Friday, October 28, 2016

Isocarboxazid


Pronunciation: eye-soe-kar-BOX-a-zid
Generic Name: Isocarboxazid
Brand Name: Marplan

Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using Isocarboxazid outweigh the risks.


Family and caregivers must closely watch patients who take Isocarboxazid. It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior. Discuss any questions with the patient's doctor.





Isocarboxazid is used for:

Treating short-term (up to 6 weeks) depression in patients who do not respond to other medications. It may also be used for other conditions as determined by your doctor.


Isocarboxazid is a monoamine oxidase (MAO) inhibitor. It works by increasing certain chemicals in the brain that help elevate mood.


Do NOT use Isocarboxazid if:


  • you are allergic to any ingredient in Isocarboxazid

  • you have high blood pressure, heart or brain blood vessel disease or problems, heart failure, liver problems, severe kidney problems, severe or frequent headache, an adrenal gland tumor (pheochromocytoma), or schizophrenia

  • you will be having surgery

  • you are eating cheese or other foods with a high tyramine content, are taking high amounts of caffeine, or you abuse alcohol

  • you are taking an anorexiant (eg, phentermine), an antihypertensive (eg, hydrochlorothiazide), apraclonidine, bupropion, buspirone, carbamazepine, cyclobenzaprine, dextromethorphan, ethanol, levodopa, meperidine, methotrimeprazine, methylphenidate, nefazodone, propoxyphene, a selective serotonin reuptake inhibitor (SSRI) (eg, fluoxetine), a serotonin-norepinephrine reuptake inhibitor (SNRI) (eg, atomoxetine), sibutramine, a sympathomimetic (eg, albuterol, amphetamine), a tetracyclic antidepressant (eg, trazodone), or a tricyclic antidepressant (eg, amitriptyline)

  • you are taking or have taken linezolid, methylene blue, or another MAO inhibitor (eg, phenelzine) within the last 14 days

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



Video: Treatment for Depression







Treatments for depression are getting better everyday and there are things you can start doing right away.






Before using Isocarboxazid:


Some medical conditions may interact with Isocarboxazid. 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 asthma, mental or mood disorders (eg, bipolar mood disorder), bronchitis, an irregular heartbeat, diabetes, epilepsy, thyroid problems, certain types of heart disease, Parkinson disease, the blood disorder porphyria, kidney problems, stroke, or suicidal thoughts or behaviors

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


  • Apraclonidine, bupropion, buspirone, carbamazepine, cyclobenzaprine, dextromethorphan, ethanol, meperidine, methotrimeprazine, phenothiazines (eg, thioridazine), propoxyphene, SNRIs (eg, atomoxetine), or tricyclic antidepressants (eg, amitriptyline) because side effects such as high blood pressure may be increased

  • Antihypertensives (eg, hydrochlorothiazide), anorexiants (eg, phentermine), catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), insulin, levodopa, meglitinide antidiabetics (eg, repaglinide), methylphenidate, sibutramine, SSRIs (eg, fluoxetine), sulfonylureas (eg, glipizide), sumatriptan, sympathomimetics (eg, albuterol, amphetamine), tetracyclic antidepressants (eg, trazodone), or tramadol because the actions and side effects of these medicines may be increased

  • Disulfiram, linezolid, methylene blue, nefazodone, other MAO inhibitors (eg, phenelzine), or tryptophan because severe unexpected toxicity may occur

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


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


  • Isocarboxazid comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Isocarboxazid refilled.

  • Isocarboxazid may be taken with or without food.

  • It may take 3 to 6 weeks for you to see the effects of Isocarboxazid. Continue taking your medicine during this time.

  • Continue to take Isocarboxazid even if you feel better. Do not miss any doses.

  • If you miss a dose of Isocarboxazid, take 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 take 2 doses at once.

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



Important safety information:


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

  • Isocarboxazid 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.

  • Children, teenagers, and young adults who take Isocarboxazid may be at increased risk for suicidal thoughts or actions. Watch all patients who take Isocarboxazid closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.

  • Avoid large amounts of caffeine-containing foods and beverages, such as coffee, tea, cocoa, cola drinks, and chocolate. If you have questions about how much is excessive, ask your doctor.

  • Isocarboxazid may cause serious increases in blood pressure if certain foods are eaten. Avoid eating foods such as aged cheeses, sour cream, red wines, beer, bologna, pepperoni, salami, summer sausage, pickled herring, liver, meat prepared with tenderizers, canned figs, raisins, bananas, avocados, soy sauce, fava beans, or yeast extracts. Obtain a complete list of foods and beverages from your doctor or pharmacist.

  • Additional monitoring of your condition is recommended at the start of treatment with Isocarboxazid and whenever a change to your dose is made.

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

  • Diabetes patients - Isocarboxazid may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.

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

  • Isocarboxazid is not recommended for use in CHILDREN younger than 16 years of age. Safety and effectiveness in this age group have not been confirmed.

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

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


If you suddenly stop taking Isocarboxazid you may experience WITHDRAWAL symptoms including anxiety; confusion; depression; diarrhea; hallucinations; headaches; restlessness; and weakness.



Possible side effects of Isocarboxazid:


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:



Abnormal skin sensations; anxiety; blurred vision; chills; constipation; diarrhea; dizziness; drowsiness; dry mouth; fainting; forgetfulness; frequent urination; headache; heavy feeling; hyperactivity; inability to urinate; lack of energy; lightheadedness when rising from a seated or lying position; muscle jerks; nausea; sedation; sleep disturbance; sleeplessness; tremors; upset stomach.



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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; chest pain; cold, clammy skin; difficulty sleeping; fast or irregular heartbeat; feelings of irritability or hostility; impotence; impulsive behavior or other unusual change in behavior; nausea; neck stiffness; panic attacks; pounding in the chest; sensitivity to light; severe headache; severe high blood pressure; severe nervousness or anxiety; severe restlessness; suicidal thoughts or behaviors; sweating; tightness in the throat or chest; vomiting; widened pupils; worsening feelings of depression; 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: Isocarboxazid 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 agitation; anxiety; cold, clammy skin; coma; confusion; difficulty breathing; dizziness; drowsiness; excitement; faintness; fast breathing; fast heartbeat; fever; flushing; hallucinations; headache; high blood pressure with a severe headache; hyperactivity; incoherence; irritability; jaw stiffness; low blood pressure; movement disorders including grimacing and rigidity; restlessness; seizures; shock; sleeplessness; sweating; unusual muscle movements; weakness.


Proper storage of Isocarboxazid:

Store Isocarboxazid at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Isocarboxazid out of the reach of children and away from pets.


General information:


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

  • Isocarboxazid 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 Isocarboxazid. 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 Isocarboxazid resources


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


  • Isocarboxazid Professional Patient Advice (Wolters Kluwer)

  • isocarboxazid Concise Consumer Information (Cerner Multum)

  • isocarboxazid Advanced Consumer (Micromedex) - Includes Dosage Information

  • Marplan Prescribing Information (FDA)



Compare Isocarboxazid with other medications


  • Depression


Glipizide



Class: Sulfonylureas
VA Class: HS502
Chemical Name: 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea
Molecular Formula: C21H27N5O4S
CAS Number: 29094-61-9
Brands: Glucotrol, Glucotrol XL, Metaglip

Introduction

Antidiabetic agent; sulfonylurea.1 2 3


Uses for Glipizide


Diabetes Mellitus


Used alone or in fixed combination with metformin as an adjunct to diet for the management of type 2 diabetes mellitus (noninsulin-dependent) in patients whose hyperglycemia cannot be controlled by diet alone.1 2 3 19 27 50 51 52 53 54 55 56 57 58 59 60 95


Used in combination with one or more other oral antidiabetic agents or insulin as an adjunct to diet and exercise in patients who do not achieve adequate glycemic control with diet, exercise, and oral antidiabetic agent monotherapy.95 120 127 128 129 130 139 154 155 157 158 161 159 160 161 162 164


Alternative therapy in some type 2 diabetic patients being treated with insulin.1 2 52 54 Useful in combination with insulin therapy to improve glycemic control and/or decrease insulin dosage in some type 2 diabetic patients.2 67


Not effective as sole therapy for patients with type 1 diabetes mellitus; insulin is necessary.


Not effective as sole therapy in patients with diabetes mellitus complicated by acidosis, ketosis, or coma.1 2


Glipizide Dosage and Administration


General



  • Adjust dosage according to tolerance and urine and/or fasting blood glucose determinations.1 Monitor glycosylated hemoglobin (hemoglobin A1c, HbA1c) to determine minimum effective dosage or detect primary or secondary failure.1 95 153



Administration


Oral Administration


Administer extended-release or conventional tablets once daily, generally with breakfast.1 95 1 Administer conventional tablets approximately 30 minutes before a meal.1 11 32


Administer glipizide in fixed combination with metformin once daily with a meal.153


Some patients may have a more satisfactory response when conventional oral tablets are administered in 2 or 3 divided doses daily.1 2 11 44 50 51 52 53 54 57 58 59 60 When dosage exceeds 15 mg daily as conventional tablets, administer in divided doses before meals of sufficient caloric content.1 2 59


Extended-release tablets should be swallowed whole and should not be divided, chewed, or crushed.95


Dosage


Adults


Diabetes Mellitus

Initial Dosage in Previously Untreated Patients

Oral

Conventional or extended-release tablets: Initially, 5 mg daily.1 95 Titrate dosage of conventional tablets in increments of 2.5–5 mg daily at intervals of at least several days1 (usually 3–7 days).2 51 54 59 60 Maximum once daily dosage, 15 mg.1


For extended-release tablets, dosage adjustment should be based on at least 2 similar consecutive fasting glucose concentrations obtained at least 7 days after the previous dose adjustment.95


Initial Dosage in Patients Transferred from Conventional to Extended-release Tablets

Oral

When transferring, administer the nearest equivalent total daily dosage once daily.95 Alternatively, 5 mg once daily as extended-release tablets and titrate dosage.95


Initial Dosage in Patients Transferred from Other Oral Antidiabetic Agents

Oral

Individualize initial dosage of glipizide; usually 5–10 mg daily.90 92 The other oral antidiabetic agent may be discontinued abruptly.1 95


Patients being transferred from a sulfonylurea agent with a longer half life (e.g., chlorpropamide) should be closely monitored for the occurrence of hypoglycemia during the initial 1–2 weeks.1 95 A drug-free interval of 2–3 days may be advisable before glipizide therapy is initiated as conventional tablets in patients being transferred from chlorpropamide, particularly if blood glucose concentration was adequately controlled with chlorpropamide.90 92


Initial Dosage in Patients Transferred from Insulin

Oral

Initially, 5 mg once daily, if insulin requirements were ≤20 units daily.1 Abruptly discontinue insulin.1


5 mg once daily if insulin requirements were >20 units daily, and reduce insulin dosage by 50%.1 Withdraw insulin gradually and adjust glipizide dosage in increments of 2.5–5 mg daily at intervals of at least several days.1


Maintenance Dosage

Oral

Maintenance dosage varies considerably, ranging from 2.5–40 mg daily.1 2 7 27 39 40 41 42 43 44 50 51 52 53 54 56 57 58 59 60 Most patients require 5–25 mg daily as conventional tablets27 39 40 41 42 43 44 50 51 52 53 54 56 57 58 59 60 or 5–10 mg daily as extended-release tablets, but higher dosages may be necessary.7 25 95


Combination Therapy with Other Oral Antidiabetic Agents

Oral

When added to therapy with other antidiabetic agents, the glipizide extended-release tablets may be initiated at a dosage of 5 mg daily.95 Base titration on clinical judgment.95


Fixed combination: 2.5 mg of glipizide and 250 mg of metformin hydrochloride once daily with a meal in treatment-naive patients.153


For more severe hyperglycemia (i.e., fasting plasma glucose concentrations of 280–320 mg/dL), 2.5 mg of glipizide and 500 mg of metformin hydrochloride twice daily.153


Dosage may be increased in increments of one tablet153 (using the tablet strength at which therapy was initiated, either 2.5 mg glipizide/250 mg metformin hydrochloride or 2.5 mg glipizide/500 mg metformin hydrochloride)163 daily every 2 weeks until the minimum effective dosage required to achieve adequate glycemic control is reached.153


Maximum daily dosage, 10 mg of glipizide and 2 g of metformin hydrochloride.153


In previously treated patients with inadequate glycemic control with monotherapy, 2.5 or 5 mg of glipizide and 500 mg of metformin hydrochloride twice daily with the morning and evening meals.153


The initial dosage of the fixed combination should not exceed the daily dosage of glipizide or metformin hydrochloride previously received.153


Titrate upward in increments not exceeding 5 mg of glipizide and 500 mg of metformin hydrochloride until adequate glycemic control is reached.153


Maximum daily dosage, 20 mg of glipizide and 2 g of metformin hydrochloride in previously treated patients.153


For patients previouly receiving both glipizide (or another sulfonylurea antidiabetic agent) and metformin, the initial dosage of the fixed-combination preparation should not exceed the daily dosages of glipizide (or equivalent dosage of another sulfonylurea) and metformin hydrochloride currently being taken.153 158 Such patients should be monitored for signs and symptoms of hypoglycemia following the switch.153 In the transfer, the decision to switch to the nearest equivalent dosage or to titrate dosage is based on clinical judgment.153


Prescribing Limits


Adults


Diabetes Mellitus

Oral

Maximum once-daily dose as conventional tablets is 15 mg.1


Maximum total daily dosage is 40 mg as divided doses of conventional tablets or 20 mg as extended-release tablets.1 95


Maximum daily dosage of the fixed combination, 10 mg of glipizide and 2 g of metformin hydrochloride.153


Special Populations


Hepatic Impairment


Conventional tablets: Initially, 2.5 mg daily;1 conservative maintenance dosage.1


Extended-release tablets: Use conservative initial and maintenance dosage.1


Adjust dosage carefully.1 27 71


Generally, do not use in patients with severe hepatic impairment.2 65 72


Renal Impairment


Use conservative initial and maintenance dosage.1 95


Use generally not recommended in patients with severe renal impairment.2 65 72


Cautious dosing recommended.


Geriatric Patients


Conventional tablets: Initially, 2.5 mg daily.1


Initially, 5 mg (extended-release tablets) may be used.1 95


Use conservative initial and maintenance dosage of glipizide-containing formulations.1 95 153


Adjust dosage carefully.1 Any dosage adjustment of glipizide in fixed combination with metformin hydrochloride requires careful assessment of renal function.153


Dosage of glipizide and metformin hydrochloride in fixed combination should not be titrated to the maximum dosage.


Debilitated or Malnourished Patients


Conservative initial and maintenance dosage of conventional and extended-release tablets.1 95


Dosage of glipizide and metformin hydrochloride in fixed combination should not be titrated to the maximum dosage.153


Cautions for Glipizide


Contraindications



  • Known hypersensitivity to glipizide or any ingredient in the formulation.1




  • Diabetes mellitus complicated by acidosis, ketosis, or coma; use of insulin is necessary.1 2




  • Monotherapy for type 1 diabetes mellitus.



Warnings/Precautions


Warnings


Cardiovascular Effects

Possible increased cardiovascular mortality reported with other sulfonylurea antidiabetic agents (i.e., tolbutamide or phenformin).1 75 However, the American Diabetes Association considers the benefits of intensive glycemic control with insulin or sulfonylureas to outweigh the risks overall.97 107 113


General Precautions


Hypoglycemia

Reported infrequently; usually mild;2 27 50 58 59 60 Possible severe hypoglycemia, especially geriatric patients, malnourished patients, and those with adrenal, pituitary, hepatic, or renal insufficiency.1 27 70 71 Strenuous exercise, alcohol ingestion, insufficient caloric intake, or use in combination with other antidiabetic agents may increase risk.1


Appropriate patient selection and careful attention to dosage are important to avoid glipizide-induced hypoglycemia.


Concurrent Illness

Possible loss of glycemic control during periods of stress (e.g., fever of any cause, trauma, infection, surgery).1 2


Temporary discontinuance of glipizide and administration of insulin may be required.1


GI Disease

Use extended-release tablets with caution in patients with severe preexisting GI narrowing, since obstruction may occur.95


Use of Fixed Combinations

When use in fixed combination with metformin hydrochloride, consider the cautions, precautions, and contraindications associated with metformin.


Specific Populations


Pregnancy

Category C.1


Many experts recommend that insulin be used during pregnancy.1 95


Lactation

Not known whether glipizide is distributed into milk;1 discontinue nursing or the drug.1


Pediatric Use

Safety and efficacy not established.1 However, the ADA states that use may be considered in children with type 2 diabetes mellitus because of greater compliance and convenience and lack of evidence demonstrating better efficacy of insulin for type 2 diabetes mellitus.117


Geriatric Use

Increased risk of hypoglycemia.1 27 71 Cautious dosing recommended.1 27 71


Hepatic Impairment

Increased risk of hypoglycemia.1 27 71 Cautious dosing recommended.1 27 71 (See Hepatic Impairment under Dosage and Administration.)


Generally, not recommended in severe impairment.2 65 72


Renal Impairment

Increased risk of hypoglycemia.1 27 71 Cautious dosing recommended.1 27 71 (See Renal Impairment under Dosage and Administration.)


Generally, not recommended in severe impairment.2 65 72


Common Adverse Effects


With conventional tablets, nausea,1 50 anorexia,50 vomiting,50 pyrosis,50 gastralgia,1 diarrhea,1 and constipation.1 2 50


With extended-release tablets, asthenia, headache, pain, dizziness, nervousness, tremor, diarrhea, hypoglycemia, and flatulence.95 With glipizide in fixed combination with metformin hydrochloride, upper respiratory tract infection, diarrhea, dizziness, hypertension, nausea/vomiting, musculoskeletal pain, headache, abdominal pain, and urinary tract infection.153


Interactions for Glipizide


Protein-bound Drugs


Potential pharmacokinetic interaction with other protein-bound drugs.1 2 47 72 80


Use with caution with protein-bound drugs.1


Specific Drugs























































































Drug



Interaction



Comments



Alcohol



Rarely, disulfiram like reactions1



Antifungals



Increased plasma concentrations of glipizide and hypoglycemic effect95



Anticoagulants, oral



Glipizide could displace or be displaced by oral anticoagulants from plasma protein binding sites1 2 47 72 80



Use with caution with protein-bound drugs1



β-Adrenergic blocking agents



Impaired glucose tolerance; increased frequency or severity of hypoglycemia and hypoglycemia-induced complications62 72 80



If concomitant therapy is necessary, a β1-selective adrenergic blocking agent may be preferred62 72



Calcium-channel blocking agents



May exacerbate diabetes mellitus1



Observe closely when concurrent therapy is initiated or discontinued1



Chloramphenicol



Increases hypoglycemic effect1 2 62 72 80



Observe closely when concurrent therapy is initiated or discontinued1



Cimetidine



Inhibits the hepatic metabolism of glipizide and potentiate hypoglycemic effect83



Glipizide dosage adjustment may be necessary when cimetidine therapy is initated or discontinued83



Contraceptives, oral



May exacerbate diabetes mellitus1 72 80



Observe closely when concurrent therapy is initiated or discontinued1



Corticosteroids



May exacerbate diabetes mellitus1 72 80



Observe closely when concurrent therapy is initiated or discontinued1



Dicumarol



Does not displace dicumarol from plasma protein binding sites1 81 82



Use with caution with protein-bound drugs1



Diuretics, nonthiazide



May exacerbate diabetes mellitus1 72 80



Observe closely when concurrent therapy is initiated or discontinued1



Diuretics, thiazide



May exacerbate diabetes mellitus72 80 84



Increased antidiabetic requirements72 80 84



Estrogens



May exacerbate diabetes mellitus1 72



Observe closely when concurrent therapy is initiated or discontinued1



Hydantoins



Glipizide could displace or be displaced by hydantoins from plasma protein binding sites1 2 47 72 80



Use with caution with protein-bound drugs1



Indoprofen



Does not displace indoprofen from plasma protein binding sites1 81 82



Use with caution with protein-bound drugs1



Isoniazid



May exacerbate diabetes mellitus1



Observe closely when concurrent therapy is initiated or discontinued1



MAO inhibitors



Increases hypoglycemic effects1 2 72 80



Observe closely when concurrent therapy is initiated or discontinued1



Niacin



May exacerbate diabetes mellitus1



Observe closely when concurrent therapy is initiated or discontinued1



NSAIAs



Glipizide could displace or be displaced by nonsteroidal anti-inflammatory agents from plasma protein binding sites1 2 47 72 80



Use with caution with protein-bound drugs1



Phenothiazines



May exacerbate diabetes mellitus1 72 80



Observe closely when concurrent therapy is initiated or discontinued1



Phenytoin



May exacerbate diabetes mellitus1 72 72



Observe closely when concurrent therapy is initiated or discontinued1



Probenecid



Increases hypoglycemic effects1 72 80



Observe closely when concurrent therapy is initiated or discontinued1



Rifampin



May exacerbate diabetes mellitus72 80



Observe closely when concurrent therapy is initiated or discontinued1



Salicylate



Does not displace salicylate from plasma protein binding sites1 81 82



Use with caution with protein-bound drugs1



Sulfonamides



Glipizide could displace or be displaced by sulfonamides from plasma protein binding sites1 2 47 72 80



Use with caution with protein-bound drugs1



Sympathomimetic agents



May exacerbate diabetes mellitus1 72



Observe closely when concurrent therapy is initiated or discontinued1



Thyroid agents



May exacerbate diabetes mellitus1 72 80



Observe closely when concurrent therapy is initiated or discontinued1


Glipizide Pharmacokinetics


Absorption


Bioavailability


Absorption is essentially complete; 1 30 31 32 33 34 35 36 37 38 80–100% of an oral dose may be absorbed.30 31 95


Onset


15–30 minutes.6 32 33


Duration


In nonfasting diabetic patients, the hypoglycemic action may persist for up to 24 hours.1 39 40 41 42 43 44


Food


Food delays the absorption of conventional tablets but does not affect peak serum concentrations achieved or the extent of absorption of the drug.32 33 Peak serum concentrations following administration of conventional tablets generally are delayed 20–40 minutes in the nonfasting state compared with the fasting state.1 32 33


Peak plasma concentrations of glipizide following adminsitration in fixed combination with metformin hydrochloride with food are delayed by 1 hour.153


Food does not affect the glycemic response or the time to absorption of extended-release tablets.95 Peak blood concentrations following administation of extended-release tablets and food are increased.95


Distribution


Extent


Following IV administration in mice, distributed into the liver and blood, with lower concentrations in the lungs, kidneys, adrenals, myocardium, salivary glands, and retroscapular fat.45 In humans, small amounts of glipizide are apparently distributed into bile30 34 37 and very small amounts are distributed into erythrocytes and saliva.30


Not known if glipizide is distributed into milk.1


Plasma Protein Binding


92–99%.30 34 36 46 95


Elimination


Metabolism


Appears to be almost completely metabolized, 30 34 35 36 37 mainly in the liver.1


Elimination Route


Glipizide and its metabolites are excreted principally in urine30 34 35 36 37 (60–90%) and to a lesser extent in feces (5–20%).30 34 35 37 95


95


Half-life


Terminal elimination half-life of glipizide averages 3–4.7 hours following oral administration in patients with normal renal and hepatic function.9 30 31 32 33 34 35 38 39 48


Terminal elimination half-life of total glipizide metabolites ranges from 2–6 hours.37


Special Populations


Renal or hepatic impairment may increase serum glipizide concentrations and reduce elimination.1 37


Severe renal impairment may decrease the renal excretion of and increase the terminal elimination half-life of glipizide metabolites.37


Stability


Storage


Oral


Tablets (conventional)

Tight, light-resistant containers90 at a temperature <30°C.1


Tablets (extended-release)

15–30°C; protect from moisture and humidity.95


Tablets (fixed-combination)

20–25°C (may be exposed to 15–30°C).153


ActionsActions



  • Sulfonylurea antidiabetic agent.1 2 3




  • Lowers blood glucose concentration in diabetic and nondiabetic individuals.2 3 5 6 7 8 9 10 11 12 13




  • Stimulates secretion of postprandial endogenous insulin from the beta cells of the pancreas.1 2 3 5 7 8 9 10 11 12 13




  • During prolonged administration, extrapancreatic effects such as enhanced peripheral sensitivity to insulin and reduction of basal hepatic glucose production contribute to the hypoglycemic action.3 5 7 8 10 12 13 14 16 17 23 24



Advice to Patients



  • Importance of regular clinical and laboratory evaluations, including blood and urine glucose determinations.1




  • Importance of adherence to diet and exercise regimen.1




  • Understanding of primary and secondary failure to oral sulfonylurea antidiabetic agents.1




  • Risks of hypoglycemia, the symptoms and treatment of hypoglycemic reactions, and conditions that predispose to the development of hypoglycemic reactions.1




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1




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




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



Preparations


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


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


























































Glipizide

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Tablets



5 mg*



Glipizide Tablets



Apotex, Mylan, Sandoz, Teva, Watson



Glucotrol (scored)



Pfizer



10 mg*



Glipizide Tablets



Apotex, Mylan, Sandoz, Teva, Watson



Glucotrol (scored)



Pfizer



Tablets, extended-release



2.5 mg*



Glipizide Tablets ER



Andrx, Greenstone



Glucotrol XL



Pfizer



5 mg*



Glipizide Tablets ER



Andrx, Greenstone, Watson



Glucotrol XL



Pfizer



10 mg*



Glipizide Tablets ER



Andrx, Greenstone, Watson



Glucotrol XL



Pfizer


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






































Glipizide Combinations

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Tablets, film-coated



2.5 mg with 250 mg Metformin Hydrochloride*



Glipizide with Metformin Hydrochloride Tablets



CorePharma, Sandoz, Teva



Metaglip



Bristol-Myers Squibb



2.5 mg with 500 mg Meformin Hydrochloride*



Glipizide with Metformin Hydrochloride Tablets



CorePharma, Sandoz, Teva



Metaglip



Bristol-Myers Squibb



5 mg with 500 mg Metformin Hydrochloride*



Glipizide with Metformin Hydrochloride Tablets



CorePharma, Sandoz, Teva



Metaglip



Bristol-Myers Squibb


Comparative Pricing


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


GlipiZIDE 10MG 24-hr Tablets (WATSON LABS): 30/$19.99 or 90/$59.97


GlipiZIDE 10MG Tablets (WATSON LABS): 90/$19.5 or 180/$21.99


GlipiZIDE 5MG Tablets (WATSON LABS): 100/$22.42 or 200/$23.65


GlipiZIDE XL 2.5MG 24-hr Tablets (GREENSTONE): 30/$18.99 or 60/$26.98


GlipiZIDE XL 5MG 24-hr Tablets (GREENSTONE): 30/$15.99 or 90/$34.98


Glucotrol 10MG Tablets (PFIZER U.S.): 60/$79.86 or 180/$219.9


Glucotrol 5MG Tablets (PFIZER U.S.): 60/$49.99 or 180/$125.96


Glucotrol XL 10MG 24-hr Tablets (PFIZER U.S.): 30/$48.99 or 90/$122.97


Glucotrol XL 2.5MG 24-hr Tablets (PFIZER U.S.): 30/$31.99 or 90/$72.97


Glucotrol XL 5MG 24-hr Tablets (PFIZER U.S.): 30/$31.99 or 90/$72.97


Metaglip 2.5-250MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 30/$33.99 or 90/$97.97


Metaglip 5-500MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 30/$42.99 or 90/$109.97



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 June 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



1. Pfizer. Glucotrol (glipizide) tablets prescribing information. New York, NY; 2000 Oct.



2. Brogden RN, Heel RC, Pakes GE et al. Glipizide: a review of its pharmacological properties and therapeutic use. Drugs. 1979; 18:329-53. [IDIS 107972] [PubMed 389600]



3. Jackson JE, Bressler R. Clinical pharmacology of sulphonylurea hypoglycaemic agents: part 1. Drugs. 1981; 22:211-45. [IDIS 140932] [PubMed 7021124]



4. Reynolds JEF, ed. Martindale: the extra pharmacopoeia. 28th ed. London: The Pharmaceutical Press; 1982:855.



5. Skillman TG, Feldman JM. The pharmacology of sulfonylureas. Am J Med. 1981; 70:361-72. [IDIS 164995] [PubMed 6781341]



6. Pisani Ceretti A, Losi S, Orsini G et al. A controlled study of the hypoglycemic and insulinopoietic effect of glipizide and glibenclamide in non-diabetic human subjects. Arzneimittelforschung. 1975; 25:675-6. [IDIS 185762] [PubMed 808231]



7. Greenfield MS, Doberne L, Rosenthal M et al. Effect of sulfonylurea treatment on in vivo insulin secretion and action in patients with non-insulin-dependent diabetes mellitus. Diabetes Care. 1982; 31:307-12.



8. Reaven GM. Effect of glipizide treatment on various aspects of glucose, insulin, and lipid metabolism in patients with noninsulin-dependent diabetes mellitus. Am J Med. 1983; 75(Suppl. 5B):8-14. [IDIS 180370] [PubMed 6369970]



9. Peterson CM, Sims RV, Jones RL et al. Bioavailability of glipizide and its effect on blood glucose and insulin levels in patients with non-insulin-dependent diabetes. Diabetes Care. 1982; 5:497-500. [PubMed 6765225]



10. Lebovitz HE, Feinglos MN. Mechanism of action of the second-generation sulfonylurea glipizide. Am J Med. 1983; 75(Suppl. 5B):46-54. [IDIS 180373] [PubMed 6369967]



11. Sartor G, Scherstén B, Melander A. Effects of glipizide and food intake on the blood levels of glucose and insulin in diabetic patients. Acta Med Scand. 1978; 203:211-4. [PubMed 345754]



12. Feinglos MN, Lebovitz HE. Sulfonylurea treatment of insulin-independent diabetes mellitus. Metabolism. 1980; 29:488-94. [PubMed 6990184]



13. Lebovitz HE, Feinglos MN, Bucholtz HK et al. Potentiation of insulin action: a probable mechanism for the anti-diabetic action of sulfonylurea drugs. J Clin Endocrinol Metab. 1977; 45:601-4. [IDIS 93603] [PubMed 903405]



14. Kolterman OG, Gray RS, Shapiro G et al. The acute and chronic effects of sulfonylurea therapy in type II diabetic subjects. Diabetes. 1984; 33:346-54. [IDIS 184146] [PubMed 6423429]



15. Gurwich EL (The Upjohn Company, Kalamazoo, MI): Personal communication; 1984 Jun 25.



16. DeFronzo RA, Ferrannini E, Koivisto V. New concepts in the pathogenesis and treatment of noninsulin-dependent diabetes mellitus. Am J Med. 1983; 74(Suppl. 1A):52-81. [IDIS 164138] [PubMed 6337486]



17. Lockwood DH, Maloff BL, Nowak SM et al. Extrapancreatic effects of sulfonylureas: potentiation of insulin action through post-binding mechanisms. Am J Med. 1983; 74(Suppl. 1A):102-8. [PubMed 6401922]



18. Larner J. Mediators of postreceptor action of insulin. Am J Med. 1983; 74(Suppl. 1A):38-51. [PubMed 6297300]



19. Fineberg SE, Schneider SH. Glipizide versus tolbutamide, an open trial: effects on insulin secretory patterns and glucose concentrations. Diabetologia. 1980; 18:49-54. [PubMed 6988265]



20. Marco J, Valverde I. Unaltered glucagon secretion after seven days of sulphonylurea administration in normal subjects. Diabe


HBVAXPRO 5mcg





1. Name Of The Medicinal Product



HBVAXPRO 5 micrograms, suspension for injection in pre-filled syringe



Hepatitis B vaccine (rDNA)


2. Qualitative And Quantitative Composition



One dose (0.5 ml) contains:



Hepatitis B virus surface antigen, recombinant (HBsAg) *.................. 5 micrograms



Adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.25 milligram Al+)



* produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast by recombinant DNA technology.



This vaccine may contain traces of formaldehyde and potassium thiocyanate, which are used during the manufacturing process. See section 4.3, 4.4 and 4.8.



For a full list of excipients, see section 6.1



3. Pharmaceutical Form



Suspension for injection in pre-filled syringe



Slightly opaque white suspension.



4. Clinical Particulars



4.1 Therapeutic Indications



HBVAXPRO is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis B virus.



The specific at risk categories to be immunised are to be determined on the basis of the official recommendations.



It can be expected that hepatitis D will also be prevented by immunisation with HBVAXPRO as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.



4.2 Posology And Method Of Administration



Posology



Individuals from birth through 15 years of age: 1 dose (0.5 ml) at each injection.



Primary vaccination:



A course of vaccination should include at least three injections.



Two primary immunisation schedules can be recommended:



0 , 1, 6 months: two injections with an interval of one month; a third injection 6 months after the first administration.



0 , 1, 2, 12 months: three injections with an interval of one month; a fourth dose should be administered at 12 months.



It is recommended that the vaccine be administered in the schedules indicated. Infants receiving the compressed regimen (0, 1, 2 months dosing schedule) must receive the 12 month booster to induce higher antibody titres.



Booster:



Immunocompetent vaccinees



The need for a booster dose in healthy individuals who have received a full primary vaccination course has not been established. However, some local vaccination schedules currently include a recommendation for a booster dose and these should be respected.



Immunocompromised vaccinees (e.g. dialysis patients, transplant patients, AIDS Patients)



In vaccinees with an impaired immune system, administration of additional doses of vaccine should be considered if the antibody level against hepatitis B virus surface antigen (anti-HBsAg) is less than 10 IU/l.



Revaccination of nonresponders



When persons who do not respond to the primary vaccine series are revaccinated, 15-25 % produce an adequate antibody response after one additional dose and 30-50 % after three additional doses. However, because data are insufficient concerning the safety of hepatitis B vaccine when additional doses in excess of the recommended series are administered, revaccination following completion of the primary series is not routinely recommended. Revaccination should be considered for high-risk individuals, after weighing the benefits of vaccination against the potential risk of experiencing increased local or systemic adverse reactions.



Special dosage recommendations:



Dosage recommendations for neonates born to mothers who are hepatitis B virus carriers



- At birth, one dose of hepatitis B immunoglobulin (within 24 hours).



- The first dose of the vaccine should be given within 7 days of birth and can be administered simultaneously with hepatitis B immunoglobulin at birth, but at a separate injection site.



- Subsequent doses of vaccine should be given according to the locally recommended vaccination schedule.



Dosage recommendation for known or presumed exposure to hepatitis B virus (e.g needlestick with contaminated needle)



- Hepatitis B immunoglobulin should be given as soon as possible after exposure (within 24 hours).



- The first dose of the vaccine should be given within 7 days of exposure and can be administered simultaneously with hepatitis B immunoglobulin but at a separate injection site.



- Serologic testing is also recommended, with the administration of subsequent doses of vaccine, if necessary, (i.e according to the serologic status of the patient) for short and long term protection.



- In the case of unvaccinated or incompletely vaccinated individuals, additional doses should be given as in the recommended immunisation schedule. The accelerated schedule including the 12 month booster dose can be proposed.



Method of administration



This vaccine should be administered intramuscularly.



The anterolateral thigh is the preferred site for injection in neonates and infants. The deltoid muscle is the preferred site for injection in children and adolescents.



Do not inject intravascularly.



Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopoenia or bleeding disorders.



Precautions to be taken before handling or administering the product: see section 6.6.



4.3 Contraindications



- History of hypersensitivity to the active substance, or to any of the excipients, or trace residuals (e.g. formaldehyde and potassium thiocyanate) (see sections 6.1 and 2)



- Vaccination should be postponed in individuals with a severe febrile illness or acute infection.



4.4 Special Warnings And Precautions For Use



As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine (see section 4.8).



This vaccine may contain traces of formaldehyde and potassium thiocyanate which are used during the manufacturing process. Therefore, hypersensitivity reactions may occur (see sections 2 and 4.8).



Use caution when vaccinating latex-sensitive individuals since the vial stopper contains dry natural latex rubber that may cause allergic reactions.



For clinical or laboratory monitoring regarding immunocompromised individuals or individuals with known or presumed exposure to hepatitis B virus, see section 4.2.



The potential risk of apnoea and the need for respiratory monitoring for 48 to 72 hours should be considered when administering the primary immunisation series to very premature infants (born



Because of the long incubation period of hepatitis B, it is possible for unrecognised hepatitis B infection to be present at the time of vaccination. The vaccine may not prevent hepatitis B infection in such cases.



The vaccine will not prevent infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E and other pathogens known to infect the liver.



Caution should be exercised when prescribing to pregnant or breast-feeding women. (see section 4.6).



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



This vaccine can be administered:



- with hepatitis B immunoglobulin, at a separate injection site.



- to complete a primary immunisation course or as a booster dose in subjects who have previously received another hepatitis B vaccine.



- concomitantly with other vaccines, using separate sites and syringes.



The concomitant administration of pneumococcal conjugate vaccine (PREVENAR) given with hepatitis B vaccine using the 0, 1 and 6 and 0, 1, 2 and 12 month schedules has not been sufficiently studied.



4.6 Pregnancy And Lactation



Fertility:



HBVAXPRO has not been evaluated in fertility studies.



Pregnancy:



There is no clinical data on the use of HBVAXPRO on pregnant women.



The vaccine should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.



Breast-feeding:



There is no clinical data on the use of HBVAXPRO on breast-feeding women.



4.7 Effects On Ability To Drive And Use Machines



No studies on the effects on the ability to drive and use machines have been performed. However, HBVAXPRO is expected to have no or negligible influence on the ability to drive and use machines.



4.8 Undesirable Effects



a. Summary of the safety profile



The most common side effects seen are injection-site reactions: transient soreness, erythema, induration.



b. Tabulated summary of adverse reactions



The following undesirable effects have been reported following the widespread use of the vaccine.



As with other hepatitis B vaccines, in many instances, the causal relationship to the vaccine has not been established.
















































Adverse reactions




Frequency




General disorders and administration site conditions


 


Local reactions (injection site): Transient soreness, Erythema, Induration




Common (




Fatigue, Fever, Malaise, Influenza-like symptoms




Very rare (<1/10,000)




Blood and the lymphatic system disorders


 


Thrombocytopenia, Lymphadenopathy




Very rare (<1/10,000)




Immune system disorders


 


Serum sickness, Anaphylaxis, Polyarteritis nodosa




Very rare (<1/10,000)




Nervous system disorders


 


Paresthesia, Paralysis (including Bell's palsy, facial paralysis), Peripheral neuropathies (polyradiculoneuritis, Guillain Barre Syndrome), Neuritis (including optical neuritis), Myelitis (including transverse Myelitis), Encephalitis, Demyelinating disease of the central nervous system, Exacerbation of multiple sclerosis, Multiple sclerosis, Seizure, Headache, Dizziness, Syncope




Very rare (<1/10,000)




Vascular disorders


 


Hypotension, Vasculitis




Very rare (<1/10,000)




Respiratory, thoracic and mediastinal disorders


 


Bronchospasm-like symptoms




Very rare (<1/10,000)




Gastrointestinal disorders


 


Vomiting, Nausea, Diarrhoea, Abdominal pain




Very rare (<1/10,000)




Skin and subcutaneous tissue disorders


 


Rash, Alopecia, Pruritus, Urticaria, Erythema multiforme, Angioedema, Eczema




Very rare (<1/10,000)




Musculoskeletal, connective tissue and bone disorders


 


Arthralgia, Arthritis, Myalgia, Pain in extremity




Very rare (<1/10,000)




Investigations


 


Elevation of liver enzymes




Very rare (<1/10,000)



c. Other special population



Apnoea in very premature infants (born



4.9 Overdose



There have been reports of administration of higher than recommended doses of HBVAXPRO.



In general, the adverse event profile reported with overdose was comparable to that observed with the recommended dose of HBVAXPRO.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Pharmacotherapeutic group: anti-infectious, ATC code: J07BC01



The vaccine induces specific humoral antibodies against hepatitis B virus surface antigen (anti-HBsAg). Development of an antibody titre against hepatitis B virus surface antigen (anti-HBsAg) equal to or greater than 10 IU/l measured 1 to 2 months after the last injection correlates with protection to hepatitis B virus infection.



In clinical trials, 96 % of 1,497 healthy infants, children, adolescents and adults given a 3 dose course of a previous formulation of Merck's recombinant hepatitis B vaccine developed a protective level of antibodies against hepatitis B virus surface antigen (



The protective efficacy of a dose of hepatitis B immunoglobulin at birth followed by 3 doses of a previous formulation of Merck's recombinant hepatitis B vaccine has been demonstrated for neonates born to mothers positive for both hepatitis B virus surface antigen (HBsAg) and hepatitis B virus e antigen (HBeAg). Among 130 vaccinated infants, the estimated efficacy in prevention of chronic hepatitis B infection was 95 % as compared to the infection rate in untreated historical controls.



Although the duration of the protective effect of a previous formulation of Merck's recombinant hepatitis B vaccine in healthy vaccinees is unknown, follow-up over 5-9 years of approximately 3,000 high-risk subjects given a similar plasma-derived vaccine has revealed no cases of clinically apparent hepatitis B infection.



In addition, persistence of vaccine-induced immunologic memory for hepatitis B virus surface antigen (HBsAg) has been demonstrated through an anamnestic antibody response to a booster dose of a previous formulation of Merck's recombinant hepatitis B vaccine. As with other hepatitis B vaccines, the duration of the protective effect in healthy vaccinees is unknown at present. The need for a booster dose of HBVAXPRO is not yet defined beyond the 12 month booster dose required for the 0, 1, 2 compressed schedule.



Reduced risk of Hepatocellular Carcinoma



Hepatocellular carcinoma is a serious complication of hepatitis B virus infection. Studies have demonstrated the link between chronic hepatitis B infection and hepatocellular carcinoma and 80 % of hepatocellular carcinomas are caused by hepatitis B virus infection. Hepatitis B vaccine has been recognized as the first anti-cancer vaccine because it can prevent primary liver cancer.



5.2 Pharmacokinetic Properties



Not applicable.



5.3 Preclinical Safety Data



Animal reproduction studies have not been conducted.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Sodium chloride



Borax



Water for injections



6.2 Incompatibilities



In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.



6.3 Shelf Life



3 years.



6.4 Special Precautions For Storage



Store in a refrigerator (2 °C – 8 °C).



Do not freeze.



6.5 Nature And Contents Of Container



0.5 ml of suspension in pre-filled syringe (glass) without needle with a plunger stopper (gray chlorobutyl ). Pack size of 1, 10, 20, 50.



0.5 ml of suspension in pre-filled syringe (glass) with 1 separate needle with a plunger stopper (gray chlorobutyl). Pack size of 1, 10.



0.5 ml of suspension in pre-filled syringe (glass) with 2 separate needles with a plunger stopper (gray chlorobutyl). Pack size of 1, 10, 20, 50.



Not all pack sizes may be marketed.



6.6 Special Precautions For Disposal And Other Handling



The vaccine should be inspected visually in order to detect any appearance of precipitate or discolouring of the content prior to administration. If these conditions exist, the product should not be administered.



Before use, the syringe should be well shaken.



Hold the syringe barrel and attach the needle by twisting in clockwise direction, until the needle fits securely on the syringe.



Any unused product or waste material should be disposed of in accordance with local requirements.



7. Marketing Authorisation Holder



SANOFI PASTEUR MSD SNC



8, rue Jonas Salk



F-69007 Lyon



France



8. Marketing Authorisation Number(S)



EU/1/01/183/004



EU/1/01/183/005



EU/1/01/183/020



EU/1/01/183/021



EU/1/01/183/022



EU/1/01/183/023



EU/1/01/183/024



EU/1/01/183/025



EU/1/01/183/030



EU/1/01/183/031



9. Date Of First Authorisation/Renewal Of The Authorisation



Date of first authorisation: 27/04/2001



Date of latest renewal: 04/08/2006



10. Date Of Revision Of The Text



03/2011



Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu





Ginkgo Biloba Controlled-Release Tablets


Pronunciation: Not applicable.
Generic Name: Ginkgo Biloba
Brand Name: Generics only. No brands available.


Ginkgo Biloba Controlled-Release Tablets are used for:

Circulation and memory loss due to brain conditions such as stroke, Alzheimer disease, and dementia. It may also have other uses. Check with your pharmacist for more details regarding the particular brand you use.


Ginkgo Biloba Controlled-Release Tablets are an herbal product. It works by increasing blood flow to the brain.


Do NOT use Ginkgo Biloba Controlled-Release Tablets if:


  • you are allergic to any ingredient in Ginkgo Biloba Controlled-Release Tablets

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



Before using Ginkgo Biloba Controlled-Release Tablets:


Some medical conditions may interact with Ginkgo Biloba Controlled-Release Tablets. 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 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 disorders or bleeding conditions

Some MEDICINES MAY INTERACT with Ginkgo Biloba Controlled-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Nonsteroidal anti-inflammatory drugs (NSAIDs; eg, aspirin, ibuprofen) or warfarin because the risk of serious bleeding may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ginkgo Biloba Controlled-Release Tablets 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 Ginkgo Biloba Controlled-Release Tablets:


Use Ginkgo Biloba Controlled-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Dosing depends on the use and the source of the product.

  • Use as directed on the package, unless instructed otherwise by your doctor.

  • Swallow whole. Do not break, crush, or chew before swallowing.

  • If you miss taking a dose of Ginkgo Biloba Controlled-Release Tablets for 1 or more days, there is no cause for concern. If your doctor recommended that you take it, try to remember your dose every day.

Ask your health care provider any questions you may have about how to use Ginkgo Biloba Controlled-Release Tablets.



Important safety information:


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

  • If you are using this product for brain conditions, consult your doctor or pharmacist. A medical evaluation or prescription medicine may be needed to treat your condition.

  • Do not exceed the recommended dose or take this product for longer than 3 months without checking with your doctor.

  • Check with your doctor before you begin taking any new medicine, either prescription or over-the-counter, including any medicine that contains aspirin or other NSAIDs (eg, ibuprofen).

  • This product has not been approved by the Food and Drug Administration (FDA) as safe and effective for any medical condition. The long-term safety of herbal products is not known. Before using any alternative medicine, talk with your doctor or pharmacist.

  • This product is not recommended for use in CHILDREN.

  • PREGNANCY and BREAST-FEEDING: Use of Ginkgo Biloba Controlled-Release Tablets are not recommended if you are pregnant or breast-feeding. If you plan on becoming pregnant, discuss with your doctor the risks of using this product during pregnancy.


Possible side effects of Ginkgo Biloba Controlled-Release Tablets:


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:



Diarrhea; dizziness; gas; headache; nausea; stomach upset.



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); fainting; pounding in the chest; skin redness; trouble speaking; unusual bruising or bleeding; 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: Ginkgo Biloba 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 seizures.


Proper storage of Ginkgo Biloba Controlled-Release Tablets:

Store at room temperature away from heat, moisture, and light unless otherwise directed on the package label. Do not store in the bathroom. Most herbal products are not in childproof containers. Keep Ginkgo Biloba Controlled-Release Tablets out of the reach of children and away from pets.


General information:


  • If you have any questions about Ginkgo Biloba Controlled-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.

  • Ginkgo Biloba Controlled-Release Tablets are 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 Ginkgo Biloba Controlled-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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