Visannette-2 Side effects

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Side effects of Visannette-2 in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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Undesirable effects are more common during the 1st months after start of intake of Visannette-2 and subside with duration of treatment. The following undesirable effects have been reported in users of Visannette-2.

The most frequently reported undesirable effects during treatment that were considered at least possibly related to Visannette-2 were headache (9%), breast discomfort (5.4%), depressed mood (5.1%), and acne (5.1%).

In addition, the majority of patients treated with Visannette-2 experience changes in their menstrual bleeding pattern. Menstrual bleeding patterns were assessed systematically using patient diaries and were analyzed using the World Health Organization (WHO) 90-days reference period method. During the first 90 days of treatment with Visannette-2 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 (2.7%), irregular bleeding (21.5%), prolonged bleeding (4%), normal bleeding, ie, none of the previous categories (22.8%). Changes in menstrual bleeding patterns were only occasionally reported as adverse event by the patients.

The frequencies of adverse drug reactions (ADRs) by MedDRA system organ classes (MedDRA SOCs) reported with Visannette-2 are summarized in the list. Within each frequency grouping, undesirable 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%).

Blood and Lymphatic System Disorders: Uncommon: Anemia.

Metabolism and Nutrition Disorders: Common: Increased weight. Uncommon: Decreased weight, increased appetite.

Psychiatric Disorders: Common: Depressed mood, sleep disorder, nervousness, loss of libido, altered mood. Uncommon: Anxiety, depression, mood swings.

Nervous System Disorders: Common: Headache, migraine. Uncommon: Autonomic nervous system imbalance, attention disturbance.

Eye Disorders: Uncommon: Dry eyes.

Ear and Labyrinth Disorders: Uncommon: Tinnitus.

Cardiac Disorders: Uncommon: Unspecified circulatory system disorder, palpitations.

Vascular Disorders: Uncommon: Hypotension.

Respiratory, Thoracic and Mediastinal Disorders: Uncommon: Dyspnoea.

Gastrointestinal Disorders: Common: Nausea, abdominal pain, flatulence, abdominal distension, vomiting. Uncommon: Diarrhoea, constipation, abdominal discomfort, gastrointestinal inflammation, gingivitis.

Skin and Subcutaneous Tissue Disorders: Common: Acne, alopecia. Uncommon: Dry skin, hyperhidrosis, pruritus, hirsutism, onychoclasis, dandruff, dermatitis, abnormal hair growth, photosensitivity reaction, pigmentation disorder.

Musculoskeletal and Connective Tissue Disorders: Common: Back pain. Uncommon: Bone pain, muscle spasms, pain in extremity, heaviness in extremities.

Renal and Urinary Disorders: Uncommon: Urinary tract infection.

Reproductive System and Breast Disorders: Common: Breast discomfort, ovarian cyst, hot flush, uterine/vaginal bleeding including spotting. Uncommon: Vaginal candidiasis, vulvovaginal dryness, genital discharge, pelvic pain, atrophic vulvovaginitis, breast mass, fibrocystic breast disease, breast induration.

General Disorders and Administration Site Conditions: Common: Asthenic conditions, irritability. Uncommon: Oedema.

Visannette-2 contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Hypersensitivity to Visannette-2 or to any of the excipients of Visannette-2.

Visannette-2 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 Visannette-2, 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 Visannette-2 in pregnant women. Animal studies and data from women exposed to Visannette-2 during pregnancy reveal no special risks on pregnancy, embryonic/fetal development, birth or development after birth for humans. However, Visannette-2 should not be administered to pregnant women because there is no need to treat endometriosis during pregnancy.


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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. European Chemicals Agency - ECHA. "17-alpha-Cyanomethyl-17-beta-hydroxy-estra-4,9(10)-dien-3-one: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
  3. NCIt. "Dienogest: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Visannette-2 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 Visannette-2. 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.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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