Friday, December 24, 2010

Pasta Zinci Oxidaty




Pasta Zinci Oxidaty may be available in the countries listed below.


Ingredient matches for Pasta Zinci Oxidaty



Zinc Oxide

Zinc Oxide is reported as an ingredient of Pasta Zinci Oxidaty in the following countries:


  • Slovakia

International Drug Name Search

Wednesday, December 22, 2010

Betaclox




Betaclox may be available in the countries listed below.


Ingredient matches for Betaclox



Dicloxacillin

Dicloxacillin sodium salt (a derivative of Dicloxacillin) is reported as an ingredient of Betaclox in the following countries:


  • Bangladesh

International Drug Name Search

Friday, December 17, 2010

Novosterol




Novosterol may be available in the countries listed below.


In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Novosterol



Prednisolone

Prednisolone 21-acetate (a derivative of Prednisolone) is reported as an ingredient of Novosterol in the following countries:


  • Italy

International Drug Name Search

Thursday, December 16, 2010

Bléomycine Bellon




Bléomycine Bellon may be available in the countries listed below.


Ingredient matches for Bléomycine Bellon



Bleomycin

Bleomycin sulfate (a derivative of Bleomycin) is reported as an ingredient of Bléomycine Bellon in the following countries:


  • France

International Drug Name Search

Sunday, December 12, 2010

New Lecicarbon




New Lecicarbon may be available in the countries listed below.


Ingredient matches for New Lecicarbon



Sodium Bicarbonate

Sodium Bicarbonate is reported as an ingredient of New Lecicarbon in the following countries:


  • Japan

Sodium Phosphate

Sodium Phosphate Monobasic anhydrous (a derivative of Sodium Phosphate) is reported as an ingredient of New Lecicarbon in the following countries:


  • Japan

International Drug Name Search

Monday, December 6, 2010

Piroxicam Hexal




Piroxicam Hexal may be available in the countries listed below.


Ingredient matches for Piroxicam Hexal



Piroxicam

Piroxicam is reported as an ingredient of Piroxicam Hexal in the following countries:


  • Germany

  • Italy

  • Luxembourg

International Drug Name Search

Sunday, December 5, 2010

Heksolin




Heksolin may be available in the countries listed below.


Ingredient matches for Heksolin



Chlorhexidine

Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Heksolin in the following countries:


  • Turkey

International Drug Name Search

Gadovist




Gadovist may be available in the countries listed below.


Ingredient matches for Gadovist



Gadobutrol

Gadobutrol is reported as an ingredient of Gadovist in the following countries:


  • Australia

  • Austria

  • Belgium

  • Bulgaria

  • Canada

  • Croatia (Hrvatska)

  • Czech Republic

  • Denmark

  • Estonia

  • Finland

  • France

  • Germany

  • Greece

  • Hungary

  • Iceland

  • Italy

  • Latvia

  • Lithuania

  • Luxembourg

  • New Zealand

  • Norway

  • Poland

  • Portugal

  • Romania

  • Russian Federation

  • Serbia

  • Slovenia

  • Spain

  • Sweden

  • Switzerland

  • Turkey

International Drug Name Search

Tuesday, November 23, 2010

Adcirca


Adcirca is a brand name of tadalafil, approved by the FDA in the following formulation(s):


ADCIRCA (tadalafil - tablet; oral)



  • Manufacturer: ELI LILLY CO

    Approval date: May 22, 2009

    Strength(s): 20MG [RLD]

Has a generic version of Adcirca been approved?


No. There is currently no therapeutically equivalent version of Adcirca available.


Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Adcirca. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents


Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.




  • Tetracyclic derivatives; process of preparation and use
    Patent 5,859,006
    Issued: January 12, 1999
    Inventor(s): Daugan; Alain Claude-Marie
    Assignee(s): ICOS Corporation
    A compound of formula (I) ##STR1## and salts and solvates thereof, in which: R.sup.0 represents hydrogen, halogen or C.sub.1-6 alkyl; R.sup.1 represents hydrogen, C.sub.1-6 alkyl, C.sub.2-6 alkenyl, C.sub.2-6 alkynyl, haloC.sub.1-6 alkyl, C.sub.3-8 cycloalkyl, C.sub.3-8 cycloalkylC.sub.1-3 alkyl, arylC.sub.1-3 alkyl or heteroarylC.sub.1-3 alkyl; R.sup.2 represents an optionally substituted monocyclic aromatic ring selected from benzene, thiophene, furan and pyridine or an optionally substituted bicyclic ring ##STR2## attached to the rest of the molecule via one of the benzene ring carbon atoms and wherein the fused ring A is a 5- or 6-membered ring which may be saturated or partially or fully unsaturated and comprises carbon atoms and optionally one or two heteroatoms selected from oxygen, sulphur and nitrogen; and R.sup.3 represents hydrogen or C.sub.1-3 alkyl, or R.sup.1 and R.sup.3 together represent a 3- or 4-membered alkyl or alkenyl chain. A compound of formula (I) is a potent and selective inhibitor of cyclic guanosine 3', 5'-monophosphate specific phosphodiesterase (cGMP specific PDE) having a utility in a variety of therapeutic areas where such inhibition is beneficial, including the treatment of cardiovascular disorders.
    Patent expiration dates:

    • November 21, 2017
      ✓ 
      Patent use: TREATMENT OF PULMONARY HYPERTENSION
      ✓ 
      Drug substance
      ✓ 
      Drug product




  • Beta-carboline drug products
    Patent 6,821,975
    Issued: November 23, 2004
    Inventor(s): Neil R.; Anderson & Kerry J.; Hartauer & Martha A.; Kral & Gregory A.; Stephenson
    Assignee(s): Lilly ICOS LLC
    A compound of structural formula (I), and pharmaceutically acceptable salts and solvates thereof, wherein the compound is in free drug particulate form, is disclosed.
    Patent expiration dates:

    • November 19, 2020
      ✓ 
      Drug substance
      ✓ 
      Drug product




  • β-carboline pharmaceutical compositions
    Patent 7,182,958
    Issued: February 27, 2007
    Inventor(s): Oren; Peter L. & Anderson; Neil R. & Kral; Martha A.
    Assignee(s): Lilly Icos LLC.
    Formulations containing a PDE5 inhibitor, a water-soluble diluent, a lubricant, a hydrophilic binder, a disintegrant, and optional microcrystalline cellulose and/or a wetting agent, and their use in treating sexual dysfunction, are disclosed.
    Patent expiration dates:

    • April 26, 2020
      ✓ 
      Drug product



Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • May 22, 2012 - NEW PRODUCT

    • May 22, 2016 - ORPHAN DRUG EXCLUSIVITY

See also...

  • Adcirca Consumer Information (Drugs.com)
  • Adcirca Consumer Information (Wolters Kluwer)
  • Adcirca Consumer Information (Cerner Multum)
  • Adcirca Advanced Consumer Information (Micromedex)
  • Tadalafil Consumer Information (Drugs.com)
  • Tadalafil Consumer Information (Wolters Kluwer)
  • Tadalafil Consumer Information (Cerner Multum)
  • Tadalafil Advanced Consumer Information (Micromedex)
  • Tadalafil AHFS DI Monographs (ASHP)

Sunday, November 21, 2010

Atropine Faure




Atropine Faure may be available in the countries listed below.


Ingredient matches for Atropine Faure



Atropine

Atropine sulfate (a derivative of Atropine) is reported as an ingredient of Atropine Faure in the following countries:


  • France

  • Monaco

International Drug Name Search

Saturday, November 20, 2010

Verbital




Verbital may be available in the countries listed below.


Ingredient matches for Verbital



Bezafibrate

Bezafibrate is reported as an ingredient of Verbital in the following countries:


  • Greece

International Drug Name Search

Thursday, November 11, 2010

Dycon




Dycon may be available in the countries listed below.


Ingredient matches for Dycon



Diclofenac

Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Dycon in the following countries:


  • Philippines

International Drug Name Search

Dinaflex




Dinaflex may be available in the countries listed below.


Ingredient matches for Dinaflex



Glucosamine

Glucosamine sulfate (a derivative of Glucosamine) is reported as an ingredient of Dinaflex in the following countries:


  • Brazil

  • Chile

  • Peru

International Drug Name Search

Sunday, November 7, 2010

Nitrepress




Nitrepress may be available in the countries listed below.


Ingredient matches for Nitrepress



Nitrendipine

Nitrendipine is reported as an ingredient of Nitrepress in the following countries:


  • Czech Republic

  • Germany

International Drug Name Search

Saturday, November 6, 2010

Desquam-X 5


Generic Name: benzoyl peroxide topical (BEN zoyl per OX ide)

Brand Names: Acne Treatment, Acne-Clear, Benzac AC, Benzac W, Benzashave 10, Benzashave 5, BenzEFoam, Benziq, Benziq Wash, BPO Foaming Cloths, Brevoxyl, Brevoxyl Acne Wash Kit, Brevoxyl-4 Creamy Wash Complete Pack, Brevoxyl-8 Creamy Wash Complete Pack, Breze, Clearplex, Clearskin, Clinac BPO, Desquam-E, Desquam-X 10, Desquam-X 5, Desquam-X Wash, Fostex Bar 10%, Fostex Gel 10%, Fostex Wash 10%, Inova, Lavoclen-4, Lavoclen-8, Loroxide, NeoBenz Micro, Neutrogena Acne Mask, Neutrogena On Spot Acne Treatment, Oscion, Oscion Cleanser, Oxy 10 Balance, Oxy Balance, Oxy Daily Wash Chill Factor, Oxy-10, Pacnex, PanOxyl, Panoxyl 10, Panoxyl 5, Panoxyl Aqua Gel, PanOxyl Maximum Strength Foaming Acne Wash, Persa-Gel, Seba-Gel, SoluCLENZ Rx, Triaz, Triaz Cleanser, Zaclir


What is Desquam-X 5 (benzoyl peroxide topical)?

Benzoyl peroxide has an antibacterial effect. It also has a mild drying effect, which allows excess oils and dirt to be easily washed away from the skin.


Benzoyl peroxide topical (for the skin) is used to treat acne.


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


What is the most important information I should know about Desquam-X 5 (benzoyl peroxide topical)?


There are many brands and forms of benzoyl peroxide available and not all brands are listed on this leaflet.


Do not use benzoyl peroxide topical while you are also using tretinoin (Altinac, Avita, Renova, Retin-A, Tretin-X). Using these medications together could cause severe skin irritation.

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.


Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Do not use benzoyl peroxide topical on sunburned, windburned, dry, chapped, irritated, or broken skin. Also avoid using benzoyl peroxide topical on wounds or on areas of eczema. Wait until these conditions have healed before using this medication.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.


Benzoyl peroxide may bleach hair or fabrics. Avoid allowing this medication to come into contact with your hair or clothing.


It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.


What should I discuss with my healthcare provider before using Desquam-X 5 (benzoyl peroxide topical)?


Do not use benzoyl peroxide topical while you are also using tretinoin (Altinac, Avita, Renova, Retin-A, Tretin-X). Using these medications together could cause severe skin irritation. FDA pregnancy category C. It is not known whether benzoyl peroxide topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether benzoyl peroxide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Desquam-X 5 (benzoyl peroxide topical)?


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


Wash your hands before and after applying this medication. Shake the lotion well just before each use.

Clean and pat dry the skin to be treated. Apply benzoyl peroxide in a thin layer and rub in gently.


Do not cover the treated skin area unless your doctor has told you to.

Benzoyl peroxide topical is usually applied one to three times daily. Follow your doctor's instructions.


Benzoyl peroxide may bleach hair or fabrics. Avoid allowing this medication to come into contact with your hair or clothing.


It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.


Store at room temperature away from moisture and heat.

What happens if I miss a dose?


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


What happens if I overdose?


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

What should I avoid while using Desquam-X 5 (benzoyl peroxide topical)?


Avoid getting this medication in your mouth or eyes. If it does get into any of these areas, rinse with water. Do not use benzoyl peroxide topical on sunburned, windburned, dry, chapped, irritated, or broken skin. Also avoid using benzoyl peroxide topical on wounds or on areas of eczema. Wait until these conditions have healed before using this medication.

Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.


Avoid using sunscreen containing PABA on the same skin treated with benzoyl peroxide, or skin discoloration may occur.


Desquam-X 5 (benzoyl peroxide topical) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using benzoyl peroxide and call your doctor at once if you have severe stinging or burning of your skin.

Less serious side effects may include:



  • mild stinging or burning;




  • itching or tingly feeling;




  • skin dryness, peeling, or flaking; or




  • redness or other irritation.



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 Desquam-X 5 (benzoyl peroxide topical)?


It is not likely that other drugs you take orally or inject will have an effect on topically applied benzoyl peroxide topical. But many drugs can interact with each other. 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 Desquam-X 5 resources


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


  • Acne Treatment Cream MedFacts Consumer Leaflet (Wolters Kluwer)

  • BenzEFoam Foam MedFacts Consumer Leaflet (Wolters Kluwer)

  • Benzac Topical Advanced Consumer (Micromedex) - Includes Dosage Information

  • Benzac AC Wash MedFacts Consumer Leaflet (Wolters Kluwer)

  • Benzefoam Prescribing Information (FDA)

  • Benzefoam Ultra Prescribing Information (FDA)

  • Brevoxyl Gel MedFacts Consumer Leaflet (Wolters Kluwer)

  • Brevoxyl Creamy Wash Prescribing Information (FDA)

  • Desquam-X Wash Prescribing Information (FDA)

  • Inova Pads MedFacts Consumer Leaflet (Wolters Kluwer)

  • NeoBenz Micro Wash Plus Pack Cream MedFacts Consumer Leaflet (Wolters Kluwer)

  • Neobenz Micro SD Prescribing Information (FDA)

  • Neobenz Micro Wash Plus Pack Prescribing Information (FDA)

  • Oxy Balance Topical Advanced Consumer (Micromedex) - Includes Dosage Information

  • Pacnex LP Prescribing Information (FDA)

  • PanOxyl Bar MedFacts Consumer Leaflet (Wolters Kluwer)

  • Triaz Cloths MedFacts Consumer Leaflet (Wolters Kluwer)

  • Triazolam Monograph (AHFS DI)



Compare Desquam-X 5 with other medications


  • Acne
  • Perioral Dermatitis


Where can I get more information?


  • Your pharmacist can provide more information about benzoyl peroxide topical.

See also: Desquam-X 5 side effects (in more detail)


Saturday, October 23, 2010

Meriol




Meriol may be available in the countries listed below.


Ingredient matches for Meriol



Methandriol

Methandriol is reported as an ingredient of Meriol in the following countries:


  • Taiwan

International Drug Name Search

Friday, October 1, 2010

Baro-Cat



barium sulfate

Dosage Form: suspension
LAFAYETTE

Baro-Cat™

BARIUM SULFATE SUSPENSION

FOR COMPUTED TOMOGRAPHY


Rx only

Baro-Cat Description


Baro-Cat is a banana-pineapple flavored ready-to-use barium sulfate suspension for use as an aid for computed tomography of the gastrointestinal tract.


The contrast medium contains 1.5% w/w (w/v) barium sulfate USP, with sorbitol, simethicone, suspending agent, potassium sorbate, citric acid, flavoring, saccharin sodium and water. Barium sulfate has the empirical formula BaSO4.



Baro-Cat - Clinical Pharmacology


Barium sulfate is an insoluble material which, because of its density, provides a positive contrast during x-ray examination. Barium sulfate is an inert radiopaque material which is not absorbed or metabolized and is eliminated intact from the body in a manner similar to other non-absorbed inorganic materials. Excretion rate is a function of gastrointestinal transit time.

Indications and Usage for Baro-Cat


Baro-Cat is indicated for use as a diagnostic aid (contrast medium) for computed tomography of the gastrointestinal tract.



Contraindications


Barium sulfate products are contraindicated in patients with known or suspected obstruction of the colon, known or suspected gastrointestinal tract perforation, suspected tracheoesophageal fistula, obstructing lesions of the small intestine, pyloric stenosis inflammation or neoplastic lesions of the rectum, recent rectal biopsy, or known hypersensitivity to barium sulfate formulations.


Barium sulfate suspensions should not be used for infants with swallowing disorders or for newborns with complete duodenal or jejunal obstruction or when distal small bowel or colon obstruction is suspected. Barium sulfate suspension is not recommended for very small preterm infants and young babies requiring small volumes of contrast media or for infants and young children when there is a possibility of leakage from the gastrointestinal tract, such as necrotizing enterocolitis, unexplained pneumoperitoneum, gasless abdomen, other bowel perforation, esophageal perforation or post operative anastomosis.


Known hypersensitivity or allergy to latex is a contraindication for the use of balloon retention enema tips containing latex. The use of a retention cuff enema tip is not necessary or desirable in patients with normal sphincter tone. The presence of adequate sphincter tone can be judged by preliminary rectal digital examination.



Warnings


Serious adverse reactions, including death, have been reported with the administration of barium sulfate formulations and are usually associated with the technique of administration, the underlying pathological condition and/or patient hypersensitivities.


Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis. Oral administration of barium sulfate suspension by an infant sucking a bottle and administration of large quantities by catheter are reported to likely result in aspiration into the tracheobronchial tree. Cardiopulmonary arrest leading to fatality has been reported in infants following aspiration. Aspiration of smaller amounts may cause inflammation.


Barium sulfate preparations used as radiopaque media contain a number of additives to provide diagnostic properties and patient palatability. Allergic responses following the use of barium sulfate suspensions have been reported. Skin irritation, redness, inflammation and hives have been reported for infants and small children following spillage of barium sulfate suspension on their skin. These responses are thought to be caused by the flavors and/or preservatives used in the product.


Barium sulfate suspension has been reported to cause obstruction of the small bowel (impaction) in pediatric patients with cystic fibrosis. It has also been reported to cause fluid overload from the absorption of water during studies in infants when Hirschsprung’s Disease is suspected.


Barium sulfate suspension intravasation can be a serious complication. Mortality has been reported as a result of vaginal or rectal intravasation and is believed to be due to massive pulmonary embolism occurring within minutes of the inciting event.


In patients with increased cranial pressure, barium sulfate suspension enemas present an additional risk of further increasing intracranial pressure.


Care must be taken during the insertion of an enema tip into the patient to prevent application of pressure to the vagus nerve which can lead to vasovagal reactions and syncopal episodes. Cardiac arrhythmia or other cardiovascular side effects can occur as a result of colon distention.

Precautions




General


Diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the requisite training and with a thorough knowledge of the particular procedure to be performed. A history of bronchial asthma, atopy, as evidenced by hay fever and eczema, a family history of allergy, or a previous reaction to a contrast agent warrant special attention. Caution should be exercised with the use of radiopaque media in severely debilitated patients and in those with marked hypertension or advanced cardiac disease.


Anaphylactic and allergic reactions have been reported during double contrast examinations in which glucagon has been used.


An increased risk of perforation has been reported in neonates with intussusception. In patients with cystic fibrosis or blind loops of the bowel or ileus, there is a risk of inspissation leading to partial or complete obstruction.


In neonates and infants with motility disorders such as Hirschsprung’s Disease, retention of large amounts of barium sulfate suspension may result in absorption of water from the suspension and fluid overload. The addition of small amounts of salt to the barium sulfate suspension has been reported to reduce the problem.


Ingestion of barium sulfate suspension is not recommended in patients with a history of food aspiration. If barium sulfate suspension is aspirated into the larynx, further administration of the suspension should be immediately discontinued.


Patient preparation for diagnostic gastrointestinal examinations frequently requires cathartics and a liquid diet. The various preparations can result in water loss for the patient. Patients should be rehydrated quickly following a barium sulfate suspension examination of the gastrointestinal tract. In patients with reduced colon motility, saline cathartics may be required after the barium sulfate suspension enema. Saline cathartics are recommended on a routine basis in patients with a history of constipation unless clinically contraindicated.


Where enema tips are used, care must be taken during insertion into the patient, since forceful or too deep insertion may cause tearing or perforation of the rectum. Insertion of an enema tip should be done only after digital examination by qualified medical personnel. When balloon retention tips are used, care should be taken to avoid overinflation of the balloon, since overfilling or asymmetrical filling may cause displacement of the tip. Such a displacement can lead to rectal perforation or barium sulfate granulomas. Inflation of the balloon should be done under fluoroscopic control by qualified medical personnel. Do not unnecessarily move the enema tip once inserted.


A specially designed enema tip is required for a barium sulfate suspension examination of a colostomy patient.


Intubation of an enteroclysis catheter should be done by qualified medical personnel. Perforation of the duodenum has been reported.


Because of reported anaphylactoid reactions to latex, the use of non-latex gloves during the procedure should be considered.



Pregnancy


Safe use of barium sulfate during pregnancy has not been established. Barium sulfate should be used in pregnant women only if the possible benefits outweigh the potential risks. Elective radiography of the abdomen is considered to be contraindicated during pregnancy due to the risk to the fetus from radiation exposure. Radiation is known to cause harm to the unborn fetus exposed in utero.

Pediatric Use


The radiographic contrast agents used for examination of children do not differ substantially from those used for adults. The variation in physical sizes of pediatric patients requires more thorough attention to individualizing dosage. The volume of barium sulfate suspension and the barium sulfate content required will also depend upon the technique used and the clinical need.



Adverse Reactions


Adverse reactions accompanying the use of barium sulfate formulations are infrequent and usually mild, though severe reactions (approximately 1 in 500,000) and fatalities (approximately 1 in 2,000,000) have occurred. Procedural complications are rare, but may include aspiration pneumonitis, barium sulfate impaction, granuloma formation, intravasation, embolization and peritonitis following intestinal perforation, vasovagal and syncopal episodes, and fatalities. EKG changes have been shown to occur following or during barium sulfate suspension enemas. It is of the utmost importance to be completely prepared to treat any such occurrence.


Due to the increased likelihood of allergic reactions in atopic patients, a complete history of known and suspected allergies as well as allergic-like symptoms, such as rhinitis, bronchial asthma, eczema and urticaria, must be obtained prior to any medical procedure.


Aspiration of large amounts of barium sulfate suspension may cause pneumonitis or nodular granulomas of interstitial lung tissues and lymph nodes; asphyxiation and death have been reported.


Transient bacteremia, beginning almost immediately and lasting up to 15 minutes, may also occur during rectal administration of barium sulfate suspension, and rarely septicemia has been reported.


A rare mild allergic reaction would most likely be generalized pruritis, erythema or urticaria (approximately 1 in 100,000 reactions). Such reactions will often respond to an antihistamine. More serious reactions (approximately 1 in 500,000) may result in laryngeal edema, bronchospasm or hypotension.


Severe reactions which may require emergency measures are often characterized by peripheral vasodilation, hypotension, reflex tachycardia, dyspnea, bronchospasm, agitation, confusion and cyanosis, progressing to unconsciousness. Treatment should be initiated immediately according to established standard of care.


Apprehensive patients may develop weakness, pallor, tinnitus, diaphoresis and bradycardia following the administration of any diagnostic agent. Such reactions are usually non-allergic in nature.


Allergic reactions to the enema accessories, in particular to retention catheters (tips) with latex cuffs, can occur. Such reactions could occur immediately and result in the previously mentioned acute allergic-like responses or might be delayed in appearance and result in a contact dermatitis. Known atopic patients, particularly those with a history of asthma or eczema, should be evaluated for alternative methods of administration in order to avoid these adverse reactions. These plastic/rubber accessories are disposable, single-use devices that must not be reused or left in the body cavity for an extended period of time.



Postmarketing Experiences


The following adverse experiences have been reported in patients receiving products containing barium sulfate. These adverse experiences are listed alphabetically: abdominal cramping, abdominal pain, diarrhea, fever, foreign body trauma relating to procedural complications, headache, laryngeal burning and irritation, leukocytosis, procedural site reactions, rash, and vomiting.



Overdosage


In rare instances, immediate repeat oral examinations utilizing standard dosages may lead to severe stomach cramps and diarrhea. Cases reported implicate a total dose in the range of 30 ounces (900 mL) of suspension. Instances of this type have resolved spontaneously and they are not considered to be life-threatening.

Baro-Cat Dosage and Administration


Individual technique will determine the suspension quantity and specific procedure used. The following are suggested for Baro-Cat use as an aid for computed tomography.

Upper G.I. Opacification


The patient should drink 300 mL of ready-to-use Baro-Cat approximately 2 hours before the CT scan and an additional 300 mL approximately 15 minutes prior to examination.


If rapid upper gastrointestinal tract transit is desired, administer the product chilled.



Total Bowel Opacification


The patient should drink 300 mL the night preceding the examination, 300 mL two hours prior to the examination and 300 mL approximately 15 minutes prior to examination.



Rectal/Colon Administration


Rectally administered Baro-Cat should be at room temperature to body temperature. Transfer the desired quantity of ready-to-use Baro-Cat into an enema administration unit, such as Empty Enema Kit. Close the slide clamp. Lubricate the tip and carefully insert.


If Empty Enema Kit is used, invert and squeeze the red ball into the bag. Return the bag to upright and with the patient in the left lateral position, open the slide clamp to administer the suspension. Coating of the entire colon may be achieved by rotating the patient 360°. For increased patient comfort, excess suspension may be drained back into the enema bag.

Pediatric Use


The quantity of suspension used and the barium sulfate concentration will depend upon patient size, technique used and clinical need.


For single patient use only. Properly discard unused portion. 



How is Baro-Cat Supplied


Catalog No. 169110. NDC 68240-622-03. 300 mL (10 fl. oz.) bottle; twenty-four (24) bottles with straws per case.


Catalog No. 169130. NDC 68240-622-09. 900 mL (30 fl. oz.) bottle; twelve (12) bottles per case.


Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from freezing.


Shake well before using.


Baro-Cat is a trademark of Mallinckrodt Inc. or its subsidiaries.


Made in Mexico

Manufactured by:

Mallinckrodt Inc.

St. Louis, MO 63042 USA

www.Mallinckrodt.com


MID 1295065 Rev 03/2009


CT CONTRAST

G.I. EXAMS
  • Pre-mixed

  • Ready-to-use

  • Flavored

tyco

Healthcare


Mallinckrodt



Package Label - Principal Display Panel - 900 mL Bottle


L A F A Y E T T E


Baro-Cat™

BARIUM SULFATE

SUSPENSION


CT CONTRAST / G.I. EXAMS


Rx only


NDC 68240-622-09

Catalog No. 169130


A banana-pineapple flavored, ready-to-use, 1.5% w/w (w/v) barium sulfate suspension USP, for use as an aid for computed tomography of the gastrointestinal tract.


Contents: Barium sulfate USP, sorbitol, simethicone, suspending agent, potassium sorbate, citric acid, flavoring, saccharin sodium and water.


Contraindications: Do not use in patients with suspected gastrointestinal tract perforation or known hypersensitivity to barium sulfate formulations.


Dosage and Administration: See package insert for complete instructions. Shake well before using.


For single patient use only. Properly discard unused portion.


Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from freezing.


Net Contents: 900 mL (30 fl. oz.)


Made in Mexico

Manufactured by Mallinckrodt Inc.

St. Louis, MO 63042 USA

www.Mallinckrodt.com


MID 1304663

Rev 03/2009


O3™ ANTIMICROBIAL TECHNOLOGY


tyco/Healthcare


MALLINCKRODT










Baro-Cat 
barium sulfate  suspension










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)68240-622
Route of AdministrationORAL, RECTALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BARIUM SULFATE (BARIUM CATION)BARIUM SULFATE15 mg  in 1 mL




















Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM 
SODIUM HYPOCHLORITE 
POTASSIUM SORBATE 
WATER 
HYDROGEN PEROXIDE 
CITRIC ACID MONOHYDRATE 
SORBITOL 
XANTHAN GUM 


















Product Characteristics
Color    Score    
ShapeSize
FlavorBANANA, PINEAPPLEImprint Code
Contains      






















Packaging
#NDCPackage DescriptionMultilevel Packaging
168240-622-0324 BOTTLE In 1 CASEcontains a BOTTLE, PLASTIC
1300 mL In 1 BOTTLE, PLASTICThis package is contained within the CASE (68240-622-03)
268240-622-0912 BOTTLE In 1 CASEcontains a BOTTLE, PLASTIC
2900 mL In 1 BOTTLE, PLASTICThis package is contained within the CASE (68240-622-09)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/200903/31/2011


Labeler - Mallinckrodt Inc. (810407189)









Establishment
NameAddressID/FEIOperations
Mallinckrodt Medical, S.A. de C.V.810407189analysis, manufacture
Revised: 08/2010Mallinckrodt Inc.

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Thursday, September 30, 2010

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Sunday, September 26, 2010

Palio




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Calcitriolo Teva




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Friday, September 17, 2010

Oranvital




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Thursday, September 16, 2010

Anexa




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Sunday, September 5, 2010

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Wednesday, September 1, 2010

Alprazolam Winthrop




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Alprazolam

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Penticillin




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Monday, August 16, 2010

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Tuesday, August 10, 2010

Desoxi


Generic Name: desoximetasone (Topical application route)

des-ox-i-MET-a-sone

Commonly used brand name(s)

In the U.S.


  • Topicort

  • Topicort LP

In Canada


  • Desoxi

  • Taro-Desoximetasone

  • Topicort Mild

Available Dosage Forms:


  • Ointment

  • Gel/Jelly

  • Cream

Therapeutic Class: Corticosteroid, Strong


Pharmacologic Class: Adrenal Glucocorticoid


Uses For Desoxi


Desoximetasone topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. This medicine is a corticosteroid (cortisone-like medicine or steroid).


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


Before Using Desoxi


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 pediatric-specific problems that would limit the usefulness of desoximetasone in children 10 years of age or older. However, because of this medicine's toxicity, it should be used with caution. Children and teenagers who must use this medicine should be checked often by their doctor since desoximetasone topical may be absorbed through the skin and can affect growth or cause other unwanted effects. Safety and efficacy have not been established in children younger than 10 years of age.


Geriatric


No information is available on the relationship of age to the effects of desoximetasone topical in geriatric patients.


Pregnancy








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

Breast Feeding


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


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


Interactions with Food/Tobacco/Alcohol


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


Other Medical Problems


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


  • Cushing's syndrome (adrenal gland disorder) or

  • Diabetes or

  • Hyperglycemia (high blood sugar) or

  • Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

  • Infection at or near the place of application or

  • Large sores, broken skin, or severe injury at the area of application—The chance of side effects may be increased.

Proper Use of desoximetasone

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


Use this medicine exactly as directed by your doctor. Do not use it for any other condition without first checking with your doctor. This medicine may cause unwanted effects if it is used too much, because more of it is absorbed into the body through the skin.


Wash your hands with soap and water before and after using this medicine.


Be very careful not to get this medicine in your eyes. Wash your hands after using your finger to apply the medicine. If you accidentally get this medicine in your eyes, flush them with water.


Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.


Unless otherwise directed by your doctor, do not apply this medicine to open wounds, burns, or broken or inflamed skin.


This medicine should only be used for problems being treated by your doctor. Check with your doctor before using it for other problems, especially if you think that an infection may be present. This medicine should not be used to treat certain kinds of skin infections or serious problems, such as severe burns.


Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.


If your doctor has ordered an occlusive dressing (airtight covering, such as kitchen plastic wrap or a special patch) to be applied over this medicine, make sure you know how to apply it. Since occlusive dressings increase the amount of medicine absorbed through your skin and the possibility of side effects, use them only as directed. If you have any questions about this, check with your doctor.


Dosing


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


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


  • For topical dosage forms (cream, gel, and ointment):
    • For redness, itching, and swelling of the skin:
      • Adults—Apply to the affected area of the skin two times a day.

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



Missed Dose


If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.


Storage


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


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


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


Precautions While Using Desoxi


It is very important that your doctor check your or your child's progress at regular visits for any problems or unwanted effects that may be caused by this medicine.


If your symptoms do not improve within a few days, or if it become worse, check with your doctor.


After applying this medicine to the skin of your child, watch the child carefully to make sure that he or she does not get any of the medicine in the eyes or mouth. This medicine can cause serious side effects, especially in children, if it gets into the mouth and is swallowed.


Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and for patients who use large amounts for a long time. Talk to your doctor if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.


Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.


Avoid using tight-fitting diapers or plastic pants on a child if this medicine is being used on the child's diaper area. Plastic pants and tight-fitting diapers may increase the chance of absorption of the medicine through the skin and the chance of side effects.


Do not use cosmetics or other skin care products on the treated skin areas.


Desoxi 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:


Rare
  • Flushing or redness of the skin

  • redness, blistering, peeling, or loosening of the skin

  • unusually warm skin

Incidence not known
  • Blistering, burning, crusting, dryness, or flaking of the skin

  • irritation

  • itching, scaling, severe redness, soreness, or swelling of the skin

  • redness and scaling around the mouth

  • thinning of the skin with easy bruising, especially when used on facial or intertriginous areas

  • thinning, weakness, or wasting away of the skin

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


Rare
  • Burning, itching, and pain in hairy areas, or pus at the root of the hair

Incidence not known
  • Acne or pimples

  • burning and itching of the skin with pinhead-sized red blisters

  • increased hair growth on the forehead, back, arms, and legs

  • lightening of normal skin color

  • lightening of treated areas of dark skin

  • reddish purple lines on the arms, face, legs, trunk, or groin

  • softening of the skin

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: Desoxi side effects (in more detail)



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


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


More Desoxi resources


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Sunday, August 1, 2010

Metformax




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Monday, July 26, 2010

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Flutamide is reported as an ingredient of Flutamide Fidia in the following countries:


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Tuesday, July 13, 2010

Darbepoetin Alfa (Albumin)


Pronunciation: dar-be-POE-e-tin AL-fa al-BUE-min
Generic Name: Darbepoetin Alfa (Albumin)
Brand Name: Aranesp

Clinical studies have shown Darbepoetin Alfa (Albumin) to increase the risk of serious side effects (eg, blood clots, stroke, heart attack, heart failure) and death in some cases. It has also been shown to increase the risk of tumor growth in patients with advanced cancer. Talk with your doctor about the risks and benefits of using Darbepoetin Alfa (Albumin). Do not use more than the recommended dose without checking with your doctor.





Darbepoetin Alfa (Albumin) is used for:

Treating anemia in patients with chronic kidney failure or certain types of cancers. It may also be used for other conditions as determined by your doctor.


Darbepoetin Alfa (Albumin) is similar to the natural protein human erythropoietin. It works by stimulating the bone marrow to produce more red blood cells. An increased number of red blood cells may reduce symptoms of anemia.


Do NOT use Darbepoetin Alfa (Albumin) if:


  • you are allergic to any ingredient in Darbepoetin Alfa (Albumin) or similar medicines (eg, erythropoietin)

  • you are allergic to products made from mammalian cells

  • you have uncontrolled or severe high blood pressure, or you have certain red blood cell problems (eg, certain types of aplasia)

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



Before using Darbepoetin Alfa (Albumin):


Some medical conditions may interact with Darbepoetin Alfa (Albumin). 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 low levels of vitamin B or folic acid in your blood

  • if you have a blood disease (eg, hemolytic anemia, porphyria, sickle cell anemia, thalassemia)

  • if you have high blood pressure, heart problems (eg, congestive heart failure), blood in your stools, seizures, recent infection or injury, cancer, certain bone problems (eg, osteofibrosis cystica), or inflammatory conditions (eg, bowel disease, rheumatoid arthritis)

Some MEDICINES MAY INTERACT with Darbepoetin Alfa (Albumin). Tell your health care provider if you are taking any other medicines.


Ask your health care provider if Darbepoetin Alfa (Albumin) 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 Darbepoetin Alfa (Albumin):


Use Darbepoetin Alfa (Albumin) as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Darbepoetin Alfa (Albumin) comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Darbepoetin Alfa (Albumin) refilled.

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

  • Do not use Darbepoetin Alfa (Albumin) if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

  • Do not shake Darbepoetin Alfa (Albumin).

  • Do not dilute or mix Darbepoetin Alfa (Albumin) with any other solutions or medicines.

  • Discard any unused portion of medicine left in the vial or syringe.

  • Use only disposable syringes and needles. Use the syringes and needles only once and dispose of them in a puncture-proof container as instructed by your health care provider.

  • Choose a new site each time you inject Darbepoetin Alfa (Albumin). Do not inject into an area that is tender, red, bruised, hard, swollen, or has scars or stretch marks.

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

  • If you miss a dose of Darbepoetin Alfa (Albumin), 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 Darbepoetin Alfa (Albumin).



Important safety information:


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

  • The risk of serious side effects may be greater is you use Darbepoetin Alfa (Albumin) in high doses. Do NOT use more than the recommended dose without checking with your doctor.

  • It is important to keep your blood pressure under control during treatment with Darbepoetin Alfa (Albumin). Do not stop taking any of your blood pressure medicines without checking with your doctor. Closely follow your doctor's instructions for diet and blood pressure monitoring.

  • Darbepoetin Alfa (Albumin) has albumin in it, which comes from human blood. There is an extremely rare risk of developing a viral disease, or a central nervous system disease called Creutzfeldt-Jakob disease. No cases of viral disease or Creutzfeldt-Jakob disease from albumin have been identified.

  • It may take 2 to 6 weeks for Darbepoetin Alfa (Albumin) to work. If your symptoms do not improve or they become worse, check with your doctor.

  • Lab tests, including blood pressure, blood cell counts, kidney function, blood electrolyte levels, and blood iron levels, will be performed while you use Darbepoetin Alfa (Albumin). These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Darbepoetin Alfa (Albumin) should be used with extreme caution in CHILDREN with chronic kidney failure younger than 1 year old or children with cancer; 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 Darbepoetin Alfa (Albumin) while you are pregnant. It is not known if Darbepoetin Alfa (Albumin) is found in breast milk. If you are or will be breast-feeding while you use Darbepoetin Alfa (Albumin), check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Darbepoetin Alfa (Albumin):


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



Constipation; cough; diarrhea; dizziness; headache; muscle, joint, back, or stomach pain; nausea or vomiting; pain, swelling, irritation, redness, or bruising at the injection site; unusual tiredness or weakness.



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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or vision changes; chest pain; confusion; fainting; fast or irregular heartbeat; flu-like symptoms (chills, fever, sore throat); one-sided weakness; redness, tenderness, or swelling of the calf; seizures; severe diarrhea, dizziness, headache, stomach pain, or vomiting; severe or persistent tiredness or weakness; slurred speech; sudden pain or numbness of an arm or leg; sudden shortness of breath; swelling of the arms or legs.



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: Darbepoetin Alfa (Albumin) 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 Darbepoetin Alfa (Albumin):

Store Darbepoetin Alfa (Albumin) in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Protect from light. Do not use past the expiration date on the vial or prefilled syringe. When traveling, transport Darbepoetin Alfa (Albumin) in the original carton in a cool carrier with a coolant, such as blue ice. To avoid freezing, be sure the medicine does not touch the coolant. Once you arrive, place the medicine in the refrigerator as soon as possible. Keep Darbepoetin Alfa (Albumin) out of the reach of children and away from pets.


General information:


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

  • Darbepoetin Alfa (Albumin) 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 Darbepoetin Alfa (Albumin). 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 Darbepoetin Alfa (Albumin) resources


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  • Darbepoetin Alfa (Albumin) Use in Pregnancy & Breastfeeding
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Monday, July 12, 2010

Intrasite Applipak




Intrasite Applipak may be available in the countries listed below.


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Carmellose

Carmellose is reported as an ingredient of Intrasite Applipak in the following countries:


  • South Africa

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Metoc




Metoc may be available in the countries listed below.


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Metoclopramide

Metoclopramide dihydrochloride (a derivative of Metoclopramide) is reported as an ingredient of Metoc in the following countries:


  • Argentina

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Tuesday, July 6, 2010

Risopent




Risopent may be available in the countries listed below.


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Clenbuterol

Clenbuterol hydrochloride (a derivative of Clenbuterol) is reported as an ingredient of Risopent in the following countries:


  • Venezuela

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Sunday, June 20, 2010

Bioval




Bioval may be available in the countries listed below.


In some countries, this medicine may only be approved for veterinary use.

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Chlorocresol

Chlorocresol is reported as an ingredient of Bioval in the following countries:


  • Poland

Chloroxylenol

Chloroxylenol is reported as an ingredient of Bioval in the following countries:


  • Poland

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Saturday, June 19, 2010

Vasocon-A




In the US, Vasocon-A is a member of the drug class ophthalmic antihistamines and decongestants.

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Antazoline

Antazoline phosphate (a derivative of Antazoline) is reported as an ingredient of Vasocon-A in the following countries:


  • United States

Naphazoline

Naphazoline hydrochloride (a derivative of Naphazoline) is reported as an ingredient of Vasocon-A in the following countries:


  • United States

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Sunday, June 13, 2010

Pasrin




Pasrin may be available in the countries listed below.


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Buspirone

Buspirone hydrochloride (a derivative of Buspirone) is reported as an ingredient of Pasrin in the following countries:


  • South Africa

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Monday, June 7, 2010

Rocaltrol Solution


Pronunciation: KAL-si-TRYE-ol
Generic Name: Calcitriol
Brand Name: Rocaltrol


Rocaltrol Solution is used for:

Managing certain conditions caused by high or low parathyroid hormone levels. It is used to manage low blood calcium levels in patients who are on chronic kidney dialysis. It may also be used for other conditions as determined by your doctor.


Rocaltrol Solution is a form of vitamin D. It works by promoting proper absorption and use of calcium and phosphate by the body in normal bone development and maintenance.


Do NOT use Rocaltrol Solution if:


  • you are allergic to any ingredient in Rocaltrol Solution

  • you have high levels of vitamin D or calcium in the blood

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



Before using Rocaltrol Solution:


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


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

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

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

  • if you have heart disease, kidney disease or kidney stones, hardening of the arteries or other blood vessel problems, or a high phosphate level in the blood

  • if you are dehydrated, have recently had surgery, or will be confined to a bed or chair for a long period of time

  • if you take a phosphate-binding medicine (eg, calcium acetate)

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


  • Thiazide diuretics (eg, hydrochlorothiazide) because the risk of high blood calcium levels may be increased

  • Digoxin because the risk of irregular heartbeat may be increased

  • Antacids that contain magnesium because high blood magnesium levels may occur

  • Barbiturates (eg, phenobarbital), cholestyramine, corticosteroids (eg, prednisone), hydantoins (eg, phenytoin), or ketoconazole because they may decrease Rocaltrol Solution's effectiveness

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


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


  • Take Rocaltrol Solution by mouth with or without food.

  • Do not take mineral oil or antacids containing magnesium with Rocaltrol Solution. These can reduce the effects of calcitriol.

  • Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.

  • If you miss a dose of Rocaltrol Solution, 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 Rocaltrol Solution.



Important safety information:


  • Rocaltrol Solution may cause drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Rocaltrol Solution. Using Rocaltrol Solution alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.

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

  • Carefully follow the diet plan provided by your doctor.

  • Check with your doctor before taking any vitamins or mineral supplements containing vitamin D or calcium, phosphorus, or antacids containing calcium or magnesium.

  • You will need to take care to not become dehydrated while you take Rocaltrol Solution. If you have normal kidney function, be sure to drink plenty of fluids. If you have kidney problems or are on dialysis, talk with your doctor about how much fluid you should drink each day. Discuss any questions with your doctor.

  • Tell your doctor you take Rocaltrol Solution if you will be having surgery or will be confined to a bed or chair for a long period of time. The risk of high blood calcium levels may be increased.

  • Lab tests, including calcium, phosphorus, magnesium, and alkaline phosphate levels, may be performed while you use Rocaltrol Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Rocaltrol Solution should be used with extreme caution in CHILDREN younger than 1 year old and in CHILDREN who are on dialysis; 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 Rocaltrol Solution while you are pregnant. It is not known if Rocaltrol Solution is found in breast milk. Do not breast-feed while taking Rocaltrol Solution.


Possible side effects of Rocaltrol Solution:


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; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; bone pain; constipation; decreased sex drive; diarrhea; difficult or painful urination; dizziness; drowsiness; dry mouth; eye redness or irritation; fever; flushing; frequent urination; headache; increased body temperature; increased thirst; irregular heartbeat; loss of appetite; mental or mood changes; metallic taste; muscle pain; nausea; runny nose; sensitivity of the eyes to sunlight; stomach pain or cramps; unexplained weight loss; unusual thinking; vomiting; weakness.



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: Rocaltrol side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dizziness; headache; irregular heartbeat; loss of appetite; mental or mood changes; nausea; stomach pain or cramps; vomiting; weakness.


Proper storage of Rocaltrol Solution:

Store Rocaltrol Solution in a tightly closed container between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Rocaltrol Solution out of the reach of children and away from pets.


General information:


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

  • Rocaltrol Solution 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 Rocaltrol Solution. 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 Rocaltrol resources


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