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AMMONIUM CHLORIDE /85

AMMONIUM CHLORIDE
AHFS 40:04

Administration Ammonium chloride injection is a concentrate that


is generally administered by slow intravenous infusion after dilution
of one or two vials (100 to 200 mEq) in 500 to 1000 mL of sodium
chloride 0.9% injection. The infusion rate in adults of the diluted
solution should not exceed 5 mL/min. (1)

Products Ammonium chloride additive solution is available in 20mL vials containing 5.35 g of ammonium chloride, which provides
100 mEq (5 mEq/mL) of NH4+ and Cl ions. The solution also contains 2 mg/mL of disodium edetate as a stabilizer and hydrochloric
acid to adjust the pH. The additive solution is intended to be used
only after further dilution in a larger volume of sodium chloride 0.9%
injection. (1)
One gram of ammonium chloride contains 18.7 mEq each of ammonium and chloride ions. (4)

Stability Store at controlled room temperature and protect from


freezing. Highly concentrated solutions of ammonium chloride may
crystallize when exposed to low temperatures. If such crystallization
does occur, warming to room temperature in a water bath is recommended. (1; 4)
Ammonium chloride is stated to be incompatible with alkalies and
their carbonates. (4)

pH About 4.4 with a range of 4 to 6. (1)


Osmolarity 10 mOsm/mL (calculated). (1)

Compatibility Information
Solution Compatibility
Ammonium chloride
Solution

Mfr

Mfr

Conc/L

Remarks

Ref

C/I

DextroseRingers injection combinations

AB

AB

400 mEq Physically compatible

DextroseRingers injection, lactated,


combinations

AB

AB

400 mEq Physically compatible

Dextrosesaline combinations

AB

AB

400 mEq Physically compatible

Dextrose 2.5%

AB

AB

400 mEq Physically compatible

Dextrose 5%

AB

AB

400 mEq Physically compatible

Dextrose 10%

AB

AB

400 mEq Physically compatible

Ionosol products

AB

AB

400 mEq Physically compatible

Ringers injection

AB

AB

400 mEq Physically compatible

Ringers injection, lactated

AB

AB

400 mEq Physically compatible

Sodium chloride 0.45%

AB

AB

400 mEq Physically compatible

Sodium chloride 0.9%

AB

AB

400 mEq Physically compatible

Sodium lactate M

AB

AB

400 mEq Physically compatible

Ref

C/I

16

Additive Compatibility
Ammonium chloride

Drug

Dimenhydrinate

Mfr

SE

Conc/L

500 mg

Mfr

AB

Conc/L

20 g

Test
Soln

D5W

Remarks

Physically compatible

15

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86/AMMONIUM CHLORIDE

Y-Site Injection Compatibility (1:1 Mixture)


Ammonium chloride
Drug

Warfarin sodium

Mfr

DU
DU
DU

Conc

0.1 mg/mLa
0.1 mg/mLb
2 mg/mLc

Mfr

AB
AB
AB

Conc

5 mEq/mL
5 mEq/mL
5 mEq/mL

Remarks

Ref

C/I

Subvisible haze forms immediately


Physically compatible for 24 hr at 23 C
Immediate turbidity becoming a precipitate
in 24 hr at 23 C

2011
2011
2011

I
C
I

Tested in dextrose 5%.


Tested in sodium chloride 0.9%.
c Tested in sterile water for injection.
b

AMOXICILLIN SODIUM
AHFS 8:12.16.08
Products Amoxicillin sodium is available in vials containing the
equivalent of amoxicillin 250 mg, 500 mg, and 1 g. (38; 115)
For intramuscular injection, reconstitute the vials with the following volumes of sterile water for injection (38; 115):
Vial Size
250 mg
250 mg
500 mg
500 mg
1g
1g

Volume of Diluent

Final Volume

1.5 mL
2.0 mL
2.0 mL
2.5 mL
2.5 mL
4.0 mL

1.7 mL
2.2 mL
2.4 mL
2.9 mL
3.3 mL
4.8 mL

Alternatively, the 1-g vial may be reconstituted with lidocaine hydrochloride 1% or procaine hydrochloride 0.5%. However, a greater
volume of local anesthetic is required to dissolve amoxicillin 1 g than
sterile water for injection. Dividing a 1-g dose into two 500-mg portions given at different sites has been suggested. (38; 115)
For intravenous injection, reconstitute the vials with the following
volumes of sterile water for injection (38):
Vial Size
250 mg
500 mg
1g

Volume of Diluent

Final Volume

5 mL
10 mL
20 mL

5.2 mL
10.4 mL
20.8 mL

Alternatively, the 250-mg vials may be reconstituted with 4.8 mL


of diluent to yield a 50-mg/mL solution. The 500-mg vials may be
reconstituted with 4.6 mL of diluent to yield a 100-mg/mL solution.
(115)
For intravenous infusion, the reconstituted drug may be added to
an intravenous solution in a minibag or burette chamber of an administration set. (38)
Sodium Content Amoxicillin sodium contains 3.3 mmol of sodium
per gram of drug. (38)
Trade Name(s) Amoxil, Clamoxyl, Ibiamox, many others.

Administration Amoxicillin sodium may be administered by intramuscular injection, direct intravenous injection over three to four minutes, or intermittent intravenous infusion over 30 to 60 minutes. (38;
115)
Stability Store amoxicillin sodium vials in a cool, dry place protected from light. (38; 115) After reconstitution with sterile water for
injection, a transient pink color or slight opalescence may appear.
Reconstituted solutions are normally a pale straw color. The reconstituted solution should be administered or diluted immediately in a
suitable infusion solution. (38; 115)
Concentration Effects Amoxicillin sodium 50 mg/mL is substantially
less stable in all infusion solutions than at lower concentrations of 10
or 20 mg/mL. (1469)
Freezing Solutions Amoxicillin sodium 10 mg/mL in sterile water for
injection was unstable when stored frozen at between 0 and 20 C
but was stable for 13 days when stored below 30 C. Amoxicillin
sodium 10 mg/mL in sterile water for injection was stable for only
two days at 0 C in the unfrozen state. (1470)
Amoxicillin sodium 10 mg/mL in sodium chloride 0.9% was stable
for 10.5 days at 0 C (unfrozen) and for 14 hours when frozen at
19 C; in dextrose 5%, the comparative times were 12.5 and 8.4
hours, respectively. (1471)
The processes of freezing and thawing increase the degradation rate
of amoxicillin sodium 10 mg/mL in sodium chloride 0.9% in PVC
bags (Travenol). Freezing and thawing (natural or microwave) could
account for a 5 to 10% loss of amoxicillin; the losses will be affected
by the time to reach the equilibrium frozen temperature. (1472)
Sorption Acetazolamide sodium was shown not to exhibit sorption
to PVC bags and tubing, polyethylene tubing, Silastic tubing, polypropylene syringes, and trilayer bags of polyethylene, polyamide, and
polypropylene. (536; 606; 1918)
Filtration Amoxicillin sodium 1.98 mg/mL in sodium chloride 0.9%
did not exhibit signicant drug loss due to sorption to a 0.22-m
cellulose ester membrane lter (Ivex-HP, Millipore). (1034)

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AMOXICILLIN SODIUM / 87

Compatibility Information
Solution Compatibility
Amoxicillin sodium
Solution

Mfr

Mfr

Conc/L

Dextrose 5%

1g

9% loss in 4 hr and 34% loss in 24 hr at room


temperature
14 and 18% losses in 3 hr at 10 and 20 g/L, respectively, and 14% loss in 1.5 hr at 50 g/L at
25 C

10, 20,
50 g
Sodium chloride 0.9%

Remarks

Ref

C/I

768

1469

1g
10, 20,
50 g
10 g

10% loss in 24 hr at room temperature


3 and 7% losses in 6 hr at 10 and 20 g/L, respectively, and 12% loss in 4 hr at 50 g/L at 25 C
Less than 3% loss in 24 hr at 0 C

768
1469

C
I

1472

Sodium chloride 0.9% with


potassium chloride 0.3%

10, 20,
50 g

4 and 9% losses in 8 hr at 10 and 20 g/L, respectively, and 9% loss in 3 hr at 50 g/L at 25 C

1469

Sodium lactate 16 M

10, 20,
50 g

10% loss in 6 hr at 10 and 20 g/L and 14% loss in


4 hr at 50 g/L at 25 C

1469

TR

Tested in PVC containers.

Additive Compatibility
Amoxicillin sodium

Drug

Mfr

Conc/L

Mfr

Test
Soln

Conc/L

Remarks

Ref

C/I

Ciprooxacin

2g

10 g

Precipitates immediately

1473

Dextran 40

10%

10, 20,
50 g
10, 20,
50 g

D5W

9, 12, and 12% amoxicillin loss at 10, 20,


and 50 g/L, respectively, in 1 hr at 25 C
12, 14, and 20% amoxicillin loss at 10, 20,
and 50 g/L, respectively, in 3 hr at 25 C

1469

1469

Blue discoloration formed in 2 hr. Amoxicillin and imipenem losses of 40 and


72%, respectively, in 12 hr

2800

10%

NS

Imipenemcilastatin sodium

GSK

4g

MSD

8g

Midazolam HCl

RC

50 and
250 mg
400 mg

BE

10 g

NS

Transient precipitate

355

BE

10 g

NS

Precipitate forms immediately

355

D5W, NS

Precipitate forms within 1 hr

1473

9% amoxicillin loss in 6 and 4 hr at 10 and


20 g/L, respectively, and 15% loss in
4 hr at 50 g/L at 25 C
10 and 13% amoxicillin loss in 4 hr at 10
and 20 g/L, respectively, and 17% loss
in 3 hr at 50 g/L at 25 C

1469

1469

RC
Peoxacin

4g

10 g

Sodium bicarbonate

2.74%

10, 20,
50 g

8.4%

10, 20,
50 g

Amoxicillin sodium added to ciprooxacin solution.

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88/AMOXICILLIN SODIUM

Y-Site Injection Compatibility (1:1 Mixture)


Amoxicillin sodium
Drug

Mfr

Conc

Mfr

Conc

Remarks

Ref

C/I

Lorazepam

WY

0.33 mg/mLa

SKB

50 mg/mL

Visually compatible for 24 hr at 22 C

1855

Midazolam HCl

RC

5 mg/mL

SKB

50 mg/mL

White precipitate forms immediately

1855

Visually compatible for 24 hr at 22 C

1767

TPN #189

50 mg/mL

Tested in sodium chloride 0.9%.


b Refer to Appendix I for the composition of parenteral nutrition solutions. TPN indicates a 2-in-1 admixture.

AMOXICILLIN SODIUMCLAVULANATE
(CO-AMOXICLAV)
AHFS 8:12.16.08
Products Amoxicillin sodiumclavulanic acid is available in 600mg vials containing amoxicillin sodium 500 mg and clavulanic acid
100 mg as the potassium salt and in 1.2-g vials containing amoxicillin
sodium 1 g and clavulanic acid 200 mg as the potassium salt. Reconstitute the 600-mg vials with 10 mL and the 1.2-g vials with 20 mL
of sterile water for injection. (38; 115)
Sodium and Potassium Content Amoxicillin sodiumclavulanic acid
contains 3.1 mmol of sodium and 1 mmol of potassium in 1.2 g of
drug product. The 600-mg vials contain 1.55 mmol of sodium and
0.5 mmol of potassium. (38)
Trade Name(s) Augmentin, Clavulin, Flanamox.
Administration Amoxicillin sodiumclavulanic acid may be administered by intravenous injection or intermittent infusion. It is not suitable for intramuscular administration. When given by intravenous
injection directly into a vein or via a drip tube, it should be injected
slowly over three to four minutes. For intravenous infusion, add the
contents of the 600-mg or 1.2-g vial to 50 or 100 mL, respectively,
of sterile water for injection or sodium chloride 0.9% and then infuse
over 30 to 40 minutes, completing the administration within four
hours of reconstitution. (38; 115)
Stability Amoxicillin sodiumclavulanic acid in intact vials should
be stored at 25 C or below. The injection should be used within 20
minutes after reconstitution with sterile water for injection. (38; 115)

The manufacturer indicates that infusions of amoxicillin sodium


clavulanic acid in sterile water for injection or sodium chloride 0.9%
are stable at 5 C for up to eight hours. Amoxicillin sodiumclavulanic acid is less stable in dextrose, dextran, or bicarbonate-containing
infusion solutions and should not be added to them. However, it may
be injected into the tubing of running infusions of these solutions.
(38; 115)
Amoxicillin sodiumclavulanic acid should not be added to infusion solutions containing dextrose, dextran, sodium bicarbonate,
blood products, proteinaceous uids, or intravenous fat emulsions.
(38; 115)
The stability of amoxicillin sodiumclavulanic acid is governed by
the more rapid degradation of clavulanic acid compared with amoxicillin. (1474)
Stability is also concentration dependent; amoxicillin sodiumclavulanic acid is less stable in high concentrations. Therefore, it is suggested that reconstituted solutions be used immediately or diluted
without delay. (1474)
Freezing Solutions Amoxicillin sodiumclavulanic acid 1.2 g reconstituted with 20 mL and diluted in 100 mL of sterile water for injection was frozen at 20 C for four hours, followed by microwave
thawing. Solutions retained only 65% of the initial clavulanic acid
content. (1474)
Sorption Amoxicillin sodiumclavulanic acid did not undergo sorption to PVC containers or administration tubing. (1474)

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AMOXICILLIN SODIUMCLAVULANATE / 89

Compatibility Information
Solution Compatibility
Amoxicillin sodiumclavulanic acid
Solution

Mfr

Mfr

Conc/L

Remarks

Ref

C/I

Dextrose 5%

BTa

BE

8.33 +
1.67 g

Physically compatible with 10% loss within 30


min at 25 C and 1.2 hr at 5 C

1474

Ringers injection

BTa

BE

8.33 +
1.67 g

Physically compatible with 10% loss in 4.1 hr at


25 C

1474

Ib

Ringers injection, lactated

BTa

BE

8.33 +
1.67 g

Physically compatible with 10% loss in 4.1 hr

1474

Ib

Sodium chloride 0.9%

BTa

BE

8.33 +
1.67 g

Physically compatible with 10% loss in 4.4 hr at


25 C and 12.5 hr at 5 C

1474

Ib

Sodium chloride 0.9% with


potassium chloride 0.3%

BTa

BE

8.33 +
1.67 g

Physically compatible with 10% loss in 3.9 hr at


25 C

1474

Ib

Sodium lactate 16 M

BTa

BE

8.33 +
1.67 g

Physically compatible with 10% loss in 4.3 hr at


25 C

1474

Ib

Ref

C/I

Precipitates immediately

1473

Physically compatible with 8% clavulanate


loss in 2 hr and 25% loss in 6 hr at
21 C. 7 to 8% amoxicillin and no metronidazole loss in 6 hr at 21 C

1920

Precipitate forms within 1 hr

1473

a
b

Tested in polyethylene containers.


Incompatible by conventional standards; may be used in shorter time periods.

Additive Compatibility
Amoxicillin sodiumclavulanic acid

Drug

Mfr

Conc/L

Ciprooxacin
BAY

10 + 2 g

5g

Peoxacin

Test
Soln

Conc/L

2g

Metronidazole

Mfr

BE

Remarks

20 + 2 g

4g

10 + 2 g

D5W, NS

Amoxicillin sodiumclavulanic acid added to ciprooxacin solution.

Y-Site Injection Compatibility (1:1 Mixture)


Amoxicillin sodiumclavulanic acid
Drug

Mfr

Conc

Mfr

Conc

Remarks

Ref

C/I

Amiodarone HCl

SAN

12.5 mg/mL

GSK

10 + 2 mg/
mL

Turbidity appeared immediately

2727

Clarithromycin

AB

4 mg/mLa

BE

20 + 4 mg/
mLa

Visually compatible for 72 hr at both 30


and 17 C

2174

Lorazepam

WY

0.33 mg/mLb

SKB

20 + 2 mg/
mL

Visually compatible for 24 hr at 22 C

1855

Midazolam HCl

RC

5 mg/mL

SKB

20 + 2 mg/
mL

White precipitate forms immediately

1855

a
b

Tested in dextrose 5%.


Tested in sodium chloride 0.9%.