pamidronic acid 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
calcium metabolism regulator, pharmaceutical aid	2048	40391-99-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: pamidronic acid pamidronate disodium pamidronate pamidronate disodium hydrate	An aminobisphosphonate that inhibits BONE RESORPTION and is used for the treatment of osteolytic lesions, bone pain, and severe HYPERCALCEMIA associated with malignancies. Molecular weight: 235.07 Formula: C3H11NO7P2 CLOGP: -4.32 LIPINSKI: 1 HAC: 8 HDO: 6 TPSA: 161.31 ALOGS: -1.17 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

pamidronic acid
pamidronate disodium
pamidronate
pamidronate disodium hydrate

An aminobisphosphonate that inhibits BONE RESORPTION and is used for the treatment of osteolytic lesions, bone pain, and severe HYPERCALCEMIA associated with malignancies.

Molecular weight: 235.07
Formula: C3H11NO7P2
CLOGP: -4.32
LIPINSKI: 1
HAC: 8
HDO: 6
TPSA: 161.31
ALOGS: -1.17
ROTB: 4

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
60	mg	P

ADMET properties:

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Property	Value	Reference
MRTD (Maximum Recommended Therapeutic Daily Dose)	5.47 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
EoM (Fraction excreted unchanged in urine)	46 %	Benet LZ, Broccatelli F, Oprea TI
t_half (Half-life)	32 hours	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
CL (Clearance)	2.50 mL/min/kg	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	1.80 L/kg	Lombardo F, Berellini G, Obach RS
BA (Bioavailability)	1 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
fu (Fraction unbound in plasma)	0.70 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Oct. 31, 1991	FDA

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Osteonecrosis of jaw	753.34	18.26	273	11634	34850	63442265
Osteonecrosis	704.12	18.26	237	11670	24293	63452822
Bone disorder	239.27	18.26	104	11803	21222	63455893
Tooth extraction	216.62	18.26	79	11828	10185	63466930
Plasma cell myeloma	168.83	18.26	97	11810	35808	63441307
Atypical femur fracture	166.12	18.26	55	11852	5317	63471798
Sequestrectomy	160.35	18.26	36	11871	790	63476325
Bone debridement	145.23	18.26	27	11880	218	63476897
Malignant neoplasm progression	118.11	18.26	108	11799	82013	63395102
Infusion site coldness	116.60	18.26	22	11885	194	63476921

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Osteonecrosis	430.41	19.58	145	6487	14745	34935554
Osteonecrosis of jaw	294.48	19.58	115	6517	17774	34932525
Tooth extraction	164.29	19.58	53	6579	4675	34945624
Bone disorder	157.74	19.58	55	6577	6160	34944139
Plasma cell myeloma	153.92	19.58	97	6535	41940	34908359
Bone debridement	104.83	19.58	20	6612	186	34950113
Pain in jaw	79.53	19.58	42	6590	12998	34937301
Sequestrectomy	78.19	19.58	16	6616	219	34950080
Exposed bone in jaw	77.08	19.58	23	6609	1563	34948736
Debridement	75.40	19.58	20	6612	883	34949416

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Osteonecrosis	978.58	16.96	324	15023	30771	79698270
Osteonecrosis of jaw	970.94	16.96	350	14997	42876	79686165
Tooth extraction	395.65	16.96	127	15220	10868	79718173
Bone disorder	388.42	16.96	144	15203	18969	79710072
Plasma cell myeloma	274.22	16.96	154	15193	53105	79675936
Bone debridement	248.58	16.96	47	15300	408	79728633
Sequestrectomy	224.29	16.96	48	15299	814	79728227
Debridement	185.65	16.96	47	15300	1698	79727343
Actinomycosis	169.24	16.96	40	15307	1079	79727962
Atypical femur fracture	162.57	16.96	54	15293	5135	79723906

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	M05BA03	MUSCULO-SKELETAL SYSTEM DRUGS FOR TREATMENT OF BONE DISEASES DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION Bisphosphonates
FDA CS	M0006519	Diphosphonates
FDA EPC	N0000175579	Bisphosphonate
MeSH PA	D050071	Bone Density Conservation Agents

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Osteitis deformans	indication	2089002	DOID:5408
Humoral hypercalcemia of malignancy	indication	47709007
Osteolytic Lesions of Multiple Myeloma	indication
Osteolytic Bone Metastases of Breast Cancer	indication
Drug-induced osteoporosis	off-label use	14651005
Prevention of Glucocorticoid-Induced Osteoporosis	off-label use
Bone Metastases	off-label use
Hypophosphatemia	contraindication	4996001
Hypocalcemia	contraindication	5291005
Hypovolemia	contraindication	28560003

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	0.71	acidic
pKa2	4.78	acidic
pKa3	5.76	acidic
pKa4	9.83	acidic
pKa5	13.04	acidic
pKa6	11.49	Basic

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Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Farnesyl pyrophosphate synthase	Enzyme	P14324	FPPS_HUMAN	INHIBITOR	Ki	7.25	CHEMBL	CHEMBL
Farnesyl pyrophosphate synthase	Enzyme		Q0GKD7_LEIDO		Ki	6.72	CHEMBL
Hypoxanthine-guanine phosphoribosyltransferase	Enzyme		HPRT_TRYBB		Ki	4.30	CHEMBL

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External reference:

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ID	Source
210	PDB_CHEM_ID
003616	NDDF
005066	NDDF
105443	RXNORM
109552-15-0	SECONDARY_CAS_RN
396032007	SNOMEDCT_US
4020311	VANDF
4020543	VANDF
420442001	SNOMEDCT_US
42496	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Pamidronate Disodium	HUMAN PRESCRIPTION DRUG LABEL	1	59923-601	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3 mg	INTRAVENOUS	ANDA	24 sections
Pamidronate Disodium	HUMAN PRESCRIPTION DRUG LABEL	1	59923-602	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	6 mg	INTRAVENOUS	ANDA	24 sections
Pamidronate Disodium	HUMAN PRESCRIPTION DRUG LABEL	1	59923-603	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	9 mg	INTRAVENOUS	ANDA	24 sections
Pamidronate Disodium	HUMAN PRESCRIPTION DRUG LABEL	1	61703-324	INJECTION, SOLUTION	3 mg	INTRAVENOUS	ANDA	12 sections
Pamidronate Disodium	HUMAN PRESCRIPTION DRUG LABEL	1	61703-325	INJECTION, SOLUTION	6 mg	INTRAVENOUS	ANDA	12 sections
Pamidronate Disodium	HUMAN PRESCRIPTION DRUG LABEL	1	61703-326	INJECTION, SOLUTION	9 mg	INTRAVENOUS	ANDA	12 sections
Pamidronate Disodium	HUMAN PRESCRIPTION DRUG LABEL	1	67457-430	INJECTION	3 mg	INTRAVENOUS	ANDA	20 sections
Pamidronate Disodium	HUMAN PRESCRIPTION DRUG LABEL	1	67457-446	INJECTION	9 mg	INTRAVENOUS	ANDA	20 sections

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