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. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia.
See Drug Abuse and Dependence 9. Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is a,a,-dimethylphenethylamine hydrochloride. The structural formula is as follows:. 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.
Phentermine hydrochloride capsule USP is available as an oral capsule containing 15 mg or 30 mg phentermine hydrochloride equivalent to 12 mg or 24 mg of phentermine base. Powder-filled capsules containing 15 mg phentermine hydrochloride equivalent to 12 mg phentermine or 30 mg phentermine hydrochloride equivalent to 24 mg phentermine and inactive ingredients: Typical actions 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. Following the administration of phentermine, phentermine reaches peak concentrations C max after 3 to 4. 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.
Studies have not been performed with phentermine to determine the potential for carcinogenesis, mutagenesis or impairment of fertility. 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.
Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure as required. 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 ].
Patients must be instructed on how much phentermine to take, and when and how to take it [see Dosage and Administration 2 ]. Advise pregnant women and nursing mothers not to use phentermine [see Use in Specific Populations 8. The risks include, but are not limited to:. Tell 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.
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We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. NDC National Drug Code - Each drug product is assigned this unique number which can be found on the drug's outer packaging. Phentermine should be discontinued in case of new, unexplained symptoms of dyspnea, angina pectoris, syncope or lower extremity edema. If this occurs, phentermine should be discontinued. The recommended dose should not be exceeded.
Discontinue drug or nursing taking into consideration importance of drug to mother. Safety and effectiveness not established. Due to substantial renal excretion, use with caution. Below is a chart of body mass index BMI based on various heights and weights. Capsules containing 15 mg or 30 mg phentermine hydrochloride equivalent to 12 mg or 24 mg phentermine base respectively 15 mg Capsules: History of cardiovascular disease e. The following adverse reactions are described, or described in greater detail, in other sections: Talk to your doctor if you are using marijuana.
If you have diabetes , check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication during treatment with this drug. If you are using the tablets made to dissolve in the mouth , your medication may contain aspartame. Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for dizziness and high blood pressure while using this drug.
This medication must not be used during pregnancy. It may harm an unborn baby. If you are pregnant or think you may be pregnant, tell your doctor right away. This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast -feeding is not recommended while using this drug. Consult your doctor before breast-feeding. What should I know regarding pregnancy, nursing and administering Phentermine HCL to children or the elderly?
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first. This drug should not be used with certain medications because very serious interactions may occur. If you are taking or have taken other appetite-suppressant drugs in the past year e.
Taking MAO inhibitors with this medication may cause a serious possibly fatal drug interaction. Avoid taking MAO inhibitors isocarboxazid , linezolid , methylene blue, moclobemide, phenelzine , procarbazine , rasagiline , safinamide, selegiline, tranylcypromine during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication.
Ask your doctor when to start or stop taking this medication. Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers such as codeine, hydrocodone , alcohol, marijuana , drugs for sleep or anxiety such as alprazolam , lorazepam , zolpidem , muscle relaxants such as carisoprodol , cyclobenzaprine , or antihistamines such as cetirizine , diphenhydramine. Check the labels on all your medicines such as allergy or cough -and-cold products because they may contain ingredients that cause drowsiness.
Ask your pharmacist about using those products safely. Some products have ingredients that could raise your heart rate or blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely especially cough -and-cold products or diet aids. Caffeine can increase the side effects of this medication. Avoid drinking large amounts of beverages containing caffeine coffee, tea, colas or eating large amounts of chocolate.
Make sure laboratory personnel and all your doctors know you use this drug. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
Does Phentermine HCL interact with other medications? If someone has overdosed and has serious symptoms such as passing out or trouble breathing , call Otherwise, call a poison control center right away. US residents can call their local poison control center at Canada residents can call a provincial poison control center. Symptoms of overdose may include: Appetite suppressants should not be used in place of proper diet. For best results, this drug must be used along with a doctor-approved diet and exercise program.
Do not share this medication with others. It is against the law. Consult your doctor for more details. If you miss a dose, take it as soon as you remember. If it is near the time of the next dose or late in the evening, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. Store in a tightly closed container at room temperature between degrees F degrees C away from light and moisture.
Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product. Information last revised July Copyright c First Databank, Inc. Phentermine Capsule Read Reviews Uses Side Effects Precautions Interactions Overdose Images Uses Uses Phentermine is used with a doctor-approved exercise , behavior change, and reduced-calorie diet program to help you lose weight.
How to use Phentermine HCL Take this medication by mouth as directed by your doctor, usually once a day, 1 hour before breakfast or 1 to 2 hours after breakfast. Side Effects Dizziness , dry mouth , difficulty sleeping, irritability, nausea , vomiting , diarrhea , or constipation may occur. In the US - Call your doctor for medical advice about side effects.
Precautions Before taking this medication , tell your doctor or pharmacist if you are allergic to it; or to any other sympathomimetic amines e. Before having surgery, tell your doctor or dentist that you are using this medication. Interactions Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Overdose If someone has overdosed and has serious symptoms such as passing out or trouble breathing , call Notes Appetite suppressants should not be used in place of proper diet.
Missed Dose If you miss a dose, take it as soon as you remember. Storage Store in a tightly closed container at room temperature between degrees F degrees C away from light and moisture.