Tuesday, October 4, 2016

Lusonex


Generic Name: guaifenesin and phenylephrine (gwye FEN e sin and FEN il EFF rin)

Brand Names: Aldex G, Aquatab D, Crantex, D-Phen 1000, D-Tab, Deconex, Deconsal II, Deconsal Pediatric, Despec, Donatussin Drops, Duomax, Duraphen 1000, Duraphen II, Duratuss, Dynex LA, ExeTuss, Extendryl G, Fenesin PE IR, Genexa LA, Gentex LA, Gilphex TR, Guaiphen-D 1200, Guaiphen-D 600, Guaiphen-PD, Guiadex PD, Guiatex PE, J-Max, Liquibid D-R, Liquibid-D, Liquibid-PD, Lusonex, Maxiphen, Medent-PE, MontePhen, Mucinex Children's Cold, Mucus Relief Sinus, Mydex, Nariz, Nasex, Nescon-PD, Nexphen PD, Norel EX, PE-Guai, Pendex, Prolex D, Refenesen PE, Reluri, Rescon-GG, Respa-PE, Robitussin Head & Chest Congestion, Simuc, Simuc-GP, Sina-12X, Sinupan, SINUvent PE, Sitrex PD, Sudafed PE Non-Drying Sinus, Sudex, Triaminic Chest & Nasal Congestion, Visonex, Wellbid-D, Xedec, Xedec II, Xpect-PE, Zotex GPX


What is Lusonex (guaifenesin and phenylephrine)?

There are many brands and forms of guaifenesin and phenylephrine available and not all brands are listed on this leaflet.


Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.


Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).


The combination of guaifenesin and phenylephrine is used to treat stuffy nose and sinus congestion, and to reduce chest congestion caused by the common cold or flu.


Guaifenesin and phenylephrine may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Lusonex (guaifenesin and phenylephrine)?


There are many brands and forms of guaifenesin and phenylephrine available and not all brands are listed on this leaflet.


Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Ask a doctor or pharmacist before using any other cough, cold, or allergy medicine. Guaifenesin and phenylephrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or phenylephrine.

What should I discuss with my healthcare provider before taking Lusonex (guaifenesin and phenylephrine)?


You should not use this medication if you are allergic to guaifenesin or phenylephrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use guaifenesin and phenylephrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use guaifenesin and phenylephrine before the MAO inhibitor has cleared from your body.

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:



  • heart disease or high blood pressure;




  • diabetes;




  • circulation problems;




  • glaucoma;




  • overactive thyroid; or




  • enlarged prostate or problems with urination.




It is not known if this medication may be harmful to an unborn baby. Do not use this medication without your doctor's advice if you are pregnant. This medication passes into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.


How should I take Lusonex (guaifenesin and phenylephrine)?


Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.


Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.


Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. Take guaifenesin and phenylephrine with food if it upsets your stomach. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash. Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Store at room temperature away from moisture and heat.

What happens if I miss a dose?


Since cough or cold medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, numbness or tingly feeling, dizziness, and feeling restless or nervous.


What should I avoid while taking Lusonex (guaifenesin and phenylephrine)?


This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of guaifenesin and phenylephrine. Ask a doctor or pharmacist before using any other cough, cold, or allergy medicine. Guaifenesin and phenylephrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or phenylephrine.

Avoid taking this medication with diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.


Lusonex (guaifenesin and phenylephrine) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeat;




  • severe dizziness, anxiety, restless feeling, or nervousness;




  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;




  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure); or




  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).



Less serious side effects may include:



  • vomiting, upset stomach;




  • warmth, tingling, or redness under your skin;




  • feeling excited or restless (especially in children);




  • sleep problems (insomnia);




  • skin rash or itching;




  • headache; or




  • dizziness.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Lusonex (guaifenesin and phenylephrine)?


Ask a doctor or pharmacist if it is safe for you to take guaifenesin and phenylephrine if you are also using any of the following drugs:



  • medicines to treat high blood pressure;




  • a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or




  • an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan, Silenor), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.



This list is not complete and other drugs may interact with guaifenesin and phenylephrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Lusonex resources


  • Lusonex Side Effects (in more detail)
  • Lusonex Use in Pregnancy & Breastfeeding
  • Lusonex Drug Interactions
  • Lusonex Support Group
  • 0 Reviews for Lusonex - Add your own review/rating


  • Lusonex Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Crantex Prescribing Information (FDA)

  • Despec Drops MedFacts Consumer Leaflet (Wolters Kluwer)

  • Entex LA Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

  • Gentex LA Sustained-Release Tablets (12 Hour) MedFacts Consumer Leaflet (Wolters Kluwer)

  • Guiatex PE Prescribing Information (FDA)

  • Rescon-GG Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

  • Sina-12X Suspension MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Lusonex with other medications


  • Cough and Nasal Congestion
  • Sinus Symptoms


Where can I get more information?


  • Your pharmacist can provide more information about guaifenesin and phenylephrine.

See also: Lusonex side effects (in more detail)


Lodine XL


Generic Name: etodolac (Oral route)

e-TOE-doe-lak

Oral route(Tablet;Capsule;Tablet, Extended Release)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Etodolac is contraindicated for the treatment of perioperative pain in the setting of CABG surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .



Commonly used brand name(s)

In the U.S.


  • Lodine

  • Lodine XL

Available Dosage Forms:


  • Tablet

  • Capsule

  • Tablet, Extended Release

Therapeutic Class: Analgesic


Pharmacologic Class: NSAID


Chemical Class: Acetic Acid (class)


Uses For Lodine XL


Etodolac is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain, and helps to relieve symptoms of arthritis (osteoarthritis and rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. However, this medicine does not cure arthritis and will help you only as long as you continue to take it .


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


Before Using Lodine XL


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 etodolac capsules and tablets in children below 18 years of age. No studies have also been done on the relationship of etodolac extended-release tablets in children below 6 years of age. Safety and efficacy have not been established in these age groups .


Geriatric


Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of etodolac in the elderly. However, elderly patients may be more sensitive to the effects of etodolac than younger adults, and are more likely to have age-related kidney problems, which may require adjustment of dosage in patients receiving etodolac .


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


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.


Interactions with Medicines


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.


  • Ketorolac

  • Pentoxifylline

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

  • Ardeparin

  • Argatroban

  • Beta Glucan

  • Bivalirudin

  • Certoparin

  • Cilostazol

  • Citalopram

  • Clopidogrel

  • Clovoxamine

  • Dabigatran Etexilate

  • Dalteparin

  • Danaparoid

  • Desirudin

  • Dipyridamole

  • Enoxaparin

  • Escitalopram

  • Femoxetine

  • Flesinoxan

  • Fluoxetine

  • Fluvoxamine

  • Fondaparinux

  • Ginkgo

  • Heparin

  • Lepirudin

  • Methotrexate

  • Nadroparin

  • Nefazodone

  • Parnaparin

  • Paroxetine

  • Pemetrexed

  • Protein C

  • Reviparin

  • Rivaroxaban

  • Sertraline

  • Sibutramine

  • Tacrolimus

  • Ticlopidine

  • Tinzaparin

  • Tirofiban

  • Vilazodone

  • Zimeldine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Acebutolol

  • Acenocoumarol

  • Acetohexamide

  • Alacepril

  • Alprenolol

  • Amiloride

  • Arotinolol

  • Atenolol

  • Azilsartan Medoxomil

  • Azosemide

  • Befunolol

  • Bemetizide

  • Benazepril

  • Bendroflumethiazide

  • Benzthiazide

  • Betaxolol

  • Bevantolol

  • Bisoprolol

  • Bopindolol

  • Bucindolol

  • Bumetanide

  • Bupranolol

  • Buthiazide

  • Candesartan Cilexetil

  • Canrenoate

  • Captopril

  • Carteolol

  • Carvedilol

  • Celiprolol

  • Chlorothiazide

  • Chlorpropamide

  • Chlorthalidone

  • Cilazapril

  • Clopamide

  • Cyclopenthiazide

  • Cyclosporine

  • Delapril

  • Desvenlafaxine

  • Dicumarol

  • Dilevalol

  • Duloxetine

  • Enalaprilat

  • Enalapril Maleate

  • Eprosartan

  • Esmolol

  • Ethacrynic Acid

  • Fosinopril

  • Furosemide

  • Gliclazide

  • Glimepiride

  • Glipizide

  • Gliquidone

  • Glyburide

  • Hydrochlorothiazide

  • Hydroflumethiazide

  • Imidapril

  • Indapamide

  • Irbesartan

  • Labetalol

  • Landiolol

  • Levobetaxolol

  • Levobunolol

  • Lisinopril

  • Losartan

  • Mepindolol

  • Methyclothiazide

  • Metipranolol

  • Metolazone

  • Metoprolol

  • Milnacipran

  • Moexipril

  • Nadolol

  • Nebivolol

  • Nipradilol

  • Olmesartan Medoxomil

  • Oxprenolol

  • Penbutolol

  • Pentopril

  • Perindopril

  • Phenprocoumon

  • Pindolol

  • Piretanide

  • Polythiazide

  • Propranolol

  • Quinapril

  • Ramipril

  • Sotalol

  • Spirapril

  • Spironolactone

  • Talinolol

  • Tasosartan

  • Telmisartan

  • Temocapril

  • Tertatolol

  • Timolol

  • Tolazamide

  • Tolbutamide

  • Torsemide

  • Trandolapril

  • Triamterene

  • Trichlormethiazide

  • Valsartan

  • Venlafaxine

  • Xipamide

  • Zofenopril

Interactions with Food/Tobacco/Alcohol


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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


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:


  • Anemia or

  • Asthma or

  • Bleeding problems or

  • Blood clots or

  • Edema (fluid retention or body swelling) or

  • Heart attack, history of or

  • Heart disease (e.g., congestive heart failure) or

  • High blood pressure or

  • Kidney disease or

  • Liver disease (e.g., hepatitis) or

  • Stomach or intestinal ulcers or bleeding or

  • Stroke, history of—Use with caution. This medicine may make these conditions worse .

  • Aspirin sensitivity, history of—This medicine should NOT be used in patients with this condition .

  • Heart surgery (e.g., coronary artery bypass graft [CABG] surgery)—This medicine should NOT be used to relieve pain right before or after the surgery .

Proper Use of etodolac

This section provides information on the proper use of a number of products that contain etodolac. It may not be specific to Lodine XL. Please read with care.


For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients .


When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.


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


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 acute pain:
    • For oral dosage form (capsules or tablets):
      • Adults—200 to 400 milligrams (mg) every 6 to 8 hours. However, the dose usually is not more than 1000 mg per day.

      • Children—Use and dose must be determined by your doctor .



  • For osteoarthritis and rheumatoid arthritis:
    • For oral dosage form (capsules or tablets):
      • Adults—300 mg two or three times a day, or 400 or 500 mg two times a day. If you will be taking this medicine for a long time, your doctor may lower your dose to 600 mg once a day. The dose usually is not more than 1000 mg per day.

      • Children—Use and dose must be determined by your doctor .


    • For oral dosage form (extended-release tablets):
      • Adults—400 mg to 1000 mg once a day.

      • Children 6 to 16 years of age—Dose is based on body weight and must be determined by your doctor.

      • Children below 6 years of age—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.


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


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Lodine XL


It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects .


This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk .


This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years old, if you are in poor health, or if you are using certain other medicines (a steroid or a blood thinner) .


Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores ulcers, white spots in mouth or on lips, or unusual tiredness or weakness .


Possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; unusual bleeding or bruising; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs .


This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once .


Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away .


Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure .


Lodine XL 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:


More common
  • Abdominal or stomach bloating, burning, cramping, or pain

  • belching

  • bloody or black, tarry stools

  • blurred vision

  • body aches or pain

  • cloudy urine

  • congestion

  • constipation

  • cough or hoarseness

  • decrease in urine output or decrease in urine-concentrating ability

  • diarrhea

  • dizziness

  • dryness or soreness of throat

  • feeling of indigestion

  • fever or chills

  • headache

  • increased bleeding time

  • itching skin

  • loss of appetite

  • lower back or side pain

  • nausea and vomiting

  • nervousness

  • pain in the chest below the breastbone

  • painful or difficult urination

  • pale skin

  • pounding in the ears

  • rash

  • runny nose

  • severe stomach pain

  • slow or fast heartbeat

  • swelling

  • tender, swollen glands in neck

  • trouble in swallowing

  • troubled breathing with exertion

  • unusual bleeding or bruising

  • unusual tiredness or weakness

  • voice changes

  • vomiting of blood or material that looks like coffee grounds

  • weight loss

Symptoms of overdose
  • Agitation

  • change in consciousness

  • confusion

  • depression

  • difficult or troubled breathing

  • hives

  • hostility

  • irregular, fast or slow, or shallow breathing

  • irritability

  • loss of consciousness

  • muscle twitching

  • pain or discomfort in chest, upper stomach, or throat

  • pale or blue lips, fingernails, or skin

  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

  • rapid weight gain

  • seizures

  • shortness of breath

  • sleepiness

  • stupor

  • swelling of face, ankles, or hands

  • tightness in chest

  • unusual drowsiness, dullness, or feeling of sluggishness

  • wheezing

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
  • Bloated, full feeling

  • continuing ringing or buzzing or other unexplained noise in ears

  • excess air or gas in stomach or intestines

  • hearing loss

  • lack or loss of strength

  • passing gas

  • sneezing

  • stuffy nose

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.

See also: Lodine XL side effects (in more detail)



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More Lodine XL resources


  • Lodine XL Side Effects (in more detail)
  • Lodine XL Use in Pregnancy & Breastfeeding
  • Drug Images
  • Lodine XL Drug Interactions
  • Lodine XL Support Group
  • 0 Reviews for Lodine XL - Add your own review/rating


  • Etodolac Prescribing Information (FDA)

  • Etodolac Professional Patient Advice (Wolters Kluwer)

  • Etodolac Monograph (AHFS DI)

  • Etodolac MedFacts Consumer Leaflet (Wolters Kluwer)

  • Lodine Prescribing Information (FDA)

  • Lodine Consumer Overview



Compare Lodine XL with other medications


  • Juvenile Rheumatoid Arthritis
  • Osteoarthritis
  • Pain
  • Rheumatoid Arthritis

Liqui-Coat Suspension





Dosage Form: suspension
LAFAYETTE

LIQUI-COAT HD™

BARIUM SULFATE SUSPENSION


Rx only

Liqui-Coat Suspension Description


Liqui-Coat HD is a raspberry-vanilla flavored, high density barium sulfate suspension for use as a contrast medium in air contrast stomach examinations.


The product contains 210% w/v (81% w/w) barium sulfate USP, suspending and dispersing agents, simethicone, artificial flavoring, potassium sorbate, sorbitol, sodium benzoate, saccharin sodium and water. Barium sulfate has the empirical formula BaSO4.



Liqui-Coat Suspension - Clinical Pharmacology


Barium sulfate is an insoluble material which, because of its density, provides a positive contrast during x-ray examination. Barium sulfate is an inert radiopaque material which is not absorbed or metabolized and is eliminated intact from the body in a manner similar to other non-absorbed inorganic materials. Excretion rate is a function of gastrointestinal transit time.



Indications and Usage for Liqui-Coat Suspension


Liqui-Coat HD is indicated for use as a contrast medium in double contrast stomach examinations.



Contraindications


Barium sulfate products are contraindicated in patients with known or suspected obstruction of the colon, known or suspected gastrointestinal tract perforation, suspected tracheoesophageal fistula, obstructing lesions of the small intestine, pyloric stenosis, inflammation or neoplastic lesions of the rectum, recent rectal biopsy, or known hypersensitivity to barium sulfate formulations.


Barium sulfate suspensions should not be used for infants with swallowing disorders or for newborns with complete duodenal or jejunal obstruction or when distal small bowel or colon obstruction is suspected.


Barium sulfate suspension is not recommended for very small preterm infants and young babies requiring small volumes of contrast media or for infants and young children when there is a possibility of leakage from the gastrointestinal tract, such as necrotizing enterocolitis, unexplained pneumoperitoneum, gasless abdomen, other bowel perforation, esophageal perforation or post operative anastomosis.



Warnings


Serious adverse reactions, including death, have been reported with the administration of barium sulfate formulations and are usually associated with the technique of administration, the underlying pathological condition and/or patient hypersensitivities.


Vomiting following oral administration of barium sulfate suspension may lead to aspiration pneumonitis. Oral administration of barium sulfate suspension by an infant sucking a bottle and administration of large quantities by catheter are reported to be likely to result in aspiration into the tracheobronchial tree. Cardiopulmonary arrest leading to fatality has been reported in infants following aspiration. Aspiration of smaller amounts may cause inflammation.


Barium sulfate preparations used as radiopaque media contain a number of additives to provide diagnostic properties and patient palatability. Allergic responses following the use of barium sulfate suspensions have been reported. Skin irritation, redness, inflammation and hives have been reported for infants and small children following spillage of barium sulfate suspension on their skin. These responses are thought to be caused by the flavors and/or preservatives used in the product.


Barium sulfate suspension has been reported to cause obstruction of the small bowel (impaction) in pediatric patients with cystic fibrosis. It has also been reported to cause fluid overload from the absorption of water during studies in infants when Hirschsprung’s Disease is suspected.



Precautions




General


Diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the requisite training and with a thorough knowledge of the particular procedure to be performed. A history of bronchial asthma, atopy, as evidenced by hay fever and eczema, a family history of allergy, or a previous reaction to a contrast agent warrant special attention. Caution should be exercised with the use of radiopaque media in severely debilitated patients and in those with marked hypertension or advanced cardiac disease.


Anaphylactic and allergic reactions have been reported during double contrast examinations in which glucagon has been used.


An increased risk of perforation has been reported in neonates with intussusception. In patients with cystic fibrosis or blind loops of the bowel or ileus, there is a risk of inspissation leading to partial or complete obstruction.


In neonates and infants with motility disorders such as Hirschsprung’s Disease retention of large amounts of barium sulfate suspension may result in absorption of water from the suspension and fluid overload. The addition of small amounts of salt to the barium sulfate suspension has been reported to reduce the problem.


Ingestion of barium sulfate suspension is not recommended in patients with a history of food aspiration. If barium sulfate suspension is aspirated into the larynx, further administration of the suspension should be immediately discontinued.


Patient preparation for diagnostic gastrointestinal examinations frequently requires cathartics and a liquid diet. The various preparations can result in water loss for the patient. Patients should be rehydrated quickly following a barium sulfate suspension examination of the gastrointestinal tract. In patients with reduced colon motility, saline cathartics may be required after the barium sulfate suspension enema. Saline cathartics are recommended on a routine basis in patients with a history of constipation unless clinically contraindicated.



Pregnancy


Safe use of barium sulfate during pregnancy has not been established. Barium sulfate should be used in pregnant women only if the possible benefits outweigh the potential risks. Elective radiography of the abdomen is considered to be contraindicated during pregnancy due to the risk to the fetus from radiation exposure. Radiation is known to cause harm to the unborn fetus exposed in utero.



Pediatric Use


The radiographic contrast agents used for examination of children do not differ substantially from those used for adults. The variation in physical sizes of pediatric patients requires more thorough attention to individualizing dosage. The volume of barium sulfate suspension and the barium sulfate content required will also depend upon the technique used and the clinical need.



Adverse Reactions


Adverse reactions accompanying the use of barium sulfate formulations are infrequent and usually mild, though severe reactions (approximately 1 in 500,000) and fatalities (approximately 1 in 2,000,000) have occurred. Procedural complications are rare, but may include aspiration pneumonitis, barium sulfate impaction, granuloma formation, intravasation, embolization and peritonitis following intestinal perforation, vasovagal and syncopal episodes, and fatalities. It is of the utmost importance to be completely prepared to treat any such occurrence.


Due to the increased likelihood of allergic reactions in atopic patients, a complete history of known and suspected allergies as well as allergic-like symptoms, e.g. rhinitis, bronchial asthma, eczema and urticaria, must be obtained prior to any medical procedure.


Aspiration of large amounts of barium sulfate suspension may cause pneumonitis or nodular granulomas of interstitial lung tissues and lymph nodes; asphyxiation and death have been reported.


A rare mild allergic reaction would most likely be generalized pruritus, erythema or urticaria (approximately 1 in 100,000 reactions). Such reactions will often respond to an antihistamine. More serious reactions (approximately 1 in 500,000) may result in laryngeal edema, bronchospasm or hypotension.


Severe reactions which may require emergency measures are often characterized by peripheral vasodilation, hypotension, reflex tachycardia, dyspnea, bronchospasm, agitation, confusion and cyanosis, progressing to unconsciousness. Treatment should be initiated immediately according to established standard of care.


Adrenocorticosteroids, even if given intravenously, exert no significant effect on the acute allergic reaction for a few hours. The administration of these steroid agents should not be regarded as emergency measures for the treatment of allergic reactions.


Apprehensive patients may develop weakness, pallor, tinnitus, diaphoresis and bradycardia following the administration of any diagnostic agent. Such reactions are usually non-allergic in nature.



Postmarketing Experiences


The following adverse experiences have been reported in patients receiving products containing barium sulfate. These adverse experiences are listed alphabetically: abdominal cramping, abdominal pain, diarrhea, fever, foreign body trauma relating to procedural complications, headache, laryngeal burning and irritation, leukocytosis, nausea, procedural site reactions, rash and vomiting.



Overdosage


In rare instances, immediate repeat oral examinations utilizing standard dosages may lead to severe stomach cramps and diarrhea. Cases reported in adults implicate a total dose in the range of 30 ounces (900 mL) of suspension. Instances of this type have resolved spontaneously and they are not considered to be life-threatening.



Liqui-Coat Suspension Dosage and Administration


Individual technique will determine the suspension quantity and specific procedure used. The following are suggested for Liqui-Coat HD use in double contrast stomach examinations.



Patient Preparation


Successful examination of the upper gastrointestinal tract requires that the stomach be empty and essentially free of fluid. This can usually be accomplished by instructing the patient to abstain from eating or drinking anything after the evening meal before the examination. The preparation for small bowel examinations, done separately or combined with an upper gastrointestinal series, is the same.



Administration


Shake the bottle of Liqui-Coat HD vigorously before use. While techniques may vary, it is suggested that the patient place a gas producing agent such as sodium bicarbonate on the tongue and wash down with 10 mL of water. Immediately following the sodium bicarbonate, and while the patient is in the upright position, have the patient drink the Liqui-Coat HD suspension. Instruct the patient not to burp. (Depending upon physician preference, the barium sulfate suspension may be given prior to sodium bicarbonate).



Pediatric Use


The quantity of suspension used and the barium sulfate concentration will depend upon patient size, technique used and clinical need.


For single patient use only. Properly discard unused portion.



How is Liqui-Coat Suspension Supplied


Catalog No. 149705. NDC 68240-328-24. 150 mL unit dose bottles; twenty-four (24) bottles per case.


Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from freezing.


Shake VIGOROUSLY before use.


Liqui-Coat HD is a trademark of Lafayette Pharmaceuticals, Inc.



DIN: 02195569

Distributed in Canada by:

tyco Healthcare

Pointe-Claire, QC, Canada H9R 5H8

Establishment License # 100689-A


Made in Mexico

Manufactured by:

Mallinckrodt Inc.

St. Louis, MO 63042 USA

www.Mallinckrodt.com


MID 1294550 Rev 04/2009


DOUBLE CONTRAST

UPPER G.I.
  • Ready-to-use

  • Unit dose

  • High density

tyco

Healthcare


Mallinckrodt









LIQUI-COAT   HD
barium sulfate  suspension










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)68240-328
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BARIUM SULFATE (BARIUM CATION)BARIUM SULFATE2100 mg  in 1 mL






























Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM 
SODIUM HYPOCHLORITE 
POTASSIUM SORBATE 
WATER 
HYDROGEN PEROXIDE 
CITRIC ACID MONOHYDRATE 
SORBITOL 
CARRAGEENAN 
SODIUM CITRATE 
SODIUM BENZOATE 
POTASSIUM CHLORIDE 
ACETIC ACID 
XANTHAN GUM 


















Product Characteristics
Color    Score    
ShapeSize
FlavorRASPBERRY, VANILLAImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
168240-328-2424 BOTTLE In 1 CASEcontains a BOTTLE, PLASTIC
1150 mL In 1 BOTTLE, PLASTICThis package is contained within the CASE (68240-328-24)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved other06/01/2009


Labeler - Mallinckrodt Inc. (810407189)









Establishment
NameAddressID/FEIOperations
Mallinckrodt Medical, S.A. de C.V.810407189analysis, manufacture
Revised: 05/2009Mallinckrodt Inc.

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  • Computed Tomography

Latuda





Dosage Form: tablet, film coated
FULL PRESCRIBING INFORMATION
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.


Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear.


Latuda is not approved for the treatment of patients with dementia-related psychosis. [see Warnings and Precautions (5.1)].




1. INDICATIONS AND USAGE


Latuda is indicated for the treatment of patients with schizophrenia.


The efficacy of Latuda in schizophrenia was established in four 6-week controlled studies of adult patients with schizophrenia [see Clinical Studies (14.1)].


The effectiveness of Latuda for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use Latuda for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2)].



2. DOSAGE AND ADMINISTRATION



. Schizophrenia


The recommended starting dose of Latuda is 40 mg once daily. Initial dose titration is not required. Latuda has been shown to be effective in a dose range of 40 mg/day to 120 mg/day [see Clinical Studies (14.1)]. In the 6-week controlled trials, there was no suggestion of added benefit with the 120 mg/day dose, but there was a dose-related increase in certain adverse reactions. Therefore, the maximum recommended dose is 80 mg/day.



. Administration Instructions


Latuda should be taken with food (at least 350 calories) [see Clinical Pharmacology (12)].



. Dosage in Special Populations


Dosage adjustments are not recommended on the basis of age, gender, and race [see Use in Specific Populations (8)].


Dose adjustment is recommended in moderate and severe renal impairment patients. The dose in these patients should not exceed 40 mg/day [see Use in Specific Populations (8)].


Dose adjustment is recommended in moderate and severe hepatic impairment patients. The dose in these patients should not exceed 40 mg/day [see Use in Specific Populations (8)].



Dosing recommendation for patients taking Latuda concomitantly with potential CYP3A4 inhibitors: When coadministration of Latuda with a moderate CYP3A4 inhibitor such as diltiazem is considered, the dose should not exceed 40 mg/day. Latuda should not be used in combination with a strong CYP3A4 inhibitor (e.g., ketoconazole) [see Contraindications (4); Drug Interactions (7.1)].



Dosing recommendation for patients taking Latuda concomitantly with potential CYP3A4 inducers: Latuda should not be used in combination with a strong CYP3A4 inducer (e.g., rifampin) [see Contraindications (4); Drug Interactions (7.1)].



3. DOSAGE FORMS AND STRENGTHS


Latuda tablets are available in the following shape and color (Table 1) with respective one-sided debossing: 20 mg (white to off-white, round, “L20”), 40 mg (white to off-white, round, “L40”), or 80 mg (pale green, oval, “L80”).
















Table 1: Latuda Tablet Presentations
Tablet StrengthTablet Color/ShapeTablet Markings
20 mgwhite to off-white roundL20
40 mgwhite to off-white roundL40
80 mgpale green ovalL80

4. CONTRAINDICATIONS


Latuda is contraindicated in any patient with a known hypersensitivity to lurasidone HCl or any components in the formulation. Angioedema has been observed with lurasidone [see Adverse Reactions (6.6)].


Latuda is contraindicated with strong CYP3A4 inhibitors (e.g., ketoconazole) and strong CYP3A4 inducers (e.g., rifampin) [see Drug Interactions (7.1)].



5. WARNINGS AND PRECAUTIONS



. Increased Mortality in Elderly Patients with Dementia-Related Psychosis


Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Latuda is not approved for the treatment of dementia-related psychosis [see Boxed Warning].



. Cerebrovascular Adverse Reactions, Including Stroke


In placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly subjects with dementia, there was a higher incidence of cerebrovascular adverse reactions (cerebrovascular accidents and transient ischemic attacks), including fatalities, compared to placebo-treated subjects. Latuda is not approved for the treatment of patients with dementia-related psychosis [see also Boxed Warning and Warnings and Precautions (5.1)].



. Neuroleptic Malignant Syndrome


A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs, including Latuda.


Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.


The diagnostic evaluation of patients with this syndrome is complicated. It is important to exclude cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system pathology.


The management of NMS should include: 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy; 2) intensive symptomatic treatment and medical monitoring; and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for NMS.


If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. If reintroduced, the patient should be carefully monitored, since recurrences of NMS have been reported.



. Tardive Dyskinesia


Tardive dyskinesia is a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements that can develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown.


The risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses.


There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic treatment, itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.


Given these considerations, Latuda should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that (1) is known to respond to antipsychotic drugs, and (2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically.


If signs and symptoms of tardive dyskinesia appear in a patient on Latuda, drug discontinuation should be considered. However, some patients may require treatment with Latuda despite the presence of the syndrome.



. Metabolic Changes


Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and body weight gain. While all of the drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile.



Hyperglycemia and Diabetes Mellitus


Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse events is not completely understood. However, epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-related adverse events in patients treated with the atypical antipsychotics. Because Latuda was not marketed at the time these studies were performed, it is not known if Latuda is associated with this increased risk.


Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.


Pooled data from short-term, placebo-controlled studies are presented in Table 2.






























Table 2: Change in Fasting Glucose


Placebo
Latuda

20 mg/day
Latuda

40 mg/day
Latuda

80 mg/day
Latuda

120 mg/day
Mean Change from Baseline (mg/dL)
n=438n=71n=352n=270n=283
Serum Glucose-0.7-0.62.5-0.92.5
Proportion of Patients with Shifts to ≥ 126 mg/dL
Serum Glucose

(≥ 126 mg/dL)
8.6%

(34/397)
11.7%

(7/60)
14.3%

( 47/328)
10.0%

(24/241)
10.0%

(26/260)

In the uncontrolled, longer-term studies (primarily open-label extension studies), Latuda was associated with a mean change in glucose of +1.6 mg/dL at week 24 (n=186), +0.3 mg/dL at week 36 (n=236) and +1.2 mg/dL at week 52 (n=244).



Dyslipidemia


Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics. Pooled data from short-term, placebo-controlled studies are presented in Table 3.










































Table 3: Change in Fasting Lipids


Placebo
Latuda

20 mg/day
Latuda

40 mg/day
Latuda

80 mg/day
Latuda

120 mg/day
Mean Change from Baseline (mg/dL)
n=418n=71n=341n=263n=268
Total cholesterol-8.5-12.3-9.4-9.8-3.8
Triglycerides-15.7-29.1-6.2-14.2-3.1
Proportion of Patients with Shifts
Total cholesterol (≥ 240 mg/dL)6.6%

(23/350)
13.8%

(8/58)
7.3%

(21/287)
6.9%

(15/216)
3.8%

(9/238)
Triglycerides

(≥ 200 mg/dL)
12.5%

(39/312)
14.3%

(7/49)
14.0%

(37/264)
8.7%

(17/196)
10.5%

(22/209)

In the uncontrolled, longer-term studies (primarily open-label extension studies), Latuda was associated with a mean change in total cholesterol and triglycerides of -4.2 (n=186) and -13.6 (n=187) mg/dL at week 24, -1.9 (n=238) and -3.5 (n=238) mg/dL at week 36 and -3.6 (n=243) and -6.5 (n=243) mg/dL at week 52, respectively.



Weight Gain


Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.


Pooled data from short-term, placebo-controlled studies are presented in Table 4. The mean weight gain was 0.75 kg for Latuda-treated patients compared to 0.26 kg for placebo-treated patients. In Study 3 [see Clinical Studies (14.1)] change in weight from baseline for olanzapine was 4.15 kg. The proportion of patients with a ≥ 7% increase in body weight (at Endpoint) was 5.6% for Latuda-treated patients versus 4.0% for placebo-treated patients.
















Table 4: Mean Change in Weight (kg) from Baseline


Placebo

(n=450)
Latuda

20 mg/day

(n=71)
Latuda

40 mg/day

(n=358)
Latuda

80 mg/day

(n=279)
Latuda

120 mg/day

(n=291)
All Patients0.26-0.150.671.140.68

In the uncontrolled, longer-term studies (primarily open-label extension studies), Latuda was associated with a mean change in weight of -0.38 kg at week 24 (n=531), -0.47 kg at week 36 (n=303) and -0.71 kg at week 52 (n=244).



. Hyperprolactinemia


As with other drugs that antagonize dopamine D2 receptors, Latuda elevates prolactin levels.


Hyperprolactinemia may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotrophin secretion. This, in turn, may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating compounds. Long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone density in both female and male patients [see Adverse Reactions (6)].


In short-term, placebo-controlled studies, the median change from baseline to endpoint in prolactin levels for Latuda-treated patients was 1.1 ng/mL and was - 0.6 ng/mL in the placebo-treated patients. The increase in prolactin was greater in female patients; the median change from baseline to endpoint for females was 1.5 ng/mL and was 1.1 ng/mL in males. The increase in prolactin concentrations was dose-dependent (Table 5).




























Table 5: Median Change in Prolactin (ng/mL) from Baseline
PlaceboLatuda

20 mg/day
Latuda

40 mg/day
Latuda

80 mg/day
Latuda

120 mg/day
All Patients-0.6

(n=430)
-1.1

(n=70)
0.3

(n=351)
1.1

(n=259)
3.3

(n=284)
Females-1.5

(n=102)
-0.7

(n=19)
-0.9

(n=99)
2.0

(n=78)
6.7

(n=70)
Males-0.5

(n=328)
-1.2

(n=51)
0.5

(n=252)
0.9

(n=181)
3.1

(n=214)

The proportion of patients with prolactin elevations ≥ 5× ULN was 3.6% for Latuda-treated patients versus 0.7% for placebo-treated patients. The proportion of female patients with prolactin elevations ≥ 5x ULN was 8.3% for Latuda-treated patients versus 1% for placebo-treated female patients. The proportion of male patients with prolactin elevations > 5x ULN was 1.9% versus 0.6% for placebo-treated male patients.


In the uncontrolled longer-term studies (primarily open-label extension studies), Latuda was associated with a median change in prolactin of -1.9 ng/mL at week 24 (n=188), -5.4 ng/mL at week 36 (n=189) and -3.3 ng/mL at week 52 (n=243).


Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent in vitro, a factor of potential importance if the prescription of these drugs is considered in a patient with previously detected breast cancer. As is common with compounds which increase prolactin release, an increase in mammary gland neoplasia was observed in a Latuda carcinogenicity study conducted in rats and mice [see Nonclinical Toxicology (13)]. Neither clinical studies nor epidemiologic studies conducted to date have shown an association between chronic administration of this class of drugs and tumorigenesis in humans, but the available evidence is too limited to be conclusive.



Leukopenia, Neutropenia and Agranulocytosis


Leukopenia/neutropenia has been reported during treatment with antipsychotic agents. Agranulocytosis (including fatal cases) has been reported with other agents in the class.


Possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count (WBC) and history of drug-induced leukopenia/neutropenia. Patients with a pre-existing low WBC or a history of drug-induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and Latuda should be discontinued at the first sign of decline in WBC, in the absence of other causative factors.


Patients with neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur. Patients with severe neutropenia (absolute neutrophil count < 1000/mm3) should discontinue Latuda and have their WBC followed until recovery.



. Orthostatic Hypotension and Syncope


Latuda may cause orthostatic hypotension, perhaps due to its α1-adrenergic receptor antagonism. The incidence of orthostatic hypotension and syncope events from short-term, placebo-controlled studies was (Latuda incidence, placebo incidence): orthostatic hypotension [0.4% (4/1004), 0.2% (1/455)] and syncope [< 0.1% (1/1004), 0%]. Assessment of orthostatic hypotension defined by vital sign changes (≥ 20 mm Hg decrease in systolic blood pressure and ≥ 10 bpm increase in pulse from sitting to standing or supine to standing positions). In short-term clinical trials orthostatic hypotension occurred with a frequency of 0.8% with Latuda 40 mg, 1.4% with Latuda 80 mg and 1.7% with Latuda 120 mg compared to 0.9% with placebo.


Latuda should be used with caution in patients with known cardiovascular disease (e.g., heart failure, history of myocardial infarction, ischemia, or conduction abnormalities), cerebrovascular disease, or conditions that predispose the patient to hypotension (e.g., dehydration, hypovolemia, and treatment with antihypertensive medications). Monitoring of orthostatic vital signs should be considered in patients who are vulnerable to hypotension.



. Seizures


As with other antipsychotic drugs, Latuda should be used cautiously in patients with a history of seizures or with conditions that lower the seizure threshold, e.g., Alzheimer's dementia. Conditions that lower the seizure threshold may be more prevalent in patients 65 years or older.


In short-term, placebo-controlled trials, seizures/convulsions occurred in < 0.1% (1/1004) of patients treated with Latuda compared to 0.2% (1/455) placebo-treated patients.



. Potential for Cognitive and Motor Impairment


Latuda, like other antipsychotics, has the potential to impair judgment, thinking or motor skills.


In short-term, placebo-controlled trials, somnolence was reported in 22.3% (224/1004) of patients treated with Latuda compared to 9.9% (45/455) of placebo patients, respectively. The frequency of somnolence increases with dose; somnolence was reported in 26.5% (77/291) of patients receiving Latuda 120 mg/day. In these short-term trials, somnolence included: hypersomnia, hypersomnolence, sedation and somnolence.


Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that therapy with Latuda does not affect them adversely.



. Body Temperature Regulation


Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic agents. Appropriate care is advised when prescribing Latuda for patients who will be experiencing conditions that may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration [see Patient Counseling Information (17.9)].



. Suicide


The possibility of a suicide attempt is inherent in psychotic illness and close supervision of high-risk patients should accompany drug therapy. Prescriptions for Latuda should be written for the smallest quantity of tablets consistent with good patient management in order to reduce the risk of overdose.


In short-term, placebo-controlled studies in patients with schizophrenia, the incidence of treatment-emergent suicidal ideation was 0.6% (6/1004) for Latuda-treated patients compared to 0.4% (2/455) on placebo. No suicide attempts or completed suicides were reported in these studies.



. Dysphagia


Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in elderly patients, in particular those with advanced Alzheimer's dementia. Latuda is not indicated for the treatment of dementia-related psychosis, and should not be used in patients at risk for aspiration pneumonia.



. Use in Patients with Concomitant Illness


Clinical experience with Latuda in patients with certain concomitant systemic illnesses is limited [see Use in Specific Populations (8.6, 8.7)]. Latuda has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease. Patients with these diagnoses were excluded from premarketing clinical studies [see Warnings and Precautions (5.1, 5.8)].



6. ADVERSE REACTIONS



. Overall Adverse Reaction Profile


The following adverse reactions are discussed in more detail in other sections of the labeling:


  • Use in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions (5.1)]

  • Cerebrovascular Adverse Reactions, Including Stroke [see Warnings and Precautions (5.2)]

  • Neuroleptic Malignant Syndrome [see Warnings and Precautions (5.3)]

  • Tardive Dyskinesia [see Warnings and Precautions (5.4)]

  • Hyperglycemia and Diabetes Mellitus [see Warnings and Precautions (5.5)]

  • Hyperprolactinemia [see Warnings and Precautions (5.6)]

  • Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.7)]

  • Orthostatic Hypotension and Syncope [see Warnings and Precautions (5.8)]

  • Seizures [see Warnings and Precautions (5.9)]

  • Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.10)]

  • Body Temperature Regulation [see Warnings and Precautions (5.11)]

  • Suicide [see Warnings and Precautions (5.12)]

  • Dysphagia [see Warnings and Precautions (5.13)]

  • Use in Patients with Concomitant Illness [see Warnings and Precautions (5.14)]

The information below is derived from a clinical study database for Latuda consisting of over 2096 patients with schizophrenia exposed to one or more doses with a total experience of 624 patient-years. Of these patients, 1004 participated in short-term, placebo-controlled schizophrenia studies with doses of 20 mg, 40 mg, 80 mg or 120 mg once daily. A total of 533 Latuda-treated patients had at least 24 weeks and 238 Latuda-treated patients had at least 52 weeks of exposure.


Adverse events during exposure to study treatment were obtained by general inquiry and voluntarily reported adverse experiences, as well as results from physical examinations, vital signs, ECGs, weights and laboratory investigations. Adverse experiences were recorded by clinical investigators using their own terminology. In order to provide a meaningful estimate of the proportion of individuals experiencing adverse events, events were grouped in standardized categories using MedDRA terminology.


The stated frequencies of adverse reactions represent the proportion of individuals who experienced at least once, a treatment-emergent adverse event of the type listed. Treatment-emergent adverse events were defined as adverse experiences, which started or worsened on or after the date of the first dose through seven days after study medication discontinuation. There was no attempt to use investigator causality assessments; i.e., all events meeting the defined criteria, regardless of investigator causality are included. It is important to emphasize that, although the reactions occurred during treatment with Latuda, they were not necessarily caused by it. The label should be read in its entirety to gain an understanding of the safety profile of Latuda.


The figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical studies. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatment, uses and investigators. The cited figures, however, do provide the prescriber with some basis for estimating the relative contribution of drug and nondrug factors to the adverse reaction incidence in the population studied.



. Clinical Studies Experience


The following findings are based on the short-term, placebo-controlled premarketing studies for schizophrenia in which Latuda was administered at daily doses ranging from 20 to 120 mg (n=1004).



Commonly Observed Adverse Reactions: The most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo) in patients treated with Latuda were somnolence, akathisia, nausea, parkinsonism and agitation.



Adverse Reactions Associated with Discontinuation of Treatment: A total of 9.4% (94/1004) Latuda-treated patients and 5.9% (27/455) of placebo-treated patients discontinued due to adverse reactions. There were no adverse reactions associated with discontinuation in subjects treated with Latuda that were at least 2% and at least twice the placebo rate.



Adverse Reactions Occurring at an Incidence of 2% or More in Latuda-Treated Patients: Adverse reactions associated with the use of Latuda (incidence of 2% or greater, rounded to the nearest percent and Latuda incidence greater than placebo) that occurred during acute therapy (up to 6 weeks in patients with schizophrenia) are shown in Table 6.































































Table 6: Adverse Reaction in 2% or More of Latuda-Treated Patients and That Occurred at Greater Incidence than in the Placebo-Treated Patients in Short-term Schizophrenia Studies

Note: Figures rounded to the nearest integer



* Somnolence includes adverse event terms: hypersomnia, hypersomnolence, sedation, and somnolence



** Parkinsonism includes adverse event terms: bradykinesia, cogwheel rigidity, drooling, extrapyramidal disorder, hypokinesia, muscle rigidity, parkinsonism, psychomotor retardation, and tremor



*** Dystonia includes adverse event terms: dystonia, oculogyric crisis, oromandibular dystonia, tongue spasm, torticollis, and trismus


Percentage of Patients Reporting Reaction
Body System or Organ Class

    Dictionary-derived Term
Placebo

(N=455)
All Latuda

(N=1004)
Gastrointestinal Disorders
    Nausea612
    Vomiting68
    Dyspepsia68
    Salivary Hypersecretion< 12
General Disorders and Administration Site Conditions
    Fatigue34
Musculoskeletal and Connective Tissue Disorders
    Back Pain34
Nervous System Disorders
    Somnolence*1022
    Akathisia315
    Parkinsonism**511
    Dystonia***15
    Dizziness35
Psychiatric Disorders
    Insomnia78
    Agitation36
    Anxiety36
    Restlessness23

. Dose-Related Adverse Reactions


Based on the pooled data from the short-term, placebo-controlled, fixed-dose studies, among the adverse reactions that occurred with a greater than 5% incidence in the patients treated with Latuda, the apparent dose-related adverse reactions were akathisia and somnolence (Table 7).

























Table 7: Dose-Related Adverse Events
Percentage of Subjects Reporting Reaction
Adverse Event Term

Placebo

(N=455)

(%)
Latuda

20 mg/day

(N=71)

(%)
Latuda

40 mg/day

(N=360)

(%)
Latuda

80 mg/day

(N=282)

(%)
Latuda

120 mg/day

(N=291)

(%)

Note: Figures rounded to the nearest integer

* Somnolence includes adverse event terms: hypersomnia, hypersomnolence, sedation, and somnolence


    Akathisia36111522
    Somnolence*1015192326

. Extrapyramidal Symptoms


In the short-term, placebo-controlled schizophrenia studies, for Latuda-treated patients, the incidence of reported EPS-related events, excluding akathisia and restlessness, was 14.7% versus 5.1% for placebo-treated patients; and the incidence of akathisia for Latuda-treated patients was 15.0% versus 3.3% for placebo-treated patients. Akathisia appeared to be dose-related and the greatest frequency of parkinsonism and dystonia occurred with the highest dose of Latuda, 120 mg/day (Table 8).





























Table 8: Percentage of EPS Compared to Placebo
Adverse Event Term

Placebo

(N=455)

(%)
Latuda

20 mg/day

(N=71)

(%)
Latuda

40 mg/day

(N=360)

(%)
Latuda

80 mg/day

(N=282)

(%)
Latuda

120 mg/day

(N=291)

(%)

Note: Figures rounded to the nearest integer



* Dystonia includes adverse event terms: dystonia, oculogyric crisis, oromandibular dystonia, tongue spasm, torticollis, and trismus



** Parkinsonism includes adverse event terms: bradykinesia, cogwheel rigidity, drooling, extrapyramidal disorder, hypokinesia, muscle rigidity, parkinsonism, psychomotor retardation, and tremor


All EPS events910242639
All EPS events, excluding Akathisia/Restlessness56131122
    Akathisia3611