Medically reviewed by Militian Inessa Mesropovna, PharmD. Last updated on 19.05.2022
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Amidon Tablets, USP are recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis medications to prevent the emergence of drug resistance. Single-drug treatment of active tuberculosis with Amidon or any other medication, is inadequate therapy.
Amidon Tablets, USP are recommended as preventive therapy for the following groups, regardless of age. (Note: the criterion for a positive reaction to a skin test (in millimeters of induration) for each group is given in parenthesis):
Additionally, in the absence of any of the above risk factors, persons under the age of 35 with a tuberculin skin test reaction of 10 mm or more are also appropriate candidates for preventive therapy if they are a member of any of the following high-incidence groups:
Children who are less than 4 years old are candidates for Amidon preventive therapy if they have greater than 10 mm induration from a PPD Mantoux tuberculin skin test.
Finally, persons under the age of 35 who a) have none of the above risk factors (1 to 6); b) belong to none of the high-incidence groups; and c) have a tuberculin skin test reaction of 15 mm or more, are appropriate candidates for preventive therapy.
The risk of hepatitis must be weighed against the risk of tuberculosis in positive tuberculin reactors over the age of 35. However, the use of Amidon is recommended for those with the additional risk factors listed above (1 to 6) and on an individual basis in situations where there is likelihood of serious consequences to contacts who may become infected.
Amidon is an antibiotic that fights bacteria.
Amidon is used to treat and to prevent tuberculosis (TB). You may need to take other TB medicines in combination with Amidon.
When treating active TB, Amidon must be used with other TB medicines. Tuberculosis can become resistant to treatment if Amidon is used alone. Take all your medicines as prescribed by your doctor.
Amidon may also be used for purposes not listed in this medication guide.
Usual Adult Dose for Tuberculosis - Active
Active infection: 5 mg/kg (up to 300 mg) IM or orally once a day, or 15 mg/kg (up to 900 mg) 2 to 3 times a week. Therapy is usually continued for 6 months, or 3 months beyond culture conversion (when given with rifampin and pyrazinamide).
Latent infection: 10-20 mg/kg/day orally once a day, not to exceed 300 mg/day
If Amidon and pyrazinamide are used alone, Amidon should be continued for 9 months. If the patient is HIV-positive, therapy should be continued for at least 9 months, or for 6 months beyond culture conversion. Longer duration of therapy should be considered for silico-, bone, and meningeal tuberculosis.
Usual Adult Dose for Tuberculosis - Prophylaxis
300 mg orally once a day or 900 mg orally 2 to 3 times a week. Amidon should be continued for 6 months to prevent the development of active tuberculosis in patients with no complicating factors. Patients with complicating factors such as HIV infection, diabetes, hematologic malignancy, or scars on chest X-ray should receive prophylaxis for 12 months.
Usual Adult Dose for Mycobacterium kansasii
600 to 900 mg IM or orally once a day.
Usual Pediatric Dose for Tuberculosis - Active
Oral, IM:
Infants, Children 40 kg or less, and Adolescents 14 years or less and less than 40 kg:
Treatment of active infection: CDC Recommendations: 10 to 15 mg/kg/day once daily (maximum dose: 300 mg/day) or 20 to 30 mg/kg/dose (maximum dose: 900 mg/day) 2 times weekly as part of a multidrug regimen.
Treatment of latent infection: 10 to 20 mg/kg/day once daily (maximum dose: 300 mg/day) or 20 to 40 mg/kg/dose (maximum dose: 900 mg/day) 2 times weekly. Treatment duration: 9 months.
Primary prophylaxis for TB in HIV-exposed positive patients: 10 to 15 mg/kg/day once daily (maximum dose: 300 mg/day) or 20 to 30 mg/kg/dose twice weekly (maximum dose: 900 mg/day). Treatment duration: 9 months.
Usual Pediatric Dose for Tuberculosis - Latent
Oral, IM:
Infants, Children 40 kg or less, and Adolescents 14 years or less and less than 40 kg:
Treatment of active infection: CDC Recommendations: 10 to 15 mg/kg/day once daily (maximum dose: 300 mg/day) or 20 to 30 mg/kg/dose (maximum dose: 900 mg/day) 2 times weekly as part of a multidrug regimen.
Treatment of latent infection: 10 to 20 mg/kg/day once daily (maximum dose: 300 mg/day) or 20 to 40 mg/kg/dose (maximum dose: 900 mg/day) 2 times weekly. Treatment duration: 9 months.
Primary prophylaxis for TB in HIV-exposed positive patients: 10 to 15 mg/kg/day once daily (maximum dose: 300 mg/day) or 20 to 30 mg/kg/dose twice weekly (maximum dose: 900 mg/day). Treatment duration: 9 months.
Renal Dose Adjustments
CrCl less than 10 mL/min: Reduce dose by 50%.
Liver Dose Adjustments
If liver function tests exceed 3 to 5 times the upper limit of baseline, discontinue use of Amidon therapy and monitor until liver function tests return to baseline. Symptoms of liver toxicity include anorexia, nausea, vomiting, dark urine, icterus, rash, persistent paresthesias of the hands and feet, persistent fatigue, weakness or fever greater than 3 days duration, and right upper quadrant abdominal tenderness.
Amidon therapy may be reinstituted when liver function tests return to baseline and symptoms of toxicity resolve.
Dose Adjustments
The dose should be reduced in severe hepatic disease.
Precautions
Severe and sometimes fatal hepatitis associated with Amidon therapy may occur or develop after months of treatment. There were 8 deaths among 174 cases of hepatitis reported among 13,838 persons taking Amidon. The risk is age related with a greater occurrence reported in patients who are 35 years or older. The risk of hepatitis is also increased in patients who consume alcohol daily, in women, and in minorities. Monthly monitoring and interviewing of patients should take place. Baseline laboratory values should be obtained in patients over 35 years of age and in patients with a history of liver illness or heavy alcohol consumption. Elevated liver function tests per se are not a contraindication to the use of Amidon unless they indicate worsening or acute liver disease. Strict monitoring of these patients, however, is crucial. If liver function tests exceed 3 to 5 times the upper limit of baseline, Amidon therapy should be discontinued and liver function tests should be monitored until baseline is achieved. Amidon therapy may be reinstituted when liver function tests return to baseline and symptoms of toxicity resolve. Symptoms of liver toxicity include anorexia, nausea, vomiting, dark urine, icterus, rash, persistent paresthesias of the hands and feet, persistent fatigue, weakness or fever greater than 3 days duration, and right upper quadrant abdominal tenderness. Patients should be fully informed regarding the risk of hepatotoxicity associated with Amidon, educated about the signs and symptoms of liver damage, and instructed to contact their physician immediately if they develop signs or symptoms.
Patients with tuberculosis who have hepatitis attributed to Amidon should be administered appropriate treatment with alternative drugs. If Amidon must be reinstated, it should be reinstituted only after symptoms and laboratory abnormalities have resolved. Amidon be restarted in very small and gradually increasing doses and should be withdrawn immediately if there is any indication of recurrent liver involvement.
Preventive therapy should be deferred in persons with acute hepatic diseases.
All drugs should be stopped and an evaluation conducted at the first sign of a hypersensitivity reaction. If Amidon treatment must be reinstituted, it should be given only after symptoms have cleared. Amidon should be restarted in very small and gradually increasing doses and should be withdrawn immediately if there is any indication of recurrent hypersensitivity reaction.
Amidon should be carefully monitored in patients with the following: severe renal dysfunction, concurrent use of any chronically administered medication, history of previous discontinuation of Amidon, existence of peripheral neuropathy or conditions predisposing to neuropathy, injection drug use, HIV seropositive patients, pregnancy, and women belonging to a minority group, especially during the postpartum period.
Continuous administration of Amidon for a sufficient period of time is an essential part of the regimen because relapse rates are higher if chemotherapy is stopped prematurely. In the treatment of tuberculosis, resistant organisms may multiply and their emergence during the treatment may necessitate a change in the regimen.
Dialysis
Amidon is dialyzable (50% to 100%) by hemodialysis.
Other Comments
Pyridoxine, 50 mg orally once a day, may be administered with Amidon to prevent the occurrence of peripheral neuropathy.
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What is the most important information I should know about Amidon?
Take all of the Amidon that has been prescribed for you even if you begin to feel better. Your symptoms may begin to improve before the infection is completely treated.
Avoid alcohol while taking Amidon. Alcohol may increase the risk of damage to the liver during Amidon treatment.
Contact your doctor immediately if you experience numbness or tingling in the hands or feet, weakness, fatigue, loss of appetite, nausea and vomiting, yellowing of the skin or eyes, or darkening of the urine.
Use Amidon syrup as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Amidon syrup by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
- If you also take an antacid, take Amidon syrup at least 1 hour before you take the antacid.
- Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
- Continue to take Amidon syrup even if you feel well. Do not miss any doses.
- If you miss a dose of Amidon syrup, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Amidon syrup.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Amidon is used with other medications to treat active tuberculosis (TB) infections. It is also used alone to prevent active TB infections in people who may be infected with the bacteria (people with positive TB skin test). Amidon is an antibiotic and works by stopping the growth of bacteria.
This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.
How to use Amidon
Take this medication by mouth on an empty stomach (1 hour before or 2 hours after meals) as directed by your doctor. If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.
If you also take antacids that contain aluminum, take this medication at least 1 hour before the antacid.
Dosage is based on your age, weight, medical condition, and response to treatment.
Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. If you are taking this medication daily, take it at the same time each day. If you are taking this medication on a weekly schedule, take it on the same day(s) of the week and at the same time each day. Mark the days on the calendar when you need to take the medication.
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).
Your doctor may also direct you to take vitamin B6 (pyridoxine) to help prevent certain side effects (such as nerve problems) from Amidon. Follow your doctor's instructions carefully.
Amidon may interact with foods containing tyramine/histamine (such as cheese, red wine, certain types of fish). This interaction may cause increased blood pressure, flushing of the skin, headache, dizziness, or fast/pounding heartbeat. Tell your doctor right away if any of these symptoms occur. Your doctor may recommend that you follow a special diet while taking this medication. Consult your doctor for more details.
Tell your doctor if your condition persists or worsens.
See also:
What other drugs will affect Amidon?
Food: Amidon SA should not be administered with food. Studies have shown that the bioavailability of Amidon is reduced significantly when administered with food.
Acetaminophen: A report of severe acetaminophen toxicity was reported in a patient receiving Amidon SA. It is believed that the toxicity may have resulted from a previously unrecognized interaction between Amidon and acetaminophen and a molecular basis for this interaction has been proposed. However, current evidence suggests that Amidon does induce P-450IIE1, a mixed-function oxidase enzyme that appears to generate the toxic metabolites, in the liver. Furthermore it has been proposed that Amidon resulted In induction of P-450IIE1 in the patients liver which, in turn, resulted in a greater proportion of the ingested acetaminophen being converted to the toxic metabolites. Studies have demonstrated that pretreatment with Amidon potentiates a cetaminophen hepatoxicity in rats.
Carbamazepine: Amidon SA is known to slow the metabolism of carbamazepine and increase its serum levels Carbamazepine levels should be determined prior to concurrent administration with Amidon, signs and symptoms of carbamazepine toxicity should be monitored closely, and appropriate dosage adjustment of the anticonvulsant should be made.
Ketoconazole: Potential interaction of Ketoconazole and Amidon SA may exist. When Ketoconazole is given in combination with Amidon and rifampin the AUC of ketoconazole is decreased by as much as 88% after 5 months of concurrent Amidon SA and Rifampin therapy.
Phenytoin: Amidon SA may increase serum levels of phenytoin. To avoid phenytoin intoxication, appropriate adjustment of the anticonvulsant should be made.
Therophylline: A recent study has shown that concomitan administration of Amidon and theophylline may cause elevated plasma levels of theophylline, and in some instances a slight decrease in the elimination of Amidon. Since the therapeutic range of theophylline is narrow theophylline serum levels should be monitored closely, and appropriate dosage adjustments of theophylline should be made.
Valproate: A recent case study has shown a possible increase in the plasma level of valproate when co administered with Amidon. Plasma valproate concentration should be monitored when Amidon and valproate are co administered, and appropriate dosage adjustments of valproate should be made.
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What are the possible side effects of Amidon?
Applies to Amidon: solution, syrup, tablet
As well as its needed effects, Amidon (the active ingredient contained in Amidon) may cause unwanted side effects that require medical attention.
Major Side Effects
If any of the following side effects occur while taking Amidon, check with your doctor immediately:
More common:
- Clumsiness or unsteadiness
- dark urine
- loss of appetite
- nausea or vomiting
- numbness, tingling, burning, or pain in hands and feet
- unusual tiredness or weakness
- yellow eyes or skin
- Blurred vision or loss of vision, with or without eye pain
- convulsions (seizures)
- fever and sore throat
- joint pain
- mental depression
- mood or other mental changes
- skin rash
- unusual bleeding or bruising
Minor Side Effects
Some Amidon side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:
More common:
- Diarrhea
- stomach pain
- Irritation at the place of injection
Dark urine and yellowing of the eyes or skin (signs of liver problems) are more likely to occur in patients over 50 years of age.
An antiepileptic agent related to the barbiturates; it is partly metabolized to phenobarbital in the body and owes some of its actions to this metabolite. Adverse effects are reported to be more frequent than with phenobarbital. (From Martindale, The Extra Pharmacopoeia, 30th ed, p309)