What happens if I overdose Ionamin?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; diarrhea; fainting; hallucinations; irregular heartbeat; mental or mood changes (eg, depression); nausea; overactive reflexes; rapid breathing; restlessness; seizures; severe dizziness or headache; stomach cramps; tiredness; tremor; vomiting.
Proper storage of Ionamin orally disintegrating tablets:
Store Ionamin orally disintegrating tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ionamin orally disintegrating tablets out of the reach of children and away from pets.
Overdose of Ionamin in details
Manifestations of acute overdosage with Ionamin 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 Ionamin 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 Ionamin excretion.
Intravenous phentolamine (REGITINE) has been suggested for possible acute, severe hypertension, if this complicates Ionamin overdosage.
What should I avoid while taking Ionamin?
Drinking alcohol can increase certain side effects of Ionamin.
Ionamin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Ionamin warnings
Coadministration With Other Drug Products for Weight Loss
Ionamin® is indicated only as short-term (a few weeks) monotherapy for the management of exogenous obesity. The safety and efficacy of combination therapy with Ionamin® and any other drug products for weight loss including prescribed drugs, over-the-counter preparations, and herbal products, or serotonergic agents such as selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. Therefore, coadministration of Ionamin® and these drug products is not recommended.
Primary Pulmonary Hypertension
Primary Pulmonary Hypertension (PPH) – a rare, frequently fatal disease of the lungs – has been reported to occur in patients receiving a combination of Ionamin with fenfluramine or dexfenfluramine. The possibility of an association between PPH and the use of Ionamin® alone cannot be ruled out; there have been rare cases of PPH in patients who reportedly have taken Ionamin alone. The initial symptom of PPH is usually dyspnea. Other initial symptoms may 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, and patients should be evaluated for the possible presence of pulmonary hypertension.
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 Ionamin with fenfluramine or dexfenfluramine for weight loss. The possible role of Ionamin in 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 Ionamin® alone cannot be ruled out; there have been rare cases of valvular heart disease in patients who reportedly have taken Ionamin alone.
Development of Tolerance, Discontinuation in Case of Tolerance
When tolerance to the anorectant effect develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued.
Effect on the Ability to Engage in Potentially Hazardous Tasks
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.
Risk of Abuse and Dependence
Ionamin® is related chemically and pharmacologically to amphetamine (d- and dll-amphetamine) and other related 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. See Drug Abuse and Dependence (9) and Overdosage (10).
The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.
Usage With Alcohol
Concomitant use of alcohol with Ionamin® may result in an adverse drug reaction.
Use in Patients With Hypertension
Use caution in prescribing Ionamin® for patients with even mild hypertension (risk of increase in blood pressure).
Use in Patients on Insulin or
Oral Hypoglycemic Medications for Diabetes Mellitus
A reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be required.
What should I discuss with my healthcare provider before taking Ionamin?
Some medical conditions may interact with Ionamin orally disintegrating tablets. 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 kidney problems, high blood pressure, diabetes, or high cholesterol or lipid levels
Some MEDICINES MAY INTERACT with Ionamin orally disintegrating tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Dexfenfluramine or fenfluramine because the risk of a possibly fatal lung problem or heart valve problems may be increased
- Furazolidone or MAOIs (eg, phenelzine) because severe side effects, such as increasing headache, high blood pressure, slow heartbeat, or elevated temperature, may occur
- Insulin, oral diabetes medicines (eg, glyburide), or SSRIs (eg, fluoxetine, sertraline) because the risk of their side effects may be increased by Ionamin orally disintegrating tablets
- Guanadrel or guanethidine because their effectiveness may be decreased by Ionamin orally disintegrating tablets
Ask your health care provider if Ionamin orally disintegrating tablets 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.
Ionamin precautions
Coadministration With Other Drug Products for Weight Loss
Ionamin® is indicated only as short-term (a few weeks) monotherapy for the management of exogenous obesity. The safety and efficacy of combination therapy with Ionamin® and any other drug products for weight loss including prescribed drugs, over-the-counter preparations, and herbal products, or serotonergic agents such as selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. Therefore, coadministration of Ionamin® and these drug products is not recommended.
Primary Pulmonary Hypertension
Primary Pulmonary Hypertension (PPH) – a rare, frequently fatal disease of the lungs – has been reported to occur in patients receiving a combination of Ionamin with fenfluramine or dexfenfluramine. The possibility of an association between PPH and the use of Ionamin® alone cannot be ruled out; there have been rare cases of PPH in patients who reportedly have taken Ionamin alone. The initial symptom of PPH is usually dyspnea. Other initial symptoms may 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, and patients should be evaluated for the possible presence of pulmonary hypertension.
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 Ionamin with fenfluramine or dexfenfluramine for weight loss. The possible role of Ionamin in 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 Ionamin® alone cannot be ruled out; there have been rare cases of valvular heart disease in patients who reportedly have taken Ionamin alone.
Development of Tolerance, Discontinuation in Case of Tolerance
When tolerance to the anorectant effect develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued.
Effect on the Ability to Engage in Potentially Hazardous Tasks
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.
Risk of Abuse and Dependence
Ionamin® is related chemically and pharmacologically to amphetamine (d- and dll-amphetamine) and other related 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. See Drug Abuse and Dependence (9) and Overdosage (10).
The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.
Usage With Alcohol
Concomitant use of alcohol with Ionamin® may result in an adverse drug reaction.
Use in Patients With Hypertension
Use caution in prescribing Ionamin® for patients with even mild hypertension (risk of increase in blood pressure).
Use in Patients on Insulin or
Oral Hypoglycemic Medications for Diabetes Mellitus
A reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be required.
What happens if I miss a dose of Ionamin?
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.
References
- DrugBank. "phentermine". http://www.drugbank.ca/drugs/DB00191 (accessed September 17, 2018).
- MeSH. "Central Nervous System Stimulants". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
