Overdose of R-Cinex/R-Cinex Kid in details
Symptoms: Rifampicin (R-Cinex/R-Cinex Kid): Nausea, vomiting, abdominal pain, pruritus, headache and increasing lethargy will probably occur within a short time after acute ingestion; unconsciousness may occur when there is severe hepatic disease. Transient increases in liver enzymes and/or bilirubin may occur. Brownish-red or orange coloration of the skin, urine, sweat, saliva, tears and feces will occur, and its intensity is proportional to the amount ingested. Facial or periorbital edema has also been reported in pediatric patients. Hypotension, sinus tachycardia, ventricular arrhythmias, seizures and cardiac arrest were reported in some fatal cases.
The minimum acute lethal or toxic dose is not well established. However, nonfatal acute overdoses in adults have been reported with doses ranging from Rifampicin (R-Cinex/R-Cinex Kid) 9-12 g. Fatal acute overdoses in adults have been reported with doses ranging from 14-60 g. Alcohol or a history of alcohol abuse was involved in some of the fatal and nonfatal reports. Nonfatal overdoses in pediatric patients ages 1-4 years of 100 mg/kg for 1-2 doses have been reported.
Isoniazid: Isoniazid overdosage produces signs and symptoms within 30 min to 3 hrs after ingestion. Nausea, vomiting, dizziness, slurring of speech, blurring of vision, and visual hallucinations (including bright colours and strange designs) are among the early manifestations. With marked overdosage, respiratory distress and CNS depression, progressing rapidly from stupor to profound coma are to be expected, along with severe, intractable seizures. Severe metabolic acidosis, acetonuria and hyperglycaemia are typical laboratory findings.
Treatment: In cases of overdosage with Rifampicin (R-Cinex/R-Cinex Kid) + isoniazid fixed-dose combination, gastric lavage should be performed as soon as possible. Following evacuation of the gastric contents, the instillation of activated charcoal slurry into the stomach may help absorb any remaining drug from the gastrointestinal tract. Antiemetic medication may be required to control severe nausea and vomiting.
Intensive supportive measures should be instituted, including airway patency, and individual symptoms treated as they arise.
If acute isoniazid overdose is suspected, even in asymptomatic patients, the administration of IV pyridoxine (vitamin B6) should be considered. In patients with seizures not controlled with pyridoxine, anticonvulsant therapy should be administered. Sodium bicarbonate should be given to control metabolic acidosis. Hemodialysis is advised for refractory cases; if this is not available, peritoneal dialysis can be used along with forced diuresis.
R-Cinex/R-Cinex Kid precautions
Rifampicin (R-Cinex/R-Cinex Kid) + isoniazid fixed-dose combination 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 Rifampicin (R-Cinex/R-Cinex Kid) + isoniazid fixed-dose combination 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.
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 >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, IV drug use and being a Black or Hispanic woman.
If the patient has no evidence of preexisting 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.
Rifampicin (R-Cinex/R-Cinex Kid): Serious immunological reactions resulting in renal impairment, haemolysis or thrombocytopenia are on record in patients who resume taking Rifampicin (R-Cinex/R-Cinex Kid) after a prolonged lapse of treatment. In this rare situation, Rifampicin (R-Cinex/R-Cinex Kid) should be immediately and permanently withdrawn.
Clinical monitoring (and liver function tests, if possible) should be performed during treatment of all patients with preexisting liver disease, who are at increased risk of further liver damage.
Patients should be warned that treatment may cause reddish coloration of all body secretions (urine, tears, saliva, sweat, semen and sputum), and that contact lenses and clothing may be irreversibly stained.
Isoniazid: Use of isoniazid should be carefully monitored in patients with current chronic liver disease or severe renal dysfunction. Severe and sometimes fatal hepatitis associated with isoniazid therapy may occur and may develop even after many months of treatment. The risk of developing hepatitis is age related. Therefore, patients should be monitored for the prodromal symptoms of hepatitis eg, fatigue, weakness, malaise, anorexia, nausea or vomiting. If these symptoms appear or if signs suggestive of hepatic damage are detected, isoniazid should be discontinued promptly, since continued use of the drug in these cases has been reported to cause a more severe form of liver damage.
Care should be exercised in the treatment of elderly or malnourished patients who may also require vitamin B6 supplementation with the isoniazid therapy.
Use of isoniazid should be carefully monitored in patients with slow acetylator status, epilepsy, history of psychosis, history of peripheral neuropathy, diabetes, alcohol dependence, HIV infection or porphyria.
Effects on the Ability to Drive or Operate Machinery: Isoniazid has been associated with vertigo, visual disorders and psychotic reactions. Patients should be informed of these, and advised that if affected, they should not drive, operate machinery or take part in any activities where these symptoms may put either themselves or others at risk.
Use in Pregnancy & Lactation: Rifampicin (R-Cinex/R-Cinex Kid): Rifampicin (R-Cinex/R-Cinex Kid) has been shown to be teratogenic in rodents when given in large doses. There are no well controlled studies with Rifampicin (R-Cinex/R-Cinex Kid) + isoniazid fixed-dose combination in pregnant women. Although Rifampicin (R-Cinex/R-Cinex Kid) has been reported to cross the placental barrier and appear in cord blood, the effect of Rifampicin (R-Cinex/R-Cinex Kid), alone or in combination with other antituberculosis drugs, on the human foetus is not known.
When administered during the last few weeks of pregnancy, Rifampicin (R-Cinex/R-Cinex Kid) can cause postnatal haemorrhages in the mother and infant, for which treatment with Vitamin K1 may be indicated.
Isoniazid: It has been reported that in both rats and rabbits, isoniazid may exert an embryocardial effect when administered orally during pregnancy, although no isoniazid-related congenital anomalies have been found in reproduction studies in mammalian species (mice, rats, rabbits).
Therefore, Rifampicin (R-Cinex/R-Cinex Kid) + isoniazid fixed-dose combination should be used in pregnant women or in women of childbearing potential only if the potential benefit justifies the potential risk to the fetus.
Rifampicin (R-Cinex/R-Cinex Kid) and isoniazid are excreted in breast milk and infants should not be breastfed by a patient receiving Rifampicin (R-Cinex/R-Cinex Kid) + isoniazid fixed-dose combination unless in the physician's judgment the potential benefit to the patient outweighs the potential risk to the infant.
In breastfed infants whose mothers are taking isoniazid, there is a theoretical risk of convulsions and neuropathy (associated with vitamin B6 deficiency), therefore, they should be monitored for early signs of these effects and consideration should be given to treating both mother and infant prophylactically with pyridoxine.
References
- 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).
- DrugBank. "Rifampicin". http://www.drugbank.ca/drugs/DB01045 (accessed September 17, 2018).
- MeSH. "Leprostatic Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
