Lozana capsules

Lozana

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

The active ingredient of Lozana 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

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

Side Effect

Possible side effects of Lozana include: fever; rapid weight gain; purple- or red-colored, or other spots on the body or inside the mouth or nose; muscle aches; hives or other skin rash.

How to Buy Lozana capsules online?

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Antes de tomar Lozana,

  • informe a su mГ©dico y farmacГ©utico si es alГ©rgica a Lozana, a cualquier otro medicamento o a alguno de los ingredientes que contienen las cГЎpsulas de Lozana. PГ­dale a su farmacГ©utico una lista de los ingredientes.
  • Informe a su mГ©dico y farmacГ©utico quГ© medicamentos con y sin receta mГ©dica, vitaminas, suplementos nutricionales y productos a base de hierbas estГЎ tomando o tiene planificado tomar. AsegГєrese de mencionar cualesquiera de los siguientes: anticoagulantes ('diluyentes de la sangre') como warfarina (Coumadin, Jantoven), atorvastatina (Lipitor, en Caduet), carbamazepina (Carbatrol, Equetro, Tegretol, otros), ciclosporina (Gengraf, Neoral, Sandimmune), medicamentos para la diabetes como insulina, lovastatina (Altoprev, en Advicor), simvastatina (Zocor, en Vytorin), o tacrolimus (Astagraf, Prograf). Es posible que su mГ©dico deba cambiar las dosis de los medicamentos o supervisarle atentamente para saber si sufre efectos secundarios.
  • Informe a su mГ©dico si tiene porfiria (una enfermedad hereditaria de la sangre que puede provocar problemas de piel o del sistema nervioso), hemorragia vaginal inexplicable; cГЎncer; o enfermedades del corazГіn o enfermedades renales. Su mГ©dico probablemente le dirГЎ que no tome Lozana.
  • Informe a su mГ©dico si estГЎ amamantando. No amamante durante su tratamiento con Lozana.
  • Informe a su mГ©dico si padece o alguna vez ha padecido de migraГ±as o dolores de cabeza, epilepsia (convulsiones), diabetes; hipoparatiroidismo (una condiciГіn en la que el cuerpo no produce suficiente hormona paratiroidea), hipertensiГіn arterial, o cualquier trastorno de la sangre.

What is Lozana (Danocrine)?

Lozana is also used to treat attacks of hereditary angioedema (an immune system disorder).

Lozana may also be used for purposes not listed in this medication guide.

Endometriosis

Lozana capsules are indicated for the treatment of endometriosis amenable to hormonal management.

CONTRAINDICATIONS

Lozana capsules should not be administered to patients with:

  1. Undiagnosed abnormal genital bleeding.
  2. Markedly impaired hepatic, renal, or cardiac function.
  3. Pregnancy (see WARNINGS).
  4. Breast feeding.
  5. Porphyria-Lozana capsules can induce ALA synthetase activity and hence porphyrin metabolism.
  6. Androgen-dependent tumor.
  7. Active thrombosis or thromboembolic disease and history of such events.
  8. Hypersensitivity to Lozana.

Keeping track

You should visit your gynaecologist about six to eight weeks after beginning treatment with Lozana to discuss how the treatment is progressing. Contact your gynaecologist if you have any problems between scheduled visits.

Lozana Dosage

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Women who take Lozana to treat endometriosis or fibrocystic breast disease should start the medication during a menstrual period.

Lozana is usually given for 6 to 9 months to treat fibrocystic breast disease or endometriosis. To prevent attacks of hereditary angioedema, you may need to use the medication long-term. Follow your doctor's instructions.

Your doctor may occasionally change your dose to make sure you get the best results.

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.

Use Lozana regularly to get the most benefit. Try not to miss any doses. Get your prescription refilled before you run out of medicine completely.

While using Lozana, you may need blood tests at your doctor's office. Visit your doctor regularly.

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.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Lozana.

Store at room temperature away from moisture and heat.

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

An overdose of Lozana 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.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Call your doctor for instructions if you have missed doses for more than 2 days in a row.

Copyright 1996-2019 Cerner Multum, Inc.

Latest Update: 11/9/2018, Version: 2.02

Mechanism of action

Use of Lozana therapy in IMHA is based upon the following reported actions of the drug.

Downregulation of Fc-receptor expression by macrophages, thereby decreasing extravascular hemolysis mediated by erythrocyte-bound antibody.

Reduced number of immunoglobulin molecules coating erythrocytes.

Alteration of T-lymphocyte immunoregulation.

Incorporation of the drug into the erythrocyte membrane, stabilizing the membrane so the erythrocyte becomes less susceptible to hemolysis.

Formulations and dose rates

Lozana (Danocrine®; 50, 100 or 200 mg capsules; Winthrop Pharmaceuticals) is not a licensed veterinary product.

Lozana is reported to have a slow onset of action (2–3 weeks), so is administered at a dose of 3–5 mg/kg q.8 h PO, concurrently with prednisolone (and/or azathioprine). Following tapering of the prednisolone dose, Lozana therapy is continued at 5 mg/kg q.24 h. Lozana may then be tapered after 2–3 months of normal hemograms.

Lozana therapy is suitable for dogs with chronic, stable IMHA but not those animals with acute-onset, severe hemolysis.

What is the most important information I should know about Lozana (Danocrine)?

You should not use this medicine if you have: undiagnosed vaginal bleeding, porphyria, severe liver or kidney disease, severe heart problems, or if you have ever had a stroke or blood clot, or cancer of the breast, uterus/cervix, or vagina.

Do not use if you are pregnant. Use effective birth control, and tell your doctor if you become pregnant.

Do not breast-feed while using this medicine.

DESCRIPTION

Lozana is a synthetic steroid derived from ethisterone. It is a white to pale yellow crystalline powder, practically insoluble or insoluble in water, and sparingly soluble in alcohol. Chemically, Lozana is 17α-Pregna-2,4-dien-20-yno -isoxazol-17-ol. The molecular formula is C22H27NO2. It has a molecular weight of 337.46 and the following structural formula:

Lozana capsules for oral administration contain 50 mg, 100 mg or 200 mg Lozana.

Lozana

Lozana was introduced in 1971 by Greenblatt and co-workers, who suggested it may have a role in mastalgia. 96 This agent, like bromocriptine, is unique in its action on the pituitary–ovarian axis. It was originally described as an impeded androgen and in monkeys it was shown to act as an antigonadotrophin, as it depressed serum follicle-stimulating hormone (FSH) and luteinizing hormone (LH) and prevented ovulation. Its action in humans is not so clearly defined because it only interferes with FSH and LH levels at high dosage. It may have a local tissue effect as it has been shown to bind to both progesterone and androgen receptors but not to oestrogen receptors.

Greenblatt's group initially used the drug for treating endometriosis but a number of papers soon followed from the same group showing the usefulness of Lozana in painful nodular breast disease. 97,98 All these reports were of uncontrolled studies and appeared to be cumulative, and were thus open to the criticisms of lack of placebo control. We therefore carried out a double-blind, placebo study in the Cardiff Mastalgia Clinic on 28 patients with cyclical mastalgia, using a detailed protocol similar to that described earlier. 99 This study showed that Lozana was clearly beneficial in cyclical mastalgia, producing both relief of symptoms and reduction in nodularity, and these effects could be obtained with doses as low as 200 mg. The lower dose gave much lower side effects, and only a 10% dropout rate was recorded in the trial.

The hormonal effects of Lozana treatment were a low luteal progesterone (suggesting anovulation) and an unchanged prolactin, so it appears the drug is working on the ovary or pituitary although only 30% of these patients were amenorrhoeic on the drug. The side effects are mainly amenorrhoea, the incidence of which increases with dose up to 100% at 600–800 mg, and various mild androgenic effects such as weight gain, acne and hirsutism. All of these effects are dose related and can be minimized by low-dose therapy. 100 Our current practice is to start at 200 mg daily and then use a maintenance dose of 100 mg daily on alternate days.

In our experience, of 295 patients treated with Lozana, 88 (30%) complained of significant adverse events and 43 had to stop treatment. However, many of these were before we had developed the low-dose regimen. A recently reported side effect has been a lowering of the voice pitch which has been permanent in a small number of cases, but our experience is that only 5% of patients notice this symptom and it is generally reversible on stopping the drug. Lozana currently appears to be the best agent for severe breast pain and nodularity with an overall improvement rate of 70% in our total group of 295 treated patients.

Another double-blind, controlled study from Nottingham reported that Lozana was superior to bromocriptine for cyclical breast pain. 101 A paper reporting the experience of a Brisbane mastalgia clinic also confirmed the efficacy of Lozana in practice, with an overall success rate of 67% compared with the rates of 30–40% for other agents. 73

Both Peters 102 and Stein et al. 103 showed a significant benefit from the somewhat similar agent gestrinone, which has androgenic, antioestrogenic and antiprogestogenic properties, and some androgenic side effects. Both double-blind, randomized, placebo-controlled studies used 2.5 mg twice weekly for 3 months, with benefits and side effects similar to Lozana. The lower dosage necessary has potential advantages regarding side effects, but the drug does not yet have the benefit of the extensive and prolonged experience with Lozana.

What other drugs will affect Lozana (Danocrine)?

Tell your doctor about all other medicines you use, especially:

This list is not complete. Other drugs may affect Lozana, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

How to use Lozana

Take this medication by mouth, usually twice daily or as directed by your doctor. You may take this medication with or without food, but it is important to choose one way and take this medication the same way with every dose.

The dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Tell your doctor if your condition does not improve or if it worsens.

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

You should not use this medication if you are allergic to Lozana, 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 Lozana 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.

Lozana 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 Lozana.

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).

Where can I get more information?

Your pharmacist can provide more information about Lozana.


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