Chloratet 90

Dosage Form: FOR ANIMAL USE ONLY



CHLORTETRACYCLINE

TYPE A MEDICATED ARTICLE GRANULAR

ACTIVE DRUG INGREDIENTS

Chlortetracycline Calcium Complex Equivalent to 90 g/lb. Chlortetracycline HCl/lb.

INGREDIENTS

Dried Streptomyces Aureofaciens Fermentation Product, Calcium Carbonate, and Mineral Oil.

FOR MANUFACTURE OF DRY FEED ONLY

Directions for Use

Chicken - (Broiler/Fryer)

DOSAGE LEVEL	INDICATION FOR USE
10-50 g/t	For an increased rate of weight gain and improved feed efficiency
100-200 g/t	Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline. (Feed continuously for 7 to 14 days)
200-400 g/t	Control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to chlortetracycline. ( Feed continuously for 7 to 14 days)

WARNING: Do not feed to chickens producing eggs for human consumption.

DOSAGE LEVEL	INDICATION FOR USE
500 g/t	Reduction of mortality due to Escherichia coli infections susceptible to chlortetracycline (Feed For 5 days)

WARNING: Do not feed to chickens producing eggs for human consumption. Withdraw 24 hours prior to slaughter.

Growing Turkeys

DOSAGE LEVEL	INDICATION FOR USE
10-50 g/t	For an increased rate of weight gain and improved feed efficiency

WARNING: Do not feed to turkeys producing eggs for human consumption.

Turkeys

DOSAGE LEVEL	INDICATION FOR USE
200 g/t	Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline. (Feed continuously for 7 to 14 days)
400 g/t	Control of hexamitiasis caused by Hexamita meleagridis susceptible to chlortetracycline. (Feed continuously for 7 to 14 days)
400 g/t	Turkey poults not over 4 weeks of age: Reduction of mortality due to paratyphoid caused by Salmonella typhimurium susceptible to chlortetracycline.
25 mg/pound body weight daily	Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) suseptible to chlortetracycline. (Feed continuously for 7 to 14 days)

WARNING: Do not feed to turkeys producing eggs for human consumption.


Growing Swine

DOSAGE LEVEL	INDICATION FOR USE
10-50 g/t	For an increased rate of weight gain and improved feed efficiency

Swine

DOSAGE LEVEL	INDICATION FOR USE
50-100 g/t	Reducing the incidence of cervical lymphadenitis (jaw abscesses) caused by Group E streptococci susceptible to chlortetracycline.

Breeding Swine

DOSAGE LEVEL	INDICATION FOR USE
400 g/t	Control of leptospirosis ( reducing the instances of abortion and shredding of leptospirae) caused by Leptospira pomona susceptible to chlortetracycline. (Feed continuously for not more than 14 days)

Swine

DOSAGE LEVEL	INDICATIONS FOR USE
10 mg/lb. body weight daily	Treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline. ( Feed for not more than 14 days. Feed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb body weight per day.)

WARNING: Five-day withdrawal period.

Calves

DOSAGE LEVEL	INDICATIONS FOR USE
0.1 mg/lb. body weight daily	Calves (up to 250 lbs.): For an increased rate of body weight gain and improved feed efficiency.
25-70 mg/head/day	Calves ( 250-400 lbs.) For an increased rate of weight gain and improved feed efficiency

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

Growing Cattle

DOSAGE LEVEL	INDICATION FOR USE
70mg/head/day	Growing cattle (over 400 lbs.): For an increased rate of weight gain, improved feed efficiency and reduction of liver condemnation due to liver abscesses. Zero-Day withdrawal period

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

Beef Cattle

DOSAGE LEVEL	INDICATION FOR USE
350 mg/head/day	For the control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline.
350 mg/head/day	Beef cattle (under 700 lbs.): Control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.
0.5 mg/lb. daily	Beef cattle (Over 700 lbs.): Control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.

WARNING: Withdraw 48 hours prior to slaughter.

For calves, beef and non-lactating dairy cattle

DOSAGE LEVEL	INDICATION FOR USE
10 mg/lb. body weight daily	Treatment of bacterial eneteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline. (Treat for not more than 5 days. Feed approximately 400 g/ton, varying with body weight and feed consumption to provide10 mg/lb body weight per day.)

WARNING: Withdraw 10 days prior to slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

NADA 48-480

ADM Alliance Nutrition Inc.

Quincy IL 62305-3115

NET WEIGHT 50 POUNDS (22.67Kg)

PRINCIPAL DISPLAY PANEL - 50 POUNDS

CHLORATET TM

90

Chlortetracycline

MEDICATED

TYPE A

PREMIX

NADA 48-480

ACTIVE INGREDIENTS

Chlortetracycline Calcium Complex Equivalent 90 G/lb. Chlortetracycline HCl/lb

INGREDIENTS

Dried Streptomyces Aureofaciens Fermentation Product

Calcium Carbonate, Mineral Oil.

FOR USE IN MANUFACTURE OF DRY FEED ONLY

SEE BACK OF BAG FOR DIRECTIONS FOR USE.

Manufactured by

ADM Alliance Nutrition Inc.

Quincy IL 62305-3115


NET WEIGHT 50 POUNDS (22.67Kg)

Chloratet 90  chlortetracycline hydrochloride  granule

Product Information Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG NDC Product Code (Source) 12286-010 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORTETRACYCLINE HYDROCHLORIDE (CHLORTETRACYCLINE) CHLORTETRACYCLINE HYDROCHLORIDE 90 g  in 0.45 kg

Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE   MINERAL OIL

Product Characteristics Color gray Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 12286-010-01 22.67 kg In 1 BAG None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA48-480	07/20/2010

Labeler - ADM Alliance Nutrition, Inc (849684428)

Establishment
Name	Address	ID/FEI	Operations
ADM ALLIANCE NUTRITION, INC.		834721284	manufacture

Revised: 07/2010ADM Alliance Nutrition, Inc

Trecator-SC

Generic Name: ethionamide (e thye on AM ide)

Brand Names: Trecator

What is Trecator-SC (ethionamide)?

Ethionamide is an antibiotic. It prevents the growth of bacteria in your body.

Ethionamide is used to treat tuberculosis (TB).

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

What is the most important information I should know about Trecator-SC (ethionamide)?

Take all of the ethionamide that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated.

Ethionamide may cause stomach upset, a loss of appetite, a metallic taste in your mouth, or excessive salivation (mouth watering). Notify your doctor if these side effects are persistent or severe.

Who should not take Trecator-SC (ethionamide)?

Before taking this medication, tell your doctor if you

• 
  

  have ever had an allergic reaction to ethionamide;

  
  


• 
  

  have liver disease; or

  
  


• 
  

  have diabetes mellitus.

  
  

You may not be able to take ethionamide, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether ethionamide will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. It is also not known whether ethionamide will harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take Trecator-SC (ethionamide)?

Take ethionamide 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 (8 ounces) of water.

Ethionamide can be taken with or without food. Taking ethionamide with food may decrease stomach upset.

Take all of the ethionamide that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated.

Ethionamide is usually combined with one or more other tuberculosis medicines.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of an ethionamide overdose are unknown.

What should I avoid while taking Trecator-SC (ethionamide)?

There are no restrictions on foods, beverages, or activities during treatment with ethionamide unless your doctor directs otherwise.

Trecator-SC (ethionamide) side effects

If you experience any of the following serious side effects, stop taking ethionamide and seek emergency medical attention:

• 
  

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

  
  


• 
  

  yellow skin or eyes;

  
  


• 
  

  dark urine;

  
  


• 
  

  numbness or tingling in your hands or feet;

  
  


• 
  

  seizures;

  
  


• 
  

  blurred or double vision; or

  
  


• 
  

  confusion or abnormal behavior.

  
  

Other, less serious side effects may be more likely to occur. Continue to take ethionamide and talk to your doctor if you experience

• 
  

  nausea, vomiting, or loss of appetite;

  
  


• 
  

  a metallic taste in your mouth;

  
  


• 
  

  excessive salivation;

  
  


• 
  

  diarrhea;

  
  


• 
  

  unusual fatigue or weakness;

  
  


• 
  

  headache;

  
  


• 
  

  mild dizziness;

  
  


• 
  

  tremors (shaking); or

  
  


• 
  

  a rash.

  
  

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.

What other drugs will affect Trecator-SC (ethionamide)?

The risk of seizures may be increased when ethionamide is used in combination with cycloserine (Seromycin) or isoniazid (Nydrazid). Special monitoring may be necessary if you are taking a combination of these medicines.

Drugs other than those listed here may also interact with ethionamide. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines.

More Trecator-SC resources

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

• Trecator-SC Advanced Consumer (Micromedex) - Includes Dosage Information


• Ethionamide Professional Patient Advice (Wolters Kluwer)


• Ethionamide Monograph (AHFS DI)


• Ethionamide MedFacts Consumer Leaflet (Wolters Kluwer)


• Trecator Prescribing Information (FDA)

Compare Trecator-SC with other medications

• Tuberculosis, Active

Where can I get more information?

• Your pharmacist has additional information about ethionamide written for health professionals that you may read.

See also: Trecator-SC side effects (in more detail)

Symlin

Generic Name: Pramlintide Acetate
Class: Amylinomimetics
Molecular Formula: C₁₇₁H₂₆₇N₅₁O₅₃S₂•xC₂H₄O₂•yH₂O
CAS Number: 196078-30-5

• Insulin-induced Hypoglycemia


• 
  

  Increased risk of severe insulin-induced hypoglycemia with concomitant pramlintide and insulin therapy, particularly in patients with type 1 diabetes.^{1 3 6 7 8 9 10 11}

  
  


• 
  

  Generally occurs within 3 hours after injection with pramlintide.¹

  
  


• 
  

  Potential for serious injuries if severe hypoglycemia occurs while operating a motor vehicle, heavy machinery, or while engaging in other high-risk activities.¹

  
  


• 
  

  Appropriate patient selection, careful patient instruction, and insulin dose adjustments required.¹ (See Hypoglycemia under Cautions.)

  
  

Introduction

Antidiabetic agent; synthetic analog of human amylin.^{1 2}

Uses for Symlin

Diabetes Mellitus

Treatment of type 1 diabetes mellitus as an adjunct to preprandial insulin therapy in patients without adequate glycemic control on insulin therapy.^{1 3}

Treatment of type 2 diabetes mellitus as an adjunct to preprandial insulin therapy with or without concomitant metformin and/or a sulfonylurea in patients without adequate glycemic control on insulin therapy alone or in combination with metformin and/or a sulfonylurea.¹

Therapy should only be considered in patients with type 1 or 2 diabetes mellitus who are receiving insulin and have failed to achieve adequate glycemic control despite individualized insulin management.¹ (See Patient Selection under Cautions.)

Symlin Dosage and Administration

General

• 
  

  Adjust dosage of pramlintide and preprandial insulin under medical supervision.^{1 4} Dosing of both insulin and pramlintide should be reviewed at least once weekly until target dose is achieved, drug is well tolerated, and blood glucose concentrations are stable.¹

  
  


• 
  

  Monitor blood glucose frequently, including before and after meals and at bedtime.^{1 4 5}

  
  

Discontinuance of Therapy

• 
  

  Discontinue therapy if any of the following occurs:

  
  


• 
  

  Recurrent unexplained hypoglycemia that requires medical assistance.¹

  
  


• 
  

  Persistent clinically important nausea.¹

  
  


• 
  

  Non-compliance with self-monitoring of blood glucose.¹

  
  


• 
  

  Noncompliance with insulin dose adjustments.¹

  
  


• 
  

  Noncompliance with scheduled clinician visits or contacts.¹

  
  

Administration

Sub-Q Administration

Administer by sub-Q injection immediately before each major meal (≥250 kcal or ≥30 g of carbohydrate).^{1 4}

Administer into abdominal wall or thigh using a conventional U-100 syringe (preferably 0.3-mL size).^{1 4} Do not administer into the arm because of variable absorption.¹

Pramlintide dosage (mcg) must be converted to insulin unit equivalents for administration using a U-100 syringe.¹ Withdraw the appropriate volume of drug from the vial;^{1 14} fill syringe to the unit mark that corresponds to the appropriate volume of solution to be administered.^{1 4} (See Table 1.)

Table 1. Conversion of Pramlintide Dose (mcg) to Insulin Unit Equivalents1

Pramlintide Dose (mcg)	Required Volume of Pramlintide Acetate Injection (mL)	Unit Mark on U-100 Insulin Syringe That Corresponds to Required Injection Volume
15	0.025	2.5
30	0.05	5
45	0.075	7.5
60	0.1	10
120	0.2	20

Injection sites should be rotated and should be >2 inches away from insulin injection sites.¹

Do not mix pramlintide injection with any type of insulin;^{1 4 5} administer pramlintide and insulin as separate injections.^{1 13} (See Compatibility.)

Omit pramlintide dose if meal is skipped or provides <250 kcal or <30 g of carbohydrates.⁴

Always use a new syringe and needle for each dose.¹

If a dose is missed, skip that dose; do not give an additional injection.¹

Dosage

Available as pramlintide acetate; dosage expressed in terms of pramlintide.¹

Dosage expressed in mcg; dosage must be converted to insulin unit equivalents if administered using a U-100 insulin syringe. (See Table 1.)¹

Prior to initiating therapy, reduce preprandial, rapid-acting, short-acting, or fixed-mix insulin dosages by 50%.^{1 4} (See Hypoglycemia under Cautions.)

Once maintenance dosage of pramlintide is attained and nausea (if experienced) has subsided, adjust dosage of preprandial insulin to achieve optimal glycemic control.^{1 4}

Adults

Diabetes Mellitus

Type 1 Diabetes Mellitus

Sub-Q

Initially, 15 mcg immediately before each major meal, ^{1 4 14} up to 4 times daily.^{2 8 9 14}

Increase dosage in increments of 15 mcg to 30, 45, or 60 mcg, as tolerated, before each major meal, when no clinically important nausea has occurred for ≥3 days at the current dosage level.¹

If nausea persists at the 45- or 60-mcg dosage level, reduce dosage to 30 mcg before each major meal.¹

If the 30-mcg dosage is not tolerated, consider discontinuance of therapy.^{1 4}

If pramlintide is reinitiated following a discontinuance for any reason, use initial dosage and dosage titration schedule.^{1 4}

Type 2 Diabetes Mellitus

Sub-Q

Initially, 60 mcg immediately before each major meal, ^{1 4} up to 3 times daily.^{8 14}

Increase dosage to 120 mcg before each major meal, when no clinically important nausea has occurred for 3–7 days.¹

If nausea persists at dosage of 120 mcg, reduce dosage to 60 mcg before each major meal.¹

If pramlintide is reinitiated following a discontinuance for any reason, use initial dosage and dosage titration schedule.^{1 4}

Prescribing Limits

Adults

Diabetes Mellitus

Type 1 Diabetes Mellitus

Sub-Q

Maximum daily dosage not established;¹⁴ however, in clinical studies, has been administered up to 4 times daily before each major meal.^{2 8 9 14}

Type 2 Diabetes Mellitus

Sub-Q

Maximum daily dosage not established;¹⁴ however, in clinical studies, has been administered up to 3 times daily before each major meal.^{8 14}

Special Populations

Hepatic Impairment

No dosage adjustment required.¹

Renal Impairment

No dosage adjustment required.^{1 14} (See Renal Impairment under Cautions.)

Geriatric Patients

Careful dosage selection recommended due to possible age-related increased sensitivity to hypoglycemia; careful patient selection for full understanding of insulin adjustments and glucose monitoring is recommended.¹

Cautions for Symlin

Contraindications

• 
  

  Confirmed diagnosis of gastroparesis.^{1 4}

  
  


• 
  

  Hypoglycemic unawareness.^{1 4}

  
  


• 
  

  Poor compliance with current insulin regimen or with self-monitoring of blood glucose concentrations.¹

  
  


• 
  

  HbA_1c >9%.¹

  
  


• 
  

  Recurrent episodes of hypoglycemia requiring medical assistance during the previous 6 months.¹

  
  


• 
  

  Concomitant therapy with drugs that stimulate GI motility.¹

  
  


• 
  

  Pediatric patients.^{1 14}

  
  


• 
  

  Known hypersensitivity to pramlintide, metacresol, or any other ingredient in the formulation.^{1 4}

  
  

Warnings/Precautions

Warnings

Patient Selection

Appropriate patient selection required for safe and effective use of pramlintide.¹ (See Diabetes Mellitus under Uses and also see Contraindications under Cautions.)

Assess patient’s glycosylated hemoglobin (HbA_1c), current insulin regimen, recent blood glucose monitoring data, history of insulin-induced hypoglycemia, and body weight prior to initiating therapy.¹

Ongoing care under the guidance of a clinician skilled in the use of insulin and supported by a diabetes educator required.¹

Hypoglycemia

Possible severe hypoglycemia, potentially resulting in serious injuries, with concomitant pramlintide and insulin therapy, particularly in patients with type 1 diabetes.^{1 3 6 7 8 9 10 11} Usually occurs within 3 hours following pramlintide injection.¹

Appropriate patient selection, careful patient instruction, frequent premeal and postmeal glucose monitoring, and an initial 50% reduction in pre-meal doses of short-acting insulin are important to avoid insulin-induced severe hypoglycemia.¹ (See Patient Selection under Cautions and also see Dosage under Dosage and Administration.)

Rapid reductions in serum glucose concentrations may precipitate symptoms of hypoglycemia (e.g., hunger, headache, sweating, tremor, irritability, difficulty concentrating, loss of consciousness, coma, seizure), regardless of glucose concentration.¹

Early symptoms of hypoglycemia may be altered or decreased in patients with long-standing diabetes mellitus or diabetic neuropathy or those receiving intensive antidiabetic drug (e.g., insulin) regimens or sympatholytic agents.¹ (See Specific Drugs under Interactions.)

Concomitant use with certain drugs (e.g., oral antidiabetic agents, ACE inhibitors, disopyramide, fibric acid derivatives, fluoxetine, MAO inhibitors, pentoxifylline, propoxyphene, salicylates, sulfonamides) may increase risk of hypoglycemia.¹ (See Specific Drugs under Interactions.)

Does not alter the counterregulatory hormonal response to insulin-induced hypoglycemia and does not appear to alter perception of hypoglycemic symptoms at plasma glucose concentrations as low as 45 mg/dL.¹

Sensitivity Reactions

Hypersensitivity Reactions

Possible localized allergic reactions (e.g., pruritus, erythema, swelling) at injection site; usually resolve in a few days to a few weeks.^{1 14}

Systemic hypersensitivity reactions reported in 5% of patients; discontinuance of therapy has not been required.^{1 14}

Specific Populations

Pregnancy

Category C.¹

Lactation

Not known whether pramlintide is distributed into milk.¹ Use only if potential benefit outweighs the risk to the infant.¹

Pediatric Use

Safety and efficacy not established in children ≤17 years of age.^{1 14}

Geriatric Use

Response in patients ≤84 years of age does not appear to differ from that in younger adults, but increased sensitivity cannot be ruled out.¹ Manage both pramlintide and insulin regimens carefully to obviate an increased risk of severe hypoglycemia.¹

Hepatic Impairment

Pharmacokinetics not evaluated but impact of hepatic impairment should be minimal.¹

Renal Impairment

No increased exposure or decreased clearance in patients with moderate or severe renal impairment (Cl_Cr 21–50 mL/minute); not studied in those undergoing dialysis.¹

Common Adverse Effects

Hypoglycemia, nausea, headache, anorexia, inflicted injury, vomiting, abdominal pain, arthralgia, fatigue, allergic reaction, dizziness, cough, pharyngitis.¹

Interactions for Symlin

Orally Administered Drugs

Possible decreased rate of absorption of concomitantly administered oral drugs.¹ Administer ≥1 hour prior to or 2 hours after pramlintide injection if rapid onset of a concomitantly orally administered drug is a critical determinant of effectiveness.¹

Specific Drugs

Drug	Interaction	Comments
Acetaminophen	Decreased peak plasma acetaminophen concentration and delayed time to peak plasma concentration 1	Administer acetaminophen 1–2 hours before or >2 hours after pramlintide injection1
Alcohol	Increased risk of hypoglycemia1
Alpha glucosidase inhibitors	Pramlintide-induced slowing of gastric emptying may influence drug effects1	Concomitant use not recommended1
Anticholinergic agents (e.g., atropine)	Pramlintide-induced slowing of gastric emptying may influence drug effects.1	Concomitant use not recommended1
ACE inhibitors	Increased risk of hypoglycemia1	Additional insulin dosage adjustments and close monitoring of blood glucose concentrations may be necessary1
Antidiabetic agents, oral	Increased risk of hypoglycemia1	Additional insulin dosage adjustments and close monitoring of blood glucose concentrations may be necessary1
Disopyramide	Increased risk of hypoglycemia1	Additional insulin dosage adjustments and close monitoring of blood glucose concentrations may be necessary1
Fibric acid derivatives	Increased risk of hypoglycemia1	Additional insulin dosage adjustments and close monitoring of blood glucose concentrations may be necessary1
Fluoxetine	Increased risk of hypoglycemia1	Additional insulin dosage adjustments and close monitoring of blood glucose concentrations may be necessary1
Insulin	Increased risk of severe hypoglycemia1 Pramlintide pharmacokinetics altered if pramlintide injection is mixed with insulin1 4 5 (See Compatibility under Stability.)	Additional insulin dosage adjustments and close monitoring of blood glucose concentrations may be necessary1 Administer pramlintide and insulin as separate injections1 13
MAO inhibitors	Increased risk of hypoglycemia1	Additional insulin dosage adjustments and close monitoring of blood glucose concentrations may be necessary1
Pentoxifylline	Increased risk of hypoglycemia1	Additional insulin dosage adjustments and close monitoring of blood glucose concentrations may be necessary1
Propoxyphene	Increased risk of hypoglycemia1	Additional insulin dosage adjustments and close monitoring of blood glucose concentrations may be necessary1
Salicylates	Increased risk of hypoglycemia1	Additional insulin dosage adjustments and close monitoring of blood glucose concentrations may be necessary1
Sulfonamides	Increased risk of hypoglycemia1	Additional insulin dosage adjustments and close monitoring of blood glucose concentrations may be necessary1
Sympatholytic agents (e.g., β-adrenergic blocking agents, clonidine, guanethidine, reserpine)	May alter or decrease manifestations of hypoglycemia1

Symlin Pharmacokinetics

Absorption

Bioavailability

Absolute bioavailability is 30–40%.¹

Distribution

Extent

Does not extensively bind to blood cells.¹

Not known whether distributed into human milk.¹

Plasma Protein Binding

Approximately 60%; does not extensively bind to albumin.¹

Elimination

Metabolism

Metabolized principally by the kidneys primarily to the active metabolite des-lys¹ pramlintide (2-37 pramlintide).¹

Half-life

Approximately 48 minutes.¹

Stability

Storage

Parenteral

Solution for Injection

With unopened vials, 2–8°C.¹ Do not freeze and protect from light.¹ Discard vial if frozen or overheated.¹ Vials in use may be stored at 2–25°C.¹ Discard unused solution after 28 days.¹

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Drug Compatibility

Incompatible with insulin (all types).¹

ActionsActions

• 
  

  An amylinomimetic agent that has physiologic actions equivalent to those of human amylin (glucoregulatory hormone synthesized by pancreatic β-cells and released with insulin in response to a meal).^{1 3}

  
  


• 
  

  Inhibits inappropriately high glucagon secretion during episodes of hyperglycemia (e.g., after a meal) in patients with type 1 or type 2 diabetes mellitus;^{1 2} does not impair normal glucagon response to hypoglycemia.³

  
  


• 
  

  Slows gastric emptying and reduces the rate of glucose absorption from a meal without altering the net absorption of ingested carbohydrate and other nutrients.^{1 3}

  
  


• 
  

  Prevents the initial postprandial glucose excursions usually observed with insulin therapy alone.^{1 3}

  
  


• 
  

  Reduces food intake and increases satiety, possibly resulting in weight loss.^{1 3}

  
  

Advice to Patients

• 
  

  Importance of adhering to diet and exercise regimen.¹ Importance of regular monitoring (preferably self-monitoring) of blood glucose and HbA_1c.¹

  
  


• 
  

  Importance of providing patient a copy of manufacturer’s patient information.¹

  
  


• 
  

  Inform patients of the potential risks and advantages of pramlintide therapy.¹

  
  


• 
  

  Importance of appropriate management of hypoglycemia and hyperglycemia, and assessment for other diabetes complications.¹ Risk of hypoglycemia in patients receiving concomitant insulin therapy.¹ Provide instructions regarding management of hypoglycemia, including recognition of symptoms, predisposing conditions, and treatment.¹

  
  


• 
  

  Risk of nausea, particularly upon initiation of therapy.¹

  
  


• 
  

  Importance of patient informing clinician of recurrent hypoglycemia or nausea.¹

  
  


• 
  

  Provide instructions regarding proper use and storage of the injection.¹ Importance of advising patient that if a dose is missed, resume the treatment regimen as prescribed with the next scheduled dose.¹

  
  


• 
  

  Importance of providing instruction on proper injection technique and of administering pramlintide using a U-100 insulin syringe (preferably a 0.3-mL size for optimal accuracy) filled to the unit mark that corresponds to the volume to be injected.¹

  
  


• 
  

  Importance of not mixing pramlintide with insulin.¹ Importance of administering pramlintide and insulin as separate injections given at least 2 inches apart.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

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

Pramlintide Acetate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for subcutaneous use	0.6 mg/mL (of pramlintide)	Symlin (with metacresol preservative)	Amylin

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 04/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

SymlinPen 120 1000MCG/ML Solution (AMYLIN PHARMACEUTICALS): 5/$349.97 or 16/$979.92

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 September 01, 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Amylin Pharmaceuticals. Symlin (pramlintide acetate) injection prescribing information. San Diego, CA; 2005 Mar.

2. Whitehouse F, Kruger DF, Fineman M et al. A randomized study and open-label extension evaluating the long-term efficacy of pramlintide as an adjunct to insulin therapy in type 1 diabetes. Diabetes Care. 2002; 25:724-30. [IDIS 479246] [PubMed 11919132]

3. Kruger DF, Gloster MA. Pramlintide for the treatment of insulin-requiring diabetes mellitus: rationale and review of clinical data. Drugs. 2004; 64:1419-32. [PubMed 15212559]

4. Amylin Pharmaceuticals. Symlin (pramlintide acetate) injection medication guide. San Diego, CA; 2005 June.

5. Institute for Safe Medication Practices. Symlin insulin adjunct present safety issues. Huntington Valley, PA; 2005 Jun. 16. From ISMP website:

6. Hussar DA. New drugs: exenatide, pramlintide acetate, and micafungin sodium. J Am Pharm Assoc (Wash DC). 2005 Jul-Aug; 45:524-7.

7. Hollander PA, Levy P, Fineman MS et al. Pramlintide as an adjunct to insulin therapy improves long-term glycemic and weight control in patients with type 2 diabetes: a 1-year randomized controlled trial. Diabetes Care. 2003; 26:784-90. [PubMed 12610038]

8. Kleppinger EL, Vivian EM. Pramlintide for the treatment of diabetes mellitus. Ann Pharmacother. 2003 Jul-Aug; 37:1082-9.

9. Ratner RE, Dickey R, Fineman M et al. Amylin replacement with pramlintide as an adjunct to insulin therapy improves long-term glycaemic and weight control in Type 1 diabetes mellitus: a 1-year, randomized controlled trial. Diabet Med. 2004; 21:1204-12. [PubMed 15498087]

10. Anon. Pramlintide (symlin) for diabetes. Med Lett Drugs Ther. 2005; 47:43-4. [PubMed 15912124]

11. Barlocco D. Pramlintide (Amylin). Curr Opin Investig Drugs. 2001; 2:1575-81. [PubMed 11763160]

12. Weyer C, Fineman MS, Strobel S et al. Properties of pramlintide and insulin upon mixing. Am J Health Syst Pharm. 2005; 62:816-22. [PubMed 15821274]

13. McQueen J. Pramlintide acetate. Am J Health Syst Pharm. 2005; 62:2363-72. [PubMed 16278328]

14. Amylin Pharmaceuticals, Inc., San Diego, CA: Personal Communication.

More Symlin resources

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

• Symlin Prescribing Information (FDA)


• Symlin Advanced Consumer (Micromedex) - Includes Dosage Information


• Symlin Vial MedFacts Consumer Leaflet (Wolters Kluwer)


• Symlin Consumer Overview


• Pramlintide MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Symlin with other medications

• Diabetes, Type 1
• Diabetes, Type 2

Tums Chewable Tablets

Pronunciation: KAL-see-um KAR-bo-nate
Generic Name: Calcium Carbonate
Brand Name: Examples include Tums and Tums Kids

Tums Chewable Tablets are used for:

Treating heartburn, sour stomach, acid indigestion, and upset stomach caused by these conditions. It is also used to treat or prevent calcium deficiency. It may also be used for other conditions as determined by your doctor.

Tums Chewable Tablets are an antacid. It works by neutralizing acid in the stomach. It also works to treat or prevent calcium deficiency by providing extra calcium to the body.

Do NOT use Tums Chewable Tablets if:

• you are allergic to any ingredient in Tums Chewable Tablets


• you have high blood calcium levels

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

Before using Tums Chewable Tablets:

Some medical conditions may interact with Tums Chewable Tablets. 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 high blood phosphate levels or high calcium levels


• if you have appendicitis, heart problems, parathyroid problems, hardening of the arteries, kidney problems, kidney stones, stomach or bowel problems (eg, blockage of your bowel, stomach bleeding), or inflammatory problems (eg, sarcoidosis)


• if you take digoxin or if you are dehydrated

Some MEDICINES MAY INTERACT with Tums Chewable Tablets. Tell your health care provider if you are taking any other medicines.

Ask your health care provider if Tums Chewable Tablets 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 Tums Chewable Tablets:

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

• Take Tums Chewable Tablets by mouth with or without food.


• Chew Tums Chewable Tablets well before you swallow it.


• If you take an azole antifungal (eg, ketoconazole), a bisphosphonate (eg, alendronate), certain cephalosporins (eg, cefpodoxime), iron, mycophenolate, a quinolone antibiotic (eg, ciprofloxacin), a cation exchange resin (eg, sodium polystyrene sulfonate), a tetracycline antibiotic (eg, doxycycline), or a thyroid hormone, ask your doctor or pharmacist how to take them with Tums Chewable Tablets.


• If you miss a dose of Tums Chewable Tablets, take it as soon as you remember. Continue to take it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use Tums Chewable Tablets.

Important safety information:

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


• This product may contain tartrazine dye (FD&C Yellow No. 5). This may cause an allergic reaction in some patients. If you have ever had an allergic reaction to tartrazine, ask your pharmacist if your product has tartrazine in it.


• Different brands of Tums Chewable Tablets may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.


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

Possible side effects of Tums Chewable Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Tums Chewable Tablets. 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).

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

See also: Tums side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Tums Chewable Tablets:

Store Tums Chewable Tablets at room temperature, below 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tums Chewable Tablets out of the reach of children and away from pets.

General information:

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


• Tums Chewable Tablets 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 Tums Chewable Tablets. 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 Tums resources

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

Compare Tums with other medications

• Duodenal Ulcer
• Erosive Esophagitis
• GERD
• Indigestion
• Stomach Ulcer

Mysoline

Generic Name: Primidone
Class: Barbiturates
VA Class: CN400
Chemical Name: 5-ethyldihydro-5-phenyl-4,6(1H, 5H)-pyrimidinedione
CAS Number: 125-33-7

REMS:

FDA approved a REMS for primidone to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Anticonvulsant; a structural analog of phenobarbital; related to barbiturate-derivative anticonvulsants.^{a b c d}

Uses for Mysoline

Used alone or with other anticonvulsants (e.g., phenytoin, phenobarbital); ^{a c d} however, some clinicians do not recommend concurrent use of primidone and phenobarbital because of possible increased sedation.^a

Generalized Seizures

Prophylactic management of tonic-clonic (grand mal) seizures, particularly those refractory to other anticonvulsant therapy.^{a c d}

Prophylactic management of other partial seizures (e.g., those with autonomic symptoms), including atonic (also known as akinetic) seizures.^{a b}

Partial Seizures

Prophylactic management of partial seizures with complex symptomatology (psychomotor seizures).^{a c d}

Prophylactic management of other partial seizures, including focal seizures.^{a b c d}

Mysoline Dosage and Administration

General

• 
  

  Closely monitor patients receiving anticonvulsant therapy for notable changes in behavior that could indicate emergence or worsening of suicidal thoughts or behavior or depression.^{d g h i} (See Suicidality Risk under Cautions.)

  
  


• 
  

  When primidone therapy is discontinued, withdraw the drug slowly to avoid precipitating seizures or status epilepticus.^{a b c d}

  
  


• 
  

  When a patient is transferred to primidone from another anticonvulsant, gradually increase primidone dosage over a period of at least 2 weeks while gradually decreasing dosage of the other anticonvulsant, to maintain adequate seizure control.^{a c}

  
  

Administration

Oral Administration

Administer orally.^{a c d}

Dosage

Adjust dosage carefully according to individual requirements and response.^{a c d} In some cases, determination of blood concentrations of the drug may be needed to achieve optimal dosage adjustment.^{c d}

May require several weeks of therapy before therapeutic efficacy can be assessed.^{c d}

Pediatric Patients

Generalized and Partial Seizures

Oral

Anticonvulsant-naive children <8 years of age: Initially, 50 mg at bedtime (days 1–3), increase to 50 mg twice daily (days 4–6), then increase to 100 mg twice daily (days 7–9).^{a c d} Follow with a maintenance dosage of 125–250 mg 3 times daily or 10–25 mg/kg daily given in divided doses.^{a c d} Alternatively, some clinicians recommend 1.25 g/m² daily in 2–4 divided doses.^a

Anticonvulsant-naive children ≥8 years of age: Initially, 100–125 mg at bedtime (days 1–3), increase to 100–125 mg twice daily (days 4–6), then increase to 100–125 mg 3 times daily (days 7–9).^{a c d} Follow with a maintenance dosage of 250 mg 3 or 4 times daily.^{a c d} Do not exceed 500 mg 4 times daily.^{a c d}

Children ≥8 years of age receiving other anticonvulsants: Initially, 100–125 mg (primidone) at bedtime; increase dosage (primidone) slowly to maintenance level while gradually decreasing dosage of other anticonvulsant.^{c d} Continue this regimen until satisfactory dosage achieved with the combination, or the other drug is withdrawn.^{c d} If primidone monotherapy is the objective, gradually increase primidone dosage while decreasing dosage of the drug being discontinued over a period of at least 2 weeks.^{a c d}

Adults

Generalized and Partial Seizures

Oral

Anticonvulsant therapy-naive adults: Initially, 100–125 mg at bedtime (days 1–3), increase to 100–125 mg twice daily (days 4–6), then increase to 100–125 mg 3 times daily (days 7–9).^{a c d} Follow with a maintenance dosage of 250 mg 3 or 4 times daily.^{a c d} Do not exceed 500 mg 4 times daily.^{a c d}

Adults receiving other anticonvulsants: Initially, 100–125 mg (primidone) at bedtime; increase dosage (primidone) slowly to maintenance level while gradually decreasing dosage of other anticonvulsant.^{c d} Continue this regimen until satisfactory dosage is achieved with the combination, or the other drug is withdrawn.^{c d} If primidone monotherapy is the objective, gradually increase primidone dosage while decreasing dosage of the drug being discontinued over a period of at least 2 weeks.^{a c d}

Prescribing Limits

Pediatric Patients

Generalized and Partial Seizures

Oral

Children ≥8 years of age: Maximum 2 g daily given in divided doses (e.g., 500 mg 4 times daily).^{a c d}

Adults

Generalized and Partial Seizures

Oral

Maximum 2 g daily given in divided doses (e.g., 500 mg 4 times daily).^{a c d}

Special Populations

No special population dosage recommendations at this time.^{c d}

Cautions for Mysoline

Contraindications

• 
  

  Porphyria.^{c d}

  
  


• 
  

  Known hypersensitivity to phenobarbital.^{c d}

  
  

Warnings/Precautions

Warnings

Shares the toxic potentials of the barbiturate-derivative anticonvulsants; observe the usual precautions of anticonvulsant therapy.^a

Suicidality Risk

Increased risk of suicidality (suicidal ideation or behavior) observed in an analysis of studies using various anticonvulsants in patients with epilepsy, psychiatric disorders (e.g., bipolar disorder, depression, anxiety), and other conditions (e.g., migraine, neuropathic pain); risk in patients receiving anticonvulsants (0.43%) was approximately twice that in patients receiving placebo (0.24%).^{d g h i j} Increased suicidality risk was observed ≥1 week after initiation of anticonvulsant therapy and continued through 24 weeks.^{d g h j} Risk was higher for patients with epilepsy compared with those receiving anticonvulsants for other conditions.^{d g h j}

Closely monitor all patients currently receiving or beginning anticonvulsant therapy for changes in behavior that may indicate emergence or worsening of suicidal thoughts or behavior or depression.^{d g h i j} Anxiety, agitation, hostility, hypomania, and mania may be precursors to emerging suicidality.^g

Balance risk of suicidality with the risk of untreated illness.^{d g} Epilepsy and other illnesses treated with anticonvulsants are themselves associated with morbidity and mortality and an increased risk of suicidality.^{d g} If suicidal thoughts or behavior emerge during anticonvulsant therapy, consider whether these symptoms may be related to the illness itself.^{d i} (See Advice to Patients.)

Withdrawal Effects

Abrupt withdrawal may result in increased seizure frequency or status epilepticus.^{a b c d}

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm.^{c d}

Reports suggest an association between use of anticonvulsants in pregnant, epileptic women and an increased incidence of birth defects in children born to these women; however, causal relationship to many anticonvulsants not established.^{c d f}

Neurologic manifestations (overactivity, tumors) reported in neonates whose mothers received primidone during pregnancy.^f

Do not discontinue anticonvulsants in pregnant women in whom the drugs are administered to prevent major seizures because of the strong possibility of precipitating status epilepticus with attendant hypoxia and threat to life.^{c d}

Carefully weigh these considerations when treating or counseling epileptic women of childbearing potential.^{c d}

Neonatal hemorrhage (with a coagulation defect resembling vitamin K deficiency) reported in newborns whose mothers were receiving primidone during pregnancy.^{b c d f} Administer prophylactic vitamin K to pregnant women taking primidone for one month prior to and during delivery.^{b c d} Additionally, administer vitamin K to the neonate immediately after birth.^{b f}

General Precautions

Laboratory Monitoring

Perform baseline CBC and a sequential multiple analysis-12 (SMA-12) test every 6 months during primidone therapy.^{a c d}

Hematologic Effects

Granulocytopenia, agranulocytosis, red-cell hypoplasia and aplasia rarely reported; may require discontinuance of primidone.^{c d}

Megaloblastic anemia may occur as a rare idiosyncrasy.^{c d} Administer folic acid.^{c d}

Specific Populations

Pregnancy

Category D.^f Safety during pregnancy not established.^{a c d} (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

North American Antiepileptic Drug (NAAED) Pregnancy Registry at 888-233-2334 (for patients); registry information also available on the website .^d

Lactation

Distributed into milk.^{a c d f} Discontinue nursing or drug if excessive somnolence or drowsiness is observed in nursing infants of women receiving the drug.^{a c d}

Pediatric Use

Safety and efficacy established in pediatric patients.^{c d}

Possible paradoxical excitement and hyperactivity or an exacerbation of existing hyperactivity in children.^b

Geriatric Use

Possible excitement, confusion, or depression.^b

Common Adverse Effects

Drowsiness, ataxia, vertigo, lethargy, anorexia, nausea, vomiting.^{a c d}

Interactions for Mysoline

Specific Drugs

Drug	Interaction	Comments
Contraceptives (oral)	Possible increased metabolism of both the estrogenic and progestinic components of oral contraceptivesb	Consider alternate methods of contraceptionb
Phenobarbital	Possible increased sedationa b	Use with caution,a if at all b
Phenytoin	Possible increase in amount of primidone converted to phenobarbital and increased sedationb
Valproic acid	Increased plasma phenobarbital concentrations and excessive somnolenceb	Observe patient for possible neurologic toxicity and monitor plasma concentrations of phenobarbital; decrease dosage of primidone if neededb

Mysoline Pharmacokinetics

Absorption

Bioavailability

Approximately 60–80% absorbed from GI tract.^a

Onset

Following oral administration, peak serum concentrations are reached in about 4 hours.^a

Plasma Concentrations

Limited data indicate that serum primidone concentrations should be maintained at 5–12 mcg/mL to adequately control seizures and minimize risk of adverse effects.^{a c d}

Distribution

Extent

Distributed into milk in substantial quantities.^{a c d}

Elimination

Metabolism

Slowly metabolized by the liver.^a Approximately 15–25% of an oral dose metabolized to phenobarbital.^a

Elimination Route

Slowly excreted in urine as phenylethylmalonamide (PEMA), phenobarbital, and p-hydroxyphenobarbital.^a

During chronic therapy, approximately 15–25% excreted in urine unchanged and approximately 50–70% excreted as PEMA.^a

Half-life

Primidone: One manufacturer stated 21 hours; other clinicians suggested 10–12 hours.^a

PEMA: 24–48 hours.^a

Special Populations

Removed by hemodialysis.^a

Stability

Storage

Oral

Tablets

Tight, light-resistant containers at 20–25°C.^{c d}

Actions

• 
  

  Shares the actions of barbiturate-derivative anticonvulsants and has sedative properties similar to phenobarbital.^a

  
  


• 
  

  Exact mechanism of antiepileptic action is unknown; primidone and its metabolites (phenobarbital and PEMA) have anticonvulsant activity.^{c d}

  
  


• 
  

  Effective in subhypnotic doses.^a

  
  

Advice to Patients

• 
  

  Risk of suicidality (anticonvulsants may increase risk of suicidal thoughts or actions in about 1 in 500 people).^{d g h i j} Importance of patients, family, and caregivers being alert to day-to-day changes in mood, behavior, and actions and immediately informing clinician of any new or worrisome behaviors (e.g., talking or thinking about wanting to hurt oneself or end one’s life, withdrawing from friends and family, becoming depressed or experiencing worsening of existing depression, becoming preoccupied with death and dying, giving away prized possessions).^{d g h j}

  
  


• 
  

  Importance of informing patients that several weeks of therapy may be required before therapeutic efficacy can be assessed.^{c d}

  
  


• 
  

  Importance of informing patients not to stop primidone therapy abruptly; may precipitate seizures or status epilepticus.^{a b c d}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal products, as well as any concomitant illnesses.^c

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed; advise pregnant women of possible risk to fetus.^{a d f} Importance of clinicians informing women about the existence of and encouraging enrollment in pregnancy registries (see Pregnancy under Cautions).^d

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{c d} (See Cautions.)

  
  

Preparations

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

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

Primidone

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	50 mg*	Mysoline (scored)	Valeant
			Primidone Tablets
		250 mg*	Mysoline (scored)	Valeant
			Primidone Tablets

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Mysoline 250MG Tablets (VALEANT): 30/$209.99 or 90/$602.66

Mysoline 50MG Tablets (VALEANT): 90/$194.24 or 270/$551.20

Primidone 250MG Tablets (AMNEAL PHARMACEUTICALS): 90/$69.99 or 270/$191.98

Primidone 50MG Tablets (LANNETT): 90/$39.99 or 270/$109.97

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 October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. AHFS drug information 2007. McEvoy GK, ed. Primidone. Bethesda, MD: American Society of Health-System Pharmacists; 2008.

b. AHFS drug information 2007. McEvoy GK, ed. Anticonvulsants General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2254-8.

c. Mutual Pharmaceuticals. Primidone tablets prescribing information. Philadelphia, PA; 2006 Nov.

d. Valeant Pharmaceuticals North America. Mysoline (primidone) tablets prescribing information. Aliso Viejo, CA; 2009 May.

e. Food and Drug Administration. Drugs or vaccines used in registries for specific diseases. From the FDA web site. Rockville, MD; Undated. Accessed 2008 Mar 20.

f. Primidone. In: Briggs GG, Freeman RK, Yaffe SJ. Drug in pregnancy and lactation: a reference guide to fetal and neonatal risk. 8th ed. Philadelphia: Lippincott Williams & Wilkins; 2008;1525-8.

g. US Food and Drug Administration. Information for healthcare professionals: suicidality and antiepileptic drugs. Rockville, MD; 2008 Jan 31. From the FDA web site.

h. US Food and Drug Administration. FDA News: FDA alerts health care providers to risk of suicidal thoughts and behavior with antiepileptic medications. Rockville, MD; 2008 Jan 31. From the FDA website.

i. US Food and Drug Administration. Suicidal behavior and ideation and antiepileptic drugs: update 5/5/2009. Rockville, MD; 2009 May 5. From the FDA website. Accessed 2009 Oct 21.

j. US Food and Drug Administration. FDA Alert: Suicidality and antiepileptic drugs. Rockville, MD; 2008 Jan 31. From the FDA website.

More Mysoline resources

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

• Mysoline Prescribing Information (FDA)


• Mysoline MedFacts Consumer Leaflet (Wolters Kluwer)


• Mysoline Concise Consumer Information (Cerner Multum)


• Mysoline Advanced Consumer (Micromedex) - Includes Dosage Information


• Primidone Prescribing Information (FDA)


• Primidone Professional Patient Advice (Wolters Kluwer)

Compare Mysoline with other medications

• Seizures

Lipram

Generic Name: pancrelipase (oral) (pan kre LYE pace)

Brand Names: Cotazym, Creon, Dygase, Ku-Zyme, Ku-Zyme HP, Kutrase, Lapase, Palcaps 10, Pancrease MT 10, Pancrease MT 16, Pancrease MT 20, Pancrease MT 4, Pancrecarb MS-16, Pancrecarb MS-4, Pancrecarb MS-8, Panocaps, Panocaps MT 16, Ultrase, Ultrase MT 12, Ultrase MT 18, Ultrase MT 20, Viokase, Viokase 16, Zenpep

What is pancrelipase?

Pancrelipase is a combination of three enzymes (proteins): lipase, protease, and amylase. These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars.

Pancrelipase is used to replace these enzymes when the body does not have enough of its own. Certain medical conditions can cause this lack of enzymes, including cystic fibrosis, chronic inflammation of the pancreas, or blockage of the pancreatic ducts.

Pancrelipase may also be used following surgical removal of the pancreas.

Pancrelipase may also be used for other purposes not listed in this medication guide.

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

You should not take pancrelipase if you are allergic to pork proteins.

Before taking pancrelipase, tell your doctor if you have gout, kidney disease, a history of intestinal blockage, a sudden onset of pancreatitis, or worsening of chronic pancreatic disease.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

If you miss a dose of this medicine, skip the missed dose and wait until your next scheduled dose to take the medicine. Do not take extra medicine to make up the missed dose.

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

You should not take pancrelipase if you are allergic to pork proteins.

If you have any of these other conditions, you may need a pancrelipase dose adjustment or special tests:

• kidney disease;


• 
  

  gout;

  
  


• 
  

  a history of blockage in your intestines;

  
  


• 
  

  a sudden onset of pancreatitis; or

  
  


• 
  

  worsening of chronic pancreatic disease.

  
  

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 pancrelipase passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take pancrelipase?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Pancrelipase should be taken with a meal or snack. Take the medicine with a full glass of water or juice.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

You may open the pancrelipase capsule and sprinkle the medicine into a spoonful of pudding or applesauce to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store in the original container at room temperature (below 78 degrees F) for up to 12 weeks. Protect from moisture or high heat. Keep the bottle tightly closed when not in use. If the medication is exposed to temperatures between 78 and 104 degrees F, throw it away after 30 days. Do not use any pancrelipase that has been exposed to temperatures above 104 degrees F.

What happens if I miss a dose?

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

What happens if I overdose?

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

Overdose symptoms may include diarrhea or stomach upset.

What should I avoid while taking pancrelipase?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Pancrelipase 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 at once if you have severe or unusual stomach pain. This could be a symptom of a rare but serious bowel disorder.

Less serious side effects may include:

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  nausea or vomiting;

  
  


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  mild stomach pain or upset;

  
  


• 
  

  diarrhea or constipation;

  
  


• 
  

  bloating or gas.

  
  


• 
  

  greasy stools;

  
  


• 
  

  rectal irritation;

  
  


• 
  

  headache, dizziness;

  
  


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  cough; or

  
  


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  weight loss.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect pancrelipase?

There may be other drugs that can interact with pancrelipase. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Lipram resources

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

• Pancrelipase Professional Patient Advice (Wolters Kluwer)


• Pancrelipase Prescribing Information (FDA)


• Pancrelipase Monograph (AHFS DI)


• Pancrelipase MedFacts Consumer Leaflet (Wolters Kluwer)


• Creon Prescribing Information (FDA)


• Creon Advanced Consumer (Micromedex) - Includes Dosage Information


• Creon MedFacts Consumer Leaflet (Wolters Kluwer)


• Creon Consumer Overview


• Creon 10 Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Dygase MedFacts Consumer Leaflet (Wolters Kluwer)


• Pancreaze Consumer Overview


• Pancreaze Prescribing Information (FDA)


• Zenpep Prescribing Information (FDA)


• Zenpep Consumer Overview

Compare Lipram with other medications

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• Cystic Fibrosis
• Pancreatic Exocrine Dysfunction

Where can I get more information?

• Your pharmacist can provide more information about pancrelipase.

See also: Lipram side effects (in more detail)