Friday, October 28, 2016

Bupivacaine


Generic Name: bupivacaine (bue PIV a kane)

Brand names: Marcaine HCl, Marcaine Spinal, Sensorcaine, Sensorcaine-MPF, Sensorcaine-MPF Spinal


What is bupivacaine?

Bupivacaine is an anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to your brain.


Bupivacaine is used as a local (in only one area) anesthetic for a spinal block.


Bupivacaine may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about bupivacaine?


You should not receive bupivacaine if you have ever had an allergic reaction to any type of numbing medicine.

Before receiving this medication, tell your doctor if you have liver disease, a bleeding or blood clotting disorder, syphilis, polio, a brain or spinal cord tumor, chronic back pain, a headache, low or high blood pressure, a curved spine, or arthritis.


This medication can cause numbness over a large portion of your body. Take care to avoid injury before the feeling has returned completely.


Spinal numbing medications can have long-lasting or permanent effects on certain body processes such as sexual function, bowel or bladder control, and movement or feeling in your legs or feet. Talk with your doctor about your specific risk of nerve damage from bupivacaine.


What should I discuss with my health care provider before receiving bupivacaine?


You should not receive bupivacaine if you have ever had an allergic reaction to any type of numbing medicine.

Before receiving bupivacaine, tell your doctor if you are allergic to any drugs, or if you have:



  • liver disease;




  • a bleeding or blood clotting disorder;




  • syphilis, polio, or a brain or spinal cord tumor;




  • chronic back pain or a headache;




  • low or high blood pressure;




  • curvature of the spine; or




  • arthritis.



If you have any of these conditions, you may not be able to receive bupivacaine, or you may need dosage adjustments or special tests during treatment.


FDA pregnancy category C. This medication may be harmful to an unborn baby. Before you receive bupivacaine, tell your doctor if you are pregnant. Bupivacaine can pass into breast milk and may harm a nursing baby. Before you receive bupivacaine, tell your doctor if you are breast-feeding a baby.

How is bupivacaine given?


Bupivacaine is given as an injection placed into an area of your lower back near your spine. You will receive this injection in a hospital or surgical setting.


Spinal numbing medications can have long-lasting or permanent effects on certain body processes such as sexual function, bowel or bladder control, and movement or feeling in your legs or feet. Talk with your doctor about your specific risk of nerve damage from bupivacaine.


What happens if I miss a dose?


Since bupivacaine is given as needed before a surgery or other medical procedure, you are not likely to be on a dosing schedule.


What happens if I overdose?


Tell your caregivers right away if you think you have received too much of this medicine.

Overdose symptoms may include extreme drowsiness, fainting, seizure (convulsions), shallow breathing, or breathing that stops.


What should I avoid after receiving bupivacaine?


This medication can cause numbness over a large portion of your body. Take care to avoid injury before the feeling has returned completely.


Bupivacaine 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:

  • weak or shallow breathing;




  • fast heart rate, gasping, feeling unusually hot;




  • slow heart rate, weak pulse;




  • feeling restless or anxious, ringing in the ears, metallic taste, speech problems, numbness or tingling around your mouth, tremors, feeling light-headed, or fainting; or




  • problems with urination.



Less serious side effects include:



  • nausea, vomiting;




  • headache, back pain;




  • dizziness;




  • or problems with sexual function.



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.


Bupivacaine Dosing Information


Usual Adult Dose for Local Anesthesia:

Bupivacaine: Most experience to date is with single doses up to 175 mg; more or less drug may be used to individualize dose

Doses may be repeated up to once every 3 hours.
Maximum dose: 400 mg per 24 hours

Local infiltration:
0.25% concentration: Inject up to the maximum dose

Epidural block:
0.75% concentration: Inject 75 to 150 mg (10 to 20 mL) once for complete motor block; not for obstetrical anesthesia
0.5% concentration: Inject 50 to 100 mg (10 to 20 mL) for moderate to complete motor block; repeat doses increase the degree of motor block
0.25% concentration: Inject 25 to 50 mg (10 to 20 mL) for partial to moderate motor block; repeat doses increase the degree of motor block

Epidural anesthesia: 0.5% and 0.75% solutions should be administered in 3 to 5 mL increments with sufficient time between doses to detect toxicity or accidental intravascular or intrathecal injection

Epidural anesthesia in obstetrics: Only 0.5% and 0.25% concentrations should be used; 0.5% solution should be administered in 3 to 5 mL increments not exceeding 50 to 100 mg at any dosing interval; repeat doses should follow a test dose containing epinephrine if not contraindicated; preservative-free product should be used

Caudal block:
0.5% concentration: Inject 75 to 150 mg (15 to 30 mL) for moderate to complete motor block; repeat doses increase the degree of motor block
0.25% concentration: Inject 37.5 to 75 mg (15 to 30 mL) for moderate motor block; repeat doses increase the degree of motor block

Peripheral nerve block:
0.5% concentration: Inject 25 mg up to the maximum dose (5 mL up to the maximum dose) for moderate to complete motor block; repeat doses increase the degree of motor block
0.25% concentration: Inject 12.5 mg up to the maximum dose (5 mL up to the maximum dose) for moderate to complete motor block; repeat doses increase the degree of motor block

Retrobulbar block:
0.75% concentration: Inject 15 to 30 mg (2 to 4 mL) for complete motor block; repeat doses increase the degree of motor block

Sympathetic block:
0.25% concentration: Inject 50 to 125 mg (20 to 50 mL)

Bupivacaine in dextrose injection:
Spinal anesthesia: Inject 7.5 mg (1 mL) for lower extremity and perineal procedures (including transurethral resection of the prostate and vaginal hysterectomy); 12 mg (1.6 mL) has been used for lower abdominal procedures (such as abdominal hysterectomy, tubal ligation, and appendectomy); doses as low as 6 mg have been used for vaginal delivery

These dosages are recommended as a guide for use in an average adult.

Usual Adult Dose for Cesarean Section:

Bupivacaine in dextrose injection:
Spinal anesthesia: 7.5 to 10.5 mg (1 to 1.4 mL) has been used

Usual Pediatric Dose for Local Anesthesia:

Bupivacaine:

Epidural block:
1.25 mg/kg/dose (preservative free)

Caudal block:
1 to 3.7 mg/kg (preservative free)

Peripheral nerve block: 5 mL dose of 0.25% or 0.5% (12.5 to 25 mg); maximum dose: 400 mg/day.

Sympathetic nerve block: 20 to 50 mL of 0.25% (no epinephrine) solution.

Continuous epidural (caudal or lumbar) infusion (preservative free):
:

Loading dose: 2 to 2.5 mg/kg (0.8 to 1 mL/kg of 0.25% bupivacaine).

Infusion dose: Infants 4 months or younger: 0.2 to 0.25 mg/kg/h; Infants older than 4 months and children: 0.4 to 0.5 mg/kg/h.

Bupivacaine in dextrose injection: Not recommended in pediatric patients less than 18 years of age.


What other drugs will affect bupivacaine?


Before receiving bupivacaine, tell your doctor if you are using any of the following drugs:



  • a blood thinner such as warfarin (Coumadin);




  • ergot medicine such as ergotamine (Ergomar, Cafergot), dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), or methylergonovine (Methergine);




  • an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate); or




  • antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Ascendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil).



If you are using any of these drugs, you may not be able to receive bupivacaine, or you may need dose adjustments or extra monitoring during anesthesia.


This list is not complete and there may be other drugs that can interact with bupivacaine. 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 bupivacaine resources


  • Bupivacaine Use in Pregnancy & Breastfeeding
  • Bupivacaine Drug Interactions
  • Bupivacaine Support Group
  • 2 Reviews for Bupivacaine - Add your own review/rating


  • Bupivacaine Prescribing Information (FDA)

  • Bupivacaine Solution MedFacts Consumer Leaflet (Wolters Kluwer)

  • Bupivacaine Hydrochloride Monograph (AHFS DI)

  • Marcaine Spinal Solution MedFacts Consumer Leaflet (Wolters Kluwer)

  • Marcaine Spinal Prescribing Information (FDA)

  • Sensorcaine Prescribing Information (FDA)



Compare bupivacaine with other medications


  • Cesarean Section
  • Local Anesthesia
  • Postoperative Pain


Where can I get more information?


  • Your doctor or pharmacist can provide more information about bupivacaine.



Drixoral Decongestant Non-Drowsy


Generic Name: pseudoephedrine (SOO doe ee FED rin)

Brand Names: Chlor Trimeton Nasal Decongestant, Contac Cold, Drixoral Decongestant Non-Drowsy, Elixsure Decongestant, Entex, Genaphed, Kid Kare Drops, Nasofed, Seudotabs, Silfedrine, Sudafed, Sudafed 12-Hour, Sudafed 24-Hour, Sudafed Children's Nasal Decongestant, Sudodrin, SudoGest, SudoGest 12 Hour, Suphedrin, Triaminic Softchews Allergy Congestion, Unifed


What is Drixoral Decongestant Non-Drowsy (pseudoephedrine)?

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


Pseudoephedrine is used to treat nasal and sinus congestion, or congestion of the tubes that drain fluid from your inner ears, called the eustachian (yoo-STAY-shun) tubes.


Pseudoephedrine may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Drixoral Decongestant Non-Drowsy (pseudoephedrine)?


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 or cold medicine. Pseudoephedrine or other decongestants 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 pseudoephedrine or a decongestant. Do not use pseudoephedrine 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. A dangerous drug interaction could occur, leading to serious side effects.

What should I discuss with my healthcare provider before taking Drixoral Decongestant Non-Drowsy (pseudoephedrine)?


Do not use pseudoephedrine 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. A dangerous drug interaction could occur, leading to serious side effects. Do not use this medication if you are allergic to pseudoephedrine or to other decongestants, diet pills, stimulants, or ADHD medications.

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



  • heart disease or high blood pressure;




  • diabetes; or




  • a thyroid disorder.




FDA pregnancy category C. It is not known whether pseudoephedrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Pseudoephedrine 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 cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.


How should I take Drixoral Decongestant Non-Drowsy (pseudoephedrine)?


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 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. Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. You may need to shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose measuring device, ask your pharmacist for one. Do not take pseudoephedrine for longer than 7 days in a row. 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 surgery, tell the surgeon ahead of time that you are using pseudoephedrine. You may need to stop using the medicine for a short time. Store at room temperature away from moisture and heat.

What happens if I miss a dose?


Since pseudoephedrine 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 feeling restless or nervous.


What should I avoid while taking Drixoral Decongestant Non-Drowsy (pseudoephedrine)?


Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.


Ask a doctor or pharmacist before using any other cough or cold medicine. Pseudoephedrine or other decongestants 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 pseudoephedrine or a decongestant.

Drixoral Decongestant Non-Drowsy (pseudoephedrine) 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 pseudoephedrine and call your doctor at once if you have a serious side effect such as:

  • fast, pounding, or uneven heartbeat;




  • severe dizziness or anxiety;




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




  • dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, anxiety, confusion, chest pain, trouble breathing, uneven heart rate, seizure).



Less serious side effects may include:



  • loss of appetite;




  • warmth, tingling, or redness under your skin;




  • feeling restless or excited (especially in children);




  • sleep problems (insomnia); or




  • skin rash or itching.



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 Drixoral Decongestant Non-Drowsy (pseudoephedrine)?


Tell your doctor about all other medicines you use, especially:



  • blood pressure medications;




  • 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), nortriptyline (Pamelor), and others.



This list is not complete and other drugs may interact with pseudoephedrine. 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 Drixoral Decongestant Non-Drowsy resources


  • Drixoral Decongestant Non-Drowsy Side Effects (in more detail)
  • Drixoral Decongestant Non-Drowsy Use in Pregnancy & Breastfeeding
  • Drixoral Decongestant Non-Drowsy Drug Interactions
  • 0 Reviews for Drixoral Decongestant Non-Drowsy - Add your own review/rating


  • Pseudoephedrine MedFacts Consumer Leaflet (Wolters Kluwer)

  • Pseudoephedrine Monograph (AHFS DI)

  • Cenafed Advanced Consumer (Micromedex) - Includes Dosage Information

  • Dimetapp Decongestant Drops MedFacts Consumer Leaflet (Wolters Kluwer)

  • Drixoral Non-Drowsy Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

  • Entex Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

  • Entex Consumer Overview

  • Sudafed Consumer Overview

  • Tylenol Simply Stuffy Liquid MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Drixoral Decongestant Non-Drowsy with other medications


  • Nasal Congestion


Where can I get more information?


  • Your pharmacist can provide more information about pseudoephedrine.

See also: Drixoral Decongestant Non-Drowsy side effects (in more detail)



Thursday, October 27, 2016

Brompheniramine, chlorpheniramine, methscopolamine, phenylephrine, and pseudoephedrine


Generic Name: brompheniramine, chlorpheniramine, methscopolamine, phenylephrine, and pseudoephedrine (BROM fen IR a meen, KLOR fen IR a meen, METH skoe POL a meen, FEN il EFF rin, SOO doe ee FED drin)

Brand Names: SymPak II


What is brompheniramine, chlorpheniramine, methscopolamine, phenylephrine, and pseudoephedrine?

Brompheniramine, chlorpheniramine, and methscopolamine are antihistamines that reduce the effects of the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.


Phenylephrine and pseudoephedrine are decongestants that shrink blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).


The combination of brompheniramine, chlorpheniramine, methscopolamine, phenylephrine, and pseudoephedrine is used to treat runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.


Brompheniramine, chlorpheniramine, methscopolamine, phenylephrine, and pseudoephedrine may also be used for purposes not listed in this medication guide.


What is the most important information I should know about this medication?


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. You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Do not use a cold medicine 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. A dangerous drug interaction could occur, leading to serious side effects.

What should I discuss with my healthcare provider before taking this medication?


Do not use a cold medicine 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. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:



  • a blockage in your digestive tract (stomach or intestines), a colostomy or ileostomy;




  • diabetes;




  • liver or kidney disease;




  • epilepsy or other seizure disorder;




  • cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;




  • enlarged prostate or urination problems;




  • low blood pressure;




  • pheochromocytoma (an adrenal gland tumor); or




  • if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).




FDA pregnancy category C. It is not known whether this medicine will harm an unborn baby. Do not use cough or cold medicine without telling your doctor if you are pregnant or plan to become pregnant while using the medicine. This medication can pass into breast milk and may harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use a cough or cold medicine without telling your doctor if you are breast-feeding a baby.

How should I take brompheniramine, chlorpheniramine, methscopolamine, phenylephrine, and pseudoephedrine?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.


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 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 take for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash.


If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken a cold medicine within the past few days. Store at room temperature away from moisture and heat.

What happens if I miss a dose?


Since cold medicine is taken when 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 severe forms of some of the side effects listed in this medication guide.


What should I avoid while taking this medication?


This medicine may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Ask a doctor or pharmacist before using any other cold, allergy, cough, or sleep medicine. Antihistamines and decongestants 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 an antihistamine or decongestant. Drinking alcohol can increase certain side effects of this medication.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.


Avoid becoming overheated or dehydrated during exercise and in hot weather. This medication can decrease sweating and you may be more prone to heat stroke.

Brompheniramine, chlorpheniramine, methscopolamine, phenylephrine, and pseudoephedrine side effects


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

  • fast or uneven heart rate;




  • pounding heartbeats or fluttering in your chest;




  • mood changes;




  • tremor, seizure (convulsions);




  • double vision;




  • ongoing diarrhea or vomiting;




  • easy bruising or bleeding, unusual weakness;




  • urinating less than usual or not at all;




  • feeling short of breath; or




  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, uneven heartbeats, seizure).



Less serious side effects may include:



  • mild headache, dizziness, drowsiness;




  • dry mouth, nose, or throat;




  • decreased sense of taste;




  • nausea, bloating, constipation;




  • blurred vision;




  • feeling nervous or restless;




  • sleep problems (insomnia); or




  • decreased sweating.



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.


Brompheniramine, chlorpheniramine, methscopolamine, phenylephrine, and pseudoephedrine Dosing Information


Usual Adult Dose for Nasal Congestion:

Brompheniramine/chlorpheniramine/methscopolamine/phenylephrine/pseudoephedrine oral kit:
1 AM tablet orally in the morning and 1 PM tablet orally in the evening.

Usual Pediatric Dose for Nasal Congestion:

Brompheniramine/chlorpheniramine/methscopolamine/phenylephrine/pseudoephedrine oral kit:
6 to 11 years: 1 AM tablet orally in the morning and 1/2 PM tablet orally in the evening.
12 years or older: 1 AM tablet orally in the morning and 1 PM tablet orally in the evening.


What other drugs will affect brompheniramine, chlorpheniramine, methscopolamine, phenylephrine, and pseudoephedrine?


Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine or methscopolamine.

Tell your doctor about all other medicines you use, especially:



  • atropine (Atreza, Sal-Tropine);




  • benztropine (Cogentin);




  • topiramate (Topamax);




  • zonisamide (Zonegran);




  • anti-nausea medications such as belladonna (Donnatal), dimenhydrinate (Dramamine), droperidol (Inapsine), methscopolamine (Pamine), or scopolamine (Transderm Scop);




  • bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), solifenacin (Vesicare), tolterodine (Detrol), or Urogesic Blue;




  • bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);




  • irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine); or




  • ulcer medicine such as glycopyrrolate (Robinul) or mepenzolate (Cantil).



This list is not complete and other drugs may interact with brompheniramine, chlorpheniramine, methscopolamine, phenylephrine, and pseudoephedrine. 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 brompheniramine, chlorpheniramine, methscopolamine, phenylephrine, and pseudoephedrine resources


  • Brompheniramine, chlorpheniramine, methscopolamine, phenylephrine, and pseudoephedrine Drug Interactions
  • Brompheniramine, chlorpheniramine, methscopolamine, phenylephrine, and pseudoephedrine Support Group
  • 0 Reviews for Brompheniramine, chlorpheniramine, methscopolamine, phenylephrine, and pseudoephedrine - Add your own review/rating


Compare brompheniramine, chlorpheniramine, methscopolamine, phenylephrine, and pseudoephedrine with other medications


  • Nasal Congestion


Where can I get more information?


  • Your pharmacist can provide more information about brompheniramine, chlorpheniramine, methscopolamine, phenylephrine, and pseudoephedrine.



Decongex-3


Generic Name: chlorpheniramine and phenylpropanolamine (klor feh NEER a meen and feh nill proe pa NO la meen)

Brand Names: A.R.M. Allergy Relief, Allerest 12 Hour, Chlornade, Condrin, Contac 12 Hour, Decongex-3, Demazin, Dura-Vent/A, Equi-Nade, Genamin, Gencold, Histade, Or-Phen-Ade, Ordrine, Ornade Spansules, Resaid, Rescon Liquid, Rhinolar-EX, Teldrin, Triac, Triaminic, Vanex Forte-R


What is Decongex-3 (chlorpheniramine and phenylpropanolamine)?

Chlorpheniramine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body. Chlorpheniramine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.


Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow to certain areas and allows nasal passages to open up.


Chlorpheniramine and phenylpropanolamine is used to treat nasal congestion and sinusitis (inflammation of the sinuses) associated with allergies, hay fever, and the common cold.


Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.


Chlorpheniramine and phenylpropanolamine may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about Decongex-3 (chlorpheniramine and phenylpropanolamine)?


Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.


Use caution when driving, operating machinery, or performing other hazardous activities. Chlorpheniramine and phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking chlorpheniramine and phenylpropanolamine.

Do not take more of this medication than is recommended. If your symptoms do not improve, or if they worsen, talk to your doctor.


Who should not take Decongex-3 (chlorpheniramine and phenylpropanolamine)?


Do not take chlorpheniramine and phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have


  • kidney disease,

  • liver disease,


  • diabetes,




  • glaucoma,




  • any type of heart disease or high blood pressure,




  • thyroid disease,




  • emphysema or chronic bronchitis, or




  • difficulty urinating or an enlarged prostate.



You may not be able to take chlorpheniramine and phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.


Chlorpheniramine and phenylpropanolamine is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. This medication passes into breast milk and may harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from chlorpheniramine and phenylpropanolamine. You may require a lower dose of this medication. Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions.

How should I take Decongex-3 (chlorpheniramine and phenylpropanolamine)?


Take chlorpheniramine and phenylpropanolamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.


Take each dose with a full glass of water. Do not crush, chew, or break the long-acting or sustained-release forms of this medication. Swallow them whole. If you are unsure of the formulation of your medicine, ask your pharmacist for help.

If you cannot swallow the tablets or capsules, look for a liquid form of the medication.


To ensure that you get a correct dose, measure the liquid forms of chlorpheniramine and phenylpropanolamine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.


Do not take more of this medication than is recommended. An overdose of this medication can cause serious harm.

Do not take chlorpheniramine and phenylpropanolamine for longer than 7 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, talk to your doctor.


Store chlorpheniramine and phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?


Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.


What happens if I overdose?


Seek emergency medical attention.

Symptoms of a chlorpheniramine and phenylpropanolamine overdose include a dry mouth, large pupils, flushing, nausea, and vomiting.


What should I avoid while taking Decongex-3 (chlorpheniramine and phenylpropanolamine)?


Use caution when driving, operating machinery, or performing other hazardous activities. Chlorpheniramine and phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking chlorpheniramine and phenylpropanolamine.

Chlorpheniramine and phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if chlorpheniramine and phenylpropanolamine is taken with any of these medications.


Decongex-3 (chlorpheniramine and phenylpropanolamine) side effects


Serious side effects are unlikely to occur. Stop taking chlorpheniramine and phenylpropanolamine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take chlorpheniramine and phenylpropanolamine and talk to your doctor or try another similar medication if you experience



  • dryness of the eyes, nose, and mouth;




  • drowsiness or dizziness;




  • blurred vision;




  • difficulty urinating; or




  • excitation in children.



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.


What other drugs will affect Decongex-3 (chlorpheniramine and phenylpropanolamine)?


Do not take chlorpheniramine and phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Do not take other over-the-counter cough, cold, allergy, diet, or sleep aids while taking chlorpheniramine and phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain chlorpheniramine, phenylpropanolamine, or other similar drugs. You may accidentally take too much of these medicines.


Chlorpheniramine and phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if chlorpheniramine and phenylpropanolamine is taken with any of these medications.


Drugs other than those listed here may also interact with chlorpheniramine and phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.



More Decongex-3 resources


  • Decongex-3 Drug Interactions
  • Decongex-3 Support Group
  • 0 Reviews for Decongex-3 - Add your own review/rating


  • Triaminic Consumer Overview



Compare Decongex-3 with other medications


  • Cold Symptoms
  • Cough and Nasal Congestion
  • Hay Fever
  • Sinusitis
  • Upper Respiratory Tract Infection


Where can I get more information?


  • Your pharmacist has additional information about chlorpheniramine and phenylpropanolamine written for health professionals that you may read.

What does my medication look like?


Many formulations of chlorpheniramine and phenylpropanolamine are available both over-the-counter and with a prescription. Ask your pharmacist any questions you have about this medication, especially if it is new to you.




Dong Quai


Pronunciation: Not applicable.
Generic Name: Dong Quai
Brand Name: Generics only. No brands available.


Dong Quai is used for:

Allergies, anemia, headaches, constipation, high blood pressure, ulcers, rheumatism, and as an antispasmodic. It is also used in women for absent, painful, or irregular menstrual periods; menstrual cramps or weakness; stomach pain after childbirth; infertility; and menopausal symptoms. It may also have other uses. Check with your pharmacist for more details regarding the particular brand you use.


Dong Quai is an herbal product. It works by promoting circulation and helping to restore balance in the hormones.


Do NOT use Dong Quai if:


  • you are allergic to any ingredient in Dong Quai

  • you have a cold, the flu, or diarrhea

  • you have a blood clotting or blood platelet disorder

  • you are pregnant or breast-feeding

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



Before using Dong Quai:


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


  • if you are planning to become pregnant

  • 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 endometriosis; cancer of the breast, ovaries, or uterus; or fibroids in the uterus

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


  • Blood thinners (eg, warfarin) because the risk of side effects, such as bleeding, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Dong Quai 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 Dong Quai:


Use Dong Quai as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Dong Quai is taken orally as teas, tablets, capsules, or alcoholic extracts. Dosing depends on the use and the source of the product.

  • Use as directed on the package, unless instructed otherwise by your doctor.

  • If you miss taking a dose of Dong Quai for 1 or more days, there is no cause for concern. If your doctor recommended that you take it, try to remember your dose every day.

Ask your health care provider any questions you may have about how to use Dong Quai.



Important safety information:


  • If you experience excessive menstrual bleeding or fever, or if you develop a rash or hives, tell your doctor immediately. Do not take any more doses of this product unless your doctor tells you to do so.

  • Use of this product may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to this product. Use a sunscreen or protective clothing if you must be outside for a long period of time.

  • Diabetes patients - If you have diabetes, Dong Quai may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.

  • Dong Quai is not recommended for use in CHILDREN.

  • PREGNANCY and BREAST-FEEDING: Do not use this product if you are pregnant. Do not breast-feed while taking this product.


Possible side effects of Dong Quai:


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:



Changes in menstrual bleeding; diarrhea; worsening of hot flashes.



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); excessive or prolonged vaginal bleeding.



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: Dong Quai 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.


Proper storage of Dong Quai:

Store at room temperature away from heat, moisture, and light unless otherwise directed on the package label. Do not store in the bathroom. Most herbal products are not in childproof containers. Keep Dong Quai out of the reach of children and away from pets.


General information:


  • If you have any questions about Dong Quai, please talk with your doctor, pharmacist, or other health care provider.

  • Dong Quai 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 Dong Quai. 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 Dong Quai resources


  • Dong Quai Side Effects (in more detail)
  • Dong Quai Use in Pregnancy & Breastfeeding
  • Dong Quai Drug Interactions
  • Dong Quai Support Group
  • 1 Review for Dong Quai - Add your own review/rating


  • Dong Quai Natural MedFacts for Professionals (Wolters Kluwer)

  • Dong Quai Natural MedFacts for Consumers (Wolters Kluwer)

  • dong quai Concise Consumer Information (Cerner Multum)



Compare Dong Quai with other medications


  • Allergies
  • Anemia
  • Constipation, Chronic
  • Headache
  • Herbal Supplementation
  • Muscle Spasm
  • Osteoarthritis
  • Premenstrual Dysphoric Disorder
  • Rheumatoid Arthritis


Benadryl Cold


Generic Name: acetaminophen, diphenhydramine, and pseudoephedrine (a SEET a MIN oh fen, dye fen HYE dra meen, SOO doe e FED rin)

Brand Names: Benadryl Cold


What is Benadryl Cold (acetaminophen, diphenhydramine, and pseudoephedrine)?

Acetaminophen is a pain reliever and fever reducer.


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


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


The combination of acetaminophen, diphenhydramine, and pseudoephedrine is used to treat headache, fever, body aches, runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.


Acetaminophen, diphenhydramine, and pseudoephedrine may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Benadryl Cold (acetaminophen, diphenhydramine, and pseudoephedrine)?


Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. Do not use cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma, emphysema, chronic bronchitis, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. Do not use this medication 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. A dangerous drug interaction could occur, leading to serious side effects. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose.

What should I discuss with my healthcare provider before taking Benadryl Cold (acetaminophen, diphenhydramine, and pseudoephedrine)?


Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not use cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma, emphysema, chronic bronchitis, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate. Do not use a cold medicine 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. A dangerous drug interaction could occur, leading to serious side effects.

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



  • liver disease, cirrhosis, or a history of alcoholism;




  • a blockage in your digestive tract (stomach or intestines);




  • diabetes;




  • kidney disease;




  • epilepsy or other seizure disorder;




  • cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;




  • enlarged prostate or urination problems;




  • pheochromocytoma (an adrenal gland tumor); or




  • if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).




It is not known whether acetaminophen, diphenhydramine, and pseudoephedrine will harm an unborn baby. Do not use cold medicine without medical advice if you are pregnant. This medication may pass into breast milk and may harm a nursing baby. Do not use cold medicine without medical advice if you are breast-feeding a baby.

How should I take Benadryl Cold (acetaminophen, diphenhydramine, and pseudoephedrine)?


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 take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. 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.

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.


If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken a cold medicine within the past few days. Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

What happens if I miss a dose?


Since cold medicine is taken when 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. An overdose of acetaminophen can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.


What should I avoid while taking Benadryl Cold (acetaminophen, diphenhydramine, and pseudoephedrine)?


Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Benadryl Cold (acetaminophen, diphenhydramine, and pseudoephedrine) 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 a serious side effect such as:

  • fast or pounding heartbeats, severe restless feeling or nervousness;




  • mood changes, confusion, hallucinations, unusual thoughts or behavior;




  • tremor, seizure (convulsions);




  • easy bruising or bleeding, unusual weakness;




  • urinating less than usual or not at all;




  • feeling short of breath;




  • nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or




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



Less serious side effects may include:



  • dizziness, drowsiness;




  • dry mouth, nose, or throat;




  • constipation;




  • blurred vision; or




  • feeling nervous or restless.



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 Benadryl Cold (acetaminophen, diphenhydramine, and pseudoephedrine)?


Ask a doctor or pharmacist before using this medicine if you regularly use other medicines that make you sleepy (such as narcotic pain medication, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by diphenhydramine.

Tell your doctor about all other medicines you use, especially:



  • diphenhydramine (Benadryl) applied to the skin;




  • leflunomide (Arava);




  • topiramate (Topamax);




  • zonisamide (Zonegran);




  • an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;




  • an antidepressant;




  • birth control pills or hormone replacement therapy;




  • bladder or urinary medications;




  • blood pressure medication;




  • a bronchodilator;




  • cancer medicine;




  • cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;




  • gout or arthritis medications (including gold injections);




  • HIV/AIDS medication;




  • medication for nausea and vomiting, stomach ulcers, or irritable bowel syndrome;




  • medicines to treat psychiatric disorders;




  • an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or




  • seizure medication.



This list is not complete and other drugs may interact with acetaminophen, diphenhydramine, and pseudoephedrine. 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 Benadryl Cold resources


  • Benadryl Cold Use in Pregnancy & Breastfeeding
  • Benadryl Cold Drug Interactions
  • Benadryl Cold Support Group
  • 0 Reviews · Be the first to review/rate this drug


Where can I get more information?


  • Your pharmacist can provide more information about acetaminophen, diphenhydramine, and pseudoephedrine.



Omalizumab


Generic Name: omalizumab (OH ma LIZ oo mab)

Brand Names: Xolair


What is omalizumab?

Omalizumab is an antibody that helps decrease allergic responses in the body.


Omalizumab is used to treat moderate to severe asthma that is caused by allergies in adults and children who are at least 12 years old.


Omalizumab is usually given after other asthma medications have been tried without successful treatment of symptoms.


Omalizumab may also be used for purposes not listed in this medication guide.


What is the most important information I should know about omalizumab?


Some people using omalizumab have had a severe, life-threatening allergic reaction to this medication, either right after the injection or hours later. Allergic reaction may occur even after using the medication regularly for a year or longer.

Get emergency medical help if you have any of these signs of an allergic reaction: wheezing, tightness in your chest, trouble breathing; hives or skin rash; feeling anxious or light-headed, fainting; warmth or tingling under your skin; or swelling of your face, lips, tongue, or throat.


Asthma is often treated with a combination of different drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.


If you also use a steroid medication, do not stop using the steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks. Your symptoms may not improve right away once you start receiving omalizumab. For best results, keep receiving the medication as directed. Talk with your doctor if your symptoms do not improve after a few weeks of treatment.

Use omalizumab regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.


Using this medication may increase your risk of certain types of cancers of the breast, skin, prostate, or salivary gland. Talk to your doctor about your individual risk.

What should I discuss with my healthcare provider before using omalizumab?


Do not use this medication if you are allergic to omalizumab.

To make sure you can safely take omalizumab, tell your doctor if you have any other medical conditions or if you take other medicines.


Using this medication may increase your risk of certain types of cancers of the breast, skin, prostate, or salivary gland. Talk to your doctor about your individual risk.

While you are using omalizumab, you may also have an increased risk of becoming infected with parasites (worms) if you live in or travel to areas where such infections are common. Talk with your doctor about what to look for and how to treat this condition.


FDA pregnancy category B. Omalizumab is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of omalizumab on the baby.


Omalizumab may pass 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. Do not give omalizumab to a child younger than 12 years old.

How should I use omalizumab?


Omalizumab is injected under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.


Omalizumab is usually given every 2 or 4 weeks.


Omalizumab is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.


Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.


Omalizumab will not work fast enough to treat an asthma attack that has already begun. Use only a fast-acting inhalation medicine to treat an asthma attack.

Asthma is often treated with a combination of different drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.


If you also use a steroid medication, do not stop using it suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks. Your symptoms may not improve right away once you start receiving omalizumab. For best results, keep receiving the medication as directed. Talk with your doctor if your symptoms do not improve after a few weeks of treatment.

Use omalizumab regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.


To be sure this medication is helping your condition, your doctor may want you to have allergy tests and lung function tests on a regular basis. Do not miss any scheduled visits to your doctor.


Store omalizumab in the refrigerator. Do not freeze. After mixing omalizumab with a diluent, store in the refrigerator and use it within 8 hours. Do not freeze. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

What happens if I miss a dose?


Contact your doctor if you miss a dose of omalizumab.


What happens if I overdose?


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

What should I avoid while using omalizumab?


Follow your doctor's instructions about any restrictions on food, beverages, or activity.


Omalizumab side effects


Some people using omalizumab have had a severe, life-threatening allergic reaction to this medication, either right after the injection or hours later. Allergic reaction may occur even after using the medication regularly for a year or longer.

Get emergency medical help if you have any of these signs of an allergic reaction:



  • wheezing, tightness in your chest, trouble breathing;




  • hives or skin rash;




  • feeling anxious or light-headed, fainting;




  • warmth or tingling under your skin; or




  • swelling of your face, lips, tongue, or throat.



Other serious side effects include easy bruising or bleeding, numbness, or unusual weakness.


Less serious side effects may include:



  • pain;




  • headache, tired feeling;




  • joint or muscle pain;




  • dizziness;




  • ear pain;




  • hair loss;




  • mild itching or skin rash;




  • sore throat or cold symptoms; or




  • redness, bruising, warmth, burning, stinging, itching, pain, or swelling of your skin where the injection was given.



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.


Omalizumab Dosing Information


Usual Adult Dose for Asthma -- Maintenance:

150 to 300 mg subcutaneously every 4 weeks or 225 to 375 mg every 2 weeks, depending on pretreatment IgE levels and patient's weight.

30 to 60 kg:
If the patient has an IgE level of >=30 to 100 intl units/mL give 150 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >100 to 200 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >200 to 300 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >300 to 400 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >400 to 500 intl units/mL give 300 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >500 to 600 intl units/mL give 300 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >600 to 700 intl units/mL give 375 mg subcutaneously every 2 weeks.

60 to 70 kg:
If the patient has an IgE level of >=30 to 100 intl units/mL give 150 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >100 to 200 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >200 to 300 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >300 to 400 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >400 to 500 intl units/mL give 300 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >500 to 600 intl units/mL give 375 mg subcutaneously every 2 weeks.
Do not dose if the patient has an IgE level >600 intl units/mL.

70 to 90 kg:
If the patient has an IgE level of >=30 to 100 intl units/mL give 150 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >100 to 200 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >200 to 300 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >300 to 400 intl units/mL give 300 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >400 to 500 intl units/mL give 375 mg subcutaneously every 2 weeks.
Do not dose if the patient has an IgE level >500 intl units/mL.

>90 kg:
If the patient has an IgE level of >=30 to 100 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >100 to 200 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >200 to 300 intl units/mL give 300 mg subcutaneously every 2 weeks.
Do not dose if the patient has an IgE level >300 intl units/mL.

Usual Pediatric Dose for Asthma -- Maintenance:

>=12 years: 150 to 300 mg subcutaneously every 4 weeks or 225 to 375 mg every 2 weeks, depending on pretreatment IgE levels and patient weight.

30 to 60 kg:
If the patient has an IgE level of >=30 to 100 intl units/mL give 150 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >100 to 200 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >200 to 300 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >300 to 400 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >400 to 500 intl units/mL give 300 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >500 to 600 intl units/mL give 300 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >600 to 700 intl units/mL give 375 mg subcutaneously every 2 weeks.

60 to 70 kg:
If the patient has an IgE level of >=30 to 100 intl units/mL give 150 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >100 to 200 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >200 to 300 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >300 to 400 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >400 to 500 intl units/mL give 300 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >500 to 600 intl units/mL give 375 mg subcutaneously every 2 weeks.
Do not dose if the patient has an IgE level >600 intl units/mL.

70 to 90 kg:
If the patient has an IgE level of >=30 to 100 intl units/mL give 150 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >100 to 200 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >200 to 300 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >300 to 400 intl units/mL give 300 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >400 to 500 intl units/mL give 375 mg subcutaneously every 2 weeks.
Do not dose if the patient has an IgE level >500 intl units/mL.

>90 kg:
If the patient has an IgE level of >=30 to 100 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >100 to 200 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >200 to 300 intl units/mL give 300 mg subcutaneously every 2 weeks.
Do not dose if the patient has an IgE level >300 intl units/mL.


What other drugs will affect omalizumab?


Before using omalizumab, tell your doctor if you are receiving allergy shots.


There may be other drugs that can interact with omalizumab. 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 omalizumab resources


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


  • omalizumab Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information

  • Omalizumab Professional Patient Advice (Wolters Kluwer)

  • Omalizumab MedFacts Consumer Leaflet (Wolters Kluwer)

  • Omalizumab Monograph (AHFS DI)

  • Xolair Prescribing Information (FDA)

  • Xolair Consumer Overview



Compare omalizumab with other medications


  • Asthma, Maintenance


Where can I get more information?


  • Your pharmacist can provide more information about omalizumab.

See also: omalizumab side effects (in more detail)



Orfadin



nitisinone

Dosage Form: capsule
Orfadin Capsules

(nitisinone)

Indications and Usage for Orfadin


Orfadin® capsules are indicated as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1 (HT-1).



DOSAGE and ADMINISTRATION


Treatment with nitisinone should be initiated by a physician experienced in the treatment of hereditary tyrosinemia type 1.


The dose of nitisinone should be adjusted in each patient. The recommended initial dose is 1 mg/kg/day divided for morning and evening administration. Since an effect of food is unknown, nitisinone should be taken at least one hour before a meal. Because of the long half-life of nitisinone, the total dose may be split unevenly as convenient in order to limit the total number of capsules given at each administration. A nutritionist skilled in managing children with inborn errors of metabolism should be employed to design a low-protein diet deficient in tyrosine and phenylalanine. For young children, capsules may be opened and the contents suspended in a small amount of water, formula or apple sauce immediately before use.



Dose Adjustment


Nitisinone treatment should block the flux through the tyrosine degradation pathway at the level of 4-hydroxy-phenylpyruvate dioxygenase. Treatment should lead to normalized porphyrin metabolism (i.e., normal erythrocyte PBG- synthase activity and urine 5 ALA). Succinylacetone should not be detectable in urine or plasma. If the biochemical parameters (except plasma succinylacetone) are not normalized within one month after start of nitisinone treatment, the dose should be increased to 1.5 mg/kg/day. For plasma succinylacetone, it may take up to three months before the level is normalized after the start of nitisinone treatment. Since plasma nitisinone concentration, plasma succinylacetone, urine 5-ALA and erythtocyte PBG-synthase activity are not routinely available, it is appropriate during regular monitoring to follow urine succinylacetone, liver function tests, alpha-fetoprotein, and serum tyrosine and phenylalanine levels. However, during the initiation of therapy and during acute exacerbations, it may be necessary to follow more closely all available biochemical parameters (see Laboratory Tests). A dose of 2 mg/kg/day may be needed, especially in infants, once liver function has improved. This dose should be considered as a maximal dose for all patients.



Contraindications


None known.



WARNINGS and PRECAUTIONS



High Plasma Tyrosine Levels


Inadequate restriction of tyrosine and phenylalanine intake can result in elevations in plasma tyrosine. Plasma tyrosine levels should be kept below 500 µmol/L in order to avoid toxic effects to the eyes (corneal ulcers, corneal opacities, keratitis, conjunctivitis, eye pain, and photophobia), skin (painful hyperkeratotic plaques on the soles and palms) and nervous system (variable degrees of mental retardation and developmental delay). In most patients, eye symptoms were transient, lasting less than one week. Six patients had prolonged episodes lasting 16 to 672 days (see WARNINGS and PRECAUTIONS, Ophthalmologic Care of Patients Treated with Nitisinone).



Transient Thrombocytopenia and Leucopenia


Patients treated with nitisinone and dietary restriction in clinical trials were observed to develop transient thrombocytopenia (3%), leucopenia (3%) or both (1.5%). One patient, who developed both leucopenia and thrombocytopenia, improved after the dose of nitisinone was decreased from 2 mg/kg to 1 mg/kg. Another patient, who developed thrombocytopenia, had nitisinone stopped for 2 weeks, but platelet values continued to be low for 3 months and slowly returned to normal after 5 months. In all other patients, platelet values and white blood cell counts normalized gradually without documented change in nitisinone dose. No patients developed infections or bleeding as a result of the episodes of leucopenia and thrombocytopenia. Platelet and white blood cell counts should be monitored regularly during nitisinone therapy.



Ophthalmologic Care of Patients Treated with Nitisinone


  • Slit-lamp examination of the eyes should be performed before initiation of nitisinone treatment.

  • Patients who develop photophobia, eye pain or signs of inflammation such as redness, swelling, or burning of the eyes during treatment with nitisinone should undergo slit-lamp reexamination and immediate measurement of the plasma tyrosine concentration.

  • A more restricted diet should be implemented if the plasma tyrosine level is above 500 µmol/L.

  • Nitisinone dosage should not be adjusted in order to lower the plasma tyrosine concentration, since the HT-1 metabolic defect may result in deterioration of the patient's clinical condition.


Risk of Porphyric Crises, Liver Failure, and Hepatic Neoplasms


Patients with hereditary tyrosinemia type 1 are at increased risk of developing porphyric crises, liver failure, or hepatic neoplasms requiring liver transplantation. These complications of HT-1 were observed in patients treated with nitisinone for a median of 22 months during the clinical trial (liver transplantation 13%, liver failure 7%, malignant hepatic neoplasms 5%, benign hepatic neoplasms 3%, porphyria 0.5%). Regular liver monitoring by imaging (ultrasound, computerized tomography, magnetic resonance imaging) and laboratory tests, including serum alpha-fetoprotein concentration is recommended. An increase in serum alpha-fetoprotein concentration may be a sign of inadequate treatment, but patients with increasing alpha-fetoprotein or signs of nodules of the liver during treatment with nitisinone should always be evaluated for hepatic malignancy.



Laboratory Tests


  • Plasma nitisinone concentration, urine and plasma succinylacetone levels, urine 5-ALA levels, and erythrocyte PBG-synthase activity were used during clinical trials to guide drug dosage. The probability of recurrence of abnormal values of urine succinylacetone was 1% at a nitisinone concentration of 37 µmol/L (95% confidence interval: 23-51 µmol/L). Assays for plasma nitisinone concentration, plasma succinyl acetone, urine 5-ALA, and erythrocyte PBG-synthase activity are not routinely available in the U.S. However, urine succinylacetone levels can be used to guide drug dose adjustment (see DOSAGE and ADMINISTRATION).

  • Serum alpha-fetoprotein concentrations are generally markedly elevated at the time of diagnosis, and gradually decrease during the course of nitisinone treatment. Increases during therapy may be a sign of inadequate treatment. An exponential increase in serum alpha-fetoprotein concentration should be promptly evaluated for potential liver neoplasia.

  • Platelet and white blood cell counts should be monitored regularly because of the risk of transient thrombocytopenia and leukopenia (see WARNINGS).

  • Serum phosphate should be measured as a screening test for patients with renal involvement at risk of secondary hypophosphatemia and rickets.

  • Plasma tyrosine levels should be kept below 500 µmol/L in order to avoid toxic effects (see WARNINGS).


Adverse Reactions


In a clinical trial of 207 patients treated with nitisinone for HT-1, the most frequent adverse effects, regardless of causality assessment, occurred in the following organ systems:


Liver and Biliary System:hepatic neoplasm 8%, liver failure 7%.


Visual System:conjunctivitis 2%, corneal opacity 2%, keratitis 2%, photophobia 2%, blepharitis 1%, eye pain 1%, cataracts 1%.


Hemic and Lymphatic:thrombocytopenia 3%, leucopenia 3%, porphyria 1%, epistaxis 1%.


Skin and Appendages:pruritis 1%, exfoliative dermatitis 1%, dry skin 1%, maculopapular rash 1%, alopecia 1%.



Adverse reactions that occurred in less than 1% of the patients, regardless of causality assessment, are:


Body as a Whole:death.


Nervous System:seizures, brain tumor, encephalopathy, headache, hyperkinesia.


Cardiovascular:cyanosis.


Digestive System:abdominal pain, diarrhea, enanthema, gastritis, gastroenteritis, gastrointestinal hemorrhage, melena, tooth discoloration.


Liver and Biliary System:elevated hepatic enzymes, hepatic function disorder, liver enlargement.


Metabolic and Nutritional Disorders:dehydration, hypoglycemia, thirst.


Resistance Mechanism Disorder:infection, septicemia, otitis.


Respiratory:bronchitis, respiratory insufficiency.


Musculoskeletal System:pathologic fracture.


Female Reproductive:amenorrhea.


Psychiatric:nervousness, somnolence.



Drug Interactions


No drug-drug interaction studies have been conducted with nitisinone.



USE IN SPECIFIC POPULATIONS



Use In Specific Populations (Pregnancy)


Nitisinone has been shown to have adverse effects on skeletal ossification in animals when given in doses providing exposures less than the human therapeutic dose of 1 mg/kg/day based on body surface area. There are no adequate and well controlled studies in pregnant women. Nitisinone should be used during pregnancy only if the potential benefit justified the potential risk to the fetus.


In pregnant mice given oral gavage doses of 5, 50, 250 mg/kg/day from gestation day 7 through 16, incomplete skeletal ossification of fetal bones was observed with doses ≥5mg/kg/day (exposures less than the human therapeutic dose of 1 mg/kg/day based on relative body surface area). In pregnant mice given the same doses from gestation day 7 through weaning, gestation length increased in mice given ≥50 mg/kg/day (exposure 4 times the human systemic exposure after 1 mg/kg/day oral dose based on relative body surface area). Decreased pup survival by 9% compared to 5% in untreated controls was observed at 5 mg/kg/day (exposures less than the human systemic exposure after 1 mg/kg/day oral dose based on relative body surface area).


In pregnant rabbits given oral gavage doses of 5, 12, 25 mg/kg/day from gestation day 7 through 19, maternal toxicity and incomplete skeletal ossification of fetal bones was observed with doses of ≥5 mg/kg/day (exposures less than the human therapeutic dose of 1 mg/kg/day based on the body surface area).



Use In Specific Populations (Nursing Mothers)


Although the exposure was not quantified, naive pups that were exposed to Orfadin® via breast milk showed signs of ocular toxicity and lower body weight. This suggests that Orfadin® is excreted via breast milk in rats. It is not known whether nitisinone is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nitisinone is administrated to a nursing woman.



Use In Specific Populations (Pediatric Use)


Nitisinone has been studied in patients ranging in age from birth to 21.7 years. The median age of enrollment in a study of 207 patients with HT-1 was 9 months.



Use In Specific Populations (Geriatric Use)


Clinical studies of nitisinone did not include any subjects aged 65 and over to determine whether they respond differently from younger subjects. HT-1 is presently a disease of the pediatric population. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in this patient population.



Overdosage


Accidental ingestion of this drug by individuals eating normal diets not restricted in tyrosine and phenylalanine will result in elevated tyrosine levels. In volunteers given a single 1 mg/kg dose of nitisinone, the plasma tyrosine level reached a maximum of 1200 µmol/L from 48 to 120 hours after dosing. After a washout period of 14 days, the mean value of plasma tyrosine was still 808 µmol/L. Fasted follow-up samples obtained from volunteers several weeks later showed tyrosine values back to normal. Nitisinone was generally well tolerated in these studies. There were no reports of changes in vital signs or laboratory data of any clinical significance. One patient did report sensitivity to sunlight. Tyrosinemia has been associated with toxicity to eyes, skin, and the nervous system (see WARNINGS).


No information about specific treatment of overdose is available. Restriction of tyrosine and phenylalanine in the diet should limit toxicity associated with tyrosinemia. Patients should be monitored for potential adverse events (see ADVERSE REACTIONS).



Orfadin Description


Orfadin® capsules contain nitisinone, which is a synthetic reversible inhibitor of 4-hydroxyphenylpyruvate dioxygenase used in the treatment of hereditary tyrosinemia type 1 (HT-1).


Nitisinone occurs as white to yellowish-white, crystalline powder. It is practically insoluble in water, soluble in 2M sodium hydroxide and in methanol, and sparingly soluble in alcohol.


Chemically, nitisinone is 2-(2-nitro-4-trifluoromethylbenzoyl) cyclohexane-1,3-dione, and the structural formula is:




Figure 1. The molecular formula is C14H10F3NO5 with a relative mass of 329.23


Orfadin® is a hard white-opaque capsule, marked as 2 mg, 5 mg or 10 mg strengths of nitisinone and is intended for oral administration. Each capsule contains 2 mg, 5 mg or 10 mg nitisinone, plus pregelatinized starch. The capsule shell is gelatin and titanium dioxide and the imprint is an iron oxide.













Orfadin 
nitisinone  capsule










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)66621-1002
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NITISINONE (NITISINONE)NITISINONE2 mg








Inactive Ingredients
Ingredient NameStrength
Titanium dioxide
Gelatin


















Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize0mm
FlavorImprint CodeNTBC;2;MG
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
166621-1002-660 CAPSULE In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02123201/18/2002







Orfadin 
nitisinone  capsule










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)66621-1005
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NITISINONE (NITISINONE)NITISINONE5 mg








Inactive Ingredients
Ingredient NameStrength
Titanium dioxide
Gelatin


















Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize0mm
FlavorImprint CodeNTBC;5;MG
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
166621-1005-660 CAPSULE In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02123201/18/2002







Orfadin 
nitisinone  capsule










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)66621-1010
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NITISINONE (NITISINONE)NITISINONE10 mg








Inactive Ingredients
Ingredient NameStrength
Titanium dioxide
Gelatin


















Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize0mm
FlavorImprint CodeNTBC;10;MG
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
166621-1010-660 CAPSULE In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02123201/18/2002


Labeler - Rare Disease Therapeutics, Inc. (966133100)

Registrant - Rare Disease Therapeutics, Inc. (966133100)









Establishment
NameAddressID/FEIOperations
Apoteket Produktion & Laboratorier AB776090099manufacture
Revised: 01/2010Rare Disease Therapeutics, Inc.

More Orfadin resources


  • Orfadin Side Effects (in more detail)
  • Orfadin Dosage
  • Orfadin Use in Pregnancy & Breastfeeding
  • Orfadin Support Group
  • 0 Reviews · Be the first to review/rate this drug


  • Orfadin Concise Consumer Information (Cerner Multum)

  • Orfadin Advanced Consumer (Micromedex) - Includes Dosage Information

  • Orfadin MedFacts Consumer Leaflet (Wolters Kluwer)

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