Alodox

Generic Name: doxycycline (DOX i SYE kleen)

Brand Names: Adoxa, Adoxa CK, Adoxa TT, Alodox, Avidoxy, Doryx, Monodox, Oracea, Oraxyl, Periostat, Vibramycin, Vibramycin Calcium, Vibramycin Monohydrate

What is Alodox (doxycycline)?

Doxycycline is a tetracycline antibiotic. It fights bacteria in the body.

Doxycycline is used to treat many different bacterial infections, such as urinary tract infections, acne, gonorrhea, and chlamydia, periodontitis (gum disease), and others.

Doxycycline is also used to treat blemishes, bumps, and acne-like lesions caused by rosacea. Doxycycline will not treat facial redness caused by rosacea.

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

What is the most important information I should know about Alodox (doxycycline)?

Do not use this medicine if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life.

Doxycycline can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using doxycycline.

You should not take this medicine if you are allergic to doxycycline or to other tetracycline antibiotics such as demeclocycline (Declomycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

Before taking doxycycline, tell your doctor if you have liver disease, kidney disease, asthma, or if you are allergic to sulfites.

Drink plenty of liquids while you are taking doxycycline. Children should not use doxycycline. Doxycycline can cause permanent yellowing or graying of the teeth in children younger than 8 years old. Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.

What should I discuss with my healthcare provider before taking Alodox (doxycycline)?

You should not take this medicine if you are allergic to doxycycline or to other tetracycline antibiotics such as demeclocycline (Declomycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

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

• 
  

  liver disease;

  
  


• 
  

  kidney disease; or

  
  


• 
  

  asthma or sulfite allergy.

  
  

If you are using doxycycline to treat gonorrhea, your doctor may test you to make sure you do not also have syphilis, another sexually transmitted disease.

FDA pregnancy category D. Do not use doxycycline if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life. Tell your doctor right away if you become pregnant during treatment.

Doxycycline can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using doxycycline.

Doxycycline passes into breast milk and may affect bone and tooth development in a nursing baby. You should not breast-feed while you are taking doxycycline. Children should not use doxycycline. Doxycycline can cause permanent yellowing or graying of the teeth in children younger than 8 years old.

How should I take Alodox (doxycycline)?

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

Take doxycycline with a full glass of water. Drink plenty of liquids while you are taking doxycycline.

Different brands of doxycycline may have different instructions about taking them with or without food.

Most brands of doxycyline may be taken with food or milk if the medicine upsets your stomach. Take Oracea or Periostat on an empty stomach, at least 1 hour before or 2 hours after a meal.

You may open a Doryx capsule or break up a Doryx tablet and sprinkle the medicine into a spoonful of applesauce to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use. Drink a full glass (8 ounces) of cool water right away.

Do not crush, break, or open a delayed-release capsule. Swallow the pill whole. Breaking or opening the pill may cause too much of the drug to be released at one time. The enteric coated pill has a special coating to protect your stomach. Breaking the pill will damage this coating.

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

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Doxycycline will not treat a viral infection such as the common cold or flu.

If you need surgery, tell the surgeon ahead of time that you are using doxycycline. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat. Throw away any unused medicine after the expiration date on the label has passed. Using expired doxycycline can cause damage to your kidneys.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include nausea, vomiting, and diarrhea.

What should I avoid while taking Alodox (doxycycline)?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking doxycycline and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid exposure to sunlight or tanning beds. Doxycycline can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Do not take iron supplements, multivitamins, calcium supplements, antacids, or laxatives within 2 hours before or after taking doxycycline.

Alodox (doxycycline) 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. Call your doctor at once if you have a serious side effect such as:

• 
  

  severe headache, dizziness, blurred vision;

  
  


• 
  

  fever, chills, body aches, flu symptoms, swollen glands, rash or itching, joint pain, or general ill feeling;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  diarrhea that is watery or bloody

  
  


• 
  

  pale or yellowed skin, dark colored urine, fever, confusion or weakness;

  
  


• 
  

  severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

  
  


• 
  

  loss of appetite, jaundice (yellowing of the skin or eyes); or

  
  


• 
  

  severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

  
  

Less serious side effects may include:

• 
  

  mild nausea, mild diarrhea;

  
  


• 
  

  upset stomach;

  
  


• 
  

  mild skin rash or itching; or

  
  


• 
  

  vaginal itching or discharge.

  
  

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 Alodox (doxycycline)?

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

• 
  

  cholesterol-lowering medications such as cholestyramine (Prevalite, Questran) or colestipol (Colestid);

  
  


• 
  

  isotretinoin (Accutane);

  
  


• 
  

  tretinoin (Renova, Retin-A, Vesanoid);

  
  


• 
  

  an antacid such as Tums, Rolaids, Milk of Magnesia, Maalox, and others;

  
  


• 
  

  a product that contains bismuth subsalicylate such as Pepto-Bismol;

  
  


• 
  

  minerals such as iron, zinc, calcium, magnesium, and over-the-counter vitamin and mineral supplements;

  
  


• 
  

  a blood thinner such as warfarin (Coumadin, Jantoven); or

  
  


• 
  

  a penicillin antibiotic such as amoxicillin (Amoxil, Augmentin, Dispermox, Moxatag), ampicillin (Principen, Unasyn), dicloxacillin (Dycill, Dynapen), oxacillin (Bactocill), or penicillin (Bicillin L-A, PC Pen VK, Pfizerpen).

  
  

This list is not complete and other drugs may interact with doxycycline. 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 Alodox resources

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

• Alodox Prescribing Information (FDA)


• Alodox Advanced Consumer (Micromedex) - Includes Dosage Information


• Doxycycline Professional Patient Advice (Wolters Kluwer)


• Doxycycline Prescribing Information (FDA)


• Doxycycline Monograph (AHFS DI)


• Doxycycline MedFacts Consumer Leaflet (Wolters Kluwer)


• Adoxa MedFacts Consumer Leaflet (Wolters Kluwer)


• Doryx Prescribing Information (FDA)


• Doryx Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Doxycycline Calcium Monograph (AHFS DI)


• Monodox Prescribing Information (FDA)


• Ocudox Convenience Kit MedFacts Consumer Leaflet (Wolters Kluwer)


• Oracea Prescribing Information (FDA)


• Oracea Consumer Overview


• Periostat MedFacts Consumer Leaflet (Wolters Kluwer)


• Periostat Prescribing Information (FDA)


• Vibra-Tabs MedFacts Consumer Leaflet (Wolters Kluwer)


• Vibramycin Prescribing Information (FDA)

Compare Alodox with other medications

• Skin Infection

Where can I get more information?

• Your pharmacist can provide more information about doxycycline.

See also: Alodox side effects (in more detail)

japanese encephalitis virus vaccine, inactivated Subcutaneous

jap-a-NEEZ en-sef-a-LYTE-is VYE-rus VAX-een, in-AK-ti-vay-ted

Commonly used brand name(s)

In the U.S.

• Je-Vax

Available Dosage Forms:

• Powder for Suspension

Therapeutic Class: Vaccine

Uses For japanese encephalitis virus vaccine, inactivated

Japanese encephalitis virus vaccine, inactivated (JE-VAX(R)) is an immunizing agent used to help prevent infection by the Japanese encephalitis virus. Japanese encephalitis is caused by the bite of a mosquito that lives in certain parts of Asia. The vaccine works by causing your body to produce its own protection (antibodies) against the virus.

This vaccine was available only from your doctor or other authorized health care professional.

The Japanese encephalitis virus vaccine, inactivated (JE-VAX(R)) is no longer marketed in the United States.

Before Using japanese encephalitis virus vaccine, inactivated

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to japanese encephalitis virus vaccine, inactivated 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

Studies on this vaccine have been done only in adults and children 1 year of age and older. There is no specific information comparing use of this vaccine in infants under 1 year of age with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of Japanese encephalitis virus vaccine in the elderly with use in other age groups, this vaccine is not expected to cause different side effects or problems in older people than it does in younger adults. In addition, immunization may be especially useful for the elderly, since older persons may have a higher risk of illness following infection with the Japanese encephalitis virus.

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

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Hives (history of)—May increase the chance of side effects of the vaccine

Proper Use of japanese encephalitis virus vaccine, inactivated

It is important that you receive 3 doses of the vaccine. If there is not enough time for you to get all 3 doses, you may get 2 doses of the vaccine. However, 2 doses of the vaccine will not protect you as well as 3 doses.

It is important that you receive all 3 doses of the vaccine at least 10 days before you plan on traveling out of the country. There is a chance of side effects that do not show up right away, and, if they do occur, they may need medical attention. In addition, the 10 days will give your body time to produce antibodies against the Japanese encephalitis virus.

Dosing

The dose of japanese encephalitis virus vaccine, inactivated 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 japanese encephalitis virus vaccine, inactivated. 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.

The number of doses you receive and the time allowed between doses of Japanese encephalitis virus vaccine, inactivated (JE-VAX(R)) will be different for different patients.

• For help preventing Japanese encephalitis:
  
  • For injection dosage form:
    
    • Adults and children 1 year of age and older—One dose injected under the skin on days zero, seven, and thirty, for a total of three doses.
    
    
    • Children up to 1 year of age—Use and dose must be determined by your doctor.
    
    
  
  

Precautions While Using japanese encephalitis virus vaccine, inactivated

Since the vaccine may not protect everyone completely, it is very important that you still use precautions to reduce your chance of mosquito bites. These include using insect repellents and mosquito netting, wearing protective clothing, and staying indoors during twilight and after dark.

japanese encephalitis virus vaccine, inactivated 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. It is very important that you tell your doctor about any side effect that occurs after a dose of the vaccine, even if the side effect goes away without treatment. Some types of side effects may mean that you should not receive any more doses of the vaccine.

Get emergency help immediately if the following side effect occurs:

Rare

• Swelling of face, lips, eyelids, throat, tongue, hands, or feet

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

Rare

• Hives


• tiredness or weakness (severe or unusual)


• wheezing or troubled breathing

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Tenderness, soreness, redness, or swelling at place of injection

Less common

• Abdominal pain


• aches or pains in muscles


• chills or fever


• dizziness


• general feeling of discomfort or illness


• headache


• itching or skin rash


• nausea or vomiting

Rare

• Joint swelling

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

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

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

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

More japanese encephalitis virus vaccine, inactivated Subcutaneous resources

• Japanese encephalitis virus vaccine, inactivated Subcutaneous Use in Pregnancy & Breastfeeding
• Japanese encephalitis virus vaccine, inactivated Subcutaneous Drug Interactions
• Japanese encephalitis virus vaccine, inactivated Subcutaneous Support Group
• 0 Reviews for Japanese encephalitis virus vaccine, inactivated Subcutaneous - Add your own review/rating

Compare japanese encephalitis virus vaccine, inactivated Subcutaneous with other medications

• Japanese Encephalitis Virus Prophylaxis

Urispas

Generic Name: Flavoxate Hydrochloride
Class: Genitourinary Smooth Muscle Relaxants
ATC Class: G04BD02
VA Class: GU201
Chemical Name: 2-piperidinoethyl 3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylate hydrochloride
CAS Number: 3717-88-2

Introduction

Genitourinary antispasmodic.^{a b}

Uses for Urispas

Overactive Bladder

Symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence associated with cystitis, prostatitis, urethritis, urethrocystitis, or urethrotrigonitis. ^b Not indicated as definitive treatment, but is compatible with drugs used for treatment of urinary tract infections.^a

Has not been shown to be more effective in the treatment of these conditions than antimuscarinic agents.^a

Urispas Dosage and Administration

Administration

Oral Administration

Administer orally 3 or 4 times daily.^{a b}

Dosage

Available as flavoxate hydrochloride; dosage expressed in terms of the salt.^b

Pediatric Patients

Oral

Children ≥12 years of age: 100 or 200 mg 3 or 4 times daily. ^{a b} May reduce dosage as symptoms improve.^{a b}

Adults

Oral

100 or 200 mg 3 or 4 times daily. ^{a b} May reduce dosage as symptoms improve.^{a b}

Special Populations

No special population dosage recommendations at this time.^b

Cautions for Urispas

Contraindications

• 
  

  Pyloric or duodenal obstruction. ^{a b}

  
  


• 
  

  Obstructive intestinal lesions or ileus.^{a b}

  
  


• 
  

  Achalasia.^{a b}

  
  


• 
  

  GI hemorrhage.^{a b}

  
  


• 
  

  Obstructive uropathies of the lower urinary tract.^{a b}

  
  

Warnings/Precautions

Warnings

Glaucoma

Use with caution in patients with suspected glaucoma. ^{a b}

Specific Populations

Pregnancy

Category B.^b

Lactation

Not known whether flavoxate is distributed into milk.^{a b} Caution if used in nursing women.^b

Pediatric Use

Safety and efficacy not established in children <12 years of age. ^{a b}

Geriatric Use

Possible increased incidence of mental confusion compared with younger adults.^b

Common Adverse Effects

Nausea, vomiting, dry mouth, vertigo, headache, mental confusion, drowsiness, nervousness, blurred vision.^b

Interactions for Urispas

No formal drug interaction studies to date.^{a b}

Urispas Pharmacokinetics

Absorption

Bioavailability

Appears to be well absorbed from the GI tract. ^a

Onset

Following oral administration in healthy males, onset of action was 55 minutes.^a

Duration

Following oral administration in healthy males, peak effect occurred at 112 minutes.^a

Distribution

Extent

Not known whether flavoxate is distributed into milk.^a

Elimination

Elimination Route

57% of an oral dose of flavoxate is excreted in urine within 24 hours.^{a b}

Special Populations

Not known whether flavoxate is dialyzable.^a

Stability

Storage

Oral

Tablets

15–30°C.^{a b}

ActionsActions

• 
  

  Exerts a direct spasmolytic (papaverine-like) action on smooth muscle of the urinary tract.^{a b}

  
  


• 
  

  Increases urinary bladder capacity in patients with evidence of bladder spasticity, possibly as a result of action on the detrusor muscle.^a

  
  

Advice to Patients

• 
  

  Risk of drowsiness or blurred vision; use caution when driving, operating machinery, or participating in activities where alertness is required.^b

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.^b

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.^b

  
  


• 
  

  Importance of informing patients of other important precautionary information.^b (See Cautions.)

  
  

Preparations

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

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Flavoxate Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	100 mg*	Urispas	Ortho-McNeil

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.

Flavoxate HCl 100MG Tablets (GLOBAL PHARMACEUTICAL CORP): 100/$99.99 or 300/$279.96

Urispas 100MG Tablets (MCNEIL): 28/$51.99 or 84/$145.97

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 September 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. AHFS drug information 2004. McEvoy GK, ed. Flavoxate. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 3600-1.

b. Ortho-McNeil Pharmaceutical, Inc. Urispas (flavoxate hydrochloride) prescribing and patient information. Raritan, NJ; 2004 Aug.

More Urispas resources

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

• Urispas Prescribing Information (FDA)


• Urispas MedFacts Consumer Leaflet (Wolters Kluwer)


• Urispas Concise Consumer Information (Cerner Multum)


• Urispas Advanced Consumer (Micromedex) - Includes Dosage Information


• Flavoxate Prescribing Information (FDA)


• Flavoxate Professional Patient Advice (Wolters Kluwer)

Compare Urispas with other medications

• Dysuria
• Overactive Bladder
• Urinary Incontinence

Cyanocobalamin (B12) Tablets

Pronunciation: sigh-an-oh-koe-BAL-uh-min
Generic Name: Cyanocobalamin (B12)
Brand Name: B-12 Dots

Cyanocobalamin (B12) is used for:

Treating or preventing low blood levels of vitamin B₁₂. It may also be used for other conditions as determined by your doctor.

Cyanocobalamin (B12) is a form of vitamin B₁₂. It works by replacing vitamin B₁₂ in the body.

Do NOT use Cyanocobalamin (B12) if:

• you are allergic to any ingredient in Cyanocobalamin (B12), including cobalt

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

Before using Cyanocobalamin (B12):

Some medical conditions may interact with Cyanocobalamin (B12). 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 an infection, Leber disease (weakened eye nerve), a buildup of waste in the blood (uremia), any kind of anemia, or low blood levels of iron or folic acid


• if you are a vegetarian


• if you drink alcohol on a regular basis

Some MEDICINES MAY INTERACT with Cyanocobalamin (B12). Tell your health care provider if you are taking any other medicines, especially any of the following:

• Chloramphenicol or other medicine that may decrease your bone marrow because effectiveness of Cyanocobalamin (B12) may be decreased; ask your doctor if you are unsure if any of your medicines may decrease your bone marrow


• Colchicine or para-aminosalicylic acid because the effectiveness of Cyanocobalamin (B12) may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Cyanocobalamin (B12) 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 Cyanocobalamin (B12):

Use Cyanocobalamin (B12) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Cyanocobalamin (B12) may be taken with or without food.


• Place Cyanocobalamin (B12) beneath your tongue and allow the tablet to dissolve.


• If you miss a dose of Cyanocobalamin (B12), 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 Cyanocobalamin (B12).

Important safety information:

• Heavy alcohol intake for more than 2 weeks may decrease the effectiveness of Cyanocobalamin (B12). Check with your doctor if you drink alcohol on a regular basis.


• You may need to have blood tests every 3 to 6 months to monitor your progress.


• Certain medicines, including antibiotics, methotrexate, or pyrimethamine, may interfere with lab tests for vitamin B₁₂ and folic acid. Be sure your doctor and lab personnel know all the medicines that you are taking.


• Do not take large doses of vitamins (megadoses or megavitamin therapy) while taking Cyanocobalamin (B12) unless directed by your doctor.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Cyanocobalamin (B12), discuss with your doctor the benefits and risks of using Cyanocobalamin (B12) during pregnancy. Cyanocobalamin (B12) is excreted in breast milk. If you are or will be breast-feeding while you are using Cyanocobalamin (B12), check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Cyanocobalamin (B12):

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Cyanocobalamin (B12) side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Cyanocobalamin (B12):

Store Cyanocobalamin (B12) at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Store upright. Do not freeze. Do not store in the bathroom. Keep Cyanocobalamin (B12) out of the reach of children and away from pets.

General information:

• If you have any questions about Cyanocobalamin (B12), please talk with your doctor, pharmacist, or other health care provider.


• Cyanocobalamin (B12) 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 Cyanocobalamin (B12). 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 Cyanocobalamin (B12) resources

• Cyanocobalamin (B12) Side Effects (in more detail)
• Cyanocobalamin (B12) Use in Pregnancy & Breastfeeding
• Cyanocobalamin (B12) Drug Interactions
• Cyanocobalamin (B12) Support Group
• 5 Reviews for Cyanocobalamin (B12) - Add your own review/rating

Compare Cyanocobalamin (B12) with other medications

• B12 Nutritional Deficiency
• Pernicious Anemia
• Schilling Test
• Vitamin B12 Deficiency

Amoxil Paediatric Suspension

1. Name Of The Medicinal Product

Amoxil® Paediatric Suspension

2. Qualitative And Quantitative Composition

Amoxil Paediatric Suspension contains 125 mg amoxicillin per 1.25 ml dose

The amoxicillin is present as the trihydrate.

3. Pharmaceutical Form

Amoxil Paediatric Suspension: citrus flavoured suspension. Presented as powder in bottles for preparing 20 ml.

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of Infection: Amoxil is a broad spectrum antibiotic indicated for the treatment of commonly occurring bacterial infections such as:

Upper respiratory tract infections

Otitis media

Acute and chronic bronchitis

Chronic bronchial sepsis

Lobar and bronchopneumonia

Cystitis, urethritis, pyelonephritis

Bacteriuria in pregnancy

Gynaecological infections including puerperal sepsis and septic abortion

Gonorrhoea

Peritonitis

Intra-abdominal sepsis

Septicaemia

Bacterial endocarditis

Typhoid and paratyphoid fever

Skin and soft tissue infections

Osteomyelitis

Dental abscess (as an adjunct to surgical management)

In children with urinary tract infection the need for investigation should be considered.

Prophylaxis of endocarditis: Amoxil may be used for the prevention of bacteraemia, associated with procedures such as dental extraction, in patients at risk of developing bacterial endocarditis.

Consideration should be given to official local guidance (e.g. national requirements) on the appropriate use of antibacterial agents.”Susceptibility of the causative organism to the treatment should be tested (if possible), although the therapy may be initiated before the results are available.

4.2 Posology And Method Of Administration

Treatment of Infection:

Adult dosage (including elderly patients):

Oral:

Standard adult dosage: 250 mg three times daily, increasing to 500 mg three times daily for more severe infections.

High dosage therapy (maximum recommended oral dosage 6 g daily in divided doses): A dosage of 3 g twice daily is recommended in appropriate cases for the treatment of severe or recurrent purulent infection of the respiratory tract.

Short course therapy: Simple acute urinary tract infection: two 3 g doses with 10-12 hours between the doses. Dental abscess: two 3 g doses with 8 hours between the doses. Gonorrhoea: single 3 g dose.

Children weighing <40kg:

The daily dosage for children is 40 - 90 mg/kg/day in two to three divided doses* (not exceeding 3 g/day) depending on the indication, severity of the disease and the susceptibility of the pathogen (see special dosage recommendations below and sections 4.4, 5.1 and 5.2).

PK/PD data indicate that dosing three times daily is associated with enhanced efficacy, thus twice daily dosing is only recommended when the dose is in the upper range.

Children weighing more than 40 kg should be given the usual adult dosage

Special dosage recommendation

Tonsillitis: 50 mg/kg/day in two divided doses.

Acute otitis media: In areas with high prevalence of pneumococci with reduced susceptibility to penicillins, dosage regimens should be guided by national/local recommendations. In severe or recurrent acute otitis media, especially where compliance may be a problem, 750 mg twice a day for two days may be used as an alternative course of treatment in children aged 3 to 10 years.

Early Lyme disease (isolated erythema migrans): 50 mg/kg/day in three divided doses, over 14-21days.

Dosage in impaired renal function:

The dose should be reduced in patients with severe renal function impairment. In patients with a creatinine clearance of less than 30 ml/min an increase in the dosage interval and a reduction in the total daily dose is recommended (see section 4.4 and 5.2):

Glomerular filtration rate >30ml/min No adjustment necessary.

Glomerular filtration rate 10-30ml/min: Amoxicillin. max. 500mg b.d

Glomerular filtration rate <10ml/min: Amoxicillin. max. 500mg/day

Renal impairment in children under 40 kg:

Creatinine clearance ml/min	Dose	Interval between administration
> 30	Usual dose	No adjustment necessary
10 – 30	Usual dose	12 h (corresponding to 2/3 of the dose)
< 10	Usual dose	24 h (corresponding to 1/3 of the dose)

Amoxil Paediatric Suspension is recommended for children under six months of age.

Prophylaxis of endocarditis:

CONDITION		ADULTS' DOSAGE (INCLUDING ELDERLY)	CHILDREN'S DOSAGE (< 40 kg)	NOTES
Dental procedures: prophylaxis for patients undergoing extraction, scaling or surgery involving gingival tissues and who have not received a penicillin in the previous month. (N.B. Patients with prosthetic heart valves should be referred to hospital - see below).	Patient not having general anaesthetic.	3 g 'Amoxil' orally, 1 hour before procedure. A second dose may be given 6 hours later, if considered necessary.	50 mg amoxicillin/kg body weight given as a single dose one hour preceding the surgical procedure	Note 1. If prophylaxis with 'Amoxil' is given twice within one month, emergence of resistant streptococci is unlikely to be a problem. Alternative antibiotics are recommended if more frequent prophylaxis is required, or if the patient has received a course of treatment with a penicillin during the previous month. Note 2 To minimise pain on injection, 'Amoxil' may be given as two injections of 500 mg dissolved in sterile 1% lidocaine solution (see Administration).
Patient having general anaesthetic: if oral antibiotics considered to be appropriate.	Initially 3 g 'Amoxil' orally 4 hours prior to anaesthesia, followed by 3 g orally (or 1 g IV or IM if oral dose not tolerated) as soon as possible after the operation.
Patient having general anaesthetic: if oral antibiotics not appropriate.	1 g 'Amoxil' IV or IM immediately before induction; with 500 mg orally, 6 hours later.
Dental procedures: patients for whom referral to hospital is recommended: a) Patients to be given a general anaesthetic who have been given a penicillin in the previous month. b) Patients to be given a general anaesthetic who have a prosthetic heart valve. c) Patients who have had one or more attacks of endocarditis.	Initially: 1 g 'Amoxil' IV or IM with 120 mg gentamicin IV or IM immediately prior to anaesthesia (if given) or 15 minutes prior to dental procedure. Followed by (6 hours later): 500 mg 'Amoxil' orally.	50 mg amoxicillin/kg body weight given as a single dose one hour preceding the surgical procedure	See Note 2. Note 3. 'Amoxil' and gentamicin should not be mixed in the same syringe. Note 4. Please consult the appropriate data sheet for full prescribing information on gentamicin.
Genitourinary Surgery or Instrumentation: prophylaxis for patients who have no urinary tract infection and who are to have genito-urinary surgery or instrumentation under general anaesthesia. In the case of Obstetric and Gynaecological Procedures and Gastrointestinal Procedures– routine prophylaxis is recommended only for patients with prosthetic heart valves.	Initially: 1 g 'Amoxil' IV or IM with 120 mg gentamicin IV or IM, immediately before induction. Followed by (6 hours later): 500 mg 'Amoxil' orally or IV or IM according to clinical condition.	See Notes 2, 3 and 4 above.
Surgery or Instrumentation of the Upper Respiratory Tract	Patients other than those with prosthetic heart valves.	1 g 'Amoxil' IV or IM immediately before induction; 500 mg 'Amoxil' IV or IM 6 hours later.	50 mg amoxicillin/kg body weight given as a single dose one hour preceding the surgical procedure	See Note 2 above. Note 5. The second dose of 'Amoxil' may be administered orally as 'Amoxil' Syrup SF/DF.
Patients with prosthetic heart valves.	Initially: 1 g 'Amoxil' IV or IM with 120 mg gentamicin IV or IM, immediately before induction; followed by (6 hours later) 500 mg 'Amoxil' IV or IM.	50 mg amoxicillin/kg body weight given as a single dose one hour preceding the surgical procedure	See Notes 2, 3, 4 and 5 above.

Prophylaxis of endocarditis: see table on previous page.

Administration:

Oral.

Treatment should be continued for 2 to 3 days following the disappearance of symptoms. It is recommended that at least 10 days treatment be given for any infection caused by beta-haemolytic streptococci in order to achieve eradictaion of the organism.

4.3 Contraindications

Amoxil is a penicillin and should not be given to penicillin-hypersensitive patients. Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics eg. cephalosporins.

4.4 Special Warnings And Precautions For Use

Before initiating therapy with amoxicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins.

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of hypersensitivity to beta-lactam antibiotics (see 4.3).

Erythematous (morbilliform) rashes have been associated with glandular fever in patients receiving amoxicillin.

Prolonged use may also occasionally result in overgrowth of non-susceptible organisms.

In patients with reduced urine output, crystalluria has been observed very rarely, predominantly with parenteral therapy. During the administration of high doses of amoxicillin, it is advisable to maintain adequate fluid intake and urinary output in order to reduce the possibility of amoxicillin crystalluria (see Section 4.9 Overdose).

In patients with renal impairment, the rate of excretion of amoxicillin will be reduced depending on the degree of impairment and it may be necessary to reduce the total daily unit amoxicillin dosage accordingly (see section 4.2).

Abnormal prolongation of prothrombin time (increased INR) has been reported rarely in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation (see sections 4.5 and 4.8).

Precaution should be taken in premature children and during the neonatal period: renal, hepatic and haematological functions should be monitored.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with Amoxil may result in increased and prolonged blood levels of amoxicillin.

In common with other antibiotics, amoxicillin may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.

Concurrent administration of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions.

In the literature there are rare cases of increased international normalised ratio in patients maintained on acenocoumarol or warfarin and prescribed a course of amoxicillin. If co-administration is necessary, the prothrombin time or international normalised ratio should be carefully monitored with the addition or withdrawal of amoxicillin (see sections 4.4 and 4.8).

It is recommended that when testing for the presence of glucose in urine during amoxicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of amoxicillin, false positive readings are common with chemical methods.

4.6 Pregnancy And Lactation

Use in pregnancy:

Animal studies with Amoxil have shown no teratogenic effects. The product has been in extensive clinical use since 1972 and its suitability in human pregnancy has been well documented in clinical studies. When antibiotic therapy is required during pregnancy, Amoxil may be considered appropriate when the potential benefits outweigh the potential risks associated with treatment.

Use in lactation:

Amoxicillin may be given during lactation. With the exception of the risk of sensitisation associated with the excretion of trace quantities of amoxicillin in breast milk, there are no known detrimental effects for the breast-fed infant.

4.7 Effects On Ability To Drive And Use Machines

Adverse effects on the ability to drive or operate machinery have not been observed.

4.8 Undesirable Effects

The following convention has been utilised for the classification of undesirable effects:-

Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000,<1/100), rare (>1/10,000, <1/1000), very rare (<1/10,000)

The majority of side effects listed below are not unique to amoxicillin and may occur when using other penicillins.

Unless otherwise stated, the frequency of adverse events has been derived from more than 30 years of post-marketing reports.

Infections and infestations
Very Rare:	Mucocutaneous candidiasis
Blood and lymphatic system disorders
Very rare:	Reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and haemolytic anaemia. Prolongation of bleeding time and prothrombin time (see section 4.4 – Special Warnings and Precautions for Use .
Immune system disorders
Very rare:	As with other antibiotics, severe allergic reactions, including angioneurotic oedema, anaphylaxis (see Section 4.4 - Special Warnings and Precautions for Use), serum sickness and hypersensitivity vasculitis.
If a hypersensitivity reaction is reported, the treatment must be discontinued. (See also Skin and subcutaneous tissue disorders).
Nervous system disorders
Very rare:	Hyperkinesia, dizziness and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses.
Gastrointestinal disorders
Clinical Trial Data
*Common:	Diarrhoea and nausea.
*Uncommon:	Vomiting.
Post-marketing Data
Very rare:	Antibiotic associated colitis (including pseudomembraneous colitis and haemorrhagic colitis). Black hairy tongue Superficial tooth discolouration has been reported in children. Good oral hygiene may help to prevent tooth discolouration as it can usually be removed by brushing.
Hepato-biliary disorders
Very rare:	Hepatitis and cholestatic jaundice. A moderate rise in AST and/or ALT.
The significance of a rise in AST and/or ALT is unclear.
Skin and subcutaneous tissue disorders
Clinical Trial Data
*Common:	Skin rash
*Uncommon:	Urticaria and pruritus
Post-marketing Data
Very rare:	Skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis and acute generalised exanthematous pustulosis (AGEP)
(See also Immune system disorders).
Renal and urinary tract disorders
Very rare:	Interstitial nephritis.
Very rare:	Crystalluria (see Section 4.9 Overdose).
*The incidence of these AEs was derived from clinical studies involving a total of approximately 6,000 adult and paediatric patients taking amoxicillin.

4.9 Overdose

Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically with attention to the water/electrolyte balance. Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see Section 4.4 Special warnings and special precautions for use).

Amoxicillin may be removed from the circulation by haemodialysis.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Amoxil is a broad spectrum antibiotic.

It is rapidly bactericidal and possesses the safety profile of a penicillin.

The wide range of organisms sensitive to the bactericidal action of Amoxil include:

Aerobes:
Gram-positive	Gram-negative
Streptococcus faecalis	Haemophilus influenzae
Streptococcus pneumoniae	Escherichia coli
Streptococcus pyogenes	Proteus mirabilis
Streptococcus viridans	Salmonella species
Staphylococcus aureus	Shigella species
(penicillin-sensitive strains only)	Bordetella pertussis
	Brucella species
Corynebacterium species	Neisseria gonorrhoeae
Bacillus anthracis	Neisseria meningitidis
Listeria monocytogenes	Vibrio cholerae
	Pasteurella septica
Anaerobes:
Clostridium species

5.2 Pharmacokinetic Properties

Amoxil is well absorbed by the oral and parenteral routes. Oral administration, usually at convenient t.d.s. dosage, produces high serum levels independent of the time at which food is taken. Amoxil gives good penetration into bronchial secretions and high urinary concentrations of unchanged antibiotic.

In preterm infants with gestational age 26-33 weeks, the total body clearance after intravenous dosing of amoxicillin, day 3 of life, ranged between 0.75 – 2 ml/min, very similar to the inuline clearance (GFR) in this population. Following oral administration, the absorption pattern and the bioavailability of amoxicillin in small children may be different to that of adults. Consequently, due to the decreased CL, the exposure is expected to be elevated in this group of patients, although this increase in exposure may in part be diminished by decreased bioavailability when given orally.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Amoxil Paediatric Suspension

The powder contains sodium benzoate (E211), sodium carboxymethylcellulose (E466), quinolene yellow (E104), peach, strawberry and lemon dry flavours and sucrose (0.6 g per 1.25 ml dose).

6.2 Incompatibilities

None known.

6.3 Shelf Life

Paediatric Suspension

36M (once reconstituted: 14 days)

6.4 Special Precautions For Storage

Prior to use, Amoxil Paediatric Suspension should be stored in a dry place.

Once dispensed, Amoxil Paediatric Suspension should be stored at 25°C or below and used within 14 days. Amoxil Paediatric Suspension may be diluted with water or Syrup BP.

6.5 Nature And Contents Of Container

Amoxil Paediatric Suspension: 125 mg per 1.25 ml: Original Pack of 20 ml with pipette and Patient Information Leaflet.

6.6 Special Precautions For Disposal And Other Handling

None.

Administrative Data

7. Marketing Authorisation Holder

Beecham Group plc

Great West Road, Brentford, Middlesex TW8 9GS

Trading as GlaxoSmithKline UK Stockley Park West, Uxbridge, Middlesex UB11 1BT

And/or

Bencard or SmithKline Beecham Pharmaceuticals, Mundells, Welwyn Garden City, Hertfordshire AL7 1EY

8. Marketing Authorisation Number(S)

Amoxil Paediatric Suspension 125 mg per 1.25 ml

00038/0107

9. Date Of First Authorisation/Renewal Of The Authorisation

07 March 1972 / 13 January 1998

10. Date Of Revision Of The Text

17 November 2010

11. Legal Status

POM

Ciclopirox Suspension

Pronunciation: sye-kloe-PEER-ox
Generic Name: Ciclopirox
Brand Name: Generic only. No brands available.

Ciclopirox Suspension is used for:

Treating athlete's foot, jock itch, ringworm, and other fungal infections of the skin. It may also be used for other conditions as determined by your doctor.

Ciclopirox Suspension is an antifungal. It works by slowing the growth of the fungus.

Do NOT use Ciclopirox Suspension if:

• you are allergic to any ingredient in Ciclopirox Suspension

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

Before using Ciclopirox Suspension:

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

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


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


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

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

Ask your health care provider if Ciclopirox Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ciclopirox Suspension:

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

• Clean the affected area with soap and water and dry thoroughly. Shake well before using a dose. Apply enough medicine to cover the affected area. Rub in gently. Do not cover unless directed by your doctor. Wash your hands immediately after using Ciclopirox Suspension, unless your hands are part of the treated area.


• To clear up your infection completely, use Ciclopirox Suspension for the full course of treatment. Keep using it even if your symptoms have improved.


• If you miss a dose of Ciclopirox Suspension, 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 Ciclopirox Suspension.

Important safety information:

• Ciclopirox Suspension is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in your eyes, rinse right away with cool tap water.


• Do not wrap or otherwise cover the treated area with bandages or wear tight-fitting clothing unless specifically directed by your doctor.


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


• If your symptoms do not get better within 4 weeks or if they get worse, check with your doctor.


• Ciclopirox Suspension should not be used in CHILDREN younger than 10 years old; safety and effectiveness in these children have not been confirmed.


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

Possible side effects of Ciclopirox Suspension:

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

Burning; itching 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); blistering; oozing; swelling.

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: Ciclopirox 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. Ciclopirox Suspension may be harmful if swallowed.

Proper storage of Ciclopirox Suspension:

Store Ciclopirox Suspension between 41 and 77 degrees F (5 and 25 degrees C). Store away from heat, moisture, and light. Keep Ciclopirox Suspension out of the reach of children and away from pets.

General information:

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


• Ciclopirox Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


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

This information is a summary only. It does not contain all information about Ciclopirox Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Ciclopirox resources

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

Compare Ciclopirox with other medications

• Cutaneous Candidiasis
• Onychomycosis, Fingernail
• Onychomycosis, Toenail
• Seborrheic Dermatitis
• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor

Listermint Rinse

Pronunciation: SO-dee-um FLOR-ide
Generic Name: Sodium Fluoride
Brand Name: Examples include Listermint and PreviDent

Listermint Rinse is used for:

Preventing dental caries.

Listermint Rinse is a fluoride rinse. It works by strengthening the teeth and decreasing the effects of acid and bacteria on the teeth.

Do NOT use Listermint Rinse if:

• you are allergic to any ingredient in Listermint Rinse

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

Before using Listermint Rinse:

Some medical conditions may interact with Listermint Rinse. 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

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

Ask your health care provider if Listermint Rinse 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 Listermint Rinse:

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

• Use Listermint Rinse at bedtime after brushing your teeth. Measure the prescribed dose and swish between your teeth for 1 minute, then spit out, unless directed otherwise by your doctor. Do not eat, drink, or rinse your mouth for 30 minutes after using Listermint Rinse.


• If you miss a dose of Listermint Rinse, 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 Listermint Rinse.

Important safety information:

• Do not exceed the dose recommended by your doctor or dentist.


• Notify your dentist if your teeth become spotted or stained.


• Listermint Rinse is not recommended for use in CHILDREN younger than 6 years old; safety and effectiveness in this age group have not been confirmed.


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

Possible side effects of Listermint Rinse:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with Listermint Rinse. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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 diarrhea; extreme thirst; increased drooling; muscle weakness; nausea; paleness of the skin; seizures; shallow, rapid breathing; shaking; stomach pain; vomiting; weak or fast heartbeat.

Proper storage of Listermint Rinse:

Store Listermint Rinse at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Keep Listermint Rinse out of the reach of children and away from pets.

General information:

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


• Listermint Rinse 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 Listermint Rinse. 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 Listermint resources

• Listermint Use in Pregnancy & Breastfeeding
• Listermint Support Group
• 3 Reviews for Listermint - Add your own review/rating

Compare Listermint with other medications

• Prevention of Dental Caries

Stalevo 125

Generic Name: carbidopa, entacapone, and levodopa (Oral route)

lee-voe-DOE-pa, kar-bi-DOE-pa, en-TAK-a-pone

Commonly used brand name(s)

In the U.S.

• Stalevo 100


• Stalevo 125


• Stalevo 150


• Stalevo 50


• Stalevo 75

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiparkinsonian

Pharmacologic Class: Dopamine Precursor

Uses For Stalevo 125

Carbidopa, entacapone, and levodopa combination is used to treat Parkinson's disease, sometimes called shaking palsy. Parkinson's disease is a disorder of the central nervous system (brain and spinal cord).

Dopamine is a naturally occurring substance in the brain that helps provide control of movement and activities such as walking and talking. In patients with Parkinson's disease, there is not enough dopamine in some parts of the brain. Levodopa (a component of this medicine) enters the brain and helps replace the missing dopamine, which allows people to function better. By increasing the amount of dopamine in the brain, levodopa helps control symptoms and helps you to perform daily activities such as dressing, walking, and handling utensils.

This medicine is a combination of three different medicines. This medicine is known as a levodopa therapy. The difference between this medicine and other levodopa treatments is that this medicine contains entacapone. Entacapone helps levodopa last longer by blocking a substance called COMT enzyme. This enzyme breaks down levodopa before it reaches the brain. When less levodopa is broken down, more is available to the brain. Increased availability of levodopa may lead to smoother and steadier levels of dopamine in the brain, which may provide better symptom control for longer periods each day. This may lead to improvement in daily activities.

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

Before Using Stalevo 125

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

Appropriate studies have not been performed on the relationship of age to the effects of carbidopa, entacapone, and levodopa combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date in elderly patients up to age 75 years have not demonstrated geriatrics-specific problems that would limit the usefulness of carbidopa, entacapone, and levodopa combination in the elderly. However, elderly patients are more likely to have age-related kidney, liver, and cardiovascular insufficiency, which may require extra caution.

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. When you are taking this medicine, 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 this medicine 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.

• Clorgyline


• Iproniazid


• Isocarboxazid


• Linezolid


• Nialamide


• Pargyline


• Phenelzine


• Procarbazine


• Selegiline


• Toloxatone


• Tranylcypromine

Using this medicine 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.

• Apomorphine


• Bitolterol


• Desipramine


• Dobutamine


• Dopamine


• Epinephrine


• Iproniazid


• Isocarboxazid


• Isoetharine


• Isoniazid


• Isoproterenol


• Linezolid


• Methyldopa


• Moclobemide


• Nialamide


• Norepinephrine


• Pargyline


• Phenelzine


• Procarbazine


• Tranylcypromine


• Venlafaxine

Using this medicine 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.

• Bromperidol


• Bupropion


• Droperidol


• Ferric Ammonium Citrate


• Fosphenytoin


• Indinavir


• Iron


• Kava


• Metoclopramide


• Phenylalanine


• Phenytoin


• Spiramycin


• Tyrosine

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• High Protein Food

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:

• Asthma or


• Biliary obstruction or blockage or


• Colitis (inflammation of the colon) or


• Depression, history of or


• Dyskinesia (abnormal muscle movements) or


• Endocrine or metabolic disease or


• Heart attack, history of or


• Heart or blood vessel disease, severe or


• Heart rhythm problems (e.g., ventricular tachycardia) or


• Hypotension (low blood pressure) or


• Kidney disease or


• Liver disease or


• Lung disease, severe or


• Psychosis (mental disorder), or history of or


• Wide-angle glaucoma (eye pressure problem)—Use with caution. May make these conditions worse.

• Melanoma (skin tumor), history of or


• Narrow–angle glaucoma (eye pressure problem) or


• Skin lesions, undiagnosed (rashes that involve changes in color or texture of the skin)—Should not be used in patients with these conditions.

• Peptic ulcer, history of—May increase risk of stomach or bowel hemorrhage.

Proper Use of carbidopa, entacapone, and levodopa

This section provides information on the proper use of a number of products that contain carbidopa, entacapone, and levodopa. It may not be specific to Stalevo 125. Please read with care.

Take this medicine exactly as directed, and every time that you are supposed to take it. It is important that you do not stop taking your medicine unless ordered by your doctor. It is also important to not start taking other medicines for your Parkinson's disease without first talking with your doctor.

Since protein may interfere with the body's response to levodopa, high protein diets should be avoided. Intake of normal amounts of protein should be spaced equally throughout the day, or taken as directed by your doctor.

You may experience a “wearing-off” effect towards the end of the dosing interval. You should tell your doctor if you have problems with this that affect your every day life. Your doctor may want to adjust your dose.

This medicine begins to release its ingredients 30 minutes after you take it.

If you are taking multivitamin tablets or plan to start taking them, discuss this first with your doctor. Iron salts (in vitamins) may keep this medicine from working properly.

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 forms (capsules or tablets):
  
  • For Parkinson's disease:
    
    • Adults—The starting dose is usually the same as the current dose you are taking. If you are starting this medicine for the first time, your doctor may want to start you on a carbidopa and levodopa combination with entacapone and gradually switch you over to this combination.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

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.

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

Precautions While Using Stalevo 125

It is very important that your doctor check your progress at regular visits to allow changes in your dose and to check for any unwanted effects.

Do not take this medicine if you have taken a monoamine oxidase (MAO) inhibitor (e.g. phenelzine [Nardil®] or tranylcypromine [Parnate®]) in the past 2 weeks.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.

Check with your doctor right away if you are having convulsions (seizures); difficulty with breathing; a fast heartbeat; a high fever; high or low blood pressure; increased sweating; loss of bladder control; severe muscle stiffness; unusually pale skin; or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause dizziness, trouble in controlling movements, or trouble in concentrating or seeing clearly. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

Dizziness, lightheadedness, or fainting may occur with this medicine, especially when you get up from a lying or sitting position suddenly. These symptoms are more likely to occur when you begin taking this medicine, or when the dose is increased. Getting up slowly may also help. If this problem continues or gets worse, check with your doctor.

This medicine may cause diarrhea, and in some cases it can be severe. It can occur months after starting this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

If you develop any unusual or strange thoughts and behavior while receiving this medicine, be sure to discuss it with your doctor. Other changes might be confusion, worsening of depression, visual hallucinations (seeing things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

Check with your doctor right away if you have dark-colored urine, fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. These may be symptoms of a condition called rhabdomyolysis.

Stop using this medicine and check with your doctor right away if you are having shortness of breath, chest tightness, or any type of breathing problem while being treated with this medicine.

It is important that your doctor check your skin regularly for signs of a skin cancer called melanoma. If you notice any unusual red, brown, or black spots on your skin, talk to your doctor right away.

It is possible that a dark color (red, brown, or black) may appear in saliva, urine, or sweat after taking this medicine. The color may cause some of your garments to become discolored. This is normal and nothing to worry about.

It is possible that you may become nauseous, especially when you are first starting your medicine.

Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor right away if you start having problems with gambling or an increased interest in sex while using this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

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.

Stalevo 125 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:

More common-Entacapone

• Twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

Incidence not known-Carbidopa and Levodopa and/or Levodopa alone

• Bleeding gums


• bloody or black, tarry stools


• bloody or cloudy urine


• change in size, shape, or color of an existing mole


• changes in skin color


• chest pain, discomfort, or tightness


• constipation


• constricted pupil


• convulsions


• cough


• difficult or labored breathing


• difficulty with speaking


• drooling


• drooping eyelid (ptosis)


• facial dryness


• fast, irregular, or pounding heartbeat


• fever with or without chills


• general feeling of illness


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


• hoarseness


• high or low blood pressure


• large, flat, blue, or purplish patches in the skin


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• loss of appetite


• loss of bladder control


• lower abdominal or stomach pain


• lower back or side pain


• mole that leaks fluid or bleeds


• muscle cramps or spasms


• muscle pain or stiffness


• muscle trembling, jerking, or stiffness


• nausea


• pain


• painful or difficult urination


• pinpoint red spots on the skin


• raised red swellings on the skin, the buttocks, legs, or ankles


• restlessness


• seizures


• severe mental changes


• shakiness and unsteady walk


• shuffling walk


• sore throat


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


• sweating


• swollen glands


• trembling, or other problems with muscle control or coordination


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting

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-Entacapone

• Absence of or decrease in body movement


• diarrhea


• dizziness


• urine discoloration

Less common-Entacapone

• Acid or sour stomach


• anxiety


• belching


• bitter, sour, or unusual taste in the mouth


• bloated


• burning feeling in the chest or stomach


• dry mouth


• excess air or gas in the stomach or intestines


• fear


• full feeling


• heartburn


• hyperventilation


• increased sweating


• indigestion


• irritability


• lack or loss of strength


• nervousness


• passing gas


• restlessness


• sleepiness or unusual drowsiness


• stomach discomfort or upset


• swollen mouth and tongue


• tenderness in the stomach area


• trouble sleeping


• urge to have bowel movement


• wheezing

Incidence not known-Carbidopa and Levodopa and/or Levodopa alone

• Being forgetful


• bladder pain


• blurred vision


• body aches or pain


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


• burning and upper abdominal or stomach pain


• burning sensation of the tongue


• clenching, gnashing, or grinding teeth


• confusion about identity, place, and time


• dark saliva


• dark sweat


• decreased mental acuity


• difficulty swallowing


• discouragement


• double vision


• ear congestion


• enlarged pupils


• excessive watering of the mouth


• fainting


• false or unusual sense of well-being


• feeling like you will pass out


• feeling of warmth


• feeling sad or empty


• flushing


• hair loss


• headache


• hiccups


• hives or welts


• increased blinking


• increased interest in sexual ability, desire, drive, or performance


• increased interest in sexual intercourse


• lack of appetite


• large, hard skin blisters


• leg pain


• loss of voice


• muscle spasm, especially of the neck and back


• nasal congestion


• nightmares


• numbness


• pain in the chest below the breastbone


• painful or prolonged erection of the penis


• pharyngeal pain


• pounding in the ears


• problems with memory or speech


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


• runny nose


• sense of stimulation


• skin rash


• sleeplessness


• slow movement


• slow or fast heartbeat


• slow reflexes


• sneezing


• swelling


• tremor, increased


• trouble concentrating


• trouble recognizing objects


• trouble thinking and planning


• urinary frequency


• urinary retention


• weight gain


• weight loss

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: Stalevo25 side effects (in more detail)

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More Stalevo 125 resources

• Stalevo 125 Side Effects (in more detail)
• Stalevo 125 Use in Pregnancy & Breastfeeding
• Stalevo 125 Drug Interactions
• 0 Reviews for Stalevo25 - Add your own review/rating

• Stalevo 125 Concise Consumer Information (Cerner Multum)


• Carbidopa/Entacapone/Levodopa MedFacts Consumer Leaflet (Wolters Kluwer)

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