Biozyl tablets

Biozyl

  • Active Ingredient: Metronidazole
  • 500 mg, 400 mg, 250 mg, 200 mg
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What is Biozyl?

The active ingredient of Biozyl brand is metronidazole. Metronidazole is an antibiotic that fights bacteria.

Used for

Biozyl is used to treat diseases such as: Amebiasis, Aspiration Pneumonia, Bacteremia, Bacterial Infection, Bacterial Vaginitis, Balantidium coli, Bone infection, Clostridial Infection, Crohn's Disease, Acute, Crohn's Disease, Maintenance, Deep Neck Infection, Dental Abscess, Dientamoeba fragilis, Diverticulitis, Dracunculiasis, Endocarditis, Giardiasis, Helicobacter Pylori Infection, Intraabdominal Infection, Joint Infection, Lemierre's Syndrome, Meningitis, Nongonococcal Urethritis, Pelvic Inflammatory Disease, Peritonitis, Pneumonia, Pouchitis, Pseudomembranous Colitis, Skin or Soft Tissue Infection, STD Prophylaxis, Surgical Prophylaxis, Trichomoniasis.

Side Effect

Possible side effects of Biozyl include: Abdominal or stomach cramps; intravenous powder for solution, intravenous solution; dizziness; sneezing; indigestion; back pain; bloating.

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What other drugs will affect Biozyl?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines and any you start or stop using, especially:

a blood thinner - warfarin, Coumadin, Jantoven.

phenytoin or phenobarbital

This list is not complete. Other drugs may interact with Biozyl, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Which drugs or supplements interact with this medication?

  • Alcohol should be avoided because Biozyl and alcohol together can cause severe nausea, vomiting, cramps, flushing, and headache.
  • Biozyl can increase the blood thinning effects of warfarin (Coumadin, Jantoven) and increase the risk of bleeding probably by reducing the breakdown of warfarin.
  • Cimetidine (Tagamet) increases blood levels of Biozyl while cholestyramine (Questran, Questran Light) reduces blood levels of Biozyl by reducing its absorption.
  • Biozyl should not be combined with amprenavir (Agenerase) for treating human immunodeficiency disease (infection with HIV) because amprenavir contains propylene glycol.
  • Biozyl blocks the breakdown of propylene glycol in the liver leading to accumulation of propylene glycol in blood. Accumulation of propylene glycol could cause seizures, increased heart rate, and lead to kidney failure.
  • Biozyl increases the blood levels of carbamazepine (Tegretol, Tegretol XR, Equetro, Carbatrol), lithium (Eskalith, Lithobid) and cyclosporine though unknown mechanisms. Serious reactions may occur if these drugs are taken with Biozyl.

8. How to cope with s >

What to do about:

  • feeling sick (nausea) - stick to simple meals and do not eat rich or spicy food. You should always try to take your Biozyl after a meal or snack.
  • being sick (vomiting) or diarrhoea - drink lots of fluids, such as water or squash to avoid dehydration. Take small, frequent sips if you are being sick. Signs of dehydration include peeing less than usual or having dark, strong-smelling pee. If your diarrhoea and vomiting continues for more than 24 hours contact your doctor for advice. Do not take any other medicines to treat diarrhoea or vomiting without speaking to a pharmacist or doctor.
  • metallic taste in your mouth or a furry tongue - drink plenty of water and eat plain foods that you usually enjoy. If your tongue is very furry, this could be a sign of thrush - ask your pharmacist or doctor for advice.

Biozyl and Other Interactions

Biozyl may make your skin more sensitive to sunlight.

Avoid prolonged exposure to the sun and wear sunscreen, protective clothing, and sunglasses when outdoors.

The medicine may also make you dizzy. Don't drive or operate machinery until you know how Biozyl affects you.

Getting the most from your treatment

  • Important: do not drink alcohol while you are on Biozyl and for 48 hours after finishing your course of treatment. This is because drinking alcohol with Biozyl is likely to make you feel very sick and cause other unpleasant effects, such as the sensation of having a 'thumping heart' (palpitations), hot flushes and headache.
  • While you are taking Biozyl your urine may look a darker colour than normal. On its own this is nothing to worry about. However, if you also experience tummy (abdominal) pain, or if you feel sick (nausea) or feel generally unwell, you should let your doctor know.
  • If you buy any medicines, check with a pharmacist that they are safe to take with Biozyl. Some cough and cold preparations contain alcohol and should not be taken with Biozyl.
  • If you need to take Biozyl for longer than ten days, your doctor may want you to have some tests. Make sure you keep any appointments that your doctor gives to you.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to Biozyl.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking Biozyl.

Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish the Biozyl, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Central Nervous System

The most serious adverse reactions reported in patients treated with Biozyl have been convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity. Since persistent peripheral neuropathy has been reported in some patients receiving prolonged administration of Biozyl, patients should be specifically warned about these reactions and should be told to stop the drug and report immediately to their physicians if any neurologic symptoms occur. In addition, patients have reported headache, syncope, dizziness, vertigo, incoordination, ataxia, confusion, dysarthria, irritability, depression, weakness, and insomnia (see WARNINGS).

DESCRIPTION

FLAGYL (Biozyl) tablets, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula:

FLAGYL (Biozyl) tablets contain 250 mg or 500 mg of Biozyl. Inactive ingredients include cellulose, FD&C Blue No. 2 Lake, hydroxypropyl cellulose, hypromellose, polyethylene glycol, stearic acid, and titanium dioxide.

Contraindications

Hypersensitivity to Biozyl or other nitroimidazoles (although cautious desensitization has been applied)

Pregnancy, 1st trimester in patients with trichomoniasis

Use of disulfiram within past 2 weeks; use of alcohol during therapy or within 3 days of discontinuing therapy

Background

Biozyl (met" roe nid' a zole) is a nitroimidazole antibiotic that is activated by reduction of its nitro group by susceptible organisms. The activated form of Biozyl is a highly reactive radical anion which targets and damages large protein molecules and DNA. Mammalian cells do not ordinarily activate Biozyl, which accounts for its lack of toxicity in humans. Biozyl was approved for use in the United States in 1963 and currently several million prescriptions are filled yearly. Biozyl is indicated for treatment and prophylaxis of infections with susceptible anaerobic bacteria and protozoa. The recommended dosage is 500 to 750 mg taken orally three times daily for 5 to 10 days. Biozyl is available alone in tablets of 250, 375, 500 and 750 mg as well as in combination with other medications, in multiple generic formulations and under several brand names including Flagyl, Metryl, Noritate, Pylera and Helida. Other formulations include injectable solutions, extended release tablets, suppositories, and topical creams. The most common side effects include metallic taste, nausea, vomiting, abdominal discomfort and diarrhea.

Cautions

Seizures and aseptic meningitis reported with increase in dose and chronic therapy

Cases of encephalopathy and peripheral neuropathy (including optic neuropathy) reported with Biozyl

Encephalopathy reported in association with cerebellar toxicity characterized by ataxia, dizziness, and dysarthria; CNS lesions seen on MRI described in reports of encephalopathy; CNS symptoms are generally reversible within days to weeks upon discontinuation of therapy; lesions seen on MRI have also been described as reversible

Peripheral neuropathy, mainly of sensory type reported and characterized by numbness or paresthesia of an extremity

Prescribing Biozyl tablets in absence of a proven or strongly suspected bacterial or parasitic infection or a prophylactic indication is unlikely to provide benefit to patient and increases risk of development of drug-resistant bacteria and parasites

Superinfection may occur with prolonged use

Severe hepatic impairment; administer lower doses with caution

Use with caution; potential accumulation in end stage renal disease; supplemental doses may be needed in patients receiving hemodialysis

Use with caution in history of heart failure, hepatic failure, H. pylori infection, renal impairment

Use with care in patients with evidence of or history of blood dyscrasia; agranulocytosis, leukopenia and neutropenia have been associated with Biozyl administration; monitor complete blood count; monitor complete blood count (CBC) for leukopenia before, during, and after prolonged repeated therapy

Avoid alcohol while taking medication and for at least three days after discontinuation

Antiandrogen: May cause gynecomastia

Known or previously unrecognized candidiasis may present more prominent symptoms during therapy and requires treatment with a candicidal agent

Biozyl injection, USP contains 790 mg of sodium per 100 mL; use care when administering injection to patients receiving a controlled sodium diet or corticosteroids or to patients predisposed to edema

Severe neurological disturbances, including encephalopathy, cerebellar symptoms, convulsive seizures, and aseptic meningitis, reported in patients treated with Biozyl; advise patients to report neurologic symptoms that occur during Biozyl administration; discontinue Biozyl treatment if any abnormal neurologic symptoms occur such as ataxia, dizziness, confusion or any other CNS adverse reaction

Cases of severe hepatotoxicity/acute hepatic failure, including cases with a fatal outcome with very rapid onset after treatment initiation in patients with Cockayne syndrome reported with products containing Biozyl for systemic use; in this population, Biozyl should therefore be used after careful benefit-risk assessment and only if no alternative treatment available; obtain liver function tests prior to start of therapy, within first 2-3 days after initiation of therapy, frequently during therapy and after end of treatment; discontinue Biozyl if elevation of liver function occurs, and monitor liver function tests until baseline values are reached; advise patients with Cockayne syndrome to stop taking Biozyl immediately if they experience any symptoms of potential liver injury, such as abdominal pain, nausea, change in stool color or jaundice, and to contact their healthcare provider

When Biozyl tablets are prescribed to treat a bacterial infection, patients should be told that the medication should be taken exactly as directed; skipping doses or not completing full course of therapy may decrease effectiveness of immediate treatment and increase likelihood that bacteria will develop resistance and will not be treatable by Biozyl tablets in the future


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