Khedezla

Khedezla is a prescription medication used to treat depression. Khedezla belongs to a group of drugs called serotonin norepinephrine reuptake inhibitors (SNRIs), which work by increasing serotonin and norepinephrine levels in the brain to maintain mental balance and improve mood.

This medication comes as an extended release tablet and is taken once a day, with or without food.

Do not divide, crush, chew, or dissolve tablets. Swallow Khedezla tablets whole.

Common side effects of Khedezla include nausea, constipation, trouble falling asleep or staying asleep, and increased sweating. Khedezla can also cause dizziness and make you feel tired. Do not drive or operate heavy machinery until you know how Khedezla affects you.

Khedezla is a prescription medicine used to treat depression. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Par Pharmaceutical, Inc.

Khedezla can cause serious side effects, including:

• See the Black Box Warning - Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions.
• Serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions.

• restlessness
• increase in blood pressure
• hallucinations (seeing and hearing things that are not real)
• diarrhea
• loss of coordination
• coma
• fast heart beat
• nausea
• increased body temperature
• vomiting
• muscle stiffness
• confusion

Khedezla may also cause other serious side effects, including:

• New or worsened high blood pressure (hypertension). Your healthcare provider should monitor your blood pressure before and while you are taking Khedezla. If you have high blood pressure, it should be controlled before you start taking this medication.
• Abnormal bleeding or bruising. Khedezla and other SNRIs/SSRIs may cause you to have an increased chance of bleeding. Taking aspirin, NSAIDs (non-steroidal anti-inflammatory drugs), or blood thinners may add to this risk. Tell your healthcare provider right away about any unusual bleeding or bruising.
• Glaucoma (increased eye pressure)
• Increased cholesterol and triglyceride levels in your blood
• Seizures (convulsions)
• Low sodium levels in your blood. Symptoms of this may include: headache, difficulty concentrating, memory changes, confusion, weakness and unsteadiness on your feet. In severe or more sudden cases, symptoms can include: hallucinations (seeing or hearing things that are not real), fainting, seizures and coma. If not treated, severe low sodium levels could be fatal.
• Allergic reactions. Some reactions can be severe such as swelling beneath the skin (e.g., throat, face, hands).
• Symptoms when stopping Khedezla (discontinuation symptoms). Side effects may occur when stopping Khedezla (discontinuation symptoms), especially when therapy is stopped suddenly. Your healthcare provider may want to decrease your dose slowly to help avoid side effects.
 Some of these side effects may include:
  • dizziness
  • anxiety
  • nausea
  • abnormal dreams
  • headache
  • tiredness
  • irritability
  • sweating
  • sleeping problems (insomnia)
  • diarrhea


 Common side effects with Khedezla include:

• nausea
• tiredness
• headache
• diarrhea
• dry mouth
• vomiting
• sweating
• anxiety
• dizziness
• tremor
• insomnia
• dilated pupils
• constipation
• decreased sex drive
• loss of appetite
• delayed orgasm and ejaculation
• sleepiness
• trouble falling asleep or staying asleep

Rare, but potentially life-threatening, conditions called serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions can happen when medicines such as Khedezla are taken with certain other medicines. Serotonin syndrome or NMS-like reactions can cause serious changes in how your brain, muscles and digestive system work. Especially tell your healthcare provider if you take the following:

• medicines to treat migraine headaches known as triptans
• medicines used to treat mood disorders, including tricyclics, lithium, selective serotonin reuptake inhibitors (SSRIs), or serotonin norepinephrine reuptake inhibitors (SNRIs)
• silbutramine
• tramadol
• St. John's Wort
• MAOIs (including linezolid, an antibiotic)
• tryptophan supplements

Ask your healthcare provider if you are not sure if you are taking any of these medicines. Do not take this medication with other medicines containing venlafaxine or desvenlafaxine.

Do not take Khedezla if you:

• are allergic to desvenlafaxine, venlafaxine or any of the ingredients in this medication.
• currently take or have taken within the last 14 days, any medicine known as an MAOI. Taking an MAOI with certain other medicines, including Khedezla, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Khedezla before you take any MAOI.

Do not drive a car or operate machinery until you know how this medication affects you.

Avoid drinking alcohol while taking Khedezla.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Khedezla there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your healthcare provider about all your medical conditions, including if you:

• have high blood pressure
• have heart problems
• have high cholesterol or high triglycerides
• have a history of a stroke
• have glaucoma
• have kidney problems
• have liver problems
• have or had bleeding problems
• have or had seizures or convulsions
• have mania or bipolar disorder
• have low sodium levels in your blood
• are pregnant or plan to become pregnant. It is not known if Khedezla will harm your unborn baby.
• are breastfeeding. Khedezla can pass into your breast milk and may harm your baby.

• medicines to treat migraine headaches known as triptans 
• medicines used to treat mood, anxiety, psychotic, or thought disorders, including tricyclics, lithium, selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), antipsychotic drugs, or other dopamine antagonists, such as metoclopramide
• silbutramine 
• tramadol 
• St. John’s Wort 
• MAOIs (including linezolid, an antibiotic) 
• tryptophan supplements 

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Khedezla will harm your unborn baby. Khedezla has not been studied in pregnant women. Khedezla should be used during pregnancy only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed. Khedezla is excreted in human breast milk. It may harm your nursing baby.

• Take Khedezla exactly as your healthcare provider has told you.
• Take Khedezla at about the same time each day.
• Khedezla may be taken either with or without food.
• Swallow Khedezla tablets whole, with fluid. Do not crush, cut, chew, or dissolve Khedezla tablets because the tablets are time-released.
• When you take Khedezla, you may see something in your stool that looks like a tablet. This is the empty shell from the tablet after the medicine has been absorbed by your body.
• It is common for antidepressant medicines such as Khedezla to take several weeks before you start to feel better. Do not stop taking Khedezla if you do not feel results right away.
• Do not stop taking or change the dose of Khedezla without talking with your healthcare provider, even if you feel better.
• Talk with your healthcare provider about how long you should use Khedezla. Take Khedezla for as long as your healthcare provider tells you to.
• If you miss a dose of Khedezla, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not try to “make up” for the missed dose by taking two doses at the same time.
• Do not take more Khedezla than prescribed by your healthcare provider. If you take more than the amount prescribed, contact your healthcare provider right away.
• In case of an overdose of Khedezla, call your healthcare provider or poison control center, or go to the emergency room right away.

Take Khedezla exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you. The dosage of Khedezla must be individualized.

The recommended dose for Khedezla is 50 mg once daily, with or without food. Khedezla should be taken at approximately the same time each day. Tablets should be swallowed whole with fluid and not divided, crushed, chewed, or dissolved.

In case of an overdose of Khedezla, call your healthcare provider or poison control center, or go to the emergency room right away.

• Store Khedezla at 68° to 77°F (20° to 25°C).
• Do not use Khedezla after the expiration date, which is on the container. The expiration date refers to the last day of that month.
• Keep Khedezla and all medicines out of the reach of children.

Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, teens, and young adults. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Khedezla is not approved for use in children under 18.