Thursday, 30 August 2012

Sinus Node Dysfunction Medications


There are currently no drugs listed for "Sinus Node Dysfunction".

Definition of Sinus Node Dysfunction: Sick sinus syndrome (otherwise known as Sinus Node Dysfunction) is the name given to a group of arrhythmias that occur because the normal pacemaker of the heart (the sinus node) fails to work normally.

Learn more about Sinus Node Dysfunction





Drug List:

Wednesday, 29 August 2012

Achromycin



Generic Name: tetracycline topical (te tra SYE kleen)

Brand Names: Achromycin, Topicycline


What is Achromycin (tetracycline topical)?

Tetracycline is used topically to treat bacterial infections such as acne.


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


What is the most important information I should know about Achromycin (tetracycline topical)?


It may take 3 weeks or more to see the effects of this medication. Do not stop using tetracycline topical if you do not see results immediately. Avoid the eyes, nose, mouth, and lips when applying tetracycline topical. If medication gets in any of these areas, rinse with water.

Tetracycline topical may cause yellowing of the skin. This staining can be removed by washing with mild soap and water.


What should I discuss with my healthcare provider before using Achromycin (tetracycline topical)?


Do not use tetracycline topical without first talking to your doctor if you have ever had an allergic reaction to it. Tetracycline topical is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not use tetracycline topical without first talking to your doctor if you are pregnant. It is not known whether tetracycline topical passes into breast milk. Do not use tetracycline without first talking to your doctor if you are breast-feeding a baby.

How should I use Achromycin (tetracycline topical)?


Use tetracycline topical exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.


Wash your hands before and after using this medication.


Clean and dry the area to which you will apply tetracycline topical. Apply the solution generously until the skin is thoroughly wet. Tetracycline is usually applied twice daily in the morning and evening. Follow your doctor's directions.

To prevent excessive irritation, avoid getting the medication in the eyes, inside of the nose or mouth, on the lips, and in areas where the skin is broken.


It may take 3 weeks or more to see the effects of this medication. Do not stop using tetracycline topical if you do not see results immediately. Store tetracycline at room temperature away from moisture and heat.

What happens if I miss a dose?


Apply the missed dose as soon as you remember.


What happens if I overdose?


An overdose of this medication is unlikely to occur. Seek emergency medical attention if tetracycline topical is ingested or a very large amount is used.

What should I avoid while taking Achromycin (tetracycline topical)?


Avoid applying the medication to broken or irritated skin.


Avoid using other topical products on the same area at the same time unless directed to do so by your doctor.


Avoid using harsh, abrasive, or irritating cleansers, perfumes, or cosmetics during treatment with tetracycline topical.


Achromycin (tetracycline topical) side effects


Serious side effects are not expected to occur from treatment with tetracycline topical.


Other, less serious side effects may be more likely to occur such as burning, stinging, or irritation of the skin. Continue to use tetracycline topical and talk to your doctor if these side effects persist or are excessive.


Tetracycline topical may cause yellowing of the skin. This staining can be removed by washing with mild soap and water.


Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.


What other drugs will affect Achromycin (tetracycline topical)?


Do not use other topical prescription or over-the-counter products on the same area at the same time unless directed to do so by your doctor.


Drugs other than those listed here may also interact with tetracycline topical. Talk to your doctor or pharmacist before using other prescription or over-the-counter medications, including herbal products.



More Achromycin resources


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


Compare Achromycin with other medications


  • Acne
  • Bacterial Skin Infection


Where can I get more information?


  • Your pharmacist has additional information about tetracycline topical written for health professionals that you may read.

What does my medication look like?


Tetracycline topical is available with a prescription under the brand name Topicycline in a solution with a strength of 2.2 mg per mL. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.



Monday, 27 August 2012

Glycopyrrolate


Pronunciation: GLYE-koe-PIR-oh-late
Generic Name: Glycopyrrolate
Brand Name: Robinul


Glycopyrrolate is used for:

Reducing secretions in the mouth, throat, airway, and stomach before surgery. It is used before and during surgery to block certain reflexes and to protect against certain side effects of some medicines. It is also used along with other medicines to treat peptic ulcers. It may also be used for other conditions as determined by your doctor.


Glycopyrrolate is an anticholinergic. It works by blocking the activity of a certain substance (acetylcholine) in the body, which decreases secretions and decreases side effects caused by medicines that may increase the action of acetylcholine in the body.


Do NOT use Glycopyrrolate if:


  • you are allergic to any ingredient in Glycopyrrolate

  • you are being treated for a peptic ulcer and you also have glaucoma, urinary blockage (eg, inability to urinate), certain stomach or bowel problems (eg, stomach or bowel blockage, bowel paralysis, severe ulcerative colitis, toxic megacolon), myasthenia gravis, or heart problems caused by bleeding

  • you are taking a solid oral doseform of potassium (eg, a tablet)

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



Before using Glycopyrrolate:


Some medical conditions may interact with Glycopyrrolate. 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 nerve problems (eg, autonomic neuropathy), Down syndrome, prostate problems, trouble urinating, liver problems, kidney problems, or increased pressure in the eyes

  • if you have heart problems (eg, coronary heart disease, heart failure), a fast or irregular heartbeat, high blood pressure, or an overactive thyroid

  • if you have stomach or bowel problems (eg, ulcerative colitis), constipation or diarrhea, hiatal hernia along with reflux disease, or if you have an ileostomy or colostomy

  • if you have a personal or family history of glaucoma

  • if the patient is a child with spastic paralysis or brain damage

  • if you are in poor health

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


  • Solid oral potassium products (eg, tablets) because the risk of stomach or bowel irritation may be increased by Glycopyrrolate

  • Anticholinergics (eg, benztropine), phenothiazines (eg, chlorpromazine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Glycopyrrolate's side effects

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


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


  • Glycopyrrolate is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Glycopyrrolate at home, a health care provider will teach you how to use it. Be sure you understand how to use Glycopyrrolate. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

  • Do not use Glycopyrrolate if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

  • If you miss a dose of Glycopyrrolate, use 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 use 2 doses at once.

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



Important safety information:


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

  • Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Glycopyrrolate; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Drinking fluids, maintaining good oral hygiene, and sucking on hard sugarless candy can help relieve dry mouth.

  • Do not become overheated in hot weather or while being active; heatstroke may occur.

  • Use Glycopyrrolate with extreme caution if you have a fever because heatstroke caused by decreased sweating may occur.

  • Glycopyrrolate may make your eyes more sensitive to sunlight. It may help to wear sunglasses.

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

  • Glycopyrrolate has benzyl alcohol in it. Do not use it in NEWBORNS or INFANTS. It may cause serious and sometimes fatal nervous system problems and other side effects.

  • Glycopyrrolate should not be used in CHILDREN to treat peptic ulcer; safety and effectiveness in children have not been confirmed.

  • Caution is advised when using Glycopyrrolate in CHILDREN; they may be more sensitive to its effects.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Glycopyrrolate while you are pregnant. It is not known if Glycopyrrolate is found in breast milk. Glycopyrrolate may decrease milk production. If you are or will be breast-feeding while you use Glycopyrrolate, check with your doctor. Discuss any possible risks to your baby, as well as any questions or concerns about this information.


Possible side effects of Glycopyrrolate:


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:



Bloated feeling; blurred vision; constipation; decreased sweating; dizziness; drowsiness; dry mouth; dry skin; enlarged pupils; headache; loss of taste; nausea; nervousness; pain, swelling, or redness at the injection site; sleeplessness; weakness.



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); chest pain; confusion; decreased sexual ability; diarrhea; difficulty focusing the eyes; difficulty urinating; excitement; fainting; fast, slow, or irregular heartbeat; fever; seizures; severe or persistent dizziness, light-headedness, or headache; shortness of breath; unusual weakness; 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: Glycopyrrolate side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; convulsions; difficulty breathing; disorientation; dry mouth; enlarged pupils; excessive thirst; flushed, hot, dry skin; muscle weakness; nausea; restlessness; seizures; unusual dizziness or drowsiness; vomiting.


Proper storage of Glycopyrrolate:

Glycopyrrolate is usually handled and stored by a health care provider. If you are using Glycopyrrolate at home, store Glycopyrrolate as directed by your pharmacist or health care provider. Keep Glycopyrrolate out of the reach of children and away from pets.


General information:


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

  • Glycopyrrolate 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 Glycopyrrolate. 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 Glycopyrrolate resources


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


  • Glycopyrrolate Professional Patient Advice (Wolters Kluwer)

  • Glycopyrrolate Monograph (AHFS DI)

  • glycopyrrolate Advanced Consumer (Micromedex) - Includes Dosage Information

  • Cuvposa Consumer Overview

  • Cuvposa Prescribing Information (FDA)

  • Robinul Prescribing Information (FDA)



Compare Glycopyrrolate with other medications


  • Anesthesia
  • Excessive Salivation
  • Peptic Ulcer

Friday, 24 August 2012

Axiron


Generic Name: testosterone topical (tes TOS ter one TOP i kal)

Brand Names: Androderm, AndroGel 2.5 g/packet, AndroGel 5 g/packet, AndroGel Packets, AndroGel Pump 1.25 g/actuation, Axiron, FIRST-Testosterone, FIRST-Testosterone MC, Fortesta, Testim


What is testosterone topical?

Testosterone is a naturally occurring male hormone necessary for many processes in the body.


Testosterone topical (for the skin) is used to treat conditions in men that result from a lack of natural testosterone.


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


What is the most important information I should know about testosterone topical?


This medication should not be used by a woman. Testosterone can cause birth defects in an unborn baby. A pregnant woman should avoid coming into contact with testosterone topical gel, or with a man's skin areas where a testosterone topical patch has been worn or the gel has been applied. If contact does occur, wash with soap and water right away. Topical testosterone is absorbed through the skin and can cause side effects or symptoms of male features in a child or woman who comes into contact with the medication. Call your doctor if a person who has close contact with you develops enlarged genitals, premature pubic hair, increased libido, aggressive behavior, male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any signs of male characteristics. The testosterone transdermal patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.

What should I discuss with my healthcare provider before using testosterone topical?


Do not use this medication if you are allergic to testosterone patches or gels, or if you have prostate cancer or male breast cancer.

To make sure you can safely use testosterone topical, tell your doctor if you have any of these other conditions:



  • diabetes;




  • sleep apnea or chronic breathing problems;



  • liver disease or kidney disease; or


  • if you are overweight.




FDA pregnancy category X. This medication should not be used by a woman. Testosterone can cause birth defects in an unborn baby. A pregnant woman should avoid coming into contact with testosterone topical patches or gels, or with a man's skin areas where a patch has been worn or the gel has been applied. If contact does occur, wash with soap and water right away. Older men who use testosterone topical may have an increased risk of prostate enlargement or cancer. If you are over 65, talk with your doctor about your specific risk. Do not use Androderm on a boy younger than 15 years old. Do not use AndroGel on a boy younger than 18 years old. Testim should not be used on anyone younger than 18 years old. The testosterone transdermal patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.

How should I use testosterone topical?


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


This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.


Apply the testosterone topical (transdermal) patch to a flat, clean, dry, and undamaged area of skin on your back, stomach, upper arm, or thigh. Wear the patch for 24 hours and then replace it with a new patch. Apply your patch at the same time each evening.


Choose a different skin area to wear each new patch you put on. You should not use the same skin area twice in a 7-day period.


After removing a patch, fold it closed with the sticky side in, and throw it away in a place where pets and children cannot reach it.


Apply the testosterone gel at the same time each day (preferably in the morning) to clean, dry, unbroken skin on the shoulders or upper arms. Open the gel pouch, and squeeze the entire contents onto the palm of your hand. Apply the gel right away and allow it to dry for at least 5 minutes before you dress. Wash your hands with soap and water after applying the gel.


Do not apply testosterone gel to your penis or your scrotum. The Testim brand of testosterone gel should also not be applied to your stomach area.

It is best to cover treated skin areas with clothing while using testosterone gel. This will help prevent getting this medicine on other people. If someone else does come into contact with a treated skin area, they must wash the contact area right away with soap and water.


To be sure this medicine is helping your condition, your blood will need to be tested often. Your prostate or liver function may also need to be tested. Visit your doctor regularly.


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


Store at room temperature away from moisture and heat. Keep each skin patch in the foil pouch until you are ready to use it. Do not use a skin patch that has been cut or damaged.

What happens if I miss a dose?


Apply the gel or skin patch as soon as you remember. Skip the missed dose if it is almost time to apply your next dose. Do not use extra patches or gel to make up the missed dose.


If a transdermal patch falls off in the morning, reapply it. If it does not stick well, apply a new patch. If the patch falls off in the afternoon and cannot be reapplied, wait until your regular patch replacement time in the evening before putting on a new patch.


What happens if I overdose?


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

What should I avoid while using testosterone topical?


Do not apply AndroGel or Testim testosterone gel to your penis or your scrotum. Testim gel should also not be applied to your stomach area.

Avoid swimming, bathing, or showering for at least 5 hours after applying AndroGel testosterone gel, or 2 hours after applying Testim testosterone gel.


Avoid using lotions, oils, or other skin products on the area where you will apply the skin patch. The patch may not stick properly to the skin.


If your doctor recommends a topical steroid medicine such as hydrocortisone to treat skin irritation caused by wearing a testosterone skin patch, avoid using an ointment form of the steroid.


Testosterone gel may be flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.

Testosterone topical side effects


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

  • burn-like blistering of the skin where the transdermal patch is worn;




  • skin irritation with patch-wearing that does not get better with time;




  • problems with urination;




  • swelling of your ankles;




  • frequent, prolonged, or bothersome erections; or




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




Topical testosterone is absorbed through the skin and can cause symptoms of male features in a woman or child who comes into contact with the medication. Call your doctor if your female partner has male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any other signs of male characteristics.

Less serious side effects may include:



  • redness, itching, burning, or hardened skin where the skin patch is worn;




  • breast swelling or tenderness;




  • increased acne or hair growth;




  • headache, depressed mood; or




  • changes in your sex drive.



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 testosterone topical?


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



  • insulin;




  • a blood thinner (warfarin, Coumadin, Jantoven); or




  • a steroid such as methylprednisolone (Medrol), prednisone (Sterapred), and others.



This list is not complete and other drugs may interact with testosterone topical. 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 Axiron resources


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


  • Axiron Prescribing Information (FDA)

  • Axiron Solution MedFacts Consumer Leaflet (Wolters Kluwer)

  • Axiron Advanced Consumer (Micromedex) - Includes Dosage Information

  • Axiron Consumer Overview

  • Testosterone Monograph (AHFS DI)

  • Testosterone Professional Patient Advice (Wolters Kluwer)

  • Testosterone Prescribing Information (FDA)

  • AndroGel Gel MedFacts Consumer Leaflet (Wolters Kluwer)

  • AndroGel Prescribing Information (FDA)

  • Androderm Patch MedFacts Consumer Leaflet (Wolters Kluwer)

  • Androderm Prescribing Information (FDA)

  • Androderm Advanced Consumer (Micromedex) - Includes Dosage Information

  • Androgel Consumer Overview

  • Delatestryl MedFacts Consumer Leaflet (Wolters Kluwer)

  • Delatestryl Prescribing Information (FDA)

  • Depo-Testosterone Prescribing Information (FDA)

  • Depo-Testosterone MedFacts Consumer Leaflet (Wolters Kluwer)

  • Fortesta Consumer Overview

  • Fortesta Gel MedFacts Consumer Leaflet (Wolters Kluwer)

  • Striant Prescribing Information (FDA)

  • Striant Advanced Consumer (Micromedex) - Includes Dosage Information

  • Striant MedFacts Consumer Leaflet (Wolters Kluwer)

  • Striant Consumer Overview

  • Testim Prescribing Information (FDA)

  • Testim Gel MedFacts Consumer Leaflet (Wolters Kluwer)

  • Testosterone Cypionate Prescribing Information (FDA)

  • Testosterone Enanthate Prescribing Information (FDA)



Compare Axiron with other medications


  • Hypogonadism, Male


Where can I get more information?


  • Your pharmacist can provide more information about testosterone topical.

See also: Axiron side effects (in more detail)


Sunday, 19 August 2012

Zagam Respipac


Generic Name: sparfloxacin (spar FLOX a sin)

Brand Names: Zagam, Zagam Respipac


What is Zagam Respipac (sparfloxacin)?

Sparfloxacin has been withdrawn from the U.S. market.


Sparfloxacin is an antibiotic in a class of drugs called fluoroquinolones. It fights bacteria in the body.


Sparfloxacin is used to treat various types of bacterial infections.


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


What is the most important information I should know about Zagam Respipac (sparfloxacin)?


Sparfloxacin has been withdrawn from the U.S. market.


Take all of the sparfloxacin that has been prescribed for you even if you begin to feel better. Your symptoms may start to improve before the infection is completely treated. Take sparfloxacin with a full glass of water (8 ounces). Drink several extra glasses of fluid each day to prevent sparfloxacin crystals from forming in the urine. Do not take antacids that contain magnesium or aluminum (e.g., Tums or Rolaids), the ulcer medicine sucralfate (Carafate), or vitamin or mineral supplements that contain iron or zinc for a minimum of 4 hours after a dose of sparfloxacin. Taking antacids, sucralfate, or vitamin or mineral supplements too close to a dose of sparfloxacin can greatly decrease the effects of the antibiotic.

What should I discuss with my healthcare provider before taking Zagam Respipac (sparfloxacin)?


Before taking this medication, tell your doctor if you have


  • kidney disease;


  • any kind of heart disease or heart problem; or




  • seizures or epilepsy.



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


Sparfloxacin is in the FDA pregnancy category C. This means that it is not known whether sparfloxacin will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment. Sparfloxacin passes into breast milk and may harm a nursing infant. It may affect bone development. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. Sparfloxacin is not approved for use by children younger than 12 years of age. Sparfloxacin may interfere with bone development.

How should I take Zagam Respipac (sparfloxacin)?


Take sparfloxacin exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.


Take each dose with a full glass of water (8 ounces). Drink several extra glasses of fluid each day to prevent the formation of sparfloxacin crystals in your urine.

Sparfloxacin may be taken with or without food.


Take sparfloxacin at evenly spaced intervals. Follow your doctor's instructions.


Do not take antacids that contain magnesium or aluminum (e.g., Tums or Rolaids), the ulcer medicine sucralfate (Carafate), or vitamin or mineral supplements that contain iron or zinc for a minimum of 4 hours after a dose of sparfloxacin. Taking antacids, sucralfate, or vitamin or mineral supplements too close to a dose of sparfloxacin can greatly decrease the effects of the antibiotic. Take all of the sparfloxacin that has been prescribed for you even if you begin to feel better. Your symptoms may start to improve before the infection is completely treated. Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?


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


What happens if I overdose?


Seek emergency medical attention.

The most common symptom of a sparfloxacin overdose is irregular or slow heartbeats.


What should I avoid while taking Zagam Respipac (sparfloxacin)?


Avoid prolonged exposure to sunlight. Sparfloxacin increases the sensitivity of the skin to sunlight, and a severe sunburn may result. If sun exposure is unavoidable, wear protective clothing and sunscreen. Call your doctor if you experience severe burning, redness, itching, rash, or swelling after exposure to the sun. Use caution when driving, operating machinery, or performing other hazardous activities. Sparfloxacin may cause dizziness. If you experience dizziness, avoid these activities.

Zagam Respipac (sparfloxacin) side effects


If you experience any of the following serious side effects, stop taking sparfloxacin and seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);




  • irregular heartbeats;




  • chest pain, chest discomfort, shortness of breath, or swelling of your legs or feet;




  • severe dizziness;




  • seizures;




  • confusion or hallucinations;




  • liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, severe fatigue); or




  • muscle or joint pain.



If you experience any of the following less serious side effects, continue taking sparfloxacin and talk to your doctor:



  • nausea, vomiting, diarrhea, or constipation;




  • headache, lightheadedness, or drowsiness;




  • ringing in the ears; or




  • increased sensitivity of the skin to sunlight.



Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.


What other drugs will affect Zagam Respipac (sparfloxacin)?


Do not take antacids that contain magnesium or aluminum (e.g., Tums or Rolaids), the ulcer medicine sucralfate (Carafate), or vitamin or mineral supplements that contain iron or zinc for a minimum of 4 hours after a dose of sparfloxacin. Taking antacids, sucralfate, or vitamin or mineral supplements too close to a dose of sparfloxacin can greatly decrease the effects of the antibiotic. Do not take sparfloxacin without first talking to your doctor if you are taking any of the following drugs:

  • the heart medicines amiodarone (Cordarone), disopyramide (Norpace), quinidine (Cardioquin, Quinidex, Quinaglute, others), procainamide (Procan SR, Pronestyl), sotalol (Betapace), and bepridil (Vascor);




  • terfenadine (Seldane, Seldane-D) or astemizole (Hismanal);




  • a tricyclic antidepressant including amitriptyline (Elavil, Endep), amoxapine (Asendin), imipramine (Tofranil), nortriptyline (Pamelor), doxepin (Sinequan), and others;




  • a phenothiazine including chlorpromazine (Thorazine), fluphenazine (Prolixin), perphenazine (Trilafon), mesoridazine (Serentil), thioridazine (Mellaril), and others;




  • erythromycin (E-Mycin, Ery-Tab, E.E.S., others); or




  • cisapride (Propulsid).



Sparfloxacin and the drugs listed above may affect the rhythm of your heartbeats. You may not be able to take sparfloxacin, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.


Drugs other than those listed here may also interact with sparfloxacin. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.



More Zagam Respipac resources


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


  • Sparfloxacin Professional Patient Advice (Wolters Kluwer)

  • sparfloxacin Advanced Consumer (Micromedex) - Includes Dosage Information



Compare Zagam Respipac with other medications


  • Bronchitis
  • Leprosy, Borderline
  • Leprosy, Lepromatous
  • Pneumonia


Where can I get more information?


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

What does my medication look like?


Sparfloxacin has been withdrawn from the U.S. market.


See also: Zagam Respipac side effects (in more detail)


Saturday, 18 August 2012

AK-Pentolate Ophthalmic


Generic Name: cyclopentolate (Ophthalmic route)

sye-kloe-PEN-toe-late

Commonly used brand name(s)

In the U.S.


  • AK-Pentolate

  • Cyclogyl

  • Cylate

  • Ocu-Pentolate

In Canada


  • Minims Cyclopentolate 0.5%

  • Minims Cyclopentolate 1%

Available Dosage Forms:


  • Solution

Therapeutic Class: Mydriatic-Cycloplegic


Pharmacologic Class: Antimuscarinic


Uses For AK-Pentolate


Cyclopentolate is used to dilate (enlarge) the pupil. It is used before eye examinations (such as cycloplegic refraction or ophthalmoscopy).


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


Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, cyclopentolate is used in certain patients with the following medical conditions:


  • Posterior synechiae

  • Uveitis

Before Using AK-Pentolate


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


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


Pediatric


Infants and young children and children with blond hair or blue eyes may be especially sensitive to the effects of cyclopentolate. This may increase the chance of side effects during treatment.


Geriatric


Elderly people are especially sensitive to the effects of cyclopentolate. This may increase the chance of side effects during treatment.


Pregnancy








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

Breast Feeding


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


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. 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.


Other Medical Problems


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


  • Brain damage (in children) or

  • Down's syndrome (mongolism) (in children and adults) or

  • Glaucoma or

  • Spastic paralysis (in children)—Cyclopentolate may make the condition worse

Proper Use of cyclopentolate

This section provides information on the proper use of a number of products that contain cyclopentolate. It may not be specific to AK-Pentolate. Please read with care.


To use:


  • First, wash your hands. Tilt the head back and with the index finger of one hand, press gently on the skin just beneath the lower eyelid and pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 2 or 3 minutes, to allow the medicine to be absorbed. This is especially important in infants.

  • Immediately after using the eye drops, wash your hands to remove any medicine that may be on them. If you are using the eye drops for an infant or child, be sure to wash the infant's or child's hands also, and do not let any of the medicine get in the infant's or child's mouth.

  • To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects.


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For ophthalmic solution (eye drops) dosage form:
    • For eye examinations:
      • Adults—One drop 40 to 50 minutes before the exam. Dose may be repeated in five to ten minutes.

      • Children—One drop 40 to 50 minutes before the exam. After five to ten minutes, another drop may be used.

      • Babies—One drop of 0.5% solution.



Missed Dose


If you miss a dose of this medicine, apply 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.


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 AK-Pentolate


After you apply this medicine to your eyes:


  • Your pupils will become unusually large and you will have blurring of vision, especially for close objects. Make sure your vision is clear before you drive, use machines, or do anything else that could be dangerous if you are not able to see well.

  • Your eyes will become more sensitive to light than they are normally. When you go out during the daylight hours, even on cloudy days, wear sunglasses that block ultraviolet (UV) light to protect your eyes from sunlight and other bright lights. Ordinary sunglasses may not protect your eyes. If you have any questions about the kind of sunglasses to wear, check with your doctor.

If these side effects continue for longer than 36 hours after you have stopped using this medicine, check with your doctor.


AK-Pentolate 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:


Symptoms of too much medicine being absorbed into the body
  • Clumsiness or unsteadiness

  • confusion

  • constipation, full feeling, passing gas, or stomach cramps or pain

  • fast or irregular heartbeat

  • convulsions (seizures)

  • fever

  • flushing or redness of face

  • hallucinations (seeing, hearing, or feeling things that are not there)

  • passing urine less often

  • skin rash

  • slurred speech

  • swollen stomach (in infants)

  • thirst or dryness of mouth

  • unusual behavior, such as disorientation to time or place, failure to recognize people, hyperactivity, or restlessness, especially in children

  • unusual drowsiness, tiredness, or weakness

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:


  • Blurred vision

  • burning of eye

  • eye irritation not present before therapy

  • increased sensitivity of eyes to light

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: AK-Pentolate Ophthalmic 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 AK-Pentolate Ophthalmic resources


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


Compare AK-Pentolate Ophthalmic with other medications


  • Pupillary Dilation
  • Refraction, Assessment
  • Uveitis

Friday, 17 August 2012

Nicotinell Icemint 4mg medicated chewing gum





1. Name Of The Medicinal Product



Nicotinell® Icemint 4 mg, medicated chewing-gums


2. Qualitative And Quantitative Composition



One piece of medicated chewing gum contains 4 mg nicotine (as 20 mg nicotine – polacrilin (1:4)).



For excipients, see section 6.1.



3. Pharmaceutical Form



Medicated chewing gum.



Each piece of coated chewing gum is off-white in colour and rectangular in shape.



4. Clinical Particulars



4.1 Therapeutic Indications



Nicotinell gum relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.



Nicotinell gum is indicated in pregnant and lactating women making a quit attempt.



Nicotinell gum should preferably be used in conjunction with a behavioural support programme.



4.2 Posology And Method Of Administration



Adults and elderly



Users should stop smoking completely during treatment with Nicotinell gum.



One piece of Nicotinell gum to be chewed when the user feels the urge to smoke. Normally, 8-12 pieces per day can be used, up to a maximum of 15 pieces per day.



The 2 mg chewing gum may not be well suited to smokers with a strong or very strong nicotine dependency.



The 4 mg chewing gum is intended to be used by smokers with a strong or very strong nicotine dependency and those who have previously failed to stop smoking with the aid of nicotine replacement therapy.



The optimal dosage form is selected according to the following table:





If an adverse event is noted when high dose forms are initiated, this should be replaced by the lower dosage form.



The characteristics of chewing-gum as a pharmaceutical form are such that individually different nicotine levels can result in the blood. Therefore, dosage frequency should be adjusted according to individual requirements within the stated maximum limit.



Directions for use:



1. One piece of gum should be chewed until the taste becomes strong.



2. The chewing gum should be rested between the gum and cheek.



3. When the taste fades, chewing should commence again.



4. The chewing routine should be repeated for 30 minutes.



The treatment time is individual. Normally, treatment should continue for at least 3 months.



After three months, the user should gradually cut down the number of pieces chewed each day until they have stopped using the product.



Treatment should be discontinued when the dose has been reduced to 1-2 pieces of gum per day. Nicotinell gum is sugar free.



Adolescents (aged 12-18 years of age)



The above recommendation can be used for adolescents aged between 12 and 18 years of age. As data are limited in this age group, medical advice should be obtained should it be found necessary to use the gum beyond 12 weeks.



Concomitant use of acidic beverages such as coffee or soda may decrease the buccal absorption of nicotine. Acidic beverages should be avoided for 15 minutes prior to chewing the gum.



4.3 Contraindications



Hypersensitivity to nicotine or any components of the gum.



Nicotinell gum should not be used by non-smokers.



4.4 Special Warnings And Precautions For Use



Any risks that may be associated with nicotine replacement therapy are substantially outweighed by the well established dangers of continued smoking.



Precautions: Users should stop smoking completely during therapy with Nicotinell gum. They should be informed that if they continue to smoke while using the gums they may experience increased adverse effects due to the hazards of smoking, including cardiovascular effects.



Cardiovascular disease



In stable cardiovascular disease Nicotinell gum presents a lesser hazard than continuing to smoke. However dependant smokers currently hospitalised as a result of a recent myocardial infarction, severe disrythmia, or recent cerebrovascular accident who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, Nicotinell gum may be considered but as data on safety in this patient group are limited, initiation should only be under medical supervision.



Diabetes mellitus



Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when nicotine replacement therapy is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.



Allergic reactions



Angioedema and urticaria have been reported.



Gastro-intestinal disease



Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastritis, or peptic ulcers and oral nicotine replacement therapy preparations should be used with caution in these conditions. Ulcerative stomatitis have been reported.



Renal and or hepatic impairment



Should be used with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.



Danger in small children



Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children. Nicotinell gum should be disposed of with care.



Pheochromocytoma and uncontrolled hyperthyroidism



Nicotinell gum should be used with caution in patients with uncontrolled hyperthyroidism or pheochromocytoma as nicotine causes the release of catecholamines.



Transferred dependence



Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.



Stopping smoking



Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs catalysed by CYP 1A2 (and possibly CYP 1A1). When a smoker stops, this may result in slower metabolism and a consequential rise in blood levels of drugs such as theophylline, tacrine, olanzaprine and clozaprine.



Other warnings



If denture wearers experience difficulty in chewing the gum, it is recommended that they use a different pharmaceutical form of nicotine replacement therapy.



Patients with rare hereditary problems of fructose intolerance should not take this medicine.



Nicotinell Icemint 4mg gum contains sorbital (E420) 0.1g per gum, a source of 0.02g fructose. Calorific value 1.2 kcal/piece of gum.



Nicotinell Icemint 4mg gum contains sodium 11.45 mg per piece of gum.



The gum base contains butylhydroxytoluene (E321) which may cause local irritation to mucous membranes.”



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



No information is available on interactions between Nicotinell gum and other drugs. No clinically relevant interactions between nicotine replacement therapy and other drugs has definitely been established, however nicotine may possibly enhance the haemodynamic effects of adenosine.



4.6 Pregnancy And Lactation



Pregnancy



Stopping smoking is the single most effective intervention for improving the health of both the pregnant smoker and her baby, and the earlier abstinence is achieved the better. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be used as the risk to the fetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but Nicotinell gums may be used in pregnancy as a safer alternative to smoking. Because of the potential for nicotine-free periods, intermittent dose forms are preferable, but patches may be necessary if there is significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when the fetus would not normally be exposed to nicotine.



Lactation



The relatively small amounts of nicotine found in breast milk during NRT use are less hazardous to the infant than second-hand smoke. Intermittent dose forms would minimize the amount of nicotine in breast milk and permit feeding when levels were at their lowest.



4.7 Effects On Ability To Drive And Use Machines



Not applicable.



4.8 Undesirable Effects



Some symptoms such as dizziness, headache and sleep disturbances may be related to the withdrawal of nicotine associated with stopping smoking.



In principle, Nicotinell gums can cause adverse reactions similar to those associated with nicotine administered by other means (including smoking) and these are mainly dose dependant. At recommended doses Nicotinell gum has not been found to cause any serious adverse effects. Excessive consumption of Nicotinell gum by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches.



Most of the side effects which are reported by patients occur generally during the first 3-4 weeks after initiation of therapy.



Nicotine from gums may sometimes cause a slight irritation of the throat and increase salivation at the start of the treatment.



The gum may stick to and in rare cases damage dentures and dental appliances.



Common (> 1/100).



Nervous system disorders: headache, dizziness



Gastrointestinal disorders: hiccups, gastric symptoms e.g. nausea, vomiting, indigestion, heartburn, increased salivation, irritation or sore mouth or throat



Musculoskeletal, connective and bone disorders: jaw muscle ache.



Uncommon (>1/1,000, <1/100)



Cardiac disorders: palpitations



Skin and subcutaneous tissue disorders: erythema, urticaria



Rare (<1/1,000)



Cardiac disorders: cardiac arrhythmias (e.g. atrial fibrillation)



Immune system disorders: hypersensitivity, angioneurotic oedema and anaphylactic reactions.



4.9 Overdose



In overdose, symptoms corresponding to heavy smoking may be seen, however the toxicity of nicotine cannot be directly compared with that of smoking, because tobacco smoke contains additional toxic substances (eg. carbon monoxide and tar).



Overdose with Nicotinell gum may only occur if many pieces are chewed simultaneously. Nicotine toxicity after ingestion will most likely be minimized as a result of early nausea and vomiting that occur following excessive nicotine exposure. Risk of poisoning by swallowing the gum is small. Since the release of nicotine from the gum is slow, very little nicotine is absorbed from the stomach and intestine, and if any is, it will be inactivated in the liver.



Chronic smokers can tolerate doses of nicotine that, in a non-smoker, would be more toxic, because of the development of tolerance.



Symptoms



The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40-60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.



Management of overdose



Following overdose, symptoms may be rapid particularly in children. All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration with oxygen should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



ATC Code: N07B A01



Pharmacotherapeutic group: Drugs used in nicotine dependence



Nicotine, the primary alkaloid in tobacco products and a naturally occurring autonomous substance, is a nicotine receptor agonist in the peripheral and central nervous systems and has pronounced CNS and cardiovascular effects. On consumption of tobacco products, nicotine has proven to be addictive, resulting in craving and other withdrawal symptoms when administration is stopped. This craving and these withdrawal symptoms include a strong urge to smoke, dysphoria, insomnia, irritability, frustration or anger, anxiety, concentration difficulties agitation and increased appetite or weight gain. The gum replaces part of the nicotine that would have been administrated via tobacco and reduces the intensity of the withdrawal symptoms and smoking urge.



“The gum contains a number of ingredients that are recognized as having properties for removal of dental staining. Studies have shown that the gum helps to improve tooth whiteness”



5.2 Pharmacokinetic Properties



When the gum is chewed, nicotine is steadily released into the mouth and is rapidly absorbed through the buccal mucosa. A proportion, by the swallowing of nicotine containing saliva, reaches the stomach and intestine where it is inactivated.



The nicotine peak plasma mean concentration after a single dose of the 4 mg coated gum is approximately 9.3 nanograms per ml (after 45 minutes) (average plasma concentration of nicotine when smoking a cigarette is 15-30 nanograms per ml).



Nicotine is eliminated mainly via hepatic metabolism; small amounts of nicotine are eliminated in unchanged form via the kidneys. The plasma half-life is approximately three hours. Nicotine crosses the blood-brain barrier, the placenta and is detectable in breast milk.



5.3 Preclinical Safety Data



No definite conclusion can be drawn on the genotoxic activity of nicotine in vitro. Nicotine was negative in in-vivo tests.



Animal experiments have shown that nicotine induces post-implantation loss and reduces the growth of foetuses.



The results of carcinogenicity assays did not provide any clear evidence of a tumorigenic effect of nicotine.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Gum base (containing butylhydroxytoluene (E321))



Calcium carbonate (E170)



Sorbitol (E420)



Sodium carbonate anhydrous



Sodium hydrogen carbonate (E500)



Polacrilin



Glycerol (E422)



Purified water



Levomenthol



Natural mint flavouring



Mint millicaps



Sucralose (E955)



Acesulfame potassium (E950)



Xylitol (E967)



Mannitol (E421)



Gelatin



Titanium dioxide (E171)



Carnauba wax (E903)



Talc (E553b)



6.2 Incompatibilities



Not applicable.



6.3 Shelf Life



2 years



6.4 Special Precautions For Storage



Do not store above 25°C.



6.5 Nature And Contents Of Container



The chewing-gum is packed in PVC/PVdC/aluminium blisters each containing either 2 or 12 pieces of gum. The blisters are packed in boxes containing 2, 12, 24, 36, 48, 60, 72, 96 108, 120 and 204 pieces of gum.



Not all pack sizes may be marketed.



6.6 Special Precautions For Disposal And Other Handling



No special requirements.



7. Marketing Authorisation Holder



Novartis Consumer Health UK Ltd



Trading as Novartis Consumer Health



Wimblehurst Road,



Horsham,



West Sussex RH12 5AB



8. Marketing Authorisation Number(S)



PL 00030/0442



9. Date Of First Authorisation/Renewal Of The Authorisation



09/03/2010



10. Date Of Revision Of The Text



February 2011



LEGAL CATEGORY


GSL




Thursday, 16 August 2012

Cytoxan oral/injection



Generic Name: cyclophosphamide (oral/injection) (sye kloe FOSS fah mide)

Brand Names: Cytoxan, Cytoxan Lyophilized, Neosar


What is cyclophosphamide?

Cyclophosphamide is a cancer (chemotherapeutic) medication. Cyclophosphamide interferes with the growth of cancer cells and slows their growth and spread in the body.


Cyclophosphamide is used to treat several types of cancer. Cyclophosphamide is also used to treat certain cases of nephrotic syndrome (kidney disease) in children.


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


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


Cyclophosphamide should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.


Serious side effects have been reported with the use of cyclophosphamide including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection such as fever; chills, or sore throat); bladder problems; and others. Talk to your doctor about the possible side effects from treatment with cyclophosphamide.


In some cases, secondary cancers have been reported to occur during and following treatment with cyclophosphamide. Talk to your doctor about the risks and benefits of this medication.


What should I discuss with my healthcare provider before taking cyclophosphamide?


Before taking cyclophosphamide, tell your doctor if you



  • have an infection or have had recent vaccinations;




  • have a low level of white blood cells or platelets (detected by blood tests);




  • have bone marrow problems;




  • have been previously treated with x-ray therapy;




  • have been previously treated with other chemotherapy medicines (i.e., Alkeran, CeeNU, Leukeran, Myleran, and others);




  • have had your adrenal glands removed;




  • need to have surgery;




  • have any unhealed wounds;




  • have a history of heart disease;



  • have liver disease; or

  • have kidney disease.

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


Cyclophosphamide is in the FDA pregnancy category D. This means that cyclophosphamide is known to be harmful to an unborn baby. Cyclophosphamide may also affect egg production in women and sperm production in men. Do not take cyclophosphamide without first talking to your doctor if you are pregnant or could become pregnant during treatment. Use of cyclophosphamide by the father prior to conception has also been associated with birth defects. Contraceptive measures are recommended during treatment with cyclophosphamide for both men and women. Cyclophosphamide passes into breast milk and may harm a nursing infant. Do not take cyclophosphamide without first talking to your doctor if you are breast feeding a baby.

How should I take cyclophosphamide?


Take cyclophosphamide exactly as directed by your doctor. If you do not understand these instructions, ask your doctor, nurse or pharmacist to explain them to you.


Take each oral dose with a large glass of water.

To avoid urinary bladder irritation during treatment with either oral or injectable cyclophosphamide, drink plenty of fluid during treatment and for 48 hours following treatment, usually 7 to 12 cups (3 quarts) per day, and empty your bladder frequently, every 2 to 3 hours including once during the night.


Taking oral cyclophosphamide on an empty stomach is preferable. If severe stomach upset occurs, take cyclophosphamide with food. Continue to take cyclophosphamide even if nausea and vomiting occurs. Do not stop taking the medicine without first talking to your doctor. Check with your doctor if vomiting occurs shortly after taking a dose of cyclophosphamide. Your doctor may want you to take another dose, but do not do this without checking with your doctor first.


If you are taking a liquid form of cyclophosphamide by mouth, use a dose measuring spoon or cup to ensure that you get the correct dose.


Injectable cyclophosphamide should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.


Your doctor will determine the correct amount and frequency of treatment with cyclophosphamide depending upon the type of cancer being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.


Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with cyclophosphamide to monitor progress and side effects.


Store cyclophosphamide oral tablets at or below 77 degrees Fahrenheit (25 degrees Celsius). Brief exposures to 86 degrees Fahrenheit (30 degrees Celsius) are permitted but the tablets should be protected from temperatures above 86 degrees Fahrenheit. Your healthcare provider will store cyclophosphamide injection as directed by the manufacturer. If you are storing cyclophosphamide injection at home, follow the directions provided by your healthcare provider. Store cyclophosphamide oral liquid in a glass container in the refrigerator for up to 14 days.

What happens if I miss a dose?


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


Contact your doctor if you miss a dose of cyclophosphamide injection.


What happens if I overdose?


Seek emergency medical attention.

Symptoms of a cyclophosphamide overdose may include decreased bone marrow function, infection, and heart problems.


What should I avoid while taking cyclophosphamide?


Cyclophosphamide can lower the activity of the immune system making you more susceptible to infection. Avoid contact with people who have colds, the flu, or other contagious illnesses. In addition, do not receive vaccines that contain a live strain of the virus (e.g., live oral polio vaccine) and avoid contact with individuals who have recently been vaccinated with a live virus.


Cyclophosphamide side effects


If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (shortness of breath; closing of your throat; difficulty breathing; swelling of your lips, face, or tongue; or hives);




  • blood in the urine;




  • black or tarry stools;




  • painful or difficult urination;




  • signs of infection such as fever; chills, or sore throat;




  • jaundice (yellowing of the skin or eyes);




  • lower back or side pain;




  • chest pain, difficulty breathing, or swelling;




  • unusual bleeding or bruising; or




  • changes in bone marrow function (detected by blood tests).



Other less serious side effects may be more likely to occur. Talk to your doctor if you experience



  • nausea, vomiting, or decreased appetite;




  • mouth sores;




  • abdominal pain;




  • diarrhea;




  • temporary hair loss;




  • temporary or permanent sterility;




  • rash;




  • changes in skin color; or




  • changes in nails.



In some cases, secondary cancers have been reported to occur during and following treatment with cyclophosphamide. Talk to your doctor about the risks and benefits of this medication.


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


What other drugs will affect cyclophosphamide?


Before taking cyclophosphamide, tell your doctor if you are taking any other medicines, especially any of the following:



  • phenobarbital (Luminal, Solfoton);




  • allopurinol (Zyloprim);




  • digoxin (Lanoxin);




  • warfarin (Coumadin);




  • a thiazide diuretic (water pill) such as chlorothiazide (Diuril), hydrochlorothiazide (HCTZ, HydroDiuril, Esidrix, Microzide, Oretic), chlorthalidone (Hygroton, Thalitone), indapamide (Lozol), metolazone (Mykrox, Zaroxolyn), and others; or




  • another chemotherapy medicine.



You may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.


Do not receive "live" vaccines during treatment with cyclophosphamide. Administration of a live vaccine may be dangerous during treatment with cyclophosphamide.

Other drugs may interact with cyclophosphamide. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including herbal products, during treatment with cyclophosphamide.



More Cytoxan resources


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


Compare Cytoxan with other medications


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  • Ewing's Sarcoma
  • Histiocytosis
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  • IgA Nephropathy
  • Multiple Myeloma
  • Multiple Sclerosis
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  • Nephrotic Syndrome
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  • Organ Transplant, Rejection Prophylaxis
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  • Prostate Cancer
  • Rheumatoid Arthritis
  • Small Cell Lung Cancer
  • Systemic Lupus Erythematosus
  • Systemic Sclerosis
  • Testicular Cancer
  • Wegener's Granulomatosus
  • Wilms' Tumor


Where can I get more information?


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

See also: Cytoxan side effects (in more detail)


Tuesday, 14 August 2012

Zaditor


Generic Name: Ketotifen Fumarate
Class: Antiallergic Agents
ATC Class: S01GX08
VA Class: OP900
Chemical Name: 10H-Benzo(4,5)cyclohepta(1,2-b)thiophen-10-one,4,9-dihydro-4-(1-methyl-4-piperidinylidene)
Molecular Formula: C19H19NOS
CAS Number: 34580-13-7

Introduction

Relatively selective histamine H1-receptor antagonist and mast-cell stabilizer.1


Uses for Zaditor


Allergic Conjunctivitis


Self-medication for temporary relief of ocular itching associated with allergic conjunctivitis (i.e., conjunctivitis due to pollen, grass, ragweed, or animal hair or dander).6 7


Zaditor Dosage and Administration


Administration


Ophthalmic Administration


Apply topically to the eye as an ophthalmic solution.6 7


Dosage


Available as ketotifen fumarate; dosage expressed in terms of ketotifen.6 7


Pediatric Patients


Allergic Conjunctivitis

Ophthalmic

One drop of a 0.025% solution in the affected eye(s) twice daily (at an interval of 8–12 hours) for those ≥3 years of age.6 7


Adults


Allergic Conjunctivitis

Ophthalmic

One drop of a 0.025% solution in the affected eye(s) twice daily (at an interval of 8–12 hours).6 7


Prescribing Limits


Pediatric Patients


Allergic Conjunctivitis

Ophthalmic

Do not administer more frequently than twice daily.6 7


Adults


Allergic Conjunctivitis

Ophthalmic

Do not administer more frequently than twice daily.6 7


Cautions for Zaditor


Contraindications



  • Known hypersensitivity to ketotifen or any ingredient in the formulation.6 7



Warnings/Precautions


Specific Populations


Pregnancy

Category C.1


Lactation

Distributed into milk in rats following oral administration.1 Cautious use is recommended.1


Pediatric Use

Safety and efficacy not established in children <3 years of age.6 7


Should not be used in children <3 years of age unless otherwise directed by a clinician.6 7


Common Adverse Effects


Conjunctival injection, headaches, rhinitis.1 Some events may be related to the underlying ocular disease.1


Zaditor Pharmacokinetics


Absorption


Bioavailability


Minimally absorbed following topical application to the eye.1


Onset


Within minutes after topical application to the eye.1


Stability


Storage


Ophthalmic


Solution

4–25°C.6 7


Do not use if solution changes color or becomes cloudy.6 7


ActionsActions



  • Suppresses the release of mediators from cells involved in hypersensitivity reactions and decreases chemotaxis and activation of eosinophils.1



Advice to Patients



  • Importance of learning and adhering to proper administration techniques to avoid contamination of the product.6 7




  • Importance of delaying insertion of contact lenses for at least 10 minutes after ketotifen instillation to prevent absorption of benzalkonium chloride by contact lenses.1 6 7




  • Not indicated for contact lens-related irritation.6 7




  • Importance of reporting new-onset eye pain or discomfort, visual disturbances, eye redness, worsening of itching, or itching lasting >72 hours.6 7




  • Importance of seeking quick medical attention if preparation is ingested orally.6 7




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any other concomitant illnesses.6 7




  • Importance of informing patient of other important precautionary information.6 7 (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


















Ketotifen Fumarate

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Ophthalmic



Solution



0.025% (of ketotifen)



Alaway (with benzalkonium chloride)



Bausch & Lomb



Zaditor (with benzalkonium chloride)



Novartis


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Alaway 0.025% Solution (BAUSCH &amp; LOMB CONS): 10/$18.99 or 30/$35.97


Zaditor 0.025% Solution (NOVARTIS): 5/$25.99 or 15/$49.97



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



1. Novartis Opthalmics. Zaditor (ketotifen fumarate) ophthalmic solution prescribing information. Duluth, GA; 2002 Oct.



2. Ciprandi G, Buscaglia S, Cerqueti PM et al. Drug treatment of allergic conjunctivitis: a review of the evidence. Drugs. 1992; 43:154-76. [IDIS 360840] [PubMed 1372215]



3. Morrow GL, Abbott RL. Conjunctivitis. Am Fam Physician. 1998; 57:735-46. [IDIS 418448] [PubMed 9490996]



4. Titi MJ. A critical look at ocular allergy drugs. Am Fam Physician. 1996; 53:2637-42. [IDIS 367250] [PubMed 8644576]



5. Galindez OA, Kaufman HE. Coping with the itchy-burnies: the management of allergic conjunctivitis. Ophthalmology. 1996; 103:1335-6. [IDIS 373485] [PubMed 8841290]



6. Novartis. Zaditor (ketotifen fumarate) drug facts. 2007. From Zaditor website (). Accessed 2007 Sep 26.



7. Bausch & Lomb. Alaway (ketotifen fumarate ) ophthalmic solution 0.025%: antihistamine eye drops. From Bausch & Lomb website (). Accessed 2007 Sep 27.



More Zaditor resources


  • Zaditor Side Effects (in more detail)
  • Zaditor Dosage
  • Zaditor Use in Pregnancy & Breastfeeding
  • Zaditor Support Group
  • 2 Reviews for Zaditor - Add your own review/rating


  • Zaditor Prescribing Information (FDA)

  • Zaditor Drops MedFacts Consumer Leaflet (Wolters Kluwer)

  • Zaditor Concise Consumer Information (Cerner Multum)

  • Zaditor Advanced Consumer (Micromedex) - Includes Dosage Information

  • Zyrtec Itchy Eye Prescribing Information (FDA)



Compare Zaditor with other medications


  • Conjunctivitis, Allergic