Tindamax Efficacy and Dosing for Bacterial Vaginosis (BV)

Why choose oral therapy with Tindamax^®?

A recent survey confirmed that 84% of patients prefer oral vs vaginal cream therapy.¹ With convenient oral dosing available in 2-day or 5-day regimens, Tindamax^® provides a simple, effective treatment option for your patients with BV.

Two convenient dosing options for BV
2 g/2-day dosing4 x 500 mg tablets once daily for 2 days, taken with food	1 g/5-day dosing2 x 500 mg tablets once daily for 5 days, taken with food





Table 1

Rapid systemic absorption
Reduced risk of migration

Tindamax^® is a rapidly absorbed systemic therapy with increased lipid solubility for efficient tissue diffusion. Unlike topical vaginal creams, systemic treatment has also been shown to reduce the risk of infection from migration of vaginal pathogens to reproductive and/or urinary tracts.²

Tindamax^® concentration in various tissues and fluids^*

Bar graph showing Tindamax<sup class='reg'>®</sup> tissue and fluid penetration. Concentration levels in the fallopian tubes after two 500-mg doses per day over a 3-day period were 22.0 µg/g. Concentration levels in vaginal secretions following 2-g PO dosing measured 19 µg/g.

* Tissue/fluid penetration is regarded as essential to therapeutic efficacy, but penetration levels have not been correlated with specific therapeutic results.

Figure 1

Bacterial vaginosis therapeutic cure rate with Tindamax^®¹

Chart showing therapeutic cure rates for BV after treatment with Tindamax<sup class='reg'>®</sup> oral tablets (1 g daily for 5 days) vs placebo. A 36.8% cure rate was achieved with Tindamax<sup class='reg'>®</sup>. A 5.1% cure rate resulted with placebo.

The therapeutic cure rate is based on the modified Intent-to-Treat (mITT) population, defined as patients with a Nugent score of less than 4^† and resolution of all 4 Amsel's criteria^††

Figure 2

In a randomized, double-blind clinical trial of 235 patients, tinidazole oral tablets demonstrated superior efficacy in patients with a baseline Nugent score ≥ 4 and all 4 Amsel's criteria—as measured by therapeutic, clinical, and microbiologic cure.

Important Safety Information

WARNING: POTENTIAL RISK FOR CARCINOGENICITY

Carcinogenicity has been seen in mice and rats treated chronically with metronidazole, another nitroimidazole agent. Although such data have not been reported for tinidazole, the two drugs are structurally related and have similar biologic effects. Its use should be reserved for the conditions described in INDICATIONS AND USAGE.

Contraindications

Prior history of hypersensitivity to tinidazole or other nitroimidazole derivatives
First trimester of pregnancy
Nursing mothers, unless breast-feeding is interrupted during tinidazole therapy and for 3 days following the last dose

Warnings and Precautions

Seizures and neuropathy have been reported. Discontinue Tindamax if abnormal neurologic signs develop
Vaginal candidiasis may develop with Tindamax and require treatment with an antifungal agent
Use Tindamax with caution in patients with blood dyscrasias. Tindamax may produce transient leukopenia and neutropenia

Adverse Reactions

Most common adverse reactions for a single 2 g dose of tinidazole (incidence >1%) are metallic/bitter taste, nausea, weakness/fatigue/malaise, dyspepsia/cramps/epigastric discomfort, vomiting, anorexia, headache, dizziness and constipation. To report SUSPECTED ADVERSE REACTIONS, contact Mission Pharmacal Company at 1-800-298-1087 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

This material is intended to provide basic information. Patients should discuss all medical advice, diagnosis, and treatment with their healthcare provider.

Please see full Prescribing Information

† Nugent score is determined by a Gram stain of a vaginal smear, taking into account the presence of normal flora (lactobacilli) and pathogenic organisms including Gardnerella vaginalis and Mobiluncus spp.

†† Amsel's criteria include: a homogeneous thin vaginal discharge; pH > 4.5; positive KOH "whiff" test (release of amine odor with alkalination of vaginal fluid); and presence of ≥ 20% "clue" cells (vaginal epithelial cells whose borders are obscured by adherent small bacteria).

Data on file. Mission Pharmacal Company.
Sobel JD. Vaginitis. N Engl J Med. 1997 Dec 25;337(26):1896-903.
Ripa T, Weström L, Mârdh PA, Andersson KE. Concentrations of tinidazole in body fluids and tissues in gynaecological patients. Chemotherapy. 1977;23(4):227-35.