THROMBO AS 75 mg Price

Overview

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This medicine contains an important and useful components, as it consists of
Acetylsalicylic acid is available in the market in concentration

Name

Duloxetine

Precaution

Duloxetine is a **serotonin-norepinephrine reuptake inhibitor (SNRI)** primarily used for the treatment of **major depressive disorder (MDD)**, **generalized anxiety disorder (GAD)**, **fibromyalgia**, and **neuropathic pain**. While effective, it should be used with caution in certain populations. For **pregnant women**, Duloxetine is categorized as a **category C drug**, meaning there is limited data on its safety, and it should be used only when the potential benefits outweigh the risks. It may be excreted into breast milk, so caution is advised when administered to breastfeeding women. Patients with **hepatic impairment**, particularly those with **liver cirrhosis** or **active liver disease**, should avoid Duloxetine, as it is extensively metabolized in the liver and can lead to increased plasma concentrations, increasing the risk of toxicity. Additionally, **renal impairment** requires careful consideration, as Duloxetine is partially eliminated by the kidneys, and dose adjustment may be necessary in patients with severe renal dysfunction. Patients with a history of **manic episodes**, **bipolar disorder**, or **severe depression** should be monitored closely, as SNRIs may increase the risk of **mania** or **hypomania**. **Hypertension** is a potential concern, as Duloxetine may increase blood pressure, particularly at higher doses, and blood pressure should be regularly monitored. Other precautions include a risk of **serotonin syndrome**, especially when combined with other serotonergic drugs (e.g., SSRIs, triptans, MAO inhibitors). Patients with **glaucoma**, **hyponatremia**, or **history of seizures** should be monitored carefully during treatment.

Indication

Duloxetine is approved for the treatment of several conditions, including **major depressive disorder (MDD)**, **generalized anxiety disorder (GAD)**, **fibromyalgia**, **neuropathic pain** (particularly **diabetic peripheral neuropathy** and **chronic musculoskeletal pain**), and **chronic low back pain**. It works by inhibiting the reuptake of serotonin and norepinephrine, which helps regulate mood and alleviate pain. The drug is also indicated in **stress urinary incontinence (SUI)** in certain countries, particularly in women, as it can improve bladder control by affecting the balance of neurotransmitters involved in muscle control. Off-label uses include its use in the treatment of **painful diabetic neuropathy**, **chronic fatigue syndrome**, and **vulvodynia**. Some studies have suggested its utility in treating **panic disorder** and **post-traumatic stress disorder (PTSD)**, but these uses are not universally accepted and require further evidence.

Contra indication

Duloxetine is contraindicated in patients with **hypersensitivity** to the drug or any of its components. It should not be used concurrently with **monoamine oxidase inhibitors (MAOIs)**, as this combination can lead to serious, potentially fatal reactions, such as **serotonin syndrome**. Patients should wait at least **14 days** after discontinuing an MAOI before starting Duloxetine, and vice versa. Additionally, **pregnant women** should avoid Duloxetine unless absolutely necessary, as the drug may harm the fetus, especially during the third trimester. It is also contraindicated in patients with **severe liver disease** (due to its hepatic metabolism) or **severe renal impairment** (e.g., **creatinine clearance <30 mL/min**). Patients with a history of **bipolar disorder** should be cautious, as Duloxetine can potentially trigger **manic or hypomanic episodes**. It should also be avoided in patients with **narrow-angle glaucoma** or a **history of seizures**, as the drug may exacerbate these conditions.

Side Effect

Common side effects of Duloxetine include: - **Nausea**: Often occurs at the start of treatment and usually resolves with continued use. - **Dry mouth**: A common anticholinergic effect. - **Drowsiness** or **fatigue**: May impair alertness and affect daily functioning. - **Dizziness**: Especially when standing up quickly, due to its potential blood pressure-lowering effects. - **Insomnia**: Sleep disturbances may occur, especially in the early phases of treatment. - **Sweating**: Increased sweating, particularly at higher doses, is a common side effect. Serious side effects, though less common, include: - **Serotonin syndrome**: Symptoms include agitation, hyperthermia, muscle rigidity, and changes in mental status. - **Suicidal thoughts**: Especially in adolescents and young adults. - **Hypertension**: A potential risk at higher doses, requiring monitoring of blood pressure. - **Liver toxicity**: Hepatotoxicity, especially in patients with pre-existing liver conditions. - **Hyponatremia**: Low sodium levels, particularly in elderly patients. If side effects persist or worsen, patients should consult their healthcare provider. In cases of severe reactions, such as serotonin syndrome or signs of liver toxicity (e.g., yellowing of the skin/eyes), immediate medical attention is necessary.

Pregnancy Category ID

3

Mode of Action

Duloxetine works as a **serotonin-norepinephrine reuptake inhibitor (SNRI)**. It primarily increases the levels of two neurotransmitters, **serotonin** and **norepinephrine**, by inhibiting their reuptake in the brain. This mechanism enhances neurotransmission in key areas of the brain involved in mood regulation, pain perception, and emotional processing, making it effective in treating depression, anxiety, and pain-related disorders. At **therapeutic doses**, Duloxetine selectively inhibits the reuptake of **serotonin** and **norepinephrine** while having minimal effect on **dopamine** reuptake. This action helps to balance neurotransmitter levels, which is believed to alleviate symptoms of depression and anxiety, as well as improve pain management in conditions like **fibromyalgia** and **neuropathic pain**. Pharmacokinetically, Duloxetine is **well-absorbed** after oral administration and is **metabolized in the liver** by the **CYP450 system** (mainly **CYP1A2** and **CYP2D6**). Its **half-life** is approximately **12 hours**, making it suitable for once-daily dosing. It is primarily excreted in the urine.

Interaction

Duloxetine has several clinically significant interactions with other medications. Co-administration with **monoamine oxidase inhibitors (MAOIs)** is contraindicated due to the risk of **serotonin syndrome**, a potentially life-threatening condition characterized by agitation, confusion, rapid heart rate, and high blood pressure. There should be a **14-day washout period** between discontinuing an MAOI and starting Duloxetine. When taken with **anticoagulants** (e.g., **warfarin**), Duloxetine may increase the risk of bleeding, particularly in patients with existing coagulopathy. Regular monitoring of **prothrombin time (PT)** and **international normalized ratio (INR)** is recommended. **Other serotonergic drugs** (e.g., **SSRIs**, **SNRIs**, **triptans**, **tramadol**) can also increase the risk of **serotonin syndrome**. **Alcohol** should be avoided during Duloxetine therapy, as it can enhance the sedative effects of the drug and increase the risk of **liver toxicity**. Patients taking **antihypertensives** should be monitored, as Duloxetine may cause a slight increase in blood pressure, particularly at higher doses. Additionally, Duloxetine may interact with **CYP450 enzyme inhibitors** or **inducers**, affecting the metabolism of both Duloxetine and other medications.

Pregnancy Category Note

Information not available

Adult Dose

For **major depressive disorder** and **generalized anxiety disorder**, the typical starting dose of Duloxetine is **30 mg daily**, which can be increased to **60 mg daily** after one week, depending on the patient’s response and tolerance. The maximum recommended dose is **120 mg per day**, but higher doses are not commonly used due to an increased risk of side effects. For **neuropathic pain**, the usual dose is **60 mg daily**, with potential increases to **120 mg daily**. In **fibromyalgia** treatment, a starting dose of **30 mg daily** is often used, with increases based on therapeutic response. It is best to take Duloxetine with food to minimize gastrointestinal side effects, and it should be swallowed whole (not crushed or chewed).

Child Dose

Duloxetine is **not approved** for use in children under the age of 18 for any condition. The safety and efficacy of Duloxetine in pediatric patients have not been established, and its use in this population could increase the risk of adverse effects such as **suicidal thoughts** and **behavioral changes**. In specific cases, pediatric use may be considered on a case-by-case basis under close medical supervision.

Renal Dose

Duloxetine should be used with caution in patients with **renal impairment**. For patients with **creatinine clearance ≥30 mL/min**, no dose adjustment is generally required, but caution is advised. For those with **severe renal impairment (creatinine clearance <30 mL/min)**, Duloxetine is generally contraindicated due to an increased risk of accumulation and potential toxicity. Close monitoring of **renal function** is recommended during treatment, especially if there are any signs of **kidney dysfunction** or if the patient is on **diuretics** or other drugs that affect renal function.

Administration

Information not available