BPO 6 Foaming Cloths

Generic Name: benzoyl peroxide

Dosage Form: cloth
BPO 6% Foaming Cloths

DESCRIPTION: BPO 3% and 6% Foaming Cloths are topical preparations containing benzoyl peroxide for use in the treatment of acne vulgaris. Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. Benzoyl peroxide (C14H10O4) is represented by the following chemical structure:

BPO 3% and 6% Foaming Cloths contain, respectively, benzoyl peroxide 3% and 6% as the active ingredient in a cream vehicle containing: cetostearyl alcohol, hydrogenated castor oil, cocamidopropyl betaine, PEG-14M, methyl paraben, mineral oil, purified water, sodium lauryl sulfate, potassium choride, glycolic acid, imidurea, sodium PCA liquid, cornstarch, titanium dioxide, sodium hydroxide, glycerine, dimethyl isosorbide.

CLINICAL PHARMACOLOGY: The mechanism of action of benzoyl peroxide is not totally understood but its antibacterial activity against Propionibacterium acnes is thought to be a major mode of action. In addition, patients treated with benzoyl peroxide show a reduction in lipids and free fatty acids, and mild desquamation (drying and peeling activity) with simultaneous reduction in comedones and acne lesions. Little is known about the percutaneous penetration, metabolism, and excretion of benzoyl peroxide, although it has been shown that benzoyl peroxide absorbed by the skin is metabolized to benzoic acid and then excreted as benzoate in the urine. There is no evidence of systemic toxicity caused by benzoyl peroxide in humans.

INDICATIONS: BPO 3% and 6% Foaming Cloths are indicated for the topical treatment of acne vulgaris.

CONTRAINDICATIONS: These preparations are contraindicated in patients with a history of hypersensitivity to any of their components.

WARNINGS: When using this product, avoid unnecessary sun exposure and use a sunscreen.  FOR EXTERNAL USE ONLY. Keep away from eyes. Keep container tightly closed.

Keep out of reach of children.

PRECAUTIONS: General - For external use only. If severe irritation develops, discontinue use and institute appropriate therapy. After reaction clears, treatment may often be resumed with less frequent application. These preparations should not be used in or near the eyes or on mucous membranes.

Information for patients - Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. Contact with any colored material (including hair and fabric) may result in bleaching or discoloration. If excessive irritation develops, discontinue use and consult your physician.

Carcinogenesis, Mutagenesis, Impairment of Fertility - Data from several studies employing a strain of mice that are highly susceptible to developing cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of these findings to humans is unknown. Benzoyl peroxide has not been found to be mutagenic (Ames Test) and there are no published data indicating it impairs fertility.

PREGNANCY: Teratogenic Effects - Pregnancy Category C. - Animal reproduction studies have not been conducted with benzoyl peroxide. It is not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzoyl peroxide should be used by a pregnant woman only if clearly needed. There are no available data on the effect of benzoyl peroxide on the later growth, development and functional maturation of the unborn child.

NURSING MOTHERS: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when benzoyl peroxide is administered to a nursing woman.

PEDIATRIC USE: Safety and effectiveness in children have not been established.

ADVERSE REACTIONS:Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.

OVERDOSAGE: If excessive scaling, erythema or edema occurs, the use of these preparations should be discontinued. To hasten resolution of the adverse effects, cool compresses may be used. After symptoms and signs subside, a reduced dosage schedule may be cautiously tried if the reaction is judged to be due to excessive use and not allergenicity.

DOSAGE AND ADMINISTRATION: Wash affected areas once or twice daily, or as directed by your physician. Wet face with water. Wet cloth with a little water and work into a full lather. Cleanse face with cloth for 10–20 seconds. Avoid eyes or mucous membranes. Rinse thoroughly and pat dry.

If drying occurs, it may be controlled by rinsing sooner or using less often. Throw away cloth. Do not flush.

HOW SUPPLIED: BPO 3% Foaming Cloths are available in boxes of 60 cloths (3.2g), (NDC 42192-124-60).

BPO 6% Foaming Cloths are available in boxes of 60 cloths (3.2g), (NDC 42192-125-60).

Store at controlled room temperature, 15° - 25°C (59° - 77°F).

All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein.

MANUFACTURED FOR: Acella Pharmaceuticals, LLC

9005 Westside Parkway

Alpharetta, GA 30009

1 - 800 - 541 - 4802                                              Rev. 0610

NDC 42192-125-60


BPO 6% Foaming Cloths


Rx only


Net weight 3.2 g each


Acella

Pharmaceuticals, LLC


Contents: benzoyl peroxide USP 6% as an active ingredient in a cream vehicle containing cetostearyl alcohol, hydrogenated castor oil, cocamidopropyl betaine, PEG-14M, methyl paraben, mineral oil, purified water, sodium lauryl sulfate, potassium choride, glycolic acid, imidurea, sodium PCA liquid, cornstarch, titanium dioxide, sodium hydroxide, glycerine, dimethyl isosorbide.


Directions: Wash affecte areas with BPO 6% Foaming cloths once or twice daily, or as directed by your physician.

1. Wet face with water.

2. Wet cloth with a little water and work into a full lather.

3. Cleanse face wuth cloth for 10 - 20 seconds, avoiding eyes and mucous membrances.

4. Rinse thoroughly and pat dry.

5. Discard cloth. Do not flush.

If drying occurs, It may be controlled by rinsing cleanser off sooner or using less often.


Precautions: See Package insert for complete Precautions and Prescribing information. For external use only. Avoid contat with eyes, eyelids, lips ad mucous membranes. If accidental contact occurs, rinse with water, Contact with any colored material (Including hair and fabric) may result in bleaching or discoloration. If excessive irritation develops, discontinue use and consult your physician.


Warnings: KEEP OUT OF REACH OF CHILDREN. When using this product, avoid unnecessary sun exposure and use a sunscreen.

Store at 15 Degree centigrade - 25 Degree C (59 Degree centigrade - 77 Degree F).


All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. NOTE: This is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. No representation is made as to generic status or bioequivalency. Please see package insert for more information.


MANUFACTURED FOR:

Acella Pharmaceuticals, LLC

Alpharetta, GA 30009

1-800-541-4802

Rx Only


60 foaming cloths - Net weight 3.2 g each


Acella

Pharmaceuticals, LLC


NDC 42192-125-60


BPO 6% Foaming Cloths


Contents: benzoyl peroxide USP 6% as an active ingredient in a cream vehicle containing cetostearyl alcohol, hydrogenated castor oil, cocamidopropyl betaine, PEG-14M, methyl paraben, mineral oil, purified water, sodium lauryl sulfate, potassium choride, glycolic acid, imidurea, sodium PCA liquid, cornstarch, titanium dioxide, sodium hydroxide, glycerine, dimethyl isosorbide.


Directions: Wash affecte areas with BPO 6% Foaming cloths once or twice daily, or as directed by your physician.

1. Wet face with water.

2. Wet cloth with a little water and work into a full lather.

3. Cleanse face wuth cloth for 10 - 20 seconds, avoiding eyes and mucous membrances.

4. Rinse thoroughly and pat dry.

5. Discard cloth. Do not flush.

If drying occurs, It may be controlled by rinsing cleanser off sooner or using less often.


Precautions: See Package insert for complete Precautions and Prescribing information. For external use only. Avoid contat with eyes, eyelids, lips ad mucous membranes. If accidental contact occurs, rinse with water, Contact with any colored material (Including hair and fabric) may result in bleaching or discoloration. If excessive irritation develops, discontinue use and consult your physician.


Warnings: KEEP OUT OF REACH OF CHILDREN. When using this product, avoid unnecessary sun exposure and use a sunscreen.

Store at 15 Degree centigrade - 25 Degree C (59 Degree centigrade - 77 Degree F).

NDC 42192-125-60


BPO 6% Foaming Cloths


Rx Only


60 foaming cloths - Net weight 3.2 g each


Acella

Pharmaceuticals, LLC


All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable.

NOTE: This is not an Orange Book product. No representation is made as to generic status or bioequivalency. Please see package insert for more information.


MANUFACTURED FOR:

Acella Pharmaceuticals, LLC

9005 Westside Parkway

Alpharetta, GA 30009

1-800-541-4802

Rev.0510v1

BPO 6 FOAMING  benzoyl peroxide  cloth

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 42192-125 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 3.2 g  in 100 g

Inactive Ingredients Ingredient Name Strength CETOSTEARYL ALCOHOL   HYDROGENATED CASTOR OIL   COCAMIDOPROPYL BETAINE   METHYLPARABEN   MINERAL OIL   WATER   SODIUM LAURYL SULFATE   GLYCOLIC ACID   IMIDUREA   TITANIUM DIOXIDE   SODIUM HYDROXIDE   DIMETHYL ISOSORBIDE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 42192-125-60 60 PACKET In 1 CARTON contains a PACKET 1 3.2 g In 1 PACKET This package is contained within the CARTON (42192-125-60)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/18/2010

Labeler - Acella Pharmaceuticals, LLC (825380939)

Revised: 12/2010Acella Pharmaceuticals, LLC

More BPO 6 Foaming Cloths resources

• BPO 6 Foaming Cloths Side Effects (in more detail)
• BPO 6 Foaming Cloths Use in Pregnancy & Breastfeeding
• BPO 6 Foaming Cloths Drug Interactions
• 0 Reviews for BPO 6ing Cloths - Add your own review/rating

Compare BPO 6 Foaming Cloths with other medications

• Acne
• Perioral Dermatitis

boceprevir

Generic Name: boceprevir (boe SEP re vir)

Brand Names: Victrelis

What is boceprevir?

Boceprevir is an antiviral medication that prevents certain virus cells from multiplying in your body.

Boceprevir is used in combination with peginterferon alfa (Pegasys, PegIntron) and ribavirin (Copegus, Rebetol, Ribasphere, RibaTab) to treat hepatitis C in adults.

Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor's advice. Every person with hepatitis C should remain under the care of a doctor.

Boceprevir is usually given to people who have never been treated for hepatitis C, or after interferon and ribavirin have been tried without successful treatment of symptoms.

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

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

Do not take boceprevir as your only medication to treat hepatitis C. Boceprevir must be used in combination with peginterferon alfa (Pegasys, PegIntron) and ribavirin (Copegus, Rebetol, Ribasphere, RibaTab). Read the medication guide or patient instructions provided with each medication in your combination therapy. Do not change your doses or medication schedule without your doctor's advice. Every person with hepatitis C should remain under the care of a doctor. Boceprevir is given together with interferon alfa and ribavirin. Ribavirin can cause birth defects or death in an unborn baby. Do not use this combination of drugs if you are pregnant, or if you are a man and your sexual partner is pregnant. Use at least 2 effective forms of birth control while either sexual partner is using interferon alfa and ribavirin. Keep using 2 forms of birth control for at least 6 months after treatment ends. The following drugs should not be used while you are taking boceprevir: alfuzosin (Uroxatral), cisapride (Propulsid), drospirenone (Angeliq, Beyaz, Safyral, Yasmin, Yaz), pimozide (Orap), lovastatin (Mevacor, Altoprev, Advicor) or simvastatin (Zocor, Simcor, Vytorin), midazolam (Versed), triazolam (Halcion), sildenafil or tadalafil when used to treat pulmonary arterial hypertension (Revatio, Adcirca), St. John's wort, rifampin (Rifadin, Rifater, Rifamate), ergonovine, ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), methylergonovine (Methergine), or the seizure medications carbamazepine (Carbatrol, Equetro, Tegretol), phenobarbital (Solfoton), or phenytoin (Dilantin).

There are many other drugs that can interact with boceprevir. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you.

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

You should not use boceprevir if you are allergic to it.

To make sure you can safely take boceprevir, tell your doctor if you have hepatitis B or cirrhosis of the liver.

There are many other drugs that can cause serious or life threatening medical problems if you take them together with boceprevir. The following drugs should not be used while you are taking boceprevir:

• 
  

  alfuzosin (Uroxatral);

  
  


• 
  

  cisapride (Propulsid);

  
  


• 
  

  drospirenone (Angeliq, Beyaz, Safyral, Yasmin, Yaz);

  
  


• 
  

  pimozide (Orap);

  
  


• 
  

  lovastatin (Mevacor, Altoprev, Advicor) or simvastatin (Zocor, Simcor, Vytorin);

  
  


• 
  

  midazolam (Versed) or triazolam (Halcion);

  
  


• 
  

  sildenafil (Revatio) or tadalafil (Adcirca) when used to treat pulmonary arterial hypertension;

  
  


• 
  

  St. John's wort;

  
  


• 
  

  the seizure medications carbamazepine (Carbatrol, Equetro, Tegretol), phenobarbital (Solfoton), phenytoin (Dilantin);

  
  


• 
  

  rifampin (Rifadin, Rifater, Rifamate); or

  
  


• 
  

  ergonovine, ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).

  
  

FDA pregnancy category X. Boceprevir is given together with interferon alfa and ribavirin. Although boceprevir is not expected to harm an unborn baby, ribavirin is known to cause birth defects or death in an unborn baby. Do not use this combination of drugs if you are pregnant, or if you are a man and your sexual partner is pregnant. If you are a woman, you may need to have a negative pregnancy test before using these medications and every month during your treatment.

• 
  

  Use at least 2 non-hormonal forms of birth control while either sexual partner is using boceprevir with interferon alfa and ribavirin. Keep using 2 forms of birth control for at least 6 months after treatment ends.

  
  


• 
  

  If you are a woman, do not use boceprevir with interferon alfa and ribavirin if you are pregnant.

  
  


• 
  

  If you are a man, do not use boceprevir with interferon alfa and ribavirin if your sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin.

  
  


• 
  

  Hormonal contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment. Ask your doctor about using a non-hormone method of birth control (such as a condom, intrauterine device (IUD), diaphragm with spermicide) to prevent pregnancy while taking boceprevir.

  
  


• 
  

  Tell your doctor right away if a pregnancy occurs while either the mother or the father is using boceprevir with interferon alfa and ribavirin.

  
  

It is not known whether boceprevir passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using boceprevir.

How should I take boceprevir?

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.

Do not take boceprevir as your only medication to treat hepatitis C. Boceprevir must be used in combination with peginterferon alfa and ribavirin. Your disease may become resistant to boceprevir if you do not take it in combination with other medicines your doctor has prescribed. Take boceprevir with food. The usual dose of boceprevir is 4 capsules taken 3 times per day, every 7 to 9 hours. Follow your doctor's instructions.

Your total daily dose of 12 capsules is contained in a single bottle of boceprevir. A carton of boceprevir contains 28 bottles for a 4-week supply.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Visit your doctor regularly. Store boceprevir capsules in the refrigerator, do not freeze. Throw away any unused capsules after the expiration date on the label has passed. You may also store the capsules at room temperature for up to 3 months. Protect the capsules from heat.

See also: Boceprevir dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 2 hours away. 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.

What should I avoid while taking boceprevir?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Boceprevir side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using boceprevir and call your doctor at once if you have a serious side effect such as:

• 
  

  pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

  
  


• 
  

  fever, chills, body aches, flu symptoms, sores in your mouth and throat.

  
  

Less serious side effects may include:

• 
  

  feeling weak, tired, or irritable;

  
  


• 
  

  headache, dizziness;

  
  


• 
  

  nausea, vomiting, loss of appetite;

  
  


• 
  

  diarrhea;

  
  


• 
  

  dry skin, hair loss;

  
  


• 
  

  altered sense of taste;

  
  


• 
  

  joint pain;

  
  


• 
  

  sleep problems (insomnia); or

  
  


• 
  

  mild skin rash.

  
  

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.

Boceprevir Dosing Information

Usual Adult Dose for Chronic Hepatitis C:

800 mg orally three times daily with food.

What other drugs will affect boceprevir?

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

• 
  

  an antibiotic;

  
  


• 
  

  an antidepressant;

  
  


• 
  

  an antifungal medication;

  
  


• 
  

  anti-malaria drugs;

  
  


• 
  

  anti-psychotic medication;

  
  


• 
  

  asthma or allergy medication (including inhaled steroids);

  
  


• 
  

  birth control or hormone replacement therapy that contains estrogen or progesterone;

  
  


• 
  

  a blood thinner or medicine to prevent blood clots;

  
  


• 
  

  cancer medicine;

  
  


• 
  

  cholesterol-lowering drugs;

  
  


• 
  

  cold or allergy medicine that contains an antihistamine;

  
  


• 
  

  gout medication;

  
  


• 
  

  heart or blood pressure medication;

  
  


• 
  

  heart rhythm medication;

  
  


• 
  

  HIV/AIDS medications;

  
  


• 
  

  medicines used to prevent organ transplant rejection;

  
  


• 
  

  narcotic medication;

  
  


• 
  

  oral diabetes medication;

  
  


• 
  

  a sedative (Valium, Xanax, BuSpar, and others);

  
  


• 
  

  seizure medication; or

  
  


• 
  

  stomach acid reducers (Prevacid, Zofran, and others).

  
  

This list is not complete and there are many other drugs that can interact with boceprevir. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More boceprevir resources

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

• boceprevir Advanced Consumer (Micromedex) - Includes Dosage Information


• Boceprevir Professional Patient Advice (Wolters Kluwer)


• Boceprevir MedFacts Consumer Leaflet (Wolters Kluwer)


• Victrelis Prescribing Information (FDA)


• Victrelis Consumer Overview

Compare boceprevir with other medications

• Hepatitis C

Where can I get more information?

• Your pharmacist can provide more information about boceprevir.

See also: boceprevir side effects (in more detail)

Bontril

Generic Name: Phendimetrazine Tartrate
Class: Anorexigenic Agents and Respiratory and Cerebral Stimulants, Miscellaneous
VA Class: GA751
CAS Number: 50-58-8

Introduction

Amphetamine congener;^c anorexigenic agent.^{a b c d f}

Uses for Bontril

Exogenous Obesity

Adjunct to caloric restriction in the short-term management (a few weeks) of exogenous obesity.^{a b c d f}

Use only for short-term monotherapy; not for use in combination with any other drug for weight loss.^{100 120 d}

Bontril Dosage and Administration

General

• 
  

  Teach patient to curtail overeating and consume a suitable diet to help induce and maintain weight loss.^c

  
  

Administration

Oral Administration

Administer conventional tablets orally 2 or 3 times daily, 1 hour before meals.^{b c f}

Administer extended-release capsules orally once daily, 30–60 minutes before the morning meal.^{a c d}

Dosage

Available as phendimetrazine tartrate; dosage expressed in terms of the salt.^{b d f}

Pediatric Patients

Exogenous Obesity

Conventional Tablets

Oral

Children ≥12 years of age: 35 mg 2 or 3 times daily, given 1 hour before meals.^b A dosage of 17.5 mg 2 or 3 times daily may be adequate for some patients.^b

Extended-release Capsules

Oral

Children ≥12 years of age: 105 mg once daily, given 30–60 minutes before the morning meal.^a

Adults

Exogenous Obesity

Conventional Tablets

Oral

35 mg 2 or 3 times daily, given 1 hour before meals.^{b c f} A dosage of 17.5 mg 2 or 3 times daily may be adequate for some patients.^{b f}

Extended-release Capsules

Oral

105 mg once daily, given 30–60 minutes before the morning meal.^{a c d}

Prescribing Limits

Pediatric Patients

Exogenous Obesity

Oral

Children ≥12 years of age: Maximum 70 mg 3 times daily (as conventional tablets).^b

Children ≥12 years of age: Maximum 105 mg once daily (as extended-release capsules).^d

Adults

Exogenous Obesity

Oral

Maximum 70 mg 3 times daily (as conventional tablets).^{b c f}

Maximum 105 mg once daily (as extended-release capsules).^d

Cautions for Bontril

Contraindications

• 
  

  Symptomatic cardiovascular disease, hyperthyroidism, moderate to severe hypertension, pulmonary hypertension, glaucoma, or advanced arteriosclerosis.^{a b c d f}

  
  


• 
  

  Highly nervous or agitated state or history of drug abuse.^{a b c d f}

  
  


• 
  

  Concurrent therapy with other CNS stimulants^{a b c d f} or anorexigenic drugs.^d

  
  


• 
  

  Within 14 days of MAO inhibitor therapy.^c

  
  


• 
  

  Known hypersensitivity or idiosyncrasy to sympathomimetic amines.^{a b c d f}

  
  

Warnings/Precautions

Warnings

Primary Pulmonary Hypertension

Risk of primary pulmonary hypertension (frequently fatal), particularly when used in combination with at least one other anorexigenic agent, or in those with a history of receiving at least one other anorexigenic agent.^{100 d} Risk increased by 23-fold when anorexigenic agents are used for >3 months.^d Increased risk following repeated courses of phendimetrazine cannot be ruled out.^d

Discontinue immediately if new-onset or exacerbation of exertional dyspnea or unexplained symptoms of angina, syncope, or edema of the lower extremities occur, and evaluate for possible pulmonary hypertension.^d

Valvular Heart Disease

Valvular heart disease reported following use of some anorexigenic agents (e.g., fenfluramine, dexfenfluramine [both no longer commercially available in the US]), particularly when used for extended periods of time, at higher than recommended dosages, and/or in combination with other anorexigenic agents.^d

Abnormal heart valve findings have been reported in some patients receiving phendimetrazine.^{c 100 120} Weigh potential risks against benefits of therapy.^d

Consider performing baseline cardiac evaluation to detect preexisting valvular heart diseases prior to initiation of therapy.^d Use not recommended in patients with known heart murmur or valvular heart disease.^d Echocardiogram during and after treatment may be useful for detecting any valvular disorders that may occur.^d

To limit unwarranted exposure and risks, continue therapy only if patient has achieved satisfactory weight loss (e.g., ≥4 pounds [1.8 kg], or as determined by physician and patient) within first 4 weeks of therapy.^d

Tolerance to Anorexigenic Effect

Tolerance to anorexigenic effect usually develops within a few weeks.^{a b d f} When it does, discontinue therapy; do not attempt to increase effect by exceeding recommended dosage.^{a b d f}

CNS Effects

Performance of activities requiring mental alertness or physical coordination may be impaired.^{a b c d f} (See Advice to Patients.)

Abuse Potential

Potential for abuse; habituation or addiction reported with phendimetrazine^c and similar drugs (e.g., amphetamines).^{a b d f}

Manifestations of chronic intoxication may include psychosis resembling schizophrenia, severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes.^{a b d f}

Abrupt discontinuance following prolonged high dosage may result in extreme fatigue, depression, and sleep EEG changes.^{a b d f}

Sensitivity Reactions

Tartrazine Sensitivity

Some preparations (e.g., 35-mg conventional tablets manufactured by Sandoz) contain tartrazine (FD&C yellow No. 5), which may cause allergic reactions including bronchial asthma in susceptible individuals.^f Incidence of tartrazine sensitivity is low, but it frequently occurs in patients who are sensitive to aspirin.^f

General Precautions

Prescribe and dispense in the smallest feasible quantity to minimize possibility of overdosage.^{a b d f}

Hypertension

Use with caution in patients with mild hypertension;^{a b c d f} monitor BP closely.^c Contraindicated in those with moderate or severe hypertension.^{a b c d f}

Diabetes Mellitus

Use with caution in patients with diabetes mellitus; insulin requirements may decrease in association with phendimetrazine use and the concomitant dietary regimen and weight loss.^c

Specific Populations

Pregnancy

Category C.^{d e}

Whether potential benefits of anorexigenic agents outweigh risks is questionable; use of these agents during pregnancy (especially during the first trimester) probably should be considered a contraindication.^c

Lactation

Not known whether phendimetrazine is distributed into milk;^d however, because of its low molecular weight, the drug is expected to distribute into milk.^e Caution if used in nursing women.^d

Pediatric Use

Use not recommended in children <12 years of age.^{a b c f}

Common Adverse Effects

Palpitation, tachycardia, increased BP, overstimulation, restlessness, dizziness, insomnia, agitation, flushing, tremor, sweating, headache, psychosis, blurred vision, dry mouth, diarrhea, constipation, nausea, stomach pain, changes in libido, urinary frequency, dysuria.^{a b c d f}

Interactions for Bontril

Specific Drugs

Drug	Interaction	Comments
Anorexigenic agents	Risk of serious cardiac problemsd	Avoid concomitant use (including with OTC drugs or herbal preparations) (see Contraindications under Cautions); phendimetrazine not recommended for patients who used any anorexigenic agents within prior yeard
CNS stimulants		Concomitant use contraindicateda b d f
Guanethidine (no longer commercially available in the US)	Decreased hypotensive effecta b c d
Insulin	Possible decrease in insulin requirements in patients with diabetes mellitusc	Use concomitantly with cautionc
MAO inhibitors	Potential for hypertensive crisisa b c d f	Phendimetrazine use during or within 14 days of MAO inhibitor use is contraindicatedc

Bontril Pharmacokinetics

Absorption

Bioavailability

Readily absorbed from the GI tract following oral administration.^c

Duration

Effects persist for about 4 hours.^c

Extended-release capsules produce prolonged therapeutic effect.^a Effects achieved with one 105-mg extended-release capsule are similar to those achieved with three 35-mg conventional tablets administered at 4-hour intervals.^{a d}

Distribution

Extent

Not known whether phendimetrazine is distributed into milk;^d however, because of its low molecular weight, the drug is expected to distribute into milk.^e

Elimination

Metabolism

Undergoes limited biotransformation.^{a d}

Elimination Route

Excreted principally in urine.^{a d}

Half-life

Conventional tablets: Approximately 1.9–3.7 hours.^{a d}

Extended-release capsules: Approximately 3.7–9.8 hours.^{a d}

Stability

Storage

Oral

Conventional Tablets and Extended-release Capsules

Tight, light-resistant containers^f at 20–25°C.^{a b d f} Protect from moisture.^{d f}

ActionsActions

• 
  

  Produces anorexigenic effect and loss of weight.^{a b c d f}

  
  


• 
  

  Like other amphetamine derivatives, has no primary effect on appetite;^{a b c d f} anorexigenic action probably is secondary to CNS stimulation.^c

  
  

Advice to Patients

• 
  

  Potential for drug to impair mental alertness or physical coordination; caution when driving or operating machinery until effects on individual are known.^{a b c d f}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., glaucoma, high BP, cardiac disease).^{a b d f}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{a b d f}

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{a b d f} (See Cautions.)

  
  

Preparations

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

Subject to control under the Federal Controlled Substances Act of 1970 as a schedule III (C-III) drug.^{a b c d f}

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

Phendimetrazine Tartrate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules, extended-release	105 mg*	Bontril Slow Release (C-III)	Valeant
			Phendimetrazine Tartrate Extended-release Capsules (C-III; with povidone)	Sandoz
	Tablets	35 mg*	Bontril PDM (C-III; with isopropyl alcohol and povidone; scored)	Valeant
			Phendimetrazine Tartrate Tablets (C-III; with povidone)	RLC, Sandoz

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 February 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

100. Wyeth-Ayerst. Dear health care professional letter regarding valvular irregularities and primary pulmonary hypertension associated with the use of Plegine. Philadelphia, PA Wyeth-Ayerst; 1998 Jun 15.

101. Deitch MW. Dear health care provider letter: Pondimin and Redux to be voluntarily withdrawn. Philadelphia, PA: Wyeth-Ayerst; 1997 Sep 15.

102. Wyeth-Ayerst. Pondimin and Redux to be voluntarily withdrawn. Philadelphia, PA: 1997 Sep 15. Press release.

103. Lumpkin MM. FDA public health advisory: reports of valvular heart disease in patients receiving concomitant fenfluramine and phentermine. Rockville, MD: Food and Drug Administration; 1997 Jul 8.

104. Connolly HM, Crary JL, McGoon MD et al. Valvular heart disease associated with fenfluramine-phentermine. N Engl J Med. 1997; 337:581-8. [IDIS 391136] [PubMed 9271479]

105. Anon. FDA steps up campaign to discourage off-label “fen/phen” use with public health advisory; agency coordinates message with NEJM, Mayo clinic. FDC Rep. 1997; (Jul 14):4-5.

106. Anon. Knoll Meridia studies continue after Redux, Pondimin withdrawal: lawsuits call for Wyeth to fund medical monitoring of patients exposed to drugs. FDC Rep. 1997; (Sep 22):5.

107. US Food and Drug Administration. Questions and answers about Phen/fen and valvular heart disease. Rockville, MD; 1997 July 8.

108. Plutowski S (Mayo Foundation for Medical Education and Research). Valvular heart disease associated with commonly prescribed diet pills. Rochester, MN; 1997 Jul 8. Press release from website ().

109. Mayo Foundation for Medical Education and Research. Information for physicians regarding pharmacologic therapy for obesity. Rochester, MN; 1997 Jul 7. Press release from website ().

110. Mayo Foundation for Medical Education and Research. Heart valve disease and fen-phen: NEJM waives embargo for Mayo Clinic announcement. Rochester, MN; 1997 Jul 8. Press release from website ().

111. Anon. FDA fenfluramine/Redux epidemiological analysis of HMO records supports findings of valvulopathy in asymptomatic patients reported from five surveys. FDC Rep. 1997; (Sep 15):3-5.

112. Connolly HM, Crary JL, McGoon MD et al. for the Mayo Foundation for Medical Education and Research. Valvular heart disease associated with fenfluramine-phentermine. Rochester, MN; 1997 Jul 8.

113. Mayo Foundation for Medical Education and Research. Information and recommendations for people taking fenfluramine and phentermine. Rochester, MN; 1997 Jul 8.

114. Graham DJ, Green L. Further cases of valvular heart disease associated with fenfluramine-phentermine. N Engl J Med. 1997; 337:635. [IDIS 391141] [PubMed 9280830]

115. Centers for Disease Control and Prevention. Cardiac valvulopathy associated with exposure to fenfluramine or dexfenfluramine: U.S. Department of Health and Human Services interim public health recommendations, November 1997. MMWR Morb Mortal Wkly Rep. 1997; 46:1061-6. [IDIS 395477] [PubMed 9385873]

116. Medeva. Ionamin (C-IV) (phentermine resin capsules) prescribing information. Rochester, NY; 1997 Oct.

117. Coyne CT. Dear health care professional letter regarding labeling changes of Ionamin (phentermine resin capsules). Rochester, NY: Medeva; 1997 Aug 8.

118. Coyne CT. Dear doctor or health care professional letter regarding appropriate use of Ionamin (phentermine resin capsules). Rochester, NY: Medeva; 1997 Sep 18.

119. SoRelle R. Fen-phen and risk of valvular disease. Circulation. 1997; 96:1705-6. [PubMed 9323046]

120. Wyeth-Ayerst. Plegine (phendimetrazine tartrate tablets) prescribing information. In: Physicians’ desk reference. 52nd ed. Montvale, NJ: Medical Economics Company Inc; 1998(Suppl A):A304.

a. Valeant Pharmaceuticals International. Bontril (phendimetrazine tartrate) slow-release capsules prescribing information. Costa Mesa, CA; 2004 Sep.

b. Valeant Pharmaceuticals International. Bontril PDM (phendimetrazine tartrate) tablets prescribing information. Costa Mesa, CA; 2004 Sep.

c. AHFS Drug Information 2007. McEvoy GK, ed. Phendimetrazine tartrate. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2496-7.

d. Sandoz Inc. Phendimetrazine tartrate extended-release capsules prescribing information. Princeton, NJ; 2006 Mar.

e. Phendimetrazine. In: Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Philadelphia, PA: Lippincott Williams & Wilkins, 2005:1276.

f. Sandoz Inc. Phendimetrazine tartrate tablets prescribing information. Princeton, NJ; 2006 Mar.

More Bontril resources

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

Compare Bontril with other medications

• Obesity

botulism immune globulin

Generic Name: botulism immune globulin (BOT ue lizm im MYOON GLOB yoo lin)

Brand Names: BabyBIG

What is botulism immune globulin?

Botulism immune globulin is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection caused by botulism toxin type A and B.

Botulism immune globulin is used to treat infant botulism caused by toxin type A or B. This medication is used in children who are younger than 1 year old.

Botulism immune globulin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about botulism immune globulin?

Before your baby receives botulism immune globulin, tell your doctor if the baby has kidney disease, diabetes, a life-threatening infection, or if the baby is dehydrated, or has recently received any vaccinations.

Your baby should not receive live-virus vaccines against polio, measles, mumps, rubella, or rotavirus for at least 5 months after receiving botulism immune globulin. Live vaccines may not work as well during this time. If your baby was recently vaccinated before treatment with botulism immune globulin, he or she may need to be vaccinated again to be fully protected. Follow your doctor's instructions.

Botulism immune globulin can be harmful to the kidneys, and these effects are increased when this medication is used together with other drugs that can harm the kidneys. Before your baby is treated with botulism immune globulin, tell your doctor if the baby is receiving chemotherapy, medicines to treat a bowel disorder, medication to prevent organ transplant rejection, antiviral medications, pain medicines, or any IV antibiotics.

To be sure this medication is not causing harmful effects, your baby may need blood tests. Do not miss any follow-up appointments after treatment with botulism immune globulin.

Botulism immune globulin is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of treating your child with this medication.

What should I discuss with my healthcare provider before my child receives botulism immune globulin?

Your baby should not receive this medication if he or she has ever had an allergic reaction to an immune globulin, or if the child has immune globulin A (IgA) deficiency with antibody to IgA.

If your baby has certain conditions, he or she may need a dose adjustment or special tests to safely use this medication. Before your baby receives botulism immune globulin, tell your doctor if the baby has:

• kidney disease;


• 
  

  diabetes;

  
  


• 
  

  a life-threatening infection;

  
  


• 
  

  if the baby is dehydrated; or

  
  


• 
  

  if the baby has recently received any vaccinations.

  
  

Botulism immune globulin is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of treating your child with this medication.

How is botulism immune globulin given?

To best participate in the care of your baby while he or she is being treated with botulism immune globulin, carefully follow all instructions provided by your baby's caregivers.

Botulism immune globulin is given as an injection through a needle placed into a vein. Your baby will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take over an hour to complete.

Your baby's breathing, blood pressure, oxygen levels, and other vital signs will be watched closely during treatment with botulism immune globulin.

To be sure this medication is not causing harmful effects, your baby may need blood tests.

Do not miss any follow-up appointments after treatment with botulism immune globulin.

What happens if a dose is missed?

Since botulism immune globulin is usually given as a single IV infusion, your baby is not likely be on a daily dosing schedule.

What happens if an overdose is given?

Since botulism immune globulin is given in a controlled medical setting by a healthcare professional, an overdose is not likely to occur.

What should be avoided after receiving botulism immune globulin?

Your baby should not receive live-virus vaccines against polio, measles, mumps, rubella, or rotavirus for at least 5 months after receiving botulism immune globulin. Live vaccines may not work as well during this time, and may not fully protect the baby from disease.

If your baby was recently vaccinated before treatment with botulism immune globulin, he or she may need to be vaccinated again to be fully protected. Follow your doctor's instructions.

Botulism immune globulin side effects

Your baby will remain under constant supervision during treatment with botulism immune globulin. 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. Tell your baby's caregivers at once if the baby has a serious side effect such as:

• 
  

  trouble breathing, blue lips, pale skin;

  
  


• 
  

  urinating less than usual, fewer wet diapers than usual;

  
  


• 
  

  fever with headache, neck stiffness, sleepiness, sensitivity to light, vomiting;

  
  


• 
  

  trouble swallowing, noisy breathing, slow breathing;

  
  


• 
  

  vomiting, diarrhea, more wet diapers than usual; or

  
  


• 
  

  feeding problems, white patches in the mouth.

  
  

Less serious side effects may include:

• 
  

  mild skin rash or redness on the baby's face, chest, back, or stomach;

  
  


• 
  

  fussiness, excessive crying; or

  
  


• 
  

  stuffy nose, cough, chills.

  
  

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.

Botulism immune globulin Dosing Information

Usual Pediatric Dose for Botulism:

Less than one year of age with infant botulism caused by toxin type A or B:

2 mL/kg (100 mg/kg), given as a single intravenous infusion as soon as the clinical diagnosis of infant botulism is made. Add 2 mL sterile water for injection to the 100 mg vial, resulting in 50 mg/mL solution. Infusion should begin within 2 hours after reconstitution is complete and should be concluded within 4 hours of reconstitution. The infusion should begin slowly. Administration should start at 0.5 mL per kg body weight per hr (25 mg/kg/hr). If no untoward reactions occur after 15 minutes, the rate may be increased to the maximum infusion rate of 1 mL/kg/hr (50 mg/kg/hr). At the recommended rates, infusion of the indicated dose should take 127.5 minutes total elapsed time.

What other drugs will affect botulism immune globulin?

Botulism immune globulin can be harmful to the kidneys, and these effects are increased when this medication is used together with other drugs that can harm the kidneys. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

Before your baby is treated with botulism immune globulin, tell your doctor about all other medications your baby is receiving, especially:

• 
  

  chemotherapy;

  
  


• 
  

  medicines to treat a bowel disorder;

  
  


• 
  

  medication to prevent organ transplant rejection;

  
  


• 
  

  antiviral medications;

  
  


• 
  

  pain or arthritis medicines, including aspirin or ibuprofen (Advil, Motrin); or

  
  


• 
  

  any IV antibiotics.

  
  

This list is not complete and there may be other drugs that can interact with botulism immune globulin. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More botulism immune globulin resources

• Botulism immune globulin Dosage
• Botulism immune globulin Drug Interactions
• Botulism immune globulin Support Group
• 0 Reviews for Botulism immune globulin - Add your own review/rating

• BabyBIG Prescribing Information (FDA)

Compare botulism immune globulin with other medications

• Botulism

Where can I get more information?

• Your doctor or pharmacist can provide more information about botulism immune globulin.

BP Allergy JR

Generic Name: chlorpheniramine and phenylephrine (KLOR fen IR a meen and FEN il EFF rin)

Brand Names: Actifed Cold & Allergy, Allan Tannate Pediatric, Allerest PE, AlleRx, BP Allergy JR, C Phen, Cardec, Ceron, Chlor-Mes Jr, ChlorTan D, Cold & Allergy Relief, CP Dec, Dallergy Drops, Dallergy-JR, Dec-Chlorphen, Ed A-Hist, Ed ChlorPed D, Histadec, Nasohist Pediatric, NoHist, Ny-Tannic, PD-Hist D, PD-Hist D Drops, PediaTan D, Phenchlor Tannate Pediatric, R-Tanna, Relera, Rinate Pediatric, Rondec, Rondex, Rynatan, Rynatan Pediatric, Sildec-PE, Sinus & Allergy Maximum Strength, Sinus & Allergy PE, Sonahist, Sudafed PE Sinus & Allergy, Tanahist-D, Triaminic Cold & Allergy

What is BP Allergy JR (chlorpheniramine and phenylephrine)?

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.

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

The combination of chlorpheniramine and phenylephrine is used to treat symptoms of the common cold or seasonal allergies, including sneezing, runny or stuffy nose, and itchy, watery eyes.

Chlorpheniramine and phenylephrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about BP Allergy JR (chlorpheniramine and phenylephrine)?

There are many brands and forms of this medication available and not all brands are listed on this leaflet.

Do not use chlorpheniramine and phenylephrine 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. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you are allergic to chlorpheniramine or phenylephrine, or if you have severe high blood pressure or coronary artery disease, narrow-angle glaucoma, a stomach ulcer, or if you are unable to urinate.

Do not use this medication during an asthma attack.

This medication 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 and phenylephrine. Older adults may be more likely to have side effects from this medicine. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

What should I discuss with my healthcare provider before taking BP Allergy JR (chlorpheniramine and phenylephrine)?

Do not use chlorpheniramine and phenylephrine 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. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you are allergic to chlorpheniramine or phenylephrine, or if you have:

• 
  

  severe or uncontrolled high blood pressure;

  
  


• 
  

  severe coronary artery disease;

  
  


• 
  

  narrow angle glaucoma;

  
  


• 
  

  a stomach ulcer;

  
  


• 
  

  if you are unable to urinate; or

  
  


• 
  

  if you are having an asthma attack.

  
  

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:

• kidney disease;


• liver disease;


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  circulation problems;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  overactive thyroid;

  
  


• 
  

  a seizure disorder such as epilepsy;

  
  


• 
  

  asthma, emphysema or chronic bronchitis; or

  
  


• 
  

  urination problems or an enlarged prostate.

  
  

It is not known whether chlorpheniramine and phenylephrine is harmful to an unborn baby. Do not take this medication with a doctor's advice if you are pregnant. It is not known whether chlorpheniramine and phenylephrine 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. Older adults may be more likely to have side effects from this medicine.

Artificially sweetened liquid cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take BP Allergy JR (chlorpheniramine and phenylephrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

The chewable tablet must be chewed before swallowing.

Measure liquid medicine with a special dose-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.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

If you need surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cold medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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.

Overdose symptoms may include some of the serious side effects listed in this medication guide.

What should I avoid while taking BP Allergy JR (chlorpheniramine and phenylephrine)?

This medication 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 and phenylephrine. Ask a doctor or pharmacist before using any other cold, allergy, or sleep medicine. Chlorpheniramine and phenylephrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or decongestant.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

BP Allergy JR (chlorpheniramine and phenylephrine) 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:

• 
  

  fast or pounding heartbeats;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, nervousness;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  easy bruising or bleeding, unusual weakness; or

  
  


• 
  

  seizure (black-out or convulsions).

  
  

Less serious side effects may include:

• 
  

  blurred vision;

  
  


• 
  

  dry nose or mouth;

  
  


• 
  

  nausea, stomach pain, constipation, loss of appetite;

  
  


• 
  

  dizziness, drowsiness;

  
  


• 
  

  problems with memory or concentration;

  
  


• 
  

  ringing in your ears; or

  
  


• 
  

  feeling restless or excited (especially in children).

  
  

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 BP Allergy JR (chlorpheniramine and phenylephrine)?

Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as other 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.

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

• 
  

  mecamylamine (Inversine);

  
  


• 
  

  methyldopa (Aldomet);

  
  


• 
  

  reserpine;

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;

  
  


• 
  

  a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton); or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), nortriptyline (Pamelor), and others.

  
  

This list is not complete and other drugs may interact with chlorpheniramine and phenylephrine. 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 BP Allergy JR resources

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

• AlleRx Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Cardec Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Dallergy-JR Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Ny-Tannic MedFacts Consumer Leaflet (Wolters Kluwer)


• Relera Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Rondec MedFacts Consumer Leaflet (Wolters Kluwer)


• Rynatan Prescribing Information (FDA)


• Sonahist Prescribing Information (FDA)

Compare BP Allergy JR with other medications

• Cold Symptoms
• Hay Fever

Where can I get more information?

• Your pharmacist can provide more information about chlorpheniramine and phenylephrine.

See also: BP Allergy JR side effects (in more detail)

Boceprevir

Pronunciation: boe-SE-pre-vir
Generic Name: Boceprevir
Brand Name: Victrelis

Boceprevir is used for:

Treating chronic hepatitis C virus (HCV) infection in certain patients. It must be used in combination with peginterferon and ribavirin.

Boceprevir is a hepatitis C protease inhibitor. It reduces the amount of HCV in the body by preventing the spread of the HCV within the body.

Do NOT use Boceprevir if:

• you are allergic to any ingredient in Boceprevir


• you are taking alfuzosin, certain anticonvulsants (eg, carbamazepine, phenobarbital, phenytoin), certain benzodiazepines (eg, midazolam, triazolam), cisapride, drospirenone, ergot derivatives (eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine), certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), lurasidone, pimozide, rifampin, or St. John's wort


• you take sildenafil or tadalafil for pulmonary arterial hypertension (PAH)

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

Before using Boceprevir:

Some medical conditions may interact with Boceprevir. 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 have HIV infection or other immune system problems; or certain blood problems, such as anemia, low blood platelet levels, or low white blood cell levels (neutropenia)


• if you have other liver problems (eg, cirrhosis, hepatitis B infection)


• if you have had an organ transplant


• if you will be having surgery

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

• Certain anticonvulsants (eg, carbamazepine, phenobarbital, phenytoin), rifampin, or St. John's wort because they may decrease Boceprevir's effectiveness


• Alfuzosin, certain benzodiazepines (eg, midazolam, triazolam), cisapride, drospirenone, ergot derivatives (eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine), certain HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin), lurasidone, or pimozide because the risk of their side effects may be increased by Boceprevir


• Sildenafil or tadalafil (when used to treat PAH) because the risk of their side effect may be increased by Boceprevir


• Hormonal birth control (eg, birth control pills) because their effectiveness may be decreased by Boceprevir


• Many prescription medicines (eg, used for asthma or breathing problems, anxiety, blood thinning, blood flow, cancer, diabetes, enlarged prostate, erectile dysfunction, gout, heart problems, HIV, immune suppression, infections, inflammation, infection, irregular heartbeat, high blood pressure, high cholesterol, mental or mood problems, opioid dependence, pain [eg, narcotics], PAH, sleep) may interact with Boceprevir, increasing the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Boceprevir 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 Boceprevir:

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

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


• Boceprevir must be taken with peginterferon and ribavirin, which come with their own Medication Guides. Be sure to read those Medication Guides each time you get them filled.


• Take Boceprevir by mouth with food (a meal or light snack).


• Boceprevir is packaged into bottles that contain enough capsules for an entire day. Be sure you know how many capsules to take for each dose.


• Boceprevir works best if it is taken at the same times each day.


• Continue to take Boceprevir even if you feel well. Do not miss any doses.


• If you miss a dose of Boceprevir, and it is more than 2 hours before your next dose, take the missed dose with food and go back to your regular dosing schedule. If you miss a dose of Boceprevir, and it is less than 2 hours before your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Boceprevir.

Important safety information:

• Boceprevir may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Boceprevir with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Boceprevir may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Boceprevir may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Boceprevir does not stop you from spreading HCV to others through sexual contact, sharing needles, or being exposed to your blood. Use barrier methods of birth control (eg, condoms) if you have HCV infection. Talk with your doctor about safe sexual practices that protect your partner. Never share needles or other injection supplies. Do not share personal items that may have blood or body fluids on them, like toothbrushes or razors.


• Do not change your dose without checking with your doctor.


• Boceprevir is not a cure for HCV infection. Remain under the care of your doctor.


• When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Boceprevir, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.


• Women who may become pregnant and men who use Boceprevir must use 2 effective forms of birth control while they take Boceprevir with ribavirin and for 6 months after treatment is stopped. Hormonal birth control (eg, birth control pills) may not be as effective while you are using Boceprevir. Talk with your doctor if you have questions about effective birth control.


• Tell your doctor or dentist that you take Boceprevir before you receive any medical or dental care, emergency care, or surgery.


• Lab tests, including complete blood cell counts and HCV antibody levels, may be performed while you use Boceprevir and for several months after you stop Boceprevir. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Boceprevir with caution in the ELDERLY; they may be more sensitive to its effects.


• Boceprevir should be used with extreme caution in CHILDREN younger than 18 years; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Boceprevir must be used with ribavirin. Ribavirin use during pregnancy has resulted in birth defects and fetal death. If you are able to become pregnant, talk with your doctor or pharmacist about the use of effective birth control while using Boceprevir. If you become pregnant, contact your doctor immediately. You will need to discuss the benefits and risks of using Boceprevir while you are pregnant. It is not known if Boceprevir is found in breast milk. Do not breast-feed while taking Boceprevir.

Possible side effects of Boceprevir:

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:

Change in taste; decreased appetite; diarrhea; dizziness; dry mouth; dry skin; hair loss; headache; irritability; joint pain; nausea; tiredness; 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); dark, tarry, or bloody stools; fainting; fast or irregular heartbeat; feeling cold, especially in the hands or feet; fever, chills, or sore throat; pale skin; severe or persistent dizziness; shortness of breath; unusual bruising or bleeding; unusual tiredness or weakness.

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: Boceprevir 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.

Proper storage of Boceprevir:

Store Boceprevir in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Boceprevir may also be stored at room temperature up to 77 degrees F (25 degrees C) for 3 months. Keep Boceprevir in the original container. Avoid exposure to excessive heat. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Boceprevir out of the reach of children and away from pets.

General information:

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


• Boceprevir 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 Boceprevir. 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.

More Boceprevir resources

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

• Boceprevir Professional Patient Advice (Wolters Kluwer)


• boceprevir Advanced Consumer (Micromedex) - Includes Dosage Information


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Bortezomib

Pronunciation: bor-TEZ-oh-mib
Generic Name: Bortezomib
Brand Name: Velcade

Bortezomib is used for:

Treating certain types of cancer (eg, mantle cell lymphoma, multiple myeloma). It may also be used for other conditions as determined by your doctor.

Bortezomib is an antineoplastic (cancer chemotherapy) medicine. It works by blocking certain proteins within the cancer cell, causing the cell to die. This helps to slow the growth and spread of the cancer.

Do NOT use Bortezomib if:

• you are allergic to any ingredient in Bortezomib, or to boron or mannitol


• you are taking rifampin or St. John's wort

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

Before using Bortezomib:

Some medical conditions may interact with Bortezomib. 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 have a history of liver problems, a low white blood cell count, low blood platelets, peripheral neuropathy (numbness, pain, or burning sensations in the hands or feet), heart problems (eg, congestive heart failure), low blood pressure, diabetes, lung problems, or herpes infection (eg, genital herpes, shingles, cold sores)


• if you are dehydrated, are on dialysis, or have a history of fainting

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

• Diabetes medicines (eg, glyburide, metformin) because the risk of high or low blood sugar may be increased


• Alpha-blockers (eg, terazosin), medicines for high blood pressure, or any other medicines that may lower your blood pressure because the risk of low blood pressure and fainting may be increased. Ask your doctor or pharmacist if you are unsure if any of your medicines may lower your blood pressure


• Ketoconazole or ritonavir because they may increase the risk of Bortezomib's side effects


• Rifampin or St. John's wort because they may decrease Bortezomib's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Bortezomib 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 Bortezomib:

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

• An extra patient leaflet is available with Bortezomib. Talk to your pharmacist if you have questions about this information.


• Drinking extra fluids while you are taking Bortezomib is recommended. Check with your doctor for instructions.


• Bortezomib is usually given as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.


• Do not use Bortezomib if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• It is very important that each dose is given at the scheduled time. If you miss a dose of Bortezomib, contact your doctor right away to establish a new dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Bortezomib.

Important safety information:

• Bortezomib may cause dizziness, fatigue, fainting, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Bortezomib with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Bortezomib may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Bortezomib may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.


• Use caution with sharp objects like safety razors or nail cutters and avoid activities such as contact sports to lower your chance of getting cut, bruised, or injured.


• Bortezomib may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Contact your doctor if you develop a feeling of tingling, numbness, pain, burning, or weakness in the arms or legs. Your dose may need to be changed.


• Carry an ID card at all times that says you take Bortezomib.


• If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions. Contact your doctor right away if you experience dizziness, lightheadedness, or fainting.


• Diabetes patients - Bortezomib may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Women of childbearing age should avoid becoming pregnant while being treated with Bortezomib. Be sure to use effective birth control while using Bortezomib.


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


• Bortezomib should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Bortezomib may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Bortezomib while you are pregnant. It is not known if Bortezomib is found in breast milk. Do not breast-feed while using Bortezomib.

Possible side effects of Bortezomib:

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:

Back, bone, or joint pain; constipation; diarrhea; dizziness; headache; lightheadedness; loss of appetite; mild muscle pain or aches; nausea; stomach pain or upset; tiredness; 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); black or bloody stools; blurred vision, vision loss, or other vision changes; burning, numbness, pain, or tingling in the hands or feet; change in the amount of urine produced; chest pain; confusion; dark urine; dehydration; fainting; fast or irregular heartbeat; mental or mood changes (including thoughts of suicide); one-sided weakness; seizures; severe or persistent diarrhea, vomiting, constipation, or stomach pain; severe or persistent headache or dizziness; severe or persistent muscle pain, cramping, or weakness; severe or persistent tiredness or weakness; shortness of breath; signs of an infection (chills, cough, fever, persistent sore throat); sluggishness; slurred speech; sudden weight gain; swelling or pain in the ankles, feet, or legs; unusual bruising or bleeding; 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: Bortezomib 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 fainting; severe or persistent dizziness; unusual bruising or bleeding.

Proper storage of Bortezomib:

Bortezomib is usually handled and stored by a health care provider. If you are using Bortezomib at home, store Bortezomib as directed by your pharmacist or health care provider. Keep Bortezomib out of the reach of children and away from pets.

General information:

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


• Bortezomib 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 Bortezomib. 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.

More Bortezomib resources

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

• Bortezomib Professional Patient Advice (Wolters Kluwer)


• Bortezomib Monograph (AHFS DI)


• bortezomib Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


• Velcade Prescribing Information (FDA)


• Velcade Consumer Overview

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• Lymphoma
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