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Infant Formulas (Systemic)

This monograph includes information on the following:

1) Infant Formulas, Hypoallergenic
2) Infant Formulas, Milk-based
3) Infant Formulas, Soy-based

VA CLASSIFICATION
Primary: TN200



Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Nutritional replacement—

Indications

Accepted

Nutritional deficiency (prophylaxis and treatment)—Infant formulas are a type of enteral nutrition indicated as the sole or partial source of nutritional support in infants to sustain growth and activity. Under most circumstances, breast-feeding is the preferred method of providing nutritional support for the infant. {01} {02}
—Hypoallergenic and soy-based formulas may also be used by older children and adults with allergies. {28}

—The Infant Formula Act of 1980 was set up by Congress to give the Food and Drug Administration (FDA) the authority to establish quality control procedures for commercial infant formula manufacturing, to establish recall procedures, to revise the list and levels of nutrients in infant formulas, and to require adequate labeling. {02} {20} {23}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:

Hypoallergenic formulas are made from casein hydrolysate and supplemented with L-cystine, L-tyrosine, and L-tryptophan. {22} Nonhypoallergenic formulas are made from nonfat milk, or nonfat milk and whey, or soy protein isolate and supplemented with L-methionine. {29}


Precautions to Consider

Pediatrics

Side effects may occur if the selected infant formula is not prepared properly or is not used with appropriate medical supervision. {30}


Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this infant formula.
Only specific interactions between enteral formulas and other oral medications have been identified in this monograph. However, enteral formulas that are administered continuously or at frequent intervals may reduce the rate and/or extent of absorption of medications that must be given on an empty stomach. {04} Although these drug interactions and/or related problems have been reported only for adult enteral nutrition formulas, they may occur with infant enteral formulas.

Phenytoin, oral    (enteral formulas have been found to decrease the absorption of phenytoin; if a nasogastric tube is used, it should be flushed 2 hours before and after administration of phenytoin; monitoring of phenytoin blood concentrations may be needed {10} {11} {12} {13})


Sucralfate    (concurrent use with enteral formulas in a nasogastric feeding tube has resulted in bezoar formation, due to the protein-binding properties of sucralfate {14} {15})


Warfarin, oral    (warfarin resistance has been reported with concurrent administration of enteral feedings, possibly due to the vitamin K found in some products; more frequent prothrombin time determinations may be needed {04} {16})



Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With physiology/laboratory test values
Electrolytes, serum    (concentrations may be increased or decreased {19} {20} {26})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Except under special circumstances, this infant formula should not be used when the following medical problems exist:
» Bowel obstruction, total or
» Ileus, preventing nutrient absorption or
» Perforated bowel    (some patients may require postpyloric feeding to achieve enteral nutrition {04})


» Immunocompromised or premature infants in hospital settings     (these patients may be susceptible to E. sakazakii infections if given milk-based powdered infant formulas.{40})


Risk-benefit should be considered when the following medical problems exist

Note: Administration of infant formulas to infants with the following medical problems may be accomplished by careful selection of an infant formula or by changing the manner of administration. {04}

Aspiration pneumonitis, especially in the presence of severe pulmonary disease    (condition may be exacerbated by introduction of nasogastric tube)


Cardiac insufficiency    (condition may be exacerbated, especially during initiation of feeding in severely malnourished patients; adjustment of intake may be required {24})


Dehydration    (condition may be exacerbated, especially if supplementary fluids are not given; infants should be monitored for signs of dehydration and malabsorption of sugars such as lactose, sucrose, and glucose {20})


Diabetes mellitus or
Hyperglycemia {32}    (the carbohydrate content of many infant formulas may require adjustment of antidiabetic therapy or addition of insulin or other antidiabetic medications to the treatment regimen in patients with diabetes mellitus or hyperglycemia {25})


Diarrhea, severe    (condition may be exacerbated by infant feedings; use of formulas with a low osmolality or altered carbohydrate content may decrease the risk of diarrhea; diarrhea may also be a sign of lactose intolerance {17} {20})


Electrolyte abnormalities    (electrolyte disturbances may occur with infant feedings; patient monitoring may be necessary {19} {20})


» Gastric function abnormalities    (gastric emptying may be delayed with enteral feedings, which may lead to retention, nausea, and/or vomiting; switching to a formula with a low osmolality or to a modified or low-fat formula may be necessary {20})


Hepatic function impairment    (enteral formulas have been reported to alter hepatic function {09} {33})


Hyperlipidemia    (the fat content of some infant formulas may exacerbate the condition {25} {34})


Ketosis    (may be caused or exacerbated by a formula that supplies more calories from fat than from protein and/or carbohydrate {20} {35})


Lactose intolerance    (some infant formulas contain lactose {18})


Pancreatic insufficiency with fat malabsorption {20}    (condition may be exacerbated; use of an infant formula with a low fat content or a formula that uses medium-chain triglycerides as part of fat may be necessary )


» Phenylketonuria    (infant formulas contain phenylalanine, which may exacerbate the condition {20})


Renal function impairment or underdeveloped renal function    (fluid, protein, electrolytes, vitamins, and minerals may need to be restricted in patients with compromised renal function {19})


Respiratory difficulty    (condition may be exacerbated, especially with high carbohydrate formulas, or regular type feeding in severely malnourished patients; adjustment of intake may be required {24} {36})


» Vomiting, severe    (severe vomiting may be a sign of gastric outlet obstruction, protein allergy, or gastroesophageal reflux {31})



Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):


Note: For healthy infants receiving infant formulas, measuring and charting growth may be the only monitoring that is necessary. {27} Any other monitoring is at the discretion of the health care provider. For premature infants or those in poor health, patient monitoring may be necessary. {03}

Albumin, serum and
Transferrin, serum and {37}
Urea nitrogen, 24-hour, urinary    (recommended periodically to assess protein status {07})


Anthropometric measurements {07}    (recommended periodically as a measure of growth and changes in lean body or adipose tissue mass {04})


Complete blood count and {04}
Electrolytes, serum and {05}
Glucose, serum and {08}
Hepatic function determinations and {06}
Mineral status and {04}
Renal function determinations {06}    (recommended periodically depending on patient condition; abnormal serum glucose may require an adjustment of insulin in diabetic patients; if a patient has abnormal renal function, there may be a need to restrict fluids, electrolytes, vitamins, and/or trace minerals)


Energy expenditure {04} {38}    (monitoring may be necessary to determine success of infant formula feedings )




Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence more frequent
    
Dehydration{20} (unusual thirst; unusual tiredness or weakness)
    
diarrhea{20}
Note: Diarrhea may produce severe dehydration, which may develop quickly (within 24 hours). Diarrhea may result from improper formula dilution. {20}



Incidence less frequent
    
Signs of milk allergy (hives; {22}wheezing{22})—estimated to occur in 0.4 to 7.5% of infants receiving formulas
    
signs of milk intolerance (abdominal distention{18}; diarrhea{18}; stomach cramps{18}; vomiting{21})





Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Infant Formulas (Systemic) .

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this infant formula
»   Conditions affecting use, especially:
Sensitivity to any ingredient in the infant formula
Other medical problems, especially bowel obstruction; gastric function abnormalities; ileus, preventing nutrient absorption; perforated bowel; immunocompromised or premature infants in hospital settings; phenylketonuria; or severe vomiting

Proper use of this infant formula
» Proper feeding

» Proper storage


Side/adverse effects
Dehydration, diarrhea, signs of milk allergy, signs of milk intolerance


General Feeding Information
Denser infant formulas are more likely to clog a feeding tube. {04}

INFANT FORMULAS


Oral Dosage Forms

INFANT FORMULAS

Strength(s) usually available
U.S.—
See Tables 1—3.

Canada—
See Tables 1—3.

Additional information:

Table 1. Infant Formulas, Hypoallergenic


Note: For comparison purposes, the contents of breast milk are presented.



Brand name
[availability]
KCal
(kJoules)
per mL
mOsm
per kg
water
Protein

Carbohydrates

Fat

Na +
mg
(mEq)
per
100 mL
K +
mg
(mEq)
per
100 mL
Ca ++
mg
(mEq)
per
100 mL
Mg ++
mg
(mEq)
per
100 mL
Phos
mg
per
100 mL
Iron
(Fe) mg
per
100 mL
Comment
Grams
per
100
mL
Source;
% KCal
Grams
per
100
mL
Source;
% KCal
Grams
per
100
mL
Source;
%KCal
Breast Milk (Mature)
0.68
(2.8)
290
1.05
Casein, whey protein; 6
7.2
Lactose; 42
3.9
Milk fat; 52
18
(0.8)
52.5
(1.3)
28
(1.4)
3.5
14
0.03
 
Alimentum Oral Solution
[U.S./Canada]
0.68
(2.8)
370
1.9
Casein hydrolysate, amino acids; 11
6.9
Sucrose, modified tapioca starch; 41
3.8

MCT * oil, safflower oil, soy oil; 48
30
(1.3)
80
(2.1)
71
(3.5)
5.1
(0.4)
51
1.2
Lactose-free
Nutramigen Oral Concentrate
[U.S.]

Oral Solution
[U.S.]

for Oral Solution
[U.S./Canada]
0.68
(2.8)
320
1.9
Enzymatically hydrolyzed casein, amino acids; 11
7.4
Corn syrup solids, modified cornstarch; 44
3.4
Palm olein, soy oil, coconut oil, high oleic sunflower oil; 45
32
(1.39)
74
(1.89)
64
(3.2)
7.4
(0.61)
43
1.22
Lactose-free
Pregestimil for Oral Solution
[U.S./Canada]
0.68
(2.8)
320
1.9
Enzymatically hydrolyzed casein, amino acids; 11
6.9
Corn syrup solids, modified cornstarch, dextrose; 41
3.8
Corn oil, MCT * oil (fractionated coconut oil), soy oil, high oleic safflower oil; 48
27
(1.17)
74
(1.89)
64
(3.2)
7.4
(0.61)
43
1.28
Lactose-free
* MCT=Medium-chain triglycerides

Table 2. Infant Formulas, Milk-based


Note: For comparison purposes, the contents of breast milk are presented.



Brand name
[availability]
KCal
(kJoules)
per mL
mOsm
per kg
water
Protein
Carbohydrates
Fat
Na +
mg
(mEq)
per
100 mL
K +
mg
(mEq)
per
100 mL
Ca ++
mg
(mEq)
per
100 mL
Mg ++
mg
(mEq)
per
100
mL
Phos
mg
per
100
mL
Iron
(Fe) mg
per
100 mL
Comment
Grams
per
100
mL
Source;
% KCal
Grams
per
100
mL
Source;
% KCal
Grams
per
100
mL
Source;
%KCal
Breast Milk (Mature)
0.68
(2.8)
290
1.05
Casein, whey protein; 6
7.2
Lactose; 42
3.9
Milk fat; 52
18
(0.8)
52.5
(1.3)
28
(1.4)
3.5
14
0.03

 
Carnation Follow-Up Formula Oral Concentrate
[U.S.]
0.67
(2.8)
326
1.8
Nonfat
milk; 10
8.9
Corn syrup
solids, lactose; 53
2.8
Palm olein, soy oil, coconut oil, high oleic safflower oil; 37
26.4
(1.7)
91.3
(2.3)
91.3
(4.6)
5.7
(0.5)
60.9
(3.9)
1.3
 
Oral Solution
[U.S.]
                             
for Oral Solution
[U.S.]
                             
Carnation Good Start Oral Concentrate
[U.S.]
0.67
(2.8)
265
1.6
Partially
hydrolyzed
whey; 9.7
7.4
Lactose, maltodextrin; 44.2
3.4
Palm olein, soy oil, coconut oil, high oleic safflower oil; 46.1
16.2
(0.7)
66.3
(1.7)
43.3
(2.2)
4.5
(0.4)
24.3
1
 
Oral Solution
[U.S.]
                             
for Oral Solution
[U.S.]
                             
Enfamil Oral Concentrate
[U.S.]

Oral Solution
[U.S.]

for Oral Solution
[U.S.]
0.68
(2.8)
300
1.45
Whey protein, casein; 9
7.3
Lactose; 43
3.6
Palm olein, soy oil, coconut oil, high oleic sunflower oil; 48
18.3
(0.8)
73
(1.87)
53
(2.7)
5.4
(0.45)
36
0.47
 
Enfamil Human Milk Fortifier Oral Powder
[U.S.]
3.6
KCal
per g
  18
per
100 g
Whey protein, sodium caseinate
71
per
100 g
Corn syrup solids, lactose
1
per
100 g
  181
(7.9)
per
100 g
400
(10.2)
per
100 g
2300
(115)
per
100 g
26
(2.1)
per
100 g
1170
N/A

 
Enfamil with Iron Oral Concentrate
[U.S.]

Oral Solution
[U.S.]

for Oral Solution
[U.S.]
0.68
(2.8)
300
1.45
Whey protein, casein; 9
7.3
Lactose; 43
3.6
Palm olein, soy oil, coconut oil, high oleic sunflower oil; 48
18.3
(0.8)
73
(1.87)
53
(2.7)
5.4
(0.45)
36
1.22
 
Enfamil Premature Formula Oral Solution
[U.S.]
0.68
(2.8)
260
2
Whey protein, casein; 12
7.5
Corn syrup solids, lactose; 44
3.5
MCT * oil, soy oil, coconut oil; 44
27
(1.17)
70
(1.79)
112
(5.6)
4.6
(0.38)
56
0.17
 
0.81
(3.4)
310
2.4
Whey protein, casein; 12
9
Corn syrup solids, lactose; 44
4.1
MCT * oil, soy oil, coconut oil; 44
32
(1.39)
83
(2.1)
134
(6.7)
5.5
(0.45)
67
0.2

 
Enfamil Premature Formula with Iron Oral Solution
[U.S.]
0.68
(2.8)
260
2
Whey protein, casein; 12
7.5
Corn syrup solids, lactose; 44
3.5
MCT * oil, soy oil, coconut oil; 44
27
(1.17)
70
(1.79)
112
(5.6)
4.6
(0.38)
56
1.22
 
0.81
(3.4)
310
2.4
Whey protein, casein; 12
9
Corn syrup solids, lactose; 44
4.1
MCT * oil, soy oil, coconut oil; 44
32
(1.39)
83
(2.1)
134
(6.7)
5.5
(0.45)
67
1.46
 
Gerber Baby Formula with Iron for Oral Solution
[U.S.]
0.68
(2.8)
320
1.43
Nonfat milk; 9
7.4
Lactose; 43
3.6
Palm olein, soy oil, coconut oil, high oleic sunflower oil; 48
20
(0.87)
73
(1.87)
53
(2.7)
5.4
(0.45)
36
1.22
 
Lactofree Oral Concentrate
[U.S.]

Oral Solution
[U.S.]

for Oral Solution
[U.S.]
0.68
(2.8)
200
1.5
Milk protein isolate; 9
7
Corn syrup solids; 42
3.7
Palm olein, soy oil, coconut oil, high oleic sunflower oil; 49
20
(0.87)
74
(1.89)
55
(2.8)
5.4
(0.45)
37
1.22
 
Preemie SMA 20 Oral Solution
[U.S./Canada]
0.68
(2.8)
268
2
Nonfat milk, demineralized whey; 11.9
7
Maltodextrin, lactose; 41.5
3.5
Coconut oil, oleic (safflower) oil, oleo and soybean oils, MCT * oil, soy lecithin; 46.7
32
(1.4)
75
(1.9)
75
(3.8)
7
(0.6)
38
0.3
 
Preemie SMA 24 Oral Solution
[U.S./Canada]
0.8
(3.4)
280
2
Nonfat milk, demineralized whey; 9.6
8.6
Maltodextrin, lactose; 41.9
4.4
Coconut oil, oleic (safflower) oil, oleo and soybean oils, MCT * oil, soy lecithin; (48.5)
32
(1.4)
75
(1.9)
75
(3.8)
7
(0.6)
40
0.3

 
Similac 13 Oral Solution
[U.S./Canada]
0.44
(1.8)
200
1.2
Nonfat milk; 11
4.6
Lactose; 42
2.3
Soy oil, coconut oil, mono- and diglycerides, soy lecithin; 47
15
(0.65)
58
(1.5)
40
(2)
3.1
(0.25)
31
0.1
 
Similac 20 Oral Solution
[U.S./Canada]
0.68
(2.8)
300
1.5
Nonfat milk; 9
7.3
Lactose; 43
3.7
Soy oil, coconut oil, mono- and diglycerides, soy lecithin; 48
18
(0.8)
71
(1.8)
49
(2.5)
4.1
(0.34)
38
0.15

 
Similac 24 Oral Solution
[U.S./Canada]
0.81
(3.3)
380
2.2
Nonfat milk; 11
8.5
Lactose; 42
4.3
Soy oil, coconut oil, mono- and diglycerides, soy lecithin; 47
28
(1.2)
107
(2.7)
73
(3.6)
5.7
(0.47)
57
0.18

 
Similac 27 Oral Solution
[U.S./Canada]
0.91
(3.8)
410
2.5
Nonfat milk; 11
9.6
Lactose; 42
4.8
Soy oil, coconut oil, mono- and diglycerides, soy lecithin; 47
31
(1.4)
121
(3.1)
82
(4.1)
6.4
(0.53)
64
0.2

 
Similac with Iron 20 Oral Solution
[U.S.]
0.68
(2.8)
300
1.5
Nonfat milk; 9
7.3
Lactose; 43
3.7
Soy oil, coconut oil, mono- and di-glycerides, soy lecithin; 48
18
(0.8)
71
(1.8)
49
(2.5)
4.1
(0.3)
38
1.2
 
Similac with Iron 24 Oral Solution
[U.S.]
0.81
(3.3)
380
2.2
Nonfat milk; 11
8.5
Lactose; 42
4.3
Soy oil, coconut oil, mono- and diglycerides, soy lecithin; 47
28
(1.2)
107
(2.7)
73
(3.6)
5.7
(0.4)
57
1.5
 
Similac Natural Care Human Milk Fortifier Oral Solution
[U.S.]
0.81
(3.3)
280
2.2
Nonfat milk, whey protein concentrate; 11
8.6
Lactose, hydrolyzed cornstarch; 42
4.4
Soy oil, coconut oil, mono- and diglycerides, soy lecithin; 47
35
(1.5)
105
(2.7)
171
(8.5)
10
(0.8)
85
0.3

 
Similac PM 60/40 for Oral Solution
[U.S./Canada]
0.68
(2.8)
280
1.6
Whey protein concentrate, sodium caseinate; 9
6.9
Lactose; 41
3.8
Corn oil, coconut oil; 50
16
(0.7)
58
(1.5)
38
(1.9)
4.1
(0.3)
19
0.15
 
Similac Special Care 20 Oral Solution
[U.S./Canada]
0.68
(2.8)
235
1.8
Nonfat milk, whey protein concentrate; 11
7.2
Lactose, hydrolyzed cornstarch; 42
3.7
Soy oil, coconut oil, mono- and diglycerides, soy lecithin; 47
29
(1.3)
87
(2.2)
122
(6.1)
8.1
(0.7)
61
0.25
 
Similac Special Care 24 Oral Solution
[U.S./Canada]
0.81
(3.3)
280
2.2
Nonfat milk, whey protein concentrate; 11
8.6
Lactose, hydrolyzed cornstarch; 42
4.4
Soy oil, coconut oil, mono- and diglycerides, soy lecithin; 47
35
(1.5)
105
(2.7)
146
(7.3)
10
(0.8)
73
0.3

 
Similac Special Care with Iron 24 Oral Solution
[U.S.]
0.81
(3.3)
280
2.2
Nonfat milk, whey protein concentrate; 11
8.6
Lactose, hydrolyzed cornstarch; 42
4.4
Soy oil, coconut oil, mono- and diglycerides, soy lecithin; 47
35
(1.5)
105
(2.7)
146
(7.3)
10
(0.8)
73
1.5
 
SMA 13 Oral Solution
[U.S./Canada]
0.44
(1.8)
191
0.98
Nonfat milk, demineralized whey; 8.9
4.7
Lactose; 42.9
2.3
Oleo, coconut oil, oleic (safflower or sunflower) oil, soybean oil, soy lecithin; 48.2
10
(0.4)
36.4
(0.9)
27.3
(1.38)
3
(0.24)
18
0.8
 
SMA 20 Oral Solution
[U.S./Canada]
0.68
(2.8)
300
1.5
Nonfat milk, demineralized whey; 8.9
7.2
Lactose; 42.9
3.6
Oleo, coconut oil, oleic (safflower or sunflower) oil, soybean oil, soy lecithin; 48.2
15
(0.65)
56
(1.4)
42
(2.1)
4.5
(0.36)
28
1.2
 
SMA 24 Oral Solution
[U.S./Canada]
0.8
(3.4)
364
1.8
Nonfat milk, demineralized whey; 8.9
8.6
Lactose; 42.9
4.3
Oleo, coconut oil, oleic (safflower or sunflower) oil, soybean oil, soy lecithin; 48.2
18
(0.78)
67
(1.7)
50.4
(2.5)
5.4
(0.44)
33.6
1.4
 
SMA 27 Oral Solution
[U.S./Canada]
0.91
(3.8)
416
2
Nonfat milk, demineralized whey; 8.9
9.7
Lactose; 42.9
4.9
Oleo, coconut oil, oleic (safflower or sunflower) oil, soybean oil, soy lecithin; 48.2
20
(0.88)
76
(1.9)
57
(2.9)
6
(0.5)
38
1.6
 
SMA Lo-Iron 13 Oral Solution
[U.S./Canada]
0.44
(1.8)
191
0.98
Nonfat milk, demineralized whey; 8.9
4.7
Lactose; 42.9
2.3
Oleo, coconut oil, oleic (safflower or sunflower) oil, soy oil, soy lecithin; 48.2
10
(0.4)
36.4
(0.9)
27.3
(1.38)
3
(0.24)
18
0.1
 
SMA Lo-Iron 20 Oral Solution
[U.S./Canada]
0.68
(2.8)
300
1.5
Nonfat milk, demineralized whey; 8.9
7.2
Lactose; 42.9
3.6
Oleo, coconut oil, oleic (safflower or sunflower) oil, soybean oil, soy lecithin; 48.2
15
(0.65)
56
(1.4)
42
(2.1)
4.5
(0.36)
28
0.15
 
SMA Lo-Iron 24 Oral Solution
[U.S./Canada]
0.8
(3.4)
364
1.8
Nonfat milk, demineralized whey; 8.9
8.6
Lactose; 42.9
4.3
Oleo, coconut oil, oleic (safflower or sunflower) oil, soybean oil, soy lecithin; 48.2
18
(0.78)
67
(1.7)
50.4
(2.5)
5.4
(0.44)
33.6
0.18
 
* Medium-chain triglycerides.

Table 3. Infant Formulas, Soy-based


Note: For comparison purposes, the contents of breast milk are presented.



Brand name
[availability]
KCal
(kJoules)
per mL
mOsm
per kg
water
Protein

Carbohydrates

Fat

Na +
mg
(mEq)
per
100 mL
K +
mg
(mEq)
per
100 mL
Ca ++
mg
(mEq)
per
100 mL
Mg ++
mg
(mEq)
per
100 mL
Phos
mg
per
100 mL
Iron
(Fe) mg
per
100 mL
Comment
Grams
per
100
mL
Source;
% KCal
Grams
per
100
mL
Source;
% KCal
Grams
per
100
mL
Source;
%KCal
Breast Milk (Mature)
0.68
(2.8)
290
1.05
Casein, whey protein; 6
7.2
Lactose; 42
3.9
Milk fat; 52
18
(0.8)
52.5
(1.3)
28
(1.4)
3.5
14
0.03
 
Alsoy Oral Solution
[U.S.]
0.68
(2.8)
270
2.1
Soy isolate; 12
6.7
Sucrose, tapioca, dextrin; 39
3.7
Soy oil; 49
28.5
(1.3)
80
(2.1)
68.3
(3.4)
7.5
(0.6)
47.9
1.3
Lactose-free
Oral Concentrate
[U.S.]
                             
Gerber Soy Formula Oral Solution
[U.S.]

Oral Concentrate
[U.S.]
0.68
(2.8)
230
2
Soy protein isolate, amino acids; 12
6.8
Corn syrup solids, sucrose; 40
3.6
Palm olein, soy oil, coconut oil, high oleic sunflower oil; 48
24
(1.04)
81
(2.1)
71
(3.6)
7.4
(0.61)
56
1.22
Lactose-free
Isomil Oral Concentrate
[U.S./Canada]

Oral Solution
[U.S./Canada]

for Oral Solution
[U.S./Canada]
0.68
(2.8)
240
1.7
Soy protein isolate, amino acids; 10
7
Corn syrup, sucrose; 41
3.7
Soy oil, coconut oil, soy lecithin, mono- and diglycerides; 49
30
(1.3)
73
(1.9)
71
(3.5)
5.1
(0.4)
51
1.2
Lactose-free
Isomil SF Oral Concentrate
[U.S.]
0.68
(2.8)
180
1.8
Soy protein isolate, amino acids; 11
6.8
Hydrolyzed cornstarch; 40
3.7
Soy oil, coconut oil, soy lecithin, mono- and diglycerides; 49
30
(1.3)
73
(1.9)
71
(3.5)
5.1
(0.4)
51
1.2
Lactose-free; sugar-free
Nursoy Oral Solution
[U.S./Canada]
0.68
(2.8)
296
1.8
Soy protein isolate, L-methionine; 11
6.9
Sucrose; 41
3.6
Oleo, coconut oil, safflower oil, soy bean oil, soy lecithin; 48
20
(0.9)
70
(1.8)
60
(3.1)
6.7
(0.5)
42
1.2
Lactose-free
for Oral Solution
[U.S.]
0.68
(2.8)
296
1.8
Soy protein isolate, L-methionine; 11
6.9
Sucrose, corn syrup solids; 41
3.6
Oleo, coconut oil, safflower oil, soy bean oil, soy lecithin; 48
20
(0.9)
70
(1.8)
60
(3.1)
6.7
(0.5)
42
1.2
Lactose-free
ProSobee Oral Concentrate
[U.S./Canada]

Oral Solution
[U.S./Canada]
0.68
(2.8)
200
2
Soy protein isolate, amino acids; 12
6.8
Corn syrup solids; 40
3.6
Palm olein, soy oil, coconut oil, high oleic sunflower oil; 48
24
(1.04)
81
(2.1)
71
(3.6)
7.4
(0.61)
56
1.22
Lactose-free; sucrose-free
RCF Oral Concentrate
[U.S./Canada]
0.41
(1.7)
74
2
Soy protein isolate, L-methionine; 20
0
Selected by physician
3.6
Soy oil, coconut oil, mono- and diglycerides, soy lecithin; 80
30
(1.3)
73
(1.9)
70
(3.5)
5
(0.41)
50
0.15
Carbohydrate-free
Soyalac Oral Concentrate
[U.S.]

Oral Solution
[U.S.]

for Oral Solution
[U.S.]
0.68
(2.8)
240
2.1
Soybean solids; 12
6.7
Sucrose, corn syrup solids, carbohydrates from soybean; 39
3.7
Soy oil; 49
30
(1.3)
80
(2.1)
63
(3.1)
8.2
(0.7)
36.9
1.3
Lactose-free
* MCT=Medium-chain triglycerides.
 Values are for a 1:1 dilution with water. However, standard dilution is one part formula base to one part prescribed carbohydrate and water solution. If carbohydrate is not added to this product, a 1:1 dilution with water provides approximately 40.6 KCal/100 mL.


Infant Formulas

Use in adults and adolescents
The administration of infant formula by continuous or intermittent feeding and the amount are very individualized and are a decision of the prescribing physician. {04}

Use in pediatrics
The administration of infant formula by continuous or intermittent feeding and the amount are very individualized and are a decision of the prescribing physician. {04}

Strength(s) usually available
U.S.—
See Table 1, pages $—$.See Table 2, pages $—$. See Table 3, pages $—$.
Canada—
See Table 1, pages $—$.See Table 2, pages $—$. See Table 3, pages $—$.
Packaging and storage:
The unopened product should be stored below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by the manufacturer.

Preparation of infant formula
For formulas in the powder form—This product must be reconstituted before administration. Follow carefully the directions for mixing on the product container.

Note: Powdered infant formulas should not be used in premature or immunocompromised infants in neonatal intensive care settings unless there is no alternative available due to an increased incidence of E. Sakazakii infections. If a powdered formula is the only option available to meet the nutritional needs of the infant, risks of infection can reduced by the following: {40}   • Reconstitute powdered formula using boiling water with subsequent refrigeration before feeding. This process will likely result in some loss of certain water soluble vitamins (e.g., thiamin, ascorbic acid).{40}
   • Prepare only a small amount of reconstituted formula for each feeding to reduce the amount and time that formula is held at room temperature.{40}
   • Minimize the length of time that reconstituted formula is held at room temperature or under refrigeration before it is fed.{40}
   • Minimize the amount of time a formula is at room temperature in the feeding bag and accompanying lines during enteral tube feeding. This time should not exceed 4 hours to avoid potential for significant microbial growth in reconstituted infant formula.{40}



For formulas in the liquid concentrate form—This product must be diluted before administration. Follow carefully the directions for mixing on the product container.

For Enfamil Human Milk Fortifier—This product comes in a powder form and is to be added to the mother's breast milk. Follow carefully the directions for mixing on the product container.

For Similac Natural Care—This product is to be added to the mother's breast milk or fed alternately with breast milk to low-birth-weight infants as directed by a physician {39}. Follow carefully the directions on the product package.

Stability:
For formulas in the ready-to-use form—Formulas should be refrigerated after opening. Any unused portions should be discarded within 24 to 48 hours after opening.

For formulas in the powder or liquid concentrate form—Any unused solution should be refrigerated and used within 24 to 48 hours after preparation, depending on the manufacturer's instructions.

For Enfamil Human Milk Fortifier—Any unused solution of fortifier plus breast milk should be refrigerated and used within 24 hours.

For Similac Natural Care—Any unused solution of fortifier plus breast milk should be refrigerated and used within 24 hours.

Auxiliary labeling:
For ready-to-use liquids and/or liquid concentrates only—

   • Shake container well before opening.



Revised: 05/10/2002



References
  1. Barness L. Infant feeding: formula, solids. Pediatr Clin North Am 1985; 3[2]: 355-62.
  1. American Academy of Pediatrics Committee on Nutrition. On the feeding of supplemental foods to infants. Pediatr 1980; 65[6]: 1178-81.
  1. Panelist comment, April, 1992.
  1. Panelists' comments, 1992.
  1. Epps D. Enteral nutrition: an overview. J Pharm Pract 1988; 1[2]: 92-9.
  1. Sheldon G, Baker C. Complications of nutritional support. Crit Care Med 1980; 8[1]: 35-7.
  1. Smith J, Heymsfield S. Enteral nutrition support: formula preparation from modular ingredients. JPEN 1983; 7[3]: 280-8.
  1. Peters A, Davidson M. Effects of various enteral feeding products on postprandial blood glucose response in patients with type I diabetes. JPEN 1992; 16[1]: 69-74.
  1. Abad-Lacruz A, Gonzalez-Huih F, Esteve M, et al. Liver function test abnormalities in patients with inflammatory bowel disease receiving artificial nutrition: a prospective randomized study of total enteral nutrition vs total parenteral nutrition. JPEN 1990; 14[6]: 618-21.
  1. Saklad J, Graves R, Sharp W. Interaction of oral phenytoin with enteral feedings. JPEN 1986; 10: 322-3.
  1. Bauer L. Interference of oral phenytoin absorption by continuous nasogastric feedings. Neurology (NY) 1982; 32: 570-2.
  1. Maynard G, Jones K, Guidry J. Phenytoin absorption from tube feedings. Arch Intern Med 1987; 147: 1821.
  1. Hatton R. Dietary interaction with phenytoin. Clin Pharm 1984; 3: 110-1.
  1. Anderson W, Weatherstone G, Veal C. Esophageal medication bezoar in a patient receiving enteral feedings and sucralfate. Am J Gastroenterol 1989; 84: 205-6.
  1. Algozzin G, Hill G, Scoggins W, Marr M. Sucralfate bezoar. N Engl J Med 1983; 309[22]: 1387.
  1. Martin J, Lutomski D. Warfarin resistance and enteral feedings. JPEN 1989; 13[2]: 206-8.
  1. Donovan G, Torres-Pinedo R. Chronic diarrhea and soy formulas. Am J Dis Child 1987; 141: 1069-71.
  1. Buller H, Rings E, Montgomery R, Grand R. Clinical aspects of lactose intolerance in children and adults. Scand J Gastroenterol 1991; 26(Suppl 188): 73-80.
  1. American Academy of Pediatrics Committee on Nutrition. Nutritional needs of low-birth-weight infants. Pediatr 1985; 75[5]: 976-86.
  1. Am Pharmaceutical Assoc. Handbook of nonprescription drugs. 9th ed. Washington DC 1990.
  1. Ford R, Hill D, Hosking C. Cows' milk hypersensitivity: immediate and delayed onset clinical patterns. Arch Dis Child 1983; 58: 856-62.
  1. American Academy of Pediatric. Hypoallergenic infant formulas. Pediatr 1989; 83[6]: 1068-9.
  1. Food and Drug Administration. 21 CFR Ch.1 (4-1-91 Edition) 73-83.
  1. Heymsfield S, Head A, McManus C, et al. Respiratory, cardiovascular, and metabolic effects of enteral hyperalimentation: influence of formula dose and composition. Am J Clin Nutr 1984; 40: 116-30.
  1. Sheldon G, Baker C. Complications of nutritional support. Crit Care Med 1980; 8[1]: 35-7.
  1. Panelists' comments, 1993.
  1. American Academy of Pediatrics Committee on Nutrition. Pediatric nutrition handbook. 3rd ed. Elk Grove Village, IL: American Academy of Pediatrics; 1993.
  1. Reviewers' comments, 1993.
  1. Manufacturer comment, 1993.
  1. Reviewers' comments, 1993.
  1. Panelist comment, 1993.
  1. Panelists' comments, 1993.
  1. Panelists' comments, 1993.
  1. Panelists' comments, 1993.
  1. Panelists' comments, 1993.
  1. Panelists' comments, 1993.
  1. Panelists' comments, 1993.
  1. Panelists' comments, 1993.
  1. Manufacturer comment, 1993.
  1. Taylor, Christine J., Ph.D., Important new drug warning from Dear Doctor letter. U.S. Food and Drug Administration. 04/11/2002.
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