R-Cinex/R-Cinex Kid Side effects

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Side effects of R-Cinex/R-Cinex Kid in details

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Rifampicin (R-Cinex/R-Cinex Kid): Reactions to Rifampicin (R-Cinex/R-Cinex Kid) occurring with either daily or intermittent dosage regimens include: Cutaneous reactions which are mild and self-limiting may occur and do not appear to be hypersensitivity reactions. Typically they consist of flushing and itching with or without a rash. Urticaria and more serious hypersensitivity reactions occur but are uncommon. Exfoliative dermatitis, pemphigoid reaction, erythema multiforme including Stevens-Johnson syndrome, Lyell's syndrome and vasculitis have been reported rarely.

Gastrointestinal reactions consist of anorexia, nausea, vomiting, abdominal discomfort, and diarrhoea. Pseudomembranous colitis has been reported with Rifampicin (R-Cinex/R-Cinex Kid) therapy.

Hepatitis can be caused by Rifampicin (R-Cinex/R-Cinex Kid) and liver function tests should be monitored.

Central Nervous System: Psychoses have been rarely reported.

Thrombocytopenia with or without purpura may occur, usually associated with intermittent therapy, but is reversible if drug is discontinued as soon as purpura occurs. Cerebral haemorrhage and fatalities have been reported when Rifampicin (R-Cinex/R-Cinex Kid) administration has been continued or resumed after the appearance of purpura.

Disseminated intravascular coagulation has also been rarely reported.

Eosinophilia, leucopenia, oedema, muscle weakness and myopathy have been reported to occur in a small percentage of patients treated with Rifampicin (R-Cinex/R-Cinex Kid).

Agranulocytosis has been reported very rarely reported.

Rare reports of adrenal insufficiency in patients with compromised adrenal function have been observed.

Reactions usually occurring with intermittent dosage regimens and probably of immunological origin include: 'Flu syndrome' consisting of episodes of fever, chills, headache, dizziness, and bone pain appearing most commonly during the 3rd to the 6th month of therapy. The frequency of the syndrome varies but may occur in up to 50 % of patients given once-weekly regimens with a dose of Rifampicin (R-Cinex/R-Cinex Kid) of ≥25 mg/kg. Shortness of breath and wheezing; decrease in blood pressure and shock; anaphylaxis; acute haemolytic anemia; acute renal failure usually due to acute tubular necrosis or acute interstitial nephritis.

If serious complications arise eg, renal failure, thrombocytopenia or haemolytic anemia, Rifampicin (R-Cinex/R-Cinex Kid) should be stopped and never restarted.

Occasional disturbances of the menstrual cycle have been reported in women receiving long-term antituberculosis therapy with regimens containing Rifampicin (R-Cinex/R-Cinex Kid).

Rifampicin (R-Cinex/R-Cinex Kid) may produce a reddish coloration of the urine, sweat, sputum and tears. The patient should be forewarned of this. Soft contact lenses may be permanently stained.

Isoniazid: Hypersensitivity Reactions: Fever, anaphylactic reactions.

Nervous System: Vertigo; polyneuritis, presenting as paresthesia, muscle weakness, loss of tendon reflexes, etc, is unlikely to occur with the recommended daily dose of Rifampicin (R-Cinex/R-Cinex Kid) + isoniazid fixed-dose combination. The incidence is higher in "slow acetylators". Other neurotoxic effects, which are uncommon with conventional doses, are convulsions, toxic encephalopathy, optic neuritis and atrophy, memory impairment and toxic psychosis. The possibility that the frequency of seizures may be increased in patients with epilepsy should be borne in mind.

Cutaneous: Rash, acne, Stevens-Johnson syndrome, exfoliative dermatitis and pemphigus.

Hematologic: Eosinophilia, agranulocytosis, thrombocytopenia, anemia, aplastic anaemia and haemolytic anaemia.

Gastrointestinal: Pancreatitis, constipation, dry mouth, nausea, vomiting and epigastric distress.

Hepatic: Severe and sometimes fatal hepatitis may occur with isoniazid therapy.

Reproductive System and Breast Disorders: Gynaecomastia.

Investigations: Antinuclear antibodies.

Metabolism and Nutrition Disorders: Hyperglycaemia.

Miscellaneous: Pellagra, systemic lupus erythematosus-like syndrome.

R-Cinex/R-Cinex Kid contraindications

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Patients who are hypersensitive to rifamycins or isoniazid or any of the excipients of R-Cinex/R-Cinex Kid. Rifampicin (R-Cinex/R-Cinex Kid) + isoniazid fixed-dose combination is contraindicated in the presence of jaundice. When given concurrently with the combination of saquinavir/ritonavir.

References

  1. DailyMed. "ISONIAZID; RIFAMPIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DTP/NCI. "Rifampicin: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
  3. European Chemicals Agency - ECHA. "Rifampicin: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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