Phentermine Weight Loss Pills Review – Phentermine is an oral sympathomimetic amine used as an adjunct for the short-term (eg, 8-12 weeks) treatment of exogenous obesity. The pharmacologic effects of phentermine are similar to those of amphetamines. The Phentermine resin complex was approved by the FDA in 1959, but is no longer sold in the US. Phentermine hydrochloride was approved by the FDA in 1973. In the mid-90s, there was renewed interest in phentermine along 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pulmonary hypertension in women receiving a combination of fenfluramine and phentermine; Fenfluramine was subsequently withdrawn from the US market in the fall of 1997. The use of phentermine with other anorectic agents for obesity has not been evaluated and is not recommended. In May 2011, the FDA approved a phentermine hydrochloride olly disintegrating tablet (Suprenza) for the treatment of exogenous obesity.1
Limited data are available in reference texts regarding the mechanism of action of this drug. Phentermine is an analog of methamphetamine. Like amphetamines, phentermine increases the release of norepinephrine and dopamine from nerve terminals and inhibits their reuptake. Thus, phentermine is classified as an indirect sympathomimetic.2 Other effects include a weak ability to increase serotonin levels in a dose-dependent manner, although the effect on serotonin happens to be less potent than that of methamphetamine itself.3 Clinical effects include CNS stimulation and increased blood pressure. Appetite suppression is believed to occur through direct stimulation of the satiety center in the hypothalamic and limbic regions.
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Tolerance to the anorexiant effects of phentermine usually develops within a few weeks of starting therapy. The mechanism of tolerance appears to be pharmacodynamic in nature; higher doses of phentermine are required to produce the same response. When tolerance to the anorexiant effects develops, it is generally recommended to discontinue phentermine rather than increase the dose.
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Phentermine is given orally. The rate and extent of exposure of phentermine under fasting conditions are equivalent regardless of the oral formulation administered.1
There are limited data on the pharmacokinetics of phentermine. Phentermine is primarily excreted by the kidneys. The elimination half-life ranges from 19-24 hours and is influenced by urinary pH. Since the pKa of phentermine is 9.84, the elimination half-life decreases to approximately 7-8 hours under acidic urinary conditions.
Oral Route: Following oral administration, most of the absorption of phentermine occurs from the small intestine. The duration of action after administration of 8 mg capsules or tablets is about 4 hours and 12-14 hours after administration of 30 mg capsules or 37.5 mg tablets.
Phentermine oral disintegrating tablet (ODT) reaches maximum concentration (Cmax) 3—4.4 hours after administration. Swallowing water before swallowing ODT did not affect AUC. Despite decreases in Cmax (approximately 5%) and AUC (approximately 12%) when phentermine ODT is administered after a high-fat/high-calorie breakfast, phentermine ODT can be administered with food or nothing. Cmax and AUC were reduced by approximately 7% and 8%, respectively, when ODT was ingested without prior disintegration.1
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Renal Injury: Use with caution in patients with renal impairment. The cumulative urinary excretion of phentermine under uncontrolled urinary pH conditions is 62–85%, and increased exposure can be expected in patients with renal impairment.1
According to the manufacturers of phentermine capsules and tablets, its products are contraindicated in patients with heart disease, advanced arteriosclerosis, moderate to severe hypertension, agitated states, or glaucoma.6 Also, oral disintegrating tablets, are contraindicated in patients with a history of cardiac disease including coronary artery disease, stroke, cardiac arrhythmias, heart failure, and uncontrolled hypertension.5 Valvular heart disease has been reported in women receiving a combination of fenfluramine and phentermine; the safety and effectiveness 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, the simultaneous administration of these 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 first symptom of PPH is usually dyspnea. Other early symptoms include: angina pectoris, syncope, or lower extremity edema. Patients should be advised to report any deterioration in exercise tolerance immediately. Treatment should be discontinued in patients who develop new, unexplained symptoms of dyspnea, angina pectoris, syncope, or lower extremity edema.
Because phentermine 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 following the use of MAOI therapy or other drugs with MAO-inhibiting activity. Monoamine oxidase inhibitors (MAOIs), or drugs that possess MAO-inhibiting activity such as furazolidone or procarbazine, may prolong and intensify the cardiac stimulation and vasopressor effects of phentermine.4
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Phentermine is contraindicated in patients with agitated states. Exacerbating these effects or causing adverse drug reactions.4 Symptoms of chronic intoxication include insomnia, irritability, personality changes, and psychotic symptoms that may be clinically indistinguishable from other psychotic disorders, such as of schizophrenia. Phentermine may worsen certain mental conditions, such as patients who exhibit excessive nervousness or agitated behavior, including psychosis, mania, or severe anxiety.
The use of phentermine may 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 know how the therapy will affect their mental and/or motor performance. In general, ingestion of ethanol may exacerbate these effects or cause adverse drug reactions.4 Advise patients to avoid alcohol while taking phentermine.
Use phentermine cautiously in patients with diabetes mellitus. Insulin or other antidiabetic drug requirements may be altered in these patients when using phentermine during weight loss and due to altered dietary regimens. Patients should monitor their blood glucose regularly and follow their healthcare provider’s recommendations.5
Appetite suppressant therapy is not recommended for use in 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. Phentermine is chemically and pharmacologically related to the widely abused amphetamines. The possibility of phentermine abuse should be kept in mind when evaluating the desirability of including a drug as part of a weight loss program. The lowest amount that is reasonable should be prescribed or given at one time to limit the potential for drug abuse or diversion.5
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Phentermine products are now classified as FDA pregnancy risk category X, as are many anorexiants used for weight loss, and are contraindicated during pregnancy.56 The safe use of phentermine during pregnancy has not been established; there are no known indications for the use of phentermine during pregnancy. Phentermine should not be taken by pregnant women or by women who may become pregnant unless, in the doctor’s opinion, the potential benefits outweigh the possible risks.6
Abrupt discontinuation of phentermine after prolonged high doses may result in severe mental depression or severe fatigue; EEG changes during sleep were also noted. A gradual withdrawal of therapy is recommended. If immediate discontinuation is medically necessary, careful monitoring and symptom management is required.4
Phentermine is contraindicated during breast-feeding.5 It is not known whether phentermine and its metabolites are excreted in human milk; however, because of the potential for serious adverse effects in nursing infants, breastfeeding while taking phentermine is not recommended.76
The safety and effectiveness of phentermine in children have not been established. Phentermine is not recommended for children or adolescents under 16 years of age. 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 phentermine; use with caution in elderly patients. Patients with renal impairment may also be more susceptible to side effects. Increased exposure 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 inhalational anesthetics during surgery can sensitize the myocardium to the effects of sympathomimetic drugs. Because of this, and its effects on blood pressure, in general, phentermine should be stopped a few days before surgery. Avoid sudden stops.
Phentermine products are now classified as FDA pregnancy risk category X, as are many anorexiants used for weight loss, and are contraindicated during pregnancy.55 The safe use of phentermine during pregnancy has not been established; there are no known indications for the use of phentermine during pregnancy. Phentermine should not be taken by pregnant women or women who may become pregnant unless, in the doctor’s opinion, the potential benefits outweigh the possible risks.5
The safety of phentermine when used with other anorexiant agents such as amphetamine, benzphetamine, dexfenfluramine, dextroamphetamine, diethylpropion, ephedrine, fenfluramine, and sibutramine8 is controversial and simultaneous use should be avoided. The role of phentermine in production
