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DRUGS & SUPPLEMENTS
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Anesir
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Anesir uses
Anesir consists of Metronidazole, Neomycin Sulfate, Nystatin.Metronidazole:
Pharmacological action
Anesir is an anti protozoal agent. It is believed that the mechanism of action is associated with DNA damage-sensitive microorganisms. Active against Trichomonas vaginalis, Gardnerella vaginalis, Giardia lamblia, Entamoeba histolytica, and obligate anaerobic bacteria (including Bacteroides spp., Fusobacterium spp.).
Aerobic bacteria are resistant to Anesir (Metronidazole).
In combination with amoxicillin Anesir (Metronidazole) is active against Helicobacter pylori. It is believed that amoxicillin inhibits the development of resistance of Helicobacter pylori to Anesir (Metronidazole).
Pharmacokinetics
Anesir (Metronidazole) well absorbed after oral administration. The bioavailability is 80%. Anesir (Metronidazole) is distributed in tissues and body fluids. This medication crosses the placental barrier and the BBB. Binding to plasma proteins is 20%. Anesir (Metronidazole) is metabolized in the liver by oxidation and binding to glucuronic acid. T1/2 is 8 hours. This drug is excreted in the urine (60-80%) and feces (6-15%).
Why is Anesir prescribed?
Trichomonazice vaginitis and urethritis in women, trichomonazice urethritis in men, giardiasis, amoebic dysentery, anaerobic infections caused by metronidazole-sensitive organisms, combination therapy of severe mixed aerobic-anaerobic infections. Preventing anaerobic infection in surgery (particularly abdominal, urinary tract). Chronic alcoholism.
Anesir (Metronidazole) in combination with amoxicillin: chronic gastritis in acute phase, gastric ulcer and duodenal ulcer in acute phase, associated with Helicobacter pylori.
For external and topical use: treatment of acne vulgaris and pink, bacterial vaginosis, treatment of long-term healing of wounds and trophic ulcers.
Dosage and administration
Anesir is administered for oral use for adults and children over 12 years in 7.5 mg / kg every 6 h or 250-750 mg 3-4 times / day. For children up to 12 years the dose is 5-16.7 mg / kg 3 times / day. For IV injections for adults and children over 12 years starting dose is 15 mg / kg, followed by 7.5 mg / kg every 6 hours or depending on the etiology of the disease - by 500-750 mg every 8 hours. The duration of treatment and frequency of tests is determined individually.
Intravaginally - 500 mg 1 time a night.
In combination with amoxicillin (2.25 g / day) daily dose of Anesir (Metronidazole) is 1.5 g; multiplicity of admission - 3 times / day. For patients with severe renal impairment (creatinine clearance less than 30 ml / min) and / or liver daily dose of Anesir (Metronidazole) is 1 g (amoxicillin - 1.5 g / day), the multiplicity of the reception is 2 times / day. This medication takes for external and local use 2 times / day, doses are determined individually.
The maximum daily dose for adults when taken orally and IV is 4 g.
Anesir (Metronidazole) side effects, adverse reactions
Digestive system: nausea, vomiting, anorexia, metallic taste in the mouth.
CNS and peripheral nervous system: headache, nervousness, irritability, insomnia, dizziness, ataxia, weakness, confusion, depression, peripheral neuropathy, seizures, hallucinations.
Allergic reactions: skin rash, itching, hives.
Hemopoietic system: leucopenia.
Local reactions: irritation.
Other: arthralgia, burning sensation in the urethra.
Anesir contraindications
Organic CNS lesions, blood diseases, liver problems, I trimester of pregnancy, hypersensitivity to Anesir (Metronidazole).
Using during pregnancy and breastfeeding
Anesir is rapidly crosses the placental barrier. In II and III trimester of pregnancy Anesir (Metronidazole) is used only for health reasons.
Anesir (Metronidazole) is excreted in breast milk. If necessary, use during lactation should solve the issue of termination of breastfeeding.
Special instructions
Patients should with careful use of Anesir (Metronidazole) in liver diseases.
In combination with amoxicillin this medication is not recommended for patients younger than 18 years. During the treatment period it is necessary the regular control of pattern of peripheral blood.
During the treatment of Trichomonas vaginitis in women and Trichomonas urethritis in men patients should refrain from sexual activity, simultaneous treatment of both partners is mandatory.
During the taking of Anesir (Metronidazole) there is a more dark staining of urine.
During treatment with Anesir (Metronidazole) should avoid alcohol because to violations of the oxidation of alcohol can accumulate acetaldehyde. As a result may develop reactions similar to those characteristic of disulfiram (abdominal cramps, nausea, vomiting, headache, a sudden rush of blood to the face).
Anesir drug interactions
Simultaneous administration of Anesir (Metronidazole) with:
Anesir in case of emergency / overdose
Symptoms: nausea, vomiting, ataxia, in severe cases - peripheral neuropathy and seizures.
Treatment: symptomatic, there is no specific antidote.
Neomycin Sulfate:
- Indications and usage
- Contraindications
- Warnings
- Precautions
- Adverse reactions
- Overdosage
- Dosage and administration
- How supplied
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Anesir (Neomycin Sulfate) tablets and other antibacterial drugs, Anesir (Neomycin Sulfate) 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.
Suppression of Intestinal Bacteria
Anesir (Neomycin Sulfate) tablets are indicated as adjunctive therapy as part of a regimen for the suppression of the normal bacterial flora of the bowel, e.g., preoperative preparation of the bowel. It is given concomitantly with erythromycin enteric-coated base (see DOSAGE AND ADMINISTRATION ).
Hepatic Coma (Portal-Systemic Encephalopathy)
Anesir (Neomycin Sulfate) has been shown to be effective adjunctive therapy in hepatic coma by reduction of the ammonia-forming bacteria in the intestinal tract. The subsequent reduction in blood ammonia has resulted in neurologic improvement.
CONTRAINDICATIONS
Anesir (Neomycin Sulfate) oral preparations are contraindicated in the presence of intestinal obstruction and in individuals with a history of hypersensitivity to the drug.
Patients with a history of hypersensitivity or serious toxic reaction to other aminoglycosides may have a cross-sensitivity to neomycin. Anesir (Neomycin Sulfate) oral preparations are contraindicated in patients with inflammatory or ulcerative gastrointestinal disease because of the potential for enhanced gastrointestinal absorption of neomycin.
WARNINGS
Additional manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions.
The risk of hearing loss continues after drug withdrawal. Aminoglycosides can cause fetal harm when administered to a pregnant woman.
Aminoglycoside antibiotics cross the placenta and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Although serious side effects to fetus or newborn have not been reported in the treatment of pregnant women with other aminoglycosides, the potential for harm exists. Animal reproduction studies of neomycin have not been conducted. If neomycin is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
PRECAUTIONS
General
Prescribing Anesir tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
As with other antibiotics, use of oral neomycin may result in overgrowth of nonsusceptible organisms, particularly fungi. If this occurs, appropriate therapy should be instituted.
Neomycin is quickly and almost totally absorbed from body surfaces (except the urinary bladder) after local irrigation and when applied topically in association with surgical procedures. Delayed-onset irreversible deafness, renal failure and death due to neuromuscular blockade (regardless of the status of renal function) have been reported following irrigation of both small and large surgical fields with minute quantities of neomycin.
Cross-allergenicity among aminoglycosides has been demonstrated.
Aminoglycosides should be used with caution in patients with muscular disorders such as myasthenia gravis or parkinsonism since these drugs may aggravate muscle weakness because of their potential curare-like effect on the neuromuscular junction.
Small amounts of orally administered neomycin are absorbed through intact intestinal mucosa.
There have been many reports in the literature of nephrotoxicity and/or ototoxicity with oral use of neomycin. If renal insufficiency develops during oral therapy, consideration should be given to reducing the drug dosage or discontinuing therapy.
An oral neomycin dose of 12 grams per day produces a malabsorption syndrome for a variety of substances, including fat, nitrogen, cholesterol, carotene, glucose, xylose, lactose, sodium, calcium, cyanocobalamin and iron.
Orally administered neomycin increases fecal bile acid excretion and reduces intestinal lactase activity.
Information for The Patient
Patients should be counseled that antibacterial drugs including Anesir (Neomycin Sulfate) tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Anesir (Neomycin Sulfate) tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Anesir (Neomycin Sulfate) tablets or other antibacterial drugs in the future.
Before administering the drug, patients or members of their families should be informed of possible toxic effects on the eighth nerve. The possibility of acute toxicity increases in premature infants and neonates.
Laboratory Tests
Patients with renal insufficiency may develop toxic neomycin blood levels unless doses are properly regulated. If renal insufficiency develops during treatment, the dosage should be reduced or the antibiotic discontinued. To avoid nephrotoxicity and eighth nerve damage associated with high doses and prolonged treatment, the following should be performed prior to and periodically during therapy: urinalysis for increased excretion of protein, decreased specific gravity, casts and cells; renal function tests such as serum creatinine, BUN or creatinine clearance; tests of the vestibulocochlearis nerve function.
Serial, vestibular and audiometric tests should be performed (especially in high-risk patients). Since elderly patients may have reduced renal function which may not be evident in the results of routine screening tests such as BUN or serum creatinine, a creatinine clearance determination may be more useful.
Drug Interactions
Caution should be taken in concurrent or serial use of other neurotoxic and/or nephrotoxic drugs because of possible enhancement of the nephrotoxicity and/or ototoxicity of neomycin (see boxed WARNINGS ).
Caution should also be taken in concurrent or serial use of other aminoglycosides and polymyxins because they may enhance neomycin’s nephrotoxicity and/or ototoxicity and potentiate neomycin sulfate’s neuromuscular blocking effects.
Oral neomycin inhibits the gastrointestinal absorption of penicillin V, oral vitamin B-12, methotrexate and 5-fluorouracil. The gastrointestinal absorption of digoxin also appears to be inhibited. Therefore, digoxin serum levels should be monitored.
Oral Anesir (Neomycin Sulfate) may enhance the effect of coumarin in anticoagulants by decreasing vitamin K availability.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed with Anesir to evaluate carcinogenic or mutagenic potential or impairment of fertility.
Pregnancy Category D
See WARNINGS section.
Nursing Mothers
It is not known whether neomycin is excreted in human milk, but it has been shown to be excreted in cow milk following a single intramuscular injection. Other aminoglycosides have been shown to be excreted in human milk. Because of the potential for serious adverse reactions from the aminoglycosides in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use
The safety and efficacy of oral Anesir (Neomycin Sulfate) in patients less than 18 years of age have not been established. If treatment of a patient less than 18 years of age is necessary, neomycin should be used with caution and the period of treatment should not exceed two weeks because of absorption from the gastrointestinal tract.
ADVERSE REACTIONS
The most common adverse reactions to oral Anesir (Neomycin Sulfate) are nausea, vomiting and diarrhea. The "Malabsorption Syndrome" characterized by increased fecal fat, decreased serum carotene and fall in xylose absorption has been reported with prolonged therapy. Nephrotoxicity, ototoxicity and neuromuscular blockage have been reported (see boxed WARNINGS and PRECAUTIONS sections).
OVERDOSAGE
Because of low absorption, it is unlikely that acute overdosage would occur with oral Anesir (Neomycin Sulfate). However, prolonged administration could result in sufficient systemic drug levels to produce neurotoxicity, ototoxicity and/or nephrotoxicity.
Hemodialysis will remove Anesir (Neomycin Sulfate) from the blood.
DOSAGE AND ADMINISTRATION
To minimize the risk of toxicity, use the lowest possible dose and the shortest possible treatment period to control the condition. Treatment for periods longer than two weeks is not recommended.
Hepatic Coma
For use as an adjunct in the management of hepatic coma, the recommended dose is 4 to 12 grams per day given in the following regimen:
- Withdraw protein from diet. Avoid use of diuretic agents.
- Give supportive therapy, including blood products, as indicated.
- Give Anesir (Neomycin Sulfate) tablets in doses of 4 to 12 grams of Anesir (Neomycin Sulfate) per day (eight to 24 tablets) in divided doses. Treatment should be continued over a period of five to six days, during which time protein should be returned incrementally to the diet.
- If less potentially toxic drugs cannot be used for chronic hepatic insufficiency, neomycin in doses of up to four grams daily (eight tablets per day) may be necessary. The risk for the development of neomycin-induced toxicity progressively increases when treatment must be extended to preserve the life of a patient with hepatic encephalopathy who has failed to fully respond. Frequent periodic monitoring of these patients to ascertain the presence of drug toxicity is mandatory (see PRECAUTIONS ). Also, neomycin serum concentrations should be monitored to avoid potentially toxic levels. The benefits to the patient should be weighed against the risks of nephrotoxicity, permanent ototoxicity and neuromuscular blockade following the accumulation of neomycin in the tissues.
Preoperative Prophylaxis for Elective Colorectal Surgery
Listed below is an example of a recommended bowel preparation regimen. A proposed surgery time of 8:00 a.m. has been used.
Pre-op Day 3: Minimum residue or clear liquid diet. Bisacodyl, 1 tablet orally at 6:00 p.m.
Pre-op Day 2: Minimum residue or clear liquid diet. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., 2:00 p.m., and 6:00 p.m. Enema at 7:00 p.m. and 8:00 p.m.
Pre-op Day 1: Clear liquid diet. Supplemental (IV) fluids as needed. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., and 2:00 p.m. Anesir (Neomycin Sulfate) (1 g) and erythromycin base (1 g) orally at 1:00 p.m., 2:00 p.m. and 11:00 p.m. No enema.
Day of Operation: Patient evacuates rectum at 6:30 a.m. for scheduled operation at 8:00 a.m.
HOW SUPPLIED
Anesir (Neomycin Sulfate) tablets USP, 500 mg (equivalent to 350 mg of neomycin base per tablet) are available as white to off-white, round, standard convex tablets debossed "LCI" on one side and "1210", on the other side and are supplied in:
Bottles of 100 (NDC 0527-1210-01)
Store at 20° to 25°C (68° to 77°F).
Dispense in tight containers as defined in the USP/NF.
Distributed By:
Lannett Company, Inc.
Philadelphia, PA 19154
Made in the USA
Rev. 01/17
CIB71710A
Nystatin:
- Description
- Clinical pharmacology
- Indications and usage
- Contraindications
- Precautions
- Adverse reactions
- Overdosage
- Dosage and administration
- How supplied
DESCRIPTION
Anesir (Nystatin), USP is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Its structural formula:
- C47H75NO17 M.W. 926.13
Anesir (Nystatin) Tablets USP contain the inactive ingredients: Corn Starch, Povidone, Compressible Sugar, Microcrystalline Cellulose, Sodium Starch Glycolate, Talc, Magnesium Stearate, Purified Water, and Coloring.
Structural formula for Anesir (Nystatin)
CLINICAL PHARMACOLOGY
Pharmacokinetics
Gastrointestinal absorption of Anesir is insignificant. Most orally administered Anesir (Nystatin) is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of Anesir (Nystatin) may occasionally occur.
Microbiology
Anesir (Nystatin) is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast like fungi. Candida albicans demonstrates no significant resistance to Anesir (Nystatin) in vitro on repeated subculture in increasing levels of Anesir (Nystatin); other Candida species become quite resistant. Generally, resistance does not develop in vivo. Anesir (Nystatin) acts by binding to sterols in the cell membrane of susceptible Candida species with a resultant change in membrane permeability allowing leakage of intracellular components. Anesir (Nystatin) exhibits no appreciable activity against bacteria, protozoa, or viruses.
INDICATIONS AND USAGE
Anesir (Nystatin) tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.
CONTRAINDICATIONS
Anesir (Nystatin) tablets are contraindicated in patients with a history of hypersensitivity to any of their components.
PRECAUTIONS
General
This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.
Pregnancy
Teratogenic Effects
Pregnancy Category C
Animal reproduction studies have not been conducted with Anesir. It is also not known whether Anesir (Nystatin) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Anesir (Nystatin) should be given to a pregnant woman only if clearly needed.
Nursing Mothers
It is not known whether Anesir (Nystatin) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Anesir (Nystatin) is administered to a nursing woman.
ADVERSE REACTIONS
Anesir is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported (see PRECAUTIONS, General).
Gastrointestinal
Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances.
Dermatologic
Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.
Other
Tachycardia, bronchospasm, facial swelling, and nonspecific myalgia have also been rarely reported.
OVERDOSAGE
Oral doses of Anesir (Nystatin) in excess of five million units daily have caused nausea and gastrointestinal upset. There have been no reports of serious toxic effects of superinfections (see CLINICAL PHARMACOLOGY, Pharmacokinetics).
DOSAGE AND ADMINISTRATION
The usual therapeutic dosage is one to two tablets (500,000 to 1,000,000 units Anesir (Nystatin)) three times daily. Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.
HOW SUPPLIED
Anesir (Nystatin) Tablets USP, 500,000 Units are round, convex, brown, film-coated tablet debossed with 93 on one side and 983 on the reverse and are packaged in bottles of 100 tablets (NDC 0093-0983-01).
Store at 20° to 25°C (68° to 77°F).
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Keep tightly closed.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Manufactured By:
TEVA CANADA LIMITED
Toronto, Canada M1B 2K9
Manufactured For:
TEVA PHARMACEUTICALS USA, INC.
North Wales, PA 19454
Rev. N 2/2016
NDC 0093-0983-01
Anesir (Nystatin)
Tablets USP
500,000 units (oral)
Rx only
100 TABLETS
TEVA
Anesir pharmaceutical active ingredients containing related brand and generic drugs:
Anesir available forms, composition, doses:
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.