New Release: Alpha testing version has been released.

Xylometazoline

R01A - Decongestants and other nasal preparations for topical use ATC R01AA07 Small molecule Natural product

JFDA label: Xylomet N/D 0.1%

Mechanism of Action

Stimulates alpha-adrenergic receptors in the arterioles of the conjunctiva and the nasal mucosa to produce vasoconstriction

Indications

Approved

  • Nasal Congestion

Contraindications

Source: Lexicomp

  • Hypersensitivity to xylometazoline or any component of the formulation Absolute
  • narrow angle glaucoma Absolute
  • patients with transphenoidal hypophysectomy or surgery exposing the dura mater Absolute
  • rhinitis sicca or atrophic rhinitis Absolute

Adverse Reactions

Very Common >10%Common 1–10%Uncommon 0.1–1% Rare 0.01–0.1%Very Rare <0.01%Not Known

Nervous system disorders (1)

Common Headache

Gastrointestinal disorders (1)

Common Nausea

General disorders and administration site conditions (1)

Common Application site burning

Respiratory, thoracic and mediastinal disorders (2)

Common Dry nose · nasal discomfort

Dosing

Source: Lexicomp

Nasal congestion: Intranasal: Drops (0.1%): Apply 2 to 3 drops in each nostril every 8 to 10 hours Metered dose spray (0.1%): 1 spray in each nostril every 8 to 10 hours Spray (0.05%, 0.1%): 1 or 2 sprays in each nostril every 8 to 10 hours
Refer to adult dosing.

Warnings & Precautions

Source: Lexicomp

Rebound nasal congestion

Frequent or prolonged use may cause nasal congestion to recur or worsen. Disease-related concerns:

Cardiovascular disease

Use with caution in patients with hypertension or heart disease.

Diabetes mellitus

Use with caution in patients with diabetes mellitus.

Thyroid disease

Use with caution in patients with thyroid disease.

Prostatic hyperplasia/Urinary obstruction

Use with caution in patients with prostatic hyperplasia and/or GU obstruction. Concurrent drug therapy issues:

Drug-drug interactions

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Other warnings:

Appropriate use

If symptoms persist longer than 3 days consult health care provider. Container should not be used by more than 1 individual.

Pregnancy & Lactation

Pregnancy

According to the manufacturer, use during pregnancy is not recommended.

Lactation

It is not known if xylometazoline is excreted in breast milk. The manufacturer recommends that caution be exercised when administering xylometazoline to nursing women.

Chemistry & Properties

2D structure
FormulaC16H24N2
Molecular weight244.38 g/mol
IUPAC name2-[(4-tert-butyl-2,6-dimethylphenyl)methyl]-4,5-dihydro-1H-imidazole
CAS526-36-3
PubChem CID5709
InChIKeyHUCJFAOMUPXHDK-UHFFFAOYSA-N
logP3.15 (XLogP 3.2)
Polar surface area24.39 Ų
H-bond acceptors / donors2 / 1
Drug-likeness (QED)0.85
Lipinski violations0
SMILESCc1cc(C(C)(C)C)cc(C)c1CC1=NCCN1

Biology & Pharmacokinetics

Pharmacokinetics

BBB penetrantNo

Enzyme interactions

EnzymeRoleDetail
CYP1A2Substrate
CYP2C19Substrate
CYP2D6Inhibitor
CYP2D6Substrate
CYP3A4Substrate

Receptor binding (top 7)

TargetActionAffinity
&alpha;2B-adrenoceptor (ADRA2B) Agonist pIC50 8.8
&alpha;2A-adrenoceptor (ADRA2A) Agonist pIC50 8.1
&alpha;2B-adrenoceptor (ADRA2B) Agonist pEC50 7.8
&alpha;2A-adrenoceptor (ADRA2A) Agonist pKi 7.6
&alpha;2C-adrenoceptor (ADRA2C) Agonist pIC50 7.2
&alpha;2C-adrenoceptor (ADRA2C) Agonist pKi 7.0
&alpha;2B-adrenoceptor (ADRA2B) Agonist pKi 5.4

Transporters

BCRP (Inhibitor)BSEP (Inhibitor)BSEP (Inhibitor)MRP1 (Inhibitor)OATP1B1 (Inhibitor)OATP1B3 (Inhibitor)P-gp (Inhibitor)P-gp (Substrate)

Registered Products (17)

BrandForm / strengthPackAgentCitizen (JOD)
Decozoline (Children) Solution 0.05 % 10 ml MIDDLE EAST PHARMA&CHEMICAL IND/JORDAN 0.750
Decozoline Adult Nasal Drops Nasal Spray 0.1 % 10 ml MIDDLE EAST PHARMA&CHEMICAL IND/JORDAN 0.810
Decozal 0.05% nasal drops Nasal Spray 0.05 % 10 ml Amman Pharmaceutical Indusries 1.040
Decozal 0.1% Nasal Drops Nasal Spray 0.1 % 10 ml Amman Pharmaceutical Indusries 1.050
OTRIVIN 0.05% NASAL DROPS Nasal Spray 0.05 % 10 ml Sukhtian Group 1.490
Decozal 0.05% Metered Dose Nasal Spray Spray 0.05 % 10 ml pack varies Amman Pharmaceutical Indusries 1.630
Decozal 0.1% Metered Dose Nasal Spray Spray 0.1 % 10 ml pack varies Amman Pharmaceutical Indusries 1.700
Xylomet N/D Nasal Drops/Spray 0.1 % 15 ml Khoury Drug Store 1.740
Otrivin 0.1% w/v Solution 0.1 % 10 ml Sukhtian Group 2.010
OTRIVIN 0.1% MD Spray Spray 0.1 % 10 ml Sukhtian Group 2.130
Decozal 0.05% Metered Dose Nasal Spray Spray 0.05 % 15 ml pack varies Amman Pharmaceutical Indusries 2.160
Decozal 0.1% Metered Dose Nasal Spray Spray 0.1 % 15 ml pack varies Amman Pharmaceutical Indusries 2.260
Decozal Menthol Metered Dose Nasal Spray Spray 0.1 % 10 ml Amman Pharmaceutical Indusries 2.360
Otrivin 0.05% MD Spray Spray 0.05 % 10 ml Sukhtian Group 2.570
Otrivin Menthol MD Spray Spray 0.10 % 10 ml Sukhtian Group 2.990
Decozal Complete Solution 0.5 mg/1 ml, 0.6 mg/1 ml 10 ml شركة عمان للصناعات الدوائية / Amman Pharmaceutical Indusries / General 3.700
Otrivin Dual Relief nasal spray Spray 0.5 mg, 0.6 mg 10 ml Sukhtian Group 4.630