Quantalan zuckerfrei

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Quantalan zuckerfrei uses


INDICATIONS AND USAGE

1) Quantalan zuckerfrei® (cholestyramine for oral suspension, USP) powder is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Quantalan zuckerfrei® (cholestyramine for oral suspension, USP) powder may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern.

Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight.

Prior to initiating therapy with Quantalan zuckerfrei resin, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded and a lipid profile performed to assess Total Cholesterol, HDL-C and triglycerides (TG). For individuals with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation:

LDL-C = Total Cholesterol - [(TG/5) + HDL-C]

For TG levels > 400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases Quantalan zuckerfrei resin may not be indicated.

Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response. A favorable trend in cholesterol reduction should occur during the first month of Quantalan zuckerfrei resin therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of Quantalan zuckerfrei resin or adding other lipid-lowering agents in combination with Quantalan zuckerfrei resin should be considered.

Since the goal of treatment is to lower LDL-C, the NCEP4 recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year. The NCEP treatment guidelines are summarized below.

LDL-Cholesterol mg/dL (mmol/L)
Definite Atherosclerotic DiseaseCoronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease) Two or More Other Risk FactorsOther risk factors for coronary heart disease (CHD) include: age (males ≥45 years; females: ≥55 years or premature menopause without estrogen replacement therapy); family history of premature CHD; current cigarette smoking; hypertension; confirmed HDL-C <35 mg/dL (<0.91 mmol/L); and diabetes mellitus. Subtract one risk factor if HDL-C is ≥60 mg/dL (≥1.6 mmol/L). Initiation Level Goal
No No ≥190 (≥4.9) <160 (<4.1)
No Yes ≥160 (≥4.1) <130 (<3.4)
Yes Yes or No ≥130 (≥3.4) ≤100 (≤2.6)

Quantalan zuckerfrei resin monotherapy has been demonstrated to retard the rate of progression2,3 and increase the rate of regression3 of coronary atherosclerosis.

2) Quantalan zuckerfrei® (cholestyramine for oral suspension, USP) powder is indicated for the relief of pruritus associated with partial biliary obstruction. Quantalan zuckerfrei resin has been shown to have a variable effect on serum cholesterol in these patients. Patients with primary biliary cirrhosis may exhibit an elevated cholesterol as part of their disease.

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CONTRAINDICATIONS

Quantalan zuckerfrei® powder is contraindicated in patients with complete biliary obstruction where bile is not secreted into the intestine and in those individuals who have shown hypersensitivity to any of its components.

WARNING

PHENYLKETONURICS: Quantalan zuckerfrei® CONTAINS 14.1 mg PHENYLALANINE PER 5.5 GRAM DOSE.

PRECAUTIONS

General

Chronic use of Quantalan zuckerfrei resin may be associated with increased bleeding tendency due to hypoprothrombinemia associated with Vitamin K deficiency. This will usually respond promptly to parenteral Vitamin K1 and recurrences can be prevented by oral administration of Vitamin K1. Reduction of serum or red cell folate has been reported over long term administration of Quantalan zuckerfrei resin. Supplementation with folic acid should be considered in these cases.

There is a possibility that prolonged use of Quantalan zuckerfrei resin, since it is a chloride form of anion exchange resin, may produce hyperchloremic acidosis. This would especially be true in younger and smaller patients where the relative dosage may be higher. Caution should also be exercised in patients with renal insufficiency or volume depletion and in patients receiving concomitant spironolactone.

Quantalan zuckerfrei resin may produce or worsen pre-existing constipation. The dosage should be increased gradually in patients to minimize the risk of developing fecal impaction. In patients with pre-existing constipation, the starting dose should be 1 packet or 1 scoop once daily for 5 to 7 days, increasing to twice daily with monitoring of constipation and of serum lipoproteins, at least twice, 4 to 6 weeks apart. Increased fluid intake and fiber intake should be encouraged to alleviate constipation and a stool softener may occasionally be indicated. If the initial dose is well tolerated, the dose may be increased as needed by one dose/day with periodic monitoring of serum lipoproteins. If constipation worsens or the desired therapeutic response is not achieved at one to six doses/day, combination therapy or alternate therapy should be considered. Particular effort should be made to avoid constipation in patients with symptomatic coronary artery disease. Constipation associated with Quantalan zuckerfrei resin may aggravate hemorrhoids.

Information for Patients

Inform your physician if you are pregnant or plan to become pregnant or are breast-feeding. Drink plenty of fluids and mix each 5.5 gram dose of Quantalan zuckerfrei® (cholestyramine for oral suspension, USP) powder in at least 2 to 3 ounces of fluid before taking. Sipping or holding the resin suspension in the mouth for prolonged periods may lead to changes in the surface of the teeth resulting in discoloration, erosion of enamel or decay; good oral hygiene should be maintained.

Laboratory Tests

Serum cholesterol levels should be determined frequently during the first few months of therapy and periodically thereafter. Serum triglyceride levels should be measured periodically to detect whether significant changes have occurred.

The LRC-CPPT showed a dose-related increase in serum triglycerides of 10.7% to 17.1% in the cholestyramine-treated group, compared with an increase of 7.9% to 11.7% in the placebo group. Based on the mean values and adjusting for the placebo group, the cholestyramine-treated group showed an increase of 5% over pre-entry levels the first year of the study and an increase of 4.3% the seventh year.

Drug Interactions

Quantalan zuckerfrei resin may delay or reduce the absorption of concomitant oral medication such as phenylbutazone, warfarin, thiazide diuretics or propranolol (basic), as well as tetracycline, penicillin G, phenobarbital, thyroid and thyroxine preparations, estrogens and progestins and digitalis. Interference with the absorption of oral phosphate supplements has been observed with another positively-charged bile acid sequestrant. Quantalan zuckerfrei resin may interfere with the pharmacokinetics of drugs that undergo enterohepatic circulation. The discontinuance of Quantalan zuckerfrei resin could pose a hazard to health if a potentially toxic drug such as digitalis has been titrated to a maintenance level while the patient was taking Quantalan zuckerfrei resin.

Because Quantalan zuckerfrei binds bile acids, Quantalan zuckerfrei resin may interfere with normal fat digestion and absorption and thus may prevent absorption of fat soluble vitamins such as A, D, E and K. When Quantalan zuckerfrei resin is given for long periods of time, concomitant supplementation with water-miscible (or parenteral) forms of fat-soluble vitamins should be considered.

SINCE Quantalan zuckerfrei RESIN MAY BIND OTHER DRUGS GIVEN CONCURRENTLY, IT IS RECOMMENDED THAT PATIENTS TAKE OTHER DRUGS AT LEAST 1 HOUR BEFORE OR 4 TO 6 HOURS AFTER Quantalan zuckerfrei RESIN (OR AT AS GREAT AN INTERVAL AS POSSIBLE) TO AVOID IMPEDING THEIR ABSORPTION.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In studies conducted in rats in which Quantalan zuckerfrei resin was used as a tool to investigate the role of various intestinal factors, such as fat, bile salts and microbial flora, in the development of intestinal tumors induced by potent carcinogens, the incidence of such tumors was observed to be greater in Quantalan zuckerfrei resin-treated rats than in control rats.

The relevance of this laboratory observation from studies in rats to the clinical use of Quantalan zuckerfrei resin is not known. In the LRC-CPPT study referred to above, the total incidence of fatal and nonfatal neoplasms was similar in both treatment groups. When the many different categories of tumors are examined, various alimentary system cancers were somewhat more prevalent in the Quantalan zuckerfrei group. The small numbers and the multiple categories prevent conclusions from being drawn. However, in view of the fact that Quantalan zuckerfrei resin is confined to the GI tract and not absorbed and in light of the animal experiments referred to above, a six-year post-trial follow-up of the LRC-CPPT5 patient population has been completed (a total of 13.4 years of in-trial plus post-trial follow-up) and revealed no significant difference in the incidence of cause-specific mortality or cancer morbidity between Quantalan zuckerfrei and placebo treated patients.

Pregnancy

Pregnancy Category C

There are no adequate and well controlled studies in pregnant women. The use of Quantalan zuckerfrei in pregnancy or lactation or by women of childbearing age requires that the potential benefits of drug therapy be weighted against the possible hazards to the mother and child. Quantalan zuckerfrei is not absorbed systemically, however, it is known to interfere with absorption of fat-soluble vitamins; accordingly, regular prenatal supplementation may not be adequate.

Nursing Mothers

Caution should be exercised when Quantalan zuckerfrei resin is administered to a nursing mother. The possible lack of proper vitamin absorption described in the "Pregnancy" section may have an effect on nursing infants.

Pediatric Use

Although an optimal dosage schedule has not been established, standard texts(6,7) list a usual pediatric dose of 240 mg/kg/day of anhydrous Quantalan zuckerfrei resin in two to three divided doses, normally not to exceed 8 g/day with dose titration based on response and tolerance.

In calculating pediatric dosages, 80 mg of anhydrous Quantalan zuckerfrei resin are contained in 110 mg of Quantalan zuckerfrei®.

The effects of long-term drug administration, as well as its effect in maintaining lowered cholesterol levels in pediatric patients, are unknown. Also see ADVERSE REACTIONS .

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ADVERSE REACTIONS

The most common adverse reaction is constipation. When used as a cholesterol-lowering agent, predisposing factors for most complaints of constipation are high dose and increased age (more than 60 years old). Most instances of constipation are mild, transient and controlled with conventional therapy. Some patients require a temporary decrease in dosage or discontinuation of therapy.

Less Frequent Adverse Reactions: Abdominal discomfort and/or pain, flatulence, nausea, vomiting, diarrhea, eructation, anorexia, steatorrhea, bleeding tendencies due to hypoprothrombinemia (Vitamin K deficiency) as well as Vitamin A (one case of night blindness reported) and D deficiencies, hyperchloremic acidosis in children, osteoporosis, rash and irritation of the skin, tongue and perianal area. Rare reports of intestinal obstruction, including two deaths, have been reported in pediatric patients.

Occasional calcified material has been observed in the biliary tree, including calcification of the gallbladder, in patients to whom Quantalan zuckerfrei resin has been given. However, this may be a manifestation of the liver disease and not drug related.

One patient experienced biliary colic on each of three occasions on which he took a Quantalan zuckerfrei for oral suspension product. One patient diagnosed as acute abdominal symptom complex was found to have a "pasty mass" in the transverse colon on x-ray.

Other events (not necessarily drug related) reported in patients taking Quantalan zuckerfrei resin include:

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OVERDOSAGE

Overdosage of Quantalan zuckerfrei resin has been reported in a patient taking 150% of the maximum recommended daily dosage for a period of several weeks. No ill effects were reported. Should an overdosage occur, the chief potential harm would be obstruction of the gastrointestinal tract. The location of such potential obstruction, the degree of obstruction, and the presence or absence of normal gut motility would determine treatment.

DOSAGE AND ADMINISTRATION

The recommended starting adult dose for Quantalan zuckerfrei® powder is one packet or one level scoopful (5.5 grams of Quantalan zuckerfrei® [cholestyramine for oral suspension, USP] powder contain 4 grams of anhydrous Quantalan zuckerfrei resin) once or twice a day. The recommended maintenance dose for Quantalan zuckerfrei® (cholestyramine for oral suspension, USP) powder is 2 to 4 packets or scoopfuls daily (8 to 16 grams anhydrous Quantalan zuckerfrei resin) divided into two doses. It is recommended that increases in dose be gradual with periodic assessment of lipid/lipoprotein levels at intervals of not less than 4 weeks. The maximum recommended daily dose is six packets or scoopfuls of Quantalan zuckerfrei® (cholestyramine for oral suspension, USP) powder (24 grams of anhydrous Quantalan zuckerfrei resin). The suggested time of administration is at mealtime but may be modified to avoid interference with absorption of other medications. Although the recommended dosing schedule is twice daily, Quantalan zuckerfrei® (cholestyramine for oral suspension, USP) powder may be administered in 1 to 6 doses per day.

Quantalan zuckerfrei® (cholestyramine for oral suspension, USP) powder should not be taken in its dry form. Always mix the dry powder with water or other fluids before ingesting. See Preparation Instructions.

Concomitant Therapy

Preliminary evidence suggests that the lipid-lowering effects of Quantalan zuckerfrei on total and LDL-cholesterol are enhanced when combined with a HMG-CoA reductase inhibitor, e.g., pravastatin, lovastatin, simvastatin and fluvastatin. Additive effects on LDL-cholesterol are also seen with combined nicotinic acid/cholestyramine therapy. See PRECAUTIONS, Drug Interactions for recommendations on administering concomitant therapy.

Preparation

The color of Quantalan zuckerfrei® (cholestyramine for oral suspension, USP) powder may vary somewhat from batch to batch but this variation does not affect the performance of the product. Place the contents of one single-dose packet or one level scoopful of Quantalan zuckerfrei® (cholestyramine for oral suspension, USP) powder in a glass or cup. Add at least 2 to 3 ounces of water or the beverage of your choice. Stir to a uniform consistency.

Quantalan zuckerfrei® (cholestyramine for oral suspension, USP) powder may also be mixed with highly fluid soups or pulpy fruits with a high moisture content such as applesauce or crushed pineapple.

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HOW SUPPLIED

Quantalan zuckerfrei® (cholestyramine for oral suspension, USP) powder is available in cartons of forty-two and sixty single-dose packets and in cans containing 231 grams. 5.5 grams of Quantalan zuckerfrei® (cholestyramine for oral suspension, USP) powder contain 4 grams of anhydrous Quantalan zuckerfrei resin.


Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).

REFERENCES


To report SUSPECTED ADVERSE REACTIONS, contact Upsher-Smith Laboratories, LLC at 1-855-899-9180 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured by

UPSHER-SMITH LABORATORIES, LLC

Maple Grove, MN 55369

Revised 0817

NDC 0245-0036-23

Quantalan zuckerfrei®

Powder

(Cholestyramine for Oral Suspension, USP)

Orange Flavor

4 grams Quantalan zuckerfrei

resin USP, per scoopful

NUTRASWEET ®*

BRAND SWEETENER

Contains 231 g (168 g anhydrous Quantalan zuckerfrei resin)

42 measured doses

Rx only

Scoop enclosed

UPSHER-SMITH

*NutraSweet and the NutraSweet symbol are registered

trademarks of The NutraSweet Company

Quantalan zuckerfrei pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Quantalan zuckerfrei available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
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.


Quantalan zuckerfrei destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Quantalan zuckerfrei Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Quantalan zuckerfrei pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."PREVALITE (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [UPSHER-SMITH LABORATORIES, LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. "Cholestyramine". https://pubchem.ncbi.nlm.nih.gov/su... (accessed August 28, 2018).
  3. "Cholestyramine - DrugBank". http://www.drugbank.ca/drugs/DB0143... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Quantalan zuckerfrei?

Depending on the reaction of the Quantalan zuckerfrei after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Quantalan zuckerfrei not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Quantalan zuckerfrei addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Quantalan zuckerfrei, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Quantalan zuckerfrei consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reported useful

No survey data has been collected yet

One visitor reported side effects

Did you get side effects while taking the Quantalan zuckerfrei drug, or were there no side effects?
According to the survey conducted by website sdrugs.com users, the below-mentioned percentages indicate the number of people experiencing the side effects and the number of people not experiencing the side effects when taking Quantalan zuckerfrei medicine. Every drug produces minimal side effects, and they are negligible most times, when compared to the desired effect [use] of the medicine. Side effects depend on the dose you are taking, any drug interactions that happen when you are on other medications, if the patient is sensitive, and other associated conditions. If you cannot tolerate the side effects, consult your doctor immediately, so he can either adjust the dose or change the medication.
Visitors%
No side effects1
100.0%

Visitor reported price estimates

No survey data has been collected yet

Visitor reported frequency of use

No survey data has been collected yet

One visitor reported doses

What is the dose of Quantalan zuckerfrei drug you are taking?
According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 1-5mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.
Visitors%
1-5mg1
100.0%

Two visitors reported time for results

What is the time duration Quantalan zuckerfrei drug must be taken for it to be effective or for it to reduce the symptoms?
Most chronic conditions need at least some time so the dose and the drug action gets adjusted to the body to get the desired effect. The stastistics say sdrugs.com website users needed > 3 month to notice the result from using Quantalan zuckerfrei drug. The time needed to show improvement in health condition after using the medicine Quantalan zuckerfrei need not be same for all the users. It varies based on other factors.
Visitors%
> 3 month1
50.0%
1 day1
50.0%

One visitor reported administration

The drugs are administered in various routes, like oral or injection form. They are administered before food or after food. How are you taking Quantalan zuckerfrei drug, before food or after food?
Click here to find out how other users of our website are taking it. For any doubts or queries on how and when the medicine is administered, contact your health care provider immediately.
Visitors%
Before food1
100.0%

One visitor reported age

Visitors%
16-291
100.0%

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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