Novigan® (Novigan)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceIbuprofen + Pitophenone + Fentpiperinium bromideIbuprofen + Pitophenone + Fentpiperinium bromide
Similar drugsTo uncover
  • Novigan®
    pills inwards 
    Dr. Reddy's Laboratories Ltd.     India
    • Dosage form: & nbspTablets, film-coated
    Composition:

    Each film-coated tablet contains:

    Active substances: ibuprofen 400 mg, pituopenone hydrochloride 5 mg, fenpiperinium bromide 0.1 mg.

    Excipients: cellulose microcrystalline 55 mg, corn starch 76 mg, glycerol 2.9 mg, silicon dioxide colloid 5 mg, talc 12 mg, magnesium stearate 4 mg; sheath: hypromellose 6 cps 5,686 mg, 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.
    Description:Round biconvex tablets, coated with a white film coating, embossed NOVIGAN on one side. View on cross-section: from white to almost white.
    Pharmacotherapeutic group:Analgesic antispasmodic combined
    ATX: & nbsp

    M.01.A.E.51   Ibuprofen in combination with other drugs

    Pharmacodynamics:

    Combined drug, has analgesic, anti-inflammatory and antispasmodic effect. Suppress the synthesis of prostaglandins (Pg). The composition of the drug includes a non-steroidal anti-inflammatory drug ibuprofen, myotropic spasmolytic agent of pituopenone hydrochloride and m-cholinoblocking agent of central and peripheral action of fenpiperinium bromide.

    Ibuprofen is a derivative of phenylpropionic acid. Has analgesic, anti-inflammatory and antipyretic effect. The main mechanism of action is oppression of biosynthesis of prostaglandins - modulators of pain sensitivity, thermoregulation and inflammation in the central nervous system and peripheral tissues. In women with primary dysmenorrhea, the elevated level of prostaglandins in myometrium is reduced, thereby reducing intrauterine pressure and the frequency of uterine contractions.

    Pitophenone hydrochloride, like papaverine, has a direct myotropic effect on the smooth muscles of the internal organs and causes it to relax. Fentipierinium bromide due to m-cholinoblocking 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.
    Pharmacokinetics:Components of the drug Novigan® are well absorbed in the gastrointestinal tract.The peak concentration in blood plasma is reached, approximately, 1-2 hours after taking the drug. The main component of the drug ibuprofen 99% binds to blood plasma proteins, can accumulate in the synovial fluid, is metabolized in the liver and is excreted 90% with urine in the form of metabolites and conjugates. A small part of the drug is excreted with bile. The half-life of plasma is 2 hours.
    Indications:
    - Weak or moderately severe pain syndrome with spasms of smooth muscles of internal organs: renal and biliary colic, dyskinesia of bile ducts, intestinal colic.
    - Gynecological diseases: dysmenorrhea.
    - Headache, including migraine.
    - Short-term symptomatic treatment for pain in the joints, neuralgia, ischialgia, myalgia.
    Contraindications:
    Hypersensitivity to any of the ingredients that make up the drug; erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding; inflammatory bowel disease in the phase of exacerbation, including,ulcerative colitis; anamnestic data on an attack of bronchial obstruction, rhinitis, urticaria, after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drug - NSAIDs (complete or incomplete acetylsalicylic acid intolerance syndrome - rhinosinusitis, urticaria, polyps of the nasal mucosa, bronchial asthma); hepatic insufficiency or active liver disease; renal failure (creatinine clearance less than 30 ml / min), progressive kidney disease; confirmed hyperkalemia; hemophilia and other disorders of blood clotting (including hypocoagulation), hemorrhagic diathesis; period after aorto-coronary bypass surgery; acute "intermittent" porphyria; granulocytopenia; disorders of hematopoiesis; deficiency of glucose-6-phosphate dehydrogenase; tachyarrhythmia; angle-closure glaucoma; diseases of the optic nerve; hyperplasia of the prostate; intestinal obstruction; pregnancy and the period of breastfeeding, age to 16 years.
    Carefully:Elderly age, congestive heart failure, cerebrovascular disease, hypertension,ischemic heart disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, nephrotic syndrome, creatinine clearance less than 30-60 ml / min, hyperbilirubinemia, stomach and duodenal ulcer (history), infection Helicobacter pylori, gastritis, enteritis, colitis, long-term use of NSAIDs, blood diseases of unclear etiology (leukopenia, anemia), smoking, frequent alcohol use, severe somatic diseases, concomitant therapy with anticoagulants (eg, warfarin), antiplatelet agents (e.g., acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (for example, prednisolone), selective serotonin reuptake inhibitors (for example, citalopram, fluoxetine, paroxetine, sertraline).
    Pregnancy and lactation:The use of the drug is prohibited during pregnancy and lactation
    Dosing and Administration:

    Inside, 1 hour before or 3 hours after eating. To avoid irritating effects on the stomach, you can take the drug immediately after eating or drink milk. In the absence of special doctor's instructions it is recommended to take Novigan® for spasmodic pains of 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 control of peripheral blood and functional state of the liver.

    Side effects:
    In the recommended doses Novigen® does not cause side effects.
    From the gastrointestinal tract: NSAID-gastropathy (abdominal pain, nausea, vomiting, heartburn, loss of appetite, diarrhea, bloating, constipation, ulceration of the mucosa of the gastrointestinal tract, 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.
    From the hepatobiliary system: hepatitis.
    From the respiratory system: shortness of breath, bronchospasm.
    From the sense organs: Hearing impairment: hearing loss, ringing or tinnitus; na¬rushenie view: toxic damage of the optic nerve, blurred vision, 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 side of the cardiovascular system, heart failure, tachycardia, elevation of blood pressure.
    From the urinary system: acute renal failure, allergic ¬ jade, nephrotic syndrome (edema), oliguria, anuria, polyuria, proteinuria, cystitis, staining the urine in red.
    Allergic reactions: skin rash (usually erythematous or urticaria), itchy skin, Quincke's edema, anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnea, fever, erythema multiforme exudative (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), eosinophilia , allergic rhinitis.
    From the hematopoiesis: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, and leukopenia.
    Other: increased or decreased sweating.
    From the laboratory indicators: 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 "hepatic" transaminases (may increase).
    If the drug has caused a change in your normal condition, stop taking it and contact your doctor immediately.
    Overdose:

    Do not exceed the indicated dose. If you exceed the dose, contact your doctor or nearest medical institution immediately. Bring the package of the drug with you. Symptoms: Abdominal pain, nausea, vomiting, lethargy, sleepiness, depression, headache, tinnitus, metabolic acidosis, coma, acute renal failure, decreased blood pressure, bradycardia, tachycardia, atrial fibrillation, respiratory arrest.

    Treatment: gastric lavage (only for an hour after ingestion), Activated carbon, alkaline drink, forced diuresis, symptomatic therapy (correction of acid-base state, blood pressure).There is no specific antidote.
    Interaction:

    In therapeutic doses, Novigan® does not enter into meaningful interactions with widely 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.

    Inhibitors of microsomal oxidation reduce the risk of hepatotoxic action.

    Reduces hypotensive activity vasodilator and natriuretic effect of furosemide and hydrochlorothiazide.

    Reduces the effectiveness of uricosuric drugs. Strengthens the effect of indirect anticoagulants, antiplatelet agents, fibrinolytics (which increases the risk of bleeding).

    Increases the side effects of mineralocorticosteroids, glucocorticosteroids (increases the risk of gastrointestinal bleeding), estrogens, ethanol; enhances the hypoglycemic effect of sulfonylurea derivatives. Antacids and colestramine reduce the absorption of ibuprofen. Increases the concentration in the blood of digoxin, lithium and methotrexate.Strengthens the effect of M-holinoblokatorov, H1-gistaminoblokatorov, butirofenonov, phenothiazines, amantadine and quinidine.

    Simultaneous administration of other NSAIDs increases the incidence of side effects. Caffeine strengthen analgesic (anesthetic) effect.

    With simultaneous administration reduces anti-inflammatory and antiaggregant ^ the effect of acetylsalicylic acid (possibly an increase in the incidence of acute

    coronary insufficiency in patients receiving small doses of acetylsalicylic acid as an antiplatelet agent after the Novigen® drug was started).

    Cefamandol, cefoperazone, cefotetan, valproic acid, plikamycin increase the frequency of hypoprothrombinemia with simultaneous administration. Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

    Cyclosporine and gold preparations increase the effect of ibuprofen on the synthesis of prostaglandins in the kidneys, which is manifested by increased nephrotoxicity. Ibuprofen increases the plasma concentration of cyclosporine and the likelihood of its hepatotoxic effects.

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


    Special instructions:
    With long-term use, control of the peripheral blood picture and the functional state of the liver and kidneys is necessary.
    To reduce the risk of developing adverse events from the gastrointestinal tract, the lowest effective dose should be used. When symptoms of gastropathy appear, careful monitoring including esophagogastroduodenoscopy, a blood test with determination of hemoglobin and hematocrit, and analysis of feces for latent blood are shown.
    If necessary, the determination of 17-ketosteroids ,. the drug should be discontinued 48 hours before the test.
    During treatment should refrain from drinking alcohol.

    Effect on the ability to drive transp. cf. and fur:During the treatment period, the patient should refrain from engaging in potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.
    Form release / dosage:Film-coated tablets.
    Packaging: For 10 tablets in PVC / aluminum blister. For 1 or 2 blisters with instructions for use in a pack of cardboard.
    Storage conditions:In a dry, protected from light place at a temperature of no higher than 25 ° C. Keep out of the reach of children!
    Shelf life:5 years. Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:Without recipe
    Registration number:P N008846
    Date of registration:22.09.2011
    The owner of the registration certificate:Dr. Reddy's Laboratories Ltd.Dr. Reddy's Laboratories Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspDR REDDY'S LABORATORIS LTD. DR REDDY'S LABORATORIS LTD. India
    Information update date: & nbsp22.09.2011
    Illustrated instructions
      Instructions
      Up