Novigan - indications for use and important features of taking the medicine. What helps "Novigan"

Novigan is an anesthetic drug that additionally relieves inflammation and eliminates the manifestation of spasm. The drug belongs to the group of combined analgesics. What helps Novigan and how to use it correctly, it is worth considering in detail.

Novigan is an Ibuprofen-based medicine.

Novigan tablets contain the following substances in their composition:

ibuprofen;
pitofenone hydrochloride;
fenpiverinium bromide.

Means Novigan has a combined effect on the human body. The medicine relieves inflammation, anesthetizes and relieves spasms. The drug is most effective if used for pain that has arisen in the muscles of the internal organs.

The combined drug has analgesic, anti-inflammatory and antispasmodic effects. Suppresses the synthesis of prostaglandins (Pg). The composition of the drug includes the non-steroidal anti-inflammatory drug ibuprofen, the myotropic antispasmodic pitofenone hydrochloride and the m-anticholinergic agent of central and peripheral action fenpiverinium bromide.

Ibuprofen is a derivative of phenylpropionic acid. It has analgesic, anti-inflammatory and antipyretic effects. The main mechanism of action is the inhibition of the biosynthesis of prostaglandins - modulators of pain sensitivity, thermoregulation and inflammation in the central nervous system and peripheral tissues.

In women with primary dysmenorrhea, it reduces the elevated level of prostaglandins in the myometrium, thereby reducing intrauterine pressure and the frequency of uterine contractions.

Pitophenone hydrochloride , like papaverine, it has a direct myotropic effect on the smooth muscles of the internal organs and causes its relaxation.

Fenpiverinium bromide, due to the m-anticholinergic action, has an additional relaxing effect on smooth muscles.

The combination of the three components of the drug leads to a mutual enhancement of their pharmacological action.

Novigan is rapidly absorbed in the gastrointestinal tract, peak plasma concentration is reached after 1-2 hours. The drug is eliminated quickly, the half-life is 2 hours.

Important! If Novigan is taken after a meal, then the absorption is markedly reduced and slowed down, but the bioavailability of the drug does not change significantly.

Most of Novigan is excreted in the urine in 24 hours, the content of ibuprofen metabolites reaches 90%. A small part of the drug is excreted in the bile.

Novigan strongly and intensively binds to plasma proteins. The plasma concentration of the free drug is approximately 20% of the administered dose. In this regard, there is no significant interaction with other drugs.

Instructions for use

A doctor should prescribe this or that drug for pain syndrome. In this case, the patient must read the description of the medicine and information regarding the rules of administration.

Simultaneous use of Novigan with other NSAIDs or non-narcotic analgesics may lead to increased toxic effects. The drug can increase the concentration of digoxin in the blood plasma, potentiate the action of insulin and oral hypoglycemic drugs, increase the toxicity of colchicine, gold and lithium preparations, methotrexate, probenecid.

May reduce the diuretic, natriuretic and antihypertensive effect of diuretics and reduce the effectiveness of many antihypertensive agents.

Indications

Novigan is used to relieve mild to moderate pain resulting from spasms of smooth muscles of internal organs in biliary, renal, intestinal colic, biliary dyskinesia, menstrual pain.

Also, the drug is effective for radiculitis, myalgia, neuralgia, joint pain, tendonitis, bursitis, it relieves toothache, headache, incl. migraine. Good reviews about Novigan, used for colds, infectious and inflammatory diseases - the remedy lowers the temperature, relieves fever.

Indications for the use of Novigan are as follows:

slight spasm or mild pain in the smooth muscles of the internal organs (disruption of the intestines, dyskinesia of the bile pathways, hepatic or biliary colic);
spasms with sciatica;
joint pain (for example, with)
diseases in gynecology;
migraine.

Contraindications

The ban on the appointment of this medication are:

increased susceptibility to the components of the drug;
bleeding in the stomach;
the formation of ulcers and erosive processes;
liver or kidney failure;
childhood. The medicine can be used from the age of 16;
hyperkalemia;
exacerbation of intestinal diseases;
a history of such ailments as rhinitis, bronchial asthma and other disorders of the respiratory organs after taking acetylsalicylic acid;
porphyria in acute form;
disturbed process of blood formation;
angle-closure glaucoma;
dysfunction of the nerve responsible for human vision;
poor blood clotting;
rehabilitation after shunting;
granulocytopenia;
lack of glucose in the body;
intestinal obstruction;
tachyarrhythmia;
the period of bearing the baby and the period of breastfeeding.

In addition to direct contraindications that preclude the appointment of the drug, there are cases when the drug is used with caution. These are advanced age, ischemia, high blood pressure, long-term use of NSAIDs, alcoholism, smoking, somatic system disorders, colitis, gastritis and other diseases.

Important! In any case, the advisability of using Novigan is assessed by the attending physician. Unauthorized treatment is unacceptable.

Doses and rules of admission

The drug is taken depending on the diet. Tablets are used 1 hour before meals and 3 hours after meals. To avoid irritation of the stomach, the drug is washed down with milk.

If the doctor has not indicated the features of taking the drug, then it is used up to 3 times a day, using one tablet. Without medical supervision, they drink the medicine for no more than 5 days, while the doctor can adjust the dosage regimen. You can continue the course of treatment only with the permission of the doctor, while the patient's condition is monitored.

Novigan tablets are taken 1-2 pieces about 4 rubles / day. The maximum allowable daily dosage is 6 tab.

For menstrual pain caused by pathologies of the female genital organs, of a physical and inflammatory nature, take one tablet every four hours. According to Novigan's instructions, it is better to take 1 hour before meals or after 3 hours. after. You can take the drug on your own, without medical prescription, only for five days.

Important! To prevent irritation of the gastrointestinal tract, Novigan should be taken with milk.

Overdose and side effects

When treating with Novigan, do not exceed the prescribed doses.

When using an increased dose of the drug, reaction inhibition, drowsiness, acidosis, and tinnitus occur. Patients experience nausea, vomiting, abdominal pain and headache. Perhaps a decrease in blood pressure, the occurrence of disturbances in the rhythm of the heart. Of the severe consequences of an overdose - coma, respiratory arrest, liver disease.

If the recommended doses of the drug are exceeded by the patient, it is urgent to consult a doctor. The doctor takes such therapeutic measures as gastric lavage, the appointment of sorbents, alkaline drinking and diuresis. There are no specific antidotes for such poisoning.

With short-term use of the drug, it is well tolerated. Side effects of the drug are expressed by intestinal erosion, stomach ulcers, allergies, bronchospasm, Quincke's edema and anaphylactic shock.

In case of side effects, it is necessary to consult a doctor, and in severe forms of violations, call an ambulance.

From the digestive system: nausea, vomiting, NSAID-gastropathy (decreased appetite, pain and discomfort in the epigastric region, abdominal pain), irritation, dryness of the oral mucosa or pain in the mouth, ulceration of the gingival mucosa, aphthous stomatitis, pancreatitis, constipation, diarrhea, flatulence, digestive disorders ; possibly - erosive and ulcerative lesions of the gastrointestinal tract, bleeding from the gastrointestinal tract, impaired liver function.
From the side of the central nervous system and peripheral nervous system: headache, dizziness, drowsiness, anxiety, nervousness and irritability, psychomotor agitation, confusion, hallucinations.
From the sense organs: hearing impairment, ringing in the ears, reversible toxic amblyopia, blurred vision or double vision, dryness and irritation of the eyes, swelling of the conjunctiva and eyelids (allergic origin), scotoma.
From the side of the respiratory system: dyspnea.
From the side of the cardiovascular system: heart failure, tachycardia, increased blood pressure.
From the urinary system: edematous syndrome, impaired renal function, acute renal failure, interstitial nephritis, proteinuria, polyuria, cystitis, urine staining red.
Allergic reactions: skin rash (usually erythematous or urticarial), pruritus, urticaria (including on the conjunctiva and mucous membranes of the nasopharynx), angioedema, angioedema, aseptic meningitis (more often in patients with autoimmune diseases), bronchospastic syndrome, anaphylactoid reactions, anaphylactic shock, fever, erythema multiforme exudative, toxic epidermal necrolysis (Lyell's syndrome), eosinophilia, allergic rhinitis.
From the side of the hematopoietic organs: aplastic anemia, hemolytic anemia, thrombocytopenic purpura, agranulocytosis, leukopenia.
Anticholinergic effects: dry mouth, decreased sweating, paresis of accommodation, tachycardia, urinary retention.

Compatibility with other drugs

If Novigan is used in the doses required for therapy, then it does not come into contact with other drugs. But still there are drugs with which this drug interacts, causing undesirable effects.

Novigan is not used with certain drugs.

The active substance of the drug can reduce the effectiveness of uricosuric drugs, furosemide and hydrochlorothiazide. The drug enhances the effect of such substances:

anticoagulants;
fibrinolytics;
antiplatelet agents;
mineralocorticosteroids;
digoxin and others.

If you use Novigan and another NSAID at the same time, then such measures increase the risk of side effects. And taking caffeine along with NSAIDs enhances the analgesic effect.

The use of cefoperazone, valproic acid and other substances together with Novigan increase the risk of hypoprothrombinemia. The simultaneous use of gold and cyclosporine preparations can enhance the development of nephrotoxicity.

Application features

If the drug is prescribed to patients for long-term use, then at this time it is necessary to monitor the health and functioning of the kidneys, as well as the liver, and the peripheral blood picture. To minimize the risk of complications associated with taking the drug, it is prescribed in small doses.

If the patient has complaints about the gastrointestinal tract, then he needs medical supervision, which consists of a blood test, feces and an examination of the intestine. To determine the presence of ketosteroids, Novigan is canceled two days before such an analysis.

During treatment with this drug, alcohol intake is unacceptable. You also need to refrain from driving, operating mechanisms that require increased concentration and reaction.

Analogues and price

You can replace Novigan with analogues. Among them are the following medications:

Inflagesic;
Brustan;
Dolaren.

To date, the price of Novigan is 90 rubles for a pack of 10 tablets, and 163 rubles for 20 tablets in a pack.

It is considered one of the most accessible means from the NVPS group.

Having studied the methods of application, purpose and features of the drug, it should be concluded that the drug is effective for pain of moderate intensity. It has many prohibitions for use and application features, so it is not recommended to prescribe this remedy on your own. When treating with Novigan, the recommended dose should also not be exceeded.

Contraindications

Contraindications to the use of Novigan are children under 16 years of age, pregnancy and lactation, as well as individual intolerance to any component that is part of the drug. When prescribing the drug, one should also take into account information about attacks of intolerance to acetylsalicylic acid in history.

Also, the use of Novigan is contraindicated in the following diseases, disorders and conditions:

granulocytopenia;
tachyarrhythmia;
acute intermittent porphyria;
deficiency of glucose-6-phosphate dehydrogenase;
angle-closure glaucoma;
prostatic hyperplasia;
intestinal obstruction, gastrointestinal bleeding, erosive and ulcerative lesions of the mucous membrane of the stomach and duodenum, ulcerative colitis and other inflammatory bowel diseases occurring in the acute stage;
hepatic and / or renal failure, as well as progressive kidney disease;
violations of the functions of the hematopoietic system, hemophilia and other disorders of blood clotting, hemorrhagic diathesis;
confirmed hyperkalemia;
diseases of the optic nerve.

The drug should be administered with caution to the following categories of patients:

elderly patients;
patients with diabetes mellitus, dyslipidemia or hyperlipidemia, nephrotic syndrome, severe somatic diseases;
patients with blood diseases;
patients suffering from congestive heart failure, arterial hypertension, cerebrovascular diseases, coronary heart disease, peripheral arterial disease;
patients with Helicobacter Pylori infection, gastritis, colitis, enteritis, gastric ulcer and duodenal ulcer in history;
patients with hyperbilirubinemia and Cl creatinine level from 30 to 60.

The use of Novigan should be limited in dosage and frequency of administration in the treatment of patients suffering from nicotine and alcohol dependence, as well as those taking antiplatelet agents, anticoagulants, SSRIs and oral corticosteroids.

Instructions for use Novigan

The combined drug has an antispasmodic, analgesic, anti-inflammatory effect. It contains ibuprofen, which is a derivative of phenylpropionic acid. It has an antipyretic effect, suitable for the treatment of toothache and during menstruation. Tablets have a therapeutic effect a couple of hours after ingestion, a day later it is excreted in the urine. Manufacturer: India, Dr. Reddy's Laboratories Ltd.

Composition and form of release

The drug is in the form of biconvex film-coated tablets. NOVIGAN embossed on one side. Blister contains 10 pieces.

Pharmacodynamics and pharmacokinetics

The drug is a complex remedy that can relieve inflammation, provide analgesic, antispasmodic effect. It suppresses the production of prostaglandins. Among the components are fenpiverinium bromide, which acts as an m-anticholinergic substance, pitofenone hydrochloride, which has a myotropic antispasmodic effect, and ibuprofen, which is a non-steroidal anti-inflammatory agent.

Fenpiverinium bromide relaxes smooth muscles due to anticholinergic properties. Pitophenone hydrochloride has a myotropic effect on the muscles of internal organs, relaxing it, relieving spasms. Ibuprofen, which is a derivative of phenylpropionic acid, relieves fever, inflammation, inhibits the production of prostaglandins, which are responsible for thermoregulation, inflammation, and pain. The drug has an effect on the central nervous system, peripheral tissues.

In primary dysmenorrhea in women, the content of prostaglandins in the myometrium decreases, intrauterine pressure and heart rate decrease. Acting together, the components of the drug reinforce each other. They are easily absorbed by the intestines, reaching a maximum content in the blood after 1-2 hours. Almost all ibuprofen is bound to plasma proteins, processed by the liver, and excreted in the urine. The drug comes out with bile.

What are Novigan tablets for?

pain caused by spasms of smooth muscles (biliary dyskinesia; renal, intestinal, biliary colic);
migraine;
spasms and pain in dysmenorrhea;
pain in the lower back, joints, nerves: neuralgia, myalgia, sciatica.

Indications for use

Due to its effective effect on the human body, the remedy is used for pain syndromes of various etiologies. It can relieve even the most severe discomfort. Perfectly explains the instruction of the drug "Novigan", from which the medication helps.

The main indications for its use are the following conditions:

Pain syndrome of weak and moderate strength, provoked by spasms of internal organs. Such conditions are observed in biliary, intestinal, renal colic. Such discomfort provokes menstrual pain, dyskinesia of the bile ducts.
Pain caused by myalgia. Discomfort occurs in the muscles. The condition provokes cell hypertonicity.
Neuralgia, sciatica. Diseases accompanied by burning pain that occurs along the course of the nerve.
Joint pains. The medicine is effective for tendinitis, bursitis.
Pain of various etiologies. The medication copes with both dental discomfort and migraine.
Colds, infectious and inflammatory diseases. The drug effectively eliminates fever, normalizes the temperature.

novigan action

Novigan tablets are quickly absorbed and show their therapeutic effect one to two hours after ingestion. After a day, the drug is completely excreted from the body - mainly through the urinary system. Novigan works, the indications for the use of which include different types of pain, due to the properties of each of the active substances separately and due to their interaction, which enhances the overall effect. Consider what these components are and how they affect pain sensations:

Ibuprofen (400 mg)- non-steroidal anti-inflammatory substance, a derivative of phenylpropionic acid. By suppressing the biosynthesis of prostaglandins (hormone-like substances that cause pain at the biochemical level), there is a decrease in pain, as well as a decrease in inflammation, swelling, and elevated body temperature.
Pitophenone hydrochloride (5 mg)- a compound that has a direct effect on spasmodic smooth muscle tissue of internal organs, eliminating spasm. Muscle tension, which provokes compression of blood vessels and nerve fibers, often causes intense pain sensations that recede when relaxation occurs.
Fenpiverinium bromide (0.1 mg)- this component belongs to the group of m-anticholinergic agents that “turn off” the receptors of internal organs that respond to the mediator of nervous excitation acetylcholine. Due to this, a decrease in the tone of smooth muscles and a weakening of the pain syndrome are achieved.

Nuances of combinations

Diuretic drugs can activate the negative effect of Novigan on the kidneys. The combination with corticosteroids is associated with a greater likelihood of ulceration, bleeding in the gastrointestinal tract. Drugs from the antiplatelet class, SSRIs, in combination with the described medication are more likely to cause bleeding in the stomach or intestines. Simultaneous ingestion of the described drug and cardiac glycosides into the body can cause an exacerbation of heart failure, a decrease in the filtration rate in the glomeruli of the kidneys, and an increase in the concentration of glycosides in the blood serum.

Lithium preparations against the background of non-hormonal anti-inflammatory drugs are more slowly excreted from the body. Consequently, the toxicity of these compounds increases, the concentration in the blood serum increases.

Combining "Novigan" and "Methotrexate", it must be taken into account that the excretion of the second compound is weakening, which means that it becomes more dangerous for the body. The poisoning effect for the kidneys increases with the combination of the described composition and cyclosporins. The use of antimicrobial compounds of the quinolone series simultaneously with non-hormonal anti-inflammatory drugs is associated with an increased likelihood of a convulsive state. "Mifepristone" on the background of NSAIDs is ineffective, so the simultaneous use of these drugs is prohibited. Anti-inflammatory compounds begin to be taken one and a half to two weeks after stopping the course of treatment with Mifepristone.

Side effects

If you take Novigan anesthetic according to the instructions, it will not cause any adverse reactions.

If the dosage is not observed, patients may experience digestive disorders. Sometimes patients complain of shortness of breath, the appearance of bronchospasm and tinnitus, impaired hearing and vision. Sometimes doctors notice heart failure, tachycardia, increased pressure, and allergic reactions in their clients.

On the part of the genitourinary system, nephrotic edema, nephritis, cystitis, oliguria, renal failure, polyuria, urine staining can be observed. In exceptional cases, anemia, thrombocytopenia, leukopenia, impaired sweating occur. In some cases, laboratory parameters of blood and urine change.

Medication dosages

It is important to use Novigan medication correctly. The use of tablets must be agreed with the doctor

After all, the dosage of the medicine depends entirely on the pathology that provoked the discomfort.

For people who are assigned to "Novigan" (tablets), the instruction recommends taking it according to the following rules:

The medicine is consumed 1 hour before meals or 3 hours after.
To eliminate the irritating effect of the drug on the stomach, it is allowed to drink a pill immediately after a meal. The same effect can be achieved if the tablet is washed down with milk.
In case of spastic pains, the medicine should be taken 1 pill three times a day.
The maximum daily dose of the drug is 3 tablets.
It is allowed to take the medicine for 5 days.

If there is a need to use the drug for a longer period, then you should definitely consult a doctor. In some cases, longer therapy is allowed. However, it is prescribed only under strict supervision of the state of the blood and the functioning of the liver.

Side effects

development of hepatitis;
shortness of breath and bronchospasm;
NSAID-gastropathy, ulceration of the mucous membrane of the gastrointestinal tract and mucous membrane of the gums, pancreatitis, pain in the mouth, irritation and dryness of the oral mucosa, aphthous stomatitis;
tachycardia, heart failure, increased blood pressure;
headache, dizziness, nervousness, anxiety, irritability, insomnia, depression, psychomotor agitation, drowsiness, confusion, hallucinations, in patients with autoimmune diseases - aseptic meningitis;
allergic nephritis, acute renal failure, proteinuria, edema, oliguria, anuria, polyuria, cystitis, urine staining red;
ringing and noise in the ears, hearing impairment, visual impairment, allergic edema of the conjunctiva and eyelids, dryness and irritation of the eyes, paresis of accommodation;
anemia, agranulocytosis, thrombocytopenia and thrombocytopenic purpura;
erythema, urticaria, skin rash and pruritus, angioedema, bronchospasm, dyspnea, fever, anaphylactoid reactions, anaphylactic shock, allergic rhinitis, toxic epidermal necrolysis, eosinophilia, erythema multiforme exudative.

The use of the drug can provoke an increase or decrease in sweating, an increase in bleeding time, a decrease in creatinine clearance and blood glucose concentration, a decrease in hematocrit and hemoglobin, as well as an increase in liver transaminases and serum creatinine levels.

If any changes occur in the patient's condition when using Novigan, you should immediately stop taking it and seek the advice of a doctor.

Nuances of pharmacological activity

1, 2 types of COX are responsible for the transformation of arachidonic acid into thromboxanes, prostaglandins. The first type of substances is contained in various tissues, activates the formation of prostaglandins, ensures the performance of various systems and tissues responsible for the integrity of the gastric mucosa. Thromboxin in the human body is responsible for vasoconstriction, platelet aggregation. The inflammatory process is associated with the production of a second COX, which is actively involved in the formation of prostaglandins. Due to these substances, the focus of inflammation is more pronounced, the patient suffers from pain.

In the instructions for use of Novigan tablets, the manufacturer mentions that the drug contains P-piperidinoethoxy-O-carbomethoxybenzophenone hydrochloride. This substance can affect muscle structures. First of all, smooth muscle tissues are affected. The activity of phosphodiesterase is inhibited, the concentration of cAMP increases, the content of calcium ions at the cellular level decreases. Under the influence of the drug, the smooth muscle fibers of the vascular system relax. A similar effect is observed in other internal organs.

In addition, in the instructions for use for Novigan tablets, the manufacturer indicates the ganglioblocking effect of the drug. The drug affects the parasympathetic nervous system, lowers the tone, reduces the motility of gastric smooth muscles, affects the excretion of urine and bile from the body, the intestinal tract.

Dosage and administration

Inside, 1 hour before or 3 hours after a meal. To avoid irritating the stomach, you can take the drug immediately after a meal or drink it with milk.

Novigan is used to relieve mild to moderate pain resulting from spasms of smooth muscles of internal organs in biliary, renal, intestinal colic, biliary dyskinesia, menstrual pain.

Also, the drug is effective for radiculitis, myalgia, neuralgia, joint pain, tendonitis, bursitis, it relieves toothache, headache, incl. migraine.

Good reviews about Novigan, used for colds, infectious and inflammatory diseases - the remedy lowers the temperature, relieves fever.

Novigan tablets are taken 1-2 pieces about 4 rubles / day. The maximum allowable daily dosage is 6 tab.

According to Novigan's instructions, it is better to take 1 hour before meals or after 3 hours. after. You can take the drug on your own, without medical prescription, only for five days.

To prevent irritation of the gastrointestinal tract, Novigan should be taken with milk.

"Novigan" is valid for more than three hours, and the period of its complete elimination is four hours. Acute intense pain at the very "height" of the disease may require more frequent use, but it is impossible to increase its single dosage. The dosage of "Novigan" per day is no more than three tablets. It is better to take it immediately before or after meals - to reduce its irritating effect on the digestive system. The use of "Novigan" for more than five days in a row, even in therapeutic doses, requires agreement with the doctor.

Substitutes

Among the analogues of the remedy can be called any analgesic antispasmodic or NSAIDs:

aspirin;
"Analgin";
paracetamol;
"Ketanov";
"Indomethacin";
"Diclofenac";
"Papaverine";
"No-shpa";
"Dibazol";
Spazmalgon;
"Baralgin";
"Novitropan".

Most often, as a replacement for Novigan, they offer a drug based on either ibuprofen (Artrocam) or a combination of metamizole sodium (analgesic) with pitophenone and fenpiverinium. Tablets "Novigan" as a means of combining three of the four components indicated, are unique in their kind.

In order to avoid irritating effects on the gastric mucosa, the tablets are taken only after a meal, but if there is an urgent need, it will be enough to drink the drug with milk. If there is no doctor's prescription, then to relieve pain, you can take only one tablet no more than three times a day, without exceeding this maximum dosage. In this case, the course can last no more than five days in a row.

Restrictions

"Novigan", due to its inhibitory effect on the peripheral and central nervous system, is incompatible with a hangover syndrome. In addition to the poor compatibility of Novigan with alcohol, the drug also has a strong negative effect on the digestive tract due to two effects.

Interference with peristalsis. Antispasmodics in Novigan reduce the activity of peristalsis of all digestive organs, including the gallbladder and pancreas.
Decreased synthesis of prostaglandins. The interaction of the drug with the walls of the stomach and intestines is inevitable. At the same time, ibuprofen blocks the synthesis of prostaglandins that protect the gastric mucosa from the aggressive environment of gastric juice. Therefore, with gastritis, duodenitis, gastric or intestinal ulcers, Novigan is contraindicated, and its most common, striking side effects are observed from the digestive tract.

Taking Novigan in the presence of erosions and ulcers in the stomach or any parts of the intestine is also problematic because ibuprofen has anticoagulant properties, increasing the risk of bleeding.

When to be careful

In this article, you can read the instructions for using an anesthetic drug Novigan. Reviews of site visitors - consumers of this medicine, as well as opinions of doctors of specialists on the use of Novigan in their practice are presented. We kindly ask you to actively add your reviews about the drug: the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not declared by the manufacturer in the annotation. Novigan analogues in the presence of existing structural analogues. Use for the treatment of headache and toothache, during menstruation in adults, children, as well as during pregnancy and lactation. The composition of the drug.

Novigan- a combined drug that has analgesic, anti-inflammatory and antispasmodic effects. Suppresses the synthesis of prostaglandins. The composition of the drug includes a non-steroidal anti-inflammatory drug (NSAID) ibuprofen, myotropic antispasmodic pitofenone hydrochloride and m-anticholinergic agent of central and peripheral action fenpiverinium bromide.

Ibuprofen is a derivative of phenylpropionic acid. It has analgesic, anti-inflammatory and antipyretic effects (reduces elevated body temperature). The main mechanism of action is the inhibition of the synthesis of prostaglandins - modulators of pain sensitivity, thermoregulation and inflammation in the central nervous system and peripheral tissues. In women with primary dysmenorrhea, it reduces elevated levels of prostaglandins in the myometrium and thereby reduces intrauterine pressure and uterine contractions.

Pitophenone hydrochloride has a direct myotropic effect on the smooth muscles of the internal organs and causes its relaxation.

Fenpiverinium bromide, due to anticholinergic action, has an additional relaxing effect on smooth muscles.

The combination of the three components of the drug leads to a mutual enhancement of their pharmacological action.

Compound

Ibuprofen + Pitophenone hydrochloride + Fenpiverinium bromide + excipients.

Pharmacokinetics

When taken orally, the components of Novigan are well absorbed from the gastrointestinal tract. The main component of the drug ibuprofen is 99% bound to plasma proteins and accumulates in the synovial fluid. Ibuprofen is metabolized in the liver and 90% is excreted in the urine as metabolites and conjugates. A small part of ibuprofen is excreted in the bile.

Indications

mild or moderate pain syndrome with spasms of smooth muscles of internal organs: renal and biliary colic, biliary dyskinesia, intestinal colic;
dysmenorrhea;
headache, incl. migraine character;
short-term symptomatic treatment for joint pain, neuralgia, sciatica, myalgia.

Release form

Coated tablets 400 mg + 5 mg + 100 mcg.

Instructions for use and dosing regimen

Inside, 1 hour before or 3 hours after a meal. To avoid irritating the stomach, you can take the drug immediately after a meal or drink it with milk.

In the absence of special prescriptions from a doctor, Novigan is recommended for spastic pains, 1 tablet up to 3 times a day. The maximum daily dose is 3 tablets. Do not exceed the indicated dose!

The course of treatment with Novigan, without consulting a doctor, should not exceed 5 days. Longer use is possible under the supervision of a physician with monitoring of peripheral blood parameters and the functional state of the liver.

Side effect

NSAID-gastropathy (abdominal pain, nausea, vomiting, heartburn, loss of appetite, diarrhea, flatulence, constipation, ulceration of the gastrointestinal mucosa, which, in some cases, are complicated by perforation and bleeding; irritation or dryness of the oral mucosa, pain in the mouth, ulceration of the mucous membrane of the gums, aphthous stomatitis);
pancreatitis;
hepatitis;
dyspnea;
bronchospasm;
headache;
dizziness;
insomnia;
anxiety;
nervousness and irritability;
psychomotor agitation;
drowsiness;
depression;
confusion;
hallucinations;
aseptic meningitis (more often in patients with autoimmune diseases);
hearing impairment;
hearing loss;
tinnitus;
visual impairment (toxic damage to the optic nerve, blurred vision, scotoma, dryness and irritation of the eyes, swelling of the conjunctiva and eyelids (allergic genesis), paresis of accommodation);
heart failure;
tachycardia;
increase in blood pressure;
acute renal failure;
allergic nephritis;
nephrotic syndrome (edema);
oliguria, anuria, polyuria;
proteinuria;
cystitis;
urine staining red;
skin rash (usually erythematous or urticaria);
skin itching;
angioedema;
anaphylactoid reactions;
anaphylactic shock;
bronchospasm or dyspnea;
fever;
erythema multiforme exudative (including Stevens-Johnson syndrome);
toxic epidermal necrolysis (Lyell's syndrome);
eosinophilia;
allergic rhinitis;
anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia;
increased or decreased sweating.

Contraindications

erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding;
inflammatory bowel disease in the acute phase, incl. ulcerative colitis;
anamnestic data on an attack of bronchial obstruction, rhinitis, urticaria, after taking acetylsalicylic acid or another NSAID (complete or incomplete acetylsalicylic acid intolerance syndrome - rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma);
liver failure or active liver disease;
renal failure (CC less than 30 ml / min), progressive kidney disease;
confirmed hyperkalemia;
hemophilia and other blood clotting disorders (including hypocoagulation), hemorrhagic diathesis;
the period after coronary artery bypass grafting;
acute intermittent porphyria;
granulocytopenia;
hematopoietic disorders;
deficiency of glucose-6-phosphate dehydrogenase;
tachyarrhythmias;
angle-closure glaucoma;
diseases of the optic nerve;
prostatic hyperplasia;
intestinal obstruction;
pregnancy;
lactation period (breastfeeding);
age up to 16 years;
hypersensitivity to any component of the drug.

Carefully:

elderly age;
congestive heart failure;
cerebrovascular diseases;
arterial hypertension;
ischemic heart disease (CHD);
dyslipidemia/hyperlipidemia;
diabetes;
peripheral arterial disease;
nephrotic syndrome;
CC less than 30-60 ml / min;
hyperbilirubinemia;
peptic ulcer of the stomach and duodenum (in history);
presence of Helicobacter pylori infection;
gastritis, enteritis, colitis;
prolonged use of NSAIDs;
blood diseases of unknown etiology (leukopenia, anemia);
smoking;
frequent use of alcohol (alcoholism);
severe somatic diseases;
concomitant therapy with the following drugs: anticoagulants (eg, warfarin), antiplatelet agents (eg, acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (GCS) (eg, prednisolone), selective serotonin reuptake inhibitors (eg, citalopram, fluoxetine, paroxetine, sertraline).

Use during pregnancy and lactation

Novigan is contraindicated during pregnancy and lactation (breastfeeding).

Use in children

Contraindicated in children under 16 years of age.

Use in elderly patients

The drug should be used with caution in elderly patients.

special instructions

With prolonged use, it is necessary to control the pattern of peripheral blood and the functional state of the liver and kidneys.

To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used. When symptoms of gastropathy appear, careful monitoring is indicated, including esophagogastroduodenoscopy, a blood test to determine hemoglobin and hematocrit, and a fecal occult blood test.

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.

During the period of treatment should refrain from drinking alcohol.

Influence on the ability to drive vehicles and control mechanisms

During the period of treatment, the patient should refrain from engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

drug interaction

At therapeutic doses, Novigan does not interact significantly with commonly used drugs.

Inducers of microsomal oxidation enzymes in the liver (phenytoin, ethanol, barbiturates, flumecinol, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites, increasing the risk of severe intoxication.

Microsomal oxidation inhibitors reduce the risk of hepatotoxicity.

The drug reduces the hypotensive activity of vasodilators and the natriuretic effect of furosemide and hydrochlorothiazide.

Reduces the effectiveness of uricosuric drugs.

Enhances the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics (which increases the risk of bleeding).

It enhances the side effects of mineralocorticoids, glucocorticoids (the risk of gastrointestinal bleeding increases), estrogen, ethanol (alcohol).

Enhances the hypoglycemic effect of sulfonylurea derivatives.

Antacids and cholestyramine reduce the absorption of ibuprofen.

The drug increases the concentration of digoxin, lithium preparations, methotrexate in the blood.

Enhances the action of m-anticholinergics, blockers of histamine H1 receptors, butyrophenones, phenothiazines, amantadine and quinidine.

The simultaneous appointment of other NSAIDs increases the incidence of side effects.

Caffeine enhances the analgesic effect.

With simultaneous administration, it reduces the anti-inflammatory and antiplatelet effect of acetylsalicylic acid (it is possible to increase the incidence of acute coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent after starting Novigan).

Cefamandol, cefoperazone, cefotetan, valproic acid, plicamycin increase the incidence of hypoprothrombinemia with simultaneous administration.

Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.

Cyclosporine and gold preparations enhance the effect of ibuprofen on the synthesis of prostaglandins in the kidneys, which is manifested by an increase in nephrotoxicity.

Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of developing its hepatotoxic effects.

Drugs that block tubular secretion reduce excretion and increase the plasma concentration of ibuprofen.

Novigan's analogues

Structural analogues for the active substance:

Novospaz.

Analogues for the therapeutic effect (means for the treatment of migraine):

Amigrenin;
Amitriptyline;
Analgin;
Anaprilin;
Andipal;
Askofen;
Betaloc;
Vasobral;
Voltaren;
Diclofenac;
Dimephosphone;
Zomig;
Ibufen;
Inderal;
Ipronal;
Caffetin;
Ketonal;
Contemnol;
Korgard;
Xanthinol nicotinate;
Kudevita;
Lexotan;
Metovit;
metoprolol;
MIG 200;
Naizilat;
Naklofen;
Nalgezin;
Next;
Nilogrin;
Nobrassite;
NovoPassit;
Nomigren;
Nurofen;
Nurofen for children;
obzidan;
Omaron;
Ormidol;
Panadeine;
Panadol;
Paracetamol;
Pentalgin;
Peritol;
Picamilon;
Plivalgin;
propranolol;
Revalgin;
Redergin;
Rudotel;
Solpadein;
Stugeron;
Sumamigren;
Topamax;
Upsarin UPSA;
Sedative (sedative) collection;
Faspik;
Febricet;
Phezam;
Flamax;
Hairumat;
Cefekon D;
Cinnarizine;
Citrapak;
Egilok;
Estecor;
Efkamon.

In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases that the corresponding drug helps with and see the available analogues for the therapeutic effect.

1 tablet contains active ingredients: 5mg pitofenone hydrochloride , 400mg , 0.1mg fenpiverinium bromide.

Excipients: 76mg cornstarch, 5mg colloidal silicon dioxide, 4mg magnesium stearate , 55mg MCC, 12mg talc, 2.9mg .

The composition of the film shell of the shell: 1.124 mg of macrogol 6000, 1.059 mg of titanium dioxide, 0.058 mg sorbic acid , 5.686mg hypromellose 6 cps, 1.957mg talc, 0.058mg polysorbate 80, 0.058mg .

Release form

The drug is available in the form of coated tablets of 10 pieces in a blister. The carton box contains 2, 10 or 20 blisters with tablets, as well as instructions for use.

There is a release form in film-coated tablets. One blister contains 10 tablets. The cardboard box contains instructions for the use of the drug, as well as one or two blisters.

pharmachologic effect

Pills render anti-inflammatory, analgesic And antispasmodic action.

Indications for Novigan's use

Novigan tablets are indicated for:

moderate or mild pain syndrome, observed when the smooth muscles of the internal organs are exposed to - intestinal, bile and, as well as in the case of ;
headaches, including those that have a migraine character;
symptomatic short-term treatment for , myalgia , sciatica and pain in the joints.

Pharmacodynamics and pharmacokinetics

Novigan is a combination drug that has antispasmodic, anti-inflammatory and analgesic effects. The medicine suppresses synthesis. The preparation contains ibuprofen, which is a non-steroidal anti-inflammatory drug, fenpiverinium bromide- m-anticholinergic agent with peripheral and central action, as well as myotropic antispasmodic pitofenone hydrochloride.

Pitophenone hydrochloride causes relaxation of the muscles of the internal organs, exerting a direct myotropic effect on it.

Ibuprofen(derived from phenylpropionic acid) has analgesic, anti-inflammatory and antipyretic effects. The main effect of the substance is reduced to the inhibition of synthesis prostaglandins, which are modulators of thermoregulation, pain sensitivity and inflammation in peripheral tissues and CNS. In women suffering from primary dysmenorrhea , the level decreases prostaglandins V myometrium thereby reducing heart rate and intrauterine pressure.

Fenpiverinium bromide It has an additional relaxing effect on smooth muscles due to its anticholinergic action.

Combined, these three main components mutually reinforce each other's pharmacological action.

The components that make up Novigan are perfectly absorbed into gastrointestinal tract. After taking, after about 1-2 hours, the peak concentration of the drug is reached. Ibuprofen, the main component of this drug, is almost completely (99%) associated with blood plasma proteins, it can also be accumulated in synovial fluid. This component metabolized in the liver and 90% excreted in the urine as conjugates And . A small part of Novigan is excreted with bile. The half-life from blood plasma is 2 hours.

Contraindications

The drug is contraindicated in:

anamnestic data about the attack, bronchial obstruction after taking acetylsalicylic acid or any other non-steroidal anti-inflammatory drug (with incomplete or complete acetylsolicylic acid intolerance syndrome - hives , polyps nasal mucosa);
inflammatory bowel disease in the acute phase, including ulcerative ;
erosive and ulcerative changes in the mucous membrane of the duodenum or stomach, as well as with active bleeding in the gastrointestinal tract;
active liver disease or liver failure;
advanced kidney disease or Cl is less than 30 ml/min);
hemophilia or any other bleeding disorder (including hypocoagulation ), hemorrhagic diathesis ;
confirmed hyperkalemia ;
acute intermittent porphyria ;
hematopoietic disorders;
tachyarrhythmias ;
deficit glucose-b-phosphate dehydrogenase;
granulocytopenia ;
closed-angle ;
intestinal obstruction;
diseases optic nerve;
the period of breastfeeding or pregnancy;
in the period after the coronary artery bypass grafting;
individual intolerance to the components contained in the preparation;
patient under 16 years of age.

In addition, the drug should be taken with caution when:

advanced age of the patient;
cerebrovascular diseases;
heart failure;
hyperlipymedia /dyslipidemia ;
arterial hypertension ;
Cl creatinine 30–60 ml/min;
ischemic heart disease;
nephrotic syndrome ;
hyperbilirubinemia ;
congestive heart failure;
diseases of peripheral arteries;
peptic ulcer of the duodenum and stomach (history);
infection Helicobacter pylori ;
esterite ;
long-term use of non-steroidal anti-inflammatory drugs;
heavy somatic diseases;
alcoholism or smoking;
blood diseases of unknown etiology ( anemia , leukopenia );
concomitant therapy with anticoagulants(For example, ), oral GKS(For example, ),antiplatelet agents ( , acetylsolicylic acid etc.), as well as using SSRIs(For example, , , citalopram, ).

Side effects

For the gastrointestinal tract: mouth pain, aphthous stomatitis , ulceration of the mucous membrane of the gastrointestinal tract, sometimes complicated by bleeding and perforation, ulceration of the mucous membrane of the gums, NSAID gastropathy(nausea, heartburn, vomiting, loss of appetite, abdominal pain, ), dryness and irritation of the mucous membrane may appear in the oral cavity, .

For the respiratory system: bronchospasm, shortness of breath.

For the hepabolic system: hepatitis .

For peripheral and central nervous system: anxiety, dizziness, confusion, insomnia, irritability and nervousness, hallucinations, psychomotor agitation , headache, drowsiness, and Aseptic most commonly seen in patients with autoimmune diseases.

For the cardiovascular system:, increased blood pressure, heart failure.
For the senses: visual disturbances - blurred visual perception, irritation and dryness of the eyes, scotoma, swelling of the eyelids and conjunctiva, paresis of accommodation, as well as hearing impairment - its deterioration, as well as ringing or noise in the ears.

For hematopoietic organs: leukopenia , anemia (including also hemolytic aplastic), thrombocytopenic purpura And thrombocytopenia .

For the urinary system: acute renal failure, allergic nephritis , oliguria , nephrotic syndrome (edema), anuria , polyuria and urine turns red.

Allergic reactions: fever, anaphylactoid reactions, dyspnea or bronchospasm, skin itching, erythema multiforme exudative(including Stevens-Johnson syndrome ), eosinophilia skin rash (usually hives or erythematous), toxic epidermal necrolysis , allergic rhinitis .

Laboratory indicators: serum concentration may decrease glucose, may increase bleeding time, may decrease clearance creatinine, a decrease in level may occur or hematocrit may increase liver activity transaminases and may also increase serum concentrations creatinine.

Other side effects: decreased or increased sweating.

In the event that changes have occurred in the normal state when taking the drug, you should immediately stop taking the drug and seek medical help without delay.

Instructions for use Novigan (Method and dosage)

The drug is taken orally one hour before a meal or after a meal three hours later. To avoid the negative irritating effect of the drug on the stomach, you can take Novigan immediately after a meal or you can drink the tablets with milk.

In the absence of any doctor's prescriptions for admission, if spastic pains Novigan is recommended to take one tablet three times a day. The maximum dose of the drug per day is three Novigan tablets.

The instructions for use also warns that without consulting a doctor, the course of taking the tablets should not last more than five days. If you need to use the drug for a longer time, then this is done only under the supervision of a doctor and strict control of indicators of the functional state of the liver and peripheral blood.

Overdose

Overdose symptoms are: lethargy, nausea, abdominal pain, drowsiness, vomiting, depression, metabolic acidosis, tinnitus, lowering blood pressure, atrial fibrillation, headache, acute renal failure, respiratory arrest and .

As a treatment, it is used: alkaline drink, gastric lavage (maximum - after 3 hours), forced diuresis, and activated charcoal is prescribed or symptomatic therapy is used (blood pressure, acid-base state is corrected). However, there is no specific drug that could be used in case of an overdose.

Interaction

When taking Novigan in therapeutic doses with other commonly used drugs, significant interactions do not occur.

Microsomal oxidation inhibitors reduce the risk of developing hepatotoxic effect.

In the liver, inducers of microsomal oxidation enzymes ( ethanol, flumecinol, phenylbutazone, phenytonin, tricyclic antidepressants, barbiturates) increases the production of hydroxylated active metabolites, thereby increasing the risk that severe intoxication will develop.

Decreases natriuretic effect And furosemide, and hypotensive activity of vasodilators.

Efficiency uricosuric drugs is reduced.

There is an increased risk that bleeding will develop due to increased drug action fibrinolytics, indirect anticoagulants And antiplatelet agents.

Absorption ibuprofen is reduced cholestyramine And antacids.

The drug enhances the likely side effects, ethanol, GKS(increased risk of gastrointestinal bleeding) mineralocorticosteroids; derivatives sulfonylurea when interacting with the drug, they increase their hypoglycemic effect.

Concentration in the blood, as well as drugs methotrexate And lithium increases.
Simultaneous administration of the drug with other non-steroidal anti-inflammatory drugs increases the frequency of possible side effects.

The action is getting stronger butyrophenones, quinidine, phenothiazines, blockers H1-histamine receptors, , m-anticholinergics.

When the drug interacts with caffeine increases analgesic effect.

In case of simultaneous administration with acetylsalicylic acid her antiplatelet And anti-inflammatory action(in patients who receive small doses of acetylsalicylic acid as an antiplatelet agent, acute coronary insufficiency may develop at an increased frequency).

Manifestations of hematotoxicity of the drug is enhanced myelotoxic drugs.

In the case of simultaneous use of Novigan with, valproic acid, cefamandol, cefotetan or plicamycin the frequency of development increases hypoprothrombinemia .

Gold preparations and enhance the effect of ibuprofen on the synthesis of PG in the kidneys, the effect of which is manifested in an increase nephrotoxicity. Plasma concentration, as well as the likelihood that its hepatotoxic effects will develop, are increased by ibuprofen.

drugs that block tubular secretion, increase the plasma concentration of the substance ibuprofen, and also lower its excretion.

Terms of sale

The drug is dispensed in pharmacies without a prescription.

Storage conditions

Novigan should be stored out of the reach of children in a dry place protected from light. The storage temperature must not exceed 25°C.

Best before date

special instructions

In the case of prolonged use of the drug, careful monitoring of the picture of the functional state of the kidneys and liver and peripheral blood is required.

To reduce the risk of developing negative effects on the gastrointestinal tract, you need to take the minimum effective dose of the drug. If symptoms appear gastropathy careful monitoring is required, which includes a stool test for the presence of occult blood, a blood test, which includes the definition hematocrit and , as well as carrying out esophagogastroduodenoscopy.

In case a definition is required 17-ketosteroids, you need to stop taking the drug 48 hours before the start of the study.

During treatment with Novigan, you should refrain from drinking alcohol.

Patients taking the drug should refrain from potentially hazardous activities that require the speed of psychomotor reactions and increased concentration of attention (driving vehicles, etc.).

newborn

The drug is contraindicated for use in infants under the age of 4 months.

With alcohol

During the course of treatment with Novigan, you should refrain from drinking alcoholic beverages.

During pregnancy and lactation

During pregnancy, the drug is contraindicated (especially you should refrain from using it in the first trimester and in the last six weeks of pregnancy), and it is also not recommended to take Novigan during breastfeeding.