1 What is Qsymia?

Brand: Qsymia

Generic: Phentermine and Topiramate

Qsymia is used together with a reduced-calorie diet and proper exercise for weight loss.

This drug is also used in overweight people who may also have diabetes, high blood pressure, high cholesterol, or heart disease.

This drug is available only through a special restricted distribution program called Qsymia REMS program.

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2 What to Know Before Using

If you are about to start Qsymia, speak with your doctor about what you need to know. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals. Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications.

Studies in children regarding the correlation of age to the effects of phentermine and topiramate have not been performed while safety and efficacy have not been established.

Studies in the elderly have not demonstrated any geriatric-specific problems that would limit the utility of phentermine and topiramate combination. Adjustments in the dose of the elderly may be required since they are more likely to have kidney, liver, or heart problems.

Proof of fetal abnormalities has been reported in studies of animal and pregnant women. This drug is contraindicated in women who are or may become pregnant because the risk clearly outweighs any possible benefit. Infant risk is still undetermined when taking this drug during breastfeeding. Discuss with your healthcare professional about the risks and benefits of this drug before breastfeeding.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as:

  • Brofaromine
  • Clorgyline
  • Furazolidone
  • Iproniazid
  • Isocarboxazid
  • Lazabemide
  • Linezolid
  • Moclobemide
  • Nialamide
  • Pargyline
  • Phenelzine
  • Procarbazine
  • Rasagiline
  • Selegiline
  • Sibutramine
  • Toloxatone
  • Tranylcypromine
  • Bromazepam
  • Buprenorphine
  • Carbinoxamine
  • Citalopram
  • Clozapine
  • Fenfluramine
  • Fentanyl
  • Flibanserin
  • Hydrocodone
  • Morphine
  • Morphine Sulfate Liposome
  • Nifedipine
  • Orlistat
  • Oxycodone
  • Oxymorphone
  • Piperaquine
  • Sodium Oxybate
  • Suvorexant
  • Tapentadol
  • Amitriptyline
  • Carbamazepine
  • Desogestrel
  • Dienogest
  • Drospirenone
  • Estradiol Cypionate
  • Estradiol Valerate
  • Ethinyl Estradiol
  • Ethynodiol Diacetate
  • Etonogestrel
  • Fosphenytoin
  • Ginkgo
  • Hydrochlorothiazide
  • Levonorgestrel
  • Medroxyprogesterone Acetate
  • Mestranol
  • Norelgestromin
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Phenobarbital
  • Phenytoin
  • Pioglitazone
  • Posaconazole
  • Valproic Acid

Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your healthcare provider for any other medical problems such as:

3 Proper Usage

Proper usage of Qsymia requires strict adherence to your doctor’s orders. Take this drug exactly as directed on the label or as prescribed by your healthcare professional. Prolonged use of increased doses of this drug can cause mental or physical dependence. This drug must be taken once a day in the morning, with or without food.

Taking this drug in the evening can cause troubles in sleeping. The extended-release capsule must be swallowed whole. Crushing, breaking, or chewing the drug is not recommended. Carefully follow your healthcare professional's instructions for a reduced-calorie diet plan and regular exercise.

Consult with your healthcare professional before starting any exercise program. Your will be advised to stop taking this drug if there is no weight reduction within the first 12 weeks of treatment. It is recommended to increase water intake daily to help prevent kidney stones. The dose of this drug will be variable for different patients.

The directions on the label or the prescription by your healthcare professional should be followed. The dosage of this drug you take depends on the medical problem for which you are using this drug. For weight loss in adults, one tablet of 3.75 milligrams of phentermine and 23 mg of topiramate are initially given once a day for 14 days.

After 14 days, your healthcare professional may increase your dose to 7.5 mg of phentermine and 46 mg of topiramate once a day. Then, your healthcare professional may increase your dose as needed up to 15 mg of phentermine and 92 mg of topiramate. Use in children is not recommended. A missed dose should be taken as soon as possible.

However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose. Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

4 Precautions to Take

Before using Qsymia, there are some precautions you must take. Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug.

Unwanted effects can be screened using blood and urine tests. This drug has teratogenic potential and it is recommended to use an effective form of birth control to keep from getting pregnant.

Inform your healthcare professional immediately if you think you have become pregnant while using this drug. A negative pregnancy test will be required before you will be allowed to take this drug. A routine pregnancy test every month during your treatment will also be required.

If you miss a period while you are using this drug, tell your healthcare professional immediately. Do not use this drug if you have used a MAO inhibitor (MAOI) such as:

within the past 14 days. Using these drugs together may cause serious unwanted effects. This drug may be habit-forming. If you think this drug is not working properly after you have taken it for a few weeks, do not increase the dose. Instead, check with your healthcare professional.

This drug may increase your heart rate. Check with your healthcare professional immediately if you have a racing heartbeat while at rest after taking this drug. This drug may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed.

Tell your healthcare professional immediately if you notice any of these side effects. Check with your healthcare professional immediately if you have a decrease in vision, blurred vision, or pain around the eyes during and after treatment with this drug. You may be referred to an ophthalmologist to have your eyes checked.

This drug may cause dizziness, drowsiness, or troubles in thinking or speaking. Be careful in taking this drug before you drive, use machines, or do anything else that could be dangerous. This drug may cause metabolic acidosis which can manifest as nausea, muscle tremors, fast breathing, problems eating, fast heartbeat, restlessness, and abdominal or stomach pain.

Tell your healthcare professional immediately if you have any of these symptoms. This drug may affect blood sugar levels. Check with your healthcare professional if you notice a change in the results of your blood or urine sugar tests or if you have any questions. This drug may increase the risk of hypotension.

If you feel dizzy, faint, or lightheaded after taking this drug, check with your healthcare professional. This drug will potentiate the effects of alcohol and other CNS depressants such as antihistamines or drug for hay fever, other allergies, or colds, prescription pain drugs, or sleep drugs.

Check with your healthcare professional before you suddenly stop taking this drug, since it may cause your seizures to return or to occur more often. Your healthcare professional may slowly taper the amount you are using before stopping completely.

Check with your healthcare professional immediately if you have symptoms of kidney stones such as sudden back pain, abdominal or stomach pain, pain while urinating, or bloody or dark urine.

Consult with your healthcare professional before taking any other prescription or nonprescription drugs, and herbal or vitamin supplements.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Qsymia. Side effects may vary for each individual and prompt medical attention should be given if they occur.

Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as:

  • Chest discomfort
  • Convulsions
  • Decreased urine
  • Fast
  • Irregular, Pounding, or Racing heartbeat or pulse
  • Loss of appetite
  • Mood changes
  • Muscle pain or cramps
  • Nausea or Vomiting
  • Numbness or Tingling in the hands, feet, or lips
  • Shortness of breath
  • Unusual tiredness or weakness
  • Blood in the urine
  • Pain in the groin or genitals
  • Sharp back pain just below the ribs
  • Blistering, Peeling, or Loosening of the skin blisters on the mouth
  • Trunk, Scalp, or Other areas
  • Blurred or Decreased vision
  • Chest pain
  • Chills or Shivering
  • Clumsiness
  • Continuing nausea or vomiting
  • A cough or a sore throat
  • Dark urine
  • Diarrhea or Light-colored stools
  • Dizziness
  • Headache
  • Increase in the frequency of seizures
  • Irregular heartbeat
  • Itching joint or muscle pain
  • Loss of appetite
  • Low body temperature
  • Muscle aches or weakness
  • Pain in the shoulders, arms, jaw, or neck
  • Red skin lesions
  • Often with a purple center
  • Red, irritated eyes
  • Shakiness in the legs, arms, hands, or feet
  • Sores, Ulcers, or White spots in the mouth or on the lips
  • Sweating, Swelling of the face
  • Tiredness and Weakness
  • Trouble thinking, speaking or walking
  • Upper right abdominal or stomach pain
  • Weak or Feeble pulse
  • Weight gain
  • Yellow eyes or skin

Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.

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