Pilocar Drops

Pronunciation: pye-loe-KAR-peen
Generic Name: Pilocarpine
Brand Name: Examples include Isopto Carpine and Piloptic

Pilocar Drops are used for:

Treating certain types of glaucoma (increased pressure in the eye) alone or in combination with other medicines. It may also be used to reverse the effects of other medicines used during eye surgeries or examinations. It may also be used for other conditions as determined by your doctor.

Pilocar Drops are a direct-acting miotic. It works by lowering the fluid pressure inside the eyeball by increasing fluid drainage from the eyeball. It also causes the pupils to constrict or get smaller (miosis).

Do NOT use Pilocar Drops if:

• you are allergic to any ingredient in Pilocar Drops


• you have a certain type of glaucoma (eg, pupillary block glaucoma), eye inflammation, or a severe eye infection

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

Before using Pilocar Drops:

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

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


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


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


• if you have a detached retina, an eye infection, or chronic obstructive pulmonary disease


• if you have had a heart attack

Some MEDICINES MAY INTERACT with Pilocar Drops. However, no specific interactions with Pilocar Drops are known at this time.

Ask your health care provider if Pilocar Drops 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 Pilocar Drops:

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

• Pilocar Drops are only for the eye. Do not get it in your nose or mouth.


• To use Pilocar Drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.


• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.


• If you miss a dose of Pilocar Drops, 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 Pilocar Drops.

Important safety information:

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


• Pilocar Drops may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.


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

Possible side effects of Pilocar Drops:

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:

Blurred vision; change in vision; eyelid twitching; headache at the temples or around the eyes; increased tearing; nearsightedness; redness or swelling of the eye; temporary stinging or burning.

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); detachment of the retina; fast or abnormal heartbeat; increase in blood pressure; poor vision at night.

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: Pilocar 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 asthma; blurred vision; diarrhea; fainting; increased saliva; increased sweating; irregular heartbeat; vomiting.

Proper storage of Pilocar Drops:

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

General information:

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


• Pilocar Drops are 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 Pilocar Drops. 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 Pilocar resources

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

Compare Pilocar with other medications

• Glaucoma
• Intraocular Hypertension

Sheerdesenz Desensitizing Treatment

Generic Name: potassium nitrate

Dosage Form: dental film
Product Information

[Patient Kit Information Panel]

TO REORDER: 1.877.236.4408

www.caogroup.com

PACKAGE CONTENTS: 4) desensitizing treatments

See package insert for dosage information. Rx Only. Dispose of properly after use. For complete safety information see product MSDS. Do not use if the packaging has been damaged, or if the safety seals are found to be broken.

REORDER #: 006-00104

Manufactured by CAO (China) Medical Equipment Co., Ltd. for CAO Group, Inc.

4628 West Skyhawk Drive

West Jordan, UT 84084

U.S.A.

877-236-4408 (tel)

801-256-9287 (fax)

www.caogroup.com

Expiration date:

MADE IN CHINA

[Side panels for the Patient Pack]

SheerDesenZ

Active Ingredient: Potassium nitrate, 12mg/film

Other Ingredients: Proprietary polymer, water/eau, xylitol, glycerin, poly(acrylic acid), peppermint oil, sucralose, potassium hydroxide

NDC#: 1406000304

[Front side of patient instruction card]

SheerDesenZ

Desensitizing Treatment

Simple.Comfort.Now

Disclaimer: CAO Group believes this information to be accurate and is offered only for the benefit of its customers for use of the product under proscribed conditions. This document is not to eb considered a warranty or guarantee of product performance, and CAO Group is not legally bound to such claims based on this document.

Shelf Life: 2 years

Manufactured by CAO (China) Medical Equipment Co., Ltd. for CAO Group, Inc.

4628 West Skyhawk Drive

West Jordan, UT 84084 U.S.A.

www.caogroup.com


13 Sept 2010

SAL-CSG010B.1

[Back panel of patient guide]

Sheer DesenZ

Desensitizing Treatment

Wear 01:00:00

Description

Sheer DesenZ™ desensitizing treatment is an easy, fast way to relieve oral pain and discomfort associated with dental procedures or even the hot/cold thermal changes teeth may experience. The thin, flexible film stays where it is placed molding to the teeth and gums to deliver relief exactly where it is needed. Yet it is easily removed when comfort is achieved.

Counter Indications

• Do not smoke while wearing the film.

• Avoid eating while wearing the film.

• Flush with copious amounts of water if accidentally placed in eye.

• Keep out of reach of young children.

• Avoid contact with clothing.

Instructions

1. Use enclosed tool to cut wrapper open.
   


2. Remove shrink wrap from tray. Carefully remove film from tray. The sticky gel side faces up. Position the film so it is centered on the arch. Firmly apply the film to the teeth, with the edge of the film just extending onto the gums.


3. Starting at the front teeth, wrap the film around the edge of the teeth and onto the back side of the teeth. Use your fingers to firmly mold the film to your teeth.


4. Remove the smaller film and position it over the premolars and molars on one side of your mouth. Apply the smaller piece as described above.


5. Wear for a maximum of one hour, or until sensitivity is gone. Repeat as directed by your dental professional.


6. To remove, grasp corner of film and begin to loosen away from teeth.


7. If film becomes difficult to remove, rinse with water.


8. Continue removing film from all surfaces. The film may come away in pieces; this is normal.


9. Brush teeth and gums to remove any remaining gel.
   

[Complete Instructions Back Page]

Caution: Federal law restricts this device to sale by or on the order of a licensed professional.

Disclaimer: CAO Group believes this information to be accurate and is offered only for the benefit of its customers for use of the product under proscribed conditions. This document is not to be considered a warranty or guarantee of product performance, and CAO Group is not legally bound to such claims based on this document.

Manufactured by CAO (China) Medical Equipment Co,. Ltd. for

CAO Group, Inc.

P 877.236.4408 F 801.256.9287

4628 West Skyhawk Drive, West Jordan, UT 84084-4501 U.S.A.

www.caogroup.com

13 Sept 2010

SAL-CAI010 B.1

[Immediate Package]

SheerDesenZ

Desensitizing Treatment


See carton for complete instructions and information. Keep out of reach of children.


For one-time use only.


CAO Group, Inc.


LOT#: [######]


EXP: [MMM YYYY]

[Patient Kit Principal Display Panel]

SheerDesenZ

Desensitizing Treatment

Patient Treatment Kit


Simple.Comfort.Now


Net Qty: 8) 0.4 gram films

Active Ingredient: Potassium nitrate, 12mg/film

SHEERDESENZ  DESENSITIZING TREATMENT potassium nitrate  film

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 14060-003 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength potassium nitrate (nitrate ion) potassium nitrate 12 mg

Inactive Ingredients Ingredient Name Strength Water 99 mg Potassium hydroxide 0.4 mg Glycerin 40 mg Xylitol 86 mg

Product Characteristics Color      Score      Shape Size Flavor PEPPERMINT (Peppermint Oil) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 14060-003-04 4 TRAY In 1 PACKAGE contains a TRAY 1 3 FILM In 1 TRAY This package is contained within the PACKAGE (14060-003-04)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/01/2010

Labeler - CAO Group, Inc. (102422578)

Revised: 10/2010CAO Group, Inc.

vardenafil

var-DEN-a-fil

Commonly used brand name(s)

In the U.S.

• Levitra


• Staxyn

Available Dosage Forms:

• Tablet


• Tablet, Disintegrating

Therapeutic Class: Erectile Dysfunction Agent

Pharmacologic Class: Phosphodiesterase Type 5 Inhibitor

Uses For vardenafil

Vardenafil is used to treat men who have erectile dysfunction (also called sexual impotence). Vardenafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly. The penis is one of the areas where this enzyme works.

Erectile dysfunction is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. When a man is sexually stimulated, his body's normal response is to increase blood flow to his penis to produce an erection. By controlling the enzyme, vardenafil helps to maintain an erection after the penis is stroked by increasing blood flow to the penis. Without physical action to the penis, such as that occurring during sexual intercourse, vardenafil will not work to cause an erection.

vardenafil is available only with your doctor's prescription.

Before Using vardenafil

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 vardenafil, the following should be considered:

Allergies

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

Vardenafil is not indicated for use in children. 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 vardenafil in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal 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 taking vardenafil, 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 vardenafil 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


• Dronedarone


• Erythrityl Tetranitrate


• Fluconazole


• Isosorbide Dinitrate


• Isosorbide Mononitrate


• Mesoridazine


• Nitroglycerin


• Pentaerythritol Tetranitrate


• Pimozide


• Posaconazole


• Sparfloxacin


• Thioridazine

Using vardenafil 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.

• Acecainide


• Amiodarone


• Amitriptyline


• Amoxapine


• Apomorphine


• Arsenic Trioxide


• Asenapine


• Astemizole


• Azimilide


• Azithromycin


• Boceprevir


• Bretylium


• Chloroquine


• Chlorpromazine


• Ciprofloxacin


• Citalopram


• Clomipramine


• Clozapine


• Crizotinib


• Dasatinib


• Desipramine


• Disopyramide


• Dofetilide


• Dolasetron


• Flecainide


• Gatifloxacin


• Granisetron


• Halofantrine


• Haloperidol


• Ibutilide


• Iloperidone


• Imipramine


• Lapatinib


• Levofloxacin


• Lopinavir


• Lumefantrine


• Mefloquine


• Methadone


• Moricizine


• Moxifloxacin


• Nilotinib


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Ondansetron


• Paliperidone


• Pazopanib


• Perflutren Lipid Microsphere


• Procainamide


• Prochlorperazine


• Promethazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinidine


• Quinine


• Ranolazine


• Salmeterol


• Saquinavir


• Sematilide


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Solifenacin


• Sorafenib


• Sotalol


• Sunitinib


• Tedisamil


• Telaprevir


• Telithromycin


• Terfenadine


• Tetrabenazine


• Toremifene


• Trazodone


• Trifluoperazine


• Trimipramine


• Vandetanib


• Vemurafenib


• Voriconazole


• Ziprasidone

Using vardenafil 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.

• Alfuzosin


• Amprenavir


• Bunazosin


• Doxazosin


• Indinavir


• Itraconazole


• Phenoxybenzamine


• Phentolamine


• Prazosin


• Tamsulosin


• Terazosin


• Trimazosin


• Urapidil

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 vardenafil. Make sure you tell your doctor if you have any other medical problems, especially:

• Abnormal penis, including curved penis and birth defects of the penis—Chance of problems occurring may be increased and vardenafil should be used with caution in these patients.

• Age greater than 50 years or


• Coronary artery disease or


• Diabetes or


• Hyperlipidemia (excess of lipids in the blood) or


• Hypertension (high blood pressure) or


• Low cup to disc ratio (eye condition also called "crowded disc") or


• Smoking—These conditions may increase risk for a serious eye problem called non-arteritic ischemic optic neuropathy or NAION.

• Angina (reoccurring chest pain) or


• Arrhythmia (irregular heartbeat) or


• Heart attack (within the last 6 months) or


• Heart failure, severe or


• Hypertension (high blood pressure), uncontrolled or


• Hypotension (low blood pressure) or


• Kidney disease, severe or


• Liver disease, severe or


• Retinal disorders (eye problem) or


• Retinitis pigmentosa (an inherited eye disorder) or


• Stroke, recent history of—Should not be used in patients with these conditions.

• Bleeding disorders or


• Stomach ulcers—Chance of problems occurring may be increased; it is not known if the medicine is safe for use in these patients.

• Bone marrow cancer or


• Leukemia (blood related cancer) or


• Multiple myeloma (blood related cancer) or


• Sickle-cell anemia (blood disorder)—Vardenafil should be used with caution in these patients as problems with prolonged erection of the penis may occur.

• Fructose intolerance—The orally disintegrating tablet contains sorbitol, which can make this condition worse.

• Heart blood flow problems—These conditions may cause you to be more sensitive to vardenafil.

• Heart disease, underlying—Chance of low blood pressure occurring is greater; vardenafil should be used carefully in these patients.

• Kidney disease or


• Liver disease—Chance of problems occurring may be increased. Lower starting doses may be used and doses increased as needed and as tolerated.

• NAION (serious eye condition) in one or both eyes, history of—May increase your chance of getting NAION again.

• Phenylketonuria (PKU)—The orally disintegrating tablet contains phenylalanine, which can make this condition worse.

• QT prolongation (rare heart condition), or history of—Use with caution. May make this condition worse.

Proper Use of vardenafil

Use vardenafil exactly as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. If too much is used, the chance of side effects or other problems is increased.

Special patient instructions come with vardenafil. Read the directions carefully before you start using vardenafil and each time you get a refill of your medicine.

You may take vardenafil with or without food.

vardenafil usually begins to work within 60 minutes after taking it. It continues to work for up to 4 hours. Stimulation is required for an erection. If you have any questions about the use and benefits of vardenafil ask your doctor.

If you are using the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Place the tablet on your tongue. It should melt quickly. The tablet should be taken without liquids. Do not break, crush, or chew it.

Use only the brand of vardenafil that your doctor prescribed. Different brands may not work the same way.

Dosing

The dose of vardenafil 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 vardenafil. 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 treatment of erectile dysfunction (as needed):
  
  • For oral dosage form (disintegrating tablets):
    
    • Adults—10 milligrams (mg) as a single dose, no more than once a day, taken 1 hour before you think sexual activity may occur.
    
    
    • Children—Use is not recommended.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Adults 65 years of age and older—5 milligrams (mg) as a single dose no more than once a day, 1 hour before sexual intercourse. Your doctor may change your dose if needed.
    
    
    • Adults up to 65 years of age—10 mg as a single dose no more than once a day, 1 hour before sexual activity. Your doctor may change your dose if needed.
    
    
    • Children—Use is not recommended.
    
    
  
  

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using vardenafil

It is important that you tell all of your doctors that you take vardenafil. If you need emergency medical care for a heart problem, it is important that your doctor knows when you last took vardenafil.

Levitra® also contains vardenafil. If you take too much vardenafil or take it together with these medicines, the chance for side effects will be higher.

If you experience a prolonged or painful erection for 4 hours or more, contact your doctor immediately. This condition may require prompt medical treatment to prevent serious and permanent damage to your penis.

vardenafil does not protect you against sexually transmitted diseases. Use protective measures and ask your doctor if you have any questions about this.

It is important to tell your doctor about any heart problems you may have now or may have had in the past. vardenafil can cause serious side effects in patients with heart problems.

Do not use vardenafil if you are also using a nitrate medicine, often used to treat angina (chest pain). Nitrate medicines include nitroglycerin, isosorbide, Imdur®, Nitro-Bid®, Nitrostat®, Nitro-Dur®, Transderm Nitro®, Nitrol® Ointment, and Nitrolingual® Spray. Some illegal ("street") drugs called "poppers" (such as amyl nitrate, butyl nitrate, or nitrite) also contain nitrates.

Do not drink excessive amounts of alcohol (e.g., 5 glasses of wine or 5 shots of whiskey) when taking vardenafil. When taken in excess, alcohol can increase your chances of getting a headache or getting dizzy, increase your heart rate, or lower your blood pressure.

If you have sudden loss of vision in one or both eyes, stop using vardenafil and contact your doctor right away.

Stop using vardenafil and check with your doctor right away if you have sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears.

Do not eat grapefruit or drink grapefruit juice while you are using vardenafil.

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.

vardenafil Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Arm, back, or jaw pain


• blindness


• blurred vision


• chest pain or discomfort


• chest tightness or heaviness


• chills


• cold sweats


• confusion


• decreased vision


• difficult or labored breathing


• difficulty with swallowing


• dizziness


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


• eye pain


• fainting


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


• headache


• hives


• itching


• nausea


• nervousness


• pain or discomfort in the arms, jaw, back, or neck


• pounding in the ears


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


• shortness of breath


• skin rash


• slow or fast heartbeat


• sweating


• tearing


• tightness in the chest


• unusual tiredness or weakness


• vomiting


• wheezing

Incidence not known

• Hearing loss

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

More common

• Feeling of warmth and redness of the face, neck, arms, and occasionally, upper chest


• sneezing


• stuffy nose

Less common

• Abnormal ejaculation


• abdominal or stomach pain


• abnormal vision


• acid or sour stomach


• back pain


• belching


• bloody nose


• body aches or pain


• burning feeling in the chest or stomach


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• changes in color vision


• changes in vision


• congestion


• cough


• diarrhea


• difficulty seeing at night


• difficulty with moving


• difficulty with swallowing


• dim vision


• dry mouth


• dryness or soreness of the throat


• excessive muscle tone


• eye pain


• face swelling


• fast heartbeat


• feeling of constant movement of self or surroundings


• fever


• general feeling of discomfort or illness


• heartburn


• hoarseness


• increased redness of the eye


• increased sensitivity of the eyes to sunlight


• indigestion


• itching skin


• joint pain


• lack or loss of strength


• loss of appetite


• muscle aches and pains


• muscle cramping


• muscle stiffness


• muscle tension or tightness


• neck pain


• pain


• pain or burning in the throat


• runny nose


• sensation of spinning


• shivering


• sleepiness or unusual drowsiness


• sleeplessness


• sore throat


• sores, ulcers, or white spots on the lips or tongue or inside the mouth


• stomach discomfort, upset, or pain


• swollen joints


• tender, swollen glands in the neck


• tenderness in the stomach area


• trouble with sleeping


• trouble with swallowing


• unable to sleep


• voice changes


• watery eyes

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: vardenafil 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 vardenafil resources

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

• Vardenafil MedFacts Consumer Leaflet (Wolters Kluwer)


• Levitra Prescribing Information (FDA)


• Levitra Monograph (AHFS DI)


• Levitra Consumer Overview


• Staxyn Prescribing Information (FDA)


• Staxyn Orally Disintegrating Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Staxyn Consumer Overview

Compare vardenafil with other medications

• Erectile Dysfunction

Cartia XT 24-Hour Sustained-Release Beads Capsules

Pronunciation: dil-TYE-a-zem
Generic Name: Diltiazem
Brand Name: Examples include Cardizem CD and Cartia XT

Cartia XT 24-Hour Sustained-Release Beads Capsules are used for:

Treating high blood pressure and chronic stable angina (chest pain). It may be used alone or in combination with other medicines. It may also be used for other conditions as determined by your doctor.

Cartia XT 24-Hour Sustained-Release Beads Capsules are a calcium channel blocker. It works by relaxing (dilating) your blood vessels, lowering blood pressure, and decreasing heart rate, which lowers the workload of the heart. It also dilates coronary arteries, which increases blood flow to the heart.

Do NOT use Cartia XT 24-Hour Sustained-Release Beads Capsules if:

• you are allergic to any ingredient in Cartia XT 24-Hour Sustained-Release Beads Capsules


• you have certain heart problems (eg, sick sinus syndrome, second- or third-degree heart block) and do not have a pacemaker, you have very low blood pressure, or you have fluid buildup in the lungs during or soon after a heart attack


• you are taking erythromycin

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

Before using Cartia XT 24-Hour Sustained-Release Beads Capsules:

Some medical conditions may interact with Cartia XT 24-Hour Sustained-Release Beads Capsules. 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 failure, a recent heart attack with lung congestion, heart block, a very slow heart rate, or other heart problems; low blood pressure; certain stomach or intestine problems (eg, narrowing); liver disease; or kidney problems


• if you are taking other medicines for high blood pressure or heart conditions

Some MEDICINES MAY INTERACT with Cartia XT 24-Hour Sustained-Release Beads Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Antiarrhythmics (eg, amiodarone, dronedarone), cimetidine, clonidine, HIV protease inhibitors (eg, atazanavir, indinavir), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Cartia XT 24-Hour Sustained-Release Beads Capsules's side effects, such as heart rhythm problems


• Moricizine or rifamycins (eg, rifampin) because they may decrease Cartia XT 24-Hour Sustained-Release Beads Capsules's effectiveness


• Benzodiazepines (eg, alprazolam), beta-blockers (eg, propranolol), buspirone, carbamazepine, cilostazol, cisapride, colchicine, corticosteroids (eg, hydrocortisone), cyclosporine, digoxin, everolimus, fentanyl, HMG-CoA reductase inhibitors (eg, simvastatin), hydantoins (eg, phenytoin), lurasidone, macrolide antibiotics (eg, erythromycin), macrolide immunosuppressants (eg, tacrolimus), nifedipine, quinidine, ranolazine, theophylline, or vasopressin antagonists (eg, tolvaptan) because the risk of their side effects, some potentially life-threatening, may be increased by Cartia XT 24-Hour Sustained-Release Beads Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cartia XT 24-Hour Sustained-Release Beads Capsules 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 Cartia XT 24-Hour Sustained-Release Beads Capsules:

Use Cartia XT 24-Hour Sustained-Release Beads Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Cartia XT 24-Hour Sustained-Release Beads Capsules by mouth with or without food.


• Swallow Cartia XT 24-Hour Sustained-Release Beads Capsules whole. Do not open, break, crush, or chew before swallowing.


• Taking Cartia XT 24-Hour Sustained-Release Beads Capsules at the same time each day will help you remember to take it.


• Continue to take Cartia XT 24-Hour Sustained-Release Beads Capsules even if you feel well. Do not miss any doses.


• If you miss a dose of Cartia XT 24-Hour Sustained-Release Beads Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Cartia XT 24-Hour Sustained-Release Beads Capsules.

Important safety information:

• Cartia XT 24-Hour Sustained-Release Beads Capsules may cause dizziness, lightheadedness, or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Cartia XT 24-Hour Sustained-Release Beads Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Cartia XT 24-Hour Sustained-Release Beads Capsules may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Cartia XT 24-Hour Sustained-Release Beads Capsules may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Cartia XT 24-Hour Sustained-Release Beads Capsules. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• Do not suddenly stop taking Cartia XT 24-Hour Sustained-Release Beads Capsules. Your condition may get worse if you suddenly stop taking it. If you need to stop Cartia XT 24-Hour Sustained-Release Beads Capsules or add a new medicine, your doctor will gradually lower your dose.


• Tell your doctor or dentist that you take Cartia XT 24-Hour Sustained-Release Beads Capsules before you receive any medical or dental care, emergency care, or surgery.


• Be sure to have your blood pressure checked regularly while taking Cartia XT 24-Hour Sustained-Release Beads Capsules.


• Lab tests, including blood pressure, electrocardiogram (ECG), and heart rate, may be performed while you use Cartia XT 24-Hour Sustained-Release Beads Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Cartia XT 24-Hour Sustained-Release Beads Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially swelling of the ankles, feet, or hands; dizziness; and slow heartbeat.


• Cartia XT 24-Hour Sustained-Release Beads Capsules 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 taking Cartia XT 24-Hour Sustained-Release Beads Capsules while you are pregnant. Cartia XT 24-Hour Sustained-Release Beads Capsules are found in breast milk. Do not breast-feed while taking Cartia XT 24-Hour Sustained-Release Beads Capsules.

Possible side effects of Cartia XT 24-Hour Sustained-Release Beads Capsules:

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

Constipation; dizziness; facial flushing; headache; lightheadedness; tiredness; 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; unusual hoarseness); chest pain; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucinations; mental or mood changes; personality changes; reddened, blistered, or swollen skin; severe or persistent dizziness, lightheadedness, nausea, or vomiting; shortness of breath; sudden weight gain; swelling of the feet, ankles, or hands; symptoms of liver problems (eg, dark urine, pale stools, yellowing of the skin or eyes); tender, bleeding, or swollen gums; unusual bleeding or bruising; unusual or persistent tiredness or weakness; vision changes.

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: Cartia XT 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; difficulty breathing, especially when lying down; dizziness; drowsiness; fainting; lightheadedness, especially when standing; loss of consciousness; nausea; nervousness; slurred speech; unusual weakness; very slow heart rate.

Proper storage of Cartia XT 24-Hour Sustained-Release Beads Capsules:

Store Cartia XT 24-Hour Sustained-Release Beads Capsules at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cartia XT 24-Hour Sustained-Release Beads Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Cartia XT 24-Hour Sustained-Release Beads Capsules, please talk with your doctor, pharmacist, or other health care provider.


• Cartia XT 24-Hour Sustained-Release Beads Capsules are 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 Cartia XT 24-Hour Sustained-Release Beads Capsules. 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 Cartia XT resources

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

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Solarcaine Aloe Extra Gel

Pronunciation: L Y E-doe-cane
Generic Name: Lidocaine
Brand Name: Solarcaine Aloe Extra

Solarcaine Aloe Extra Gel is used for:

Temporarily relieving pain and itching associated with minor cuts, skin scrapes, minor burns (including sunburn), minor skin irritation, and insect bites.

Solarcaine Aloe Extra Gel is an anesthetic. It works by preventing nerves from transmitting painful impulses to the brain.

Do NOT use Solarcaine Aloe Extra Gel if:

• you are allergic to any ingredient in Solarcaine Aloe Extra Gel or to similar medications (eg, amide-type local anesthetics)


• there are signs of infection (eg, oozing, warmth, pain) or tissue damage in the affected area

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

Before using Solarcaine Aloe Extra Gel:

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

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


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


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


• if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any anesthetic medicine


• if you have heart, liver, or kidney problems

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

• Amiodarone, beta-blockers (eg, atenolol), cimetidine, or mexiletine because side effects, such as sluggishness, confusion, slow breathing, low blood pressure, or slow heartbeat, may occur

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

Use Solarcaine Aloe Extra Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Wash and completely dry the affected area. Apply a thin layer of Solarcaine Aloe Extra Gel to the affected area. Gently rub the medicine in until it is evenly distributed.


• Wash your hands immediately after using Solarcaine Aloe Extra Gel, unless your hands are part of the treated area.


• Solarcaine Aloe Extra Gel is for external use only. Avoid contact with eyes. If contact occurs, wash out the eye at once with water or saline and protect it until the numbness is gone.


• Do not bandage or wrap the affected area, unless directed otherwise by your doctor.


• If you miss a dose of Solarcaine Aloe Extra Gel, 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.

Ask your health care provider any questions you may have about how to use Solarcaine Aloe Extra Gel.

Important safety information:

• Solarcaine Aloe Extra Gel may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.


• Solarcaine Aloe Extra Gel may cause a numbing effect at the application site. Do not scratch, rub, or expose the area to extreme hot or cold temperatures until the numbness is gone.


• Use caution when applying Solarcaine Aloe Extra Gel over large areas.


• Do not use more medicine, apply more often, or use for longer than prescribed. Your condition will not improve faster, but the risk of side effects may be increased.


• Tell your doctor or dentist that you take Solarcaine Aloe Extra Gel before you receive any medical or dental care, emergency care, or surgery.


• PREGNANCY and BREAST-FEEDING: It is not known if Solarcaine Aloe Extra Gel can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Solarcaine Aloe Extra Gel while you are pregnant. It is not known if Solarcaine Aloe Extra Gel is found in breast milk after topical use. If you are or will be breast-feeding while you use Solarcaine Aloe Extra Gel, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Solarcaine Aloe Extra Gel:

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:

Redness or swelling at the application site.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); excessive irritation; signs of infection in the affected area (eg, warmth, oozing, pain).

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: Solarcaine Aloe Extra 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. Solarcaine Aloe Extra Gel may be harmful if swallowed.

Proper storage of Solarcaine Aloe Extra Gel:

Store Solarcaine Aloe Extra Gel at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Keep Solarcaine Aloe Extra Gel out of the reach of children and away from pets.

General information:

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


• Solarcaine Aloe Extra Gel 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.


• Discard unused medicine and packaging in the trash out of the reach of children and pets.


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

This information is a summary only. It does not contain all information about Solarcaine Aloe Extra Gel. 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 Solarcaine Aloe Extra resources

• Solarcaine Aloe Extra Side Effects (in more detail)
• Solarcaine Aloe Extra Use in Pregnancy & Breastfeeding
• 0 Reviews for Solarcaine Aloe Extra - Add your own review/rating

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• Sunburn

CALPOL Sugar Free Infant suspension (P)

1. Name Of The Medicinal Product

CALPOL Sugar Free Infant suspension

2. Qualitative And Quantitative Composition

CALPOL Sugar Free Infant suspension contains 120 mg Paracetamol in each 5 ml.

Excipients: maltitol liquid (E965), sorbitol liquid (E420), methyl parahydroxybenzoate (E218), ethyl parahydroxybenzoate (E214), propyl parahydroxybenzoate (E216) and carmoisine (E122). See section 4.4 for further information.

For full list of excipients, see section 6.1.

3. Pharmaceutical Form

Oral Suspension.

A pink strawberry flavoured suspension.

4. Clinical Particulars

4.1 Therapeutic Indications

CALPOL Sugar Free Infant suspension is indicated for the treatment of mild to moderate pain and as an antipyretic. It can be used in many conditions including headache, toothache, earache, teething, sore throat, colds & influenza, aches and pains and post-immunisation fever.

4.2 Posology And Method Of Administration

Age : 2 – 3 months	Dose
1. Post-vaccination fever	2.5 ml (small end of spoon) If necessary, after 4-6 hours, give a second 2.5 ml dose
2. Other causes of Pain and Fever - if your baby weighs over 4 kg and was born after 37 weeks
• Do not give to babies less than 2 months of age. • Do not give more than 2 doses. • Leave at least 4 hours between doses. • If further doses are needed, talk to your doctor or pharmacist.

Children aged 3 months – 6 years:

Child's Age	How Much	How often (in 24 hours)
3 – 6 months	One 2.5 ml spoonful (small end)	4 times
6 – 24 months	One 5 ml spoonful (large end)	4 times
2 – 4 years	One 5 ml spoonful (large end) and one 2.5 ml spoonful (small end)	4 times
4 – 6 years	Two 5 ml spoonfuls (large end)	4 times
• Do not give more than 4 doses in any 24 hour period • Leave at least 4 hours between doses • Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist

It is important to shake the bottle for at least 10 seconds before use.

The Elderly:

In the elderly, the rate and extent of paracetamol absorption is normal but plasma half-life is longer and paracetamol clearance is lower than in young adults.

4.3 Contraindications

CALPOL Sugar Free Infant suspension is contra-indicated in patients with known hypersensitivity to paracetamol, or any of the other components.

4.4 Special Warnings And Precautions For Use

Care is advised in the administration of paracetamol to patients with severe renal impairment or severe hepatic impairment.

The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.

Concomitant use of other paracetamol-containing products should be avoided.

Due to the presence of maltitol liquid (E965) and sorbitol liquid (E420), patients with rare hereditary problems of fructose intolerance should not take this medicine.

Ethyl (E214), Propyl (E216) and Methyl (E218) parahydroxybenzoate may cause allergic reactions (possibly delayed).

Carmoisine (E122) may cause allergic reactions.

The label contains the following statements:

Contains paracetamol.

Do not give this medicine with any other paracetamol containing products.

For oral use only

Never give more medicine than shown in the table.

Do not overfill the spoon.

Always use the spoon supplied with the pack.

Do not give to babies less than 2 months of age.

For infants 2-3 months no more than 2 doses should be given.

Do not give more than 4 doses in any 24 hour period.

Leave at least 4 hours between doses.

Do not give this medicine to your child for more than 3 days without speaking to your doctor or pharmacist

As with all medicines, if your child is currently taking any other medicine consult your doctor or pharmacist before using this product.

Keep out of the reach and sight of children.

Do not store above 25°C. Keep bottle in the outer carton.

Shake the bottle for at least 10 seconds before use. (bottle only)

Do not exceed the stated dose.

If symptoms persist consult your doctor.

Immediate medical advice should be sought in the event of an overdose, even if the child seems well. (label)

Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage. (leaflet)

Talk to your doctor: If your child has an inherited intolerance to fructose or been diagnosed with an intolerance to some other sugars. (leaflet)

The sorbitol (E420) and maltitol (E965) content of this product means that this product is unsuitable for people with inherited intolerance to fructose. (leaflet)

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Chronic alcohol intake can increase the hepatotoxicity of paracetamol overdose and may have contributed to the acute pancreatitis reported in one patient who had taken an overdose of paracetamol. Acute alcohol intake may diminish an individual's ability to metabolise large doses of paracetamol, the plasma half-life of which can be prolonged.

The use of drugs that induce hepatic microsomal enzymes, such as anticonvulsants and oral contraceptives, may increase the extent of metabolism of paracetamol, resulting in reduced plasma concentrations of the drug and a faster elimination rate.

4.6 Pregnancy And Lactation

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Adverse effects of paracetamol are rare. Very rarely hypersensitivity and anaphylatic reactions including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causality related to paracetamol.

Most reports of adverse reactions to paracetamol relate to overdose with the drug.

Chronic hepatic necrosis has been reported in a patient who took daily therapeutic doses of paracetamol for about a year and liver damage has been reported after daily ingestion of excessive amounts for shorter periods. A review of a group of patients with chronic active hepatitis failed to reveal differences in the abnormalities of liver function in those who were long-term users of paracetamol nor was the control of their disease improved after paracetamol withdrawal.

Nephrotoxicity following therapeutic doses of paracetamol is uncommon, but papillary necrosis has been reported after prolonged administration.

4.9 Overdose

Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk Factors:

If the patient

a) Is on long term treatment with carbamezipine, phenobarbital, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

Or

b) Regularly consumes ethanol in excess of recommended amounts.

Or

c) Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia, and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol has analgesic and antipyretic effects similar to those of aspirin and is useful in the treatment of mild to moderate pain. It has only weak anti-inflammatory effects.

5.2 Pharmacokinetic Properties

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are reached 30-90 minutes post dose and the plasma half-life is in the range of 1 to 3 hours after therapeutic doses. Drug is widely distributed throughout most body fluids. Following therapeutic doses 90-100% of the drug is recovered in the urine within 24 hours almost entirely following hepatic conjugation with glucuronic acid (about 60%), sulphuric acid (about 35%) or cysteine (about 3%). Small amounts of hydroxylated and deacetylated metabolites have also been detected. Children have less capacity for glucuronidation of the drug than do adults. In overdosage there is increased N-hydroxylation followed by glutathione conjugation. When the latter is exhausted, reaction with hepatic proteins is increased leading to necrosis.

5.3 Preclinical Safety Data

The active ingredient of this product is a well known constituent of medicinal products and its safety profile is well documented.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Maltitol liquid

Sorbitol solution (70% non crystallising) (E420)Glycerol

Dispersible cellulose

Xanthan gum

Ethyl parahydroxybenzoate (E214)

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Polysorbate 80

Strawberry flavour

Carmoisine (E122)

Purified water

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C. Keep bottle in the outer carton.

6.5 Nature And Contents Of Container

Amber glass bottle with plastic screw cap, a polyethylene or polyvinylidene chloride (PVDC) laminate faced wad.

or

Amber glass bottle with a two-piece plastic child resistant, tamper evident closure fitted with a polyethylene or polyvinylidene chloride (PVDC) laminate faced wad.

or

Amber glass bottle with a three-piece plastic child resistant, tamper evident closure fitted with a polyethylene or polyvinylidene chloride (PVDC) laminate faced wad.

Pack sizes

140 ml, 200 ml and 1000 ml. A spoon with a 5 ml and 2.5 ml measure is supplied with this pack.

1000 ml amber glass bottle with an aluminium cap fitted with a polyethylene wad.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

UK

8. Marketing Authorisation Number(S)

PL 15513/0006

9. Date Of First Authorisation/Renewal Of The Authorisation

28 April 1997 / 13^th September 2004

10. Date Of Revision Of The Text

6^th June 2011

Cystadane

Generic Name: betaine (Oral route)

BEE-ta-een

Commonly used brand name(s)

In the U.S.

• Cystadane

Available Dosage Forms:

• Powder for Suspension


• Tablet

Therapeutic Class: Digestant

Uses For Cystadane

Betaine is used to treat a lack of or defect in certain enzymes that causes too much homocysteine in the blood and urine. This medicine removes the extra homocysteine from the body.

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

Before Using Cystadane

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

This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults. However, children may require more frequent changes in their dose than adults.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal 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.

Proper Use of Cystadane

Betaine powder should be mixed with 4 to 6 ounces of juice, milk, or water until completely dissolved. The solution should be used immediately after mixing.

Do not use if the powder does not dissolve completely or gives a colored solution.

Betaine should be taken with meals.

It is important that you follow any special instructions from your doctor, such as taking folic acid, pyridoxine (vitamin B 6), and vitamin B 12 supplements. If you have any questions about this, check with your doctor.

Dosing

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

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

• For oral dosage form (powder for solution):
  
  • To prevent buildup of homocysteine:
    
    • Adults, teenagers, and children 3 years of age and older—The starting dose is usually 3 grams taken two times a day with meals. Your doctor may adjust your dose as needed.
    
    
    • Children younger than 3 years of age—The dose is based on body weight and must be determined by your doctor. Betaine should be taken with meals.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Cystadane

Your doctor should check your progress at regular visits to make sure that this medicine is working properly.

Cystadane 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.

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:

Less common

• Diarrhea


• nausea


• stomach upset

Betaine may cause a body odor. Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

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.

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More Cystadane resources

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

• Cystadane Prescribing Information (FDA)


• Cystadane Concise Consumer Information (Cerner Multum)


• Cystadane Powder MedFacts Consumer Leaflet (Wolters Kluwer)

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