Relenza - instructions for use, reviews, analogs and form of release (powder for inhalation 5 mg with inhaler Dischaler, tablets) of a drug based on zanamivir for the treatment and prevention of influenza in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Relenza. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of physicians specialists on the use of Relenza in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues Relensa in the presence of existing structural analogues.Use of treatment and prevention of influenza in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

Relenza - antiviral drug, highly selective inhibitor of neuraminidase (surface enzyme of the influenza virus). Viral neuraminidase provides the release of viral particles from the infected cell and can accelerate the penetration of the virus through the mucosal barrier to the surface of epithelial cells, thereby ensuring the infection of other cells in the airways. The inhibitory activity of zanamivir (the active agent of the Relensa preparation) includes all 9 subtypes of neuraminidase of influenza viruses, incl. circulating and virulent for various species. Half of the inhibitory concentration (IC50) for strains of virus A and B is from 0.09 to 95.2 pM.

Replication of the influenza virus is limited to the cells of the superficial epithelium of the respiratory tract. Zanamivir acts in the extracellular space, reducing the reproduction of both types of influenza A and B virus, preventing the release of viral particles from the cells of the superficial epithelium of the respiratory tract.

The effectiveness of Relenza in case of inhalation has been confirmed in controlled clinical trials.The use of zanamivir as a therapy for acute infections caused by the influenza virus led to a decrease in the release of the virus (compared to placebo). The development of resistance to Relenza has not been documented.

Clinical efficacy and safety

Zanamivir, used in the doses used in the treatment of influenza, in healthy people at risk (usually in contact with the sick), facilitates the symptomatology and shortens the duration of the disease. A combined analysis of the results of 3 studies showed that the median time to alleviate the symptoms of the disease was reduced to 1.5 days in patients in the zanamivir group compared with patients in the placebo group (p less than 0.001). The number of complications decreased in the group of zanamivir 171/769 (22%) compared with placebo 208/711 (29%) and the relative risk was: 0.77; (95% CI: 0.65-0.92, p = 0.004). The use of antibiotics for the treatment of complications after influenza also decreased from 136/711 (19%) in the placebo group to 110/769 (14%) in the zanamivir group (relative risk: 0.76; 95% CI: 0.60-0.95; p = 0.021) . The optimal efficacy of zanamivir was shown in the case of starting treatment as soon as possible after the appearance of the first symptoms of the disease.

It has been shown that zanamivir is also effective as a means of preventing influenza in children older than 5 years and in adults. The percentage of effective protection is 67-79% compared with placebo and 56-61% compared to active control.

Composition

Zanamivir + auxiliary substances.

Pharmacokinetics

When inhaled, the absolute bioavailability of the drug is low (2% on average). Systemic absorption is approximately 10-20%. Due to low absorption, the concentration of active substance in the blood plasma is low (a low degree of absorption persists with repeated inhalations). After inhalation, zanamivir is distributed in the tissues of the respiratory tract, reaching high concentrations. When used in a single dose of 10 mg, zanamivir is defined in the epithelial layer of the respiratory tract, which is the main site of replication of the influenza virus. The concentration of zanamivir at 12 hours and 24 hours after inhalation is approximately 340 and 52 times, respectively, greater than the mean IC50 value for viral neuraminidase. The high concentration of zanamivir in the respiratory tract provides rapid inhibition of viral neuraminidase.Zanamivir accumulates mainly in the tissues of the oropharynx and lung (an average of 77.6% and 13.2%, respectively). Zanamivir is excreted by the kidneys unchanged and is not metabolized.

In elderly patients at a therapeutic dose of 20 mg per day, bioavailability is low (10-20%), as a result of which the systemic effect of zanamivir is absent. Changes in pharmacokinetics associated with age are unlikely (dose adjustment is not required).

In children, the pharmacokinetics of zanamivir was evaluated in a controlled trial in 24 patients aged 3 months to 12 years using a nebulizer (10 mg) and a powder inhaler (10 mg). Pharmacokinetic parameters in children did not differ from those in adults.

Indications

• treatment and prevention of infection caused by the influenza A and B virus in children older than 5 years and adults.

Forms of release

Powder for inhalation dosed at 5 mg in a single dose in a rotadisk.

Other dosage forms, be it pills, capsules or drops, do not exist.

Instructions for use and dosage

It is intended only for inhalation in the respiratory tract using the attached Dischaler inhaler.Other inhaled preparations, for example, high-speed bronchodilators, should be taken before the beginning of inhalation with Relens.

In the treatment of influenza A and B in adults and children older than 5 years, it is recommended to prescribe 2 inhalations (2 × 5 mg) 2 times a day for 5 days. The daily dose is 20 mg.

Elderly patients and patients with impaired renal and hepatic function do not need dose adjustment.

To achieve the optimal effect, treatment should be started as early as possible.

For the prevention of influenza A and B in adults and children older than 5 years, it is recommended to prescribe 2 inhalations (2 × 5 mg) once a day for 10 days. The daily dose is 10 mg. The course of prevention can be extended to 1 month if the risk of the disease persists for more than 10 days.

Elderly patients and patients with impaired renal and hepatic function do not need dose adjustment.

Rules for the application of Diskhaler

Device Diskhaler used for inhalation of the rotadisk (release form Relenza). The dischaler consists of the following parts:

• a body with a lid and a plastic needle for piercing the cell of the rotadisk;
• cover for the mouthpiece;
• A sliding tray with a mouthpiece and a rotating wheel,on which is placed the Rotadisk.

Rotadisk consists of 4 blisters, each of which contains a certain dose of the drug.

The rotadisk can be stored in the device for inhalation of the dischaler; nevertheless, the blister should be pierced immediately before inhalation of the drug. Failure to comply with this recommendation may disrupt the work of Diskhaler and, accordingly, reduce the effectiveness of the drug.

Important: Do not pierce the rotadisk before it is placed in the dischaler.

Loading the rotadisk in Diskhaler

1. Remove the cover from the mouthpiece, make sure that the mouthpiece is clean inside and out.

2. Gently pull out the drawer until the plastic clips come out, grasping the corners of the tray. The tray should be pushed all the way out so that the notches on the side of the clips are visible.

3. Pull out the tray completely by grasping the large and index finger of the notch on the side of the clips.

4. Place the rotadisk on the wheel with the cells down and insert the tray back into the Dischaler.

Carrying out inhalations

1. Lift the Dischaler's cover up to the stop to pierce the upper and lower foil of the Rotadisk. Close the cover.

Important: Do not lift the cover before the drawer is fully installed.

2. After a full exhalation, place the mouthpiece between the teeth, tightly grasp the mouthpiece with lips, without closing the air holes on both sides of the mouthpiece. Make a slow deep breath (always through the mouth, not through the nose). Remove the mouthpiece from the mouth. Hold your breath as far as possible. Slowly exhale. Do not breathe out into the inhaler.

3. Carefully pull the drawer out one push at a time, without pressing the clips, and push it in. In this case, the rotadisk will rotate by one cell and ready for the next inhalation.

Important: puncture the cell only immediately before inhalation.

For repeated inhalations, repeat step 1 and 2.

Replacing an empty rotadisk

Each rotadisk contains 4 cells. After four inhalations, the empty rotadisk should be replaced with a new one (observing steps 2-4 of the instructions).

Important: Children should use an inhalation device under the supervision of adults.

Side effect

• allergic reactions, including swelling of the face and larynx;
• bronchospasm;
• difficulty breathing;
• rash;
• hives;
• severe skin reactions, including erythema polymorph, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Contraindications

• hypersensitivity to the components of the drug.

Application in pregnancy and lactation

Efficacy and safety of Relenza during pregnancy and lactation (breastfeeding) has not been studied.

In experimental animal studies, it was shown that zanamivir penetrates the placental barrier and is excreted in breast milk, nevertheless, there is no teratogenic effect or a decrease in fertility or clinical manifestations of any disorders in the pre- and postnatal periods. Information on penetration through the placental barrier or into human milk is not present.

However, Relenza should not be used during pregnancy and during breastfeeding, especially in the first trimester, unless the expected benefit to the mother exceeds the possible risk to the fetus.

Use in children

The drug is prescribed for children older than 5 years.

Application in elderly patients

Older patients are not required to adjust the dose.

special instructions

Very rare isolated reports on the development of bronchospasm and / or worsening of the function of respiration after the application of Relenza have been recorded, incl.without previous illnesses in the anamnesis. In case of development of one of the above-listed phenomena, you should stop taking zanamivir and consult a doctor.

Patients with respiratory diseases should have short-range bronchodilators as an ambulance in the treatment with zanamivir.

Infection caused by the influenza virus may be associated with various neurological and behavioral disorders. Reports received in the postmarketing period (predominantly registered in children in Japan) reported seizures, delirium, hallucinations and deviant behavior in patients infected with the influenza virus and taking neuraminidase inhibitors, including zanamivir. These phenomena were observed mainly in the early stages of the disease, often had a sudden onset and a rapid onset of the outcome. The causal relationship between the administration of zanamivir and the above undesirable phenomena has not been proven. If any psychoneurological symptoms occur, the risk / benefit ratio of further treatment with zanamivir should be assessed for each individual patient.

Impact on the ability to drive vehicles and manage mechanisms

Does not affect.

Drug Interactions

Data on the drug interaction of Relenza is not available.

Analogues of the Relensa drug

There are no structural analogs to the active substance of Relenza. The drug contains a unique active substance that does not have direct analogs.

Analogues on the curative effect (funds for the treatment of influenza):

• Algiers;
• Alfaron;
• Amben;
• Amizon;
• Amiksin;
• Anaferon;
• Anaferon child;
• Antigrippin;
• Arbidol;
• Aflubin;
• Bronchicum;
• Vaxigrip;
• Vaccine influenza inactivated;
• Viferon;
• Hexapneumine;
• Genferon Light;
• Grippferon;
• Isoprinosine;
• Ibuprofen;
• Immunal;
• Immunoglobulin;
• Immunorm;
• Ingavirin;
• IRS 19;
• Kagocel;
• Lavomax;
• Levopron;
• Libexin;
• Linkas;
• Liprokhin;
• Nurofen;
• Orvire;
• Oseltamivir;
• Oscillococcinum;
• Paxelidine;
• Panavir;
• Polyoxidonium;
• Reaferon EU Lipint;
• Remantadine;
• Rengalin;
• Sakhol;
• Sulfadimethoxin;
• Tamiflu;
• Trekrezan;
• Fluuarix;
• Cycloferon;
• Cigapan;
• Eifitol;
• Eladon;
• Endobulin;
• Ergoferon;
• Erespal;
• Echinacea.

Similar medicines:

Other medicines: