简介:
部份中文昂斯妥凝膠处方资料(仅供参考)
睾酮素凝胶1%为一睾酮素置换疗法,适应症为先天及后天的内生睾酮素缺乏症。
英文藥名:Androgel gel
中文藥名:昂斯妥凝膠
廠商名稱:友華生技
成分及含量:Testosterone 50mg/5g /包
衛署適應症:經臨床徵象及實驗室檢驗確認因睪固酮缺乏之男性生殖腺功能不足症的替代療法。
藥理作用:
睪固酮不導致睪丸的發育,其可降低腦下垂體性腺激素的分泌 。
用法用量:
每天推薦劑量是一天一次於相同時間使用5g gel,使用時間已早晨較佳,但每天不得超過10g。塗抹於乾淨且乾燥之無傷口肩部、手臂或腹部,不可將Androgel gel直接塗抹於生殖器,使用後應以肥皂和水洗手。
副作用:
紅斑、皮膚乾燥、乳房疼痛。
注意事項:
1.下列患者不得使用:患有乳癌及已知或懷疑有攝護腺癌的男性、對睪固酮或凝膠內其他任何成份過敏者。
2.使用Androgel 可能導致有或無鬱血性心臟衰竭之水腫的嚴重併發症,患有心、腎或肝疾病者應立刻停藥。
AndrogelGeneric Name: testosterone (Topical application route)
tes-TOS-ter-one
Topical application routeGel/Jelly
Secondary Exposure to Testosterone
Virilization has been reported in children who were secondarily exposed to testosterone gel
Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel
Healthcare providers should advise patients to strictly adhere to recommended instructions for use
Virilization has been reported in children who were secondarily exposed to testosterone gel. Healthcare providers should advise patients to strictly adhere to instructions for use and ensure that children avoid contact with unwashed or unclothed testosterone application sites .
Commonly used brand name(s):
In the U.S.
Androgel
First-Testosterone
First-Testosterone MC
Testim
Available Dosage Forms:
Gel/Jelly
Kit
Therapeutic Class: Endocrine-Metabolic Agent
Pharmacologic Class: Androgen
Uses For Androgel
Testosterone is used for the treatment of males whose bodies do not make enough natural testosterone, a condition called hypogonadism. Testosterone is a male hormone responsible for the growth and development of the male sex organs and maintenance of secondary sex characteristics.
This medicine is available only with your doctor's prescription.
Before Using Androgel
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of testosterone in children. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of testosterone in the elderly. However, elderly patients may be at an increased risk for developing heart and blood vessel problems, or prostate problems (including prostate cancer), which may require caution in patients receiving testosterone.
Pregnancy
Pregnancy Category |
Explanation |
All Trimesters |
X |
Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit. |
Breast Feeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Anisindione
Bupropion
Dicumarol
Paclitaxel
Paclitaxel Protein-Bound
Phenprocoumon
Warfarin
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Licorice
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Breast cancer (males) or
Prostate cancer, known or suspected—Should not be used in patients with these conditions.
Diabetes or
Enlarged prostate or
Lung disease or breathing problems (e.g., sleep apnea) or
Problems with passing urine—Use with caution. May make these conditions worse.
Heart disease or
Kidney disease or
Liver disease—Use with caution. Testosterone may cause edema (fluid retention) in patients with these conditions.
Proper Use of testosterone
This section provides information on the proper use of a number of products that contain testosterone. It may not be specific to Androgel. Please read with care.
This medicine comes with a medication guide and patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
This medicine is available in two forms: individual packets or multi-dose pump. If you are using the pump gel for the first time, prime the pump before measuring out your first dose. Hold the pump over a sink and press the pump all the way down at least 3 times or until the gel begins to flow freely. Rinse the medicine discarded into the sink down the drain. Place the palm of your hand under the pump and press the pump the proper number of times to measure out your correct dose.
If you are using the gel in foil packets, tear the packet completely open along the perforation. Squeeze the entire contents directly onto the skin where you will apply the gel. You may also empty the packet into the palm of your hand and then apply the medicine. Throw away the empty foil packet in a place where children and pets cannot reach it.
To use the gel:
Make sure that you wash your hands with soap and water before and after applying the gel.
Apply the gel to a clean, dry, intact skin of the shoulders, upper arms, or stomach (unless your doctor tells you to use it on another part of your body). Do not apply this medicine to your scrotum or your penis. Do not use the medicine on skin that has a cut, scrape, or other type of injury.
Allow the gel to dry on your skin before you cover it with clothing.
The gel form can be transferred to another person if they touch or rub the skin where the gel was placed or if some of the gel remains on your hands. To keep this from happening, wash your hands again after applying the gel. Also, wash the area where you applied the gel with soap and water if you expect to have a skin-to-skin contact with another person.
This medicine may be flammable. Do not use it near heat, an open flame, or while smoking.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For topical dosage form (gel):
For hormone replacement:
Adults—At first, apply 5 grams to a clean, dry, intact skin once a day (usually in the morning). Your doctor may increase your dose as needed, up to a maximum dose of 10 grams.
Children—Use and dose must be determined by your doctor.
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