Cholestyramine Light

Cholestyramine for Oral Suspension USP Light

 

Rx only

Cholestyramine Light Description

Cholestyramine for Oral Suspension USP Light powder, the chloride salt of a basic anion exchange resin, a cholesterol-lowering agent, is intended for oral administration. Cholestyramine resin is quite hydrophilic, but insoluble in water. Cholestyramine resin is not absorbed from the digestive tract. Each 5.7 grams of Cholestyramine for Oral Suspension USP Light powder contain 4 grams of cholestyramine resin. It is represented by the following structural formula:

Representation of structure of main polymeric groups

Inactive Ingredients: aspartame, citric acid anhydrous, colloidal silicon dioxide, fructose, mannitol, mono ammonium glycyrrhizinate, pectin, propylene glycol alginate, sorbitol, xanthan gum, natural and artificial orange flavor, D&C yellow No. 10 aluminum lake and FD&C yellow No. 6 aluminum lake.

Cholestyramine Light - Clinical Pharmacology

Cholesterol is probably the sole precursor of bile acids. During normal digestion, bile acids are secreted into the intestines. A major portion of the bile acids is absorbed from the intestinal tract and returned to the liver via the enterohepatic circulation. Only very small amounts of bile acids are found in normal serum.

Cholestyramine resin adsorbs and combines with the bile acids in the intestine to form an insoluble complex which is excreted in the feces. This results in a partial removal of bile acids from the enterohepatic circulation by preventing their absorption.

The increased fecal loss of bile acids due to cholestyramine resin administration leads to an increased oxidation of cholesterol to bile acids, a decrease in beta lipoprotein or low density lipoprotein plasma levels and a decrease in serum cholesterol levels. Although in man, cholestyramine resin produces an increase in hepatic synthesis of cholesterol, plasma cholesterol levels fall.

In patients with partial biliary obstruction, the reduction of serum bile acid levels by cholestyramine resin reduces excess bile acids deposited in the dermal tissue with resultant decrease in pruritus.

Clinical Studies

In a large, placebo-controlled, multi-clinic study, LRC-CPPT1, hypercholesterolemic subjects treated with cholestyramine resin had mean reductions in total and low-density lipoprotein cholesterol (LDL-C) which exceeded those for diet and placebo treatment by 7.2% and 10.4%, respectively. Over the seven-year study period the cholestyramine resin group experienced a 19% reduction (relative to the incidence in the placebo group) in the combined rate of coronary heart disease death plus non-fatal myocardial infarction (cumulative incidences of 7% cholestyramine resin and 8.6% placebo). The subjects included in the study were men aged 35 to 59 with serum cholesterol levels above 265 mg/dL and no previous history of heart disease. It is not clear to what extent these findings can be extrapolated to females and other segments of the hypercholesterolemic population. (See also PRECAUTIONS, Carcinogenesis, Mutagenesis, Impairment of Fertility.)

Two controlled clinical trials have examined the effects of cholestyramine monotherapy upon coronary atherosclerotic lesions using coronary arteriography. In the NHLBI Type II Coronary Intervention Trial2, 116 patients (80% male) with coronary artery disease (CAD) documented by arteriography were randomized to cholestyramine resin or placebo for five years of treatment. Final study arteriography revealed progression of coronary artery disease in 49% of placebo patients compared to 32% of the cholestyramine resin group (p<0.05).

In the St. Thomas Atherosclerosis Regression Study (STARS)3, 90 hypercholesterolemic men with CAD were randomized to three blinded treatments: usual care, lipid-lowering diet and lipid-lowering diet plus cholestyramine resin. After 36 months, follow-up coronary arteriography revealed progression of disease in 46% of usual care patients, 15% of patients on lipid-lowering diet and 12% of those receiving diet plus cholestyramine resin (p<0.02). The mean absolute width of coronary segments decreased in the usual care group, increased slightly (0.003 mm) in the diet group and increased by 0.103 mm in the diet plus cholestyramine group (p<0.05). Thus in these randomized controlled clinical trials using coronary arteriography, cholestyramine resin monotherapy has been demonstrated to slow progression2,3 and promote regression3 of atherosclerotic lesions in the coronary arteries of patients with coronary artery disease.

The effect of intensive lipid-lowering therapy on coronary atherosclerosis has been assessed by arteriography in hyperlipidemic patients. In these randomized, controlled clinical trials, patients were treated for two to four years by either conventional methods (diet, placebo or in some cases low dose resin) or intensive combination therapy using diet plus colestipol (an anion exchange resin with a mechanism of action and an effect similar on serum lipids to that of Cholestyramine for Oral Suspension Light) plus either nicotinic acid or lovastatin. When compared to conventional measures, intensive lipid-lowering combination therapy significantly reduced the frequency of progression and increased the frequency of regression of coronary atherosclerotic lesions in patients with or at risk for coronary artery disease.

Indications and Usage for Cholestyramine Light

1) Cholestyramine for Oral Suspension USP Light 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. Cholestyramine for Oral Suspension USP Light 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 cholestyramine 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 cholestyramine 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 cholestyramine resin therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine resin or adding other lipid-lowering agents in combination with cholestyramine 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.

* Coronary heart disease or peripheral vascular disease (including symptomatic carotid artery disease). † Other 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).
		LDL-Cholesterol mg/dL (mmol/L)
Definite Atherosclerotic Disease*	Two or More Other Risk Factors†	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)

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

2) Cholestyramine for Oral Suspension USP Light powder, is indicated for the relief of pruritus associated with partial biliary obstruction. Cholestyramine 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.

Contraindications

Cholestyramine for Oral Suspension USP Light 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.

Warnings

PHENYLKETONURICS: CHOLESTYRAMINE FOR ORAL SUSPENSION USP LIGHT POWDER CONTAINS 22.4 mg PHENYLALANINE PER 5.7 GRAM DOSE.

Precautions

General

Chronic use of cholestyramine 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 cholestyramine resin. Supplementation with folic acid should be considered in these cases.

There is a possibility that prolonged use of cholestyramine 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. Cholestyramine resin may produce or worsen preexisting constipation. The dosage should be increased gradually in patients to minimize the risk of developing fecal impaction. In patients with preexisting constipation, the starting dose should be 1 pouch 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 (at monthly intervals) 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 cholestyramine 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 5.7 gram dose of Cholestyramine for Oral Suspension USP Light 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

Cholestyramine resin may delay or reduce the absorption of concomitant oral medication such as phenylbutazone, warfarin, thiazide diuretics (acidic) 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. Cholestyramine resin may interfere with the pharmacokinetics of drugs that undergo enterohepatic circulation. The discontinuance of cholestyramine 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 cholestyramine resin.

Because cholestyramine binds bile acids, cholestyramine 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 cholestyramine resin is given for long periods of time, concomitant supplementation with water-miscible (or parenteral) forms of fat soluble vitamins should be considered.

SINCE CHOLESTYRAMINE 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 CHOLESTYRAMINE 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 cholestyramine 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 cholestyramine resin-treated rats than in control rats.

The relevance of this laboratory observation from studies in rats to the clinical use of cholestyramine 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 cholestyramine group. The small numbers and the multiple categories prevent conclusions from being drawn. However, in view of the fact that cholestyramine 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 cholestyramine and placebo treated patients.

Pregnancy

Pregnancy Category C

 There are no adequate and well controlled studies in pregnant women. The use of cholestyramine 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. Cholestyramine is not absorbed systemically, however, it is known to interfere with absorption of fat-soluble vitamins; accordingly, regular prenatal supplementation may not be adequate (see PRECAUTIONS, Drug Interactions).

Nursing Mothers

Caution should be exercised when cholestyramine resin is administered to a nursing mother. The possible lack of proper vitamin absorption described in PRECAUTIONS, Pregnancymay 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 cholestyramine 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, 70.2 mg of anhydrous cholestyramine resin are contained in 100 mg of Cholestyramine for Oral Suspension USP Light.

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.

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 cholestyramine 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 cholestyramine 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 cholestyramine resin include:

Gastrointestinal:GI-rectal bleeding, black stools, hemorrhoidal bleeding, bleeding from known duodenal ulcer, dysphagia, hiccups, ulcer attack, sour taste, pancreatitis, rectal pain, diverticulitis.

Laboratory Test Changes:Liver function abnormalities.

Hematologic:Prolonged prothrombin time, ecchymosis, anemia.

Hypersensitivity:Urticaria, asthma, wheezing, shortness of breath.

Musculoskeletal:Backache, muscle and joint pains, arthritis.

Neurologic:Headache, anxiety, vertigo, dizziness, fatigue, tinnitus, syncope, drowsiness, femoral nerve pain, paresthesia.

Eye:Uveitis.

Renal:Hematuria, dysuria, burnt odor to urine, diuresis.

Miscellaneous:Weight loss, weight gain, increased libido, swollen glands, edema, dental bleeding, dental caries, erosion of tooth enamel, tooth discoloration.

Overdosage

Overdosage of cholestyramine 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.

Cholestyramine Light Dosage and Administration

The recommended starting adult dose for Cholestyramine for Oral Suspension USP Light powder is one pouch or one level scoopful (5.7 grams of Cholestyramine for Oral Suspension USP Light powder contains 4 grams of anhydrous cholestyramine resin) once or twice a day. The recommended maintenance dose for Cholestyramine for Oral Suspension USP Light powder is 2 to 4 pouches or scoopfuls daily (8 to 16 grams anhydrous cholestyramine 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 6 pouches or scoopfuls of Cholestyramine for Oral Suspension USP Light powder (24 grams of anhydrous cholestyramine 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, Cholestyramine for Oral Suspension USP Light powder may be administered in 1 to 6 doses per day.

Cholestyramine for Oral Suspension USP Light 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 cholestyramine 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 the PRECAUTIONS, Drug Interactionsfor recommendations on administering concomitant therapy.

Preparation

The color of Cholestyramine for Oral Suspension USP Light 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 pouch or one level scoopful of Cholestyramine for Oral Suspension USP Light 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.

Cholestyramine for Oral Suspension USP Light powder may also be mixed with highly fluid soups or pulpy fruits with a high moisture content such as applesauce or crushed pineapple.

How is Cholestyramine Light Supplied

Cholestyramine for Oral Suspension USP Light powder orange flavor is available in cartons of sixty 5.7 gram pouches and in cans containing 239.4 grams. Each 5.7 gram dose of Cholestyramine for Oral Suspension USP Light powder contains 4 grams of anhydrous cholestyramine resin.

Carton of 60 pouches

Can, 239.4 g (containing a scoop that is not interchangeable with scoops from other products)

Storage

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

REFERENCES

1. The Lipid Research Clinics Coronary Primary Prevention Trial Results: (I) Reduction in Incidence of Coronary Heart Disease; (II) The Relationship of Reduction in Incidence of Coronary Heart Disease to Cholesterol Lowering. JAMA. 1984; 251:351-374.

2. Brensike JF, Levy RI, Kelsey SF, et al. Effects of therapy with cholestyramine on progression of coronary arteriosclerosis: results of the NHLBI type II coronary intervention study. Circulation 1984; 69:313-24.

3. Watte, GF, Lewis B, Brunt JNH, Lewis ES, et al. Effects on coronary artery disease of lipid-lowering diet or diet plus cholestyramine, in the St. Thomas Atherosclerosis Regression Study (STARS). Lancet 1992; 339:563-69.

4. National Cholesterol Education Program. Second Report of the Expert panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). Circulation 1994 Mar;89 (3):1333-445.

5. The Lipid Research Clinics Investigators. The Lipid Research Clinics Coronary Primary Prevention Trial: Results of 6 Years of Post-Trial Follow-up. Arch Intern Med 1992; 152:1399-1410.

6. Behrman RE et al (eds): Nelson, Textbook of Pediatrics, ed 15. Philadelphia, PA, WB Saunders Company, 1996.

7. Takemoto CK et al (eds): Pediatric Dosage Handbook, ed 3. Cleveland/Akron, OH, Lexi-Comp, Inc., 1996/1997.

To report SUSPECTD ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured for

Sandoz Inc.

Princeton, NJ 08540

Manufactured by

Epic Pharma LLC

Laurelton, NY 11413

Rev. 09/08

MF0939REV09/08

OS7246

PRINCIPAL DISPLAY PANEL

NDC 0185-0939-97

Cholestyramine for Oral Suspension USP Light Powder

4 grams cholestyramine resin USP, per scoopful.*

Orange Flavor

NDC 0185-0939-98

Cholestyramine for Oral Suspension USP Light Powder

4 gram cholestyramine resin USP, per pouch*

Orange Flavor

Cholestyramine Light  Cholestyramine Light  powder, for suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0185-0939 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHOLESTYRAMINE (CHOLESTYRAMINE) CHOLESTYRAMINE 4 g  in 5.7 g

Inactive Ingredients Ingredient Name Strength ASPARTAME   CITRIC ACID ANHYDROUS   COLLOIDAL SILICON DIOXIDE   D&C YELLOW NO. 10   FD&C YELLOW NO. 6   FRUCTOSE   MANNITOL   GLYCYRRHIZIN, AMMONIATED   ORANGE   PECTIN   PROPYLENE GLYCOL ALGINATE   SORBITOL   XANTHAN GUM

Product Characteristics Color YELLOW Score      Shape Size Flavor ORANGE Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0185-0939-97 239.4 g In 1 CAN None 2 0185-0939-98 60 POUCH In 1 CARTON contains a POUCH 2 5.7 g In 1 POUCH This package is contained within the CARTON (0185-0939-98)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074558	11/04/1994

Labeler - Eon Labs, Inc. (012656273)

Revised: 06/2011Eon Labs, Inc.

More Cholestyramine Light resources

• Cholestyramine Light Side Effects (in more detail)
• Cholestyramine Light Dosage
• Cholestyramine Light Use in Pregnancy & Breastfeeding
• Cholestyramine Light Drug Interactions
• Cholestyramine Light Support Group
• 1 Review for Cholestyramine Light - Add your own review/rating

• Cholestyramine Light Concise Consumer Information (Cerner Multum)


• Cholestyramine Powder MedFacts Consumer Leaflet (Wolters Kluwer)


• cholestyramine Advanced Consumer (Micromedex) - Includes Dosage Information


• Cholestyramine Professional Patient Advice (Wolters Kluwer)


• Cholestyramine Resin Monograph (AHFS DI)

Compare Cholestyramine Light with other medications

• Crohn's Disease
• Hyperlipoproteinemia
• Hyperlipoproteinemia Type IIa, Elevated LDL
• Hyperlipoproteinemia Type IIb, Elevated LDL VLDL
• Irritable Bowel Syndrome
• Pruritus of Partial Biliary Obstruction

Cefpodoxime

Generic Name: cefpodoxime (SEF poe DOX eem)

Brand Names: Vantin

What is cefpodoxime?

Cefpodoxime is in a group of drugs called cephalosporin (SEF a low spor in) antibiotics. It works by fighting bacteria in your body.

Cefpodoxime is used to treat many different types of infections caused by bacteria.

Cefpodoxime may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about cefpodoxime?

Do not take this medication if you are allergic to cefpodoxime, or to similar antibiotics, such as Ceftin, Cefzil, Keflex, Omnicef, and others.

Before taking this medication, tell your doctor if you are allergic to any drugs (especially penicillin). Also tell your doctor if you have kidney disease or a history of intestinal problems.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Cefpodoxime will not treat a viral infection such as the common cold or flu.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

What should I discuss with my healthcare provider before taking cefpodoxime?

Do not take this medication if you are allergic to cefpodoxime or to other cephalosporin antibiotics, such as:

• 
  

  cefaclor (Raniclor);

  
  


• 
  

  cefadroxil (Duricef);

  
  


• 
  

  cefazolin (Ancef);

  
  


• 
  

  cefdinir (Omnicef);

  
  


• 
  

  cefditoren (Spectracef);

  
  


• 
  

  cefixime (Suprax);

  
  


• 
  

  cefprozil (Cefzil);

  
  


• 
  

  ceftibuten (Cedax);

  
  


• 
  

  cefuroxime (Ceftin);

  
  


• 
  

  cephalexin (Keflex); or

  
  


• 
  

  cephradine (Velosef); and others.

  
  

Before taking cefpodoxime, tell your doctor if you are allergic to any drugs (especially penicillins) or if you have:

• 
  

  kidney disease (or if you are on dialysis); or

  
  


• 
  

  a history of intestinal problems, such as colitis.

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Cefpodoxime passes into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take cefpodoxime?

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 this medicine with a full glass of water. The cefpodoxime tablet should be taken with food.

Cefpodoxime oral suspension (liquid) can be taken with or without food.

Shake the liquid well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

This medication can cause you to have false results with certain medical tests, including urine glucose (sugar) tests. Tell any doctor who treats you that you are using cefpodoxime.

Take cefpodoxime for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Cefpodoxime will not treat a viral infection such as the common cold or flu. Store the tablets at room temperature away from moisture, heat, and light. Store cefpodoxime oral liquid in the refrigerator. Do not allow it to freeze. Throw away any unused medication that is older than 14 days.

What happens if I miss a dose?

Take the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use 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.

Overdose symptoms may include nausea, vomiting, stomach pain, and diarrhea.

What should I avoid while taking cefpodoxime?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Cefpodoxime side effects

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:

• 
  

  diarrhea that is watery or bloody;

  
  


• 
  

  fever, chills, body aches, flu symptoms;

  
  


• 
  

  unusual bleeding or bruising;

  
  


• 
  

  cough, wheezing, chest tightness, trouble breathing;

  
  


• 
  

  fast or pounding heartbeats;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  seizure (convulsions);

  
  


• 
  

  pale or yellowed skin, dark colored urine, fever, confusion or weakness;

  
  


• 
  

  jaundice (yellowing of the skin or eyes);

  
  


• 
  

  fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

  
  


• 
  

  swelling, rapid weight gain, feeling short of breath (even with mild exertion); or

  
  


• 
  

  increased thirst, loss of appetite, urinating less than usual or not at all.

  
  

Less serious side effects may include:

• 
  

  nausea, vomiting, stomach pain, mild diarrhea, bloating, gas, constipation;

  
  


• 
  

  stiff or tight muscles;

  
  


• 
  

  back pain, muscle pain;

  
  


• 
  

  headache, tired feeling;

  
  


• 
  

  anxiety, nervousness, feeling restless or hyperactive;

  
  


• 
  

  numbness or tingly feeling, warmth or redness under your skin;

  
  


• 
  

  dizziness, spinning sensation;

  
  


• 
  

  strange dreams, nightmares;

  
  


• 
  

  stuffy nose;

  
  


• 
  

  dry mouth, unusual or unpleasant taste in your mouth;

  
  


• 
  

  white patches or sores inside your mouth or on your lips;

  
  


• 
  

  diaper rash in an infant taking liquid cefpodoxime

  
  


• 
  

  mild itching or skin rash; or

  
  


• 
  

  vaginal itching or discharge.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Cefpodoxime Dosing Information

Usual Adult Dose for Bronchitis:

Acute bacterial exacerbation of chronic bronchitis: 200 mg orally every 12 hours for 10 days

Usual Adult Dose for Cystitis:

100 mg orally every 12 hours for 7 days

Usual Adult Dose for Gonococcal Infection -- Uncomplicated:

Uncomplicated urethral, cervical, or female anorectal infections: 200 mg orally one time

Alternatively, the Centers for Disease Control and Prevention suggest 400 mg orally one time may be effective for both male and female patients as an oral alternative for the treatment of uncomplicated gonorrhea of the cervix, urethra, or rectum.

Doxycycline therapy for 7 days (if not pregnant) or single dose azithromycin is also recommended to treat possible concurrent chlamydial infection.

The patient's sexual partner(s) should also be evaluated/treated.

Cefpodoxime is not indicated for pharyngeal N gonorrhoeae infections.

Usual Adult Dose for Gonococcal Infection -- Disseminated:

400 mg orally twice a day

Initial therapy for disseminated gonococcal infections requires parenteral therapy which should be continued for 24 to 48 hours after clinical improvement is observed. Oral therapy may then be administered to complete a total course of at least 1 week.

Doxycycline therapy for 7 days (if not pregnant) or single dose azithromycin is also recommended to treat possible concurrent chlamydial infection.

The patient's sexual partner(s) should also be evaluated/treated.

Usual Adult Dose for Pneumonia:

Community-acquired pneumonia: 200 mg orally every 12 hours for 14 days

Usual Adult Dose for Pyelonephritis:

100 mg orally every 12 hours
Therapy should be continued for about 14 days, depending on the nature and severity of the infection.

Usual Adult Dose for Sinusitis:

200 mg orally every 12 hours for 10 days

Usual Adult Dose for Skin or Soft Tissue Infection:

Uncomplicated infection: 400 mg orally every 12 hours for 7 to 14 days

Usual Adult Dose for Tonsillitis/Pharyngitis:

100 mg orally every 12 hours for 5 to 10 days
There are insufficient data to establish efficacy in the subsequent prophylaxis of rheumatic fever.

Usual Adult Dose for Upper Respiratory Tract Infection:

100 mg orally every 12 hours
Therapy should be continued for approximately 10 to 14 days, depending on the nature and severity of the infection.

Usual Pediatric Dose for Bronchitis:

Acute bacterial exacerbation of chronic bronchitis:
12 years or older: 200 mg orally every 12 hours for 10 days

Usual Pediatric Dose for Cystitis:

12 years or older: 100 mg orally every 12 hours for 7 days

Usual Pediatric Dose for Gonococcal Infection -- Uncomplicated:

Uncomplicated urethral, cervical, or female anorectal infections:
12 years or older: 200 mg orally one time

Alternatively, the Centers for Disease Control and Prevention suggest 400 mg orally one time may be effective for both male and female patients as an oral alternative for the treatment of uncomplicated gonorrhea of the cervix, urethra, or rectum.

Doxycycline therapy for 7 days (if not pregnant) or single dose azithromycin is also recommended to treat possible concurrent chlamydial infection.

The patient's sexual partner(s) should also be evaluated.

Cefpodoxime is not indicated for pharyngeal N gonorrhoeae infections.

Usual Pediatric Dose for Gonococcal Infection -- Disseminated:

12 years or older: 400 mg orally twice a day

Initial therapy for disseminated gonococcal infections requires parenteral therapy which should be continued for 24 to 48 hours after clinical improvement is observed. Oral therapy may then be administered to complete a total course of at least 1 week.

Doxycycline therapy for 7 days (if not pregnant) or single dose azithromycin is also recommended to treat possible concurrent chlamydial infection.

The patient's sexual partner(s) should also be evaluated/treated.

Usual Pediatric Dose for Otitis Media:

2 months through 12 years: 5 mg/kg/dose (maximum 200 mg) orally every 12 hours for 5 days
Maximum dose: 400 mg/day

Usual Pediatric Dose for Pneumonia:

Community-acquired pneumonia:
12 years or older: 200 mg orally every 12 hours for 14 days

Usual Pediatric Dose for Sinusitis:

2 months through 12 years: 5 mg/kg/dose (maximum 200 mg) orally every 12 hours for 10 days
Maximum dose: 400 mg/day

12 years or older: 200 mg orally every 12 hours for 10 days

Usual Pediatric Dose for Skin or Soft Tissue Infection:

Uncomplicated infection:
12 years or older: 400 mg orally every 12 hours for 7 to 14 days

Usual Pediatric Dose for Tonsillitis/Pharyngitis:

2 months through 12 years: 5 mg/kg/dose (maximum 100 mg) orally every 12 hours for 5 to 10 days
Maximum dose: 200 mg/day

12 years or older: 100 mg orally every 12 hours for 5 to 10 days

There are insufficient data to establish efficacy in the subsequent prophylaxis of rheumatic fever.

What other drugs will affect cefpodoxime?

Before taking cefpodoxime, tell your doctor if you are using any of the following drugs:

• 
  

  lithium (Lithobid);

  
  


• 
  

  probenecid (Benemid);

  
  


• 
  

  methotrexate (Rheumatrex, Trexall);

  
  


• 
  

  antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir);

  
  


• 
  

  cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), plicamycin (Mithracin), streptozocin (Zanosar), or tretinoin (Vesanoid);

  
  


• 
  

  a diuretic (water pill) such as bumetanide (Bumex), furosemide (Lasix), indapamide (Lozol), hydrochlorothiazide (HCTZ, HydroDiuril, Hyzaar, Lopressor, Vasoretic, Zestoretic), metolazone (Mykrox, Zarxolyn), spironolactone (Aldactazide, Aldactone), torsemide (Demadex), and others;

  
  


• 
  

  a medication that reduces stomach acid, such as an antacid, or cimetidine (Tagamet), famotidine (Pepcid), omeprazole (Prilosec), ranitidine (Zantac), and others;

  
  


• 
  

  IV antibiotics such as amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), amikacin (Amikin), bacitracin (Baci-IM), capreomycin (Capastat), gentamicin (Garamycin), kanamycin (Kantrex), streptomycin, or vancomycin (Vancocin, Vancoled);

  
  


• 
  

  medicines used to prevent organ transplant rejection, such as sirolimus (Rapamune) or tacrolimus (Prograf);

  
  


• 
  

  medicines used to treat ulcerative colitis, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine); or

  
  


• 
  

  pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), diclofenac (Cataflam, Voltaren), etodolac (Lodine), ibuprofen (Advil, Motrin), indomethacin (Indocin), naproxen (Aleve, Naprosyn), and others.

  
  

This list is not complete and there may be other drugs that can interact with cefpodoxime. 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 taking a new medication without telling your doctor.

More cefpodoxime resources

• Cefpodoxime Side Effects (in more detail)
• Cefpodoxime Use in Pregnancy & Breastfeeding
• Drug Images
• Cefpodoxime Drug Interactions
• Cefpodoxime Support Group
• 2 Reviews for Cefpodoxime - Add your own review/rating

• cefpodoxime Advanced Consumer (Micromedex) - Includes Dosage Information


• Cefpodoxime MedFacts Consumer Leaflet (Wolters Kluwer)


• Cefpodoxime Proxetil Monograph (AHFS DI)


• Vantin Prescribing Information (FDA)

Compare cefpodoxime with other medications

• Bladder Infection
• Bronchitis
• Gonococcal Infection, Disseminated
• Gonococcal Infection, Uncomplicated
• Kidney Infections
• Otitis Media
• Pneumonia
• Sinusitis
• Skin Infection
• Tonsillitis/Pharyngitis
• Upper Respiratory Tract Infection

Where can I get more information?

• Your pharmacist can provide more information about cefpodoxime.

See also: cefpodoxime side effects (in more detail)

Hyphed

Generic Name: chlorpheniramine, hydrocodone, and pseudoephedrine (KLOR fe NEER a meen, HYE droe KOE done, SOO doe ee FED rin)

Brand Names: Cordron-HC, Cordron-HC NR, Detuss, Hydrocof-HC, Hydron PCS, Hyphed, JayCof-HC, Notuss-Forte, P-V-Tussin Syrup, Q-V Tussin, Welltuss HC, Zutripro

What is Hyphed (chlorpheniramine, hydrocodone, and pseudoephedrine)?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Hydrocodone is a narcotic cough medicine.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of chlorpheniramine, hydrocodone, and pseudoephedrine is used to treat runny or stuffy nose, sinus congestion, and cough caused by the common cold or flu.

Chlorpheniramine, hydrocodone, and pseudoephedrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Hyphed (chlorpheniramine, hydrocodone, and pseudoephedrine)?

Do not take this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use chlorpheniramine, hydrocodone, and pseudoephedrine before the MAO inhibitor has cleared from your body. Chlorpheniramine, hydrocodone, and pseudoephedrine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine, hydrocodone, and pseudoephedrine. Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine, hydrocodone, and pseudoephedrine. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Never share hydrocodone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

What should I discuss with my healthcare provider before taking Hyphed (chlorpheniramine, hydrocodone, and pseudoephedrine)?

Do not take this medication if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. Serious, life threatening side effects can occur if you use chlorpheniramine, hydrocodone, and pseudoephedrine before the MAO inhibitor has cleared from your body. You should not use chlorpheniramine, hydrocodone, and pseudoephedrine if you are allergic to it.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

• 
  

  asthma, COPD, sleep apnea, or other breathing disorder;

  
  


• liver or kidney disease;


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  diabetes;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  curvature of the spine;

  
  


• 
  

  a history of head injury or brain tumor;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  low blood pressure;

  
  


• 
  

  glaucoma;

  
  


• 
  

  gallbladder disease;

  
  


• 
  

  Addison's disease or other adrenal gland disorders;

  
  


• 
  

  enlarged prostate, urination problems;

  
  


• 
  

  mental illness; or

  
  


• 
  

  a history of drug or alcohol addiction.

  
  

Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Never share hydrocodone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. FDA pregnancy category C. It is not known whether chlorpheniramine, hydrocodone, and pseudoephedrine will harm an unborn baby. Hydrocodone may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using chlorpheniramine, hydrocodone, and pseudoephedrine. It is not known whether chlorpheniramine, hydrocodone, and pseudoephedrine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Hyphed (chlorpheniramine, hydrocodone, and pseudoephedrine)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

You may take this medication with or without food.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Store at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Hydrocodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of hydrocodone can be fatal.

Overdose symptoms may include extreme drowsiness, feeling restless or nervous, vomiting, stomach pain, warmth or tingly feeling, seizure (convulsions), pinpoint pupils, confusion, cold and clammy skin, weak pulse, shallow breathing, fainting, or breathing that stops.

What should I avoid while taking Hyphed (chlorpheniramine, hydrocodone, and pseudoephedrine)?

Chlorpheniramine, hydrocodone, and pseudoephedrine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine, hydrocodone, and pseudoephedrine.

Hyphed (chlorpheniramine, hydrocodone, and pseudoephedrine) side effects

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. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  fast, pounding, or uneven heartbeats;

  
  


• 
  

  shallow breathing, slow heartbeat;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, chest pain, shortness of breath, seizure); or

  
  


• 
  

  upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  nausea, vomiting, upset stomach, constipation;

  
  


• 
  

  dry mouth;

  
  


• 
  

  blurred vision;

  
  


• 
  

  dizziness, drowsiness;

  
  


• 
  

  problems with memory or concentration;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  ringing in your ears;

  
  


• 
  

  warmth, tingling, or redness under your skin; or

  
  


• 
  

  skin rash or itching.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Hyphed (chlorpheniramine, hydrocodone, and pseudoephedrine)?

Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine, hydrocodone, and pseudoephedrine.

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

• 
  

  blood pressure medication;

  
  


• 
  

  cimetidine (Tagamet);

  
  


• 
  

  rifampin (Rifadin, Rifater, Rifamate, Rimactane);

  
  


• 
  

  zidovudine (Retrovir, AZT);

  
  


• 
  

  an antidepressant;

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  medication to treat irritable bowel syndrome;

  
  


• 
  

  bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

  
  


• 
  

  aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);

  
  


• 
  

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

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or

  
  


• 
  

  medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), pimozide (Orap), or thioridazine (Mellaril).

  
  

This list is not complete and other drugs may interact with chlorpheniramine, hydrocodone, and pseudoephedrine. 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.

More Hyphed resources

• Hyphed Use in Pregnancy & Breastfeeding
• Hyphed Drug Interactions
• Hyphed Support Group
• 0 Reviews for Hyphed - Add your own review/rating

• Hyphed Advanced Consumer (Micromedex) - Includes Dosage Information


• Histinex PV Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Tussend MedFacts Consumer Leaflet (Wolters Kluwer)


• Zutripro Prescribing Information (FDA)


• Zutripro Consumer Overview

Compare Hyphed with other medications

• Cough and Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about chlorpheniramine, hydrocodone, and pseudoephedrine.

Heartburn Relief Drug Facts

Generic Name: ranitidine

Dosage Form: tablet
Kroger Co. Heartburn Relief Drug Facts

Active ingredient (in each tablet)

Ranitidine 75 mg (as ranitidine hydrochloride 84 mg)

Purpose

Acid reducer

Uses

• relieves heartburn associated with acid indigestion and sour stomach


• prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages

Warnings

Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

Do not use

• if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.


• with other acid reducers

Ask a doctor before use if you have

• frequent chest pain


• frequent wheezing, particularly with heartburn


• unexplained weight loss


• nausea or vomiting


• stomach pain


• had heartburn over 3 months. This may be a sign of a more serious condition


• heartburn with lightheadedness, sweating or dizziness


• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness

Stop use and ask a doctor if

• your heartburn continues or worsens


• you need to take this product for more than 14 days

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 12 years and over:


• to relieve symptoms, swallow 1 tablet with a glass of water


• to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn


• can be used up to twice daily (do not take more than 2 tablets in 24 hours)


• children under 12 years: ask a doctor

Other information

• do not use if printed foil under cap is broken or missing


• store at 20° - 25°C (68° - 77°F)


• avoid excessive heat or humidity


• this product is sugar free

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, diethyl phthalate, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, titanium dioxide.

Questions or comments?

1-800-632-6900

Principal Display Panel

Compare to active ingredient of Zantac 75® - see bottom panel

Heartburn Relief

Ranitidine Tablets, 75 mg

Acid Reducer

Relieves & Prevents Heartburn Associated with Acid Indigestion & Sour Stomach

# Doses {Replace "#" with number tablets in package}

Heartburn Relief Carton

HEARTBURN RELIEF  ACID REDUCER ranitidine  tablet

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 30142-271 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE 75 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color PINK Score no score Shape HEXAGON (6 sided) Size 8mm Flavor Imprint Code W75 Contains

Packaging # NDC Package Description Multilevel Packaging 1 30142-271-39 1 BOTTLE In 1 CARTON contains a BOTTLE 1 30 TABLET In 1 BOTTLE This package is contained within the CARTON (30142-271-39) 2 30142-271-72 1 BOTTLE In 1 CARTON contains a BOTTLE 2 60 TABLET In 1 BOTTLE This package is contained within the CARTON (30142-271-72)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076760	05/22/2009

Labeler - Kroger Company (006999528)

Revised: 03/2010Kroger Company

More Heartburn Relief Drug Facts resources

• Heartburn Relief Drug Facts Use in Pregnancy & Breastfeeding
• Drug Images
• Heartburn Relief Drug Facts Drug Interactions
• Heartburn Relief Drug Facts Support Group
• 32 Reviews for Heartburn Relief Drug Facts - Add your own review/rating

Compare Heartburn Relief Drug Facts with other medications

• Duodenal Ulcer
• Duodenal Ulcer Prophylaxis
• Erosive Esophagitis
• Gastric Ulcer Maintenance Treatment
• Gastrointestinal Hemorrhage
• GERD
• Indigestion
• Pathological Hypersecretory Conditions
• Stomach Ulcer
• Stress Ulcer Prophylaxis
• Surgical Prophylaxis
• Zollinger-Ellison Syndrome

Chloromycetin Ophthalmic Ointment

chloramphenicol

Dosage Form: ophthalmic ointment

WARNING

Bone marrow hypoplasia including aplastic anemia and death has been reported following topical application of chloramphenicol. Chloramphenicol should not be used when less potentially dangerous agents would be expected to provide effective treatment.

Description

Each gram of Chloromycetin Ophthalmic Ointment, 1% contains 10 mg of chloramphenicol in a special base of liquid petrolatum and polyethylene. It contains no preservatives. Sterile ointment.

The chemical names for chloramphenicol are:

(1) Acetamide, 2,2-dichloro-N-[2-hydroxy-1-(hydroxymethyl)-2-(4-nitrophenyl) ethyl]-, and

(2) D-threo-(—)-2,2-Dichloro-N-[β-hydroxy-α-(hydroxymethyl)-p-nitrophenethyl] acetamide.

Chloramphenicol has the following empirical and structural formulas:

Clinical Pharmacology

Chloramphenicol is a broad-spectrum antibiotic originally isolated from Streptomyces venezuelae. It is primarily bacteriostatic and acts by inhibition of protein synthesis by interfering with the transfer of activated amino acids from soluble RNA to ribosomes. It has been noted that chloramphenicol is found in measurable amounts in the aqueous humor following local application to the eye. Development of resistance to chloramphenicol can be regarded as minimal for staphylococci and many other species of bacteria.

Indications and Usage

Chloramphenicol should be used only in those serious infections for which less potentially dangerous drugs are ineffective or contraindicated. Bacteriological studies should be performed to determine the causative organisms and their sensitivity to chloramphenicol (see Boxed Warning).

Chloromycetin Ophthalmic Ointment, 1% (Chloramphenicol Ophthalmic Ointment, USP) is indicated for the treatment of surface ocular infections involving the conjunctiva and/or cornea caused by chloramphenicol-susceptible organisms.

The particular antiinfective drug in this product is active against the following common bacterial eye pathogens:

Staphylococcus aureus

Streptococcus, including Streptococcus pneumoniae

Escherichia coli

Haemophilus influenzae

Klebsiella/Enterobacter species

Moraxella lucunata

    (Morax-Axenfeld bacillus)

Neisseria species

This product does not provide adequate coverage against:

Pseudomonas aeruginosa

Serratia marcescens

Contraindications

This product is contraindicated in persons sensitive to any of its components.

Warnings

SEE BOXED WARNING

Ophthalmic ointments may retard corneal wound healing.

Precautions

The prolonged use of antibiotics may occasionally result in overgrowth of nonsusceptible organisms including fungi. If new infections appear during medication, the drug should be discontinued and appropriate measures should be taken.

In all serious infections the topical use of chloramphenicol should be supplemented by appropriate systemic medication.

Adverse Reactions

Blood dyscrasias have been reported in association with the use of chloramphenicol (see WARNINGS).

Allergic or inflammatory reactions due to individual hypersensitivity and occasional burning or stinging may occur with the use of Chloromycetin Ophthalmic Ointment.

Dosage and Administration

A small amount of ointment placed in the lower conjunctival sac every three hours, or more frequently if deemed advisable by the prescribing physician. Administration should be continued day and night the first 48 hours, after which the interval between applications may be increased. Treatment should be continued for at least 48 hours after the eye appears normal.

How Supplied

N 0071–3070–07

Chloromycetin Ophthalmic Ointment, 1% (Chloramphenicol Ophthalmic Ointment, USP) is supplied, sterile, in ophthalmic ointment tubes of 3.5 grams.

Chloromycetin, brand of chloramphenicol. Reg US Pat Off

Caution—Federal law prohibits dispensing without prescription.

March 1997

©1997, Warner-Lambert Co.

PARKE-DAVIS

Div of Warner-Lambert Co/Morris Plains, NJ 07950 USA

CHLOROMYCETIN  chloramphenicol  ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0071-3070 Route of Administration OPHTHALMIC DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength chloramphenicol (chloramphenicol) Active 10 MILLIGRAM  In 1 GRAM

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0071-3070-07 3.5 g (GRAM) In 1 TUBE None

Revised: 10/2006PARKE-DAVIS

More Chloromycetin Ophthalmic Ointment resources

• Chloromycetin Ophthalmic Ointment Side Effects (in more detail)
• Chloromycetin Ophthalmic Ointment Dosage
• Chloromycetin Ophthalmic Ointment Drug Interactions
• Chloromycetin Ophthalmic Ointment Support Group
• 0 Reviews for Chloromycetin Ophthalmic - Add your own review/rating

Compare Chloromycetin Ophthalmic Ointment with other medications

• Conjunctivitis, Bacterial

Hydrocodone/Ibuprofen

Pronunciation: HYE-droe-KOE-done/EYE-bue-PROE-fen
Generic Name: Hydrocodone/Ibuprofen
Brand Name: Examples include Reprexain and Vicoprofen

Hydrocodone/Ibuprofen is used for:

Short-term treatment of pain.

Hydrocodone/Ibuprofen is an opioid analgesic and nonsteroidal anti-inflammatory drug (NSAID) combination. Exactly how it works is not known. Ibuprofen may block certain substances in the body that cause inflammation. Hydrocodone may affect opiate receptors in the brain to decrease pain.

Do NOT use Hydrocodone/Ibuprofen if:

• you are allergic to any ingredient in Hydrocodone/Ibuprofen


• you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or an NSAID (eg, ibuprofen, celecoxib)


• you have severe kidney problems or you have severe diarrhea or other bowel problems caused by antibiotics or food poisoning


• you have recently had or will be having bypass heart surgery


• you are in the last 3 months of pregnancy


• you take sodium oxybate (GHB) or you have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Hydrocodone/Ibuprofen:

Some medical conditions may interact with Hydrocodone/Ibuprofen. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you are allergic to other narcotic medicines (eg, medicines that contain codeine, morphine, oxycodone)


• if you or a family member has a history of mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse, or if you drink alcohol


• if you have a history of kidney, liver, or lung problems, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers)


• if you have a history of swelling or fluid buildup, lupus, asthma, growths in the nose (nasal polyps), or mouth inflammation


• if you have high blood pressure, blood disorders, bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel problems, or if you are at risk for any of these problems


• if you have Addison disease, thyroid problems, an enlarged prostate, or trouble urinating


• if you have asthma or breathing problems, seizures, growths in the brain, a recent head injury, or if you have had recent surgery


• if you have poor health, dehydration or low fluid volume, or low blood sodium levels

Some MEDICINES MAY INTERACT with Hydrocodone/Ibuprofen. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin), corticosteroids (eg, prednisone), heparin, salicylates (eg, aspirin), or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of bleeding, including stomach bleeding, may be increased


• Antihistamines (eg, diphenhydramine), barbiturates (eg, phenobarbital), cimetidine, narcotic pain medicine (eg, codeine), or sodium oxybate (GHB) because the risk of excessive drowsiness or severe breathing problems may be increased


• Anticholinergics (eg, benztropine), MAOIs (eg, phenelzine), probenecid, or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Hydrocodone/Ibuprofen's side effects


• Naltrexone or rifampin because they may decrease Hydrocodone/Ibuprofen's effectiveness


• Cyclosporine, lithium, methotrexate, or quinolones (eg, ciprofloxacin) because the risk of their side effects may be increased by Hydrocodone/Ibuprofen


• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Hydrocodone/Ibuprofen

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hydrocodone/Ibuprofen may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Hydrocodone/Ibuprofen:

Use Hydrocodone/Ibuprofen as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Hydrocodone/Ibuprofen comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Hydrocodone/Ibuprofen refilled.


• Take Hydrocodone/Ibuprofen by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• If you miss a dose of Hydrocodone/Ibuprofen and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Hydrocodone/Ibuprofen.

Important safety information:

• Hydrocodone/Ibuprofen may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Hydrocodone/Ibuprofen with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Hydrocodone/Ibuprofen; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Serious stomach ulcers or bleeding can occur with the use of Hydrocodone/Ibuprofen. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Hydrocodone/Ibuprofen with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Hydrocodone/Ibuprofen has ibuprofen in it. Before you start any new medicine, check the label to see if it has ibuprofen in it too. If it does or you are not sure, check with your doctor or pharmacist.


• Do not take aspirin while you take Hydrocodone/Ibuprofen unless your doctor tells you to. If you already take aspirin for a heart or other condition, talk with your doctor about whether or not you should continue to take it with Hydrocodone/Ibuprofen.


• Lab tests, including liver function, kidney function, complete blood cell counts, and blood pressure, may be performed while you use Hydrocodone/Ibuprofen. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Hydrocodone/Ibuprofen with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding.


• Hydrocodone/Ibuprofen should be used with extreme caution in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Hydrocodone/Ibuprofen may cause harm to the fetus. Do not take it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hydrocodone/Ibuprofen while you are pregnant. It is not known if Hydrocodone/Ibuprofen is found in breast milk. Do not breast-feed while taking Hydrocodone/Ibuprofen.

When used for long periods of time or at high doses, Hydrocodone/Ibuprofen may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Hydrocodone/Ibuprofen stops working well. Do not take more than prescribed.

Some people who use Hydrocodone/Ibuprofen for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you suddenly stop taking Hydrocodone/Ibuprofen, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Hydrocodone/Ibuprofen:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Anxiety; constipation; diarrhea; dizziness; dry mouth; gas; headache; heartburn; increased sweating; loss of appetite; nausea; nervousness; stomach pain or upset; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody, black, or tarry stools; blurred vision; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; slow or shallow breathing; stiff neck; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Hydrocodone/Ibuprofen side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; cold and clammy skin; coma; confusion; decreased urination; loss of consciousness; ringing in the ears; severe dizziness or drowsiness; severe muscle weakness; severe nausea or stomach pain; slow or troubled breathing; unusual bleeding or bruising; vomit that looks like coffee grounds.

Proper storage of Hydrocodone/Ibuprofen:

Store Hydrocodone/Ibuprofen at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hydrocodone/Ibuprofen out of the reach of children and away from pets.

General information:

• If you have any questions about Hydrocodone/Ibuprofen, please talk with your doctor, pharmacist, or other health care provider.


• Hydrocodone/Ibuprofen is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Hydrocodone/Ibuprofen. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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