Expiration date: 06/2025

Clinico-pharmacological group

(Vasoconstrictor drugs for local application in ENT practice)

Release form, composition and packaging

Nasal sprays of pale yellow color, clear, with the smell of eucalyptus.

1 ml contains:

tramazoline hydrochloride monohydrate 1.265 mg, that corresponds to the content of tramazoline hydrochloride 1.18 mg

Excipients: citric acid monohydrate - 3.906 mg, sodium hydroxide - 2.23 mg, benzalkonium chloride - 202 µg, hypromellose (hydroxypropyl methylcellulose) - 506 µg of povidone - 30.36 mg, glycerol 85% - 10.12 mg, magnesium sulphate heptahydrate - 714 in µg, of magnesium chloride hexahydrate - 510 mcg, calcium chloride dihydrate - 164 µg, of sodium bicarbonate is 20 g, sodium chloride - 2.651 mg, cineole (evkaliptola) - 101 mcg, levomenthol (L-menthol) - 202 g,camphor racemic - 202 µg purified water to 1 ml 10 ml - vials dark glass (1) with a metering device and nasal adapter packs cardboard.

Pharmacological action:

The active ingredient of the drug Mucosolvan Reno - tramazoline hydrochloride, an ALPHA2-agonists, causing vasoconstriction. When applied to mucous membranes of the nose due to the vasoconstrictive action of the drug reduces swelling. As a result, the patency of the nasal passages is quickly restored nasal breathing permanently relieved.The action of the drug starts within the first 5 minutes and lasts for 8-10 hours

Pharmacokineticpharmacodynamic studies in humans have not been conducted. 

The pharmacokinetics of tramazoline studied in rats, rabbits and monkeys. It is shown that after the drug orally or intranasally absorbed 50-80% of the administered dose. Tramazoline and its metabolites are distributed in all the internal organs, the Cmax observed in the liver.After oral or local application of the main metabolites determined in urine. Terminal T1/2 ranges from 5 to 7 p.m.

Dosage

Adults and children over 6 years appoint one injection in each nostril (4 sprays in each nostril per day).You should not use the drug more than 5-7 days without a doctor's prescription.

Instructions for use of the vial with a metering ustroystvami injection it is necessary to clear the nasal passages.1. Remove the protective cap.2. Before first use you need to produce a few sprays into the air until a stable cloud aerosol. After this the metering device is ready to use.3. To introduce the tip into the nostril and make one injection.Repeat the procedure for the other nasal passage. After removing the tip to produce a normal breath in through your nose.4. To wear the protective cap.It is recommended to clean the tip after each use.

Overdose:

Symptoms: after the increase in blood pressure and tachycardia possible (especially in children) drop in blood pressure, shock, reflex bradycardia, lowering of body temperature.By analogy with other alpha-sympathomimetics, the clinical picture of intoxication can be indistinct, because phases of stimulation and depression of CNS and the cardiovascular system can replace each other.Especially in children intoxication leads to effects on the Central nervous system with convulsions and coma, bradycardia, respiratory depression. Symptoms stimulate the Central nervous system are anxiety, agitation, hallucinations, and seizures. Symptoms of CNS depression include decreased body temperature, lethargy, drowsiness and coma.In addition, may develop the following symptoms: mydriasis, miosis, sweating, fever, pallor, cyanosis of the lips, disorders of the cardiovascular system (including heart failure), breathing problems (including respiratory failure, respiratory arrest), psychiatric disorders.Treatment: in the case of the nasal of overdose, immediately wash or clean the nose. You may need symptomatic treatment.

Drug interactions:

Some antidepressants (MAO inhibitors and tricyclic antidepressants) and vasoconstrictors with concomitant administration may cause an increase in blood pressure.Combined intake with tricyclic antidepressants can lead to the development of arrhythmias.Simultaneous administration of antihypertensive agents (especially those that affect the sympathetic nervous system) can lead to various cardiovascular effects.

Pregnancy and lactation:

Long experience with the application shows that the rest of Reno has no negative impact on pregnancy. The safety of the drug during lactation has not been confirmed. Reno Mucosolvan should not be used in the first trimester of pregnancy. In the later stages of pregnancy and during lactation use of the drug is allowed only after consulting a doctor.

Side effects:

From the nervous system: rare (?0.01% and <,, 0="" 1="" -="" p="">,

From the side of cardiovascular system: uncommon (?0.1% and <,,1%) -="" p="">,

The respiratory system: often (?1% and <,,10 -="" 0="" 1="" 01="" p="">,

From the digestive system: often (?0.1% and <,,1%) -="" p="">,

The immune system: frequency not set* - hypersensitivity.

The skin and subcutaneous tissue** frequency not set* - rash, itching, swelling of the skin.

Other: frequency not set* - swelling of the mucous membrane**, fatigue.

* Adverse events, whose connection with the drug was regarded as a possible, was with the broad use of the drug. The frequency of these rare events is difficult to assess.

** As symptoms of hypersensitivity.

Terms and conditions of storage:

The drug should be stored out of reach of children at temperature not exceeding 25°C. shelf Life - 5 years.

Indications:

• swelling of the nasal mucosa, nasal congestion caused by acute respiratory infections and/or pollinosis (rhinitis, hay fever),
  
• in case of sinusitis, and otitis media (Eustachian) to facilitate outflow of the contents of the paranasal sinuses (on the recommendation of a physician).
  

Contraindications:

• angle-closure glaucoma,
  
• atrophic rhinitis,
  
• operations on the skull, carried out through the nasal cavity (in history),
  
• children up to age 6 years
  
• hypersensitivity to tramazoline hydrochloride or benzalkonium hydrochloride, as well as other components of the drug.
  

With caution

Patients with hypertension, heart disease, hyperthyroidism, prostatic hypertrophy, pheochromocytoma, porphyria drug should be used only on the recommendation of a doctor due to the potential risk of systemic absorption of the drug.

Use caution when taking MAO inhibitors, tricyclic antidepressants, vasopressor drugs and antihypertensive drugs.

Special instructions:

If after 7 days of the drug the positive dynamics of symptoms is not observed, should decide on discontinuing the drug or continuing treatment. Prolonged use of nasal vasoconstrictor drugs may lead to the development of chronic inflammation and congestion, and atrophy of the nasal mucosa.

Avoid falling drug in the eye.

Effects on ability to drive vehicles and management mechanisms

Studies on the effect of the drug on the ability to drive and use machinery has not been conducted. However, the drug can adverse effects such as hallucination, drowsiness, sedation, dizziness and fatigue. It is therefore necessary to exercise caution when driving and machinery.

The appearance of these side effects, you should avoid potentially dangerous tasks like driving and machinery.