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Overview

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This medicine contains an important and useful components, as it consists of
Dimethyl sulphoxide, Fluorouracil, Salicylic acidis available in the market in concentration

Name

Leuprolide acetate

Precaution

Before initiating treatment with **Leuprolide Acetate**, it is essential for patients to consult with their healthcare provider, especially if they have any of the following conditions: - **Pregnancy**: Leuprolide should not be used during pregnancy due to the potential risk of **harm to the fetus**. If a patient becomes pregnant while receiving this treatment, it is important to discontinue the medication immediately and consult a healthcare provider. - **Breastfeeding**: Leuprolide is not recommended during breastfeeding, as it may affect milk production or be excreted into breast milk. - **Bone Health**: Long-term use of Leuprolide can lead to decreased bone mineral density, increasing the risk of **osteoporosis** or bone fractures. Patients should be monitored for **bone health**, and preventive measures (e.g., calcium and vitamin D supplementation) may be recommended. - **Heart Conditions**: Leuprolide may affect the cardiovascular system, leading to **hot flashes**, **palpitations**, or **arrhythmias**. It should be used cautiously in patients with existing **heart disease**. - **Liver or Kidney Dysfunction**: In patients with **liver or kidney disease**, dose adjustments may be necessary, as these organs are involved in metabolizing and clearing the drug. - **Psychiatric Disorders**: Leuprolide may affect mood and cause **depression**, **anxiety**, or **irritability**. Monitoring for mental health changes is advised during treatment. - **Hypersensitivity**: Patients with a history of **allergic reactions** to leuprolide or other components of the medication should avoid its use.

Indication

Leuprolide Acetate is a **gonadotropin-releasing hormone (GnRH) agonist** used to treat several conditions related to hormone-sensitive processes, including: - **Prostate Cancer**: Leuprolide is used to treat **advanced prostate cancer** by reducing testosterone levels, which are necessary for the growth of cancer cells. - **Endometriosis**: It is used to treat **endometriosis** by reducing estrogen production, which helps to shrink endometrial tissue and relieve pain. - **Uterine Fibroids**: Leuprolide can be used in the short-term treatment of **symptomatic uterine fibroids**, reducing the size of fibroids and controlling symptoms like bleeding and pelvic pressure. - **Precocious Puberty**: Leuprolide is used to treat **precocious puberty** in children by delaying the onset of puberty until an appropriate age. - **Ovarian Stimulation**: In assisted reproductive technology (ART) like **in vitro fertilization (IVF)**, Leuprolide is used to **suppress premature ovulation** and control ovarian function. Leuprolide works by lowering the levels of **sex hormones** (testosterone in men and estrogen in women), helping to manage hormone-related diseases.

Contra indication

Leuprolide should be avoided or used with extreme caution in the following conditions: - **Pregnancy**: Leuprolide is contraindicated during pregnancy due to potential harm to the developing fetus. Effective contraception should be used during treatment. - **Hypersensitivity**: Individuals with known **hypersensitivity** or **allergic reactions** to leuprolide or any components of the formulation should not use this medication. - **Severe Liver Disease**: Caution is required in patients with severe liver dysfunction, as this may affect the metabolism of the drug. - **Breastfeeding**: Leuprolide should not be used during breastfeeding due to potential effects on milk production and infant health. - **Prostate Cancer with Bone Metastasis**: Caution is advised when using Leuprolide in patients with **advanced prostate cancer with bone metastasis** as the drug may accelerate bone loss, leading to complications.

Side Effect

The use of **Leuprolide Acetate** can cause a range of side effects, some of which may require medical attention. These include: - **Hot Flashes**: A common side effect due to reduced estrogen levels, especially in women, leading to feelings of warmth, sweating, and flushed skin. - **Headache**: Many patients experience **headaches**, especially in the early stages of treatment. - **Injection Site Reactions**: Redness, swelling, or pain at the injection site may occur. - **Mood Changes**: Leuprolide can cause changes in mood, including **depression**, **irritability**, or **anxiety**. Mental health monitoring is recommended during therapy. - **Bone Loss**: Long-term use of Leuprolide can lead to decreased **bone mineral density** and an increased risk of fractures, especially in women with **endometriosis** or those undergoing treatment for **breast cancer**. - **Fatigue**: Some patients report feeling unusually **tired** or lethargic during treatment. - **Ovarian Cysts**: In some women, ovarian cysts may develop, though these are usually benign. - **Nausea and Vomiting**: Some patients may experience gastrointestinal discomfort, including nausea and vomiting. - **Sexual Dysfunction**: Leuprolide can lead to **decreased libido**, **erectile dysfunction**, or **amenorrhea** in both men and women. Serious side effects include: - **Severe Allergic Reactions**: Symptoms such as **rash**, **swelling of the face or throat**, **difficulty breathing**, or **dizziness** should prompt immediate discontinuation of the drug and medical attention. - **Severe Bone Pain**: Patients with prostate cancer may experience **bone pain**, which may worsen with treatment.

Pregnancy Category ID

5

Mode of Action

Leuprolide Acetate is a **GnRH agonist** that works by initially stimulating the **pituitary gland** to produce an increase in **luteinizing hormone (LH)** and **follicle-stimulating hormone (FSH)**. Over time, however, continuous administration of Leuprolide causes a **downregulation** of the GnRH receptors in the pituitary gland, resulting in a **decrease in LH and FSH** secretion. This suppresses the production of **sex hormones** (testosterone in men and estrogen in women). - In men, this leads to a reduction in **testosterone** levels, which can shrink **prostate tumors**. - In women, it decreases **estrogen** levels, helping to manage **endometriosis**, **uterine fibroids**, and certain types of **breast cancer**. Leuprolide also effectively prevents **precocious puberty** in children by delaying the onset of puberty.

Interaction

Leuprolide can interact with several other medications and substances, which may alter its effectiveness or cause adverse effects. Key interactions include: - **Hormonal Medications**: Combining Leuprolide with other hormonal therapies, such as **oral contraceptives**, **estrogen**, or **progestin**, may interfere with the efficacy of the treatment, leading to unpredictable outcomes. - **Antidiabetic Drugs**: Leuprolide may affect **glucose metabolism**, increasing blood sugar levels. If used in combination with **insulin** or **oral hypoglycemic agents**, adjustments to the diabetes treatment regimen may be necessary. - **CYP3A4 Inhibitors**: Drugs that inhibit **CYP3A4**, such as **ketoconazole** or **itraconazole**, may increase the levels of leuprolide, raising the potential for side effects. - **Other GnRH Agonists/Antagonists**: Caution should be taken when combining Leuprolide with other **GnRH**-based therapies or treatments that suppress sex hormones, as this may result in **hormonal imbalances**. - **Tamoxifen**: In patients undergoing treatment for **breast cancer**, combining Leuprolide with **tamoxifen** (an estrogen receptor modulator) may have additive effects on reducing estrogen, potentially leading to more severe side effects.

Pregnancy Category Note

Information not available

Adult Dose

The dosage of **Leuprolide Acetate** varies depending on the condition being treated. Below are typical dosage ranges: - **Prostate Cancer**: 7.5 mg via intramuscular (IM) injection once a month or 22.5 mg every 3 months. - **Endometriosis**: 3.75 mg via IM or subcutaneous (SC) injection once a month, or 11.25 mg every 3 months. - **Uterine Fibroids**: 3.75 mg IM or SC injection once a month, or 11.25 mg every 3 months. - **Precocious Puberty**: 3.75 mg IM or SC injection every 4 weeks. The dosing may vary depending on the specific formulation used (e.g., **depot injections** or **implant**).

Child Dose

For children with **precocious puberty**, the typical dose of **Leuprolide Acetate** is: - **3.75 mg IM or SC** injection every 4 weeks. The dosage can be adjusted based on the child’s weight and the response to treatment. Pediatric patients should be carefully monitored for side effects, especially **growth** and **pubertal changes**.

Renal Dose

No specific dose adjustments are necessary for patients with **renal impairment**. However, renal function should be monitored regularly, especially in patients who have significant kidney dysfunction. Leuprolide's elimination is not significantly affected by kidney function.

Administration

Information not available