Phentermine 37.5mg Capsules

Manufacturer KVK 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
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Pregnancy Category
Category X
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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 short-term weight loss. It works by affecting certain chemicals in your brain to help reduce 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, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions precisely. The dosage schedule for this medication may vary depending on the product. Some products are designed to be taken once daily, either before breakfast or 1 to 2 hours after breakfast. Others may need to be taken multiple times a day, approximately 30 minutes before meals. It's crucial to understand the specific dosage schedule recommended 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 for guidance.

Storing and Disposing of Your Medication

To maintain the quality and safety of your medication, store it at room temperature in a dry place, avoiding bathrooms. Keep your medication in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to store your medication. Keep all medications out of reach of pets.

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 local drug take-back programs in your area.

Missing 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.
  • Adopt healthy eating habits and lifestyle changes for long-term weight management.
  • Avoid alcohol while taking phentermine.
  • Do not take phentermine in the evening as it can cause insomnia.

Dosing & Administration

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Adult Dosing

Standard Dose: 37.5 mg orally once daily in the morning, before breakfast or 1-2 hours after breakfast.
Dose Range: 15 - 37.5 mg

Condition-Specific Dosing:

Initial Therapy: Typically 15 mg or 30 mg once daily, titrated up to 37.5 mg if needed and tolerated.
Short-term Use: Indicated for short-term (a few weeks) use in conjunction with a regimen of weight reduction based on caloric restriction, exercise, and behavior modification.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not recommended for children under 16 years of age. Safety and efficacy not established.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment recommended, but use with caution.
Moderate: Consider dose reduction (e.g., 15 mg daily) or avoid use due to increased systemic exposure and potential for accumulation.
Severe: Contraindicated.
Dialysis: Contraindicated. Not dialyzable to a significant extent.

Hepatic Impairment:

Mild: No specific dose adjustment recommended, but use with caution.
Moderate: Use with caution; consider lower doses. Data are limited.
Severe: Contraindicated. Data are limited.

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 may also cause the release of dopamine and serotonin, contributing to its anorectic effects. The exact mechanism of action in weight reduction is not fully understood.
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Pharmacokinetics

Absorption:

Bioavailability: Not precisely quantified, but well absorbed.
Tmax: 3-4 hours
FoodEffect: Food may slightly delay absorption but does not significantly affect the extent of absorption. Can be taken before or 1-2 hours after breakfast.

Distribution:

Vd: Not precisely quantified, but widely distributed.
ProteinBinding: Not extensively protein bound (approximately 17%).
CnssPenetration: Yes, readily crosses the blood-brain barrier.

Elimination:

HalfLife: 19-24 hours (highly variable, pH-dependent)
Clearance: Renal clearance is significant and pH-dependent.
ExcretionRoute: Renal (primarily unchanged)
Unchanged: 70-80% (dependent on urine pH)
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Pharmacodynamics

OnsetOfAction: Within 1-2 hours
PeakEffect: 3-4 hours (correlates with Tmax)
DurationOfAction: Approximately 12-14 hours (due to long half-life and sustained release formulations)
Confidence: High

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 or dizziness
+ Passing out
+ Changes in eyesight
Changes in behavior or mood
Shakiness
Heart valve problems or increased pressure in the lungs, which can be life-threatening. If you experience any of the following, call your doctor right away:
+ Dizziness or passing out
+ 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
Difficulty getting or maintaining an erection
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
  • Fainting spells
  • Swelling in the ankles or legs
  • Severe headache
  • Blurred vision
  • Palpitations or racing heart
  • Unusual changes in mood or behavior
  • Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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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.
Presence of certain health conditions, such as glaucoma, agitation, anxiety, or an overactive thyroid gland.
Kidney disease or being on dialysis, as this may affect how your body processes the medication.
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, due to the risk of severely high blood pressure.
Current use of medications such as fluoxetine, fluvoxamine, linezolid, methylene blue, paroxetine, or sertraline, as these can interact with this drug.
Use of any other weight loss medications, whether prescription, over-the-counter, or natural products.
Pregnancy or the possibility of being pregnant, 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 if it is safe to take this medication with your other drugs and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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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.

Until you are aware of how this medication affects you, avoid operating a vehicle or engaging in any activities that require your full attention.

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 period 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, consult your doctor. Do not take more than the prescribed dose.

If you have been taking this medication for several weeks, consult your doctor before discontinuing its use. Your doctor may recommend a gradual 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 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 may increase your risk of hypoglycemia (low blood sugar) if you are taking diabetes medications. Immediately contact your doctor if you experience symptoms of hypoglycemia, such as dizziness, headache, drowsiness, weakness, tremors, rapid heartbeat, confusion, hunger, or sweating.

Follow the diet and exercise plan recommended by your doctor.

Before consuming alcohol, discuss its potential effects with your doctor.

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
  • Rhabdomyolysis
  • Arrhythmias
  • Hypertension or hypotension
  • Circulatory collapse
  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal cramps
  • Convulsions
  • Coma

What to Do:

Seek immediate medical attention or call Poison Control (1-800-222-1222). Management is largely supportive, including gastric lavage, activated charcoal, and sedation for CNS overstimulation. Acidification of the urine may increase excretion.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs): Concurrent use or within 14 days of MAOI administration due to risk of hypertensive crisis.
  • Other centrally acting anorectic agents: Increased risk of pulmonary hypertension and other serious adverse cardiovascular events.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, St. John's Wort): Risk of serotonin syndrome.
  • Alcohol: May potentiate CNS effects and increase risk of adverse reactions.
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Major Interactions

  • Antihypertensive agents (e.g., guanethidine, clonidine, methyldopa, diuretics, beta-blockers): Phentermine may antagonize the hypotensive effects.
  • Insulin and oral hypoglycemic agents: May alter blood glucose levels; dose adjustment may be required.
  • Thyroid hormones: May potentiate the effects of phentermine.
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Moderate Interactions

  • Adrenergic neuron blocking drugs: Reduced hypotensive effect.
  • Caffeine and other stimulants: Increased risk of CNS stimulation and cardiovascular effects.
  • Urinary alkalinizers (e.g., sodium bicarbonate, acetazolamide): Decrease phentermine excretion, potentially increasing its effects and toxicity.
  • Urinary acidifiers (e.g., ammonium chloride, ascorbic acid): Increase phentermine excretion, potentially decreasing its effects.
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Minor Interactions

  • None specifically categorized as minor with significant clinical impact.

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 pre-existing cardiovascular conditions or risk factors.

Timing: Prior to initiation of therapy.

Weight and BMI

Rationale: To establish baseline for assessing efficacy and to ensure patient meets criteria for therapy.

Timing: Prior to initiation of therapy.

Medical History (especially cardiovascular, psychiatric, and thyroid disorders)

Rationale: To identify contraindications or conditions requiring caution.

Timing: Prior to initiation of therapy.

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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: Persistent elevation above baseline or development of hypertension/tachycardia.

Weight and BMI

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

Target: Expected weight loss of at least 5% within 12 weeks.

Action Threshold: Lack of adequate weight loss (e.g., <3% in 12 weeks) or plateau.

Signs/Symptoms of Pulmonary Hypertension (e.g., dyspnea, angina pectoris, syncope, lower extremity edema)

Frequency: At each follow-up visit.

Target: Absence of symptoms.

Action Threshold: Development of any symptoms; requires immediate discontinuation and evaluation.

Signs/Symptoms of CNS stimulation or psychiatric changes (e.g., insomnia, nervousness, agitation, mood changes)

Frequency: At each follow-up visit.

Target: Absence of severe symptoms.

Action Threshold: Development of severe or intolerable symptoms.

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Symptom Monitoring

  • Chest pain
  • Shortness of breath (dyspnea)
  • Fainting (syncope)
  • Swelling in legs/ankles (edema)
  • Palpitations
  • Dizziness
  • Severe headache
  • Blurred vision
  • Nervousness
  • Insomnia
  • Agitation
  • Tremor
  • Dry mouth
  • Constipation
  • Unusual fatigue or weakness

Special Patient Groups

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Pregnancy

Contraindicated in pregnancy (Pregnancy Category X). Weight loss during pregnancy offers no potential benefit to the pregnant woman and may result in fetal harm. Phentermine can cause fetal toxicity, including congenital anomalies.

Trimester-Specific Risks:

First Trimester: High risk of congenital anomalies and fetal harm.
Second Trimester: Continued risk of fetal harm.
Third Trimester: Continued risk of fetal harm.
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Lactation

Contraindicated during breastfeeding (Lactation Risk L5). Phentermine is excreted into breast milk and can cause serious adverse reactions in a breastfed infant, including irritability, poor feeding, and sleep disturbances.

Infant Risk: High risk of adverse effects due to excretion into breast milk and potential for CNS stimulation in the infant.
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Pediatric Use

Not recommended for children under 16 years of age. Safety and efficacy have not been established in this population. Use in adolescents (16-18 years) should be approached with extreme caution and only if benefits clearly outweigh risks, under strict medical supervision.

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Geriatric Use

Use with caution in elderly patients (65 years and older). Elderly patients may be more sensitive to the adverse effects of phentermine, particularly cardiovascular and CNS effects. Consider starting with a lower dose and titrating slowly. Renal function should be monitored, as phentermine is primarily renally eliminated.

Clinical Information

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Clinical Pearls

  • Phentermine is intended for short-term use (typically 3-6 months) as an adjunct to diet and exercise, not as a standalone or long-term solution for obesity.
  • Tolerance to the anorectic effect may develop within a few weeks. If this occurs, the drug should be discontinued, rather than increasing the dose.
  • Abrupt discontinuation after prolonged high-dose use may result in extreme fatigue and mental depression; gradual tapering may be considered.
  • Patients should be advised about the potential for primary pulmonary hypertension (PPH) and valvular heart disease, though the risk is low with phentermine monotherapy.
  • Monitor for signs of drug abuse or dependence, as phentermine has abuse potential.
  • Take phentermine early in the morning to avoid insomnia.
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Alternative Therapies

  • Orlistat (Xenical, Alli)
  • Liraglutide (Saxenda)
  • Naltrexone/Bupropion (Contrave)
  • Semaglutide (Wegovy)
  • Setmelanotide (Imcivree - for specific genetic conditions)
  • Bariatric surgery (for severe obesity)
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Cost & Coverage

Average Cost: $15 - $50 per 30 capsules (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic), often requires prior authorization or is not covered by some plans due to off-label use for long-term weight management or classification as a lifestyle drug.
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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 discuss them with 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.