Showing posts with label Q. Show all posts
Showing posts with label Q. Show all posts

Tuesday, October 18, 2016

Quinine


Pronunciation: KWYE-nine
Generic Name: Quinine
Brand Name: Qualaquin

Quinine may cause serious and life-threatening bleeding problems. In some cases, kidney injury can also occur. Tell your doctor immediately if you experience unusual bleeding or bruising (eg, bleeding gums; severe nose bleed; dark urine; black, tarry, or bloody stools; unusual purple, brown, or red spots on the skin).


Quinine is not approved to treat or prevent nighttime leg cramps. The risk of taking Quinine for nighttime leg cramps may be greater than the possible benefits. Talk with your doctor if you have questions about this information.





Quinine is used for:

Treating malaria. It is usually used with other antimalarial medicines. It may also be used for other conditions as determined by your doctor.


Quinine is an antimalarial. It works by killing the malaria parasite.


Do NOT use Quinine if:


  • you are allergic to any ingredient in Quinine, or to mefloquine or quinidine

  • you have a history of a low platelet count (thrombocytopenia), certain blood problems (eg, blackwater fever, intravascular hemolysis), or bleeding problems (eg, hemolytic-uremic syndrome/thrombotic thrombocytopenic purpura [HUS/TTP]) caused by using Quinine in the past

  • you have glucose-6-phosphate dehydrogenase (G6PD) deficiency, inflammation of the optic (eye) nerve (optic neuritis), or myasthenia gravis

  • you have a certain type of irregular heartbeat (eg, QT prolongation), a slow heartbeat, or uncorrected low blood potassium levels

  • you are taking astemizole, atorvastatin, cisapride, a class IA antiarrhythmic (eg, disopyramide, procainamide, quinidine), a class III antiarrhythmic (eg, amiodarone, dofetilide, sotalol), halofantrine, a macrolide antibiotic (eg, erythromycin, troleandomycin), mefloquine, pimozide, rifampin, ritonavir, or terfenadine

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



Before using Quinine:


Some medical conditions may interact with Quinine. 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 problems (eg, slow or irregular heartbeat), liver or kidney problems, nerve or muscle problems, depression, low blood sugar, low blood potassium levels, seizures, or a family history of G6PD deficiency

  • if you have had an abnormal electrocardiogram (ECG)

  • if you have vision or hearing problems (eg, ringing in the ears), eye pain, or a bleeding disorder (eg, thrombocytopenic purpura)

  • if you are scheduled for surgery or anesthesia

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


  • Astemizole, cisapride, class IA antiarrhythmics (eg, disopyramide, procainamide, quinidine), class III antiarrhythmics (eg, amiodarone, dofetilide, sotalol), halofantrine, macrolide antibiotics (eg, erythromycin, troleandomycin), mefloquine, pimozide, or terfenadine because the risk of their side effects, including irregular heartbeat, may be increased by Quinine

  • Heparin or oral anticoagulants (eg, warfarin) because the risk of their side effects, such as bleeding, may be increased by Quinine

  • Azole antifungals (eg, ketoconazole), H2 antagonists (eg, cimetidine), mefloquine, ritonavir, tetracycline antibiotics (eg, doxycycline), or urinary alkalinizers (eg, acetazolamide, sodium bicarbonate) because they may increase the risk of Quinine's side effects

  • Rifamycins (eg, rifampin) because it may decrease Quinine's effectiveness

  • Carbamazepine, debrisoquine, desipramine, dextromethorphan, digoxin, certain HMG-CoA reductase inhibitors (eg, atorvastatin, lovastatin, simvastatin), metoprolol, paroxetine, phenobarbital, or phenytoin because the risk of their side effects may be increased by Quinine

  • Anticholinesterase medicines (eg, neostigmine) or theophyllines (eg, aminophylline) because their effectiveness may be decreased by Quinine

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


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


  • Quinine comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Quinine refilled.

  • Take Quinine by mouth with food to reduce the risk of stomach upset.

  • Do not take an antacid that has aluminum or magnesium in it within 1 hour before or 2 hours after you take Quinine.

  • Take Quinine for the full course of treatment. Keep taking it even if you feel better in a few days. Do not miss any doses.

  • If you miss a dose of Quinine, take it as soon as possible. If it has been more than 4 hours since the missed 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 Quinine.



Important safety information:


  • Quinine may cause dizziness, light-headedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Quinine 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 Quinine before you receive any medical or dental care, emergency care, or surgery.

  • If your symptoms do not get better within 1 to 2 days or if they get worse, or if your fever comes back after finishing treatment with Quinine, check with your doctor.

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

  • Quinine may cause low blood sugar. Pregnant women may be at higher risk of low blood sugar. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens.

  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

  • Quinine may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury.

  • Serious and life-threatening bleeding problems may occur with Quinine. This could also lead to severe kidney problems. Tell your doctor right away if you notice symptoms of unusual bleeding or bruising (eg, bleeding gums; severe nose bleed; dark urine; black, tarry, or bloody stools; unusual purple, brown, or red spots on the skin).

  • Quinine should NOT be used to treat or prevent nighttime leg cramps. It should also NOT be used to prevent malaria. Talk with your doctor about other ways to treat nighttime leg cramps or to prevent malaria.

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

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

  • Quinine should be used with extreme caution in CHILDREN younger than 16 years; 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 risks of taking Quinine while you are pregnant. Quinine is found in breast milk. If you are or will be breast-feeding while you take Quinine, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Quinine:


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:



Dizziness; flushing; headache; nausea; sweating.



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, unusual hoarseness); black, tarry, or bloody stools; blurred vision, changes in how you see color, double vision, light sensitivity, blindness, or other unusual vision changes; chest pain; confusion; dark or bloody urine; decreased amount of urine or trouble urinating; decreased hearing, hearing loss, or ringing in the ears; fainting; fast or irregular heartbeat; fatigue; fever, chills, or sore throat; loss of appetite; low blood sugar symptoms (eg, anxiety, dizziness, fast heartbeat, headache, tremors, unusual sweating); mood or mental problems; muscle weakness; nervousness; pale skin; personality changes; red, swollen, blistered, or peeling skin; seizures; severe dizziness, light-headedness, or flushing; severe nosebleed; severe or persistent nausea, vomiting, or diarrhea; speech problems; stomach or back pain; sudden onset of cold sweat; unusual purple, brown, or red spots on your skin; unusual bleeding or bruising; unusual tiredness or weakness; yellowing of the eyes or 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: Quinine 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 confusion; dilated pupils; fainting; hearing problems; increased hunger; increased sweating; loss of consciousness; nausea and vomiting; rash; ringing in the ears; seizures; severe diarrhea, dizziness, drowsiness, headache, or weakness; slow, fast, or irregular heartbeat; slow or shallow breathing; stomach cramping or pain; urine discoloration; vision problems (eg, blurred vision, vision loss).


Proper storage of Quinine:

Store Quinine at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Quinine out of the reach of children and away from pets.


General information:


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

  • Quinine 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 Quinine. 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 Quinine resources


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


  • Quinine Natural MedFacts for Professionals (Wolters Kluwer)

  • Qualaquin Prescribing Information (FDA)

  • Quinine Sulfate Monograph (AHFS DI)

  • quinine Concise Consumer Information (Cerner Multum)

  • quinine Advanced Consumer (Micromedex) - Includes Dosage Information



Compare Quinine with other medications


  • Malaria
  • Nocturnal Leg Cramps

Monday, October 17, 2016

quinupristin and dalfopristin Intravenous


kwin-ue-PRIS-tin, dal-foe-PRIS-tin


Intravenous route(Powder for Solution)

Quinupristin/dalfopristin has been approved for marketing in the United States for vancomycin-resistant Enterococcus faecium (VREF) bacteremia under FDA's accelerated approval regulations that allow marketing of products for use in life-threatening conditions when other therapies are not available. Approval of this indication is based upon quinupristin/dalfopristin’s ability to clear VREF from the bloodstream, with clearance of bacteremia considered to be a surrogate endpoint. There are no results from well-controlled clinical studies that confirm the validity of this surrogate marker .



Commonly used brand name(s)

In the U.S.


  • Synercid

Available Dosage Forms:


  • Powder for Solution

Therapeutic Class: Antibiotic


Chemical Class: Streptogramin


Uses For quinupristin and dalfopristin


Quinupristin and dalfopristin injection is used to treat infections of the skin and the blood. It may also be used for other conditions as determined by your doctor. It is given by injection and is used mainly for serious infection for which other medicine may not work.


Quinupristin and dalfopristin belong to the family of medicine called antibiotics. Antibiotics are medicines used in the treatment of infections caused by bacteria. They work by killing bacteria or preventing their growth. Quinupristin and dalfopristin will not work for colds, flu, or other virus infections.


quinupristin and dalfopristin is available only with your doctor's prescription.


Before Using quinupristin and dalfopristin


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 quinupristin and dalfopristin, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to quinupristin and dalfopristin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies have not been performed on the relationship of age to the effects of quinupristin and dalfopristin injection in children younger than 16 years of age. Safety and efficacy have not been established.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of quinupristin and dalfopristin injection in the elderly.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving quinupristin and dalfopristin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using quinupristin and dalfopristin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Cisapride

  • Pimozide

Using quinupristin and dalfopristin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Astemizole

  • Atorvastatin

  • Cerivastatin

  • Fluvastatin

  • Haloperidol

  • Lovastatin

  • Pravastatin

  • Simvastatin

  • Terfenadine

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


  • Amlodipine

  • Carbamazepine

  • Cyclosporine

  • Delavirdine

  • Diazepam

  • Diltiazem

  • Disopyramide

  • Docetaxel

  • Felodipine

  • Indinavir

  • Isradipine

  • Lacidipine

  • Lidocaine

  • Manidipine

  • Methylprednisolone

  • Midazolam

  • Nevirapine

  • Nicardipine

  • Nifedipine

  • Nilvadipine

  • Nimodipine

  • Nisoldipine

  • Nitrendipine

  • Paclitaxel

  • Quinidine

  • Ritonavir

  • Tacrolimus

  • Verapamil

  • Vinblastine

  • Vincamine

  • Vincristine

  • Vincristine Liposome

  • Vindesine

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of quinupristin and dalfopristin. Make sure you tell your doctor if you have any other medical problems, especially:


  • Colitis (inflammation of the colon) or

  • Diarrhea, severe—Use with caution. May make these conditions worse.

  • Liver disease—Liver disease may increase blood levels of quinupristin and dalfopristin, increasing the chance of side effects.

Proper Use of quinupristin and dalfopristin


A nurse or other trained health professional will give you quinupristin and dalfopristin in a hospital. quinupristin and dalfopristin is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 60 minutes.


To help clear up your infection completely, quinupristin and dalfopristin must be given for the full time of treatment, even if you begin to feel better after a few days. Also, it works best when there is a constant amount in the blood. To help keep the amount constant, quinupristin and dalfopristin must be given on a regular schedule.


Precautions While Using quinupristin and dalfopristin


Your doctor will check your progress closely while you are receiving quinupristin and dalfopristin. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.


If your symptoms do not improve or if they become worse, call your doctor.


quinupristin and dalfopristin may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop receiving quinupristin and dalfopristin. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


quinupristin and dalfopristin 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 or nurse immediately if any of the following side effects occur:


More common
  • Swelling, redness, or pain at the injection site

Less common
  • Changes in skin color

  • dry, red, hot, or irritated skin

  • joint pain

  • muscle pain

  • pain

  • redness, burning sensation, or pain under the skin usually in the injection site

  • swelling of the foot or leg

  • tenderness

Rare
  • Agitation

  • anxiety

  • back, leg, or stomach pains

  • black, tarry stools

  • bleeding gums

  • bloating or swelling of the face, arms, hands, lower legs, or feet

  • blood in the urine

  • bloody, black, or tarry stools

  • blue lips, fingernails, or skin

  • blurred vision

  • bone pain

  • burning, tingling, numbness, or pain in the hands, arms, feet, or legs

  • chest pain or discomfort

  • chest pain, possibly moving to the left arm, neck, or shoulder

  • chills

  • coma

  • confusion

  • constipation

  • convulsions or seizures

  • cough or hoarseness

  • darkened urine

  • decreased urine output

  • difficult, fast, or labored breathing

  • difficult or painful urination

  • difficulty with moving

  • difficulty with swallowing

  • dizziness

  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

  • drowsiness

  • extremely shallow or slow breathing

  • fainting

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

  • feeling of warmth or heat

  • flushing or redness of the skin, especially on the face and neck

  • general body swelling

  • general tiredness and weakness

  • hallucinations

  • headache

  • high fever

  • hives

  • inability to speak

  • increased thirst

  • indigestion

  • irritability

  • itching

  • light-colored stools

  • loss of appetite

  • loss of bladder control

  • loss of consciousness

  • loss of strength or energy

  • lower back or side pain

  • muscle pain or cramps

  • muscle stiffness or weakness

  • nausea or vomiting

  • no blood pressure or pulse

  • nosebleeds

  • not breathing

  • pain in the joints

  • pains in the stomach, side, or abdomen, possibly radiating to the back

  • pale skin

  • problems with bleeding or clotting

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

  • rapid weight gain

  • redness, burning sensation, or pain in the vagina

  • sensation of pins and needles

  • severe bloody diarrhea

  • severe or sudden headache

  • shakiness in the legs, arms, hands, or feet

  • shortness of breath

  • skin rash

  • skin rash with red patches

  • slurred speech

  • sore throat

  • sores on the skin

  • sores, ulcers, or white spots on the lips or in the mouth

  • stabbing pain

  • stiff neck

  • stopping of the heart

  • sweating

  • swelling of the face, ankles, or hands

  • swollen glands

  • temporary blindness

  • tightness in the chest

  • tingling of the hands or feet

  • total body jerking

  • trembling or shaking of the hands or feet

  • troubled breathing

  • unconsciousness

  • unexplained bleeding or bruising

  • unusual tiredness or weakness

  • unusual weight gain or loss

  • upper right abdominal or stomach pain

  • vomiting

  • vomiting of blood or material that looks like coffee grounds

  • weakness in the arm or leg on one side of the body, sudden and severe

  • wheezing

  • worsening of the underlying disease

  • yellowing of the eyes or skin

Incidence not known
  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


Rare
  • Acid or sour stomach

  • ankle, knee, or great toe joint pain

  • belching

  • cold sweats

  • cool, pale skin

  • cramps in the legs

  • depression

  • excessive muscle tone

  • heartburn

  • hives or welts

  • increased hunger

  • itching of the vagina or genital area

  • joint stiffness or swelling

  • lower back or side pain

  • muscle tension or tightness

  • nightmares

  • pain during sexual intercourse

  • redness of the skin

  • shakiness

  • sleeplessness

  • stomach discomfort, upset, or pain

  • sweating

  • swelling or inflammation of the mouth

  • thick, white vaginal discharge with no odor or with a mild odor

  • trouble sleeping

  • unable to sleep

  • white patches in the mouth, tongue, or throat

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


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



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


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


More quinupristin and dalfopristin Intravenous resources


  • Quinupristin and dalfopristin Intravenous Use in Pregnancy & Breastfeeding
  • Quinupristin and dalfopristin Intravenous Drug Interactions
  • Quinupristin and dalfopristin Intravenous Support Group
  • 0 Reviews for Quinupristin and dalfopristin Intravenous - Add your own review/rating


Compare quinupristin and dalfopristin Intravenous with other medications


  • Bacteremia
  • Methicillin-Resistant Staphylococcus Aureus Infection
  • Skin Infection

Quinzyme


Pronunciation: ue-BIK-wi-none
Generic Name: Ubiquinone
Brand Name: Quinzyme


Quinzyme is used for:

Dietary management of low levels of ubiquinone (coenzyme Q-10) in certain patients with high cholesterol.


Quinzyme is a medical food. It works by providing ubiquinone (coenzyme Q-10) to the body to meet nutritional requirements.


Do NOT use Quinzyme if:


  • you are allergic to any ingredient in Quinzyme

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



Before using Quinzyme:


Some medical conditions may interact with Quinzyme. 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 problems (eg, congestive heart failure) or diabetes

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


  • Anticoagulants (eg, warfarin) because their effectiveness may be decreased by Quinzyme

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


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


  • Do not swallow this tablet whole. Place the tablet in your mouth and allow it to completely dissolve. The tablet dissolves quickly and can be swallowed with saliva. Quinzyme may be taken with or without water.

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

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

  • If you miss a dose of Quinzyme, take it as soon as you remember. Continue to take it as directed by your doctor or on the package label.

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



Important safety information:


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

  • Quinzyme should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

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


Possible side effects of Quinzyme:


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 upset.



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).



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: Quinzyme 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 Quinzyme:

Store Quinzyme 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. Most herbal products are not in childproof containers. Keep Quinzyme out of the reach of children and away from pets.


General information:


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

  • Quinzyme 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 Quinzyme. 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 Quinzyme resources


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


  • Ubiquinone Natural MedFacts for Professionals (Wolters Kluwer)

  • Ubiquinone Natural MedFacts for Consumers (Wolters Kluwer)

  • QuinZyme Concise Consumer Information (Cerner Multum)



Compare Quinzyme with other medications


  • Dietary Supplementation

QuinZyme


Generic Name: ubiquinone (ue BIK wi none)

Brand Names: Co-Q10, Coenzyme Q10, LiQsorb, Liquid Co-Q10, NutraDrops, QuinZyme


What is QuinZyme (ubiquinone)?

Ubiquinone, also called Coenzyme Q-10, is a coenzyme that is made naturally in the body.


Ubiquinone has been used in congestive heart failure, gum disease, and type 2 diabetes. It has also been used to replace low levels of ubiquinone caused by taking certain cholesterol medications.


Ubiquinone has not been approved by the FDA to treat any disease, and it should not be substituted for prescription medications.

Ubiquinone may also have uses other than those listed in this product guide.


What is the most important information I should know about QuinZyme (ubiquinone)?


Ubiquinone has not been approved by the FDA to treat any disease, and it should not be substituted for prescription medications.

Ubiquinone has not been evaluated by the FDA for safety, effectiveness, or purity. All potential risks and/or advantages of this product may not be known. Additionally, there are no regulated manufacturing standards in place for these compounds. Some marketed herbal supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.


What should I discuss with my healthcare provider before taking QuinZyme (ubiquinone)?


Before taking ubiquinone, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use this product if you have:



  • allergies (especially to plants);




  • diabetes; or




  • a blood (platelet) disorder.




Do not take ubiquinone without telling your doctor if you are pregnant or could become pregnant. It is not known whether ubiquinone will be harmful to an unborn baby. Do not take ubiquinone without telling your doctor if you are breast-feeding a baby. It is not known whether ubiquinone will be harmful to a nursing infant. Do not give any herbal/health supplement to a child without a doctor's advice.

How should I take QuinZyme (ubiquinone)?


Ubiquinone has not been evaluated by the FDA for safety, effectiveness, or purity. All potential risks and/or advantages of this product may not be known. Additionally, there are no regulated manufacturing standards in place for these compounds. Some marketed herbal supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.


If you choose to take ubiquinone, use it exactly as directed on the label, or as prescribed by your doctor, pharmacist, or other health care provider.


Take the ubiquinone capsule or tablet with a full glass of water.

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


To take disintegrating tablet, use dry hands to remove the tablet from the package, and place it in your mouth. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.


Do not take more of this product than is recommended. Too much medicine could be dangerous.

Store ubiquinone at room temperature, away from light, heat, and moisture. Keep the medicine bottle closed when not in use.


What happens if I miss a dose?


Skip the missed dose if it is almost time for your next scheduled dose. Do not use 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 QuinZyme (ubiquinone)?


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


QuinZyme (ubiquinone) 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.

Less serious side effects are more likely to occur, and you may have none at all.


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 QuinZyme (ubiquinone)?


The following drugs can interact with ubiquinone. Tell your doctor if you are using any of these:



  • a beta blocker blood pressure medication such as atenolol (Tenormin), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;




  • a blood thinner such as warfarin (Coumadin);




  • doxorubicin (Adriamycin); or




  • diabetes medication.



This list is not complete and other drugs may interact with ubiquinone. 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 QuinZyme resources


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


  • Ubiquinone Natural MedFacts for Professionals (Wolters Kluwer)

  • Ubiquinone Natural MedFacts for Consumers (Wolters Kluwer)

  • Coenzyme Q10 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Quinzyme MedFacts Consumer Leaflet (Wolters Kluwer)



Compare QuinZyme with other medications


  • Dietary Supplementation


Where can I get more information?


  • Consult with a licensed healthcare professional before using any herbal/health supplement. Whether you are treated by a medical doctor or a practitioner trained in the use of natural medicines/supplements, make sure all your healthcare providers know about all of your medical conditions and treatments.

See also: QuinZyme side effects (in more detail)


Friday, October 14, 2016

Qutenza



capsaicin

Dosage Form: patch
FULL PRESCRIBING INFORMATION

Indications and Usage for Qutenza


Qutenza is indicated for the management of neuropathic pain associated with postherpetic neuralgia.



Qutenza Dosage and Administration



Special Precautions


  • Only physicians or health care professionals under the close supervision of a physician are to administer Qutenza.

  • Use only nitrile gloves when handling Qutenza, and when cleaning capsaicin residue from the skin. Do not use latex gloves as they do not provide adequate protection.

  • Immediately after use, dispose of used and unused patches, Cleansing Gel and other treatment materials in accordance with the local biomedical waste procedures.

  • Use Qutenza only on dry, intact (unbroken) skin.

  • Apply the Qutenza patch within 2 hours of opening the pouch.


Dosing


The recommended dose of Qutenza is a single, 60-minute application of up to four patches.


Treatment with Qutenza may be repeated every three months or as warranted by the return of pain (not more frequently than every three months).



Instructions for Use



Prepare


Put on nitrile gloves. Inspect the pouch. Do not use if the pouch has been torn or damaged.



Identify


The treatment area (painful area including areas of hypersensitivity and allodynia) must be identified by a physician and marked on the skin.



If necessary, clip hair (do not shave) in and around the identified treatment area to promote patch adherence.


Qutenza can be cut to match the size and the shape of the treatment area.


Gently wash the treatment area with mild soap and water and dry thoroughly.



Anesthetize


Pre-treat with a topical anesthetic to reduce discomfort associated with the application of Qutenza.


Apply topical anesthetic to the entire treatment area and surrounding 1 to 2 cm, and keep the local anesthetic in place until the skin is anesthetized prior to the application of Qutenza patch.



Remove the topical anesthetic with a dry wipe. Gently wash the treatment area with mild soap and water and dry thoroughly.



Apply


Tear open the pouch along the three dashed lines, remove the Qutenza patch.


Inspect the Qutenza patch and identify the outer surface backing layer with the printing on one side and the capsaicin-containing adhesive on the other side. The adhesive side of the patch is covered by a clear, unprinted, diagonally-cut release liner.


Cut Qutenza before removing the protective release liner.


The diagonal cut in the release liner is to aid in its removal. Peel a small section of the release liner back, and place the adhesive side of the patch on the treatment area.


While you slowly peel back the release liner from under the patch with one hand, use your other hand to smooth the patch down on to the skin.



Once Qutenza is applied, leave in place for 60 minutes.


To ensure Qutenza maintains contact with the treatment area, a dressing, such as rolled gauze, may be used.


Instruct the patient not to touch the patch or treatment area.



Remove


Remove Qutenza patches by gently and slowly rolling them inward.




Cleanse


After removal of Qutenza, generously apply Cleansing Gel to the treatment area and leave on for at least one minute. Remove Cleansing Gel with a dry wipe and gently wash the area with mild soap and water and dry thoroughly.



Dispose of all treatment materials as described. [see Dosage and Administration (2.1)]


Inform the patient that the treated area may be sensitive for a few days to heat (e.g., hot showers/baths, direct sunlight, vigorous exercise).



Dosage Forms and Strengths


Qutenza patch contains 8% capsaicin (640 mcg/cm2). Each patch contains a total of 179 mg of capsaicin.



Contraindications


None.



Warnings and Precautions



Eye and Mucous Membrane Exposure


Do not apply Qutenza to the face or scalp to avoid risk of exposure to the eyes or mucous membranes.



Aerosolization of Capsaicin


Aerosolization of capsaicin can occur upon rapid removal of Qutenza patches. Therefore, remove Qutenza patches gently and slowly by rolling the adhesive side inward [see Dosage and Administration (2.3)].


If irritation of eyes or airways occurs, remove the affected individual from the vicinity of Qutenza. Flush eyes and mucous membranes with cool water.


Inhalation of airborne capsaicin can result in coughing or sneezing. Provide supportive medical care if shortness of breath develops.



Unintended Skin Exposure


If skin not intended to be treated comes in contact with Qutenza, apply Cleansing Gel for one minute and wipe off with dry gauze. After the Cleansing Gel has been wiped off, wash the area with soap and water.



Application Associated Pain


Even following use of a local anesthetic prior to administration of Qutenza, patients may experience substantial procedural pain. Prepare to treat acute pain during and following the application procedure with local cooling (such as an ice pack) and/or appropriate analgesic medication, such as opioids. Opioids may affect the ability to perform potentially hazardous activities such as driving or operating machinery.



Increase in Blood Pressure


In clinical trials, increases in blood pressure occurred during or shortly after exposure to Qutenza. The changes averaged less than 10 mm Hg, although some patients had greater increases and these changes lasted for approximately two hours after patch removal. Increases in blood pressure were unrelated to the pretreatment blood pressure but were related to treatment-related increases in pain. Monitor blood pressure periodically during the treatment and provide adequate support for treatment related pain.


Patients with unstable or poorly controlled hypertension, a recent history of cardiovascular or cerebrovascular events may be at an increased risk of adverse cardiovascular effects. Consider these factors prior to initiating Qutenza treatment.



Adverse Reactions


The following serious adverse reactions are discussed elsewhere in the labeling:


Application-Associated Pain [see Warnings and Precautions (5.4)]


Increase in Blood Pressure [see Warnings and Precautions (5.5)]



Clinical Trials Experience


Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in clinical practice.


Across all controlled and uncontrolled trials, more than 1,600 patients have received Qutenza. A total of 394 patients received more than one treatment application and 274 patients were followed for 48 weeks or longer.


In controlled clinical studies, 98% of patients completed ≥ 90% of the intended patch application duration. Among patients treated with Qutenza, 1% discontinued prematurely due to an adverse event.



Controlled Clinical Studies



Common Adverse Reactions


Adverse reactions occurring in ≥ 5% of patients in the Qutenza group and at an incidence greater than in the control group were application site erythema, application site pain, application site pruritus and application site papules.


Table 1 summarizes all adverse reactions, regardless of causality, occurring in ≥ 1% of patients with postherpetic neuralgia in the Qutenza group for which the incidence was greater than in the control group. The majority of application site reactions were transient and self-limited. Transient increases in pain were commonly observed on the day of treatment in patients treated with Qutenza. Pain increases occurring during patch application usually began to resolve after patch removal. On average, pain scores returned to baseline by the end of the treatment day and then remained at or below baseline levels. A majority of Qutenza-treated patients in clinical studies had adverse reactions with a maximum intensity of "mild" or "moderate".































































TABLE 1: Treatment-emergent adverse reaction incidence (%) in controlled trials in Postherpetic Neuralgia (Events in ≥ 1% of Qutenza-treated patients and at least 1% greater in the Qutenza group than in the Control group)
Body System

Preferred Term
Qutenza

60 minutes

(N = 622)

%
Control

60 minutes

(N = 495)

%
General Disorders and Administration Site Conditions
Application Site Erythema6354
Application Site Pain4221
Application Site Pruritus64
Application Site Papules63
Application Site Edema41
Application Site Swelling21
Application Site Dryness21
Infections and Infestations
Nasopharyngitis42
Bronchitis21
Sinusitis31
Gastrointestinal Disorders
Nausea52
Vomiting31
Skin and Subcutaneous Tissue Disorder
Pruritus2< 1
Vascular Disorders
Hypertension21

Other Adverse Reactions Observed During the Clinical Studies of Qutenza


General Disorders and Administration Site Conditions: Application site urticaria, Application site paresthesia, Application site dermatitis, Application site hyperesthesia, Application site excoriation, Application site warmth, Application site anesthesia, Application site bruising, Application site inflammation, Application site exfoliation, Peripheral edema


Nervous System Disorders: Headache, Burning sensation, Peripheral sensory neuropathy, Dizziness, Dysgeusia, Hyperesthesia, Hypoesthesia


Respiratory, Thoracic and Mediastinal Disorders: Cough, Throat irritation


Skin and Subcutaneous Tissue Disorders: Abnormal skin odor



Drug Interactions


No clinical drug interaction studies have been performed.


Data from in vitro cytochrome P450 inhibition and induction studies show that capsaicin does not inhibit or induce liver cytochrome P450 enzymes at concentrations which far exceed those measured in blood samples. Therefore, interactions with systemic medicinal products are unlikely.



USE IN SPECIFIC POPULATIONS



Pregnancy



Teratogenic effects: Pregnancy Category B


There are no adequate and well-controlled studies evaluating Qutenza in pregnant women.


There was no evidence of fetal teratogenicity in embryofetal developmental toxicological studies conducted in pregnant rats and rabbits in which Qutenza patches (rats) or liquid (rabbits) were applied once daily for a 3 hour duration during the period of fetal organogenesis up to doses corresponding to an 11-fold (rat, 32 mg capsaicin patch/day) and 37-fold (rabbit, 260 mg capsaicin/day) margin over the maximum recommended human dose [MRHD] based on a Cmax exposure comparison.


In a peri- and post-natal reproduction toxicology study, pregnant female rats were treated with Qutenza patches at doses up to 32 mg capsaicin patch/rat/day applied once daily for a 3 hours duration during gestation and lactation (from gestation day 7 through day 28 postpartum). Analyses of milk samples on day 14 of the lactation period demonstrated measurable levels of capsaicin in the dam's milk at all dose levels. There were no effects on survival, growth, learning and memory tests (passive avoidance and water maze), sexual maturation, mating, pregnancy, and fetal development in the offspring of mothers treated with capsaicin up to 32 mg capsaicin patch/rat/day (corresponding to an 11-fold margin over the MRHD based on Cmax exposure).



Labor and Delivery


The effects of Qutenza on labor and delivery are unknown.



Nursing Mothers


There are no adequate and well-controlled studies in nursing women. Studies in rat have demonstrated capsaicin is excreted into breast milk of this species. It is unknown whether capsaicin is excreted in human breast milk. Because Qutenza is administered as a single 60-minute application and capsaicin is rapidly cleared from the bloodstream [see Clinical Pharmacology (12.3)], mothers can reduce infant exposure by not breast-feeding after treatment on the day of treatment.



Pediatric Use


The safety and effectiveness of Qutenza in patients younger than 18 years of age have not been studied.



Geriatric Use


In controlled clinical studies of Qutenza in neuropathic pain associated with postherpetic neuralgia, 75% of patients were 65 years and older and 43% of patients were 75 years and older.


Safety and effectiveness were similar in geriatric patients and younger patients. No dose adjustments are required in geriatric patients.



Overdosage


There is no clinical experience with Qutenza overdose in humans.


There is no specific antidote for overdose with capsaicin. In case of suspected overdose, remove patches gently, apply Cleansing Gel for one minute, wipe off with dry gauze and gently wash the area with soap and water. Use supportive measures and treat symptoms as clinically warranted.



Qutenza Description


Qutenza (capsaicin) 8% patch contains capsaicin in a localized dermal delivery system. The capsaicin in Qutenza is a synthetic equivalent of the naturally occurring compound found in chili peppers. Capsaicin is soluble in alcohol, acetone, and ethyl acetate and very slightly soluble in water.


Qutenza is a single-use patch stored in a foil pouch. Each Qutenza patch is 14 cm x 20 cm (280 cm2) and consists of a polyester backing film coated with a drug-containing silicone adhesive mixture, and covered with a removable polyester release liner.


The backing film is imprinted with "capsaicin 8%". Each Qutenza patch contains a total of 179 mg of capsaicin (8% in adhesive, 80 mg per gram of adhesive) or 640 micrograms (mcg) of capsaicin per square cm of patch.


The empirical formula is C18H27NO3, with a molecular weight of 305.42. The chemical compound capsaicin [(E)-8-methyl-N-vanillyl-6-nonenamide] is an activating ligand for transient receptor potential vanilloid 1 receptor (TRPV1) and it has the following structure:



FIGURE 1:

Structural Formula of Capsaicin

The patch contains the following inactive ingredients: diethylene glycol monoethyl ether, dimethicone, ethyl cellulose, polyester film, silicone adhesive and white ink.


Qutenza is supplied with a Cleansing Gel which is used to remove residual capsaicin from the skin after treatment. Cleansing Gel consists of the following ingredients: butylated hydroxyanisole, carbomer copolymer, edetate disodium, polyethylene glycol, purified water, and sodium hydroxide.



Qutenza - Clinical Pharmacology



Mechanism of Action


Capsaicin is an agonist for the transient receptor potential vanilloid 1 receptor (TRPV1), which is an ion channel-receptor complex expressed on nociceptive nerve fibers in the skin. Topical administration of capsaicin causes an initial enhanced stimulation of the TRPV1-expressing cutaneous nociceptors that may be associated with painful sensations. This is followed by pain relief thought to be mediated by a reduction in TRPV1-expressing nociceptive nerve endings [see Clinical Pharmacology (12.2)]. Over the course of several months, there may be a gradual re-emergence of painful neuropathy thought to be due to TRPV1 nerve fiber reinnervation of the treated area.



Pharmacodynamics


Two studies evaluated the pharmacodynamic effects of Qutenza on sensory function and epidermal nerve fiber (ENF) density in healthy volunteers. Consistent with the known pharmacodynamic effects of capsaicin on TRPV1-expressing nociceptive nerve endings, reduced ENF density and minor changes in cutaneous nociceptive function (heat detection and sharp sensation) were noted one week after exposure to Qutenza. ENF density reduction and sensory changes were fully reversible.



Pharmacokinetics


Pharmacokinetic data in humans showed transient, low (< 5 ng/mL) systemic exposure to capsaicin in about one third of PHN patients following 60-minute applications of Qutenza. The highest plasma concentration of capsaicin detected was 4.6 ng/mL and occurred immediately after Qutenza removal. Most quantifiable levels were observed at the time of Qutenza removal and were below the limit of quantitation 3 to 6 hours after Qutenza removal. No detectable levels of metabolites were observed in any subject.



Nonclinical Toxicology



Carcinogenesis, Mutagenesis, Impairment of Fertility



Carcinogenesis


Adequate carcinogenicity studies have not been conducted with Qutenza or capsaicin.



Mutagenesis


Capsaicin was not mutagenic in the Ames, mouse micronucleus and chromosomal aberration in human peripheral blood lymphocytes assays. As with other catechol-containing compounds (e.g., dopamine), capsaicin showed a weak mutagenic response in the mouse lymphoma assay.



Impairment of Fertility


A fertility and reproductive toxicology study was conducted in rats with exposure to Qutenza patches daily for 3 hours/day beginning 28 days before cohabitation, through cohabitation and continuing through the day before sacrifice (approximately 49 days of treatment). The results revealed a statistically significant reduction in the number and percent of motile sperm. Sperm motility obtained from the vas deferens was reduced in all capsaicin treatment groups (16, 24 and 32 mg capsaicin patch/rat/day). Though a "no effect" level was not determined, dose levels used in the study correspond to a 13- to 28-fold exposure margin over the mean Cmax associated with the maximal human recommended dose. Sperm counts were reduced in the vas deferens or cauda epididymis in the 24 and 32 mg capsaicin patch/rat/day dose groups (79 and 69%, respectively) compared to the placebo patch treated control group; however, these reductions did not adversely affect fertility. As this animal model has a large excess of sperm generating capacity relative to the threshold necessary for fertilization, the lack of an effect on fertility in this species is of unknown significance for human risk assessment.



Clinical Studies



Postherpetic Neuralgia


The efficacy of Qutenza, was established in two 12-week, double-blind, randomized, dose-controlled, multicenter studies. These studies enrolled patients with postherpetic neuralgia (PHN) persisting for at least 6 months following healing of herpes zoster rash and a baseline score of 3-9 on an 11-point Numerical Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (worst possible pain). Qutenza and a control patch were each applied as a single 60-minute application. The control used in these studies looked similar to Qutenza but contained a low concentration of the active ingredient, capsaicin (3.2 mcg/cm2, 0.04% w/w) to retain blinding regarding the known application site reactions of capsaicin (such as burning and erythema). The baseline mean pain scores across the 2 studies was approximately 6.0. Patients who entered the study on stable doses of pain-control medications were required to keep dosing stable throughout the duration of the study. Approximately half of the patients were taking concomitant medications including anticonvulsants, non-SSRI antidepressants, or opioids for their PHN at study entry. Prior to study patch application a topical anesthetic was applied to the treatment area for 60 minutes. Patients were permitted to use local cooling and additional analgesic medications for treatment-related discomfort as needed through Day 5. Patients recorded their pain daily in a diary.


PHN Study 1: In this 12-week study, the Qutenza group demonstrated a greater reduction in pain compared to the Control group during the primary assessment at Week 8. The percent change in average pain from baseline to Week 8 was -18% (±2%) for the low-dose control and -29% (±2%) for Qutenza.


For various degrees of improvement in pain from baseline to study endpoint, Figure 2 shows the fraction of patients achieving that degree of improvement. The figure is cumulative, so that patients whose change from baseline is, for example, 50%, are also included at every level of improvement below 50%. Patients who did not complete the study through Week 12 or who showed no improvement at Week 12 were assigned 0% improvement. Some patients experienced a decrease in pain as early as Week 1, which persisted throughout the study. The proportion of patients experiencing ≥ 30% reduction in pain intensity from baseline for each week through Week 12 is shown in Figure 3.



FIGURE 2:

Patients Achieving Various Percentages of Reduction in Pain Intensity at

Week 12 – Study 1



FIGURE 3:

Weekly Proportion of Patients Achieving ≥ 30% Pain

Intensity Reduction – Study 1*

*The same patients may not have responded at each timepoint.


PHN Study 2: In this 12-week study the Qutenza group demonstrated a greater reduction in pain compared to the Control group during the primary assessment at Week 8. The percent change in average pain from baseline to Week 8 was -26% (±2%) for the low-dose control and -33% (±2%) for Qutenza.


For various degrees of improvement in pain from baseline to study endpoint, Figure 4 shows the fraction of patients achieving that degree of improvement. The figure is cumulative, so that patients whose change from baseline is, for example, 50%, are also included at every level of improvement below 50%. Patients who did not complete the study through Week 12 or who showed no improvement at Week 12 were assigned 0% improvement. Some patients experienced a decrease in pain as early as Week 1, which persisted throughout the study. The proportion of patients achieving ≥ 30% reduction in pain intensity from baseline for each week through Week 12 is shown in Figure 5.



FIGURE 4:

Patients Achieving Various Percentages of Reduction in Pain Intensity at

Week 12 – Study 2



FIGURE 5:

Weekly Proportion of Patients Achieving ≥ 30% Pain

Intensity Reduction – Study 2*

*The same patients may not have responded at each timepoint.



How Supplied/Storage and Handling



How Supplied


Qutenza (capsaicin) 8% patch is a single-use patch stored in a sealed pouch (NDC 49685-920-00).


Each individual patch is printed with "capsaicin 8%".


Cleansing Gel is provided in a 50 g tube.


Qutenza is available in the following presentations:


Carton of 1 patch and 50 g tube of Cleansing Gel


(NDC 49685-928-01).


Carton of 2 patches and 50 g tube of Cleansing Gel


(NDC 49685-928-02).



Storage


Store carton between 20° to 25°C (68° to 77°F). Excursions between 15°C and 30°C (59°F and 86°F) are allowed.


Keep the patch in the sealed pouch until immediately before use.



Handling and Disposal


Qutenza contains capsaicin capable of producing severe irritation of eyes, skin, respiratory tract and mucous membranes. Do not dispense Qutenza to patients for self-administration. It is critical that health care professionals who administer Qutenza have completely familiarized themselves with proper dosing, handling, and disposal procedures before handling Qutenza to avoid accidental or inadvertent capsaicin exposure to themselves or others [see Dosage and Administration (2)].


  • Do not touch Qutenza, treatment areas, and all used supplies or other materials placed in contact with the treatment area without wearing nitrile gloves.

  • Wear nitrile gloves at all times while handling Qutenza and cleaning treatment areas. Do NOT use latex gloves.

  • Do not hold Qutenza near eyes or mucous membranes.

  • Immediately after use, dispose of used and unused patches, patch clippings, unused Cleansing Gel and associated treatment supplies in accordance with local biomedical waste procedures.


Patient Counseling Information


  • Inform patients that exposure of the skin to Qutenza may result in transient erythema and burning sensation. Instruct patients not to touch the patch and that if they accidentally touch the Qutenza patch it may burn and/or sting.

  • Instruct patients that if irritation of eyes or airways occurs, or if any of the side effects become severe, to notify their doctor immediately.

  • Inform patients that the treated area may be sensitive to heat (e.g., hot showers/bath, direct sunlight, vigorous exercise) for a few days following treatment.

  • Inform patients that they may be given medication to treat acute pain during and after the Qutenza application procedure. Some of these medications, such as opioids, may affect the ability to perform potentially hazardous activities such as driving or operating machinery.

  • Inform patients that as a result of treatment-related increases in pain, small transient increases in blood pressure may occur during and shortly after Qutenza treatment and that blood pressure will be monitored during the treatment procedure. Instruct patients to inform the physician if they have experienced any recent cardiovascular event

  • Instruct patients to notify their physician if they are pregnant or breast feeding.


Manufactured for NeurogesX, Inc., San Mateo, CA 94404, USA


     by Lohmann Therapie-Systeme AG (LTS), Andernach, Germany


Qutenza® is a registered trademark of NeurogesX, Inc.



PRINCIPAL DISPLAY PANEL - Pouch Label


NDC 49685-920-00


              Qutenza™

              (capsaicin) 8% patch


Rx only. For topical use only.

One single-use patch (179 mg capsaicin)


Inactive Ingredients: Diethylene glycol monoethyl ether, dimethicone, ethyl cellulose, polyester film, silicone adhesive, and white ink


Dosage/Instructions for Use: See Full Prescribing Information.


Qutenza™ contains capsaicin and may cause irritation.


Store between 20° to 25°C (68° to 77°F). Excursions between 15°C and 30°C (59°F and 86°F) are allowed. Keep Qutenza™ in the sealed pouch until immediately before use.


(NDC Barcode)


Manufactured for NeurogesX, Inc. San Mateo, CA 94404, USA

by Lohmann Therapie-Systeme AG (LTS) Andernach, Germany

©NeurogesX, Inc. 2009 Rev. November 2009


N E U R O G E S X          MADE IN GERMANY




PRINCIPAL DISPLAY PANEL - Cleansing Gel Label


Cleansing Gel for Qutenza™

50g          (capsaicin) 8% patch


For topical use only.


Instructions for Use:

See Full Prescribing Information for Qutenza™.


Store between 20° to 25°C (68° to 77°F). Excursions between 15°C and 30°C (59°F and 86°F) are allowed.


Ingredients:

Butylated hydroxyanisole, carbomer copolymer, edetate disodium, polyethylene glycol, purified water, and sodium hydroxide.


Rev. November 2009


Manufactured for NeurogesX, Inc. San Mateo, CA 94404, USA

by Contract Pharmaceuticals Limited Canada (CPL)

Mississauga, ON L5N 6L6, Canada


©NeurogesX, Inc. 2009

MADE IN CANADA

(Barcode-FPO)


N E U R O G E S X

0920-99

109268

Patent Pending




PRINCIPAL DISPLAY PANEL - Carton 1


NDC 49685-928-01

1 Patch

One single-use patch (179 mg capsaicin)

One-single-use 50 g tube of Cleansing Gel


              Qutenza™

              (capsaicin) 8% patch


Rx only. For topical use only.


Dosage/Instructions for Use:

See Full Prescribing Information.


Qutenza™ contains capsaicin and may cause irritation. Qutenza™ should be administered by a physician or healthcare professional under the close supervision of a physician.


Manufactured for NeurogesX, Inc. San Mateo, CA 94404, USA

by Lohmann Therapie-Systeme AG (LTS) Andernach, Germany

©NeurogesX, Inc. 2009

For questions about Qutenza™ call NeurogesX Medical Affairs

1-877-900-NGSX (6479) Rev. November 2009


N E U R O G E S X




PRINCIPAL DISPLAY PANEL - Carton 2


NDC 49685-928-02

2 Patches

Two single-use patches (179 mg capsaicin)

One-single-use 50 g tube of Cleansing Gel


              Qutenza™

              (capsaicin) 8% patch


Rx only. For topical use only.


Dosage/Instructions for Use:

See Full Prescribing Information.


Qutenza™ contains capsaicin and may cause irritation. Qutenza™ should be administered by a physician or healthcare professional under the close supervision of a physician.


Manufactured for NeurogesX, Inc. San Mateo, CA 94404, USA

by Lohmann Therapie-Systeme AG (LTS) Andernach, Germany

©NeurogesX, Inc. 2009

For questions about Qutenza™ call NeurogesX Medical Affairs

1-877-900-NGSX (6479) Rev. November 2009


N E U R O G E S X
























Qutenza 
capsaicin  kit






Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)49685-928






















Packaging
#NDCPackage DescriptionMultilevel Packaging
149685-928-011 POUCH In 1 CARTONcontains a POUCH
11 KIT In 1 POUCHThis package is contained within the CARTON (49685-928-01)
249685-928-022 POUCH In 1 CARTONcontains a POUCH
21 KIT In 1 POUCHThis package is contained within the CARTON (49685-928-02)











QUANTITY OF PARTS
Part #Package QuantityTotal Product Quantity
Part 11 PATCH  280 cm2
Part 21 TUBE  50 g



Part 1 of 2
Qutenza 
capsaicin  patch










Product Information
NDC Product Code (Source)49685-920  
Route of AdministrationCUTANEOUSDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
capsaicin (capsaicin)capsaicin640 ug  in 1 cm2





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
149685-920-001 PATCH In 1 POUCHcontains a PATCH
1280 cm2 In 1 PATCHThis package is contained within the POUCH (49685-920-00)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02239503/01/2010




Part 2 of 2
CLEANSING GEL FOR Qutenza 
cleansing  gel










Product Information
   
Route of AdministrationTOPICALDEA Schedule    






Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
No Active Ingredients Found














Inactive Ingredients
Ingredient NameStrength
butylated hydroxyanisole 
edetate disodium 
polyethylene glycol 300 
water 
sodium hydroxide 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
150 g In 1 TUBENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02239503/01/2010











Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02239503/01/2010


Labeler - NeurogesX, Inc. (004475971)









Establishment
NameAddressID/FEIOperations
Lohmann Therapie-Systeme AG (LTS) (Germany)342693590MANUFACTURE









Establishment
NameAddressID/FEIOperations
SGS INSTITUT FRESENIAS GmBH (Germany)317219699ANALYSIS









Establishment
NameAddressID/FEIOperations
SGS US Testing Co Inc. (New Jersey)093840643ANALYSIS









Establishment
NameAddressID/FEIOperations
Sharp Corporation (Allentown, PA)143696495RELABEL, REPACK









Establishment
NameAddressID/FEIOperations
Sharp Corporation (Conshocken, PA)002346625RELABEL, REPACK









Establishment
NameAddressID/FEIOperations
Contract Pharmaceuticals Limited Canada (CPL)248761249MANUFACTURE









Establishment
NameAddressID/FEIOperations
Innopharm, a Division of CPL (Canada)201939910ANALYSIS









Establishment
NameAddressID/FEIOperations
Bodycote Materials Testing Canada, Inc. (Canada)255439424ANALYSIS
Establis