Otrivin Complex nasal spray dispensed, 10ml

Product description

Otrivin Complex nasal spray. It contains 2 active components: a vasoconstrictor component that reduces swelling and nasal congestion, and an anticholinergic component that stops the flow from the nose. Helps to deal with 3 symptoms at once: congestion, swelling of the mucous membrane, flow from the nose. It starts working in 5-10 minutes. It has a long-lasting effect for 6-8 hours*. * Instructions for medical use, RU No. LP-002976 dated 27.04.2015

Composition

Active ingredients:

Ipratropium bromide monohydrate 0.6 mg,

xylometazoline hydrochloride 0.5 mg;

Auxiliary substances:

Glycerol (85%) 27.9 mg,

disodium edetate dihydrate 0.5 mg,

concentrated hydrochloric acid up to pH 4.5,

sodium hydroxide up to pH 4.5,

water up to 1 ml

Pharmacological action

Xylometazoline belongs to the group of local vasoconstrictors (decongestants) with alpha-adrenomimetic action, causes narrowing of the blood vessels of the nasal mucosa, thus eliminating edema and hyperemia of the nasopharyngeal mucosa. Relieves congestion, facilitating nasal breathing in rhinitis. Ipratropium bromide has an anticholinergic effect. When applied intranasally, it reduces nasal secretion, stopping the flow from the nose due to competitive inhibition of cholinergic receptors located in the epithelium of the nasal cavity. In therapeutic concentrations, it does not irritate the mucous membrane, does not cause its hyperemia. The drug begins to act in 5-10 minutes and has a lasting effect for 6-8 hours. “

Clinical pharmacology

When administered intranasally, ipratropium bromide and xylometazoline hydrochloride are poorly absorbed and are present in the blood plasma in insignificant amounts.

Indications

Symptomatic treatment of edema and hyperemia of the nasal cavity, acute respiratory diseases with rhinitis (runny nose) accompanied by congestion, acute allergic rhinitis, pollinosis, sinusitis.

Use during pregnancy and lactation

The use of the drug during pregnancy and lactation is contraindicated.

Contraindications

Hypersensitivity to the components of the drug, hypersensitivity to atropine or similar compounds (hyoscyamine, scopolamine), glaucoma, surgical interventions on the meninges (in the anamnesis), pregnancy (I trimester), atrophic rhinitis, age up to 18 years.

Side effects

Classification of the frequency of adverse reactions: very often-more than 1/10 appointments (≥ 10%); often-more than 1/100, but less than 1/10 appointments (≥1%, but ≤ 10%); infrequently – more than 1/1000, but less than 1/100 appointments (≥ 0.1%, but ≤ 1%); rarely – more than 1/10000, but less than 1/1000 appointments (≥ 0.01%, but ≤ 0.1%); very rarely – less than 1/10000 appointments (≤ 0.01%).

Nervous system disorders:

Often: headache.

Rarely: dizziness.

Very rare: insomnia.

From the digestive system:

Often: dry mouth.

Infrequently: dyspepsia, nausea.

From the side of the senses:

Rarely: increased intraocular pressure, mydriasis, eye pain, deterioration in angle-closure glaucoma;

Very rare: violation of the clarity of visual perception. From the urinary system:

Rare: difficulty urinating.

Respiratory system disorders:

Often: nasal bleeding, irritation and / or dryness of the nasopharyngeal mucosa, burning sensation, tingling, sneezing, nasal hypersecretion;

Infrequently: nasal congestion (with frequent and / or prolonged use of the drug).

From the cardiovascular system:

Rare: rapid heartbeat, supraventricular tachycardia, atrial fibrillation;

Very rare: arrhythmic pulse.

From the side of the skin:

Rare: pruritus, skin rash, urticaria.

Allergic reactions:

Rarely: systemic allergic reactions (anaphylactic reaction, angioedema of the tongue, lips and face, laryngospasm).

If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

The drug is incompatible with monoamine oxidase inhibitors, tri – and tetracyclic antidepressants.

Sympathomimetic drugs cause the release of catecholamines, including norepinephrine, which has a vasoconstrictive effect, resulting in increased blood pressure.

With a significant increase in blood pressure, treatment with Otrivin® The complex should be canceled, and symptomatic treatment should be performed.

Concomitant use with tri-and tetracyclic antidepressants may enhance the sympathomimetic effect of xylometazoline.

With the concomitant use of other drugs with anticholinergic activity, it is possible to increase the anticholinergic effect of ipratropium bromide.

How to take, course of use and dosage

Intranasally.

For patients over the age of 18 years: 1 injection in each nasal passage 3 times a day. The drug is used for no more than 7 days without consulting a doctor. Prolonged use of xylometazoline can cause swelling of the nasal mucosa and increased secretion, which is due to the development of increased sensitivity of cells to the active substances of the drug, the so-called reverse effect.

One injection of Otrivin® The complex contains about 70 mcg of xylometazoline hydrochloride and 84 mcg of ipratropium bromide.

Overdose

For nasal use of Otrivin® Complex acute overdose is unlikely, because the absorption of the drug is extremely insignificant.

In case of overdose of xylometazoline, the clinical picture is characterized by: nausea, sweating, lowering of body temperature, headache, bradycardia, accommodation disorders, arterial hypertension, respiratory depression, coma. Hypertension may be replaced by hypotension. Symptomatic therapy should be carried out under the supervision of a doctor.

With excessive use of ipratropium bromide, overdose is unlikely due to extremely low absorption of the substance into the blood, but dry mouth, difficulty in accommodation, and tachycardia may develop. Treatment is symptomatic.

A significant overdose can cause symptoms associated with the cholinolytic effect of the drug on the part of the central nervous system, including hallucinations, for which cholinesterase inhibitors are prescribed.

Description

Nasal spray in the form of a clear, colorless or slightly colored solution, almost odorless.

Special instructions

Before use, it is necessary to clean the nasal passages. It should not be used for a long time, for example, in chronic rhinitis.

Avoid contact with the eyes or around the eyes. In case of contact, temporary blurred vision, irritation, pain, redness of the eyes may occur, and an exacerbation of angle-closure glaucoma may develop. You should rinse your eyes thoroughly with cold water if the drug gets into them and consult a doctor for eye pain or blurred vision.

Influence on the ability to drive vehicles and mechanisms

Application of the drug Otrivin® The complex in therapeutic doses does not affect the ability to drive vehicles and mechanisms.

Form of production

10 ml of the drug in a bottle of PVP, equipped with a pump metering device with a tip made of polypropylene and a protective cap made of polyethylene. The bottle together with the instructions for use is placed in a cardboard box.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C.

Shelf

life is 3 years.

Active ingredient

Ipratropium Bromide, Xylometazoline

Dosage form

nasal spray

Description

Pregnant women in the second and third trimester as prescribed by a doctor, For adults

Indications

Sinusitis, Runny Nose, Allergy, Allergic Rhinitis, Otitis, Pollinosis