.

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

During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).

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.

Please refer to the WARNINGS and PRECAUTIONS sections. No information provided.

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.

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 ).

15 mg, yellow/grey capsules, imprinted with “IONAMIN 15.”