Rifadin

Rifadin is an FDA-registered drug product whose active ingredient is RIFAMPICIN. It is labelled by Sanofi-Aventis U.S. LLC and marketed as a human prescription drug product. Identifiers on file: NDC 0068-0660, label effective 20260825. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing RIFAMPICIN are most often described in connection with: rifadin infusion, doctor nurse, daily dose, too much, kilogram body, patients weighing, needs given, slow drip. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

3. How Rifadin Infusion is given Rifadin Infusion is given by a doctor or nurse. This is because it needs to be given as a slow drip into a vein (infusion). How much is given If you are not sure why you are being given Rifadin Infusion or have any questions about how much Rifadin Infusion is being given to you, speak to your doctor or nurse. Tuberculosis (TB) The usual dose is: - Adults: A single daily dose of 600mg given over 2–3 hours - Children: Up to 20mg per kilogram of body weight each day. The maximum dose is 600mg each day. Leprosy Your doctor may prescribe a monthly or daily dose - Patients weighing less than 50kg: A single daily dose of 450mg - Patients weighing more than 50kg: A single daily dose of 600mg Brucellosis, Legionnaires Disease or other serious bacterial infections The amount you are given will depend on how severe your infection is - Adults: 600mg–1200mg each day. The dose is given in 2–4 divided doses. Elderly patients Your doctor may need to monitor you more closely. People with Liver problems You should not be given any more than 8mg per kilogram of body weight each day. If you are given more Rifadin Infusion than you should Your doctor will carefully calculate how much Rifadin Infusion you should get. Therefore, it is unlikely your doctor or nurse will give you too much of this medicine. But, if you think that you have been given too much or too little Rifadin Infusion, tell your doctor or nurse. You may feel sick (nausea), be sick (vomiting), have stomach pain, itching or a headache. You may also feel tired, sleepy, dizzy or light-headed. Other signs of having too much includes swelling of the face, eyes or eyelids, slurring of speech, difficulty breathing, fast heartbeat, uneven heartbeats, fits and heart attack. If you miss a dose of Rifadin Infusion Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed. However, if you think you may have missed a dose, then talk to your doctor or nurse. Tests Having Rifadin Infusion may affect the results of some blood tests. In particular, tests for folate, vitamin B 12 and liver function. If you are going to have a blood test, it is important to tell your doctor that you are having Rifadin Infusion.

4. Possible side effects Like all medicines, Rifadin Infusion can cause side effects, although not everybody gets them. Tell a nurse or doctor straight away if you notice any of the following serious side effects: You have an allergic reaction . The signs may include: a rash, swallowing or breathing problems, wheezing, swelling of your lips, face, throat or tongue. Nausea (feeling sick) or vomiting (being sick) fever, feeling tired, loss of appetite (anorexia), dark-coloured urine, light-coloured faeces, yellowing of the skin or whites of the eyes, itching, rash or upper stomach pain. These symptoms may be signs of liver injury. Serious skin rashes including Stevens-Johnson syndrome, toxic epidermal necrolysis. These can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. See also section 2 . Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome). See also section 2 . A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalized exanthematous pustulosis). See also section 2 . You bruise more easily than usual. Or you may have a painful rash of dark red spots under the skin which do not go away when you press on them (purpura). This could be because of a serious blood problem. You have high blood levels of uric acid You have severe bleeding (haemorrhage) Paradoxical drug reaction - Symptoms of tuberculosis can return, or new symptoms can occur after initial improvement during treatment. Paradoxical reactions have been reported as early as 2 weeks and as late as 18 months after beginning anti-tuberculosis treatment. Paradoxical reactions are typically associated with fever, swollen lymph nodes (lymphadenitis), breathlessness, and cough. Patients with paradoxical drug reaction can also experience headaches, loss of appetite, and weight loss. You have chills, tiredness, unusually pale skin colour, shortness of breath, fast heartbeat or dark-coloured urine. This could be signs of a serious type of anaemia. You have blood in your urine or an increase or decrease in amount of urine you produce. You may also get swelling, especially of the legs, ankles or feet. This may be caused by serious kidney problems. You have a sudden severe headache. This could be a sign of bleeding in the brain. New or sudden worsening of shortness of breath and wheezing, possibly with a cough or fever. These could be symptoms of inflammation of the lungs (interstitial lung disease/pneumonitis). You get confused, sleepy, cold clammy skin, shallow or difficult breathing, a racing heartbeat or your skin is paler than normal. These could be signs of shock. You get more infections more easily than normal. Signs include fever, sore throat or mouth ulcers. This could be because you have a low number of white blood cells. You have bleeding from your nose, ear, gums, throat, skin or stomach. Signs may include a feeling of tenderness and swelling in your stomach, purple spots on your skin and black or tar-like stools. Mental problems with unusual thoughts and strange visions (hallucinations) Severe watery diarrhoea that will not stop and you are feeling weak and have a fever. This may be something called 'Pseudomembranous colitis'. Flu-like symptoms including chills, fever, headache, dizziness and bone pains Inflammation of the liver – yellowing of the skin and white part of eyes, increase in the blood level of liver enzymes. Blood clots in small blood vessels (thrombotic microangiopathy) – Symptoms may include increased bruising, bleeding, fever, extreme weakness, headache, dizziness or light-headedness. Your doctor may find changes in your blood and the function of your kidneys. Tell your doctor as soon as possible if you have any of the following side effects: Water retention (oedema) which may cause swollen face, stomach, arms or legs Muscle weakness or pain or loss of muscle reflexes Dizziness, feel lightheaded and faint especially when you stand or sit up quickly (due to low blood pressure) Swollen fingers, toes or ankles Being unable to concentrate, feeling nervous, irritable or depressed Feeling very tired and weak or difficulty sleeping (insomnia) Short-term memory loss, anxiety, being less alert or responsive Wasting of muscles or other body tissues Weight loss, night sweats and fever. These could be signs of a blood condition called eosinophilia. Feeling sick (nausea) or being sick (vomiting) Tell your doctor, nurse or pharmacist if any of the following side effects get serious or lasts longer than a few days: Skin flushing or itching Irregular periods Loss of appetite (anorexia) Headache Diarrhoea or stomach discomfort Pain, redness or swelling at the site of injection Other side effects you should discuss with your doctor if you are concerned about them You notice a discolouration (yellow, brown, orange or red colour) in your teeth, urine, sweat, phlegm (sputum), saliva or tears. This is quite common, and you need not worry. However, the colour may permanently stain soft contact lenses. The colour in tears may last for some time after you have stopped having Rifadin Infusion. Blood tests A blood test may show changes in the way the liver is working. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Rifadin used for?
3. How Rifadin Infusion is given Rifadin Infusion is given by a doctor or nurse. This is because it needs to be given as a slow drip into a vein (infusion). How much is given If you are not sure why you are being given Rifadin Infusion or have any questions about how much Rifadin Infusion is being given to you, speak to your doctor or nurse. Tuberculosis (TB) The usual dose is: - Adults: A …

Who makes Rifadin?
Sanofi-Aventis U.S. LLC is the labeler of record for Rifadin.

Is Rifadin prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Rifadin been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.