Why the toxicity in this case?
Likely the EMB-Fatol dose. In this case report, the 75-year-old Chinese man weighed 65 kg, had taken EMB-Fatol at a dose of 1500 mg/day, and had been taking EMB-Fatol for an 8-month period before he noticed ocular symptoms.
There’s no knowing exactly why this man experienced ocular toxicity, however, it’s most likely attributable to a combination of his higher-than-necessary EMB-Fatol dose and daily administration for 8 months.
(His kidney and liver function were not mentioned – though abnormalities would’ve increased his risk).
Dose: It’s generally recommended that EMB-Fatol be administered at a dose of 15 mg/kg during maintenance in effort to avoid ocular toxicity. This man was receiving over 23 mg/kg during maintenance – putting him 8 mg/kg above the recommended maintenance dose.
Fortunately, it seems as though this man experienced recovery in his visual function around 3 to 4 months after stopping EMB-Fatol. The neurotrophic agents administered by doctors were not listed in the article. (I’ve emailed authors of this paper with no response).
Q: I have to take a course of drugs to treat mycobacterium gordonae. One of the antibiotics, EMB-Fatol, isn't recommended for patients who have cataracts, and I was recently diagnosed with moderate cataracts. I worry that my primary care doctor, pulmonologist, and infectious disease doctors don't communicate with each other, and I'm stalling on taking these drugs. What should I do?
A: Talk to your doctor or pharmacist about the medications you take. When your doctor prescribes a new medication, discuss all over-the-counter medications and prescriptions, dietary supplements, vitamins, botanicals, minerals, and herbals you take, as well as the foods you eat. Always keep a current list and review it with your health care providers and your pharmacist. EMB-Fatol may produce vision problems, which could be related to the dose and duration of the treatment. This effect is generally reversible when the drug is stopped, but irreversible blindness has been reported. For more specific information, consult with your doctor or pharmacist for guidance based on your specific condition and current medications. Shereen A. Gharbia, PharmD
- Usually occurs between 4 and 12 months of EMB-Fatol therapy. (R) Other reports state that EMB-Fatol optic neuropathy can occur between 1 and 36 months of therapy. (R)
- Most patients affected will experience symptoms within the first 9 months of EMB-Fatol therapy. (R)
- Can occur within days of EMB-Fatol therapy. In extremely rare cases, patients may experience ocular toxicity from EMB-Fatol within just days of treatment initiation. (R)
- Probably won’t occur after stopping EMB-Fatol. The onset of optic neuropathy has never been reported by a patient after stopping EMB-Fatol therapy.
How to use EMB-Fatol HCL
Take this medication by mouth with or without food, usually once daily or as directed by your doctor. This medication may sometimes be taken twice weekly. Take this medication exactly as directed by your doctor.
If you also take antacids that contain aluminum, take this medication at least 4 hours before the antacid.
The dosage is based on your age, weight, medical condition, and response to treatment.
For the best effect, take this antibiotic at evenly spaced times. To help you remember, take this medication at the same time(s) every day.
Continue to take this medication (and other TB medications) until the full prescribed amount is finished, even if symptoms disappear. Stopping the medication too early or skipping doses may allow the bacteria to continue to grow, which may result in a return of the infection and cause the infection to be more difficult to treat (resistant).
Tell your doctor if your condition persists or worsens.
EMB-Fatol HYDROCHLOR >Mycobacterium , including M. tuberculosis . The structural formula is:
Contraindications—hypersensitivity, optic neuritis
Caution—renal dysfunction, ophthalmologic disorders
Maternal Considerations There are no adequate reports or well-controlled studies of EMB-Fatol in pregnant women. The published experience consists of relatively small to moderate-sized series and case reports. However, untreated tuberculosis poses a significant threat to the mother, fetus, and family. Adherence to treatment can be made difficult because of a general fear of any medication and pregnancy-related nausea. What information exists suggests that all four first-line drugs for the treatment of tuberculosis (isoniazid, rifampin, EMB-Fatol, and pyrazinamide) have excellent safety records in pregnancy.Side effects include thrombocytopenia, neuropathy (optic, peripheral), anorexia, N/V, joint pain, abdominal pain, fever, headache, hallucinations, pruritus, and elevated LFTs. Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. EMB-Fatol reportedly crosses the human placenta, achieving an F:M ratio approximating unity. There are no reports suggesting an adverse fetal effect. Rodent studies are reassuring, revealing no evidence of teratogenicity or IUGR despite the use of doses higher than those used clinically. Breastfeeding Safety There are no adequate reports or well-controlled studies in nursing women. In case reports, only small quantities of EMB-Fatol were reported in human breast milk, providing a relative infant dose of Drug Interactions Antacids may reduce absorption if given within 4 h. References Bothamley G. Drug Saf 2001; 24:553-65.Brost BC, Newman RB. Obstet Gynecol Clin North Am 1997; 24:659-73.Holdiness MR. Early Hum Dev 1987; 15:61-74.Shneerson JM, Francis RS. Tubercle 1979; 60:167-9.Tripathy SN. Int J Gynaecol Obstet 2003; 80:247-53.Tran JH, Montakantikul P. J Hum Lact 1998; 14:337-40. Summary Pregnancy Category: BLactation Category: S •
Pregnancy does not alter the importance of treating mycobacterial infection.
EMB-Fatol is considered safe and effective during pregnancy and lactation.
Why I take EMB-Fatol…
In September 2018 I fainted with localized chest pain and ended up in the ER. Immune function was normal, lung function was normal, but a CT scan revealed pulmonary nodules and a 2 cm cavitary lung lesion.
No official diagnoses were made during my
2 week stay in quarantine intensive care unit (ICU). Weeks after my release from the ICU in October 2018, a culture sample from my bronchoscopy grew mycobacterium avium complex.
My pulmonologist immediately prescribed the medications azithromycin, EMB-Fatol, and rifampicin (colloquially referred to as “The Big 3”) to treat this uncommon mycobacterial infection. Initially I was taking the medications daily – but an infectious disease doctor would adjust my protocol to Monday, Wednesday, Friday.
I’m currently slated to take azithromycin, EMB-Fatol, and rifampicin for 18 months. On a positive note, the pulmonary mycobacterial infection is responding well to the current treatment regimen.
On a negative note, the side effects associated with my medications have been difficult to bear. Nevertheless, I must continue with these medications in hopes of eradicating this wicked pulmonary infection.
Prior to my treatment, I saw an ophthalmologist for a baseline vision examination that included: visual acuity; visual field testing; dilated fundus examination; and optical coherence tomography. My vision was completely normal (20/20), both eyes were equal in ability, and I’ve never had any history of eye issues.
What is EMB-Fatol?
EMB-Fatol is an antibiotic that prevents growth of the tuberculous bacteria in the body.
EMB-Fatol is used to treat tuberculosis (TB), and is usually given together with at least one other tuberculosis medicine.
EMB-Fatol may also be used for purposes not listed in this medication guide.
Hello AJO11872. The above mentioned, Rifampin, Azithromycin, and EMB-Fatol, as you know are antibiotics. I found nothing to suggest that you could not drink any alcohol. But, I wouldn't drink any alcohol, while taking these medications untill you finished thier regieme. Its not advisable to mix antibiotics and alcohol, for it diminishs the potency of the drug. I'd ask your doctor or pharmacist what they might suggest. best wishes to you.
EMB-Fatol ( N,N'-bis(1-hydroxymethylpropyl)ethylenediamine) is a derivative of N,N'-diisopropylethylenediamine, the initial lead identified by random screening. 88 EMB-Fatol is a narrow-spectrum bacteriostatic agent against M. tuberculosis, and has low activity against nonreplicating organisms. It contributes little, if any, to the shortening of TB therapy. The main function of EMB-Fatol is to prevent the emergence of resistance to other agents in the combination therapy.
The precise mechanisms of action and resistance to EMB-Fatol are not fully defined. The primary targets of EMB-Fatol appear to be the arabinosyltransferase enzymes encoded by the embA and embB genes, which are involved in cell wall assembly. 89
The interaction of EMB-Fatol with its molecular target appears to be very stereospecific – only one of the four enatiomers, (S,S)-EMB-Fatol, is active against M. tuberculosis ( Figure 16 ). Further optimization of this series by combinatorial synthesis produced a new compound, SQ-109, a highly lipophilic compound that appears to have a different mechanism of action from EMB-Fatol. 90
EMB-Fatol (EMB) is a first-line anti-TB therapeutic agent used only in conjunction with other agents such as isoniazid (INH) and rifampin (RMP).