Dr James Schaller
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Tindamax Education Data: Risks and Cautions

While no hand out on a medication is perfect, in this one we try to give you a sense of some side effects and risks. The use of this medication in Lyme is both OFF LABEL, and NOT the standard of care by most infectious disease physicians. They feel Lyme is gone with 30 days of antibiotics.

Some clinical physicians who treat Lyme, believe that the cyst form of Lyme is not a dead breakdown product of killed Lyme bacteria, but is actually an active seed-like structure. Just be aware that most physicians feel all Lyme is dead with one antibiotic in 30 days.

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Approved by the FDA in May 2004, Tindamax marked the first advancement in the treatment of various parasites like trichomoniasis in over 40 years.

Tindamax has been found to provide long lasting action with low risk of stomach upset and is believed to spare protective vaginal lactobacilli.

Side Effects

3% of patients report nausea.

1.5% had vomiting. We hope starting this medication slowly will decrease this uncomfortable side effect.

Other side effects are: metal taste, belly pain, decreased appetite, weakness and fatigue.

Cancer Risk

Another drug related to this one and in the same family, Metronidazole, has been reported to be carcinogenic in mice and rats but not hamsters. In several studies metronidazole showed evidence of pulmonary, hepatic and lymphatic tumorigenesis in mice and mammary and hepatic tumors in female rats. Tinidazole carcinogenicity studies in rats, mice or hamsters have not been reported.

While we do not have enough data to offer full information on the cancer risk of this medication, it is recommended, "unnecessary use of a tinidazole should be avoided." Of course, since most infection physicians would say chronic Lyme does not exist after 30 days, they would also say there is not need to use it.

Drug Interactions

Warfarin and other oral coumarin anticoagulants. Tinidazole may enhance the effect of warfarin and other coumarin anticoagulants, resulting in a prolongation of prothrombin time.

Alcohols, Disulfiram. Alcoholic beverages and preparations containing ethanol or propylene glycol should be avoided during tinidazole therapy and for three days afterward because abdominal cramps, nausea, vomiting, headaches and flushing may occur. Psychotic reactions have been reported in alcoholic patients using metronidazole and disulfiram concurrently. Though no similar reactions have been reported with tinidazole, tinidazole should not be given to patients who have taken disulfiram within the last two weeks.

Lithium. Metronidazole has been reported to elevate serum lithium levels. It is not known if tinidazole shares this property with metronidazole.

Phenytoin, Fosphenytoin. Administration of oral metronidazole and intravenous phenytoin was reported to result in prolongation of the half-life and reduction in the clearance of phenytoin.

Cyclosporine, Tacrolimus. There are several case reports suggesting that metronidazole has the potential to increase the levels of cyclosporine and tacrolimus. During tinidazole co-administration with either of these drugs, the patient should be monitored for signs of calcineurin-inhibitor associated toxicities.

Fluorouracil. Metronidazole was shown to decrease the clearance of fluorouracil, resulting in an increase in side-effects without an increase in therapeutic benefits. If the concomitant use of tinidazole and fluorouracil cannot be avoided, the patient should be monitored for fluorouracil-associated toxicities.

Simultaneous administration of tinidazole with phenobarbital, rifampin, phenytoin and fosphenytoin (a pro-drug of phenytoin) may accelerate the elimination of tinidazole, decreasing the plasma level of tinidazole. Simultaneous administration of drugs that inhibit the activity of liver microsomal enzymes, such as cimetidine and ketoconazole, may prolong the half-life and decrease the plasma clearance of tinidazole, increasing the plasma level of tinidazole.

Cholestyramine. Cholestyramine was shown to decrease the oral bioavailability of metronidazole by 21%. Thus, it is advisable to separate dosing of cholestyramine and tinidazole to minimize any potential effect on the oral bioavailability of tinidazole.

Oxytetracycline. Oxytetracycline was reported to antagonize the therapeutic effect of metronidazole.

ALL POSSIBLE DRUG INTERACTIONS ARE NOT KNOWN NOR INCLUDED ON THIS LIST.

Drug/Laboratory Test Interactions

Tinidazole, like metronidazole, may interfere with certain types of determinations of serum chemistry values, such as AST/SGOT, ALT/ SGPT, LDH, triglycerides, and hexokinase glucose. Values of zero may be observed.

Other Warnings

Tindamax has not been studied in pregnant women. Tindamax crosses the placental barrier and is contraindicated during the first trimester of pregnancy. If you could become pregnant, use two forms of birth control, and report any possible pregnancy to your family doctor, your GYN and Dr. Schaller immediately. All single birth control forms fail. Period. Injury to the fetus is possible.

Convulsive seizures are possible.

Nerve problems called "peripheral neuropathy" has been reported and typically with numb feelings or sleepy feelings in hands arms, legs or feet.

If you have any abnormal neurological signs or symptoms stop taking the drug and have a prompt neurology evaluation. If you already have any neurological illness or brain illness, you are at a risk when taking this medication signs.

If you have liver problems you will most likely accumulate the drug in your blood and dose adjustments need to be made. Since this medication is broken down in the liver, you always have a risk of liver damage.

Do not drink alcoholic beverages while taking Tindamax and for four days after you are done.

If you have any history of blood cell abnormalities, you are at higher risk for blood cell disease while using this medication. This medication might also cause blood problems.

Dosing

The dosing for the treatment of any Lyme form, cyst or otherwise, is not approved by the FDA. Indeed, it is not the accepted approach of most infection specialists.

You will be proposed taking this medication longer than is common. For example, for Amebiasis infections in the Intestines adults take a 2 g dose per day for 3 days taken with food. And then are felt to be cured. In children older than three years of age, 50 mg/kg/day (up to 2 g per day) is given for 3 days with food.

It would start any dose at a low dose and increase only after you have no side effects.

Source: package insert, www.tindamax.com and www.drugs.com/tindamax.html



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