Wednesday, September 21, 2016

Mavik


Generic Name: trandolapril (tran DOE la pril)

Brand Names: Mavik


What is Mavik (trandolapril)?

Trandolapril is an ACE inhibitor. ACE stands for angiotensin converting enzyme.


Trandolapril is used to treat high blood pressure (hypertension), and to improve survival after a heart attack.


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


What is the most important information I should know about Mavik (trandolapril)?


Do not use trandolapril if you are pregnant. It could harm the unborn baby. Stop using this medication and tell your doctor right away if you become pregnant. You should not use this medicine if you are allergic to trandolapril or similar medicines, such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), or ramipril (Altace). Avoid drinking alcohol. It can further lower your blood pressure and may increase some of the side effects of trandolapril. Do not use salt substitutes or potassium supplements while taking trandolapril, unless your doctor has told you to. Follow your doctor's instructions about the type and amount of liquids you should drink while taking trandolapril. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

What should I discuss with my healthcare provider before taking Mavik (trandolapril)?


You should not use this medicine if you are allergic to trandolapril or to any other ACE inhibitor, such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), or ramipril (Altace).

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



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




  • liver disease;




  • heart disease or congestive heart failure;




  • diabetes; or




  • a connective tissue disease such as Marfan syndrome, Sjogren's syndrome, lupus, scleroderma, or rheumatoid arthritis.




FDA pregnancy category D. Do not use trandolapril if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Trandolapril can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control while taking trandolapril. Trandolapril can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using trandolapril.

How should I take Mavik (trandolapril)?


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


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


Trandolapril can be taken with or without food.


Conditions that may cause very low blood pressure include: vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low salt diet, or taking diuretics (water pills). Follow your doctor's instructions about the type and amount of liquids you should drink while taking trandolapril. Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Your blood pressure will need to be checked often. Your kidney or liver function may also need to be tested. Visit your doctor regularly.


If you need surgery, tell the surgeon ahead of time that you are using trandolapril.

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


Store at room temperature away from moisture and heat.

What happens if I miss a dose?


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


What happens if I overdose?


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

Overdose symptoms may include feeling extremely dizzy or light-headed, or fainting.


What should I avoid while taking Mavik (trandolapril)?


Avoid drinking alcohol. It can further lower your blood pressure and may increase some of the side effects of trandolapril. Do not use salt substitutes or potassium supplements while taking trandolapril, unless your doctor has told you to.

Mavik (trandolapril) side effects


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

  • urinating less than usual, or not at all;




  • swelling, weight gain, feeling short of breath;




  • feeling like you might pass out;




  • chest pain, trouble breathing;




  • pounding heartbeats or fluttering in your chest;




  • fever, chills, body aches, flu symptoms;




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




  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling); or




  • low calcium (numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes).



Less serious side effects may include:



  • cold symptoms such as stuffy nose, sneezing, sore throat;




  • cough;




  • muscle pain;




  • dizziness, drowsiness, headache;




  • sleep problems (insomnia);




  • upset stomach, diarrhea, constipation; or




  • mild skin itching or rash.



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


What other drugs will affect Mavik (trandolapril)?


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



  • gold injections to treat arthritis;




  • lithium (Lithobid, Eskalith);




  • a diuretic (water pill); or




  • aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others.



This list is not complete and other drugs may interact with trandolapril. 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 Mavik resources


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


  • Mavik Prescribing Information (FDA)

  • Mavik MedFacts Consumer Leaflet (Wolters Kluwer)

  • Mavik Monograph (AHFS DI)

  • Mavik Advanced Consumer (Micromedex) - Includes Dosage Information

  • Trandolapril Prescribing Information (FDA)

  • Trandolapril Professional Patient Advice (Wolters Kluwer)



Compare Mavik with other medications


  • Diabetic Kidney Disease
  • Heart Attack
  • Heart Failure
  • High Blood Pressure
  • Left Ventricular Dysfunction


Where can I get more information?


  • Your pharmacist can provide more information about trandolapril.

See also: Mavik side effects (in more detail)


Metahistine D


Generic Name: pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine (fen IR a meen/pie RILL a meen/fen ill toe LOX a meen/fen ill proe pa NOLE a meen)

Brand Names: Delhist D, Delhistine D, Histine-D, Iohist D, KG-Hist D, Liqui-Histine-D, Metahistine D, Multihist D, Multihistamine-D, Poly-D, Poly-Histine-D, Prohistine-D, Trihist-D


What is Metahistine D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?

Pheniramine, pyrilamine, and phenyltoloxamine are antihistamines. They block the effects of the naturally occurring chemical histamine in the body. Pheniramine, pyrilamine, and phenyltoloxamine prevent sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.


Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow to certain areas and allows nasal and respiratory (breathing) passages to open up.


Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine is used to treat nasal congestion and sinusitis (inflammation of the sinuses) associated with allergies, hay fever, and the common cold.


Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.


Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about Metahistine D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?


Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.


Use caution when driving, operating machinery, or performing other hazardous activities. Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking this medication.

Do not take more of this medication than is recommended. If your symptoms do not improve, or if they worsen, talk to your doctor.


Who should not take Metahistine D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?


Do not take pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have


  • kidney disease,

  • liver disease,


  • diabetes,




  • glaucoma,




  • any type of heart disease or high blood pressure,




  • thyroid disease,




  • emphysema or chronic bronchitis, or




  • difficulty urinating or an enlarged prostate.



You may not be able to take pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.


Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine passes into breast milk and may harm a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine. You may require a lower dose of this medication. Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions.

How should I take Metahistine D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?


Take pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.


Take each dose with a full glass of water. Do not crush, chew, or break the long-acting or sustained-release forms of this medication. Swallow them whole. If you are unsure about the formulation of the medicine, ask your pharmacist for help.

If you cannot swallow the tablets or capsules, look for a liquid form of this medication.


To ensure that you get a correct dose, measure the liquid form of pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.


Do not take more of this medication than is recommended. An overdose can cause serious harm.

Do not take pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine for longer than 7 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, talk to your doctor.


Store pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?


Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.


What happens if I overdose?


Seek emergency medical attention.

Symptoms of a pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine overdose include a dry mouth, large pupils, flushing, nausea, and vomiting.


What should I avoid while taking Metahistine D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?


Use caution when driving, operating machinery, or performing other hazardous activities. Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine.

Metahistine D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine) side effects


Serious side effects are unlikely to occur. Stop taking pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine and talk to your doctor or try another similar medication if you experience



  • dryness of the eyes, nose, and mouth;




  • drowsiness or dizziness;




  • blurred vision;




  • difficulty urinating; or




  • excitation in children.



Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.


What other drugs will affect Metahistine D (pheniramine/ pyrilamine/ phenyltoloxamine/ phenylpropanolamine)?


Do not take pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Do not take other over-the-counter cough, cold, allergy, diet, or sleep aids while taking pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain pheniramine, pyrilamine, phenyltoloxamine, phenylpropanolamine, or other similar drugs. You may accidentally take too much of these medicines.


Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine is taken with any of these medications.


Drugs other than those listed here may also interact with pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.



More Metahistine D resources


  • Metahistine D Drug Interactions
  • Metahistine D Support Group
  • 0 Reviews for Metahistine D - Add your own review/rating


Compare Metahistine D with other medications


  • Allergies
  • Eye Dryness/Redness
  • Eye Redness/Itching
  • Hay Fever
  • Nasal Congestion
  • Rhinorrhea
  • Sinusitis
  • Upper Respiratory Tract Infection


Where can I get more information?


  • Your pharmacist has additional information about pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine written for health professionals that you may read.

What does my medication look like?


Pheniramine/pyrilamine/phenyltoloxamine/phenylpropanolamine is available with a prescription under the brand names Poly-Histine-D (capsules and elixir) and Liqui-Histine Elixir. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.



Maxitrol Ophthalmic Suspension





Dosage Form: ophthalmic suspension
MAXITROL®

(neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension)

Sterile

DESCRIPTION


MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) is a multiple dose anti-infective steroid combination in sterile suspension form for topical application. The chemical structure for the active ingredient, dexamethasone, is:



Established name: dexamethasone


Chemical name: pregna-1, 4-diene-3, 20-dione, 9-fluoro-11,17, 21-trihydroxy-16-methyl-, (11β, 16α)-.


The other active ingredients are neomycin sulfate and polymyxin B sulfate. The structural formula for neomycin sulfate is:



The structural formula for polymyxin B sulfate is:



Each mL contains: Actives: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Inactives: hypromellose 2910 0.5%, sodium chloride, polysorbate 20, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water, benzalkonium chloride 0.004% (preservative).



CLINICAL PHARMACOLOGY


Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case.


When a decision to administer both a corticosteroid and an antimicrobial is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered, plus assured compatibility of ingredients when both types of drugs are in the same formulation and, particularly, that the correct volume of drug is delivered and retained. The relative potency of corticosteroids depends on the molecular structure, concentration and release from the vehicle.



INDICATIONS AND USAGE


For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists.


Ocular corticosteroids are indicated in inflammatory conditions of the papebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies.


The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.


The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa.


This product does not provide adequate coverage against: Serratia marcesens and streptococci, including Streptococcus pneumoniae.



CONTRAINDICATIONS


MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. MAXITROL® is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.



WARNINGS


Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections.


Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.


Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication.


If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently. The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.


Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.


MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye. Products containing neomycin sulfate may cause cutaneous sensitization.



PRECAUTIONS



General


The initial prescription and renewal of the medication order beyond 20 mL of MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be re-evaluated.


As fungal infections of the cornea are particularly prone to develop coincidentally with long-term corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate.


If this product is used for 10 days or longer, intraocular pressure should be monitored (see WARNINGS). Prolonged use of topical anti-bacterial agents may give rise to overgrowth of nonsusceptible organisms including fungi.



Information for Patients


If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician.


This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Keep bottle tightly closed when not in use. Keep out of reach of children.



Carcinogenesis, Mutagenesis, Impairment of Fertility


Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate. Treatment of cultured human lymphocytes in vitro with neomycin increased the frequency of chromosome aberrations at the highest concentration (80 μg/mL) tested. However, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown. Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown.



Pregnancy



Teratogenic Effects


Pregnancy Category C. Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application in multiples of the therapeutic dose.


In the mouse, corticosteroids produce fetal resorptions and a specific abnormality, cleft palate. In the rabbit, corticosteroids have produced fetal resorptions and multiple abnormalities involving the head, ears, limbs, palate, etc. There are no adequate or well-controlled studies in pregnant women. MAXITROL® Suspension should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.



Nursing Mothers


Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when MAXITROL® Ophthalmic Suspension is administered to a nursing woman.



Pediatric Use


Safety and effectiveness in pediatric patients below the age of 2 years have not been established.



Geriatric Use


No overall differences in safety or effectiveness have been observed between elderly and younger patients.



ADVERSE REACTIONS


Adverse reactions have occurred with corticosteroid/anti-infective combination drugs which can be attributed to the corticosteroid component, the anti-infective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available.


Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitizations. The reactions due to the corticosteroid component are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing. Corticosteroid-containing preparations have also been reported to cause perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, and conjunctival hyperemia have occasionally been reported following use of steroids.



DOSAGE AND ADMINISTRATION


One to two drops in the conjunctival sac(s). In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used up to four to six times daily.


Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.


FOR TOPICAL OPHTHALMIC USE ONLY.



HOW SUPPLIED


MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) is supplied as a sterile ophthalmic suspension in a white, low density polyethylene DROP-TAINER® dispenser with a pink, polypropylene cap.


5 mL in 8 mL bottle (NDC 0998-0630-06)


STORAGE: Store upright at 8° - 27°C (46° - 80° F).


Rx Only



Revised: April 2008


Printed in USA


© 2000, 2007, 2008 Alcon, Inc.


ALCON LABORATORIES, INC.


Fort Worth, Texas 76134 USA


9003574-0408



PRINCIPAL DISPLAY PANEL


NDC 0998-0630-06


Alcon®


Maxitrol®


(neomycin and


polymyxin B sulfates


and dexamethasone


ophthalmic


suspension)


5 mL   Sterile











MAXITROL 
neomycin sulfate, polymyxin b sulfate and dexamethasone  suspension










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)0998-0630
Route of AdministrationOPHTHALMICDEA Schedule    














Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (NEOMYCIN)NEOMYCIN3.5 mg  in 1 mL
POLYMYXIN B SULFATE (POLYMYXIN B)POLYMYXIN B SULFATE10000 [USP'U]  in 1 mL
DEXAMETHASONE (DEXAMETHASONE)DEXAMETHASONE1 mg  in 1 mL


















Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
HYPROMELLOSE 2910 (4000 MPA.S) 
SODIUM CHLORIDE 
POLYSORBATE 20 
HYDROCHLORIC ACID 
SODIUM HYDROXIDE 
WATER 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
10998-0630-065 mL In 1 BOTTLE, PLASTICNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA05002311/15/1964


Labeler - Alcon Laboratories, Inc. (008018525)

Registrant - Alcon Laboratories, Inc. (008018525)









Establishment
NameAddressID/FEIOperations
Alcon Laboratories, Inc.008018525MANUFACTURE
Revised: 08/2011Alcon Laboratories, Inc.

More Maxitrol Ophthalmic Suspension resources


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


  • AK-Trol Concise Consumer Information (Cerner Multum)

  • Maxitrol Concise Consumer Information (Cerner Multum)

  • Maxitrol Drops MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Maxitrol Ophthalmic Suspension with other medications


  • Blepharitis
  • Conjunctivitis, Bacterial
  • Keratitis
  • Keratoconjunctivitis
  • Uveitis

Metformin Hydrochloride



Class: Biguanides
ATC Class: A10BA02
VA Class: HS502
Chemical Name: 1,1-Dimethylbiguanide monohydrochloride
Molecular Formula: C4H11N5•HCl
CAS Number: 1115-70-4
Brands: Actoplus Met, Avandamet, Fortamet, Glucophage, Glucophage XR, Glucovance, Glumetza, Metaglip, Riomet


Special Alerts:


[UPDATED 02/04/2011] FDA notified healthcare professionals and patients that information on the cardiovascular risks (including heart attack) of rosiglitazone has been added to the physician labeling and patient Medication Guide. This information was first announced by FDA on September 23, 2010 as part of new restrictions for prescribing and use of this drug.


Rosiglitazone is sold as a single-ingredient product under the brand name Avandia. Rosiglitazone is also sold as a combination product under the brand name Avandamet (contains rosiglitazone and metformin) and under the brand name Avandaryl (contains rosiglitazone and glimepiride).


In addition to describing the cardiovascular risks, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:



  • In patients already being treated with these medicines




  • In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).




For more information visit the FDA website at: and .

[Posted 09/23/2010] ISSUE: FDA notified healthcare professionals and patients that it will significantly restrict the use of the diabetes drug rosiglitazone (Avandia) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with rosiglitazone


BACKGROUND: Rosiglitazone is in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 diabetes mellitus. Rosiglitazone also is available in combination with other diabetes medications, metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl.


RECOMMENDATION: FDA will require that GSK develop a restricted access program for rosiglitazone under a risk evaluation and mitigation strategy, or REMS. Under the REMS, rosiglitazone will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take pioglitazone (Actos), the only other drug in this class. Current users of rosiglitazone who are benefiting from the drug will be able to continue using the medication if they choose to do so.


Doctors will have to attest to and document their patients' eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks. The agency anticipates that the REMS will limit use of rosiglitazone significantly. For more information visit the FDA website at: and .





  • Lactic acidosis rare but potentially fatal.1 6 18 20 27 29 30 62 89 96 158 Increased risk of lactic acidosis in patients with renal impairment, advanced age, metformin plasma concentrations >5 mcg/mL.1 2 62 96 119




  • Generally has occurred in diabetic patients with severe renal insufficiency who frequently had concomitant medical and/or surgical problems and were receiving multiple drugs.1 2 3 20 50 62 64 76 96 123 158 164 165




  • Periodically monitor renal function and use the minimum effective dosage.1 32 62 63 65 76 85 91 93 96 123 124 158 164 165 Withhold promptly in patients with any condition associated with hypoxemia, sepsis, or dehydration.1 2 62 63 93 Avoid use in patients with clinical or laboratory evidence of hepatic impairment.1 2 63 65 85 91 93 156 158 Discontinue therapy temporarily in patients undergoing surgery or receiving parenteral iodinated radiographic contrast media.1 2 30 62 63 93 158 Drugs that may affect renal function or alter metformin elimination should be used with caution.1




  • Advise patients not to consume excessive amounts of alcohol.1 2 63 76 91 93 158




  • If lactic acidosis occurs, discontinue metformin.1 30 Immediate hospitalization and treatment required.1




Introduction

Antidiabetic agent; a biguanide, chemically and pharmacologically unrelated to sulfonylurea antidiabetic agents.1 2 3 4 18 20 22 23 27 28 29 30 33 72 146 243 245 246


Uses for Metformin Hydrochloride


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 as monotherapy for the management of patients with type 2 diabetes mellitus that cannot be controlled by diet alone.1 3 4 6 8 15 16 17 18 19 20 27 29 95 166


Used in combination with a sulfonylurea, repaglinide, or thiazolidinedione antidiabetic agent for the management of patients with type 2 diabetes who do not achieve adequate glycemic control on monotherapy with metformin or any of these drugs.1 3 6 15 18 20 22 27 29 30 48 59 78 88 95 97 99 112 134 166 191 234 237 238 239 241 242 243 245 246 249 250 Used concomitantly with nateglinide in patients who no longer respond adequately to metformin despite appropriate diet, exercise, and metformin monotherapy.248


May be used with insulin to improve glycemic control and/or decrease the required dosage of insulin.1 3 6 88 90 94 95 146


Commercially available in fixed combination with glyburide or glipizide for use as initial therapy in the management of patients with type 2 diabetes mellitus whose hyperglycemia cannot be controlled by diet and exercise alone.234 254


Fixed combinations with glyburide or glipizide used as second-line therapy in patients who do not achieve adequate control of hyperglycemia despite therapy with diet, exercise, and initial treatment with a sulfonylurea antidiabetic agent or metformin.234 254


Add a thiazolidinedione antidiabetic agent to metformin in fixed combination with glyburide in patients who have inadequate glycemic control with the fixed combination.234


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.


Commercially available in fixed combination with rosiglitazone for use when treatment with rosiglitazone and metformin is appropriate (i.e., as initial therapy in patients whose hyperglycemia cannot be controlled by diet and exercise alone and as second-line therapy in patients who do not achieve adequate control of hyperglycemia despite therapy with diet, exercise, and treatment with rosiglitazone or metformin).a


Metformin is the preferred initial oral antidiabetic agent for patients with type 2 diabetes mellitus.264


Not effective as sole therapy in patients with diabetes mellitus complicated by acidosis, ketosis, or coma.1 6 30 146 191 192


Metformin Hydrochloride Dosage and Administration


General



  • Sulfonylurea agent may be abruptly discontinued (no transition period generally required) when therapy is transferred from most sulfonylurea antidiabetic agents to metformin.1 2




  • Patients whose therapy is transferred from chlorpropamide to metformin should be monitored closely for hypoglycemia during the initial 2 weeks following transfer.1 2 30




  • Goal of therapy should be to reduce both fasting glucose and glycosylated hemoglobin (hemoglobin A1c [HbA1c]) values to normal or near normal using the lowest effective dosage of metformin hydrochloride, either when used as monotherapy or combined with another oral antidiabetic agent (e.g., sulfonylurea, acarbose).1 8 13 14 78 85 88 105 134 146 166 234 235 243 245 246



Administration


Oral Administration


Administer orally with meals to reduce adverse GI effects.1 2 3 18 53 85


Administer conventional tablets 2 or 3 times daily.1 Administer in 2 divided doses if total dosage ≤2 g daily or in 3 divided doses if total dosage is >2 g daily.1


Administer extended-release tablets once daily with the evening meal.1


Dosage


Available as metformin hydrochloride; dosage expressed in terms of the salt.1


Individualize dosage carefully based on patient’s glycemic response and tolerance.1 4 243 245 246


Pediatric Patients


Diabetes Mellitus

Oral

Conventional tablets or oral solution in children 10–16 years of age: Initially, 500 mg twice daily with meals as monotherapy.1 257 258 Titrate dosage in increments of 500 mg daily at weekly intervals to a maximum of 2 g daily given in divided doses.1 257 258


Adults


Diabetes Mellitus

Initial Dosage in Previously Untreated Patients

Oral

Conventional tablets or oral solution: Initially, 500 mg twice daily with the morning and evening meal.1 4 134 243 245 246 257 259 Titrate dosage by 500 mg daily at weekly intervals to a total of 2 g daily1 2 14 18 21 30 85 134 257 or to 850 mg twice daily after 2 weeks.1 257 Clinically important responses generally not observed at dosages <1.5 g daily.1 257 Usual maintenance dosage is 850 mg twice daily.1 259


Alternatively, give initial dosage of 500–850 mg once daily in the morning.1 2 3 4 23 30 146 243 245 246 If initial dosage is 850 mg daily, titrate dosage by 850 mg daily every other week to a total of 2 g daily.1 2 3 4 18 22 85 243 245 246


For additional glycemic control, administer up to a maximum daily dosage of 2.55 g given in divided doses.1 257


Extended-release tablets (Glucophage XR) in patients ≥17 years of age: Initially, 500 mg once daily with the evening meal.1 259 Titrate dosage by 500 mg daily at weekly intervals to a maximum of 2 g daily.1 259 If glycemic control is not achieved with 2 g once daily, consider administering 1 g twice daily.1 259 If >2 g daily is required, switch to conventional tablet formulation and increase dosage up to 2.55 g daily in divided doses (preferably 3 doses for daily dosages >2 g).1 259


Extended-release tablets (Fortamet) in patients ≥17 years of age: Initially, 1 g daily with the evening meal; 500 mg daily may be used when clinically appropriate.258 Titrate dosage by 500 mg daily at weekly intervals to a maximum of 2.5 g daily with the evening meal.258


Initial Dosage of Metformin Hydrochloride in Fixed Combination with Glipizide (Metaglip)

Oral

Initially, 250 mg of metformin hydrochloride and 2.5 mg of glipizide once daily with a meal.254 For more severe hyperglycemia (fasting plasma glucose concentrations of 280–320 mg/dL), 500 mg of metformin hydrochloride and 2.5 mg of glipizide twice daily.254 Titrate in increments of one tablet (using the tablet strength at which therapy was initiated) daily at 2-week intervals until adequate blood glucose control is achieved or maximum daily dosage of 2 g of metformin hydrochloride and 10 mg of glipizide is reached.254 256


Efficacy of metformin hydrochloride and glipizide in fixed combination not established in patients with fasting plasma glucose concentrations >320 mg/dL.254 No experience with total initial daily dosages exceeding 2 g of metformin hydrochloride and 10 mg of glipizide.254


Initial Dosage of Metformin Hydrochloride in Fixed Combination with Glyburide (Glucovance)

Oral

Initially, 250 mg of metformin hydrochloride and 1.25 mg of glyburide once daily with a meal.234 For more severe hyperglycemia (i.e., fasting plasma glucose concentrations >200 mg/dL or glycosylated hemoglobin >9%), 250 mg of metformin hydrochloride and 1.25 mg of glyburide twice daily with the morning and evening meal.234 Titrate dosage in increments of 250 mg of metformin hydrochloride and 1.25 mg of glyburide daily at 2-week intervals adequate control of blood glucose is achieved or a maximum daily dosage of 2 g of metformin hydrochloride and 10 mg of glyburide.234


The fixed combination of metformin hydrochloride 500 mg and glyburide 5 mg should not be used as initial therapy due to an increased risk of hypoglycemia.234


Initial Dosage of Metformin Hydrochloride in Fixed Combination with Rosiglitazone (Avandamet)

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.


Oral

Initially, 500 mg of metformin hydrochloride and 2 mg of rosiglitazone once or twice daily.a For more severe hyperglycemia (i.e., HbA1c >11% or fasting plasma glucose concentrations >270 mg/dL), consider 500 mg of metformin hydrochloride and 2 mg of rosiglitazone twice daily.a If additional glycemic control needed after 4 weeks, titrate dosage upward in increments of 500 mg of metformin hydrochloride and 2 mg of rosiglitazone per day until adequate glycemic control is achieved or a maximum daily dosage of 2 g of metformin hydrochloride and 8 mg of rosiglitazone is reached.a


Initial Dosage in Patients Transferred to Metformin Hydrochloride in Fixed Combination with Glipizide (Metaglip)

Oral

In previously treated patients, 500 mg of metformin hydrochloride and 2.5 or 5 mg of glipizide twice daily with the morning and evening meals.254 The initial dosage of glipizide and metformin hydrochloride in fixed combination should not exceed the daily dosage of metformin hydrochloride or glipizide (or the equivalent dosage of another sulfonylurea) previously received.254 Titrate dosage in increments not exceeding 500 mg of metformin hydrochloride and 5 mg of glipizide until adequate control of blood glucose is achieved or a maximum daily dosage of 2 g of metformin hydrochloride and 20 mg of glipizide is reached.254


For patients switching from combined therapy with separate preparations, the initial dosage of the fixed-combination preparation of glipizide and metformin hydrochloride should not exceed the daily dosages of glipizide (or equivalent dosage of another sulfonylurea antidiabetic agent) and metformin hydrochloride currently being taken.254 Use clinical judgment regarding whether to switch to the nearest equivalent dosage or to titrate dosage.254 Titrate dosage in increments of not more than 5 mg of glipizide and 500 mg of metformin hydrochloride until adequate control of blood glucose is achieved or maximum daily dosage of 20 mg of glipizide and 2 g of metformin hydrochloride is reached.254


Initial Dosage in Patients Transferred to Metformin Hydrochloride in Fixed Combination with Glyburide (Glucovance)

Oral

Initially, 500 mg of metformin hydrochloride and 2.5 or 5 mg of glyburide twice daily with the morning and evening meal.234 For patients previously receiving metformin hydrochloride or glyburide (or another sulfonylurea agent), the initial dosage of metformin hydrochloride or glyburide should not exceed the dosage (or equivalent dosage) received previously.234 For patients previously receiving both metformin hydrochloride and glyburide (or another sulfonylurea agent) separately, the initial dosage should not exceed the previous dosage of metformin hydrochloride and glyburide (or the equivalent dosage of the other sulfonylurea) administered separately.234 Titrate dosage in increments not exceeding 500 mg of metformin hydrochloride and 5 mg of glyburide until adequate control of blood glucose is achieved or a maximum daily dosage of 2 g of metformin hydrochloride and 20 mg of glyburide is reached.158 234


For patients whose hyperglycemia is not adequately controlled on therapy with metformin hydrochloride in fixed combination with glyburide, a thiazolidinedione (e.g., pioglitazone, rosiglitazone) may be added at its recommended initial dosage and the dosage of the fixed combination may be continued unchanged.234 In patients requiring further glycemic control, titrate thiazolidinedione dosage upward as recommended.234


Initial Dosage in Patients Transferred to Metformin Hydrochloride in Fixed Combination with Rosiglitazone (Avandamet)

Oral

In patients not adequately controlled on monotherapy with metformin hydrochloride or rosiglitazone, dosage of the fixed combination is based on the patient’s current dosages of metformin hydrochloride and/or rosiglitazone.247 (See Table.)


In patients inadequately controlled on metformin monotherapy, the usual initial dosage of rosiglitazone is 4 mg daily given with patient's existing dosage of metformin hydrochloride.a


In patients inadequately controlled on rosiglitazone monotherapy, the usual initial dosage of metformin hydrochloride is 1 g daily given with patient's existing dosage of rosiglitazone.a


Individualize therapy in patients already receiving metformin hydrochloride at dosages not available in the fixed combination (i.e., dosages other than 1 or 2 g).247






















Table 1. Initial Dosage of the Fixed Combination of Metformin Hydrochloride and Rosiglitazone (Avandamet)a

Prior Therapy



Usual Initial Dosage of Avandamet



Total Daily Dosage



Tablet strength



Number of tablets



Metformin Hydrochloride



1 g



2 mg/500 mg



1 tablet twice daily



2 g



2 mg/1 g



1 tablet twice daily



Rosiglitazone



4 mg



2 mg/500 mg



1 tablet twice daily



8 mg



4 mg/500 mg



1 tablet twice daily


The tablet strength of the fixed combination that is selected should be the one that most closely provides the patient’s existing dosage of metformin hydrochloride or rosiglitazone, respectively.247 (See Table.)


If additional glycemic control is needed following transfer, titrate dosage upward in increments of 500 mg of metformin hydrochloride and/or 4 mg of rosiglitazone per day until adequate glycemic control is achieved or a maximum daily dosage of 2 g of metformin hydrochloride and 8 mg of rosiglitazone is reached.a Following increase in dosage of metformin hydrochloride, further dosage adjustment recommended if adequate glycemic control not achieved in 1–2 weeks.a Following increase in dosage of rosiglitazone, further dosage adjustment recommended if adequate glycemic control not achieved in 8–12 weeks.a


For patients switching from combined therapy with separate preparations, the initial dosage of the fixed-combination preparation of metformin hydrochloride and rosiglitazone should be the same as the daily dosage of metformin hydrochloride and rosiglitazone currently being taken.247


Initial Metformin Hydrochloride Dosage in Patients Transferred from Insulin

Oral

Initially, 500 mg once daily; increase dosage by 500 mg daily at weekly intervals adequate control of blood glucose is achieved or a maximum daily dosage of 2.5 g (conventional tablets) or 2 g (extended-release tablets) is reached.1 Concurrent insulin dosage initially remains unchanged.1 When fasting plasma glucose concentration decreases to <120 mg/dL, decrease insulin dosage by 10–25%.1


Prescribing Limits


Pediatric Patients


Oral

Children 10–16 years of age: Maximum 2 g daily as conventional tablets or oral solution.1 257


Adults


Oral

Maximum 2.55 g daily (conventional tablets or oral solution; 2.5 g daily as Fortamet extended-release tablets; or 2 g daily as certain other extended-release tablets (e.g., Glucophage).1 2 3 4 14 18 22 85 257 258 259 Switch to conventional tablets for further dosage titration if required dosage exceeds 2 g daily while on extended-release tablets.1 259


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.


For the fixed combination with glyburide, maximum daily dosage as second-line therapy is 2 g of metformin hydrochloride and 20 mg of glyburide.234 For the fixed combination with glipizide, maximum daily dosage is 2 g of metformin hydrochloride and 20 mg of glipizide.254 256 For the fixed combination with rosiglitazone, maximum daily dosage is 2 g of metformin hydrochloride and 8 mg of rosiglitazone.247


Special Populations


Geriatric Patients


Maintenance dosage generally should not be titrated to the maximum recommended for younger adults;1 2 3 4 165 1 limited data suggest reducing initial dosage by approximately 33% in geriatric patients.30 174


Cautions for Metformin Hydrochloride


Contraindications



  • Sole therapy in patients with type 1 diabetes and in patients with diabetes complicated by acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma.1 2 234 247




  • Renal impairment (e.g., ≥1.5 or 1.4 mg/dL in men or women, respectively) or abnormal Scr.1 2 18 20 91 234 Renal impairment may result from conditions such as cardiovascular collapse (shock), AMI, or septicemia.1 2 18 20 91 234




  • Congestive heart failure requiring drug therapy (e.g., digoxin, furosemide).1 209 214 215




  • Known hypersensitivity to metformin hydrochloride or any ingredient in the formulations.1 2 234 247 254



Warnings/Precautions


Warnings


Lactic Acidosis

See Boxed Warning.


General Precautions


Hypoglycemia

Uncommon in patients receiving metformin as monotherapy.1 15 30 78 94 99 Debilitated, malnourished, or geriatric patients and patients with renal or hepatic impairment or adrenal or pituitary insufficiency may be particularly susceptible.1 2 Strenuous exercise, alcohol ingestion, insufficient caloric intake, or use in combination with other antidiabetic agents may increase risk.1 2 Hypoglycemia may be difficult to recognize in geriatric patients or in those receiving β-adrenergic blocking agents.1 83 91 128 143 153 159 (See Specific Drugs under Interactions.)


Hematologic Effects

Decreased serum vitamin B12 concentrations, 1 18 with or without clinical manifestations (e.g., anemia).1


Symptoms rapidly reversible following discontinuation of metformin or supplementation with vitamin B12.1 3 6 20 30 70 77 82 134 Monitor hematologic parameters (e.g., hemoglobin, serum vitamin B12 concentrations)1 82 114 122 134 148 prior to initiation of therapy and at least annually during treatment and any abnormality properly investigated.


Consider periodic supplementation with parenteral vitamin B12 in patients at high risk for developing subnormal serum vitamin B12 concentrations (e.g., alcoholics, patients with low calcium or vitamin B12 intake or absorption).1 82 114 122 134 148


Cardiovascular Effects

Possible increased cardiovascular mortality associated with other biguanide antidiabetic agents (i.e., phenformin).1 191 192 200 The American Diabetes Association (ADA) and other clinicians do not recommend changing current guidelines regarding the use of metformin as monotherapy or in combination with sulfonylureas pending the results of further studies of metformin alone or in combination with sulfonylureas.220 221 224


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.


Use of metformin in combination with rosiglitazone and insulin is not indicated; adverse cardiovascular events (e.g., edema, heart failure) have occurred with combined rosiglitazone and insulin therapy.247


Concurrent Illness

Evaluate serum electrolytes and ketones, blood glucose, and if indicated, blood pH, lactate, pyruvate, and metformin concentrations for evidence of ketoacidosis or lactic acidosis.1 88 134 156 169


Temporary withdrawal of metformin therapy and administration of insulin may be required to maintain glycemic control during periods of stress.1


Use of Fixed Combinations

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.


When used in fixed combination with glipizide, glimepiride, or rosiglitazone, consider the cautions, precautions, and contraindications associated with the concomitant agent.234 247 254


Specific Populations


Pregnancy

Category B.1


Most clinicians recommend use of insulin during pregnancy in diabetic patients to maintain optimum control of blood glucose concentrations.1 3 4 18 72 88 92


Lactation

Distributed into milk in rats; not known if distributed into milk in humans.1 85 Discontinue nursing or the drug.1 3 4


Pediatric Use

Safety and efficacy of metformin as conventional tablets or oral solution in children <10 years of age have not been established.1 257


Safety and efficacy of metformin as extended-release tablets in children <17 years of age have not been established.1 258 259


Safety and efficacy of metformin in fixed combination with glipizide or rosiglitazone in children have not been established.1 3 4 30 134 234 247 254 Data from a clinical trial in children 9–16 years of age comparing combined therapy with metformin and glyburide (Glucovance) with each drug as monotherapy did not reveal unexpected safety findings.234


Geriatric Use

Insufficient number of geriatric patients in controlled clinical trials of metformin hydrochloride conventional (Glucophage) and extended-release tablets (Glucophage XR) to determine if such patients respond differently than younger adults.1 With another extended-release preparation of metformin hydrochloride (Fortamet), no overall differences in safety or efficacy in geriatric patients were observed compared with younger adults.258


Use with caution, since renal function declines with age.1 3 4 30 85 174


Monitor renal function periodically.1 2 3 4 164 165


Do not initiate in patients ≥80 years of age without confirmation of adequate renal function as measured by Clcr.1 209 214


Geriatric patients particularly susceptible to hypoglycemia,1 2 which may be difficult to recognize.1 83 91 128 143 153 159


Renal Impairment

Evaluate renal function prior to initiation of therapy and at least annually thereafter.1 2 77 85 234


Monitor more frequently if development of impaired renal function is anticipated (e.g., those with blood glucose concentrations >300 mg/dL, those who may develop renal dysfunction as a result of polyuria and volume depletion).156


Discontinue metformin if evidence of renal impairment is present.1 2 156 164


Patients whose serum creatinine concentrations exceed the upper limit of normal for their age should not receive metformin.1


Hepatic Impairment

Avoid use.1 165 Elimination of lactate may be substantially reduced.1 (See Boxed Warning.)


Common Adverse Effects


Diarrhea,1 31 48 49 53 78 109 118 122 135 nausea,1 31 53 78 109 118 122 vomiting,1 118 122 abdominal bloating, abdominal cramping or pain,1 31 35 42 53 118 122 flatulence,1 anorexia.1 3 6 18


Interactions for Metformin Hydrochloride


Cationic Agents Secreted by Proximal Renal Tubules


Pharmacokinetic interaction with cimetidine (decreased excretion of metformin).1 75


Potential pharmacokinetic interaction with other cationic drugs that undergo substantial tubular secretion (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, vancomycin).1 30


Monitor carefully; consider dosage adjustment of either agent.1


Protein-bound Drugs


Pharmacokinetic interaction unlikely.1


Drugs That May Antagonize Hypoglycemic Effects


Calcium-channel blocking agents, corticosteroids, thiazide diuretics, estrogens and progestins (e.g., oral contraceptives), isoniazid, niacin, phenothiazines, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline); observe patient closely for evidence of altered glycemic control when such drugs are added to or withdrawn from therapy.1 30 80 85 91 120 121 134 139 143 151 152 153 154 159 160


Specific Drugs










Drug



Interaction



Comments



ACE inhibitors



Potential risk of hypoglycemia/hyperglycemia when ACE inhibitor therapy is initiated/withdrawn131 132 134 152 155 160



Monitor blood glucose concentrations during dosage adjustments with either agent130 131 132 134 152 155 160



Alcohol



Increased risk of hypoglycemia and lactic acidosis1 2

Metadate CD Controlled-Release Capsules


Pronunciation: METH-il-FEN-i-date
Generic Name: Methylphenidate
Brand Name: Metadate CD

Use Metadate CD Controlled-Release Capsules with caution if you have a history of emotional problems or alcohol or substance abuse. Abuse of Metadate CD Controlled-Release Capsules may cause it to not work as well. Abuse may also lead to addiction and severe mental changes. Do not suddenly stop using Metadate CD Controlled-Release Capsules. Depression and other mental problems may occur. Your doctor should slowly lower your dose over a period of time if you need to stop using it.





Metadate CD Controlled-Release Capsules are used for:

Treating attention deficit hyperactivity disorder (ADHD). It may also be used for other conditions as determined by your doctor.


Metadate CD Controlled-Release Capsules are a central nervous system stimulant. Exactly how it works is not known.


Do NOT use Metadate CD Controlled-Release Capsules if:


  • you are allergic to any ingredient in Metadate CD Controlled-Release Capsules

  • you have severe anxiety, agitation, or tension

  • you have glaucoma or overactive thyroid

  • you have motor tics (involuntary movements), Tourette syndrome, or a family history of Tourette syndrome

  • you have severe high blood pressure, certain heart problems (eg, heart defect, angina, irregular heartbeat, heart failure), or have had a recent heart attack

  • you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or have taken an MAOI within the past 14 days

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



Before using Metadate CD Controlled-Release Capsules:


Some medical conditions may interact with Metadate CD Controlled-Release Capsules. 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 high blood pressure, heart problems (eg, fast or irregular heartbeat), or heart attack, or if a family member has a history of irregular heartbeat or sudden death

  • if you have a history of seizures or abnormal electroencephalograms (EEGs)

  • if you have a history of overactive thyroid, chronic fatigue, cystic fibrosis, or stomach or bowel problems (eg, blockage, inflammation, narrowing)

  • if you have a history of mood or mental problems (eg, agitation, anxiety, bipolar disorder, depression, psychosis, tension), abnormal thoughts, hallucinations, suicidal thoughts or attempts, or alcohol or other substance abuse or dependence, or if a family member has a history of any of these problems

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


  • MAOIs (eg, phenelzine) because severe high blood pressure may occur

  • Clonidine because serious side effects may occur

  • Anticoagulants (eg, warfarin), certain anticonvulsants (eg, phenobarbital, phenytoin, primidone), phenylbutazone, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or tricyclic antidepressants (eg, imipramine) because the risk of their side effects may be increased by Metadate CD Controlled-Release Capsules

  • Medicines for high blood pressure (eg, guanethidine, metoprolol) because their effectiveness may be decreased by Metadate CD Controlled-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Metadate CD Controlled-Release Capsules 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 Metadate CD Controlled-Release Capsules:


Use Metadate CD Controlled-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Metadate CD Controlled-Release Capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Metadate CD Controlled-Release Capsules refilled.

  • Take Metadate CD Controlled-Release Capsules by mouth in the morning before breakfast.

  • Swallow Metadate CD Controlled-Release Capsules whole. Do not break, crush, or chew before swallowing.

  • If you cannot swallow the capsule whole, you may open it and sprinkle the contents over a spoonful of applesauce. Mix the medicine with the applesauce and swallow the mixture right away, followed by a glass of water. Do not crush or chew the medicine before swallowing. Do not store the mixture for future use.

  • If you take an antacid, H2 antagonist (eg, ranitidine), or proton pump inhibitor (eg, omeprazole), ask your doctor or pharmacist how to take it with Metadate CD Controlled-Release Capsules.

  • If you miss a dose of Metadate CD Controlled-Release Capsules, 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 Metadate CD Controlled-Release Capsules.



Important safety information:


  • Metadate CD Controlled-Release Capsules may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Metadate CD Controlled-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do NOT take more than the recommended dose without checking with your doctor.

  • If your symptoms do not get better within 1 month or if they get worse, check with your doctor.

  • Serious effects, including heart attack, stroke, and sudden death, have occurred with the use of stimulant medicines in patients with heart defects or other serious heart problems. If you have a heart defect or other serious problem, talk with your doctor about other therapies to treat your condition.

  • Tell your doctor or dentist that you take Metadate CD Controlled-Release Capsules before you receive any medical or dental care, emergency care, or surgery.

  • Lab tests, including blood pressure, heart function, complete blood cell counts, and platelet counts, may be performed while you use Metadate CD Controlled-Release Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Metadate CD Controlled-Release Capsules may affect growth rate and weight gain in CHILDREN and teenagers in some cases. They may need regular growth and weight checks while they take Metadate CD Controlled-Release Capsules.

  • Caution is advised when using Metadate CD Controlled-Release Capsules in CHILDREN; they may be more sensitive to its effects, especially loss of appetite, stomach pain, weight loss, trouble sleeping, and fast heartbeat.

  • Metadate CD Controlled-Release Capsules should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Metadate CD Controlled-Release Capsules while you are pregnant. It is not known if Metadate CD Controlled-Release Capsules are found in breast milk. If you are or will be breast-feeding while you use Metadate CD Controlled-Release Capsules, check with your doctor. Discuss any possible risks to your baby.

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


Some people who use Metadate CD Controlled-Release Capsules for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. Do not suddenly stop taking Metadate CD Controlled-Release Capsules. If you do, you may have WITHDRAWAL symptoms. These may include depression or other mental problems. If you need to stop Metadate CD Controlled-Release Capsules, your doctor will lower your dose over time.



Possible side effects of Metadate CD Controlled-Release Capsules:


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:



Dizziness; headache; loss of appetite; nausea; nervousness; stomach pain; trouble sleeping.



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; joint pain; purple or brownish red spots on the skin); behavior changes (eg, aggression, hostility, restlessness); blurred vision or other vision problems; chest pain; confusion; dark urine; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; mental or mood changes (eg, agitation, anxiety, depression, irritability, panic attacks, persistent crying, unusual sadness); one-sided weakness; seizures; severe or persistent dizziness or headache; shortness of breath; slurred speech; suicidal thoughts or attempts; tremor; uncontrolled speech or muscle movements; unusual bruising or bleeding; 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: Metadate CD 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 confusion; dilated pupils; fast or irregular heartbeat; fever; flushing; hallucinations; loss of consciousness; muscle twitching; seizures; severe or persistent headache; tremors; unusual sweating; vomiting.


Proper storage of Metadate CD Controlled-Release Capsules:

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


General information:


  • If you have any questions about Metadate CD Controlled-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.

  • Metadate CD Controlled-Release Capsules 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 Metadate CD Controlled-Release Capsules. 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 Metadate CD resources


  • Metadate CD Side Effects (in more detail)
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  • 24 Reviews for Metadate CD - Add your own review/rating


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