ORIGINAL FOR FAST EFFECTIVE NASAL CONGESTION RELIEF

Delivers the medication in a fine mist to help clear nasal congestion from 2 minutes. Lasts up to 10 hours.¹

Adult Metered Dose

0.1% Nasal Spray
* Also available in drops

Otrivin Adult Metered-dose effectively relieves nasal congestion from 2 minutes. Quickly provides a sensation of improved nasal airflow with long-lasting relief.¹

How to use

How to use

Otrivin Adult Metered-dose should be administered as follows: 1 spray in each nostril up to 3 times per day.

Detailed instructions:¹

1. Clear your nose.
2. Lean forward slightly and insert the nozzle into a nostril.
3. Spray and breathe in gently through the nose at the same time.
4. Repeat for the other nostril.

If cold symptoms persist or worsen consult your doctor or pharmacist. To avoid possible spread of infection, only one person should use each pack.
Product information

Product information

COMPOSITION

OTRIVIN ADULT DROPS and OTRIVIN ADULT METERED-DOSE SPRAY: 1 ml contains 1 mg of xylometazoline hydrochloride. Preservative: 0,011 % m/v benzalkonium chloride.
Excipients: disodium edetate, disodium phosphate dodecahydrate, methylhydroxypropyl -cellulose, purified water, sodium chloride, sodium dihydrogen phosphate dihydrate, sorbitol 70 % (non-crystallising).

PHARMACOLOGICAL CLASSIFICATION

A16.1 Nasal Decongestants

PHARMACOLOGICAL ACTION

OTRIVIN contains xylometazoline, which belongs to the group of the arylalkyl imidazolines.
OTRIVIN has a vasoconstrictor action, producing decongestion of the nasal and pharyngeal mucosa when administered locally.

The effect of OTRIVIN sets in within a few minutes and persists for several hours.

INDICATIONS

Decongestion of naso-pharyngeal mucosa in colds, sinusitis, otitis media and to facilitate rhinoscopy.

CONTRAINDICATIONS

Hypersensitivity to the ingredients.
Hyperthyroidism.
Ischaemic heart disease.
Patients being treated with monoamine oxidase (MAO) - inhibitors or 10 days after stopping treatment.
OTRIVIN should not be employed in status post transsphenoidal hypophysectomy (or after transnasal or transoral surgical interventions in which the dura mater has been exposed).

WARNINGS and SPECIAL PRECAUTIONS

OTRIVIN should be used with caution in patients with hypertension, cardiovascular disease, narrow-angle glaucoma and diabetes mellitus.
OTRIVIN should be used with caution in patients showing a strong reaction to sympathomimetic agents, as evidenced by signs of insomnia, dizziness, etc.
Do not exceed the recommended dose, especially in children and in the elderly.
OTRIVIN should not be employed uninterruptedly for periods exceeding two weeks: prolonged or excessive use may cause rebound congestion. Chronic use may lead to atrophic rhinitis.

INTERACTIONS

Concurrent use of tricyclic or tetracyclic antidepressants may potentiate the systemic effects of xylometazoline.

PREGNANCY AND LACTATION

The use of OTRIVIN during pregnancy is not advisable due to its potential systemic absorption.
OTRIVIN should be used with caution during lactation.

DOSAGE AND DIRECTIONS FOR USE

OTRIVIN ADULT DROP and OTRIVIN ADULT METERED-DOSE SPRAY (1 mg/ml) are for nasal administration only, in adults and children over 12 years of age:

2 to 3 drops of the 1 mg/ml solution into each nostril per application, or one puff from the metered-dose spray, into each nostril per application; a total of 3 applications a day is usually sufficient.

OTRIVIN should be used after blowing the nose.

USE OF OTRIVIN METERED-DOSE SPRAY

Remove the protective cap. Before the first application, perform several pumping motions until an even spray appears in the air.

Insert the nozzle into the nostril and press once firmly on the spray head, and breathe in at the same time. Then withdraw the nozzle before releasing pressure. Repeat the operation in the other nostril. Replace the protective cap.

SIDE EFFECTS

The following side effects have been encountered:

Rebound congestion after discontinuation. A burning sensation in the nose and throat, local irritation, nausea, headache, dryness of the nasal mucosa, epistaxis, anosmia, dizziness, palpitations and insomnia.

Less frequently: Skin rash or transient visual disturbances.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT

Signs

In instances of accidental poisoning in children, the clinical picture may be marked chiefly by signs such as acceleration and irregularity of the pulse, elevated blood pressure and sometimes clouding of consciousness, sweating, drowsiness, coma, convulsions, circulatory collapse.

Treatment

Symptomatic treatment under medical supervision is indicated.

IDENTIFICATION

Drops and Metered-Dose Spray: Clear, colourless solution.

PRESENTATION

OTRIVIN ADULT DROPS (1 mg/ml solution):
Polyethylene dropper bottles containing 10 ml.

OTRIVIN ADULT METERED-DOSE SPRAY (1 mg/ml solution):
Polyethylene metered-dose spray bottle containing 10 ml.

STORAGE INSTRUCTIONS

OTRIVIN ADULT DROPS: Store at or below 25 °C.
OTRIVIN ADULT METERED- DOSE SPRAY: Store at or below 30 °C.
Keep out of the reach of children.

REGISTRATION NUMBERS

OTRIVIN ADULT DROPS and OTRIVIN ADULT METERED-DOSE SPRAY 1 mg/ml:
H/16.1/1382

Download product information

¹ Xylometazoline Hydrochloride. Global Datasheet

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For additional prescribing information, refer to the OTRIVIN package insert approved by SAHPRA.

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* By reducing congestion and aiding in drainage of paranasal sinuses. Acute use of up to 10 days.
** Unblocks nose for up to 10 hours - Eccles R, Martensson K, Chen SC. Effects of intranasal xylometazoline in patients with common cold. Curr Med Res Opin 2010; 26(4): 889-899.
* Reduce congestion and drainage of paranasal sinuses. Acute use of up to 10 days.

S1 Otrivin Adult drops. Each 1 ml contains 1 mg of xylometazoline hydrochloride. Preservative: benzalkonium chloride 0.011% m/v. Reg. no.: H/16.1/1382.
S1 Otrivin Adult Metered-dose spray. Each 1 ml contains 1 mg of xylometazoline hydrochloride. Preservative: benzalkonium chloride 0.011% m/v. Reg. no.: H/16.1/1382.
S1 Otrivin Menthol Metered-dose spray. Each 1 ml contains 1 mg of xylometazoline hydrochloride. Preservative: benzalkonium chloride 0.01% m/v. Reg. no.: 31/16.1/0319.
S1 Otrivin Paediatric drops. Each 1 ml contains 0,5 mg of xylometazoline hydrochloride. Preservative: benzalkonium chloride 0.011% m/v. Reg. no.: H/16.1/1381.
S1 Otrivin Paediatric Metered-dose spray. Each 1 ml contains 0,5 mg of xylometazoline hydrochloride. Preservative: benzalkonium chloride 0.011% m/v. Reg no.: H/16.1/1381

Legals

S1 Otrivin Adult drops. Each 1 ml contains 1 mg of xylometazoline hydrochloride. Preservative: benzalkonium chloride 0.011% m/v. Reg. no.: H/16.1/1382.
S1 Otrivin Adult Metered-dose spray. Each 1 ml contains 1 mg of xylometazoline hydrochloride. Preservative: benzalkonium chloride 0.011% m/v. Reg. no.: H/16.1/1382.
S1 Otrivin Menthol Metered-dose spray. Each 1 ml contains 1 mg of xylometazoline hydrochloride. Preservative: benzalkonium chloride 0.01% m/v. Reg. no.: 31/16.1/0319.
S1 Otrivin Paediatric drops. Each 1 ml contains 0, 5 mg of xylometazoline hydrochloride. Preservative: benzalkonium chloride 0.011% m/v. Reg. no.: H/16.1/1381.
S1 Otrivin Paediatric Metered-dose spray. Each 1 ml contains 0, 5 mg of xylometazoline hydrochloride. Preservative: benzalkonium chloride 0.011% m/v. Reg no.: H/16.1/1381