Elashine Side effects

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What are the possible side effects of Elashine?

Get emergency medical help if you have any signs of an allergic reaction to Elashine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

Common Elashine side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Elashine 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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The following important adverse reactions observed with the use of Elashine CI are discussed in greater detail in the Warnings and Precautions section (5):

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In the two clinical trials with Elashine CI, over 3,900 women, who were treated for up to 7 years, reported the following adverse reactions, which may or may not be related to the use of Elashine CI. The population studied ranges in age from 15 to 51 years, of which 46% were White, 50% Non-White, and 4.9% Unknown race. The patients received 150 mg Elashine CI every 3-months (90 days). The median study duration was 13 months with a range of 1–84 months. Fifty eight percent of patients remained in the study after 13 months and 34% after 24 months.

Table 1 Adverse Reactions that Were Reported by More than 5% of Subjects
Body System* Adverse Reactions [Incidence (%)]
*
Body System represented from COSTART medical dictionary.
Body as a Whole Headache (16.5%)

Abdominal pain/discomfort (11.2%)

Metabolic/Nutritional Increased weight> 10lbs at 24 months (37.7%)
Nervous Nervousness (10.8%)

Dizziness (5.6%)

Libido decreased (5.5%)

Urogenital Menstrual irregularities:

(bleeding (57.3% at 12 months, 32.1% at 24 months)

amenorrhea (55% at 12 months, 68% at 24 months)

Table 2 Adverse Reactions that Were Reported by between 1 and 5% of Subjects
Body System* Adverse Reactions [Incidence (%)]
*
Body System represented from COSTART medical dictionary.
Body as a Whole Asthenia/fatigue (4.2%)

Backache (2.2%)

Dysmenorrhea (1.7%)

Hot flashes (1.0%)

Digestive Nausea (3.3%)

Bloating (2.3%)

Metabolic/Nutritional Edema (2.2%)
Musculoskeletal Leg cramps (3.7%)

Arthralgia (1.0%)

Nervous Depression (1.5%)

Insomnia (1.0%)

Skin and Appendages Acne (1.2%)

No hair growth/alopecia (1.1%)

Rash (1.1%)

Urogenital Leukorrhea (2.9%)

Breast pain (2.8%)

Vaginitis (1.2%)

Adverse reactions leading to study discontinuation in ≥ 2% of subjects: bleeding (8.2%), amenorrhea (2.1%), weight gain (2.0%)

Post-marketing Experience

The following adverse reactions have been identified during post approval use of Elashine CI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

There have been cases of osteoporosis including osteoporotic fractures reported post-marketing in patients taking Elashine CI.

Table 3 Adverse Reactions Reported during Post-Marketing Experience
Body System* Adverse Reactions
*
Body System represented from COSTART medical dictionary.
Body as a Whole Chest pain, Allergic reactions including angioedema, Fever, Pain at injection site, Chills, Axillary swelling
Cardiovascular Syncope, Tachycardia, Thrombophlebitis, Deep vein thrombosis, Pulmonary embolus, Varicose veins
Digestive Changes in appetite, Gastrointestinal disturbances, Jaundice, Excessive thirst, Rectal bleeding
Hematologic and Lymphatic Anemia, Blood dyscrasia
Musculoskeletal Osteoporosis
Neoplasms Cervical cancer, Breast cancer
Nervous Paralysis, Facial palsy, Paresthesia, Drowsiness
Respiratory Dyspnea and asthma, Hoarseness
Skin and Appendages Hirsutism, Excessive sweating and body odor, Dry skin, Scleroderma
Urogenital Lack of return to fertility, Unexpected pregnancy, Prevention of lactation, Changes in breast size, Breast lumps or nipple bleeding, Galactorrhea, Melasma, Chloasma, Increased libido, Uterine hyperplasia, Genitourinary infections, Vaginal cysts, Dyspareunia

What is the most important information I should know about Elashine?

Elashine 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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Known hypersensitivity to Elashine acetate or to any other ingredients of Provera.

Undiagnosed vaginal bleeding; known, suspected or history of breast carcinoma; previous idiopathic or current venous thromboembolism (deep vein thrombosis, pulmonary embolism); active or recent (within the past year) arterial thromboembolic disease (eg, angian, myocardial infarction); known liver dysfunction or disease; missed abortion; known or suspected pregnancy.

Thrombophlebitis, thromboembolic disorders and where there is a high risk of developing such manifestations (presence or history of arterial fibrillation, valvular disorders, endocarditis, heart failure, thromboembolic ishcaemic attack, cerebral infarction; atherosclerosis; immediate post-surgery period); hypercalcaemia in patients with osseous metastases, metrorrhagia.

Progestogens are known to be porphyrogenic. Patients with history of attacks or aged <30 are at greatest risk of an acute attack while on progesterone treatment. A careful assessment of potential benefit should be made where this risk is present.

Use in pregnancy: Elashine acetate is contraindicated in women who are pregnant. If Elashine acetate is used during pregnancy, or if the patient becomes pregnant while using Provera, the patient should be apprised of the potential hazard to the fetus.

Some reports suggest an association between intrauterine exposure to progestational drugs in the 1st trimester of pregnancy and genital abnormalities in male and female fetuses.

Infants from unintentional pregnancies that occur 1-2 months after injection of Elashine acetate injectable suspension may be at an increased risk of low birth weight, which, in turn, is associated with an increased risk of neonatal death. The attributable risk is low because pregnancies while on Elashine acetate are uncommon.

Use in lactation: Elashine acetate and/or its metabolites are secreted in breast milk. Therefore, the use of Provera whilst breastfeeding is not recommended.


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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