DRUGS & SUPPLEMENTS
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Cymex-TZ is a broad-spectrum antimicrobial drug of fluoroquinolone group with bactericidal action. Inhibits DNA gyrase and inhibits the synthesis of bacterial DNA. Highly active against most gram-negative bacteria: Pseudomonas aeruginosa, Haemophilus influenzae, Escherichia coli, Shigella spp., Salmonella spp., Neisseria meningitidis, Neisseria gonorrhoeae.
Cymex-TZ (Ciprofloxacin) is active against Staphylococcus spp. (including strains producing and not producing penicillinase, methicillin-resistant strains), some strains of Enterococcus spp., Campylobacter spp., Legionella spp., Mycoplasma spp., Chlamydia spp., Mycobacterium spp.
Cymex-TZ (Ciprofloxacin) is active against bacteria producing beta-lactamases.
Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides resistant to Cymex-TZ (Ciprofloxacin). The effect on Treponema pallidum is studied not enough.
Cymex-TZ (Ciprofloxacin) rapidly absorbed from the gastrointestinal tract. Bioavailability after oral administration of 70%. Eating has a little effect on the absorption of Cymex-TZ (Ciprofloxacin). Plasma protein binding is 20-40%. Distributed in tissues and body fluids. It penetrates the cerebrospinal fluid: the concentration of Cymex-TZ (Ciprofloxacin) for not inflamed meninges reach 10% with inflammation - up to 37%. High concentrations are achieved in bile. Excreted in the urine and bile.
Infectious-inflammatory diseases caused by microorganisms susceptible to Cymex-TZ (Ciprofloxacin), including respiratory diseases, diseases of abdominal and pelvic organs, bones, joints, skin, septicemia; severe infections of ENT organs. Treatment of postoperative infections. Prevention and treatment of infections in patients with reduced immunity.
For Cymex-TZ (Ciprofloxacin) local use: acute and subacute conjunctivitis, blepharoconjunctivitis, blepharitis, bacterial corneal ulcers, keratitis, keratoconjunctivitis, chronic dacryocystitis, meybomity. Infectious lesions in the eyes from injury or contact with foreign bodies. Preoperative prophylaxis in ophthalmic surgery.
Individual. For oral administration dose of Cymex-TZ is 250-750 mg 2 times / day. Treatment duration is from 7-10 days to 4 weeks.
For IV administration a single dose is 200-400 mg, the multiplicity of the introduction is 2 times / day, duration of treatment - 1-2 weeks and more if necessary. May be IV injected as jet but more preferably a drip for 30 minutes.
When Cymex-TZ (Ciprofloxacin) applied topically instilled 1-2 drops into the lower conjunctival sac of the affected eye every 1-4 hours. After improving the intervals between instillation can be increased. The maximum oral daily dose for adults is 1.5 g.
Digestive system: nausea, vomiting, diarrhea, abdominal pain, increase in liver transaminases, alkaline phosphatase, LDH, bilirubin, pseudomembranous colitis.
CNS: headache, dizziness, fatigue, insomnia, nightmares, hallucinations, fainting, disorders of vision.
Urinary system: crystalluria, glomerulonephritis, dysuria, polyuria, albuminuria, hematuria, transient increase of serum creatinine.
Hemopoietic system: eosinophilia, leukopenia, neutropenia, changes in the number of platelets.
Cardiovascular system: tachycardia, cardiac arrhythmias, hypotension.
Allergic reactions: itching, urticaria, Quincke's edema, Stevens-Johnson syndrome, arthralgia.
Adverse reactions associated with the chemotherapeutic effect: candidiasis.
Local reactions: pain, phlebitis (for IV injections). When applying eye drops in some cases may be mild pain and conjunctival hyperemia.
Pregnancy, lactation, childhood and adolescence to 15 years, increased sensitivity to Cymex-TZ (Ciprofloxacin) and other drugs hinolonovogo series; deficiency of glucose-6-phosphate dehydrogenase; in ophthalmology: viral keratitis.
Pronounced cerebral arteriosclerosis, cerebral circulatory disorder, mental illness, epilepsy, epileptic syndrome, marked renal and / or hepatic insufficiency.
Contraindicated in pregnancy ; Cymex-TZ (Ciprofloxacin) crosses the placenta, excreted in breast milk.
In experimental studies found that it causes arthropathy. In experiments on rats and mice treated with Cymex-TZ (Ciprofloxacin) in doses exceeding the usual daily dose for a person 6 times, adverse effects on the fetus is not revealed. In experiments on rabbits treated with oral dose of Cymex-TZ (Ciprofloxacin) 30 and 100 mg / kg, it is shown that the drug causes disruption of the gastrointestinal tract, leading to loss of body weight in females and increase the number of miscarriages but teratogenicity not found. When IV introduction to the doses of 20 mg / kg Cymex-TZ (Ciprofloxacin) did not exert toxic effects on the mother and embryo, showed no teratogenicity. The use of local forms of Cymex-TZ (Ciprofloxacin) in pregnancy is possible if the anticipated benefits exceed the potential risk to the fetus.
Category of the fetus by FDA - C.
Cymex-TZ (Ciprofloxacin) is excreted in breast milk, so the period of lactation should decide, stop taking Cymex-TZ (Ciprofloxacin) or breastfeeding based on the degree of importance of the use of drugs for the mother.
With careful use of local forms of Cymex-TZ (Ciprofloxacin) in breast-feeding (not known whether Cymex-TZ (Ciprofloxacin) is excreted in breast milk when applied topically).
Patients with impaired renal function requires correction dosing regimen. With caution used in elderly patients, with cerebral arteriosclerosis, cerebral circulatory disorders, epilepsy, convulsive syndrome of unknown etiology.
During treatment patients with Cymex-TZ (Ciprofloxacin) should receive enough amounts of liquids.
In the case of persistent diarrhea Cymex-TZ (Ciprofloxacin) should not be taken.
At the same time of Cymex-TZ (Ciprofloxacin) IV introduction and barbiturates is necessary to monitor heart rate, blood pressure, ECG. In the course of treatment is necessary to monitor blood concentrations of urea, creatinine, hepatic transaminases.
In the period of treatment may decrease the reactivity (especially when used with alcohol).
Not allowed the introduction of Cymex-TZ (Ciprofloxacin) subconjunctival or directly into the anterior chamber of the eye.
Due to the threat of adverse reactions from the CNS Cymex-TZ should be used only according to the life in the pathology of the CNS in history: organic brain lesions, epilepsy, lowering the convulsive threshold, severe atherosclerosis of the brain (risk of circulatory disorders, stroke), the elderly, with severely impaired renal function and liver (requires monitoring concentrations in blood plasma).
Patients with allergic reactions to fluoroquinolone derivatives in history may develop reactions to Cymex-TZ (Ciprofloxacin). During the period of treatment should avoid sunlight and UV radiation, intense physical exercise, control of drinking mode, pH of urine.
Reported cases of crystalluria, particularly in patients with alkaline reaction of urine (pH 7 or more). In order to avoid the development of crystalluria unacceptable excess of the recommended daily dose, should also be adequate fluid intake and maintaining acidic urine.
If you have pain in the tendons or the first signs tendovaginitah treatment should be discontinued (described isolated cases of inflammation or tendon rupture during fluoroquinolone treatment).
It can reduce the speed of psychomotor reactions, especially against the backdrop of alcohol, that should be considered for patients who work with potentially dangerous machinery or drive vehicles.
If you have severe diarrhea, pseudomembranous colitis should be excluded (for which Cymex-TZ (Ciprofloxacin) is contraindicated). At the same time of barbiturates IV injections requires monitoring function of the cardiovascular system (heart rate, BP, ECG). Teenagers under 18 years shall be appointed only if the pathogen resistance to other chemotherapeutic drugs. The solution in the form of eye drops are not designed for intraocular injections. The use of other ophthalmic means the interval between injections should be at least 5 minutes.
Activity increases when combined with beta-lactam antibiotics, aminoglycosides, vancomycin, clindamycin, metronidazole. Sukralfat, bismuth preparations, antacids containing aluminum ions, magnesium or calcium, cimetidine, ranitidine, vitamin and mineral supplement, iron sulfate, zinc, didanosine (recommended for 2 hours before or 4 hours after these drugs) reduce the suction. Probenecid, azlocillin increase the concentration in the blood. Decreases clearance and increases in plasma caffeine, aminophylline and theophylline (increased likelihood of side effects). Cymex-TZ (Ciprofloxacin) enhances the effect of warfarin and other oral anticoagulants (prolongs bleeding time). Increases nephrotoxicity of cyclosporine, increase the risk of CNS excitability and convulsive reactions against the background of NSAIDs. Medicines alkalinizing the urine (citrates, sodium bicarbonate, carbonic anhydrase inhibitors) reduce the solubility (increases the probability of crystalluria). Infusion solutions of Cymex-TZ (Ciprofloxacin) ready to use can be combined with infusion solutions: 0.9% sodium chloride solution, Ringer's solution, Ringer lactate, 5 and 10% dextrose, 10% solution of fructose, and a solution containing 5% dextrose with 0,225 or 0.45% sodium chloride. Incompatible with solutions having a pH > 7.
May occur after receiving a single large dose or prolonged use. If a single dose of less than 150 mg / kg, acute poisoning feel light, 150-300 mg / kg - moderate, when using higher doses - heavy.
Symptoms: No specific symptoms.
Treatment: gastric lavage, the use of emetic drugs, the introduction of large quantities of liquid, the creation of acidic urine, in addition - hemodialysis and peritoneal dialysis (can be derived only 10% of the drug), all events are held on the background to maintain vital functions. The specific antidote is unknown.
WARNING: POTENTIAL RISK FOR CARCINOGENICITY
See full prescribing information for complete boxed warning.
Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent ( 13.1). Although such data have not been reported for Cymex-TZ (Tinidazole), the two drugs are structurally related and have similar biologic effects. Use should be limited to approved indications only.
Indications and Usage, Bacterial Vaginosis ( 1.4) 5/2007
Dosage and Administration, Bacterial Vaginosis ( 2.6) 5/2007
Other pathogens commonly associated with vulvovaginitis such as Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans and Herpes simplex virus should be ruled out.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cymex-TZ (Tinidazole) and other antibacterial drugs, Cymex-TZ (Tinidazole) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Alcoholic beverages should be avoided when taking Cymex-TZ (Tinidazole) and for 3 days afterwards .
Procedure for Extemporaneous Pharmacy Compounding of the Oral Suspension: Pulverize four 500 mg oral tablets with a mortar and pestle. Add approximately 10 mL of cherry syrup to the powder and mix until smooth. Transfer the suspension to a graduated amber container. Use several small rinses of cherry syrup to transfer any remaining drug in the mortar to the final suspension for a final volume of 30 mL. The suspension of crushed tablets in artificial cherry syrup is stable for 7 days at room temperature. When this suspension is used, it should be shaken well before each administration.
Amebic Liver Abscess: The recommended dose in adults is a 2 g dose per day for 3-5 days taken with food. In pediatric patients older than three years of age, the recommended dose is 50 mg/kg/day (up to 2 g per day) for 3-5 days with food. There are limited pediatric data on durations of therapy exceeding 3 days, although a small number of children were treated for 5 days without additional reported adverse reactions. Children should be closely monitored when treatment durations exceed 3 days.
To report SUSPECTED ADVERSE REACTIONS, contact Mission Pharmacal Company at 1-855-778-0177or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Among 3669 patients treated with a single 2 g dose of Cymex-TZ (Tinidazole), in both controlled and uncontrolled trichomoniasis and giardiasis clinical studies, adverse reactions were reported by 11.0% of patients. For multi-day dosing in controlled and uncontrolled amebiasis studies, adverse reactions were reported by 13.8% of 1765 patients. Common (≥ 1% incidence) adverse reactions reported by body system are as follows. (Note: Data described in Table 1 below are pooled from studies with variable designs and safety evaluations.)
Other adverse reactions reported with Cymex-TZ (Tinidazole) include:
Central Nervous System: Two serious adverse reactions reported include convulsions and transient peripheral neuropathy including numbness and paresthesia . Other CNS reports include vertigo, ataxia, giddiness, insomnia, drowsiness.
Gastrointestinal: tongue discoloration, stomatitis, diarrhea
Hypersensitivity: urticaria, pruritis, rash, flushing, sweating, dryness of mouth, fever, burning sensation, thirst, salivation, angioedema
Renal: darkened urine
Hematopoietic: transient neutropenia, transient leukopenia
Other: Candida overgrowth, increased vaginal discharge, oral candidiasis, hepatic abnormalities including raised transaminase level, arthralgias, myalgias, and arthritis.
|2 g single dose||Multi-day dose|
|GI: Metallic/bitter taste||3.7%||6.3%|
|Total patients with adverse reactions||11.0% |
Adverse Reactions in Pediatric Patients: In pooled pediatric studies, adverse reactions reported in pediatric patients taking Cymex-TZ (Tinidazole) were similar in nature and frequency to adult findings including nausea, vomiting, diarrhea, taste change, anorexia, and abdominal pain.
Bacterial vaginosis: The most common adverse reactions in treated patients (incidence >2%), which were not identified in the trichomoniasis, giardiasis and amebiasis studies, are gastrointestinal: decreased appetite, and flatulence; renal: urinary tract infection, painful urination, and urine abnormality; and other reactions including pelvic pain, vulvo-vaginal discomfort, vaginal odor, menorrhagia, and upper respiratory tract infection .
Severe acute hypersensitivity reactions have been reported on initial or subsequent exposure to Cymex-TZ (Tinidazole). Hypersensitivity reactions may include urticaria, pruritis, angioedema, Stevens-Johnson syndrome and erythema multiforme.
The following drug interactions were reported for metronidazole, a chemically-related nitroimidazole and may therefore occur with Cymex-TZ (Tinidazole):
Alcohols, Disulfiram: Alcoholic beverages and preparations containing ethanol or propylene glycol should be avoided during Cymex-TZ (Tinidazole) therapy and for 3 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 Cymex-TZ (Tinidazole), Cymex-TZ (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 Cymex-TZ (Tinidazole) shares this property with metronidazole, but consideration should be given to measuring serum lithium and creatinine levels after several days of simultaneous lithium and Cymex-TZ (Tinidazole) treatment to detect potential lithium intoxication.
Phenytoin, Fosphenytoin: Concomitant administration of oral metronidazole and intravenous phenytoin was reported to result in prolongation of the half-life and reduction in the clearance of phenytoin. Metronidazole did not significantly affect the pharmacokinetics of orally-administered phenytoin.
Cyclosporine, Tacrolimus: There are several case reports suggesting that metronidazole has the potential to increase the levels of cyclosporine and tacrolimus. During Cymex-TZ (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 Cymex-TZ (Tinidazole) and fluorouracil cannot be avoided, the patient should be monitored for fluorouracil-associated toxicities.
Cholestyramine: Cholestyramine was shown to decrease the oral bioavailability of metronidazole by 21%. Thus, it is advisable to separate dosing of cholestyramine and Cymex-TZ (Tinidazole) to minimize any potential effect on the oral bioavailability of Cymex-TZ (Tinidazole).
Oxytetracycline: Oxytetracycline was reported to antagonize the therapeutic effect of metronidazole.
Cymex-TZ (Tinidazole), like metronidazole, may produce transient leukopenia and neutropenia; however, no persistent hematological abnormalities attributable to Cymex-TZ (Tinidazole) have been observed in clinical studies. Total and differential leukocyte counts are recommended if re-treatment is necessary.
The use of Cymex-TZ (Tinidazole) in pregnant patients has not been studied. Since Cymex-TZ (Tinidazole) crosses the placental barrier and enters fetal circulation it should not be administered to pregnant patients in the first trimester.
Embryo-fetal developmental toxicity studies in pregnant mice indicated no embryo-fetal toxicity or malformations at the highest dose level of 2,500 mg/kg (approximately 6.3-fold the highest human therapeutic dose based upon body surface area conversions). In a study with pregnant rats a slightly higher incidence of fetal mortality was observed at a maternal dose of 500 mg/kg (2.5-fold the highest human therapeutic dose based upon body surface area conversions). No biologically relevant neonatal developmental effects were observed in rat neonates following maternal doses as high as 600 mg/kg (3-fold the highest human therapeutic dose based upon body surface area conversions). Although there is some evidence of mutagenic potential and animal reproduction studies are not always predictive of human response, the use of Cymex-TZ (Tinidazole) after the first trimester of pregnancy requires that the potential benefits of the drug be weighed against the possible risks to both the mother and the fetus.
Pediatric Administration: For those unable to swallow tablets, Cymex-TZ (Tinidazole) tablets may be crushed in artificial cherry syrup, to be taken with food .
Patients undergoing hemodialysis: If Cymex-TZ (Tinidazole) is administered on the same day as and prior to hemodialysis, it is recommended that an additional dose of Cymex-TZ (Tinidazole) equivalent to one-half of the recommended dose be administered after the end of the hemodialysis .
Treatment of Overdosage: There is no specific antidote for the treatment of overdosage with Cymex-TZ (Tinidazole); therefore, treatment should be symptomatic and supportive. Gastric lavage may be helpful. Hemodialysis can be considered because approximately 43% of the amount present in the body is eliminated during a 6-hour hemodialysis session.
Cymex-TZ (Tinidazole) is a synthetic antiprotozoal and antibacterial agent. It is 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazole, a second-generation 2-methyl-5-nitroimidazole, which has the following chemical structure:
Cymex-TZ (Tinidazole) pink oral tablets contain 500 mg of Cymex-TZ (Tinidazole). Inactive ingredients include croscarmellose sodium, FD&C Red 40 lake, FD&C Yellow 6 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized corn starch, titanium dioxide, and triacetin.
Administration of Cymex-TZ (Tinidazole) tablets with food resulted in a delay in T max of approximately 2 hours and a decline in C max of approximately 10% , compared to fasted conditions. However, administration of Cymex-TZ (Tinidazole) with food did not affect AUC or T 1/2 in this study.
In healthy volunteers, administration of crushed Cymex-TZ (Tinidazole) tablets in artificial cherry syrup, [prepared as described in Dosage and Administration ( 2.2) ] after an overnight fast had no effect on any pharmacokinetic parameter as compared to tablets swallowed whole under fasted conditions.
Distribution: Cymex-TZ (Tinidazole) is distributed into virtually all tissues and body fluids and also crosses the blood-brain barrier. The apparent volume of distribution is about 50 liters. Plasma protein binding of Cymex-TZ (Tinidazole) is 12%. Cymex-TZ (Tinidazole) crosses the placental barrier and is secreted in breast milk.
Metabolism: Cymex-TZ (Tinidazole) is significantly metabolized in humans prior to excretion. Cymex-TZ (Tinidazole) is partly metabolized by oxidation, hydroxylation, and conjugation. Cymex-TZ (Tinidazole) is the major drug-related constituent in plasma after human treatment, along with a small amount of the 2-hydroxymethyl metabolite.
Cymex-TZ (Tinidazole) is biotransformed mainly by CYP3A4. In an in vitro metabolic drug interaction study, Cymex-TZ (Tinidazole) concentrations of up to 75 µg/mL did not inhibit the enzyme activities of CYP1A2, CYP2B6, CYP2C9, CYP2D6, CYP2E1, and CYP3A4.
The potential of Cymex-TZ (Tinidazole) to induce the metabolism of other drugs has not been evaluated.
Elimination: The plasma half-life of Cymex-TZ (Tinidazole) is approximately 12-14 hours. Cymex-TZ (Tinidazole) is excreted by the liver and the kidneys. Cymex-TZ (Tinidazole) is excreted in the urine mainly as unchanged drug (approximately 20-25% of the administered dose). Approximately 12% of the drug is excreted in the feces.
Patients with impaired renal function: The pharmacokinetics of Cymex-TZ (Tinidazole) in patients with severe renal impairment (CrCL < 22 mL/min) are not significantly different from the pharmacokinetics seen in healthy subjects. However, during hemodialysis, clearance of Cymex-TZ (Tinidazole) is significantly increased; the half-life is reduced from 12.0 hours to 4.9 hours. Approximately 43% of the amount present in the body is eliminated during a 6-hour hemodialysis session . The pharmacokinetics of Cymex-TZ (Tinidazole) in patients undergoing routine continuous peritoneal dialysis have not been investigated.
Patients with impaired hepatic function: There are no data on Cymex-TZ (Tinidazole) pharmacokinetics in patients with impaired hepatic function. Reduction of metabolic elimination of metronidazole, a chemically-related nitroimidazole, in patients with hepatic dysfunction has been reported in several studies .
Antibacterial: Culture and sensitivity testing of bacteria are not routinely performed to establish the diagnosis of bacterial vaginosis ; standard methodology for the susceptibility testing of potential bacterial pathogens, Gardnerella vaginalis, Mobiluncus spp. or Mycoplasma hominis, has not been defined. The following in vitro data are available, but their clinical significance is unknown. Cymex-TZ (Tinidazole) is active in vitro against most strains of the following organisms that have been reported to be associated with bacterial vaginosis:
Antiprotozoal: Cymex-TZ (Tinidazole) demonstrates activity both in vitro and in clinical infections against the following protozoa: Trichomonas vaginalis; Giardia duodenalis (also termed G. lamblia); and Entamoeba histolytica.
For protozoal parasites, standardized susceptibility tests do not exist for use in clinical microbiology laboratories.
Drug Resistance: The development of resistance to Cymex-TZ (Tinidazole) by G. duodenalis, E. histolytica, or bacteria associated with bacterial vaginosis has not been examined.
Cross-resistance: Approximately 38% of T. vaginalis isolates exhibiting reduced susceptibility to metronidazole also show reduced susceptibility to Cymex-TZ (Tinidazole) in vitro. The clinical significance of such an effect is not known.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cymex-TZ (Tinidazole) and other antibacterial drugs, Cymex-TZ (Tinidazole) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Cymex-TZ (Tinidazole) was mutagenic in the TA 100, S. typhimurium tester strain both with and without the metabolic activation system and was negative for mutagenicity in the TA 98 strain. Mutagenicity results were mixed (positive and negative) in the TA 1535, 1537, and 1538 strains. Cymex-TZ (Tinidazole) was also mutagenic in a tester strain of Klebsiella pneumonia. Cymex-TZ (Tinidazole) was negative for mutagenicity in a mammalian cell culture system utilizing Chinese hamster lung V79 cells (HGPRT test system) and negative for genotoxicity in the Chinese hamster ovary (CHO) sister chromatid exchange assay. Cymex-TZ (Tinidazole) was positive for in vivo genotoxicity in the mouse micronucleus assay.
In a 60-day fertility study, Cymex-TZ (Tinidazole) reduced fertility and produced testicular histopathology in male rats at a 600 mg/kg/day dose level (approximately 3-fold the highest human therapeutic dose based upon body surface area conversions). Spermatogenic effects resulted from 300 and 600 mg/kg/day dose levels. The no observed adverse reaction level for testicular and spermatogenic effects was 100 mg/kg/day (approximately 0.5-fold the highest human therapeutic dose based upon body surface area conversions). This effect is characteristic of agents in the 5-nitroimidazole class.
A repeated-dose toxicology study has been performed in beagle dogs using oral dosing of Cymex-TZ (Tinidazole) at 100 mg/kg/day, 300 mg/kg/day, and 1000 mg/kg/day for 28-days. On Day 18 of the study, the highest dose was lowered to 600 mg/kg/day due to severe clinical symptoms. The two compound-related effects observed in the dogs treated with Cymex-TZ (Tinidazole) were increased atrophy of the thymus in both sexes at the middle and high doses, and atrophy of the prostate at all doses in the males. A no-adverse-effect level (NOAEL) of 100 mg/kg/day for females was determined. There was no NOAEL identified for males because of minimal atrophy of the prostate at 100 mg/kg/day (approximately 0.9-fold the highest human dose based upon plasma AUC comparisons).
|Outcome||Cymex-TZ (Tinidazole) |
1 g × 5 days
|Cymex-TZ (Tinidazole) |
2 g × 2 days
|% Cure||% Cure||% Cure|
97.5% CI 3
97.5% CI 3
Nugent Score Cure
97.5% CI 3
Nugent score of at least 4
2Difference in cure rates (Tindamax-placebo)
3CI: confidence interval
p-values for both Cymex-TZ (Tinidazole) regimens vs. placebo for therapeutic, clinical and
Nugent score cure rates for both 2 and 5 days <0.001
The therapeutic cure rates reported in this clinical study conducted with Cymex-TZ (Tinidazole) were based on resolution of 4 out of 4 Amsel's criteria and a Nugent score of <4. The cure rates for previous clinical studies with other products approved for bacterial vaginosis were based on resolution of either 2 or 3 out of 4 Amsel's criteria. At the time of approval for other products for bacterial vaginosis, there was no requirement for a Nugent score on Gram stain, resulting in higher reported rates of cure for bacterial vaginosis for those products than for those reported here for Cymex-TZ (Tinidazole).
Depending on the reaction of the Cymex-TZ after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Cymex-TZ not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Cymex-TZ addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology