However, limited data in adults suggests that phentermine is non-addictive and produces no withdrawal-like symptoms. Sleepiness symptom score 0. Following the administration of phentermine, phentermine reaches peak concentrations C max after 3. They used stimulant obesity medication for longer and at higher 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. The case report by Steidl et al. International Journal of Obesity 38, —; doi: Safety Data Sheets - An Introduction safety training video - GHS compliant Safetycare
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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.
Requirements may be altered [ see Warnings and Precautions 5. 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 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.
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 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 that 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 tachycardia, 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. Phentermine hydrochloride USP is a sympathomimetic amine anorectic. 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.
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.
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. Available in tablets and capsules containing Dispense in a tight container as defined in the USP, with a child-resistant closure as required. The risks include, but are not limited to:. Your doctor will adjust the dose to find the best dose for you. Use this medication regularly and exactly as prescribed in order to get the most benefit from it.
To help you remember, take it at the same time s each day. This medication is usually taken for only a few weeks at a time. It should not be taken with other appetite suppressants see also Drug Interactions section. The possibility of serious side effects increases with longer use of this medication and use of this drug along with certain other diet drugs. This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses.
In such cases, withdrawal symptoms such as depression , severe tiredness may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away. Though it helps many people, this medication may sometimes cause addiction. Do not increase your dose, take it more often, or use it for a longer time than prescribed.
Properly stop the medication when so directed. This medication may stop working well after you have been taking it for a few weeks. Talk with your doctor if this medication stops working well. Do not increase the dose unless directed by your doctor. Your doctor may direct you to stop taking this medication. What conditions does Phentermine HCL treat?
Dizziness , dry mouth , difficulty sleeping, irritability, nausea , vomiting , diarrhea , or constipation may occur. If these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This medication may raise your blood pressure.
Check your blood pressure regularly and tell your doctor if the results are high. Tell your doctor right away if any of these unlikely but serious side effects occur: Stop taking this medication and seek immediate medical attention if any of these rare but very serious side effects occur: This drug may rarely cause serious sometimes fatal lung or heart problems pulmonary hypertension , heart valve problems.
If you notice any of the following unlikely but very serious side effects, stop taking this medication and consult your doctor or pharmacist right away: A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Call your doctor for medical advice about side effects. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at List Phentermine HCL side effects by likelihood and severity. Before taking this medication , tell your doctor or pharmacist if you are allergic to it; or to any other sympathomimetic amines e. This product may contain inactive ingredients, which can cause allergic reactions or other problems.
Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: Before using this medication, tell your doctor or pharmacist your medical history, especially of: This drug may make you dizzy or blur your vision. It may also rarely make you drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely.
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.