Gestodene

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Gestodene API

 

Haorui supplies high quality Gestodene API produced by our GMP facility that has been successfully inspected by the FDA. We offer competitive prices and support our products with reliable technical and regulatory services.  Gestodene API is available from R&D to commercial quantities. Please contact us for more details.

 

  The following information is provided for general information purposes ONLY.

 

What is Gestodene?

Gestodene may increase the chances of developing blood clots or cancers such as breast or cervical cancer. However, it may provide some protection against ovarian and endometrial cancer. You and your prescriber will need to weigh up the risks and benefits of taking Gestodene.

Hormonal contraceptives will only prevent a pregnancy if they are taken regularly. It is important you take this medicine at the same time each day. If you want immediate contraceptive cover then start to take Gestodene on the first day of your menstrual period. If you do not start taking Gestodene on the first day of your menstrual period you will need to take extra contraceptive precautions for at least seven days until Gestodene starts to work. For more information about starting Gestodene and if you need to take extra contraceptive precautions ask your prescriber, family planning nurse or read the patient information leaflet that comes with your medicine.

Once you have started to take Gestodene, you should take it once a day for 21 days. After this you should not take any more tablets for the next seven days. Start a new strip of Gestodene immediately after the seven day tablet-free break. During this break you will usually have a withdrawal bleed. If you do not have a withdrawal bleed during the tablet-free break and you have taken all your pills properly, you are very unlikely to be pregnant. But, if you miss two withdrawal bleeds in a row you should immediately contact your prescriber or family planning nurse. This is because there is a possibility that you could be pregnant and you must not take Gestodene during pregnancy.

In certain situations the effectiveness of Gestodene may be reduced and you will need to take extra contraceptive precautions. These situations include: missing a dose by more than 12 hours; taking other medicines that interact with Gestodene; having diarrhea, vomiting or any medical condition which interferes with the absorption of your medicine. If any of these situations occur during the last seven days of your tablet strip you should not have a tablet-free break between strips of tablets. Start taking the next strip of tablets without a break.

As there is no gap between strips you will not have a withdrawal bleed at the end of the first strip. But you may have some menstrual bleeding while you are taking the second strip and you should have a withdrawal bleed once you finish the second strip. For more information about situations when the effectiveness of Gestodene may be reduced and when to take additional contraceptive precautions ask your prescriber, family planning nurse or read the patient information leaflet that comes with your medicine.

Other information about Gestodene:

bullet you may have light and irregular periods or no periods at all when you stop taking Gestodene

 

 

How does Gestodene work?

Gestodene contains two hormones that are similar to the hormones estrogen and progesterone that are produced by the body. Gestodene comes in a strip of 21 tablets. Each strip contains three types of tablets– six beige, five dark brown and ten white tablets. These tablets contain different amounts of estrogen and progestogen. Gestodene is used to prevent women from becoming pregnant. It works by preventing the release of eggs from the ovary and changes the lining of the uterus which makes it difficult for an egg to develop. It also increases the thickness of vaginal fluid which can stop a sperm from reaching an egg.

 

 

Who should not use Gestodene?

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

bullet are allergic or sensitive to or have had a reaction to any of the ingredients in the medicine
bullet are obese
bullet are pregnant or think you may be pregnant
bullet have a bleed in the brain
bullet have a movement disorder
bullet have a problem such as otosclerosis that became worse during pregnancy or after taking oral contraceptives
bullet have an inflammatory bowel disease such as Crohn's disease or ulcerative colitis
bullet have asthma
bullet have blood problems
bullet have cardiovascular problems
bullet have chloasma
bullet have diabetes or have risk factors for developing diabetes
bullet have epilepsy
bullet have gallstones
bullet have had certain problems during pregnancy such as jaundice, rashes or itching
bullet have high blood pressure
bullet have kidney problems
bullet have lupus or a lupus-like problem
bullet have metabolic problems
bullet have migraines
bullet have multiple sclerosis
bullet have or have had benign breast disease, breast cancer or a family history of breast cancer
bullet have or have had depression
bullet have or have had endometrial cancer
bullet have or have had liver problems such as jaundice or liver tumors
bullet have or have had phlebitis
bullet have otosclerosis
bullet have porphyria
bullet have risk factors for developing blood clots such as smoking, having a personal or family history of blood clots, being over 35 years of age, being immobile for a long period of time, having thrombophlebitis, having problems with blood clotting, have had recent surgery or trauma, are about to have surgery or have given birth in the last six to eight weeks
bullet have sickle cell anaemia
bullet have tetany
bullet have uterine problems such as fibroids
bullet have vaginal bleeding and the cause of the bleeding is not known
bullet have varicose veins
bullet wear contact lenses

 

How should I use Gestodene?

Hormonal contraceptives will only prevent a pregnancy if they are taken regularly. It is important you take this medicine at the same time each day. When you first start to take Gestodene you may need to take extra contraceptive precautions until it starts to work. You may also need to take extra contraceptive precautions in certain situations. These situations include missing a dose by more than 12 hours or vomiting within three to four hours of taking Gestodene. Ask your prescriber, family planning nurse or read the patient information leaflet that comes with your medicine for more information about when to take additional contraceptive precautions.

Other information about Gestodene:

bullet for information about when you should start to take this medicine you should ask your prescriber, pharmacist or read the patient information leaflet that comes with your medicine
bullet you should start a new pack the day after you finish the current one. Do not have a break between packs

 

What happens if I miss a Gestodene dose?

Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. You may also need to take extra contraceptive precautions.

 

What happens if I overdose?

There have been no reports of serious deleterious effects from overdose. Symptoms that may occur in this case are nausea, vomiting and, in young girls, slight vaginal bleeding. There are no antidotes and further treatment should be symptomatic.

 

What should I avoid while using Gestodene?

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

bullet Possibly Pregnant
bullet Severe disturbances of liver function, jaundice or persistent itching during a previous pregnancy, Dubin-Johnson syndrome, Rotor syndrome, previous or existing liver tumors.
bullet History of confirmed venous thromboembolism (VTE). Family history of idiopathic VTE. Other known risk factors for VTE.
bullet Existing or previous arterial thrombotic or embolic processes, conditions which predispose to them e.g. disorders of the clotting processes, valvular heart disease and atrial fibrillation.
bullet Sickle-cell anemia.
bullet Mammary or endometrial carcinoma, or a history of these conditions.
bullet Severe diabetes mellitus with vascular changes.
bullet Disorders of lipid metabolism.
bullet History of herpes gestationis.
bullet Deterioration of otosclerosis during pregnancy.
bullet Undiagnosed abnormal vaginal bleeding.
bullet Hypersensitivity to any of the components of Gestodene.

 

What are the possible side effects of Gestodene?

The frequency of these side-effects is unknown

bullet breast tenderness
bullet cervical cancer - this has been reported in women who have taken combined estrogen and progestogen contraceptives for a long period of time
bullet changes in libido
bullet changes to menstruation or bleeding patterns such as lighter menstrual periods, irregular spotting or bleeding in between menstrual periods, irregular menstrual periods or not having a menstrual period at all. Seek immediate medical advice if you do not have two withdrawal bleeds in a row or if you have any spotting or bleeding in between menstrual periods after taking Gestodene for some time
bullet changes to weight
bullet changes to your awareness - seek immediate medical advice if you suddenly develop hearing or eye problems
bullet chloasma - this may be worsened if you expose your skin to sunlight. If you are prone to chloasma do not expose your skin to sunlight while taking Gestodene
bullet depressed mood
bullet epilepsy - you or your carer must seek immediate medical advice if you have seizures more often
bullet headaches– seek immediate medical advice if you have an unusually bad headache or if your headaches occur more often
bullet intolerance to contact lenses - seek medical advice if you develop an intolerance to wearing contact lenses
bullet liver problems such as liver tumors - some liver tumors may be life-threatening. Seek medical advice if you develop jaundice, itching or if you have pain or discomfort in the upper part of your stomach
bullet may affect the results for certain tests
bullet migraine– seek immediate medical advice if you get a migraine-type headache for the first time or if your migraine-type headaches become worse
bullet nausea
bullet reduced glucose tolerance  - people with diabetes may be advised to adjust their anti-diabetic therapy
bullet some conditions may occur for the first time or get worse during treatment with Gestodene. If any of these happen to you, seek medical advice. Examples include: diabetes, raised blood pressure, varicose veins, phlebitis, otosclerosis, multiple sclerosis, depression, porphyria, tetany, chorea, kidney problems, obesity, systemic lupus erythematosus, fibroids in the uterus, gall-stones, heart and circulation problems, asthma, breast cancer or other breast problems
bullet stomach upsets such as diarrhea or vomiting - if you have diarrhea or vomiting after taking Gestodene you may need to take extra contraceptive precautions. For more information speak to your prescriber, family planning nurse or read the patient information leaflet that comes with this medicine
bullet thromboembolic problems such as heart attacks, strokes, deep vein thromboses or pulmonary embolisms - some of these problems may be fatal. Seek immediate medical advice if you have feelings of pain and tightness in the chest, pain on breathing or coughing, painful or swollen legs

Hormonal contraceptives may also increase the chances of developing breast cancer. You and your prescriber will need to weigh up the benefits and risks of taking Gestodene before you start to take it. Women who take Gestodene need to regularly examine their breasts for any changes or lumps.

 

 

What other drugs will affect Gestodene?

The following medicines may interact with Gestodene:

bullet carbamazepine
bullet griseofulvin
bullet phenobarbital
bullet phenylbutazone
bullet phenytoin
bullet primidone
bullet rifampicin

The following types of medicine may interact with Gestodene:

bullet antibiotics
bullet barbiturates
bullet liver enzyme inducers

 

 

Where can I get more information?

If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

 

Gestodene Storage

Gestodene does not require any special storage conditions.

 

Nursing Mothers use of Gestodene

The use of Gestodene during lactation may lead to a reduction in the volume of milk produced and to a change in its composition. Minute amounts of the active substances are excreted with the milk. Mothers who are breast-feeding may be advised instead to use a progestogen-only pill.

 

Pregnancy and use of Gestodene

If pregnancy occurs during medication with oral contraceptives, the preparation should be withdrawn immediately. Pregnancy is a reason for stopping immediately because it has been suggested by some investigations that oral contraceptives taken in early pregnancy may slightly increase the risk of fetal malformations. Other investigations have failed to support these findings. The possibility therefore cannot be excluded, but it is certain that if a risk exists at all, it is very small.

 

Disclaimer:

 

Information on this page is provided for general information purposes. You should not make a clinical treatment decision based on information contained in this page without consulting other references including the package insert of the drug, textbooks and where relevant, expert opinion. We cannot be held responsible for any errors you make in administering drugs mentioned on this page, nor for use of any erroneous information contained on this page.    

 

 

 

 

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