Thursday, September 29, 2016

Phoslo



calcium acetate

Dosage Form: capsule
FULL PRESCRIBING INFORMATION

INDICATIONS & USAGE


Phoslo® is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).



DOSAGE & ADMINISTRATION


The recommended initial dose of Phoslo® for the adult dialysis patient is 2 gelcaps with each meal.  Increase the dose gradually to lower serum phosphorus levels to the target range, as long as hypercalcemia does not develop.  Most patients require 3-4 gelcaps with each meal.



DOSAGE FORMS & STRENGTHS


Capsule:  667 mg calcium acetate per gelcap.



CONTRAINDICATIONS


Patients with hypercalcemia.



WARNINGS AND PRECAUTIONS



Hypercalcemia


Patients with end stage renal disease may develop hypercalcemia when treated with calcium, including calcium acetate (Phoslo®).  Avoid the use of calcium supplements, including calcium-based nonprescription antacids, concurrently with Phoslo®.


An overdose of Phoslo may lead to progressive hypercalcemia, which may require emergency measures.  Therefore, early in the treatment phase during the dosage adjustment period, monitor serum calcium levels twice weekly.  Should hypercalcemia develop, reduce the Phoslo® dosage or discontinue the treatment, depending on the severity of hypercalcemia.


More severe hypercalcemia (Ca>12 mg/dL) is associated with confusion, delirium, stupor and coma.  Severe hypercalcemia can be treated by acute hemodialysis and discontinuing Phoslo® therapy.


Mild hypercalcemia (10.5 to 11.9 mg/dL) may be asymptomatic or manifest as constipation, anorexia, nausea, and vomiting.  Mild hypercalcemia is usually controlled by reducing the Phoslo® dose or temporarily discontinuing therapy.  Decreasing or discontinuing Vitamin D therapy is recommended as well.


Chronic hypercalcemia may lead to vascular calcification and other soft-tissue calcification.  Radiographic evaluation of suspected anatomical regions may be helpful in early detection of soft tissue calcification.  The long term effect of Phoslo® on the progression of vascular or soft tissue calcification has not been determined.


Hypercalcemia (>11 mg/dL) was reported in 16% of patients in a 3-month study of a solid dose formulation of calcium acetate; all cases resolved upon lowering the dose or discontinuing treatment.


Maintain the serum calcium-phosphorus (Ca x P) product below 55 mg2/dL2.



Concomitant Use with Medications


Hypercalcemia may aggravate digitalis toxicity.



ADVERSE REACTIONS


Hypercalcemia is discussed elsewhere [see Warnings and Precautions (5.1)].



Clinical Trial Experience


Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.


In clinical studies, calcium acetate has been generally well tolerated.


Phoslo® was studied in a 3-month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and in a two week double-blind, placebo-controlled, cross-over study with 69 enrolled ESRD hemodialysis patients.  Adverse reactions (>2% on treatment) from these trials are presented in Table 1.
























Table 1: Adverse Reactions in Patients with End-Stage Renal Disease Undergoing Hemodialysis
Preferred TermTotal adverse reactions reported for calcium acetate

n = 167

n (%)
3-mo, open-label study of calcium acetate

n = 98

n (%)
Double-blind, placebo-controlled, cross-over study of calcium acetate

n = 69
Calcium acetate

n (%)
Placebo

n (%)
Nausea6 (3.6)6 (6.1)0 (0.0)0 (0.0)
Vomiting4 (2.4)4 (4.1)0 (0.0)0 (0.0)
Hypercalcemia21 (12.6)16 (16.3)5 (7.2)0 (0.0)

Mild hypercalcemia may be asymptomatic or manifest itself as constipation, anorexia, neusea, and vomiting.  More severe hypercalcemia is associated with confusion, delirium, stupor, and coma.  Decreasing dialysate calcium concentration could reduce the incidence and severity of Phoslo®-induced hypercalcemia.  Isolated cases of pruritus have been reported, which may represent allergic reactions.



Postmarketing Experience


Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure.


The following additional adverse reactions have been identified during post-approval of calcium acetate:  dizziness, edema, and weakness.



DRUG INTERACTIONS


The drug interaction of Phoslo® is characterized by the potential of calcium to bind to drugs with anionic functions (e.g., carboxyl and hydroxyl groups).  Phoslo® may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism.


There are no empirical data on avoiding drug interactions between calcium acetate or Phoslo® and most concomitant drugs.  When administering an oral medication with Phoslo® where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, administer the drug one hour before or three hours after Phoslo® or calcium acetate.  Monitor blood levels of the concomitant drugs that have a narrow therapeutic range.  Patients taking anti-arrhythmic medications for the control of arrhythmias and anti-seizure medications for the control of seizure disorders were excluded from the clinical trials with all forms of calcium acetate.



Ciprofloxacin


In a study of 15 healthy subjects, a co-administered single dose of 4 calcium acetate tablets approximately 2.7 g, decreased the bioavailability of ciprofloxacin by approximately 50%.



USE IN SPECIFIC POPULATIONS



PREGNANCY


Pregnancy Category C


Phoslo® contains calcium acetate.  Animal reproduction studies have not been conducted with Phoslo®, and there are no adequate and well controlled studies of Phoslo® use in pregnant women.  Patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see Warnings and Precautions (5.1)].  Maintenance of normal serum calcium levels is important for maternal and fetal well being.  Hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism.  Phoslo® treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment.



  LABOR & DELIVERY


The effects of Phoslo® on labor and delivery are unknown.



  NURSING MOTHERS


Phoslo® contains calcium acetate and is excreted in human milk.  Human milk feeding by a mother receiving Phoslo® is not expected to harm an infant, provided maternal serum calcium levels are appropriately monitored.



  PEDIATRIC USE


Safety and effectiveness in pediatric patients have not been established.



  GERIATRIC USE


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



OVERDOSAGE


Administration of Phoslo® in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1)].



DESCRIPTION


Phoslo® acts as a phosphate binder.  Its chemical name is calcium acetate.  Its molecular formula is C4H6CaO4, and its molecular weight is 158.17.  Its structural formula is:





Each opaque gelcap with a blue cap and white body is spin printed in blue and white ink with “Phoslo®” printed on the cap and “667 mg” printed on the body.  Each gelcap contains 667 mg calcium acetate, USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium, and 10 mg of the inert binder, polyethylene glycol 8000 NF.  The gelatin cap and body have the following inactive ingredients: FD&C blue #1, D&C red #28, titanium dioxide, USP and gelatin, USP.



CLINICAL PHARMACOLOGY


Patients with ESRD retain phosphorus and can develop hyperphosphatemia.  High serum phosphorus can precipitate serum calcium resulting in ectopic calcification.  Hyperphosphatemia also plays a role in the development of secondary hyperparathyroidism in patients with ESRD.



  MECHANISM OF ACTION


Calcium acetate, (Phoslo®) when taken with meals, combines with dietary phosphate to form an insoluble calcium phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.



  PHARMACODYNAMICS


Orally administered calcium acetate from pharmaceutical dosage forms is systemically absorbed up to approximately 40% under fasting conditions and up to approximately 30% under non-fasting conditions.  This range represents data from both healthy subjects and renal dialysis patients under various conditions.



NONCLINICAL TOXICOLOGY



  CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY


No carcinogenicity, mutagenicity, or fertility studies have been conducted with calcium acetate.



CLINICAL STUDIES


Effectiveness of calcium acetate in decreasing serum phosphorus has been demonstrated in two studies of the calcium acetate solid dosage form.


Ninety-one patients with end-stage renal disease who were undergoing hemodialysis and were hyperphosphatemic (serum phosphorus >5.5 mg/dL) following a 1-week phosphate binder washout period contributed efficacy data to an open-label, non-randomized study.


The patients received calcium acetate 667 mg tablets at each meal for a period of 12 weeks.  The initial starting dose was 2 tablets per meal for 3 meals a day, and the dose was adjusted as necessary to control serum phosphorus levels.  The average final dose after 12 weeks of treatment was 3.4 tablets per meal.  Although there was a decrease in serum phosphorus, in the absence of a control group the true magnitude of effect is uncertain.


The data presented in Table 2 demonstrate the efficacy of calcium acetate in the treatment of hyperphosphatemia in end-stage renal disease patients.  The effects on serum calcium levels are also presented.
























Table 2: Average Serum Phosphorous and Calcium Levels at Pre-Study, Interim, and Study Completion Time points
ParameterPre-StudyWeek 4bWeek 8Week 12p-valuec
a Values expressed as mean ± SE.
b Ninety-one patients completed at least 6 weeks of the study.
c ANOVA of difference in values at pre-study and study completion.
Phosphorus (mg/dL)a7.4 ± 0.175.9 ± 0.165.6 ± 0.175.2 ± 0.17≤0.01
Calcium (mg/dL)a8.9 ± 0.099.5 ± 0.109.7 ± 0.109.7 ± 0.10≤0.01

There was a 30% decrease in serum phosphorus levels during the 12 week study period (p<0.01).  Two-thirds of the decline occurred in the first month of the study.  Serum calcium increased 9% during the study mostly in the first month of the study.


Treatment with the phosphate binder was discontinued for patients from the open-label study, and those patients whose serum phosphorus exceeded 5.5 mg/dL were eligible for entry into a double-blind, placebo-controlled, cross-over study.  Patients were randomized to receive calcium acetate or placebo, and each continued to receive the same number of tablets as had been individually established during the previous study.  Following 2 weeks of treatment, patients switched to the alternative therapy for an additional 2 weeks.


The phosphate binding effect of calcium acetate is shown in the Table 3.





















Table 3: Serum Phosphorus and Calcium Levels at Study Initiation and After Completion of Each Treatment Arm
ParameterPre-StudyPost-Treatmentp-valueb
Calcium AcetatePlacebo
a Values expressed as mean ± SE.
b ANOVA of calcium acetate vs. placebo after 2 weeks of treatment.
Phosphorus (mg/dL)a7.3 ± 0.185.9 ± 0.247.8 ± 0.22<0.01
Calcium (mg/dL)a8.9 ± 0.119.5 ± 0.138.8 ± 0.12<0.01

Overall, 2 weeks of treatment with calcium acetate statistically significantally (p<0.01) decreased serum phosphorus by a mean of 19% and increased serum calcium by a statistically significant (p<0.01) but clinically unimportant mean of 7%.



HOW SUPPLIED/STORAGE AND HANDLING


Gelcap A white and blue gelcap for oral administration containing 667 mg calcium acetate (anhydrous Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium.


Gelcap NDC 49230-640-21 Bottles of 200


STORAGE:  Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP “Controlled Room Temperature”].



PATIENT COUNSELING INFORMATION


Inform patients to take Phoslo® with meals, adhere to their prescribed diets, and avoid the use of calcium supplements including nonprescription antacids.  Inform the patients about the symptoms of hypercalcemia [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)].


Advise patients who are taking an oral medication where reduction in the bioavailability of that medication would have clinically significant effect on its safety and efficacy to take the drug one hour before or three hours after Phoslo®.


Manufactured for


Fresenius Medical Care North America


Waltham, MA  02451


by


Pharmaceutics International, Inc.


10819 Gilroy Road


Hunt Valley, MD  21031


100623.02 04 / 2011                                                



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL










Phoslo 
calcium acetate  capsule










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)49230-640
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM ACETATE (CALCIUM CATION)CALCIUM ACETATE667 mg














Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 8000 
FD&C BLUE NO. 1 
D&C RED NO. 28 
TITANIUM DIOXIDE 
GELATIN 


















Product Characteristics
ColorWHITE, BLUEScoreno score
ShapeCAPSULESize20mm
FlavorImprint CodePhoslo;667mg
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
149230-640-211 BOTTLE In 1 CARTONcontains a BOTTLE
1200 CAPSULE In 1 BOTTLEThis package is contained within the CARTON (49230-640-21)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02116004/02/2001


Labeler - Fresenius Medical Care North America (075684324)









Establishment
NameAddressID/FEIOperations
Pharmaceutics International, Inc.878265586MANUFACTURE









Establishment
NameAddressID/FEIOperations
Kemira Chemicals Inc403364669API MANUFACTURE
Revised: 04/2011Fresenius Medical Care North America

More Phoslo resources


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


  • calcium acetate Concise Consumer Information (Cerner Multum)

  • PhosLo Concise Consumer Information (Cerner Multum)

  • PhosLo Advanced Consumer (Micromedex) - Includes Dosage Information

  • PhosLo MedFacts Consumer Leaflet (Wolters Kluwer)

  • Phoslyra Solution MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Phoslo with other medications


  • Hyperphosphatemia

Wednesday, September 28, 2016

Novaflor


Generic Name: lactobacillus acidophilus (LAK toe ba SIL us AS sid OFF il us)

Brand Names: Acidophilus, Acidophilus Extra Strength, Bacid, Flora-Q 2, Novaflor, RisaQuad, RisaQuad 2, Superdophilus


What is Novaflor (lactobacillus acidophilus)?

Lactobacillus acidophilus is a bacteria that exists naturally in the body, primarily in the intestines and the vagina. Lactobacillus acidophilus helps maintain an acidic environment in the body, which can prevent the growth of harmful bacteria.


Lactobacillus acidophilus has been used to treat or prevent vaginal yeast infections, yeast infections of the mouth, diarrhea caused by taking antibiotics, and urinary tract infections. Lactobacillus acidophilus may work by helping the body maintain normal consistency of bacteria in the stomach, intestines, and vagina.


Lactobacillus acidophilus has not been approved by the FDA to treat any disease, and it should not be substituted for prescription medications.

Lactobacillus acidophilus has not been evaluated by the FDA for safety, effectiveness, or purity. All potential risks and/or advantages of lactobacillus acidophilus may not be known. Additionally, there are no regulated manufacturing standards in place for these compounds. Some marketed herbal supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.


Lactobacillus acidophilus may also have be used for other purposes not listed in this product guide.


What is the most important information I should know about Novaflor (lactobacillus acidophilus)?


Lactobacillus acidophilus has not been approved by the FDA to treat any disease, and it should not be substituted for prescription medications.

Lactobacillus acidophilus has not been evaluated by the FDA for safety, effectiveness, or purity. All potential risks and/or advantages of lactobacillus acidophilus may not be known. Additionally, there are no regulated manufacturing standards in place for these compounds. Some marketed herbal supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.


Talk to your doctor before taking lactobacillus acidophilus if you have any other medical conditions, allergies, or if you take other medicines or herbal/health supplements. Under certain conditions, it may be dangerous for you to take lactobacillus acidophilus.


Do not take lactobacillus acidophilus without first talking to your doctor if you are pregnant or may become pregnant during treatment. Do not take lactobacillus acidophilus without first talking to your doctor if you are breast-feeding a baby. Do not give any herbal/health supplement to a child without the advice of a doctor.

What should I tell my healthcare provider before taking Novaflor (lactobacillus acidophilus)?


Talk to your doctor before taking lactobacillus acidophilus if you have any other medical conditions, allergies, or if you take other medicines or herbal/health supplements. Under certain conditions, it may be dangerous for you to take lactobacillus acidophilus.


Do not take lactobacillus acidophilus without first talking to your doctor if you are pregnant or may become pregnant during treatment. Do not take lactobacillus acidophilus without first talking to your doctor if you are breast-feeding a baby. Do not give any herbal/health supplement to a child without the advice of a doctor.

How should I take Novaflor (lactobacillus acidophilus)?


When considering the use of herbal supplements, seek the advice of your doctor. You may also consider consulting a practitioner who is trained in the use of herbal/health supplements.


Do not take more of this product than is directed.

If you choose to take lactobacillus acidophilus, use it as directed on the package or as directed by your doctor, pharmacist, or other healthcare provider. Do not use more of this product than is recommended on the label.


Lactobacillus acidophilus is available in capsule and tablet form. Powder or liquid forms may also be available. Some dairy products, especially yogurt, also contain lactobacillus acidophilus.


Do not use many different forms (such as tablets, topical formulations, and others) of lactobacillus acidophilus at the same time, unless your healthcare professional has told you to. You may get too much of this product if you use different forms together.

Store lactobacillus acidophilus in a sealed container as directed on the product label, away from moisture, heat, and light.


What happens if I miss a dose?


No information is available about missing a dose of lactobacillus acidophilus. Consult your doctor, pharmacist, or healthcare provider for instructions if you miss a dose.


What happens if I overdose?


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

What should I avoid while taking Novaflor (lactobacillus acidophilus)?


Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using lactobacillus acidophilus.


Novaflor (lactobacillus acidophilus) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may be more likely, and you may have none at all.


Tell your doctor, pharmacist, herbalist, or other healthcare provider about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Novaflor (lactobacillus acidophilus)?


There may be other drugs that can interact with lactobacillus acidophilus. Tell your healthcare provider about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your healthcare provider.



More Novaflor resources


  • Novaflor Support Group
  • 0 Reviews for Novaflor - Add your own review/rating


  • Lactobacillus Acidophilus Monograph (AHFS DI)

  • Acidophilus Natural MedFacts for Professionals (Wolters Kluwer)

  • Acidophilus Natural MedFacts for Consumers (Wolters Kluwer)

  • Acidophilus Consumer Overview



Compare Novaflor with other medications


  • Clostridial Infection
  • Diarrhea
  • Irritable Bowel Syndrome
  • Oral Thrush
  • Traveler's Diarrhea
  • Urinary Tract Infection
  • Vaginal Yeast Infection


Where can I get more information?


  • Consult with a licensed healthcare professional before using any herbal/health supplement. Whether you are treated by a medical doctor or a practitioner trained in the use of natural medicines/supplements, make sure all your healthcare providers know about all of your medical conditions and treatments.


Norocillin





Dosage Form: FOR ANIMAL USE ONLY
Norocillin

Injectable Antibiotic

NADA 065-010, APPROVED BY FDA


For use in Cattle, Sheep, Swine and Horses.


PENICILLIN G PROCAINE INJECTABLE SUSPENSION U.S.P.


READ ENTIRE BROCHURE CAREFULLY BEFORE USING THIS PRODUCT



Description:


Norocillin is a suspension of penicillin G procaine in 100, 250, and 500 mL multiple dose vials. Each mL is designed to provide 300,000 units of penicillin G as procaine in a stable suspension. Penicillin G procaine is an antibacterial agent which has activity against a variety of pathogenic organisms, mainly in the Gram-positive category.



Indications:


Norocillin is indicated for treatment of bacterial pneumonia (shipping fever) caused by Pasteurella multocida in cattle and sheep, erysipelas caused by Erysipelothrix rhusiopathiae in swine, and strangles caused by Streptococcus equi in horses.



Directions for Use:


A thoroughly cleaned, sterile needle and syringe should be used for each injection (needles and syringes may be sterilized in boiling water for 15 minutes).Before withdrawing the solution from the bottle, disinfect the rubber cap top with 70% alcohol. The injection site should be similarly disinfected with alcohol. Needles of 16 to 18 gauge and 1 to 1.5 inches long are adequate for intramuscular injections.


In livestock intramuscular injections should be made by directing the needle of suitable gauge and length into the fleshy part of a thick muscle, such as rump, hip, or thigh region; avoid blood vessels and major nerves. Before injecting the solution, pull back gently on the plunger. If blood appears in the syringe, a blood vessel has been entered; withdraw the needle and select a different site.



Dosage:


Norocillin is administered by the intramuscular route. The product is ready for injection after warming the vial to room temperature and shaking to ensure a uniform suspension.


The daily dose of penicillin is 3,000 units per pound of body weight (1 mL per 100 lbs body weight). Continue daily treatment until recovery is apparent and for at least one day after symptoms disappear, usually in two to three days.


Treatment should not exceed four consecutive days.


No more than 10 mL should be injected at any one site. Rotate injection sites for each succeeding treatment.



Care of Sick Animals:


The use of antibiotics in the management of diseases is based on an accurate diagnosis and an adequate course of treatment. When properly used in the treatment of diseases caused by penicillin-susceptible organisms, most animals treated with Norocillin show a noticeable improvement within 24 to 48 hours. If improvement does not occur within this period of time, the diagnosis and course of treatment should be re-evaluated. It is recommended that the diagnosis and treatment of animal diseases be carried out by a veterinarian.


Since many diseases look alike but require different types of treatment, the use of professional veterinary and laboratory services can reduce treatment time, costs and needless losses. Good housing, sanitation and nutrition are important in the maintenance of healthy animals and are essential in the treatment of disease.



Residue Warnings:


Exceeding the daily dosage of 3,000 units per pound of body weight, administering for more than four consecutive days, or exceeding the maximum injection site volume per injection site may result in antibiotic residues beyond the withdrawal time. Milk taken from treated dairy animals within 48 hours after the last treatment must not be used for food. Discontinue use of this drug for the following time period before treated animals are slaughtered for food:


Cattle – 14 days, Sheep – 9 days, Swine – 7 days.


A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.



Warning:


Do not use in horses intended for human consumption. Not for use in humans. Keep out of reach of children.



Precautions:


Intramuscular injection in cattle, sheep, and swine may result in a local tissue reaction which persists beyond the withdrawal period of 14 days (cattle), 9 days (sheep), or 7 days (swine). This may result in trim loss of edible tissue at slaughter.


Allergic or anaphylactic reactions, sometimes fatal, have been known to occur in animals hypersensitive to penicillin and procaine. Such reactions can occur unpredictably with varying intensity. Animals administered penicillin G procaine should be kept under close observation for at least one half hour. Should allergic or anaphylactic reactions occur, discontinue use of the product and call a veterinarian. If respiratory distress is severe, immediate injection of epinephrine or antihistamine following manufacturer's recommendations may be necessary.


As with all antibiotic preparations, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. A lack of response by the treated animal, or the development of new signs or symptoms suggest that an overgrowth of nonsusceptible organisms has occurred. In such instances, consult your veterinarian.


It is advisable to avoid giving penicillin in conjunction with bacteriostatic drugs such as tetracyclines.



Storage Conditions:


Norocillin should be stored between 2 to 8°C (36 to 46°F).


Restricted Drug - California. Use Only as Directed.


Made in the UK.


Norbrook Laboratories Limited

Newry, BT35 6PU, Co. Down, Northern Ireland


011670I01


Norbrook®



Principal Display Panel – 500 mL Vial Label


Norocillin


STERILE PENICILLIN G PROCAINE INJECTABLE SUSPENSION U.S.P.


NDC 55529-021-05


INJECTABLE ANTIBIOTIC IN AQUEOUS SUSPENSION 300,000 UNITS PER mL


ANTIBIOTIC


FOR INTRAMUSCULAR INJECTION ONLY


NADA 065-010, APPROVED BY FDA


Net Contents: 500 mL


Norbrook®










Norocillin 
penicillin g procaine  injection, suspension










Product Information
Product TypeOTC ANIMAL DRUGNDC Product Code (Source)55529-021
Route of AdministrationINTRAMUSCULARDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
penicillin G procaine (penicillin G procaine)penicillin G procaine300000 [USP'U]  in 1 mL
























Inactive Ingredients
Ingredient NameStrength
penicillin G potassium 
procaine hydrochloride 
potassium phosphate, monobasic 
potassium phosphate, dibasic 
sodium formaldehyde sulfoxylate 
polysorbate 80 
methylparaben 
water 
carboxymethylcellulose sodium 
lecithin, soybean 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      


















Packaging
#NDCPackage DescriptionMultilevel Packaging
155529-021-02100 mL In 1 VIAL, GLASSNone
255529-021-04250 mL In 1 VIAL, GLASSNone
355529-021-05500 mL In 1 VIAL, GLASSNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA06501010/01/2008


Labeler - Norbrook Laboratories Limited (214580029)









Establishment
NameAddressID/FEIOperations
Station Works214580029MANUFACTURE, ANALYSIS









Establishment
NameAddressID/FEIOperations
Carnbane Industrial Estate211218325MANUFACTURE
Revised: 12/2010Norbrook Laboratories Limited



Nalex CR Controlled-Release Capsules


Pronunciation: gwye-FEN-ah-sin/sue-do-eh-FED-rin
Generic Name: Guaifenesin/Pseudoephedrine
Brand Name: Examples include Entex PSE and Nalex CR


Nalex CR Controlled-Release Capsules are used for:

Relieving congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.


Nalex CR Controlled-Release Capsules are a decongestant and expectorant combination. It works by constricting blood vessels, reducing swelling in the nasal passages, and thinning and loosening mucus in the airway. This allows you to breathe more easily and makes coughs more productive.


Do NOT use Nalex CR Controlled-Release Capsules if:


  • you are allergic to any ingredient in Nalex CR Controlled-Release Capsules

  • you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)

  • you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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



Before using Nalex CR Controlled-Release Capsules:


Some medical conditions may interact with Nalex CR Controlled-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


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

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

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

  • if you have a fast, slow, or irregular heartbeat

  • if you have a history of adrenal gland problems (eg, tumor), heart problems, high blood pressure, diabetes, heart blood vessel problems, stroke, glaucoma, an enlarged prostate, seizures, or an overactive thyroid

  • if you have chronic cough

Some MEDICINES MAY INTERACT with Nalex CR Controlled-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Nalex CR Controlled-Release Capsules's side effects

  • Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased

  • Bromocriptine because the risk of its side effects may be increased by Nalex CR Controlled-Release Capsules

  • Guanethidine, guanadrel, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Nalex CR Controlled-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nalex CR Controlled-Release Capsules 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 Nalex CR Controlled-Release Capsules:


Use Nalex CR Controlled-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Nalex CR Controlled-Release Capsules by mouth with or without food.

  • Take Nalex CR Controlled-Release Capsules with a full glass of water (8 oz/240 mL) unless your doctor tells you otherwise.

  • If you miss a dose of Nalex CR Controlled-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Nalex CR Controlled-Release Capsules.



Important safety information:


  • Nalex CR Controlled-Release Capsules may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Nalex CR Controlled-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do not take appetite suppressants while you are taking Nalex CR Controlled-Release Capsules without checking with your doctor.

  • Nalex CR Controlled-Release Capsules has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.

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

  • If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.

  • Nalex CR Controlled-Release Capsules may interfere with certain lab test results. Make sure that all of your doctors and lab personnel know that you are taking Nalex CR Controlled-Release Capsules.

  • Tell your doctor or dentist that you take Nalex CR Controlled-Release Capsules before you receive any medical or dental care, emergency care, or surgery.

  • Use Nalex CR Controlled-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects.

  • Caution is advised when using Nalex CR Controlled-Release Capsules in CHILDREN; they may be more sensitive to its effects.

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


Possible side effects of Nalex CR Controlled-Release Capsules:


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



Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.



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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor.



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


See also: Nalex CR side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.


Proper storage of Nalex CR Controlled-Release Capsules:

Store Nalex CR Controlled-Release Capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Nalex CR Controlled-Release Capsules out of the reach of children and away from pets.


General information:


  • If you have any questions about Nalex CR Controlled-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.

  • Nalex CR Controlled-Release Capsules are 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 Nalex CR Controlled-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Nalex CR resources


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


Compare Nalex CR with other medications


  • Cough and Nasal Congestion

Coffo-Selt




Coffo-Selt may be available in the countries listed below.


Ingredient matches for Coffo-Selt



Caffeine

Caffeine is reported as an ingredient of Coffo-Selt in the following countries:


  • Austria

Phenazone

Phenazone is reported as an ingredient of Coffo-Selt in the following countries:


  • Austria

International Drug Name Search

Tuesday, September 27, 2016

Milrinone




In the US, Milrinone (milrinone systemic) is a member of the drug class inotropic agents and is used to treat Heart Failure.

US matches:

  • Milrinone

  • Milrinone Lactate

  • Milrinone Dextrose

  • Milrinone Injection

  • Milrinone Lactate in Dextrose Injection

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

C01CE02

CAS registry number (Chemical Abstracts Service)

0078415-72-2

Chemical Formula

C12-H9-N3-O

Molecular Weight

211

Therapeutic Categories

Cardiac stimulant, cardiotonic agent

Vasodilator

Chemical Name

[3,4'-Bipyridine]-5-carbonitrile, 1,6-dihydro-2-methyl-6-oxo-

Foreign Names

  • Milrinonum (Latin)
  • Milrinon (German)
  • Milrinone (French)
  • Milrinona (Spanish)

Generic Names

  • Milrinone (OS: BAN, USAN, DCF)
  • Win 47203-2 (IS: SterlingWinthr)
  • Milrinone (PH: USP 32)

Brand Names

  • Coritrope
    Sanofi-Aventis, Indonesia


  • Corotrop
    Sanofi-Aventis, Austria; Sanofi-Aventis, Switzerland; Sanofi-Aventis, Czech Republic; Sanofi-Aventis, Germany


  • Corotrope
    Sanofi Aventis, Tunisia; Sanofi-Aventis, Argentina; Sanofi-Aventis, Belgium; Sanofi-Aventis, France; Sanofi-Aventis, Hungary; Sanofi-Aventis, Poland; Sanofi-Aventis, Slovakia; Sanofi-Aventis S.A., Spain; Sanofi-Synthelabo, Greece; Sanofi-Synthelabo, Luxembourg; Sanofi-Synthelabo, Peru


  • Milicor
    Samarth, India


  • Milrila
    Astellas, Japan


  • Milrila K
    Astellas, Japan


  • Milrinon Labatec
    Labatec, Switzerland


  • Milrinone Xin Shi Dai Pharm
    Xin Shi Dai Pharm, China


  • Primacor
    Sanofi-Aventis, Israel


  • Apo-Milrinone
    Apotex, Canada


  • Corotrop
    Sanofi-Aventis, Sweden


  • Corotrope
    Sanofi-Aventis, Chile; Sanofi-Aventis, Colombia; Sanofi-Aventis, Netherlands; Sanofi-Aventis, Venezuela


  • Milrinone Lactate Injection
    Bedford, United States


  • Milrinone Lactate
    Apotex, United States; APP, United States; Baxter, United States; Bedford, United States; Ben Venue, Israel; Bioniche, United States; Gland, United States; Hikma, United States; Hospira, United States; International Medication Systems, United States; Mayne, United States


  • Primacor
    Sanofi-Aventis, Australia; Sanofi-Aventis, Brazil; Sanofi-Aventis, United Kingdom; Sanofi-Aventis, Hong Kong; Sanofi-Aventis, Mexico; Sanofi-Aventis, Malaysia; Sanofi-Aventis, New Zealand; Sanofi-Aventis, Singapore; Sanofi-Aventis, Thailand; Sanofi-Aventis, Taiwan; Sanofi-Aventis, United States

International Drug Name Search

Glossary

BANBritish Approved Name
DCFDénomination Commune Française
ISInofficial Synonym
OSOfficial Synonym
PHPharmacopoeia Name
Rec.INNRecommended International Nonproprietary Name (World Health Organization)
USANUnited States Adopted Name

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

NuLYTELY with Flavor Packs


Generic Name: polyethylene glycol electrolyte solution (pall ee ETH il een GLYE kol ee LEK troe lyte)

Brand Names: Colyte, Colyte with Flavor Packs, GoLYTELY, MoviPrep, NuLYTELY, NuLYTELY Cherry, NuLYTELY Lemon Lime, NuLYTELY Orange, NuLYTELY with Flavor Packs, PEG-3350 with Electolytes, TriLyte with Flavor Packs


What is NuLYTELY with Flavor Packs (polyethylene glycol electrolyte solution)?

Polyethylene glycol electrolyte solution is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements. This medication also contains potassium, sodium, and other minerals to replace electrolytes that are passed from the body in the stool.


Polyethylene glycol electrolyte solution is used to clean the bowel before colonoscopy, a barium x-ray, or other intestinal procedures.


Polyethylene glycol electrolyte solution may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about NuLYTELY with Flavor Packs (polyethylene glycol electrolyte solution)?


Do not use this medication if you are allergic to polyethylene glycol or any other electrolyte solutions (such as Pedialyte or Gatorade).

You should also not take polyethylene glycol electrolyte solution if you have a perforated bowel, a bowel obstruction or severe constipation, or colitis or toxic megacolon. If you have any these conditions, you could have dangerous or life-threatening side effects from polyethylene glycol electrolyte solution.


People with eating disorders (such as anorexia or bulimia) should not take polyethylene glycol electrolyte solution without the advice of a doctor.

Talk to your healthcare provider if you are not able to consume all of the solution. Incomplete cleansing of the bowel may affect the scheduled procedure.


What should I discuss with my health care provider before taking NuLYTELY with Flavor Packs (polyethylene glycol electrolyte solution)?


Do not use this medication if you are allergic to polyethylene glycol or any other electrolyte solutions (such as Pedialyte or Gatorade), or if you have:

  • a perforated bowel;




  • a bowel obstruction or severe constipation; or




  • colitis or toxic megacolon.



If you have any these conditions, you could have dangerous or life-threatening side effects from polyethylene glycol electrolyte solution.


People with eating disorders (such as anorexia or bulimia) should not use this medication without the advice of a doctor.

Before taking polyethylene glycol electrolyte solution, tell your doctor if you are allergic to any drugs, or if you have:



  • nausea or vomiting;




  • trouble swallowing; or




  • a history of bowel obstruction, diverticulitis, ulcerative colitis, or other chronic bowel disease.



If you have any of these conditions, you may need a dose adjustment or special tests to safely take polyethylene glycol electrolyte solution.


FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether polyethylene glycol electrolyte solution passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more likely to have serious side effects from this medicine.


How should I take NuLYTELY with Flavor Packs (polyethylene glycol electrolyte solution)?


Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.


Do not take polyethylene glycol electrolyte solution if it has been less than 2 hours since you last ate solid food. For best results, take the medicine 3 to 4 hours after you last ate.

Do not add any flavorings to this medicine, such as sugar, honey, artificial sweetener, fruit juices, or other beverages.


Chilling the medicine in a refrigerator may make it taste better. Shake the liquid well just before you measure a dose. Drink this medicine in the exact portions at the exact time intervals prescribed by your doctor.

Polyethylene glycol electrolyte solution will produce watery diarrhea. Keep taking the medicine until your stool is watery and clear. In most cases, at least 3 liters of polyethylene glycol electrolyte solution is needed for the full effect.


The usual dose of the medication is 8 ounces every 10 minutes. Drink each portion as quickly as possible, rather than sipping it slowly. The first watery stool should appear within 1 hour after you start drinking polyethylene glycol electrolyte solution.


You may be instructed not to drink or eat anything before your medical test or procedure. Follow your doctor's instructions about the type and amount of liquids you should drink for at least 24 hours before and after your test or procedure.

Throw away any polyethylene glycol electrolyte solution you have not used within 48 hours after it was mixed.


What happens if I miss a dose?


Talk to your doctor if you cannot drink all of the medication prescribed for you. Your test or procedure may need to be rescheduled if your bowel is not completely cleansed.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine at one time.

An overdose of this medication is not expected to produce life-threatening symptoms.


What should I avoid while taking NuLYTELY with Flavor Packs (polyethylene glycol electrolyte solution)?


Avoid taking other medications, vitamins, or mineral supplements within 1 hour before drinking polyethylene glycol electrolyte solution. Any medications you take just before a bowel cleansing will not be properly absorbed into your body.


Do not use other laxatives while using polyethylene glycol electrolyte solution unless your doctor has told you to.

NuLYTELY with Flavor Packs (polyethylene glycol electrolyte solution) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor if you have any of these serious side effects:

  • severe stomach pain or bloating;




  • no bowel movement within 2 hours after use; or




  • gagging, choking, or vomiting.



If you have any of these side effects, you may need to drink the medication more slowly, or stop using it for a short time.


Less serious side effects may include:



  • mild stomach cramps, gas, or bloating;




  • rectal pain or irritation;




  • nausea; or




  • passing gas.



This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect NuLYTELY with Flavor Packs (polyethylene glycol electrolyte solution)?


There may be other drugs that can interact with polyethylene glycol electrolyte solution. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More NuLYTELY with Flavor Packs resources


  • NuLYTELY with Flavor Packs Side Effects (in more detail)
  • NuLYTELY with Flavor Packs Use in Pregnancy & Breastfeeding
  • NuLYTELY with Flavor Packs Support Group
  • 1 Review for NuLYTELY with Flavor Packs - Add your own review/rating


  • Colyte Advanced Consumer (Micromedex) - Includes Dosage Information

  • Colyte Solution MedFacts Consumer Leaflet (Wolters Kluwer)

  • Colyte Prescribing Information (FDA)

  • GoLYTELY Solution (Jug) MedFacts Consumer Leaflet (Wolters Kluwer)

  • MoviPrep Advanced Consumer (Micromedex) - Includes Dosage Information

  • MoviPrep Prescribing Information (FDA)

  • MoviPrep Consumer Overview

  • MoviPrep MedFacts Consumer Leaflet (Wolters Kluwer)

  • NuLYTELY Prescribing Information (FDA)

  • NuLYTELY Solution MedFacts Consumer Leaflet (Wolters Kluwer)



Compare NuLYTELY with Flavor Packs with other medications


  • Bowel Preparation
  • Constipation, Chronic
  • Gastrointestinal Decontamination


Where can I get more information?


  • Your pharmacist can provide more information about polyethylene glycol electrolyte solution.

See also: NuLYTELY with Flavor Packs side effects (in more detail)