Congenil

Oxymetazoline

Oxymetazoline

Description

Oxymetazoline is used for its vasoconstrictor properties, acting on a- adrenoreceptors. It is used as a topical agent on the nasal mucosa where it causes vasoconstriction of the arterioles thus reducing blood flow and diminishing swelling of the mucosa. This results in improved potency of the airways and better drainage of the sinuses.

Composition

Congenil 0.025% sterile paediatric nasal drops: Each ml nasal drop contains Oxymetazoline Hydrochloride USP 0.25 mg.

Congenil 0.05% sterile nasal drops: Each ml nasal drop contains Oxymetazoline Hydrochloride USP 0.5 mg.

Indications

Nasal congestion associated with allergic & infectious rhinitis, sinusitis & common cold.

Dosages and Administration

2 to 3 drops should be inistilled into each nostril twice (2 times) daily. The drops should be instilled into one nostril at a time, in the head –low position to reduce the risk of the patient swallowing any of the solution. Treatment course should not normally exceed 3 to 5 days and on no account should it be continued for longer than 2 weeks.

Use in Paediatric

Children under 5 years of age should not use Congenil 0.05% nasal drops. Children with ages between 2 to 5 years can suitably use Congenil 0.025% paediatric nasal drops.

Side Effects

Stinging, discomfort or dryness locally in the nose are encountered infrequently. Headache has also been reported. Prolonged use may lead to rebound vasodilatation (drug-induced rhinitis). Overuse may result in sedation in children. Oxymetazoline may also result in short-lived rise in pressure, followed by prolonged hypotension and sedation.

Contraindications

Mono-amino oxidase inhibitor (MAO inhibitor), tricyclic antidepressant.

Drug Interactions

Oxymetazoline causes hypertensive crisis if used simultaneously with MAO inhibitor or trycyclic antidepressant.

Use in Pregnancy and Lactation

Although it is not clearly known whether Oxymetazoline can cause fetal harm or affect reproduction capacity, one study reported that, Oxymetazoline did not affect maternal blood pressure and pulse rates, and therefore is safe in the third trimester of a normal pregnancy. It is not known if this agent is excreted in breast milk. So caution should be exercised when administering to a nursing mother.

Pharmaceutical Precautions

Store in a cool and dry place, protect from light. Keep all medicines out of the reach of children. Should be dispensed only on the prescription of a registered physician. Close the dropper immediately after use. Do not use for longer than one month after opening the dropper.

Commercial Supply

Congenil 0.025 % Sterile Paediatric Nasal Drops: Each plastic dropper bottle contains 10 ml sterile nasal drops.

Congenil 0.05% Sterile Nasal Drops: Each plastic dropper bottle contains 10 ml sterile nasal drops