Flomist Ox Nasal Spry

FLOMIST OX Nasal Spray

FLOMIST OX Nasal Spray is a prescription medication manufactured by Cipla Ltd., designed for intranasal administration.

Composition

FLOMIST OX Nasal Spray contains two active ingredients:

• Fluticasone Furoate: 27.5 micrograms (mcg) per spray actuation (0.028% w/w). Fluticasone furoate is a corticosteroid that reduces inflammation in the nasal passages.
• Oxymetazoline Hydrochloride: 50 micrograms (mcg) per spray actuation (0.050% w/w). Oxymetazoline is a decongestant that narrows blood vessels in the nasal passages, helping to reduce swelling and congestion.

Uses

FLOMIST OX Nasal Spray is indicated for the treatment of symptoms associated with allergic rhinitis, particularly when accompanied by nasal congestion. It helps relieve symptoms such as sneezing, runny nose, congestion, stuffy nose, and watery eyes caused by perennial allergic rhinitis.

Dosage and Administration

FLOMIST OX Nasal Spray is for intranasal use only.

• The recommended starting dose is two spray actuations in each nostril once daily. This delivers a total daily dose of 110 mcg of Fluticasone Furoate and 200 mcg of Oxymetazoline Hydrochloride.
• Once adequate symptom control is achieved, the dose may be reduced to one spray actuation in each nostril once daily for maintenance (55 mcg Fluticasone Furoate and 100 mcg Oxymetazoline Hydrochloride daily).
• The device should be shaken before use. Before the first use or if unused for 30 days or more, prime the pump by pressing the mist release button at least six times until a fine mist appears. Patients should blow their nose gently before use.

Side Effects

Common side effects may include headache, nosebleeds (epistaxis), nasal dryness and discomfort, nasal irritation, and sneezing. Other reported adverse events include rhinalgia, transient ocular changes, blurred vision, nasal septum perforation, dry mouth, stomatitis, and local irritation. Prolonged use may lead to rebound congestion or nasal damage.

Precautions

FLOMIST OX Nasal Spray is contraindicated in individuals with hypersensitivity to its ingredients and in children under 12 years of age. It should be avoided by patients who have undergone recent trans-nasal surgery, those with chronic nasal inflammation with very dry nasal passages (rhinitis sicca or atrophic rhinitis), cardiovascular disease, hyperthyroidism, angle closure glaucoma, or prostatic enlargement. Prolonged use of Oxymetazoline can lead to rebound congestion. Systemic effects of nasal corticosteroids can occur with high doses or prolonged periods. Pregnant or breastfeeding women should consult their doctor before use.

Storage

Store FLOMIST OX Nasal Spray below 30°C, in a cool and dry place away from sunlight, and out of the reach of children.

FLOMIST OX Nasal Spray is a medication used to treat symptoms associated with allergic rhinitis and nasal congestion. It contains two active ingredients: Fluticasone Furoate, a corticosteroid, and Oxymetazoline Hydrochloride, a decongestant.

Here are some frequently asked questions about FLOMIST OX Nasal Spray:

What is FLOMIST OX Nasal Spray used for?

FLOMIST OX Nasal Spray is indicated for the treatment of symptoms of allergic rhinitis with nasal congestion. This includes symptoms such as sneezing, runny nose, watery eyes, itching, swelling, and congestion or stuffiness.

How does FLOMIST OX Nasal Spray work?

This nasal spray combines two active ingredients: Fluticasone Furoate and Oxymetazoline Hydrochloride. Fluticasone Furoate is a corticosteroid that acts as a potent anti-inflammatory, reducing swelling and irritation in the nasal passages by inhibiting the release of inflammatory chemicals. Oxymetazoline is a decongestant that narrows blood vessels in the nasal lining, which helps to reduce swelling and clear nasal congestion.

What is the usual dosage of FLOMIST OX Nasal Spray?

The recommended starting dose is two spray actuations into each nostril once daily. Once adequate symptom control is achieved, the dose may be reduced to one spray actuation in each nostril daily for maintenance. It is administered only by the intranasal route. The device should be shaken before use and primed (by pressing several times until a fine mist appears) if it has not been used for 30 days or more.

What are the possible side effects of FLOMIST OX Nasal Spray?

Common side effects include epistaxis (nosebleeds), nasal ulceration, nasal dryness and discomfort, sneezing, and headache. Other possible adverse events include blurred vision, nasal septum perforation, dry mouth, local irritation, insomnia, hypertension, and hypersensitivity reactions. Prolonged use of the decongestant component (Oxymetazoline) may lead to rebound congestion.

Is FLOMIST OX Nasal Spray safe during pregnancy or breastfeeding?

Pregnancy: There are no adequate data on the use of FLOMIST OX Nasal Spray in pregnant women. While animal studies with glucocorticoids have shown potential for malformations, this is less likely with recommended nasal doses due to minimal systemic exposure. However, some sources advise against oxymetazoline during pregnancy due to potential links to birth defects. It is recommended to consult your doctor, who will prescribe it only if the benefits outweigh the potential risks.

Breastfeeding: It is unknown if fluticasone furoate or oxymetazoline are excreted in human breast milk. If breastfeeding, use should only be considered if the expected benefit to the mother is greater than any possible risk to the child. Always consult your doctor before using this medication while breastfeeding.

Can FLOMIST OX Nasal Spray be taken with other medications?

Caution is advised when taken with potent CYP3A inhibitors (such as ritonavir, cobicistat, ketoconazole, or itraconazole), as these can increase the systemic exposure to fluticasone furoate and potentially increase side effects. Co-administration with monoamine oxidase inhibitors (MAOIs), nonselective beta-adrenergic antagonists, or tricyclic antidepressants is not recommended due to the risk of hypertension from oxymetazoline.

What precautions should be taken when using FLOMIST OX Nasal Spray?

This spray is contraindicated for children under 12 years of age. Do not use it if you have a known hypersensitivity to any of its ingredients. Avoid use if you have recently undergone trans-nasal surgery, or if you have chronic nasal inflammation with very dry nasal passages (rhinitis sicca or atrophic rhinitis). It should also be used with caution in patients with cardiovascular disease, hyperthyroidism, angle-closure glaucoma, or prostatic enlargement. Prolonged use should be avoided to prevent rebound congestion. Systemic corticosteroid effects, such as growth retardation in children or visual disturbances, can occur with high doses or prolonged use, so children should be on the lowest effective dose. Always blow your nose gently before use and do not share the spray with others to prevent the spread of infection.

What happens if a dose is missed?

If you miss a dose, use it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten one.

How should FLOMIST OX Nasal Spray be stored?

Store FLOMIST OX Nasal Spray in a cool and dry place, protected from direct sunlight, and at a temperature below 30°C. Keep it out of the sight and reach of children.