Saflab

Each capsule contains Azithromycin (Saflab) dihydrate 262.05 mg equivalent to Azithromycin (Saflab) base 250 mg. It also contains anhydrous lactose, maize starch, magnesium stearate and sodium lauryl sulfate as excipients. The capsule shell contains gelatin, titanium dioxide (E171) and up to 1,000 ppm sulfur dioxide.

Each tablet contains Azithromycin (Saflab) dihydrate 262.05 mg equivalent to Azithromycin (Saflab) base 250 mg. It also contains pre-gelatinized starch, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate and sodium lauryl sulfate as excipients. The film-coating contains hydroxypropyl cellulose, triacetin and titanium dioxide (E171).

Each 5 mL of powder for oral suspension contains Azithromycin (Saflab) dihydrate 209.64 mg equivalent to Azithromycin (Saflab) base 200 mg. It also contains sucrose (1.94 g/100 mg dose), anhydrous tribasic sodium phosphate, hydroxypropyl cellulose, xanthan gum, artificial cherry, creme de vanilla and banana flavors as excipients.

Each sachet contains Azithromycin (Saflab) dihydrate 100.16 mg equivalent to Azithromycin (Saflab) base 100 mg. It also contains sucrose (1.85 g/Azithromycin (Saflab) 100-mg dose), anhydrous tribasic sodium phosphate, hydroxypropyl cellulose, xanthan gum, artificial cherry, creme de vanilla and banana flavors as excipients. It also contains a dry powder which yields, when added to water, a white to off-white suspension, cherry/banana with a slight vanilla odor.

Each vial contains Azithromycin (Saflab) dihydrate 524.1 mg equivalent to Azithromycin (Saflab) base 500 mg. It also contains anhydrous citric acid and sodium hydroxide as excipients. It is supplied in lyophilized form under a vacuum in a 10-mL vial for IV administration. Upon reconstitution, Azithromycin (Saflab) powder yields a solution containing the equivalent of Azithromycin (Saflab) 100 mg/mL.

Azithromycin (Saflab) is 9-deoxy-9a-aza-9a-methyl-9a-homoerythromycin A. The molecular weight is 749.

Fluconazole (Saflab) (Fluconazole (Saflab)) is designated chemically as 2,4-difluoro-α,α¹-bis(1H-1,2,4-triazol-l-ylmethyl) benzyl alcohol with an empirical formula of C₁₃H₁₂F₂N₆O and a molecular weight of 306.3.

Fluconazole (Saflab) is a white crystalline solid which is slightly soluble in water and saline.

Lactobacillus (Saflab) is a genus of Gram-positive facultative anaerobic or microaerophilic bacteria. They are a major part of the lactic acid bacteria group, named as such because most of its members convert lactose and other sugars to lactic acid. They are common and usually benign. In humans they are present in the vaginal and the gastrointestinal tract, where they are symbiotic and make up a small portion of the gut flora. Many species are prominent in decaying plant material. The production of lactic acid makes its environment acidic, which inhibits the growth of some harmful bacteria. Several members of the genus have had their genome sequenced.

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

Azithromycin (Saflab) extended-release granules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of designated microorganisms in the specific conditions listed as follows.

Adults: Acute uncomplicated bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.

Mild to moderate community-acquired pneumonia (CAP) due to Chlamydia pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Mycoplasma pneumoniae or Streptococcus pneumoniae.

Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. (Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis. Azithromycin (Saflab) is often effective in the eradication of susceptible strains of Streptococcus pyogenes from the nasopharynx. Because some strains are resistant to Azithromycin (Saflab), susceptibility tests should be performed when patients are treated with Azithromycin (Saflab)). Data establishing efficacy of Azithromycin (Saflab) in subsequent prevention of rheumatic fever are not available.

Pediatrics: Mild to moderate community-acquired pneumonia in pediatric patients 6 months of age or older due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae, in patients appropriate for oral therapy. Pediatric use in this indication is based on extrapolation of adult efficacy.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Azithromycin (Saflab) and other antibacterial drugs, Azithromycin (Saflab) should be used only to treat 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.

Appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to Azithromycin (Saflab). Therapy with Azithromycin (Saflab) may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly.

Fluconazole (Saflab) (Fluconazole (Saflab)) is indicated for the treatment of:

1. Vaginal candidiasis (vaginal yeast infections due to Candida).
2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, Fluconazole (Saflab) was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia.
3. Cryptococcal meningitis. Before prescribing Fluconazole (Saflab) (Fluconazole (Saflab)) for AIDS patients with cryptococcal meningitis, please see Clinical Studies section. Studies comparing Fluconazole (Saflab) to amphotericin B in non-HIV infected patients have not been conducted.

Prophylaxis. Fluconazole (Saflab) is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.

Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.

Restoration of Lactobacillus (Saflab) flora after anti-infective/chemotherapeutic treatment; atrophic vaginitis due to estrogen deficiency, as co-medication to hormone replacement therapy; vag discharge of unknown origin or mild to moderate cases of bacterial vaginosis & candidiasis.

Bacterial Vaginosis

Secnidazole (Saflab) 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 Secnidazole (Saflab) and other antibacterial drugs, Secnidazole (Saflab) 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.

Azithromycin (Saflab) injection is used to treat bacterial infections in many different parts of the body. It is also used to prevent Mycobacterium avium complex (MAC) disease in patients infected with the human immunodeficiency virus (HIV).

Azithromycin (Saflab) belongs to the class of drugs known as macrolide antibiotics. It works by killing bacteria or preventing their growth. However, Azithromycin (Saflab) will not work for colds, flu, or other virus infections. Azithromycin (Saflab) injection may be used for other problems as determined by your doctor.

Azithromycin (Saflab) is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, Azithromycin (Saflab) is used in certain patients with the following medical condition:

• Trachoma (treatment).

Fluconazole (Saflab) injection is used to treat serious fungal or yeast infections, such as vaginal candidiasis, oropharyngeal candidiasis (thrush, oral thrush), esophageal candidiasis (candida esophagitis), other candida infections (including urinary tract infections, peritonitis [inflammation of the lining of the abdomen or stomach], and infections that may occur in different parts of the body), or fungal (cryptococcal) meningitis. Fluconazole (Saflab) works by killing the fungus or yeast, or preventing its growth.

Fluconazole (Saflab) injection is also used to prevent candidiasis in patients having bone marrow transplants, who receive cancer or radiation treatment.

Fluconazole (Saflab) is to be given only by or under the direct supervision of a doctor.

Lactobacillus (Saflab) acidophilus is a bacteria that exists naturally in the body, primarily in the intestines and the vagina. Lactobacillus (Saflab) acidophilus has been used as a probiotic, or "friendly bacteria."

Lactobacillus (Saflab) acidophilus has been used in alternative medicine as a likely effective aid in treating diarrhea in children with rotavirus.

Lactobacillus (Saflab) acidophilus has been used in alternative medicine as a possibly effective aid (in children or adults) in preventing diarrhea caused by antibiotics, travel, chemotherapy, or hospitalization. Lactobacillus (Saflab) acidophilus is also possibly effective in treating irritable bowel syndrome, bacterial vaginal infection, colic in babies, lung infections in children, skin problems in children who are allergic to milk, and other conditions.

Lactobacillus (Saflab) acidophilus has also been used to treat lactose intolerance, Crohn's disease, overgrowth of bacteria in the intestines, or vaginal yeast infections caused by antibiotics. However, research has shown that Lactobacillus (Saflab) acidophilus may not be effective in treating these conditions.

Other uses not proven with research have included treating indigestion, urinary tract infections, intestinal problems in premature babies, high cholesterol, lyme disease, cold sores, acne, cancer, the common cold, and other conditions.

It is not certain whether Lactobacillus (Saflab) acidophilus is effective in treating any medical condition. Medicinal use of this product has not been approved by the FDA. Lactobacillus (Saflab) acidophilus should not be used in place of medication prescribed for you by your doctor.

Lactobacillus (Saflab) acidophilus is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Lactobacillus (Saflab) acidophilus may also be used for other purposes not listed in this product guide.

Secnidazole (Saflab) is an antibiotic that fights bacteria.

Secnidazole (Saflab) is used in women to treat bacterial vaginal infections.

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

Secnidazole (Saflab) may also be used for purposes not listed in this medication guide.

Azithromycin (Saflab) for oral suspension (single dose 1 g packet) can be taken with or without food after constitution. However, increased tolerability has been observed when tablets are taken with food.

Azithromycin (Saflab) for oral suspension (single dose 1 g packet) is not for pediatric use. For pediatric suspension see the prescribing information for Azithromycin (Saflab) (Azithromycin (Saflab) for oral suspension) 100 mg/5 mL and 200 mg/5 mL bottles.

Directions for administration of Azithromycin (Saflab) for oral suspension in the single dose packet (1 g): The entire contents of the packet should be mixed thoroughly with two ounces (approximately 60 mL) of water. Drink the entire contents immediately; add an additional two ounces of water, mix, and drink to ensure complete consumption of dosage. The single dose packet should not be used to administer doses other than 1000 mg of Azithromycin (Saflab).

Sexually Transmitted Diseases

The recommended dose of Azithromycin (Saflab) for the treatment of non-gonococcal urethritis and cervicitis due to C. trachomatis is a single 1 gram (1000 mg) dose of Azithromycin (Saflab). This dose can be administered as one single dose packet (1 g).

Mycobacterial Infections

Prevention of Disseminated MAC Infections

The recommended dose of Azithromycin (Saflab) for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of Azithromycin (Saflab) may be combined with the approved dosage regimen of rifabutin.

Treatment of Disseminated MAC Infections

Azithromycin (Saflab) should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of 15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of Azithromycin (Saflab) plus ethambutol at the discretion of the physician or health care provider.

How supplied

Dosage Forms And Strengths

Azithromycin (Saflab) 600 mg tablets (engraved on front with “PFIZER” and on back with “308”) are supplied as white, modified oval-shaped, film-coated tablets containing Azithromycin (Saflab) dihydrate equivalent to 600 mg Azithromycin (Saflab). These are packaged in bottles of 30 tablets.

Azithromycin (Saflab) for oral suspension 1000 mg/5 mL is supplied in single-dose packets containing Azithromycin (Saflab) dihydrate equivalent to 1 gram of Azithromycin (Saflab).

Storage And Handling

Azithromycin (Saflab) 600 mg tablets (engraved on front with “PFIZER” and on back with “308”) are supplied as white, modified oval-shaped, film-coated tablets containing Azithromycin (Saflab) dihydrate equivalent to 600 mg Azithromycin (Saflab). These are packaged in bottles of 30 tablets. Azithromycin (Saflab) tablets are supplied as follows:

Bottles of 30 NDC 0069-3080-30

Tablets should be stored at or below 30°C (86°F).

Azithromycin (Saflab) for oral suspension is supplied in single-dose packets containing Azithromycin (Saflab) dihydrate equivalent to 1 gram of Azithromycin (Saflab) as follows:

Boxes of 10 single-dose packets (1 g) NDC 0069-3051-07

Boxes of 3 single-dose packets (1 g) NDC 0069-3051-75

Store single-dose packets between 5° and 30°C (41° and 86°F).

Distributed by: Pfizer Labs Division of Pfizer Inc., NY, NY 10017. Revised: Dec 2015

Dosage and Administration in Adults

Single Dose: Vaginal Candidiasis: The recommended dosage of Fluconazole (Saflab) for vaginal candidiasis is 150 mg as a single oral dose.

Multiple Dose: SINCE ORAL ABSORPTION IS RAPID AND ALMOST COMPLETE, THE DAILY DOSE OF Fluconazole (Saflab) IS THE SAME FOR ORAL (TABLETS AND SUSPENSION) AND INTRAVENOUS ADMINISTRATION. In general, a loading dose of twice the daily dose is recommended on the first day of therapy to result in plasma concentrations close to steady-state by the second day of therapy.

The daily dose of Fluconazole (Saflab) for the treatment of infections other than vaginal candidiasis should be based on the infecting organism and the patient’s response to therapy. Treatment should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection. Patients with AIDS and cryptococcal meningitis or recurrent oropharyngeal candidiasis usually require maintenance therapy to prevent relapse.

Oropharyngeal Candidiasis: The recommended dosage of Fluconazole (Saflab) for oropharyngeal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Clinical evidence of oropharyngeal candidiasis generally resolves within several days, but treatment should be continued for at least 2 weeks to decrease the likelihood of relapse.

Esophageal Candidiasis: The recommended dosage of Fluconazole (Saflab) for esophageal candidiasis is 200 mg on the first day, followed by 100 mg once daily. Doses up to 400 mg/day may be used, based on medical judgment of the patient’s response to therapy. Patients with esophageal candidiasis should be treated for a minimum of three weeks and for at least two weeks following resolution of symptoms.

Systemic Candida Infections: For systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia, optimal therapeutic dosage and duration of therapy have not been established. In open, noncomparative studies of small numbers of patients, doses of up to 400 mg daily have been used.

Urinary Tract Infections and Peritonitis: For the treatment of Candida urinary tract infections and peritonitis, daily doses of 50 to 200 mg have been used in open, noncomparative studies of small numbers of patients.

Cryptococcal Meningitis: The recommended dosage for treatment of acute cryptococcal meningitis is 400 mg on the first day, followed by 200 mg once daily. A dosage of 400 mg once daily may be used, based on medical judgment of the patient’s response to therapy. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10 to 12 weeks after the cerebrospinal fluid becomes culture negative. The recommended dosage of Fluconazole (Saflab) for suppression of relapse of cryptococcal meningitis in patients with AIDS is 200 mg once daily.

Prophylaxis in Patients Undergoing Bone Marrow Transplantation: The recommended Fluconazole (Saflab) daily dosage for the prevention of candidiasis in patients undergoing bone marrow transplantation is 400 mg, once daily. Patients who are anticipated to have severe granulocytopenia (less than 500 neutrophils per cu mm) should start Fluconazole (Saflab) prophylaxis several days before the anticipated onset of neutropenia, and continue for 7 days after the neutrophil count rises above 1000 cells per cu mm.

Dosage and Administration in Children

The following dose equivalency scheme should generally provide equivalent exposure in pediatric and adult patients:

Experience with Fluconazole (Saflab) in neonates is limited to pharmacokinetic studies in premature newborns. Based on the prolonged half-life seen in premature newborns (gestational age 26 to 29 weeks), these children, in the first two weeks of life, should receive the same dosage (mg/kg) as in older children, but administered every 72 hours. After the first two weeks, these children should be dosed once daily. No information regarding Fluconazole (Saflab) pharmacokinetics in full-term newborns is available.

Oropharyngeal Candidiasis: The recommended dosage of Fluconazole (Saflab) for oropharyngeal candidiasis in children is 6 mg/kg on the first day, followed by 3 mg/kg once daily. Treatment should be administered for at least 2 weeks to decrease the likelihood of relapse.

Esophageal Candidiasis: For the treatment of esophageal candidiasis, the recommended dosage of Fluconazole (Saflab) in children is 6 mg/kg on the first day, followed by 3 mg/kg once daily. Doses up to 12 mg/kg/day may be used based on medical judgment of the patient’s response to therapy. Patients with esophageal candidiasis should be treated for a minimum of three weeks and for at least 2 weeks following the resolution of symptoms.

Systemic Candida Infections: For the treatment of candidemia and disseminated Candida infections, daily doses of 6 to 12 mg/kg/day have been used in an open, noncomparative study of a small number of children.

Cryptococcal Meningitis: For the treatment of acute cryptococcal meningitis, the recommended dosage is 12 mg/kg on the first day, followed by 6 mg/kg once daily. A dosage of 12 mg/kg once daily may be used, based on medical judgment of the patient’s response to therapy. The recommended duration of treatment for initial therapy of cryptococcal meningitis is 10 to 12 weeks after the cerebrospinal fluid becomes culture negative. For suppression of relapse of cryptococcal meningitis in children with AIDS, the recommended dose of Fluconazole (Saflab) is 6 mg/kg once daily.

Dosage in Patients with Impaired Renal Function

Fluconazole (Saflab) is cleared primarily by renal excretion as unchanged drug. There is no need to adjust single dose therapy for vaginal candidiasis because of impaired renal function. In patients with impaired renal function who will receive multiple doses of Fluconazole (Saflab), an initial loading dose of 50 to 400 mg should be given. After the loading dose, the daily dose (according to indication) should be based on the following table:

Patients on regular dialysis should receive 100% of the recommended dose after each dialysis; on non-dialysis days, patients should receive a reduced dose according to their creatinine clearance.

These are suggested dose adjustments based on pharmacokinetics following administration of multiple doses. Further adjustment may be needed depending upon clinical condition.

When serum creatinine is the only measure of renal function available, the following formula (based on sex, weight, and age of the patient) should be used to estimate the creatinine clearance in adults:

Females: 0.85 x above value

Although the pharmacokinetics of Fluconazole (Saflab) has not been studied in children with renal insufficiency, dosage reduction in children with renal insufficiency should parallel that recommended for adults. The following formula may be used to estimate creatinine clearance in children:

(Where K=0.55 for children older than 1 year and 0.45 for infants.)

Administration

Fluconazole (Saflab) for

Oral Suspension USP is administered orally. Fluconazole (Saflab) can be taken with or without food.

Directions for Mixing the

Oral Suspension

Prepare a suspension at time of dispensing as follows: tap bottle until all the powder flows freely. To reconstitute, add 24 mL of distilled water or Purified Water (USP) to Fluconazole (Saflab) bottle and shake vigorously to suspend powder. Each bottle will deliver 35 mL of suspension. The concentrations of the reconstituted suspensions are as follows:

Note: Shake oral suspension well before using. Before Reconstitution: Store at 20° to 25°C (68° to 77°F). After Reconstitution: Store suspension at 5° to 25°C (41° to 77°F). Discard unused portion after 2 weeks. Protect from freezing.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule,

Oral:

Lactobacillus (Saflab): L. acidophilus, L. casei, L. delbrueckii, and L. rhamnosus GG 10 billion live cultures [also includes Bifidobacterium lactis, and B. longum]

Culturelle: L. rhamnosus GG 10 billion colony-forming units

Dofus: L. acidophilus and L. bifidus 10:1 ratio [beet root powder base]

Lactobacillus (Saflab): L. acidophilus and L. paracasei ≥8 billion colony-forming units [also contains Bifidobacterium and S. thermophilus] [DSC]

Lactobacillus (Saflab):

100: L. acidophilus 1 billion colony-forming units [milk, soy, and yeast free; rice derived]

600: L. acidophilus 6 billion colony-forming units [milk, soy, and yeast free; rice derived]

Lacto-Bifidus:

100: L. bifidus 1 billion colony-forming units [milk, soy, and yeast free; rice derived]

600: L. bifidus 6 billion colony-forming units [milk, soy, and yeast free; rice derived]

Lacto-Pectin: L. acidophilus, L. casei, L. plantarum, L. rhamnosus, Bifidobacterium breve, and B. longum 20 billion colony-forming units

Lacto-TriBlend:

100: L. acidophilus, L. bifidus, and L. bulgaricus 1 billion colony-forming units [milk, soy and yeast free; rice derived]

600: L. acidophilus, L. bifidus, and L. bulgaricus 6 billion colony-forming units [milk, soy and yeast free; rice derived]

Megadophilus, Lactobacillus (Saflab): L. acidophilus 2 billion units [available in dairy based or dairy free formulations]

Prodigen: L. acidophilus 42 billion colony-forming units and Bifidobacterium lactis 39 billion colony-forming units

RisaQuad: L. acidophilus and L. paracasei 8 billion colony-forming units [also includes Bifidobacterium and Streptococcus thermophilus]

RisaQuad-2: L. acidophilus and L. paracasei 16 billion colony-forming units [gluten free; also includes Bifidobacterium and Streptococcus thermophilus]

Visbiome: L. acidophilus, L. plantarum, L. paracasei, L. bulgaricus, Bifidobacterium breve, B. longum, B. infantis, and Streptococcus thermophilus112 billion live cells [gluten free; contains lactose, milk protein]

VSL #3: L. acidophilus, L. plantarum, L. paracasei, L. bulgaricus, Bifidobacterium breve, B. longum, B. infantis, and Streptococcus thermophilus 112 billion live cells [gluten free]

Caplet,

Oral:

Risa-Bid: L. acidophilus and L. bulgaricus [also contains Bifidobacterium bifidum and Streptococcus thermophilus]

Granules:

Culturelle Baby Grow + Thrive: L. rhamnosus and Bifidobacterium animalis 3.5 billion colony-forming untis with cholecalciferol 400 IU per packet (30s) [contains sucrose]

Lactobacillus (Saflab): L. acidophilus and L. bulgaricus 100 million live cells per 1 g packet (12s) [contains milk, sodium 5 mg/packet, soy]

Lactobacillus (Saflab): L. acidophilus and L. bulgaricus 100 million live cells per 1 g packet (12s) [gluten free; contains calcium 5 mg/packet, lactose 380 mg/packet, potassium 20 mg/packet, sodium 5 mg/packet, sucrose 34 mg/packet, whey, evaporated milk, and soy peptone]

Liquid,

Oral:

Culturelle Baby Grow + Thrive: L. rhamnosus and Bifidobacterium animalis 2.5 billion colony-forming units with cholecalciferol 400 IU per 5 drops (9 mL)

Powder,

Oral:

Lacto-TriBlend: L. acidophilus, L. bifidus, and L. bulgaricus 10 billion colony-forming units per ¼ teaspoon (60 g) [milk, soy, and yeast free; rice derived]

Megadophilus, Lactobacillus (Saflab): L. acidophilus 2 billion units per half-teaspoon (49 g, 70 g, 84 g, 126 g) [available in dairy based or dairy free (garbanzo bean) formulations]

MoreDophilus: L. acidophilus 12.4 billion units per teaspoon (30 g, 120 g) [dairy free, yeast free; soy and carrot derived]

Visbiome: L. acidophilus, L. plantarum, L. paracasei, L. bulgaricus 450 billion live cells per packet (30s) [gluten free; contains lactose, milk protein; also contains Bifidobacterium breve, B. longum, B. infantis, and Streptococcus thermophilus; lemon flavor and unflavored]

VSL #3: L. acidophilus, L. plantarum, L. paracasei, L. bulgaricus 450 billion live cells per sachet (10s, 30s) [gluten free; also contains Bifidobacterium breve, B. longum, B. infantis, and Streptococcus thermophilus; lemon cream flavor and unflavored]

VSL #3-DS: L. acidophilus, L. plantarum, L. paracasei, L. bulgaricus 900 billion live cells per packet (20s,) [gluten free; also contains Bifidobacterium breve, B. longum, B. infantis, and Streptococcus thermophilus]

Tablet,

Oral:

Lactobacillus (Saflab): L. acidophilus and L. bulgaricus 1 million colony-forming units [contains lactose, nonfat dried milk, whey]

Lactobacillus (Saflab): L. acidophilus 200 million units [dairy free, yeast free; soy based]

Tablet, chewable,

Oral:

Dialyvite Probiotic: L. acidophilus and Bifidobacterium lactis 10 billion cells [orange cream flavor]

Lactobacillus (Saflab): L. acidophilus and L. bulgaricus 1 million live cells [gluten free; contains calcium 5.2 mg/4 tablets, lactose 960 mg/4 tablets, potassium 20 mg/4 tablets, sodium 5.6 mg/4 tablets, and sucrose 500 sucrose/4 tablets; contains whey, evaporated milk, and soy peptone]

Pedia-Lax Probiotic Yums: L. reuteri 100 million organisms [dye free, gluten free, sugar free; contains milk protein; strawberry flavor]

ReZyst IM: L. acidophilus and Bifidobacterium 150 mg [3 billion lives cells; berry flavor] [DSC]

Wafer,

Oral:

Generic: L. acidophilus 90 mg and L. bifidus 25 mg (100s) [provides 1 billion organisms/wafer at time of manufacture]

Dosing: Adult

Dietary supplement/medical food:

Oral: Dosing varies by manufacturer; consult product labeling.

Acidophilus products: 2 capsules 2 to 4 times daily or 1 to 2 wafers 2 to 4 times daily

Culturelle Digestive Health capsule and chewable tablet: 1 capsule or chewable tablet once daily; may increase chewable tablet to twice daily to alleviate digestive distress or during travel

Lactobacillus (Saflab): 4 tablets 3 to 4 times daily

Lactobacillus (Saflab): 1 capsule once daily

Lactobacillus (Saflab): 1 packet or 4 tablets 3 to 4 times daily

Visbiome:

Irritable bowel syndrome: 2 to 4 capsules or ½ to 1 packet per day

Pouchitis: 2 to 4 packets/day

Ulcerative colitis (active): 4 to 8 packets/day

Ulcerative colitis (maintenance): 4 to 8 capsules or 1 to 2 packets per day

VSL #3: 1 to 8 packets or 2 to 8 capsules/day

VSL #3-DS: 1 to 4 packets/day

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Dietary supplement: Note: Product formulations and labeling for use in pediatric patients may vary among available formulations; consult product labeling.

Culturelle:

Baby Grow and Thrive Drops: Lactobacillus (Saflab) rhamnosus GG 400 million CFU, Bifidobacterium animalis 100 million CFU, and cholecalciferol 2 mcg/drop: Infants:

Oral: 5 drops once daily.

Baby Grow and Thrive Packets: Lactobacillus (Saflab) rhamnosus GG 3 billion CFU, Bifidobacterium animalis 500 million CFU, and cholecalciferol 10 mcg/packet: Children ≤2 years:

Oral: 1 packet once daily.

Kids Daily Probiotic Packets: Lactobacillus (Saflab) rhamnosus GG 5 billion CFU/packet: Children <3 years:

Oral: 1 packet once or twice daily.

Kids Daily Probiotic Chewables: Lactobacillus (Saflab) rhamnosus GG 5 billion CFU/tablet: Children ≥3 years and Adolescents:

Oral: 1 tablet once or twice daily.

Digestive Health Daily Probiotic Chewable: Lactobacillus (Saflab) rhamnosus GG 10 billion CFU, inulin 200 mg, and vitamin C 6 mg/tablet: Children ≥12 years and Adolescents:

Oral: 1 tablet once or twice daily.

Digestive Health Daily Probiotic Capsule: Lactobacillus (Saflab) rhamnosus GG 10 billion CFU and inulin 200 mg/capsule: Children ≥12 years and Adolescents:

Oral: 1 capsule once or twice daily.

Digestive Health Extra Strength: Lactobacillus (Saflab) rhamnosus GG 20 billion CFU and inulin 200 mg/capsule: Children ≥12 years and Adolescents:

Oral: 1 capsule once daily.

Gerber:

Soothe Probiotic Colic Drops: Lactobacillus (Saflab) reuteri 20 million CFU/drop: Infants:

Oral: 5 drops once daily.

Soothe Vitamin D and Probiotic Drops: Lactobacillus (Saflab) reuteri 20 million CFU and cholecalciferol 2 mcg/drop: Infants:

Oral: 5 drops once daily.

Good Start Toddler Digestive and Immune Support Probiotic Packet: Lactobacillus (Saflab) reuteri 100 million CFU/packet: Children:

Oral: 1 packet once daily.

Good Start Kids Digestive and Immune Support Probiotic Tablet: Lactobacillus (Saflab) reuteri 100 million CFU/tablet: Children ≥3 years:

Oral: 1 tablet once daily.

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 Secnidazole (Saflab)

• Secnidazole (Saflab) Side Effects
• During Pregnancy
• Drug Interactions
• En Español
• 1 Review
• Drug class: amebicides

Consumer resources

• Secnidazole (Saflab)
• Secnidazole (Saflab) (Advanced Reading)

Other brands: Secnidazole (Saflab)

Professional resources

• Secnidazole (Saflab) (AHFS Monograph)
• Secnidazole (Saflab) (Wolters Kluwer)

Related treatment guides

• Bacterial Vaginitis

See also:
What is the most important information I should know about Azithromycin (Saflab)?

You should not use this medication if you have ever had jaundice or liver problems caused by taking Azithromycin (Saflab). You should not use Azithromycin (Saflab) if you are allergic to it or to similar drugs such as erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), clarithromycin (Biaxin), telithromycin (Ketek), or troleandomycin (Tao).

There are many other medicines that can interact with Azithromycin (Saflab). Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Take this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Azithromycin (Saflab) will not treat a viral infection such as the common cold or flu.

Avoid taking an antacid within 2 hours before or after you take Azithromycin (Saflab). Some antacids can make it harder for your body to absorb Azithromycin (Saflab).

See also:
What is the most important information I should know about Fluconazole (Saflab)?

Fluconazole (Saflab) (Fluconazole (Saflab)) is contraindicated in patients who have shown hypersensitivity to Fluconazole (Saflab) or to any of its excipients. There is no information regarding cross-hypersensitivity between Fluconazole (Saflab) and other azole antifungal agents. Caution should be used in prescribing Fluconazole (Saflab) to patients with hypersensitivity to other azoles. Coadministration of terfenadine is contraindicated in patients receiving Fluconazole (Saflab) (Fluconazole (Saflab)) at multiple doses of 400 mg or higher based upon results of a multiple dose interaction study. Coadministration of other drugs known to prolong the QT interval and which are metabolized via the enzyme CYP3A4 such as cisapride, astemizole, erythromycin, pimozide, and quinidine are contraindicated in patients receiving Fluconazole (Saflab).

See also:
What is the most important information I should know about Lactobacillus (Saflab)?

Congenital galactosemia, glucose and lactose intolerance, lactase deficiency in patients with disabling. Hypersensitivity to this drug or one of its components Gynecological : Hypersensitivity. Estrogen-dependent tumors, endometriosis, vag hemorrhaging of unknown origin, females who are not yet sexually mature

See also:
What is the most important information I should know about Secnidazole (Saflab)?

Hypersensitivity

Secnidazole (Saflab) is contraindicated in patients who have shown hypersensitivity to Secnidazole (Saflab), other ingredients of the formulation, or other nitroimidazole derivatives.

Use Azithromycin (Saflab) drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Azithromycin (Saflab) drops. Talk to your pharmacist if you have questions about this information.
• Azithromycin (Saflab) drops is for use in the eye only. Do not swallow it.
• Wash your hands immediately before you use Azithromycin (Saflab) drops.
• To use Azithromycin (Saflab) drops, turn the bottle upside down and shake once before each use. Remove the cap while the bottle is still upside down. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Gently squeeze the bottle to drop the medicine into the pouch, then gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
• If a drop does not come out of the bottle when using your dose, repeat these steps.
• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
• Do not wear contact lenses while you are using Azithromycin (Saflab) drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.
• To clear up your infection completely, use Azithromycin (Saflab) drops for the full course of treatment. Keep using it even if you feel better in a few days.
• If you miss a dose of Azithromycin (Saflab) drops, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Azithromycin (Saflab) drops.

Use Fluconazole (Saflab) solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Fluconazole (Saflab) solution is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Fluconazole (Saflab) solution at home, a health care provider will teach you how to use it. Be sure you understand how to use Fluconazole (Saflab) solution. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Fluconazole (Saflab) solution if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• To clear up your infection completely, use Fluconazole (Saflab) solution for the full course of treatment. Keep using it even if you feel better in a few days. Do not miss any doses.
• Fluconazole (Saflab) solution works best if it is taken at the same time each day.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Fluconazole (Saflab) solution, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Fluconazole (Saflab) solution.

Use Lactobacillus (Saflab) granules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• The contents of 1 packet of Lactobacillus (Saflab) granules should be added to cereal, food, or milk 3 or 4 times a day.
• If you miss a dose of Lactobacillus (Saflab) granules, take it as soon as you remember. Continue to take it as directed by your doctor or on the package label.

Ask your health care provider any questions you may have about how to use Lactobacillus (Saflab) granules.

Use: Labeled Indications

Oral, IV:

Chancroid: Treatment of genital ulcer disease (in men) due to Haemophilus ducreyi (chancroid)

Chronic obstructive pulmonary disease, acute exacerbation: Treatment of acute bacterial exacerbations of chronic obstructive pulmonary disease (COPD) due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae

Mycobacterium avium complex: Prevention of Mycobacterium avium complex (MAC) in patients with advanced HIV infection; treatment of disseminated MAC (in combination with ethambutol) in patients with advanced HIV infection

Otitis media, acute: Treatment of acute otitis media due to H. influenzae, M. catarrhalis, or S. pneumoniae

Pneumonia, community-acquired: Treatment of community-acquired pneumonia (CAP) due to Chlamydophila pneumoniae, H. influenzae, Legionella pneumophila, M. catarrhalis, Mycoplasma pneumoniae, or S. pneumoniae

Skin and skin structure infection, uncomplicated: Treatment of uncomplicated skin and skin structure infections due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae

Streptococcal pharyngitis (group A): Treatment of pharyngitis/tonsillitis due to S. pyogenes as an alternative to first-line therapy

Urethritis/cervicitis: Treatment of urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae

Off Label Uses

Acne vulgaris

Data from controlled trials support the use of Azithromycin (Saflab) in the treatment of acne vulgaris in adults with moderate to severe acne.

Based on the American Academy of Dermatology guidelines of care for the management of acne vulgaris, Azithromycin (Saflab), in combination with topical therapy, may be considered as a treatment option for moderate and severe acne and forms of inflammatory acne that are resistant to topical treatments. However, its use should be limited to patients who cannot receive a tetracycline (ie, pregnant women). Concomitant topical therapy with benzoyl peroxide or a retinoid should be administered with systemic antibiotic therapy (eg, Azithromycin (Saflab)) and continued for maintenance after the antibiotic course is completed.

Babesiosis

Data from a prospective, nonblinded, randomized trial in patients with non-life-threatening babesiosis, support the use of Azithromycin (Saflab) (in combination with atovaquone) for the treatment of this condition.

Based on the CDC Yellow Book, the ACG guideline for the diagnosis, treatment, and prevention of acute diarrheal infections in adults, and the IDSA practice guidelines for the diagnosis and management of infectious diarrhea, Azithromycin (Saflab) is effective and recommended treatment for patients with travelers' diarrhea. Due to increased levels of resistance to fluoroquinolones, Azithromycin (Saflab) may be a recommended first-line treatment, especially in regions with a high prevalence of Campylobacter (eg, Southeast Asia, India) or in geographical areas with suspected fluoroquinolone-resistant pathogens or enterotoxigenic Escherichia coli.

Use: Labeled Indications

Treatment of candidiasis (esophageal, oropharyngeal, peritoneal, urinary tract, vaginal); systemic candida infections (eg, candidemia, disseminated candidiasis, pneumonia); and cryptococcal meningitis; and antifungal prophylaxis in allogeneic hematopoietic cell transplant recipients

Off Label Uses

Blastomycosis

Data from a randomized, multicenter, open-label study comparing Fluconazole (Saflab) 400 mg versus 800 mg suggest that the use of Fluconazole (Saflab) at each of these doses is effective for the treatment of non-life-threatening blastomycosis.

Probiotics contain different types of micro-organisms such as yeast (saccharomyces boulardii) and bacteria (such as Lactobacillus (Saflab), bifidobacterium). Micro-organisms (flora) are naturally found in the stomach/intestines/vagina. Some conditions (such as antibiotic use, travel) can change the normal balance of bacteria/yeast. Probiotics are used to improve digestion and restore normal flora.

Probiotics have been used to treat bowel problems (such as diarrhea, irritable bowel), eczema, vaginal yeast infections, lactose intolerance, and urinary tract infections.

Probiotics are available in foods (such as yogurt, milk, juices, soy beverages) and as dietary supplements (capsules, tablets, powders). Different products have different uses. Check the label for information on uses for your particular product.

Some diet supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details regarding the particular brand you use.

The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.

How to use Lactobacillus (Saflab)

Follow all directions on the product package. Refer to the label directions for your specific product to see if the dose should be swallowed whole, chewed, sprinkled onto food or mixed with liquid. If you are uncertain about any of the information, consult your doctor or pharmacist.

Some probiotic products may contain live bacteria (such as bifidobacteria). Antibiotics may prevent these products from working well. Take any product containing live bacteria at least 2 to 3 hours before or after taking antibiotics. Follow the directions for your specific product.

If you are taking this product for diarrhea due to antibiotics, do not use it if you have a high fever or for more than 2 days, unless directed by your doctor. You may have a serious problem that requires medical treatment.

If your condition persists or worsens, or if you think you may have a serious medical problem, seek immediate medical attention.

Secnidazole (Saflab) 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 Azithromycin (Saflab)?

Antacids: In a pharmacokinetic study investigating the effects of simultaneous administration of antacid with Azithromycin (Saflab), no effect on overall bioavailability was seen, although peak serum concentrations were reduced by approximately 24%. In patients receiving both Azithromycin (Saflab) and antacids, the drugs should not be taken simultaneously. Co-administration of Azithromycin (Saflab) extended-release granules for oral suspension with a single dose of 20 mL co-magaldrox (aluminum hydroxide and magnesium hydroxide) did not affect the rate and extent of Azithromycin (Saflab) absorption.

Cetirizine: In healthy volunteers, co-administration of a 5-day regimen of Azithromycin (Saflab) with 20 mg cetirizine at steady-state resulted in no pharmacokinetic interaction and no significant changes in the QT interval.

Didanosine (Dideoxyinosine): Co-administration of 1,200 mg/day Azithromycin (Saflab) with 400 mg/day didanosine in six HIV-positive subjects did not appear to affect the steady-state pharmacokinetics of didanosine as compared to placebo.

Digoxin: Concomitant administration of macrolide antibiotics, including Azithromycin (Saflab), with P-glycoprotein substrates such as digoxin, has been reported to result in increased serum levels of the P-glycoprotein substrate. Therefore, if Azithromycin (Saflab) and P-glycoprotein substrates such as digoxin are administered concomitantly, the possibility of elevated serum digoxin concentrations should be considered. Clinical monitoring, and possibly serum digoxin levels, during treatment with Azithromycin (Saflab) and after its discontinuation are necessary.

Ergot: There is a theoretical possibility of interaction between Azithromycin (Saflab) and ergot derivatives.

Zidovudine: Single 1,000 mg doses and multiple 1,200 mg or 600 mg doses of Azithromycin (Saflab) had little effect on the plasma pharmacokinetics or urinary excretion of zidovudine or its glucuronide metabolite. However, administration of Azithromycin (Saflab) increased the concentrations of phosphorylated zidovudine, the clinically active metabolite, in peripheral blood mononuclear cells. The clinical significance of this finding is unclear, but it may be of benefit to patients.

Azithromycin (Saflab) does not interact significantly with the hepatic cytochrome P450 system. It is not believed to undergo the pharmacokinetic drug interactions as seen with erythromycin and other macrolides. Hepatic cytochrome P450 induction or inactivation via cytochrome-metabolite complex does not occur with Azithromycin (Saflab).

Pharmacokinetic studies have been conducted between Azithromycin (Saflab) and the following drugs known to undergo significant cytochrome P450-mediated metabolism.

Atorvastatin: Co-administration of atorvastatin (10 mg daily) and Azithromycin (Saflab) (500 mg daily) did not alter the plasma concentrations of atorvastatin (based on a HMG CoA-reductase inhibition assay). However, post-marketing cases of rhabdomyolysis in patients receiving Azithromycin (Saflab) with statins have been reported.

Carbamazepine: In a pharmacokinetic interaction study in healthy volunteers, no significant effect was observed on the plasma levels of carbamazepine or its active metabolite in patients receiving concomitant Azithromycin (Saflab).

Cimetidine: In a pharmacokinetic study investigating the effects of a single dose of cimetidine, given 2 hours before Azithromycin (Saflab), on the pharmacokinetics of Azithromycin (Saflab), no alteration of Azithromycin (Saflab) pharmacokinetics was seen.

Coumarin-Type

Oral Anticoagulants:

Cyclosporin: In a pharmacokinetic study with healthy volunteers who were administered a 500 mg/day oral dose of Azithromycin (Saflab) for 3 days and were then administered a single 10 mg/kg oral dose of cyclosporin, the resulting cyclosporin C_max and AUC_0-5 were found to be significantly elevated. Consequently, caution should be exercised before considering concurrent administration of these drugs. If co-administration of these drugs is necessary, cyclosporin levels should be monitored and the dose adjusted accordingly.

Efavirenz: Co-administration of a single dose of 600 mg Azithromycin (Saflab) and 400 mg efavirenz daily for 7 days did not result in any clinically significant pharmacokinetic interactions.

Fluconazole: Co-administration of a single dose of 1,200 mg Azithromycin (Saflab) did not alter the pharmacokinetics of a single dose of 800 mg fluconazole. Total exposure and half-life of Azithromycin (Saflab) were unchanged by the co-administration of fluconazole; however, a clinically insignificant decrease in C_max (18%) of Azithromycin (Saflab) was observed.

Indinavir: Co-administration of a single dose of 1,200 mg Azithromycin (Saflab) had no statistically significant effect on the pharmacokinetics of indinavir administered as 800 mg three times daily for 5 days.

Methylprednisolone: In a pharmacokinetic interaction study in healthy volunteers, Azithromycin (Saflab) had no significant effect on the pharmacokinetics of methylprednisolone.

Midazolam: In healthy volunteers, co-administration of 500 mg/day Azithromycin (Saflab) for 3 days did not cause clinically significant changes in the pharmacokinetics and pharmacodynamics of a single dose of 15 mg midazolam.

Nelfinavir: Co-administration of Azithromycin (Saflab) (1,200 mg) and nelfinavir at steady-state (750 mg three times daily) resulted in increased Azithromycin (Saflab) concentrations. No clinically significant adverse effects were observed and no dose adjustment was required. Although no dosage adjustment of Azithromycin (Saflab) is recommended when administered with nelfinavir, close monitoring for known side effects of Azithromycin (Saflab), such as liver enzyme abnormalities and hearing impairment, is warranted.

Rifabutin: Co-administration of Azithromycin (Saflab) and rifabutin did not affect the serum concentrations of either drug.

Neutropenia was observed in subjects receiving concomitant treatment of Azithromycin (Saflab) and rifabutin. Although neutropenia has been associated with the use of rifabutin, a causal relationship to combination with Azithromycin (Saflab) has not been established.

Sildenafil: In normal healthy male volunteers, there was no evidence of an effect of Azithromycin (Saflab) (500 mg daily for 3 days) on the AUC and C_max of sildenafil or its major circulating metabolite.

Terfenadine: Pharmacokinetic studies have reported no evidence of an interaction between Azithromycin (Saflab) and terfenadine. There have been rare cases reported where the possibility of such an interaction could not be entirely excluded; however, there was no specific evidence that such an interaction had occurred.

Theophylline: There is no evidence of a clinically significant pharmacokinetic interaction when Azithromycin (Saflab) and theophylline are co-administered to healthy volunteers.

Triazolam: In 14 healthy volunteers, co-administration of 500 mg Azithromycin (Saflab) on Day 1 and 250 mg on Day 2 with 0.125 mg triazolam on Day 2 had no significant effect on any of the pharmacokinetic variables for triazolam compared to triazolam and placebo.

Trimethoprim/Sulfamethoxazole: Co-administration of trimethoprim/sulfamethoxazole DS (160 mg/800 mg) for 7 days with 1,200 mg Azithromycin (Saflab) on Day 7 had no significant effect on peak concentrations, total exposure or urinary excretion of either trimethoprim or sulfamethoxazole. Azithromycin (Saflab) serum concentrations were similar to those seen in other studies.

Incompatibilities: Not applicable.

See also:
What other drugs will affect Fluconazole (Saflab)?

Anticoagulants: Bleeding events (bruising, epistaxis, gastrointestinal bleeding, hematuria, and melena), have been reported, in association with increases in prothrombin time in patients receiving Fluconazole (Saflab) concurrently with warfarin. Prothrombin time in patients receiving coumarin-type anticoagulant should be carefully monitored.

Fluconazole (Saflab): There was no significant pharmacokinetic interaction between Fluconazole (Saflab) and Fluconazole (Saflab).

Benzodiazepines (Short Acting): Following oral administration of midazolam, Fluconazole (Saflab) resulted in substantial increases in midazolam concentrations and psychomotor effects. This effect on midazolam appears to be more pronounced following oral administration of Fluconazole (Saflab) than with Fluconazole (Saflab) administered intravenously. If concomitant benzodiazepine therapy is necessary in patients being treated with Fluconazole (Saflab), consideration should be given to decreasing the benzodiazepine dosage, and the patients should be appropriately monitored.

Cisapride: Cisapride increased risk of ventricular arrhythmia troubles notably torsades de pointes. The interaction between Fluconazole (Saflab) and cisapride yielded significant increase in cisapride plasma levels and prolongation of QTc interval. Coadministration of cisapride is contraindicated in patients receiving Fluconazole (Saflab).

Cyclosporin: Fluconazole (Saflab) slowly increase cyclosporin concentrations in renal transplant patients. Fluconazole (Saflab) did not affect cyclosporine levels in patients with bone marrow transplants. Cyclosporin plasma concentration monitoring in patients receiving Fluconazole (Saflab) is recommended.

Hydrochlorothiazide: Interaction between multiple-dose hydrochlorothiazide and Fluconazole (Saflab) has increased plasma concentrations of Fluconazole (Saflab) by 40%. An effect of this magnitude should not necessitate a change in the Fluconazole (Saflab) dose regimen in subjects receiving concomitant diuretics, although the prescriber should bear it in mind.

Oral Contraceptives:

Phenytoin: Concomitant administration of Fluconazole (Saflab) and phenytoin may increase the levels of phenytoin to a clinically significant degree. If it is necessary to administer both drugs concomitantly, phenytoin levels should be monitored and the phenytoin dose adjusted to maintain therapeutic levels.

Pimozide: Combination of Fluconazole (Saflab) will increase the risk of ventricular arrhythmia troubles notably torsades de pointes.

Rifabutin: An interaction exists when Fluconazole (Saflab) is administered concurrently with rifabutin, leading to increased serum levels of rifabutin. There have been reports of uveitis in patients to whom Fluconazole (Saflab) and rifabutin were coadministered. Patients receiving rifabutin and Fluconazole (Saflab) concomitantly should be carefully monitored.

Rifampicin: Concomitant administration of Fluconazole (Saflab) and rifampicin resulted in a 25% decrease in the AUC and a 20% shorter half-life of Fluconazole (Saflab). In patients receiving concomitant rifampicin, an increase of the Fluconazole (Saflab) dose should be considered.

Sulfonylureas: Fluconazole (Saflab) has been shown to prolong the serum half-life of concomitantly administered oral sulfonylureas (chlorpropamide, glibenclamide, glipizide and tolbutamide) in healthy volunteers. Fluconazole (Saflab) and oral sulfonylureas may be coadministered to diabetic patients, but the possibility of a hypoglycemic episode should be borne in mind.

Tacrolimus: An interaction exists when Fluconazole (Saflab) is administered concomitantly with tacrolimus, leading to increased serum levels of tacrolimus. There have been reports of nephrotoxicity in patients also. Patients receiving tacrolimus and Fluconazole (Saflab) concomitantly should be carefully monitored.

Terfenadine: Concomitant Fluconazole (Saflab) and terfenadine causes palpitations, tachycardia, dizziness, and chest pain where the relationship of the adverse events to drug therapy or underlying medical condition was not clear. Because of the potential seriousness of such an interaction, it is recommended that terfenadine not be taken in combination with Fluconazole (Saflab).

Theophylline: Patients who are receiving high dose theophylline or who are otherwise at increased risk for theophylline toxicity should be observed for signs of theophylline toxicity while receiving Fluconazole (Saflab), and therapy modified appropriately it signs of toxicity develop.

Zidovudine: Increased levels of zidovudine most likely caused by the decreased conversion of zidovudine to its major metabolite. Patients receiving this combination of Fluconazole (Saflab) and zidovudine should be monitored for the development of zidovudine-related adverse reaction.

Use of Fluconazole (Saflab) in combination with astemizole or other drugs metabolized by the cytochrome P-450 system may be associated with elevations in serum levels of these drugs.

Oral Fluconazole (Saflab) is coadministered with food, cimetidine, antacids or following total body irradiation for bone marrow transplantation. No clinically significant impairment of Fluconazole (Saflab) absorption.

See also:
What other drugs will affect Lactobacillus (Saflab)?

Lactobacillus (Saflab) acidophilus is sensitive to anti-infective agents.

See also:
What other drugs will affect Secnidazole (Saflab)?

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

Secnidazole (Saflab) and Estriol: Antibiotics may diminish the therapeutic effect of Secnidazole (Saflab) 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 Azithromycin (Saflab)?

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.

Adults:

The data described below reflect exposure to Azithromycin (Saflab) in 728 adult patients. All patients received a single 2 g oral dose of Azithromycin (Saflab). The population studied had community-acquired pneumonia and acute bacterial sinusitis.

In controlled clinical trials with Azithromycin (Saflab), the majority of the reported treatment-related adverse reactions were gastrointestinal in nature and mild to moderate in severity.

Overall, the most common treatment-related adverse reactions in adult patients receiving a single 2 g dose of Azithromycin (Saflab) were diarrhea/loose stools (12%), nausea (4%), abdominal pain (3%), headache (1%), and vomiting (1%). The incidence of treatment-related gastrointestinal adverse reactions was 17% for Azithromycin (Saflab) and 10% for pooled comparators.

Treatment-related adverse reactions following Azithromycin (Saflab) treatment that occurred with a frequency of <1% included the following:

Cardiovascular: Palpitations, chest pain

Gastrointestinal: Constipation, dyspepsia, flatulence, gastritis, oral moniliasis

Genitourinary: Vaginitis

Nervous system: Dizziness, vertigo

General: Asthenia

Allergic: Rash, pruritus, urticaria

Special senses: Taste perversion

Pediatric Patients:

The data described below reflect exposure to Azithromycin (Saflab) in 907 pediatric patients. The population was 3 months to 12 years of age. All patients received a single 60 mg/kg oral dose of Azithromycin (Saflab).

As in adults, the most common treatment-related adverse reactions in pediatric subjects were gastrointestinal in nature. The pediatric subjects all received a single 60 mg/kg dose (equivalent to 27 mg/lb) of Azithromycin (Saflab).

In a trial with 450 pediatric subjects (ages 3 months to 48 months), vomiting (11%), diarrhea (10%) loose stools (9%), and abdominal pain (2%) were the most frequently reported treatment-related gastrointestinal adverse reactions. Many treatment related gastrointestinal adverse reactions with an incidence greater than 1% began on the day of dosing in these subjects [43% (68/160)] and most [53% (84/160)] resolved within 48 hr of onset. Treatment-related adverse events that were not gastrointestinal, occurring with a frequency ≥ 1% were: rash (5%), anorexia (2%), fever (2%), and dermatitis (2%).

In a second trial of 337 pediatric subjects, ages 2 years to 12 years, the most frequently reported treatment-related adverse reactions also included vomiting (14%), diarrhea (7%), loose stools (2%), nausea (4%) and abdominal pain (4%).

A third trial investigated the tolerability of two different concentrations of Azithromycin (Saflab) oral suspension in 120 pediatric subjects (ages 3 months to 48 months), all of whom were treated with Azithromycin (Saflab). The study evaluated the hypothesis that a more dilute, less viscous formulation (the recommended 27 mg/mL concentration of Azithromycin (Saflab)) is less likely to induce vomiting in young children than a more concentrated suspension used in other pediatric studies. The vomiting rate for subjects taking the dilute concentration Azithromycin (Saflab) was 3% (2/61). The rate was numerically lower but not statistically different from the vomiting for the more concentrated suspension Across both treatment arms, the only treatment-related adverse events with a frequency of ≥ 1% were vomiting (6%, 7/120) and diarrhea (2%, 2/120).

Treatment-related adverse reactions with a frequency of < 1% following Azithromycin (Saflab) treatment in all 907 pediatric subjects in the Phase 3 studies were:

Body as a whole: Chills, fever, flu syndrome, headache;

Digestive: Abnormal stools, constipation, dyspepsia, flatulence, gastritis, gastrointestinal disorder, hepatitis;

Hematologic and lymphatic: Leukopenia;

Nervous system: Agitation, emotional liability, hostility, hyperkinesia, insomnia, irritability, paresthesia, Somnolence;

Respiratory: Asthma, bronchitis, cough, dyspnea, pharyngitis, rhinitis;

Skin and appendages: Dermatitis, fungal dermatitis, maculopapular rash, pruritus, urticaria;

Special senses: Otitis media, taste perversion;

Urogenital: Dysuria.

Postmarketing Experience with Other Azithromycin (Saflab) Products

Because these reactions are reported voluntarily from a population of uncertain size, reliably estimating their frequency or establishing a causal relationship to drug exposure is not always possible.

Adverse events reported with Azithromycin (Saflab) immediate release formulations during the postmarketing period for which a causal relationship may not be established include:

Allergic: Arthralgia, edema, urticaria and angioedema

Cardiovascular: Palpitations and arrhythmias including ventricular tachycardia and hypotension

There have been reports of QT prolongation and torsades de pointes.

Gastrointestinal: Anorexia, constipation, dyspepsia, flatulence, vomiting/diarrhea, pseudomembranous colitis, pancreatitis, oral candidiasis, pyloric stenosis, and rare reports of tongue discoloration

General: Asthenia, paresthesia, fatigue, malaise and anaphylaxis

Genitourinary: Interstitial nephritis, acute renal failure and vaginitis

Hematopoietic: Thrombocytopenia, mild neutropenia

Liver/biliary: Adverse reactions related to hepatic dysfunction have been reported in postmarketing experience with Azithromycin (Saflab).

Nervous system: Convulsions, dizziness/vertigo, headache, somnolence, hyperactivity, nervousness, agitation and syncope

Psychiatric: Aggressive reaction and anxiety

Skin/appendages: Pruritus, rash, photosensitivity, serious skin reactions including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS.

Special senses: Hearing disturbances including hearing loss, deafness and/or tinnitus and reports of taste/smell perversion and/or loss

Laboratory Abnormalities

In subjects with normal baseline values, the following clinically significant laboratory abnormalities (irrespective of drug relationship) were reported in Azithromycin (Saflab) clinical trials in adults and pediatric patients:

Adults:

Laboratory abnormalities with an incidence of greater than or equal to 1%: reduced lymphocytes and increased eosinophils; reduced bicarbonate. Laboratory abnormalities with an incidence of less than 1%: leukopenia, neutropenia, elevated bilirubin, AST, ALT, BUN, creatinine, alterations in potassium. Where follow-up was provided, changes in laboratory tests appeared to be reversible.

Pediatric Patients:

Laboratory abnormalities with an incidence of greater than or equal to 1%: elevated eosinophils, BUN, and potassium; decreased lymphocytes; and alterations in neutrophils; with an incidence of less than 1%: elevated SGOT, SGPT and creatinine; decreased potassium; and alterations in sodium and glucose.

See also:
What are the possible side effects of Fluconazole (Saflab)?

Fluconazole (Saflab) is generally well tolerated.

In some patients, particularly those with serious underlying diseases such as AIDS and cancer, changes in renal and hematological function test results and hepatic abnormalities have been observed during treatment with Fluconazole (Saflab) and comparative agents, but the clinical significance and relationship to treatment is uncertain.

In Patients Receiving A Single Dose For Vaginal Candidiasis

During comparative clinical studies conducted in the United States, 448 patients with vaginal candidiasis were treated with Fluconazole (Saflab), 150 mg single dose. The overall incidence of side effects possibly related to Fluconazole (Saflab) was 26%. In 422 patients receiving active comparative agents, the incidence was 16%. The most common treatment-related adverse events reported in the patients who received 150 mg single dose Fluconazole (Saflab) for vaginitis were headache (13%), nausea (7%), and abdominal pain (6%). Other side effects reported with an incidence equal to or greater than 1% included diarrhea (3%), dyspepsia (1%), dizziness (1%), and taste perversion (1%). Most of the reported side effects were mild to moderate in severity. Rarely, angioedema and anaphylactic reaction have been reported in marketing experience.

In Patients Receiving Multiple Doses For Other Infections

Sixteen percent of over 4000 patients treated with Fluconazole (Saflab) (Fluconazole (Saflab)) in clinical trials of 7 days or more experienced adverse events. Treatment was discontinued in 1.5% of patients due to adverse clinical events and in 1.3% of patients due to laboratory test abnormalities.

Clinical adverse events were reported more frequently in HIV infected patients (21%) than in non-HIV infected patients (13%); however, the patterns in HIV infected and non-HIV infected patients were similar. The proportions of patients discontinuing therapy due to clinical adverse events were similar in the two groups (1.5%).

The following treatment-related clinical adverse events occurred at an incidence of 1% or greater in 4048 patients receiving Fluconazole (Saflab) for 7 or more days in clinical trials: nausea 3.7%, headache 1.9%, skin rash 1.8%, vomiting 1.7%, abdominal pain 1.7%, and diarrhea 1.5%.

Hepatobiliary

In combined clinical trials and marketing experience, there have been rare cases of serious hepatic reactions during treatment with Fluconazole (Saflab). The spectrum of these hepatic reactions has ranged from mild transient elevations in transaminases to clinical hepatitis, cholestasis and fulminant hepatic failure, including fatalities. Instances of fatal hepatic reactions were noted to occur primarily in patients with serious underlying medical conditions (predominantly AIDS or malignancy) and often while taking multiple concomitant medications. Transient hepatic reactions, including hepatitis and jaundice, have occurred among patients with no other identifiable risk factors. In each of these cases, liver function returned to baseline on discontinuation of Fluconazole (Saflab).

In two comparative trials evaluating the efficacy of Fluconazole (Saflab) for the suppression of relapse of cryptococcal meningitis, a statistically significant increase was observed in median AST (SGOT) levels from a baseline value of 30 IU/L to 41 IU/L in one trial and 34 IU/L to 66 IU/L in the other. The overall rate of serum transaminase elevations of more than 8 times the upper limit of normal was approximately 1% in Fluconazole (Saflab)-treated patients in clinical trials. These elevations occurred in patients with severe underlying disease, predominantly AIDS or malignancies, most of whom were receiving multiple concomitant medications, including many known to be hepatotoxic. The incidence of abnormally elevated serum transaminases was greater in patients taking Fluconazole (Saflab) concomitantly with one or more of the following medications: rifampin, phenytoin, isoniazid, valproic acid, or oral sulfonylurea hypoglycemic agents.

Post-Marketing Experience

In addition, the following adverse events have occurred during post-marketing experience.

Immunologic: In rare cases, anaphylaxis (including angioedema, face edema and pruritus) has been reported.

Body as a Whole: Asthenia, fatigue, fever, malaise.

Cardiovascular: QT prolongation, torsade de pointes.

Central Nervous System: Seizures, dizziness.

Hematopoietic and Lymphatic: Leukopenia, including neutropenia and agranulocytosis, thrombocytopenia.

Metabolic: Hypercholesterolemia, hypertriglyceridemia, hypokalemia.

Gastrointestinal: Cholestasis, dry mouth, hepatocellular damage, dyspepsia, vomiting.

Other Senses: Taste perversion.

Musculoskeletal System: myalgia.

Nervous System: Insomnia, paresthesia, somnolence, tremor, vertigo.

Skin and Appendages: Acute generalized exanthematous-pustulosis, drug eruption, increased sweating, exfoliative skin disorders including Stevens-Johnson syndrome and toxic epidermal necrolysis, alopecia.

Adverse Reactions In Children

The pattern and incidence of adverse events and laboratory abnormalities recorded during pediatric clinical trials are comparable to those seen in adults.

In Phase II/III clinical trials conducted in the United States and in Europe, 577 pediatric patients, ages 1 day to 17 years were treated with Fluconazole (Saflab) at doses up to 15 mg/kg/day for up to 1,616 days. Thirteen percent of children experienced treatment-related adverse events. The most commonly reported events were vomiting (5%), abdominal pain (3%), nausea (2%), and diarrhea (2%). Treatment was discontinued in 2.3% of patients due to adverse clinical events and in 1.4% of patients due to laboratory test abnormalities. The majority of treatment-related laboratory abnormalities were elevations of transaminases or alkaline phosphatase.

Percentage of Patients With Treatment-Related Side Effects

See also:
What are the possible side effects of Lactobacillus (Saflab)?

An increase in stomach gas may occur, but usually goes away with continued treatment. If this effect persists or worsens, notify your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: signs of infection (such as high fever, chills).

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also:
What are the possible side effects of Secnidazole (Saflab)?

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 Secnidazole (Saflab). Secnidazole (Saflab) 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 Secnidazole (Saflab). 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 Secnidazole (Saflab)-treated arm.

Most Common Adverse Reactions

Among 197 patients treated with a single 2 g dose of Secnidazole (Saflab) 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 Secnidazole (Saflab)-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 Secnidazole (Saflab) 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.