Tipranavir Solution

Pronunciation: tye-PRAN-a-vir
Generic Name: Tipranavir
Brand Name: Aptivus

Tipranavir Solution is used along with another HIV medicine (ritonavir). Serious and sometimes fatal bleeding in the brain has occurred with this combination. Contact your doctor right away if you develop symptoms of bleeding in the brain. These may include confusion, vision or speech problems, or one-sided weakness.

Serious and sometimes fatal liver problems have also been reported with this combination. Patients who have hepatitis B or C may be at greater risk. Contact your doctor at once if you develop symptoms of liver problems. Such symptoms may include yellowing of the eyes or skin, dark urine, pale stools, stomach pain or tenderness, severe or persistent nausea, or loss of appetite.

Discuss any questions or concerns with your doctor.

Tipranavir Solution is used for:

Treating HIV infection. Tipranavir Solution should be used with ritonavir.

Tipranavir Solution is a protease inhibitor. It works by blocking the growth of an enzyme (HIV protease) that the HIV virus needs to reproduce in the body.

Do NOT use Tipranavir Solution if:

• you are allergic to any ingredient in Tipranavir Solution


• you have moderate to severe liver disease


• you are taking alfuzosin, certain antiarrhythmics (eg, amiodarone, bepridil, flecainide, propafenone, quinidine), astemizole, certain benzodiazepines (eg, midazolam, triazolam), certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), cisapride, ergot derivatives (eg, ergonovine, ergotamine), other HIV protease inhibitors (eg, saquinavir), pimozide, rifampin, salmeterol, a serotonin 5-HT₁ receptor antagonist (eg, eletriptan, sumatriptan), St. John's wort, or terfenadine


• you are taking sildenafil for pulmonary arterial hypertension (PAH)

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

Before using Tipranavir Solution:

Some medical conditions may interact with Tipranavir Solution. 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 had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any other sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide


• if you have cholesterol or lipid problems, diabetes or a family history of diabetes, liver problems (eg, hepatitis B or C), abnormal liver function tests, kidney problems, or bleeding problems (eg, hemophilia)


• if you take vitamin E or you have had a recent injury or other medical condition that may increase your risk of bleeding or serious bruising


• if you will be having or have recently had surgery


• if you have never taken another medicine for HIV infection

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

• Certain antiarrhythmics (eg, amiodarone, bepridil, flecainide, propafenone, quinidine), astemizole, certain benzodiazepines (eg, midazolam, triazolam), cisapride, ergot derivatives (eg, ergonovine, ergotamine), certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), pimozide, salmeterol, serotonin 5-HT₁ receptor antagonists (eg, eletriptan, sumatriptan), or terfenadine because the risk of side effects, including heart or blood vessel problems, muscle problems, or severe breathing problems, may be increased


• Alfuzosin because the risk for severe low blood pressure may be increased


• Rifampin or St. John's wort because they may decrease Tipranavir Solution's effectiveness


• Sildenafil (when used for PAH) because the risk of its side effects may be increased by Tipranavir Solution


• Other HIV protease inhibitors (eg, saquinavir) because their effectiveness may be decreased by Tipranavir Solution


• Anticoagulants (eg, warfarin), antiplatelet medicines (eg, clopidogrel), and many prescription and nonprescription medicines (eg, used for aches and pains, asthma, erectile dysfunction, PAH, diabetes, gout, high blood pressure, high cholesterol, HIV, immune system suppression, infections, inflammation, irregular heartbeat, nasal allergies, seizures), multivitamin products, and herbal or dietary supplements (eg, coenzyme Q10, garlic, ginkgo, ginseng, herbal teas, St. John's wort) may interact with Tipranavir Solution, increasing the risk of side effects

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

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

• An extra patient leaflet is available with Tipranavir Solution. Talk to your pharmacist if you have questions about this information.


• Tipranavir Solution is taken at the same time with another medicine called ritonavir. If you are taking Tipranavir Solution with ritonavir capsule or solution, it can be taken with or without meals. If you are taking Tipranavir Solution with ritonavir tablets, it must be taken with meals.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you are also taking didanosine, do not take it within 2 hours of taking Tipranavir Solution. Check with your doctor if you have questions.


• Taking Tipranavir Solution at the same time each day will help you remember to take it.


• Take Tipranavir Solution on a regular schedule to get the most benefit from it.


• Continue to use Tipranavir Solution even if you feel well. Do not miss any doses. Failure to do so may decrease the effectiveness of Tipranavir Solution and increase the risk that your HIV infection will no longer be sensitive to Tipranavir Solution or to other similar medicines.


• If you miss a dose of Tipranavir Solution, 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 Tipranavir Solution.

Important safety information:

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


• Tell your doctor or dentist that you take Tipranavir Solution before you receive any medical or dental care, emergency care, or surgery.


• Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Tipranavir Solution. The cause and long-term effects of these changes are not known. Discuss any concerns with your doctor.


• Tipranavir Solution may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, cough, fever, shortness of breath, sore throat, weakness) after you start Tipranavir Solution.


• When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Tipranavir Solution, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.


• Tipranavir Solution is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.


• Tipranavir Solution does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.


• Tipranavir Solution may increase triglyceride and lipid levels. The long-term chance of complications from these increased triglyceride and lipid levels, such as heart attack and stroke, are not known at this time.


• Hemophilia patients - Report all bleeding episodes to your doctor.


• Tipranavir Solution may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.


• Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Tipranavir Solution may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Tipranavir Solution. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Hormonal birth control (eg, birth control pills) may not work as well while you are using Tipranavir Solution. To prevent pregnancy, use an extra form of birth control (eg, condoms).


• Women who take estrogens for birth control or hormone replacement may have an increased risk of rash from Tipranavir Solution. Contact your doctor if you develop a rash.


• Lab tests, including viral load, CD4 count, triglyceride and lipid levels, and liver function, may be performed while you use Tipranavir Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Tipranavir Solution with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Tipranavir Solution in CHILDREN; they may be more sensitive to its effects, especially rash.


• Use Tipranavir Solution with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risk of using Tipranavir Solution while you are pregnant. It is not known if Tipranavir Solution is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Tipranavir Solution to the baby.

Possible side effects of Tipranavir Solution:

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:

Cough; diarrhea; headache; nausea; tiredness; vomiting.

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); body fat changes; confusion; dark urine; depression; difficulty urinating; dizziness; excessive hunger, thirst, or urination; fast heartbeat; fever, chills, or sore throat; flu-like symptoms; fruit-like breath odor; itching; joint pain or stiffness; loss of appetite; mental or mood changes; mouth sores or ulcers; muscle pain; numbness or tingling; pale stools; red, blistered, swollen, or peeling skin; severe or persistent nausea; slurred speech or one-sided weakness; stomach pain or tenderness; throat tightness; unusual bruising or bleeding; unusual drowsiness or tiredness; unusual weakness; vision changes; yellowing of the skin or eyes.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

See also: Tipranavir 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 Tipranavir Solution:

Store Tipranavir Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Do not refrigerate or freeze. Tipranavir Solution must be used within 60 days after opening the bottle. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tipranavir Solution out of the reach of children and away from pets.

General information:

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


• Tipranavir Solution 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 Tipranavir Solution. 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 Tipranavir resources

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

Compare Tipranavir with other medications

• HIV Infection

Carb Pseudo-Tan

Generic Name: carbetapentane and pseudoephedrine (kar BAY ta PEN tane and SOO doe ee FED rin)

Brand Names: Allres Pd, Carb Pseudo-Tan, Corzall, Pseudacarb, Re-Tann, Respi-TANN, Respi-Tann Pd

What is Carb Pseudo-Tan (carbetapentane and pseudoephedrine)?

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

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

The combination of carbetapentane and pseudoephedrine is used to treat cough and nasal and sinus congestion caused by the common cold, flu, or bronchitis.

Carbetapentane and pseudoephedrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Carb Pseudo-Tan (carbetapentane and pseudoephedrine)?

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 cough, cold, or allergy medicine. Many combination medicines available over the counter may contain similar drug ingredients. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains a decongestant or cough suppressant. Do not take a cough or 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 Carb Pseudo-Tan (carbetapentane and pseudoephedrine)?

Do not take a cough or 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 take this medication if you are allergic to carbetapentane or pseudoephedrine, or if you have severe or untreated high blood pressure or coronary artery disease.

To make sure you can safely take carbetapentane and pseudoephedrine, tell your doctor if you have any of these other conditions:

• 
  

  heart disease or high blood pressure;

  
  


• 
  

  a seizure disorder;

  
  


• 
  

  glaucoma;

  
  


• 
  

  an enlarged prostate or problems with urination;

  
  


• 
  

  diabetes; or

  
  


• 
  

  a thyroid disorder.

  
  

FDA pregnancy category C. It is not known whether carbetapentane and pseudoephedrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Carbetapentane and 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.

How should I take Carb Pseudo-Tan (carbetapentane 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.

Do not give this medication to a child younger than 2 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.

Measure liquid medicine 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.

The chewable tablet must be chewed before you swallow it.

Do not take carbetapentane and 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 if you have taken a cough or cold medicine within the past few days.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cough or 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.

What should I avoid while taking Carb Pseudo-Tan (carbetapentane and pseudoephedrine)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of carbetapentane and 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 cough, cold, or allergy medicine. Many combination medicines available over the counter may contain similar drug ingredients. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains a decongestant or cough suppressant.

Carb Pseudo-Tan (carbetapentane 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 taking this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  confusion, hallucinations;

  
  


• 
  

  slow, shallow breathing;

  
  


• 
  

  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, upset stomach;

  
  


• 
  

  warmth, redness, or tingling under your skin;

  
  


• 
  

  feeling excited or restless;

  
  


• 
  

  sleep problems (insomnia); or

  
  


• 
  

  mild 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 Carb Pseudo-Tan (carbetapentane and pseudoephedrine)?

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

• 
  

  celecoxib (Celebrex);

  
  


• 
  

  cinacalcet (Sensipar);

  
  


• 
  

  darifenacin (Enablex);

  
  


• 
  

  imatinib (Gleevec);

  
  


• 
  

  quinidine (Quin-G);

  
  


• 
  

  ranolazine (Ranexa)

  
  


• 
  

  ritonavir (Norvir, Kaletra);

  
  


• 
  

  sibutramine (Meridia);

  
  


• 
  

  terbinafine (Lamisil);

  
  


• 
  

  medicines to treat high blood pressure;

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip), bupropion (Wellbutrin, Zyban), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), paroxetine (Paxil), sertraline (Zoloft), and others; or

  
  


• 
  

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

  
  

This list is not complete and other drugs may interact with carbetapentane 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 Carb Pseudo-Tan resources

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

• Corzall Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Corzall Prescribing Information (FDA)


• Respi-Tann Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Carb Pseudo-Tan with other medications

• Cough and Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about carbetapentane and pseudoephedrine.

See also: Carb Pseudo-Tan side effects (in more detail)

Interféron alfacon-1

Interféron alfacon-1 may be available in the countries listed below.

Ingredient matches for Interféron alfacon-1

Interferon Alfacon-1

Interféron alfacon-1 (DCF) is known as Interferon Alfacon-1 in the US.

International Drug Name Search

Glossary

DCF	Dénomination Commune Française

Click for further information on drug naming conventions and International Nonproprietary Names.

Morphgesic 60mg Tablets

1. Name Of The Medicinal Product

Rhotard Morphine SR 60 mg Tablets

Morphgesic SR 60 mg Tablets

2. Qualitative And Quantitative Composition

Rhotard Morphine SR 60 mg Tablets/ Morphgesic SR 60 mg Tablets contain 60mg Morphine Sulphate.

Each 60mg tablet is an orange coloured biconvex round film coated tablet.

3. Pharmaceutical Form

Controlled release tablets

4. Clinical Particulars

4.1 Therapeutic Indications

For the prolonged relief of severe pain.

4.2 Posology And Method Of Administration

Route of administration: Oral

Rhotard Morphine SR/ Morphgesic SR tablets should be swallowed whole and not chewed.

Adults:

The dosage is dependent upon the severity of the pain and the patient's previous history of analgesic requirements. The tablets should normally be administered twice daily at 12 hourly intervals. One or two 10 mg tablets (10mg) twice daily is the recommended starting dosage for a patient presenting with severe pain. With increasing severity of pain it is recommended that the dosage of morphine be increased to achieve the desired relief. The dosage may be varied by choosing combinations of available strengths (10, 30, 60, and 100 mg) or by using higher strength tablets alone.

It is recommended that a patient transferred from another oral morphine preparation, having similar bioavailability to oral morphine liquid, should receive the same total morphine dose in one 24-hour period. This total dose should be divided between the morning and evening administration. Dosage titration and clinical assessment may be appropriate.

Where a patient had previously received parenteral morphine prior to being transferred to Rhotard Morphine SR/ Morphgesic SR tablets, a higher dosage of morphine may be required. Individual dosage adjustment will be necessary to compensate for any reduction in analgesic effect associated with oral administration.

When Rhotard Morphine SR/ Morphgesic SR is to be given for the relief of post-operative pain, it is not advisable to administer it during the first 24 hours. Following this initial period, the dosage should be at the physician's discretion.

Some patients may require supplemental parenteral morphine which is perfectly acceptable. Careful attention should be paid to the total morphine dosage however, and the prolonged effects of morphine in the Rhotard Morphine SR/ Morphgesic SR formulation should also be borne in mind.

Rhotard Morphine SR/ Morphgesic SR tablets should be used with caution post-operatively (as with all morphine preparations) but especially in cases of 'acute abdomen' and following abdominal surgery.

Gastric motility should have returned and be maintained.

Children:

Rhotard Morphine SR/ Morphgesic SR tablets are not recommended for paediatric use.

4.3 Contraindications

Respiratory depression, paralytic ileus, delayed gastric emptying, obstructive airways disease, known morphine sensitivity or acute hepatic disease. It is also contra-indicated in the presence of hypersensitivity to any of the constituents, acute alcoholism, head injuries and conditions in which intracranial pressure is raised. Neither should it be given during an attack of bronchial asthma nor heart failure secondary to chronic lung disease.

Not recommended for pre-operative use or for the first 24 hours post-operatively.

Not recommended during pregnancy and lactation.

Concurrent administration of monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuation of their use.

4.4 Special Warnings And Precautions For Use

Rhotard Morphine SR/ Morphgesic SR tablets should be given with caution or in reduced doses to patients with hypothyroidism, adrenocortical insufficiency, impaired kidney or liver function, prostatic hypertrophy or shock. It should be used with caution in patients with either obstructive bowel disorders or myasthenia gravis.

Caution in patients with convulsive disorders, hypotension with hypovolaemia, the elderly, opioid dependent patients, diseases of the biliary tract, pancreatitis and inflammatory bowel disorders.

Should not be used where there is a possibility of paralytic ileus occurring. Should paralytic ileus be suspected to occur during use, treatment should be discontinued immediately.

As with all morphine preparations, patients who are to undergo cordotomy or other pain relieving surgical procedures should not receive Rhotard Morphine SR/ Morphgesic SR tablets for 24 hours prior to surgery. If further treatment is then indicated, the dosage should be adjusted to the new post-operative requirement.

It is not possible to ensure bio-equivalence between different brands of controlled release morphine products. Therefore, it should be emphasised that patients, once titrated to an effective dose should not be changed from Rhotard Morphine SR/ Morphgesic SR tablets to other slow, sustained or controlled release morphine or other potent narcotic analgesic preparations without retitration and clinical assessment.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Rhotard Morphine SR/ Morphgesic SR should not be concurrently administered with monoamine oxidase inhibitors (MAOI's) or used within two weeks of discontinuation of MAOI use. The depressant effects of morphine are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, tricyclic antidepressants and phenothiazines. The action of morphine may in turn affect the activities of other compounds, for example its gastro-intestinal effects may delay absorption as with mexilitine or may be counteractive as with metoclopramide.

Cimetidine inhibits the metabolism of morphine.

Morphine potentiates the effects of tranquillisers, muscle relaxants and anti-hypertensives.

Mixed agonist/antagonist opioid analgesics (e.g. Buprenorphine, nalbuphine, pentazocine) should not be administered to a patient who has received a course of therapy with a pure opioid agonist analgesic.

4.6 Pregnancy And Lactation

Rhotard Morphine SR/ Morphgesic SR tablets are contraindicated during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

Patients taking Rhotard Morphine SR/ Morphgesic SR should not operate machines.

4.8 Undesirable Effects

The commonest side-effects of morphine when administered at normal doses are nausea, vomiting, constipation, drowsiness and confusion. Micturition may be difficult and there may be ureteric or biliary spasm. There is also an antidiuretic effect. Dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypothermia, restlessness, changes of mood and miosis also occur. These effects occur more commonly in ambulant patients than in those at rest in bed. Raised intracranial pressure occurs in some patients. Larger doses of morphine produce respiratory depression and hypotension with circulatory failure and deepening coma. Death may occur from respiratory failure. Toxic doses vary considerably with the individual. Tolerance and dependence may occur.

Paralytic ileus may be associated with opioid usage. Other effects include bronchospasm, headache, disorientation, hallucinations, rash, myoclonus, decreased libido and colic.

Morphine has histamine releasing effects which may be responsible in part for reactions such as urticaria and pruritus.

4.9 Overdose

In acute poisoning by Rhotard Morphine SR/ Morphgesic SR tablets, the stomach should be emptied by aspiration and lavage. A laxative may be given to aid peristalsis. Signs of morphine toxicity and overdose are likely to consist of pin-point pupils, respiratory depression and hypotension. Circulatory failure and deepening coma may occur in more severe cases.

Treatment of respiratory failure and shock may require intensive supportive therapy. In addition to this the specific antagonist naloxone hydrochloride should be administered at a dose of 0.4 to 2 mg iv. This dose should be repeated at intervals of 2 to 3 minutes if required, up to a total dose of 10mg.

The physician should be aware that Rhotard Morphine SR/ Morphgesic SR tablets remaining in the intestine will continue to release morphine sulphate for a period of hours.

Rhabdomyolysis progressing to renal failure has been reported in opioid overdosage.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Morphine is an opioid analgesic. It acts mainly on the central nervous system and on smooth muscle. Although morphine is predominantly a central nervous system depressant it has some central stimulant actions which results in nausea and vomiting and miosis. Morphine generally increases smooth muscle tone, especially the sphincters of the gastro-intestinal tract.

Morphine and related analgesics may produce both physical and psychological dependence and should therefore be used with discrimination. Tolerance may also develop.

Morphine is an analgesic used for the symptomatic relief of moderate to severe pain, especially that associated with neoplastic disease, myocardial infarction and surgery. When pain is likely to be short of duration, a short-acting analgesic is usually preferred in addition to relieving pain, morphine also alleviates the anxiety associated with severe pain. It is useful as a hypnotic where sleeplessness is due to pain and may also relieve the pain of biliary or renal colic, although an antispasmodic may also be required since morphine may increase smooth muscle tone.

Morphine reduces intestinal motility and is used in the symptomatic treatment of diarrhoea. It also relieves the dyspnoea of left ventricular failure and of pulmonary oedema. It is effective for the suppression of cough, but codeine is usually preferred as there is less risk of dependence. Morphine has been used pre-operatively as an adjunct to anaesthesia for pain relief and to allay anxiety. It has also been used in high doses as a general anaesthetic in specialised procedures. Morphine is usually administered as the sulphate, although the hydrochloride and the tartrate are used in similar doses; the acetate has also been used. Routes of administration include the oral, subcutaneous, intramuscular, intravenous, intraspinal and rectal routes. Parenteral doses may be intermittent injections or continuous or intermittent infusions adjusted according to individual analgesic requirements.

5.2 Pharmacokinetic Properties

Morphine has a plasma half life of about 2 to 3 hours and if given IV must be administered frequently. Rhotard Morphine SR/ Morphgesic SR, being a sustained release preparation of morphine, has the advantage that it is only administered twice daily.

A summary of the morphine pharmacokinetic parameters is given below:

(a) Half life; plasma half life; about 2-3 hours

(b) Volume of distribution; about 3-5 litres/KG

(c) Clearance; plasma clearance; about 15 to 20 ml/min/kg

(d) Protein binding; in plasma 20-35%

Pharmacokinetic parameters pertinent to Rhotard Morphine SR/ Morphgesic SR are summarised in the following table:

Parameters	Rhotard Morphine SR/ Morphgesic SR Tablets Fasting (A)	Rhotard Morphine SR/ Morphgesic SR Tablets Food (B)
AUC (0-t) (ng.h/ml)	46.02 ± 18.85	59.88 ± 20.52
Cmax (ng/ml)	9.2 ± 3.6	13.6 ± 4.6
T max hours	2.5 ± 1.7	3.9 ± 1.6

5.3 Preclinical Safety Data

No preclinical safety data are available which are additional to the experience gained in man with morphine over many years.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose, Hydroxyethylcellulose, Hypromellose (E464), Povidone, Talc, Magnesium Stearate, Macrogol and Industrial Methylated Spirits 99% BP.

Rhotard Morphine SR 60 mg Tablets/ Morphgesic SR 60 mg Tablets contain the colourants listed below:

Titanium Dioxide (E171)

FD&C Yellow #6/Sunset Yellow FCF Lake (E110)

6.2 Incompatibilities

None.

6.3 Shelf Life

36 Months

6.4 Special Precautions For Storage

¹Do not store above 25°C. Store in the original package.

6.5 Nature And Contents Of Container

Each pack contains either 10 or 60 tablets in PVC blister packs with aluminium foil lidding.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Waymade plc

Trading as : Sovereign Medical

Sovereign House

Miles Gray Road

Basildon

Essex.

SS14 3FR

United Kingdom

And trading as Amdipharm

Regency House

Miles Gray Road

Basildon

Essex

SS14 3AF

United Kingdom

8. Marketing Authorisation Number(S)

PL 06464/1653

9. Date Of First Authorisation/Renewal Of The Authorisation

28 June 2002

10. Date Of Revision Of The Text

April 2003

Cholestyramine Powder

Pronunciation: koe-LES-teer-a-meen
Generic Name: Cholestyramine
Brand Name: Examples include Prevalite and Questran

Cholestyramine Powder is used for:

Lowering blood cholesterol levels. It is used along with changes in diet. It is used to relieve itching caused by partial biliary obstruction. It may also be used for other conditions as determined by your doctor.

Cholestyramine Powder is a bile acid sequestrant/anion-exchange resin. It works by increasing the removal of bile acids from the body. As the body loses bile acids, it replaces them by converting cholesterol from the blood to bile acids. This causes the blood level of cholesterol to decrease.

Do NOT use Cholestyramine Powder if:

• you are allergic to any ingredient in Cholestyramine Powder


• you have a complete obstruction of your biliary tract, severe constipation (eg, impacted feces), high blood chloride levels, or certain types of elevated blood lipid levels (type III, IV, or V hyperlipidemia)


• if you are taking mycophenolate

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

Before using Cholestyramine Powder:

Some medical conditions may interact with Cholestyramine Powder. 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 heart disease; constipation; hemorrhoids; gallbladder problems; blood, bleeding, or clotting problems; high blood levels of triglycerides; poor absorption from the intestinal tract or other intestinal problems; kidney problems; or phenylketonuria (PKU)


• if you are dehydrated

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

• Anticoagulants (eg, warfarin), beta-blockers (eg, propranolol), digoxin, digitoxin, estrogens, hormonal contraceptives (eg, birth control pills), mycophenolate, penicillins (eg, amoxicillin), phenobarbital, phenylbutazone, phosphate supplements, progestins (eg, medroxyprogesterone), tetracyclines (eg, doxycycline), thiazide diuretics (eg, hydrochlorothiazide), or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Cholestyramine Powder


• Spironolactone because the risk of high blood chloride levels may be increased

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

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

• Cholestyramine Powder is usually taken by mouth with meals.


• Cholestyramine Powder may decrease the absorption of other medicines. All other medicines should be taken at least 1 hour before or 4 hours after taking Cholestyramine Powder. Check with your doctor if you have any questions about taking your other medicines along with Cholestyramine Powder.


• If you are also taking anticoagulants (eg, warfarin), take Cholestyramine Powder at least 6 hours after you take the anticoagulant unless directed otherwise by your doctor.


• Do not take Cholestyramine Powder in its dry form. Always mix with water or other fluids before taking.


• If you are taking Cholestyramine Powder with a beverage, add the prescribed amount of medicine to 2 to 6 ounces/60 to 180 mL of water or other noncarbonated liquid before taking. Stir until well mixed (it will not dissolve) before drinking. After drinking all the liquid, rinse the glass with more liquid and drink it to ensure that all medicine is received.


• Cholestyramine Powder may also be mixed with soups (chicken noodle, tomato) or fruits (eg, applesauce, crushed pineapple) containing plenty of fluid.


• Do not sip Cholestyramine Powder or hold it in your mouth for a long period of time because this may cause tooth changes such as discoloration, decay, or erosion of enamel. Maintain good oral hygiene while you are using Cholestyramine Powder.


• Drink several glasses (8 ounces/240 mL) of water or other liquid daily, unless directed otherwise by your doctor.


• If you miss a dose of Cholestyramine Powder, 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 Cholestyramine Powder.

Important safety information:

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


• If you experience constipation while taking Cholestyramine Powder, talk to your doctor about increased fiber intake and use of a stool softener to help relieve this side effect.


• Phenylketonuria patients - Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.


• The color of the powder may vary from batch to batch. This is normal and does not change the effect.


• Hormonal birth control (eg, birth control pills) may not work as well while you are using Cholestyramine Powder. To prevent pregnancy, use an extra form of birth control (eg, condoms).


• Lab tests, including lipid and cholesterol levels and prothrombin times, may be performed while you use Cholestyramine Powder. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Cholestyramine Powder with caution in the ELDERLY; they may be more sensitive to its effects, especially constipation.


• Caution is advised when using Cholestyramine Powder in CHILDREN; they may be more sensitive to its effects, especially high blood chloride levels.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cholestyramine Powder while you are pregnant. It is not known if Cholestyramine Powder is found in breast milk. If you are or will be breast-feeding while you use Cholestyramine Powder, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Cholestyramine Powder:

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:

Constipation.

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); black or bloody stools; irritation of the skin, tongue, or anal area; severe constipation; severe or persistent nausea; shortness of breath; stomach pain; unusual bruising or bleeding; vomiting.

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: Cholestyramine 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 constipation; feeling of fullness.

Proper storage of Cholestyramine Powder:

Store Cholestyramine Powder at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cholestyramine Powder out of the reach of children and away from pets.

General information:

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


• Cholestyramine Powder 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 Cholestyramine Powder. 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 Cholestyramine resources

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

Compare Cholestyramine with other medications

• Crohn's Disease
• Hyperlipoproteinemia
• Hyperlipoproteinemia Type IIa, Elevated LDL
• Hyperlipoproteinemia Type IIb, Elevated LDL VLDL
• Irritable Bowel Syndrome
• Pruritus of Partial Biliary Obstruction

pyrithione Topical

pir-i-THYE-one

Commonly used brand name(s)

In the U.S.

• 2 in 1 Dandruff


• Beta Med


• DermaZinc


• DHS Zinc


• Skincure


• Zincon


• Znp

Available Dosage Forms:

• Shampoo


• Spray


• Cream


• Bar


• Lotion


• Soap

Therapeutic Class: Dermatological Agent

Chemical Class: Pyrethrums

Uses For pyrithione

Pyrithione is used to help control the symptoms of dandruff and seborrheic dermatitis of the scalp.

pyrithione is available without a prescription.

Before Using pyrithione

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 pyrithione, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to pyrithione 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

Although there is no specific information comparing use of pyrithione in children with use in other age groups, pyrithione is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of pyrithione in the elderly with use in other age groups, pyrithione is not expected to cause different side effects or problems in older people than it does in younger adults.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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.

Proper Use of pyrithione

For best results, use pyrithione at least 2 times a week or as directed by your doctor.

To use:

• Before applying this shampoo, wet the hair and scalp with lukewarm water.


• Apply enough shampoo to the scalp to work up a lather and rub in well, then rinse.


• Apply the shampoo again and rinse thoroughly.

Keep pyrithione away from the eyes. If you should accidentally get some in your eyes, flush them thoroughly with water.

Dosing

The dose of pyrithione 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 pyrithione. 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 bar dosage form:
  
  • For dandruff and seborrheic dermatitis:
    
    • Adults and children—Apply to the affected skin of body, face, or scalp once a day at least two times a week. Lather, massage into affected area, rinse, and repeat.
    
    
  
  

• For cream dosage forms:
  
  • For dandruff or seborrheic dermatitis:
    
    • Adults and children—Apply one to three times a day to affected skin on the body, face, or scalp or as directed by the doctor.
    
    
    • For Brylcreem Antidandruff—Adults: Apply to scalp once a day after shampooing and toweling hair dry. Massage into scalp for one minute.
    
    
    • Children—Use and dose must be determined by the doctor.
    
    
  
  

• For lotion dosage form:
  
  • For dandruff and seborrheic dermatitis:
    
    • For DermaZinc Scalp: Adults—Apply to scalp one to three times a day or as directed by the doctor.
    
    
    • For DermaZinc Spray: Adults—Apply one spray to affected skin of body, face, or scalp one to three times a day or as directed by the doctor. Medicine should cover a three-inch-square area. Treatment should continue for one week after symptoms lessen.
    
    
    • For DermaZinc Baby: Children—Apply to affected skin of face, body, or scalp one to four times a day or as directed by the doctor.
    
    
  
  

• For lotion shampoo dosage forms:
  
  • For dandruff and seborrheic dermatitis:
    
    • Adults and children up to 2 years of age—Use once a day as a shampoo on the scalp at least two times a week; however, may be used every day. Apply to wet hair and leave on the scalp for several minutes or massage into scalp vigorously before rinsing.
    
    
    • Children up to 2 years of age—Use and dose must be determined by the doctor.
    
    
  
  

Missed Dose

If you miss a dose of pyrithione, 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.

Precautions While Using pyrithione

If your condition does not get better after regular use of pyrithione, or if it gets worse, check with your doctor.

pyrithione 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 as soon as possible if any of the following side effects occur:

Less common or rare

• Irritation of skin

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

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

See also: pyrithione Topical side effects (in more detail)

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.

More pyrithione Topical resources

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

Compare pyrithione Topical with other medications

• Dandruff
• Seborrheic Dermatitis

Folbee Plus

Pronunciation: VYE-ta-min/BYE-oh-tin/FOE-lik AS-id
Generic Name: Vitamin B Complex/Vitamin C/Biotin/Folic Acid
Brand Name: Examples include: Folbee Plus and Nephrocaps

Folbee Plus is used for:

A dietary supplement for certain patients with high blood levels of homocysteine or kidney failure, or those who are on dialysis or do not receive the proper amount of vitamins from their diet. It may also be used for other conditions as determined by your doctor.

Folbee Plus is a vitamin and folic acid combination. It works by providing vitamins and folic acid to the body to help meet nutritional requirements.

Do NOT use Folbee Plus if:

• you are allergic to any ingredient in Folbee Plus

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

Before using Folbee Plus:

Some medical conditions may interact with Folbee Plus. 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 anemia (eg, pernicious anemia)


• if you are receiving dialysis

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

• Hydantoins (eg, phenytoin) or levodopa because their effectiveness may be decreased by Folbee Plus

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

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

• Folbee Plus may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• If you miss a dose of Folbee Plus, 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 Folbee Plus.

Important safety information:

• Folbee Plus may cause drowsiness. This effect may be worse if you take it with alcohol or certain medicines. Use Folbee Plus with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not take large doses of vitamins (megadoses or megavitamin therapy) while you use Folbee Plus unless your doctor tells you to.


• Folbee Plus contains pyridoxine (vitamin B₆) and folic acid. Before you start any new medicine, check the label to see if it has pyridoxine or folic acid in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Folbee Plus may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Folbee Plus.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Folbee Plus while you are pregnant. It is not known if Folbee Plus is found in breast milk. If you are or will be breast-feeding while you use Folbee Plus, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Folbee Plus:

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:

Drowsiness; headache; mild diarrhea; nausea.

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); feeling of swelling of the entire body; numbness or tingling of the skin.

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: Folbee Plus 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 Folbee Plus:

Store Folbee Plus 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 Folbee Plus out of the reach of children and away from pets.

General information:

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


• Folbee Plus 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 Folbee Plus. 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 Folbee Plus resources

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

• multivitamin Concise Consumer Information (Cerner Multum)


• Folplex Prescribing Information (FDA)


• Foltabs 800 Prescribing Information (FDA)


• Infuvite Pediatric Prescribing Information (FDA)


• Nephrocaps Prescribing Information (FDA)


• Nephrocaps


• Renal Caps Prescribing Information (FDA)


• Vitamin A Monograph (AHFS DI)

Compare Folbee Plus with other medications

• Dietary Supplementation
• Hyperhomocysteinemia

E. E. S. Liquid Suspension

Pronunciation: e-RITH-roe-MYE-sin ETH-il-SUX-i-nate
Generic Name: Erythromycin Ethylsuccinate
Brand Name: E. E. S. Liquid

E. E. S. Liquid Suspension is used for:

Treating infections caused by certain bacteria or amoebas. It may also be used to prevent attacks of rheumatic fever in patients who are unable to use other medicines.

E. E. S. Liquid Suspension is a macrolide antibiotic. It works by slowing the growth of, or sometimes killing, sensitive bacteria by reducing the production of important proteins needed by the bacteria to survive.

Do NOT use E. E. S. Liquid Suspension if:

• you are allergic to any ingredient in E. E. S. Liquid Suspension


• you are taking astemizole, cisapride, conivaptan, diltiazem, dofetilide, an ergot alkaloid (eg, dihydroergotamine, ergotamine), everolimus, an HIV protease inhibitor (eg, ritonavir), imidazoles (eg, ketoconazole), nilotinib, pimozide, a QT-prolonging agent (eg, quinidine, sotalol), a quinolone (eg, ciprofloxacin), a streptogramin (eg, quinupristin/dalfopristin), terfenadine, or verapamil

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

Before using E. E. S. Liquid Suspension:

Some medical conditions may interact with E. E. S. Liquid Suspension. 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 kidney or liver disease, myasthenia gravis, an irregular heartbeat, or the blood disease porphyria

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

• Astemizole, cisapride, diltiazem, dofetilide, an HIV protease inhibitor (eg, ritonavir), imidazoles (eg, ketoconazole), nilotinib, pimozide, a QT-prolonging agent (eg, quinidine, sotalol), a quinolone (eg, ciprofloxacin), a streptogramin (eg, quinupristin/dalfopristin), terfenadine, or verapamil because side effects, such as heart toxicity or irregular heartbeat, may occur. Check with your doctor if you have questions about which medicines may affect your heartbeat.


• Conivaptan, ergot alkaloids (eg, dihydroergotamine, ergotamine), or everolimus because the risk of their side effects may be increased by E. E. S. Liquid Suspension


• Many prescription and nonprescription medicines (eg, used for aches and pains, allergies, blood thinning, breathing problems, cancer, diabetes, erection problems, gout, heart problems, high blood calcium levels, high blood pressure, high cholesterol, HIV infection, inflammation, infections, low blood sodium levels, migraine, mood or mental problems, overactive bladder, Parkinson disease, prevention of organ transplant rejection, seizures, stomach problems, trouble sleeping), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) may also interact with E. E. S. Liquid Suspension. Ask your doctor or pharmacist if you are unsure if any of your medicines might interfere with E. E. S. Liquid Suspension.

This may not be a complete list of all interactions that may occur. Ask your health care provider if E. E. S. Liquid Suspension 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 E. E. S. Liquid Suspension:

Use E. E. S. Liquid Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take E. E. S. Liquid Suspension by mouth with or without food.


• Shake well before each use.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• Do not eat grapefruit or drink grapefruit juice while you take E. E. S. Liquid Suspension. Serious heart problems can occur.


• To clear up your infection completely, take E. E. S. Liquid Suspension for the full course of treatment. Keep taking it even if you feel better in a few days.


• If you miss a dose of E. E. S. Liquid Suspension, 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 E. E. S. Liquid Suspension.

Important safety information:

• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.


• E. E. S. Liquid Suspension only works against bacteria or amoebas; it does not treat viral infections (eg, the common cold).


• Be sure to use E. E. S. Liquid Suspension for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of E. E. S. Liquid Suspension may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Tell your doctor or dentist that you take E. E. S. Liquid Suspension before you receive any medical or dental care, emergency care, or surgery.


• Rarely, patients taking E. E. S. Liquid Suspension have developed reversible hearing loss. The risk is greater if you have kidney problems or you take high doses of E. E. S. Liquid Suspension. Contact your doctor if you develop decreased hearing or hearing loss.


• E. E. S. Liquid Suspension may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking E. E. S. Liquid Suspension.


• Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed while you use E. E. S. Liquid Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use E. E. S. Liquid Suspension with extreme caution in CHILDREN younger than 10 years old who have diarrhea or an infection of the stomach or bowel.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using E. E. S. Liquid Suspension while you are pregnant. E. E. S. Liquid Suspension is found in breast milk. If you are or will be breast-feeding while you use E. E. S. Liquid Suspension, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of E. E. S. Liquid Suspension:

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; loss of appetite; nausea; stomach pain; vomiting.

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); bloody stools; decreased hearing or hearing loss; irregular heartbeat; muscle weakness; red, swollen, blistered or peeling skin; severe diarrhea; severe stomach pain/cramps; symptoms of liver problems (eg, yellowing of the skin or eyes, pale stools, severe or persistent nausea, vomiting, loss of appetite, or dark urine).

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: E. E. S. 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 hearing loss; severe diarrhea, nausea, stomach upset, or vomiting.

Proper storage of E. E. S. Liquid Suspension:

Store E. E. S. Liquid Suspension at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). If not used within 14 days, store in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Keep E. E. S. Liquid Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about E. E. S. Liquid Suspension, please talk with your doctor, pharmacist, or other health care provider.


• E. E. S. Liquid Suspension 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 E. E. S. Liquid Suspension. 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 E. E. S. Liquid resources

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Umecta PD

urea

Dosage Form: topical emulsion
Umecta PD

Description

Rx only

For topical use only

Not for ophthalmic use


Umecta is a keratolytic, emollient which is a gentle, yet potent, tissue softener for nails and skin


Each gram of Umecta PD bioadhesive emulsion and topical suspension contains40% urea, sodium hyaluronate 0.3%, BHT, butyrospermum parkii fruit oil, citric acid, dimethylacrylamide (and) acrylic acid (and) polystyrene ethyl methacrylate copolymer, disodium EDTA, glyceryl stearate, glycine soja sterol, helianthus annuus oil, hydroxypropylmethyl cellulose, purified water, sodium citrate, stearic acid.

Clinical Pharmacology

Urea gently dissolves the intercellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate which can result in the softening and eventual debridement of the nail plate.

Pharmacokinetics

The mechanism of action of topically applied urea is not yet known.

Indications and Uses

For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns, and calluses, as well as damaged, ingrown and devitalized nails.

Contraindications

Known hypersensitivity to any of the listed ingredients.

Warnings

For external use only. Avoid contact with eyes, lips or mucous membranes.

Precautions

This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use.

Pregnancy Category C

Animal reproduction studies have not been conducted with Umecta. It is also not known whether Umecta can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Umecta should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Umecta is administered to a nursing woman.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Adverse Reactions

Transient stinging, burning, itching, or irritation may occur and normally disappear on discontinuing the medication.

Dosage and Administration

Apply Umecta emulsion/topical suspension or Umecta mousse to affected skin twice per day or as directed by a physician. Rub in until completely absorbed.

How Supplied

Umecta PD™ (urea, 40% - sodium hyaluronate 0.3%) bioadhesive emulsion is available in a:7 oz. bottle NDC 68712-017-02


Store at controlled room temperature 15-30°C (59-86°F).

Manufactured for:

Innocutis Holdings LLC

Charleston, SC 29401

Toll Free: 1-800-499-4468

www.innocutis.com

www.umecta.com

Umecta PD  UREA urea   emulsion

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68712-017 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UREA) UREA 400 mg  in 1 g

Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE   SHEA BUTTER   CITRIC ACID MONOHYDRATE   EDETATE DISODIUM   GLYCERYL MONOSTEARATE   SOYBEAN OIL   SUNFLOWER OIL   HYPROMELLOSES   WATER   SODIUM CITRATE   STEARIC ACID   HYALURONATE SODIUM

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68712-017-01 3 g In 1 PACKET None 2 68712-017-02 198.5 g In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2007

Labeler - Innocutis Holdings LLC (071501252)

Establishment
Name	Address	ID/FEI	Operations
Sonar Products		104283945	manufacture

Revised: 12/2011Innocutis Holdings LLC

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