Orni 500 Mg Tablet (10 Tab)

ORNI 500 MG Tablet

ORNI 500 MG Tablet, manufactured by ZYDUS HEALTHCARE LIMITED (also referred to as Zydus Cadila), is an antibiotic and antiprotozoal medication used to treat a variety of bacterial and parasitic infections.

• Name:

  • Common Name: Ornidazole 500 mg Tablet
  • Brand Name: ORNI 500 MG Tablet

• Composition:

  • Active Ingredient: Ornidazole 500 mg
  • Excipients: The tablets may also contain maize starch, microcrystalline cellulose, hydroxypropylmethylcellulose, magnesium stearate, talc, and titanium dioxide.

• Uses: ORNI 500 MG Tablet is prescribed for the treatment of various bacterial and parasitic infections, and also for prophylaxis during surgery.

  • Bacterial Infections: Effective against anaerobic bacteria in different body parts, including the liver, stomach, intestines, vagina, brain, heart, lungs, and skin. It is also used for dental infections, leg ulcers, and pressure sores.
  • Parasitic Infections: Treats infections caused by protozoa such as:
    • Amoebiasis (intestinal and liver infections caused by Entamoeba histolytica, including amoebic dysentery).
    • Giardiasis (infections caused by Giardia lamblia).
    • Trichomoniasis (genitourinary infections caused by Trichomonas vaginalis).
    • Bacterial vaginosis.
  • Surgical Prophylaxis: Used to prevent infections before and after surgical procedures, particularly in abdominal and gynecological operations.

• Dosage and Administration: ORNI 500 MG Tablet should be taken exactly as prescribed by a doctor, typically during or immediately after a meal to avoid stomach upset.

  • Adults and Children over 35 kg:
    • Acute Trichomoniasis: Single dose of 1500 mg (3 tablets) in the evening.
    • Chronic Trichomoniasis: 500 mg (1 tablet) twice a day for 5 days.
    • Amoebic Dysentery: 1500 mg once a day for 3 days, or 1000 mg twice a day for 3 days for patients over 60 kg.
    • Other Forms of Amoebiasis: 500 mg (1 tablet) twice a day for 5-10 days.
    • Giardiasis: 1000 mg or 1500 mg as a single dose for 1-2 days.
    • Surgical Prophylaxis: 1500 mg orally 12 hours before surgery, then 500 mg every 12 hours for 3 to 5 days postoperatively.
  • Children (weighing 35 kg or less): Dose ranges from 25 mg to 40 mg per kg body weight per day, given as a single dose for up to 10 days, depending on the infection.
  • Administration: Swallow tablets whole with a glass of water; do not crush or chew. Complete the full course of treatment even if symptoms improve.

• Side Effects: Most side effects are mild and resolve over time.

  • Common Side Effects: Nausea, vomiting, abdominal pain, digestive disorders, loss of appetite, an unpleasant metallic taste in the mouth, dry mouth, headache, dizziness, insomnia, skin rash, itching.
  • Serious Side Effects (Rare): Cholestatic hepatitis, increased liver enzyme values, jaundice, pancreatitis, erythema multiforme, angioedema, colitis, diplopia, myalgia, arthralgia, agranulocytosis, thrombocytopenia, pancytopenia, anaphylaxis, leucopenia (low white blood cells), vertigo, seizures, nerve pain (peripheral neuropathy), ataxia, mental confusion, tremor, rigidity, poor coordination, or temporary loss of consciousness.

• Precautions:

  • Allergies: Contraindicated in individuals with hypersensitivity to Ornidazole or other nitroimidazole antimicrobial agents.
  • Alcohol: Avoid alcohol consumption during treatment and for at least three days after completing the course, as it may lead to a disulfiram-like reaction.
  • Liver Impairment: Use with caution in patients with liver disease. Dosage adjustments may be necessary, and the dosing interval might be doubled in severe cases.
  • Kidney Impairment: Generally, no dose adjustment is needed for renal impairment, but an additional dose may be required for patients undergoing hemodialysis.
  • Neurological Disorders: Use with caution in patients with CNS diseases such as epilepsy, multiple sclerosis, or other convulsion disorders, as it may aggravate these conditions. Discontinue if peripheral neuropathy, ataxia, vertigo, or confusion occurs.
  • Blood Disorders: Regular blood tests (leukocyte counts) should be performed before and during prolonged treatment, especially in patients with a history of blood disorders.
  • Pregnancy and Breastfeeding: Not recommended during early pregnancy or breastfeeding unless absolutely necessary and prescribed by a doctor after evaluating benefits and risks.
  • Driving and Operating Machinery: May cause dizziness, somnolence, or confusion, so caution is advised when driving or operating machinery.
  • Drug Interactions:
    • Can enhance the effect of coumarin anticoagulants (blood thinners).
    • Can prolong the muscle relaxant effect of vecuronium bromide.
    • Concurrent use with disulfiram may lead to acute confusion or psychosis.
    • Caution with medicines like lithium, cimetidine, phenytoin, and phenobarbital.

• Storage: Store ORNI 500 MG Tablet in a cool, dry place where the temperature stays below 30°C (or 25°C), and protect from light and dampness. Keep it in its blister pack and out of reach of children.

What is ORNI 500 MG TABLET used for?

ORNI 500 MG TABLET, containing Ornidazole, is an antibiotic primarily used to treat various bacterial and parasitic infections. It is effective against infections caused by anaerobic bacteria (bacteria that do not use oxygen) and protozoa like Entamoeba histolytica, Giardia lamblia, and Trichomonas vaginalis. These infections can include amoebiasis (intestinal and liver infections), giardiasis, trichomoniasis (a sexually transmitted infection), and bacterial vaginosis. It is also prescribed for infections in the vaginal, urinary tract, intestinal areas, and as a preventive measure against infections during and after surgery, particularly in abdominal or genitourinary procedures. ORNI 500 MG TABLET may also be used for dental infections, leg ulcers, and pressure sores.

How does ORNI 500 MG TABLET work?

ORNI 500 MG TABLET contains Ornidazole, a nitroimidazole derivative. It works by entering the infection-causing organisms (bacteria and parasites) and being reduced to form cytotoxic products. These products interact with the microbial DNA, damaging its helical structure and inhibiting protein synthesis. This action ultimately leads to the death of the susceptible microorganisms, thereby treating the infection.

What is the usual dosage for ORNI 500 MG TABLET?

The dosage of ORNI 500 MG TABLET varies depending on the type and severity of the infection, as well as the patient's age and weight. For adults, typical dosages might include 500 mg twice a day for 5-10 days for amoebiasis, or a single dose of 1 to 1.5 grams for giardiasis or trichomoniasis. For surgical prophylaxis, a dose of 1.5 grams may be given 12 hours before surgery, followed by 500 mg every 12 hours for 3-5 days post-operatively. Children's doses are typically calculated based on body weight. It is crucial to swallow the tablets whole with a glass of water, preferably during or immediately after a meal to prevent stomach upset. Always take the medicine exactly as prescribed by your doctor and complete the full course of treatment.

What are the possible side effects of ORNI 500 MG TABLET?

Common side effects can include nausea, vomiting, headache, dizziness or vertigo, a metallic taste in the mouth, stomach upset, loss of appetite, constipation or diarrhea, and sleepiness or tiredness. Skin reactions may also occur. More serious, though less common, side effects that require immediate medical attention can include severe skin rash, itching, hives, swelling of the face, lips, mouth, or throat (which may cause difficulty in swallowing or breathing), swelling of the hands, feet, or ankles (signs of an allergic reaction), rigidity, poor coordination, seizures, loss of consciousness, confusion, or nerve damage (especially with high or prolonged doses).

Is ORNI 500 MG TABLET safe during pregnancy or breastfeeding?

Pregnancy: ORNI 500 MG TABLET is generally not recommended during pregnancy unless it is absolutely necessary and the potential benefits of treatment outweigh the risks to the unborn baby. While animal studies have not shown direct harm, controlled studies in pregnant women are lacking.

Breastfeeding: It is also not recommended during breastfeeding unless deemed essential by a doctor. It is not definitively known whether Ornidazole passes into breast milk. Some experts suggest avoiding breastfeeding for at least 3 days after a single dose to minimize infant exposure.

Can ORNI 500 MG TABLET be taken with other medications?

ORNI 500 MG TABLET can interact with certain medications. It may enhance the effect of blood thinners like warfarin, increasing the risk of bleeding. It can also prolong the muscle-relaxant effect of vecuronium bromide. Concurrent use with cimetidine may prolong the half-life of ornidazole, while phenobarbital or phenytoin can reduce its half-life. Combining it with disulfiram may lead to confusion or psychosis. Plasma levels of lithium may also increase. Additionally, antacids containing aluminum or magnesium may reduce the absorption of ornidazole. Always inform your doctor or pharmacist about all other medicines, including over-the-counter drugs, vitamins, and herbal supplements you are taking.

What precautions should be taken while using ORNI 500 MG TABLET?

Do not take ORNI 500 MG TABLET if you have a known allergy to ornidazole or other similar nitroimidazole antibiotics (such as metronidazole). Inform your doctor if you have any pre-existing health conditions, especially epilepsy, multiple sclerosis, liver disease, or other central nervous system disorders. Regular blood tests may be recommended if you have a history of blood disorders or are on prolonged treatment. It is important to avoid alcohol consumption during treatment with ORNI 500 MG TABLET and for at least 3 days after completing the course, as it may cause adverse reactions. Since this medicine can cause dizziness, drowsiness, or light-headedness, exercise caution when driving or operating machinery. Always complete the entire prescribed course of treatment, even if your symptoms improve, to prevent antibiotic resistance and ensure the infection is fully cleared.

What happens if a dose of ORNI 500 MG TABLET is missed?

If you miss a dose of ORNI 500 MG TABLET, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to compensate for the missed one. If you are unsure, consult your doctor or pharmacist for advice.

How should ORNI 500 MG TABLET be stored?

Store ORNI 500 MG TABLET in its original blister pack until it is time to take it. Keep the tablets in a cool, dry place, with the temperature remaining below 30°C, and protect them from light. Avoid storing the medicine in a bathroom, near a sink, in a car, or on window sills, as heat and dampness can degrade the medication. Always keep ORNI 500 MG TABLET out of the reach of young children.