Description
Latin name
Novigan
Release form
Coated tablets.
packaging 10 pcs
Pharmacological action
Pharmacodynamics
Combined drug, has analgesic, anti-inflammatory and antispasmodic effects. Suppresses the synthesis of prostaglandins (Pg). The composition of the drug includes a non-steroidal anti-inflammatory drug – ibuprofen, myotropic antispasmodic – pitophenone hydrochloride and m-anticholinergic agent of central and peripheral action – fenpiverinia bromide.
Ibuprofen is a phenylpropionic acid derivative. 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, which reduces the intrauterine pressure and the frequency of uterine contractions.
Pitophenone hydrochloride, like papaverine, has a direct myotropic effect on the smooth muscles of internal organs and causes its relaxation.
Fenpiverinia bromide due to m-anticholinergic action has an additional relaxing effect on smooth muscles.
The combination of the three components of the drug leads to a mutual strengthening of their pharmacological action.
Pharmacokinetics
The components of Novigan® are well absorbed in the gastrointestinal tract. The peak concentration in plasma is reached approximately 1-2 hours after taking the drug. The main component of the drug – ibuprofen is 99% bound to plasma proteins, can accumulate in the synovial fluid, is metabolized in the liver and excreted 90% in the urine in the form of metabolites and conjugates. A small part of the drug is excreted with bile. The plasma half-life is 2 hours.
Indications
Mild or moderate pain with spasms of smooth muscles of the internal organs: renal and biliary colic, biliary dyskinesia, intestinal colic.
Gynecological diseases: dysmenorrhea.
Headache, including migraine.
Short-term symptomatic treatment for joint pain, neuralgia, sciatica, myalgia.
Use during pregnancy and lactation
Contraindicated in pregnancy and lactation.
Composition of
Each film-coated tablet contains: Active substances:
ibuprofen 400 mg,
pitophenone hydrochloride 5 mg,
fenpiverinium bromide 0.1 mg.
Excipients:
microcrystalline cellulose 55 mg,
corn starch 76 mg,
glycerol 2.9 mg,
silicon dioxide colloidal 5 mg,
talcum 12 mg,
magnesium stearate 4 mg srdl 6 mg srdl 686 srdl kpld 686 srdlk srdl macrogol 6000 1.124 mg,
talc 1.957 mg,
titanium dioxide 1.059 mg,
polysorbate-80 0.058 mg,
sorbic acid 0.058 mg,
dimethicone 0.058 mg.
Dosage and administration
Inside, 1 hour before or 3 hours after eating. In order to avoid irritating effects on the stomach, you can take the drug immediately after eating or drink milk.
Unless specifically prescribed by a doctor, it is recommended that you take Novigan® for spastic pain, 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 medical advice should not exceed 5 days. Longer use is possible under the supervision of a physician with control of peripheral blood counts and the functional state of the liver.
Side effects of
In recommended doses, Novigan® does not cause side effects.
From the gastrointestinal tract: NSAID gastropathy (abdominal pain, nausea, vomiting, heartburn, decreased appetite, diarrhea, flatulence, constipation of ulceration of the gastrointestinal mucosa, which in some cases are complicated by perforation and bleeding, irritation or dryness of the mucous membrane oral cavity, pain in the mouth, ulceration of the gum mucosa, aphthous stomatitis, pancreatitis.
from the hepatobiliary system: hepatitis.
from the respiratory system: shortness of breath, bronchospasm.
from the organs feelings: hearing impairment: hearing loss, ringing or tinnitus visual impairment: toxic damage to the optic nerve, blurred visual perception, scotoma, dryness and irritation of the eyes, swelling of the conjunctiva and eyelids (allergic genesis), paresis of accommodation.
From the central and peripheral nervous system: headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression, confusion, hallucinations, aseptic meningitis (more often in patients with autoimmune diseases).
From the cardiovascular system: heart failure, tachycardia, increased blood pressure.
From the urinary system: acute renal failure, allergic nephritis, nephrotic syndrome (edema), oliguria, anuria, polyuria, proteinuria, cystitis, urine staining in red.
Allergic reactions: skin rash (usually erythematic or urticaria), skin itching, Quincke’s edema, anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnea, fever, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), eosinophilia, allergic rhinitis.
From the hemopoietic organs: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia.
Other: increased or decreased sweating.
From the laboratory side: bleeding time (may increase), serum glucose concentration (may decrease), creatinine clearance (may decrease), hematocrit or hemoglobin (may decrease), serum creatinine concentration (may increase), activity of “liver” transaminases (may increase).
If taking the drug caused a change in your normal condition, stop taking it and consult a doctor immediately.
Drug Interaction
At therapeutic doses, Novigan® does not enter into meaningful interactions with commonly used drugs.
Inductors 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 hepatotoxic action.
Reduces the antihypertensive activity of vasodilators and the natriuretic effect of furosemide and hydrochlorothiazide.
Reduces the effectiveness of uricosuric drugs.
Increases the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics (which increases the risk of bleeding).
Increases the side effects of mineralocorticosteroids, GCS (increases the risk of gastrointestinal bleeding), estrogens, ethanol enhances the hypoglycemic effect of sulfonylurea derivatives.
Antacids and cholestyramine reduce ibuprofen absorption.
Increases blood concentration of digoxin, lithium and methotrexate.
Enhances the action of m-cholin blockers, H1-histamine receptor blockers, butyrophenones, phenothiazines, amantadine and quinidine.
Simultaneous administration of other NSAIDs increases the incidence of side effects.
Caffeine enhances analgesic (analgesic) effect.
At the same time reduces the anti-inflammatory and antiaggregant effect of acetylsalicylic acid (possibly increasing the frequency of acute coronary insufficiency in patients receiving low doses of acetylsalicylic acid as an antiaggregant 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 increase the effect of ibuprofen on GHG synthesis in the kidneys, which is manifested by an increase in nephrotoxicity. Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of its hepatotoxic effects.
drugs that block tubular secretion reduce excretion and increase plasma concentrations of ibuprofen.
Overdose
Symptoms: abdominal pain, nausea, vomiting, drowsiness, drowsiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, decreased BP, bradycardia, bradycardia, bradycardia.
Treatment: gastric lavage (only within one hour after ingestion), appointment of activated charcoal, alkaline drink, forced diuresis, symptomatic therapy (correction of acid-base state, blood pressure). There is no specific antidote for the drug.
Do not exceed the recommended dose. If the recommended doses are exceeded, you should immediately consult your doctor or your nearest health care facility (pack your medicine with you).
Storage conditions
At a temperature not exceeding 25 C.
Keep out of the reach of children!
Expiration
5 years.
Fenpyverynyya bromide
Prescription terms and conditions from
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dosage form
dosage form
tablets
