Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. However, this medication may cause an increase in blood pressure that could possibly lead to nosebleeds. In Bray, George A. S4 Prescription only CA: It is chemically related to amphetamines and may also increase metabolism. Take the missed dose as soon as you remember. The Facts of Phentermine
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Phentermine may produce cardiovascular, gastrointestinal, and CNS side effects; rare cases of pulmonary hypertension and cardiac valvular disease have been reported. It should not be used by people who have a history of drug abuse , have cardiovascular disease , hyperthyroidism , glaucoma , or are pregnant , planning to become pregnant, or breast-feeding. It should not be taken by anyone taking a monoamine oxidase inhibitor.
Drinking alcohol while using phentermine may cause adverse effects. It was first introduced in , and became part of the drug combination fen-phen that was withdrawn from the market in due to the fenfluramine component damaging people's heart valves. Different formulations of phentermine as a single agent are available under various brand names, in many countries. Phentermine is used for a short period of time to promote weight loss, if exercise and calorie reduction are not sufficient, and in addition to exercise and calorie reduction.
Phentermine is approved for up to 12 weeks of use and most weight loss occurs in the first weeks. Phentermine use is contraindicated in those who: Phentermine may decrease the effect of drugs like clonidine , methyldopa , and guanethidine. Drugs to treat hypothyroidism may increase the effect of phentermine. Rare cases of pulmonary hypertension and cardiac valvular disease have been reported. There is no evidence that phentermine is safe for women who are pregnant. Other adverse effects include: Phentermine has some similarity in its pharmacodynamics with its parent compound, amphetamine , as they both are TAAR1 agonists ,  where the activation of TAAR1 in monoamine neurons facilitates the efflux or, release into the synapse, of these neurochemicals; at clinically relevant doses, phentermine primarily acts as a releasing agent of norepinephrine in neurons , although, to a lesser extent, it releases dopamine and serotonin into synapses as well.
The primary mechanism of phentermine's action in treating obesity is the reduction of hunger perception, which is a cognitive process mediated primarily through several nuclei within the hypothalamus in particular, the lateral hypothalamic nucleus , arcuate nucleus , and ventromedial nucleus. Outside the brain, phentermine releases norepinephrine and epinephrine — also known as noradrenaline and adrenaline respectively — causing fat cells to break down stored fat as well. In , phentermine first received approval from the United States FDA as an appetite-suppressing drug.
Phentermine was marketed with fenfluramine or dexfenfluramine as a combination appetite suppressant and fat burning agent under the popular name fen-phen. In , after 24 cases of heart valve disease in fen-phen users, fenfluramine and dexfenfluramine were voluntarily taken off the market at the request of the FDA.
Phentermine is still available by itself in most countries, including the US. In contrast, amphetamine preparations are classified as Schedule II controlled substances. For some patients, half tablet Phentermine Hydrochloride Tablets are indicated only as short-term a few weeks 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 prescribed drugs, over-the-counter preparations, and herbal products, or serotonergic agents such as selective serotonin reuptake inhibitors e.
Therefore, coadministration of phentermine and these drug products 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; there have been rare cases of PPH in patients who reportedly have taken phentermine 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.
The possible role of phentermine 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 phentermine alone cannot be ruled out; there have been rare cases of valvular heart disease in patients who reportedly have taken phentermine alone.
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. Phentermine 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. Phentermine is related chemically and pharmacologically to amphetamine d- and dll-amphetamine and other related stimulant drugs 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. See Drug Abuse and Dependence 9 and Overdosage The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. Concomitant use of alcohol with phentermine may result in an adverse drug reaction.
Use caution in prescribing phentermine for patients with even mild hypertension risk of increase in blood pressure. A reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be required. The following adverse reactions are described, or described in greater detail, in other sections:. Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis.
Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Use of phentermine is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis. Requirements may be altered [see Warnings and Precautions 5. Phentermine may decrease the hypotensive effect of adrenergic neuron blocking drugs.
Phentermine is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to obligatory weight gain that occurs in maternal tissues during pregnancy. Phentermine has pharmacologic activity similar to amphetamine d- and dll-amphetamine [see Clinical Pharmacology Animal reproduction studies have not been conducted with phentermine.
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. It is not known if phentermine is excreted in human milk; however, other amphetamines are present in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in pediatric patients have not been established. Because pediatric obesity is a chronic condition requiring long-term treatment, the use of this product, approved for short-term therapy, is not recommended. 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. Based on the reported excretion of phentermine in urine, exposure increases can be expected in patients with renal impairment [see Clinical Pharmacology Use caution when administering phentermine to patients with renal impairment.
Phentermine is related chemically and pharmacologically to the amphetamines. Amphetamines and other stimulant drugs have been extensively abused and 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. Abuse of amphetamines 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 these drugs to many times than 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. A severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.
Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmia, hypertension or hypotension, and circulatory collapse.
Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Overdosage of pharmacologically similar compounds has resulted in fatal poisoning usually terminates in convulsions and coma. Management of acute phentermine hydrochloride 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 phentermine excretion. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia. See Drug Abuse and Dependence 9.