DATA STABILITAS SERBUK INJEKSI SETELAH DIREKONSTITUSI

FARMASI RS HERMINA DAAN MOGOT

STABILITAS
NO. NAMA OBAT KANDUNGAN PRODUSEN
SUHU 8 - 25ᵒC SUHU 2 - 8ᵒC
CEFTRIAXONE CEFTRIAXONE HEXPHARM JAYA 6 JAM 24 JAM

8 JAM (WFI BOLUS

MEROFEN MEROPENEM DANKOS INJEK) 48 JAM
8 JAM (NACL 0,9%; 1-
20MG/ML) 48 JAM

3 JAM (D5%; D5%

NACL 0,225%; D5%
NACL 0,9%; D5% KCL
0,15%; MANITOL 2,5%
ATAU 10%; 1-
20MG/ML)
14 JAM

2 JAM (D10%; D%
BICNAT 0,02% INFUS)
8 JAM

24 JAM

BROADCED CEFTRIAXONE KALBE 24 JAM

6 JAM

TERFACEF CEFTRIAXONE SANBE 24 JAM

CEFXON CEFTRIAXONE LAPI 6 JAM 24 JAM

MEROTIK MEROPENEM LAPI 2 JAM 12 JAM

WFI (2 JAM); LARUTAN

(1-20MG/ML) DAPAT
DISIMPAN SELAMA 4 WFI (12 JAM);
JAM (NACL 0,9%, RL), 1 LARUTAN (1-
JAM (D5%, D10%, D5% 20MG/ML) DAPAT
+NACL 0,9%, D5%+RL), DISIMPAN
2 JAM (D5%+NACL SELAMA 24 JAM
0,45%, D5%+NACL (NACL 0,9%), 16
0,225%, MANITOL JAM (MANITOL),
2,5%) 12 JAM (RL), 4
JAM (D5%, , D5%
+RL), 2 JAM
(D10%, D5%
MEROSAN MEROPENEM +NACL 0,9%)
 24 JAM

ZITHROMAX AZITHROMYCIN PFIZER 7 HARI

WFI, RL & NACL 0,9%

45MG/ML (8 JAM);
0,75 GRAM (1,6 ML)
ATAU 1,5 GRAM (3,2
ML)MAX.
KONSENTRASI 125-250
MG/ML
BACTESYN AMPICILIN SULBACTAM KALBE
WFI & NACL 0,9% 45MG/ML (48 JAM) 30MG/ML (72 JAM); RL 4

CEFTAZIDIM CEFTAZIDIME NOVELL 18 JAM 7 HARI

ZIDIFEC CEFTAZIDIME SANBE -

CEFOTAXIME 12 JAM
LAPIXIME LAPI -
PRANZA PANTOPRAZOLE KALBE 12 JAM; 96 JAM (DIH) -
PUMPISEL PANTOPRAZOLE SANBE 12 JAM -
CERNEVIT MULTIVITAMIN KALBE - 24 JAM
OMZ OMEPRAZOLE FERRON 4 JAM -

-
TOPAZOL PANTOPRAZOLE LAPI 12 JAM

24 JAM
KALFOXIM CEFOTAXIME KALBE 5 HARI
BACTESYN AMPICILLIN-SULBACTAM
 PEMBERIAN FISIK
IV: 1 GR DILARUTKAN WARNA LARUTAN JERNIH
DALAM 10 ML PELARUT SAMPAI KUNING ORANGE
DISUNTIK BOLUS 2-4 MENIT;
IM: 1 GR CEFXON
DILARUTKAN DALAM 3,5 ML
LIDOKAIN 1% DI SUNTIK
INTRAGLUTEAL DALAM,
LARUTAN DALAM LIDOKAIN
TIDAK BOLEH DIBERIKAN
SECARA IV.

IV BOLUS: 1 GR DILARUTKAN
DLM PELARUT 10 ML
DIBERIKAN SECARA IV
SALAMA 2-4 MENIT; IV
INFUS: 1 GRAM BROADCED (+) 9,6 ML PELARUT; WARNA
DALAM 25-100ML NACL LARUTAN JERNIH SAMPAI
BERIKAN SELAMA 30 MENIT KUNING ORANGE

1 GR TERFACEF DILARUTAN KUNING MUDA - MERAH

DALAM 10 ML WFI BERIKAN COKLAT TERGANTUNG
IV 2-4 MENIT LAMANYA PENYIMPANAN
 IV: 1GR CEFXON (+) 10 ML PELARUT
DILARUTKAN DALAM 10 ML
PELARUT DISUNTIK BOLUS 2-
4 MENIT; IM: 1 GR CEFXON
DILARUTKAN DALAM 3,5 ML
LIDOKAIN 1% DI SUNTIK
INTRAGLUTEAL DALAM,
LARUTAN DALAM LIDOKAIN
TIDAK BOLEH DIBERIKAN
SECARA IV.

IV BOLUS: DIBERIKAN ± 5 LARUTAN JERNIH, TIDAK

MENIT (REKONSTITUSI BERWARNA, ATAU
DENGAN 20 ML WFI BERWARNA KUNING MUDA
250MG/5ML); IV DRIP: ± 15- JERNIH. TIDAK BOLEH
30 MENIT (REKONSTITUSI DICAMPUT DENGAN
DENGAN 50-200 ML DENGAN OBAT LAIN,
PEKARUT) KOMPATIBEL DENGAN NACL
0,9%, D5%, D10%, D0,02%,
BCNAT 0,9%, NACL 0,9% +
D5%, D5% + NACL 0,225%,
D5% + KCL 0,15%, MANITOL
2,5% ATAU 10%

IV BOLUS: 500 MG + 10 ML
(50MG/ML), 1 GRAM + 20
ML (50MG/ML); IV DRIP: LARUTAN JERNIH ATAU TIDAK
DILARUTAKAN DENGAN BERWARNA ATAU
PELARUT 50-200 M. BERWARNA KUNING PUCAT
IV: 500 MG DITAMBAH 5 ML
WFI (100MG/ML);
LARUTKAN DALAM 250 ML
(2 MG/ML) ATAU 500 ML (1
MG/ML) PELARUT.
PEMAKAIAN INFUS MINIMAL
SELAMA 1 JAM . MINIMAL
PENGGUNAAN SELAMA 2
HARI YANG DIIKUTI DENGAN
TERAPI ORAL SAMPAI 7-10
HARI.KONSENTRASI 1
MG/ML PEMBERIAN LEBIH
DARI 3 JAM DAN 2 MG/ML
LEBIH DARI 1 JAM.

IV BOLUS: PEMBERIAN KURANG STABIL DALAM

SELAMA 3 MENIT; IV DRIP: PELARUT YANG
PEMBERIAN SELAMA 15-30 MENGANDUNF DEXTROSE,
MENIT; IM: DAPAT CARBOHIDRATE, TIDAK
MENGGUNAKAN LIDOCAIN BOLEH DIVAMPUR DENGA
ATAU 0,5% WFI PRODUK DARAH, PROTEIN

WARNA LARUTAN KUNING

KE KUNING KECOKLATAN
DAPAT DIBERIKAN SECARA IV TERGANTUNG PELARUT,
ATAU IM. KOMPATIBEL KONSNETRASI DAN KONDIS
DENGAN WFI, NACL 0,9%, PENYIMPANAN.
D5% KONSENTRASI 4MG/ML.

DAPAT DIBERIKAN SECARA IV

ATAU IM (WFI, LIDOCAIN).
KOMPATIBEL DENGAN WFI,
NACL 0,9%, D5%. PREPARASI:
IM (+ 3ML 280MG/ML); IV
(+10 ML 100MG/ML)

IV: INJEKSI SELAM 3-5 PELARUTAN 1 GRAM

MENIT; IM: DILARUTKAN LAPUXIME DIYTAMBAHKAN 3
DLAAM LIGNOCAIN 1%. ML WFI
WFI, NS, D5%
NS, D5%
WFI (+5ML), NS, D5 KUNING KEORENAN
(+) 10 ML PELARUT ND, WFI

PEMBERIAN SELAMA 2
MENIT (10ML), 15 MENIT
(+) 10 ML NS, D5 (100ML)
IV, IM; PEMBERIAN INFUS
WFI, ND, D5. RL, D5-NS SELAMA 20-60 MENIT
DOSIS

DEWASA & ANAK >12 TAHUN: 1-2 GRAM 1X SEHARI ATAU DOSIS TERBAGI TIDAK LEBIH DARI 4 GRAM; BAYI 14 HARI: 20-50
ANAK > 3 BULAN < 12 TAHUN: 10-20 MG/KGBB SETIAP 8 JAM ; ANAK >50 KG: MENGGUNAKAN DOSIS DEWASA (MENING

DEWASA & ANAK >12 TAHUN: 1-2 GRAM / HARI (DOSIS TUNGGAL ATAU TERBAGI), TIDAK LEBIH DARI 4 GRAM/HARI; BAYI
JA
DOSIS: 1,5 - 12 GRAM/HARI TERBAGI SETIAP 6 ATAU 8 JAM DOSIS MAKSIMAL SULBACTAM 4 GRAM. INFEKSI YANG TIDAK S

DEWASA: 1-6 GRAM/HARI DENGAN DOSIS TERBAGI; ANAK DAN BAYI >2 BULAN: 30-100MG/KGBB/HARI DIBERIKAN DALAM

DEWASA: 1 GRAM TIAP 8-12 JAM; NEONATUS: 30MG/KGBB TIAP 12 JAM; BAYI >1 BULAN - 12 TAHUN: 20-50 MG/KGBB TIA
V 50 MG/KGBB ATAU LEBIH HARUS DIBERIKAN MELALUI INFUS PALING SEDIKIT 30 MENIT
MPAI 48 JAM SETELAH DEMAM. TERAPI DIBERIKAN SELAMA 5-14 HARI.
CEFOTAXIME Administration: I.M.

Inject deep I.M. into large muscle mass.

Administration: I.V.

Inject direct I.V. over 3-5 minutes. Infuse intermittent infusion over 30 minutes.

Administration: I.V. Detail

pH: 5.0-7.5 (injectable solution)

Dietary Considerations

Sodium content of 1 g: 50.5 mg (2.2 mEq)

Reconstitution

Reconstituted solution is stable for 12-24 hours at room temperature and 7-10 days when refrigerated and

Compatibility

Stable in D51/4NS, D51/2NS, D5NS, D5W, D10W, LR, NS; variable stability (consult detailed reference) in periton
0 days when refrigerated and for 13 weeks when frozen. For I.V. infusion in NS or D 5W, solution is stable for 24 hours at room temperatu

detailed reference) in peritoneal dialysis solutions

ble for 24 hours at room temperature, 5 days when refrigerated, or 13 weeks when frozen in Viaflex® plastic containers. Thawed soluti
® plastic containers. Thawed solutions previously of frozen premixed bags are stable for 24 hours at room temperature or 10 days when
om temperature or 10 days when refrigerated.
CEFTRIAXONE Administration: I.M.

Inject deep I.M. into large muscle mass; a concentration of 250 mg/mL or 350 mg/mL is recommended for all

Administration: I.V.

Refer to Compatibility. Do not reconstitute or coadminister with calcium-containing solutions. Infuse intermitt

Administration: I.V. Detail

pH: 6.6 (premixed infusion solution); 6.7 (1% aqueous solution)

Dietary Considerations

Sodium contents: ~83 mg (3.6 mEq) per ceftriaxone 1 g

Storage

Powder for injection: Prior to reconstitution, store at room temperature ≤25°C (≤77°F). Protect

Premixed solution (manufacturer premixed): Store at -20°C; once thawed, solutions are stable for 3 days

Stability of reconstituted solutions:

10-40 mg/mL: Reconstituted in D5W, D10W, NS, or SWFI: Stable for 2 days at room temperature of 25Â

100 mg/mL:

Reconstituted in D5W, SWFI, or NS: Stable for 2 days at room temperature of 25°C (77°F) or fo

Reconstituted in lidocaine 1% solution or bacteriostatic water: Stable for 24 hours at room temp

250-350 mg/mL: Reconstituted in D5W, NS, lidocaine 1% solution, bacteriostatic water, or SWFI: Stabl

Reconstitution

I.M. injection: Vials should be reconstituted with appropriate volume of diluent (including D 5W, NS, SWFI,

Volume to add to create a 250 mg/mL solution:

250 mg vial: 0.9 mL

500 mg vial: 1.8 mL

 1 g vial: 3.6 mL

2 g vial: 7.2 mL

Volume to add to create a 350 mg/mL solution:

500 mg vial: 1.0 mL

1 g vial: 2.1 mL

2 g vial: 4.2 mL

I.V. infusion: Infusion is prepared in two stages: Initial reconstitution of powder, followed by dilution t

Vials: Reconstitute powder with appropriate I.V. diluent (including SWFI, D 5W, D10W, NS) to create an

250 mg vial: 2.4 mL

500 mg vial: 4.8 mL

1 g vial: 9.6 mL

2 g vial: 19.2 mL

Note: After reconstitution of powder, further dilution into a volume of compatible solution (eg, 5

Piggyback bottle: Reconstitute powder with appropriate I.V. diluent (D 5W or NS) to create a resulting

1 g bottle:10 mL

2 g bottle: 20 mL

Note: After reconstitution, to prepare the final infusion solution, further dilution to 50 mL or 100

Compatibility

Stable in D5W with KCl 10 mEq, D51/4NS with KCl 20 mEq, D51/2 NS, D5W, D10W, NS, mannitol 5%, mannitol 10%,
 mg/mL is recommended for all vial sizes except the 250 mg size (250 mg/mL is suggested); can be diluted with 1:1 water and 1% lidocaine

aining solutions. Infuse intermittent infusion over 30 minutes.

≤25°C (≤77°F). Protect from light.

d, solutions are stable for 3 days at room temperature of 25°C (77°F) or for 21 days refrigerated at 5°C (41°F). Do not refreeze.

days at room temperature of 25°C (77°F) or for 10 days when refrigerated at 4°C (39°F). Stable for 26 weeks when frozen at -20°C wh

mperature of 25°C (77°F) or for 10 days when refrigerated at 4°C (39°F).

table for 24 hours at room temperature of 25°C (77°F) or for 10 days when refrigerated at 4°C (39°F).

cteriostatic water, or SWFI: Stable for 24 hours at room temperature of 25°C (77°F) or for 3 days when refrigerated at 4°C (39°F).

diluent (including D 5W, NS, SWFI, bacteriostatic water, or 1% lidocaine) to make a final concentration of 250 mg/mL or 350 mg/mL.
of powder, followed by dilution to final infusion solution.

WFI, D 5W, D10W, NS) to create an initial solution of ~100 mg/mL. Recommended volume to add:

me of compatible solution (eg, 50-100 mL of D 5W or NS) is recommended.

D 5W or NS) to create a resulting solution of ~100 mg/mL. Recommended initial volume to add:

, further dilution to 50 mL or 100 mL volumes with the appropriate I.V. diluent (including D 5W or NS) is recommended.

NS, mannitol 5%, mannitol 10%, sodium bicarbonate 5%, bacteriostatic water, sterile water for injection. Incompatible with calcium-contai
1:1 water and 1% lidocaine for I.M. administration.

F). Do not refreeze.

s when frozen at -20°C when reconstituted with D 5W or NS. Once thawed (at room temperature), solutions are stable for 2 days at room t

rated at 4°C (39°F).

mL or 350 mg/mL.
patible with calcium-containing solutions (eg, LR, Hartmann’s solution, parenteral nutrition solutions). Variable stability (consult detaile
stable for 2 days at room temperature of 25°C (77°F) or for 10 days when refrigerated at 4°C (39°F); does not apply to manufacturer's
le stability (consult detailed reference) in peritoneal dialysis solutions.
ot apply to manufacturer's premixed bags. Do not refreeze.
DEXAMETASONE

Storage

Injection solution: Store at room temperature; protect from light and freezing.

Stability of injection of parenteral admixture at room temperature (25°C): 24 hours.

Stability of injection of parenteral admixture at refrigeration temperature (4°C): 2 days; protect from light and freezin

Reconstitution

Injection should be diluted in 50-100 mL NS or D 5W.

Compatibility

Stable in D5W, NS.

protect from light and freezing.
ONDANSETRON

Administration: I.M.

Should be given undiluted.

Administration: I.V.
IVPB: Dilute in 50 mL D5W or NS. Infuse over 15-30 minutes; 24-hour continuous infusions have been reported, but are rar

Chemotherapy-induced nausea and vomiting: Give first dose 30 minutes prior to beginning chemotherapy.

I.V. push: Prevention of postoperative nausea and vomiting: Single doses may be administered I.V. injection over 2-5 minutes as

Administration: I.V. Detail

pH: 3-4

Administration: Oral

Oral dosage forms should be given 30 minutes prior to chemotherapy; 1-2 hours before radiotherapy; 1 hour prior to the induc

Orally-disintegrating tablets: Do not remove from blister until needed. Peel backing off the blister, do not push tablet throu

The I.V. preparation has been successful when administered orally.

Dietary Considerations

Take without regard to meals.

Orally-disintegrating tablet contains <0.03 mg phenylalanine

Storage

Oral solution: Store between 15°C and 30°C (59°F and 86°F). Protect from light.

Premixed bag: Store between 2°C and 30°C (36°F and 86°F). Protect from light.

Tablet: Store between 2°C and 30°C (36°F and 86°F).

Vial: Store between 2°C and 30°C (36°F and 86°F). Protect from light. Stable when mixed in D 5W or NS for 48 hours a

Reconstitution

Prior to I.V. infusion, dilute in 50 mL D 5W or NS.

Compatibility

Stable in D51/2NS, D5NS, D5W, mannitol 10%, LR, NS, sodium chloride 3%; do not mix injection with alkaline solutions.
been reported, but are rarely used.

chemotherapy.

jection over 2-5 minutes as undiluted solution.

y; 1 hour prior to the induction of anesthesia.

er, do not push tablet through. Using dry hands, place tablet on tongue and allow to dissolve. Swallow with saliva.

n D 5W or NS for 48 hours at room temperature.

kaline solutions.
PANTOPRAZOLE

Storage

Oral: Store tablet and oral suspension at controlled room temperature of 20°C to 25°C (68°F to 77°F).

I.V.: Prior to reconstitution, store at controlled room temperature of 20°C to 25°C (68°F to 77°F). Protect from light. W

Reconstitution

Reconstitute with 10 mL NS (final concentration 4 mg/mL). Reconstituted solution may be given intravenously (over 2 minutes

Compatibility

Stable in D5W, LR, NS.

F to 77°F).

7°F). Protect from light. When reconstituted, solution is stable up to 96 hours at room temperature (Johnson, 2005). The preparation shou

avenously (over 2 minutes) or may be added to 100 mL D 5W, NS, or LR (for 15-minute infusion).
005). The preparation should be stored at 3°C to 5°C (37°F to 41°F) if it is stored beyond 48 hours to minimize discoloration. If further
ize discoloration. If further diluting in 100 mL of D 5W, LR, or NS, dilute within 6 hours of reconstitution. Diluted solution is stable at room te
solution is stable at room temperature for up to 24 hours from the time of initial reconstitution; protection from light is not required.
light is not required.
RANITIDINE

Administration: I.M.

No dilution is needed

Administration: I.V.

Intermittent bolus: Dilute vials to 2.5 mg/mL; infuse at 4 mL/minute (5 minutes)

Intermittent infusion: Dilute vials to 0.5 mg/mL; infuse at 5-7 mL/minute (15-20 minutes)

Continuous I.V. infusion: Administer at 6.25 mg/hour and titrate dosage based on gastric pH by continuous infusion over 2

Administration: I.V. Detail

I.V. must be diluted and may be administered IVP or IVPB or continuous I.V. infusion.

pH: 6.7-7.3

Administration: Oral

EFFERdose®: Should not be chewed, swallowed whole, or dissolved on tongue: 25 mg tablet: Dissolve in at least 5 mL (1 teasp

Dietary Considerations

Oral dosage forms may be taken with or without food.

Zantac® EFFERdose®: Effervescent tablet 25 mg contains sodium 1.33 mEq/tablet and phenylalanine 2.81 mg/tablet

Storage

Injection: Vials: Store between 4°C to 30°C (39°F to 86°F). Protect from light. Solution is a clear, colorless to yellow so

Premixed bag: Store between 2°C to 25°C (36°F to 77°F). Protect from light.

EFFERdose® formulations: Store between 2°C to 30°C (36°F to 86°F).

Syrup: Store between 4°C to 25°C (39°F to 77°F). Protect from light.

Tablets: Store in dry place, between 15°C to 30°C (59°F to 86°F). Protect from light.

Reconstitution
Vials can be mixed with NS or D5W.

Intermittent bolus injection: Dilute to maximum of 2.5 mg/mL.

Intermittent infusion: Dilute to maximum of 0.5 mg/mL.

Compatibility

Stable in D51/2NS, D5W, D10W, fat emulsion 10%, LR, NS, sodium bicarbonate 5%; for injection, do not add other medication
continuous infusion over 24 hours

lve in at least 5 mL (1 teaspoonful) of water; wait until completely dissolved before administering

alanine 2.81 mg/tablet

clear, colorless to yellow solution; slight darkening does not affect potency. Vials mixed with NS or D 5W are stable for 48 hours at room tem
o not add other medications to premixed bag; variable compatibility (consult detailed reference) in D5LR, TPN.
e for 48 hours at room temperature.