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Thursday, October 27, 2016

Bebulin VH

Pronunciation: FAK-tuhr nine
Generic Name: Factor IX (Recombinant) Complex
Brand Name: Examples include Bebulin VH and Profilnine SD

Because Bebulin VH is made from human blood, it is possible you may develop infections from it (eg, hepatitis, viral infections). Notify your doctor immediately if you develop any signs of an infection or hepatitis (eg, fever, persistent sore throat, unusual fatigue, yellowing eyes or skin, dark urine). You may develop blood clots with the use of Bebulin VH. Notify your doctor if you develop arm or leg pain/swelling, trouble breathing, or chest pain.

Bebulin VH is used for:

Controlling and preventing bleeding episodes in patients with hemophilia B.

Bebulin VH is a clotting factor. It works by correcting defects in patients who have deficiencies of certain clotting factors.

Do NOT use Bebulin VH if:

you are allergic to any ingredient in Bebulin VH

you are allergic to hamster protein

you have severe blood clotting problems (eg, fibrinolysis, disseminated intravascular coagulation)

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

Before using Bebulin VH:

Some medical conditions may interact with Bebulin VH. 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 liver disease, have a bleeding disorder, are at risk for blood clots, or have recently undergone surgery

Some MEDICINES MAY INTERACT with Bebulin VH. However, no specific interactions with Bebulin VH are known at this time.

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

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

Bebulin VH is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Bebulin VH at home, carefully follow the injection procedures taught to you by your health care provider.

Always wash your hands and carefully follow procedures for preparing and giving yourself Bebulin VH.

To use Bebulin VH, warm both vials to room temperature.

Do not shake vial after adding diluent.

Bebulin VH will be given through a vein after it is mixed with sterile water for injection.

Use Bebulin VH within 3 hours after the solution is mixed. Do not use leftover medicine or use Bebulin VH beyond the expiration date on the container.

If Bebulin VH contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.

Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.

If you miss a dose of Bebulin VH, contact your doctor immediately.

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

Important safety information:

Additional monitoring of your dose or condition may be needed if you are taking drugs that aid blood clotting (eg, tranexamic acid, aminocaproic acid) or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, aspirin, ibuprofen).

LAB TESTS, including blood tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.

Use Bebulin VH with extreme caution in NEWBORNS. Safety and effectiveness have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Bebulin VH, discuss with your doctor the benefits and risks of using Bebulin VH during pregnancy. It is unknown if Bebulin VH is excreted in breast milk. If you are or will be breast-feeding while you are using Bebulin VH, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Bebulin VH:

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:

Chills; flushing; headache; nausea; stinging at the injection site; tiredness; vomiting.

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); arm or leg pain/swelling; chest pain; dark urine; fever; persistent sore throat; unusual fatigue; yellowing of the eyes or skin.

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: Bebulin VH 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 Bebulin VH:

Store Bebulin VH in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). It may also be stored at room temperature, not to exceed 77 degrees F (25 degrees C), for up to 6 months. Do not freeze. Do not store in the bathroom. Keep Bebulin VH out of the reach of children and away from pets.

General information:

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

Bebulin VH 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 Bebulin VH. 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

More Bebulin VH resources

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

Bebulin VH Prescribing Information (FDA)

Bebulin VH Concise Consumer Information (Cerner Multum)

Bebulin VH Advanced Consumer (Micromedex) - Includes Dosage Information

Profilnine SD Prescribing Information (FDA)

Compare Bebulin VH with other medications

Factor IX Deficiency
Factor VII Deficiency
Hemophilia A with Inhibitors
Hemophilia B

Buprenex

Pronunciation: byoo-pre-NOR-feen
Generic Name: Buprenorphine
Brand Name: Buprenex

Buprenex is used for:

Treating moderate to severe pain.

Buprenex is a narcotic analgesic. It works by working in the brain and nervous system to decrease pain.

Do NOT use Buprenex if:

you are allergic to any ingredient in Buprenex

you are taking sodium oxybate (GHB)

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

Before using Buprenex:

Some medical conditions may interact with Buprenex. 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 blood or electrolyte problems, breathing or lung problems (eg, chronic obstructive pulmonary disease), underactive thyroid, adrenal gland problems (eg, Addison disease), liver or kidney problems, an enlarged prostate gland, trouble urinating, a blockage of your bladder or urethra, gallbladder problems, or stomach problems

if you have a history of recent head injury, growths in the brain (eg, tumor), or increased pressure in the brain, or muscle problems (eg, myasthenia gravis)

if you have a history of mental or mood problems, drug or alcohol abuse, or if you have a physical dependence on narcotic medicines (eg, morphine) or other opiates (eg, heroin)

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

Azole antifungals (eg, ketoconazole), HIV protease inhibitors (eg, ritonavir), or macrolide antibiotics (eg, erythromycin) because the side effects of Buprenex may be increased

Benzodiazepines (eg, diazepam), cimetidine, narcotic pain medicine (eg, codeine), phenothiazines (eg, chlorpromazine), or sodium oxybate (GHB) because the risk of severe drowsiness, severe breathing problems, and seizures may be increased

Naltrexone or rifampin because the effectiveness of Buprenex may be decreased

Methadone because effectiveness may be decreased by Buprenex

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

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

Buprenex is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Buprenex at home, carefully follow the injection procedures taught to you by your health care provider.

If Buprenex contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.

Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.

If you miss a dose of Buprenex, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

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

Important safety information:

Buprenex may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Buprenex. Using Buprenex alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Buprenex. Buprenex will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.

Buprenex may cause dizziness, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness.

Buprenex may cause withdrawal symptoms if you have a physical dependence on narcotic medicines (eg, morphine) or other opiates (eg, heroin). Talk with your doctor if you are dependent on narcotic medicines or other opiates.

Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Buprenex.

LAB TESTS, including liver function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.

Use Buprenex with caution in the ELDERLY because they may be more sensitive to its effects, especially decreased breathing and drowsiness.

Use Buprenex with extreme caution in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Buprenex, discuss with your doctor the benefits and risks of using Buprenex during pregnancy. Buprenex is excreted in breast milk. Do not breast-feed while taking Buprenex.

When used for long periods of time or at high doses, some people develop a need to continue taking Buprenex. This is known as DEPENDENCE or addiction.

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

Possible side effects of Buprenex:

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:

Constipation; dizziness; drowsiness; headache; nausea; sweating; vomiting;

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); anxiety or nervousness; dark urine; fast or irregular heartbeat; mental or mood changes (eg, depression); pale stools; pain, redness, or swelling at the injection site; slow or shallow breathing; unusual weakness; vision changes; yellowing of eyes or skin.

See also: Buprenex 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 excessive drowsiness; severe dizziness; very slow and shallow breathing; very small pupils.

Proper storage of Buprenex:

Buprenex is usually handled and stored by a health care provider. If you are using Buprenex at home, store Buprenex as directed by your pharmacist or health care provider.

General information:

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

Buprenex 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 Buprenex. 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

More Buprenex resources

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

Buprenex Prescribing Information (FDA)

Buprenex Advanced Consumer (Micromedex) - Includes Dosage Information

Buprenorphine Hydrochloride Monograph (AHFS DI)

Butrans Advanced Consumer (Micromedex) - Includes Dosage Information

Butrans Consumer Overview

Subutex Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Buprenex with other medications

Pain

Byetta

Generic Name: Exenatide
Class: Incretin Mimetics
Molecular Formula: C₁₈₄H₂₈₂N₅₀O₆₀S
CAS Number: 141732-76-5

Special Alerts:

[Posted 11/02/2009] FDA notified healthcare professionals of revisions to the prescribing information for exenatide (Byetta) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency. Exenatide, an incretin-mimetic, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

From April 2005 through October 2008, FDA received 78 cases of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency), in patients using exenatide. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems. Labeling changes include:

Information regarding post-market reports of acute renal failure and insufficiency, highlighting that exenatide should not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) or end-stage renal disease.

Recommendations to healthcare professionals that caution should be applied when initiating or increasing doses of exenatide from 5 mcg to 10 mcg in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/min).

Recommendations that healthcare professionals monitor patients carefully for the development of kidney dysfunction, and evaluate the continued need for exenatide if kidney dysfunction is suspected while using the product.

Information about kidney dysfunction in the patient Medication Guide to help patients understand the benefits and potential risks associated with exenatide.

For more information visit the FDA website at: and .

REMS:

FDA approved a REMS for exenatide to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Antidiabetic agent; synthetic glucagon-like peptide-1 (GLP-1) mimetic (incretin mimetic).¹ ² ³ ⁴

Uses for Byetta

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Diabetes Mellitus

Used in combination with metformin and/or a sulfonylurea or a thiazolidinedione, as an adjunct to diet and exercise for the management of type 2 (noninsulin dependent) diabetes mellitus (NIDDM).¹ Should be added to, not substituted for, metformin, sulfonylurea, or thiazolidinedione therapy.¹

Safety and efficacy have not been shown in combination with insulin, d-phenylalanine derivatives, meglitinides, or α-glucosidase inhibitors.¹

Byetta Dosage and Administration

Administration

Administer by sub-Q injection using the prefilled injection pen.¹ ⁷ No data available on safety or efficacy of IV or IM administration.¹

Sub-Q Administration

Administer by sub-Q injection twice daily, prior to (i.e., within 60 minutes of) morning and evening meals.¹ ⁷ ¹⁴

Alternatively, administer before 2 main meals of the day, approximately ≥6 hours apart.¹ ⁷ ¹⁴

Do not administer after a meal.¹ ⁷ ¹⁴

Administer into the abdomen, thigh, or upper arm.¹ ⁷

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Give in combination with metformin and/or sulfonylurea or thiazolidinedione therapy.¹ If used in combination with a sulfonylurea, adjustment of sulfonylurea dosage may be necessary.¹ No dosage adjustment is required when used in combination with metformin or a thiazolidinedione.¹ (See Specific Drugs under Interactions.)

Adults

Diabetes Mellitus

Sub-Q

Initially, 5 mcg twice daily.¹ ⁷ ¹⁴ If needed, may increase to 10 mcg twice daily after 1 month.¹ ⁷

Special Populations

Hepatic Impairment

Dosage adjustment not required.¹ ¹⁴

Renal Impairment

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

No dosage adjustment required in patients with mild to moderate impairment (Cl_cr 30–80 mL/minute); use not recommended in patients with end-stage renal disease or severe renal impairment (Cl_cr <30 mL/minute).¹ ⁹ ¹²

Geriatric Patients

Careful dosage selection recommended due to possible age-related decrease in renal function and concomitant disease and drug therapy; however, dosage requirements generally similar in geriatric patients and younger adults.¹

Obese Patients

Dosage adjustment not required.¹

Cautions for Byetta

Contraindications

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Known hypersensitivity to exenatide or any ingredient in the formulation.¹

Warnings/Precautions

Sensitivity Reactions

Generalized pruritus and/or urticaria, macular or papular rash, and angioedema reported during postmarketing experience.¹ Anaphylactic reaction reported rarely.¹

General Precautions

Pancreatitis

Acute pancreatitis reported during postmarketing experience with exenatide.¹ ¹⁷ ²⁰

Persistent, severe abdominal pain, which may be accompanied by vomiting, is the hallmark symptom of acute pancreatitis.¹

Most patients who developed pancreatitis had at least one other risk factor for acute pancreatitis (e.g., gallstones, severe hypertriglyceridemia, alcohol use) and required hospitalization.¹⁷

Potentially fatal hemorrhagic or necrotizing pancreatitis requiring hospitalization reported with exenatide.²⁰

Serious complications include dehydration and renal failure, suspected ileus, phlegmon, and ascites; most patients improved upon discontinuance of exenatide.¹⁷

Healthcare providers should be alert for signs and symptoms of acute pancreatitis (e.g., unexplained, severe abdominal pain that may radiate to the back; nausea; vomiting; elevated serum amylase or lipase concentrations).¹⁷

If pancreatitis is suspected, therapy with exenatide and other potentially suspected drugs should be discontinued, confirmatory tests performed (e.g., serum amylase or lipase concentrations, radiologic imaging), and appropriate therapy initiated.¹ ¹⁷ ²⁰ Patients should be carefully monitored until recovery.²⁰

Exenatide should not be resumed if pancreatitis is confirmed and an alternative etiology for pancreatitis has not been identified.¹ ¹⁷ ²⁰

Insulin-Requiring Patients

Not a substitute for insulin in insulin-requiring patients.¹

Do not use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.¹

Renal Effects

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Deterioration of renal function (e.g., increased S_cr, renal impairment, worsened chronic renal failure, acute renal failure sometimes requiring hemodialysis) reported rarely with exenatide.¹

Exenatide has not been found to be directly nephrotoxic in preclinical or clinical studies.¹

Renal effects usually were reversible with supportive treatment and discontinuance of potentially causative agents, including exenatide.¹ (See Renal Impairment under Cautions.)

Hypoglycemia

Possible dose-related hypoglycemia with concomitant sulfonylurea therapy;¹ ³ ⁵ usually mild-to-moderate in intensity and resolves with oral carbohydrate administration.¹ (See Specific Drugs under Interactions.)

No alteration of counterregulatory hormone responses to insulin-induced hypoglycemia reported.¹ ¹⁴ ¹⁵

GI Effects

Adverse GI effects (e.g., nausea, vomiting, diarrhea) reported commonly.¹ Use not recommended in patients with severe GI disease (e.g., gastroparesis).¹ ¹⁴

Immunogenicity

Antibodies to exenatide have developed in patients receiving exenatide therapy; clinical relevance is unknown.¹ ³ ⁹

Antibody titers diminish over time in most patients.¹

Formation of high titers of such antibodies could result in failure of adequate glycemic control.¹ If inadequate glycemic control or failure to achieve targeted glycemic control occurs, consider alternative antidiabetic therapy.¹

Specific Populations

Pregnancy

Category C.¹

Pregnancy registry at 800-633-9081.¹

Lactation

Distributed into milk in mice; not known whether distributed into human milk.¹ Discontinue nursing or the drug.¹

Pediatric Use

Safety and efficacy not established in children <17 years of age.¹ ¹⁴

Geriatric Use

No substantial differences in safety and efficacy nor in pharmacokinetics relative to younger adults.¹ ⁹

Hepatic Impairment

Pharmacokinetics not evaluated, but impact of hepatic impairment should be minimal.¹ ¹⁴

Renal Impairment

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Decreased clearance in patients with end-stage renal disease (ESRD) receiving dialysis; possible decreased tolerance to therapy due to adverse GI effects.¹ ¹² Use not recommended in patients with ESRD or severe renal impairment (Cl_cr <30 mL/minute).¹ ⁹

Common Adverse Effects

Nausea, hypoglycemia, vomiting, diarrhea, jittery feeling, dizziness, headache, dyspepsia.¹

Interactions for Byetta

Orally Administered Drugs

Possible decreased rate and extent of absorption of concomitantly administered oral drugs; use with caution with oral drugs requiring rapid GI absorption.¹

Specific Drugs

Drug	Interaction	Comments
Acetaminophen	Decreased acetaminophen AUC and peak plasma concentrations, delayed time to peak plasma concentrations of acetaminophen¹	Administer acetaminophen ≥1 hour prior to exenatide administration¹ ¹¹
Antidiabetic agents (sulfonylureas)	Increased risk of hypoglycemia¹	Consider dosage reduction of sulfonylurea¹
Anti-infective agents, oral	Possible decreased rate and extent of anti-infective absorption¹	Administer anti-infective agent ≥1 hour prior to exenatide administration¹ ⁹
Digoxin	Decreased peak plasma digoxin concentrations and delayed time to peak plasma concentration; no change in steady-state AUC and renal clearance of digoxin⁹ ¹⁰
Lisinopril	Delayed time to peak plasma lisinopril concentrations; no change in steady-state AUC or peak plasma lisinopril concentrations ¹ ⁹ ¹³
Lovastatin	Decreased lovastatin AUC and peak plasma concentrations and delayed time to peak plasma concentration¹ ⁹	Not associated with consistent changes in lipid profiles compared with baseline¹ ⁹
Metformin	No increased incidence of hypoglycemia reported¹ ⁶	Dosage adjustments not required¹
Oral contraceptives	Possible decreased rate and extent of oral contraceptive absorption¹	Administer oral contraceptive ≥1 hour prior to exenatide administration¹ ⁹
Warfarin	Delayed time to peak plasma concentration of warfarin; no change in AUC or peak plasma warfarin concentrations¹

Byetta Pharmacokinetics

Manufacturer states pharmacokinetics are independent of dose, age, gender, race, and patient weight.¹

Absorption

Bioavailability

Following sub-Q administration, peak plasma concentration usually attained in 2.1 hours.¹

Absorption is similar when injected into abdomen, thigh, or arm.¹

Distribution

Extent

Distributed into milk in mice; not known whether distributed into human milk.¹

Elimination

Metabolism

Primarily proteolytic degradation after glomerular filtration.¹

Elimination Route

Excreted principally in urine.¹

Half-life

2.4 hours.¹

Special Populations

Decreased clearance in patients with end-stage renal disease receiving dialysis.¹ Clearance is slightly decreased in patients with mild to moderate renal impairment.¹

Stability

Storage

Parenteral

Solution for Injection

Before use, 2–8°C.¹ After first use, ≤25ºC.¹ Do not freeze; protect from light.¹ Discard pen 30 days after first use.¹

Actions

A synthetic analog of a naturally occurring peptide isolated from the saliva of Heloderma suspectum (Gila monster); is a glucagon-like peptide-1 (GLP-1) mimetic (incretin mimetic).¹ ² ³ ⁴ ⁵ ⁶ ⁸

Structurally and pharmacologically unrelated to insulin, sulfonylureas, meglitinides, biguanides, thiazolidinediones, and α-glucosidase inhibitors.¹

Lowers fasting and postprandial glucose concentrations in patients with type 2 diabetes mellitus.¹ ² ³ ⁸

Improves pancreatic β-cell function by increasing glucose-dependent insulin synthesis, secretion and acute β-cell responsiveness (i.e., first phase insulin response).¹ ² ³ ⁴ ⁸ ¹⁴

Inhibits inappropriately high glucagon secretion (e.g., after a meal) in patients with type 2 diabetes mellitus¹ ³ ⁸ but does not impair normal glucagon response to hypoglycemia.¹

Slows gastric emptying, which reduces the rate of glucose absorption from a meal and reduces food intake.¹ ² ⁵ ⁶ ⁸

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Importance of adhering to diet and exercise regimen.¹ ⁷ Importance of regular monitoring (preferably self-monitoring) of blood glucose and HbA_1c.¹ ⁷

Importance of informing patients not to administer the drug after a meal.¹ ⁷

Importance of providing patient a copy of manufacturer’s patient information.¹ ⁷

Inform patients of the potential risks and advantages of exenatide therapy.¹

Importance of appropriate management of hypoglycemia and hyperglycemia, and assessment for other diabetes complications.¹ Risk of hypoglycemia in patients receiving concomitant sulfonylurea hypoglycemic therapy.¹ Provide instructions regarding management of hypoglycemia, including recognition of symptoms, predisposing conditions, and treatment.¹

Risk of nausea, particularly upon initiation of therapy.¹ ⁷

Provide instructions regarding proper use and storage of the injection pen and injection technique.¹ ⁷ Importance of advising patient that if a dose is missed, resume the treatment regimen as prescribed with the next scheduled dose.¹ ⁷

Importance of seeking prompt medical attention if unexplained, persistent, severe abdominal pain with or without nausea and vomiting occurs.¹ ⁷ ¹⁷

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹ ⁷

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., GI disease, severe kidney disease).¹ ⁷ Advise patients regarding the timing of administration with concomitant oral drugs (e.g., oral contraceptives, anti-infective agents).¹ ⁷

Importance of informing patients of other important precautionary information.¹ (See Cautions.)

Preparations

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

Exenatide
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for subcutaneous use	250 mcg/mL	Byetta (available as prefilled cartridge pen)	Amylin

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Byetta 10 MCG Pen 10MCG/0.04ML Solution (AMYLIN PHARMACEUTICALS): 2/$281.98 or 7/$825.01

Byetta 5 MCG Pen 5MCG/0.02ML Solution (AMYLIN PHARMACEUTICALS): 1/$313.46 or 4/$868.71

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 October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Amylin Pharmaceuticals. Byetta (exenatide) injection prescribing information. San Diego, CA; 2008 Jun.

2. Scott V, Rodgers PT, Scates AC. Incretin mimetics as emerging treatments for type 2 diabetes. Ann Pharmacother. 2005; 39:110-8. [IDIS 534323] [PubMed 15562141]

3. Buse JB, Henry RR, Hans J et al. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in sulfonylurea-treated patients with type 2 diabetes. Diabetes Care. 2004; 27:2628-35. [IDIS 534649] [PubMed 15504997]

4. Nuack MA. Glucagon-like peptide (GLP-1): a promising approach and a novel treatment for patients with type 2 diabetes. Int J Clin Pract. S138:45-52.

5. Kendall DM, Riddle MC, Rosenstock J et al. Effects of exenatide (exendin-4) on glycemic control over 30 weeks in patients with type 2 diabetes treated with metformin and a sulfonylurea. Diabetes Care. 2005; 28:1083-91. [IDIS 538293] [PubMed 15855571]

6. Defronzo RA, Ratner RE, Han J et al. Effects of exenatide (exendin-4) on glycemic control and weight over 30 weeks in metformin-treated patients with type 2 diabetes. Diabetes Care. 2005; 28:1092-100. [IDIS 538294] [PubMed 15855572]

7. Amylin Pharmaceuticals. Byetta (exenatide) injection patient information. San Diego, CA; 2008 Jun.

8. Kolterman OG, Kim DD, Shen L et al. Pharmacokinetics, pharmacodynamics, and safety of exenatide in patients with type 2 diabetes mellitus. Am J Health- Syst Pharm. 2005; 62:173-81. [IDIS 538343] [PubMed 15700891]

9. Keating GM. Exenatide. Drugs. 2005; 65(12):1681-92; discussion 1693-5. [PubMed 16060703]

10. Kothare PA, Soon DK, Linnebjerg H et al. Effect of exenatide on the steady-state pharmacokinetics of digoxin. J Clin Pharmacol. 2005; 45(9):1032-7. [PubMed 16100297]

11. Blase E, Taylor K, Gao HY et al. Pharmacokinetics of an oral drug (acetaminophen) administered at various times in relation to subcutaneous injection of exenatide (exendin-4) in healthy subjects. J Clin Pharmacol. 2005; 45(5):570-7. [PubMed 15831781]

12. Linnebjerg H, Hothare P, Park S, et al. Exenatide pharmacokinetics in patients with mild to moderate renal dysfunction and end stage renal disease [abstract no. 469-P]. Diabetes. 2005; 54 (Suppl 1):A116.

13. Kothare P, Linnebjerg H, Atkins M, et al. Effect of exenatide on lisinopril pharmacodynamics in patients treated for hypertension [abstract no. PI-24]. Clin Pharmacol Ther. 2005; 77 (2):P14.

14. Amylin Pharmaceuticals, Inc., San Diego, CA: Personal communication.

15. Degn KB, Brock B, Juhl CB et al. Effect of intravenous infusion of exenatide (synthetic exendin-4) on glucose-dependent insulin secretion and counterregulation during hypoglycemia. Diabetes. 2004; 53:2397-403. [PubMed 15331551]

16. Zinman B, Hoogwerf BJ, Garcia SD et al. The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med. 2007; 146:477-85. [PubMed 17404349]

17. Food and Drug Administration, Center for Drug Evaluation and Research. FDA alert: Information for healthcare professional exenatide (marketed as Byetta). Rockville MD: Food and Drug Administration; 2007 Oct 2. Available from FDA website. Accessed 2007 Nov 2.

18. Jones MC. Therapies for diabetes: pramlintide and exenatide. Am Fam Physician. 2007; 75:1831-5. [PubMed 17619527]

19. Mikhail N. Exenatide: a novel approach for treatment of type 2 diabetes. South Med J. 2006; 99:1271-9. [PubMed 17195423]

20. Food and Drug Administration, Center for Drug Evaluation and Research. FDA alert: Information for healthcare professionals exenatide (marketed as Byetta). Rockville MD: Food and Drug Administration; 2008 Aug 18. Available from FDA website. Accessed 2008 Oct 10.

More Byetta resources

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

Compare Byetta with other medications

Diabetes, Type 2

benzyl benzoate Topical

BEN-zil BEN-zoe-ate

Available Dosage Forms:

Lotion

Therapeutic Class: Scabicide

Chemical Class: Benzoic Acid

Uses For benzyl benzoate

Benzyl benzoate is used to treat lice and scabies infestations. benzyl benzoate is believed to be absorbed by the lice and mites and to destroy them by acting on their nervous system.

benzyl benzoate is available without a prescription.

Before Using benzyl benzoate

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 benzyl benzoate, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to benzyl benzoate 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

Although there is no specific information comparing use of benzyl benzoate in children with use in other age groups, benzyl benzoate is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of benzyl benzoate in the elderly with use in other age groups. However, older people may have dry skin and the medicine may make the condition worse.

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.

Proper Use of benzyl benzoate

Benzyl benzoate usually comes with patient directions. Read them carefully before using benzyl benzoate.

Use benzyl benzoate only as directed. Do not use more of it and do not use it more often than recommended on the label. To do so may increase the chance of absorption through the skin and the chance of side effects.

Keep benzyl benzoate away from the eyes and other mucous membranes, such as the inside of the nose, because it may cause irritation . If you accidentally get some in your eyes, flush them thoroughly with water at once.

Do not use benzyl benzoate on open wounds, such as cuts or sores on the skin or scalp. To do so may increase the amount of absorption, which may increase the chance of side effects.

Your sexual partner or partners, especially, and all members of your household may need to be treated also, since the infestation may spread to persons in close contact. If these persons have not been examined for infestation or if you have any questions about this, check with your doctor.

To use benzyl benzoate for lice:

If your hair has any cream, lotion, ointment, or oil-based product on it, shampoo, rinse, and dry your hair and scalp well before applying benzyl benzoate.

Apply enough medicine to thoroughly wet the dry hair and scalp or skin.

Allow the medicine to remain on the affected areas for 24 hours.

Then, thoroughly wash the affected areas with warm water and soap or regular shampoo.

Rinse thoroughly and dry with a clean towel.

After rinsing and drying, use a fine-toothed comb (less than 0.3 mm between the teeth) to remove any remaining nits (eggs) or nit shells from your hair, or, if you have fine hair, you may use a tweezer or your fingernails to pick nits out.

To use benzyl benzoate for scabies:

If your skin has any cream, lotion, ointment, or oil on it, wash, rinse, and dry your skin well before applying benzyl benzoate.

If you take a bath or shower before using benzyl benzoate, dry the skin well before applying the medicine.

Apply enough medicine to cover the entire skin surface from the neck down, including the soles of your feet, and rub in well.

Allow the medicine to remain on the body for 24 hours.

Then, thoroughly wash the body with warm water and soap.

Rinse thoroughly and dry with a clean towel.

Immediately after using benzyl benzoate, wash your hands to remove any medicine that may be on them.

Treatment may need to be repeated for severe infestation.

Dosing

The dose of benzyl benzoate 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 benzyl benzoate. 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 topical dosage form (emulsion):
- For lice infestation:
  - Adults—Use just one time. For severe cases, treatment may be repeated two or three times after twenty-four hours.
  - Children—
    - For infants: Use mixed with three parts of water, just one time.
    - For older children: Use mixed with an equal quantity of water, just one time.
- For scabies infestation:
  - Adults—Use just one time. For severe cases, treatment may be repeated after twenty-four hours one time anytime within five days.
  - Children—
    - For infants: Use mixed with three parts of water, just one time.
    - For older children: Use mixed with an equal quantity of water, just one time.

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 benzyl benzoate

To prevent reinfection or spreading of the infection to other people, good health habits are required. These include the following:

For lice infestation:
- Disinfecting or washing combs, curlers, and brushes in very hot water (65 °C or 150 °F) for about 10 minutes immediately after using.
- Washing in very hot water all recently worn clothing and used bed linens and towels, and drying them in a hot dryer for at least 20 minutes. Articles that cannot be washed may be dry-cleaned, pressed with a hot iron, or just placed in a hot dryer.
- Sealing stuffed toys and other non-washable articles in a plastic bag for 2 weeks, or placing these items in the freezer (in sealed plastic bags) for 12 to 24 hours.
- Vacuuming all rugs, mattresses, pillows, furniture, and car seats to get rid of fallen hairs with lice.

For scabies infestation: Washing all recently worn clothing such as underwear and pajamas, and used sheets, pillowcases, and towels in very hot water or dry-cleaning.

benzyl benzoate 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 as soon as possible if any of the following side effects occur:

Symptoms of overdose

Blister formation, crusting, itching, oozing, reddening, or scaling of skin

difficulty in urinating (dribbling)

jerking movements

sudden loss of consciousness

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:

Less common or rare

Burning or itching of skin

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.

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.

What is brompheniramine, dihydrocodeine, and phenylephrine?

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

Dihydrocodeine is a narcotic cough suppressant.

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

The combination of brompheniramine, dihydrocodeine, and phenylephrine is used to treat nasal congestion, sneezing, runny nose, and cough caused by the common cold.

Dihydrocodeine will not treat a cough that is caused by smoking, asthma, or emphysema.

Brompheniramine, dihydrocodeine, and phenylephrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about brompheniramine, dihydrocodeine, and phenylephrine?

Do not use this medication if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take a cough and cold medicine before the MAO inhibitor has cleared from your body. You should not use brompheniramine, dihydrocodeine, and phenylephrine if you are allergic to it, or if you have peptic ulcer, severe or uncontrolled high blood pressure, severe coronary artery disease, ischemic heart disease (reduced circulation of blood to the heart), narrow-angle glaucoma, if you are breast-feeding a baby, or if you are unable to urinate.

Before taking this medication, tell your doctor if you have heart disease or high blood pressure, asthma or other breathing disorder, diabetes, a thyroid disorder, glaucoma, kidney or liver disease, gallbladder disease, pancreatitis, Addison's disease or other adrenal gland disorder, a seizure disorder, head injury or brain tumor, an enlarged prostate, problems with urination, mental illness, or a history of drug or alcohol addiction.

Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Brompheniramine, dihydrocodeine, and phenylephrine should not be given to a child younger than 6 years old.

What should I discuss with my healthcare provider before taking brompheniramine, dihydrocodeine, and phenylephrine?

Do not use this medication if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take a cough and cold medicine before the MAO inhibitor has cleared from your body. You should also not take codeine if you are having an asthma attack or if you have a bowel obstruction called paralytic ileus. You should not use brompheniramine, dihydrocodeine, or phenylephrine, if you have ever had an allergic reaction to it, or if you have:

severe or uncontrolled high blood pressure;

severe coronary artery disease;

narrow-angle glaucoma;

peptic ulcer;

if you are unable to urinate;

if you are pregnant;

if you are having an asthma attack.

If you have certain conditions, you may need a dose adjustment or special tests to safely take brompheniramine, dihydrocodeine, and phenylephrine. Before taking this medication, tell your doctor if you have:

heart disease or high blood pressure;

ischemic heart disease (reduced circulation of blood to the heart);

asthma, COPD, or other breathing disorder;

glaucoma;

diabetes;

kidney or liver disease;

a thyroid disorder;

enlarged prostate, urination problems;

gallbladder disease or pancreatitis;

Addison's disease or other adrenal gland disorders;

a history of head injury or brain tumor;

epilepsy or other seizure disorder;

mental illness; or

a history of drug or alcohol addiction.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Dihydrocodeine may cause breathing problems or addiction/withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant while you are taking this medication. This medication can pass into breast milk and may harm a nursing baby. The use of dihydrocodeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more sensitive to the side effects of this medication. Dihydrocodeine may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

How should I take brompheniramine, dihydrocodeine, and phenylephrine?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Cold medicine is usually taken for only a short time until your symptoms clear up.

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

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache or skin rash. Store brompheniramine, dihydrocodeine, and phenylephrine at room temperature away from moisture and heat.

Keep track of how much of this medicine has been used from the bottle. Dihydrocodeine is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

See also: Brompheniramine, dihydrocodeine, and phenylephrine dosage (in more detail)

What happens if I miss a dose?

Since cough and cold medicine is usually taken only 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. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of dihydrocodeine can be fatal.

Overdose symptoms may include extreme drowsiness, pinpoint pupils, cold and clammy skin, limp muscles, fainting, seizure (convulsions), shallow breathing or breathing that stops.

What should I avoid while taking brompheniramine, dihydrocodeine, and phenylephrine?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol while you are taking this medication. Alcohol can add to the side effects of brompheniramine, dihydrocodeine, and phenylephrine.

Tell your doctor if you regularly use other medicines that make you sleepy (such as pain medication, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by brompheniramine, dihydrocodeine, and phenylephrine.

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Brompheniramine or phenylephrine are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains brompheniramine or phenylephrine.

Brompheniramine, dihydrocodeine, 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 any of these serious side effects:

fast or pounding heartbeat;

feeling like you might pass out;

weak or shallow breathing;

confusion, hallucinations;

severe dizziness, anxiety, restless feeling, or nervousness;

seizure (convulsions); or

painful or difficult urination.

Less serious side effects may include:

dizziness, drowsiness, headache, tired feeling;

feeling excited or restless;

increased dreaming;

increased sweating or urination;

nausea, vomiting, diarrhea, constipation, loss of appetite;

dry mouth;

blurred vision, dry eyes; or

mild skin rash or itching.

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

Brompheniramine, dihydrocodeine, and phenylephrine Dosing Information

Usual Adult Dose for Cough and Nasal Congestion:

Brompheniramine/dihydrocodeine/phenylephrine 4 mg-3 mg-7.5 mg/5 mL oral liquid:
5 mL orally every 4 to 6 hours not to exceed 30 mL daily.

Usual Pediatric Dose for Cough and Nasal Congestion:

Brompheniramine/dihydrocodeine/phenylephrine 4 mg-3 mg-7.5 mg/5 mL oral liquid:
6 to 11 years: 2.5 mL orally every 4 to 6 hours not to exceed 15 mL daily.
12 years or older: 5 mL orally every 4 to 6 hours not to exceed 30 mL daily.

What other drugs will affect brompheniramine, dihydrocodeine, and phenylephrine?

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

methyldopa (Aldomet);

mecamylamine (Inversine);

reserpine;

promethazine (Phenergan, Adgan, Anergan 50, Pentazine);

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

an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

This list is not complete and there may be other drugs that can interact with brompheniramine, dihydrocodeine, and phenylephrine. 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 brompheniramine, dihydrocodeine, and phenylephrine resources

Brompheniramine, dihydrocodeine, and phenylephrine Dosage
Brompheniramine, dihydrocodeine, and phenylephrine Use in Pregnancy & Breastfeeding
Brompheniramine, dihydrocodeine, and phenylephrine Drug Interactions
Brompheniramine, dihydrocodeine, and phenylephrine Support Group
0 Reviews for Brompheniramine, dihydrocodeine, and phenylephrine - Add your own review/rating

Compare brompheniramine, dihydrocodeine, and phenylephrine with other medications

Cold Symptoms
Cough and Nasal Congestion

Where can I get more information?

Your pharmacist can provide more information about brompheniramine, dihydrocodeine, and phenylephrine.

Bicillin L-A

Generic Name: penicillin G benzathine (PEN i SILL in G BEN za theen)

Brand Names: Bicillin L-A

What is Bicillin L-A (penicillin G benzathine)?

Penicillin G benzathine is a slow-onset antibiotic that fights bacteria in your body.

Penicillin G benzathine is used to treat many different types of severe infections, including strep infections, rheumatic fever, and syphilis.

Penicillin G benzathine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Bicillin L-A (penicillin G benzathine)?

You should not receive this medication if you are allergic to penicillin. Tell your doctor if you have ever had an allergic reaction to a cephalosporin antibiotic such as Ceftin, Cefzil, Omnicef, Keflex, and others.

Before you receive penicillin G benzathine, tell your doctor if you have asthma or a history of allergies, liver disease, kidney disease, or heart disease.

Be sure to receive all doses your doctor has prescribed. Your symptoms may get better before the infection is completely cleared.

After you have finished your treatment with penicillin G benzathine, your doctor may want to do tests to make sure your infection has completely cleared up.

What should I discuss with my healthcare provider before receiving Bicillin L-A (penicillin G benzathine)?

You should not receive this medication if you are allergic to penicillin. Tell your doctor if you have ever had an allergic reaction to a cephalosporin antibiotic such as cefdinir (Omnicef), cefprozil (Cefzil), cefuroxime (Ceftin), cephalexin (Keflex), and others.

To make sure you can safely receive penicillin G benzathine, tell your doctor if you have any of these other conditions:

asthma or a history of allergies;

liver disease;

kidney disease; or

heart disease.

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

How is penicillin G benzathine given?

Penicillin G benzathine is injected into a muscle. A healthcare provider will give you this injection.

Penicillin G benzathine must be injected slowly into a muscle of the buttock.

Penicillin G benzathine is sometimes given only once or only for a few days until your symptoms clear up. Be sure to receive all doses your doctor has prescribed. Your symptoms may get better before the infection is completely cleared.

After you have finished your treatment with penicillin G benzathine, your doctor may want to do tests to make sure your infection has completely cleared up.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your penicillin G benzathine injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include seizure (convulsions).

What should I avoid while receiving Bicillin L-A (penicillin G benzathine)?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Bicillin L-A (penicillin G benzathine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

diarrhea that is watery or bloody;

fever, swollen glands, rash or itching, muscle or joint pain, night sweats, general ill feeling;

feeling like you might pass out;

skin rash with bruising, severe tingling, numbness, pain, muscle weakness;

pale or yellowed skin, dark colored urine, weakness;

easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

urinating less than usual or not at all;

fast or pounding heartbeats;

slow heart rate, weak pulse, fainting, slow breathing;

confusion, agitation, hallucinations, ringing in your ears, unusual thoughts or behavior;

seizure (convulsions);

pain, swelling, bruising, irritation, or skin changes where the injection was given; or

hardening of your skin in the thigh where the injection was given, trouble bending your knee.

Less serious side effects may include:

nausea, vomiting;

blurred vision;

dizziness; or

tired feeling.

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 Bicillin L-A (penicillin G benzathine)?

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

methotrexate (Rheumatrex, Trexall);

probenecid (Benemid);

birth control pills;

a blood thinner such as warfarin (Coumadin, Jantoven); or

a tetracycline antibiotic, such as doxycycline (Doryx, Oracea, Periostat, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

This list is not complete and other drugs may interact with penicillin G benzathine. 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 Bicillin L-A resources

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

Bicillin L-A Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Bicillin L-A Advanced Consumer (Micromedex) - Includes Dosage Information

Penicillin G Benzathine/Potassium/Sodium Monograph (AHFS DI)

Compare Bicillin L-A with other medications

Actinomycosis
Anthrax
Anthrax Prophylaxis
Aspiration Pneumonia
Bacterial Infection
Clostridial Infection
Congenital Syphilis
Cutaneous Bacillus anthracis
Deep Neck Infection
Diphtheria
Endocarditis
Fusospirochetosis, Trench Mouth
Joint Infection
Leptospirosis
Lyme Disease, Arthritis
Lyme Disease, Carditis
Lyme Disease, Erythema Chronicum Migrans
Lyme Disease, Neurologic
Meningitis
Meningitis, Meningococcal
Meningitis, Pneumococcal
Neurosyphilis
Otitis Media
Pneumonia
Prevention of Perinatal Group B Streptococcal Disease
Rat-bite Fever
Rheumatic Fever Prophylaxis
Skin Infection
Strep Throat
Syphilis, Early
Syphilis, Latent
Tertiary Syphilis
Tonsillitis/Pharyngitis
Upper Respiratory Tract Infection

Where can I get more information?

Your doctor or pharmacist can provide more information about penicillin G benzathine.

See also: Bicillin L-A side effects (in more detail)

Bondronat

Generic Name: ibandronate (Intravenous route)

eye-BAN-droe-nate

Commonly used brand name(s)

In the U.S.

Boniva

In Canada

Bondronat

Available Dosage Forms:

Solution

Therapeutic Class: Calcium Regulator

Chemical Class: Bisphosphonate

Uses For Bondronat

Ibandronate injection is used to treat osteoporosis (thinning of the bone) in women after menopause.

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

Before Using Bondronat

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 ibandronate injection 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 ibandronate injection in the elderly.

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

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 may cause an increased risk of certain side effects 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.

Dairy Food

food

Proper Use of ibandronate

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

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

This medicine is usually given once every 3 months. If you missed a dose, call your doctor to make another appointment as soon as possible.

Your doctor will give you a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

This medicine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.

Precautions While Using Bondronat

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

It is important that you eat a well-balanced diet with an adequate amount of calcium and vitamin D (found in milk or other dairy products). It is recommended that you receive calcium and vitamin D supplements while receiving this medicine.

It is important that you tell all of your health care providers that you are receiving ibandronate injection. If you are having dental procedures while using ibandronate injection, you may have an increased chance of getting a severe problem with your jaw.

Make sure you tell your doctor about any new medical problems, especially with your teeth or jaws. Tell your doctor if you have severe bone, joint, or muscle pain while using this medicine.

This medicine may increase your risk of developing fractures of the thigh bone. This may be more common if you use it for a long time. Check with your doctor right away if you have a dull or aching pain in the thighs, groin, or hips.

Bondronat 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 or nurse immediately if any of the following side effects occur:

More common

Back pain

blurred vision

difficulty with moving

dizziness

headache

muscle pain or stiffness

nervousness

pain in the joints

pounding in the ears

slow or fast heartbeat

Less common

Bladder pain

bloody or cloudy urine

body aches or pain

chills

cough

cough producing mucus

diarrhea

difficult, burning, or painful urination

difficulty with breathing

ear congestion

fever

frequent urge to urinate

general feeling of discomfort or illness

loss of appetite

loss of voice

lower back or side pain

muscle aches and pains

muscle cramping

nasal congestion

nausea

pain in the arms or legs

pain, swelling, or redness in the joints

runny nose

shivering

shortness of breath

sneezing

sore throat

sweating

swollen joints

tightness in the chest

trouble sleeping

unusual tiredness or weakness

vomiting

wheezing

Incidence not known

Blurred vision or other change in vision

decreased vision

eye pain

eye redness

eye tenderness

increased tearing

sensitivity of the eye to light

severe eye pain

tearing

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

Symptoms of overdose

Abdominal or stomach cramps

bone pain

confusion

convulsions

difficulty with breathing

drowsiness

irregular heartbeats

muscle cramps in the hands, arms, feet, legs, or face

muscle spasms (tetany) or twitching seizures

numbness and tingling around the mouth, fingertips, or feet

trembling

tremor

trouble breathing

More common

Abdominal or stomach pain

Less common

Acid or sour stomach

belching

burning feeling in the chest or stomach

constipation

diarrhea

discouragement

feeling sad or empty

heartburn

indigestion

irritability

lack of appetite

loss of interest or pleasure

rash

red streaks on the skin

sleeplessness

stomach discomfort, upset, or pain

stuffy nose

swelling, tenderness, or pain at the injection site

tenderness in the stomach area

tiredness

trouble concentrating

unable to sleep

weakness

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: Bondronat side effects (in more detail)

More Bondronat resources

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

Boniva Prescribing Information (FDA)

Boniva Monograph (AHFS DI)

Boniva MedFacts Consumer Leaflet (Wolters Kluwer)

Boniva Consumer Overview

Compare Bondronat with other medications

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