Novo-Passit oral solution bottle 100 ml

Composition

active ingredients: guaifenesin, liquid extract for Novo-Passit;

1 ml of solution contains: extract for Novo-Passit liquid (Hyperici herba (St. John’s wort herb), Passiflorae herba (passionflower herb), Valerianae radix (valerian root), Crataegi folium cum flore (hawthorn leaves and flowers), Lupuli flos (hop cones), Melissae herba (melissa herb), Sambusi flos (elderberry flowers)) (1:13, extractant water) 0.0775 g, guaifenesin 0.04 g;

excipients: sodium cyclamate, xanthan gum, invert sugar, sodium saccharin, sodium benzoate (E 211), ethanol 96%, orange flavor, sodium citrate, maltodextrin, propylene glycol, purified water.

Release form

Oral solution.

Pharmacodynamics.

The pharmacologically active components of the drug are guaifenesin and an extract from medicinal plants, which have a predominantly sedative effect. The sedative effect of the extract is combined with the muscle relaxant and anxiolytic effect of guaifenesin (relaxes smooth muscles).

Pharmacokinetics.

Guaifenesin is rapidly absorbed from the gastrointestinal tract, metabolized in the liver by conjugation with glucuronic acid, and excreted in the form of inactive metabolites, mainly in the urine.

The biological half-life is approximately 1 hour.

Mild form of neurasthenia, especially accompanied by anxiety, fear, sadness, irritability, increased fatigue or decreased concentration, mild forms of insomnia, asthenia or neurotic memory disorders. supportive therapy for migraine, headache caused by nervous overstrain; vascular psychosomatic disorders with neurocirculatory asthenia, neurogenic tetany, pain in the face; climacteric syndrome. functional diseases of the gastrointestinal tract, dyspeptic syndrome without organic lesions, irritable bowel syndrome and additional therapy for organic diseases of the gastrointestinal tract of neurotic genesis. psychosomatic dermatoses accompanied by itching (atopic eczema, urticaria).

Hypersensitivity to the active substances or auxiliary components of the drug, myasthenia gravis; simultaneous use of cyclosporine or tacrolimus; depression and other conditions accompanied by depression of the central nervous system; bradycardia.

For the drug in the form of a solution: usually the drug is prescribed 5 ml (1 teaspoon) 3 times a day. If necessary, the dose is increased to 10 ml 3 times a day or reduced to 2.5 ml in the morning and afternoon and 5 ml in the evening. The dose can be changed according to the patient’s condition. The intervals between taking the drug should be 4-6 hours. The maximum daily dose is 30 ml.

The drug can be mixed with drinks (juice, except grapefruit, tea).

The drug should be used with caution in severe liver and kidney diseases, intoxication with substances that suppress the function of the central nervous system.

When using the drug, patients, especially those with fair skin, should avoid prolonged exposure to UV radiation (sunbathing, solarium, diathermy).

Patients receiving treatment with indinavir or other antiretroviral drugs should avoid the use of St. John’s wort, as it may lead to the development of resistance to antiretroviral drugs and reduce the effectiveness of treatment.

St. John’s wort and antidepressants – selective serotonin reuptake inhibitors or triptans – should not be used simultaneously.

Use with caution in patients with severe organic diseases of the digestive tract.

In elderly patients, treatment should begin with the minimum dose.

While using the drug, you should refrain from drinking alcoholic beverages.

There may be a specific sensitivity to the smell of valerian.

Guaifenesin should be discontinued 48 hours before urine collection for analysis for the determination of vanillylmandelic acid and 5-hydroxyindoleacetic acid in urine using nitrosonaphthol as a reagent.

The drug in the form of a solution contains 12.19% vol. ethanol, one dose (5 ml) contains 0.481 g of ethanol, which should be taken into account when used during pregnancy and breastfeeding, in children and in patients from risk groups (with liver diseases, epilepsy, alcoholism).

One dose (5 ml) of the solution contains 1.99 g of a mixture of fructose and glucose. This should be taken into account when treating patients with diabetes mellitus. The drug should not be used in patients with hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Pregnancy and breastfeeding

Due to insufficient data on the safety of the drug during pregnancy and breastfeeding, its use is contraindicated during this period.

Children

The drug is prescribed to children over 12 years of age.

Drivers

Due to the fact that Novo-Passit contains ethanol and guaifenesin, when using the drug, a decrease in the speed of psychomotor reactions is possible, which manifests itself individually in each patient (see Side effects). Therefore, you should refrain from potentially hazardous activities that require increased attention, such as driving vehicles or working with other mechanisms.

• Immune system disorders: hypersensitivity reactions, vasculitis.
• From the nervous system: dizziness, drowsiness, inhibition of emotional reactions, depression.
• On the part of the digestive system: feeling of discomfort in the digestive tract, nausea, vomiting, cramps, heartburn, diarrhea or constipation.
• Skin and subcutaneous tissue disorders: rash, itching, urticaria, photosensitivity (during treatment, ultraviolet (UV) radiation should be avoided), hyperemia, skin edema.
• Musculoskeletal and connective tissue disorders: muscle weakness.
• Respiratory system: difficulty breathing.
• From the cardiovascular system: increased blood pressure, tachycardia, bradycardia, ventricular tachycardia.
• General disorders: increased fatigue, general weakness, decreased mental and physical performance.

Initially, it manifests itself as depression of the central nervous system, drowsiness. Later, these symptoms may be accompanied by nausea, mild muscle weakness, joint pain, and a feeling of heaviness in the stomach.

The following symptoms may also be observed: a feeling of bitterness in the mouth, unpleasant sensations in the liver area; headache, dizziness, lethargy, general weakness, hand tremors, dilated pupils, a feeling of tightness in the chest, abdominal pain, decreased hearing and vision, tachycardia; decreased blood pressure, bradycardia; decreased concentration.

Urolithiasis has been reported with guaifenesin overdose.

Treatment is symptomatic according to the general principles of overdose therapy. There is no specific antidote.

Guaifenesin enhances the analgesic effect of paracetamol and acetylsalicylic acid and enhances the effects of alcohol, sedative antihistamines and other substances that suppress the function of the central nervous system. The central effect of muscle relaxants may enhance the side effects of guaifenesin, especially muscle weakness.

St. John’s wort may induce CYP 3A4, CYP 1A2 and 2C9 cytochrome P450 isoenzymes, which may lead to a decrease in the effect of other concomitantly used drugs that are metabolized by these isoenzymes. This effect may also be due to the ability to induce the intestinal transport system P-glycoprotein. This interaction was first observed in healthy volunteers with the simultaneous administration of indinavir and St. John’s wort. It can also be expected that a similar interaction occurs with other retroviral protease inhibitors (aprenavir, nelfinavir, ritonavir, saquinavir), as well as non-nucleotide reverse transcriptase inhibitors (delavirdine, efavirenz, nevirapine) used in the treatment of HIV-1-positive patients. With the simultaneous use of antiretroviral drugs and St. John’s wort, their effectiveness decreases with the possible emergence of resistance. Therefore, St. John’s wort should not be used simultaneously with these drugs.

Significant clinical interactions with St. John’s wort have also been described with the simultaneous use of cyclosporine, digoxin and warfarin. The interaction may lead to a decrease in the concentration of the drugs in the blood plasma and, consequently, to a decrease in the therapeutic effect.

St. John’s wort should not be used with cyclosporine. If the patient is taking cyclosporine, St. John’s wort should be discontinued and the cyclosporine dose adjusted based on plasma cyclosporine levels. Patients should be closely monitored for any signs of tissue rejection after transplantation.

There is also a possibility of St. John’s wort interacting with antiepileptic drugs.

St. John’s wort has been observed to interact with many other drugs and substances that are biotransformed under the influence of the cytochrome P450 3A4 isoenzyme, including grapefruit juice.

In patients receiving treatment with indinavir or other antiretroviral drugs, the use of St. John’s wort should be avoided, as interaction with it may lead to a decrease in their effect with the possible emergence of resistance.

Concomitant administration of St. John’s wort with digoxin is not recommended. If it is necessary to prescribe St. John’s wort, the level of digoxin in the blood plasma should be monitored and the dose adjusted accordingly. When the dose of digoxin is increased, the dose of St. John’s wort remains unchanged; a doctor should be consulted regarding discontinuation of therapy.

The simultaneous use of St. John’s wort with warfarin is not recommended. If it is necessary to prescribe St. John’s wort, prothrombin time should be monitored during warfarin therapy and the dose adjusted accordingly. When the dose of warfarin is increased, the dose of St. John’s wort remains unchanged; a specialist should be consulted regarding discontinuation of treatment.

Concomitant use of St. John’s wort and tacrolimus may lead to subtherapeutic concentrations of tacrolimus, which may lead to graft rejection. Patients should avoid concomitant use of St. John’s wort and tacrolimus. In the event of concomitant use of St. John’s wort and tacrolimus, St. John’s wort should be discontinued and the plasma levels of tacrolimus should be monitored, as a dose reduction of the latter may be necessary.

Concomitant use with oral contraceptives may cause abnormal uterine bleeding (menorrhagia, hypermenorrhagia, metrorrhagia). In rare cases, a decrease in the contraceptive effect may occur. It is recommended to use combined oral hormonal contraceptives in combination with other methods of contraception (barrier methods) during St. John’s wort therapy.

St. John’s wort perforated can significantly reduce the effect of theophylline, so simultaneous use is not recommended. In cases where it is necessary to take St. John’s wort, it is necessary to monitor the level of theophylline in the blood plasma and, if necessary, adjust the dose of theophylline without changing the dose of St. John’s wort.

Concomitant therapy with amitriptyline is not recommended.

Concomitant treatment with St. John’s wort and anticonvulsants (carbamazepine, phenobarbital, phenytoin) is not recommended. A decrease in the level of the drug in the blood plasma and the occurrence of seizures are possible. If it is necessary to prescribe St. John’s wort, the level of anticonvulsants in the blood plasma (for example, increased seizure activity) and signs of a decrease in the effectiveness of the drug should be monitored. In the event of discontinuation of St. John’s wort therapy, the dose of anticonvulsants may not be reduced, but symptoms of toxicity of anticonvulsants should be monitored.

Clinically significant pharmacodynamic interactions have been observed with antidepressants – selective serotonin reuptake inhibitors and triptans. Due to the increased risk of adverse reactions associated with these interactions, St. John’s wort should not be used concomitantly with these drugs.

The use of St. John’s wort is not recommended for patients taking antibiotics, sulfonamides, antihypertensive calcium channel blockers, female sex hormones, and hypocholesterolemic agents (statins).

Passionflower. When used simultaneously with drugs that depress the CNS, such as barbiturates and tranquilizers, the sedative and hypnotic effect of the drug is enhanced.

Concomitant use with benzodiazepines is not recommended. Concomitant use with disulfiram should be avoided.

During treatment with the drug, you should not drink alcoholic beverages.

Valerian. Enhances the effects of alcohol, sedatives, hypnotics, hypotensive, anxiolytic and antispasmodic drugs.

Hawthorn. Enhances the effect of sedatives, hypnotics, antiarrhythmics, and cardiac glycosides.

Melissa. With simultaneous use, the effect of other sedatives and hypnotics may be enhanced.

Effect on laboratory test results. Guaifenesin may cause false-positive results in diagnostic tests for the determination of 5-hydroxyindoleacetic acid (photometric method using nitrosonaphthol as a reagent) and vanillylmandelic acid in urine. Novo-Passit should be discontinued 48 hours before urine collection for this test.

In the original packaging at a temperature not exceeding 25 °C. Do not freeze. After first opening the bottle, the shelf life is 28 days.