Tuesday, October 25, 2016

dextromethorphan, phenylephrine, and pyrilamine


Generic Name: dextromethorphan, phenylephrine, and pyrilamine (dex troe meh THOR fan, feh nill EH frin, pie RIH la meen)

Brand names: Codal-DM Syrup, Codimal DM, Codituss DM, Poly Hist DM, ...show all 15 brand names.


What is dextromethorphan, phenylephrine, and pyrilamine?

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.


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


Pyrilamine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.


The combination of dextromethorphan, phenylephrine, and pyrilamine is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.


Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.


Dextromethorphan, phenylephrine, and pyrilamine may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about dextromethorphan, phenylephrine, and pyrilamine?


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. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine, decongestant, or cough suppressant. Dextromethorphan, phenylephrine, and pyrilamine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

What should I discuss with my healthcare provider before taking dextromethorphan, phenylephrine, and pyrilamine?


Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Before taking this medication, tell your doctor if you are allergic to dextromethorphan, phenylephrine, or pyrilamine, or if you have:


  • kidney disease;

  • liver disease;


  • diabetes;




  • glaucoma;




  • heart disease or high blood pressure;




  • a thyroid disorder;




  • a stomach ulcer or a stomach obstruction;




  • emphysema or chronic bronchitis; or




  • an enlarged prostate or urination problems.



If you have any of these conditions, you may not be able to use dextromethorphan, phenylephrine, and pyrilamine, or you may need a dosage adjustment or special tests during treatment.


FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Dextromethorphan, phenylephrine, and pyrilamine can pass into breast milk and may 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 cough-and-cold medications 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 dextromethorphan, phenylephrine, and pyrilamine?


Use this medication exactly as directed on the label or as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor.


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. Take this medicine with a full glass of water.

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 where you can get one.


Take this medicine with food or milk if it upsets your stomach.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.


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.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.


Store the medication at room temperature away from moisture and heat.

What happens if I miss a dose?


Since cough or cold medicine is usually taken only 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. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an overdose may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions). confusion, blurred vision, dry mouth, nausea, vomiting, and seizure (convulsions).


What should I avoid while taking dextromethorphan, phenylephrine, and pyrilamine?


This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by dextromethorphan, phenylephrine, and pyrilamine.


Avoid taking 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.


Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. Antihistamines, decongestants, and cough suppressants are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine, decongestant, or cough suppressant.

Dextromethorphan, phenylephrine, and pyrilamine 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;




  • confusion, hallucinations, unusual thoughts or behavior;




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




  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);




  • confusion, hallucinations;




  • slow, shallow breathing;




  • urinating less than usual or not at all;




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




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



Keep taking the medication and talk to your doctor if you have any of these less serious side effects:



  • blurred vision;




  • dry mouth;




  • nausea, stomach pain, constipation;




  • mild loss of appetite, stomach upset;




  • warmth, tingling, or redness under your skin;




  • feeling excited or restless;




  • sleep problems (insomnia);




  • restless or excitability (especially in children);




  • skin rash or itching;




  • dizziness, drowsiness;




  • problems with memory or concentration; or




  • ringing in your ears.



Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.


Dextromethorphan, phenylephrine, and pyrilamine Dosing Information


Usual Adult Dose for Allergic Rhinitis:

Suspension: 5 to 10 mL orally every 12 hours.
Tablet: 1 to 2 tablets orally every 12 hours.
Liquid: 5 to 10 mL orally every 4 to 6 hours, not to exceed 60 mg of phenylephrine in 24 hours.

Usual Adult Dose for Cold Symptoms:

Suspension: 5 to 10 mL orally every 12 hours.
Tablet: 1 to 2 tablets orally every 12 hours.
Liquid: 5 to 10 mL orally every 4 to 6 hours, not to exceed 60 mg of phenylephrine in 24 hours.

Usual Adult Dose for Sinusitis:

Suspension: 5 to 10 mL orally every 12 hours.
Tablet: 1 to 2 tablets orally every 12 hours.
Liquid: 5 to 10 mL orally every 4 to 6 hours, not to exceed 60 mg of phenylephrine in 24 hours.

Usual Pediatric Dose for Allergic Rhinitis:

2 years to Suspension: 2.5 mL orally every 12 hours.
Tablet: 1/2 tablet orally every 12 hours.
Liquid: 2.5 mL orally every 4 to 6 hours, not to exceed 15 mg of phenylephrine in 24 hours.

6 years to Suspension: 5 mL orally every 12 hours.
Tablet: 1/2 to 1 tablet orally every 12 hours.
Liquid: 5 mL orally every 4 to 6 hours, not to exceed 30 mg of phenylephrine in 24 hours.

=>12 years:
Suspension: 5 to 10 mL orally every 12 hours.
Tablet: 1 to 2 tablets orally every 12 hours.
Liquid: 5 to 10 mL orally every 4 to 6 hours, not to exceed 60 mg of phenylephrine in 24 hours.

Usual Pediatric Dose for Cold Symptoms:

2 years to Suspension: 2.5 mL orally every 12 hours.
Tablet: 1/2 tablet orally every 12 hours.
Liquid: 2.5 mL orally every 4 to 6 hours, not to exceed 15 mg of phenylephrine in 24 hours.

6 years to Suspension: 5 mL orally every 12 hours.
Tablet: 1/2 to 1 tablet orally every 12 hours.
Liquid: 5 mL orally every 4 to 6 hours, not to exceed 30 mg of phenylephrine in 24 hours.

=>12 years:
Suspension: 5 to 10 mL orally every 12 hours.
Tablet: 1 to 2 tablets orally every 12 hours.
Liquid: 5 to 10 mL orally every 4 to 6 hours, not to exceed 60 mg of phenylephrine in 24 hours.

Usual Pediatric Dose for Sinusitis:

2 years to Suspension: 2.5 mL orally every 12 hours.
Tablet: 1/2 tablet orally every 12 hours.
Liquid: 2.5 mL orally every 4 to 6 hours, not to exceed 15 mg of phenylephrine in 24 hours.

6 years to Suspension: 5 mL orally every 12 hours.
Tablet: 1/2 to 1 tablet orally every 12 hours.
Liquid: 5 mL orally every 4 to 6 hours, not to exceed 30 mg of phenylephrine in 24 hours.

=>12 years:
Suspension: 5 to 10 mL orally every 12 hours.
Tablet: 1 to 2 tablets orally every 12 hours.
Liquid: 5 to 10 mL orally every 4 to 6 hours, not to exceed 60 mg of phenylephrine in 24 hours.


What other drugs will affect dextromethorphan, phenylephrine, and pyrilamine?


Before taking this medication, tell your doctor if you are using any of the following drugs:



  • an antidepressant;




  • a diuretic (water pill);




  • medication to treat irritable bowel syndrome;




  • celecoxib (Celebrex);




  • cinacalcet (Sensipar);




  • darifenacin (Enablex);




  • imatinib (Gleevec);




  • quinidine (Quinaglute, Quinidex);




  • ranolazine (Ranexa)




  • ritonavir (Norvir);




  • sibutramine (Meridia);




  • terbinafine (Lamisil);




  • medicines to treat high blood pressure;




  • aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);




  • bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol); or




  • a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others.



There may be other drugs that can affect dextromethorphan, phenylephrine, and pyrilamine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More dextromethorphan, phenylephrine, and pyrilamine resources


  • Dextromethorphan, phenylephrine, and pyrilamine Side Effects (in more detail)
  • Dextromethorphan, phenylephrine, and pyrilamine Use in Pregnancy & Breastfeeding
  • Dextromethorphan, phenylephrine, and pyrilamine Drug Interactions
  • Dextromethorphan, phenylephrine, and pyrilamine Support Group
  • 2 Reviews for Dextromethorphan, phenylephrine, and pyrilamine - Add your own review/rating


Compare dextromethorphan, phenylephrine, and pyrilamine with other medications


  • Cold Symptoms
  • Hay Fever
  • Sinusitis


Where can I get more information?


  • Your pharmacist has information about dextromethorphan, phenylephrine, and pyrilamine written for health professionals that you may read.

See also: dextromethorphan, phenylephrine, and pyrilamine side effects (in more detail)


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Dextromethorphan/Guaifenesin/Pseudoephedrine


Pronunciation: DEX-troe-meth-OR-fan/gwye-FEN-e-sin/SOO-doe-e-FED-rin
Generic Name: Dextromethorphan/Guaifenesin/Pseudoephedrine
Brand Name: Maxifed DM


Dextromethorphan/Guaifenesin/Pseudoephedrine is used for:

Relieving congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.


Dextromethorphan/Guaifenesin/Pseudoephedrine is a decongestant, cough suppressant, and expectorant combination. It works by constricting blood vessels, reducing swelling in the nasal passages, and loosening mucus and lung secretions in the chest, making coughs more productive. The cough suppressant works in the brain to help decrease the cough reflex.


Do NOT use Dextromethorphan/Guaifenesin/Pseudoephedrine if:


  • you are allergic to any ingredient in Dextromethorphan/Guaifenesin/Pseudoephedrine

  • you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)

  • you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.



Before using Dextromethorphan/Guaifenesin/Pseudoephedrine:


Some medical conditions may interact with Dextromethorphan/Guaifenesin/Pseudoephedrine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have a history of glaucoma, enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, mental or mood problems (eg, depression), an overactive thyroid, seizures, or stroke

  • if you have a chronic cough, chronic obstructive pulmonary disease (COPD), or other lung problems (eg, asthma, chronic bronchitis, emphysema), or if your cough produces large amounts of mucus

  • if you are in poor health or are very overweight

Some MEDICINES MAY INTERACT with Dextromethorphan/Guaifenesin/Pseudoephedrine. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Dextromethorphan/Guaifenesin/Pseudoephedrine's side effects

  • Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased

  • Bromocriptine because the risk of its side effects may be increased by Dextromethorphan/Guaifenesin/Pseudoephedrine

  • Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Dextromethorphan/Guaifenesin/Pseudoephedrine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Dextromethorphan/Guaifenesin/Pseudoephedrine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Dextromethorphan/Guaifenesin/Pseudoephedrine:


Use Dextromethorphan/Guaifenesin/Pseudoephedrine as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Dextromethorphan/Guaifenesin/Pseudoephedrine by mouth with or without food.

  • Take Dextromethorphan/Guaifenesin/Pseudoephedrine with a full glass of water (8 oz/240 mL).

  • Drink plenty of water while taking Dextromethorphan/Guaifenesin/Pseudoephedrine.

  • If you miss a dose of Dextromethorphan/Guaifenesin/Pseudoephedrine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Dextromethorphan/Guaifenesin/Pseudoephedrine.



Important safety information:


  • Dextromethorphan/Guaifenesin/Pseudoephedrine may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Dextromethorphan/Guaifenesin/Pseudoephedrine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do not take appetite suppressants while you are taking Dextromethorphan/Guaifenesin/Pseudoephedrine without checking with your doctor.

  • Dextromethorphan/Guaifenesin/Pseudoephedrine has pseudoephedrine and dextromethorphan in it. Before you start any new medicine, check the label to see if it has pseudoephedrine or dextromethorphan in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • Do NOT exceed the recommended dose or take Dextromethorphan/Guaifenesin/Pseudoephedrine for longer than prescribed without checking with your doctor.

  • If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor or pharmacist.

  • Do not use Dextromethorphan/Guaifenesin/Pseudoephedrine for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.

  • Dextromethorphan/Guaifenesin/Pseudoephedrine may interfere with certain lab tests. Be sure that your doctor and lab personnel know you are taking Dextromethorphan/Guaifenesin/Pseudoephedrine.

  • Tell your doctor or dentist that you take Dextromethorphan/Guaifenesin/Pseudoephedrine before you receive any medical or dental care, emergency care, or surgery.

  • Use Dextromethorphan/Guaifenesin/Pseudoephedrine with caution in the ELDERLY; they may be more sensitive to its effects.

  • Dextromethorphan/Guaifenesin/Pseudoephedrine should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: It is not known if Dextromethorphan/Guaifenesin/Pseudoephedrine can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Dextromethorphan/Guaifenesin/Pseudoephedrine while you are pregnant. It is not known if Dextromethorphan/Guaifenesin/Pseudoephedrine is found in breast milk. Do not breast-feed while taking Dextromethorphan/Guaifenesin/Pseudoephedrine.


Possible side effects of Dextromethorphan/Guaifenesin/Pseudoephedrine:


All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Diarrhea; dizziness; drowsiness; excitability; headache; irritability; nausea; stomach upset; trouble sleeping.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast, slow, or irregular heartbeat; fever; hallucinations; mental or mood changes (eg, anxiety, nervousness); paleness; seizures; severe or persistent dizziness, lightheadedness, or headache; tremor.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Dextromethorphan/Guaifenesin/Pseudoephedrine side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; difficulty urinating; fast or shallow breathing; hallucinations; paleness; restlessness; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.


Proper storage of Dextromethorphan/Guaifenesin/Pseudoephedrine:

Store Dextromethorphan/Guaifenesin/Pseudoephedrine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dextromethorphan/Guaifenesin/Pseudoephedrine out of the reach of children and away from pets.


General information:


  • If you have any questions about Dextromethorphan/Guaifenesin/Pseudoephedrine, please talk with your doctor, pharmacist, or other health care provider.

  • Dextromethorphan/Guaifenesin/Pseudoephedrine is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Dextromethorphan/Guaifenesin/Pseudoephedrine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Dextromethorphan/Guaifenesin/Pseudoephedrine resources


  • Dextromethorphan/Guaifenesin/Pseudoephedrine Side Effects (in more detail)
  • Dextromethorphan/Guaifenesin/Pseudoephedrine Dosage
  • Dextromethorphan/Guaifenesin/Pseudoephedrine Use in Pregnancy & Breastfeeding
  • Dextromethorphan/Guaifenesin/Pseudoephedrine Drug Interactions
  • Dextromethorphan/Guaifenesin/Pseudoephedrine Support Group
  • 5 Reviews for Dextromethorphan/Guaifenesin/Pseudoephedrine - Add your own review/rating


  • Altarussin CF Concise Consumer Information (Cerner Multum)



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  • Cough and Nasal Congestion

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DigiFab


Generic Name: digoxin immune FAB (di JOX in im MYOON FAB)

Brand Names: Digibind, DigiFab


What is DigiFab (digoxin immune FAB)?

Digoxin immune FAB is used as an antidote to treat a life-threatening overdose of digoxin or digitoxin.


Digoxin immune FAB is not for treating a mild digitalis overdose.


Digoxin immune FAB may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about DigiFab (digoxin immune FAB)?


If possible, before you receive digoxin immune FAB, tell your doctor if you have heart disease or kidney disease, or if you are allergic to antibiotics or papaya extracts such as papain or chymopapain.

In an emergency situation, it may not be possible before you are treated to tell your caregivers about any health conditions you have or if you are pregnant or breast-feeding. However, make sure any doctor caring for you afterward knows that you received this medication.


After treatment with digoxin immune FAB, you will be watched to make sure the medication has been effective and you no longer have any effects of the digitalis overdose.


What should I discuss with my health care provider before receiving DigiFab (digoxin immune FAB)?


If possible, before you receive digoxin immune FAB, tell your doctor if you have:

  • heart disease;




  • kidney disease;




  • if you are allergic to antibiotics; or




  • if you are allergic to papaya extracts such as papain or chymopapain (Chymodiactin).




FDA pregnancy category C. Digoxin immune FAB may be harmful to an unborn baby. Tell your doctor if you are pregnant before receiving this medication. It is not known whether digoxin immune FAB passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

In a poisoning situation, it may not be possible to tell your caregivers that you are pregnant or breast-feeding before you are treated with digoxin immune FAB. However, make sure any doctor caring for your pregnancy or your baby knows that you have received the medication.


How is digoxin immune FAB given?


Digoxin immune FAB is given as an injection through a needle placed into a vein. You will receive this injection in a hospital or emergency setting. The medicine must be given slowly through an IV infusion, and each dose can take up to 30 minutes to complete.


To be sure this medication is helping your condition and not causing harmful side effects, your blood will need to be tested on a regular basis. This will help your doctor determine how long to treat you with digoxin immune FAB.


This medication can cause you to have unusual results with certain digitalis tests. Tell any doctor who treats you that you have been treated with digoxin immune FAB.


What happens if I miss a dose?


Since digoxin immune FAB is given in an emergency situation by a healthcare professional, it is not likely that you will miss a dose.


What happens if I overdose?


An overdose of this medication is unlikely since it is given by a healthcare provider.


What should I avoid after receiving DigiFab (digoxin immune FAB)?


Follow your doctor's instructions about any restrictions on food, beverages, or activity after you are treated with digoxin immune FAB.


DigiFab (digoxin immune FAB) 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. Tell your caregivers at once if you have any of these serious side effects:

  • fever;




  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);




  • low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);




  • feeling short of breath, even with mild exertion; or




  • swelling, rapid weight gain.



This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect DigiFab (digoxin immune FAB)?


This list is not complete and there may be other drugs that can interact with digoxin immune FAB. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.



More DigiFab resources


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


  • DigiFab MedFacts Consumer Leaflet (Wolters Kluwer)

  • Digibind Prescribing Information (FDA)

  • Digifab Prescribing Information (FDA)



Compare DigiFab with other medications


  • Digitalis Glycoside Toxicity


Where can I get more information?


  • Your doctor or pharmacist can provide more information about digoxin immune FAB.

See also: DigiFab side effects (in more detail)


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DexPak Jr


Generic Name: dexamethasone (Oral route)

dex-a-METH-a-sone

Commonly used brand name(s)

In the U.S.


  • Baycadron Elixer

  • Decadron

  • Dekpak 13 Day Taperpak

  • Dexamethasone Intensol

  • DexPak

  • DexPak 10 Day TaperPak

  • DexPak Jr

  • Zema-Pak

Available Dosage Forms:


  • Solution

  • Elixir

  • Tablet

Therapeutic Class: Endocrine-Metabolic Agent


Pharmacologic Class: Adrenal Glucocorticoid


Uses For DexPak Jr


Dexamethasone provides relief for inflamed areas of the body. It is used to treat a number of different conditions, such as inflammation (swelling), severe allergies, adrenal problems, arthritis, asthma, blood or bone marrow problems, kidney problems, skin conditions, and flare-ups of multiple sclerosis. Dexamethasone is a corticosteroid (cortisone-like medicine or steroid). It works on the immune system to help relieve swelling, redness, itching, and allergic reactions.


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


Before Using DexPak Jr


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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of dexamethasone in children. However, pediatric patients are more likely to have slower growth and bone problems if dexamethasone is used for a long time. Recommended doses should not be exceeded, and the patient should be carefully monitored during therapy.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dexamethasone in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for elderly patients receiving dexamethasone.


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.


  • Praziquantel

  • Rilpivirine

  • Rotavirus Vaccine, Live

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.


  • Aldesleukin

  • Boceprevir

  • Bupropion

  • Darunavir

  • Dasatinib

  • Efavirenz

  • Etravirine

  • Fosamprenavir

  • Imatinib

  • Ixabepilone

  • Lapatinib

  • Nevirapine

  • Nilotinib

  • Quetiapine

  • Rivaroxaban

  • Romidepsin

  • Sunitinib

  • Telaprevir

  • Temsirolimus

  • Thalidomide

  • Ticagrelor

  • Vandetanib

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.


  • Alatrofloxacin

  • Alcuronium

  • Aminoglutethimide

  • Aprepitant

  • Aspirin

  • Atracurium

  • Balofloxacin

  • Caspofungin

  • Cinoxacin

  • Ciprofloxacin

  • Clinafloxacin

  • Enoxacin

  • Fleroxacin

  • Fluindione

  • Flumequine

  • Fosaprepitant

  • Fosphenytoin

  • Gallamine

  • Gemifloxacin

  • Grepafloxacin

  • Hexafluorenium

  • Itraconazole

  • Levofloxacin

  • Licorice

  • Lomefloxacin

  • Metocurine

  • Moxifloxacin

  • Norfloxacin

  • Ofloxacin

  • Pancuronium

  • Pefloxacin

  • Phenobarbital

  • Phenytoin

  • Primidone

  • Prulifloxacin

  • Rifampin

  • Rifapentine

  • Ritonavir

  • Rosoxacin

  • Rufloxacin

  • Saiboku-To

  • Sparfloxacin

  • Temafloxacin

  • Tosufloxacin

  • Trovafloxacin Mesylate

  • Vecuronium

  • Warfarin

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:


  • Cataracts or

  • Congestive heart failure or

  • Cushing's syndrome (adrenal gland problem) or

  • Diabetes or

  • Eye infection or

  • Fluid retention or

  • Glaucoma or

  • Hyperglycemia (high blood sugar) or

  • Hypertension (high blood pressure) or

  • Infection (eg, bacterial, virus, fungus) or

  • Mood changes, including depression or

  • Myasthenia gravis (severe muscle weakness) or

  • Osteoporosis (weak bones) or

  • Peptic ulcer, active or history of or

  • Personality changes or

  • Stomach or intestinal problems (eg, diverticulitis, ulcerative colitis) or

  • Tuberculosis, inactive—Use with caution. May make these conditions worse.

  • Fungal infections or

  • Herpes simplex eye infection—Should not be used in patients with these conditions.

Proper Use of dexamethasone

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


Take this medicine exactly 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. To do so may increase the chance for unwanted effects.


Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.


The Dexamethasone Intensol™ solution is a concentrated liquid. Measure the concentrated liquid with the special oral dropper that comes with the package. The liquid should be added to water, juice, soda or a soda-like beverage, applesauce, or pudding. Stir the mixture well and drink or eat it right away. Do not store the mixture for future use.


If you use this medicine for a long time, do not suddenly stop using it without checking first with your doctor. You may need to slowly decrease your dose before stopping it completely.


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 forms (solution, tablets):
    • Dose depends on medical condition:
      • Adults—At first, 0.75 to 9 milligrams (mg) per day. Your doctor may adjust your dose as needed.

      • Children—Dose is based on body weight and must be determined by your doctor. At first, 0.02 to 0.3 mg per kilogram (kg) of body weight per day, divided and taken 3 or 4 times a day. Your doctor may adjust your dose as needed.



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.


Throw away any unused Dexamethasone Intensol™ solution 90 days after the bottle is opened for the first time.


Precautions While Using DexPak Jr


If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any unwanted effects that may be caused by this medicine. Blood or urine tests may be needed to check for unwanted effects.


Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.


If you are using this medicine for a long time, tell your doctor about any extra stress or anxiety in your life, including other health concerns and emotional stress. Your dose of this medicine might need to be changed for a short time while you have extra stress.


Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor right away if you have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.


While you are being treated with dexamethasone, do not have any immunizations (vaccines) without your doctor's approval. Dexamethasone may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.


Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).


This medicine might cause thinning of the bones (osteoporosis) or slow growth in children if used for a long time. Tell your doctor if you have any bone pain or if you have an increased risk for osteoporosis. If your child is using this medicine, tell the doctor if you think your child is not growing properly.


This medicine may cause changes in mood or behavior for some patients. Tell your doctor right away if you have depression; mood swings; a false or unusual sense of well-being; trouble with sleeping; or personality changes while taking this medicine.


Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain skin tests.


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 or vitamin supplements.


DexPak Jr 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
  • Aggression

  • agitation

  • anxiety

  • blurred vision

  • decrease in the amount of urine

  • dizziness

  • fast, slow, pounding, or irregular heartbeat or pulse

  • headache

  • irritability

  • mental depression

  • mood changes

  • nervousness

  • noisy, rattling breathing

  • numbness or tingling in the arms or legs

  • pounding in the ears

  • shortness of breath

  • swelling of the fingers, hands, feet, or lower legs

  • trouble thinking, speaking, or walking

  • troubled breathing at rest

  • weight gain

Incidence not known
  • Abdominal cramping and/or burning (severe)

  • abdominal pain

  • backache

  • bloody, black, or tarry stools

  • cough or hoarseness

  • darkening of skin

  • decrease in height

  • decreased vision

  • diarrhea

  • dry mouth

  • eye pain

  • eye tearing

  • facial hair growth in females

  • fainting

  • fatigue

  • fever or chills

  • flushed, dry skin

  • fractures

  • fruit-like breath odor

  • full or round face, neck, or trunk

  • heartburn and/or indigestion (severe and continuous)

  • increased hunger

  • increased thirst

  • increased urination

  • loss of appetite

  • loss of sexual desire or ability

  • lower back or side pain

  • menstrual irregularities

  • muscle pain or tenderness

  • muscle wasting or weakness

  • nausea

  • pain in back, ribs, arms, or legs

  • painful or difficult urination

  • skin rash

  • sleeplessness

  • sweating

  • trouble healing

  • trouble sleeping

  • unexplained weight loss

  • unusual tiredness or weakness

  • vision changes

  • vomiting

  • vomiting of material that looks like coffee grounds

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
  • Increased appetite

Incidence not known
  • Abnormal fat deposits on the face, neck, and trunk

  • acne

  • dry scalp

  • lightening of normal skin color

  • red face

  • reddish purple lines on the arms, face, legs, trunk, or groin

  • swelling of the stomach area

  • thinning of the scalp hair

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.



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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Labels:

Daraprim


Generic Name: Pyrimethamine, Sulfadoxine and Pyrimethamine
Class: Antimalarials
VA Class: AP101
CAS Number: 58-14-0


  • Fixed Combination of Sulfadoxine and Pyrimethamine (Fansidar )


  • Severe reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis), including fatalities, reported.168 (See Dermatologic and Hypersensitivity Reactions under Cautions.)




  • Discontinue at first sign of rash, significant myelosuppression, or active bacterial or fungal infection.168




Introduction

Antimalarial and antiparasitic agent; folic acid antagonist.167 168 a Pyrimethamine commercially available as single-entity preparation or in fixed combination with sulfadoxine (Fansidar).167 168


Uses for Daraprim


Malaria


Pyrimethamine (single-entity preparation)167 and fixed-combination preparation containing sulfadoxine and pyrimethamine (Fansidar)104 128 139 168 186 188 have been used for prevention (prophylaxis) of malaria, but are no longer recommended by CDC or others for malaria prevention.203 212 b c Resistance to pyrimethamine is prevalent worldwide;167 resistance to Fansidar is widespread in certain areas (e.g., Amazon basin area of South America, Southeast Asia, other parts of Asia, large parts of Africa).203 b Consider use of Fansidar for malaria prophylaxis only in individuals traveling to areas where chloroquine-resistant Plasmodium falciparum malaria is endemic and susceptible to the drug and only when other antimalarials (chloroquine, mefloquine, doxycycline, fixed combination of atovaquone and proguanil hydrochloride [Malarone]) are unavailable or contraindicated.168


Although pyrimethamine (single-entity preparation) has been used in conjunction with a sulfonamide for treatment of acute malaria, it should not be used alone167 and is not included in current CDC recommendations for treatment of malaria.c Fansidar has been used in conjunction with oral quinine sulfate for treatment of uncomplicated or mild to moderate malaria caused by chloroquine-resistant P. falciparum,186 187 189 but is not included in current CDC recommendations for treatment of uncomplicated or severe malaria.c


Fansidar has been used for presumptive self-treatment of malaria† in travelers without sulfonamide sensitivity traveling to areas where resistance to the drug has not been reported,188 189 208 b but CDC generally recommends the fixed combination of atovaquone and proguanil (Malarone) for such treatment.203 b


Detailed recommendations regarding prevention of malaria available from CDC at 877-394-8747 or .b


Assistance with diagnosis or treatment of malaria available from CDC Malaria Epidemiology Branch by contacting CDC Malaria Hotline at 770-488-7788 from 8:00 a.m. to 4:30 p.m. Eastern Standard Time, CDC Emergency Operation Center at 770-488-7100 after hours, on weekends, and holidays or at .b


Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia


Pyrimethamine (single-entity preparation) and leucovorin used in conjunction with dapsone for prevention of of Pneumocystis jiroveci (formerly Pneumocystis carinii) pneumonia† (PCP).171 172 173 174 175 176 177 178 179 180 196 199 203 208 214 Pyrimethamine and Fansidar are not included in current CDC, NIH, and IDSA recommendations for treatment of PCP.214 215


Pyrimethamine and leucovorin used in conjunction with dapsone is one of several alternatives that can be used for prevention of initial episodes of PCP (primary prophylaxis)† in HIV-infected adults and adolescents when co-trimoxazole (the drug of choice) cannot be used.199 203 208 Only limited data available regarding use of this regimen for such prophylaxis in children.d


Pyrimethamine and leucovorin used in conjunction with dapsone is one of several alternatives that can be used for long-term suppressive or chronic maintenance therapy (secondary prophylaxis) of PCP† in HIV-infected adults and adolescents when co-trimoxazole (the drug of choice) cannot be used.199 203 208 214 Only limited data available regarding use of this regimen for such prophylaxis in children.d


Although Fansidar has been used for prophylaxis of PCP† in HIV-infected individuals, including those who do not tolerate co-trimoxazole prophylaxis,128 129 130 131 134 135 136 146 165 166 180 183 203 the drug is not recommended by USPHS/IDSA, CDC, NIH, or others as a preferred or alternative drug for prevention of PCP.180 199 203 214


Toxoplasmosis


Pyrimethamine (single-entity preparation) is used in conjunction with other anti-infectives for treatment or prevention† of toxoplasmosis caused by Toxoplasma gondii.167 199 214 215


Pyrimethamine and leucovorin used in conjunction with sulfadiazine is the regimen of choice for initial treatment of toxoplasmosis in adults, adolescents, or children, including HIV-infected individuals.184 185 203 208 214 215


Pyrimethamine and leucovorin used in conjunction with clindamycin is a preferred alternative for treatment of toxoplasmosis in immunocompromised adults, adolescents, or children who are unable to tolerate the sulfonamide component of the regimen of choice or have failed to respond to or have relapsed after the treatment of choice.152 153 154 155 158 164 184 193 194 198 203 208 214 215 Pyrimethamine and leucovorin used in conjunction with atovaquone or azithromycin also are alternatives for treatment of toxoplasmosis in adults and adolescents when the regimen of choice cannot be used; these regimens have not been studied in children.214 When a parenteral regimen is indicated, some experts suggest use of oral pyrimethamine in conjunction with parenteral co-trimoxazole or parenteral clindamycin.214


Pyrimethamine and leucovorin used in conjunction with sulfadiazine is the regimen of choice for treatment of symptomatic or asymptomatic congenital toxoplasmosis.208 215 Empiric treatment of the infant should be strongly considered if the mother had symptomatic Toxoplasma infection during pregnancy, even if the mother was treated.215


Pyrimethamine and leucovorin used in conjunction with dapsone is the recommended alternative regimen for prevention of T. gondii encephalitis (primary prophylaxis)† in HIV-infected adults, adolescents, and children when the regimen of choice (co-trimoxazole) cannot be used.178 195 199 210 211 Pyrimethamine and leucovorin used in conjunction with atovaquone is another alternative for primary prophylaxis of toxoplasmosis in HIV-infected adults and adolescents when the regimen of choice (co-trimoxazole) cannot be used.199 203


Pyrimethamine and leucovorin used in conjunction with sulfadiazine is the regimen of choice for long-term suppressive or chronic maintenance therapy (secondary prophylaxis) to prevent relapse of T. gondii encephalitis† in HIV-infected adults, adolescents, or children who have completed treatment for the disease.199 214 215


Pyrimethamine and leucovorin in conjunction with clindamycin is an alternative in adults, adolescents, or children and pyrimethamine and leucovorin used in conjunction with atovaquone is an alternative in adults and adolescents for secondary prophylaxis of toxoplasmosis in HIV-infected individuals when the regimen of choice cannot be used.199 214


Isosporiasis


Pyrimethamine (single-entity preparation) has been used for treatment of isosporiasis† caused by Isospora belli in certain patients, including HIV-infected individuals, when the drug of choice (co-trimoxazole) could not be used (e.g., because of sulfonamide sensitivity).192 214


Daraprim Dosage and Administration


Administration


Oral Administration


Pyrimethamine (single-entity preparation): Administer orally.167 If anorexia or vomiting occurs, give with a meal to minimize adverse GI effects.167


Fixed combination containing pyrimethamine and sulfadoxine (Fansidar): Administer orally with plenty of fluids after a meal.168 Swallow whole; do not chew.168


For children and others unable to swallow tablets, extemporaneous oral suspensions of pyrimethamine may be prepared by crushing pyrimethamine tablets (single-entity preparation) and mixing with water, cherry syrup, or other sucrose-containing solution.109 (See Stability.) Shake oral suspension prior to each dose.109


Dosage


Dosage of Fansidar is given in terms of number of tablets.168 Each tablet contains 500 mg of sulfadoxine and 25 mg of pyrimethamine.168


Pediatric Patients


Malaria (Pyrimethamine)

Prevention of Malaria

Oral

Infants and children <4 years of age: Manufacturer recommends 6.25 mg once weekly.167


Children 4–10 years of age: Manufacturer recommends 12.5 mg once weekly.167


Children >10 years of age: Manufacturer recommends 25 mg once weekly.167


Consider that resistance to pyrimethamine is prevalent worldwide.167 (See Malaria under Uses.)


Treatment of Malaria

Oral

Children 4–10 years of age: Manufacturer recommends 25 mg once daily for 2 days, followed by 12.5 mg once weekly for ≥10 weeks.167


Consider that resistance to pyrimethamine is prevalent worldwide.167 (See Malaria under Uses.)


Malaria (Fansidar)

Prevention of Malaria

Oral













Prevention of Malaria in Children >2 Months of Age (Fansidar).168

Weight (kg)



Dosage (Once Weekly)



5–10



0.25 tablet



11–20



0.5 tablet



21–30



0.75 tablet



31–45



1 tablet



>45



1.5 tablets


Initiate prophylaxis 1 or 2 days prior to entering a malarious area and continue for 4–6 weeks after leaving the area.168 If there are concerns about tolerance or drug interactions, it may be advisable to initiate prophylaxis sooner prior to travel in individuals receiving other drugs to ensure that the combination of drugs is well tolerated and to allow ample time if a switch to another antimalarial is required.d


Terminal prophylaxis with primaquine may be indicated during the final 2 weeks or immediately following Fansidar prophylaxis if exposure occurred in areas where P. ovale or P. vivax are endemic.d


Consider that resistance to sulfadoxine and pyrimethamine has been reported.203 205 (See Malaria under Uses.)


Treatment of Uncomplicated P. falciparum Malaria

Oral













Treatment of Uncomplicated P. falciparum Malaria in Children >2 Months of Age (Fansidar).168

Weight (kg)



Dosage (Single Dose)



5–10



0.5 tablet



11–20



1 tablet



21–30



1.5 tablets



31–45



2 tablets



>45



3 tablets


Consider that resistance to sulfadoxine and pyrimethamine has been reported.203 205 (See Malaria under Uses.)


Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia† (Pyrimethamine)

Prevention (Primary Prophylaxis)†

Oral

Adolescents: 50 mg once weekly with oral leucovorin (25 mg once weekly) in conjunction with oral dapsone (50 mg once daily).199 203 Alternatively, 75 mg once weekly with oral leucovorin (25 mg once weekly) in conjunction with oral dapsone (200 mg once weekly).199 203


Criteria for initiating or discontinuing primary PCP prophylaxis† in HIV-infected adolescents are the same as those recommended for adults.199 (See Adults under Dosage and Administration.)


Prevention of Recurrence (Secondary Prophylaxis)†

Oral

Adolescents: 50 mg once weekly with oral leucovorin (25 mg once weekly) in conjunction with oral dapsone (50 mg once daily).199 203 214 Alternatively, 75 mg once weekly with oral leucovorin (25 mg once weekly) in conjunction with oral dapsone (200 mg once weekly).199 203 214


Criteria for initiating or discontinuing secondary PCP prophylaxis in adolescents are the same as those recommended for adults.214 (See Adults under Dosage and Administration.)


Toxoplasmosis (Pyrimethamine)

Treatment

Oral

Manufacturer recommends 1 mg/kg daily in 2 divided doses for 2–4 days, then reduce dosage by 50% and continue for approximately 1 month.167 Must be used in conjunction with a sulfonamide.167


Treatment of Congenital Toxoplasmosis

Oral

2 mg/kg (up to 50 mg) once daily for 2 days, then 1 mg/kg (up to 25 mg) once daily for 2–6 months, then 1 mg/kg 3 times weekly; used in conjunction with oral or IM leucovorin (10 mg with each pyrimethamine dose) and oral sulfadiazine (50 mg/kg twice daily).215


Optimal duration of treatment unclear and should be determined in consultation with an expert; treatment often is continued for 12 months.208 215


Treatment in HIV-infected Infants and Children

Oral

2 mg/kg (up to 50 mg) once daily for 3 days, then 1 mg/kg once daily; used in conjunction with oral leucovorin (10–25 mg once daily) and oral sulfadiazine (25–50 mg/kg 4 times daily).215 Alternatively, pyrimethamine 2 mg/kg once daily for 3 days, then 1 mg/kg once daily used in conjunction with oral leucovorin (10–25 mg once daily) and oral or IV clindamycin (5–7.5 mg/kg 4 times daily).215


Continue acute treatment for ≥6 weeks; a longer duration may be appropriate if disease is extensive or response incomplete at 6 weeks.215


Treatment in HIV-infected Adolescents

Oral

200 mg once, then 50 mg once daily in those weighing <60 kg or 75 mg once daily in those weighing ≥60 kg; used in conjunction with oral leucovorin (at least 10–20 mg once daily) and oral sulfadiazine (1 g every 6 hours in those weighing <60 kg or 1.5 g every 6 hours in those weighing ≥60 kg).214


Alternatively, 200 mg once, then 50 mg once daily in those weighing <60 kg or 75 mg once daily in those weighing ≥60 kg; used in conjunction with oral leucovorin (at least 10–20 mg once daily) and either oral or IV clindamycin (600 mg every 6 hours), oral atovaquone (1.5 g twice daily), or oral azithromycin (0.9–1.2 g once daily).214


Continue acute treatment for ≥6 weeks; a longer duration may be appropriate if disease is extensive or response incomplete at 6 weeks.214


Prevention (Primary Prophylaxis) in HIV-Infected Infants and Children†

Oral

1 mg/kg once daily used in conjunction with oral leucovorin (5 mg once every 3 days) and dapsone (2 mg/kg or 15 mg/m2 once daily).199


Primary prophylaxis against T. gondii encephalitis should be initiated in all HIV-infected infants and children with severe immunosuppression who are seropositive for Toxoplasma IgG antibody.199 d


The safety of discontinuing primary toxoplasmosis prophylaxis in HIV-infected children receiving potent antiretroviral therapy has not been extensively studied to date.199


Prevention (Primary Prophylaxis) in HIV-Infected Adolescents†

Oral

50 mg once weekly used in conjunction with oral leucovorin (25 mg once weekly) with oral dapsone (50 mg once daily).199 Alternatively, 75 mg once weekly used in conjunction with oral leucovorin (25 mg once weekly) and oral dapsone (200 mg once weekly).199


Alternatively, 25 mg once daily used in conjunction with oral leucovorin (10 mg once daily) and oral atovaquone (1.5 g once daily).199


Criteria for initiating or discontinuing primary prophylaxis against toxoplasmosis in adolescents are the same as those recommended for adults.199 (See Adults under Dosage and Administration.)


Prevention of Recurrence (Secondary Prophylaxis) in HIV-infected Infants and Children†

Oral

1 mg/kg or 15 mg/m2 (up to 25 mg) once daily used in conjunction with oral leucovorin (5 mg once every 3 days) and either oral sulfadiazine (85–120 mg/kg daily in 2–4 divided doses) or, alternatively, oral clindamycin (20–30 mg/kg daily in 4 divided doses).199


Secondary prophylaxis against toxoplasmosis generally is continued for life.199 214 215 The safety of discontinuing secondary toxoplasmosis prophylaxis in HIV-infected infants and children receiving potent antiretroviral therapy has not been extensively studied.199 214 215


Prevention of Recurrence (Secondary Prophylaxis) in HIV-infected Adolescents†

Oral

Dosage for secondary prophylaxis against toxoplasmosis in adolescents and criteria for initiation or discontinuance of such prophylaxis in this age group are the same as those recommended for adults.199 214 (See Adults under Dosage and Administration.)


Adults


Malaria (Pyrimethamine)

Prevention of Malaria

Oral

Manufacturer recommends 25 mg once weekly.167


Consider that resistance to pyrimethamine is prevalent worldwide.167 (See Malaria under Uses.)


Treatment of Acute Malaria

Oral

Manufacturer recommends 50 mg once daily for 2 days, followed by 25 mg once weekly for ≥10 weeks.167


Manufacturer states 25 mg once daily for 2 days in conjunction with a sulfonamide will initiate transmission control and suppression of non-falciparum malaria.167


Consider that resistance to pyrimethamine is prevalent worldwide.167 (See Malaria under Uses.)


Malaria (Fansidar)

Prevention of Malaria

Oral

Fansidar: 1 tablet once weekly or 2 tablets once every 2 weeks.168


Initiate prophylaxis 1 or 2 days prior to entering a malarious area and continue for 4–6 weeks after leaving the area.168 If there are concerns about tolerance or drug interactions, it may be advisable to initiate prophylaxis sooner prior to travel in individuals receiving other drugs to ensure that the combination of drugs is well tolerated and to allow ample time if a switch to another antimalarial is required.b


Terminal prophylaxis with primaquine may be indicated during the final 2 weeks or immediately following Fansidar prophylaxis if exposure occurred in areas where P. ovale or P. vivax are endemic.b


Consider that resistance to sulfadoxine and pyrimethamine has been reported.203 205 (See Malaria under Uses.)


Treatment of Uncomplicated P. falciparum Malaria

Oral

Fansidar: 2–3 tablets as a single dose.168


For treatment of chloroquine-resistant P. falciparum malaria, single Fansidar dose has been used in conjunction with a quinine regimen given for 3–7 days;189 administer Fansidar dose on last day of quinine therapy.189


Pneumocystis jiroveci (Pneumocystis carinii) Pneumonia† (Pyrimethamine)

Prevention (Primary Prophylaxis)†

Oral

50 mg once weekly used in conjunction with oral leucovorin (25 mg once weekly) and oral dapsone (50 mg once daily).199 203 214 Alternatively, 75 mg once weekly used in conjunction with oral leucovorin (25 mg once weekly) and oral dapsone (200 mg once weekly).199 203 214


Initiate primary prophylaxis against PCP in HIV-infected adults and adolescents with CD4+ T-cell counts <200/mm3 or a history of oropharyngeal candidiasis.199 Also consider primary prophylaxis if CD4+ T-cell percentage is <14% or there is a history of an AIDS-defining illness.199


Primary prophylaxis can be discontinued in adults and adolescents responding to potent antiretroviral therapy who have a sustained (3 months or longer) increase in CD4+ T-cell counts from <200/mm3 to >200/mm3.199


Reinitiate primary prophylaxis if CD4+ T-cell count decreases to <200/mm3.199


Prevention of Recurrence (Secondary Prophylaxis)†

Oral

50 mg once weekly used in conjunction with oral leucovorin (25 mg once weekly) and oral dapsone (50 mg once daily).199 203 214 Alternatively, 75 mg once weekly used in conjunction with oral leucovorin (25 mg once weekly) and oral dapsone (200 mg once weekly).199 203 214


Initiate long-term suppressive therapy or chronic maintenance therapy (secondary prophylaxis) to prevent recurrence in those with a history of PCP.199 214


Discontinuance of secondary prophylaxis is recommended in those who have a sustained (3 months or longer) increase in CD4+ T-cell counts to >200/mm3199 214 since such prophylaxis appears to add little benefit in terms of disease prevention and discontinuance reduces medication burden, potential for toxicity, drug interactions, selection of drug-resistant pathogens, and cost.199


Reinitiate secondary prophylaxis if CD4+ T-cell count decreases to <200/mm3 or if PCP recurs at a CD4+ T-cell count >200/mm3.199 214 It probably is prudent to continue secondary prophylaxis for life in those who had PCP episodes when they had CD4+ T-cell counts >200/mm3.199


Toxoplasmosis (Pyrimethamine)

Treatment

Oral

Manufacturer recommends 50–75 mg once daily in conjunction with a sulfonamide for 1–3 weeks; reduce dosage of both drugs by 50% and continue for 4–5 additional weeks.167


Treatment in HIV-infected Adults

Oral

200 mg once, then 50 mg once daily in those weighing <60 kg or 75 mg once daily in those weighing ≥60 kg; used in conjunction with oral leucovorin (at least 10–20 mg once daily) and oral sulfadiazine (1 g every 6 hours in those weighing <60 kg or 1.5 g every 6 hours in those weighing ≥60 kg).214


Alternatively, 200 mg once daily, then 50 mg once daily in those weighing <60 kg or 75 mg once daily in those weighing ≥60 kg; used in conjunction with oral leucovorin (at least 10–20 mg once daily) and either oral or IV clindamycin (600 mg every 6 hours), oral atovaquone (1.5 g twice daily), or oral azithromycin (0.9–1.2 g once daily).214


Continue acute treatment for ≥6 weeks; a longer duration may be appropriate if disease is extensive or response incomplete at 6 weeks.214


Prevention (Primary Prophylaxis) in HIV-Infected Adults†

Oral

50 mg once weekly used in conjunction with oral leucovorin (25 mg once weekly) and oral dapsone (50 mg once daily).199 Alternatively, 75 mg once weekly used in conjunction with oral leucovorin (25 mg once weekly) and oral dapsone (200 mg once weekly).199


Alternatively, 25 mg once daily used in conjunction with oral leucovorin (10 mg once daily) and oral atovaquone (1.5 g once daily).199


Discontinuance of primary toxoplasmosis prophylaxis is recommended in HIV-infected adults and adolescents who have a sustained (3 months or longer) increase in CD4+ T-cell counts to >200/ mm3 since such prophylaxis appears to add little benefit in terms of disease prevention and discontinuance reduces medication burden, potential for toxicity, drug interactions, selection of drug-resistant pathogens, and cost.199


Reinitiate primary prophylaxis if CD4+ T-cell count decreases to <100–200/mm3.199


Prevention of Recurrence (Secondary Prophylaxis) in HIV-infected Adults†

Oral

25–50 mg once daily in conjunction with oral leucovorin (10–25 mg once daily) and either oral sulfadiazine (0.5–1 g every 6 hours) or, alternatively, oral clindamycin (300–450 mg every 6–8 hours).199 214


Alternatively, 25 mg once daily with oral leucovorin (10 mg once daily) and oral atovaquone (750 mg every 6–12 hours).199 214


Initiate long-term suppressive therapy or chronic maintenance therapy (secondary prophylaxis) in all patients who have completed initial treatment of toxoplasmosis encephalitis (TE).199 214


Consideration can be given to discontinuing secondary prophylaxis in adults or adolescents who successfully completed initial treatment for TE, are asymptomatic with respect to TE, and have a sustained (6 months or longer) increase in CD4+ T-cell counts to >200/mm3.199 214


Reinitiate secondary prophylaxis if CD4+ T-cell count decreases to <200/mm3.199 214


Isosporiasis† (Pyrimethamine)

Oral

50–75 mg once daily or in divided doses with oral leucovorin (5–10 mg) once daily.203 214


Prescribing Limits


Pediatric Patients


Toxoplasmosis (Pyrimethamine)

Treatment of HIV-infected Infants and Children

Oral

Maximum 25–50 mg per dose.215


Prevention of Recurrence (Secondary Prophylaxis) in HIV-infected Infants and Children†

Oral

Maximum 25 mg per dose.199


Special Populations


No special population dosage recommendation at this time.167 168


Cautions for Daraprim


Contraindications


  • Pyrimethamine


  • Hypersensitivity to pyrimethamine or any ingredient in the formulation.167




  • Megaloblastic anemia caused by folate deficiency.167



  • Fixed Combination of Sulfadoxine and Pyrimethamine (Fansidar )


  • Hypersensitivity to pyrimethamine, sulfonamides, or any ingredient in the formulation.168




  • Megaloblastic anemia caused by folate deficiency.168




  • Repeated prophylactic (prolonged) use in patients with renal or hepatic failure or blood dyscrasias.168




  • Infants <2 months of age.168




  • Prophylaxis in pregnancy at term.168 (See Pregnancy under Cautions.)




  • Prophylaxis in nursing women.168 (See Lactation under Cautions.)



Warnings/Precautions


Warnings


Severe Reactions

Fatalities due to erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis reported with Fansidar;110 111 112 114 132 136 139 140 143 144 145 168 fatalities related to hypersensitivity, hepatocellular necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias reported with sulfonamides.111 112 132 138 140 168 (See Dermatologic and Hypersensitivity Reactions under Cautions.)


Discontinue pyrimethamine or Fansidar at first sign of rash, sore throat, fever, arthralgia, cough, shortness of breath, pallor, jaundice, or glossitis.167 168


Discontinue Fansidar if significant myelosuppression or active bacterial or fungal infection occurs.110 159 168


Hematologic Effects

Agranulocytosis, aplastic anemia, megaloblastic anemia, thrombocytopenia, leukopenia, hemolytic anemia, purpura, hypoprothrombinemia, methemoglobinemia, and eosinophilia reported with sulfonamides and/or with pyrimethamine.114 168


High pyrimethamine dosage may deplete folic acid stores and cause reversible bone marrow depression.167 Use with caution in patients with possible folate deficiency, including malabsorption syndrome, alcoholism, pregnancy (see Pregnancy under Cautions), and in those receiving drugs affecting folate levels (see Interactions).167 Hematologic effects may also occur with lower pyrimethamine dosages in certain individuals.167 Reduce or discontinue pyrimethamine or Fansidar if signs of folic or folinic acid deficiency occur.167 168 Perform CBCs twice weekly.167 (See Laboratory Monitoring under Cautions.)


Pyrimethamine dosage used for treatment of toxoplasmosis approaches toxic levels and is associated with adverse effects resulting from folic acid deficiency.167 a Megaloblastic anemia, leukopenia, thrombocytopenia, and pancytopenia reported.167 When pyrimethamine is used for treatment of toxoplasmosis, give leucovorin (folinic acid) concomitantly.167 203 (See Toxoplasmosis under Pediatric Patients and also under Adults, in Dosage and Administration.) Adverse hematologic effects, including megaloblastic anemia, generally reversible when drug discontinued.a


Leukopenia (generally mild and reversible) reported when Fansidar administered for ≥2 months for malaria prevention.168


Carcinogenicity

Manufacturer states pyrimethamine may be carcinogenic.167 Chronic granulocytic leukemia and reticulum cell sarcoma reported rarely after long-term use for treatment of toxoplasmosis; increase in lung tumors reported in animal study.167


Sensitivity Reactions


Dermatologic and Hypersensitivity Reactions

Fatalities due to erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis reported with Fansidar.110 111 112 114 132 136 139 140 143 144 145 159 168 Other hypersensitivity reactions, including serum-sickness reactions,168 vasculitis (cutaneous or generalized),140 urticaria,168 pruritus,140 168 exfoliative dermatitis,132 168 and photosensitivity,140 168 also reported.


Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and anaphylaxis reported with pyrimethamine single-entity preparation, especially when used with a sulfonamide.167 Periorbital edema,168 conjunctival and scleral injection,168 arthralgia,168 allergic myocarditis,168 slight hair loss,168 Lyell’s syndrome,168 allergic pericarditis,168 pulmonary eosinophilia,167 and pulmonary infiltrates resembling eosinophilic or allergic alveolitis also reported in patients receiving a sulfonamide or pyrimethamine.168


Use Fansidar with caution in patients with severe allergy or bronchial asthma.168


Avoid excessive sun exposure when taking Fansidar.168


Discontinue at first sign of rash, sore throat, fever, arthralgia, cough, shortness of breath, pallor, jaundice, or glossitis.167 168


General Precautions


Precautions Related to Prevention or Treatment of Malaria

Pyrimethamine and Fansidar are not included in current CDC recommendations for prevention or treatment of malaria.b c Consider that resistance to pyrimethamine is prevalent worldwide167 and resistance to Fansidar is widespread in certain areas.203 b (See Malaria under Uses.)


Do not use Fansidar for treatment of severe malaria.168 Has not been evaluated for treatment of cerebral malaria or other severe manifestations of complicated malaria, including hyperparasitemia, pulmonary edema, or renal failure.168 Patients with severe malaria are not candidates for oral therapy.168


If recrudescent P. falciparum infections occur after treatment with Fansidar or if prophylaxis with the drug fails, use a different blood schizonticide.168


Patients with G6PD Deficiency

Hemolysis may occur if Fansidar is used in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency.168 e


Renal Effects

Renal failure, hematuria, interstitial nephritis, elevated BUN and serum creatinine, toxic nephrosis with oliguria and anuria, and crystalluria reported in patients receiving a sulfonamide or pyrimethamine.167 168


Fansidar contains a sulfonamide and shares the toxic potentials of the sulfonamides.168 Sulfonamides have been associated with renal toxicity manifested by renal colic, nephritis, urolithiasis, toxic nephrosis with anuria and oliguria, hematuria, proteinuria, crystalluria, kidney stone formation, and elevation of BUN and serum creatinine concentrations.e Nephritis and hemolytic-uremic syndrome also reported.e


Adverse renal effects usually are the result of crystalluria.e Risk of crystalluria may be decreased by maintaining an adequate urinary output and by increasing urinary pH.e Unless the urine is highly acidic and/or the drug is relatively insoluble, alkalinization of the urine usually is not necessary if urinary output is maintained at a minimum of 1.5 L daily.e


Perform urinalysis and assess kidney function frequently during sulfonamide therapy.e Perform urinalysis (including microscopic examination) and renal function tests when Fansidar is used in patients with impaired renal function.168 (See Laboratory Monitoring under Cautions.) Maintain adequate fluid intake to minimize risk of crystalluria and stone formation.168 e


If persistent, heavy crystalluria, hematuria, or oliguria occurs, sulfonamide therapy should be discontinued and alkali therapy maintained.e


Hepatic Effects

Abnormal liver function test results (e.g., elevated serum ALT, AST, alkaline phosphatase, and bilirubin concentrations),132 140 141 142 jaundice,113 114 132 140 142 hepatomegaly,132 and hepatitis,132 142 168 sometimes fatal,132 reported with Fansidar.


Adverse hepatic effects have been associated with severe cutaneous reactions to Fansidar.112 132 (See Dermatologic and Hypersensitivity Reactions under Cautions.)


GI Effects

Adverse GI effects (anorexia, abdominal cramps, vomiting, atrophic glossitis, gastritis)167 may occur with high pyrimethamine dosage.167 Administration with a meal may reduce anorexia and vomiting.167


Nervous System Effects

Ataxia, tremors, seizures, and respiratory failure reported with high pyrimethamine dosage.a Headache, light-headedness, insomnia, depression, malaise, fatigue, and irritability also reported rarely.a


In patients with seizure disorders being treated for toxoplasmosis, use low initial pyrimethamine dosage to avoid potential nervous system toxicity.167


Reversible hyperesthesia reported rarely with Fansidar.140


Laboratory Monitoring

Monitor CBC, including platelet counts, twice weekly in patients receiving high pyrimethamine dosage.167


If Fansidar is used for >3 months, regularly monitor liver enzyme tests, CBCs, and urinalysis for crystalluria.168 If used in patients with impaired renal function, monitor renal function and regularly perform urinalysis (including microscopic examination).168


Use of Fixed Combinations

When pyrimethamine is used in fixed combination with sulfadoxine, consider the cautions, precautions, and contraindications associated with sulfadoxine.168


Specific Populations


Pregnancy

Category C.167 168


Fansidar contraindicated for malaria prophylaxis in pregnant women at term.168


Use pyrimethamine or Fansidar during pregnancy only when potential benefits outweigh possible risks;167 168 if pyrimethamine is used to treat toxoplasmosis during pregnancy, administer leucovorin concurrently to decrease hematologic toxicity.167 197


Women of childbearing potential should use effective contraceptive measures while receiving pyrimethamine or Fansidar;167 168 avoid pregnancy for 3 months following the last dose of the fixed combination.168


Lactation

Pyrimethamine distributed i

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