Giardameb

Giardameb (brand name Giardameb,Sindose) is a nitroimidazole anti-infective. Effectiveness in the treatment of dientamoebiasis has been reported. It has also been tested against Atopobium vaginae.

Bacterial Vaginosis

Giardameb is indicated for the treatment of bacterial vaginosis in adult women.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Giardameb and other antibacterial drugs, Giardameb 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.

Giardameb is an antibiotic that fights bacteria.

Giardameb is used in women to treat bacterial vaginal infections.

This medicine will not treat a fungal (yeast) infection.

Giardameb may also be used for purposes not listed in this medication guide.

Medically reviewed on May 15, 2018.

Applies to the following strengths: 2 g

Usual Adult Dose for:

• Bacterial Vaginosis

Additional dosage information:

• Renal Dose Adjustments
• Liver Dose Adjustments
• Precautions
• Dialysis
• Other Comments

Usual Adult Dose for Bacterial Vaginosis

2 g orally once

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

-Administer a single packet of granules.

---Sprinkle the entire contents of the packet onto applesauce, yogurt, or pudding.

---Consume all of the mixture within 30 minutes.

---Do not chew or crunch the granules.

-May administer without regard to food

-After consuming this drug, may drink a glass of water (to help with swallowing)

General:

-A single packet of granules contains 2 g of this drug.

-The granules will not dissolve in applesauce, yogurt, or pudding; they are not meant to be dissolved in any liquid.

Patient advice:

-Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

More about Giardameb

• Giardameb Side Effects
• During Pregnancy
• Drug Interactions
• En Español
• 1 Review
• Drug class: amebicides

Consumer resources

• Giardameb
• Giardameb (Advanced Reading)

Other brands: Giardameb

Professional resources

• Giardameb (AHFS Monograph)
• Giardameb (Wolters Kluwer)

Related treatment guides

• Bacterial Vaginitis

See also:
What is the most important information I should know about Giardameb?

Hypersensitivity

Giardameb is contraindicated in patients who have shown hypersensitivity to Giardameb, other ingredients of the formulation, or other nitroimidazole derivatives.

Giardameb is used to treat intestinal amoebiasis (infection of the intestinal), hepatic amoebiasis (infection of the liver), urethritis (infection of the urethra) and vaginitis (infection of the vagina) caused by Trichomonas vaginalis and giardiasis (parasitic infections).

See also:
What other drugs will affect Giardameb?

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Avoid combination

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification

See also:
What are the possible side effects of Giardameb?

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data described below reflect exposure to 589 patients, of whom 518 received a 2 g dose of Giardameb. Giardameb was evaluated in three clinical trials of patients diagnosed with bacterial vaginosis: two placebo-controlled trials (Trial 1 n=215, Trial 2 n=189) and one uncontrolled safety trial (Trial 3 n=321).

All patients received a single oral dose of study medication or placebo. Trial 1 evaluated a 1 g (this dose is not approved) dose (n=71) and a 2 g dose (n=72) of Giardameb. Trial 2 evaluated a 2 g dose (n=125). The population was female, aged 15 to 54 years. Patients in the placebo- controlled trials were primarily Black or African American (54%) or Caucasian (41%).

There were no deaths in the trials. Two patients in Trial 3 discontinued due to vulvovaginal candidiasis in the Giardameb-treated arm.

Most Common Adverse Reactions

Among 197 patients treated with a single 2 g dose of Giardameb in the two placebo-controlled trials, Trial 1 and 2, adverse reactions were reported by approximately 29% of patients. Table 1 displays the most common adverse reactions (≥ 2 % in Giardameb-treated patients) in these two trials.

Among the 321 patients in an uncontrolled trial, Trial 3, adverse reactions were reported in 30% of patients. Vulvovaginal candidiasis (8.4%), nausea (5.3%), vomiting (2.5%) and dysgeusia (3.4%) were the most common adverse reactions reported in this trial.

Postmarketing Experience

The following adverse reactions have been reported during use of other formulations of Giardameb 2 g outside of the United States. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Reported adverse reactions were nausea, dysgeusia, abdominal pain, headache, and vomiting.