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RIFINAH is a brand name for Pyrazinamide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Rifinah is indicated in the treatment of all forms of tuberculosis, including fresh, advanced and chronic cases.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Another antituberculosis drug may be given concurrently with Rifinah until the susceptibility of the infecting organism to rifampicin and isoniazid has been confirmed.
Adults:
Patients should be given the following single daily dose preferably on an empty stomach at least 30 minutes before a meal or 2 hours after a meal: Rifinah 150: Patients weighing less than 50 kg – 3 tablets.
Rifinah 300:
Patients weighing 50 kg or more – 2 tablets.
Use in the elderly:
Caution should be exercised in such patients especially if there is evidence of liver impairment. Method of administration For oral administration.
The following CIOMS frequency rating is used, when applicable:
Very common (≥ 1/10); Common (≥ 1/100 to < 1/ 10); Uncommon (≥ 1/1,000 to <1/100); Rare (≥ 1/10,000 to <1/1,000); Very rare (<1/10,000), Not known (cannot be estimated from available data). Rifampicin Reactions occurring with either daily or intermittent dosage regimens include: System organ class Frequency Preferred Term Infections and infestations Not known Pseudomembranous colitis Influenza Common Thrombocytopenia with or without purpura, usually associated with intermittent therapy, but is reversible if drug is discontinued as soon as purpura occurs.
2% (53/573) (data between October 2007 and March 2010) and higher frequency is reported as 25% (19/76) (data between 2000 and 2010). Isoniazid System organ class Frequency Preferred Term Hepatobiliary disorders Uncommon Severe and sometimes fatal hepatitis may occur with isoniazid therapy Uncommon Other neurotoxic effects, which are uncommon with conventional doses, are convulsions, toxic encephalopathy, optic neuritis and atrophy, memory impairment and toxic psychosis.
Nervous system disorders Not known Vertigo Polyneuritis associated with isoniazid, presenting as paraesthesia, muscle weakness, loss of tendon reflexes etc, is unlikely to occur with the recommended daily dose of Rifater. The incidence is higher in “slow acetylators”.
The possibility that the frequency of seizures may be increased in patients with epilepsy should be borne in mind. Cerebellar syndrome (including cerebellar ataxia, ataxia, dysdiadochokinesis, balance disorders, nystagmus, dysmetria) mainly in patients with chronic kidney disease.
4) Exfoliative dermatitis Pemphigus Alopecia Vascular disorders Not known Vasculitis Endocrine disorders Not known Gynecomastia Gastrointestinal disorders Not known Constipation Dry mouth Nausea Vomiting Epigastric distress Pancreatitis Metabolism and nutrition disorders Not known Hyperglycaemia Pellagra Investigations Not known Anti-nuclear bodies General disorders and administration site conditions Not known Fever Musculoskeletal and connective tissue disorders Not known Systemic lupus erythromatosus-like syndrome Pyrazinamide System organ class Frequency Preferred Term Rare Acute yellow atrophy Death Hepatobiliary disorders Not known The hepatic reaction is the most […]
Rifampicin should be given under the supervision of a respiratory or other suitably qualified physician. Warnings and precautions associated with rifampicin and isoniazid, alone or in combination Rifinah is a combination of 2 drugs, each of which has been associated with liver dysfunction.
All tuberculosis patients should have pre-treatment measurements of liver function. Adults treated for tuberculosis with Rifinah should have baseline measurements of hepatic enzymes, bilirubin, serum creatinine, a complete blood count and a platelet count (or estimate).
Patients should be seen at least monthly during therapy and should be questioned specifically about symptoms associated with adverse reactions. If the patient has no evidence of pre-existing liver disease and normal pre-treatment liver function, liver function tests need only be repeated if fever, vomiting, jaundice or other deterioration in the patient’s condition occurs.
All patients with abnormalities should have follow-up, including laboratory testing, if necessary. However, because there is a higher frequency of isoniazid-associated hepatitis among persons older than 35 years of age, a transaminase measurement should be obtained at baseline and at least monthly during therapy in this age group.
Other factors associated with an increased risk of hepatitis include daily use of alcohol, chronic liver disease, intravenous drug use and being a black or Hispanic woman. Cases of thrombotic microangiopathy (TMA), manifested as thrombotic thrombocytopenic purpura (TTP) or haemolytic uremic syndrome (HUS), including fatal cases, have been reported with Rifinah use.
If laboratory or clinical findings associated with TMA occur in a patient receiving Rifinah, treatment should be discontinued and thorough evaluation for TMA performed, including platelet levels, renal function, serum lactate dehydrogenase (LDH) and a blood film for schistocytes (erythrocyte fragmentation).
5)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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ADAMTS13 activity and anti-ADAMTS13-antibody determination should be completed. If anti-ADAMTS13-antibody is elevated in conjunction with low ADAMTS13 activity, treatment with Rifinah should not be resumed and patients should be treated accordingly (consider plasma exchange).
8). It is important to note that early manifestations of hypersensitivity, such as fever, lymphadenopathy or biological abnormalities (including eosinophilia, liver abnormalities) may be present even though rash is not evident. If such signs or symptoms are present, the patient should be advised to consult immediately their physician.
Severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalised exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported in association with Rifinah treatment.
At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. Most of these reactions occurred within 2 days to 2 months after treatment initiation; the time to onset can vary depending on the conditions.
If signs and symptoms suggestive of these reactions appear, Rifinah should be withdrawn immediately and an alternative treatment considered. If the patient has developed a serious reaction such as SJS, TEN or AGEP with the use of Rifinah, treatment with Rifinah must not be restarted in this patient at any time.
Paradoxical drug reaction After initial improvement of tuberculosis under therapy with Rifinah, the symptoms may worsen again. In affected patients, clinical or radiological deterioration of existing tuberculous lesions or the development of new lesions have been detected.
Such reactions have been observed within the first few weeks or months of initiation of tuberculosis therapy. Cultures are usually negative, and such reactions do not usually indicate treatment failure. The cause of this paradoxical reaction is still unclear, but an exaggerated immune reaction is suspected as a possible cause.
In case a paradoxical reaction is suspected, symptomatic therapy to suppress the exaggerated immune reaction should be initiated if necessary. Furthermore, continuation of the planned tuberculosis combination therapy is recommended.
Patients should be advised to seek medical advice immediately if their symptoms worsen. The symptoms that occur are usually specific to the affected tissues. 8). Rifinah should be discontinued if an alternative aetiology for the signs and symptoms cannot be established.
Warnings and precautions associated with rifampicin Patients with impaired liver function should only be given rifampicin in cases of necessity, and then with caution and under close medical supervision. In these patients, lower doses of rifampicin are recommended and careful monitoring of liver function, especially serum glutamic pyruvic transaminase (SGPT) and serum glutamic oxaloacetic transaminase (SGOT) should initially be carried out prior to therapy, weekly for two weeks, then every two weeks for the next six weeks.
If signs of hepatocellular damage occur, rifampicin should be withdrawn. Rifampicin should also be withdrawn if clinically significant changes in hepatic function occur. The need for other forms of antituberculosis therapy and a different regimen should be considered.
Urgent advice should be obtained from a specialist in the management of tuberculosis. If rifampicin is re-introduced after liver function has returned to normal, liver function should be monitored daily. In patients with impaired liver function, elderly patients, malnourished patients and possibly children […]