Monday, 31 May 2010

Pen-Vi-K




Pen-Vi-K may be available in the countries listed below.


Ingredient matches for Pen-Vi-K



Phenoxymethylpenicillin

Phenoxymethylpenicillin potassium (a derivative of Phenoxymethylpenicillin) is reported as an ingredient of Pen-Vi-K in the following countries:


  • Mexico

International Drug Name Search

Wednesday, 26 May 2010

Halidor




Halidor may be available in the countries listed below.


Ingredient matches for Halidor



Bencyclane

Bencyclane fumarate (a derivative of Bencyclane) is reported as an ingredient of Halidor in the following countries:


  • Bulgaria

  • Georgia

  • Hungary

  • Poland

  • Romania

  • Russian Federation

International Drug Name Search

Sunday, 23 May 2010

Sécobarbital




Sécobarbital may be available in the countries listed below.


Ingredient matches for Sécobarbital



Secobarbital

Sécobarbital (DCF) is known as Secobarbital in the US.

International Drug Name Search

Glossary

DCFDénomination Commune Française

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

Monday, 17 May 2010

Butalbital and Acetaminophen





Warning




HEPATOTOXICITY


ACETAMINOPHEN HAS BEEN ASSOCIATED WITH CASES OF ACUTE LIVER FAILURE, AT TIMES RESULTING IN LIVER TRANSPLANT AND DEATH. MOST OF THE CASES OF LIVER INJURY ARE ASSOCIATED WITH THE USE OF ACETAMINOPHEN AT DOSES THAT EXCEED 4000 MILLIGRAMS PER DAY, AND OFTEN INVOLVE MORE THAN ONE ACETAMINOPHEN-CONTAINING PRODUCT.



Butalbital and Acetaminophen Description

Butalbital and Acetaminophen are supplied in tablet form for oral administration.


Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula:


C11H16N2O3 MW = 224.26



Acetaminophen (4’-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:


C8H9NO2 MW = 151.16



Each tablet contains:


Butalbital ……………………………… 50 mg


Warning: May be habit-forming.


Acetaminophen ……………………….. 325 mg


In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.



Butalbital and Acetaminophen - Clinical Pharmacology


This combination drug product is intended as a treatment for tension headache.


It consists of a fixed combination of Butalbital and Acetaminophen. The role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood.



Pharmacokinetics


The behavior of the individual components is described below.


Butalbital: Butalbital is well absorbed from the gastrointestinal tract and is expected to distribute to most tissues in the body. Barbiturates in general may appear in breast milk and readily cross the placental barrier. They are bound to plasma and tissue proteins to a varying degree and binding increases directly as a function of lipid solubility.


Elimination of butalbital is primarily via the kidney (59% to 88% of the dose) as unchanged drug or metabolites. The plasma half-life is about 35 hours. Urinary excretion products include parent drug (about 3.6% of the dose), 5-isobutyl-5-(2,3-dihydroxypropyl) barbituric acid (about 24% of the dose), 5-allyl-5(3-hydroxy-2-methyl-1-propyl) barbituric acid (about 4.8% of the dose), products with the barbituric acid ring hydrolyzed with excretion of urea (about 14% of the dose), as well as unidentified materials. Of the material excreted in the urine, 32% is conjugated.


The in vitro  plasma protein binding of butalbital is 45% over the concentration range of 0.5 to 20 mcg/mL. This falls within the range of plasma protein binding (20% to 45%) reported with other barbiturates such as phenobarbital, pentobarbital, and secobarbital sodium. The plasma-to-blood concentration ratio was almost unity indicating that there is no preferential; distribution of butalbital into either plasma or blood cells (See OVERDOSAGE for toxicity information.).


Acetaminophen: Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts  of other conjugates and unchanged drug.


See OVERDOSAGE for toxicity information.



Indications and Usage for Butalbital and Acetaminophen


Butalbital and Acetaminophen tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.


Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.



Contraindications


This product is contraindicated under the following conditions:


  • Hypersensitivity or intolerance to any component of this product.

  • Patients with porphyria.


Warnings


Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.



Hepatotoxicity


Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.


The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.


Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.



Hypersensitivity/anaphylaxis


There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue Butalbital and Acetaminophen tablets immediately and seek medical care if they experience these symptoms. Do not prescribe Butalbital and Acetaminophen tablets for patients with acetaminophen allergy.



Precautions



General


Butalbital and Acetaminophen tablets should be prescribed with caution in certain special-risk patients, such as the elderly or debilitated, and those with severe impairment of renal or hepatic function, or acute abdominal conditions.



Information for Patients/Caregivers


  • Do not take Butalbital and Acetaminophen tablets if you are allergic to any of its ingredients.

  • If you develop signs of allergy such as a rash or difficulty breathing, stop taking Butalbital and Acetaminophen tablets and contact your healthcare provider immediately.

  • Do not take more than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.

This product may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product.


Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided.


Butalbital may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.



Laboratory Tests


In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.



Drug Interactions


The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors.


Butalbital and Acetaminophen may enhance the effects of:  other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.



Drug/Laboratory Test Interactions


Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.



Carcinogenesis, Mutagenesis, Impairment of Fertility


No adequate studies have been conducted in animals to determine whether acetaminophen or butalbital have a potential for carcinogenesis, mutagenesis or impairment of fertility.



Pregnancy


Teratogenic Effects

Pregnancy Category C


Animal reproduction studies have not been conducted with this combination product. It is also not known whether Butalbital and Acetaminophen can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only when clearly needed.


Nonteratogenic Effects

Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbital-containing drug during the last two months of pregnancy. Butalbital was found in the infant’s serum. The infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms.



Nursing Mothers


Barbiturates and acetaminophen are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of potential for serious adverse reactions in nursing infants from Butalbital and Acetaminophen, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.



Pediatric Use


Safety and effectiveness in pediatric patients below the age of 12 have not been established.



Geriatric Use


 Clinical studies of Butalbital and Acetaminophen tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.


Butalbital is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.



Adverse Reactions



Frequently Observed


The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.



Infrequently Observed


All adverse events tabulated below are classified as infrequent.


Central Nervous: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital.


Autonomic Nervous System: dry mouth, hyperhidrosis.


Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation.


Cardiovascular: tachycardia.


Musculoskeletal: leg pain, muscle fatigue.


Genitourinary: diuresis.


Miscellaneous: pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions.


Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported.


The following adverse drug events may be borne in mind as potential effects of the components of this product. Potential effects of high dosage are listed in the OVERDOSAGE section.


Acetaminophen:  allergic reactions, rash, thrombocytopenia, agranulocytosis.



Drug Abuse and Dependence



Abuse and Dependence


Butalbital: Barbiturates may be habit-forming:  Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1500 mg. As tolerance to barbiturates develops, the amount needed  to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between an intoxication dosage and fatal dosage becomes smaller. The lethal dose of a barbiturate is far less if  alcohol is also ingested. Major withdrawal symptoms (convulsions and delirium) may occur within 16 hours and last up to 5 days after abrupt cessation of these drugs. Intensity of withdrawal symptoms gradually declines over a period of approximately 15 days. Treatment of barbiturate dependence consists of cautious and gradual withdrawal of the drug. Barbiturate-dependent patients can be withdrawn by using a number of different withdrawal regimens. One method involves initiating treatment at the patient’s regular dosage level and gradually decreasing the daily dosage as tolerated by the patient.



Overdosage


Following an acute overdosage, toxicity may result from the barbiturate or the acetaminophen.



Signs and Symptoms


Toxicity from barbiturate poisoning includes drowsiness, confusion, and coma; respiratory depression; hypotension; and hypovolemic shock.


In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necroses, hypoglycemic coma and coagulation defects may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.



Treatment


A single or multiple drug overdose with Butalbital and Acetaminophen is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption.


Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Assisted or controlled ventilation should also be considered


Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.


Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.



Butalbital and Acetaminophen Dosage and Administration


Oral: One to two tablets every four hours as needed. Total daily dosage should not exceed six tablets.


Extended and repeated use of this product is not recommended because of the potential for physical dependence.



How is Butalbital and Acetaminophen Supplied


Butalbital and Acetaminophen tablets, each tablet of which contains butalbital 50 mg (Warning: May be habit-forming) and acetaminophen 325 mg, are supplied in bottles of 100 tablets. Tablets are uncoated, white, capsule-shaped and are debossed “MIA/106”.



Storage


Protect from light and moisture. Store at 20° to 25°C (68° to 86°F) [see USP Controlled Room Temperature].


Dispense in a tight, light-resistant container with a child-resistant closure.



Rx only


Manufactured by:


MIKART, INC.


Atlanta, GA 30318


Code 613Z00


Rev. 05/11



PRINCIPAL DISPLAY PANEL










Butalbital and Acetaminophen 
Butalbital and Acetaminophen  tablet










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0603-2540
Route of AdministrationORALDEA Schedule    











Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BUTALBITAL (BUTALBITAL)BUTALBITAL50 mg
ACETAMINOPHEN (ACETAMINOPHEN)ACETAMINOPHEN325 mg


















Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
POVIDONE 
CROSPOVIDONE 
SILICON DIOXIDE 
STARCH, CORN 
STEARIC ACID 


















Product Characteristics
ColorWHITEScore2 pieces
ShapeCAPSULESize14mm
FlavorImprint CodeMIA;106
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
10603-2540-21100 TABLET In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA08998706/03/1999


Labeler - Qualitest Pharmaceuticals (011103059)
Revised: 08/2011Qualitest Pharmaceuticals

More Butalbital and Acetaminophen resources


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


Compare Butalbital and Acetaminophen with other medications


  • Headache

Saturday, 15 May 2010

Procaina Serra




Procaina Serra may be available in the countries listed below.


Ingredient matches for Procaina Serra



Procaine

Procaine hydrochloride (a derivative of Procaine) is reported as an ingredient of Procaina Serra in the following countries:


  • Spain

International Drug Name Search

Aciclovir Mabo




Aciclovir Mabo may be available in the countries listed below.


Ingredient matches for Aciclovir Mabo



Acyclovir

Aciclovir is reported as an ingredient of Aciclovir Mabo in the following countries:


  • Spain

International Drug Name Search

Friday, 14 May 2010

Panacid




Panacid may be available in the countries listed below.


Ingredient matches for Panacid



Piromidic Acid

Piromidic Acid is reported as an ingredient of Panacid in the following countries:


  • Japan

International Drug Name Search

Thursday, 13 May 2010

Detrol LA



Generic Name: tolterodine (Oral route)


tol-TER-oh-deen TAR-trate


Commonly used brand name(s)

In the U.S.


  • Detrol

  • Detrol LA

Available Dosage Forms:


  • Capsule, Extended Release

  • Tablet

Therapeutic Class: Urinary Antispasmodic


Pharmacologic Class: Tolterodine


Uses For Detrol LA


Tolterodine is used to treat symptoms of an overactive bladder, such as incontinence (loss of bladder control) or a frequent need to urinate.


Tolterodine belongs to the group of medicines called antispasmodics. It helps decrease muscle spasms of the bladder and the frequent urge to urinate caused by these spasms.


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


Before Using Detrol LA


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 performed to date have not demonstrated that tolterodine is useful in children.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tolterodine in the elderly. However, elderly patients are more likely to have age-related kidney or liver problems, which may require an adjustment in the dose for patients receiving tolterodine.


Pregnancy








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

Breast Feeding


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


Interactions with Medicines


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


  • Potassium

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.


  • Amiodarone

  • Clarithromycin

  • Cyclosporine

  • Donepezil

  • Erythromycin

  • Galantamine

  • Itraconazole

  • Ketoconazole

  • Miconazole

  • Propafenone

  • Quinidine

  • Rivastigmine

  • Vinblastine

  • Warfarin

Interactions with Food/Tobacco/Alcohol


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


Other Medical Problems


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


  • Heart rhythm problems (e.g., QT prolongation), or history of or

  • Intestinal or stomach problems (e.g., blockage, intestinal atony, pyloric stenosis) or

  • Myasthenia gravis (severe muscle weakness) or

  • Narrow-angle glaucoma, controlled or

  • Urinary problems (e.g., blockage)—Use with caution. May make these conditions worse.

  • Kidney disease or

  • Liver disease (including cirrhosis)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

  • Liver disease, severe—Use is not recommended for patients taking tolterodine extended-release capsules.

  • Narrow-angle glaucoma, uncontrolled or

  • Stomach problems (e.g., gastric retention) or

  • Urinary retention (hard to pass urine)—Should not be used in patients with these conditions.

Proper Use of tolterodine

This section provides information on the proper use of a number of products that contain tolterodine. It may not be specific to Detrol LA. Please read with care.


Take this medicine only as directed. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects. Also, do not change your dose without checking first with your doctor.


This medicine comes with a patient information insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.


You may take this medicine with or without food.


Swallow the extended-release capsule whole with water. Do not crush, open, or chew it.


Take this medicine at the same time each day.


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 bladder problems:
    • For oral dosage form (tablets):
      • Adults—At first, 2 milligrams (mg) two times a day. Your doctor may adjust your dose if needed.

      • Children—Use and dose must be determined by your doctor.


    • For oral dosage form (extended-release capsules):
      • Adults—4 milligrams (mg) once a day. Your doctor may adjust your dose if needed.

      • 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 Detrol LA


It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.


Tolterodine may cause serious types of allergic reactions, including anaphylaxis and angioedema. Anaphylaxis and angioedema can be life-threatening and require immediate medical attention. Stop using this medicine and call your doctor right away if you have a rash; itching; hoarseness; lightheadedness, dizziness, or fainting; trouble breathing; trouble swallowing; or any swelling of your hands, face, mouth, or throat after using this medicine.


This medicine may cause some people to become dizzy, drowsy, or have blurred vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy, not alert, or not able to see well.


This medicine may cause dryness in the mouth, nose, and throat. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.


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.


Detrol LA 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
  • Abnormal vision, including difficulty with adjusting to distances

  • bloody or cloudy urine

  • difficult, burning, or painful urination

  • frequent urge to urinate

Less common
  • Chest pain

  • chills

  • cough

  • diarrhea

  • fever

  • general feeling of discomfort or illness

  • headache

  • joint pain

  • loss of appetite

  • muscle aches and pains

  • nausea

  • pain or tenderness around the eyes and cheekbones

  • shivering

  • shortness of breath or troubled breathing

  • sore throat

  • stuffy or runny nose

  • sweating

  • tightness of the chest or wheezing

  • trouble with sleeping

  • vomiting

Incidence not known
  • Being forgetful

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

  • confusion about identity, place, and time

  • difficulty with swallowing

  • dizziness

  • fast, pounding, or irregular heartbeat or pulse

  • hives

  • itching

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

  • mood or mental changes

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

  • rapid weight gain

  • seeing, hearing, or feeling things that are not there

  • skin rash

  • tingling of the hands or feet

  • unusual tiredness or weakness

  • unusual weight gain or 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
  • Abdominal or stomach pain

  • constipation

  • drowsiness

  • dry eyes

  • dry mouth

  • upset stomach

Less common
  • Acid or sour stomach

  • belching

  • blurred vision

  • difficulty with moving

  • dizziness or lightheadedness

  • dry skin

  • fear or nervousness

  • feeling of constant movement of self or surroundings

  • heartburn

  • indigestion

  • sensation of spinning

  • sleepiness or unusual drowsiness

  • stomach discomfort

  • weight gain

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: Detrol LA side effects (in more detail)



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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 Detrol LA resources


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


  • Detrol LA Prescribing Information (FDA)

  • Detrol LA Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

  • Detrol MedFacts Consumer Leaflet (Wolters Kluwer)

  • Detrol Prescribing Information (FDA)

  • Detrol Monograph (AHFS DI)

  • Detrol Consumer Overview



Compare Detrol LA with other medications


  • Overactive Bladder
  • Urinary Incontinence

Tuesday, 11 May 2010

Clinwas Topico




Clinwas Topico may be available in the countries listed below.


Ingredient matches for Clinwas Topico



Clindamycin

Clindamycin dihydrogen phosphate (a derivative of Clindamycin) is reported as an ingredient of Clinwas Topico in the following countries:


  • Spain

International Drug Name Search

Friday, 7 May 2010

Belatacept


Pronunciation: bel-AT-a-sept
Generic Name: Belatacept
Brand Name: Nulojix

Belatacept weakens your immune system. This may increase the risk of cancer or serious and sometimes fatal infections. Tell your doctor right away if you notice symptoms of infection (eg, fever, chills, or persistent, sore throat), a change in the size or appearance of a mole, or unusual lumps or growths.


Belatacept may increase the risk of a condition called posttransplant lymphoproliferative disorder (PTLD), especially in the brain. PTLD may lead to cancer and may be fatal. Your risk may be increased if you are infected with a virus called cytomegalovirus (CMV). It may also be increased if you use medicine that suppresses certain parts of the immune system. It may also be increased if you have never been exposed to a virus called the Epstein-Barr virus (EBV). You will be tested before you use Belatacept to see if you have been exposed to EBV. Do not use Belatacept if you have never been exposed to EBV.


Tell your doctor right away if you develop symptoms such as mental or mood changes (eg, behavior changes, confusion, memory problems, trouble thinking), decreased strength or weakness on one side of the body, trouble walking or talking, or vision changes. Discuss any questions or concerns with your doctor.


Use of Belatacept in liver transplant patients is not recommended. There is an increased risk of transplant loss and death.





Belatacept is used for:

Preventing organ rejection after a kidney transplant in certain patients. It is used with other medicines.


Belatacept is a selective costimulation blocker. It works by stopping the immune system from attacking healthy tissues in the body.


Do NOT use Belatacept if:


  • you are allergic to any ingredient in Belatacept

  • you have not been exposed to the Epstein-Barr virus (EBV) or if it is unknown whether you have been exposed to it

  • you have had a liver transplant

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



Before using Belatacept:


Some medical conditions may interact with Belatacept. 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 CMV infection, herpes infection, or any other infection (eg, bacterial, fungal, protozoal, or viral)

  • if you have tuberculosis (TB) or a positive skin test for TB, or you have recently been in close contact with someone who has had TB

  • if you have blood cell problems (eg, anemia, low white blood cell levels), blood electrolyte problems (eg, high or low blood potassium levels), diabetes, or high blood pressure

  • if you have a history of cancer (eg, skin cancer)

  • if you have had an organ transplant other than a kidney (eg, liver)

  • if you are scheduled to receive a vaccination

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


  • Live vaccinations because their effectiveness may be decreased by Belatacept

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


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


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

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

  • If you miss a dose of Belatacept, contact your doctor right away.

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



Important safety information:


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

  • Belatacept may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.

  • Tell your doctor or dentist that you use Belatacept before you receive any medical or dental care, emergency care, or surgery.

  • Do not receive a live vaccine (eg, measles, mumps) while you are using Belatacept. Talk with your doctor before you receive any vaccine.

  • You may need to have a TB skin test before you begin using Belatacept. Contact your doctor with any questions you may have about whether you should receive a TB skin test before using Belatacept.

  • Belatacept may increase your risk of developing cancer, including skin cancer. To decrease your risk of skin cancer, avoid using sunlamps or tanning booths. Limit your exposure to the sun. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. Discuss with your doctor any questions or concerns about increased cancer risk.

  • Some patients treated with Belatacept have developed severe and sometimes fatal infections, such as progressive multifocal leukoencephalopathy (PML) or BK virus infection. BK virus infection may cause kidney problems or loss of the transplanted kidney. Tell your doctor right away if you notice symptoms of PML (eg, confusion; disorientation; depression; changes in thinking, strength, or vision; one-sided weakness; trouble walking or talking; loss of balance or coordination) or kidney problems (eg, change in the amount of urine, difficult or painful urination, blood in the urine).

  • Patients who take Belatacept may have an increased risk of developing high blood sugar or diabetes. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.

  • Lab tests, including EBV serotype, kidney function, and TB, may be performed while you use Belatacept. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

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

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Belatacept while you are pregnant. It is not known if Belatacept is found in breast milk. Do not breast-feed while using Belatacept.


Possible side effects of Belatacept:


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:



Acne; anxiety; back or joint pain; constipation; diarrhea, dizziness; headache; nausea; trouble sleeping; vomiting.



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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the appearance or size of a mole; decreased strength or weakness on one side of your body; fainting; fever, chills, or persistent sore throat; flu-like symptoms; increased or painful urination; mental or mood changes (eg, behavior changes, confusion, memory problems, trouble thinking); mouth sores or inflammation; new or worsening cough; night sweats; severe or persistent headache or dizziness; shortness of breath; severe or persistent diarrhea, nausea, or vomiting; stomach pain; swelling of the hands, ankles, or feet; swollen glands; symptoms of high or low blood potassium levels (eg, muscle pain, weakness, or cramping; irregular heartbeat; tingling sensation; trouble breathing; dizziness); symptoms of kidney problems (eg, change in the amount of urine produced, difficult or painful urination, blood in the urine); tenderness at the transplant site; tremors; trouble walking or talking; unexplained weight loss; unusual lumps or growths; unusual 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: Belatacept 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 Belatacept:

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


General information:


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

  • Belatacept 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 Belatacept. 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 Belatacept resources


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


  • Belatacept Professional Patient Advice (Wolters Kluwer)

  • belatacept Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

  • Nulojix Prescribing Information (FDA)

  • Nulojix Consumer Overview



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