Elashine Side effects

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• Side effects of Elashine in details
• Elashine contraindications
• Elashine reviews

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:

• vaginal bleeding if you have already gone through menopause;

• a light-headed feeling, like you might pass out;

• a breast lump;

• symptoms of depression (sleep problems, dizziness, mood changes, headache);

• fever;

• jaundice (yellowing of the skin or eyes);

• swelling in your hands, ankles, or feet;

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Common Elashine side effects may include:

• spotting or breakthrough bleeding;

• changes in your menstrual periods;

• vaginal itching or discharge;

• breast tenderness or discharge;

• headache, dizziness, feeling nervous or depressed;

• bruising or swelling of your veins;

• premenstrual type symptoms (bloating, fluid retention, mood changes);

• sleep problems (insomnia);

• itching, rash, acne, hair growth, loss of scalp hair;

• stomach discomfort, bloating, nausea;

• weight gain; or

• vision changes and difficulty wearing contact lenses.

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

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

• Loss of Bone Mineral Density
• Thromboembolic disease
• Breast Cancer
• Anaphylaxis and Anaphylactoid Reactions
• Bleeding Irregularities
• Weight Gain

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.

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.

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

• Elashine injectable suspension may cause drowsiness, dizziness, light-headedness, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Elashine injectable suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Elashine injectable suspension may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or protective clothing when exposed to the sun, sunlamps, or tanning booths.
• Elashine injectable suspension may cause a decrease in the amount of calcium in your bones and make your bones weaker. This effect is of most concern during adolescence (teenage years) and early adulthood. If you need to use Elashine injectable suspension as a long-term birth control method (more than 2 years), your health care provider may test you for weak bones. Discuss any questions or concerns with your doctor.
• Check with your doctor to see whether you should take a calcium and vitamin D supplement while you use Elashine injectable suspension.
• You may experience menstrual cycle changes while using Elashine injectable suspension, including irregular or unpredictable bleeding or spotting, or an increase or decrease in menstrual bleeding. Contact your doctor right away if you experience unusually heavy or continuous bleeding, or any other severe or persistent menstrual changes.
• You may skip a menstrual period or your menstrual periods may stop completely while you use Elashine injectable suspension. If you have been receiving Elashine injectable suspension regularly every 3 months, you are probably not pregnant. However, if you think you may be pregnant, contact your doctor right away.
• Elashine injectable suspension may take time to wear off after your last dose. You may not be able to become pregnant for several months after stopping Elashine injectable suspension. Discuss any questions or concerns with your doctor.
• Diabetes patients - Elashine injectable suspension may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Elashine injectable suspension does not stop the spread of HIV or sexually transmitted diseases (STDs) to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have an HIV infection or an STD. Do not share needles, injection supplies, or items like toothbrushes or razors.
• Elashine injectable suspension may interfere with certain lab tests, including urinary steroid levels, gonadotropin and other hormone levels, thyroid function, blood clotting, liver function, and blood cholesterol. Be sure your doctor and lab personnel know you are using Elashine injectable suspension.
• Lab tests, including bone density and blood pressure checks, may be performed while you use Elashine injectable suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Elashine injectable suspension should not be used in CHILDREN who have not had their first menstrual period; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Elashine injectable suspension if you are pregnant. If you think you may be pregnant, contact your doctor right away. Elashine injectable suspension is found in breast milk. If you are or will be breast-feeding while you use Elashine injectable suspension, check with your doctor. Discuss any possible risks to your baby.

Elashine contraindications

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