Aminosyn-PF Injection

Dosage Form: injection, solution
Aminosyn® -PF 10%

Sulfite-Free

AN AMINO ACID INJECTION - PEDIATRIC FORMULA

Pharmacy Bulk Package − Not for Direct Infusion.

Flexible Plastic Container

Rx only

Aminosyn-PF Injection Description

Aminosyn®-PF 10%, Sulfite-Free, (an amino acid injection — pediatric formula) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn-PF 10% is oxygen sensitive. The Pharmacy Bulk Package is a sterile dosage form which contains multiple single doses for use only in a pharmacy bulk admixture program. The formulation is described below:

Aminosyn-PF 10%
An Amino Acid Injection — Pediatric Formula
Essential Amino Acids (mg/100 mL)
Isoleucine	760
Leucine	1200
Lysine (acetate)*	677
Methionine	180
Phenylalanine	427
Threonine	512
Tryptophan	180
Valine	673
* Amount cited is for lysine alone and does not include the acetate salt.

Nonessential Amino Acids (mg/100 mL)
Alanine	698
Arginine	1227
Aspartic Acid	527
Glutamic Acid	820
Glycine	385
Histidine	312
Proline	812
Serine	495
Taurine	70
Tyrosine	44

Electrolytes (mEq/L)
Sodium (Na+)	None
Potassium (K+)	None
Chloride (Cl−)	None
Acetate (C2H3O2−) a	46

Product Characteristics
Protein Equivalent (Approx. grams/L)	100
Total Nitrogen (grams/L)	15.2
Osmolarity (mOsmol/L)	788
pH (range)	5.5 (5.0 to 6.5)
Specific Gravity	1.03
a From lysine acetate.

The formulas for the individual amino acids present in Aminosyn-PF 10% are as follows:

Essential Amino Acids
Isoleucine	CH3CH2CH(CH3)CH(NH2)COOH
Leucine	(CH3)2CHCH2CH(NH2)COOH
Lysine Acetate	H2N(CH2)4CH(NH2)COOH • CH3COOH
Methionine	CH3S(CH2)2CH(NH2)COOH
Phenylalanine
Threonine	CH3CH(OH)CH(NH2)COOH
Tryptophan
Valine	(CH3)2CHCH(NH2)COOH

Nonessential Amino Acids
Alanine	CH3CH(NH2)COOH
Arginine	H2NC(NH)NH(CH2)3CH(NH2)COOH
L-Aspartic Acid	HOOCCH2CH(NH2)COOH
L-Glutamic Acid	HOOC(CH2)2CH(NH2)COOH
Glycine	H2NCH2COOH
Histidine
Proline
Serine	HOCH2CH(NH2)COOH
Taurine	H2N − CH2CH2− SO3H
Tyrosine

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.

The Pharmacy Bulk Package is designed for use with manual, gravity flow operations and automated compounding devices for preparing sterile parenteral nutrient admixtures; it contains no bacteriostat. Multiple single doses may be dispensed during continual aliquoting operations. Withdrawal of container contents should be promptly completed within 4 hours after initial closure puncture.

Aminosyn-PF Injection - Clinical Pharmacology

Aminosyn-PF 10%, Sulfite-Free, (an amino acid injection — pediatric formula) contains a mixture of essential and nonessential amino acids as well as taurine. The amino acid composition has been specifically formulated to provide a well-tolerated nitrogen source for nutritional support and therapy for infants and young children. When administered in conjunction with a cysteine hydrochloride additive, Aminosyn-PF 10% results in plasma amino acid concentrations approximating a profile consistent with that of a breast-fed infant.

The rationale for Aminosyn-PF 10% is based on the observation of inadequate levels of essential amino acids in the plasma of infants receiving total parenteral nutrition (TPN) using conventional amino acid solutions.

Clinical studies in infants who required TPN therapy showed that infusion of Aminosyn-PF 10% resulted in plasma amino acid concentrations approximating those of normal breast or formula fed infants. In addition, weight gains, nitrogen balance, and serum protein concentrations were consistent with an improving nutritional status.

When infused with hypertonic dextrose as a calorie source, supplemented with cysteine hydrochloride, electrolytes, vitamins, and minerals, Aminosyn-PF 10% provides TPN for infants and young children, with the exception of essential fatty acids.

It is thought that the acetate from lysine acetate under the conditions of parenteral nutrition, does not impact net acid-base balance when renal and respiratory functions are normal. Clinical evidence seems to support this thinking; however, confirmatory experimental evidence is not available. The amounts of sodium and acetate in Aminosyn-PF 10% are not of clinical significance.

The addition of a cysteine hydrochloride additive will contribute to the chloride load.

The electrolyte content of any additives that are introduced should be carefully considered and included in input computations.

The human newborn conjugates bile with taurine which becomes the primary method of biliary excretion. Taurine deficiency because of its effect on bile salt conjugation and, therefore, on bile salt flow may be of major importance in the genesis of cholestasis. Taurine has also been shown to play a role in central nervous system development.

Indications and Usage for Aminosyn-PF Injection

Aminosyn-PF 10%, Sulfite-Free, (an amino acid injection — pediatric formula) is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with Aminosyn-PF 10% is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children 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) protein requirements are substantially increased as with extensive burns. Dosage, route of administration, and concomitant infusion of non-protein 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 Infusion

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 infants or those requiring long-term parenteral nutrition.

Peripheral Parenteral Nutrition

For moderately catabolic or depleted patients in whom the central venous route is not indicated, diluted amino acid solutions mixed with 5 to 10% dextrose solutions may be infused by peripheral vein, supplemented, if desired, with fat emulsion.

Contraindications

Aminosyn-PF 10%, Sulfite-Free, (an amino acid injection — pediatric formula) is contraindicated in patients with untreated anuria, hepatic coma, inborn errors of amino acid metabolism (including those involving branched chain amino acid metabolism such as maple syrup urine disease and isovaleric acidemia), 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 osmolalities, 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 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.

Administration of amino acid solutions to a patient with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma.

Hyperammonemia is of special significance in infants, as its occurrence in the syndrome caused by genetic metabolic defects is sometimes associated, although not necessarily in a causal relationship, with mental retardation. This reaction appears to be dose-related and is more likely to develop during prolonged therapy. It is essential that blood ammonia levels be measured frequently in infants.

Conservative doses of amino acids should be given, dictated by the nutritional status of the patient. Should symptoms of hyperammonemia develop, amino acid dosage levels should be reduced and titrated against serum ammonia levels.

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

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require the use of additional electrolyte supplements.

Strongly hypertonic nutrient solutions should be administered via an intravenous catheter placed in a central vein, preferably the superior vena cava.

Care should be taken to avoid circulatory overload, particularly in patients with cardiac insufficiency.

Special care must be taken when giving hypertonic dextrose to a diabetic or pre-diabetic patient. To prevent severe hyperglycemia in such patients, insulin may be required.

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

The effect of infusion of amino acids, without dextrose, upon carbohydrate metabolism of children is not known at this time. It is essential to provide adequate exogenous dextrose calories concurrently with amino acids. Administration of amino acids without carbohydrates may result in the accumulation of ketone bodies in the blood. Correction of this ketonemia may be achieved by the administration of carbohydrate.

Essential fatty acid deficiency (EFAD) is becoming increasingly recognized in patients on long term TPN (more than 5 days). The use of fat emulsion to provide 4 — 10% of total caloric intake as linoleic acid may prevent EFAD.

Peripheral administration of Aminosyn-PF 10%, Sulfite-Free, (an amino acid injection — pediatric formula) requires appropriate dilution and provision of adequate calories. Care should be taken to assure proper placement of the needle within the lumen of the vein. The venipuncture site should be inspected frequently for signs of infiltration. If venous thrombosis or phlebitis occurs, discontinue infusion or change infusion site and initiate appropriate treatment.

Extraordinary electrolyte losses such as may occur during protracted nasogastric suction, vomiting, diarrhea, or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation.

Metabolic acidosis can be prevented or readily controlled by adding a portion of the cations in the electrolyte mixture as acetate salts and in the case of hyperchloremic acidosis, by keeping the total chloride content of the infusate to a minimum.

Aminosyn-PF 10% contains no chloride.

Aminosyn-PF 10% 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.

Aminosyn-PF 10% contains no more than 25 mcg/L of aluminum.

To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration.

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).

1. 
   

   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.

   
   


2. 
   

   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 container and set should never exceed 24 hours.

   
   


3. 
   

   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. CLINICAL EVALUATION AND LABORATORY DETERMINATIONS, AT THE DISCRETION OF THE ATTENDING PHYSICIAN ARE NECESSARY FOR PROPER MONITORING DURING ADMINISTRATION. Do not withdraw venous blood for blood chemistries through the peripheral infusion site, as interference with estimations of nitrogen-containing substances may occur. Blood studies should include glucose, urea nitrogen, serum electrolytes, ammonia, cholesterol, acid-base balance, serum proteins, kidney and liver function tests, osmolarity and hemogram. White blood count and blood cultures are to be determined if indicated. Urinary osmolality and glucose should be determined as necessary.

   
   

Pregnancy Category C

Animal reproduction studies have not been conducted with Aminosyn-PF 10%. It is also not known whether Aminosyn-PF 10% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Aminosyn-PF 10% should be given to a pregnant woman only if clearly needed.

Adverse Reactions

Local reactions consisting of erythema, phlebitis and thrombosis at the infusion site have occurred with peripheral intravenous infusion of amino acids particularly if other substances, such as antibiotics, are also administered through the same site. In such cases the infusion site should be changed promptly to another vein. Use of large peripheral veins, inline filters, and slowing the rate of infusion may reduce the incidence of local venous irritation. Electrolyte additives should be spread throughout the day. Irritating additive medications may need to be injected at another venous site.

Generalized flushing, fever and nausea also have been reported during peripheral infusions of amino acid solutions.

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 overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS and PRECAUTIONS.

Aminosyn-PF Injection Dosage and Administration

Aminosyn-PF 10%, Sulfite-Free, is an amino acid injection-pediatric formula not intended for direct infusion. Admixtures should be made by or under the direction of a pharmacist using strict aseptic technique under a laminar flow hood. Admixtures must be stored under refrigeration and used within 24 hours of admixing.

The total daily dose of the solution depends on the daily protein requirements and on the patient’s metabolic and clinical response.

Pediatric requirements for parenteral nutrition are constrained by the greater relative fluid requirements of the infant and greater caloric requirements per kilogram than in the adult.

The recommended intravenous dose of Aminosyn-PF 10% is up to 2.5 g amino acid/kg/day for infants up to 10 kg. For infants and children larger than 10 kg, the total daily dose of amino acids should be up to 25 g amino acids/day for the first 10 kg of body weight plus 1.0 to 1.25 g amino acid for each kg of body weight over 10 kg. Initial amino acid dosage levels of 1.0 g/kg/day may be increased gradually in increments of 0.5 g/kg/day to approximate desired intake levels.

Aminosyn-PF 10% should be diluted with dextrose prior to use. Nonprotein calories should constitute approximately 100 to 130 kcal/kg/day. Part of the nonprotein caloric requirement may be provided as lipid emulsion administered concurrently to provide up to 60% of daily calories at a dose not to exceed 4 g fat/kg/day. Fluid intake for the infant receiving central venous TPN should be approximately 125 mL/kg/day (range: 100 to 175 mL/kg/day), depending on the clinical condition of the patient. Fat emulsion coadministration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (EFAD). Serum lipids should be monitored for evidence of EFAD in patients maintained on fat-free TPN. Premature infants with respiratory distress syndrome suspected of having a patent ductus arteriosus should be given fluids more cautiously.

Cysteine is considered to be an essential amino acid for infants, especially preterm infants with potentially immature enzyme pathways. Therefore, addition of a cysteine supplement to the TPN admixture is recommended. The intake of cysteine by the preterm infant ingesting maternal milk is approximately 78 mg/kg/day. The suggested intravenous dosage level for Cysteine Hydrochloride Injection, USP is 500 mg (10 mL) for every 12.5 g (125 mL) of Aminosyn-PF 10% administered (see package insert for Cysteine Hydrochloride Injection, USP). In order to avoid potential insolubility of cysteine hydrochloride in admixtures, the foregoing concentration should not be exceeded.

In many patients, provision of adequate calories in the form of hypertonic dextrose may require the administration of exogenous insulin to prevent hyperglycemia and glycosuria. To prevent rebound hypoglycemia, a solution containing 5% dextrose should be administered when hypertonic dextrose solutions are abruptly discontinued.

SERUM ELECTROLYTES SHOULD BE MONITORED FREQUENTLY. Electrolytes may be added to the nutrient solution as indicated by the patient’s clinical condition and laboratory determinations of plasma values. Major electrolytes are sodium, chloride, potassium, phosphate, magnesium and calcium. Daily administration of intravenous vitamin supplements including a complete complement of fat and water-soluble vitamins is required. Trace metal additives including zinc, copper, manganese, and chromium should also be provided, especially when long-term parenteral therapy is anticipated.

Calcium and phosphorus are added to the solution as indicated.

Potentially incompatible ions such as calcium and phosphate may be added to alternate infusate bottles to avoid precipitation. In patients with hyperchloremic or other metabolic acidosis, sodium and potassium may be added as the acetate or lactate salts to provide bicarbonate alternates. Bicarbonate should not be administered during infusion of the nutritional solution unless deemed absolutely necessary.

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

To ensure the precise delivery of the small volumes of fluid necessary for total parenteral nutrition in infants, accurately calibrated and reliable infusion systems should be used.

Central Venous Nutrition

Hypertonic mixtures of amino acids and dextrose may be safely administered by continuous infusion through a central venous catheter with the tip located in the superior vena cava. Initial infusion rates should be slow, and gradually increased to the recommended 60-125 mL per kilogram body weight per day. If administration rate should fall behind schedule, no attempt to “catch up” to planned intake should be made. In addition to meeting protein needs, the rate of administration, particularly during the first few days of therapy, is governed by the patient’s glucose tolerance. Daily intake of amino acids and dextrose should be increased gradually to the maximum required dose as indicated by frequent determinations of glucose levels in blood and urine.

Peripheral Parenteral Nutrition

For patients in whom the central venous route is not indicated and who can consume adequate calories enterally, Aminosyn-PF 10% may be administered by peripheral vein with parenteral nonprotein calories. The concentration of dextrose in the final admixture is 5 to 10%, and simultaneous administration of lipid emulsion is recommended both as a calorie source and to attenuate the potentially irritating effects of the hypertonic nutritional admixture. Fat emulsion may comprise up to 60% of the daily caloric intake at a dosage level not to exceed 4 g fat/kg/day. It is essential that peripheral infusion be accompanied by adequate caloric intake.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. COLOR VARIATION FROM PALE YELLOW TO YELLOW IS NORMAL AND DOES NOT ALTER EFFICACY.

Recommended Directions for Use of the Pharmacy Bulk Package

Use Aseptic Technique

1. 
   

   During use, container must be stored, and all manipulations performed, in an appropriate laminar flow hood.

   
   


2. 
   

   Remove cover from outlet port at bottom of container.

   
   


3. 
   

   Insert piercing pin of sterile transfer set and suspend unit in a laminar flow hood. Insertion of a piercing pin into the outlet port should be performed only once in a Pharmacy Bulk Package solution. Once the outlet site has been entered, the withdrawal of container contents should be completed promptly in one continuous operation. Should this not be possible, a maximum time of 4 hours from transfer set pin or implement insertion is permitted to complete fluid transfer operations; i.e., discard container no later than 4 hours after initial closure puncture.

   
   


4. 
   

   Sequentially dispense aliquots of Aminosyn-PF 10% into I.V. containers using appropriate transfer set. During fluid transfer operations, the Pharmacy Bulk Package should be maintained under the storage conditions recommended in the labeling.

   
   
   

   Additives may be incompatible with fluid withdrawn from this container. Consult with pharmacist, if available. When compounding admixtures, use aseptic technique. Mix thoroughly. Do not store solutions containing additives. Because of the potential for life-threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrient mixture.

   
   

WARNING: Do not use flexible container in series connections.

How is Aminosyn-PF Injection Supplied

Aminosyn -PF 10%, Sulfite-Free, (an amino acid injection — pediatric formula) is supplied as a Pharmacy Bulk Package in 1000 mL flexible plastic containers NDC 0409-4179-05.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. It is recommended that the product be stored at room temperature (25°C). Avoid exposure to light.

Revised: June, 2008

Printed in USA	EN-1817
Hospira, Inc., Lake Forest, IL 60045 USA

IM-1003

WR-0310

AMINOSYN-PF  isoleucine,leucine,lysine acetate,methionine,phenylalanine,threonine,tryptophan,valine,alanine,arginine,aspartic acid,glutamic acid,glycine,histidine,proline,serine,taurine,tyrosine  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0409-4179 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Isoleucine (Isoleucine) Isoleucine 760 mg  in 100 mL Leucine (Leucine) Leucine 1200 mg  in 100 mL Lysine acetate (Lysine) Lysine acetate 677 mg  in 100 mL Methionine (Methionine) Methionine 180 mg  in 100 mL Phenylalanine (Phenylalanine) Phenylalanine 427 mg  in 100 mL Threonine (Threonine) Threonine 512 mg  in 100 mL Tryptophan (Tryptophan) Tryptophan 180 mg  in 100 mL Valine (Valine) Valine 673 mg  in 100 mL Alanine (Alanine) Alanine 698 mg  in 100 mL Arginine (Arginine) Arginine 1227 mg  in 100 mL Aspartic Acid (Aspartic Acid) Aspartic Acid 527 mg  in 100 mL Glutamic Acid (Glutamic Acid) Glutamic Acid 820 mg  in 100 mL Glycine (Glycine) Glycine 385 mg  in 100 mL Histidine (Histidine) Histidine 312 mg  in 100 mL Proline (Proline) Proline 812 mg  in 100 mL Serine (Serine) Serine 495 mg  in 100 mL Taurine (Taurine) Taurine 70 mg  in 100 mL Tyrosine (Tyrosine) Tyrosine 44 mg  in 100 mL

Inactive Ingredients Ingredient Name Strength Water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0409-4179-05 6 BAG In 1 CASE contains a BAG 1 1000 mL In 1 BAG This package is contained within the CASE (0409-4179-05)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019492	12/24/2009

Labeler - Hospira, Inc. (141588017)

Revised: 12/2009Hospira, Inc.

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Apresoline

Generic Name: hydralazine (Oral route, Injection route, Intravenous route)

hye-DRAL-a-zeen

Commonly used brand name(s)

In the U.S.

• Apresoline

Available Dosage Forms:

• Powder for Solution


• Tablet


• Solution

Therapeutic Class: Peripheral Vasodilator

Uses For Apresoline

Hydralazine belongs to the general class of medicines called antihypertensives. It is used to treat high blood pressure (hypertension). It is also used to control high blood pressure in the mother during pregnancy (pre-eclampsia or eclampsia) or in emergency situations when blood pressure is extremely high (hypertensive crisis).

High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Hydralazine works by relaxing blood vessels and increasing the supply of blood and oxygen to the heart while reducing its workload.

Hydralazine may also be used for other conditions as determined by your doctor.

Hydralazine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not specifically included in product labeling, hydralazine is used in certain patients with the following medical condition:

• Congestive heart failure

Before Using Apresoline

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

Allergies

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

Pediatric

Although there is no specific information comparing use of hydralazine in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults. However, the oral solution contains aspartame, which is converted to phenylalanine in the body. Children with phenylketonuria cannot process phenylalanine and high levels of this substance in body fluids may cause brain damage.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of hydralazine in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Metoprolol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Enteral Nutrition


• food

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart or blood vessel disease or


• Stroke—Lowering blood pressure may make problems resulting from these conditions worse

• Kidney disease—Effects may be increased because of slower removal of hydralazine from the body


• Phenylketonuria—The oral solution of hydralazine contains aspartame, which is converted to phenylalanine in the body. Patients with phenylketonuria cannot process phenylalanine and high levels of this substance in body fluids may cause brain damage

Proper Use of Apresoline

For patients taking this medicine for high blood pressure:

• In addition to the use of the medicine your doctor has prescribed, treatment for your high blood pressure may include weight control and care in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.


• Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.


• Remember that hydralazine will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life . If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

For patients taking the oral solution form of hydralazine :

• The oral solution may be mixed with fruit juice or applesauce. If mixed with fruit juice or applesauce, take immediately after mixing. Be sure to take all of the mixture to get the full dose of the medicine.

This medicine works best if there is a constant amount in the blood. To help keep this amount constant, do not miss any doses and take the medicine at the same times each day.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (oral solution and tablets):
  
  • For high blood pressure:
    
    • Adults—40 to 200 milligrams (mg) per day divided into two or four doses
    
    
    • Children—Dose is based on body weight. The usual dose is 0.75 to 7.5 mg per kilogram (kg) (0.34 to 3.4 mg per pound) of body weight a day. This is divided into two or four doses.
    
    
  
  


• For injection dosage form:
  
  • For high blood pressure:
    
    • Adults—5 to 40 mg injected into a muscle or a vein. Your doctor may repeat the dose as needed.
    
    
    • Children—Dose is based on body weight. The usual dose is 1.7 to 3.5 mg per kg (0.77 to 1.6 mg per pound) of body weight a day. This is divided into four to six doses and injected into a muscle or a vein.
    
    
  
  
  • For high blood pressure during pregnancy:
    
    • Adults—5 mg injected into a vein every fifteen to twenty minutes.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep the bottle closed when you are not using it. Keep it in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Apresoline

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly.

Hydralazine may cause some people to have headaches or to feel dizzy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

The oral solution contains 1.4 milligrams (mg) of phenylalanine per teaspoonful (5 mL). Patients with phenylketonuria cannot process phenylalanine and high levels of this substance in body fluids may cause brain damage.

For patients taking this medicine for high blood pressure :

• Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

Apresoline Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

• Blisters on skin


• chest pain


• general feeling of discomfort or illness or weakness


• joint pain


• muscle pain


• numbness, tingling, pain, or weakness in hands or feet


• skin rash or itching


• sore throat and fever


• swelling of feet or lower legs


• swelling of lymph glands

Rare

• Fever


• general feeling of discomfort or illness


• sore throat


• weakness

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

More common

• Diarrhea


• fast heartbeat


• headache


• loss of appetite


• nausea or vomiting


• pounding heartbeat

Less common

• Constipation


• dizziness or lightheadedness


• redness or flushing of face


• shortness of breath


• stuffy nose


• watery eyes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Apresoline side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Apresoline resources

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

• Apresoline Prescribing Information (FDA)


• Apresoline Concise Consumer Information (Cerner Multum)


• Hydralazine MedFacts Consumer Leaflet (Wolters Kluwer)


• Hydralazine Prescribing Information (FDA)


• Hydralazine Hydrochloride Monograph (AHFS DI)

Compare Apresoline with other medications

• Heart Failure
• High Blood Pressure
• Hypertensive Emergency

Atuss HD

Generic Name: chlorpheniramine, hydrocodone, and pseudoephedrine (klor feh NEER ah meen, hye droe KOE doe N, sue do eh FEH drin)

Brand Names: Atuss HD, Atuss HS, Cordron-HC, Cordron-HC NR, Histinex PV, Hydrocof-HC, Hydrotuss HC, Hyphed, Notuss-Forte, P-V-Tussin Syrup, Pediatex HC, Q-V Tussin

What is Atuss HD (chlorpheniramine, hydrocodone, and pseudoephedrine)?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Hydrocodone is in a group of drugs called narcotics and is similar to codeine. Hydrocodone is a cough suppressant that affects the signals in the brain that trigger cough reflex.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of chlorpheniramine, hydrocodone, and pseudoephedrine is used to treat cough, sneezing, itching, watery eyes, runny nose, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

Chlorpheniramine, hydrocodone, and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Atuss HD (chlorpheniramine, hydrocodone, and pseudoephedrine)?

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not take this medication with alcohol, other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Hydrocodone should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Hydrocodone is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription. Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine, decongestant, or cough suppressant. This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What should I discuss with my healthcare provider before taking Atuss HD (chlorpheniramine, hydrocodone, and pseudoephedrine)?

Do not use this medication if you are allergic to hydrocodone or other narcotic pain relievers such as fentanyl (Actiq, Duragesic), hydromorphone (Dilaudid, Palladone), methadone (Methadose, Dolophine), morphine (Kadian, MS Contin, Oramorph, and others), oxycodone (Oxycontin), and oxymorphone (Opana). Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Before taking chlorpheniramine, hydrocodone, and pseudoephedrine, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  kidney or liver disease;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  enlarged prostate or urination problems;

  
  


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  asthma, COPD, sleep apnea, or other breathing disorders;

  
  


• 
  

  a history of head injury or brain tumor;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  low blood pressure;

  
  


• 
  

  gallbladder disease;

  
  


• 
  

  Addison's disease or other adrenal gland disorders;

  
  


• 
  

  mental illness; or

  
  


• 
  

  a history of drug or alcohol addiction.

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely use this medication.

FDA pregnancy category C. Hydrocodone may be harmful to an unborn baby, and could cause addiction or withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Hydrocodone should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Hydrocodone is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

How should I take Atuss HD (chlorpheniramine, hydrocodone, and pseudoephedrine)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Cough or cold medicine is usually taken for only a short time until your symptoms clear up.

Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

Store this medicine at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

Since cough or cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of hydrocodone can be fatal. Overdose symptoms may include extreme dizziness or drowsiness, confusion, feeling restless or nervous, cold and clammy skin, warmth or tingly feeling, nausea, vomiting, slow or shallow breathing, slow heart rate, pinpoint pupils, fainting, seizure (convulsions), or coma.

What should I avoid while taking Atuss HD (chlorpheniramine, hydrocodone, and pseudoephedrine)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid becoming overheated or dehydrated during exercise and in hot weather.

Do not drink alcohol while you are taking this medication. Alcohol can increase some of the side effects of chlorpheniramine, hydrocodone, and pseudoephedrine. Do not take this medication with other narcotic pain medications, sedatives, tranquilizers, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Life-threatening side effects may result.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. Chlorpheniramine and pseudoephedrine are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains chlorpheniramine or pseudoephedrine.

Atuss HD (chlorpheniramine, hydrocodone, and pseudoephedrine) 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. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  fast, pounding, or uneven heartbeats;

  
  


• 
  

  shallow breathing, slow heartbeat;

  
  


• 
  

  severe dizziness, fainting, anxiety, restless feeling, nervousness, or tremor;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

  
  


• 
  

  urinating less than usual or not at all; or

  
  


• 
  

  increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

  
  

Less serious side effects may include:

• 
  

  blurred vision;

  
  


• 
  

  dry mouth;

  
  


• 
  

  nausea, vomiting, stomach pain, constipation, mild loss of appetite;

  
  


• 
  

  mild dizziness, drowsiness;

  
  


• 
  

  problems with memory or concentration;

  
  


• 
  

  ringing in your ears;

  
  


• 
  

  warmth, tingling, or redness under your skin;

  
  


• 
  

  restless or excitability (especially in children);

  
  


• 
  

  sleep problems (insomnia); or

  
  


• 
  

  skin rash or itching.

  
  

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

What other drugs will affect Atuss HD (chlorpheniramine, hydrocodone, and pseudoephedrine)?

Before taking this medication, tell your doctor if you are using any of the following drugs:

• 
  

  cimetidine (Tagamet);

  
  


• 
  

  rifampin (Rifadin, Rifater, Rifamate, Rimactane);

  
  


• 
  

  zidovudine (Retrovir, AZT);

  
  


• 
  

  antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others;

  
  


• 
  

  aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others;

  
  


• 
  

  bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

  
  


• 
  

  a diuretic (water pill), or blood pressure medication;

  
  


• 
  

  medication to treat irritable bowel syndrome;

  
  


• 
  

  medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), pimozide (Orap), or thioridazine (Mellaril); or

  
  


• 
  

  seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).

  
  

This list is not complete and there may be other drugs that can interact with chlorpheniramine, hydrocodone, and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Atuss HD resources

• Atuss HD Use in Pregnancy & Breastfeeding
• Drug Images
• Atuss HD Drug Interactions
• Atuss HD Support Group
• 0 Reviews for Atuss HD - Add your own review/rating

• Histinex PV Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Hyphed Advanced Consumer (Micromedex) - Includes Dosage Information


• Tussend MedFacts Consumer Leaflet (Wolters Kluwer)


• Zutripro Prescribing Information (FDA)


• Zutripro Consumer Overview

Compare Atuss HD with other medications

• Cough and Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about chlorpheniramine, hydrocodone, and pseudoephedrine.

amikacin Injection

a-mi-KAY-sin

Injection route(Solution)

Therapy has been associated with potential neurotoxicity, ototoxicity, and nephrotoxicity. Patients with impaired renal function, advanced age, dehydration, and those who receive high dosage or prolonged therapy are at an increased risk of toxicity. Monitor renal and auditory function during therapy and discontinue therapy or adjust dose if there is evidence of ototoxicity or nephrotoxicity. Aminoglycoside-induced ototoxicity is usually irreversible. Serum concentrations of aminoglycosides should be monitored when feasible to assure adequate levels and to avoid potentially toxic levels. Neuromuscular blockade and respiratory paralysis have also been reported following administration. Concurrent use of other potentially neurotoxic or nephrotoxic agents, or potent diuretics should be avoided .

Commonly used brand name(s)

In the U.S.

• Amikin


• Amikin Pediatric

Available Dosage Forms:

• Solution

Therapeutic Class: Antibiotic

Chemical Class: Aminoglycoside

Uses For amikacin

Amikacin injection is used to treat serious bacterial infections in many different parts of the body. amikacin is for short-term use only (7 to 10 days).

Amikacin belongs to the class of medicines known as aminoglycoside antibiotics. It works by killing bacteria or preventing their growth. However, amikacin will not work for colds, flu, or other virus infections.

Amikacin injection is usually used for serious bacterial infections for which other medicines may not work. However, it may also cause some serious side effects, including damage to your hearing, sense of balance, and kidneys. These side effects may be more likely to occur in elderly patients and newborn infants. You and your doctor should talk about the benefits of amikacin as well as the risks.

amikacin is to be administered only by or under the immediate supervision of your doctor.

Before Using amikacin

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

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of amikacin injection in children. However, amikacin should be used with caution in premature and newborn infants.

Geriatric

No information is available on the relationship of age to the effects of amikacin injection in geriatric patients. However, elderly patients are more likely to have kidney problems, which may require caution and an adjustment in the dose for patients receiving amikacin injection.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving amikacin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Alcuronium


• Atracurium


• Cidofovir


• Cisatracurium


• Colistimethate Sodium


• Decamethonium


• Doxacurium


• Ethacrynic Acid


• Fazadinium


• Furosemide


• Gallamine


• Hexafluorenium


• Lysine


• Metocurine


• Mivacurium


• Pancuronium


• Pipecuronium


• Rapacuronium


• Rocuronium


• Succinylcholine


• Tacrolimus


• Tubocurarine


• Vancomycin


• Vecuronium

Using amikacin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ibuprofen

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of amikacin. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or


• Sulfite allergy, history of—amikacin contains sodium metabisulfite which may cause an allergic reaction in patients with these conditions.

• Kidney disease, severe or


• Muscle problems or


• Myasthenia gravis (severe muscle weakness) or


• Nerve problems or


• Parkinson's disease—Use with caution. May make these condition worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of amikacin from the body.

Proper Use of amikacin

A nurse or other trained health professional will give you amikacin. amikacin is given as a shot into a muscle or into a vein.

To help clear up your infection completely, keep using amikacin for the full time of treatment, even if you begin to feel better after a few days. Also, amikacin works best when there is a constant amount in the blood. To help keep the amount constant, you must receive amikacin on a regular schedule.

To keep your kidneys working well and help prevent kidney problems, drink extra fluids so you will pass more urine while you or your child are receiving amikacin.

Precautions While Using amikacin

Your doctor will check your progress closely while you or your child are receiving amikacin. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to receive it. Blood, urine, hearing, and nerve tests may be needed to check for unwanted effects.

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

Using amikacin while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

amikacin may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have itching; hives; hoarseness; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive amikacin.

Stop using amikacin and check with your doctor right away if you or your child have sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears. Tell your doctor if you or your child have dizziness or lightheadedness; feeling of constant movement of self or surroundings; or sensation of spinning. These may be symptoms of a damage to your hearing or sense of balance.

Tell your doctor right away if you have trouble using your muscles or trouble breathing while receiving amikacin.

Check with your doctor right away if you or your child have blood in the urine, change in frequency of urination or amount of urine, difficulty with breathing, drowsiness, increased thirst, loss of appetite, nausea or vomiting, swelling of feet or lower legs, or weakness. These may be symptoms of a serious kidney problem.

amikacin may cause nerve problems. Check with your doctor right away if you or your child have numbness, skin tingling, muscle twitching, or seizures.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

amikacin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known

• Agitation


• black, tarry stools


• bloody or cloudy urine


• bluish lips or skin


• blurred vision


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• chest pain


• chills


• coma


• confusion


• cough


• decrease in the amount of urine


• decreased urine output


• depression


• difficulty with breathing


• difficulty with moving


• dizziness


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• drowsiness


• dry mouth


• feeling of fullness in the ears


• fever


• headache


• hearing loss


• irritability


• lethargy


• loss of balance


• loss or change in hearing


• muscle pain or stiffness


• muscle twitching


• nausea


• not breathing


• pain in the joints


• pain in the lower back or side


• painful or difficult urination


• pale skin


• rapid weight gain


• ringing or buzzing in the ears


• seizures


• shakiness in the legs, arms, hands, or feet


• shortness of breath


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• stupor


• sweating


• swelling of the face, ankles, or hands


• swollen glands


• thirst


• trembling or shaking of the hands or feet


• trouble with hearing


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness

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

Incidence not known

• Skin rash


• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: amikacin Injection side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More amikacin Injection resources

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

Compare amikacin Injection with other medications

• Bacteremia
• Bone infection
• Cystic Fibrosis
• Febrile Neutropenia
• Intraabdominal Infection
• Joint Infection
• Meningitis
• Nosocomial Pneumonia
• Peritonitis
• Pneumonia
• Skin Infection
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AlleRx DF Dose Pack

Generic Name: chlorpheniramine and methscopolamine (klor fen EER uh meen and meth sko POL uh meen)

Brand Names: aeroHist, AlleRx DF Dose Pack, Ryneze

What is AlleRx DF Dose Pack (chlorpheniramine and methscopolamine)?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Methscopolamine reduces the secretions of certain organs in the body.

The combination of chlorpheniramine and methscopolamine is used to treat symptoms of the common cold or seasonal allergies, including sneezing, runny or stuffy nose, and itchy, watery eyes.

Chlorpheniramine and methscopolamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about AlleRx DF Dose Pack (chlorpheniramine and methscopolamine)?

Do not use chlorpheniramine and methscopolamine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Dangerous side effects may occur if you take chlorpheniramine and methscopolamine before the MAO inhibitor has cleared from your body. Do not use this medication if you are allergic to chlorpheniramine or methscopolamine, or if you have severe high blood pressure or coronary artery disease, narrow-angle glaucoma, a stomach ulcer, or if you are unable to urinate.

Do not use this medication during an asthma attack.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid becoming overheated in hot weather. Chlorpheniramine and methscopolamine increases the risk of heat stroke because it causes decreased sweating and can make you more sensitive to sunlight.

Avoid drinking alcohol. It can increase some of the side effects of chlorpheniramine and methscopolamine.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety), or medicines that may cause restlessness (such as caffeine, stimulants, diet pills, and decongestants contained in over-the-counter cold medicines). They can add to the side effects of chlorpheniramine and methscopolamine.

What should I discuss with my healthcare provider before taking AlleRx DF Dose Pack (chlorpheniramine and methscopolamine)?

Do not use chlorpheniramine and methscopolamine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Dangerous side effects may occur if you take chlorpheniramine and methscopolamine before the MAO inhibitor has cleared from your body. Do not use this medication if you are allergic to chlorpheniramine or methscopolamine, or if you have:

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  severe or uncontrolled high blood pressure;

  
  


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  severe coronary artery disease;

  
  


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  narrow angle glaucoma;

  
  


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  a stomach ulcer;

  
  


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  if you are unable to urinate; or

  
  


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  if you are having an asthma attack.

  
  

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have:

• kidney disease;


• liver disease;


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  diabetes;

  
  


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  glaucoma;

  
  


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  heart disease, high blood pressure, or circulation problems;

  
  


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  overactive thyroid;

  
  


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  a seizure disorder such as epilepsy;

  
  


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  asthma, emphysema or chronic bronchitis; or

  
  


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  urination problems or an enlarged prostate.

  
  

If you have any of these conditions, you may not be able to use chlorpheniramine and methscopolamine, or you may need a dosage adjustment or special tests during treatment.

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. Chlorpheniramine and methscopolamine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medicine. Do not give this medication to a child younger than 6 years old.

How should I take AlleRx DF Dose Pack (chlorpheniramine and methscopolamine)?

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

Take this medicine with a full glass of water. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

The chewable tablet must be chewed before swallowing.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Contact your doctor if your symptoms do not improve or if they get worse after taking this medicine for 7 days.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using chlorpheniramine and methscopolamine. You may need to stop using the medication for a short time before having a medical test.

Store chlorpheniramine and methscopolamine at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Symptoms of a chlorpheniramine and methscopolamine overdose may include nausea, vomiting, severe drowsiness, shallow breathing, ringing in your ears, problems with balance or coordination, hallucinations (seeing things), sleep problems (insomnia), feeling restless or excited, blurred vision, tremors, flushed face, and seizure (convulsions).

What should I avoid while taking AlleRx DF Dose Pack (chlorpheniramine and methscopolamine)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid becoming overheated in hot weather. Chlorpheniramine and methscopolamine increases the risk of heat stroke because it causes decreased sweating and can make you more sensitive to sunlight.

Avoid drinking alcohol. It can increase some of the side effects of chlorpheniramine and methscopolamine.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety), or medicines that may cause restlessness (such as caffeine, stimulants, diet pills, and decongestants contained in over-the-counter cold medicines). They can add to the side effects of chlorpheniramine and methscopolamine.

AlleRx DF Dose Pack (chlorpheniramine and methscopolamine) 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. Stop using chlorpheniramine and methscopolamine and call your doctor at once if you have any of these serious side effects:

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  problems with balance or coordination;

  
  


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  severe drowsiness, feeling light-headed, fainting;

  
  


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  extreme thirst and hot, dry skin;

  
  


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  breathing problems;

  
  


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  easy bruising or bleeding, unusual weakness;

  
  


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  fever, chills, body aches, flu symptoms;

  
  


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  fast or uneven heart beats;

  
  


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  tight feeling in your chest;

  
  


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  seizure (convulsions);

  
  


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  hallucinations (seeing things that are not there); or

  
  


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  tremors.

  
  

Continue using this medication and talk with your doctor if you have any of these less serious side effects:

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  dry mouth, stomach pain, changes in appetite;

  
  


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  drowsiness, dizziness, weakness, headache;

  
  


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  dry eyes, blurred vision;

  
  


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  painful or difficult urination;

  
  


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  increased sweating;

  
  


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  skin rash; or

  
  


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  feeling nervous or excited (especially in children).

  
  

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 AlleRx DF Dose Pack (chlorpheniramine and methscopolamine)?

Before taking this medication, tell your doctor if you are using any of the following drugs:

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  antacids;

  
  


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  medicine to treat diarrhea (such as Immodium, Kaopectate, Pepto-Bismol);

  
  


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  atropine (Donnatal, and others);

  
  


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  belladonna;

  
  


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  clidinium (Quarzan);

  
  


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  dicyclomine (Bentyl);

  
  


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  glycopyrrolate (Robinul);

  
  


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  hyoscyamine (Anaspaz, Cystospaz, Levsin, and others);

  
  


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  mepenzolate (Cantil);

  
  


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  methantheline (Provocholine);

  
  


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  methscopolamine (Pamine);

  
  


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  propantheline (Pro-Banthine); or

  
  


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  scopolamine (Transderm-Scop).

  
  


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  a beta-blocker such as acebutolol (Sectral), atenolol (Tenormin), betaxolol (Kerlone), bisoprolol (Zebeta), carteolol (Cartrol), carvedilol (Coreg), esmolol (Brevibloc), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), penbutolol (Levatol), pindolol (Visken), propranolol (Inderal, InnoPran), sotalol (Betapace), or timolol (Blocadren);

  
  


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  a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

  
  


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  antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Ascendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil).

  
  

If you are using any of these drugs, you may not be able to use chlorpheniramine and methscopolamine, or you may need dosage adjustments or special tests during treatment.

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

More AlleRx DF Dose Pack resources

• AlleRx DF Dose Pack Side Effects (in more detail)
• AlleRx DF Dose Pack Use in Pregnancy & Breastfeeding
• AlleRx DF Dose Pack Drug Interactions
• AlleRx DF Dose Pack Support Group
• 6 Reviews for AlleRx DF Dose Pack - Add your own review/rating

• Allergy DN II Prescribing Information (FDA)


• Dexodryl Chewable Tablet MedFacts Consumer Leaflet (Wolters Kluwer)


• Ryneze 12-Hour Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare AlleRx DF Dose Pack with other medications

• Rhinitis

Where can I get more information?

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

See also: AlleRx DF Dose Pack side effects (in more detail)