Monday, October 24, 2016

dapsone


Generic Name: dapsone (DAP sone)

Brand Names:


What is dapsone?

Dapsone is an antiinfective medication.


Dapsone is used in the treatment of dermatitis herpetiformis (a skin condition) and leprosy (Hansen's disease).


Dapsone may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about dapsone?


In rare cases, dapsone has been associated with serious, and sometimes fatal blood and liver problems. Contact your doctor immediately if you experience a sore throat, fever, pale skin, bruising or pinpoint red spots on the skin, or yellowing of the skin or eyes. These may be symptoms of blood or liver problems. Contact your doctor immediately if you develop a rash while taking dapsone. In rare cases, dapsone has been associated with serious, and sometimes fatal, skin reactions.

What should I discuss with my healthcare provider before taking dapsone?


Do not take dapsone without first talking to your doctor if you have

  • glucose 6-phosphate dehydrogenase (G6PD) deficiency;




  • methemoglobin reductase deficiency (hemoglobin M); or



  • liver disease.

You may not be able to take dapsone, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.


Dapsone is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not take dapsone without first talking to your doctor if you are pregnant or could become pregnant during treatment. Dapsone passes into breast milk and may affect a nursing baby. Do not take dapsone without first talking to your doctor if you are nursing a baby.

How should I take dapsone?


Take dapsone exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.


Take each dose with a full glass of water.

Taking dapsone with food may decrease stomach upset, should it occur.


It is important to take dapsone regularly to get the most benefit.


Your doctor may want you to have blood tests or other forms of monitoring during treatment with dapsone.


Store dapsone at room temperature away from moisture and heat.

See also: Dapsone dosage (in more detail)

What happens if I miss a dose?


Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose. Do not take a double dose of this medication, unless otherwise directed by your doctor.


What happens if I overdose?


Seek emergency medical attention if an overdose is suspected.

Symptoms of a dapsone overdose may include nausea, vomiting, excitation, seizures, and bluish skin color.


What should I avoid while taking dapsone?


Avoid prolonged exposure to sunlight. Dapsone may increase the sensitivity of the skin to sunlight and sunburn may be more likely to occur. If exposure to the sun is unavoidable, wear a sunscreen and protective clothing.

Dapsone side effects


In rare cases, dapsone has been associated with serious, and sometimes fatal blood and/or liver problems. Contact your doctor immediately if you experience a sore throat, fever, pale skin, bruising or pinpoint red spots on the skin, or yellowing of the skin or eyes. These may be symptoms of blood or liver problems. Contact your doctor immediately if you develop a rash while taking dapsone. In rare cases, dapsone has been associated with serious, and sometimes fatal, skin reactions. If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);




  • bluish skin color;




  • muscle weakness;




  • numbness or tingling;




  • abdominal pain;




  • difficulty breathing;




  • dark colored urine or pale colored stools; or




  • unusual tiredness.



Other, less serious side effects may be more likely to occur. Notify your doctor if you experience



  • nausea or vomiting;




  • blurred vision;




  • ringing in the ears;




  • headache;




  • insomnia; or




  • increased sensitivity of the skin to sunlight.



Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.


Dapsone Dosing Information


Usual Adult Dose for Leprosy -- Lepromatous:

50 to 100 mg orally once a day for 2-5 years.

Usual Adult Dose for Leprosy -- Tuberculoid:

100 mg orally once a day for 6 months. Rifampin is additionally recommended to reduce the incidence of dapsone resistance. If the disease relapses, this regimen should be repeated.

Usual Adult Dose for Dermatitis Herpetiformis:

50 mg orally once a day continued on a life-long basis. Dosage may be advanced to 300 mg/day. Dosage reduction to a minimum maintenance level as soon as possible is recommended.

Usual Adult Dose for Pneumocystis Pneumonia:

100 mg orally once a day for 14 to 21 days. Used in combination with trimethoprim.

Usual Adult Dose for Pneumocystis Pneumonia Prophylaxis:

100 mg orally twice a week. Therapy should be continued on a life-long basis. The addition of pyrimethamine appears to significantly increase the activity of dapsone for PCP prophylaxis.

Usual Adult Dose for Toxoplasmosis -- Prophylaxis:

100 mg orally twice a week continued on a life-long basis.

Usual Pediatric Dose for Leprosy:

1 to 2 mg/kg (up to 100 mg) orally once a day.

Usual Pediatric Dose for Pneumocystis Pneumonia Prophylaxis:

> 1 month:
2 mg/kg/day (up to 100 mg) orally once a day.

Alternate dosing:
> 1 month:
4 mg/kg orally once weekly. Maximum dose = 200 mg.

Usual Pediatric Dose for Toxoplasmosis -- Prophylaxis:

> 1 month:

2 mg/kg/day (or 15 mg/m2) orally once a day. Maximum dose = 25 mg. Dapsone should be administered as part of combination therapy for prophylaxis of toxoplasmosis.


What other drugs will affect dapsone?


Many other drugs can interact with dapsone, especially those that may also affect the blood. Do not take any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products, during treatment with dapsone without first talking to your doctor.



More dapsone resources


  • Dapsone Dosage
  • Dapsone Use in Pregnancy & Breastfeeding
  • Drug Images
  • Dapsone Drug Interactions
  • Dapsone Support Group
  • 6 Reviews for Dapsone - Add your own review/rating


  • dapsone Advanced Consumer (Micromedex) - Includes Dosage Information

  • Dapsone Prescribing Information (FDA)

  • Dapsone Professional Patient Advice (Wolters Kluwer)

  • Dapsone Monograph (AHFS DI)

  • Dapsone MedFacts Consumer Leaflet (Wolters Kluwer)



Compare dapsone with other medications


  • Bullous Pemphigoid
  • Dermatitis Herpetiformis
  • Leprosy
  • Leprosy, Lepromatous
  • Leprosy, Tuberculoid
  • Leukocytoclastic Vasculitis
  • Pemphigoid
  • Pemphigus
  • Pneumocystis Pneumonia
  • Pneumocystis Pneumonia Prophylaxis
  • Toxoplasmosis, Prophylaxis


Where can I get more information?


  • Your pharmacist has more information about dapsone written for health professionals that you may read.


Ademetionine




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

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

A16AA02

CAS registry number (Chemical Abstracts Service)

0029908-03-0

Chemical Formula

C15-H22-N6-O5-S

Molecular Weight

398

Therapeutic Categories

Dietary supplement

Antirheumatic agent

Chemical Name

Adenosine, 5'-[(3-amino-3-carboxypropyl)methylsulfonio]-5'-deoxy-, hydroxide, inner salt

Foreign Names

  • Ademetioninum (Latin)
  • Ademetionin (German)
  • Ademetionin (French)
  • Ademetionina (Spanish)

Generic Names

  • Adenosylmethionin (IS)
  • Methioninyl Adenylate (IS)
  • S-Adenosyl-L-Methionine (IS)
  • S-Adenosyl-Methionine (IS)
  • S-Adénosyl-Méthionine (IS)
  • SAM (IS)
  • SAMe (IS)
  • SAM-e (IS)
  • Ademetionine disulfate di-p-toluenesulfonate (IS)

Brand Names

  • Denosyl (veterinary use)
    Nature Vet, Australia; Vetpharm, New Zealand


  • Donamet
    Abbott, Italy


  • Heptor
    Verofarm, Russian Federation


  • Samyr
    Abbott, Italy


  • Transmetil
    Abbott, China; Abbott, Italy


  • Tunik
    Baliarda, Argentina


  • Gumbaral
    AWD.pharma, Germany


  • Heptral
    Abbott, Georgia; Abbott, Russian Federation


  • Transmetil
    Abbott, Czech Republic

International Drug Name Search

Glossary

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

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

Friday, October 21, 2016

Elliotts B Solution





Dosage Form: injection, solution
ELLIOTTS B® SOLUTION (buffered intrathecal electrolyte/dextrose injection)

Rx Only

Elliotts B Solution Description


Elliotts B® Solution is a sterile, nonpyrogenic, isotonic solution containing no bacteriostatic preservatives. Elliotts B Solution is a diluent for intrathecal administration of methotrexate sodium and cytarabine.


Each 10 mL of Elliotts B Solution contains:



















Sodium Chloride, USP73 mg
Sodium Bicarbonate, USP19 mg
Dextrose, USP8 mg
Magnesium Sulfate • 7H2O, USP3 mg
Potassium Chloride, USP3 mg
Calcium Chloride • 2H2O, USP2 mg
Sodium Phosphate, dibasic • 7H2O, USP2 mg
Water for Injection, USPqs 10 mL


Concentration of Electrolytes:

















Sodium149 mEq/literBicarbonate22.6 mEq/liter
Potassium4.0 mEq/literChloride132 mEq/liter
Calcium2.7 mEq/literSulfate2.4 mEq/liter
Magnesium2.4 mEq/literPhosphate1.5 mEq/liter


The formulae and molecular weights of the ingredients are:




























INGREDIENTMOLECULAR

FORMULA
MOLECULAR

WEIGHT
Sodium Chloride
NaCl
58.44
Sodium Bicarbonate
NaHCO3
84.01
Dextrose
C6H12O6
180.16
Magnesium Sulfate • 7H2O
Mg2SO4 • 7H2O
246.48
Potassium Chloride
KCl
74.55
Calcium Chloride • 2H2O
CaCl2 • 2H2O
147.01
Sodium Phosphate, dibasic • 7H2O
Na2HPO4 • 7H2O
268.07



The pH of Elliotts B Solution is 6.0-7.5, and the osmolarity is 288 mOsmol per liter (calculated).


Elliotts B Solution - Clinical Pharmacology


Elliotts B Solution provides a buffered salt solution for use as a diluent for the intrathecal administration of methotrexate sodium and cytarabine. It has been demonstrated that Elliotts B Solution is comparable to cere­brospinal fluid in pH, electrolyte composition, glucose content, and osmolarity:



Comparison of Electrolyte Composition, pH and Nonelectrolytic Constituents of Elliotts B Solution and CSF


































Solution



Na+

mEq/L



K+

mEq/L



Ca++

mEq/L



Mg++

mEq/L



HCO3-

mEq/L



Cl-

mEq/L



pH



Phosphorus

mg/dL



Glucose

mg/dL



Cerebrospinal Fluid



117-137



2.3-4.6



2.2



2.2



22.9



113-127



7.31



1.2-2.1



45-80



Elliotts B Solution



149



4.0



2.7



2.4



22.6



132



6.0-7.5



2.3



80


The approximate buffer capacity of Elliotts B Solution is 1.1 X 10-2 equivalents when the challenge solution is 0.01 N HCl and 7.8 X 10-3 equivalents when the challenge solution is 0.01 N NaOH.1




Compatibility studies with methotrexate sodium and cytarabine indicate these drugs are physically compati­ble with Elliotts B Solution.




Indications and Usage for Elliotts B Solution


Elliotts B Solution is indicated as a diluent for the intrathecal administration of methotrexate sodium and cytarabine for the prevention or treatment of meningeal leukemia or lymphocytic lymphoma.



Contraindications


None known.



Warnings


Intrathecal administration of drugs such as methotrexate sodium and cytarabine should be performed by per­sonnel skilled in the technique of lumbar puncture under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents. The labeling for methotrexate sodium and cytarabine should be consulted.



Precautions





General


Particular attention should be taken to assure the maintenance of sterile technique throughout the procedure. (See DOSAGE AND ADMINISTRATION.)



Carcinogenesis, Mutagenesis, Impairment of Fertility


No standard mutagenicity or carcinogenicity studies have been conducted with Elliotts B Solution.



Usage in Pregnancy


Pregnancy Category C





All components of Elliotts B Solution are normal body constituents. Animal reproduction studies have not been conducted with Elliotts B Solution.



Adverse Reactions


Adverse reactions may occur with any given intrathecal injection due to the chemotherapy or the technique of intrathecal administration.  (See product labeling for methotrexate sodium and cytarabine.)




Preservative-free methotrexate sodium and cytarabine should be used to minimize adverse reactions due to preservatives.




If an adverse reaction does occur, discontinue the administration, evaluate the patient, institute appropriate therapeutic countermeasures and, if possible, save the remainder of the unused solution(s) for examination.



Overdosage


Elliotts B Solution is a diluent. In the event of a drug, fluid or solute overload following administration, evalu­ate the patient's condition, and institute appropriate corrective treatment. (See product labeling for methotrexate sodium and cytarabine.)



Elliotts B Solution Dosage and Administration


See product labeling for methotrexate sodium and cytarabine.




Elliotts B Solution is intended for intrathecal administration only.  Elliotts B Solution does not contain antibac­terial preservatives and introduction of contaminated solutions into the cerebrospinal fluid may have extremely serious consequences. Therefore, administration of intrathecal solutions should be accomplished as soon as possible after preparation.



A sterile filter-needle should be used to withdraw the contents of the ampule.




Intrathecal drug products should be inspected visually for particulate matter and discoloration prior to admin­istration.



Preparation and Administration Precautions


Elliotts B Solution is a diluent for the cytotoxic anticancer agents, methotrexate sodium and cytarabine. Care should be exercised in the handling and preparation of infusion solutions with these products. (See product labeling for methotrexate sodium and cytarabine.)



How is Elliotts B Solution Supplied







NDCSIZE
67871-007-10
10 mL ampule

Elliotts B Solution is available in single-use clear glass ampules, packaged 10 ampules per box.


Store at controlled room temperature, 20º-25ºC (68º-77ºF) [See USP].


Preservative Free.  Discard unused portion.  Use only if solution is clear and ampule is intact.


Manufactured by:  Ben Venue Laboratories, Inc.

                            Bedford, Ohio  44146


Distributed by:    QOL Medical LLC

                         Kirkland, WA  98033

                         1-866-528-4750

                         www.elliottsbsolution.com

REFERENCES:


1. Cradock JC, et al. Evaluation of some pharmaceutical aspects of intrathecal methotrexate sodium, cytara­bine and hydrocortisone sodium succinate.  American Journal of Hospital Pharmacy (1978); 35:402.


Rev. 09/06

Part No. 210





PACKAGING


Ampule labeling:




Box labeling:










ELLIOTTS B 
buffered intrathecal electrolyte/dextrose  injection, solution










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)67871-007
Route of AdministrationINTRATHECALDEA Schedule    


























Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
sodium chloride (sodium cation and chloride ion)sodium chloride73 mg  in 10 mL
sodium bicarbonate (sodium cation and bicarbonate ion)sodium bicarbonate19 mg  in 10 mL
dextrose (dextrose)dextrose8 mg  in 10 mL
magnesium sulfate, unspecified (magnesium cation and sulfate ion)magnesium sulfate, unspecified3 mg  in 10 mL
potassium chloride (potassium cation and chloride ion)potassium chloride3 mg  in 10 mL
calcium chloride (calcium cation and chloride ion)calcium chloride2 mg  in 10 mL
sodium phosphate (sodium cation and phosphate ion)sodium phosphate2 mg  in 10 mL






Inactive Ingredients
Ingredient NameStrength
Water10 mL  in 10 mL


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
167871-007-1010 AMPULE In 1 BOXcontains a AMPULE (67871-007-01)
167871-007-0110 mL In 1 AMPULEThis package is contained within the BOX (67871-007-10)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02057709/01/2006


Labeler - QOL Medical LLC (140026258)
Revised: 03/2011QOL Medical LLC

Thiamine Hydrochloride Injection




Thiamine HCL 100 mg/mL Injection, USP 2 mL Multi Dose Vial

Description


Thiamine Hydrochloride Injection, USP is a sterile solution of thiamine hydrochloride in Water for Injection for intramuscular (IM) or slow intravenous (IV) administration.


Each mL contains: Thiamine hydrochloride 100 mg; chlororbutanol anhydrous (chloral derivative) 0.5%; monothioglycerol 0.5%; Water for Injection q.s.  Sodium hydroxide may have been added for pH adjustment (2.5 to 4.5).


Thiamine hydrochloride, or vitamin B1, occurs as white crystals or crystalline powder that  usually has a slight characteristic odor.  Freely soluble in water; soluble in glycerin; slightly soluble in alcohol; insoluble in ether and benzene.  Thiamine is rapidly destroyed in neutral or alkaline solutions but is stable in the dry state.  It is reasonably stable to heat in acid solution.


The chemical name of thiamine hydrochloride is thiazolium, 3-[(4-amino-2-methyl-5-pyrimidinyl)mythyl]-5-(2-hydroxyethyl)-4-methyl-chloride, monohydrochloride and it has the following structural formula:




Clinical Pharmacology


The water soluble vitamins are widely distributed in both plants and animals. They are absorbed in man by both diffusion and active transport mechanisms. These vitamins are structurally diverse (derivatives of sugar, pyridine, purines, pyrimidine, organic acid complexes and nucleotide complex) and act as coenzymes, as oxidation-reduction agents, possibly as mitochondrial agents. Metabolism is rapid, and the excess is excreted in the urine.


Thiamine is distributed in all tissues. The highest concentrations occur in liver, brain, kidney and heart. When thiamine intake is greatly in excess of need, tissue stores increase two to three times. If intake is insufficient, tissues become depleted of their vitamin content. Absorption of thiamine following IM administration is rapid and complete.


Thiamine combines with adenosine triphosphate (ATP) to form thiamine pyrophosphate, also known as cocarboxylase, a coenzyme. Its role in carbohydrate metabolism is the decarboxylation of pyruvic acid in the blood and -ketoacids to acetaldehyde and carbon dioxide. Increased levels of pyruvic acid in the blood indicate vitamin B1 deficiency.


The requirement for thiamine is greater when the carbohydrate content of the diet is raised. Body depletion of vitamin B1 can occur after approximately three weeks of total absence of thiamine in the diet.



Indications and Usage


Thiamine Hydrochloride Injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. Thiamine Hydrochloride Injection should be used where rapid restoration of thiamine is necessary, as in Wernicke’s encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe. It is also indicated when giving IV dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure.


Thiamine Hydrochloride Injection is also indicated in patients with established thiamine deficiency who cannot take thiamine orally due to coexisting severe anorexia, nausea, vomiting, or malabsorption. Thiamine hydrochloride injection is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vitamins should usually be given



Contraindications




A history of sensitivity to thiamine or to any of the ingredients in this drug is a contraindication.  (See WARNINGS for further information.)

Warnings


WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.


Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.


Serious hypersensitivity/anaphylactic reactions can occur, especially after repeated administration. Deaths have resulted from IV or IM administration of thiamine (see package insert for ADVERSE REACTIONS).


Routine testing for hypersensitivity, in many cases, may not detect hypersensitivity. Nevertheless, a skin test should be performed on patients who are suspected of drug allergies or previous reactions to thiamine, and any positive responders should not receive thiamine by injection.


If hypersensitivity to thiamine is suspected (based on history of drug allergy or occurrence of adverse reactions after thiamine administration), administer one-hundredth of the dose intradermally and observe for 30 minutes. If no reaction occurs, full dose can be given; the patient should be observed for at least 30 minutes after injection. Be prepared to treat anaphylactic reactions regardless of the precautions taken.


Treatment of anaphylactic reactions includes maintaining a patent airway and the use of epinephrine, oxygen, vasopressors, steroids and antihistamines.



Precautions


General

Simple vitamin B1 deficiency is rare.  Multiple vitamin deficiencies should be suspected in any case of dietary inadequacy.


Information for Patients

The patient should be advised as to proper dietary habits during treatment so that relapses will be less likely to occur with reduction in dosage or cessation of injection therapy. 


Usage in Pregnancy

Pregnancy Category A- Studies in pregnant women have not shown that thiamine hydrochloride increases the risk of fetal abnormalities if administered during pregnancy.  If the drug is sued during pregnancy, the possibility of fetal harm appears remote.  Because studies cannot rule out the possibility of harm however, thiamine hydrochloride should be used during pregnancy only if clearly needed. 


Nursing Mothers

It is not known whether this drug is excreted in human milk.  Because many drugs are excreted in human milk, caution should be exercised when thiamine hydrochloride is administered to a nursing mother. 



Adverse Reactions


An occasional individual may develop a hypersensitivity or life-threatening anaphylactic reaction to thiamine, especially after repeated  injection.  collapse and death have been reported.  A feeling of warmth, pruritus, urticaria, weakness, sweating, nausea, restlessness, tightness of the throat, angioneurotic edema, cyanosis, pulmonary edema, and hemorrhage into the gastrointestinal tract have also been reported.  Some tenderness and induration may follow IM use (see WARNINGS).



Overdosage


Parenteral doses of 100 to 500 mg singly have been administered without toxic effects.  However, dosages exceeding 30 mg three times a day are not utilized effectively. 


When the body tissues are saturated with thiamine, it is excreted in the urine as pyrimidine.  As the intake of thiamine is further increased, it appears unchanged in the urine. 



Dosage and Administration


 “Wet” beriberi with myocardial failure must be treated as an emergency cardiac condition, and thiamine must be administered slowly by the IV route in this situation (see WARNINGS).


In the treatment of beriberi, 10 to 20 mg of thiamine hydrochloride are given IM three times daily for as long as two weeks. (See WARNINGS regarding repeated injection of thiamine.) An oral therapeutic multivitamin preparation containing 5 to 10 mg thiamine, administered daily for one month, is recommended to achieve body tissue saturation.


Infantile beriberi that is mild may respond to oral therapy, but if collapse occurs, doses of 25 mg may cautiously be given IV.


Poor dietary habits should be corrected and an abundant and well-balanced dietary intake should be prescribed.


Patients with neuritis of pregnancy in whom vomiting is severe enough to preclude adequate oral therapy should receive 5 to 10 mg of thiamine hydrochloride IM daily.


In the treatment of Wernicke-Korsakoff syndrome, thiamine hydrochloride has been administered IV in an initial dose of 100 mg, followed by IM doses of 50 to 100 mg daily until the patient is consuming a regular, balanced diet. (See WARNINGS regarding repeated injections of thiamine.)


Patients with marginal thiamine status to whom dextrose is being administered should receive 100 mg thiamine hydrochloride in each of the first few liters of IV fluid to avoid precipitating heart failure.


Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.



How Supplied











Product No.NDC No.Thiamine HCL/mLVolume
1302
63323-013-02
100 mg
2 mL

2 mL size is a multiple dose vial, packaged 25 vials per tray. Store at 20° to 25°C (68° to 77°F)  [see USP Controlled Room Temperature].

PROTECT FROM LIGHT.

Use only if solution is clear and seal intact.


APP

APP Pharmaceuticals, LLC

Schaumburg, IL 60173


45819E

Revised: May 2008

Sample Outer Label










THIAMINE HYDROCHLORIDE  
thiamine hydrochloride  injection, solution










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)52584-005 (63323-013)
Route of AdministrationINTRAMUSCULAR, INTRAVENOUSDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Thiamine Hydrochloride (Thiamine)Thiamine Hydrochloride100 mg  in 1 mL





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
152584-005-021 VIAL In 1 BAGcontains a VIAL, MULTI-DOSE
12 mL In 1 VIAL, MULTI-DOSEThis package is contained within the BAG (52584-005-02)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA08055609/01/2010


Labeler - General Injectables & Vaccines, Inc (108250663)
Revised: 01/2012General Injectables & Vaccines, Inc

Thursday, October 20, 2016

Indomethacin




In the US, Indomethacin (indomethacin systemic) is a member of the drug class nonsteroidal anti-inflammatory agents and is used to treat Ankylosing Spondylitis, Back Pain, Bartter Syndrome, Bursitis, Cluster Headaches, Frozen Shoulder, Gitelman Syndrome, Gout - Acute, Langerhans' Cell Histiocytosis, Osteoarthritis, Pain, Patent Ductus Arteriosus, Rheumatoid Arthritis, Sciatica and Tendonitis.

US matches:

  • Indomethacin

  • Indomethacin Capsules

  • Indomethacin Suppositories

  • Indomethacin Suspension

  • Indomethacin Sustained-Release Capsules

  • Indomethacin Intravenous

  • Indomethacin Rectal

  • Indomethacin ER

  • Indomethacin Injection

Ingredient matches for Indomethacin



Indometacin

Indomethacin (USAN) is also known as Indometacin (Rec.INN)

International Drug Name Search

Glossary

Rec.INNRecommended International Nonproprietary Name (World Health Organization)
USANUnited States Adopted Name

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

Triamterene



Class: Potassium-sparing Diuretics
VA Class: CV704
CAS Number: 396-01-0
Brands: Dyazide, Dyrenium, Maxzide



  • Hyperkalemia (i.e., serum potassium concentrations ≥5.5 mEq/L) may occur with all potassium-sparing agents, including triamterene.b c d More likely to occur in patients with renal impairment and diabetes (even without evidence of renal impairment), and in geriatric or severely ill patients or those receiving prolonged therapy with large doses.a b c d




  • Uncorrected hyperkalemia may be fatal; monitor serum potassium concentrations at frequent intervals especially during initial therapy, after dosage adjustment, or in patients with concurrent illness that may affect renal function.b c d




Introduction

Potassium-sparing diuretic; pteridine derivative.b


Uses for Triamterene


Edema


Management of edema associated with CHF, cirrhosis of the liver, or nephrotic syndrome.b


Management of steroid-induced edema, idiopathic edema, and edema caused by secondary hyperaldosteronism.b


May be used alone but most valuable when used in combination with other diuretics to promote diuresis and/or decrease potassium excretion caused by kaliuretic diuretics.b


May be particularly useful in patients excreting excessive amounts of potassium (especially those who cannot tolerate potassium supplements) and for those in whom potassium loss could be detrimental, such as patients receiving digitalis glycosides or those with myasthenia gravis.a b


Promotes increased diuresis in patients resistant or only partially responsive to thiazides or other diuretics because of secondary hyperaldosteronism.b


May be effective in some patients unresponsive to spironolactone; unlike spironolactone, diuretic effect of triamterene is independent of aldosterone concentrations.a


Used in fixed combination with hydrochlorothiazide for treatment of edema in patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked.c d


Used in fixed combination with hydrochlorothiazide for treatment of edema in patients who develop hypokalemia during hydrochlorothiazide monotherapy.c d


Do not use for routine therapy in pregnant women with mild edema who are otherwise healthy.b c d


CHF


In the management of edema associated with CHF, generally used in conjunction with other more effective, rapidly acting diuretics (e.g., thiazides, chlorthalidone, loop diuretics).a Some patients resistant to triamterene monotherapy may respond to such combined therapy.a


Most experts state that all patients with symptomatic CHF who have evidence or a prior history of fluid retention generally should receive diuretic therapy in conjunction with moderate sodium restriction (≤3 g of sodium daily), an ACE inhibitor, and usually a β-adrenergic blocking agent, with or without a cardiac glycoside.112 113


Most experts state that the diuretics of choice for most patients with CHF are loop diuretics (e.g., bumetanide, ethacrynic acid, furosemide, torsemide).a


Do not use diuretics as monotherapy in CHF even if symptoms (e.g., peripheral edema, pulmonary congestion) are well controlled; diuretics alone do not prevent progression of heart failure.


Once fluid retention in CHF has resolved, diuretic therapy should be maintained to prevent its recurrence. Ideally, diuretic therapy should be adjusted according to changes in body weight (as an indicator of fluid retention) rather than maintained at a fixed dosage.


Diuretics should be continued in CHF and comorbid conditions (e.g., hypertension) where ongoing therapy with the drugs is indicated.


Hypertension


Triamterene alone has little if any hypotensive effect; however, it may be used with another diuretic (e.g., hydrochlorothiazide) or a hypotensive agent in the management of mild to moderate hypertension.a However, JNC 7 recommends that thiazides be used as initial therapy for the treatment of uncomplicated hypertension in most patients, either alone or combined with other classes of antihypertensive drugs that have demonstrated benefit (e.g., ACE inhibitors, angiotensin II receptor antagonists, β-blockers, calcium-channel blockers).119


Used principally in patients with diuretic-induced hypokalemia or to prevent hypokalemia in patients receiving diuretics who are at risk of this adverse effect.a


Used in fixed combination with hydrochlorothiazide for treatment of hypertension in patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked.c d


Used in fixed combination with hydrochlorothiazide for treatment of hypertension in patients who develop hypokalemia during hydrochlorothiazide monotherapy.c d


Used in fixed combination with hydrochlorothiazide for treatment of hypertension as an adjunct to other antihypertensive drugs (e.g., β-blockers).c d


Triamterene Dosage and Administration


General



  • Monitor serum potassium concentrations following changes in dosage or with concurrent illness or drug therapy.b d (See Hyperkalemia under Cautions and also see Interactions.)




  • Avoid use of potassium-sparing diuretics, including triamterene, in patients with renal insufficiency, in those with hyperkalemia who have serum potassium concentrations >5 mEq/L while not receiving drug therapy, and in those who develop hyperkalemia during therapy.109 119 b c d




  • Do not use concurrent potassium supplementation or potassium-containing salt substitutes.b Discontinue potassium supplementation when triamterene is added to other diuretic therapy or when patients are switched to triamterene from other diuretics.b




  • Do not use fixed-combination triamterene/hydrochlorothiazide tablets or capsules for initial therapy of edema or hypertension, except in patients in whom the clinical consequences of hypokalemia represent an important risk (e.g., patients receiving cardiac glycosides or patients with cardiac arrhythmias).a c d




  • Do not use as initial monotherapy in severe CHF since bowel edema or intestinal hypoperfusion may delay absorption and subsequent therapeutic effect.a




  • Careful etiologic diagnosis should precede the use of any diuretic.a



Administration


Oral Administration


Capsules: Administer orally twice daily after meals.b


Fixed-combination triamterene/hydrochlorothiazide tablets or capsules: Administer orally once daily.c d


Twice-daily administration of the fixed combination of triamterene and hydrochlorothiazide may increase risk of electrolyte imbalance and renal dysfunction.d


Dosage


Individualize dosage according to patient’s requirements and response.b


If added to an existing antihypertensive regimen, initially reduce dosage of each antihypertensive agent and then individualize dosage according to patient’s requirements and response.b


Abrupt discontinuance may result in rebound kaliuresis; taper dosage gradually.b


Different commercially available fixed-combination triamterene/hydrochlorothiazide preparations may not be therapeutic equivalents.a The oral bioavailabilities of the individual drugs and the amounts and ratios of these drugs in various commercially available fixed-combination preparations may differ.a


Pediatric Patients


Usual Dosage

Oral

Initially, 2–4 mg/kg daily or 115 mg/m2 daily, given in a single dose or 2 divided doses after meals.a e


If necessary, increase dosage to 6 mg/kg daily.a Do not exceed 300 mg daily.b e


Hypertension

Oral

Initially, 1–2 mg/kg daily given in 2 divided doses after meals.120 Increase dosage as necessary up to 3–4 mg/kg daily given in 2 divided doses.120 Do not exceed 300 mg daily.120


Adults


Edema

Monotherapy

Oral

Initially, 100 mg twice daily after meals.b After edema is controlled, usual maintenance dosage is 100 mg daily or every other day.a Do not exceed 300 mg daily.b


Combination Therapy

Oral

When Dyazide, Maxzide or Maxzide-25 mg, or therapeutically equivalent formulations of these combinations are used, the usual dosage in terms of triamterene is 37.5–75 mg once daily.c d


Patients receiving 25 mg of hydrochlorothiazide who become hypokalemic may be switched to Maxzide-25 mg (37.5 mg triamterene/25 mg hydrochlorothiazide).d


Patients receiving 50 mg of hydrochlorothiazide who become hypokalemic may be switched to Maxzide (75 mg triamterene/50 mg hydrochlorothiazide).d


Hypertension

Monotherapy

Oral

Usual dosage recommended by JNC 7 as monotherapy: 50–100 mg daily.119 Some patients may benefit from dividing the daily dosage into 2 doses.119


Combination Therapy

Oral

Usually combined with a kaliuretic diuretic.a


In conjunction with a kaliuretic diuretic, an initial triamterene dosage of 25 mg once daily has been recommended.109 Titrate dosage upward as needed and tolerated to a suggested maximum triamterene dosage of 100 mg daily.109 119


Initially, administer each drug separately to adjust dosage.a


May use in fixed combination with hydrochlorothiazide if optimum maintenance dosage corresponds to drug ratio in combination preparation.a


Administer each drug separately whenever dosage adjustment is necessary.a


When Dyazide, Maxzide or Maxzide-25 mg, or therapeutically equivalent formulations of these combinations are used, the usual dosage in terms of triamterene is 37.5–75 mg once daily.d


Patients receiving 25 mg of hydrochlorothiazide who become hypokalemic may be switched to Maxzide-25 mg (37.5 mg triamterene/25 mg hydrochlorothiazide).d


Patients receiving 50 mg of hydrochlorothiazide who become hypokalemic may be switched to Maxzide (75 mg triamterene/50 mg hydrochlorothiazide).d


If BP is not adequately controlled by use of 75 mg once daily (of triamterene in the fixed combination of triamterene/hydrochlorothiazide), another antihypertensive agent may be added.d


Prescribing Limits


Pediatric Patients


Oral

Maximum 300 mg daily.120


Adults


Oral

Maximum 300 mg daily.b


The manufacturer states there is no clinical experience to date with dosages of fixed-combination Maxzide or Maxzide-25 mg exceeding 75 mg of triamterene and 50 mg of hydrochlorothiazide daily.d


Special Populations


Hepatic Impairment


No specific dosage recommendations for hepatic impairment; caution if using fixed combination with hydrochlorothiazide because of risk of precipitating hepatic coma.c d (See Contraindications under Cautions.)


Renal Impairment


No specific dosage recommendations for renal impairment; do not use in patients with renal impairment and elevated serum potassium; discontinue in patients who develop hyperkalemia while on the drug.b (See Contraindications under Cautions and also see Hyperkalemia under Cautions.)


Cautions for Triamterene


Contraindications



  • Anuria, severe or progressive renal disease or dysfunction (except possibly nephrosis), acute or chronic renal insufficiency, substantial renal impairment.b c d




  • Preexisting hyperkalemia (≥5.5 mEq/L).b d




  • History of triamterene-induced hyperkalemia.b c d




  • Concurrent potassium supplementation, including potassium salts or potassium-containing salt substitutes.b (See Interactions.)




  • Concurrent therapy with potassium-sparing agents (e.g., spironolactone, amiloride hydrochloride, or fixed-combination formulations containing triamterene).b (See Interactions.)




  • Severe hepatic disease.b




  • Known hypersensitivity to triamterene or any ingredient in the formulation.b c d



Warnings/Precautions


Warnings


Hyperkalemia

Hyperkalemia (i.e., serum potassium concentrations ≥5.5 mEq/L) may occur with all potassium-sparing agents, including triamterene.b c d (See Boxed Warning.) Serum potassium concentrations persistently >6 mEq/L require careful observation and treatment.b


If hyperkalemia occurs, discontinue triamterene; if using a triamterene/hydrochlorothiazide fixed combination, switch to a thiazide alone.b c d


Evaluate BUN and serum potassium concentrations regularly, especially in patients with suspected or confirmed renal insufficiency.b Monitor serum potassium concentrations closely in geriatric and diabetic patients.b


Warning signs of hyperkalemia include paresthesias, muscular weakness, fatigue, flaccid paralysis of the extremities, bradycardia, and shock.c d


Hyperkalemia has been associated with cardiac irregularities.b Obtain ECG if hyperkalemia present or suspected.b If ECG does not show widening of QRS or arrhythmia in the presence of hyperkalemia, usually sufficient to discontinue triamterene and any potassium supplementation and switch to a thiazide alone.b May administer sodium polystyrene sulfonate to enhance excretion of excess potassium.b


Presence of widened QRS complex or arrhythmia in association with hyperkalemia requires prompt additional therapy.b For tachyarrhythmia, infuse 44 mEq of sodium bicarbonate or 10 mL of 10% calcium gluconate or calcium chloride over several minutes.b For asystole, bradycardia, or AV block, transvenous pacing also is recommended.b The effect of calcium and sodium bicarbonate is transient and repeated administration may be required.b When indicated by the clinical situation, excess potassium may be removed by dialysis or oral or rectal administration of sodium polystyrene sulfonate.b Infusion of glucose and insulin has also been used to treat hyperkalemia.b


Potassium Supplementation

Do not use potassium supplementation (e.g., potassium salts, high potassium diet, salt substitutes) in patients receiving triamterene alone.b Discontinue potassium supplements when triamterene is added to existing diuretic therapy or when patients are switched to triamterene from other diuretics.b


Do not use potassium supplementation with fixed-combination triamterene/hydrochlorothiazide except in severe cases of hypokalemia or if dietary intake of potassium is markedly impaired.a c Such concomitant therapy may be associated with rapid increases in serum potassium concentrations.c Monitor serum potassium concentrations frequently if potassium supplementation is used, especially in patients receiving digitalis or with a history of cardiac arrhythmias.c (See Interactions.)


If serious hypokalemia (serum potassium <3.0 mEq/L demonstrated by repeat serum potassium determinations) occurs in a patient receiving fixed-combination triamterene/hydrochlorothiazide, discontinue fixed combination and initiate potassium supplementation.c


If hyperkalemia occurs in a patient receiving fixed-combination triamterene/hydrochlorothiazide and supplemental potassium therapy, discontinue supplementation and substitute a thiazide diuretic alone for fixed-combination triamterene/hydrochlorothiazide until potassium concentrations return to normal.c


Sensitivity Reactions


Hypersensitivity Reactions

Hypersensitivity reactions (e.g., anaphylaxis, rash, photosensitivity) reported; monitor for blood dyscrasias, liver damage or other idiosyncratic reactions.b


General Precautions


Use of Fixed Combinations

When triamterene is used in fixed combination with hydrochlorothiazide, consider the cautions, precautions, and contraindications associated with hydrochlorothiazide.d


Use during Pregnancy

Routine use of diuretics, including triamterene, in otherwise healthy women exposes mother and fetus to unnecessary risk and is not generally indicated.b c d Diuretics do not prevent development of toxemia of pregnancy and do not appear to be beneficial in the treatment of toxemia.b c d


Edema may develop during pregnancy due to comorbid pathology or the physiologic and mechanical consequences of pregnancy.b c d Diuretic therapy may be appropiate in the management of edema due to a pathologic cause manifesting during pregnancy.b c d However, dependent edema in pregnancy resulting from restriction of venous return by the gravid uterus may be treated by elevating the lower extremities and using support hose; diuretic therapy to lower intravascular volume is not appropriate in such cases.b c d


Hypervolemia and associated edema, including generalized edema, occurs in the majority of pregnant women and is not harmful to fetus or mother.b c d Increased recumbency will generally provide relief; however, edema may cause extreme discomfort which is not relieved by rest.b c d Rarely, in such cases, a short course of diuretic therapy may be appropriate to provide relief.b c d


Electrolyte Imbalance

Electrolyte imbalance may worsen or develop during diuretic therapy, including triamterene.b Risk of electrolyte imbalance is increased in patients with CHF, renal disease, or cirrhosis.b Full-dose diuretic therapy in patients on restricted salt intake may cause a low-salt syndrome.b


Monitor serum electrolytes regularly.d


Renal Effects

Elevations in BUN and/or Scr may occur, possibly secondary to a reversible reduction of GFR or a depletion of the intravascular fluid volume.d May occur more frequently in patients receiving twice-daily dosing with fixed combination of triamterene and hydrochlorothiazide.d


Monitor BUN and Scr, especially in geriatric patients and those with suspected or confirmed hepatic or renal disease.d If azotemia increases, discontinue fixed-combination triamterene/hydrochlorothiazide preparation.d


Nitrogen Retention

May cause mild nitrogen retention, which is reversible upon drug discontinuance; seldom observed with intermittent (every-other-day) therapy.b


Metabolic Acidosis

May cause a decreasing alkali reserve with the possibility of metabolic acidosis.b


Avoid use of potassium-sparing diuretics in severely ill patients in whom respiratory or metabolic acidosis may occur; acidosis may result in rapid increases in serum potassium concentrations.c d Perform frequent assessments of acid-base balance and serum electrolytes.c d


Megaloblastosis

Triamterene is a weak folic acid antagonist and may contribute to the appearance of megaloblastosis, especially in patients with depleted folic acid stores (e.g., pregnant women, alcoholics).a b Patients with cirrhosis and splenomegaly may have marked hematologic abnormalities; these patients should have periodic blood studies and be observed for exacerbations of underlying liver disease.b


Hyperuricemia

May cause elevations in serum uric acid concentrations, especially in patients predisposed to gouty arthritis.b


Renal Calculi

Has been reported in renal calcluli associated with usual calculus components.b c d Manufacturers state that triamterene may be used with caution in patients with histories of renal calcluli;b c d however, some clinicians recommend that the drug not be used in these patients because of the risk of triamterene nephrolithiasis.a


If a patient passes a urinary calculus during triamterene therapy, the drug should be discontinued and the calculus analyzed for the presence of triamterene and/or its metabolites.a


Rebound Kaliuresis

Because triamterene conserves potassium, it has been suggested that patients who have received intensive therapy or have been given the drug for prolonged periods may develop a rebound kaliuresis if such therapy is discontinued abruptly.b Discontinue drug gradually in such patients.b


Specific Populations


Pregnancy

Category C.b c d


Lactation

Distributed into milk in animals and is likely to distribute into human milk.b Discontinue nursing or the drug.b


Pediatric Use

Safety and efficacy in pediatric patients remain to be fully established for triamterene or triamterene in fixed combination with hydrochlorothiazide;b c however, some experts have suggested a triamterene dosage for hypertension based on limited clinical experience.120


Geriatric Use

Reduced clearance and increased risk of hyperkalemia; monitor serum potassium concentrations frequently.b c d (See Hyperkalemia under Cautions.)


Hepatic Impairment

Use with caution in patients with impaired hepatic function.a Do not use in patients with severe hepatic disease.a Diuretic therapy in such patients should be initiated while the patient is hospitalized, because rapid alterations in fluid and electrolyte balance may precipitate hepatic coma.a Monitor serum potassium concentrations closely in patients with hepatic cirrhosis and administer potassium supplementation if required.a (See Contraindications under Cautions.)


Potassium loss has been reported during triamterene therapy in some patients with hepatic cirrhosis and may result in signs and symptoms of hepatic coma or precoma.a


Patients with cirrhosis and splenomegaly may have marked hematologic abnormalities; these patients should have periodic blood studies and be observed for exacerbations of underlying liver disease.b (See Megablastosis under Cautions.)


Renal Impairment

Use with caution; increased risk of hyperkalemia.b Monitor serum potassium concentrations closely.b Do not use in patients with renal impairment and elevated serum potassium; discontinue in patients who develop hyperkalemia while on the drug.b (See Contraindications under Cautions and also see Hyperkalemia under Cautions.)


Common Adverse Effects


Hyperkalemia, azotemia, increased BUN and creatinine, renal calculi, jaundice and/or liver enzyme abnormalities, nausea and vomiting, diarrhea, thrombocytopenia, megaloblastic anemia, weakness, fatigue, dizziness, headache, dry mouth.b


Interactions for Triamterene


Specific Drugs, Foods, and Laboratory Tests






















































Drug, Food, or Test



Interaction



Comments



ACE inhibitor



Increased risk of hyperkalemiab c d



Use caution with concomitant ACE inhibitor therapy; monitor serum potassium concentrations frequentlya b d


Use potassium-sparing diuretics with great caution, if at all, in patients receiving an ACE inhibitor (e.g., enalapril) for CHFa


Discontinue or reduce dosage of potassium-sparing diuretics as necessary in patients receiving an ACE inhibitora



Anesthetic agents



Possible potentiation of anesthetic effectsb



Antidiabetic agents (e.g., insulin, oral agents)



Possible increase in blood glucose concentrationb



Adjust dosage of antidiabetic agent during triamterene therapy and after discontinuanceb



Antihypertensive agents



Possible additive antihypertensive effectsb



Blood products



Increased risk of hyperkalemiab


May promote potassium accumulation; plasma from blood bank may contain up to 30 mEq/L of potassium and whole blood may contain up to 65 mEq/L if stored for >10 daysb



Chlorpropamide



Possible increased risk of severe hyponatremiab c



Diuretics



Possible potentiation of diuretic effectsb



Diuretics, potassium-sparing (e.g. amiloride, spironolactone, other fixed-dose combination formulations containing triamterene)



Increased risk of hyperkalemia; fatalities reportedb



Concomitant use contraindicatedb



Laxatives



Possible decreased potassium-retaining effects of triamterenec


Chronic use or overuse of laxatives may reduce serum potassium concentrations by promoting excessive potassium loss from Gl tractc



Lithium



Reduced renal clearance of lithium and increased risk of lithium toxicityb c



Concomitant use generally contraindicated; if concomitant therapy is necessary, monitor serum lithium concentrations closely and adjust dosageb c



Nondepolarizing neuromuscular blocking agents



Potential increase in neuromuscular blockadeb



NSAIAs (e.g., indomethacin)



Concomitant use with indomethacin may adversely affect renal function (e.g., decreased Clcr, acute anuric renal failure)105 106



Concomitant use with indomethacin not recommendeda


Use caution with other concomitant NSAIAsa c



Preanesthetic agents



Possible potentiation of effects of preanesthetic agentb



Potassium supplements, potassium-containing medications (e.g., parenteral penicillin G potassium) and/or foods containing potassium (e.g., salt substitutes, low-salt milk)



Increased risk of hyperkalemia, especially in patients with renal insufficiencyb



Concomitant use generally contraindicatedb



Tests, fluorometric (e.g., lactic dehydrogenase activity)



Possible interference due to pale blue fluorescence in urinea



Tests, fluorometric assay for quinidine



Interferes with the fluorometric assay of quinidine; the two drugs have similar fluorescence spectrab c


Triamterene Pharmacokinetics


Absorption


Bioavailability


Triamterene and fixed combinations with hydrochlorothiazide are rapidly absorbed following oral administration;c d peak plasma concentrations achieved within 1–4 hours.a b d Interindividual variation in degree of absorption reported.a


Oral bioavailabilities of triamterene and hydrochlorothiazide from Dyazide capsules are comparable to those of aqueous suspensions of the individual drugs, averaging 85 and 82%, respectively, for the fixed-dose formulation and 100 and 100%, respectively, for the suspensions.111 Dyazide capsules also are bioequivalent to single-entity 25-mg hydrochlorothiazide tablets and 37.5-mg triamterene capsules.110


Oral bioavailabilities of triamterene and hydrochlorothiazide from Maxzide tablets are comparable to those of aqueous suspensions of the individual drugs.d The hydrochlorothiazide component of Maxzide tablets is bioequivalent to single-entity hydrochlorothiazide tablet formulations.d


Onset


Onset of diuresis following oral administration of triamterene usually occurs within 2–4 hours; maximum therapeutic effect may not occur until after several days of therapy.b


Onset of diuresis after oral administration of Dyazide usually occurs within 1 hour and peaks at 2–3 hours.c


Duration


After oral administration of triamterene, diuresis diminishes in approximately 7–9 hours,a b although the total duration of action may be ≥24 hours.a


After oral administration of Dyazide, diuresis diminishes in approximately 7–9 hours.c


Food


Administration of Dyazide with a high-fat meal in healthy adults increased the average bioavailabilities of triamterene, 6-p-hydroxytriamterene, and hydrochlorothiazide by about 67, 50, and 17%, respectively; increased the peak concentrations of triamterene and its p-hydroxy metabolite; and delayed absorption of the active drugs by up to 2 hours.110


Administration with food does not affect absorption of triamterene or hydrochlorothiazide from Maxzide tablets.d


Distribution


Extent


Distributed into bile.a


Crosses the placenta and distributes into milk in animals.b


Plasma Protein Binding


Approximately 67%.b


Elimination


Metabolism


Primarily metabolized to 6-p-hydroxytriamterene and its sulfate conjugate.b 107


Elimination Route


Excreted in urine, primarily as 6-p-hydroxytriamterene.b


Half-life


100–150 minutes.a


Special Populations


Renal clearances of triamterene, hydroxytriamterene sulfate, and hydrochlorothiazide may be reduced in geriatric patients receiving combined triamterene and hydrochlorothiazide therapy, principally as a result of age-related reductions in renal function.107 a


Stability


Storage


Oral


Capsules

Tight, light resistant containers at 15–30°C.a b


Fixed-dose Combination Formulations

Dyazide capsules: Tight, light resistant containers at 20–25°C.c


Maxzide tablets: Tight, light resistant containers at 15–30°C.d


ActionsActions



  • A pteridine derivative, potassium-sparing diuretic that is structurally related to folic acid.a b




  • Does not competitively inhibit aldosterone; activity is independent of aldosterone concentrations.b




  • Does not inhibit carbonic anhydrase.a




  • Acts directly on the distal renal tubule of the nephron to depress aldosterone-stimulated reabsorption of sodium and excretion of potassium and hydrogen at that site.b




  • Increases excretion of sodium, calcium, magnesium, and bicarbonate.a




  • Potassium excretion usually reduced; serum concentrations of potassium and chloride are usually increased.a b




  • Serum bicarbonate concentrations consistently decreased; urinary pH increased slightly.a




  • Reductions in glomerular filtration observed during daily, but not intermittent, administration; suggests a reversible effect on renal blood flow.a




  • Although effective alone, often used in combination with other diuretics that act at different sites in the nephron.a




  • Little if any hypotensive effect when used alone.a



Advice to Patients



  • Importance of taking drug after meals to help avoid stomach upset.b




  • Importance of informing patients that if a single daily dose is prescribed, it may be preferable to take it in the morning to minimize the effect of increased frequency of urination on nighttime sleep.b




  • Importance of informing patients that if a dose is missed, the patient should take only the prescribed dose at the next dosing interval.b




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




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.b c d




  • Importance of informing patients of other important precautionary information. (See Cautions.)b c d



Preparations


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


















Triamterene

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Capsules



50 mg



Dyrenium (with benzyl alcohol and povidone)



WellSpring



100 mg



Dyrenium (with benzyl alcohol and povidone)



WellSpring


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











































Triamterene and Hydrochlorothiazide (Co-triamterzide)

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Capsules



37.5 mg Triamterene and Hydrochlorothiazide 25 mg*



Dyazide (with benzyl alcohol and povidone)



GlaxoSmithKline



Triamterene and Hydrochlorothiazide Capsules



Barr, Mylan, Sandoz, UDL



50 mg Triamterene and Hydrochlorothiazide 25 mg*



Triamterene and Hydrochlorothiazide Capsules



TEVA, Sandoz



Tablets



37.5 mg Triamterene and Hydrochlorothiazide 25 mg*



Maxzide-25 mg (scored)



Mylan



Triamterene and Hydrochlorothiazide Tablets



Barr, Mylan, Pliva, Sandoz, Watson



75 mg Triamterene and Hydrochlorothiazide 50 mg*



Maxzide (scored)



Mylan



Triamterene and Hydrochlorothiazide Tablets



Barr, Mylan, Pliva, Sandoz, Teva, UDL, Watson


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Dyazide 37.5-25MG Capsules (GLAXO SMITH KLINE): 30/$45.99 or 90/$109.92


Dyrenium 100MG Capsules (WELLSPRING PHARMACEUTICAL CORP): 30/$75.99 or 90/$205.53


Dyrenium 50MG Capsules (WELLSPRING PHARMACEUTICAL CORP): 30/$49.83 or 90/$124.54


Maxzide 75-50MG Tablets (MYLAN): 30/$79.99 or 90/$219.96


Maxzide-25 37.5-25MG Tablets (MYLAN BERTEK): 30/$37.5 or 90/$85.87


Triamterene-HCTZ 37.5-25MG Capsules (SANDOZ): 100/$19.99 or 200/$25.98


Triamterene-HCTZ 37.5-25MG Tablets (SANDOZ): 100/$29.99 or 200/$45.96


Triamterene-HCTZ 50-25MG Capsules (SANDOZ): 100/$155.99 or 300/$439.98


Triamterene-HCTZ 75-50MG Tablets (SANDOZ): 100/$17.99 or 300/$39.96



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.


† Use is not currently included in the labeling approved by the US Food and Drug Administration.




References


Only references cited for selected revisions after 1984 are available electronically.



100. Upton RA, Williams RL, Lin ET et al. Absence of a significant pharmacokinetic interaction between hydrochlorothiazide and triamterene when coadministered. J Pharmacokinet Biopharm. 1984; 12:575-86. [IDIS 197834] [PubMed 6533293]



101. Blume CD, Williams RL, Upton RA et al. Bioequivalence study of a new tablet formulation of triamterene and hydrochlorothiazide. Am J Med. 1984; 77(Suppl 5A):59-61. [IDIS 192689] [PubMed 6496560]



102. Blume CD, Williams RL. A new antihypertensive agent: Maxzide (75 mg triamterene/50 mg hydrochlorothiazide). Am J Med. 1984; 77(Suppl 5A):52-8. [IDIS 192688] [PubMed 6388327]



104. Houston MC. Thiazides and thiazide-like diuretics in hypertension. Ann Intern Med. 1985; 103:303. [IDIS 202760] [PubMed 4014913]



105. Favre L, Glasson P, Vallotton MB. Reversible acute renal failure from combined triamterene and indomethacin. Ann Intern Med. 1982; 96:317-20. [IDIS 146179] [PubMed 6949485]



106. Weinberg MS, Quigg RJ, Salant DJ et al. Anuric renal failure precipitated by indomethacin and triamterene. Nephron. 1985; 40:216-8. [PubMed 4000350]



107. Williams RL, Thornhill MD, Upton RA et al. Absorption and disposition of two combination formulations of hydr