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09
2021

nitazoxanide 500 mg

How is this medicine (Nitazoxanide Tablets) best taken? ALINIA Tablets (500 mg) ALINIA tablets are round, yellow, film-coated tablets debossed with ALINIA on one side and 500 on the other side. There were no d 3 days 4 -11 years 10 mL of ALINIA for Oral Suspension (200 mg nitazoxanide) taken orally every 12 hours with food 12 years and older One ALINIA Tablet (500 mg nitazoxanide) taken orally every 12 hours with food or 25 mL of ALINIA Tizoxanide (the active metabolite of nitazoxanide) is highly bound to plasma protein (>99.9%). Interference with the PFOR enzyme-dependent electron transfer reaction may not be the only pathway by which nitazoxanide exhibits antiprotozoal activity. ALINIA tablets are round, yellow, film-coated tablets debossed with ALINIA on one side and 500 on the other side. Check with your pharmacist. Therefore, monitor for adverse reactions when administering nitazoxanide concurrently with other highly plasma protein-bound drugs with narrow therapeutic indices, as competition for binding sites may occur (e.g., warfarin). The tablets are packaged in HDPE bottles of 12 and 30 tablets. Alinia belongs to a class of drugs called Antiparasitic Agents. ALINIA Tablets and ALINIA for Oral Suspension have not been studied for the treatment of diarrhea caused by G. lamblia in HIV-infected or immunodeficient patients. Tell your Nitazoxanida: Infórmate sobre efectos secundarios, dosis, precauciones y más en MedlinePlus You will need to talk about any risks to your baby. Following oral administration of ALINIA Tablets or Oral Suspension, the parent drug, nitazoxanide, is not detected in plasma. Tizoxanide then undergoes conjugation, primarily by glucuronidation. No information regarding the presence of nitazoxanide in human milk, the effects on the breastfed infant, or the effects on milk production is available. Advise patients and parents/caregivers of pediatric patients taking ALINIA Tablets or ALINIA for Oral Suspension of the following information: ALINIA Tablets and ALINIA for Oral Suspension should be taken with food. For more information, ask your doctor or pharmacist. Keep all drugs out of the reach of children and pets. Usual Adult Dose for Cryptosporidiosis: 500 mg orally every 12 hours for 3 days Use: For the treatment of diarrhea due to Giardia lamblia or Cryptosporidium parvum. In general, the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients should be considered when prescribing ALINIA Tablets and ALINIA for Oral Suspension. Nitazoxanide brands in Pakistan Nitazoxanide is available in following trade names in Pakistan, click on any dosage to view brands of this drug. while you are pregnant. Follow all instructions closely. Chemically, nitazoxanide is 2-acetyloxy- N- (5-nitro-2-thiazolyl)benzamide. If you have any questions about this medicine (nitazoxanide tablets), please talk Use this medicine (nitazoxanide tablets) as ordered by your doctor. Last updated on Nov 10, 2020. The reconstituted suspension may be stored for 7 days at room temperature, after which any unused portion must be discarded. A higher cure rate of 88% was observed in Egyptian patients infected with Fasciola spp. Available for Android and iOS devices. The structural formula is: ALINIA Tablets contain 500 mg of nitazoxanide and the following inactive ingredients: maize starch, pregelatinized corn starch, hydroxypropyl methylcellulose, sucrose, sodium starch glycollate, talc, magnesium stearate, soy lecithin, polyvinyl alcohol, xanthan gum, titanium dioxide, FD&C Yellow No. Nitazoxanide is an antiprotozoal [ see Microbiology]. The relevance of stool examination results in these patients is unknown. Excipient information presented when available (limited, particularly for generics); consult specific product labeling. Furthermore, the safety and efficacy of ALINIA for Oral Suspension for the treatment of diarrhea caused by G. lamblia or C. parvum in pediatric patients 12 to 17 years of age has been established based on two (2) randomized controlled studies with 44 pediatric subjects treated with ALINIA for Oral Suspension 100 mg/5 mL. A double-blind, placebo-controlled trial did not produce clinical cure rates that were significantly different from the placebo control when conducted in hospitalized, severely malnourished pediatric patients with acquired immune deficiency syndrome (AIDS) in Zambia. Seventeen adults hospitalised with hepatic amoebiasis were treated with 500 mg nitazoxanide twice daily for 10 days. Approximately two-thirds of the oral dose of nitazoxanide is excreted in the feces and one-third in the urine. ALINIA Tablets and ALINIA for Oral Suspension have not been shown to be superior to placebo for the treatment of diarrhea caused by C. parvum in HIVinfected or immunodeficient patients [ see Clinical Studies]. Inpatient Study, Malnourished¶, age 12-35 months. ALINIA for Oral Suspension (patients 1 year of age and older) and ALINIA Tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum. Another study was conducted in Zambia in malnourished pediatric patients admitted to the hospital with diarrhea caused by C. parvum. The safety and efficacy of ALINIA Tablets for the treatment of diarrhea caused by G. lamblia or C. parvum in pediatric patients 12 to 17 years of age has been established based on three (3) randomized controlled studies with 47 pediatric subjects treated with ALINIA Tablets 500 mg. A single ALINIA Tablet contains a greater amount of nitazoxanide than is recommended for use in pediatric patients 11 years or younger. In a double-blind, controlled trial conducted in Egypt in adults and adolescents with diarrhea and with or without enteric symptoms (e.g., abdominal pain/cramps, nausea, vomiting) caused by C. parvum, a three-day course of treatment with ALINIA Tablets administered 500 mg BID was compared with a placebo tablet for 3 days. 10 Aluminum Lake, FD&C Yellow No. The safety and efficacy of ALINIA for Oral Suspension for the treatment of diarrhea caused by G. lamblia or C. parvum in pediatric patients 1 to 11 years of age has been established based on three (3) randomized, controlled studies with 104 pediatric subjects treated with ALINIA for Oral Suspension 100 mg/5 mL. Nitazoxanide produced no evidence of systemic maternal toxicity when administer once daily via oral gavage to pregnant female rats at levels up to 3200 mg/kg/day during the period of organogenesis. Pregnancy: No data with pregnant women to inform of drug-associated risk; No teratogenicity or fetotoxicity observed in animal reproduction studies with administration of nitazoxanide to pregnant rats and rabbits during organogenesis at exposures 30 and 2 times, respectively, the exposure at maximum recommended human dose of 500 mg twice daily based on body surface area (BSA) Clinical response was evaluated 4 to 7 days following the end of treatment. How to use. The antiprotozoal activity of nitazoxanide is believed to be due to interference with the pyruvate:ferredoxin oxidoreductase (PFOR) enzyme-dependent electron transfer reaction which is essential to anaerobic energy metabolism. advice about side effects. Some drugs may have another patient information leaflet. The reconstituted suspension has a pink color and strawberry flavor. (NYE-ta-ZOX-a-nide) Brand name (s) Alinia. Nitazoxanide dosing information. Some patients with ‘well’ clinical responses had G. lamblia cysts in their stool samples 4 to 7 days following the end of treatment. Overall, nitazoxanide treatment reduces the duration of diarrhea and oocyst shedding. Recent work (C & EN Sept. 14, 2009, p. 6 Aluminum Lake, and FD&C Blue No. ALINIA Tablets and ALINIA for Oral Suspension contain the active ingredient, nitazoxanide, a synthetic antiprotozoal for oral administration. Nitazoxanide belongs to the class of drugs known as thiazolides. Uses. Do not take 2 doses at the same time or extra doses. Nitazoxanide and its metabolite, tizoxanide, are active in vitro in inhibiting the growth of (i) sporozoites and oocysts of C. parvum and (ii) trophozoites of G. lamblia. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for ALINIA and any potential adverse effects on the breastfed infant from ALINIA or from the underlying maternal condition. Tap bottle until all powder flows freely. The recommended dose for treating diarrhea caused by Giardia lamblia or Cryptosporidium parvum in children 1 to 11 years of age is 5 to 10 ml every 12 hours with food for 3 days. Do not give to a child younger than 12 years of age. When ALINIA for Oral Suspension was administered with food, the AUCt of tizoxanide and tizoxanide glucuronide increased by about 45-50% and the Cmax increased by ≤10%. Protozoa are suspected as the cause when diarrhea lasts more than 7 days. Follow all instructions closely. Long-term carcinogenicity studies have not been conducted. Nitazoxanide was administered twice daily for 3 days at doses of 500 mg (age ≥12 years), 200 mg (age 4–11 years) or 100 mg (age 1–3 years). The relevance of stool examination results in these patients is unknown. You may report side effects to the FDA at 1-800-332-1088. [See USP Controlled Room Temperature]. Clinical cure (resolution of diarrhea) rates range from 72-88% 1. Lancer Therapeutics - Offering Nitazoxanide 500mg Tablets, Packaging Size: 10x10 at Rs 800/box in Chandigarh. Pink-colored powder formulation that, when reconstituted as directed, contains 100 mg nitazoxanide/5 mL. What is the efficacy? Nitazoxanide. Read about company. Generic Alinia (nitazoxanide) is an antiprotozoal agent.Generic Alinia (nitazoxanide) is used to treat diarrhea in adults and … Throw away unused or expired drugs. [See USP Controlled Room Temperature], The reconstituted suspension may be stored for 7 days at room temperature, after which any unused portion must be discarded [see DOSAGE AND ADMINISTRATION], Manufacturer Information: Romark, L.C., 3000 Bayport Drive, Suite 200, Tampa, FL 33607. Signs of an allergic reaction, like rash; Store in a dry place. The pharmacokinetics of tizoxanide and tizoxanide glucuronide following administration of ALINIA for Oral Suspension in pediatric patients 1-11 years of age are provided above in Table 3. ALINIA 500 (Alinia 500 mg) Generic Name: nitazoxanide. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Che cosa è generico Alinia (nitazoxanide)? ALINIA for Oral Suspension is not bioequivalent to ALINIA Tablets. Get contact details and address | ID: 15079670733 Alinia Tablets contain 500 mg of nitazoxanide and the following inactive ingredients: maize starch, pregelatinized corn starch, hydroxypropyl methylcellulose, sucrose, sodium starch glycollate, talc, magnesium stearate, soy lecithin, polyvinyl alcohol, xanthan gum, titanium dioxide, FD&C Yellow No. The safety of ALINIA was evaluated in 2177 HIV-uninfected subjects 12 months of age and older who received ALINIA Tablets or ALINIA for Oral Suspension at the recommended dose for at least three days. Alinia (Nitazoxanide) 500 mg tablets are FDA-approved for the treatment of Cryptosporidium Parvum & Giardia Lamblia infections in adults and kids 12 and over Call your doctor for medical advice about side effects. Nitazoxanide is a light yellow crystalline powder. A second double-blind, controlled trial (Study 2) conducted in Egypt in adults and adolescents with diarrhea and with or without enteric symptoms (e.g., abdominal colic, abdominal tenderness, abdominal cramps, abdominal distention, fever, bloody stool) caused by G. lamblia compared ALINIA Tablets administered 500 mg BID for 3 days to a placebo tablet. Generico Alinia (nitazoxanide) è un agente antiprotozoi.Generico Alinia (nitazoxanide) è usato per trattare la diarrea negli adulti e nei bambini, causati dal protozoi Giardia lamblia. Take this medication by mouth with food as … See additional information. with your doctor, nurse, pharmacist, or other health care provider. Nitazoxanide did not adversely affect male or female fertility in the rat at 2400 mg/kg/day (approximately 20 times the clinical adult dose adjusted for body surface area). Alinia for oral suspension is available as: Store the unsuspended powder at 25°C (77°F); excursions permitted to 15 C-30°C (59 F-86°F). Revised: Jun 2019. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Nitazoxanide (Alinia) has comparable efficacy to metronidazole and is available in suspension for children as young as 1 year of age (100 mg twice a day for 3 days for younger than 4 years, 200 mg twice a day for 3 days for ages 4 to 11 years, 500 mg twice a day for adults). It is not known if Alinia is safe and effective in children younger than 1 year of age. Digestive Disorders: Common Misconceptions, Migraines: Medical Marijuana and CBD Oils, 5 mL of ALINIA for Oral suspension (100 mg nitazoxanide) taken orally every 12 hours with food, 10 mL of ALINIA for Oral Suspension (200 mg nitazoxanide) taken orally every 12 hours with food, One ALINIA Tablet (500 mg nitazoxanide) taken orally every 12 hours with food or 25 mL of ALINIA for Oral Suspension (500 mg nitazoxanide) taken orally every 12 hours with food. 500 mg PO every 12 hours with food for 3 days. Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following is a list of adverse reactions spontaneously reported with ALINIA Tablets which were not included in clinical trial listings: Gastrointestinal disorders: diarrhea, gastroesophageal reflux disease, Respiratory, thoracic and mediastinal disorders: dyspnea, Skin and subcutaneous tissue disorders: rash, urticaria. Some patients with ‘well’ clinical responses had C. parvum oocysts in their stool samples 3 to 7 days following the end of treatment. Single Ingredient There are no data with ALINIA in pregnant women to inform a drug-associated risk. Keep all drugs in a safe place. NITAZOXANIDE is an anti-infective. Single oral doses of up to 4000 mg nitazoxanide have been administered to healthy adult volunteers without significant adverse effects. A third group of patients received open-label ALINIA for Oral Suspension administered 500 mg/25 mL of suspension BID for 3 days. ALINIA for Oral Suspension: The container should be kept tightly closed, and the suspension should be shaken well before each administration. For patients age 1-3 years, 5 mL of Alinia for Oral Suspension (100 mg); patients age 4-11 years, 10 mL of Alinia for Oral Suspension (200 mg); adults and children over 12 years, 1 Alinia Tablet (500 mg) or 25 mL of Alinia for Oral Suspension (500 mg). Nitazoxanide was genotoxic in one tester strain (TA100) in the Ames bacterial mutation assay. Pill with imprint ALINIA 500 is Yellow, Round and has been identified as Alinia 500 mg. Safety data were analyzed separately for 280 HIV-uninfected subjects ≥12 years of age receiving ALINIA at the recommended dose for at least three days in 5 placebocontrolled clinical trials and for 256 HIV-uninfected subjects 1 through 11 years of age in 7 controlled clinical trials. The pharmacokinetic parameners of the metabolites, tizoxanide and tizoxanide glucuronide are shown in Tables 2 and 3 below. The lowest GoodRx price for the most common version of generic Nitazoxanide is around $219.81, 74% off the average retail price of $870.56. The study medication was administered as 1 nitazoxanide 500‐mg tablet or a matching placebo twice daily for 3 days. Generic Name: Nitazoxanide Tablets (nye ta ZOX a nide)Brand Name: Alinia. Nitazoxanide is currently available in two oral dosage forms: a tablet (500 mg) and an oral suspension (100 mg per 5 ml when reconstituted). If it is close to the time for your next dose, skip the missed dose and go back to your normal time. The DNA-derived PFOR protein sequence of C. parvum appears to be similar to that of G. lamblia. Use: For the treatment of diarrhea due to Giardia lamblia or Cryptosporidium parvum. Doses of Alinia vary according to age. You are encouraged to report negative side effects of prescription drugs to the FDA. Included as part of the PRECAUTIONS section. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Patients should be managed based upon clinical response to treatment. Clinical response was evaluated 3 to 7 days post-therapy with a ‘well’ response defined as ‘no symptoms, no watery stools and no more than 2 soft stools within the past 24 hours’ or ‘no symptoms and no unformed stools within the past 48 hours.’ The following clinical response rates were obtained: Table 7: Clinical Response Rates in Pediatric Patients 3 to 7 Days Post-therapy Intent-to-Treat Analyses % (Number of Successes/Total). A third group of patients received open-label ALINIA for Oral Suspension administered 500 mg/25 mL of suspension BID for 3 days. The reconstituted suspension has a pink color and strawberry flavor. Alinia is a prescription medicine used to treat the symptoms of Diarrhea caused by Cryptosporidium Parvum or Giardia Lablia (“Traveler’s diarrhea”). Nitazoxanide (NTZ) is a broad-spectrum anti-infective drug that markedly modulates the survival, growth, and proliferation of a range of extracellular and intracellular protozoa, helminths, anaerobic and microaerophilic bacteria, in addition to … The reconstituted suspension has a pink color and strawberry flavor. This medicine may interact with other drugs or health problems. The most common side effects of Alinia include: Tell the doctor if you have any side effect that bothers you or that does not go away. Keep taking this medicine (nitazoxanide tablets) as you have been told by your doctor or other health care provider, even if you feel well. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Know uses, side effects, dosage, contraindications, substitutes, benefit, interactions, purpose, drug interactions, precautions, warnings etc. You may report side effects to FDA at 1-800-FDA-1088. The tablets are packaged in HDPE bottles of 12 and 30 tablets. The pharmacokinetics of nitzoxanide in patients with compromised renal or hepatic function has not been studied. Read all information given to you. any drug without checking with your doctor. In this study, the pediatric patients received a three day course of nitazoxanide suspension (100 mg BID in pediatric patients ages 12-47 months, 200 mg BID in pediatric patients ages 4 through 11 years) and were evaluated for response four days after the end of treatment. 500 mg orally every 12 hours for 3 days. Data sources include IBM Watson Micromedex (updated 1 Apr 2021), Cerner Multum™ (updated 5 Apr 2021), ASHP (updated 6 Apr 2021) and others. You must check Following oral administration of a single ALINIA Tablet every 12 hours for 7 consecutive days, there was no significant accumulation of nitazoxanide metabolites tizoxanide or tizoxanide glucuronide detected in plasma. Alinia / Nizonide 500mg (Nitazoxanide) Available for orders - you will receive your item after 3 weeks. Do not share your drugs with others and do not take anyone else's drugs. [ see DOSAGE AND ADMINISTRATION]. Call your doctor or get medical Take a missed dose as soon as you think about it. Nitazoxanide is an inhibitor of pyruvate-ferredoxin oxidoreductase (PFOR); Antimicrobial recently found to kill both non-replicating and replicating mycobacteria. Nitazoxanide(Alinia) generic is an antiprotozoal compound, effective in treating diarrhea caused by Cryptosporidium and Giardia. what signs you had. Clinical studies of ALINIA Tablets and ALINIA for Oral Suspension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Be ready to tell or show what was In two double-blind, controlled trials in pediatric patients with diarrhea and with or without enteric symptoms (e.g., abdominal distention, colic, left iliac fossa tenderness) caused by C. parvum, a three-day course of treatment with nitazoxanide (100 mg BID in pediatric patients ages 12-47 months, 200 mg BID in pediatric patients ages 4 through 11 years) was compared with a placebo. FDA approved anti-parasitic drug (2002). ALINIA Tablets and ALINIA for Oral Suspension were administered with food in clinical trials and hence they are recomended to be administered with food [see DOSAGE AND ADMINISTRATION]. In the event of overdose, gastric lavage may be appropriate soon after oral administration. In vitro studies have demonstrated that tizoxanide has no significant inhibitory effect on cytochrome P450 enzymes. swelling of your face, lips, tongue or throat, Measure 48 mL of water for preparation of the 100 mg/5 mL suspension. Add remainder of water and again shake vigorously. Some patients with ‘well’ clinical responses had C. parvum oocysts in their stool samples 4 to 7 days following the end of treatment. There is no specific antidote for overdose with ALINIA. (100 mg nitazoxanide) taken orally every 12 hours with food controlled clinical trials. The following adverse reactions have been identified during post approval use of ALINIA. home Nitazoxanide was administered orally to pregnant rats at doses of 0, 200, 800 or 3200 mg/kg/day on gestation days 6 to 15. Patients should be managed based upon clinical response to treatment. Round, yellow, film-coated tablets debossed with ALINIA on one side and 500 on the other side. Check with your The suspension may be stored at room temperature for 7 days, after which any unused portion must be discarded. In plasma, more than 99% of tizoxanide is bound to proteins. The pharmacokinetics of tizoxanide and tizoxanide glucuronide following administration of ALINIA Tablets in pediatric patients 12-17 years of age are provided above in Table 2. One study was conducted in Egypt in outpatients ages 1 through 11 years with diarrhea caused by C. parvum. These are not all the possible side effects of Alinia. Bottles of 12 tablets NDC 67546-111-14Bottles of 30 tablets NDC 67546-111-12, Store the tablets at 25 C (77 F); excursions permitted to 15 C-30 C (59 F-86 F). It works by stopping the growth of certain protozoa that cause diarrhea. There were no differences between the adverse reactions reported for ALINIA-treated subjects based upon age. For both of these studies, clinical response was evaluated 4 to 7 days following the end of treatment. ALINIA for Oral Suspension and ALINIA Tablets have not been shown to be effective for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients [ see Clinical Studies]. 3.2 ALINIA for Oral Suspension (100 mg/5 mL) Pink-colored powder formulation that, when reconstituted as directed, contains 100 mg nitazoxanide/5 mL. Multiple doses of nitazoxanide also appear to be efficacious against infections with A. lumbricoides and T. trichiura ( … If you have questions about side effects, call your doctor. Usual Adult Dose for Giardiasis: 500 mg orally every 12 hours for 3 days Use: For the treatment of diarrhea due to Giardia lamblia or Cryptosporidium parvum The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. However, many people have no side effects or only have minor side effects. Usual Adult Dose for Cryptosporidiosis. No teratogenicity or fetotoxicity was observed in animal reproduction studies with administration of nitazoxanide to pregnant rats and rabbits during organogenesis at exposure 30 and 2 times, respectively, the exposure at the maximum recommended human dose of 500 mg twice daily based on body surface area (BSA). Tell your doctor if you are breast-feeding. A potential for development of resistance by C. parvum or G. lamblia to nitazoxanide has not been examined. who received nitazoxanide (200 or 500 mg twice daily for 6 days) ( Kabil et al., 2000 ). Tizoxanide is excreted in the urine, bile and feces, and tizoxanide glucuronide is excreted in urine and bile. There may be drug take-back programs in your area. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. to make sure that it is safe for you to take this medicine (nitazoxanide tablets) with all of your drugs and health problems. *Clinical response rates statistically significantly higher compared to placebo. For protozoa such as C. parvum and G. lamblia, standardized tests for use in clinical microbiology laboratories are not available. Nitazoxanide was not genotoxic in the Chinese hamster ovary (CHO) cell chromosomal aberration assay or the mouse micronucleus assay. 40 and artificial strawberry flavoring. Keep taking this medicine (nitazoxanide tablets) as you have been told by your doctor or other health care provider, even if you feel well. Tell your doctor about the allergy and We comply with the HONcode standard for trustworthy health information -, Dwarf Tapeworm Infection (Hymenolepis nana). taken, how much, and when it happened. See additional information. Safety and efficacy of ALINIA for Oral Suspension in pediatric patients less than one year of age has not been studied. Use this medicine (nitazoxanide tablets) as ordered by your doctor. pharmacist if you have questions about the best way to throw out drugs. Alinia is taken every 12 hours with food for 3 days. Nitazoxanide is in a class of medications called antiprotozoal agents. Read all information given to you. A clinical response of ‘well’ was defined as ‘no symptoms, no watery stools and no more than 2 soft stools within the past 24 hours’ or ‘no symptoms and no unformed stools within the past 48 hours.’ The following clinical response rates were obtained: Table 6: Clinical Response Rates in Adult and Adolescent Patients 4 to 7 Days Post-therapy % (Number of Successes/Total). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical response rates, evaluated 2 to 6 days following the end of treatment, were 71% (15/21) in the nitazoxanide group and 42.9% (9/21) in the placebo group. Patients should be managed based upon clinical response to treatment.

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