Zyvox
Zyvox is an antibiotic containing the active substance linezolid, which acts against bacterial infections caused by certain germs. This medicine should only be used as prescribed by a doctor for the treatment of severe pneumonia contracted in hospital, as well as complicated skin and soft tissue infections when other antibiotics are ineffective against these germs.
What Does Zyvox Contain?
Active ingredients
Film-coated tablets
1 film-coated tablet contains 600 mg linezolid.
Granules for oral suspension
1 ml of oral suspension (after reconstitution with 123 ml of water) contains 20 mg of linezolid.
Excipients
Film-coated tablets
Microcrystalline cellulose, maize starch, hydroxypropyl cellulose, sodium carboxymethyl starch (type A), hypromellose, magnesium stearate, macrogol 400, titanium dioxide, carnauba wax.
White to off-white film-coated tablet engraved "ZYV" on one side and "600" on the other.
Granules for drinkable suspension
Sugar, citric acid, anhydrous sodium citrate, microcrystalline cellulose, sodium carmellose, aspartame (E 951), mannitol (E 421), xanthan gum, sodium benzoate (E 211), anhydrous colloidal silica, sodium chloride, sorbitol* (E 420), fructose*, maltodextrin*, glycyrrhizic acid, ammonium glycyrrhizate, medium chain triglycerides, flavourings (orange, peppermint, vanilla): contain ethanol, maltodextrin*, propylene glycol, benzyl alcohol, modified starch*.
* produced from genetically modified maize.
30 ml of drinkable suspension (6 measuring spoons of 5 ml) correspond to a unit dose of 600 mg of linezolid and contain 9.68 g of digestible carbohydrates.
Forms and Strengths
The following packs are available from pharmacies only on non-renewable medical prescription:
- Zyvox 600 mg: 10 film-coated tablets
- Zyvox 20 mg/ml: 1 bottle of granules for 150 ml of oral suspension.
Uses
In general, the recommended doses are as follows:
Adults
600 mg administered twice daily.
Zyvox oral suspension is generally prepared by the pharmacist from the granules using the following procedure:
Gently shake the granules and prepare 123 ml of tap water. Start by adding half the water to the bottle and shaking vigorously. Then add the rest of the water and shake vigorously again until the suspension is homogeneous. This produces 150 ml of ready-to-use Zyvox oral suspension. Zyvox suspension and Zyvox film-coated tablets may be taken before, during or after a meal.
Dialysis patients should take Zyvox after dialysis.
Once initiated, antibiotic treatment should be continued for the full duration prescribed by the doctor, even if symptoms of the disease disappear before the infection is fully resolved. If the treatment is used for too short a time or stopped prematurely, the disease may relapse.
If you have accidentally swallowed too many Zyvox film-coated tablets or suspension, please tell your doctor immediately.
If you forget to take a dose, continue treatment as normal as soon as you remember. Never double the dose.
Treatment with Zyvox generally lasts 10 to 14 days, but may be continued for up to 28 days.
Children and adolescents under 18 years of age
Limited data are available on efficacy and safety in children and adolescents. Therefore, the use of Zyvox is not recommended in this age group in the absence of further data.
Side Effects
Taking or using Zyvox may cause the following side effects:
Common (affects 1 to 10 people in 100)
The most common side effects are nausea, diarrhoea, vomiting, bloating and headaches, cramps, as well as changes in metallic taste, high blood sugar (hyperglycaemia), fungal infections and changes in liver tests.
If severe and persistent diarrhoea accompanied by abdominal cramps and fever occurs, stop taking Zyvox and tell your doctor. If diarrhoea occurs, you must not take medicines that inhibit intestinal peristalsis (the movement of the intestine).
Occasional (affects 1 to 10 people in 1,000)
Additionally, the following side effects may sometimes occur: chills, fever, dizziness, blurred vision, fatigue, insomnia, tinnitus, dry mouth, excessive thirst, gastrointestinal issues, abdominal discomfort, constipation, inflammation of the oral mucosa, tongue swelling or discoloration, acute pancreatitis (indicated by sudden severe upper abdominal pain, nausea, and vomiting), increased urination, tingling, numbness, changes in blood pressure, skin reactions such as redness and itching, excessive sweating, and vaginal inflammation.
Treatment with Zyvox may occasionally lead to changes in the blood count, such as a lack of red blood cells, white blood cells or platelets. Symptoms of such changes in the blood count may include reduced performance, tiredness, fever, chills, small haematomas, bleeding from the mucous membranes and disturbed wound healing.
Rare (affects 1 to 10 people in 10,000)
In rare cases, convulsions have been observed following the administration of Zyvox, mainly in predisposed individuals.
Taking this drug may cause inflammation of the blood vessels in the skin with a subsequent rash and tissue damage. Stop taking Zyvox immediately in the event of inflammatory skin changes and contact your doctor.
Taking Zyvox may lead to muscle breakdown (rhabdomyolysis). Contact your doctor if you experience muscle pain or weakness, possibly accompanied by fever, nausea and vomiting or a brownish discolouration of the urine.
Very rare (affects less than one person in 10,000)
Very rarely, disturbances of sensation and/or visual disturbances such as blurred or imprecise vision, changes in colour perception, spots in the visual field (known as peripheral and/or optic neuropathy) have been observed. Please inform your doctor immediately if you notice any such visual disturbances.
Similarly, superficial discolouration of the teeth has been observed in very rare cases following the use of Zyvox. In the cases that could be followed up, the discolouration was eliminated with dental hygiene measures (manually).
Serious cutaneous and hypersensitivity reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported. Discontinue Zyvox at the first indication of an allergic reaction, such as skin redness, blistering rash, swelling of the face, skin, or mucous membranes, asthma symptoms, breathing difficulties, or circulatory issues, and immediately contact your doctor.
Isolated cases (frequency unknown)
Cases of lactic acidosis have been observed following the administration of Zyvox. Please also inform your doctor immediately if you experience very severe and recurrent nausea or vomiting.
The active substance in Zyvox may slightly inhibit certain substances in the body (known as monoamine oxidases). Due to interactions with other medications or components in food, isolated cases of adverse drug reactions have been reported which can be attributed to this property. Signs of these interactions may take the form of anxiety, tremors, cramps, flushing, headaches, heart palpitations, shortness of breath and high blood pressure.
If you experience one or more of the following symptoms, contact your doctor or hospital immediately:
- involuntary muscle contractions
- nausea and vomiting
- restlessness
- mental confusion
- desire to sleep
- disturbances of consciousness
- rapid involuntary eye movements
- heart palpitations
- coordination disorders
- psychosis accompanied by visual hallucinations and hyperexcitability
- coma
- severe breathing difficulties, or
- convulsions.
Precautions
Zyvox may interact with many medicines, such as antidepressants, certain heart or asthma medicines, certain medicines used to treat colds or coughs (e.g. containing the active ingredients pseudoephedrine or phenylpropanolamine), anorectics, medicines containing rifampicin, certain migraine medicines (known as triptans), analgesics (e.g. with the active ingredients pethidine, tramadol or buprenorphine), anxiolytics containing buspirone as an active ingredient (e.g. with the active ingredients pethidine, tramadol or buprenorphine), antidepressants (e.g. with the active ingredients pethidine, tramadol or buprenorphine). with the active ingredients pethidine, tramadol or buprenorphine), anxiolytics containing buspirone as an active ingredient, medicines containing adrenaline, noradrenaline and dopamine as active ingredients, medicines used in Parkinson's disease containing selegiline as an active ingredient. This can lead to a potentially fatal situation known as serotonin syndrome (serious changes in the functioning of the brain, muscles and digestive tract due to high levels of serotonin in the body) This is why you should tell your doctor or pharmacist about all the medicines you are taking.
If you are taking an oral contraceptive ("pill"), please bear in mind that its effectiveness may be reduced during antibiotic treatment. For this reason, your doctor or pharmacist may recommend additional contraceptive measures.
Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with the use of Zyvox. These reactions are often preceded by fever and/or flu-like symptoms.
Stop using Zyvox immediately at the first signs of inflammatory skin changes and allergic reactions (e.g. reddening of the skin, blistering rash, swelling of the face, skin or mucous membranes, asthma, respiratory distress, circulatory problems) and inform your doctor immediately.
If diarrhoea occurs during or after treatment with Zyvox, especially if it is severe, persistent and/or bloody, this may indicate infection with the pathogen Clostridium difficile. If such a complication is suspected, you should immediately stop taking Zyvox and seek advice from your doctor. In the event of diarrhoea, you should not take medicines that slow down intestinal peristalsis (the movement of the intestine).
Zyvox is sometimes not well tolerated when taken at the same time as certain food components. Consequently, avoid consuming large quantities of mature cheese, yeast extracts, soya-based products (e.g. soya sauce) or alcoholic beverages. If you develop throbbing headaches after meals, please tell your doctor or pharmacist.
If you have uncontrolled high blood pressure, hypertensive crises due to a tumour (such as a pheochromocytoma or carcinoid tumour), an overactive thyroid gland or certain psychological illnesses (such as depression, bipolar psychosis or mental confusion), you should only take Zyvox if close monitoring and control of blood pressure is possible.
If you suffer from epilepsy or have had epileptic seizures in the past, please inform your doctor or pharmacist. Please also inform them if you have severely limited kidney or liver function.
Also inform your doctor or pharmacist if you experience nausea/feeling unwell accompanied by muscle weakness, convulsions, headaches or mental confusion. These may be signs of hyponatremia (a decrease in the concentration of sodium in the blood) which may be linked to taking Zyvox. Muscle pain or weakness, possibly accompanied by fever, nausea and vomiting or brown urine, may also be signs of rhabdomyolysis (muscle breakdown), which has been observed in rare cases with Zyvox.
This medicine may affect reactions, driving ability and the ability to use tools or machines. Caution should be exercised by drivers and users of machinery, particularly at the start of treatment and during long-term treatment (visual disturbances).
Excipients of particular interest
Film-coated tablets
Zyvox film-coated tablets contain less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. they are essentially "sodium-free".
Granules for oral suspension
Zyvox granules contain 68.4 mg sodium (the main component of table salt) per unit dose (30 ml suspension). This is equivalent to 3.4% of the recommended maximum daily dietary intake of sodium for an adult.
This medicine contains 60 mg sodium benzoate per unit dose (30 ml suspension).
Zyvox granules contain 6.32 g of sucrose per unit dose (30 ml of suspension). This should be taken into account for patients with diabetes mellitus. If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking Zyvox granules for oral suspension.
Zyvox granules contain 210 mg aspartame per unit dose (30 ml suspension). Aspartame contains a source of phenylalanine. It may be dangerous for people with phenylketonuria (PKU), a rare genetic disease characterised by the accumulation of phenylalanine which cannot be eliminated properly.
Zyvox granules contain 262.8 mg sorbitol and 100.8 mg fructose per unit dose (30 ml suspension). Sorbitol is a source of fructose. If you are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder characterised by the inability to break down fructose, consult your doctor before taking or receiving this medication. Fructose can damage teeth.
Zyvox granules contain 6 mg of alcohol (ethanol) per unit dose (30 ml of suspension). The amount contained in 30 ml of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol contained in this medicine is unlikely to have any noticeable effect.
What else do you need to consider?
The antibiotic in Zyvox does not work against all the micro-organisms that cause infectious diseases. Using the wrong antibiotic or the wrong dose can cause complications. Consequently, never use it on your own initiative to treat other illnesses or other people.
Granules for oral suspension
30 ml of prepared suspension (6 measuring spoons of 5 ml) corresponds to a single dose of 600 mg of linezolid and contains 9.68 g of digestible carbohydrates.
The sugar content of the suspension should be taken into account if you suffer from diabetes mellitus.
When should Zyvox not be used?
In the event of known or suspected hypersensitivity (allergy) to any of the ingredients of Zyvox.
Pregnancy and Breastfeeding
If you are pregnant, planning to become pregnant or are breast-feeding, you should only take Zyvox with the express agreement of your doctor or pharmacist.