Visanne Uses

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Visanne indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Herbal preparations containing St John’s wort are used, frequently for self-medication, in the treatment of depression. Such preparations are also promoted for the treatment of other nervous disorders such as insomnia and anxiety, particularly if associated with the menopause.

Hypericin, a major constituent of St John’s wort, has been investigated as an antiviral in the treatment of HIV infection and AIDS.

St John’s wort has been used in homoeopathic preparations.

Visanne description

Visanne is an orally-active semisynthetic, steroidal progestogen (or progestin). It is available for use as an oral contraceptive in combination with ethinylestradiol. It has antiandrogenic activity and as a result can improve androgenic symptoms. It is a non-ethinylated progestin which is structurally related to testosterone. Visanne given in isolation is available for the treatment of endometriosis under the trade name Visanne.

Visanne dosage

1 tab daily without any break, taken preferably at the same time each day with some liquid as needed. Tablets must be taken continuously without regard to vaginal bleeding. When a pack is finished the next one should be started without interruption.

Tablet-taking can be started on any day of the menstrual cycle.

There is no experience with Visanne treatment >15 months in patients with endometriosis.

The efficacy of Visanne may be reduced in the event of missed tablets, vomiting and/or diarrhea (if occurring within 3-4 hrs after tab taking). In the event of missed tablet(s), the woman should take 1 tab only, as soon as she remembers, and should then continue the next day to take the tab at her usual time. A tablet not absorbed due to vomiting or diarrhea should likewise be replaced by 1 tablet.

Renal Impairment: There are no data suggesting the need for a dosage adjustment in patients with renal impairment.

Hepatic Impairment: Visanne is contraindicated in patients with present or past severe hepatic disease.

Administration: For oral use.

Visanne interactions

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Effects of Other Medicaments on Visanne: Individual Enzyme Inducers or Inhibitors (CYP3A4): Progestogens including Visanne are metabolized mainly by the cytochrome P450 (CYP450) 3A4 system (CYP3A4) located both in the intestinal mucosa and in the liver. Therefore, inducers or inhibitors of CYP3A4 may affect the progestogen drug metabolism.

An increased clearance of sex hormones due to enzyme induction may reduce the therapeutic effect of Visanne and may result in adverse effects eg, changes in the uterine bleeding profile.

A reduced clearance of sex hormones due to enzyme inhibition may increase the exposure to Visanne and may result in adverse effects.

Substances with Enzyme-Inducing Properties: Interactions can occur with drugs (eg, phenytoin, barbiturates, primidone, carbamazepine, rifampicin and possibly also oxcarbazepine, topiramate, felbamate, griseofulvin, nevirapine and products containing St. John's wort) that induce microsomal enzymes (eg, CYP450 enzymes) which can result in increased clearance of sex hormones.

Maximum enzyme induction is generally not seen for 2-3 weeks but may then be sustained for at least 4 weeks after the cessation of therapy.

The effect of the CYP3A4 inducer rifampicin was studied in healthy postmenopausal women. Co-administration of rifampicin with estradiol valerate/Visanne tablets led to significant decreases in steady state concentrations and systemic exposures of Visanne. The systemic exposure of Visanne at steady state, measured by AUC0-24 hrs, was decreased by 83%.

Substances with Enzyme-Inhibiting Properties: Known CYP3A4 inhibitors eg, azole antifungals (eg, ketoconazole, itraconazole, fluconazole), cimetidine, verapamil, macrolides (eg, erythromycin, clarithromycin and roxithromycin), diltiazem, protease inhibitors (eg, ritonavir, saquinavir, indinavir, nelfinavir), antidepressants (eg, nefazodone, fluvoxamine, fluoxetine) and grapefruit juice may increase plasma levels of progestogens and result in adverse effects.

In a study investigating the effect of CYP3A4 inhibitors (ketoconazole, erythromycin) on the combination of estradiol valerate/Visanne, steady state Visanne plasma levels were increased. Co-administration with the strong inhibitor ketoconazole resulted in a 186% increase of AUC0-24 hrs at steady state for Visanne. When co-administered with the moderate inhibitor erythromycin, the AUC0-24 hrs of Visanne at steady state was increased by 62%. The clinical relevance of these interactions is unknown.

Effects of Visanne on Other Medicaments: Based on in vitro inhibition studies, a clinically relevant interaction of Visanne with the CYP450 enzyme-mediated metabolism of other medicaments is unlikely.

Note: The prescribing information of concomitant medications should be consulted to identify potential interactions.

Drug-Food Interactions: A standardized high fat meal did not affect the bioavailability of Visanne.

Other Forms of Interactions: The use of progestogens may influence the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, plasma levels of (carrier) proteins eg, lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis. Changes generally remain within the normal laboratory range.

Visanne side effects

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Summary of the Safety Profile: Adverse effects are more common during the first months after start of intake of Visanne and subside with duration of treatment. The following adverse effects have been reported in users of Visanne.

The most frequently reported adverse effects during treatment that were considered at least possibly related to Visanne were headache (9%), breast discomfort (5.4%), depressed mood (5.1%) and acne (5.1%).

The frequencies of adverse drug reactions (ADRs) by MedDRA system organ classes (MedDRA SOCs) reported with Visanne are summarized in the table as follows. Within each frequency grouping, adverse effects are presented in order of decreasing frequency. Frequencies are defined as common (≥1/100 to <1/10) and uncommon (≥1/1000 to <1/100).

*The frequencies are based on pooled data of 4 clinical trials including 332 patients (100%).

*The most appropriate MedDRA term (version 11.0) to describe a certain adverse reaction is listed. Synonyms or related conditions are not listed, but should be taken into account as well.

Description of Selected Adverse Reactions: Uterine Bleeding Irregularities: Menstrual bleeding patterns were assessed systematically using patient diaries and were analyzed using the WHO 90 days reference period method. During the first reference period (ie, first 90 days of treatment with Visanne): The following bleeding patterns were observed (n=290; 100%): Amenorrhea (1.7%), infrequent bleeding (27.2%), frequent bleeding (13.4%), irregular bleeding (35.2%), prolonged bleeding (38.3%), normal bleeding ie, none of the previous categories (19.7%).

During the 4th reference period, the following bleeding patterns were observed (n=149; 100%): Amenorrhea (28.2%), infrequent bleeding (24.2%), frequent bleeding (27.2%), irregular bleeding (21.5%), prolonged bleeding (4%), normal bleeding ie, none of the previous categories (22.8%), changes in menstrual bleeding were only occasionally reported as adverse event by the patients.

Visanne contraindications

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Hypersensitivity to Visanne or to any of the excipients of Visanne.

Visanne should not be used in the presence of any of the conditions listed as follows, which are partially derived from information on other progestogen-only preparations. Should any of the conditions appear during the use of Visanne, treatment must be discontinued immediately: Active venous thromboembolic disorder, arterial and cardiovascular disease, present or in history (eg, myocardial infarction, cerebrovascular accident, ischemic heart disease); diabetes mellitus with vascular involvement; presence or history of severe hepatic disease as long as liver function values have not returned to normal, liver tumors (benign or malignant); known or suspected sex hormone-dependent malignancies; undiagnosed vaginal bleeding.

Use in pregnancy: There are limited data from the use of Visanne in pregnant women. Animal studies and data from women exposed to Visanne during pregnancy reveal no special risks on pregnancy, embryonic/fetal development, birth or development after birth for humans. However, Visanne should not be administered to pregnant women because there is no need to treat endometriosis during pregnancy.



Active ingredient matches for Visanne:

Dienogest in Austria, Bulgaria, Croatia (Hrvatska), Germany, Slovenia, Sweden, Switzerland.


Unit description / dosage (Manufacturer)Price, USD
Visanne 2 mg x 2 x 14's
Visanne tab 2 mg 28's (Bayer)
Visanne tab 2 mg 2 x 14's (Bayer HealthCare Pharma)
Visanne tab 2 mg / 2 x 14 1 x 28's (Bayer)

List of Visanne substitutes (brand and generic names):

2.5 mg x 10's (Mano (Orchid Chemicals & Pharmaceuticals Ltd.))$ 0.37
5 mg x 10's (Mano (Orchid Chemicals & Pharmaceuticals Ltd.))$ 0.44
5 mg x 1 mL x 1ml (Mano (Orchid Chemicals & Pharmaceuticals Ltd.))$ 0.32
Dine 2.5mg TAB / 10 (Mano (Orchid Chemicals & Pharmaceuticals Ltd.))$ 0.37
Dine 5mg TAB / 10 (Mano (Orchid Chemicals & Pharmaceuticals Ltd.))$ 0.44
Dine 5mg x 1mL AMP / 1ml (Mano (Orchid Chemicals & Pharmaceuticals Ltd.))$ 0.32
Dine 5 mg Tablet (Mano (Orchid Chemicals & Pharmaceuticals Ltd.))$ 0.05
Dine 2.5 mg Tablet (Mano (Orchid Chemicals & Pharmaceuticals Ltd.))$ 0.04
DINE 2.5 MG TABLET 1 strip / 20 tablets each (Mano (Orchid Chemicals & Pharmaceuticals Ltd.))$ 3.97
DINE 2.5 MG TABLET 1 strip / 10 tablets each (Mano (Orchid Chemicals & Pharmaceuticals Ltd.))$ 0.46
DINE 5 MG TABLET 1 strip / 10 tablets each (Mano (Orchid Chemicals & Pharmaceuticals Ltd.))$ 0.55
DINE tab 2.5 mg x 10's (Mano (Orchid Chemicals & Pharmaceuticals Ltd.))$ 0.37
DINE tab 5 mg x 10's (Mano (Orchid Chemicals & Pharmaceuticals Ltd.))$ 0.44
DINE inj 5 mg x 1 mL x 1ml (Mano (Orchid Chemicals & Pharmaceuticals Ltd.))$ 0.32
Dine 2.5mg TAB / 10 (Mano (Orchid Chemicals & Pharmaceuticals Ltd.))$ 0.37
Dine 5mg TAB / 10 (Mano (Orchid Chemicals & Pharmaceuticals Ltd.))$ 0.44
Dine 5mg x 1mL AMP / 1ml (Mano (Orchid Chemicals & Pharmaceuticals Ltd.))$ 0.32
Dine 5mg Tablet (Mano (Orchid Chemicals & Pharmaceuticals Ltd.))$ 0.06
DINOFIRST 2MG CAPSULE 1 strip / 10 capsules each (Akumentis Healthcare Ltd)$ 7.92
Dinofirst 2mg Tablet (Akumentis Healthcare Ltd)$ 0.87
DINOGEST 2 MG TABLET 1 strip / 10 tablets each (Koye Pharmaceuticals Pvt ltd)$ 7.92
Dinogest 2mg Capsule (Koye Pharmaceuticals Pvt ltd)$ 0.79
Dinosis 2mg Tablet (Jay Ell Healthcare Pvt. Ltd)$ 0.63
ENDOFIT 2MG TABLET 1 strip / 10 tablets each (Akumentis Healthcare Ltd)$ 7.92
ENDOHEAL 2 MG TABLET 1 strip / 10 tablets each (Akumentis Healthcare Ltd)$ 7.92
Endoheal 2mg Tablet (Akumentis Healthcare Ltd)$ 0.79
ENDOREG 2 MG TABLET 1 strip / 14 tablets each (Jagsonpal Pharmaceuticals Ltd)$ 10.00
Endoreg 2mg Tablet (Jagsonpal Pharmaceuticals Ltd)$ 0.71
ENDOSIS 2 MG CAPSULE 1 strip / 10 capsules each (Pharmanova India Drugs Pvt Ltd)$ 7.92
Endosis 2mg Soft Gelatin Capsule (Pharmanova India Drugs Pvt Ltd)$ 7.92
Primogest 2mg Tablet (Suremed Lifecare Pvt Ltd)$ 0.79
RUMIGEST 2MG TABLET 1 strip / 10 tablets each (Alembic Pharmaceuticals Ltd)$ 8.25
Rumigest 2mg Capsule (Alembic Pharmaceuticals Ltd)$ 0.83

References

  1. DailyMed. "DIENOGEST; ESTRADIOL VALERATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "Dienogest". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "Dienogest". http://www.drugbank.ca/drugs/DB09123 (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Visanne are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Visanne. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

1 consumer reported useful

Was the Visanne drug useful in terms of decreasing the symptom or the disease?
According to the reports released by ndrugs.com website users, the below mentioned percentages of users say the drug is useful / not useful to them in decreasing their symptoms/disease. The usefulness of the drug depends on many factors, like severity of the disease, perception of symptom, or disease by the patient, brand name used [matters only to a certain extent], other associated conditions of the patient. If the drug is not effective or useful in your case, you need to meet the doctor to get re-evaluated about your symptoms/disease, and he will prescribe an alternative drug.
Users%
Useful1
100.0%


2 consumers reported price estimates

Was the price you paid to purchase the drug reasonable? Did you feel it was expensive?
The below mentioned numbers have been reported by ndrugs.com website users about whether the Visanne drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.
Users%
Expensive2
100.0%


3 consumers reported time for results

To what extent do I have to use Visanne before I begin to see changes in my health conditions?
As part of the reports released by ndrugs.com website users, it takes 1 month and a few days before you notice an improvement in your health conditions.
Please note, it doesn't mean you will start to notice such health improvement in the same time frame as other users. There are many factors to consider, and we implore you to visit your doctor to know how long before you can see improvements in your health while taking Visanne. To get the time effectiveness of using Visanne drug by other patients, please click here.
Users%
1 month1
33.3%
> 3 month1
33.3%
3 month1
33.3%


10 consumers reported age

Users%
30-459
90.0%
16-291
10.0%


Consumer reviews


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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