Over The Counter Weight Loss Pills Like Phentermine – Phentamine is an oral sympathomimetic amine used as an adjunct for short-term (eg, 8-12 weeks) treatment of exogenous obesity. The pharmacological effects of phentamine are similar to amphetamines. Phentermine resin complex was approved by the FDA in 1959, but is no longer marketed in the US. Phentermine hydrochloride was FDA approved in 1973. In the mid-90s, there was renewed interest in phentermine in combination with another anorectic, fenfluramine, for the treatment of obesity and substance abuse, however, little scientific data supports this practice. On July 8, 1997, the FDA issued a ‘Dear Health Care Professional’ letter warning physicians about the development of valvular heart disease and pulmonary hypertension in women receiving the combination of fenfluramine and phentermine; Fenfluramine was subsequently withdrawn from the US. In May 2011, the FDA approved a phentermine hydrochloride oral disintegrating tablet (Suprenza) for the treatment of exogenous obesity.
Limited data are available in reference texts about the mechanism of action of this drug. Phentamine is an analogue of methamphetamine. Similar to the amphetamines, phentamine increases the release of norepinephrine and dopamine from nerve terminals and inhibits their reuptake. Thus, phentamine is classified as an indirect sympathomimetic.2 Other effects include a weak ability to dose-dependently increase serotonin levels, although the effect on serotonin levels is less strong than that of methamphetamine itself.3 Clinical effects include CNS stimulation and elevation of blood pressure. Appetite suppression is believed to occur through direct stimulation of the satiety center in the hypothalamic and limbic region.
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Tolerance to the anorexic effect of phentermine usually develops within a few weeks of starting therapy. The mechanism of tolerance is pharmacodynamic in nature; Higher doses of phentermine are required to produce the same response. When tolerance develops to the anorexic effect, it is generally recommended that phentermine be discontinued rather than the dose increased.
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Phentermine is administered orally. The rate and extent of phentermine exposure under fasting conditions is equivalent regardless of oral formulation administered.
Limited data exist on the pharmacokinetics of phentermine. Phentermine is primarily excreted through the kidneys. The elimination half-life ranges from 19 to 24 hours and is influenced by urinary pH. Because the pKa of phentermine is 9.84, the elimination half-life decreases to about 7-8 hours under acidic urinary conditions.
Oral route: After oral administration, most absorption of phentermine occurs from the small intestine. The duration of action after administration of the 8 mg capsules or tablets is about 4 hours and 12-14 hours after administration of the 30 mg capsules or the 37.5 mg tablets.
Phentermine oral disintegrating tablet (ODT) reaches peak concentrations (Cmax) 3-4.4 hours after administration. Water ingestion before swallowing the ODT did not affect the AUC. Despite a decrease in Cmax (approximately 5%) and AUC (approximately 12%) when phentermine ODT was administered after a high-fat/high-calorie breakfast, phentermine ODT can be administered with or without food. The Cmax and AUC are decreased by approximately 7% and 8%, respectively, when the ODT is swallowed without prior disintegration.
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Renal Impairment: Use with caution in patients with renal impairment. Cumulative urinary excretion of phentermine under uncontrolled urinary pH conditions is 62-85%, and exposure increases can be expected in patients with renal impairment.
According to the manufacturers of Phentamine capsules and tablets, its products are contraindicated in patients with cardiac disease, advanced arteriosclerosis, moderate to severe hypertension, agitated states or glaucoma. Diseases include coronary artery disease, stroke, cardiac arrhythmias, heart failure and uncontrolled hypertension. The safety and efficacy of combination therapy with phentermine and any other drug products for weight loss, including selective serotonin reuptake inhibitors (eg, fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. Therefore, coadministration of the drug products for weight loss is not recommended. Additionally, primary pulmonary hypertension (PPH) has been reported to occur in patients receiving a combination of phentermine with fenfluramine or dexfenfluramine. The possibility of an association between the use of phentermine alone and PPH or valvular heart disease 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 immediately report any deterioration in exercise tolerance. Treatment should be stopped in patients who develop new, unexplained symptoms of dyspnea, angina pectoris, syncope, or lower extremity edema.
Because phentamine is a sympathomimetic agent, it is contraindicated in patients with hyperthyroidism. It should also be used with caution in patients with thyroid disease.
Phentermine is contraindicated for use during or within 14 days after the use of MAOI therapy or other drugs with MAO-inhibiting activity. Monoamine oxidase inhibitors (MAOIs), or drugs possessing MAO-inhibiting activity such as furazolidone or procarbazine, may prolong and intensify the cardiac stimulation and vasopressor effects of phentermine.
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Phentermine is contraindicated in patients with agitated states. exacerbate the effects or cause an adverse drug reaction.4 Symptoms of chronic intoxication include insomnia, irritability, changes in personality, and psychotic symptoms that may be clinically indistinguishable from other psychotic disorders, such as schizophrenia. Phentermine may exacerbate certain mental conditions, such as those patients who exhibit highly nervous or agitated behavior, including psychosis, mania, or severe anxiety.
The use of phentermine can cause dizziness, mask signs of fatigue or the need for rest, or impair a patient’s ability to participate in activities that require mental alertness. Advise patients to use caution when driving or operating machinery, or performing other tasks that require mental alertness until they are aware of how therapy will affect their mental and/or motor performance. In general, ethanol ingestion may intensify the effects or cause an adverse drug reaction.4 Advise patients to avoid alcohol while taking phentermine.
Use phentermine cautiously in patients with diabetes mellitus. Requirements for insulin or other antidiabetic medications may be altered in these patients when using phentamine during weight loss and due to altered dietary regimen. Patients should monitor their blood glucose regularly and follow the recommendations of their health care provider.5
Appetite suppressant therapy is not recommended for patients with a history of anorexia nervosa or other eating disorders. The use of phentermine is contraindicated in patients with a known history of drug or substance abuse. Phentamine is chemically and pharmacologically related to the amphetamines which have been extensively abused. The possibility of abuse of phentermine should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. The smallest amount equal should be prescribed or dispensed at one time in order to limit the potential for overuse or drug diversion.
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Phentermine products are now classified as FDA pregnancy risk category X, like many anorectants used for weight loss, and are contraindicated during pregnancy.56 Safe use of phentermine during pregnancy has not been established; There is no known indication for use of phentermine during pregnancy. Phentermine should not be taken by pregnant women or by women who may become pregnant unless, in the opinion of the doctor, the potential benefits outweigh the possible hazards.
Abrupt discontinuation of phentermine after prolonged high doses may result in severe mental depression or extreme fatigue; Sleep EEG changes were also noted. Gradual withdrawal of therapy is recommended. If immediate discontinuation is medically necessary, careful monitoring and symptom management is warranted.4
Phentermine is contraindicated during breastfeeding.5 It is not known whether phentermine and its metabolites are excreted in breast milk; However, because of the potential for serious adverse effects in nursing infants, breastfeeding while taking phentermine is not recommended.76
Safety and effectiveness of phentermine in children have not been established. Phentermine is not recommended for children or adolescents 16 years and under. There is no established use of phentermine in infants or neonates.45
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The debilitated or geriatric patient may be more susceptible to the CNS and sympathomimetic side effects of phentamine; Use with caution in elderly patients. Patients with renal impairment may also be more susceptible to side effects. Exposure increases can be expected in patients with renal impairment or renal failure. Use caution when administering phentermine to patients with renal impairment.4
The use of inhalation anesthetics during surgery may sensitize the myocardium to the effects of sympathomimetic drugs. Because of this, and its effect on blood pressure, in general, phentermine should be discontinued several days before surgery. Avoid sudden stops.
Phentermine products are now classified as FDA pregnancy risk category X, like many anorectants used for weight loss, and are contraindicated during pregnancy.55 Safe use of phentermine during pregnancy has not been established; There is no known indication for use of phentermine during pregnancy. Phentermine should not be taken by pregnant women or by women who may become pregnant unless, in the opinion of the doctor, the potential benefits outweigh the possible hazards.
The safety of phentermine when used with other anorexic agents such as amphetamine, benamphetamine, dexphenfluramine, dextroamphetamine, diethylpropion, ephedrine, fenfluramine, and sibutramine8 is controversial and concurrent use should be avoided. The role of phentermine in the production
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