Saturday, August 11, 2018

Visan

Description overdue on 09/17/2014

  • Latin name: Visanne
  • ATC code: G03D
  • Active substance: Dienogest (Dienogest)
  • Manufacturer: Bayer Schering Pharma AG (Germany)
Photos of the drug
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  • Composition
  • Product form
  • Pharmacological action
  • Pharmacodynamics and pharmacokinetics
  • Indications
  • Contraindications
  • Side effects
  • Visan, instructions for use (method and dosage)
  • Overdose
  • Cooperation
  • Terms of sale
  • Storage conditions
  • Shelf life
  • Cautions
  • Analogs
  • Babies
  • With alcohol
  • During pregnancy (and lactation)
  • Reviews
  • Price, where to buy

 Visan

Composition

One tablet pharmaceutical formulation comprising:

  • micronized Dienogest (basic biological active ingredient) - 2 mg;
  • lactose monohydrate - 62, 8 mg;
  • potato starch - 36 mg;
  • microcrystalline cellulose (MCC) - 18 mg;
  • Povidone K 25 - 8, 1 mg;
  • talc - 4, 05 mg;
  • crospovidone - 2, 7 mg;
  • Magnesium stearate - 1 35 mg.

Product form

The pharmacy kiosks drug comes in the form tablets white or close to white color 2 mg, which are packed in blisters (blisters) of PVC or aluminum foil designed for 14 pieces. Tablets of circular shape with a flat surface and beveled edges. Each is engraved on one side with the letter "B". The cardboard box contains 2, 6 or 12 plates.

Pharmacological action

Dienogest , The main active component of tablets Visan, a chemical derivative nortestosterone That is characterized by strong   anti-androgen activity . The active substance has a relative affinity with progesterone by 10%, which is manifested in a strong progestagenic effect.

Dienogest binds to receptors, intended for progesterone in the woman's uterus, after which exerts its therapeutic effects. Thus, when endometriosis   reduced endogenous production Estradiol , Whereby it suppressed the trophic influence on euktopicheskom, and ectopic levels. Subsequently, under continuous treatment tablets, the active component, creating specific endocrine environment It causes the initial stage decidualization endometrial tissue that is affected by layering peeling sheets. The next step is atrophy endometroidnyh lesions liquidation pathophysiological causes of this nosological unit.


It should not be forgotten that the biological effects of dienogest also include immunological and antiangiogenic . These properties of the active component of the pharmaceutical preparation to allow women largely inhibit cell proliferation, maturation and germination of newly formed blood vessels in the covers. Thus suppressing the tendency to spread endometriosis.

Pharmacodynamics and pharmacokinetics

The drug is used for oral receiving and then quickly and completely absorbed from the gastrointestinal tract. The maximum serum concentration (47 ng / mL) is reached within 1, 5 hours after the single dose tablets Visan. Bioavailability biologically active components of unprecedented 91%. It should also be noted that within certain limits (single dose of from 1 to 8 mg), the pharmacokinetic ability of the drug dose-dependent .

Once in the blood, the main effective component is associated with a non-specific way albumin (about 90%), the remaining 10% are in the free form of serum Steroid . The drug has a weak cumulative abilities   - After daily use of tablets Visan concentration of active ingredient rises to 1, 24 times. The equilibrium amount of drug in the main blood flow observed after 4 days course of conservative therapy.

Metabolised Dienogest by hydroxylation with the formation of active metabolites. Primary enzyme involved in the metabolic pathways of the active component is CYP3A4 What is important in determining the clinical interactions with various kinds of pharmaceutical preparations. Products exchange quickly enough output excreted through kidney and bowel - The rate of clearance from the serum was 64 ml / min. The half-life drugs - 9-10 hours. Interestingly, the elimination of the drug takes place in two stages. First of all, in the first 24 hours of the kidney is allocated the bulk of a single dose, and then for 6 days, the principal amount accepted and suck the tablets.

Indications

Endometriosis - a gynecological disease entities, which develops in women of reproductive age. From the viewpoint of the pathophysiology of the disease is intensive growth of endometrial cells   (inner layer of tissue covering the wall of the uterus) outside the boundaries of a typical localization. Intensively proliferative tissue has specific receptors for the female hormones that is newly formed cells are exposed to the menstrual cycle. As a result, this sequence changes monthly hemorrhage cause inflammation Since blood can not normally be released from the uterine wall.

Main symptoms Disease:

  • pelvic pain   the cyclical nature;
  • lengthening of menstrual bleeding;
  • an increase in the volume of the genital organs;
  • infertility ;
  • dyspareunia - Pain during sexual intercourse;
  • a fourth step of bowel or bladder also causes intense pain.

Contraindications

  • increased individual sensitivity to the constituent components of the pharmaceutical formulation;
  • intolerance hereditary or acquired biologically active substances of the drug;
  • sharp thrombophlebitis ;
  • venous thromboembolism;
  • bleeding from the vagina to the unclear cause and pathogenesis;
  • diabetes   (especially in the presence of vascular complications);
  • atherosclerotic lesions of the vascular bed;
  • Heart Disease   (in particular coronary artery disease , Stroke or transient ischemic attack);
  • liver disease, changing the parameters of functional tests;
  • cholestatic jaundice   pregnant women in history;
  • benign and malignant neoplasms of the liver;
  • carbohydrate metabolism   - Galactose intolerance, glucose-galactose malabsorption, lactase deficiency;
  • hormone-dependent malignant tumors (eg breast adenoma);
  • childhood and adolescence before reaching 18 years of age.

Use medicine carefully   (recommended passage of the conservative therapeutic course in a specialized hospital under the supervision of qualified medical personnel) should be at:

  • depression;
  • ectopic pregnancy (or the presence of this disease in history);
  • hypertension;
  • chronic heart failure;
  • clinically proven migraine with aura;
  • hyperlipidemia .

Side effects

Side effects are usually at the beginning of the course   Conservative therapy and continue treatment as their number and strength is largely reduced. Adverse effects of reorganization for convenience divided into system and displays the frequency (the pharmaceutical literature establishes the following rules of side effects - often from 1/1000 to 1/10, but rarely from 1/1000 to 1/100):

  • On the side hematopoietic system : infrequently - anemia .
  • Nutritional   and metabolic   violation: often - increased body mass index; rarely - weight loss, or increased appetite.
  • Digestive system : Often - nausea . vomiting , Pain in the epigastric or in the abdomen, bloating, and abdominal bloating; rarely - constipation or diarrhea, inflammatory gastrointestinal disease, gingivitis.
  • On the side skin : Often - acne (acne with lesions of the sebaceous glands), alopecia (hair loss); rarely - dry skin, hyperhidrosis (excessive accumulation of fluid and excretion), pruritus, hirsutism (excessive terminal hair growth on male type), hypertrichosis, onihoklaziya (fragility of the nail plate), dandruff, dermatitis with various pathogens, pigmentation disorders, photo sensitivity reaction.
  • Reproductive system : Often - breast enlargement, breast tenderness , Cystic lesions of the ovaries, irregular uterine bleeding, amenorrhea; Infrequent - vaginal candidosis, dry mucous membranes vulvovaginal area, pelvic pain, Atrophic vulvovaginitis , Genital discharge, fibrocystic disease of the breast or sealing of the mammary glands of another origin.
  • Central nervous system : Often - headache, migraine, violation of sleep and wakefulness, decreased libido Frequent mood swings; rare - imbalance of the peripheral nervous system, depression, attention deficit disorder , Anxiety.
  • On the side senses : Rare - dryness of eyeballs, ringing in the ears.
  • Cardiovascular system : Infrequent - circulatory problems unexplained, heart palpitations , Hypotension.
  • On the side   Musculoskeletal System : Often - pain Which are located at the bottom of the back; infrequently - bone pain, especially in the extremities, muscle cramps short " nepripodemnye limb "(Unpleasant feeling of heaviness in the arms and legs).
  • The urinary system : infrequently - infection urinary tract and bladder.
  • Other: often - asthenia (fatigue, malaise and irritability); Infrequent - edema.

Visan, instructions for use (method and dosage)

Tablets are designed to receive inside . Start a conservative course of treatment can be any day of the menstrual cycle. Dosage   is 1 tablet per day. The pharmaceutical preparation should be used regularly every day, at the same time. This fact is explained hormonal fluctuations   during the day, that is, the therapeutic effect of the drug would be much higher if the instruction to be executed most Visan correctly.

Unless finished packaging It is necessary to immediately acquire the following within the duration of a course of conservative therapy. When skip one or more receptions Further treatment continued the same dosage (one tablet per day) from the earliest possible moment, but this break adversely affects the outcome of reorganization (the rate can be longer than originally anticipated). If after reception of a pharmaceutical preparation for 3-4 hours is observed a hearty vomiting or diarrhea Then instead of unabsorbed tablets should drink another to maintain a constant concentration of the active drug components.

Overdose

When using an excess concentration of the drug may occur following symptoms Nausea and vomiting, spotting and metrorrhagia smearing nature of the sexual organs. Specific antidote on overdose among drug Visanne pharmaceutical products does not currently exist, because under the above adverse effects of further therapy should be discontinued and conduct symptomatic treatment .

Cooperation

The metabolism of the active ingredients of the drug Visan is closely linked with the system of biological catalysts isoenzyme SYP3A (microsomal enzyme system Cytochrome P-450 ) Respectively exhibit clinically significant interaction group of drugs that are in some way affect the biochemical properties of the metabolic functions.

Typical inducers of enzyme system

Medicaments which increase the activity of biological catalysts cytochrome indirectly contribute increase clearance of sex hormones . Since the main active component of Visan - derivative of hormone-like substances, respectively metabolism pills is also undergoing some changes. Primarily, this results in a significant reduce the therapeutic effect   (bioactive substance circulates long enough in the main blood flow). Also, a clinical interaction may cause side effects For example, change of character uterine bleeding (amount, consistency, tenderness and so on).

For drugs that act in this manner include: Phenytoin , Antibiotics, carbamazepine and rifampicin, barbiturates , Primidone, felbamate, Grizeofulivin used in the fight against pathogenic fungi, as well as products based on medicinal St. John's Wort .

Maximum inductive influence on the enzymes observed immediately, but only 2-3 weeks after But retained the pharmaceutical effect continuously - takes at least 4 weeks after cessation of combined therapy to restore the usual rate of metabolic pathways.

The substances that can inhibit the action of enzymes

Inhibitors of the enzyme systems in the joint reorganization with Visa greatly increase the concentration of progestogens in the plasma component of blood, and therefore cause   severe side effects   from the list above. That action the following groups of drugs:

  • Antifungal   Vehicles - ketoconazole, itraconazole, fluconazole;
  • macrolides   - Erythromycin, Clarithromycin, Roxithromycin;
  • protease inhibitors   - Ritonavir, indinavir, saquinavir,
  • antidepressants   - Fluoxetine, fluvoxamine, Nefazodone;
  • other groups of drugs - cimetidine, verapamil, diltiazem.

Compatibility of the drug with food

Eating high fat   It does not affect the ability of the components of the pharmacokinetic and therapeutic effect exerted by them, that is, during the course of conservative therapy does not require a special diet. However, the diet should be deleted grapefruit juice Because it contains trace elements that act as inhibitors of the enzyme cytochrome (see above potential adverse effects).

Non-drug interactions

The active components of active pills may slightly Visan distort the results of clinical tests . For example, the effect of the pharmaceutical preparation must be considered when biochemical liver function tests, thyroid, adrenals and kidneys. And fractional change parameters such as the concentration of proteins (including specific transporters vectors), lipids and lipoproteins, hemocoagulation constants, parameters of carbohydrate metabolism.

Terms of sale

Sold only by the assurance of a drug receptor Form.

Storage conditions

Visanne tablets should be stored out of reach of young children place at constant temperature no higher than 30 degrees Celsius.

Shelf life

5 years

Cautions

Visan - the drug, which included guest hormonal component . This means that after a course of conservative therapy drug, the body undergoes certain changes in the level of biological hormones, especially since receiving the drug was preceded by a serious gynecological pathology such as endometriosis. As a consequence, during the course of therapy with oral tablets marked a temporary fertility (ovulation suppression).

But do not panic once again to arrange. Periods After Visan begin immediately, but within one to two to three months, which is the norm, with the return of the natural menstrual cycle   and the possibility of recovering the reproductive system of the female body. Of course, immediately after the course of a pharmaceutical preparation should be a consultation with a qualified professional.

Analogs Visan

Match code ATC 4th level:
  •  Visan  Progesterone is
  •  Visan  Depo-Provera
  •  Visan  Prozhestozhel
  •  Visan  Norkolut
  •  Visan  Utrozhestan
  •  Visan  Djufaston

As such analogues in drug Visan at the moment at the pharmaceutical market there. It is the best means to treat such diseases as endometriosis . At times when sluggish disease and related indications, this product can be replaced with other hormonal agents that do not have proven reliability and clinically proven effect in this disease entities.

Thus, for example, drug analogs are often presented Visan drugs Janine or " Ethinylestradiol + Dienogest ", Which are essentially one and the same pharmaceutical name (first name used for commercial purposes, as is more common on the shelves of kiosks, and the second - is an international non-proprietary name).

A huge number of women at the topical pharmaceutical forums and Internet resources wonders, so that it is better - or Jeanine Visan, and what positive qualities in therapeutic practice is preferable to choose in the treatment of endometriosis .

First of all, we should understand that Jeanine is classified as monophasic contraceptive   pharmaceutical preparation. That is, the drug is oral contraceptive   hormone based active ingredients. This and nothing else is the main objective purpose of this remedy.

Of course, on the Internet you can find information that conducted clinical trials Janine as a means to combat endometriosis. However, the composite components of the pharmaceutical preparation also includes etilenestradiol and a large amount of auxiliary substances, which largely extend the list of adverse effects and side effects of the therapeutic course.

Accordingly, the question Visan or Jeanine endometriosis is not correct in its essence. Most definitely should choose a tablet Visan As this pharmaceutical drug has been specifically designed to deal with gynecological diseases.

Babies

Compatible with alcohol

During pregnancy (and lactation)

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