Description:
Tinidazole is a drug used against protozoan infections. It is widely known throughout Europe and the developing world as a treatment for a variety of amoebic and parasitic infections. It was developed in 1972 and is a prominent member of the nitroimidazole antibiotic class.
Tinidazole is marketed by Mission Pharmacal under the brand name Tindamax, by Pfizer under the names Fasigyn and Simplotan, and in some Asian countries as Sporinex.
Basic information:
Chemical name: Tinidazole
MF: C8H13N3O4S
MW: 247.27
CAS: 19387-91-8
Appearance: white powder
Purity: over 99%
Usage: antitrichomonal drug
COA:
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Product name | Tinidazole | ||
CAS No. | 19387-91-8 | Outer Packing | 50KG |
Production date | 2017.02.20 | Shelf life | 2019.02.19 |
Standard adopted | SFDA(IDL) | ||
Items of analysis | Specification | Results | |
Characters |
White or pale yellow crystalline powder |
Conforms | |
Solubility | Practically insoluble in water , soluble in acetone and in methylene chloride, springly soluble in methanol. | Conforms | |
Identification | 1,2,3 | Conforms | |
Appearance of solution | The sample soiution is clear.Any opalescence produced with test solution is moatnore produced is not more pronounced than reference suspension 1and any colour produced is not more intense than reference solutiom Y5 | Conforms | |
Impurity A | NMT 0.2% | N.D | |
Impurity B | NMT 0.2% | 0.053% | |
Any other unidentified impurity | NMT0.1% | 0.054% | |
Total impurities | NMT 0.4% | 0.170% | |
Monochlorobenzene | ≤ 360ppm | 10ppm | |
Loss on drying | NMT 0.5% | 0.24% | |
Sulphated ash | NMT 0.1% | 0.04% | |
Heavy metals | NMT 10ppm | Conforms | |
Assay | NLT 99.0% | 100.13% | |
Conclusion | Qualified |
Background:
Tinidazole (tye nid' a zole) is an oral, broad spectrum antimicrobial that has activity against bacteria as well as several parasites such as Entamoeba histolytica, Giardia duodenalis and Trichomonas vaginalis. Â Tinidazole is a nitroimidazole similar to metronidazole and is activated intracellularly by bacterial or parasitic enzymes to a radical anion, which damages large protein molecules and DNA. Â Tinidazole was approved for use in the United States in 2004 and current indications are for treatment of trichomoniasis, giardiasis, amebiasis and bacterial vaginosis. Â Tinidazole is available in tablets of 250 and 500 mg and the dose varies by indication, being 2 grams as a single oral dose in adults with trichomoniasis and giardiasis, and for 3 to 5 days for moderate or severe forms of amebiasis. Â Oral tinidazole is generally well tolerated if being used generally for only 1 to 5 days. Â Side effects can include metallic or bitter taste, fatigue, dizziness, headache, dyspepsia, nausea, and a disulfiram-like response to alcohol. Â Rare, but potential serious adverse events include allergic reactions, anaphylaxis and toxic megacolon.
How to use Tinidazole:
Take this medication by mouth as directed by your doctor, usually once daily. To prevent stomach upset, take this medication with food. The dosage is based on your medical condition and response to treatment. For children, the dosage is also based on weight.
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 until the full prescribed amount is finished, even if symptoms disappear after a short time. Stopping the medication too early may result in a return of the infection.
Tell your doctor if your condition lasts or gets worse.
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of tinidazole in children below 3 years of age. Safety and efficacy have not been established. It is only used in children three years of age and older for the treatment of giardiasis and amebiasis .
Geriatric
Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of tinidazole in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require adjustment of dosage in patients receiving tinidazole.
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