Elashine Overdose

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What happens if I overdose Elashine?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately.

Proper storage of Elashine injectable suspension (subcutaneous):

Store Elashine injectable suspension (subcutaneous) at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Elashine injectable suspension (subcutaneous) out of the reach of children and away from pets.

Overdose of Elashine in details

When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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Overdosage of estrogen plus progestin therapy may cause nausea and vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of CE plus MPA together with institution of appropriate symptomatic care.

What should I avoid while taking Elashine?

This medication will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

This medicine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Elashine warnings

Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.

Loss of Bone Mineral Density

Use of depo-subQ Elashine (Elashine acetate) 104 reduces serum estrogen levels and is associated with significant loss of bone mineral density (BMD) as bone metabolism accommodates to a lower estrogen level. This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. It is unknown if use of depo-subQ Elashine (Elashine acetate) 104 by younger women will reduce peak bone mass and increase the risk for osteoporotic fracture in later life. In both adults and adolescents, the decrease in BMD appears to be at least partially reversible after depo-subQ Elashine (Elashine acetate) 104 is discontinued and ovarian estrogen production increases. A study to assess the reversibility of loss of BMD in adolescents is ongoing.

depo-subQ Elashine (Elashine acetate) 104 should be used long-term (e.g., longer than 2 years) only if other methods of birth control are inadequate. BMD should be evaluated when a woman needs to use depo-subQ Elashine (Elashine acetate) 104 long-term. In adolescents, interpretation of BMD results should take into account patient age and skeletal maturity.

Other treatments should be considered in the risk/benefit analysis for the use of depo-subQ Elashine (Elashine acetate) 104 in women with osteoporosis risk factors. depo-subQ Elashine (Elashine acetate) 104 can pose an additional risk in patients with risk factors for osteoporosis (e.g., metabolic bone disease, chronic alcohol and/or tobacco use, anorexia nervosa, strong family history of osteoporosis or chronic use of drugs that can reduce bone mass such as anticonvulsants or corticosteroids).

Although there are no studies addressing whether calcium and Vitamin D lessen BMD loss in women using depo-subQ Elashine (Elashine acetate) 104, all patients should have adequate calcium and Vitamin D intake.

BMD Changes in Adult Women after Long-Term Treatment for Contraception

A study comparing changes in BMD in women using depo-subQ Elashine 104 with women using Depo-Elashine Contraceptive Injection (Depo-Elashine CI, 150 mg) showed no significant differences in BMD loss between the two groups after two years of treatment. Mean percent changes in BMD in the depo-subQ Elashine (Elashine acetate) 104 group are listed in Table 3.

Table 3 : Mean Percent Change from Baseline in BMD in Women Using depo-subQ Elashine (Elashine acetate) 104

Figure 4 : Mean (25th, 75th Percentiles) Number of Bleeding and/or Spotting Days in the Subgroup of Women with Bleeding and/or Spotting by Month for Women Treated with depo-subQ Elashine (Elashine acetate) 104 in Contraception Studies

The changes in menstrual patterns in the two endometriosis trials are presented in Figures 5 and 6.

Figure 5 : Percentages of depo-subQ Elashine (Elashine acetate) 104 Treated Women with Amenorrhea per 30-Day Month in Endometriosis Studies (Combined ITT Population, N=289)

Figure 6 : Mean (25th, 75th Percentiles) Number of Bleeding and/or Spotting Days in the Subgroup of Women with Bleeding and/or Spotting by Month for Women Treated with depo-subQ Elashine (Elashine acetate) 104 in Endometriosis Studies Combined

Cancer Risks

Long-term, case-controlled surveillance of users of depot Elashine acetate IM 150 mg (Depo-Elashine CI, 150 mg) found slight or no increased overall risk of breast cancer and no overall increased risk of ovarian, liver, or cervical cancer, and a prolonged, protective effect of reducing the risk of endometrial cancer.

A pooled analysis reports an average annual incidence rate for breast cancer for US women, all races, age 30 to 34 years of 26.7 per 100,000. A RR of 2.19, thus, increases the possible risk from 26.7 to 58.5 cases per 100,000 women. The attributable risk, thus, is 31.8 per 100,000 women per year.]

The relative rate of invasive squamous-cell cervical cancer in women who ever used Depo-Elashine CI (150 mg) was estimated to be 1.11 (95% CI 0.96 to 1.29). No trends in risk with duration of use or times since initial or most recent exposure were observed.

Thromboembolic Disorders

Although MPA has not been causally associated with the induction of thrombotic or thromboembolic disorders, there have been rare reports of serious thrombotic events in women using Depo-Elashine CI (150 mg). Any patient who develops thrombosis while undergoing therapy with depo-subQ Elashine 104 should discontinue treatment unless she has no other acceptable options for birth control.

Ocular Disorders

Medication should not be re-administered pending examination if there is a sudden partial or complete loss of vision or if there is a sudden onset of proptosis, diplopia or migraine. If examination reveals papilledema or retinal vascular lesions, medication should not be re-administered.

Ectopic Pregnancy

Healthcare providers should be alert to the possibility of an ectopic pregnancy among women using depo-subQ Elashine (Elashine acetate) 104 who become pregnant or complain of severe abdominal pain.

Anaphylaxis and Anaphylactoid Reaction

Serious anaphylactic reactions have been infrequently reported in women using Depo-Elashine CI (150 mg). If an anaphylactic reaction occurs, appropriate emergency medical treatment should be instituted.

What should I discuss with my healthcare provider before taking Elashine?

Some medical conditions may interact with Elashine injectable suspension (subcutaneous). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Elashine injectable suspension (subcutaneous). Tell your health care provider if you are taking any of the following medicines.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Elashine injectable suspension (subcutaneous) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Elashine precautions

Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
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Physical Examination

It is good medical practice for all women to have annual history and physical examinations, including women using depo-subQ Elashine (Elashine acetate) 104. The physical examination, however, may be deferred until after initiation of depo-subQ Elashine (Elashine acetate) 104 if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.

Fluid Retention

Because progestational drugs may cause some degree of fluid retention, conditions that might be influenced by this condition, such as epilepsy, migraine, asthma, and cardiac or renal dysfunction, require careful observation.

Weight Gain

Weight gain is a common occurrence in women using depo-subQ Elashine 104. In three large clinical trials using depo-subQ Elashine (Elashine acetate) 104, the mean weight gain was 3.5 lb in the first year of use. In a small, two-year study comparing depo-subQ Elashine (Elashine acetate) 104 to Depo-Elashine CI (150 mg), the mean weight gain observed for women using depo-subQ Elashine (Elashine acetate) 104 (7.5 lb) was similar to the mean weight gain for women using Depo-Elashine CI, 150 mg (7.6 lb).

Although there are no data related to weight gain beyond 2 years for depo-subQ Elashine (Elashine acetate) 104, the data on Depo-Elashine CI (150 mg) may be relevant. In a clinical study, after five years, 41 women using Depo-Elashine CI (150 mg) had a mean weight gain of 11.2 lb, while 114 women using non-hormonal contraception had a mean weight gain of 6.4 lb.

Return to Ovulation and Fertility

Return to ovulation is likely to be delayed after stopping therapy. Among 15 women who received multiple doses of depo-subQ Elashine (Elashine acetate) 104:

However, ovulation has occurred as early as 14 weeks after a single dose of depo-subQ Elashine (Elashine acetate) 104, and therefore it is important to follow the recommended dosing schedule.

Return to fertility also is likely to be delayed after stopping therapy. Among 28 women using depo-subQ Elashine (Elashine acetate) 104 for contraception who stopped treatment to become pregnant, 1 became pregnant within 1 year of her last injection. A second woman became pregnant 443 days after her last injection. Seven women were lost to follow-up.

Depression

Patients with a history of treatment for clinical depression should be carefully monitored while receiving depo-subQ Elashine (Elashine acetate) 104.

Injection Site Reactions

In 5 clinical studies of depo-subQ Elashine (Elashine acetate) 104 involving 2,325 women (282 treated for up to 6 months, 1,780 treated for up to 1 year and 263 women treated for up to 2 years), 5% of women reported injection site reactions, and 1% had persistent skin changes, typically described as small areas of induration or atrophy.

Carbohydrate/Metabolism

Some patients receiving progestins may exhibit a decrease in

Liver Function

If jaundice or any other liver abnormality develops in any woman receiving depo-subQ Elashine (Elashine acetate) 104, treatment should be stopped while the cause is determined. Treatment may be resumed when liver function is acceptable and when the healthcare provider has determined that depo-subQ Elashine (Elashine acetate) 104 did not cause the abnormality.

Laboratory Tests

The pathologist should be advised of progestin therapy when relevant specimens are submitted. The physician should be informed that certain endocrine and liver function tests, and blood components may be affected by progestin therapy:

  1. Plasma and urinary steroid levels are decreased (e.g., progesterone, estradiol, pregnanediol, testosterone, cortisol).
  2. Plasma and urinary gonadotropin levels are decreased (e.g., LH, FSH).
  3. SHBG concentrations are decreased.
  4. T-uptake values may decrease.
  5. There may be small changes in coagulation factors.
  6. Sulfobromophthalein and other liver function test values may be increased slightly.
  7. There may be small changes in lipid profiles.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Pregnancy

Although depo-subQ Elashine (Elashine acetate) 104 should not be used during pregnancy, there appears to be little or no increased risk of birth defects in women who have inadvertently been exposed to Elashine acetate injections in early pregnancy. Neonates exposed to Elashine acetate in-utero and followed to adolescence showed no evidence of any adverse effects on their health including their physical, intellectual, sexual or social development.

Nursing Mothers

Although the drug is detectable in the milk of mothers receiving Depo-Elashine CI (150 mg), milk composition, quality, and amount are not adversely affected. Neonates and infants exposed to Elashine acetate from breast milk have been studied for developmental and behavioral effects through puberty, and no adverse effects have been noted.

Pediatric Use

depo-subQ Elashine (Elashine acetate) 104 is not indicated before menarche. Use of depo-subQ Elashine (Elashine acetate) 104 is associated with significant loss of bone mineral density (BMD). This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. In adolescents, interpretation of BMD results should take into account patient age and skeletal maturity. It is unknown if use of depo-subQ Elashine (Elashine acetate) 104 by younger women will reduce peak bone mass and increase the risk for osteoporotic fractures in later life. Other than concerns about loss of BMD, the safety and effectiveness are expected to be the same for postmenarchal adolescents and adult women.

Geriatric Use

depo-subQ Elashine (Elashine acetate) 104 is intended for use in women with childbearing potential. Studies with depo-subQ Elashine (Elashine acetate) 104 in geriatric women have not been conducted.

Information for Patients

What happens if I miss a dose of Elashine?

When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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