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Thursday, October 27, 2016

Prevacid 24 HR

Generic Name: lansoprazole

Dosage Form: capsule, coated, extended release
Prevacid 24 HR

Lansoprazole delayed-release capsules 15mg / acid reducer

Active ingredient

Lansoprazole 15mg

Purpose

Acid reducer

Uses

treats frequent heartburn (occurs 2 or more days a week)

not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Warnings

Allergy alert: Do not use if you are allergic to lansoprazole

Do Not Use

if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.

Ask Doctor

warfarin (blood-thinning medicine)

prescription antifungal or anti-yeast medicines

digoxin (heart medicine)

theophylline (asthma medicine)

tacrolimus (immune system medicine)

atazanavir (medicine for HIV infection)

Stop use and ask a doctor if

your heartburn continues or worsens

you need to take this product for more than 14 days

you need to take more than 1 course of treatment every 4 months

If pregnant or breast feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

In case of overdose

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults 18 years of age and older

this product is to be used once a day (every 24 hours), every day for 14 days

it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours
14-Day Course of Treatment
- swallow 1 capsule with a glass of water before eating in the morning
- take every day for 14 days
- do not take more than 1 capsule a day
- swallow whole. Do not crush or chew capsules.
- do not use for more than 14 days unless directed by your doctor
Repeated 14-Day Courses (if needed)
- you may repeat a 14-day course every 4 months
- do not take for more than 14 days or more often than every 4 months unless directed by a doctor

children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.

Other information

read the directions, warnings and package insert before use

keep the carton and package insert. They contain important information.

store at 20-250 C (68-77 0 F)

keep product out of high heat and humidity

protect product from moisture

Inactive ingredients

colloidal silicon dioxide, D&C red No. 28, FD&C blue No. 1, FD&C green No. 3, FD&C red No. 40, gelatin, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, starch, sucrose, sugar sphere, talc, titanium dioxide

Questions or Comments?

Questions or comments? 1-800-452-0051

Distributed by: Novartis Consumer Health, Inc.,

PREVACID® is a registered trademark of Takeda Pharmaceuticals North America, Inc.

Principal Display Panel

PREVACID 24 HR
lansoprazole capsule, coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	0067-6286
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LANSOPRAZOLE (LANSOPRAZOLE)	LANSOPRAZOLE	15 mg

Inactive Ingredients
Ingredient Name	Strength
COLLOIDAL SILICON DIOXIDE
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C GREEN NO. 3
FD&C RED NO. 40
GELATIN
HYDROXYPROPYL CELLULOSE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
MAGNESIUM CARBONATE
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
POLYETHYLENE GLYCOL
POLYSORBATE 80
STARCH, CORN
SUCROSE
TALC
TITANIUM DIOXIDE

Product Characteristics
Color	BLUE (Teal) , PINK	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	P24HR
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0067-6286-14	14 CAPSULE In 1 BOTTLE	None
2	0067-6286-28	2 BOTTLE In 1 PACKAGE, COMBINATION	contains a BOTTLE
2		14 CAPSULE In 1 BOTTLE	This package is contained within the PACKAGE, COMBINATION (0067-6286-28)
3	0067-6286-42	3 BOTTLE In 1 PACKAGE, COMBINATION	contains a BOTTLE
3		14 CAPSULE In 1 BOTTLE	This package is contained within the PACKAGE, COMBINATION (0067-6286-42)
4	0067-6286-98	60000 CAPSULE In 1 DRUM	None
5	0067-6286-99	49500 CAPSULE In 1 DRUM	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA022327	11/12/2009

Labeler - Novartis Consumer Health, Inc. (879821635)

Revised: 08/2009Novartis Consumer Health, Inc.

More Prevacid 24 HR resources

Prevacid 24 HR Side Effects (in more detail)
Prevacid 24 HR Use in Pregnancy & Breastfeeding
Drug Images
Prevacid 24 HR Drug Interactions
Prevacid 24 HR Support Group
27 Reviews for Prevacid 24 HR - Add your own review/rating

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Antihemophilic factor (factor VIII) injection

Generic Name: antihemophilic factor (factor VIII) (injection) (an TEE hee moe FIH lick FAC tor)

Brand names: Advate rAHF-PFM, Alphanate, Helixate, Helixate FS, Hemofil-M, Humate-P, Koate-DVI, Koate-HP, Kogenate, Kogenate FS, Monarc-M, Monoclate-P, Recombinate, Refacto, ...show all 31 brand names.

What is antihemophilic factor (factor VIII)?

Antihemophilic factor (factor VIII) is a naturally occurring protein in the blood that helps blood to clot. A lack of factor VIII is the cause of hemophilia A.

Antihemophilic factor (factor VIII) is used to treat or prevent bleeding in people with hemophilia A.

Antihemophilic factor (factor VIII) may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about antihemophilic factor (factor VIII)?

Some forms of this medication are made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Some viruses, such as parovovirus B19 and hepatitis A, may be more difficult to identify or remove from antihemophilic factor (factor VIII). Parovovirus can seriously affect pregnant women and people with weak immune systems. Symptoms of parovovirus B19 infection include fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain. Symptoms of hepatitis A may include several days to weeks of poor appetite, tiredness, and low-grade fever followed by nausea, vomiting, and stomach pain. Dark-colored urine and jaundice (yellowing of the skin or eyes) may also occur. Contact your doctor if you develop any of these symptoms after treatment with antihemophilic factor (factor VIII).

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding disorder.

Your body may develop antibodies to this medication, making it less effective. Contact your doctor if this medicine does not seem to be working as well as before in controlling your bleeding.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using antihemophilic factor (factor VIII). You may need to stop using the medicine for a short time.

What should I discuss with my healthcare provider before using antihemophilic factor (factor VIII)?

This medication comes in many different strengths. Be sure the strength printed on the medicine bottle label is correct for the dose your doctor has prescribed for you.

Do not use this medication if you have:

a history of allergy to antihemophilic factor; or

a history of allergy to products made with human or animal proteins, especially mouse proteins.

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

How should I use antihemophilic factor (factor VIII)?

This medication is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give your first injection. Then you will be given instructions on how to use your injections at home. Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of needles and other items used in giving the medicine.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Your body may develop antibodies to this medication, making it less effective. Contact your doctor if this medicine does not seem to be working as well as before in controlling your bleeding.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using antihemophilic factor (factor VIII). You may need to stop using the medicine for a short time.

Store the powder medicine in the refrigerator. Do not freeze. Do not mix this medicine with the liquid diluent until you are ready to give the injection. Once the medicine has been mixed, you must use it within 3 hours. Do not refrigerate the mixed medicine. Keep it at room temperature. You may also store the powder at room temperature for up to 6 months or until the expiration date printed on the label (whichever comes first). Do not put the medicine back into the refrigerator once you have kept it at room temperature.

What happens if I miss a dose?

Contact your doctor for instructions if you miss a dose of this medication.

What happens if I overdose?

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

What should I avoid while using antihemophilic factor (factor VIII)?

There are no restrictions on food, beverages, or activity while using this medication unless your doctor has told you otherwise.

Antihemophilic factor (factor VIII) 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 any of these serious side effects:

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

fever, chills, runny nose, and drowsiness followed about 2 weeks later by a rash and joint pain;

fast heart rate, chest pain, trouble breathing;

feeling light-headed, fainting; or

pain, redness, swelling, or oozing where the medicine was injected.

Other, less serious side effects may be more likely to occur, such as:

unusual taste in your mouth;

cough, runny or stuffy nose;

mild itching;

swelling in your hands, ankles, or feet;

headache or dizziness;

mild nausea, diarrhea, stomach pain;

sweating;

joint pain; or

chills or flushing (warmth or tingly feeling).

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.

What other drugs will affect antihemophilic factor (factor VIII)?

Other drugs that affect bleeding or blood-clotting may interact with antihemophilic factor (factor VIII) and cause dangerous side effects or make the medicine less effective.

There may be other drugs that can affect antihemophilic factor (factor VIII). 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.

Where can I get more information?

Your pharmacist has additional information about antihemophilic factor (factor VIII) written for health professionals that you may read.

What does my medication look like?

Antihemophilic factor (factor VIII) is available with a prescription under several brand names. Generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Wednesday, October 26, 2016

Aminosyn-HBC

Flexible Plastic Container

Rx only

Aminosyn-HBC Description

Aminosyn®-HBC 7%, Sulfite-Free, (an amino acid injection high branched chain) is a sterile, nonpyrogenic, hypertonic solution for intravenous infusion. Aminosyn-HBC 7% is oxygen sensitive. The solution contains the following crystalline amino acids:

Essential Amino Acids (mg/100 mL)

Isoleucine	789
Leucine	1576
Lysine (acetate)*	265
Methionine	206
Phenylalanine	228
Threonine	272
Tryptophan	88
Valine	789


Nonessential Amino Acids (mg/100 mL)

Alanine	660
Arginine	507
Histidine**	154
Proline	448
Serine	221
Tyrosine	33
Glycine	660

*Amount cited is for lysine alone and does not include the acetate salt.
**Histidine is considered essential for patients in renal failure.


Crystalline Amino Acids (g/100 mL)	7
Branched Chain Amino Acids (g/100 mL)	3.2
Nitrogen (approx. g/100 mL)	1.12
Acetate (C2H3O2-)a (mEq/Liter)	71a
Osmolarity (mOsmol/liter)	623
pHb (Range)	5.2 (4.5 to 6.0)

aIncludes acetate from acetic acid used in processing and from lysine acetate.
bMay contain hydrochloric acid for pH adjustment.

The formulas for the individual amino acids present in Aminosyn-HBC 7% are as follows:

Essential Amino Acids

Isoleucine, USP	C6H13NO2
Leucine, USP	C6H13NO2
Lysine Acetate, USP	C6H14N2O2• CH3COOH
Methionine, USP	C5H11NO2S
Phenylalanine, USP	C9H11NO2
Threonine, USP	C4H9NO3
Tryptophan, USP	C11H12N2O2
Valine, USP	C5H11NO2

Nonessential Amino Acids

Alanine, USP	C3H7NO2
Arginine, USP	C6H14N4O2
Histidine, USP	C6H9N3O2
Proline, USP	C5H9NO2
Serine, USP	C3H7NO3
Tyrosine, USP	C9H11NO3
Glycine, USP	C2H5NO2

The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly.

Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.

Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

Aminosyn-HBC - Clinical Pharmacology

Aminosyn-HBC 7%, Sulfite-Free, (an amino acid injection — high branched chain) provides a mixture of biologically utilizable essential and nonessential crystalline amino acids in concentrated form for protein synthesis. The solution contains a high (45%) concentration of the branched chain amino acids (isoleucine, leucine and valine) relative to other general purpose amino acid injections. Aminosyn-HBC 7%, when mixed with a concentrated source of calories such as hypertonic dextrose, supplemented with appropriate electrolytes, vitamins and trace metals and infused by central vein with or without fat emulsion, provides total parenteral nutrition (TPN) for the severely compromised patient.

Aminosyn-HBC 7% may also be administered peripherally with minimal caloric supplementation in order to conserve lean body mass in the well-nourished, mildly catabolic patient.

A high concentration of the branched chain amino acids is present in Aminosyn-HBC 7% because these amino acids have been reported to be metabolically active in the compromised patient.

The acetate content of the solution, under conditions of parenteral nutrition, would not be expected to affect acid-base status adversely when renal and respiratory functions are normal; confirmatory clinical/experimental evidence is not available. The amount of sodium present is not clinically significant. The concentration of chloride present is typical for TPN regimens.

Indications and Usage for Aminosyn-HBC

Parenteral nutrition with Aminosyn-HBC 7%, Sulfite-Free, (an amino acid injection — high branched chain) is indicated to prevent nitrogen loss or treat negative nitrogen balance in adults where (1) the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is not feasible by these routes; (2) gastrointestinal absorption of protein is impaired; or (3) nitrogen homeostasis is substantially impaired as with severe trauma or sepsis. Dosage, route of administration and concomitant infusion of nonprotein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutrition support, and vein tolerance. See DOSAGE AND ADMINISTRATION for additional information.

Central Venous Nutrition: Central venous infusion should be considered when amino acid solutions are to be admixed with hypertonic dextrose to promote protein synthesis in hypercatabolic or severely depleted patients, or those requiring long-term parenteral nutrition. See SPECIAL PRECAUTIONS FOR CENTRAL INFUSIONS.

Peripheral Parenteral Nutrition: For moderately catabolic or depleted patients in whom the central venous route is not indicated, diluted amino acid solutions with minimal caloric supplementation may be infused by peripheral vein, supplemented, if desired, with fat emulsion.

Contraindications

Aminosyn-HBC 7%, Sulfite-Free, (an amino acid injection — high branched chain) is contraindicated in patients with anuria, hepatic coma, inborn errors of amino acid metabolism (especially those involving branched chain amino acid metabolism such as Maple Syrup Urine Disease and Isovaleric Acidemia), severe or uncorrected electrolyte or acid-base imbalance, hyperammonemia or other disorders involving impaired nitrogen utilization, or hypersensitivity to one or more amino acids present in the solution.

Warnings

Safe, effective use of parenteral nutrition requires a knowledge of nutrition as well as clinical expertise in recognition and treatment of the complications which can occur. Frequent evaluation and laboratory determinations are necessary for proper monitoring of parenteral nutrition. Studies should include blood sugar, serum proteins, kidney and liver function tests, electrolytes, hemogram, carbon dioxide content, serum osmolarities, blood cultures, and blood ammonia levels.

Administration of amino acids in the presence of impaired renal function or gastrointestinal bleeding may augment an already elevated blood urea nitrogen. Patients with azotemia from any cause should not be infused with amino acids without regard to total nitrogen intake.

Administration of amino acid solutions that have not been specifically formulated to treat patients with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma.

Conservative doses of amino acids should be given, dictated by the nutritional status of the patient. Should symptoms of hyperammonemia develop, amino acid administration should be discontinued and the patient's clinical status re-evaluated.

Administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the solutions.

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

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

Precautions

Special care must be taken when administering hypertonic glucose to provide calories in diabetic or prediabetic patients.

Do not withdraw venous blood for blood chemistries through the peripheral infusion site, as interference with estimations of nitrogen-containing substances may occur.

Intravenously administered amino acids should be used with caution in patients with history of renal disease, pulmonary disease, or with cardiac insufficiency so as to avoid excessive fluid accumulation.

The effect of infusion of amino acids, without dextrose, upon carbohydrate metabolism of children is not known at this time.

Nitrogen intake should be carefully monitored in patients with impaired renal function.

Aminosyn-HBC 7%, Sulfite -Free, (an amino acid injection — high branched chain) contains no added phosphorus. Patients, especially those with hypophosphatemia, may require the addition of phosphate. To prevent hypocalcemia, calcium supplementation should always accompany phosphate administration. To assure adequate intake, serum levels should be monitored frequently.

For long-term total nutrition, or if a patient has inadequate fat stores, it is essential to provide adequate exogenous calories concurrently with the amino acids. Concentrated dextrose solutions are an effective source of such calories. Such strongly hypertonic nutrient solutions should be administered through an indwelling intravenous catheter with the tip located in the superior vena cava.

Aminosyn-HBC contains no more than 25 mcg/L of aluminum.

SPECIAL PRECAUTIONS FOR

CENTRAL INFUSIONS

ADMINISTRATION BY CENTRAL VENOUS CATHETER SHOULD BE USED ONLY

BY THOSE FAMILIAR WITH THIS TECHNIQUE AND ITS COMPLICATIONS.

Central vein infusion (with added concentrated carbohydrate solutions) of amino acid solutions requires a knowledge of nutrition as well as clinical expertise in recognition and treatment of complications. Attention must be given to solution preparation, administration and patient monitoring. IT IS ESSENTIAL THAT A CAREFULLY PREPARED PROTOCOL, BASED ON CURRENT MEDICAL PRACTICES, BE FOLLOWED, PREFERABLY BY AN EXPERIENCED TEAM.

SUMMARY HIGHLIGHTS OF COMPLICATIONS (See also Current Medical Literature).

Technical

The placement of a central venous catheter should be regarded as a surgical procedure. One should be fully acquainted with various techniques of catheter insertion. For details of technique and placement sites, consult the medical literature. X-ray is the best means of verifying catheter placement. Complications known to occur from the placement of central venous catheters are pneumothorax, hemothorax, hydrothorax, artery puncture and transection, injury to the brachial plexus, malposition of the catheter, formation of arteriovenous fistula, phlebitis, thrombosis and air and catheter emboli.

Septic

The constant risk of sepsis is present during administration of total parenteral nutrition. It is imperative that the preparation of the solution and the placement and care of catheters be accomplished under strict aseptic conditions.

Solutions should ideally be prepared in the hospital pharmacy under a laminar flow hood using careful aseptic technique to avoid inadvertent touch contamination. Solutions should be used promptly after mixing.

Storage should be under refrigeration and limited to a brief period of time, preferably less than 24 hours.

Administration time for a single bottle and set should never exceed 24 hours.

Metabolic

The following metabolic complications have been reported with TPN administration: Metabolic acidosis and alkalosis, hypophosphatemia, hypocalcemia, osteoporosis, hyperglycemia, and glycosuria, rebound hypoglycemia, osmotic diuresis and dehydration, elevated liver enzymes, hypo- and hypervitaminosis, electrolyte imbalances and hyperammonemia in children. Frequent evaluations are necessary especially during the first few days of therapy to prevent or minimize these complications.

Administration of glucose at a rate exceeding the patient’s utilization rate may lead to hyperglycemia, coma and death.

Pregnancy:

Teratogenic effects.

Pregnancy Category C: Animal reproduction studies have not been performed with Aminosyn-HBC 7%. It is not known whether Aminosyn-HBC 7% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Aminosyn-HBC 7% should be given to a pregnant woman only if clearly needed.

Pediatric Use:

Safety and effectiveness in children have not been established.

Geriatric Use:

Clinical studies of Aminosyn-HBC 7% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported 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 dosage range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Drug Interactions

Because of its antianabolic activity, concurrent administration of tetracycline may reduce the potential anabolic effects of amino acids infused with dextrose as part of a parenteral feeding regimen.

Additives may be incompatible. Consult with pharmacist if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Adverse Reactions

See WARNINGS and SPECIAL PRECAUTIONS FOR CENTRAL VENOUS NUTRITION.

Reactions secondary to the administration technique or the solution include febrile response, infection at the injection site, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia.

Local reactions at the infusion site, consisting of a warm sensation, erythema, phlebitis and thrombosis have been reported with peripherally administered amino acid solutions, especially if other substances are also administered through the same site.

Generalized flushing, fever and nausea have been reported during peripheral administration of amino acids.

Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential.

If electrolyte supplements are required during peripheral infusions, it is recommended that additives be administered throughout the day in order to avoid possible vein irritation. Irritating additive medications may require injection at another site and should not be added directly to the amino acid infusate.

Phosphorus deficiency may lead to impaired tissue oxygenation and acute hemolytic anemia. Relative to calcium, excessive phosphorus intake can precipitate hypocalcemia with cramps, tetany and muscular hyperexcitability.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

Overdosage

In the event of fluid, electrolyte or metabolic imbalances re-evaluate the patient and institute appropriate corrective measures; see WARNINGS and PRECAUTIONS.

Aminosyn-HBC Dosage and Administration

Aminosyn-HBC 7%, Sulfite-Free, (an amino acid injection — high branched chain) is administered intravenously. The total dose depends upon daily protein requirements and the patient's metabolic and clinical response. The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, is probably the best means of assessing individual protein requirements.

While Recommended Dietary Allowances for oral protein are approximately 0.8 g/kg of body weight for the healthy adult, protein and caloric requirements in traumatized or malnourished patients may be substantially increased. To satisfy protein needs and promote positive nitrogen balance, the daily dosage level of amino acids for adult patients with adequate caloric intake is approximately 1.5 g/kg of body weight. Severely catabolic states may require higher dosage levels. Such higher doses must be accompanied by frequent laboratory evaluation. Fat emulsion may be administered to help meet energy requirements. Fat emulsion coadministration should be considered when prolonged parenteral nutrition is required in order to prevent essential fatty acid deficiency (E.F.A.D.). Serum lipids should be monitored for evidence of E.F.A.D. in patients maintained on fat-free total parenteral nutrition.

For optimum amino acid utilization, sufficient intracellular electrolytes (sodium, magnesium, and phosphate) should be provided. Approximately 60 to 180 mEq of potassium, 10 to 30 mEq of magnesium, and 10 to 40 mM of phosphate/day appear necessary to achieve optimum metabolic response. In addition, sufficient quantities of the major extracellular electrolytes (sodium, calcium and chloride) must be given. In patients with hyperchloremic or other metabolic acidoses, sodium and potassium may be added as the acetate or lactate salts to provide bicarbonate precursors. The electrolyte content of Aminosyn-HBC 7% must be considered when calculating daily electrolyte intake. Serum electrolytes, including magnesium and phosphorus, should be monitored frequently. If a patient's nutritional intake is primarily parenteral, trace metals and vitamins, especially the water-soluble vitamins, should also be provided.

Central Venous Nutrition: For severely catabolic, depleted patients or those who require long-term parenteral nutrition, central venous nutrition should be considered. Total parenteral nutrition may be started with admixtures containing lower concentrations of dextrose; dextrose concentrations may be gradually increased to approximate estimated energy requirements as the patient’s glucose tolerance increases.

In adults, strongly hypertonic admixtures of amino acids and dextrose may be safely administered only by continuous infusion through a central venous catheter with the tip located in the superior vena cava. A mixture containing 500 mL of Aminosyn-HBC 7% with 500 mL of concentrated dextrose supplemented with electrolytes, trace metals and vitamins may be administered over a period of approximately 8 hours. If prescribed administration rates should fall behind schedule, no attemptto “catch up” to planned intake should be made. In addition to meeting protein requirements, the administration is also governed by the patient’s glucose tolerance, especially during the first few days of therapy. The daily intake of the amino acid/dextrose admixture should be increased gradually to the maximum required dose, based on serial determinations of urine and blood sugar levels. To prevent hyperglycemia and glycosuria, certain patients may require exogenous insulin in order to receive adequate calories from hypertonic dextrose. To prevent rebound hypoglycemia, a solution containing 5% dextrose should be administered when hypertonic dextrose infusions are abruptly discontinued.

Peripheral Parenteral Nutrition: For the moderately catabolic, depleted patient in whom aggressive central venous nutrition is not necessary, Aminosyn-HBC 7% may be given by peripheral vein with hypocaloric energy supplements. Dextrose in a final concentration of up to 10% and/or lipid emulsion may be administered.

Fat provides approximately 9 kcal/gram and in long-term therapy (more than 5-7 days) will prevent essential fatty acid deficiency. Parenteral fat emulsion may be administered simultaneously with amino acid-dextrose admixtures via a Y-type administration set to supplement caloric intake. Fat, however, should not provide more than 60% of the total caloric intake.

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

WARNING: Do not use flexible container in series connections.

How is Aminosyn-HBC Supplied

Aminosyn-HBC 7%, Sulfite-Free, (an amino acid injection — high branched chain) is supplied in 500 and 1000 mL single-dose containers (List No. 4168).

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C).

Avoid exposure to light.


©Hospira 2004	EN-0212	Printed in USA

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

AMINOSYN
isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, histidine, proline, serine, tyrosine and glycine injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0409-4168
Route of Administration	INTRAVENOUS	DEA Schedule

INGREDIENTS
Name (Active Moiety)	Type	Strength
Isoleucine (Isoleucine)	Active	789 MILLIGRAM In 100 MILLILITER
Leucine (Leucine)	Active	1576 MILLIGRAM In 100 MILLILITER
Lysine acetate (Lysine)	Active	265 MILLIGRAM In 100 MILLILITER
Methionine (Methionine)	Active	206 MILLIGRAM In 100 MILLILITER
Phenylalanine (Phenylalanine)	Active	228 MILLIGRAM In 100 MILLILITER
Threonine (Threonine)	Active	272 MILLIGRAM In 100 MILLILITER
Tryptophan (Tryptophan)	Active	88 MILLIGRAM In 100 MILLILITER
Valine (Valine)	Active	789 MILLIGRAM In 100 MILLILITER
Alanine (Alanine)	Active	660 MILLIGRAM In 100 MILLILITER
Arginine (Arginine)	Active	507 MILLIGRAM In 100 MILLILITER
Histidine (Histidine)	Active	154 MILLIGRAM In 100 MILLILITER
Proline (Proline)	Active	448 MILLIGRAM In 100 MILLILITER
Serine (Serine)	Active	221 MILLIGRAM In 100 MILLILITER
Tyrosine (Tyrosine)	Active	33 MILLIGRAM In 100 MILLILITER
Glycine (Glycine)	Active	660 MILLIGRAM In 100 MILLILITER
Acetic Acid	Inactive
Hydrochloric Acid	Inactive

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0409-4168-03	12 BAG In 1 CASE	contains a BAG
1		500 mL (MILLILITER) In 1 BAG	This package is contained within the CASE (0409-4168-03)
2	0409-4168-05	6 BAG In 1 CASE	contains a BAG
2		1000 mL (MILLILITER) In 1 BAG	This package is contained within the CASE (0409-4168-05)

Revised: 09/2006Hospira, Inc.

More Aminosyn-HBC resources

Aminosyn-HBC Dosage
Aminosyn-HBC Drug Interactions
Aminosyn-HBC Support Group
0 Reviews · Be the first to review/rate this drug

Americaine Ointment

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

Americaine Ointment is used for:

Temporarily relieving pain, burning, and itching caused by hemorrhoids or other rectal conditions.

Americaine Ointment is a topical anesthetic. It works by numbing the skin.

Do NOT use Americaine Ointment if:

you are allergic to any ingredient in Americaine Ointment

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

Before using Americaine Ointment:

Some medical conditions may interact with Americaine Ointment. 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 diabetes, peripheral vascular problems, or skin irritation

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

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

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

Americaine Ointment is for external use around the outside of the rectum only. Do not use Americaine Ointment inside the rectum.

Cleanse area with mild soap and warm water when possible and rinse thoroughly. Gently dry by patting or blotting with tissue or a soft cloth. Apply to affected area as instructed.

If your symptoms do not improve within 7 days, stop using Americaine Ointment and contact your doctor.

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

Ask your health care provider any questions you may have about how to use Americaine Ointment.

Important safety information:

If you notice any new symptoms or your symptoms get worse, contact your doctor.

If ointment contacts clothing or fabrics, wash in warm water only. Do not bleach.

Possible side effects of Americaine Ointment:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); rectal bleeding, redness, irritation, swelling, or pain.

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: Americaine 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. Americaine Ointment may be harmful if swallowed.

Proper storage of Americaine Ointment:

Store Americaine Ointment 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 Americaine Ointment out of the reach of children and away from pets.

General information:

If you have any questions about Americaine Ointment, please talk with your doctor, pharmacist, or other health care provider.

Americaine Ointment is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Americaine Ointment. 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

More Americaine resources

Americaine Side Effects (in more detail)
Americaine Use in Pregnancy & Breastfeeding
Americaine Support Group
0 Reviews for Americaine - Add your own review/rating

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Anal Itching
Hemorrhoids

Adefovir Dipivoxil

Class: Nucleosides and Nucleotides
VA Class: AM800
Chemical Name: [[[2-(6-Amino-9-H-purin-9-yl)ethoxy]methyl]phosphinylidene]bis(oxymethylene) ester 2,2-dimethyl propanoic acid
Molecular Formula: C₂₀H₃₂N₅O₈P
CAS Number: 142340-99-6
Brands: Hepsera

Severe acute exacerbations of hepatitis may occur in patients who discontinue adefovir.¹ (See Exacerbations of Hepatitis under Cautions.) Closely monitor hepatic function in such patients.¹

In patients at risk of or having underlying renal dysfunction, chronic administration of adefovir may result in nephrotoxicity.¹ Closely monitor renal function in such patients; dosage adjustments may be required.¹

HIV resistance may emerge in chronic HBV patients who have unrecognized or untreated HIV infection.¹ (See Individuals Coinfected with HBV and HIV under Cautions.)

Lactic acidosis and severe hepatomegaly with steatosis (including some fatalities) reported in patients receiving nucleoside analogs.¹ (See Lactic Acidosis and Severe Hepatomegaly with Steatosis under Cautions.)

Introduction

Antiviral; acyclic nucleotide.¹

Uses for Adefovir Dipivoxil

Chronic Hepatitis B Virus (HBV) Infection

Treatment of chronic HBV infection in adults and adolescents ≥12 years of age with evidence of active HBV replication and either persistent elevations in serum aminotransferases (ALT or AST) or histologic evidence of active disease.¹ The relationship between treatment response (histologic, virologic, biochemical, serologic) to adefovir and long-term outcomes such as hepatocellular carcinoma or decompensated cirrhosis is not known.¹

May be effective in HBeAg-positive patients;¹ ³ ²³ HBeAg-negative (anti-HBe- and HBV-DNA-positive) patients;¹ ⁴ ¹¹ ¹⁶ and pre- and post-liver transplantation patients.¹ ¹¹ ¹⁶ ²¹

May be effective in patients with lamivudine-resistant HBV.¹ ⁸ ¹¹ ¹⁸

Treatment of chronic HBV infection is complex and rapidly evolving and should be directed by clinicians familiar with the disease; consult a specialist to obtain the most up-to-date information.⁹

Adefovir Dipivoxil Dosage and Administration

Administration

Oral Administration

Administer orally without regard to food.¹

Dosage

Available as adefovir dipivoxil; dosage expressed in terms adefovir dipivoxil.¹

Pediatric Patients

Chronic Hepatitis B Virus (HBV) Infection

Oral

Adolescents 12–17 years of age: 10 mg once daily.¹

Optimal duration of treatment unknown.¹ ⁹ Has been continued for up to 5 years in adults in controlled clinical studies.¹ ¹² ¹⁷

Adults

Chronic Hepatitis B Virus (HBV) Infection

Oral

10 mg once daily.¹

Optimal duration of treatment unknown.¹ ⁹ Has been continued for up to 5 years in adults in controlled clinical studies.¹ ¹² ¹⁷

Special Populations

Hepatic Impairment

Dosage adjustments not necessary in hepatic impairment.¹ ⁵

Renal Impairment

Decrease dosage in adults with baseline Cl_cr <50 mL/minute.¹

Dosage for Adults with Renal Impairment1
Cl_cr (mL/min)	Dosage
30–49	10 mg once every 48 hours
10–29	10 mg once every 72 hours
<10 (not undergoing hemodialysis)	Dosage recommendations not available
Hemodialysis patients	10 mg once every 7 days following dialysis

These dosage guidelines for adults with renal impairment have not been clinically evaluated.¹ In addition, these dosages were derived from data involving patients with preexisting renal impairment and may not be appropriate for those in whom renal impairment evolves during adefovir therapy.¹ Closely monitor clinical response and renal function.¹

Safety and efficacy not studied in adolescents with renal impairment.¹ Data insufficient to make dosage recommendations for adolescents 12–17 years of age with underlying renal impairment;¹ use caution and closely monitor renal function.¹

Cautions for Adefovir Dipivoxil

Contraindications

Known hypersensitivity to adefovir or any ingredient in the formulation.¹

Warnings/Precautions

Warnings

Exacerbations of Hepatitis

Clinical and laboratory evidence of severe acute exacerbations of hepatitis have occurred following discontinuance of HBV therapy, including adefovir therapy.¹

Exacerbations of hepatitis (ALT elevations at least 10 times the ULN) reported in up to 25% of patients following discontinuance of adefovir, usually within 12 weeks after discontinuance.¹ These exacerbations generally occurred in the absence of HBeAg seroconversion and presented as elevations in ALT and reemergence of viral replication.¹

Although these exacerbations may be self-limited or resolve with reinitiation of therapy, severe exacerbations (including fatalities) have been reported.¹

In patients with compensated liver function, exacerbations have not generally been accompanied by hepatic decompensation.¹ However, patients with advanced liver disease or cirrhosis may be at higher risk for hepatic decompensation than those with compensated liver function.¹

Closely monitor hepatic function at repeated intervals with both clinical and laboratory follow-up for several months or longer after adefovir is discontinued.¹ If appropriate, resumption of anti-HBV therapy may be warranted.¹

Nephrotoxicity

Nephrotoxicity, characterized by a delayed onset, is the principal dose-limiting toxicity of adefovir and also may occur in patients receiving chronic (long-term) therapy with recommended dosage of the drug.¹

Delayed onset of gradual increases in serum creatinine and decreases in serum phosphorus were the treatment-limiting toxicities of adefovir in clinical studies evaluating use of high dosages for treatment of HIV infection† (60 or 120 mg daily) or use of high dosages for treatment of chronic HBV infection (30 mg daily).¹

Long-term administration in dosages recommended for the treatment of HBV infection (10 mg daily) also may result in delayed nephrotoxicity.¹ By week 96 or week 240, 2 or 3% of patients who received adefovir had serum creatinine increases of ≥0.5 mg/dL from baseline (by Kaplan Meier estimates), respectively.¹

In pre- or post-liver transplantation patients receiving the usually recommended dosage (10 mg daily), most of whom had some degree of baseline renal insufficiency, 37 or 32% had increases in serum creatinine concentrations of 0.3 mg/dL or greater from baseline by week 48, respectively, and 53 or 51% had serum creatinine increases of 0.3 mg/dL or greater from baseline by week 96, respectively.¹

Although overall risk of nephrotoxicity is low in patients with adequate renal function, consider possibility of nephrotoxicity in patients at risk of or having underlying renal dysfunction and in those receiving concomitant therapy with nephrotoxic agents.¹ (See Nephrotoxic Drugs or Drugs Eliminated by Renal Excretion under Interactions.)

Closely monitor renal function in all patients receiving adefovir, especially those with preexisting renal impairment or other risks for renal impairment.¹ Dosage adjustments may be necessary.¹ (See Renal Impairment under Dosage and Administration.)

Individuals Coinfected with HBV and HIV

Use of adefovir for the treatment of chronic HBV infection in patients with unrecognized or untreated HIV infection may result in emergence of HIV resistance.¹ Although adefovir has in vitro activity against HIV,²² dosage of the drug used for treatment of HBV infection (10 mg daily) has not been shown to suppress HIV RNA levels in HIV-infected patients.¹ ¹⁴ ¹⁶

Offer HIV antibody testing to all patients prior to initiating adefovir.¹

Lactic Acidosis and Severe Hepatomegaly with Steatosis

Lactic acidosis and severe hepatomegaly with steatosis (including some fatalities) reported in patients receiving nucleoside analogs alone or in conjunction with antiretrovirals.¹ Most reported cases have involved women; obesity and long-term therapy with nucleoside reverse transcriptase inhibitors (NRTIs) also may be risk factors.¹

Nucleoside analogs should be used with particular caution in patients with known risk factors for liver disease; however, lactic acidosis and severe hepatomegaly with steatosis have been reported in patients with no known risk factors.¹

Discontinue adefovir in any patient with clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).¹

Clinical Resistance

Resistance to adefovir may result in viral load rebound of HBV, which may lead to exacerbation of HBV infection; if the patient has impaired hepatic function, this may lead to liver decompensation and death.¹

To reduce risk of clinical resistance in patients with lamivudine-resistant HBV, use adefovir in conjunction with lamivudine; do not use adefovir monotherapy¹ ⁹

Patients with serum HBV DNA levels >1000 copies/mL after 48 weeks of adefovir treatment are at greater risk of developing clinical resistance.¹ To reduce risk of clinical resistance in patients receiving monotherapy with the drug, consider treatment modification if serum HBV DNA levels remain >1000 copies/mL with continued treatment.¹

Specific Populations

Pregnancy

Category C.¹

Pregnancy registry at 800-258-4263.¹

Data not available regarding the effect of adefovir therapy during pregnancy on transmission of HBV to the infant;¹ such infants should receive HBV vaccine according to the usual childhood immunization schedule to prevent neonatal acquisition of HBV.¹

Lactation

Not known whether adefovir is distributed into milk.¹ Discontinue nursing or drug, taking into account the importance of the drug to the woman.¹

Pediatric Use

Safety and efficacy not established in children <12 years of age.¹

Geriatric Use

Experience in those ≥65 years of age insufficient to determine whether they respond differently than younger adults.¹

Use with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.¹

Renal Impairment

Dosage adjustments recommended for adults if Cl_cr <50 mL/minute.¹ ⁵ (See Renal Impairment under Dosage and Administration.)

Has not been evaluated in adolescents 12–17 years of age with renal impairment.¹ Use caution in such adolescents and monitor renal function closely.¹

Common Adverse Effects

Asthenia, headache, abdominal pain, nausea, flatulence, diarrhea, dyspepsia.¹

Interactions for Adefovir Dipivoxil

Adefovir does not inhibit CYP isoenzymes, including CYP1A2, 2C9, 2C19, 2D6, and 3A4.¹ Adefovir is not a substrate for CYP isoenzymes; potential of the drug to induce these enzymes is unknown.¹

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Pharmacokinetic interactions with drugs affecting or metabolized by CYP isoenzymes unlikely.¹

Nephrotoxic Drugs or Drugs Eliminated by Renal Excretion

Concomitant use with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of adefovir and/or the other drug.¹ Monitor closely for adverse effects if adefovir is used concomitantly with drugs excreted renally or with drugs known to affect renal function.¹

Specific Drugs

Drug	Interaction	Comments
Acetaminophen	No pharmacokinetic interaction¹
Co-trimoxazole	No pharmacokinetic interaction¹
Didanosine	No pharmacokinetic interaction with didanosine delayed-release capsules containing enteric-coated pellets¹
Entecavir	No pharmacokinetic interaction²⁴
Ibuprofen	No effect on pharmacokinetics of ibuprofen;¹ increased adefovir plasma concentrations and AUC;¹ may occur because of increased oral bioavailability of adefovir;¹	Clinical importance unknown¹
Immunosuppressive agents (cyclosporine, tacrolimus)	Cyclosporine: Effect on adefovir concentrations unknown¹ Tacrolimus: No pharmacokinetic interaction¹
Lamivudine	No pharmacokinetic interaction¹ Additive antiviral effects against HBV¹
Telbivudine	No pharmacokinetic interaction²⁵ In vitro evidence of additive antiviral effects against HBV²⁵
Tenofovir	No pharmacokinetic interaction¹	Should not be used concomitantly for treatment of chronic HBV infection²⁰

Adefovir Dipivoxil Pharmacokinetics

Absorption

Bioavailability

Following oral administration of adefovir dipivoxil, approximate bioavailability of adefovir is 59%.¹ Peak plasma concentration of adefovir attained within 0.58–4 hours.¹

Food

Food does not affect AUC of adefovir.¹

Special Populations

Adolescents 12–17 years of age with compensated liver disease: Peak plasma concentrations and AUC similar to those reported in adults.¹

Distribution

Extent

Not known whether adefovir distributed into human milk.¹

Plasma Protein Binding

≤4%.¹

Elimination

Metabolism

Following oral administration, adefovir dipivoxil is converted to the active adefovir.¹

Adefovir is not metabolized by CYP isoenzymes.¹

Elimination Route

Adefovir is excreted in urine by glomerular filtration and active tubular secretion.¹

Following oral administration of adefovir dipivoxil, 45% of dose eliminated in urine as adefovir over 24 hours at steady-state.¹

Removed by hemodialysis; effect of peritoneal dialysis unknown.¹

Half-life

Terminal elimination half-life of adefovir: 7.48 hours.¹

Special Populations

In adults with nonchronic HBV infection and hepatic impairment, no substantial differences in pharmacokinetics in those with moderate to severe hepatic impairment compared with those without hepatic impairment.¹

In adults with moderate to severe renal impairment or end-stage renal disease requiring hemodialysis, clearance decreased and half-life prolonged.¹

Pharmacokinetics not studied in geriatric adults.¹

Pharmacokinetics not studied in adolescents 12–17 years of age with renal impairment.¹

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).¹

Actions and SpectrumActions

Adefovir available as adefovir dipivoxil, a diester prodrug that is inactive until converted in vivo to adefovir and phosphorylated to adefovir diphosphate.¹

An acyclic nucleotide antiviral.¹

Active in vitro and in vivo against HBV.¹ ²

Also has some in vitro activity against herpes simplex virus types 1 and 2 (HSV-1 and HSV-2), HIV-1 and HIV-2, human papillomavirus (HPV), Epstein-Barr virus, and varicella zoster virus, but has not been shown to be effective in clinical infections caused by these viruses.² ¹⁵ ²²

HBV with reduced susceptibility to adefovir can develop in some patients during long-term use.¹ ⁹ ¹² ¹⁶ ¹⁷

Cross-resistance can occur among the nucleoside antivirals used for treatment of HBV.²⁶ ²⁸

Some strains of HBV may be cross-resistant to both adefovir and lamivudine,²⁶ ²⁷ ²⁸ but some lamivudine-resistant HBV may be susceptible to adefovir and some adefovir-resistant isolates may be susceptible to lamivudine.¹ ⁹ ¹⁶ ¹⁹ ²¹ ²⁶

In vitro studies indicate that some HBV with mutations associated with adefovir resistance may have decreased susceptibility to entecavir.²⁴

Advice to Patients

Advise patient of the risks and benefits of adefovir and other alternatives for treatment of HBV infection and importance of reading the adefovir patient package insert before starting treatment.¹

Importance of remaining under the care of a clinician while taking adefovir and not discontinuing the drug without first informing a clinician.¹

Importance of following a regular dosage schedule and avoiding missed doses.¹

Risk of exacerbations of hepatitis when adefovir is discontinued and importance of close monitoring of liver function and HBV levels for several months or longer after the drug is stopped.¹

Risk of nephrotoxicity and importance of monitoring renal function during treatment, especially in those with preexisting renal impairment or other risks for renal impairment.¹

Importance of immediately reporting to clinicians any signs or symptoms of lactic acidosis (e.g., weakness/fatigue, unusual muscle pain, trouble breathing, stomach pain with nausea and vomiting, cold intolerance especially in the arms and legs, dizziness or feeling light-headed, fast or irregular heart beat) or any signs or symptoms of hepatotoxicity (e.g., jaundice, dark urine, bowel movements light in color, anorexia, nausea, stomach pain).¹ Importance of reporting any other unusual symptoms or if any known symptom persists or worsens.¹

Risk of emergence of HIV resistance in patients with unrecognized or untreated HIV infection; importance of HIV antibody testing prior to initiation of adefovir therapy and anytime during therapy if possible exposure to HIV occurs.¹

Advise patients with lamivudine-resistant HBV that they should receive adefovir in conjunction with lamivudine and should not receive adefovir monotherapy.¹

Advise patients that it is not known whether adefovir will prevent transmission of HBV to others and that appropriate measures should be taken to prevent sexual or other transmission of the virus.¹

Advise patients that the optimal duration of treatment and the relationship between treatment response and long-term outcomes (hepatocellular carcinoma, decompensated cirrhosis) are not known.¹

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

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

Importance of advising 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.

Adefovir Dipivoxil
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	10 mg	Hepsera	Gilead

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.

Hepsera 10MG Tablets (GILEAD SCIENCES): 30/$1013.97 or 90/$2931.05

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.

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

References

1. Gilead Sciences, Inc. Hepsera (adefovir dipivoxil) tablet prescribing information. Foster City, CA; 2008 May.

2. Dusheiko G. Adefovir dipivoxil for the treatment of HBeAg-positive chronic hepatitis B. Paper presented at the European Association for the Study of the Liver (EASL) international consensus conference on hepatitis B. Geneva, Switzerland, 2002 Sep 13-14. From the EASL website. Accessed 2003 Jan.

3. Marcellin P, Chung TT, Lim SG et al. Adefovir dipivoxil for the treatment of hepatitis B e antigen-positive chronic hepatitis B. N Engl J Med. 2003; 348:808-16. [IDIS 494875] [PubMed 12606735]

4. Hadziyannis SJ, Tassopoulos NC, Heathcote EJ et al. Adefovir dipivoxil for the treatment of hepatitis B e antigen-negative chronic hepatitis B. N Engl J Med. 2003; 348:800-7. [IDIS 494874] [PubMed 12606734]

5. Knight W, Hayashi S, Behnhamou Y et al. Dosing guidelines for adefovir dipivoxil in the treatment of chronic hepatitis B patients with renal or hepatic impairment. In: Posters of the 37th Annual Meeting of the European Association for the Study of the Liver (EASL), Madrid, Spain, 2002 Apr 17–21. Poster #308.

7. Anon. Gilead adefovir hep B resistance potential shows need for combo trials. FDC Rep. 2002; (Aug 12):5-6.

8. Perrillo R, Schiff E, Yoshida E et al. Adefovir dipivoxil for the treatment of lamivudine-resistant hepatitis B mutants. Hepatology. 2000; 32:129-34. [PubMed 10869300]

9. Lok AS, McMahon BJ. Chronic hepatitis B. Hepatology. 2007; 45:507-39. [PubMed 17256718]

10. Anon. FDA approves new treatment for chronic hepatitis B. FDA Talk Paper. Rockville, MD: Food and Drug Administration; 2002 Sep 20.

11. Hadziyannis SJ. Papatheodoridis GV. Treatment of HBeAg negative chronic hepatitis B: treatment with new drugs (adefovir and others). Paper presented at the European Association for the Study of the Liver (EASL) international consensus conference on hepatitis B. Geneva, Switzerland, 2002 Sep 13-14. From the EASL website. Accessed 2003 Jan.

12. Marcellin P, Chang TT, Lim SG et al. Long-term efficacy and safety of adefovir dipivoxil for the treatment of hepatitis B e antigen-positive chronic hepatitis B. Hepatology. 2008; 48:750-8. [PubMed 18752330]

14. Fisher EJ, Chaloner K, Cohn DL et al. The safety and efficacy of adefovir dipivoxil in patients with advanced HIV disease: a randomized, placebo-controlled trial. AIDS. 2001; 15:1695-700. [PubMed 11546945]

15. Kamp W, Schokker J, Cambridge E et al. Effect of weekly adefovir (PMEA) infusions on HIV-1 virus load: results of a phase I/II study. Antivir Ther. 1999; 4:101-7. [PubMed 10682155]

16. Gilead Sciences, Inc, Foster City, CA: Personal communication.

17. Hadziyannis SJ, Tassopoulos NC, Heathcote EJ et al. Long-term therapy with adefovir dipivoxil for HBeAg-negative chronic hepatitis B for up to 5 years. Gastroenterology. 2006; 131:1743-51. [PubMed 17087951]

18. Peters MG, Hann Hw H, Martin P et al. Adefovir dipivoxil alone or in combination with lamivudine in patients with lamivudine-resistant chronic hepatitis B. Gastroenterology. 2004; 126:91-101. [PubMed 14699491]

19. Xiong S, Yang H, Westland C et al. Resistance surveillance of HBeAg negative chronic hepatitis B patients treated for two years with adefovir dipivoxil. Presented at the 11th international symposium on viral hepatitis and liver disease, 2003. Sydney, Australia, 2003 Apr 6-10.

20. Gilead Sciences. Viread (tenofovir disoproxil fumarate) tablets prescribing information. Foster City, CA; 2008 Aug.

21. Schiff E, Lai CL, Hadziyannis S et al. Adefovir dipivoxil for wait-listed and post-liver transplantation patients with lamivudine-resistant hepatitis B: final long-term results. Liver Transpl. 2007; 13:349-60. [PubMed 17326221]

22. Balzarini J, Schols D, Laethem KV et al. Pronounced in vitro and in vivo antiretroviral activity of 5-substituted 2,4-diamino-6-[2-(phosphonomethoxy)ethyoxy] pyrimidines. J Antimicrob Chemother. 2007; 59:80-6. [PubMed 17124193]

23. Jonas MM, Kelly D, Pollack H et al. Safety, efficacy, and pharmacokinetics of adefovir dipivoxil in children and adolescents (age 2 to <18 years) with chronic hepatitis B. Hepatology. 2008; 47:1863-71. [PubMed 18433023]

24. Bristol-Myers Squibb Company. Baraclude (entecavir) tablets and oral solution prescribing information. Princeton, NJ; 2008 Feb.

25. Idenix Pharmaceuticals. Tyzeka (telbivudine) tablets prescribing information. Cambridge, MA; 2006 Oct.

26. Gerolami R, Bourliere M, Colson P et al. Unusual selection of rtA181V HBV mutants cross-resistant to adefovir following prolonged lamivudine monotherapy: report of two cases. Antivir Ther. 2006; 11:1103-6. [PubMed 17302381]

27. Karatayli E, Karayalçin S, Karaaslan H et al. A novel mutation pattern emerging during lamivudine treatment shows cross-resistance to adefovir dipivoxil treatment. Antivir Ther. 2007; 12:761-8. [PubMed 17713159]

28. Villet S, Pichoud C, Billioud G et al. Impact of hepatitis B virus rtA181V/T mutants on hepatitis B treatment failure. J Hepatol. 2008; 48:747-55. [PubMed 18331765]

More Adefovir Dipivoxil resources

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

Compare Adefovir Dipivoxil with other medications

Hepatitis B