Adipex-P 37.5mg Capsules

Manufacturer TEVA Active Ingredient Phentermine(FEN ter meen) Pronunciation FEN ter meen
It is used for weight loss.
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Drug Class
Anorexiant
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Pharmacologic Class
Sympathomimetic amine; Central nervous system stimulant
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Pregnancy Category
Category X
FDA Approved
May 1959
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DEA Schedule
Schedule IV

Overview

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What is this medicine?

Phentermine is a prescription medication used for a short period of time to help people lose weight. It works by affecting certain chemicals in your brain to decrease your appetite. It should be used along with a doctor-approved diet, exercise, and behavior change program.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. The dosage schedule for this medication varies depending on the product. Some products are taken once daily, either before breakfast or 1 to 2 hours after breakfast. Others are taken multiple times a day, 30 minutes before meals. It's essential to understand the specific dosage schedule for your medication.

To minimize potential sleep disturbances, avoid taking this medication late in the evening. If you have any questions or concerns about taking your medication, consult your doctor or pharmacist.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding storage in a bathroom. Keep your medication in a safe and secure location, out of sight and reach of children and pets, and inaccessible to others. Consider using a locked box or area to store your medication.

When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist or healthcare provider. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to explore drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosage schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Follow a reduced-calorie diet as prescribed by your doctor or dietitian.
  • Engage in regular physical activity as recommended by your healthcare provider.
  • Adopt healthy eating habits and behavior modifications to support long-term weight management.
  • Avoid alcohol while taking this medication, as it can increase side effects.
  • Do not take phentermine in the evening, as it can cause insomnia.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 37.5 mg orally once daily before breakfast or 1-2 hours after breakfast
Dose Range: 15 - 37.5 mg

Condition-Specific Dosing:

obesity: For short-term (a few weeks) use in conjunction with a regimen of weight reduction based on caloric restriction, exercise, and behavior modification in patients with an initial BMI of 30 kg/m² or greater, or 27 kg/m² or greater with at least one weight-related comorbidity (e.g., hypertension, diabetes, dyslipidemia).
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established (Safety and efficacy not established in patients under 16 years of age)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, but use with caution.
Moderate: Use with caution; consider lower dose (e.g., 15 mg).
Severe: Contraindicated (CrCl < 15 mL/min).
Dialysis: Contraindicated

Hepatic Impairment:

Mild: No specific adjustment recommended, but use with caution.
Moderate: Use with caution; consider lower dose.
Severe: Use with caution; not well-studied.

Pharmacology

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Mechanism of Action

Phentermine is a sympathomimetic amine with pharmacologic activity similar to the amphetamines. It stimulates the release of norepinephrine from nerve terminals in the hypothalamus, leading to appetite suppression. It also causes the release of dopamine and, to a lesser extent, serotonin. The primary mechanism for appetite suppression is believed to be through its effects on the central nervous system, particularly the satiety center in the hypothalamus.
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Pharmacokinetics

Absorption:

Bioavailability: Not precisely quantified, but well-absorbed.
Tmax: 3-4.4 hours
FoodEffect: Food may slightly delay absorption but does not significantly affect overall bioavailability. Can be taken with or without food, but typically recommended before breakfast or 1-2 hours after.

Distribution:

Vd: Not precisely quantified, but widely distributed.
ProteinBinding: Not extensively protein bound (approx. 17%).
CnssPenetration: Yes

Elimination:

HalfLife: 19-24 hours (can be prolonged in alkaline urine)
Clearance: Primarily renal clearance; dependent on urinary pH.
ExcretionRoute: Renal (urine)
Unchanged: Approximately 70-80% excreted unchanged in urine, depending on urinary pH.
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Pharmacodynamics

OnsetOfAction: Within 1-2 hours
PeakEffect: 3-4.4 hours
DurationOfAction: 12-20 hours

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness or fainting
+ Changes in vision
Changes in behavior or mood
Shakiness
Rare but serious side effects, including:
+ Heart valve problems
+ Increased pressure in the lungs (which can be fatal)
+ If you experience any of the following, call your doctor right away:
- Dizziness or fainting
- Persistent tiredness or weakness
- Fast or abnormal heartbeat
- Chest pain
- Shortness of breath
- Swelling in your arms or legs
- Decreased ability to exercise

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, or if they bother you or persist, contact your doctor or seek medical help:

Dizziness or headache
Feeling nervous or excitable
Diarrhea or constipation
Dry mouth
Trouble sleeping
Bad taste in your mouth
Decreased interest in sex
Erectile dysfunction
Restlessness

This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Chest pain, shortness of breath, or difficulty breathing (especially with exertion)
  • Fainting or dizziness
  • Swelling in your ankles or legs
  • Unusual changes in mood or behavior (e.g., severe anxiety, agitation, restlessness, hallucinations)
  • Severe headache
  • Blurred vision
  • Numbness or weakness on one side of the body
  • Slurred speech
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions and situations to ensure safe treatment:

Any allergies you have, including allergies to this medication, other drugs, foods, or substances, and the symptoms you experienced.
A history of heart disease, including heart failure or abnormal heartbeat, as well as high blood pressure or stroke.
Existing health conditions such as glaucoma, agitation, anxiety, or an overactive thyroid gland.
Kidney disease or dialysis treatment.
Recent use (within the last 14 days) of certain medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to very high blood pressure.
Current use of medications such as fluoxetine, fluvoxamine, linezolid, methylene blue, paroxetine, or sertraline.
Use of any other weight loss medications, whether prescription, over-the-counter, or natural products.
Pregnancy or potential pregnancy, as this medication should not be taken during pregnancy.
* Breast-feeding, as you should not breast-feed while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine the safety of taking this medication with your other treatments and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require your full attention, such as driving, wait until you understand how this medication affects you.

Adhere to your doctor's prescribed duration for taking this medication. Do not exceed the recommended treatment period. If you have been taking this medication for an extended time or at high doses, you may develop tolerance, which means the medication may not be as effective, and you may require higher doses to achieve the same effect. If you notice the medication is not working as well as it previously did, contact your doctor. Do not take more than the prescribed amount.

If you have been taking this medication for several weeks, consult your doctor before stopping its use. Your doctor may recommend gradually tapering off the medication to minimize potential withdrawal effects. Be aware that this medication can be habit-forming, and long-term use should be avoided. If you have a history of substance or alcohol abuse, inform your doctor.

Before initiating treatment with this medication, your doctor may require you to undergo certain heart tests. If you have any questions or concerns, discuss them with your doctor. Monitor your blood pressure and heart rate as instructed by your doctor.

If you have diabetes and are taking medications to manage your blood sugar levels, consult your doctor. Weight loss can increase the risk of hypoglycemia (low blood sugar) in individuals taking diabetes medications. Be aware of the signs of low blood sugar, which include dizziness, headache, drowsiness, weakness, tremors, rapid heartbeat, confusion, hunger, and sweating. If you experience any of these symptoms, contact your doctor immediately.

Follow the diet and exercise plan recommended by your doctor. Additionally, consult your doctor before consuming alcohol. This medication is not intended for children under the age of 17; do not administer it to them.
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Overdose Information

Overdose Symptoms:

  • Restlessness
  • Tremor
  • Hyperreflexia
  • Rapid breathing
  • Confusion
  • Assaultiveness
  • Hallucinations
  • Panic states
  • High fever
  • Overactive reflexes
  • Rapid or irregular heartbeat
  • High or low blood pressure
  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal cramps
  • Convulsions
  • Coma

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management is primarily supportive, including gastric lavage, activated charcoal, and sedation for CNS overstimulation. Acidification of the urine may increase phentermine excretion.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI use due to risk of hypertensive crisis)
  • Other anorectic agents (e.g., fenfluramine, dexfenfluramine, sibutramine) due to risk of primary pulmonary hypertension and/or valvular heart disease
  • Other sympathomimetic amines (e.g., pseudoephedrine, ephedrine, stimulants)
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Major Interactions

  • Alcohol (may enhance CNS effects and increase risk of adverse cardiovascular effects)
  • Antihypertensive agents (e.g., guanethidine, clonidine, methyldopa - phentermine may antagonize their effects, leading to increased blood pressure)
  • Thyroid hormones (may increase CNS stimulation and cardiovascular effects)
  • Serotonergic drugs (e.g., SSRIs, SNRIs, triptans - theoretical risk of serotonin syndrome, though less pronounced than with other anorexiants)
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Moderate Interactions

  • Insulin and oral hypoglycemic agents (phentermine may alter blood glucose levels, requiring dosage adjustment of antidiabetic agents)
  • Tricyclic antidepressants (TCAs - may potentiate the pressor effects of phentermine)
  • Caffeine and other CNS stimulants (additive stimulant effects)
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Minor Interactions

  • Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide - may increase phentermine half-life and duration of action)
  • Urinary acidifiers (e.g., ammonium chloride, ascorbic acid - may decrease phentermine half-life and duration of action)

Monitoring

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Baseline Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Rationale: Phentermine is a sympathomimetic and can cause increases in BP and HR. Baseline assessment is crucial to identify contraindications or high-risk patients.

Timing: Prior to initiation of therapy

Weight and BMI

Rationale: To establish baseline and track efficacy.

Timing: Prior to initiation of therapy

Medical History (especially cardiovascular, psychiatric, and substance abuse)

Rationale: To identify contraindications (e.g., history of cardiovascular disease, uncontrolled hypertension, hyperthyroidism, glaucoma, agitated states, history of drug abuse) and assess risk.

Timing: Prior to initiation of therapy

Electrolytes, Renal and Hepatic Function

Rationale: To assess baseline organ function, especially renal function due to excretion pathway and contraindication in severe impairment.

Timing: Prior to initiation of therapy (if clinically indicated)

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Routine Monitoring

Blood Pressure (BP) and Heart Rate (HR)

Frequency: Regularly, at each follow-up visit (e.g., monthly)

Target: Maintain within acceptable limits; significant increases warrant discontinuation.

Action Threshold: Sustained elevation above baseline or development of hypertension (e.g., >140/90 mmHg) or tachycardia (e.g., >100 bpm) warrants re-evaluation and potential discontinuation.

Weight and BMI

Frequency: Regularly, at each follow-up visit (e.g., monthly)

Target: Evidence of weight loss (e.g., 5% weight loss in 12 weeks)

Action Threshold: Lack of significant weight loss after 4-12 weeks may indicate non-response and warrant discontinuation.

Signs and Symptoms of Pulmonary Hypertension or Valvular Heart Disease

Frequency: Periodically, at each follow-up visit

Target: Absence of symptoms

Action Threshold: Development of dyspnea, chest pain, syncope, or lower extremity edema warrants immediate discontinuation and cardiac evaluation.

Psychiatric Status (mood, anxiety, agitation)

Frequency: Regularly, at each follow-up visit

Target: Stable mood, absence of excessive agitation or anxiety

Action Threshold: Development or worsening of agitation, anxiety, insomnia, or psychotic symptoms warrants re-evaluation and potential discontinuation.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath (dyspnea)
  • Fainting (syncope)
  • Swelling in ankles/legs (peripheral edema)
  • Palpitations
  • Dizziness
  • Agitation
  • Anxiety
  • Insomnia
  • Restlessness
  • Tremor
  • Headache
  • Dry mouth
  • Constipation
  • Unusual changes in mood or behavior

Special Patient Groups

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Pregnancy

Contraindicated (Category X). Phentermine can cause fetal harm. Weight loss during pregnancy offers no benefit to the 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.

Trimester-Specific Risks:

First Trimester: Potential for fetal malformations and adverse developmental effects.
Second Trimester: Risk of fetal growth restriction and other adverse outcomes.
Third Trimester: Risk of fetal growth restriction and other adverse outcomes.
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Lactation

Not recommended (L4 - Possibly Hazardous). Phentermine is excreted into breast milk. Due to the potential for serious adverse reactions in the breastfed infant (e.g., stimulation, cardiovascular effects), 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.

Infant Risk: Irritability, insomnia, poor feeding, weight loss, cardiovascular effects (e.g., tachycardia).
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Pediatric Use

Safety and efficacy have not been established in pediatric patients under 16 years of age. Use is generally not recommended.

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Geriatric Use

Use with caution in elderly patients (65 years and older) due to the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy. Start with the lowest effective dose (e.g., 15 mg) and monitor closely for adverse effects, especially cardiovascular and CNS effects.

Clinical Information

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Clinical Pearls

  • Phentermine is indicated for short-term use (a few weeks) only, as its effectiveness tends to wane over time and the risks of long-term use (e.g., pulmonary hypertension) are significant.
  • It is crucial to emphasize that phentermine is an adjunct to, not a substitute for, a comprehensive weight management program including diet, exercise, and behavior modification.
  • Patients should be carefully screened for cardiovascular disease, uncontrolled hypertension, hyperthyroidism, glaucoma, and history of drug abuse before initiation.
  • Monitor blood pressure and heart rate regularly. Discontinue if sustained increases occur.
  • Educate patients on the signs and symptoms of pulmonary hypertension (e.g., dyspnea, chest pain, syncope) and valvular heart disease, and instruct them to seek immediate medical attention if these occur.
  • Avoid evening dosing to prevent insomnia.
  • Tolerance to the anorectic effect usually develops within a few weeks. When this occurs, the drug should be discontinued rather than increasing the dose.
  • Withdrawal symptoms (e.g., fatigue, depression) may occur upon abrupt discontinuation, especially after prolonged high-dose use. Tapering may be considered.
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Alternative Therapies

  • Orlistat (Xenical, Alli)
  • Bariatric surgery (for eligible patients)
  • Lifestyle interventions alone (diet, exercise, behavior therapy)
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Cost & Coverage

Average Cost: $15 - $50 per 30 capsules (generic 37.5mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 for generic; Tier 3 or higher for brand names. Coverage varies widely by insurance plan and may require prior authorization.
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.