Likmez is a ready-to-use liquid suspension of metronidazole, which is an antibiotic that may be used to treat certain bacterial infections. Likmez does not need refrigeration and the suspension is a strawberry-peppermint flavor. The strength is 500mg/5ml.

Likmez has been approved to treat:

• trichomoniasis (a sexually transmitted infection) in adults
• amebiasis (an infection caused by a parasite) in adults and children
• anaerobic bacterial infections (infections caused by bacteria that do not need oxygen to survive) in adults.

Metronidazole is thought to work by first diffusing into the cytoplasm of the anaerobic bacteria where it is then activated and reduced into a short-lived nitroso free radical which can interact with DNA, causing a loss of the helical DNA structure, strand breakage, and bacterial death.

Likmez is quickly absorbed after oral administration, and peak concentrations are reached between 15 minutes and 6 hours after administration (average time: 45 minutes [on an empty stomach]; 2.5 hours [with food]). Although it starts to work quickly, it may take a couple of days before you start to feel better or notice an improvement in your symptoms. It is important that you still finish the course of Likmez that your doctor has prescribed, even if you feel better, because the infection may still be present, and it could flare up or recur if you haven’t finished the course.

Likmez was FDA-approved on September 25, 2023. It belongs to the class of medicines known as nitroimidazole antimicrobials.

Do not take Likmez if you have a history of hypersensitivity reactions to Likmez, metronidazole, or other nitroimidazole medicines, such as secnidazole or tinidazole

Should not be taken by people who have taken disulfiram within the last two weeks.

During treatment with Likmez and for at least 3 days after you have finished your course, you will not be able to drink alcohol or take products containing propylene glycol.

Seizures and other nervous system abnormalities such as encephalopathy, meningitis, and peripheral neuropathy have been reported in patients treated with metronidazole. You should stop using Likmez immediately if you experience any neurological symptoms such as seizures, headaches, visual changes, weakness, numbness, or tingling.

Likmez may not be suitable for people with a history of blood dyscrasias and it may cause mild transient leukopenia. It may also interfere with certain laboratory tests and interact with certain medications.

Metronidazole has been shown to be carcinogenic in rats and mice and unnecessary use should be avoided.

This medicine will not treat a viral infection such as the common cold or flu.

Take exactly as your healthcare provider tells you to.

• Shake the oral suspension well before each use. Always use an accurate measuring device to measure the correct amount of Likmez. Do not use a household teaspoon or tablespoon to measure your medicine. You can ask your pharmacist for the measuring device you should use and how to measure the correct dose.
• May be taken with or without food.
• The dose of Likmez depends on the infection being treated.
• The dosage should be reduced by 50% in those with severe hepatic impairment.
• In patients undergoing hemodialysis, consider a supplementary dose following the hemodialysis session, depending on the patient's clinical situation.
• Likmez will not treat a vaginal yeast infection. You may even develop a new vaginal yeast infection, which may need to be treated with antifungal medication. Tell your doctor if you have symptoms such as itching or discharge during or after treatment with this medicine.
• Do not share this medicine with another person, even if they have the same symptoms you have.

Trichomoniasis (adults)

• One-day treatment: 20grams (20mL) as a single oral dose or a split dose given on the same day
• 7-day course: 250mg (2.5mL) three times daily for 7 consecutive days.

Amebiasis (adults/children)

• Adults: acute amebic dysentery. 750mg (7.5mL) three times daily for 5 to 10 days.
• Adults: amebic liver abscess. 500mg (5mL) or 750mg (7.5mL) three times daily for 5 to 10 days.
• Children: 35mg/kg/24 hours to 50mg/kg/24 hours divided into three doses daily for 10 days. Maximum 2,250mg/24 hours or 750mg (7.5mL) per dose.

Anaerobic Bacterial Infections (adults)

For more serious anaerobic infections, intravenous metronidazole is usually administered initially.

• Adults: 7.5 mg/kg every 6 hours (this works out at approximately 500mg [5mL] for a 70kg adult) orally for 7 to 10 days. Maximum dose 4g (40ml)/24 hours.
• A longer course of treatment may be required for bone, joint, lower respiratory tract, and endocardium infections.

Take exactly as your healthcare provider tells you to.

• Shake the oral suspension well before each use. Always use an accurate measuring device to measure the correct amount of Likmez. Do not use a household teaspoon or tablespoon to measure your medicine. You can ask your pharmacist for the measuring device you should use and how to measure the correct dose.
• May be taken with or without food.
• The dose of Likmez depends on the infection being treated.
• The dosage should be reduced by 50% in those with severe hepatic impairment.
• In patients undergoing hemodialysis, consider a supplementary dose following the hemodialysis session, depending on the patient's clinical situation.
• Likmez will not treat a vaginal yeast infection. You may even develop a new vaginal yeast infection, which may need to be treated with antifungal medication. Tell your doctor if you have symptoms such as itching or discharge during or after treatment with this medicine.
• Do not share this medicine with another person, even if they have the same symptoms you have.

Trichomoniasis (adults)

• One-day treatment: 20grams (20mL) as a single oral dose or a split dose given on the same day
• 7-day course: 250mg (2.5mL) three times daily for 7 consecutive days.

Amebiasis (adults/children)

• Adults: acute amebic dysentery. 750mg (7.5mL) three times daily for 5 to 10 days.
• Adults: amebic liver abscess. 500mg (5mL) or 750mg (7.5mL) three times daily for 5 to 10 days.
• Children: 35mg/kg/24 hours to 50mg/kg/24 hours divided into three doses daily for 10 days. Maximum 2,250mg/24 hours or 750mg (7.5mL) per dose.

Anaerobic Bacterial Infections (adults)

For more serious anaerobic infections, intravenous metronidazole is usually administered initially.

• Adults: 7.5 mg/kg every 6 hours (this works out at approximately 500mg [5mL] for a 70kg adult) orally for 7 to 10 days. Maximum dose 4g (40ml)/24 hours.
• A longer course of treatment may be required for bone, joint, lower respiratory tract, and endocardium infections.

Do not take Likmez if you:

• are allergic to metronidazole or other nitroimidazole medicines, such as secnidazole or tinidazole
• have taken disulfiram (a medicine used to help people stop drinking alcohol) in the last 2 weeks. Taking Likmez with disulfiram can cause psychotic symptoms (seeing or hearing things that are not there) in people who drink alcohol
• drink alcohol or use products with propylene glycol during treatment with Likmez and for at least 3 days after you stop taking it, because this can cause side effects including abdominal cramps, nausea, vomiting, headaches, and flushing
• have Cockayne Syndrome (a rare genetic disorder that affects growth and development).

Before taking LIKMEZ, tell your healthcare provider about all of your medical conditions, including if you:

• have liver problems
• have kidney problems
• have medical problems that affect the brain
• have a yeast infection
• have a history of blood problems
• take any medications, especially warfarin, lithium, busulfan, cimetidine, phenytoin, or phenobarbital.

Tell your doctor if you are pregnant or intend to become pregnant. The use of metronidazole during pregnancy has been well-studied and it is not known to cause birth defects, stillbirth, low birth weight, or preterm delivery. A review of 17 studies found that treating bacterial vaginosis and trichomoniasis with metronidazole reduced the risk of preterm birth and was effective and offered no teratogen risk.

Tell your doctor if you are breastfeeding or plan to breastfeed. Likmez can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking metronidazole. If you are breastfeeding, you may consider pumping and throwing away your breast milk during treatment with Likmez and for 48 hours after your last dose and feeding your infant stored human milk or formula.

Take the missed dose as soon as you remember. Do not skip any doses of Likmez or stop taking it, even if you begin to feel better until you have finished your prescribed treatment. Taking all of your Likmezdoses will help ensure that all of the bacteria are killed and lower the risk of bacteria becoming resistant to Likmez.

If you take too much Likmez, call your healthcare provider or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, numbness, tingling, or problems with balance or muscle movement.

Do not drink alcohol or consume foods, medicines, or other products that contain alcohol or propylene glycol while taking Likmez and for 3 days after your last dose. You may have unpleasant effects such as headaches, nausea, vomiting, stomach cramps, and warmth or tingling under your skin.

Get emergency medical help if you have signs of an allergic reaction to Likmez (hives, itching, warmth, or tingling; fever, joint pain; dry mouth, dry vagina; stuffy nose, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Likmez may cause serious side effects including:

• Nervous system problems, including brain disorder (encephalopathy), inflammation of the brain and spinal cord membranes (aseptic meningitis), numbness or tingling in the hands or feet (peripheral neuropathy), and seizures (convulsions). Tell your healthcare provider right away if you have any nervous system problems while taking Likmez
• Worsening yeast infection (candidiasis) symptoms in people with a known yeast infection or a yeast infection they were not aware of
• Low white blood cell count (leukopenia) in people with a history of blood problems. This can affect how well the body fights infection.

The most common side effects of Likmez include

• Diarrhea
• Nausea
• Headache
• Pain in the upper abdomen and abdominal cramping
• Vomiting
• Weight loss
• Constipation.

Other side effects of Likmez may include allergic reactions: such as itching, hives (urticaria), flushing of the skin, red skin rash that can be widespread, blisters and separation of skin layers, nasal congestion, dryness of the mouth and vagina, and fever.

Abnormal heart rhythms (QT prolongation) may also occur. Metronidazole can cause life-threatening liver problems in people with Cockayne syndrome. If you have this condition, stop taking this medicine and contact your doctor if you have signs of liver failure--nausea, stomach pain (upper right side), dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

These are not all the possible side effects of Likmez. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective. Tell your doctor about all your current medicines. Many drugs can affect metronidazole, especially:

• an antidepressant;
• asthma medication;
• busulfan or other cancer medicine
• cimetidine
• heart or blood pressure medication;
• lithium or other antipsychotic medicine;
• medicine to treat malaria, HIV, or other infection; or
• a blood thinner, such as warfarin, Coumadin, or Jantoven.
• medications that inhibit cytochrome p450 enzymes (CYP2C9 and possibly others), such as phenytoin or phenobarbital.
• medications with the potential for prolonging the QT Interval, such as quinidine, procainamide, dofetilide, ibutilide, sotalol, and amiodarone.

Drinking alcohol while taking Likmez is not recommended because the combination of metronidazole and alcohol can cause a reaction (often referred to as a disulfiram-like reaction) in some people. Symptoms may include flushing, headaches, nausea, vomiting, and stomach cramps. The product information and health professionals recommend not drinking alcohol during metronidazole treatment and for 3 days after finishing the course.

This list is not complete and many other drugs may interact with Likmez. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.