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Therapeutic Category
- Topical Local Decongestants
- Ear, Nose, and Oropharynx
- Pharmaceutical Form : Nazal Drops
- Composition : Oxymetazoline Hcl 0.5 mg / 1 ml
- Active Substance : Oxymetazoline Hcl
Mechanism of action:
Oxymetazoline is a direct-acting sympathomimetic amine. It acts on alpha-adrenergic receptors in the vessels of the nasal mucosa producing vasoconstriction and decongestion. Onset of action is within minutes and lasts 6-8 hours.
Pharmacokinetic:
With local use on the nasal mucosa, there is no absorption of oxymetazoline hydrochloride.
Indications:
- Symptomatic treatment of nasal congestion (cold, upper respiratory allergies or hay fever, sinusitis).
- Temporarily relieves sinus congestion and pressure.
Contraindications:
- In case of hypersensitivity to the active substance or to any of the excipients
- In patients taking monoamine oxidase inhibitors (MAOIs), furazolidone or in patients who have taken MAOIs in the previous two weeks.
- In patients taking drugs that potentially increase the blood pressure.
- In patients with narrow-angle glaucoma. It should not be used by patients after trans-sphenoidal hypophysectomy.
- Phaeochromocytoma, Metabolic disorders (eg, hyperthyroidism, diabetes).
- Children under 6 years of age.
- Where there is inflammation of the skin and mucosa of the nasal vestibule and encrustation (rhinitis sicca).
- In patients with Severe cardiovascular diseases (eg, coronary heart disease, hypertension) or cardiac asthma
Pregnancy and lactation:
Category C:
There are no controlled studies in women. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
It is unknown if oxymetazoline solution is excreted in breast milk. The recommended dose should not be exceeded because overdosing can decrease placental blood flow and reduce milk production.
Caution should be exercised during pregnancy and lactation as oxymetazoline may be systemically absorbed.
The safety of its use in lactation and pregnancy has not been established. Therefore, use only when clearly indicated.
Dosage and administration:
It should not be used for more than 3 days unless advised to do so by the doctor.
Therapy duration should not exceed 5 days.
Children under 6 years of age: contraindicated
Adults and children above than 12 years of age: 2-3 drops into each nostril twice daily.
Children 6 – 12 years of age: 1 drop into each nostril twice daily
The recommended dose should not be exceeded.
Before Administration for both the drops and spray, gently blow the nose.
If the patient misses a dose and are using it regularly, it should be used as soon as possible, it should not be used 2 doses at once.
Overdose:
Symptoms of moderate or severe overdose can be mydriasis, nausea, cyanosis, fever, spasms, tachycardia, cardiac arrhythmia, cardiac arrest, hypertension, oedema of the lungs, dyspnoea, and psychic disturbance.
Symptomatic treatment of overdose is required. In the case of moderate or severe inadvertent oral consumption, the administration of activated carbon and sodium sulphate or gastro-lavage in the case of large amounts should be undertaken. Further treatment is supportive and symptomatic.
Storage conditions:
Store at room temperature (15-30) °C, protect from the light.
How supplied: Carton box contains 10 mL plastic bottle.