Colestipol Hydrochloride

Class: Bile Acid Sequestrants
VA Class: CV350
CAS Number: 37296-80-3
Brands: Colestid

Introduction

Antilipemic agent; bile acid sequestrant.

Uses for Colestipol Hydrochloride

Dyslipidemias

Adjunct to dietary therapy to decrease elevated serum total and LDL-cholesterol concentrations in the management of primary hypercholesterolemia in patients who do not respond adequately to diet.^{166 167}

Generally has no clinically relevant effect on serum triglyceride concentrations.^{100 167} However, because triglyceride concentrations may be increased in some patients,¹⁶⁷ do not use alone in the management of hypertriglyceridemia.^d

As effective as cholestyramine in lowering serum cholesterol concentrations.^d Select bile acid sequestrant based on patient tolerance, including palatability and taste preference, and cost.^{136 163}

Colestipol Hydrochloride Dosage and Administration

General

• 
  

  Patients should be placed on a standard lipid-lowering diet before initiation of colestipol therapy and should remain on this diet during treatment with the drug.^{166 167}

  
  


• 
  

  To optimize antilipemic effects while minimizing the risk of adverse GI effects, adjust dosage carefully and titrate slowly.^{135 136 166}

  
  


• 
  

  Instruct patients to take other drugs at least 1 hour before or 4 hours after taking colestipol tablets or suspension to minimize possible interference with absorption.^{166 167} (See Effects on GI Absorption of Drugs under Interactions.)

  
  

Monitoring during Antilipemic Therapy

• 
  

  Monitor lipoprotein concentrations periodically to ensure that target LDL-cholesterol goals are achieved and maintained at <100 mg/dL (optional goal: <70 mg/dL) for patients with CHD or CHD risk equivalents; <130 mg/dL (optional goal: <100 mg/dL) for patients with ≥2 risk factors and 10-year risk of 10–20%; <130 mg/dL for patients with ≥2 risk factors and 10-year risk <10%; or <160 mg/dL for patients with 0–1 risk factor.

  
  

Administration

Oral Administration

Administer tablets one at a time; promptly swallow whole, using plenty of water or other appropriate liquid.¹⁶⁷ The tablets must not be cut, crushed, or chewed.¹⁶⁷

To avoid accidental inhalation or esophageal distress, do not administer colestipol hydrochloride for oral suspension in its dry form.¹⁶⁶

To minimize excessive swallowing of air, advise patients to avoid rapid ingestion of suspensions of the drug.¹³⁶ After the mixture is ingested, rinse the glass with a small amount of additional fluid and ingest the remaining liquid to ensure that the entire dose has been taken.¹⁶⁶

Reconstitution

Add the prescribed amount of colestipol hydrochloride granules to at least 90 mL of a liquid (e.g., fruit juice, water, milk, soft drink) and stir until completely mixed (colestipol will not dissolve in the liquid).¹⁶⁶ Palatability and compliance may be increased if the entire next-day’s dose is mixed in one of these liquids in the evening and then refrigerated.¹²¹ Use of a heavy or pulpy fruit juice may minimize complaints about consistency of suspensions of the drug.^{135 136 166} If a carbonated beverage is used, mix the powder slowly in a large glass to minimize excessive foaming; however, use of a carbonated beverage as a vehicle may be associated with adverse GI effects.¹⁶⁶

Alternatively, mix colestipol powder with milk in hot or regular breakfast cereals, a highly fluid soup, or pulpy fruit (e.g., crushed pineapple, pears, peaches, fruit cocktail).¹⁶⁶

Dosage

Available as colestipol hydrochloride; expressed in terms of the salt.^{166 167}

One dose (1 packet or 1 level teaspoon) of colestipol hydrochloride granules contains 5 g of colestipol hydrochloride.¹⁶⁶ One dose (1 packet or 1 level scoop) of flavored colestipol hydrochloride granules contains 7.5 g of granules, which contains 5 g of colestipol hydrochloride.¹⁶⁶

Pediatric Patients

Dyslipidemias†

Oral

Pediatric dosage has not been established;^{100 166 167} however, dosages of 10–20 g or 500 mg/kg daily in 2–4 divided doses have been used.^{115 116 118 119} Lower dosages (e.g., 125–250 mg/kg daily) have also been used in some children when serum cholesterol concentrations were only 15–20% above normal after dietary management alone.¹¹⁷

Adults

Dyslipidemias

Oral (Tablets)

Initially, 2 g once or twice daily.¹⁶⁷ Increase dosage by 2 g once or twice daily at intervals of 1 or 2 months.¹⁶⁷ Usual daily dosage range is 2–16 g taken once or in divided doses.¹⁶⁷

If the desired therapeutic effect is not achieved with the usual dosage of 2–16 g daily with good compliance and acceptable adverse effects, consider combined therapy or alternative treatment.¹⁶⁷

If triglyceride concentrations increase markedly, consider reducing dosage, discontinuing therapy, or using combined or alternative treatment.¹⁶⁷

Oral (Granules for oral suspension)

Initially, 5 g (1 packet or 1 level scoop) once or twice daily.^{100 166} Titrate dose upward as necessary in 5-g increments at 1- or 2-month intervals.^{135 136 166} Usual daily dosage range is 5–30 g (1–6 packets or level scoops) taken once or in divided doses.^{100 166}

If the desired therapeutic effect is not achieved with the usual dosage of 1–6 doses per day with good compliance and acceptable adverse effects, consider combined therapy or alternative treatment.¹⁶⁶

If triglyceride concentrations increase markedly, consider reducing dosage, discontinuing therapy, or using combined or alternative treatment.¹⁶⁶

Patients with preexisting constipation receiving granules for oral suspension: Initially, 5 g once daily for 5–7 days; then increase dosage to 5 g twice daily and monitor constipation and serum lipoprotein values, at least twice, 4–6 weeks apart.¹⁶⁶ Thereafter, increase dosage as needed by 1 dose per day (at monthly intervals) with periodic monitoring of serum lipoprotein values;¹⁶⁶ adjust dosage accordingly to achieve the desired effect while avoiding excessive dosage.^{135 136} If constipation worsens or the desired effect is not achieved with acceptable adverse effects with the usual dosage of 1–6 doses per day, consider combined therapy or alternative treatment.^{135 136 166}

30 g daily (as granules for oral suspension) has been used in combination with niacin in adults with heterozygous familial hypercholesterolemia.^{111 112 113 114}

Cautions for Colestipol Hydrochloride

Contraindications

• 
  

  Known hypersensitivity to colestipol or any ingredient in the formulation.¹⁶⁶

  
  

Warnings/Precautions

Warnings

Administration

To avoid accidental inhalation or esophageal distress, do not administer colestipol hydrochloride for oral suspension in its dry form.¹⁶⁶ Always mix colestipol hydrochloride granules with water or other fluids before ingesting.¹⁶⁶ (See Administration under Dosage and Administration.)

Phenylketonuria

Individuals with phenylketonuria (i.e., homozygous genetic deficiency of phenylalanine hydroxylase) and other individuals who must restrict their intake of phenylalanine should be warned that Flavored Colestid granules for oral suspension contain aspartame (NutraSweet), which is metabolized in the GI tract following oral administration to provide 18.2 mg of phenylalanine per 7.5-g packet.¹⁶⁶

General Precautions

GI Effects

Mild and, occasionally, severe constipation has occurred.^{166 167} Exacerbation of preexisting constipation and aggravation of hemorrhoids secondary to constipation may occur.^{166 167} Encourage increased fluid and fiber intake to alleviate constipation;^{111 114 121 136 166 167 173} a stool softener can be added if necessary.^{135 136 166 167} In addition, adjust dosage carefully and titrate slowly to minimize adverse GI effects (e.g., fecal impaction).^{135 166 167} (See Dosage under Dosage and Administration.) Make particular effort to avoid constipation in patients with symptomatic CHD.^{166 167} Discontinuation of colestipol therapy may be required in some patients.^{166 167}

Difficulty swallowing and transient esophageal obstruction have been reported rarely.^{166 167} Patients with a history of swallowing difficulties or choking with food, liquids, or other tablets or capsules should consult a clinician before initiating therapy with colestipol hydrochloride tablets.¹⁶⁷ If abdominal pressure or discomfort (secondary to esophageal obstruction) occurs, advise patients to consult a clinician prior to administering the next dose.¹⁶⁷

Abdominal discomfort (including pain and cramping), belching, flatulence, indigestion, heartburn, nausea, vomiting, and diarrhea or loose stools also have been reported.^{166 167} Bleeding hemorrhoids and blood in the stool have been reported infrequently.^{166 167} Peptic ulceration, cholecystitis, and cholelithiasis have been reported occasionally but are not necessarily drug-related.^{166 167}

Fat-soluble Vitamin Deficiency

May interfere with the absorption of folic acid and fat-soluble vitamins (e.g., vitamins A, D, E, K).^{166 167} Prolonged use may be associated with an increased bleeding tendency as a result of hypoprothrombinemia secondary to vitamin K deficiency.^{166 167} (See Specific Drugs under Interactions.)

Hypothyroidism

Theoretical risk for the development of hypothyroidism, especially in patients with limited thyroid reserve.^{166 167}

Hyperchloremic Acidosis

Because colestipol is the chloride form of an anion-exchange resin, there is a possibility that prolonged use may lead to the development of hyperchloremic acidosis.^{135 166 167}

Specific Populations

Pregnancy

Category B.^c

Interferes with absorption of fat-soluble vitamins, which may be detrimental even in the presence of supplementation.^{166 167}

Lactation

Use with caution; possible lack of proper vitamin absorption associated with colestipol therapy may have an effect on nursing infants.^{166 167}

Pediatric Use

Safety and efficacy not established.^{166 167}

Common Adverse Effects

Constipation.^{166 167}

Interactions for Colestipol Hydrochloride

Effects on GI Absorption of Drugs

May bind to a number of drugs in the GI tract and may delay or reduce their absorption.^{166 167} Instruct patients to allow as long a time interval as possible between ingestion of other drugs and colestipol.^{166 167} The manufacturer recommends administering other drugs at least 1 hour before or 4 hours after colestipol.^{166 167}

Consider the possibility that discontinuance of colestipol in patients stabilized on potentially toxic drugs that bind to the resin may lead to toxicity and that administration of colestipol to patients stabilized on other drugs may reduce the effect of these drugs.^{166 167}

Specific Drugs

Drug	Interaction	Comments
Antidiabetic agents (sulfonylureas)	Decreased antilipemic effects of colestipold
β-adrenergic blocking agents (propranolol)	Decreases and/or delays GI absorption of propranolol;133 134 135 166 167 effect on absorption of other β-adrenergic blocking agents not fully determined134 135 166 167	Monitor closely whenever colestipol therapy is initiated or discontinued in patients receiving propranolol;133 135 166 167 adjust propranolol dosage as necessary133 134
Digoxin	Colestipol may bind digoxin in the GI tract and impair its absorption166 167
Diuretics, thiazide (e.g., hydrochlorothiazide, chlorothiazide)	Substantially decreased absorption of diuretic166 167	Decreases absorption of chlorothiazide even when administered 1 hour before colestipol hydrochloride166 167
Fat-soluble Vitamins (i.e., vitamins A, D, E, K)	Decreased absorption of fat-soluble vitamins166 167	Consider supplemental administration of vitamins A and D if colestipol is to be given for a prolonged period.d Bleeding secondary to vitamin K deficiency usually responds promptly to parenteral administration of phytonadione; recurrences can be prevented by oral administration of phytonadione166 167
Furosemide	Substantially decreased absorption of furosemide166 167
Gemfibrozil	Substantially decreased absorption of gemfibrozil166 167
Hydrocortisone	Possible interference with absorption of hydrocortisone166 167
Lovastatin	Possible additive antilipemic effects166 167
Niacin	Additive antilipemic effects166 167
Penicillin G	Substantially decreased absorption of penicillin G166 167
Phosphate supplements, oral	Possible interference with absorption of oral phosphate supplements166 167
Tetracycline	Substantially decreased absorption of tetracycline166 167

Colestipol Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Not absorbed from the GI tract.^{166 167}

Onset

Therapeutic response usually occurs within 1 month.^{166 167}

Elimination

Elimination Route

Binds to bile acids in the intestine and forms a nonabsorbable complex that is excreted in feces.^{166 167}

Stability

Storage

Oral

Tablets

20–25°C.^{166 167}

Granules for Suspension

20–25°C.¹⁰⁰

Actions and SpectrumActions

• 
  

  Binds to bile acids in the intestine and forms a nonabsorbable complex that is excreted in feces.^{166 167} Partial removal of bile acids from the enterohepatic circulation via this mechanism results in increased conversion of cholesterol to bile acids in the liver.^{166 167} This causes an increased demand for cholesterol in liver cells, resulting in a compensatory increase in hepatic uptake (and thus systemic clearance) of circulating LDL-cholesterol.^{166 167}

  
  


• 
  

  Reduces serum total and LDL-cholesterol concentrations.^{166 167} Serum triglyceride concentrations may increase or remain unchanged.^{166 167}

  
  


• 
  

  Antilipemic effects are additive when used with lovastatin or niacin.^{166 167}

  
  

Advice to Patients

• 
  

  Importance of adherence to prescribed directions for use.^{166 167} (See Oral Administration Under Dosage and Administration.)

  
  


• 
  

  Importance of adherence to National Cholesterol Education Program (NCEP)’s dietary recommendations.^{166 167}

  
  


• 
  

  Inform patients that colestipol hydrochloride tablets may be larger than typical tablets or capsules.¹⁶⁷ (See GI Effects under Cautions.)

  
  


• 
  

  Importance of administering other medications at least 1 hour before or 4 hours after colestipol.^{166 167}

  
  


• 
  

  For phenylketonurics, importance to inform them that Flavored Colestid granules for oral suspension contains aspartame.¹⁶⁶

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{166 167}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.^{166 167}

  
  


• 
  

  Importance of informing patients of other important precautionary information. (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Colestipol Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	For suspension	5 g/packet or calibrated scoop*	Colestid Granules	Pfizer
			Colestipol Hydrochloride for Oral Suspension	Global
		5 g/7.5 g packet or calibrated scoop	Colestid Flavored Granules (with aspartame)	Pfizer
	Tablets (micronized)	1 g	Colestid (with povidone)	Pfizer

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Colestid 1GM Tablets (PFIZER U.S.): 120/$106 or 360/$302.98

Colestid 5GM Granules (PFIZER U.S.): 500/$150.99 or 1500/$435.98

Colestid 5GM Packet (PFIZER U.S.): 30/$85.99 or 90/$239.96

Colestid 5GM Packet (PFIZER U.S.): 90/$213.33 or 270/$640

Colestid Flavored 5GM Granules (PFIZER U.S.): 450/$129.99 or 1350/$375.96

Colestid Flavored 5GM/7.5GM Packet (PFIZER U.S.): 60/$165.99 or 180/$496

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions May 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

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166. Upjohn. Colestid (colestipol hydrochloride for oral suspension) and Flavored Colestid (colestipol hydrochloride for oral suspension) granules for oral suspension prescribing information. Kalamazoo, MI; 1998 Mar.

167. Pfizer. Colestid (micronized colestipol hydrochloride) tablets prescribing information. New York, NY; 2006 Jun.

168. Gibbons RJ, Chatterjee K, Daley J et al. ACC/AHA/ACP-ASIM guidelines for the management of patients with chronic stable angina: a report of the American College of Cardiology, American Heart Association Task Force on Practice Guidelines (Committee on Management of Patients with Chronic Stable Angina). J Am Coll Cardiol. 1999; 33:2092-197. [IDIS 429504] [PubMed 10362225]

169. Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Survival Study (4S). Lancet. 1994; 344:1383-9. [IDIS 338582] [PubMed 7968073]

170. Sacks FN, Pfeffer MA, Maye LA et al. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. N Engl J Med. 1996; 335:1001-9. [IDIS 372985] [PubMed 8801446]

171. The Long-term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. N Engl J Med. 1998; 339:1349-57. [IDIS 430942] [PubMed 9841303]

172. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive summary of the third report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of high Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA. 2001; 285:2486-97. [IDIS 464555] [PubMed 11368702]

173. Anon. Choice of lipid-regulating drugs. Med Lett Drugs Ther. 2001; 43:43-8. [PubMed 11378632]

174. National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults: Adult Treatment Panel III Report. From AHA web site.

c. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 6th ed. Baltimore, MD: Williams & Wilkins; 2002:324-5.

d. AHFS Drug Information 2003. McEvoy GK , ed. Colestipol hydrochloride. Bethesda, MD: American Society of Health-System Pharmacists; 2003:1594-6.

More Colestipol Hydrochloride resources

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

• Colestipol Prescribing Information (FDA)


• Colestid Prescribing Information (FDA)


• Colestid Concise Consumer Information (Cerner Multum)


• Colestid Advanced Consumer (Micromedex) - Includes Dosage Information


• Colestid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Colestipol Hydrochloride with other medications

• Hyperlipoproteinemia
• Hyperlipoproteinemia Type IIa, Elevated LDL
• Hyperlipoproteinemia Type IIb, Elevated LDL VLDL

Cylert

Generic Name: pemoline (Oral route)

PEM-oh-leen

Oral route(Tablet;Tablet, Chewable)

Pemoline has been associated with life-threatening hepatic failure and should not ordinarily be considered as first line drug therapy for Attention Deficit Hyperactivity Disorder (ADHD). Treatment should be initiated only in individuals without liver disease and with normal baseline liver function tests. Monitor serum ALT (SGPT) levels at baseline, and every 2 weeks thereafter. Discontinue if serum ALT (SGPT) is increased to a clinically significant level, or any increase greater than or equal to 2 times the upper limit of normal, or if clinical signs and symptoms suggest liver failure. Obtain written informed consent from the patient prior to initiation of therapy .

Commonly used brand name(s)

In the U.S.

• Cylert

Available Dosage Forms:

• Tablet


• Tablet, Chewable

Therapeutic Class: CNS Stimulant

Chemical Class: Amphetamine Related

Uses For Cylert

Pemoline belongs to the group of medicines called central nervous system (CNS) stimulants. It is used to treat children with attention-deficit hyperactivity disorder (ADHD).

Pemoline increases attention and decreases restlessness in children who are overactive, cannot concentrate for very long or are easily distracted, and are emotionally unstable. This medicine is used as part of a total treatment program that also includes social, educational, and psychological treatment.

Rarely, pemoline has caused serious liver problems. You and your doctor should talk about the good this medicine will do as well as the risks of using it. In addition, you will be asked to sign an informed consent form stating that you understand and agree to accept the risk of liver problems.

This medicine is available only with your doctor's prescription.

Before Using Cylert

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Slowed growth rate in children who received medicines like pemoline for a long period of time has been reported. Some doctors recommend medicine-free periods during treatment with pemoline to help prevent slowed growth.

Pemoline may make behavior worse in children with serious mental illness.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Drug abuse or dependence (or history of)—Dependence on pemoline may develop.

• Gilles de la Tourette's syndrome or other tics or


• Liver disease or


• Mental illness (severe)—Pemoline may make the condition worse.

• Kidney disease—Higher blood levels of pemoline may occur, increasing the chance of side effects.

Proper Use of Cylert

For patients taking the chewable tablet form of this medicine:

• These tablets must be chewed before swallowing. Do not swallow whole.

Sometimes this medicine must be taken for 3 to 4 weeks before improvement is noticed.

Take pemoline only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral or chewable dosage forms (tablets):
  
  • Children 6 years of age and over—To start, 37.5 milligrams (mg) every morning. Your doctor may increase your dose if needed. However, the dose is usually not more than 112.5 mg a day.
  
  
  • Children up to 6 years of age—Use and dose must be determined by the doctor.
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Cylert

Your doctor should check your progress at regular visits to make sure that this medicine does not cause unwanted effects. In addition, you must have your blood tested every other week to see if this medicine is affecting your liver.

Dark urine or yellow eyes or skin may be a sign of a serious unwanted effect on your liver. Check with your doctor immediately if you develop dark urine or yellow eyes or skin.

This medicine may cause some people to become dizzy or less alert than they are normally. Make sure you know how you react to this medicine before you ride a bicycle or do anything else that could be dangerous if you are dizzy or are not alert.

If you have been using this medicine for a long time and you think you may have become mentally or physically dependent on it, check with your doctor. Some signs of dependence on pemoline are:

• a strong desire or need to continue taking the medicine.


• a need to increase the dose to receive the effects of the medicine.


• withdrawal side effects (for example, mental depression, unusual behavior, or unusual tiredness or weakness) occurring after the medicine is stopped.

If you take this medicine in large doses for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely.

Cylert Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Some side effects will have signs or symptoms that you can see or feel. Your doctor may watch for others by doing certain tests.

Pemoline may cause some serious side effects, including liver problems. Also, medicines like pemoline, when used for a long time, have been reported to slow the growth rate of children. Some doctors recommend medicine-free periods during treatment with pemoline. Pemoline may also cause unwanted effects on behavior in children with severe mental illness.

Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Dark urine


• yellow eyes or skin

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

• Convulsions (seizures)


• hallucinations (seeing, hearing, or feeling things that are not there)


• nausea and vomiting


• shortness of breath, troubled breathing, wheezing, or tightness in chest


• skin rash


• sores, ulcers, or white spots on lips or in mouth


• swollen or painful glands


• uncontrolled movements of eyes, tongue, lips, face, arms, or legs


• unusual bleeding or bruising


• unusual tiredness


• vocal sounds you cannot control

Symptoms of overdose

• Agitation


• confusion


• convulsions (seizures)—may be followed by coma


• false sense of well-being


• fast heartbeat


• hallucinations (seeing, hearing, or feeling things that are not there)


• headache (severe)


• high blood pressure


• high fever


• large pupils


• muscle trembling or twitching


• restlessness


• sweating


• vomiting

This medicine may also cause the following side effects that your doctor will watch for:

Rare

• Liver problems


• slow growth in children

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Loss of appetite


• trouble in sleeping


• weight loss

Less common

• Dizziness


• drowsiness


• headache


• increased irritability


• mental depression


• stomachache

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Abdominal pain


• convulsions (seizures)


• headache


• mental depression


• nausea


• unusual behavior


• unusual tiredness or weakness


• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Cylert side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Cylert resources

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

• Cylert Prescribing Information (FDA)


• Cylert Concise Consumer Information (Cerner Multum)

Compare Cylert with other medications

• ADHD
• Sexual Dysfunction, SSRI Induced

Casodex

Generic Name: bicalutamide (Oral route)

bye-ka-LOO-ta-mide

Commonly used brand name(s)

In the U.S.

• Casodex

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiandrogen

Uses For Casodex

Bicalutamide is used together with another medicine to treat stage D metastatic prostate cancer (cancer that has spread) in men. Bicalutamide belongs to the group of medicines called antiandrogens. It works by blocking the effects of testosterone (a male hormone), which helps stop the growth and spread of cancer cells. Bicalutamide will always be given together with a luteinizing hormone-releasing hormone (LHRH) analog (e.g., goserelin or leuprolide).

This medicine is available only with your doctor's prescription.

Before Using Casodex

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of bicalutamide in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bicalutamide in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol


• Dicumarol


• Phenprocoumon

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes or


• Liver disease (including hepatitis)—Use with caution. May make these conditions worse.

Proper Use of Casodex

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine usually comes with a patient information leaflet. Read it carefully and make sure you understand it before taking this medicine. If you have any questions, ask your doctor.

It is best to take this medicine at the same time each day. If you have been directed to take the medicine once a day, you may take it either in the morning or in the evening.

This medicine should be started at the same time as treatment with a luteinizing hormone-releasing hormone (LHRH) analog (such as goserelin, leuprolide, Lupron®, or Zoladex®). Do not stop taking these medicines without checking with your doctor first.

You may take this medicine with food or on an empty stomach.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  • For prostate cancer:
    
    • Adults—50 milligrams (mg) once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Casodex

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Women who are pregnant or may become pregnant should not use bicalutamide tablets. Bicalutamide may cause harm in unborn babies.

Liver problems may occur while you are taking this medicine. Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: clay-colored stools; dark urine; fever; headache; loss of appetite; nausea and vomiting; pain or tenderness in the upper right side of the stomach; unusual tiredness or weakness; or yellow eyes or skin.

This medicine may cause swelling of the breasts (gynecomastia) and breast pain in some patients. If you have questions about this, talk to your doctor.

Using this medicine with an LHRH analog may affect blood sugar levels. If you notice a change in the results of your blood sugar tests or if you have any questions, check with your doctor.

This medicine may affect the results of the prostate specific antigen (PSA) test, which may be used to detect prostate cancer. Make sure you tell all of your doctors that you are using this medicine.

If you plan to have children, talk with your doctor before using this medicine. This medicine may cause some men to become infertile (unable to have children), at least temporarily.

This medicine may make you sleepy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Casodex Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Bloating or swelling of the face, arms, hands, lower legs, or feet


• blood in the urine


• blurred vision


• body aches or pain


• congestion


• cough or hoarseness


• cough producing mucus


• difficult or labored breathing


• dizziness


• dryness or soreness of the throat


• fever or chills


• headache


• lower back or side pain


• nervousness


• painful or difficult urination


• pounding in the ears


• rapid weight gain


• runny nose


• shortness of breath


• slow or fast heartbeat


• sweating


• tender, swollen glands in the neck


• tightness in the chest


• tingling of the hands or feet


• trouble with swallowing


• unusual weight gain or loss


• voice changes


• wheezing

Less common

• Abnormal growth filled with fluid or semisolid material


• ankle, knee, or great toe joint pain


• arm, back, or jaw pain


• bleeding from the rectum or bloody stools


• blindness


• bloody nose


• burning while urinating


• burning, tingling, numbness, or pain in the hands, arms, feet, or legs


• change in bowel habits


• chest pain or discomfort


• chest tightness or heaviness


• chills


• confusion


• decrease in frequency of urination


• decrease in urine volume


• decreased vision


• difficulty in passing urine (dribbling)


• difficulty with swallowing or eating


• dilated neck veins


• dry mouth


• fainting


• fast or irregular heartbeat


• fever


• irregular breathing


• joint stiffness or swelling


• lightheadedness


• loss of appetite


• lump or swelling in the abdomen


• nausea


• no blood pressure or pulse


• noisy breathing


• pain in the neck


• pain or discomfort in the arms, jaw, back, or neck


• painful blisters on trunk of the body


• persistent non-healing sore


• rapid, shallow breathing


• reddish patch or irritated area


• sensation of pins and needles


• shiny bump


• stabbing pain


• stomach discomfort


• stopping of heart


• sunken eyes


• swelling of the face, fingers, feet, or lower legs


• thirst


• tumor


• unconsciousness


• unexplained weight loss


• unusual tiredness or weakness


• vomiting


• weight gain


• white, yellow or waxy scar-like area


• wrinkled skin


• yellow skin or eyes

Incidence not known

• Hives or welts


• itching


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• redness of the skin


• skin rash

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach


• belching


• breast pain


• constipation


• decreased interest in sexual intercourse


• diarrhea


• difficulty with moving


• dry skin


• hair loss or thinning of the hair


• heartburn


• inability to have or keep an erection


• indigestion


• lack or loss of strength


• leg cramps


• loss in sexual ability, desire, drive, or performance


• loss of strength or energy


• muscle aching or cramping


• muscle pain or weakness


• nervousness


• pain in the pelvis


• pain or tenderness around the eyes and cheekbones


• passing of gas


• sleepiness or unusual drowsiness


• stomach pain, fullness, or discomfort


• stuffy or runny nose


• swelling of the breasts or breast soreness in both females and males

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Casodex side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Casodex resources

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

• Casodex Prescribing Information (FDA)


• Casodex Consumer Overview


• Casodex Monograph (AHFS DI)


• Casodex MedFacts Consumer Leaflet (Wolters Kluwer)


• Bicalutamide Prescribing Information (FDA)


• Bicalutamide Professional Patient Advice (Wolters Kluwer)

Compare Casodex with other medications

• Prostate Cancer

Cardura

Generic Name: doxazosin (dox AY zo sin)

Brand Names: Cardura, Cardura XL

What is doxazosin?

Doxazosin is in a group of drugs called alpha-adrenergic (AL-fa ad-ren-ER-jik) blockers. Doxazosin relaxes your veins and arteries so that blood can more easily pass through them. It also relaxes the muscles in the prostate and bladder neck, making it easier to urinate.

Doxazosin is used to treat hypertension (high blood pressure), or to improve urination in men with benign prostatic hyperplasia (enlarged prostate).

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

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

You should not use this medication if you are allergic to doxazosin or similar medicines such as alfuzosin (Uroxatral), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), or terazosin (Hytrin). Doxazosin may cause dizziness or fainting, especially when you first start taking it or when you start taking it again. Be careful if you drive or do anything that requires you to be alert. Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. If you stop taking doxazosin for any reason, call your doctor before you start taking it again. You may need a dose adjustment.

Doxazosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using doxazosin before surgery unless your surgeon tells you to.

Tell your doctor about all other medications you use, especially other blood pressure medications including diuretics (water pills).

What should I discuss with my doctor before taking doxazosin?

You should not use this medication if you are allergic to doxazosin or similar medicines such as alfuzosin (Uroxatral), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), or terazosin (Hytrin).

If you have liver disease or a history of prostate cancer, you may need a dose adjustment or special tests to safely take doxazosin.

Doxazosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using doxazosin before surgery unless your surgeon tells you to.

FDA pregnancy category C. It is not known whether doxazosin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether doxazosin 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 doxazosin?

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.

Your doctor may occasionally change your dose to make sure you get the best results.

Doxazosin lowers blood pressure and may cause dizziness or fainting, especially when you first start taking it, or when you start taking it again. Call your doctor if you have severe dizziness or feel like you might pass out.

You may feel very dizzy when you first wake up. Be careful when standing or sitting up from a lying position.

If you stop taking doxazosin for any reason, call your doctor before you start taking it again. You may need a dose adjustment.

Your blood pressure or prostate will need to be checked often. Visit your doctor regularly.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Some things can cause your blood pressure to get too low. This includes vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Store at room temperature away from moisture and heat.

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.

If you miss your doses for several days in a row, contact your doctor before restarting the medication. You may need a lower dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include extreme dizziness or fainting.

What should I avoid while taking doxazosin?

Doxazosin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

To prevent dizziness, avoid standing for long periods of time or becoming overheated during exercise and in hot weather.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can increase certain side effects of doxazosin.

Doxazosin 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 a serious side effect such as:

• 
  

  feeling like you might pass out;

  
  


• 
  

  fast or pounding heartbeats, fluttering in your chest;

  
  


• 
  

  trouble breathing;

  
  


• 
  

  swelling in your hands, ankles, or feet; or

  
  


• 
  

  penis erection that is painful or lasts 4 hours or longer.

  
  

Less serious side effects may include:

• 
  

  mild dizziness;

  
  


• 
  

  tired feeling, drowsiness;

  
  


• 
  

  headache;

  
  


• 
  

  nausea; or

  
  


• 
  

  runny nose.

  
  

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 doxazosin?

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

• 
  

  sildenafil (Viagra, Revatio)

  
  


• 
  

  tadalafil (Cialis);

  
  


• 
  

  vardenafil (Levitra); or

  
  


• 
  

  other blood pressure medications, including diuretics (water pills).

  
  

This list is not complete and other drugs may interact with doxazosin. 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 Cardura resources

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

• Cardura Monograph (AHFS DI)


• Cardura Prescribing Information (FDA)


• Cardura Consumer Overview


• Cardura Advanced Consumer (Micromedex) - Includes Dosage Information


• Cardura MedFacts Consumer Leaflet (Wolters Kluwer)


• Doxazosin Prescribing Information (FDA)


• Cardura XL Prescribing Information (FDA)


• Cardura XL Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Cardura with other medications

• Benign Prostatic Hyperplasia
• High Blood Pressure
• Raynaud's Syndrome

Where can I get more information?

• Your pharmacist can provide more information about doxazosin.

See also: Cardura side effects (in more detail)

ConZip

Generic Name: tramadol (Oral route)

TRAM-a-dol

Commonly used brand name(s)

In the U.S.

• ConZip


• FusePaq Synapryn


• Rybix ODT


• Ryzolt


• Ultram


• Ultram ER

Available Dosage Forms:

• Capsule, Extended Release


• Tablet, Extended Release


• Tablet, Disintegrating


• Tablet


• Suspension

Therapeutic Class: Analgesic

Chemical Class: Opioid

Uses For ConZip

Tramadol is used to relieve moderate to moderately severe pain, including pain after surgery. The extended-release or long-acting tablets are used for chronic ongoing pain.

Tramadol belongs to the group of medicines called opioid analgesics. It acts in the central nervous system (CNS) to relieve pain. When tramadol is used for a long time, it may become habit-forming (causing mental or physical dependence). Physical dependence may lead to side effects when you stop taking the medicine.

This medicine is available only with your doctor's prescription.

Before Using ConZip

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Rybix™ ODT, Ryzolt™, and Ultram® tablets in children younger than 16 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Ultram® ER extended-release tablets in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tramadol in the elderly. However, elderly patients are more likely to have unwanted side effects (e.g., constipation; lightheadedness, dizziness, or fainting; stomach upset; weakness) and age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving tramadol.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rasagiline


• Selegiline

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetophenazine


• Amitriptyline


• Amoxapine


• Bromperidol


• Carbamazepine


• Chlorpromazine


• Chlorprothixene


• Citalopram


• Clobazam


• Clomipramine


• Clorgyline


• Clovoxamine


• Clozapine


• Cyclobenzaprine


• Desipramine


• Desvenlafaxine


• Dothiepin


• Doxepin


• Duloxetine


• Escitalopram


• Ethopropazine


• Femoxetine


• Fluoxetine


• Flupenthixol


• Fluphenazine


• Fluvoxamine


• Haloperidol


• Imipramine


• Isocarboxazid


• Ketamine


• Linezolid


• Lofepramine


• Loxapine


• Melperone


• Mesoridazine


• Methotrimeprazine


• Milnacipran


• Mirtazapine


• Moclobemide


• Molindone


• Nortriptyline


• Olanzapine


• Paroxetine


• Penfluridol


• Perphenazine


• Phenelzine


• Pimozide


• Pipotiazine


• Prochlorperazine


• Promazine


• Promethazine


• Propiomazine


• Protriptyline


• Remoxipride


• Risperidone


• Sertraline


• Sulpiride


• Tapentadol


• Thiethylperazine


• Thioridazine


• Thiothixene


• Tranylcypromine


• Trifluoperazine


• Triflupromazine


• Trimeprazine


• Trimipramine


• Venlafaxine


• Vilazodone


• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Digoxin


• Quinidine


• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, history of or


• CNS depression or


• Depression, history of or


• Drug abuse, history of or


• Head injury or


• Hormonal problems or


• Increased pressure in the head or


• Infections of the central nervous system (CNS) or


• Mental illness, history of or


• Phenylketone allergy, history of or


• Respiratory depression (hypoventilation or slow breathing) or


• Seizures or epilepsy, history of or


• Stomach problems, severe—Use with caution. The chance of serious side effects may be increased.

• Breathing or lung problems (e.g., asthma, hypercapnia), severe—Should not be used in patients with this condition.

• Kidney disease or


• Liver disease (including cirrhosis)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Phenylketonuria (PKU)—The orally disintegrating tablet contains phenylalanine, which can make this condition worse.

Proper Use of tramadol

This section provides information on the proper use of a number of products that contain tramadol. It may not be specific to ConZip. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

If you think that this medicine is not working as well after you have been taking it for a few weeks, do not increase the dose. Instead, check with your doctor.

If you are using the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Do not break, crush, or chew it. Place the tablet in your mouth. It should melt quickly. After the tablet has melted, swallow or take a sip of water.

Swallow the extended-release tablets whole with liquids. Do not break, crush, or chew it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For chronic pain:
  
  • For oral dosage form (extended-release tablets):
    
    • Adults—At first, 100 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 300 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Adults and teenagers 16 years of age and older—At first, 50 to 100 milligrams (mg) every four to six hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 400 mg per day.
    
    
    • Children younger than 16 years of age—Use and dose must be determined by your doctor.
    
    
  
  

• For moderate to severe pain:
  
  • For oral dosage form (disintegrating tablets):
    
    • Adults and teenagers 16 years of age and older—At first, 50 to 100 milligrams (mg) every four to six hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 400 mg per day.
    
    
    • Children younger than 16 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Adults and teenagers 16 years of age and older—At first, 25 milligrams (mg) per day, taken every morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 400 mg per day.
    
    
    • Children younger than 16 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using ConZip

It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly and to check for any unwanted effects.

This medicine will add to the effects of alcohol and other CNS depressants (medicine that makes you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Do not drink alcoholic beverages, and check with your doctor or dentist before taking any of these medicines while you are using this medicine.

Make sure your doctor knows about all the other medicines you are using. This medicine may increase your risk for seizures. (convulsions) and may cause a serious condition called serotonin syndrome.

This medicine can increase thoughts of suicide. Tell your doctor right away if you start to feel more depressed or have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure your caregiver knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Tell your doctor if you have any sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let your doctor know if you or anyone in your family has bipolar disorder (manic-depressive disorder) or has tried to commit suicide.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; swelling of your hands, face, or mouth; or chest pain while you are using this medicine.

This medicine may cause some people to become drowsy, dizzy, lightheaded, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Make sure your doctor knows if you are pregnant, may be pregnant, or planning to become pregnant.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.

Nausea or vomiting may occur, especially after the first couple of doses. This effect may go away if you lie down for awhile. However, if nausea or vomiting continues, check with your doctor. Lying down for a while may also help relieve some other side effects, such as dizziness or lightheadedness that may occur.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the doctor or dentist in charge that you are taking this medicine. Taking tramadol together with medicines that are used during surgery or dental or emergency treatments may cause increased side effects.

If you think you or someone else may have taken an overdose of tramadol, get emergency help at once. Signs of an overdose include convulsions (seizures); difficult or troubled breathing; irregular, fast or slow, or shallow breathing; pale or blue lips, fingernails, or skin; pinpoint pupils of the eyes, or shortness of breath.

Do not stop suddenly taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms such as anxiety, diarrhea, headache, nausea, shivering, sweating, tremors, or trouble with sleeping.

ConZip Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common or rare

• Abdominal or stomach fullness


• abnormal or decreased touch sensation


• blisters under the skin


• bloating


• blood in the urine


• blood pressure increased


• blurred vision


• change in walking and balance


• chest pain or discomfort


• chills


• convulsions (seizures)


• darkened urine


• difficult urination


• dizziness or lightheadedness when getting up from a lying or sitting position


• fainting


• fast heartbeat


• frequent urge to urinate


• gaseous abdominal or stomach pain


• heart rate increased


• indigestion


• irregular heartbeat


• loss of memory


• numbness and tingling of the face, fingers, or toes


• numbness, tingling, pain, or weakness in the hands or feet


• pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion


• pain or discomfort in the arms, jaw, back, or neck


• pains in the stomach, side, or abdomen, possibly radiating to the back


• pale bluish-colored or cold hands or feet


• recurrent fever


• seeing, hearing, or feeling things that are not there


• severe cramping


• severe nausea


• severe redness, swelling, and itching of the skin


• shortness of breath


• sweats


• trembling and shaking of the hands or feet


• trouble performing routine tasks


• weak or absent pulses in the legs


• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Change in consciousness


• decreased awareness or responsiveness


• difficulty with breathing


• lack of muscle tone


• lightheadedness


• loss of consciousness


• pinpointed pupils of the eyes


• severe sleepiness


• shortness of breath


• slow or irregular heartbeat


• unusual tiredness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach pain


• agitation


• anxiety


• constipation


• cough


• diarrhea


• discouragement


• drowsiness


• dry mouth


• feeling of warmth


• feeling sad or empty


• feeling unusually cold


• fever


• general feeling of discomfort or illness


• headache


• heartburn


• irritability


• itching of the skin


• joint pain


• loss of appetite


• loss of interest or pleasure


• loss of strength or weakness


• muscle aches and pains


• nausea


• nervousness


• redness of the face, neck, arms, and occasionally, upper chest


• restlessness


• runny nose


• shivering


• skin rash


• sleepiness or unusual drowsiness


• sore throat


• stuffy nose


• sweating


• tiredness


• trouble concentrating


• unusual feeling of excitement


• weakness

Less common or rare

• Abnormal dreams


• appetite decreased


• back pain


• bladder pain


• blistering, crusting, irritation, itching, or reddening of the skin


• bloody or cloudy urine


• body aches or pain


• change in hearing


• clamminess


• cold flu-like symptoms


• confusion


• cough producing mucus


• cracked, dry, or scaly skin


• decreased interest in sexual intercourse


• difficult, burning, or painful urination


• difficulty with moving


• disturbance in attention


• ear congestion


• ear drainage


• earache or pain in ear


• excessive gas


• fall


• false or unusual sense of well-being


• feeling hot


• feeling jittery


• flushing or redness of the skin


• general feeling of bodily discomfort


• goosebumps


• headache, severe and throbbing


• hoarseness


• hot flashes


• inability to have or keep an erection


• itching, pain, redness, swelling, tenderness, or warmth on the skin


• joint sprain


• joint stiffness


• joint swelling


• loss in sexual ability, desire, drive, or performance


• loss of voice


• lower back or side pain


• muscle aching or cramping


• muscle injury


• muscle pain or stiffness


• muscle spasms or twitching


• nasal congestion


• neck pain


• night sweats


• pain


• pain in the limbs


• pain or tenderness around the eyes and cheekbones


• pain, swelling, or redness in the joints


• skin discoloration


• swelling


• swelling of the hands, ankles, feet, or lower legs


• tightness of the chest


• trouble in holding or releasing urine


• trouble with sleeping


• troubled breathing


• weight increased or decreased

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Gooseflesh


• high blood pressure


• increased sweating


• increased yawning


• shivering or trembling


• unusually large pupils

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: ConZip side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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More ConZip resources

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

• ConZip Prescribing Information (FDA)


• ConZip Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Rybix ODT Prescribing Information (FDA)


• Rybix ODT Orally Disintegrating Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Ryzolt Prescribing Information (FDA)


• Ryzolt Consumer Overview


• Ryzolt Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Tramadol MedFacts Consumer Leaflet (Wolters Kluwer)


• Tramadol Hydrochloride Monograph (AHFS DI)


• Ultram Prescribing Information (FDA)


• Ultram Consumer Overview


• Ultram ER Prescribing Information (FDA)

Compare ConZip with other medications

• Back Pain
• Pain