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0.5% W/V METRONIDAZOLE INJECTION USP Price

Active Substance: Metronidazole.

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Overview

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

Name

Metronidazole

Precaution

Before using **Metronidazole**, it is important for patients to consult their healthcare provider to evaluate their specific medical conditions and potential interactions. Key precautions include: - **Alcohol Consumption**: Patients must avoid consuming **alcohol** during treatment with Metronidazole and for at least 48 hours after completing the medication. Alcohol can trigger a **disulfiram-like reaction**, leading to symptoms like **flushing**, **nausea**, **vomiting**, and **headache**. - **Liver Disease**: Caution is necessary for individuals with **liver impairment** or **hepatic disease**, as Metronidazole is metabolized by the liver. In such cases, dosage adjustments may be required, and liver function should be closely monitored. - **Neurological Effects**: Metronidazole can cause neurological side effects, including **seizures**, **dizziness**, or **confusion**, particularly with prolonged use or high doses. Patients with **central nervous system (CNS)** disorders should use this drug with caution. - **Pregnancy and Breastfeeding**: Metronidazole is classified as **Category B** for pregnancy, meaning it is generally considered safe but should be used only if the benefits outweigh the risks. It can pass into breast milk, so caution is advised in breastfeeding women, and consultation with a healthcare provider is essential. - **Blood Disorders**: Metronidazole may cause **leukopenia** (low white blood cell count) or **thrombocytopenia** (low platelet count), particularly with prolonged use. Blood counts should be monitored during treatment, especially in patients receiving long-term therapy.

Indication

**Metronidazole** is an antibiotic and antiprotozoal medication commonly prescribed to treat a variety of infections caused by anaerobic bacteria and certain protozoa: - **Bacterial Infections**: Metronidazole is effective against anaerobic bacterial infections, such as **bacterial vaginosis**, **pelvic inflammatory disease (PID)**, **intra-abdominal infections** (e.g., diverticulitis, appendicitis), and **skin infections**. - **Protozoal Infections**: It is used to treat **protozoal infections** like **trichomoniasis** (a sexually transmitted infection caused by *Trichomonas vaginalis*), **amebiasis** (caused by *Entamoeba histolytica*), and **giardiasis** (a parasitic infection caused by *Giardia lamblia*). - **Clostridium difficile-associated Diarrhea**: Metronidazole is sometimes used as part of the treatment regimen for **Clostridium difficile** infections that cause severe diarrhea. - **Helicobacter pylori Eradication**: It is used in combination with other antibiotics to eradicate **Helicobacter pylori** in patients with **peptic ulcers**. - **Surgical Prophylaxis**: Metronidazole is used in certain surgeries, particularly those involving the abdominal area, to prevent anaerobic infections.

Contra indication

Metronidazole should not be used in the following situations: - **Hypersensitivity**: It is contraindicated in patients who have a known **hypersensitivity** or **allergy** to **Metronidazole** or any of its components. - **First Trimester of Pregnancy**: Although generally safe during pregnancy, Metronidazole should be avoided during the **first trimester** unless absolutely necessary. Consultation with a healthcare provider is critical in this case. - **Alcohol Use**: **Alcohol consumption** during Metronidazole therapy is contraindicated due to the risk of a **disulfiram-like reaction**. - **Severe Liver Disease**: Patients with **severe liver impairment** should avoid Metronidazole or use it only with close monitoring and dosage adjustments. - **Central Nervous System Disorders**: Patients with a history of **seizures** or other **neurological disorders** may be contraindicated for Metronidazole therapy due to its potential to cause **neurological side effects**.

Side Effect

Metronidazole is generally well tolerated, but it can cause side effects, some of which may be severe: - **Gastrointestinal Distress**: The most common side effects include **nausea**, **vomiting**, **diarrhea**, and **metallic taste**. These effects are usually mild and resolve after completing the course of therapy. - **Neurological Effects**: Rarely, Metronidazole can cause **seizures**, **dizziness**, **headache**, and **peripheral neuropathy** (tingling or numbness in the hands or feet). These symptoms are more likely with prolonged use or high doses. - **Allergic Reactions**: Some patients may develop **skin rashes**, **pruritus** (itching), or more severe reactions like **angioedema** (swelling of the face, lips, or throat). Severe allergic reactions, though rare, should be treated promptly. - **Blood Disorders**: Metronidazole may cause **leukopenia** (low white blood cell count), **thrombocytopenia** (low platelet count), and **anemia**. Routine blood tests are advised for long-term use. - **Hepatotoxicity**: Rarely, **liver toxicity** can occur, presenting as **yellowing of the skin or eyes** (jaundice), dark urine, and elevated liver enzymes. Liver function tests should be monitored during therapy. - **Disulfiram-like Reaction**: As mentioned, consuming alcohol during Metronidazole treatment may lead to a **disulfiram-like reaction**, causing symptoms like **flushing**, **nausea**, **vomiting**, and **abdominal pain**.

Pregnancy Category ID

2

Mode of Action

Metronidazole works by **disrupting the DNA** of microorganisms, inhibiting their ability to replicate and causing cell death. It has the following actions: - **DNA Inhibition**: Metronidazole is metabolized inside the **anaerobic microorganisms** (bacteria and protozoa), where it is reduced to an active form. This active form interferes with the DNA of the organisms by breaking its strands, preventing the microorganism from replicating and leading to its death. - **Selective Targeting**: Metronidazole selectively targets **anaerobic bacteria** and **protozoa**, which lack oxygen-based metabolic processes. It is effective against a wide range of organisms, including those that do not respond well to other antibiotics.

Interaction

Metronidazole interacts with several medications and substances, affecting its efficacy or safety: - **Alcohol**: The most significant interaction is with alcohol. A **disulfiram-like reaction** can occur, leading to symptoms such as **flushing**, **nausea**, **vomiting**, and **headache**. Alcohol should be completely avoided during treatment and for 48 hours after completion. - **Warfarin**: Metronidazole can enhance the anticoagulant effect of **warfarin**, increasing the risk of **bleeding**. Close monitoring of **international normalized ratio (INR)** is recommended, and dose adjustments may be needed. - **Lithium**: Metronidazole may increase the **serum levels of lithium**, leading to **lithium toxicity**. Regular monitoring of lithium levels is required. - **Cimetidine**: The use of **cimetidine** (a histamine-2 blocker) can reduce the metabolism of Metronidazole, increasing its concentration in the blood. This can enhance the risk of **adverse effects**. - **Phenytoin and Phenobarbital**: These medications may reduce the effectiveness of Metronidazole by increasing its metabolism. **Dosage adjustments** may be needed for patients on these anticonvulsants. - **Cyclosporine**: Metronidazole can increase the concentration of **cyclosporine**, a drug used to prevent organ rejection, raising the risk of **toxicity**. Monitoring of cyclosporine levels is necessary. - **5-Fluorouracil (5-FU)**: Metronidazole can enhance the toxicity of **5-fluorouracil**, an anti-cancer medication, requiring careful monitoring and dose adjustments.

Pregnancy Category Note

Information not available

Adult Dose

The usual adult dosage for **Metronidazole** varies depending on the condition being treated: - **For bacterial vaginosis**: The standard dose is **500 mg twice daily** for **7 days**. - **For trichomoniasis**: The typical dose is **2 g as a single dose** or **500 mg twice daily for 7 days**. - **For amebiasis**: The dose is usually **750 mg three times daily** for **7-10 days**. - **For Clostridium difficile-associated diarrhea**: The typical dose is **500 mg three times daily** for **10-14 days**. - **For Helicobacter pylori eradication**: The typical dose is **500 mg three times daily** in combination with other antibiotics like **clarithromycin**.

Child Dose

In children, Metronidazole dosage is based on age and weight: - **For pediatric infections like trichomoniasis or giardiasis**, the dose is usually **15 mg/kg/day** divided into 2-3 doses, typically given for **5-10 days**. - For **bacterial infections**, the dose for children ranges from **7.5-15 mg/kg/day** depending on the severity and type of infection, with the total daily dose divided into 2-3 doses.

Renal Dose

**Metronidazole** is primarily eliminated by the liver, but patients with **renal impairment** may require dose adjustments: - For patients with **severe renal impairment** (CrCl <30 mL/min), a reduced dose may be necessary to avoid drug accumulation, especially in cases of prolonged treatment. - Regular monitoring of renal function is recommended for patients receiving long-term Metronidazole therapy.

Administration

Information not available

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