The combined drug Novigan quickly eliminates the painful symptoms of algomenorrhea, colic in the stomach and abdominal cavity, and can be used for fever and migraines. The formula of the drug provides improved well-being with cramps, elevated body temperature, and headaches of various origins.
Composition, dosage form
Novigan is available in the form of tablets for oral use: film-coated, packaged in metallized blisters. Each pill contains:
- ibuprofen: 0.4 g;
- fenpiverinium bromide: 0.005 g;
- pitofenone: 0.1 g.
Auxiliary compounds that stabilize the state of the drug and give it shape:
- glycerol;
- talc;
- starch;
- magnesium stearate;
- polysorbate and others.
The secondary cardboard packaging of the medicine contains from 2 to 10 blisters with tablets and detailed instructions included.
The mechanism of action of the drug Novigan
Novigan tablets effectively relieve various types of pain and physical discomfort. The drug is used as an analgesic, antispasmodic and anti-inflammatory. Ibuprofen in its composition provides a blockade of prostaglandins, including those in the peripheral nervous system and tissues of internal organs. At the same time, the substance affects the thermoregulation center, reducing fever and associated discomfort.
Pitophenone hydrochloride is a myotropic antispasmodic that relaxes smooth muscle fibers. Its use helps relieve painful contractions of vascular walls and cavitary organs. Fenpiverinium bromide complements and prolongs its action, having an anticholinergic effect.
The tablet shell quickly dissolves in the stomach cavity, the active substances are absorbed into the blood and distributed in the body fluids, partially binding to plasma proteins. The maximum concentration is usually achieved within 1 hour, and the pharmacological effect develops within 15–20 minutes after administration. The drug is transformed by liver cells, metabolites leave the body along with urine. Residues of the drug remain in tissues and blood for no more than 12 hours.
Novigan has a symptomatic effect, reducing the painful manifestations of pathological conditions. It does not affect the course and causes of chronic diseases.
Novigan, 400 mg+5 mg+0.1 mg, film-coated tablets, 20 pcs.
In recommended doses, Novigan ® does not cause side effects.
From the gastrointestinal tract: NSAID gastropathy (abdominal pain, nausea, vomiting, heartburn, loss of appetite, diarrhea, flatulence, constipation; ulceration of the mucous membrane of the gastrointestinal tract, which in some cases are complicated by perforation and bleeding; irritation or dryness of the mucous membrane membranes of the 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 senses: 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 origin), accommodation paresis.
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, red staining of urine.
Allergic reactions: skin rash (usually erythematous or urticaria), pruritus, 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.
From the hematopoietic organs: anemia (including hemolytic, aplastic), thrombocytopenia and thrombocytopenic purpura, agranulocytosis, leukopenia.
Other: increased or decreased sweating.
From the laboratory parameters: bleeding time (may increase), serum glucose concentration (may decrease), creatinine clearance (may decrease), hematocrit or hemoglobin (may decrease), serum creatinine concentration (may increase), liver transaminase activity ( may increase).
If the drug causes a change in your usual condition, stop taking it and call your doctor immediately.
Indications for use
It is recommended to take Novigan for any pain syndrome, including those accompanied by spasms or colic:
- for painful menstruation: active components significantly reduce the production of prostaglandins in the female myometrium, relieve pressure in the vessels of the uterus and appendages, help get rid of cramping attacks before the start of the cycle and throughout menstruation;
- with inflammatory processes in the pelvic and abdominal organs: adnexitis, renal colic, pain in the liver, intestines, gall bladder;
- with cystitis;
- for tension headaches caused by poor circulation due to cervical osteochondrosis, for migraines, and meteosensitivity;
- with myositis;
- with neuralgic syndrome;
- for inflammation and degenerative processes in the joints and spine: arthritis, osteoarthrosis, sciatica, lumbodynia;
- for mechanical injuries of joint structures and muscles: bruises, pinching, dislocations, sprains and torn ligaments;
- during the recovery period after surgical interventions.
If necessary, Novigan can be used to relieve toothache. Ibuprofen in its composition reduces the sensitivity of nerves, reducing unpleasant symptoms.
Contraindications
The use of the drug is prohibited for the following health conditions:
- bronchial asthma;
- hypersensitivity to acetylsalicylic acid and other NSAIDs;
- for disorders of blood coagulation and composition, pathologies of the hematopoietic organs;
- for diseases and dystrophy of the optic nerve, glaucoma;
- gastric ulcer, acute colitis, pancreatitis, gastritis, erosive lesions of the gastrointestinal mucosa;
- with a tendency to internal bleeding;
- in the period after heart surgery, with acute cardiac arrhythmias.
Novigan is also not applicable in the early stages of pregnancy - in the first trimester, and in the last month before childbirth. It is contraindicated for nursing women and children under 14 years of age.
The drug is prescribed with caution to the elderly, patients with diabetes mellitus, angina pectoris, hypertension, renal or liver failure.
Novigan® Lady
There have been no specific studies of drug interactions between the combination of drotaverine and ibuprofen with other drugs.
Ibuprofen
The simultaneous use of ibuprofen with the following drugs should be avoided.
Acetylsalicylic acid (ASA): with the exception of low doses, no more than 75 mg per day. When used simultaneously, ibuprofen reduces the anti-inflammatory and antiplatelet effects of ASA.
Other NSAIDs, in particular selective COX-2 inhibitors: simultaneous use of two or more drugs from the NSAID group should be avoided due to a possible increased risk of side effects.
Use with caution with the following medications.
Anticoagulants and thrombolytic drugs: NSAIDs may enhance the effect of anticoagulants (eg, warfarin) and thrombolytic drugs.
Antihypertensives (angiotensin-converting enzyme (ACE) inhibitors and angiotensin II antagonists) and diuretics: NSAIDs may reduce the effectiveness of drugs in these groups. In some patients with impaired renal function (eg, dehydrated patients or elderly patients with impaired renal function), concomitant use of ACE inhibitors or angiotensin II antagonists and cyclooxygenase inhibitors may lead to a deterioration of renal function, including the development of acute renal failure. (usually reversible).
These interactions should be considered in patients taking coxibs concomitantly with ACE inhibitors or angiotensin II antagonists. In this regard, caution should be exercised when using the above drugs together, especially in elderly people. It is necessary to prevent dehydration in such patients, and consider monitoring renal function after initiation of this combination treatment and periodically thereafter.
Diuretics and ACE inhibitors may increase the nephrotoxicity of NSAIDs.
Glucocorticoids: Increased risk of gastrointestinal ulcers or bleeding.
Antiplatelet agents and selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding.
Cardiac glycosides: simultaneous use of NSAIDs and cardiac glycosides can lead to worsening heart failure, a decrease in glomerular filtration rate and an increase in the concentration of cardiac glycosides in the blood plasma.
Lithium preparations: there is evidence of the likelihood of an increase in the concentration of lithium in the blood plasma during the use of NSAIDs.
Methotrexate: there is evidence of the likelihood of an increase in the concentration of methotrexate in the blood plasma during the use of NSAIDs.
Cyclosporine: Increased risk of nephrotoxicity with concomitant use of NSAIDs and cyclosporine.
Mifepristone: NSAIDs should be started no earlier than 8-12 days after taking mifepristone. since NSAIDs may reduce the effectiveness of mifeprestone.
Tacrolimus: Concomitant use of NSAIDs and tacrolimus may increase the risk of nephrotoxicity.
Zidovudine: Concomitant use of NSAIDs and zidovudine may result in increased hematotoxicity.
Quinolone antibiotics: Patients receiving concomitant NSAIDs and quinolone antibiotics may have an increased risk of seizures.
Myelotoxic drugs: increased hematotoxicity.
Cefamandole, cefoperazone, cefotetan, valproic acid, plicamycin: increased incidence of hypoprothrombinemia.
Drugs that block tubular secretion: decreased excretion and increased plasma concentrations of ibuprofen.
Inducers of microsomal oxidation (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants): increased production of hydroxylated active metabolites, increased risk of severe intoxication.
Microsomal oxidation inhibitors: reducing the risk of hepatotoxicity.
Oral hypoglycemic drugs and insulin, sulfonylurea derivatives: increased effect of drugs.
Antacids and cholestyramine: decreased absorption.
Uricosuric drugs: decreased effectiveness of drugs.
Caffeine: increased analgesic effect.
Drotaverine
Levodopa. PDE inhibitors like papaverine reduce the antiparkinsonian effect of levodopa. When prescribing drotaverine simultaneously with levodopa, increased rigidity and tremor may occur.
Other antispasmodics, including m-anticholinergics. Mutual enhancement of antispasmodic action.
Side effects
While taking the drug, reactions from the gastrointestinal tract and nervous system are possible:
- loss of appetite, dry mouth, unpleasant taste, nausea, epigastric pain;
- dizziness, insomnia or increased drowsiness;
- decreased urine volume;
- increased sweating;
- visual disturbances;
- increased level of leukocytes in the blood, decreased clotting;
- bronchospasm;
- tachycardia, increased blood pressure.
Possible signs of an allergy to the drug: swelling of the mucous membranes of the eyes and eyelids, lacrimation, urticaria, itching, aphthous stomatitis, vasomotor rhinitis, laryngeal edema. In such cases, immediate discontinuation of the medication is required.
Side effects
The incidence of side effects is classified according to WHO recommendations as very common (≥10%); often (≤1%, <10%); uncommon (≥0.1%, <1%); rare (≥0.01%, <0.1%); very rare, including isolated reports (<0.01%).
From the digestive system:
often - NSAID gastropathy (abdominal pain, nausea, vomiting, heartburn, loss of appetite, diarrhea, flatulence, constipation); uncommon - ulceration of the gastrointestinal mucosa, which in some cases is complicated by perforation and bleeding, irritation and dryness of the oral mucosa, pain in the mouth, ulceration of the gum mucosa, aphthous stomatitis; very rarely - pancreatitis, hepatitis, liver dysfunction, hepatotoxicity.
From the respiratory system:
rarely - shortness of breath, bronchospasm.
From the senses:
rarely - hearing loss, ringing or tinnitus; infrequently - blurred visual perception, scotoma, dryness and irritation of the eye, swelling of the conjunctiva and eyelids (allergic origin), amblyopia; very rarely - accommodation paresis, toxic damage to the optic nerve.
From the central nervous system and peripheral nervous system:
uncommon - headache, dizziness, insomnia, anxiety, nervousness and irritability, psychomotor agitation, drowsiness, depression; very rarely - confusion, hallucinations, aseptic meningitis (more often in patients with autoimmune diseases).
From the CCC side:
infrequently - tachycardia, increased blood pressure; rarely - heart failure.
From the urinary system:
uncommon - nephrotic syndrome (edema), oliguria, anuria, polyuria, proteinuria, cystitis, red urine; rarely - acute renal failure, allergic nephritis.
Allergic reactions:
uncommon - skin rash (usually erythematous or urticaria), itching; very rarely - Quincke's edema, anaphylactoid reactions, anaphylactic shock, bronchospasm or dyspnea, fever, exudative erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), allergic rhinitis.
From the hematopoietic organs:
uncommon - thrombocytopenia and thrombocytopenic purpura; very rarely - anemia (including hemolytic, aplastic), agranulocytosis, leukopenia, eosinophilia.
Other:
very rarely - increased or decreased sweating.
From the laboratory parameters:
increased bleeding time, decreased serum glucose concentration, decreased creatinine clearance, hematocrit or Hb level, increased serum creatinine concentration, increased liver transaminase activity.
How to use Novigan: instructions
It is recommended to take the drug in short courses: no more than 5 days in a row. The maximum dose of tablets is 3 pieces: 1 three times a day. If well tolerated, Novigan can be taken between meals: 2–3 hours after meals or 1 hour before meals. If you have stomach problems, it is not advisable to take the tablets on an empty stomach. It is safer to take them with food.
Treatment should not be combined with taking tranquilizers, other NSAIDs, drinking alcohol or caffeine-containing products. This may increase side effects and cause intoxication.
