FASIGYN (Tinidazole) 500mg

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FASIGYN Brand is manufactured by PFIZER

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FASIGYN (Tinidazole) 500mg

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What is FASIGYN (Tinidazole)?
FASIGYN (Tinidazole) is an antibiotic that fights bacteria in the body.FASIGYN (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.FASIGYN (Tinidazole) may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about FASIGYN (Tinidazole)?
Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. FASIGYN (Tinidazole) will not treat a viral infection such as the common cold or flu. Do not drink alcohol while taking FASIGYN (Tinidazole) and for at least 3 days after finishing the medication. You may have unpleasant side effects such as fast heartbeats, severe nausea, vomiting, sweating, and warmth or tingling under your skin. A medicine similar to FASIGYN (Tinidazole) has caused cancer in laboratory animals. It is not known if FASIGYN (Tinidazole) would have the same effect in animals, or in humans. Talk with your doctor about your specific cancer risk.


What should I discuss with my healthcare provider before taking FASIGYN (Tinidazole)?
Do not use this medication if you are allergic to FASIGYN (Tinidazole), or: if you are in the first 3 months of pregnancy;if you are breast-feeding a baby (you should stop breast-feeding during treatment with FASIGYN (Tinidazole)); orif you are allergic to metronidazole (Flagyl).


Before taking this medication, tell your doctor if you are allergic to any drugs, or if you have:
kidney disease (or if you are on dialysis);epilepsy or other seizure disorder;a blood cell disorder such as anemia; ora weak immune system.If you have any of these conditions, you may not be able to use FASIGYN (Tinidazole), or you may need dosage adjustments or special tests during treatment.FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. FASIGYN (Tinidazole) should not be taken during the first three months of pregnancy. FASIGYN (Tinidazole) can pass into breast milk and may harm a nursing baby. If you are breast-feeding, you will need to stop while you are taking FASIGYN (Tinidazole) and for at least 3 days after finishing the medicine. Throw away any breast milk you have pumped while using FASIGYN (Tinidazole), and do not feed this milk to your baby. A medicine similar to FASIGYN (Tinidazole) has caused cancer in laboratory animals. It is not known if FASIGYN (Tinidazole) would have the same effect in animals, or in humans. Talk with your doctor about your specific cancer risk.


How should I take FASIGYN (Tinidazole)?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.Take FASIGYN (Tinidazole) with a full glass (8 ounces) of water. Take this medication with food. Some infections are treated with only one dose. Follow your doctor's instructions.Do not give this medication to another person, even if they have the same symptoms you have. If you are treating a sexually transmitted infection, make sure your sexual partner seeks medical attention to be treated also.Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. FASIGYN (Tinidazole) will not treat a viral infection such as the common cold or flu. Store FASIGYN (Tinidazole) at room temperature away from moisture and heat. 


What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.


What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a FASIGYN (Tinidazole) overdose are not known.


What should I avoid while taking FASIGYN (Tinidazole)?
Do not drink alcohol while taking FASIGYN (Tinidazole) and for 3 days after finishing the medication. You may have unpleasant side effects such as fast heartbeats, severe nausea, vomiting, sweating, and warmth or tingling under your skin. Check the label of the products and other medicines you use, such as mouthwash or cough and cold medicines. Alcohol in these products can also cause a reaction if you use them while taking FASIGYN (Tinidazole).


Side effects of FASIGYN (Tinidazole) 
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: seizures;fever, chills, body aches, flu symptoms;numbness, burning, pain, or tingly feeling; orfever, sore throat, and headache with a severe blistering, peeling, and red skin rash.


Less serious side effects may be more likely to occur, such as:
vaginal yeast infection (itching, white discharge);an unpleasant metallic taste in your mouth;nausea, vomiting, loss of appetite, indigestion;constipation, diarrhea, stomach cramps;dark-colored urine;headache, dizziness;muscle or joint pain;dry mouth, thirst, change in the color of your tongue;white patches or sores inside your mouth or on your lips; orminor skin rash or itching.Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. 


FASIGYN (Tinidazole) Dosing Information
Usual Adult Dose for Trichomoniasis:2 g orally once with foodThe sexual partners should be treated with the same dose at the same time.Usual Adult Dose for Giardiasis:2 g orally once with foodUsual Adult Dose for Amebiasis:Intestinal: 2 g orally once a day with food for 3 daysAmebic liver abscess: 2 g orally once a day with food for 3 to 5 daysUsual 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 daysUsual Pediatric Dose for Trichomoniasis:2 g orally once with foodThe 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 foodUsual Pediatric Dose for Amebiasis:3 years or older: Intestinal: 50 mg/kg (up to 2 g) orally once a day with food for 3 daysAmebic liver abscess: 50 mg/kg (up to 2 g) orally once a day with food for 3 to 5 daysClose monitoring is recommended when treatment durations exceed 3 days.


What other drugs will affect FASIGYN (Tinidazole)?
If you are taking a blood thinner such as warfarin (Coumadin), you may need a dose adjustment or special tests while you are taking FASIGYN (Tinidazole), and for up to 8 days after you stop taking it.Before taking FASIGYN (Tinidazole), tell your doctor if you are using any of the following drugs:amiodarone (Cordarone, Pacerone);cimetidine (Tagamet);cholestyramine (Questran, Prevalite);cyclosporine (Neoral, Sandimmune) or tacrolimus (Prograf);dexamethasone (Decadron, Hexadrol);fluorouracil (Adrucil, Efudex, Carac, Flurorplex);griseofulvin (Fulvicin, Grifulvin, Grisactin);lithium (Lithobid, Eskalith, and others);rifampin (Rifadin, Rimactane, Rifater);St. John's wort;antibiotics such as azithromycin (Zithromax), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Ery-Tab, Erythrocin), itraconazole (Sporanox), or ketoconazole (Nizoral);HIV medication such as nevirapine (Viramune), delavirdine (Rescriptor), or efavirenz (Sustiva); orseizure medication such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).If you are using any of these drugs, you may not be able to use FASIGYN (Tinidazole), or you may need dosage adjustments or special tests during treatment.There may be other drugs not listed that can affect FASIGYN (Tinidazole). Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Generic Name Tinidazole
Search Name Fasigyn Brand 500mg Tab
Supply Name FASIGYN
Brand Generic BRAND NAME
Presentation Foil in Box
Dosage Tab
USA Brand Fasigyn
Manufacture PFIZER
Strength 500mg
Search Terms Fasigyn ,FASIGYN ,Tinidazole
Origin India

Use spaces to separate tags. Use single quotes (') for phrases.

FOR THE CONSUMER

Along with its needed effects, tinidazole (the active ingredient contained in Fasigyn) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking tinidazole:

Rare:
-Change in consciousness
-cough
-difficulty breathing
-loss of consciousness
-noisy breathing
-shortness of breath
-tightness in chest
-wheezing

Incidence unknown:
-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

Some side effects of tinidazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common:
-Bitter taste
-metallic taste

Less common:
-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

Rare:
-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

Incidence unknown:
-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
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.