Roxithromycin

🧬 Cross-allergy: Macrolides

JFDA label: Roximac-150mg tablet

Indications

Approved

• Bacterial Infections — bacterial disease

Antimicrobial Spectrum

Expected / intrinsic spectrum (EUCAST breakpoints & labels) — not local resistance. Source: EUCAST v16.

Bacteria

Organism	Activity	MIC
Moraxella catarrhalis	Susceptible	0.51 mg/L
Staphylococcus spp.	Susceptible	11.0 mg/L
Streptococcus A/B/C/G	Susceptible	0.51 mg/L
Streptococcus pneumoniae	Susceptible	0.51 mg/L

Class profile

gramStatus	Gram+
spectrumBreadth	Moderate
atypicalCoverage	Yes
isBactericidal	0
moaCategory	Protein synthesis inhibitor (50S ribosomal, 23S rRNA)
pdIndex	Time-dependent
postAntibioticEffect	Prolonged
mrsaCoverage	0
resistanceMechanisms	Target site methylation (erm genes),Active efflux (mef genes)

Pregnancy & Lactation

Monitoring

Efficacy	Culture and susceptibility testing; clinical resolution (temperature, WBC, CRP, procalcitonin)
Toxicity	Renal function (dose adjustment in renal impairment); hepatic function for hepatically cleared agents; signs of C. difficile infection (diarrhoea)
Clinical pearl	Culture results guide de-escalation to narrower-spectrum therapy. Review antibiotic appropriateness at 48–72 h (antimicrobial stewardship).
Counseling	Complete the full course. Report persistent diarrhoea, rash, or lack of improvement after 48–72 h.

Chemistry & Properties

Formula	C41H76N2O15
Molecular weight	837.06 g/mol
IUPAC name	(3R,4S,5S,6R,7R,9R,10E,11S,12R,13S,14R)-6-[(2S,3R,4S,6R)-4-(dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-14-ethyl-7,12,13-trihydroxy-4-[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy-10-(2-methoxyethoxymethoxyimino)-3,5,7,9,11,13-hexamethyl-oxacyclotetradecan-2-one
CAS	80214-83-1
PubChem CID	6915744
InChIKey	RXZBMPWDPOLZGW-XMRMVWPWSA-N
logP	2.21 (XLogP 3.1)
Polar surface area	216.89 Ų
H-bond acceptors / donors	17 / 5
Drug-likeness (QED)	0.08
Lipinski violations	2

SMILES

CC[C@H]1OC(=O)[C@H](C)[C@@H](O[C@H]2C[C@@](C)(OC)[C@@H](O)[C@H](C)O2)[C@H](C)[C@@H](O[C@@H]2O[C@H](C)C[C@H](N(C)C)[C@H]2O)[C@](C)(O)C[C@@H](C)/C(=N\OCOCCOC)[C@H](C)[C@@H](O)[C@]1(C)O

Biology & Pharmacokinetics

Pharmacokinetics

BBB penetrant	No

Enzyme interactions

Enzyme	Role	Detail
CYP2B6	Inhibitor	—
CYP2C19	Substrate	—
CYP3A4	Substrate	—

Receptor binding (top 1)

Target	Action	Affinity
motilin receptor (MLNR)	Agonist	pIC50 6.2

Transporters

BCRP (Inhibitor)BSEP (Inhibitor)BSEP (Inhibitor)MDR1 (Inhibitor)MRP1 (Inhibitor)MRP2 (Inhibitor)MRP3 (Inhibitor)MRP4 (Inhibitor)OATP1B1 (Inhibitor)OATP1B1 (Inhibitor)OATP1B3 (Inhibitor)OATP1B3 (Inhibitor)OCTN2 (Inhibitor)P-gp (Inhibitor)MDR1 (Substrate)P-gp (Substrate)

Registered Products (13)

Brand	Form / strength	Pack	Agent	Citizen (JOD)
Romac	Tablet 150 mg	10 tab	THE JORDANIAN PHARMACEUTICAL MANUFACTURING COMPANY/JORDAN	3.350
ROXAMED F.C.TABS.	Film-Coated Tablet 150 mg	10 tab pack varies	Dar Al Dawa Development and Investment Co Ltd/Jordan	3.770
Roximac-150mg tablet	Tablet 150 mg	10 tab pack varies	AL-RAM PHARMA.INDUS.CO.LTD/JORDAN	3.770
Roxipharm	Tablet 150 mg	10 tab	Pharma International Company/ Jordan	3.770
Ruxid 150 Tablets	Tablet 150 mg	10 tab pack varies	UNITED PHARM.MFG.CO.LTD(UPM)/JORDAN	3.770
Ruxid 300 Tablets	Tablet 300 mg	7 tab pack varies	UNITED PHARM.MFG.CO.LTD(UPM)/JORDAN	5.600
Ruxid 150 Tablets	Tablet 150 mg	20 tab pack varies	UNITED PHARM.MFG.CO.LTD(UPM)/JORDAN	7.160
Romac	Tablet 300 mg	10 tab	THE JORDANIAN PHARMACEUTICAL MANUFACTURING COMPANY/JORDAN	8.000
Ruxid 300 Tablets	Tablet 300 mg	10 tab pack varies	UNITED PHARM.MFG.CO.LTD(UPM)/JORDAN	8.000
Ruxid 300 Tablets	Tablet 300 mg	14 tab pack varies	UNITED PHARM.MFG.CO.LTD(UPM)/JORDAN	10.640
ROXAMED F.C.TABS.	Film-Coated Tablet 150 mg	500 tab pack varies	Dar Al Dawa Development and Investment Co Ltd/Jordan	160.140
Roximac-150mg tablet	Tablet 150 mg	500 tab pack varies	AL-RAM PHARMA.INDUS.CO.LTD/JORDAN	160.230
Roximac-150mg tablet	Tablet 150 mg	1000 tab pack varies	AL-RAM PHARMA.INDUS.CO.LTD/JORDAN	320.450