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tinidazole 500 mg tablet generic tindamax

Out of Stock Manufacturer WEST-WARD/HIKMA 00054034807
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Uses

Amebiasis

Tinidazole is used orally in the treatment of intestinal amebiasis and amebic liver abscess caused by Entamoeba histolytica in adults and children older than 3 years of age. Tinidazole is designated an orphan drug by the US Food and Drug Administration (FDA) for treatment of amebiasis.

The regimen of choice for symptomatic intestinal amebiasis or extraintestinal disease (including liver abscess) is treatment with a nitroimidazole derivative (oral tinidazole or oral metronidazole) followed by treatment with a luminal amebicide (oral iodoquinol or oral paromomycin). The sequential use of these drugs ensures eradication of tissue-invading trophozoites as well as cysts in the intestinal lumen. In patients with severe disease who do not respond to or cannot tolerate these drugs, some clinicians suggest that a regimen of dehydroemetine (available in the US only from the US Centers for Disease Control and Prevention [CDC]) followed by a luminal amebicide can be considered. For further information on treatment of amebiasis,

Tinidazole and metronidazole are not recommended for treatment of asymptomatic cyst passers; these patients should be treated with a luminal amebicide such as iodoquinol, paromomycin, or diloxanide furoate (not commercially available in the US). For information on treatment of asymptomatic amebiasis, .

Use of oral tinidazole (usually 2 g daily for 3 days) in patients with intestinal amebiasis is supported by published reports involving more than 1400 patients worldwide. Results of 4 randomized, controlled studies (one single-blind and 3 open-label) in 220 patients have shown that intestinal amebiasis cure rates of 86-93% were achieved with the currently recommended tinidazole regimen (2 g daily for 3 days). A similar cure rate was reported in a clinical series of 40 pediatric patients with intestinal amebiasis treated with the currently recommended pediatric regimen of 50 mg/kg of tinidazole daily for 3 days.

Use of oral tinidazole (usually 2 g daily for 2-5 days) in patients with liver abscess is supported by published reports involving more than 470 patients worldwide. Results of 7 randomized, controlled studies (one double-blind, 1 single-blind, and 5 open-label) in 133 patients have shown that liver abscess cure rates of 81-100% were achieved with tinidazole (2 g daily for 2-5 days) accompanied by aspiration of the liver abscess (when clinically necessary).

Giardiasis

Tinidazole is used orally in the treatment of giardiasis caused by Giardia duodenalis (also known as G. lamblia or G. intestinalis) in adults and children older than 3 years of age. Tinidazole is designated an orphan drug by the FDA for use in this condition.

Drugs of choice for the treatment of giardiasis are metronidazole, tinidazole, or nitazoxanide; alternative agents include paromomycin (especially in pregnant women), furazolidone (no longer commercially available in the US), or quinacrine (not commercially available in the US). Although tinidazole appears to be as effective or more effective than metronidazole for the treatment of giardiasis and may be better tolerated, limited safety and efficacy information is available in pediatric patients less than 3 years of age. For further information on treatment of giardiasis,

Use of oral tinidazole (2-g single dose) in patients with giardiasis is supported by published reports involving more than 1600 adult and pediatric patients worldwide. Results of 8 controlled studies in 619 patients have shown that giardiasis cure rates of about 80-100% were achieved (299 patients received the currently recommended tinidazole regimen, a single 2-g dose in adults and a single 50-mg/kg [up to 2-g] dose in children). In 3 of these studies in which metronidazole was compared with tinidazole, comparative giardiasis cure rates of about 76-93% were achieved with various dosage regimens of metronidazole given for 2-3 days. However, data comparing tinidazole (2-g single dose) with metronidazole (given in the usually recommended dosage of 250 mg 3 times daily for 5-7 days) are limited.

Trichomoniasis

Tinidazole is used orally in the treatment of symptomatic and asymptomatic trichomoniasis in adults in whom Trichomonas vaginalis has been demonstrated by an appropriate diagnostic procedure (e.g., wet smear and/or culture, OSOM Trichomonas Rapid Test, Affirm VP III).

The nitroimidazole derivatives, tinidazole and metronidazole, are the only drugs currently commercially available in the US that are effective in the treatment of this disease. Although in some limited studies a single dose of tinidazole was associated with a higher cure rate than a single dose of metronidazole, the relative efficacy of tinidazole and metronidazole in the treatment of trichomoniasis has not been adequately studied to date in large, well-controlled studies. Tinidazole reportedly has been effective for the treatment of trichomoniasis in some patients who did not respond to metronidazole, but there is evidence from in vitro studies that some T. vaginalis isolates with reduced susceptibility to metronidazole may also have reduced susceptibility to tinidazole.

The goal of treatment is to provide symptomatic relief, achieve microbiologic cure, reduce transmission, and prevent reinfection; to achieve this goal, both the index patient and sexual (particularly steady) partner(s) should be treated simultaneously. Because trichomoniasis is a sexually transmitted disease with a potential for serious sequelae, the CDC and other experts recommend that infected individuals and their sexual contacts be treated regardless of symptomatology; therefore, asymptomatic sexual contacts should be treated presumptively even when T. vaginalis has not been demonstrated. For further information on treatment of trichomoniasis,

Use of oral tinidazole (single 2-g dose) in patients with trichomoniasis is supported by published reports involving more than 2800 patients worldwide. Results of 4 published, blinded, randomized comparative studies in 172 patients have shown that trichomoniasis cure rates of about 92-100% were achieved with the currently recommended tinidazole regimen (single 2-g dose). Test-of-cure in these studies was assessed by culture at time points within 1 week to 1 month post-treatment. In 4 other published, blinded, randomized comparative studies in 116 patients, in which test-of-cure was assessed by wet mount within 7-14 days post-treatment, trichomoniasis cure rates ranged from 80-100%. In these studies, efficacy of tinidazole was superior to placebo and comparable to metronidazole. When efficacy of a single 2-g dose of tinidazole was assessed in 4 open-label trials in 142 men (1 comparative study with metronidazole and 3 single-arm studies), parasitologic evaluation of the urine (pre- and post-treatment) indicated trichomoniasis cure rates of 83-100%.

Bacterial Vaginosis

Tinidazole is used orally for the treatment of bacterial vaginosis (formerly called Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in nonpregnant women. Other pathogens commonly associated with vulvovaginitis (e.g., Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans, herpes simplex viruses) should be ruled out.

The principal goal in the treatment of bacterial vaginosis in nonpregnant women is to provide relief of vaginal symptoms and signs of infection and to reduce the risk for infectious complications after hysterectomy or abortion. Other potential benefits include a reduction in other infectious complications, including human immunodeficiency virus (HIV) infection and other sexually transmitted diseases (STDs). The CDC states that treatment of bacterial vaginosis is indicated in all nonpregnant women who are symptomatic. The CDC-recommended regimens for treatment of bacterial vaginosis in nonpregnant women are a 7-day regimen of oral metronidazole (500 mg twice daily); a 5-day regimen of intravaginal metronidazole gel; or a 7-day regimen of intravaginal clindamycin cream. Alternative regimens recommended by the CDC for these women are a 7-day regimen of oral clindamycin or a 3-day regimen of intravaginal clindamycin suppositories. Routine treatment of sex partners is not recommended. CDC recommendations were issued in 2006; use of tinidazole for bacterial vaginosis was approved by the US Food and Drug Administration (FDA) in 2007.

Results of clinical studies indicate that tinidazole is effective for the treatment of bacterial vaginosis. In one study, nonpregnant women with bacterial vaginosis were randomized to receive tinidazole 1 g daily for 5 days, tinidazole 2 g daily for 2 days, or placebo. Therapeutic cure (clinical cure and microbiologic cure) was reported in 36.8, 27.4, or 5.1% of those receiving tinidazole 1 g daily for 5 days, tinidazole 2 g daily for 2 days, or placebo, respectively, 21-30 days following completion of therapy.

Nongonococcal Urethritis

Tinidazole is used orally for the treatment of recurrent and persistent urethritis in patients with nongonococcal urethritis who have already been treated with a recommended regimen.

The CDC currently recommends that nongonococcal urethritis in adults be treated with a single oral dose of azithromycin or a 7-day regimen of oral doxycycline; alternative regimens recommended by the CDC are a 7-day regimen of oral erythromycin base or ethylsuccinate or a 7-day regimen of oral ofloxacin or oral levofloxacin. Patients treated for nongonococcal urethritis should be instructed to abstain from sexual intercourse until 7 days after initiation of treatment and to return for evaluation if symptoms persist or recur after completion of therapy; symptoms alone (without documentation of signs or laboratory evidence of urethral inflammation) are not sufficient basis for retreatment. Patients with persistent or recurrent urethritis who were not compliant with the treatment regimen or were reexposed to an untreated sexual partner(s) should be retreated with the initial regimen. If the patient has recurrent and persistent urethritis, was compliant with the regimen, and reexposure can be excluded, the CDC recommends a single 2-g dose of oral metronidazole or oral tinidazole given in conjunction with a single 1-g dose of oral azithromycin (if azithromycin was not used in the initial regimen).

Dosage and Administration

Administration

Tinidazole is administered orally with food. Although food does not affect oral bioavailability of tinidazole, the drug should be given with meals to reduce the incidence of epigastric discomfort and other adverse GI effects.

For children and other patients unable to swallow tablets, an extemporaneous tinidazole suspension containing 66.7 mg/mL can be prepared in the following manner. Grind 2 g of tinidazole (four 500-mg tablets) to a fine powder with a mortar and pestle. Add approximately 10 mL of cherry syrup to the powder and mix until smooth; the suspension should then be transferred to a graduated amber container. Several small rinses of cherry syrup should be used to transfer any remaining drug in the mortar to the final suspension for a final volume of 30 mL. The tinidazole suspension containing 66.7 mg/mL prepared with cherry syrup is stable for 7 days at room temperature. The suspension should be shaken well before each administration and given with food.

The manufacturer recommends that alcohol not be consumed during or for 3 days following completion of tinidazole therapy.

Dosage

Amebiasis

The usual adult dosage of tinidazole for treatment of intestinal amebiasis and amebic liver abscess caused by Entamoeba histolytica is 2 g once daily. The usual duration of therapy is 3 days for intestinal amebiasis and 3-5 days for amebic liver abscess.

The usual oral dosage of tinidazole for treatment of intestinal amebiasis and amebic liver abscess caused by E. histolytica in pediatric patients older than 3 years of age is 50 mg/kg once daily (up to 2 g). The usual duration of therapy is 3 days for intestinal amebiasis and 3-5 days for amebic liver abscess.(See Pediatric Use under Cautions.)

Tinidazole therapy should be followed by therapy with a luminal amebicide (oral iodoquinol or oral paromomycin).(See Uses: Amebiasis.)

Giardiasis

The usual adult dosage of tinidazole for treatment of giardiasis caused by Giardia duodenalis (also known as G. lamblia or G. intestinalis) is a single 2-g dose.

The usual dosage of tinidazole for treatment of giardiasis in children older than 3 years of age is a single dose of 50 mg/kg (up to 2 g).

Trichomoniasis

The usual adult dosage of tinidazole for treatment of trichomoniasis caused by Trichomonas vaginalis is a single 2-g dose. Sexual partners of the patient should be treated simultaneously using the same dosage.

If treatment failure occurs following an initial metronidazole treatment regimen (e.g., a single 2-g dose of oral metronidazole) and reinfection has been excluded, the CDC recommends that the patient be retreated with a single 2-g dose of tinidazole; if retreatment fails, then 2 g of tinidazole should be given once daily for 5 days. If the multiple-dose regimen is ineffective, consultation with a specialist is recommended and in vitro susceptibility testing of T. vaginalis isolates may be indicated.

Although safety and efficacy for treatment of trichomoniasis in children have not been established, some clinicians suggest a single dose of 50 mg/kg (up to 2 g) in pediatric patients.

Bacterial Vaginitis

The usual dosage of tinidazole for the treatment of bacterial vaginosis in nonpregnant women is 2 g once daily for 2 days or 1 g once daily for 5 days.

Nongonococcal Urethritis

For the treatment of recurrent and persistent urethritis in patients who have already received a regimen recommended for the treatment of nongonococcal urethritis (see Uses: Nongonococcal Urethritis), the CDC recommends a single 2-g dose of oral tinidazole in conjunction with a single 1-g dose of oral azithromycin.

Special Populations

No dosage adjustment of tinidazole is necessary in patients with renal impairment, unless the patient is undergoing hemodialysis. The pharmacokinetics of tinidazole in patients with severe renal impairment (creatinine clearance less than 22 mL/minute) are similar to the pharmacokinetics observed in healthy individuals.

Clearance of tinidazole is increased and elimination half-life is decreased in patients undergoing hemodialysis; 43% of tinidazole present in the body is eliminated during a 6-hour hemodialysis session. The manufacturer states that if tinidazole is administered on a day when dialysis is performed, an additional dose (equivalent to 50% of the recommended dose) should be given after the dialysis session. The effect of continuous ambulatory peritoneal dialysis (CAPD) on the pharmacokinetics of tinidazole has not been studied.

Pharmacokinetics of tinidazole have not been evaluated in patients with hepatic impairment; however, several studies indicate that elimination of metronidazole (a chemically related nitroimidazole) may be reduced and plasma concentrations increased in patients with hepatic impairment. Pending systematic evaluation of tinidazole in patients with hepatic impairment, usual dosage of tinidazole should be administered with caution in such patients.

Cautions

Contraindications

History of hypersensitivity reaction to tinidazole or other nitroimidazole derivatives.

The first trimester of pregnancy.

Breast-feeding.(See Lactation under Cautions.)

Warnings/Precautions

Warnings

Carcinogenicity

Metronidazole, a chemically related nitroimidazole anti-infective, is carcinogenic in mice and rats following chronic oral administration. Animal studies evaluating the carcinogenicity potential of tinidazole have not been reported to date. The manufacturer states that tinidazole should be reserved for approved indications only and unnecessary use should be avoided. For additional information on the carcinogenicity of metronidazole,

Nervous System Effects

Convulsive seizures and peripheral neuropathy (characterized by numbness or paresthesia of an extremity) have been reported with tinidazole and other nitroimidazoles (e.g., metronidazole).

If abnormal neurologic signs develop, tinidazole should be promptly discontinued.

Sensitivity Reactions

Hypersensitivity reactions (e.g., urticaria, pruritus, rash, flushing, sweating, dryness of mouth, fever, burning sensation, thirst, salivation, angioedema, bronchospasm, dyspnea, Stevens-Johnson syndrome, erythema multiforme) reported.

General Precautions

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of tinidazole and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing. In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.

History of Blood Dyscrasia

Tinidazole should be used with caution in patients with evidence or history of blood dyscrasia.

As with other nitroimidazoles (e.g., metronidazole), transient leukopenia and neutropenia may occur in patients receiving tinidazole; persistent hematologic abnormalities have not been reported to date.

If retreatment with tinidazole is necessary, total and differential leukocyte counts should be performed.

Candidiasis

Use of tinidazole may result in vaginal candidiasis. If infection occurs, appropriate therapy should be instituted.

Laboratory Test Interferences

Tinidazole, like metronidazole, may interfere with determination of serum AST (SGOT), ALT (SGPT), LDH, triglycerides, or glucose when such determinations are based on the decrease in ultraviolet absorbance that occurs during oxidation of NADH to NAD. Falsely decreased values, including values of zero, may result.

Specific Populations

Pregnancy

Category C for the second and third trimesters of pregnancy, but contraindicated during the first trimester.

Tinidazole has not been evaluated for the treatment of bacterial vaginosis in pregnant women.

Lactation

Tinidazole is distributed into milk in concentrations similar to serum concentrations. Breast-feeding should be interrupted during tinidazole therapy and for 72 hours following the last dose.

Pediatric Use

Safety and efficacy of tinidazole not established in pediatric patients 3 years of age or younger. Some data available regarding safety and efficacy for treatment of giardiasis in pediatric patients younger than 3 years of age.

Safety and efficacy of tinidazole in pediatric patients older than 3 years of age established only for treatment of amebiasis or giardiasis.

Pediatric patients should be monitored closely when the duration of tinidazole therapy exceeds 3 days (e.g., for treatment of amebic liver abscess). Only limited data are available regarding tinidazole therapy exceeding 3 days in pediatric patients, although the drug has been used for 5 days in a small number of children without an increase in the severity and incidence of adverse effects.

Adverse effects reported in pediatric patients receiving tinidazole are similar in nature and frequency to those reported in adults and include nausea, vomiting, diarrhea, taste change, anorexia, and abdominal pain.

Geriatric Use

Experience in those 65 years of age or older insufficient to determine whether they respond differently than younger adults.

Careful dosage selection recommended due to possible age-related decrease in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.

Hepatic Impairment

Use with caution. Although the pharmacokinetics of tinidazole have not been evaluated in patients with hepatic impairment, reduced elimination and increased plasma concentrations of metronidazole (a chemically similar nitroimidazole) have been reported in patients with hepatic dysfunction.

Renal Impairment

Pharmacokinetics of tinidazole in patients with severe renal impairment (creatinine clearance less than 22 mL/minute) and healthy individuals are similar.

Tinidazole is removed by hemodialysis; approximately 43% of the drug is eliminated from the body during a 6-hour hemodialysis session. The half-life of tinidazole is reduced from 12 hours to 4.9 hours during hemodialysis. An additional dose may be necessary in patients undergoing hemodialysis.(See Special Populations under Dosage and Administration.)

The effects of continuous ambulatory peritoneal dialysis (CAPD) on the pharmacokinetics of tinidazole have not been studied.

Common Adverse Effects

Adverse effects occurring in 1% or more of patients receiving a single 2-g dose of tinidazole include GI effects (metallic/bitter taste, nausea, anorexia, dyspepsia/cramps/epigastric discomfort, vomiting, constipation) and nervous system effects (weakness/fatigue/malaise, dizziness, headache).

Drug Interactions

No formal drug interaction studies have been performed to date with tinidazole; however, interactions associated with metronidazole, a chemically related nitroimidazole, can be expected to occur in patients receiving tinidazole. For further information on interactions associated with metronidazole,

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

Metabolism of tinidazole is mediated principally by the cytochrome P-450 (CYP) isoenzyme 3A4. Drugs that induce this isoenzyme (e.g., phenobarbital, rifampin, phenytoin, fosphenytoin) may reduce tinidazole plasma concentrations. Conversely, concomitant use of tinidazole with drugs that inhibit CYP3A4 (e.g., cimetidine, ketoconazole) may increase tinidazole plasma concentrations.

Tinidazole did not inhibit CYP1A2, CYP2B6, CYP2C9, CYP2D6, CYP2E1, or CYP3A4 in an in vitro metabolic drug interaction study.

The effect of concomitant tinidazole on the metabolism of other drugs via enzyme induction has not been evaluated.

Alcohol

Alcoholic beverages and preparations containing alcohol or propylene glycol may result in abdominal cramps, nausea, vomiting, headaches, and flushing and should be avoided during and for 3 days following tinidazole.

Antifungal Agents

Potential pharmacokinetic interaction with ketoconazole (prolonged half-life, decreased clearance, increased plasma concentrations of tinidazole).

Cholestyramine

Cholestyramine has decreased the oral bioavailability of metronidazole by 21%; because of the potential for a similar interaction with tinidazole, the manufacturer recommends separating doses of tinidazole and cholestyramine.

Cimetidine

Potential pharmacokinetic interaction (prolonged half-life, decreased clearance, increased plasma concentrations of tinidazole).

Coumarin Anticoagulants

Potential pharmacologic interaction; increased prothrombin time (PT) and enhanced anticoagulant effects reported with metronidazole. Monitor PT and warfarin dosage carefully during concomitant use and for up to 8 days after the last tinidazole dose.

Disulfiram

Psychotic reactions have been reported when metronidazole and disulfiram were used concomitantly. Although such reactions have not been reported to date with tinidazole, the drugs should not be used concomitantly and tinidazole should not be given to patients who have received disulfiram within the last 2 weeks.

Fluorouracil

Pharmacokinetic interaction (decreased fluorouracil clearance) and increased fluorouracil-associated adverse effects reported with metronidazole. If concomitant use of tinidazole and fluorouracil cannot be avoided, monitor for fluorouracil toxicity.

Immunosuppressive Agents

Several case reports suggest a potential pharmacokinetic interaction (increased plasma concentrations of cyclosporine or tacrolimus) with metronidazole. Because of the potential for a similar interaction with tinidazole, monitor for cyclosporine or tacrolimus toxicity if used concomitantly with one of these drugs.

Lithium

Pharmacokinetic interaction (increased plasma lithium concentration) reported with metronidazole. Although such interaction has not been reported to date with tinidazole, serum lithium and creatinine concentrations should be measured after several days of concomitant lithium and tinidazole therapy to detect potential lithium intoxication.

Phenobarbital

Potential pharmacokinetic interaction (increased elimination and decreased plasma concentrations of tinidazole).

Phenytoin or Fosphenytoin

Pharmacokinetic interaction (prolonged half-life and reduced clearance of phenytoin) reported when IV phenytoin used concomitantly with oral metronidazole; not reported with oral phenytoin. Possible increased elimination and decreased plasma concentrations of tinidazole

Rifampin

Potential pharmacokinetic interaction (increased elimination and decreased plasma concentrations of tinidazole).

Tetracyclines

Potential pharmacologic interaction (inhibition of therapeutic effect) reported when metronidazole used concomitantly with oxytetracycline (no longer commercially available in the US).

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