Septanazal nasal spray 0.1mg + 0.005/dose 10ml

NAME OF PREPARATION

SeptaName

QUALITY AND QUANTITATIVE COMPOSITION

Composition

1 dose of the drug is 0.1 ml of solution.

The nominal number of doses of the drug in the vial - 90 doses

PHARMACEUTICAL FORM

Transparent, colorless solution.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

Xylometazoline - local vasoconstrictor (decongestant) with alpha-adrenomimetic activity, causes narrowing of the blood vessels of the mucous membrane of the nasal cavity, restores the patency of the nasal passages, eliminates nasal congestion, facilitates nasal breathing. The effect of xylometazoline usually occurs within a few minutes after its use and lasts up to 10 hours. Dexapanthenol - vitamin B, a derivative of pantothenic acid. Dexpanthenol is converted in the body into pantothenic acid, which is a component of coenzyme A (CoA), and participates in the processes of acetylation, carbohydrate and fat metabolism, in the synthesis of acetylcholine,corticosteroids, porphyrins, stimulates the recovery of the skin and mucous membranes, normalizes cellular metabolism, accelerates mitosis and increases the strength of collagen fibers. It has a regenerating, metabolic and weak anti-inflammatory effect.

Pharmacokinetics

Xylometazoline when applied topically, it is practically not absorbed. Concentrations in the blood plasma are so small that they can not be determined by modern analytical methods.

Dexapanthenol when applied topically, it is quickly absorbed by the skin and converted into pantothenic acid, binds to plasma proteins (mainly beta-globulin and albumin). Its concentration in the blood - 0.5-1 mg / ml, in the serum - 100 mcg / l. Pantothenic acid is not metabolized in the body (except for inclusion in CoA), it is excreted unchanged.

CLINICAL DATA

Indications for use

Acute respiratory diseases with rhinitis, acute allergic rhinitis, vasomotor rhinitis, sinusitis, otitis media (as part of combination therapy to reduce swelling of the nasopharyngeal mucosa), to facilitate rhinoscopy, restore impaired nasal breathing after surgical interventions in the nasal cavity.

Contraindications

Hypersensitivity to any of the components of the drug; arterial hypertension, tachycardia, marked atherosclerosis, glaucoma; atrophic rhinitis; hyperthyroidism, porphyria, prostatic hyperplasia,surgery on the meninges (in history), simultaneous use with monoamine oxidase inhibitors (MAO) and tricyclic antidepressants; pregnancy, breastfeeding period, children under 6 years old;

Carefully: Diabetes mellitus, pheochromocytoma, diseases of the cardiovascular system (including ischemic heart disease, angina), hypersensitivity to the action of adrenergic drugs, accompanied by insomnia, dizziness, arrhythmia, tremor, high blood pressure (BP).

Use during pregnancy and breastfeeding

Given that there is no data on the reproductive toxicity of the drug Septanazal, its use during pregnancy and during breastfeeding is not recommended.

Dosage and administration

Intranasal.

For adults and children over 6 years old.

One metered injection in each nasal passage 3-4 times a day.

Duration of therapy 3-5 days

Side effect

With frequent or long-term use: irritation and / or dryness of the nasal mucosa, burning, tingling, sneezing, hypersecretion, allergic reactions, swelling of the nasal mucosa, nausea, vomiting, headache, dry rhinitis, palpitations, increased blood pressure, tachycardia, insomnia, blurred vision, depression (with prolonged use of high doses).

Overdose

Symptoms:

In cases of overdose or accidental ingestion, the following symptoms may occur: mydriasis, nausea, vomiting, cyanosis, fever, convulsions, tachycardia, cardiac arrhythmias, vascular insufficiency, cardiac arrest, increased blood pressure, pulmonary edema, impaired respiratory function, hallucination.

Patients may also develop symptoms of depression from the central nervous system, accompanied by drowsiness, a decrease in body temperature, bradycardia, shock, cessation of breathing, and coma.

Treatment: intake of enterosorbents (activated carbon) and gastric lavage, oxygen ventilation of the lungs. In order to reduce blood pressure, 5mg of phentolamine 0.9% sodium chloride solution is used by intravenous administration or 100mg of phentolamine inside. Vasoconstrictive drugs are contraindicated. If necessary, use antipyretic and anticonvulsant drugs.

Interaction with other drugs

Simultaneous use with inhibitors MAO and tricyclic antidepressants may lead to increased systemic effects

Special notes

Before use, you must clean the nasal passages.

Do not use for more than 5 days.

Does not contain preservatives. After opening the bottle, the drug should be used within 12 weeks.

Impact on the ability to perform potentially hazardous activities that require special attention and quick reactions (for example, driving vehicles, working with moving machinery).

During the period of use of the drug should be precautionary measures, or avoid driving vehicles and occupations of other potentially hazardous activities that require high concentration of attention and speed of psychomotor reactions.

PHARMACEUTICAL DATA

Release form

Spray nasal dosed,

5 mg + 0.1 mg / dose.

10 ml (90 doses) of the drug in a vial of high-density polyethylene with a dosing device (pump) and a transparent protective cap of the combined material.

1 bottle together with the application instruction is placed in a pack cardboard.

Storage conditions

At a temperature not higher than 25 ° С, in the original package.

Keep out of the reach of children.