Lactobacillus/Norfloxacin/Tinidazole

Restoration of lactobacillus 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.

Norfloxacin is indicated for the treatment of adults with the following infections caused by susceptible strains of the designated microorganisms:

Urinary tract infections

Uncomplicated urinary tract infections (including cystitis) due to Enterococcus faecalis, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Staphylococcus epidermidis, Staphylococcus saprophyticus, Citrobacter freundii1, Enterobacter aerogenes1, Enterobacter cloacae1, Proteus vulgaris1, Staphylococcus aureus1, or Streptococcus agalactiae1.

Complicated urinary tract infections due to Enterococcus faecalis, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, or Serratia marcescens1.

Sexually transmitted diseases

Uncomplicated urethral and cervical gonorrhea due to Neisseria gonorrhoeae.

Prostatitis

Prostatitis due to Escherichia coli.

Penicillinase production should have no effect on norfloxacin activity.

Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to norfloxacin. Therapy with norfloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be given. Repeat culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agents but also on the possible emergence of bacterial resistance.

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

Trichomoniasis

Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis. The organism should be identified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, partners of infected patients should be treated simultaneously in order to prevent re-infection.

Giardiasis

Tinidazole is indicated for the treatment of giardiasis caused by Giardia duodenalis (also termed G. lamblia) in both adults and pediatric patients older than three years of age.

Amebiasis

Tinidazole is indicated for the treatment of intestinal amebiasis and amebic liver abscess caused by Entamoeba histolytica in both adults and pediatric patients older than three years of age. It is not indicated in the treatment of asymptomatic cyst passage.

Bacterial Vaginosis

Tinidazole is indicated for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, or anaerobic vaginosis) in non-pregnant women.

Other pathogens commonly associated with vulvovaginitis such as Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans and Herpes simplex virus should be ruled out.

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

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

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

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

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

Norfloxacin is used to treat certain bacterial infections in many different parts of the body. Norfloxacin may mask or delay the symptoms of syphilis. It is not effective against syphilis infections.

Norfloxacin belongs to the class of medicines known as quinolone antibiotics. It works by killing bacteria or preventing their growth. However, norfloxacin will not work for colds, flu, or other virus infections.

norfloxacin is available only with your doctor's prescription.

Tinidazole (tinidazole) is an antibiotic that fights bacteria in the body.

Tinidazole is used to treat certain infections caused by bacteria, such as infection of the intestines or vagina. It is also used to treat certain sexually transmitted infections.

Tinidazole may also be used for purposes other than those listed in this medication guide.

Dosage Forms

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

Capsule,

Oral:

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

Lactobacillus:

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

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

Lactobacillus: 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: 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: 4 tablets 3 to 4 times daily

Lactobacillus: 1 capsule once daily

Lactobacillus: 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 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 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 rhamnosus GG 5 billion CFU/packet: Children <3 years:

Oral: 1 packet once or twice daily.

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

Oral: 1 tablet once or twice daily.

Digestive Health Daily Probiotic Chewable: Lactobacillus 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 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 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 reuteri 20 million CFU/drop: Infants:

Oral: 5 drops once daily.

Soothe Vitamin D and Probiotic Drops: Lactobacillus 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 reuteri 100 million CFU/packet: Children:

Oral: 1 packet once daily.

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

Oral: 1 tablet once daily.

Tablets Norfloxacin should be taken at least one hour before or at least two hours after a meal or ingestion of milk and/or other dairy products. Multivitamins, other products containing iron or zinc, antacids containing magnesium and aluminum, sucralfate, or Videx® (Didanosine), chewable/buffered tablets or the pediatric powder for oral solution, should not be taken within 2 hours of administration of norfloxacin. Tablets Norfloxacin should be taken with a glass of water. Patients receiving Norfloxacin should be well hydrated.

Normal Renal Function

The recommended daily dose of Norfloxacin is as described in the following chart:

Renal Impairment

Norfloxacin may be used for the treatment of urinary tract infections in patients with renal insufficiency. In patients with a creatinine clearance rate of 30 mL/min/1.73 m² or less, the recommended dosage is one 400-mg tablet once daily for the duration given above. At this dosage, the urinary concentration exceeds the MICs for most urinary pathogens susceptible to norfloxacin, even when the creatinine clearance is less than 10 mL/min/1.73 m².

When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

Elderly

Elderly patients being treated for urinary tract infections who have a creatinine clearance of greater than 30 mL/min/1.73 m² should receive the dosages recommended under Normal Renal Function.

Elderly patients being treated for urinary tract infections who have a creatinine clearance of 30 mL/min/1.73 m² or less should receive 400 mg once daily as recommended under Renal Impairment.

How supplied

No. 8338 — Tablets Norfloxacin 400 mg are white to off-white, oval shaped, film-coated tablets, coded 705 on one side and plain on the other. They are supplied as follows:

NDC 0006-0705-20 unit of use bottles of 20. Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Keep container tightly closed.

Manufactured by: Merck Sharp & Dohme (Italia) S.p. A. Via Emilia, 21 27100 Pavia, Italy. Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. Revised: July 2016

Usual Adult Dose for Trichomoniasis

2 g orally once with food

The sexual partners should be treated with the same dose at the same time.

Usual Adult Dose for Giardiasis

2 g orally once with food

Usual Adult Dose for Amebiasis

Intestinal: 2 g orally once a day with food for 3 days

Amebic liver abscess: 2 g orally once a day with food for 3 to 5 days

Usual Adult Dose for Bacterial Vaginosis

Nonpregnant, adult women: 2 g orally once a day with food for 2 days or 1 g orally once a day with food for 5 days

Usual Pediatric Dose for Trichomoniasis

2 g orally once with food

The sexual partners should be treated with the same dose at the same time.

Usual Pediatric Dose for Giardiasis

3 years or older: 50 mg/kg (up to 2 g) orally once with food

Usual Pediatric Dose for Amebiasis

3 years or older:

Intestinal: 50 mg/kg (up to 2 g) orally once a day with food for 3 days

Amebic liver abscess: 50 mg/kg (up to 2 g) orally once a day with food for 3 to 5 days

Close monitoring is recommended when treatment durations exceed 3 days.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No data available for dosing adjustments for tinidazole. However, caution should be used in dosing patients with severe hepatic dysfunction due to reduction of metabolic elimination of metronidazole in this patient population.

Dose Adjustments

No adjustment recommended

Precautions

Convulsive seizures and peripheral neuropathy have been reported. The drug should be discontinued if patient experiences abnormal neurological symptoms. Tinidazole should be administered cautiously to patients with diseases of the central nervous system.

Tinidazole may produce transient leukopenia and neutropenia, However no persistent hematological abnormalities attributable to tinidazole have been observed clinically. If retreatment is necessary, total and differential leukocyte counts are recommended.

Alcoholic beverages should be avoided during and for 3 days after tinidazole therapy.

Animal studies have revealed carcinogenicity with another agent in the nitroimidazole class (metronidazole). Therefore, unnecessary use of tinidazole should be avoided.

Tinidazole is contraindicated during the first trimester of pregnancy.

Tinidazole is contraindicated in women who are breastfeeding. Interruption of breastfeeding is recommended for the duration of treatment and for 72 hours following the last dose.

To reduce the risk of development of drug resistant organisms, antibiotics should only be used to treat or prevent proven or suspected infections caused by bacteria. Culture and susceptibility information should be considered when selecting treatment or, if no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy. Patients should be advised to avoid missing doses and to complete the entire course of therapy.

Dialysis

Hemodialysis: On the day of hemodialysis, if tinidazole is administered prior to hemodialysis, an additional dose equivalent to one-half of the original dose should be administered after the end of hemodialysis.

Peritoneal dialysis: Data not available

Other Comments

Bioavailability is not affected by food.

For patients unable to swallow tablets, tinidazole tablets may be crushed in artificial cherry syrup and administered with food. The oral suspension may be prepared as follows:

1. Crush four 500 mg oral tablets to a powder with mortar and pestle.

2. Add about 10 mL cherry syrup to the powder and mix until smooth.

3. Transfer the suspension to a graduated amber container.

4. Use several small rinses of cherry syrup to transfer any remaining drug in the mortar to the final suspension for a total volume of 30 mL.

The oral suspension should be shaken well before each administration. The oral suspension of crushed tablets in artificial cherry syrup is stable for 7 days at room temperature.

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

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 Norfloxacin?

You should not use norfloxacin if you have a history of myasthenia gravis, or if you are allergic to norfloxacin or similar antibiotics such as ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), ofloxacin (Norfloxacin), and others.

You should not use this medication if you have ever had swelling or tearing of a tendon caused by taking norfloxacin or similar antibiotics.

Before taking norfloxacin, tell your doctor if you have a heart rhythm disorder, kidney or liver disease, muscle weakness or trouble breathing, joint problems, a condition called pseudotumor cerebri, a history of seizures, a history of head injury or brain tumor, low levels of potassium in your blood (hypokalemia), a personal or family history of Long QT syndrome, or if you have ever had an allergic reaction to an antibiotic.

Avoid taking antacids, vitamin or mineral supplements, sucralfate (Carafate), or didanosine (Videx) powder or chewable tablets within 2 hours before or after you take norfloxacin.

Norfloxacin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. These effects may be more likely to occur if you are over 60, if you take steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking norfloxacin and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions.

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

Hypersensitivity to tinidazole, other 5-nitroimidazole derivatives or to any of the excipients of Tinidazole.

As with other drugs of similar structure, tinidazole is also contraindicated in patients having or with a history of blood dyscrasias, although no persistent hematologic abnormalities have been noted in clinical or animal studies.

Use in pregnancy: Tinidazole crosses the placental barrier. Since the effects of compounds of this class on fetal development are unknown, the use of tinidazole during the 1st trimester is contraindicated. There is no evidence that tinidazole is harmful during the latter stages of pregnancy, but its use during the 2nd and 3rd trimesters requires that the potential benefits be weighed against possible hazards to the mother or fetus.

Use in lactation: Tinidazole is distributed in breast milk. Tinidazole may be present in breast milk for >72 hrs after administration. Women should not nurse during and for at least 3 days after having discontinued taking tinidazole.

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

• The contents of 1 packet of Lactobacillus should be added to cereal, food, or milk 3 or 4 times a day.
• If you miss a dose of Lactobacillus, 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.

Use norfloxacin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Norfloxacin comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get norfloxacin refilled.
• Take norfloxacin by mouth on an empty stomach at least 1 hour before or 2 hours after a meal or eating or drinking milk or other dairy products.
• Take norfloxacin with a full glass of water (8 oz/240 mL).
• Drinking extra fluids while you are taking norfloxacin is recommended. Check with your doctor for instructions.
• Do not take any products containing magnesium, aluminum, calcium, iron, or zinc (eg, antacids, quinapril, vitamins/minerals); didanosine; sucralfate; or bismuth subsalicylate within 2 hours before or 2 hours after taking norfloxacin.
• To clear up your infection completely, take norfloxacin for the full course of treatment. Keep taking it even if you feel better in a few days.
• Do not miss any doses. If you miss a dose of norfloxacin, take 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 take 2 doses at once.

Ask your health care provider any questions you may have about how to use norfloxacin.

Use tinidazole as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take tinidazole by mouth with food.
• If you have trouble swallowing the tablets, check with your doctor or pharmacist.
• If you take cholestyramine, do not take it at the same time you take tinidazole. Talk with your doctor about how you should take cholestyramine with tinidazole.
• If more than one dose of tinidazole is required, continue using tinidazole for the full course of treatment in order to clear up your infection completely, even if you feel better in a few days. Do not miss any doses.
• If you miss a dose of tinidazole, take 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 take 2 doses at once.

Ask your health care provider any questions you may have about how to use tinidazole.

Probiotics contain different types of micro-organisms such as yeast (saccharomyces boulardii) and bacteria (such as lactobacillus, 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

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.

Use: Labeled Indications

Uncomplicated and complicated urinary tract infections caused by susceptible gram-negative and gram-positive bacteria; sexually transmitted disease (eg, uncomplicated urethral and cervical gonorrhea) caused by N. gonorrhoeae; prostatitis due to E. coli

Note: As of April 2007, the CDC no longer recommends the use of fluoroquinolones for the treatment of gonococcal disease.

Limitations of use: Because fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions (eg, tendinitis and tendon rupture, peripheral neuropathy, CNS effects), reserve norfloxacin for use in patients who have no alternative treatment options for acute uncomplicated urinary tract infections.

Off Label Uses

Infectious Diarrhea

Based on the Infectious Diseases Society of American (IDSA) Practice Guidelines for the Management of Infectious Diarrhea, norfloxacin given for infectious diarrhea is effective and recommended in the management of this condition.

Spontaneous bacterial peritonitis (prevention)

Data from controlled trials support use of norfloxacin as primary long-term prophylaxis in cirrhotic patients with low protein ascites, or as secondary long-term prophylaxis in patients who have experienced a prior SBP episode. In cirrhotic patients with an active GI bleed, short-term prophylaxis with twice-daily norfloxacin may be used as monotherapy or following initial ceftriaxone therapy. According to AASLD and EASL guidelines, long-term prophylaxis with daily norfloxacin should be considered as secondary prophylaxis in patients who have experienced a prior SBP episode, and as primary prophylaxis in cirrhotic patients with low protein ascites. Twice-daily norfloxacin for short-term prophylaxis (7 days) can be used in cirrhotic patients with GI hemorrhage. Increasing bacterial resistance rates to antibiotics used in the treatment and prevention of SBP have been documented; therefore, local epidemiological patterns should be considered, and use of antibiotic prophylaxis should be restricted to patients at high risk of SBP.

Use: Labeled Indications

Amebiasis: Treatment of intestinal amebiasis and amebic liver abscess caused by Entamoeba histolytica in adults and pediatric patients older than 3 years.

Limitations of use: Not indicated for the treatment of asymptomatic cyst passage.

Bacterial vaginosis: Treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, or anaerobic vaginosis) in adult women.

Giardiasis: Treatment of giardiasis caused by Giardia duodenalis (also termed Giardia lamblia) in adults and pediatric patients older than 3 years.

Trichomoniasis: Treatment of trichomoniasis caused by Trichomonas vaginalis; treat partners of infected patients simultaneously to prevent reinfection.

Off Label Uses

Helicobacter pylori eradication

Based on the American College of Gastroenterology Clinical Guideline for the Treatment of Helicobacter pylori Infection, tinidazole is an effective and recommended component of a multiple-drug regimen for the treatment of this condition.

Prophylaxis against sexually transmitted diseases following sexual assault

Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, tinidazole, in combination with ceftriaxone and azithromycin, is a recommended regimen for prophylaxis against sexually transmitted diseases following sexual assault in adolescents and adults.

Urethritis, nongonococcal (persistent and recurrent)

Based on the CDC sexually transmitted diseases treatment guidelines, tinidazole is effective and recommended as treatment for recurrent and persistent urethritis for men who have sex with women and who live in areas where T. vaginalis is prevalent. Compliance with initial regimen and lack of reexposure to an untreated sex partner should be excluded prior to use. Sex partners should be referred for evaluation and appropriate treatment.

See also:
What other drugs will affect Lactobacillus?

Lactobacillus acidophilus is sensitive to anti-infective agents.

See also:
What other drugs will affect Norfloxacin?

Quinolones, including Norfloxacin, have been shown in vitro to inhibit CYP1A2. Concomitant use with drugs metabolized by CYP1A2 (e.g., caffeine, clozapine, ropinirole, tacrine, theophylline, tizanidine) may result in increased substrate drug concentrations when given in usual doses. Patients taking any of these drugs concomitantly with norfloxacin should be carefully monitored.

Elevated plasma levels of theophylline have been reported with concomitant quinolone use. There have been reports of theophylline-related side effects in patients on concomitant therapy with norfloxacin and theophylline. Therefore, monitoring of theophylline plasma levels should be considered and dosage of theophylline adjusted as required.

Elevated serum levels of cyclosporine have been reported with concomitant use of cyclosporine with Norfloxacin. Therefore, cyclosporine serum levels should be monitored and appropriate cyclosporine dosage adjustments made when these drugs are used concomitantly.

Quinolones, including Norfloxacin, may enhance the effects of oral anticoagulants, including warfarin or its derivatives or similar agents. When these products are administered concomitantly, prothrombin time or other suitable coagulation tests should be closely monitored.

The concomitant administration of quinolones including Norfloxacin with glyburide (a sulfonylurea agent) has, on rare occasions, resulted in severe hypoglycemia. Therefore, monitoring of blood glucose is recommended when these agents are co-administered.

Diminished urinary excretion of Norfloxacin has been reported during the concomitant administration of probenecid and Norfloxacin.

The concomitant use of nitrofurantoin is not recommended since nitrofurantoin may antagonize the antibacterial effect of Norfloxacin in the urinary tract.

Multivitamins, or other products containing iron or zinc, antacids or sucralfate, should not be administered concomitantly with, or within 2 hours of, the administration of Norfloxacin, because they may interfere with absorption resulting in lower serum and urine levels of Norfloxacin.

Videx® (Didanosine) chewable/buffered tablets or the pediatric powder for oral solution should not be administered concomitantly with, or within 2 hours of, the administration of Norfloxacin, because these products may interfere with absorption resulting in lower serum and urine levels of Norfloxacin.

Some quinolones have also been shown to interfere with the metabolism of caffeine. This may lead to reduced clearance of caffeine and a prolongation of the plasma half-life that may lead to accumulation of caffeine in plasma when products containing caffeine are consumed while taking Norfloxacin.

The concomitant administration of a non-steroidal anti-inflammatory drug (NSAID) with a quinolone, including Norfloxacin, may increase the risk of CNS stimulation and convulsive seizures. Therefore, Norfloxacin should be used with caution in individuals receiving NSAIDS concomitantly.

See also:
What other drugs will affect Tinidazole?

Although not specifically identified in studies with tinidazole, the following drug interactions were reported for metronidazole, a chemically-related nitroimidazole. Therefore, these drug interactions may occur with tinidazole.

Potential Effects Of Tinidazole On Other Drugs

Warfarin And Other

Oral Coumarin Anticoagulants

As with metronidazole, tinidazole may enhance the effect of warfarin and other coumarin anticoagulants, resulting in a prolongation of prothrombin time. The dosage of oral anticoagulants may need to be adjusted during tinidazole co-administration and up to 8 days after discontinuation.

Alcohols, Disulfiram

Alcoholic beverages and preparations containing ethanol or propylene glycol should be avoided during tinidazole therapy and for 3 days afterward because abdominal cramps, nausea, vomiting, headaches, and flushing may occur. Psychotic reactions have been reported in alcoholic patients using metronidazole and disulfiram concurrently. Though no similar reactions have been reported with tinidazole, tinidazole should not be given to patients who have taken disulfiram within the last two weeks.

Lithium

Metronidazole has been reported to elevate serum lithium levels. It is not known if tinidazole shares this property with metronidazole, but consideration should be given to measuring serum lithium and creatinine levels after several days of simultaneous lithium and tinidazole treatment to detect potential lithium intoxication.

Phenytoin, Fosphenytoin

Concomitant administration of oral metronidazole and intravenous phenytoin was reported to result in prolongation of the half-life and reduction in the clearance of phenytoin. Metronidazole did not significantly affect the pharmacokinetics of orally-administered phenytoin.

Cyclosporine, Tacrolimus

There are several case reports suggesting that metronidazole has the potential to increase the levels of cyclosporine and tacrolimus. During tinidazole co-administration with either of these drugs, the patient should be monitored for signs of calcineurin-inhibitor associated toxicities.

Fluorouracil

Metronidazole was shown to decrease the clearance of fluorouracil, resulting in an increase in side-effects without an increase in therapeutic benefits. If the concomitant use of tinidazole and fluorouracil cannot be avoided, the patient should be monitored for fluorouracil-associated toxicities.

Potential Effects Of Other Drugs On Tinidazole

CYP3A4 Inducers And Inhibitors

Simultaneous administration of tinidazole with drugs that induce liver microsomal enzymes, i.e., CYP3A4 inducers such as phenobarbital, rifampin, phenytoin, and fosphenytoin (a pro-drug of phenytoin), may accelerate the elimination of tinidazole, decreasing the plasma level of tinidazole. Simultaneous administration of drugs that inhibit the activity of liver microsomal enzymes, i.e., CYP3A4 inhibitors such as cimetidine and ketoconazole, may prolong the half-life and decrease the plasma clearance of tinidazole, increasing the plasma concentrations of tinidazole.

Cholestyramine

Cholestyramine was shown to decrease the oral bioavailability of metronidazole by 21%. Thus, it is advisable to separate dosing of cholestyramine and tinidazole to minimize any potential effect on the oral bioavailability of tinidazole.

Oxytetracycline

Oxytetracycline was reported to antagonize the therapeutic effect of metronidazole.

Laboratory Test Interactions

Tinidazole, like metronidazole, may interfere with certain types of determinations of serum chemistry values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactate dehydrogenase (LDH), triglycerides, and hexokinase glucose. Values of zero may be observed. All of the assays in which interference has been reported involve enzymatic coupling of the assay to oxidation-reduction of nicotinamide adenine dinucleotide (NAD+↔ NADH). Potential interference is due to the similarity of absorbance peaks of NADH and tinidazole.

Tinidazole, like metronidazole, may produce transient leukopenia and neutropenia; however, no persistent hematological abnormalities attributable to tinidazole have been observed in clinical studies. Total and differential leukocyte counts are recommended if re-treatment is necessary.

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

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 Norfloxacin?

Applies to norfloxacin: oral tablet

As well as its needed effects, norfloxacin (the active ingredient contained in Norfloxacin) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking norfloxacin, check with your doctor immediately:

Rare

• Chest pain or discomfort
• chills
• diarrhea
• discouragement
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling sad or empty
• fever
• flushing or redness of the skin
• hives or welts
• increased sweating
• irritability
• irritation or soreness of the mouth
• itching of the rectal area
• itching skin
• lack of appetite
• loss of interest or pleasure
• nausea
• pain and inflammation at the joints
• pain or discomfort in the arms, jaw, back, or neck
• redness of the skin
• shortness of breath
• skin rash
• sweating
• swelling of the foot or hand
• swelling of the stomach
• tingling of the fingers
• tiredness
• trouble with concentrating
• trouble with sleeping
• unusually warm skin
• vomiting

• Abdominal or stomach cramps or tenderness
• anxiety
• back, leg, or stomach pains
• black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating
• blood in the urine or stools
• blurred vision
• bone pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• clay-colored stools
• cold sweats
• constipation
• cool, pale skin
• cough or hoarseness
• cracks in the skin
• dark-colored urine
• decreased frequency or amount of urine
• diarrhea, watery and severe, which may also be bloody
• difficulty with breathing, chewing, swallowing, or talking
• difficulty with moving
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• double vision
• drooping eyelids
• dry mouth
• dry skin
• false sense of well-being
• fever with or without chills
• fruit-like breath odor
• general body swelling
• general feeling of tiredness or weakness
• greatly decreased frequency of urination or amount of urine
• headache
• inability to move the arms and legs
• increased blood pressure
• increased hunger
• increased sensitivity of the skin to sunlight
• increased thirst
• increased urination
• indigestion
• irregular or slow heart rate
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• loss of heat from the body
• lower back or side pain
• mood or mental changes
• mood swings
• muscle aching or cramping
• muscle pain or stiffness
• muscle weakness
• nervousness
• nightmares
• nosebleeds
• numbness or tingling in the hands, feet, or lips
• pain or burning while urinating
• pain, inflammation, or swelling in the calves, shoulders, or hands
• pain, swelling, or redness in the joints
• painful or difficult urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• personality changes
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• red, swollen skin
• scaly skin
• seizures
• severe sunburn
• severe tiredness
• shakiness and unsteady walk
• skin rash
• slurred speech
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sores, welting, or blisters
• stomach pain, continuing
• sudden decrease in the amount of urine
• sudden numbness and weakness in the arms and legs
• swelling of the face, fingers, or lower legs
• swelling or inflammation of the mouth
• swollen glands
• tightness in the chest
• unexplained weight loss
• unpleasant breath odor
• unsteadiness, awkwardness, trembling, or other problems with muscle control or coordination
• unusual behavior, such as disorientation to time or place, failure to recognize people, hyperactivity, or restlessness
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight loss
• vomiting of blood
• weakness in the arms, hands, legs, or feet
• weight gain
• wheezing
• yellowing of the eyes or skin

Minor Side Effects

Some norfloxacin side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common:

• Lack or loss of strength

• Acid or sour stomach
• belching
• bitter taste
• cramps
• excess air or gas in the stomach or intestines
• full feeling
• heartburn
• heavy bleeding
• pain
• passing gas
• sleepiness or unusual drowsiness
• sleeplessness
• stomach discomfort, upset, or pain
• unable to sleep
• weight loss

• Change in taste
• continuing ringing or buzzing or other unexplained noise in the ears
• hearing loss
• itching of the vagina or outside genitals
• loss of taste
• pain during sexual intercourse
• seeing double
• thick, white curd-like vaginal discharge without odor or with mild odor
• uncontrolled eye movements

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

Applies to tinidazole: oral tablet

As well as its needed effects, tinidazole (the active ingredient contained in Tinidazole) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking tinidazole, check with your doctor immediately:

Rare

• Change in consciousness
• cough
• difficulty breathing
• loss of consciousness
• noisy breathing
• shortness of breath
• tightness in chest
• wheezing

• Black, tarry stools
• bleeding gums
• blood in urine or stools
• burning, numbness, tingling, or painful sensations
• chest pain
• chills
• difficulty swallowing
• fast, irregular, pounding, or racing heartbeat or pulse
• fever
• hives
• increased transaminase levels
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lower back or side pain
• nausea
• painful or difficult urination
• pale skin
• pinpoint red spots on skin
• reddening of the skin, especially around ears
• seizures
• sore throat
• sores, ulcers, or white spots on lips or in mouth
• swelling of eyes, face, or inside of nose
• swollen glands
• ulcers
• unsteadiness or awkwardness
• unusual bleeding or bruising
• unusual tiredness or weakness
• weakness in arms, hands, legs, or feet

Minor Side Effects

Some tinidazole side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:

• Bitter taste
• metallic taste

• Acid or sour stomach
• belching
• cramps
• difficulty having a bowel movement (stool)
• dizziness
• general feeling of discomfort or illness
• headache
• heartburn
• indigestion
• loss of appetite
• pain or discomfort in chest, upper stomach, or throat
• vomiting
• weight loss

• Body aches or pain
• coating on tongue
• congestion
• depression
• dryness or soreness of throat
• hoarseness
• mood or mental changes
• runny nose
• tender, swollen glands in neck
• voice changes

• Abnormal liver
• darkened urine
• diarrhea
• difficulty in moving
• feeling of constant movement of self or surroundings
• giddiness
• lightheadedness
• muscle pain or stiffness
• pain, swelling, or redness in joints
• sensation of spinning
• shakiness and unsteady walk
• sleepiness
• sleeplessness
• swelling or inflammation of the mouth
• tongue discoloration
• trembling, or other problems with muscle control or coordination
• trouble sleeping
• unable to sleep
• white or brownish vaginal discharge
• white patches in the mouth or throat or on the tongue

Lactobacillus 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.

A synthetic fluoroquinolone (fluoroquinolones) with broad-spectrum antibacterial activity against most gram-negative and gram-positive bacteria. Norfloxacin inhibits bacterial DNA gyrase. [PubChem]

Each vaginal suppository contains tioconazole 100 mg and tinidazole 150 mg. It also contains witepsol as excipient.