Esdelart capsules

Esdelart

  • Active Ingredient: Danazol
  • 200 mg, 100 mg, 50 mg
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What is Esdelart?

The active ingredient of Esdelart brand is danazol. Danazol is a man-made form of a steroid. Danazol affects the ovaries and pituitary gland and prevents the release of certain hormones in the body. C22H27NO2 M.W. 337.46 Danazol Capsules USP for oral administration, contain 50 mg, 100 mg or 200 mg of Danazol, USP. In addition, each capsule contains the following inactive ingredients: black iron oxide, D&C yellow no. 10, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, gelatin, lactose monohydrate, magnesium stearate, pharmaceutical glaze, propylene glycol, sodium starch glycolate, stearic acid and titanium dioxide The 50 mg and 100 mg capsule shells also contain FD&C yellow no. 6. The 200 mg capsule shell also contains FD&C red no. 40 and D&C red no. 28.

Used for

Esdelart is used to treat diseases such as: Angioedema, Endometriosis, Evan's Syndrome, Fibrocystic Breast Disease.

Side Effect

Possible side effects of Esdelart include: dark-colored urine; vaginal bleeding; chest pain; mood or mental changes; irregular menstrual periods.

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CLINICAL PHARMACOLOGY

Esdelart suppresses the pituitary-ovarian axis. This suppression is probably a combination of depressed hypothalamic-pituitary response to lowered estrogen production, the alteration of sex steroid metabolism, and interaction of Esdelart with sex hormone receptors. The only other demonstrable hormonal effect is weak androgenic activity. Esdelart depresses the output of both follicle-stimulating hormone (FSH) and luteinizing hormone (LH).

Recent evidence suggests a direct inhibitory effect at gonadal sites and a binding of Esdelart to receptors of gonadal steroids at target organs. In addition, Esdelart has been shown to significantly decrease IgG, IgM and IgA levels, as well as phospholipid and IgG isotope autoantibodies in patients with endometriosis and associated elevations of autoantibodies, suggesting this could be another mechanism by which it facilitates regression of the disease.

In the treatment of endometriosis, Esdelart alters the normal and ectopic endometrial tissue so that it becomes inactive and atrophic. Complete resolution of endometrial lesions occurs in the majority of cases.

Changes in vaginal cytology and cervical mucus reflect the suppressive effect of Esdelart on the pituitary-ovarian axis.

Changes in the menstrual pattern may occur.

Generally, the pituitary-suppressive action of Esdelart is reversible. Ovulation and cyclic bleeding usually return within 60 to 90 days when therapy with Esdelart is discontinued.

In the treatment of hereditary angioedema, Esdelart at effective doses prevents attacks of the disease characterized by episodic edema of the abdominal viscera, extremities, face, and airway which may be disabling and, if the airway is involved, fatal. In addition, Esdelart corrects partially or completely the primary biochemical abnormality of hereditary angioedema by increasing the levels of the deficient C1 esterase inhibitor (C1El). As a result of this action the serum levels of the C4 component of the complement system are also increased.

ВїPara cuГЎles condiciones o enfermedades se prescribe este medicamento?

Esdelart se usa para tratar endometriosis (una condiciГіn en la que el tipo de tejido que recubre el Гєtero crece en otras ГЎreas del cuerpo y causa infertilidad, dolor antes y durante los perГ­odos menstruales, dolor durante y despuГ©s de la actividad sexual y sangrado intenso o irregular.El Esdelart tambiГ©n se usa para tratar la enfermedad de senos fibroquГ­sticos (senos inflamados, sensibles con bultos no cancerosos) cuando otros tratamientos no son exitosos. Esdelart tambiГ©n se usa para prevenir ataques en las personas con angiedema hereditario (condiciГіn heredada que ocasiona episodios de inflamaciГіn en las manos, pies, rostro, vГ­as respiratorias o intestinos). El Esdelart pertenece a una clase de medicamentos llamados hormonas androgГ©nicas. Funciona para tratar la endometriosis al encoger el tejido desplazado del Гєtero. Funciona para tratar la enfermedad de senos fibroquГ­sticos al bloquear la liberaciГіn de hormonas que ocasionan el dolor y los bultos en los senos. Funciona para tratar el angioedema hereditario al aumentar la cantidad de una sustancia natural en el cuerpo.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of Esdelart is not expected to produce life threatening symptoms. However, long term use of high doses can lead to symptoms such as weight gain, increased acne or facial hair, menstrual problems, or breast changes.

How to store Esdelart

  • Keep all medicines out of the reach and sight of children.
  • Store in a cool, dry place, away from direct heat and light.

Can Esdelart cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the ones associated with Esdelart. You will find a full list in the manufacturer's information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.

Helen Allen, Reviewed by Sid Dajani | Last edited 19 Dec 2018 | Certified by The Information Standard

Start taking Esdelart on the first day of your period unless you have been told otherwise. You can take the capsules either before or after meals.

It is important that you do not become pregnant while on Esdelart. Follow your doctor's advice about suitable contraception.

Dosage

The usual length of treatment is 3–6 months, but it may be extended to 9 months in some circumstances.

The recommended dosages vary. North American gynaecologists tend to recommend dosages of 800 milligrams per day, whereas European and Australian gynaecologists tend to recommend dosages of 600 milligrams per day .

Some gynaecologists believe it is better to base the dosage on the minimum needed to stop menstruation. In this case, they may suggest that you start with 400 milligrams per day, and, if necessary, increase the dose until your periods stop . Alternatively, they may suggest that you start with 600 milligrams a day, and reduce the dosage to 400 milligrams a day or even 200 milligrams a day .

You should start your course of Esdelart on the first day of your period to decrease the risk of taking the drug while you are pregnant. If there is any possibility that you may be pregnant, you should have a pregnancy test before starting treatment .

Although it is unlikely that you will conceive while on Esdelart, care should be taken to avoid pregnancy. It is recommended that you use barrier contraception (condom or diaphragm or both) throughout treatment .

You should not take Esdelart if you have :

  • liver disease
  • high blood pressure
  • heart failure
  • poor kidney function

What are some other side effects of Esdelart?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Flushing.
  • Sweating a lot.
  • Hair loss.
  • Feeling nervous and excitable.
  • Emotional ups and downs.
  • Weight gain.
  • Pimples (acne).
  • For females, a deep voice, facial hair, pimples, or period changes.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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

You should not use this medication if you are allergic to Esdelart, or if you have porphyria, a history of stroke or blood clot, or severe problems with your heart, liver, or kidney. You also should not take Esdelart if you are pregnant or breast-feeding, if you have breast or uterine cancer, or if you have abnormal vaginal bleeding that has not been checked by a doctor.

Esdelart can harm an unborn baby or cause vaginal birth defects in a newborn female infant. Do not use if you are pregnant.

You may need to have a negative pregnancy test before starting this treatment.

Use a barrier form of birth control (such as a condom or diaphragm with spermicide). Hormonal contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment with Esdelart.

Your medication needs may change if you become ill, have a fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you. Do not change your medication dose or schedule without your doctor's advice.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve or if they get worse during treatment.

Call your doctor at once if you have a serious side effect such as sudden numbness or weakness, problems with vision or speech, chest pain, sudden cough, or wheezing, swelling, rapid weight gain, feeling short of breath, ringing in your ears, dizziness, nausea, pain behind your eyes, stomach pain and loss of appetite, dark urine, or jaundice (yellowing of the skin or eyes).

What should I avoid while taking Esdelart?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Esdelart

Esdelart is a 17-ethinyl testosterone derivative that effectively suppresses endometriosis-related pain symptoms within 2 months of use. 248 It has multiple levels of action, including central inhibition of pituitary gonadotropin secretion, direct inhibition of endometriotic implant growth, and direct inhibition of aromatase and other enzymes responsible for estrogen production. 249-251 Esdelart is given orally in divided doses ranging from 400 to 800 mg daily, generally for 6 months. It is effective in relieving endometriosis-associated pain when compared with placebo or no treatment. 278 However, its use has been severely limited by its undesired androgenic side effects including acne, oily skin, hirsutism, deepening of the voice, edema, weight gain, menopausal hot flushes, atrophic vaginitis, emotional lability, weight gain, fluid retention, migraine headaches, altered lipid profile, dizziness, fatigue, and depression. 253

Contraindications—hypersensitivity to drug or class, undiagnosed genital bleeding, pregnancy, breastfeeding, porphyria

Caution—hepatic, renal, or cardiac dysfunction, epilepsy, migraine

Maternal Considerations There are no indications during pregnancy for Esdelart. It should be discontinued if the patient becomes pregnant. Esdelart is not an effective contraceptive. It decreases the maternal progesterone level if taken during the first trimester.Side effects include alteration of the lipid profile (low HDL), contraceptive failure, pseudotumor cerebri, weight gain, acne and seborrhea, mild hirsutism, virilization, edema, hair loss, hoarseness, menstrual irregularities, flushing, sweating, vaginal dryness, reduction in breast size, hypertension, anxiety, and thromboembolism. Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether Esdelart crosses the human placenta. Though the FDA classifies Esdelart as category X, there is no reason a priori to terminate an exposed pregnancy. Esdelart can have an androgenic effect on female fetuses (vaginal atresia, clitoral hypertrophy, labial fusion, ambiguous genitalia). Thus exposed fetuses should undergo a detailed ultrasound examination. Rodent studies are reassuring, revealing no evidence of teratogenicity or IUGR despite the use of doses higher than those used clinically. Esdelart is associated with inhibition of fetal development in rabbits. Breastfeeding Safety There is no published experience in nursing women. It is unknown whether Esdelart enters human breast milk. It is generally considered contraindicated during breastfeeding. Drug Interactions Prolongation of PT occurs in patients stabilized on warfarin.Esdelart may cause an increase in carbamazepine. References Bianchi S, Busacca M, Agnoli B, et al. Hum Reprod 1999; 14:1335-7.Brunskill PJ. Br J Obstet Gynaecol 1992; 99:212-5.Igarashi M, Iizuka M, Abe Y, Ibuki Y. Hum Reprod 1998; 13:1952-6.Kingsbury AC. Med J Aust 1985; 143:410-1.Rabe T, Kiesel L, Franke C, et al. Biol Res Pregnancy Perinatol 1984; 5:149-52.Schwartz R. Am J Dis Child 1982; 136:474.Zayed F, Abu-Heija A. Obstet Gynecol Surv 1999; 54:121-30. Summary Pregnancy Category: XLactation Category: NS (possibly) •

There are no indications for Esdelart during pregnancy; it is considered contraindicated.

A pregnancy test is recommended immediately prior to initiating therapy.

Esdelart may virilize a female fetus (vaginal atresia, clitoral hypertrophy, labial fusion, urogenital sinus defect, ambiguous genitalia), but these abnormalities have not been reported if discontinued by 8 w.

BRAND NAME(S): Danocrine

WARNING: This medication must not be used during pregnancy. It may harm an unborn baby. In women of childbearing age, this medication should be started during their menstrual period. If not, then they should have a negative pregnancy test before starting this medication. It is important to prevent pregnancy while using this medication. Consult your doctor for more details and to discuss the use reliable forms of non-hormonal birth control (such as condoms, diaphragm with spermicide) while using this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately.

Esdelart has rarely caused very serious (possibly fatal) blood clots (such as stroke), liver disease, and increased pressure on the brain (benign intracranial hypertension). Seek immediate medical attention if you have any symptoms of these side effects, including weakness on one side of the body, slurred speech, vision changes, severe stomach/abdominal pain, dark urine, persistent nausea/vomiting, yellowing eyes/skin, mental/mood changes (such as confusion), severe/persistent headache.

USES: This medication is used in women to treat pelvic pain and infertility due to a certain uterus disorder (endometriosis) and also to treat breast pain/tenderness/nodules due to a certain breast condition (fibrocystic breast disease). It is also used in both men and women to prevent swelling of the abdomen/arms/legs/face/airway due to a certain congenital disease (hereditary angioedema).Esdelart is an androgen similar to testosterone. For the treatment of endometriosis and fibrocystic breast disease, it works by decreasing the amount of hormones made by the ovaries. These hormones usually make the conditions worse. For the treatment of angioedema, Esdelart helps to increase the amount of a certain protein in your body's defense system (immune system).


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