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Phentermine - FDA prescribing information, side effects and uses

Openmedi.orgPhentermine 37.5mg side effects


6/16/2014
01:45 | Author: Kayla Henderson

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Phentermine - FDA prescribing information, side effects and uses

Impotence, changes in libido.

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

Phentermine hydrochloride tablets 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/m 2, or ≥ 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).

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The usual adult dose is one tablet (37.5 mg) daily, as prescribed by the physician, administered before breakfast or 1 to 2 hours after breakfast. The dosage may be adjusted to the patient’s need. For some patients, half tablet (18.75 mg) daily may be adequate, while in some cases it may be desirable to give half tablets (18.75 mg) two times a day.

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.

In relatively short-term clinical trials, adult obese subjects instructed in dietary management and treated with “anorectic” drugs lost more weight on the average than those treated with placebo and diet.

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

Patients must be informed that Phentermine hydrochloride is 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, and that coadministration of Phentermine with other drugs for weight loss is not recommended [ see Indications and Usage ( 1 ) and Warnings and Precautions ( 5.1 ) ]

A reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be required.

WADA Class WADA Anti-Doping Classification.

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The patients must also be informed about.

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Concomitant use of alcohol with Phentermine may result in an adverse drug reaction.

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.

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.g., fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. Therefore, coadministration of Phentermine and these drug products is not recommended.

l patients to keep Phentermine in a safe place to prevent theft, accidental overdose, misuse or abuse. Selling or giving away Phentermine may harm others and is against the law. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 Manufactured by: InvaGen Pharmaceuticals, Inc Hauppauge, NY 11788 Rev: 02/14.

See also, for example, Adverse Reactions ( 6 ) and Use in Specific Populations ( 8 ).

C 10 H 15 N•HCl M.W. 185.7.

CNS stimulants Adderall, Vyvanse, Concerta, Ritalin, methylphenidate, Strattera.

The limited usefulness of agents of this class, including Phentermine hydrochloride tablets USP, [ see Clinical Pharmacology ( 12.1, 12.2 ) ] should be measured against possible risk factors inherent in their use such as those described below. Exogenous Obesity.

Use of Phentermine is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis.

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Studies have not been performed with Phentermine to determine the potential for carcinogenesis, mutagenesis or impairment of fertility.

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

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 d l l-amphetamine) [ see Clinical Pharmacology ( 12.1 ) ]. 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.

Phentermine hydrochloride is not recommended for use in pediatric patients ≤ 16 years of age.

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

Dosage should be individualized to obtain an adequate response with the lowest effective dose.

Patients must be instructed on how much Phentermine to take, and when and how to take it [ see Dosage and Administration ( 3 ) ]

Following the administration of Phentermine, Phentermine reaches peak concentrations (C max ) after 3 to 4.4 hours. Drug Interactions.

Requirements may be altered [ see Warnings and Precautions ( 5.9 ) ]

Patients must be informed about the risks of use of Phentermine (including the risks discussed in Warnings and Precautions), about the symptoms of potential adverse reactions and when to contact a physician and/or take other action. The risks include, but are not limited to:

Tablets containing 37.5 mg Phentermine hydrochloride (equivalent to 30 mg Phentermine base).

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Phentermine hydrochloride tablet USP is available as an oral tablet containing 37.5 mg of Phentermine hydrochloride (equivalent to 30 mg of Phentermine base). Each Phentermine hydrochloride tablet also contains the following inactive ingredients: lactose monohydrate, dibasic calcium phosphate anhydrous, microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, sugar spheres and magnesium stearate.

The natural history of obesity is measured over several years, whereas the studies cited are restricted to a few weeks’ duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.

Phentermine is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and d l l-amphetamine). Drugs of this class used in obesity are commonly known as “anorectics” or “anorexigenics.” It has not been established that the primary action of such drugs in treating obesity is one of appetite suppression since other central nervous system actions, or metabolic effects, may also be involved.

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

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 is related chemically and pharmacologically to amphetamine (d- and d l l-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 ( 10 ).

Typical of amphetamines include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for.

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Coffee contains beneficial nutrients, but fattening sweeteners can dampen these benefits. The Academy of Nutrition and Dietetics offers this advice when it.

Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis. Gastrointestinal.

CSA Schedule 4 Some potential for abuse.

Below is a chart of body mass index (BMI) based on various heights and weights.

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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 C max and AUC increase 13% and 42%, respectively. Specific Populations Renal Impairment.

Availability Rx Prescription only.

Approval History Calendar Drug history at FDA.

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.

Pregnancy Category X Not for use in pregnancy.

The following adverse reactions are described, or described in greater detail, in other sections:

Phentermine was not studied in patients with renal impairment. The literature reported cumulative urinary excretion of Phentermine under uncontrolled urinary pH conditions is 62% to 85%. Exposure increases can be expected in patients with renal impairment. Use caution when administering Phentermine to patients with renal impairment.

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Phentermine was not studied in patients with renal impairment. Based on the reported excretion of Phentermine in urine, exposure increases can be expected in patients with renal impairment. Use caution when administering Phentermine to patients with renal impairment [ see Clinical Pharmacology ( 12.3 ) ]

Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether.

Data sources include Micromedex (updated Sep 26th, 2014), Cerner Multum (updated Oct 16th, 2014), Wolters Kluwer (updated Oct 9th, 2014) and others. To view content sources and attributions, refer to our editorial policy.

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).

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.

Phentermine Hydrochloride 37.5 mg- 30 Tablets.

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. 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.

Phentermine may decrease the hypotensive effect of adrenergic neuron blocking drugs. Teratogenic Effects Pregnancy Category X.

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 immediay 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.

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

Advise pregnant women and nursing mothers not to use Phentermine [ see Use in Specific Populations ( 8.1, 8.3 ) ]

Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows:

Generic Name: Phentermine hydrochloride Dosage Form: tablet.

Late evening medication should be avoided because of the possibility of resulting insomnia.

Store at 20° to 25°C (68° to 77°F).

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Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevation of blood pressure, ischemic events. Central Nervous System.

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.

Keep out of the reach of children.

Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia. See Drug Abuse and Dependence ( 9.3 ).

Phentermine hydrochloride tablets USP 37.5 mg contains Phentermine hydrochloride (equivalent to 30 mg Phentermine base). Available in white with blue specks, modified capsule shaped, biconvex tablets debossed with I on the left side of bisect and G on the right side of bisect on one side and 359 on the other. Supplied in bottles of 30s (NDC, 100’s (NDC and 1000s (NDC.

Limiting you and family members to appropriate portion sizes can help maintain healthy weights and avoid overeating. The Letsmove.gov website offers these.

The following adverse reactions to Phentermine have been identified: Cardiovascular.

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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.

Phentermine is a Schedule IV controlled substance.

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 37.5mg side effects