TDM Monitoring Sampling Guideline Form 2022 Iso Code

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HSAJB/FAR-66/VER2.

0/2022

HOSPITAL SULTANAH AMINAH JOHOR BAHRU (HSAJB) Pharmacy Ref No:


CLINICAL PHARMACOKINETICS SERVICE
Therapeutic Drug Monitoring (TDM) Request Form PhIS Report No:

 3 – 5 ml of blood sample is needed for analysis of 1 – 3 drugs. Date Received :


Note :  Use plain tubes for all the drugs except for Cyclosporin/Tacrolimus/Sirolimus/Everolimus (EDTA tube).
 Correct information is crucial as interpretation of results is dependent on the information provided. Time Received :
PATIENT PROFILE
Name : Ward/Unit : RN :
Age : Gender : M/F Race: M /C/ I/O IC :
Weight (kg) : Height (cm) : DOA :
CLINICAL SUMMARY AND DIAGNOSIS

PATIENT CONDITION INDICATION FOR REQUEST


 Oedema  Liver Disease  Dehydration  Therapeutic Monitoring  Non-compliance
Others
 Dialysis  Burn  Fit Frequency: ….………  Suspected Toxicity 
……………………….
LATEST LAB RESULTS CONCURRENT MEDICATIONS
Parameters Date Results (unit) Parameters Date Results(unit)
Blood Urea Temperature
Na+ / K+ WBC
Creatinine ALT / AST / ALP
Albumin HR
Culture & Sensitivity

Drug Analysis Dose Pre-dose / Post- dose


Present Dose Dose Given Random
( Tick  where Started Post 2 / C0 / Post 6 / C2
Regimen
appropriate )
Date Time Date Time Date Time Date Time Date Time
Acetaminophen
Amikacin
Carbamazepine
Cyclosporin
Digoxin
Everolimus
Gentamicin
Lithium
Methotrexate
Phenobarbitone
Phenytoin
Salicylate
Sirolimus
Tacrolimus
Theophylline
Valproic acid
Vancomycin
Others (please specify):
REFER TO TDM SERUM SAMPLING GUIDELINES(refer back page)
For injectable drug being analysed : REQUESTED BY:
Infusion rate : ……………………………………………….
Duration of Infusion : …………………………………….. Doctor’s Signature : _______________ Name & Stamp : _______________ Date : ___________
Drug analysis Result Therapeutic Range Calculated Pharmacokinetic Parameters Time
Finished:
Ke : hr-1 t1/2 : hr Vd: L/kg
FOR PHARMACY USE ONLY

Cmin : µg/ml Cmax : µg/ml


Test done
AUC24: µg.hr/ml by:
Css : Cadjusted : CrCl:
Pharmacist’s Assessment & Recommendation :

Pharmacist’s signature & stamp


Informed : DR / SN / PF ……………………on ……………… at …………………am/pm
HSAJB/FAR-66/VER2.0/2022
TDM SERUM SAMPLING GUIDE
DRUG STEADY STATE SAMPLING TIME THERAPEUTIC RANGE
(Time to monitor plasma concentrations) (*The target reference ranges may SAMPLE
SINGLE DAILY MULTIPLE SINGLE DAILY MULTIPLE varybasedon institutional reference& STABILITY
DOSING DOSING DOSING DOSING indication)

Trough:
SDD: <2 mcg/ml
AMIKACIN Neonates: < 5mcg/ml
1st sample MDD & Dialysis : <10mcg/ml
Pre 8 hours
Post 2 hours
0 – 30 min
AMINOGLYCOSIDE

#Peak:
before dose Neonates, MDD: 20-40 mcg/ml
2nd sample
SDD : *60 mcg/ml
2nd dose 3rdor4thdose Post 6 hours
Post
Trough:
30 min after 30 SDD, Neonates & synergistic: <1mcg/ml
(or any two post min infusion MDD & Dialysis: <2mcg/ml
sampling at completed
least 2 t1/2 apart) #Peak:

Neonates: 5-12 mcg/ml


GENTAMICIN 4 hours
MDD: 5-10 mcg/ml
SDD: *10-30 mcg/ml
Synergy: 3-4 mcg/ml (conventional dosing against
Impaired Renal Function: Gram positive organism)
After24 hours (after 1st stat dose) or Pre-HD
#
adjustable according to indication
Normal Renal Function : Trough:
4thdose Non-complicated infection :10 – 15 mcg/ml
Impaired Renal Function : Complicated infection :15 – 20 mcg/ml
Trough level: 30mins before dose
After 24hours (after 1st stat dose) Peak: 25 – 40 mcg/ml
VANCOMYCIN Peak level: 1 hour after the infusion 4 hours
completed
Continuous Infusion: Continuous Infusion: 15 ‒ 25mcg/mL
Take a sample after 12 – 24 hours of
starting the continuous infusion AUC24/MIC : 400-600mg.h/L
Initiation : 2-3 weeks (Induction Phase)
CARBAMAZEPINE MD : 2-5 days after initiation and dose Pre: 0 – 30 min before dose 4 – 12 mcg/ml 8 hours
changes
Epilepsy : 10 – 40 mcg/ml
Without LD : 2- 3 weeks
PHENOBARBITAL Pre: 0 – 30 min before dose Refractory status epileptics : > 70mcg/ml 8 hours
After LD : 2 – 3 hrs after administration
(up to 100mcg/ml)
With LD :Oral: 24 hours
IV : 2 hours (if rapid therapeutic 10-20 mcg/ml
PHENYTOIN Pre: 0 – 30 min before dose 8 hours
concentration is needed) Neonates: 8 – 15 mcg/mL
Without LD :7 – 10 days
Epilepsy : 50 – 100 mcg/ml
VALPROIC ACID 2- 4 days Pre: 0 – 30 min before dose 2 days
Psychiatric Disorder: 50 – 125 mcg/ml
Adults : 2days
Children : 1 – 2 days
Apnoea/Bradycardia in neonates : 5 – 10 mcg/ml
THEOPHYLLINE Infants : 1 – 5 days Pre: 0 – 30 min before dose 8 hours
Asthma/COAD : 10 – 20 mcg/ml
Newborn : 120 hrs (5 days)
Premature neonates : 150 hrs (6 days)
Pre :
Without LD : 7 – 14 days 0-30 min before dose
CHF : 0.5 – 0.9 ng/mL
DIGOXIN With LD : 12 – 24 hours Post : 8 hours
AF : 0.8 – 2 ng/mL
ESRD : 15-20 days Oral : At least 6 hours after dose
IV : At least 4 hours after dose
According to drug indication

CYCLOSPORINE Co: Immediately before next dose


3-5 days General Therapeutic Range: 7 days
(EDTA tube) C2: 2 hours after dose
C0∼100-500mcg/L
C2∼600 - 1700mcg/L
TACROLIMUS
3 – 5 days Pre : 0 – 30 min before dose 5 – 20 mg / ml 7 days
(EDTA tube)
SIROLIMUS Adults : 5 – 7days
Pre : 0 – 30 min before dose 4 – 24 mg/ml 8 days
(EDTA tube) Children : 3 – 5 days
METHOTREXATE 24 - 48 hours 24hr or 48hr post infusion Variable – Refer to specific protocols 2 days
(Room Temp)

Toxic :>200 mg/L


Therapeutic : 5 – 7 days Therapeutic : 1 – 3 hours after dose
SALICYLATE Anti-inflammatory : 150 ‒ 300 mg/L 8 hours
Toxicity :Random Toxicity :Random
Rheumatic Fever: 250 ‒ 400 mg/L
Toxicity : 4 hours after single acute
ingestion
PARACETAMOL Toxicity : 4 hours after ingestion Refer Rummack Matthew Nomogram 8 hours
Unknown Ingestion Time: 2 samples
at 2 hours interval
Pre: 12 hours after dose
(twice daily dosing)
LITHIUM 4 – 5 days 0.5 – 1.5 mmol/L 24 hours
Pre: 24 hours after dose
(once daily dosing)
References:
i) Martindale 33th Ed. 2002ii) Basic Clinical Pharmacokinetic (Winter) 2010 iii) Drug Information Handbook 10 th Ed. 2003 iv) British National Formulary, Vol. 70 Sept 2015 v) Micromedex(R) Healthcare
Series 2018vi)Infectious Disease Society of America vii)Drug Doses, Frank Shank, 17 th Edition 2017vii)https://journals.lww.com/drug-monitoring/Abstract/200/08000/
Stability_of_Sirolimus_Rapamycin_in_Whole_Blood.10.aspx., viii)https://journals.lww.com/drug-monitoring/Abstract/2003/02000/In_Vitro_Stability_Study_of_Methotrexate_in_Blood.12.aspx. Ix) Gidwani
Lithium Stability Study 2018. x) Clinical Therapeutic/Vol.22, SUPPL.B,2000 Measurement of Sirolimus in Whole Blood using High Performance Liquid Chromatography with Ultraviolet Detection, D.W.Holt
et.al., xi) Stability of Tacrolimus (FK506) and Cyclosporin G in Whole Blood, T.M. Annesley. et. al., TDM 17:361-365 1995 Lippincott-Raven Publishers, Philadelphia

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