Saturday 26 December 2009

Ovahormon




Ovahormon may be available in the countries listed below.


Ingredient matches for Ovahormon



Estradiol

Estradiol 3,17ß-dipropionate (a derivative of Estradiol) is reported as an ingredient of Ovahormon in the following countries:


  • Japan

Estradiol 3-benzoate (a derivative of Estradiol) is reported as an ingredient of Ovahormon in the following countries:


  • Japan

International Drug Name Search

Friday 25 December 2009

Extina


Extina is a brand name of ketoconazole topical, approved by the FDA in the following formulation(s):


EXTINA (ketoconazole - aerosol, foam; topical)



  • Manufacturer: STIEFEL LABS INC

    Approval date: June 12, 2007

    Strength(s): 2% [RLD][AT]

Has a generic version of Extina been approved?


A generic version of Extina has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Extina and have been approved by the FDA:


ketoconazole aerosol, foam; topical



  • Manufacturer: PERRIGO ISRAEL

    Approval date: August 25, 2011

    Strength(s): 2% [AT]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Extina. 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.




  • Topical antifungal composition
    Patent 7,553,835
    Issued: June 30, 2009
    Inventor(s): Davey; Greg & Abram; Albert Zorko
    Assignee(s): Stiefel Research Australia Pty Ltd
    The subject matter relates to a topical, foamable composition including at least one antifungal agent, said composition characterised in that said at least one antifungal agent is able to penetrate the upper layers of skin and is retained in or on an area to be treated for a prolonged period of time, and in that it has a residual non-volatile component content of less than 25%. The subject matter furthermore relates to a method of treating fungal diseases including jock itch, tinea, dandruff and sebborheic dermatitis by applying to the affected area of a patient requiring such treatment the antifungal composition.
    Patent expiration dates:

    • October 19, 2018
      ✓ 
      Patent use: TREATMENT OF SEBORRHEA DERMATITIS IN HUMANS
      ✓ 
      Drug product




  • Topical antifungal composition
    Patent 8,026,238
    Issued: September 27, 2011
    Inventor(s): Davey; Greg & Abram; Albert Zorko
    Assignee(s): Stiefel Research Australia, Pty Ltd
    A topical, foamable composition is provided that includes at least one antifungal agent that is able to penetrate the upper layers of skin and is retained in or on an area to be treated for a prolonged period of time, and that has a residual non-volatile component content of less than 25%. In addition, a method of treating fungal diseases including jock itch, tinea, dandruff and sebborheic dermatitis is provided, and includes applying to the affected area of a patient requiring such treatment an antifungal composition.
    Patent expiration dates:

    • October 19, 2018
      ✓ 
      Patent use: TOPICAL TREATMENT OF SEBORRHEIC DERMATITIS IN IMMUNOCOMPETETENT PATIENTS 12 YEARS OF AGE AND OLDER
      ✓ 
      Drug product



See also...

  • Extina Consumer Information (Drugs.com)
  • Extina Foam Consumer Information (Wolters Kluwer)
  • Extina Consumer Information (Cerner Multum)
  • Extina Topical Advanced Consumer Information (Micromedex)
  • Ketoconazole Cream Consumer Information (Wolters Kluwer)
  • Ketoconazole Foam Consumer Information (Wolters Kluwer)
  • Ketoconazole Gel Consumer Information (Wolters Kluwer)
  • Ketoconazole Shampoo Consumer Information (Wolters Kluwer)
  • Ketoconazole topical Consumer Information (Cerner Multum)
  • Ketoderm Topical Advanced Consumer Information (Micromedex)
  • Ketoconazole Topical Advanced Consumer Information (Micromedex)
  • Ketoconazole topical AHFS DI Monographs (ASHP)

Saturday 19 December 2009

Omeprazolo Pensa




Omeprazolo Pensa may be available in the countries listed below.


Ingredient matches for Omeprazolo Pensa



Omeprazole

Omeprazole is reported as an ingredient of Omeprazolo Pensa in the following countries:


  • Italy

International Drug Name Search

Diabinese



chlorpropamide

Dosage Form: Tablets, USP

For Oral Use



Diabinese Description


Diabinese® (chlorpropamide), is an oral blood-glucose-lowering drug of the sulfonylurea class. Chlorpropamide is 1-[(p-Chlorophenyl)sulfonyl]-3-propylurea, C10H13ClN2O3S, and has the structural formula:



Chlorpropamide is a white crystalline powder, that has a slight odor. It is practically insoluble in water at pH 7.3 (solubility at pH 6 is 2.2 mg/mL). It is soluble in alcohol and moderately soluble in chloroform. The molecular weight of chlorpropamide is 276.74. Diabinese is available as 100 mg and 250 mg tablets.


Inert ingredients are: alginic acid; Blue 1 Lake; hydroxypropyl cellulose; magnesium stearate; precipitated calcium carbonate; sodium lauryl sulfate; starch.



Diabinese - Clinical Pharmacology


Diabinese appears to lower the blood glucose acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets. The mechanism by which Diabinese lowers blood glucose during long-term administration has not been clearly established. Extra-pancreatic effects may play a part in the mechanism of action of oral sulfonylurea hypoglycemic drugs. While chlorpropamide is a sulfonamide derivative, it is devoid of antibacterial activity.


Diabinese may also prove effective in controlling certain patients who have experienced primary or secondary failure to other sulfonylurea agents.


A method developed which permits easy measurement of the drug in blood is available on request.


Chlorpropamide does not interfere with the usual tests to detect albumin in the urine.


Diabinese is absorbed rapidly from the gastrointestinal tract. Within one hour after a single oral dose, it is readily detectable in the blood, and the level reaches a maximum within two to four hours. It undergoes metabolism in humans and it is excreted in the urine as unchanged drug and as hydroxylated or hydrolyzed metabolites. The biological half-life of chlorpropamide averages about 36 hours. Within 96 hours, 80–90% of a single oral dose is excreted in the urine. However, long-term administration of therapeutic doses does not result in undue accumulation in the blood, since absorption and excretion rates become stabilized in about 5 to 7 days after the initiation of therapy.


Diabinese exerts a hypoglycemic effect in healthy subjects within one hour, becoming maximal at 3 to 6 hours and persisting for at least 24 hours. The potency of chlorpropamide is approximately six times that of tolbutamide. Some experimental results suggest that its increased duration of action may be the result of slower excretion and absence of significant deactivation.



Indications and Usage for Diabinese


Diabinese is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.



Contraindications


Diabinese is contraindicated in patients with:


  1. Known hypersensitivity to any component of this medicine.

  2. Type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.


Warnings



SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY


The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who were randomly assigned to one of four treatment groups (Diabetes, 19 [supp. 2]:747–830, 1970).


UGDP reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 2½ times that of patients treated with diet alone. A significant increase in total mortality was not observed, but the use of tolbutamide was discontinued based on the increase in cardiovascular mortality, thus limiting the opportunity for the study to show an increase in over-all mortality. Despite controversy regarding the interpretation of these results, the findings of the UGDP study provide an adequate basis for this warning. The patient should be informed of the potential risks and advantages of Diabinese and of alternative modes of therapy.


Although only one drug in the sulfonylurea class (tolbutamide) was included in this study, it is prudent from a safety standpoint to consider that this warning may also apply to other oral hypoglycemic drugs in this class, in view of their close similarities in mode of action and chemical structure.



Precautions



General


Macrovascular Outcomes

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Diabinese or any other anti-diabetic drug.


Hypoglycemia

All sulfonylurea drugs including chlorpropamide are capable of producing severe hypoglycemia, which may result in coma, and may require hospitalization. Patients experiencing hypoglycemia should be managed with appropriate glucose therapy and be monitored for a minimum of 24 to 48 hours (see Overdosage section). Proper patient selection, dosage, and instructions are important to avoid hypoglycemic episodes. Regular, timely carbohydrate intake is important to avoid hypoglycemic events occurring when a meal is delayed or insufficient food is eaten or carbohydrate intake is unbalanced. Renal or hepatic insufficiency may affect the disposition of Diabinese and may also diminish gluconeogenic capacity, both of which increase the risk of serious hypoglycemic reactions. Elderly, debilitated or malnourished patients, and those with adrenal or pituitary insufficiency are particularly susceptible to the hypoglycemic action of glucose-lowering drugs. Hypoglycemia may be difficult to recognize in the elderly, and in people who are taking beta-adrenergic blocking drugs. Hypoglycemia is more likely to occur when caloric intake is deficient, after severe or prolonged exercise, when alcohol is ingested, or when more than one glucose-lowering drug is used.


Because of the long half-life of chlorpropamide, patients who become hypoglycemic during therapy require careful supervision of the dose and frequent feedings for at least 3 to 5 days. Hospitalization and intravenous glucose may be necessary.


Loss of control of blood glucose

When a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma, infection, or surgery, a loss of control may occur. At such times, it may be necessary to discontinue Diabinese and administer insulin.


The effectiveness of any oral hypoglycemic drug, including Diabinese, in lowering blood glucose to a desired level decreases in many patients over a period of time, which may be due to progression of the severity of the diabetes or to diminished responsiveness to the drug. This phenomenon is known as secondary failure, to distinguish it from primary failure in which the drug is ineffective in an individual patient when first given. Adequate adjustment of dose and adherence to diet should be assessed before classifying a patient as a secondary failure.



Geriatric Use


The safety and effectiveness of Diabinese in patients aged 65 and over has not been properly evaluated in clinical studies. Adverse event reporting suggests that elderly patients may be more prone to developing hypoglycemia and/or hyponatremia when using Diabinese. Although the underlying mechanisms are unknown, abnormal renal function, drug interaction and poor nutrition appear to contribute to these events.



INFORMATION FOR PATIENTS


Patients should be informed of the potential risks and advantages of Diabinese and of alternative modes of therapy. They should also be informed about the importance of adherence to dietary instructions, of a regular exercise program, and of regular testing of blood glucose.


The risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and responsible family members. Primary and secondary failure should also be explained.


Patients should be instructed to contact their physician promptly if they experience symptoms of hypoglycemia or other adverse reactions.



Physician Counseling Information for Patients


In initiating treatment for type 2 diabetes, diet should be emphasized as the primary form of treatment. Caloric restriction and weight loss are essential in the obese diabetic patient. Proper dietary management alone may be effective in controlling the blood glucose and symptoms of hyperglycemia. The importance of regular physical activity should also be stressed, and cardiovascular risk factors should be identified and corrective measures taken where possible. Use of Diabinese or other antidiabetic medications must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitution or as a convenient mechanism for avoiding dietary restraint. Furthermore, loss of blood glucose control on diet alone may be transient, thus requiring only short-term administration of Diabinese or other antidiabetic medications. Maintenance or discontinuation of Diabinese or other antidiabetic medications should be based on clinical judgment using regular clinical and laboratory evaluations.



LABORATORY TESTS


Blood glucose should be monitored periodically. Measurement of glycosylated hemoglobin should be performed and goals assessed by the current standard of care.



Hemolytic Anemia


Treatment of patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency with sulfonylurea agents can lead to hemolytic anemia. Because Diabinese belongs to the class of sulfonylurea agents, caution should be used in patients with G6PD deficiency and a non-sulfonylurea alternative should be considered. In post marketing reports, hemolytic anemia has also been reported in patients who did not have known G6PD deficiency.



Drug Interactions



The following products can lead to hypoglycemia


The hypoglycemic action of sulfonylurea may be potentiated by certain drugs including nonsteroidal anti-inflammatory agents and other drugs that are highly protein bound, salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, monoamine oxidase inhibitors, and beta adrenergic blocking agents. When such drugs are administered to a patient receiving Diabinese, the patient should be observed closely for hypoglycemia. When such drugs are withdrawn from a patient receiving Diabinese, the patient should be observed closely for loss of control.


Miconazole

A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported. Whether this interaction also occurs with intravenous, topical, or vaginal preparations of miconazole is not known.


Alcohol

In some patients, a disulfiram-like reaction may be produced by the ingestion of alcohol. Moderate to large amounts of alcohol may increase the risk of hypoglycemia (ref.1), (ref. 2).



The following products can lead to hyperglycemia


Certain drugs tend to produce hyperglycemia and may lead to loss of control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid.


When such drugs are administered to a patient receiving Diabinese, the patient should be closely observed for loss of control. When such drugs are withdrawn from a patient receiving Diabinese, the patient should be observed closely for hypoglycemia.


Since animal studies suggest that the action of barbiturates may be prolonged by therapy with chlorpropamide, barbiturates should be employed with caution.


Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with Diabinese have not been conducted to evaluate carcinogenic or mutagenic potential.


Rats treated with continuous Diabinese therapy for 6 to 12 months showed varying degrees of suppression of spermatogenesis at a dose level of 250 mg/kg (five times the human dose based on body surface area). The extent of suppression seemed to follow that of growth retardation associated with chronic administration of high-dose Diabinese in rats. The human dose of chlorpropamide is 500 mg/day (300 mg/M2). Six- and 12-month toxicity work in the dog and rat, respectively, indicates the 150 mg/kg is well tolerated. Therefore, the safety margins based upon body-surface-area comparisons are three times human exposure in the rat and 10 times human exposure in the dog.



Pregnancy


Teratogenic Effects

Pregnancy Category C


Animal reproductive studies have not been conducted with Diabinese. It is also not known whether Diabinese can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Diabinese should be given to a pregnant woman only if the potential benefits justify the potential risk to the patient and fetus.


Because data suggest that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities, many experts recommend that insulin be used during pregnancy to maintain blood glucose levels as close to normal as possible.


Nonteratogenic Effects

Prolonged severe hypoglycemia (4 to 10 days) has been reported in neonates born to mothers who were receiving a sulfonylurea drug at the time of delivery. This has been reported more frequently with the use of agents with prolonged half-lives. If Diabinese is used during pregnancy, it should be discontinued at least one month before the expected delivery date and other therapies instituted to maintain blood glucose levels as close to normal as possible.


Nursing Mothers

An analysis of a composite of two samples of human breast milk, each taken five hours after ingestion of 500 mg of chlorpropamide by a patient, revealed a concentration of 5 mcg/mL. For reference, the normal peak blood level of chlorpropamide after a single 250 mg dose is 30 mcg/mL. Therefore, it is not recommended that a woman breast feed while taking this medication.


Use in Children

Safety and effectiveness in children have not been established.


Ability to Drive and Use Machines

The effect of Diabinese on the ability to drive or operate machinery has not been studied. However, there is no evidence to suggest that Diabinese may affect these abilities. Patients should be aware of the symptoms of hypoglycemia and take caution while driving and operating machinery.



Adverse Reactions



Body as a Whole


Disulfiram-like reactions have rarely been reported with Diabinese (see DRUG INTERACTIONS).



Central and Peripheral Nervous System


Dizziness and headache.



Hypoglycemia


See PRECAUTIONS and OVERDOSAGE sections.



Gastrointestinal


Gastrointestinal disturbances are the most common reactions; nausea has been reported in less than 5% of patients, and diarrhea, vomiting, anorexia, and hunger in less than 2%. Other gastrointestinal disturbances have occurred in less than 1% of patients including proctocolitis. They tend to be dose-related and may disappear when dosage is reduced.



Liver/Biliary


Cholestatic jaundice may occur rarely; Diabinese should be discontinued if this occurs. Hepatic porphyria and disulfiram-like reactions have been reported with Diabinese.



Skin/Appendages


Pruritus has been reported in less than 3% of patients. Other allergic skin reactions, e.g., urticaria and maculopapular eruptions have been reported in approximately 1% or less of patients. These may be transient and may disappear despite continued use of Diabinese; if skin reactions persist the drug should be discontinued.


As with other sulfonylureas, porphyria cutanea tarda and photosensitivity reactions have been reported.


Skin eruptions rarely progressing to erythema multiforme and exfoliative dermatitis have also been reported.



Hematologic Reactions


Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia (see PRECAUTIONS), aplastic anemia, pancytopenia, and eosinophilia have been reported with sulfonylureas.



Metabolic/Nutritional Reactions


Hypoglycemia (see PRECAUTIONS and OVERDOSAGE sections). Hepatic porphyria and disulfiram-like reactions have been reported with Diabinese. See DRUG INTERACTIONS section.



Endocrine Reactions


On rare occasions, chlorpropamide has caused a reaction identical to the syndrome of inappropriate antidiuretic hormone (ADH) secretion. The features of this syndrome result from excessive water retention and include hyponatremia, low serum osmolality, and high urine osmolality. This reaction has also been reported for other sulfonylureas.



Overdosage


Overdosage of sulfonylureas including Diabinese can produce hypoglycemia. Mild hypoglycemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalization. If hypoglycemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dL. Patients should be closely monitored for a minimum of 24 to 48 hours since hypoglycemia may recur after apparent clinical recovery.



Diabinese Dosage and Administration


There is no fixed dosage regimen for the management of type 2 diabetes with Diabinese or any other hypoglycemic agent. The patient's blood glucose must be monitored periodically to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels may also be of value in monitoring the patient's response to therapy.


Short-term administration of Diabinese may be sufficient during periods of transient loss of control in patients usually controlled well on diet.


The total daily dosage is generally taken at a single time each morning with breakfast. Occasionally cases of gastrointestinal intolerance may be relieved by dividing the daily dosage. A LOADING OR PRIMING DOSE IS NOT NECESSARY AND SHOULD NOT BE USED.



Initial Therapy


1. The mild to moderately severe, middle-aged, stable type 2 diabetes patient should be started on 250 mg daily. In elderly patients, debilitated or malnourished patients, and patients with impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycemic reactions (see PRECAUTIONS section). Older patients should be started on smaller amounts of Diabinese, in the range of 100 to 125 mg daily.


2. No transition period is necessary when transferring patients from other oral hypoglycemic agents to Diabinese. The other agent may be discontinued abruptly and chlorpropamide started at once. In prescribing chlorpropamide, due consideration must be given to its greater potency.


Many mild to moderately severe, middle-aged, stable type 2 diabetes patients receiving insulin can be placed directly on the oral drug and their insulin abruptly discontinued. For patients requiring more than 40 units of insulin daily, therapy with Diabinese may be initiated with a 50 per cent reduction in insulin for the first few days, with subsequent further reductions dependent upon the response.


During the initial period of therapy with chlorpropamide, hypoglycemic reactions may occasionally occur, particularly during the transition from insulin to the oral drug. Hypoglycemia within 24 hours after withdrawal of the intermediate or long-acting types of insulin will usually prove to be the result of insulin carry-over and not primarily due to the effect of chlorpropamide.


During the insulin withdrawal period, the patient should self-monitor glucose levels at least three times daily. If they are abnormal, the physician should be notified immediately. In some cases, it may be advisable to consider hospitalization during the transition period.


Five to seven days after the initial therapy, the blood level of chlorpropamide reaches a plateau. Dosage may subsequently be adjusted upward or downward by increments of not more than 50 to l25 mg at intervals of three to five days to obtain optimal control. More frequent adjustments are usually undesirable.



Maintenance Therapy


Most moderately severe, middle-aged, stable type 2 diabetes patients are controlled by approximately 250 mg daily. Many investigators have found that some milder diabetics do well on daily doses of 100 mg or less. Many of the more severe diabetics may require 500 mg daily for adequate control. PATIENTS WHO DO NOT RESPOND COMPLETELY TO 500 MG DAILY WILL USUALLY NOT RESPOND TO HIGHER DOSES. MAINTENANCE DOSES ABOVE 750 mg DAILY SHOULD BE AVOIDED.



How is Diabinese Supplied

















StrengthTablet DescriptionTablet CodeNDCPackage Size
Diabinese (chlorpropamide) 100 mgBlue, D-shaped, scored3930069-3930-66100's
Diabinese (chlorpropamide) 250 mgBlue, D-shaped, scored3940069-3940-66


0069-3940-82
100's


1000's

RECOMMENDED STORAGE: Store below 86°F (30°C).



Rx only



LAB-0039-5.0


February 2009








Diabinese 
chlorpropamide  tablet










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0069-3930
Route of AdministrationORALDEA Schedule    





























INGREDIENTS
Name (Active Moiety)TypeStrength
chlorpropamide (chlorpropamide)Active100 MILLIGRAM  In 1 TABLET
alginic acidInactive 
Blue 1 LakeInactive 
hydroxypropyl celluloseInactive 
magnesium stearateInactive 
precipitated calcium carbonateInactive 
sodium lauryl sulfateInactive 
starchInactive 






















Product Characteristics
ColorblueScore2 pieces
ShapeSEMI-CIRCLE (D-shaped)Size7mm
FlavorImprint CodePfizer;393
Contains      
CoatingfalseSymbolfalse










Packaging
#NDCPackage DescriptionMultilevel Packaging
10069-3930-66100 TABLET In 1 BOTTLENone






Diabinese 
chlorpropamide  tablet










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0069-3940
Route of AdministrationORALDEA Schedule    





























INGREDIENTS
Name (Active Moiety)TypeStrength
chlorpropamide (chlorpropamide)Active250 MILLIGRAM  In 1 TABLET
alginic acidInactive 
Blue 1 LakeInactive 
hydroxypropyl celluloseInactive 
magnesium stearateInactive 
precipitated calcium carbonateInactive 
sodium lauryl sulfateInactive 
starchInactive 






















Product Characteristics
ColorblueScore2 pieces
ShapeSEMI-CIRCLE (D-shaped)Size10mm
FlavorImprint CodePfizer;394
Contains      
CoatingfalseSymbolfalse














Packaging
#NDCPackage DescriptionMultilevel Packaging
10069-3940-66100 TABLET In 1 BOTTLENone
20069-3940-821000 TABLET In 1 BOTTLENone

Revised: 03/2009Pfizer Labs

More Diabinese resources


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


  • Diabinese Concise Consumer Information (Cerner Multum)

  • Diabinese MedFacts Consumer Leaflet (Wolters Kluwer)

  • Diabinese Monograph (AHFS DI)

  • Diabinese Advanced Consumer (Micromedex) - Includes Dosage Information

  • Chlorpropamide Professional Patient Advice (Wolters Kluwer)



Compare Diabinese with other medications


  • Diabetes, Type 2

Friday 18 December 2009

R.Lens




R.Lens may be available in the countries listed below.


Ingredient matches for R.Lens



Chlorhexidine

Chlorhexidine is reported as an ingredient of R.Lens in the following countries:


  • Tunisia

International Drug Name Search

Wednesday 16 December 2009

Bamster




Bamster may be available in the countries listed below.


Ingredient matches for Bamster



Barium Sulfate

Barium Sulfate is reported as an ingredient of Bamster in the following countries:


  • Japan

International Drug Name Search

Tuesday 15 December 2009

Neptalip




Neptalip may be available in the countries listed below.


Ingredient matches for Neptalip



Bezafibrate

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


  • Mexico

International Drug Name Search

Tuesday 1 December 2009

Omeprazol-Zys




Omeprazol-Zys may be available in the countries listed below.


Ingredient matches for Omeprazol-Zys



Omeprazole

Omeprazole is reported as an ingredient of Omeprazol-Zys in the following countries:


  • Netherlands

International Drug Name Search

Tuesday 24 November 2009

Tramadol-Sandoz




Tramadol-Sandoz may be available in the countries listed below.


Ingredient matches for Tramadol-Sandoz



Tramadol

Tramadol hydrochloride (a derivative of Tramadol) is reported as an ingredient of Tramadol-Sandoz in the following countries:


  • Belgium

  • Czech Republic

  • Finland

  • France

  • Germany

International Drug Name Search

Monday 23 November 2009

Bioceftrax




Bioceftrax may be available in the countries listed below.


Ingredient matches for Bioceftrax



Ceftriaxone

Ceftriaxone is reported as an ingredient of Bioceftrax in the following countries:


  • Venezuela

International Drug Name Search

Ofuxal




Ofuxal may be available in the countries listed below.


Ingredient matches for Ofuxal



Alfuzosin

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


  • Greece

International Drug Name Search

Saturday 21 November 2009

Lactocur




Lactocur may be available in the countries listed below.


Ingredient matches for Lactocur



Lactulose

Lactulose is reported as an ingredient of Lactocur in the following countries:


  • Luxembourg

International Drug Name Search

Amofilin




Amofilin may be available in the countries listed below.


Ingredient matches for Amofilin



Aminophylline

Aminophylline is reported as an ingredient of Amofilin in the following countries:


  • Peru

International Drug Name Search

Friday 20 November 2009

Artroxicam




Artroxicam may be available in the countries listed below.


Ingredient matches for Artroxicam



Piroxicam

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


  • Italy

International Drug Name Search

Remexin




Remexin may be available in the countries listed below.


Ingredient matches for Remexin



Ethinylestradiol

Ethinylestradiol is reported as an ingredient of Remexin in the following countries:


  • Taiwan

Norethisterone

Norethisterone 17ß-acetate (a derivative of Norethisterone) is reported as an ingredient of Remexin in the following countries:


  • Taiwan

International Drug Name Search

Monday 16 November 2009

Mediflex




Mediflex may be available in the countries listed below.


Ingredient matches for Mediflex



Glucosamine

Glucosamine is reported as an ingredient of Mediflex in the following countries:


  • Vietnam

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


  • Indonesia

International Drug Name Search

Monday 9 November 2009

Rhinocort Aqua


Generic Name: budesonide (Nasal route)

bue-DES-oh-nide

Commonly used brand name(s)

In the U.S.


  • Rhinocort

  • Rhinocort Aqua

In Canada


  • Gen-Budesonide Aq

Available Dosage Forms:


  • Aerosol Powder

  • Spray

Therapeutic Class: Anti-Inflammatory


Pharmacologic Class: Adrenal Glucocorticoid


Uses For Rhinocort Aqua


Budesonide nasal spray is used to treat an itchy or runny nose, sneezing, or other symptoms caused by hay fever (allergic rhinitis). It is a steroid (cortisone-like medicine) that works by preventing the inflammation that occurs with allergic reactions.


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


Before Using Rhinocort Aqua


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


Allergies


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


Pediatric


Appropriate studies have not been performed on the relationship of age to the effects of budesonide nasal spray in children younger than 6 years of age. Safety and efficacy have not been established.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of budesonide nasal spray in the elderly.


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 usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Boceprevir

  • Bupropion

  • Telaprevir

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.


  • Erythromycin

  • Itraconazole

  • Ketoconazole

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:


  • Cataracts, history of or

  • Glaucoma, history of—Use with caution. May make these conditions worse.

  • Chicken pox (includes recent exposure) or

  • Herpes simplex infection of the eye or

  • Infections (virus, bacteria, fungus, or parasite), any type and untreated or

  • Measles (includes recent exposure) or

  • Tuberculosis, active or history of—Can reduce the body's ability to fight off these infections.

  • Injury to the nose, recent or

  • Nose surgery, recent or

  • Sores or ulcers in the nose, recent—This medicine may prevent proper healing of these conditions.

  • Liver disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

Proper Use of budesonide

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


Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the amount that is absorbed from the nose and the chance of unwanted effects. Do not change your dose or stop using this medicine without checking with your doctor first.


This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.


This medicine is only used in the nose. Do not get it in your eyes. If it does get in the eyes, rinse them with water right away and call your doctor.


In order for this medicine to help you, it must be used on a regular basis as ordered by your doctor. This medicine usually begins to work in about 2 days, but up to 2 weeks may pass before you feel its full effects.


Do not use this medicine for any other nose problem without checking with your doctor first.


To use the spray:


  • Shake the bottle gently before each use.

  • When you use the spray for the first time, you must prime the bottle. Pump the bottle 8 times or until a fine spray comes out.

  • Gently blow your nose before using the spray. Insert the tip of the bottle into your nostril.

  • Close the opposite nostril with a finger and lean your head slightly forward.

  • Spray into your nostril and breathe gently inward. Lean your head backward for a few seconds.

  • If a second dose is needed in the same nostril, lean the head slightly forward and repeat the same steps.

  • Spray the opposite nostril using the same steps.

  • Do not blow your nose for 15 minutes after using the spray.

  • Wipe the tip of the bottle with a clean tissue and put the cap back on.

  • If you do not use the bottle for 2 days, prime it again by releasing one spray.

  • If you do not use the bottle for more than 14 days, clean the spray tip and prime it again by releasing two sprays.

  • After you prime the bottle, there will only be 120 doses or sprays. Keep track of the number of sprays you use. Throw the bottle away after you use 120 sprays even if some liquid remains in the bottle.

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 nasal dosage form (spray):
    • For treatment of allergic rhinitis:
      • Adults, teenagers, and children 12 years of age and older—At first, one spray in each nostril once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 4 sprays in each nostril per day.

      • Children 6 to 11 years of age—At first, one spray in each nostril once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 2 sprays in each nostril per day.

      • Children younger than 6 years of age—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.


After you prime the bottle, there will only be 120 doses or sprays. Keep track of the number of sprays you use. Throw the bottle away after you use 120 sprays even if some liquid remains in the bottle.


Precautions While Using Rhinocort Aqua


It is very important that your doctor check the progress of you or your child 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.


If you or your child feel that your symptoms do not improve within a few days or if they become worse, check with your doctor.


This medicine may increase your risk of having some unwanted effects in the nose. Check with your doctor right away if you or your child have bloody mucus; sores inside the nose; unexplained nosebleeds; or a whistling sound when you breathe while you are using this medicine.


This medicine may cause thrush (a type of fungus infection) in the nose or throat. Tell your doctor right away if you or your child have white patches in the throat, or pain when you eat or swallow.


This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.


You may get infections more easily while you are using this medicine. Avoid close contact with anyone who has chickenpox or measles if you have never had these infections. This is especially important for children. Tell your doctor right away if you think you have been exposed to chickenpox or measles.


Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you or your child have more than one of these symptoms while you are using this medicine: darkening of the skin; diarrhea; dizziness; fainting; loss of appetite; mental depression; nausea; skin rash; unusual tiredness or weakness; or weight loss.


This medicine may slow down a child's growth if it is used for a long time. Talk to your child's doctor if you think your child is not growing properly or if you have any questions about this.


Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).


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.


Rhinocort Aqua 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
  • Bloody nose

Less common
  • Body aches or pain

  • congestion

  • cough

  • difficulty with breathing

  • dryness or soreness of the throat

  • fever

  • hoarseness

  • noisy breathing

  • runny nose

  • shortness of breath

  • tender, swollen glands in the neck

  • tightness in the chest

  • trouble with swallowing

  • voice changes

  • wheezing

Incidence not known
  • Backache

  • blistering, crusting, irritation, itching, or reddening of the skin

  • bloody mucus

  • blurred vision

  • cracked, dry, or scaly skin

  • darkening of the skin

  • decreased vision

  • diarrhea

  • difficulty with swallowing

  • dizziness

  • eye pain

  • facial hair growth in females

  • fainting

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

  • full or round face, neck, or trunk

  • headache

  • hives or welts

  • increased thirst or urination

  • irritability

  • itching

  • lack or slowing of normal growth in children

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

  • loss of appetite

  • loss of sexual desire or ability

  • menstrual irregularities

  • mental depression

  • muscle wasting

  • nausea or vomiting

  • nosebleeds

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

  • skin rash

  • swelling

  • tearing

  • unusual tiredness or weakness

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


Incidence not known
  • Burning, itching, swollen, or sore throat

  • loss of sense of smell

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: Rhinocort Aqua 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 Rhinocort Aqua resources


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


  • Rhinocort Aqua Prescribing Information (FDA)

  • Rhinocort Aqua eent Monograph (AHFS DI)

  • Rhinocort Aqua Spray MedFacts Consumer Leaflet (Wolters Kluwer)

  • Rhinocort Aqua Consumer Overview



Compare Rhinocort Aqua with other medications


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Wednesday 4 November 2009

Octorax




Octorax may be available in the countries listed below.


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Enalapril

Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Octorax in the following countries:


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Monday 2 November 2009

Thiatab




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Thiamine

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Saturday 31 October 2009

Fluconazol Farmachif




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Fluconazole

Fluconazole is reported as an ingredient of Fluconazol Farmachif in the following countries:


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Tuesday 27 October 2009

Ethimox




Ethimox may be available in the countries listed below.


Ingredient matches for Ethimox



Amoxicillin

Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Ethimox in the following countries:


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Monday 26 October 2009

Opipramol dura




Opipramol dura may be available in the countries listed below.


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Opipramol

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Friday 23 October 2009

Adriamycin




In the US, Adriamycin (doxorubicin systemic) is a member of the drug class antibiotics/antineoplastics and is used to treat Acute Lymphoblastic Leukemia, Acute Myeloblastic Leukemia, Bladder Cancer, Breast Cancer, Cancer, Hodgkin's Lymphoma, Lung Cancer, Lymphoma, Multiple Myeloma, Neuroblastoma, Osteosarcoma, Ovarian Cancer, Soft Tissue Sarcoma, Stomach Cancer, Thyroid Cancer and Wilms' Tumor.

US matches:

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Doxorubicin

Doxorubicin is reported as an ingredient of Adriamycin in the following countries:


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


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Sunday 18 October 2009

Vinblastine Sulphate




Vinblastine Sulphate may be available in the countries listed below.


UK matches:

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Ingredient matches for Vinblastine Sulphate



Vinblastine

Vinblastine Sulphate (BANM) is known as Vinblastine in the US.

International Drug Name Search

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Saturday 10 October 2009

Tertensif Retard 2care4




Tertensif Retard 2care4 may be available in the countries listed below.


Ingredient matches for Tertensif Retard 2care4



Indapamide

Indapamide hemihydrate (a derivative of Indapamide) is reported as an ingredient of Tertensif Retard 2care4 in the following countries:


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Wednesday 7 October 2009

Sertagyn




Sertagyn may be available in the countries listed below.


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Sertaconazole

Sertaconazole nitrate (a derivative of Sertaconazole) is reported as an ingredient of Sertagyn in the following countries:


  • Italy

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Sunday 4 October 2009

Sulfoid




Sulfoid may be available in the countries listed below.


Ingredient matches for Sulfoid



Sulfamethoxazole

Sulfamethoxazole is reported as an ingredient of Sulfoid in the following countries:


  • Mexico

Trimethoprim

Trimethoprim is reported as an ingredient of Sulfoid in the following countries:


  • Mexico

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Wednesday 30 September 2009

Metlazel




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Metoclopramide

Metoclopramide is reported as an ingredient of Metlazel in the following countries:


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Monday 21 September 2009

Flumiquil




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

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Flumequine

Flumequine is reported as an ingredient of Flumiquil in the following countries:


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Sunday 20 September 2009

Glicina Salf




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Ingredient matches for Glicina Salf



Glycine

Glycine is reported as an ingredient of Glicina Salf in the following countries:


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Thursday 17 September 2009

Viani Diskus




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Fluticasone

Fluticasone propionate (a derivative of Fluticasone) is reported as an ingredient of Viani Diskus in the following countries:


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Salmeterol

Salmeterol xinafoate (a derivative of Salmeterol) is reported as an ingredient of Viani Diskus in the following countries:


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Thursday 10 September 2009

Ophthalmo-Azulen




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Guaiazulene

Guaiazulene is reported as an ingredient of Ophthalmo-Azulen in the following countries:


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Monday 7 September 2009

Opipram




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Opipramol

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


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Thursday 3 September 2009

Triclobacter




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Triclocarban

Triclocarban is reported as an ingredient of Triclobacter in the following countries:


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Thursday 20 August 2009

Solumedrol




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Methylprednisolone

Methylprednisolone 21-(sodium succinate) (a derivative of Methylprednisolone) is reported as an ingredient of Solumedrol in the following countries:


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Wednesday 19 August 2009

Méloxicam Biogaran




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Meloxicam

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Cevimeline




In the US, Cevimeline (cevimeline systemic) is a member of the drug class cholinergic agonists and is used to treat Sjogren's Syndrome.

US matches:

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  • Cevimeline Hydrochloride

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

N07AX03

CAS registry number (Chemical Abstracts Service)

0107233-08-9

Chemical Formula

C10-H17-N-O-S

Molecular Weight

199

Therapeutic Category

Nootropic

Chemical Names

(+/-)-cis-2-Methylspiro[1,3-oxathiolane-5,3'-quinuclidine] (WHO)

cis-2-Methylspiro(1,3-oxathiolane-5,3')quinuclidine hydrochloride hydrate (2:2:1)

Spiro(1-azabicyclo(2.2.2)octane-3,5'-(1,3)oxathiolane), 2'-methyl-, hydrochloride, hydrate (2:1), cis-

Spiro[1-azabicyclo[2.2.2]octane-3,5'-[1,3]oxathiolane], 2'-methyl-, cis- (USAN)

Foreign Names

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  • Cevimelin (German)
  • Céviméline (French)
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Generic Names

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  • AF 102 B (IS)
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  • FKS 508 (IS)
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Glossary

ISInofficial Synonym
OSOfficial Synonym
Rec.INNRecommended International Nonproprietary Name (World Health Organization)
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WHOWorld Health Organization

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Saturday 15 August 2009

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Friday 14 August 2009

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Saturday 1 August 2009

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Thursday 23 July 2009

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Wednesday 22 July 2009

Ciprofat




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Monday 20 July 2009

Intermezzo


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


INTERMEZZO (zolpidem tartrate - tablet; sublingual)



  • Manufacturer: PURDUE PHARMA

    Approval date: November 23, 2011

    Strength(s): 1.75MG, 3.5MG [RLD]

Has a generic version of Intermezzo been approved?


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


Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Intermezzo. 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.




  • Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof
    Patent 7,658,945
    Issued: February 9, 2010
    Inventor(s): Singh; Nikhilesh N.
    Assignee(s): Transcept Pharmaceuticals, Inc.
    The present invention provides novel compositions for the delivery of a hypnotic agent across the oral mucosa. In particular, the buffer system in the compositions of the present invention raises the pH of saliva to a pH greater than about 7.8, thereby facilitating the substantially complete conversion of the hypnotic agent from its ionized to its un-ionized form. As a result, the dose of hypnotic agent is rapidly and efficiently absorbed by the oral mucosa with surprisingly low inter-subject variability. Furthermore, delivery of the hypnotic agent across the oral mucosa advantageously bypasses hepatic first pass metabolism of the drug and avoids enzymatic degradation of the drug within the gastrointestinal tract. Methods for using the compositions of the present invention for treating sleep disorders such as insomnia are also provided.
    Patent expiration dates:

    • April 15, 2027
      ✓ 
      Patent use: METHOD FOR TREATING INSOMNIA
      ✓ 
      Drug product




  • Compositions for delivering hypnotic agents across the oral mucosa and methods of use thereof
    Patent 7,682,628
    Issued: March 23, 2010
    Inventor(s): Singh; Nikhilesh N.
    Assignee(s): Transcept Pharmaceuticals, Inc.
    The present invention provides novel compositions for the delivery of a hypnotic agent across the oral mucosa. In particular, the buffer system in the compositions of the present invention raises the pH of saliva to a pH greater than about 7.8, thereby facilitating the substantially complete conversion of the hypnotic agent from its ionized to its un-ionized form. As a result, the dose of hypnotic agent is rapidly and efficiently absorbed by the oral mucosa with surprisingly low inter-subject variability. Furthermore, delivery of the hypnotic agent across the oral mucosa advantageously bypasses hepatic first pass metabolism of the drug and avoids enzymatic degradation of the drug within the gastrointestinal tract. Methods for using the compositions of the present invention for treating sleep disorders such as insomnia are also provided.
    Patent expiration dates:

    • February 16, 2025
      ✓ 
      Patent use: METHOD FOR TREATING INSOMNIA



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:
    • November 23, 2014 - NEW PRODUCT

See also...

  • Intermezzo Consumer Information (Drugs.com)
  • Intermezzo Consumer Information (Cerner Multum)
  • Zolpidem Consumer Information (Drugs.com)
  • Zolpidem Consumer Information (Wolters Kluwer)
  • Zolpidem Extended-Release Tablets Consumer Information (Wolters Kluwer)
  • Zolpidem Oral Spray Consumer Information (Wolters Kluwer)
  • Zolpidem Consumer Information (Cerner Multum)
  • Zolpidem Oral, Oromucosal Advanced Consumer Information (Micromedex)
  • Zolpidem Tartrate AHFS DI Monographs (ASHP)

Saturday 18 July 2009

Benzocaine Liquid


Pronunciation: BEN-zoe-kane
Generic Name: Benzocaine
Brand Name: Anbesol


Benzocaine Liquid is used for:

Treating pain from mouth and gum irritations (eg, canker sores). It may also be used for other conditions as determined by your doctor.


Benzocaine Liquid in a local anesthetic. It works by numbing sensitive and painful areas.


Do NOT use Benzocaine Liquid if:


  • you are allergic to any ingredient in Benzocaine Liquid or to other local anesthetics (eg, butacaine, procaine)

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



Before using Benzocaine Liquid:


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


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

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

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

Some MEDICINES MAY INTERACT with Benzocaine Liquid. Because little, if any, of Benzocaine Liquid is absorbed into the blood, the risk of it interacting with another medicine is low.


Ask your health care provider if Benzocaine Liquid 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 Benzocaine Liquid:


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


  • An adult should supervise the use of Benzocaine Liquid if the patient is a CHILD younger than 12 years old.

  • To use a dose of Benzocaine Liquid, follow the instructions provided by your doctor or on the product label.

  • Wash your hands before and after you use Benzocaine Liquid. Apply medicine to the affected area by using cotton, a cotton swab, or a clean fingertip.

  • Do not eat or drink for at least 1 hour after using Benzocaine Liquid.

  • Do not use Benzocaine Liquid within 1 hour of your previous dose or use more than 4 times per day, unless your doctor or dentist tells you otherwise.

  • If you miss a dose of Benzocaine Liquid, use it as soon as you remember. Continue to use it as directed by your doctor or on the package label.

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



Important safety information:


  • Do not get Benzocaine Liquid in your eyes. If you get it in your eyes, rinse at once with cool water.

  • Do NOT use more than the recommended dose or use for longer than 7 days without checking with your doctor or dentist.

  • If your symptoms do not get better within 7 days or if they get worse, check with your doctor.

  • Contact your doctor if you have persistent or worsening pain, redness, or irritation, or if you develop swelling, rash, or a fever. Tell your doctor if you have mouth sores that keep coming back.

  • Benzocaine Liquid may cause harm if more than the amount used to treat pain is swallowed. If this occurs, contact your poison control center or emergency room right away.

  • Benzocaine Liquid should not be used in CHILDREN younger than 2 years old without checking with the child's doctor or dentist; safety and effectiveness in these children have not been confirmed.

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


Possible side effects of Benzocaine Liquid:


All medicines may cause side effects, but many people have no, or minor, side effects. 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); mouth burning, irritation, redness, swelling, or tenderness.



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



If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Benzocaine Liquid may cause harm if more than is used for pain is swallowed. Symptoms may include blue skin or lips; trouble breathing.


Proper storage of Benzocaine Liquid:

Store Benzocaine Liquid at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Keep Benzocaine Liquid out of the reach of children and away from pets.


General information:


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

  • Benzocaine Liquid 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 Benzocaine Liquid. 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.

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