Otrivin 10ml – Adult Nasal Spray Relieve Allergic Rhinitis and Sinusitis

Product Name:

Otrivin Menthol (preservative-free) 1.0 mg/ml nasal spray, solution

Otrivin Composition:

Spray contains 1.0 mg of xylometazoline hydrochloride per milliliter. You can find the full list of excipients in section 6.1.

Pharmaceutical Form:

The product is a solution in the form of a nasal spray.

Clinical Information:

Therapeutic Indications: Otrivin Nasal Spray is used to treat rhinitis and can relieve congestion in sinusitis and facilitate rhinoscopy.

Otrivin Dosage and Administration:

For adults and children above twelve years of age, use one spray in each nostril as needed, 2-3 times daily, for a maximum of ten days.

Before using Otrivin Nasal Spray for the first time, you need to prime the pump by actuating it four times. Once primed, the pump will remain charged for regular daily use. However, if the spray does not eject during a full actuation stroke or if the product has not been used for more than six days, you should re-prime the pump with four actuations as initially performed.

Each spray delivers 0.14 ml (equivalent to 0.14 mg of xylometazoline hydrochloride).

Otrivin Menthol is not recommended for children below 12 years of age due to insufficient safety data. It is advisable to administer the last application shortly before bedtime.

Otrivin Contraindications:

Do not use Spray if you are hypersensitive to xylometazoline hydrochloride, menthol, or any of the other excipients. The product is contraindicated in individuals with narrow-angle glaucoma, after transsphenoidal hypophysectomy or surgery exposing the duramater, as well as in patients with rhinitis sicca or atrophic rhinitis.

Special Warnings and Precautions:

Exercise caution when using Otrivin Menthol in patients who are sensitive to adrenergic substances, as it may result in symptoms such as sleep disturbances, dizziness, tremors, cardiac arrhythmias, or elevated blood pressure. Additionally, use Otrivin Nasal Spray with caution in the following situations:

• Patients with hypertension or cardiovascular disease.
• Patients with long QT syndrome treated with xylometazoline, as they may be at increased risk of serious ventricular arrhythmias.
• Patients with hyperthyroidism, diabetes mellitus, or phaeochromocytoma.
• Patients with prostatic hypertrophy.
• Patients treated with monoamine oxidase inhibitors (MAOIs) or who have received them in the last two weeks.

To avoid a rebound effect in the form of nasal congestion and drug-induced rhinitis, use Otrivin for a maximum of ten successive days. Prolonged use may lead to physical drug dependence and/or atrophy of the nasal mucosa.

Avoid instilling decongestant preparations containing menthol directly into the nostrils of infants and young children, as it has resulted in acute respiratory distress with cyanosis and respiratory arrest. Do not exceed the recommended dose, especially in children and the elderly.

Otrivin Menthol should not be used in children aged less than 12 years.

Pregnancy and Lactation:

Pregnancy:

Due to its potential systemic vasoconstrictor effect, exercise caution and avoid using Otrivin Menthol during pregnancy. Lactation: It is not known if xylometazoline is excreted in breast milk. Therefore, use Otrivin Menthol only under medical advice while breastfeeding.

Fertility:

There are no adequate data on the effects of Otrivin on fertility, and no animal studies are available. However, considering the very low systemic exposure to xylometazoline hydrochloride, effects on fertility are highly unlikely.

Effects on Ability to Drive and Use Machines:

There is no specific information available regarding the effects of Otrivin Menthol on driving and operating machinery.

Undesirable Effects:

Adverse reactions associated with Otrivin Nasal Spray include:

Immune System Disorders:

Not known: Hypersensitivity reactions (angioedema, rash, pruritus)

Nervous System Disorders:

Common: Headache

Eye Disorders: Not known: Visual impairment

Cardiac Disorders: Not known: Irregular heart rate and increased heart rate

Respiratory, Thoracic, and Mediastinal Disorders: Common: Nasal dryness or discomfort, burning sensation Very rare: Rebound congestion

Gastrointestinal Disorders: Common: Nausea

Investigations: Not known: Increased blood pressure.

Report any suspected adverse reactions through the national reporting system to help monitor the benefit-risk balance of the product.

Otrivin Overdose: Toxicity:

Excessive use or accidental ingestion of Otrivin Menthol may lead to various symptoms, including severe dizziness, perspiration, headache, respiratory depression, coma, seizures, hypothermia, hypertension, peripheral vasoconstriction, cold extremities, bradycardia, mydriasis, bronchospasm, and convulsions. It is important to note that small children are more susceptible to toxicity than adults.

Treatment:

In case of overdose, immediate medical supervision is essential to initiate appropriate supportive measures. These measures may include close observation for several hours, administration of activated charcoal in specific situations, monitoring of respiration and circulation, and the possibility of providing supplemental oxygen and a respirator. In the case of a seizure, appropriate anticonvulsant therapy such as diazepam is recommended.

Pharmaceutical Particulars:

Excipients: Menthol, cineole, disodium edetate, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride, sorbitol, macrogol glycerol hydroxystearate, purified water. The product does not contain any preservatives.

Incompatibilities:

Not applicable.

Shelf Life:

The shelf life of Otrivin Menthol is 30 months.

Special Precautions for Storage: Store Otrivin Menthol below 25°C.