Vesomni
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Vesomni is a combined (m-anticholinergic and alpha 1- adrenergic blocker) drug for symptom control and treatment of benign prostatic hyperplasia.
Release form and composition
Dosage form - tablets with modified release, film-coated: round biconvex, brownish-red, engraved on one side "6 / 0.4" (10 pcs. In a blister, in a cardboard box 1 or 3 blisters).
1 tablet contains:
- active ingredients: solifenacin succinate (first layer) - 6 mg, tamsulosin hydrochloride (second layer) - 0.4 mg;
- auxiliary components: macrogol 7,000,000, mannitol, maltose, macrogol 8000, magnesium stearate;
- shell composition: opadry red 03F45072 (macrogol 8000, hypromellose 6 mPa · s, iron oxide red dye).
Indications for use
The use of Vesomni is indicated for the treatment of men with symptoms of benign prostatic hyperplasia:
- symptoms of filling (irritative symptoms), from moderate to severe (frequent urination, urgent urge to urinate);
- emptying symptoms (obstructive symptoms).
Contraindications
- severe liver failure;
- moderate to severe hepatic impairment while taking ketoconazole or other strong inhibitors of the CYP3A4 isoenzyme;
- severe gastrointestinal diseases (including toxic megacolon);
- hemodialysis;
- angle-closure glaucoma;
- myasthenia gravis;
- orthostatic hypotension;
- violation of the metabolism of the isoenzyme CYP2D6 when combined with strong inhibitors of CYP3A4 or strong inhibitors of CYP2D6, such as paroxetine;
- age up to 18 years;
- hypersensitivity to the components of the drug.
With caution, Vesomni should be prescribed in case of severe renal failure, the risk of urinary retention, obstructive diseases of the gastrointestinal tract (GIT), decreased gastrointestinal motility, hiatal hernia, gastroesophageal reflux, concomitant use of bisphosphonates (drugs that cause or enhance) esophagous neuropathy, QT prolongation syndrome, hypokalemia, moderate hepatic failure (7-9 points on the Child-Pugh scale).
In addition, caution should be exercised with concomitant therapy with strong and moderate CYP3A4 inhibitors, including verapamil, ritonavir, nelfinavir, ketoconazole, and itraconazole.
Method of administration and dosage
The tablets should be taken orally, swallowing whole (damage to the membrane may impair the tablet's extended release properties), regardless of food intake.
Recommended dosage: 1 pc. Once a day.
Side effects
Side effects registered in clinical trials, both of the drug itself and of its active components (solifenacin and tamsulosin), which can potentially occur with the use of Vesomni:
- infections and invasions: infrequently - urinary tract infections, cystitis;
- on the part of the immune system: the frequency is unknown - anaphylactic reaction;
- metabolism and nutrition: frequency unknown - decreased appetite, hyperkalemia;
- from the side of the psyche: very rarely - hallucinations, psychosis; frequency unknown - nonsense;
- from the nervous system: often - dizziness; infrequently - drowsiness, headache, dysgeusia; rarely - fainting;
- on the part of the organs of vision: often - blurred vision; infrequently - dry eyes; frequency unknown - intraoperative iris instability, glaucoma;
- on the part of the cardiovascular system: infrequently - palpitations, orthostatic hypotension; frequency unknown - pirouette-type tachycardia, prolongation of the QT interval, atrial fibrillation, arrhythmia, tachycardia;
- on the part of the respiratory system, chest and mediastinum: infrequently - rhinitis, dry nose; frequency unknown - shortness of breath, dysphonia;
- from the gastrointestinal tract: often - dyspepsia, dry mouth, nausea, constipation, abdominal pain; infrequently - diarrhea, dry throat, vomiting, gastroesophageal reflux disease; rarely - colonic obstruction, coprostasis; frequency unknown - intestinal obstruction, abdominal discomfort;
- on the part of the hepatobiliary system: the frequency is unknown - impaired liver function, increased activity of hepatic enzymes;
- dermatological reactions: infrequently - itchy skin, rash, dry skin, allergic rash; rarely - Quincke's edema; very rarely - Stevens-Johnson syndrome, erythema multiforme; frequency unknown - exfoliative dermatitis;
- on the part of the musculoskeletal system: frequency unknown - muscle weakness;
- from the urinary system: infrequently - difficulty urinating; frequency unknown - urinary retention, renal failure;
- from the reproductive system: often - ejaculation disorders; very rarely - priapism;
- others: often - fatigue; infrequently - asthenia, peripheral edema.
special instructions
Vesomni is well tolerated by patients, even with prolonged use, no special adverse reactions have been identified.
If symptoms of anaphylactic reactions appear, you should stop taking the tablets and consult a doctor.
The presence of tamsulosin in the composition of the drug can cause a decrease in blood pressure (BP), sometimes significant. Since there is a risk of fainting, patients are advised to sit or lie down when dizziness or general weakness appears, until the signs of orthostatic hypotension have completely disappeared.
In patients with prolonged QT interval syndrome and hypokalemia, the use of the drug can cause prolongation of the QT interval and tachycardia of the "pirouette" type.
When planning surgery for glaucoma or cataracts, the patient should inform the ophthalmologist about the previous or ongoing use of Vesomni. This will reduce the risk of complications associated with the syndrome of intraoperative instability of the iris, both during surgery and in the postoperative period.
In case of mild to moderate renal failure, as well as mild liver failure (7 or less points on the Child-Pugh scale), the drug is indicated.
Therapy with the drug can cause dizziness, fatigue, blurred vision, therefore, care should be taken when driving vehicles and mechanisms.
Drug interactions
With the simultaneous use of Vesomni:
- ketoconazole (a potent inhibitor of the isoenzyme CYP3A4) in a daily dose of 400 mg causes an increase in plasma concentration by 3 times of solifenacin and 2.8 times of tamsulosin;
- verapamil (a moderate inhibitor of CYP3A4) leads to an increase in plasma concentration of solifenacin by about 1.6 times and 2.2 times of tamsulosin;
- paroxetine (a strong inhibitor of CYP2D6) in a daily dose of 20 mg increases the content of tamsulosin in blood plasma by 1.6 times;
- metoclopramide, cisapride and other stimulants of gastrointestinal motility may reduce their effect;
- R- or S-warfarin does not violate its pharmacokinetics and does not affect prothrombin time;
- furosemide can slightly reduce the concentration of tamsulosin; this does not require a change in the dose of the drug;
- rifampicin and other inducers of the CYP3A4 isoenzyme can enter into pharmacokinetic interaction with the drug;
- atenolol, enalapril, theophylline do not interact with tamsulosin;
- digoxin does not change its pharmacokinetics;
- blockers of alpha 1 -adrenergic receptors can contribute to the hypotensive effect;
- amitriptyline, diazepam, diclofenac, warfarin, glibenclamide, propranolol, trichloromethiazide, simvastatin, chlormadinone do not affect the change in the free fraction of tamsulosin in plasma;
- diclofenac, warfarin can increase the rate of elimination of tamsulosin.
The effect of Vesomni on the change in the clearance of drugs metabolized by isoenzymes CYP1A1 / 2, 3A4, 2D6, 2E1, 2C9, 2C19, 2B6, 2C8 is unlikely.
Tamsulosin does not change the free fractions of propranolol, diazepam, trichloromethiazide, chlormadinone.
Analogs
Vezomni's analogues are: Avodart, Alfuzosin, Alfirum, Alfater, Omnika Dalfaz, Omnik, Dalfuzin, Kornam, Setegis, Urorek.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 30 ° C.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
