Amrizol Dosage

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Dosage of Amrizol in details

infoThe dose of a drug and dosage of the drug are two different terminologies. Dose is defined as the quantity or amount of medicine given by the doctor or taken by the patient at a given period. Dosage is the regimen prescribed by the doctor about how many days and how many times per day the drug is to be taken in specified dose by the patient. The dose is expressed in mg for tablets or gm, micro gm sometimes, ml for syrups or drops for kids syrups. The dose is not fixed for a drug for all conditions, and it changes according to the condition or a disease. It also changes on the age of the patient.
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In elderly patients the pharmacokinetics of Amrizol may be altered and therefore monitoring of serum levels may be necessary to adjust the Amrizol dosage accordingly.

Treatment of Anaerobic Infections

The recommended dosage schedule for adults is:

Loading Dose 15 mg/kg infused over one hour (approximately 1 g for a 70-kg adult).
Maintenance Dose 7.5 mg/kg infused over one hour every six hours (approximately 500 mg for a 70-kg adult). The first maintenance dose should be instituted six hours following the initiation of the loading dose.

Parenteral therapy may be changed to oral Amrizol when conditions warrant, based upon the severity of the disease and the response of the patient to Amrizol Injection, USP RTU treatment. The usual adult oral dosage is 7.5 mg/kg every six hours.

A maximum of 4 g should not be exceeded during a 24-hour period.

Patients with severe hepatic disease metabolize Amrizol slowly, with resultant accumulation of Amrizol and its metabolites in the plasma. Accordingly, for such patients, doses below those usually recommended should be administered cautiously. Close monitoring of plasma Amrizol levels and toxicity is recommended.

In patients receiving Amrizol Injection, USP RTU in whom gastric secretions are continuously removed by nasogastric aspiration, sufficient Amrizol may be removed in the aspirate to cause a reduction in serum levels.

The dose of Amrizol Injection, USP RTU should not be specifically reduced in anuric patients since accumulated metabolites may be rapidly removed by dialysis.

The usual duration of therapy is 7 to 10 days; however, infections of the bone and joint, lower respiratory tract and endocardium may require longer treatment.

Prophylaxis

For surgical prophylactic use, to prevent postoperative infection in contaminated or potentially contaminated colorectal surgery, the recommended dosage schedule for adults is:

  1. 15 mg/kg infused over 30 to 60 minutes and completed approximately one hour before surgery; followed by
  2. 7.5 mg/kg infused over 30 to 60 minutes at 6 and 12 hours after the initial dose.

It is important that (1) administration of the initial preoperative dose be completed approximately one hour before surgery so that adequate drug levels are present in the serum and tissues at the time of initial incision, and (2) Amrizol Injection, USP RTU be administered, if necessary, at 6-hour intervals to maintain effective drug levels. Prophylactic use of Amrizol Injection, USP RTU should be limited to the day of surgery only, following the above guidelines.

Caution: Amrizol Injection, USP RTU is to be administered by slow intravenous drip infusion only, either as a continuous or intermittent infusion. Additives should not be introduced into Amrizol Injection, USP RTU. If used with a primary intravenous fluid system, the primary solution should be discontinued during Amrizol infusion. DO NOT USE EQUIPMENT CONTAINING ALUMINUM (e.g., NEEDLES, CANNULAE) THAT WOULD COME IN CONTACT WITH THE DRUG SOLUTION.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

How supplied

Amrizol Injection, USP RTU is supplied in 100 mL single dose plastic containers, each containing an iso-osmotic, buffered solution of 500 mg Amrizol as follows:

2B3421 -NDC 0338-1055-48 -500 mg/100 mL

Store at controlled room temperature, 59° to 86°F (15° to 30°C) and protect from light during storage. Do not remove unit from overwrap until ready for use. The overwrap is a moisture barrier. The inner bag maintains the sterility of the product. After removing overwrap, check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired.

Directions For Use Of Viaflex Plus Plastic Container

Amrizol Injection, USP RTU is a ready-to-use iso-osmotic solution. No dilution or buffering is required. Do not refrigerate. Each container of Amrizol Injection, USP RTU contains 14 mEq of sodium.

Warning: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.

To open

Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for leaks. Do not add supplementary medication.

Preparation for Administration
  1. Suspend container from eyelet support.
  2. Remove protector from outlet port at bottom of container.
  3. Attach administration set. Refer to complete directions accompanying set.

REFERENCES

3. Ralph, E.D. and Kirby, W.M.M.: Bioassay of Amrizol with Either Anaerobic and Aerobic Incubation, J. Infect. Dis. 132:587-591 (Nov.) 1975; or Gulaid, et al.: Determination of Amrizol and its Major Metabolites in Biological Fluids by High Pressure Liquid Chromatography. BR.J.Clin. Pharmacol. 6:430-432, 1978.

Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Rev. April, 2011

What other drugs will affect Amrizol?

Tell your doctor about all other medicines you use, especially:

  • cimetidine (Tagamet);

  • seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);

  • a blood thinner such as warfarin (Coumadin, Jantoven);

  • lithium (Lithobid, Eskalith, others); or

  • disulfiram (Antabuse).

This list is not complete and other drugs may interact with Amrizol. 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.

Amrizol interactions

infoInteractions are the effects that happen when the drug is taken along with the food or when taken with other medications. Suppose if you are taking a drug Amrizol, it may have interactions with specific foods and specific medications. It will not interact with all foods and medications. The interactions vary from drug to drug. You need to be aware of interactions of the medicine you take. Most medications may interact with alcohol, tobacco, so be cautious.
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Oral Amrizol has been reported to potentiate the anticoagulant effect of coumarin and warfarin resulting in a prolongation of prothrombin time. Drug interactions should be kept in mind when Amrizol (Amrizol) is prescribed for patients who are receiving anticoagulant treatment, although they are less likely to occur with topical Amrizol administration because of low absorption.

Carcinogenesis, Mutagenesis and Impairment of Fertility: Amrizol has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats but not in studies involving hamsters. In several long term studies in mice, oral doses of approximately 225 mg/m2/day or greater (approximately 37 times the human topical dose on a mg/m2 basis) were associated with an increase in pulmonary tumors and lymphomas. Several long term oral studies in the rat have shown statistically significant increases in mammary and hepatic tumors at doses >885 mg/m2/day (144 times the topical human dose).

Amrizol has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a dose-related increase in the frequency of micronuclei was observed in mice after intraperitoneal injections. An increase in chromosomal aberrations in peripheral blood lymphocytes was reported in patients with Crohn's disease who were treated with 200 to 1200 mg/day of Amrizol for 1 to 24 months. However, in another study, no increase in chromosomal aberrations in circulating lymphocytes was observed in patients with Crohn's disease treated with the drug for 8 months.

In one published study, using albino hairless mice, intraperitoneal administration of Amrizol at a dose of 45 mg/m2/day (approximately 7 times the human topical dose on a mg/m2 basis) was associated with an increase in ultraviolet radiation-induced skin carcinogenesis. Neither dermal carcinogenicity nor photocarcinogenicity studies have been performed with Amrizol or any marketed Amrizol formulations.

Pregnancy: Teratogenic Effects: Pregnancy Category B. There are no adequate and well controlled studies with the use of Amrizol (Amrizol) in pregnant women. Amrizol crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral administration of Amrizol to rats or mice at 200 and 20 times, respectively, the expected clinical dose. However, oral Amrizol has shown carcinogenic activity in rodents. Because animal reproduction studies are not always predictive of human response, Amrizol (Amrizol) should be used during pregnancy only if clearly needed. Nursing Mothers: After oral administration, Amrizol is secreted in breast milk in concentrations similar to those found in the plasma. Even though blood levels taken after topical Amrizol application are significantly lower than those achieved after oral Amrizol, 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 and the risk to the infant.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.


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References

  1. DailyMed. "BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. FDA/SPL Indexing Data. "140QMO216E: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
  3. MeSH. "Anti-Infective Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Amrizol are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Amrizol. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

User reports

1 consumer reported frequency of use

How frequently do I need to take Amrizol?
It was reported by ndrugs.com website users that Amrizol should ideally be taken 3 times in a day as the most common frequency of the Amrizol. You should you adhere strictly to the instructions and guidelines provided by your doctor on how frequently this Amrizol should be taken. Get another patient's view on how frequent the capsule should be used by clicking here.
Users%
3 times in a day1
100.0%


1 consumer reported doses

What doses of Amrizol drug you have used?
The drug can be in various doses. Most anti-diabetic, anti-hypertensive drugs, pain killers, or antibiotics are in different low and high doses and prescribed by the doctors depending on the severity and demand of the condition suffered by the patient. In our reports, ndrugs.com website users used these doses of Amrizol drug in following percentages. Very few drugs come in a fixed dose or a single dose. Common conditions, like fever, have almost the same doses, e.g., [acetaminophen, 500mg] of drug used by the patient, even though it is available in various doses.
Users%
201-500mg1
100.0%


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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