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Pharmacological properties

the pharmacologically active components of the drug novopassit are guaifenesin and extracts of medicinal plants that have a predominantly sedative effect. St. Johns wort herb has an antidepressant property. the mechanism of action is to inhibit the reuptake of serotonin and suppress MAO. Valerian extract (Valerian officinalis) has hypnotic and sedative effects. the mechanism of action is associated with the effect on gamma receptors and chloride channels, the opening of chloride channels and the suppression of neural excitability. the soothing property of the extract is combined with the anxiolytic and muscle relaxant effects of guaifenesin (relaxes smooth muscles).

Pharmacokinetics Guaifenesin is rapidly absorbed in the digestive tract, metabolized in the liver by conjugation with glucuronic acid, and excreted as inactive metabolites, mainly with urine. T½ is about 1 hour

Indications

A mild form of neurasthenia, especially accompanied by anxiety, fear, sadness, irritability, increased fatigue or decreased concentration of attention, mild forms of insomnia, asthenia, or neurotic memory impairment. supportive therapy for migraine, headache, caused by nervous strain; vascular psychosomatic disorders with neurocirculatory asthenia, neurogenic tetany, pain in the face; menopausal 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 origin. psychosomatic dermatoses accompanied by itching (atopic eczema, urticaria).

Application

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 in accordance with the condition of the patient. 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, with the exception of grapefruit, tea).

For the preparation in the form of tablets: adults and children over the age of 12 are usually prescribed 1 tablet 3 times a day. If necessary, the daily dose can be increased (2 tablets 3 times a day) or reduced (½ tablets in the morning and in the afternoon and 1 tablet in the evening). The dose can be changed in accordance with the condition of the patient. The interval between doses is 4-6 hours. The maximum daily dose is 6 tablets (dry extract for Novo-Passit 0.9 g / guaifenesin 1.2 g). The recommended duration of use is 4–5 weeks. For longer periods of use, consult your doctor.

Tablets are washed down with a sufficient amount of liquid (water, tea or fruit juice, except for grapefruit).

Contraindications

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

Side effects

From the immune system: hypersensitivity reactions, vasculitis.

From the side of the nervous system: dizziness, drowsiness, inhibition of emotional reactions, depression.

From the digestive system: discomfort in the digestive tract, nausea, vomiting, cramping, heartburn, diarrhea or constipation.

On the part of the skin and subcutaneous tissue: rash, itching, urticaria, photosensitivity (ultraviolet (UV) radiation should be avoided during treatment), hyperemia, and skin edema.

From the musculoskeletal system and connective tissue: muscle weakness.

From the respiratory system: shortness of breath.

From the cardiovascular system: increased blood pressure, tachycardia, bradycardia, ventricular tachycardia.

General disorders: increased fatigue, general weakness, decreased mental and physical performance.

special instructions

Use the drug with caution in case of severe diseases of the liver and kidneys, intoxication with substances that inhibit the function of the central nervous system.

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

Patients who receive treatment with indinavir or other antiretroviral drugs should avoid the use of perforated hypericum, as this can lead to the development of resistance to antiretroviral drugs and reduce the effectiveness of treatment.

St. Johns wort and antidepressants should not be used at the same time - selective serotonin reuptake inhibitors or triptans.

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

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

During the use of the drug should refrain from drinking alcoholic beverages.

Specific sensitivity to valerian odor may occur.

Guaifenesin should be discontinued 48 hours before urine collection for analysis to determine vanillyl mandelic acid and 5-hydroxyindoleacetic acid in the 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 considered when used during pregnancy and lactation, in children and in patients from risk groups (with liver diseases, epilepsy, alcoholism).

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

The drug in the form of tablets should not be used in patients with hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

During pregnancy and breastfeeding. Due to insufficient data on the safety of the drug during pregnancy and lactation, it is contraindicated in this period.

Children. The drug is prescribed for children over the age of 12 years.

The ability to influence the reaction rate when driving vehicles and working with other mechanisms. Due to the fact that Novo-Passit contains ethanol and guaifenesin, when using the drug, it is possible to reduce the speed of psychomotor reactions, which is manifested individually in each patient (see ADVERSE EFFECTS). Therefore, you should refrain from potentially dangerous activities that require increased attention, such as driving vehicles or working with other mechanisms.

Interactions

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

Perforated St. Johns wort can cause the induction of isoenzymes CYP 3A4, CYP 1A2 and 2C9 of cytochrome P450, which can cause a decrease in the effect of other drugs used simultaneously and which are metabolized by these isoenzymes. The indicated effect may also be due to the ability to induce the intestinal transport system P-glycoprotein.This interaction was first detected in healthy volunteers while taking indinavir and perforated hypericum. It can also be expected that this interaction also occurs with other retroviral protease inhibitors (aprenavir, nelfinavir, ritonavir, saquinavir), as well as non-nucleotide reverse transcriptase inhibitors (delaverdine, efavirenz, nevirapine) used in the treatment of HIV-1-positive patients. With the simultaneous use of antiretroviral drugs and St. Johns wort perforated, their effectiveness decreases with the possible occurrence of resistance. Therefore, St. Johns wort should not be used simultaneously with these drugs.

Significant clinical interactions with St. Johns wort have also been described while taking cyclosporine, digoxin, and warfarin. The interaction can lead to a decrease in the concentration of drugs in the blood plasma and, accordingly, to a decrease in the therapeutic effect.

St. Johns wort can not be used with cyclosporine. If the patient uses cyclosporin, then it is necessary to cancel the St. Johns wort and, on the basis of determining the level of cyclosporin in the blood plasma, adjust the dose of cyclosporin. Care should be taken to monitor any signs of tissue rejection in patients after transplantation.

There is also the possibility of interaction of St. Johns wort perforated with antiepileptic drugs.

St. Johns wort interacts with many other drugs and substances that are biotransformed under the influence of the 3A4 isoenzyme of cytochrome P450, including the action of grapefruit juice.

In patients receiving treatment with indinavir or other antiretroviral drugs, the use of perforated St. Johns wort should be avoided, since interaction with it may lead to a decrease in their action with the possible occurrence of resistance.

The simultaneous appointment of St. Johns wort with digoxin is not recommended. If necessary, the appointment of St. Johns wort should monitor the level of digoxin in the blood plasma and adjust the dose accordingly. With an increase in the dose of digoxin, the dose of St. Johns wort remains unchanged, you should consult your doctor regarding discontinuation of therapy.

The simultaneous use of St. Johns wort with warfarin is not recommended. If it is necessary to prescribe St. Johns wort, prothrombin time should be monitored during warfarin therapy and the dose should be adjusted accordingly. With an increase in the dose of warfarin, the dose of St. Johns wort remains unchanged, you should consult a specialist regarding discontinuation of treatment.

The simultaneous use of St. Johns wort and tacrolimus can contribute to the accumulation of subtherapeutic concentrations of tacrolimus, which can lead to transplant rejection. Patients should avoid taking perforated hypericum and tacrolimus at the same time. In the case of the simultaneous use of St. Johns wort and tacrolimus, you should stop taking St. Johns wort and monitor the level of tacrolimus in the blood plasma, since it may be necessary to reduce the dose of the latter.

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

Perforated St. Johns wort can significantly reduce the effect of theophylline, so the simultaneous use is not recommended. In the case when there is a need to take St. Johns wort, it is necessary to control the theophylline level in blood plasma and, if necessary, adjust the dose of theophylline without changing the dose of St. Johns wort.

Concomitant therapy with amitriptyline is not recommended.

Simultaneous treatment with St. Johns wort and anticonvulsants (carbamazepine, phenobarbital, phenytoin) is not recommended. Perhaps a decrease in the level of the drug in the blood plasma and the occurrence of seizures. If necessary, the appointment of St. Johns wort should monitor the level of anticonvulsants in the blood plasma (for example, an increase in convulsive activity) and signs of a decrease in the effectiveness of the drug. In the case of termination of therapy with St. Johns wort, the dose of anticonvulsants can not be reduced, however, symptoms of toxicity of anticonvulsants should be monitored.

Clinically significant pharmacodynamic interactions were observed with the use of antidepressants - selective serotonin reuptake inhibitors and triptans. Due to the increased risk of adverse reactions associated with these interactions, St. Johns wort should not be used simultaneously with these drugs.

The use of St. Johns wort is not recommended in patients who take antibiotics, sulfonamides, antihypertensive calcium channel blockers, female sex hormones, hypocholesterolemic agents (statins).

Passionflower. With simultaneous use with drugs that depress the central nervous system, such as barbiturates, 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 should not drink alcoholic beverages.

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

Hawthorn. Increases the effect of sedatives, hypnotics and antiarrhythmic drugs, cardiac glycosides.

Melissa. With simultaneous use, it is possible to enhance the action of other sedatives and hypnotics.

Influence on the results of laboratory tests. Guaifenesin can cause false positive results of diagnostic tests for the determination of 5-hydroxyindoleacetic acid (photometric method using nitrosonaphthol as a reagent) and vanillylmindic acid in the urine. The use of Novo-Passit must be stopped 48 hours before urine collection for this analysis.

Overdose

Initially manifested by inhibition of central nervous system function, drowsiness. later, these symptoms may be accompanied by nausea, mild muscle weakness, joint pain and a feeling of heaviness in the stomach.

Symptoms may also be observed: a feeling of bitterness in the mouth, discomfort in the liver; headache, dizziness, lethargy, general weakness, trembling hands, dilated pupils, chest tightness, abdominal pain, decreased hearing and visual acuity, tachycardia; decreased blood pressure, bradycardia; decreased attention span.

With an overdose of guaifenesin, urolithiasis has been reported.

Symptomatic treatment according to the general principles of therapy in case of an overdose. There is no specific antidote.

Storage conditions

In the original packaging at temperatures up to 25 ° c. do not freeze. after the first opening of the bottle, the shelf life is 28 days.

Medicinal product information for healthcare professionals.