Desvenlafaxine (oral route)


    Brand Name

    US Brand Name

    Khedezla

    Pristiq


    Description

    Desvenlafaxine is used to treat depression. It belongs to a group of medicines known as serotonin and norepinephrine reuptake inhibitors (SNRIs). These medicines are thought to work by increasing the activity of chemicals called serotonin and norepinephrine in the brain.

    This medicine is available only with your doctor's prescription.

    This product is available in the following dosage forms:

    • Tablet, Extended Release

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of desvenlafaxine in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of desvenlafaxine in the elderly. However, elderly patients are more likely to have low blood pressure, hyponatremia (low sodium in the blood), and age-related kidney problems, which may require an adjustment in the dose for patients receiving desvenlafaxine.

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Bromopride
    • Isocarboxazid
    • Linezolid
    • Methylene Blue
    • Metoclopramide
    • Ozanimod
    • Phenelzine
    • Procarbazine
    • Rasagiline
    • Safinamide
    • Selegiline
    • Tranylcypromine

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Abciximab
    • Aceclofenac
    • Acemetacin
    • Acenocoumarol
    • Alfentanil
    • Almotriptan
    • Amineptine
    • Amitriptyline
    • Amitriptylinoxide
    • Amoxapine
    • Amphetamine
    • Amtolmetin Guacil
    • Anagrelide
    • Anileridine
    • Apixaban
    • Ardeparin
    • Argatroban
    • Aripiprazole
    • Aspirin
    • Atomoxetine
    • Bemiparin
    • Benzhydrocodone
    • Benzphetamine
    • Betrixaban
    • Bivalirudin
    • Bromfenac
    • Brompheniramine
    • Bufexamac
    • Buprenorphine
    • Bupropion
    • Buspirone
    • Butorphanol
    • Cangrelor
    • Carbamazepine
    • Carvedilol
    • Celecoxib
    • Certoparin
    • Chlorpheniramine
    • Choline Salicylate
    • Cilostazol

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

    • Ethanol

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Bipolar disorder (mood disorder with mania and depression), or risk of or
    • Bleeding problems or
    • Glaucoma, angle-closure or
    • Heart or blood vessel disease or
    • Hyperlipidemia (high cholesterol or triglycerides in the blood) or
    • Hypertension (high blood pressure) or
    • Hyponatremia (low sodium levels in the blood) or
    • Interstitial lung disease, or history of or
    • Mania or hypomania, history of or
    • Seizures, history of or
    • Stroke, history of or
    • Tachycardia (fast heartbeat)—Use with caution. May make these conditions worse.
    • Kidney disease, moderate to severe or
    • Liver disease, moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

    Proper Use

    Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

    This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

    You may have to take desvenlafaxine for several weeks before you begin to feel better.

    Take the tablet with or without food at about the same time every day.

    Swallow the extended-release tablet whole with water. Do not dissolve, crush, break, or chew it.

    Part of the tablet may pass into your stools. This is normal and nothing to worry about.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For oral dosage form (extended-release tablets):
      • For depression:
        • Adults—50 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
        • Children—Use and dose must be determined by your doctor.

    Missed Dose

    If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

    Storage

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.


    Precautions

    It is important that your doctor check your progress at regular visits, to allow for changes in your dose and to help reduce any side effects. Blood and urine tests may be needed to check for any unwanted effects.

    Do not take desvenlafaxine with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking desvenlafaxine within 14 days after you stop using an MAO inhibitor. Wait 7 days after stopping desvenlafaxine before you start taking an MAO inhibitor. If you take them together or do not wait the proper amount of time, you may develop confusion, agitation, restlessness, stomach or bowel symptoms, a sudden high body temperature, an extremely high blood pressure, or severe seizures.

    Do not take any medicine that contains venlafaxine (Effexor®) while you are using Khedezla® or Pristiq®.

    Desvenlafaxine may cause some teenagers and young adults 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. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

    Do not stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely to decrease the chance of side effects, such as agitation, breathing problems, chest pain, confusion, diarrhea, dizziness or lightheadedness, fast or irregular heartbeat, feeling more excited or energetic than usual, headache, increased sweating, irritability, muscle pain, nausea, numbness or tingling feeling, restlessness, ringing in your ears, runny nose, seizures, thoughts of hurting yourself or others, trouble sleeping, trembling or shaking, unusual dreams, unusual mood or behavior, unusual tiredness or weakness, vision changes, or vomiting.

    Desvenlafaxine may cause a serious condition called serotonin syndrome if taken together with some medicines. Do not use desvenlafaxine with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, amphetamines, or some pain or migraine medicines (eg, meperidine, methadone, rizatriptan, sumatriptan, tramadol, Demerol®, Methadose®, Frova®, Imitrex®, Maxalt®, Relpax®, Ultram®, Zomig®). Check with your doctor first before using any other medicines with desvenlafaxine.

    Tell your doctor right away if you have chest discomfort, cough, or trouble breathing while using this medicine. These might be symptoms of a serious lung problem.

    This medicine may increase your risk for bleeding problems. Make sure your doctor knows if you are also taking other medicines that thin the blood, including aspirin, NSAIDs (eg, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®), or warfarin (Coumadin®, Jantoven®).

    This medicine may cause hyponatremia (low sodium in the blood). This is more common in elderly patients, those who are taking diuretic medicines for high blood pressure, or those who have decreased amounts of fluid in the body due to severe diarrhea or vomiting. Check with your doctor right away if you have confusion, headache, memory problems, trouble concentrating, weakness, or feel unsteady when standing.

    This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

    Check with your doctor right away if you have decreased interest in sexual intercourse, delayed or inability to have an orgasm in women, inability to have or keep an erection in men, or loss in sexual ability, desire, drive, or performance. These could be symptoms of sexual dysfunction.

    The use of alcohol is not recommended in patients who are using this medicine.

    Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.


    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    Less common

    • Chills
    • cold sweats
    • confusion
    • continuous ringing, buzzing, or other unexplained noise in the ears
    • decreased interest in sexual intercourse
    • delayed or inability to have an orgasm
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • fast, pounding, or irregular pulse
    • fear or nervousness
    • headache
    • hearing loss
    • inability to have or keep an erection
    • loss in sexual ability, desire, drive, or performance
    • numbness or tingling in the arms or legs
    • shakiness in the legs, arms, hands, or feet
    • trouble thinking, speaking, or walking
    • weakness

    Incidence not known

    • Blistering, peeling, or loosening of the skin
    • bloating
    • blood in the stool or urine
    • chest tightness, discomfort, or pain
    • cough
    • dark urine
    • diarrhea
    • dilated or enlarged pupils (black part of the eye)
    • dizziness
    • feeling irritated
    • fainting
    • fast, irregular, or pounding heartbeat
    • fever
    • hives, itching, or rash
    • hoarseness
    • indigestion
    • joint pain, stiffness, or swelling
    • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
    • loss of appetite
    • loss of bladder control
    • muscle pain
    • muscle spasm or jerking of all extremities
    • nausea
    • nosebleeds
    • pains in the stomach, side, or abdomen, possibly radiating to the back
    • red skin lesions, often with a purple center
    • red, irritated eyes
    • red skin
    • seizures
    • sore throat
    • sores, ulcers, or white spots in the mouth or on the lips
    • sudden loss of consciousness
    • swelling of the eyelids, face, lips, hands, or feet
    • talking, feeling, or acting with excitement
    • trouble breathing or swallowing
    • unusual bleeding or bruising
    • unusual tiredness or weakness
    • vomiting
    • vomiting blood
    • yellow eyes or skin

    Get emergency help immediately if any of the following symptoms of overdose occur:

    Symptoms of overdose

    • Agitation
    • bloating
    • dark urine
    • feeling of constant movement of self or surroundings
    • irregular heartbeat recurrent
    • light-colored stools
    • muscle cramp or stiffness
    • nausea
    • overactive reflexes
    • poor coordination
    • restlessness
    • seizures
    • sensation of spinning
    • shivering
    • stomach pain
    • vomiting
    • yellow eyes or skin

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    • Decreased appetite
    • increased sensitivity of the eyes to light
    • sleepiness or unusual drowsiness
    • trouble sleeping

    Less common

    • Change in taste
    • decreased weight
    • difficult urination
    • jitteriness
    • lack or loss of strength
    • loss of taste

    Incidence not known

    • Decrease in smell
    • loss of sense of smell

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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