Sunday, 29 April 2012

Adcal 1500mg chewable tablets





Adcal 1500mg Chewable Tablets



Calcium carbonate






Read leaflet carefully before you start taking this medicine



  • Keep this leaflet. You may need to read it again.

  • If you have further questions, please ask your doctor or pharmacist.

  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

  • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.




In this leaflet:



  • 1. What these tablets do

  • 2. Check before you take...

  • 3. How to take the tablets

  • 4. Possible side effects

  • 5. Storing your medicine

  • 6. Further information





What these tablets do



Adcal contains calcium which is essential for healthy bones and teeth. Adcal provides extra calcium to your diet. It is therefore used in conditions where your body's calcium levels need to be increased. Adcal can be prescribed by doctors for certain bone conditions.





Check before you take






Do not take if you:



  • Are allergic (hypersensitive) to calcium carbonate or any of the other ingredients in Adcal Chewable Tablets (see Section 6 Further Information).






Take special care:



Tell your doctor or pharmacist if you:



  • Have high levels of calcium in your blood (hypercalcaemia) or high levels of calcium in your urine (hypercalciuria). If you are unsure your doctor will advise you

  • Have problems with your kidneys, for example kidney stones

  • Have sarcoidosis (inflammation that produces lumps of cells in various organs in the body). Your doctor will be able to tell you if you do

  • Have previously been told by your doctor that you have an intolerance to some sugars

  • Are taking any other medication, even those you may have bought for yourself without prescription.






Taking other medicines with Adcal



Tell your doctor if you are taking calcium supplements or antacids for indigestion, digitalis drugs (eg. Lanoxin), diuretics or corticosteroids.



If you are taking thyroxine, bisphosphonates, iron or fluoride medicines, tetracycline or quinolone antibiotics make sure your doctor knows this. When taking these medicines leave a period of about 4 hours before taking your Adcal tablets. Do not take them at the same time.



Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines taken without a prescription.





Pregnancy and breast-feeding



In pregnancy or when breast feeding, Adcal should only be used under medical supervision. Ask your doctor or pharmacist for advice before taking any medicine.





Important information about some of the ingredients of Adcal



  • The tablets contain a small amount of sugar and may be harmful to the teeth if used for a prolonged period





How to take the tablets



Always take Adcal exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.




Adults, elderly and children over 12 years of age - 2 tablets daily, ideally one tablet taken in the morning and one in the evening. Adcal tablets should be chewed. Do not swallow whole.








Children under 12 - Adcal must not be given to children under 12 years.



If you take more Adcal than you should - You should only take what your doctor recommends. If you take too many Adcal tablets contact your doctor or pharmacist if you can do so. If not, go to the nearest hospital casualty department immediately, taking the Adcal pack and remaining tablets with you.







If you forget to take Adcal - If you forget to take your tablet, take it as soon as possible and continue to take the tablets as normal. Do not take a double dose to make up for a forgotten tablet.



If you stop taking Adcal - Always talk to your doctor or pharmacist before stopping using Adcal.



If you have any further questions on the use of this product, ask your doctor or pharmacist.





Possible side effects





Like all medicines, Adcal can cause side effects, although not everybody gets them.




Rare side effects (affecting fewer than 1 in 1,000 people)



  • Constipation, wind, feeling sick, stomach ache, diarrhoea

  • Skin rash

  • Hypercalcaemia (too much calcium in your blood) or hypercalciuria (too much calcium in your urine).

If you are on long term treatment your doctor may, from time to time wish to check the level of calcium in your blood and take urine samples to monitor kidney function.




If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.





Storing your medicine



  • Keep out of the reach and sight of children.

  • Do not store above 25°C.

  • Keep the container tightly closed.

  • Do not use Adcal after the expiry date that is printed on the carton label has passed.

  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.




Further information



  • Each tablet contains 1500mg calcium carbonate, (equivalent to 600mg calcium). It also contains xylitol (E967), polydextrose, pre-gelatinised starch, sodium saccharin (E954), magnesium stearate, propylene glycol (E1520) and maltodextrin as a constituent of the flavouring.

  • The tablets are white, flat faced and circular in shape

  • Adcal tablets are provided in packs of 100 tablets.


Marketing Authorisation Holder:




ProStrakan Limited

Galabank Business Park

Galashiels

Scotland

TD1 1QH





Manufacturer:




Pharmaserve Ltd

Swinton

Manchester

UK





Additional information



If you have been prescribed Adcal Chewable Tablets for the treatment or prevention of osteoporosis and would like further information you should speak to your doctor or contact the National Osteoporosis Society on 0845 1303076. The National Osteoporosis Society is a national charity dedicated to offering advice, information and support to all osteoporosis sufferers and those at risk of the disease.





This leaflet was last approved in 06/2008



PG0626



SK0015






Saturday, 28 April 2012

Sebomin MR






Sebomin 100mg MR capsules



(minocycline hydrochloride)



Read all of this leaflet carefully before you start taking this medicine.


  • Keep this leaflet. You may need to read it again.

  • If you have any further questions, ask your doctor or pharmacist.

  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.



Index



  • 1 What Sebomin MR capsules are and what they are used for


  • 2 Before you take


  • 3 How to take


  • 4 Possible side effects


  • 5 How to store


  • 6 Further information




What Sebomin MR capsules are and what they are used for


Sebomin MR capsules contain a medicine called minocycline hydrochloride. This belongs to a group of medicines called tetracycline antibiotics. Sebomin MR capsules are used to treat acne.




Before you take



Do not take Sebomin MR capsules and tell your doctor if you:


  • are allergic (hypersensitive) to minocycline, other similar antibiotics (such as tetracycline or doxycycline) or any other ingredient in Sebomin MR capsules (see section 6)

  • are pregnant or breast-feeding

  • have had complete kidney failure

  • are giving it to a child under 12 years old.

Do not take Sebomin MR capsules if any of the above apply to you. If you are not sure, talk to your doctor before taking Sebomin MR capsules.




Take special care with Sebomin MR capsules and tell your doctor if you:


  • have kidney or liver disease

  • are sensitive to sunlight or artificial light (e.g. sunbeds)

  • have systemic lupus erythematosus (SLE), a condition characterised by a rash (especially on the face), hair loss, fever, a feeling of general discomfort and illness and joint pain.



Taking other medicines


Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:



  • penicillins (to treat infections) e.g. amoxicillin


  • anticoagulants (to stop the blood clotting) e.g. warfarin


  • oral contraceptives (the pill). Sebomin MR capsules may make the oral contraceptive pill less effective. You should use additional contraceptive precautions e.g. a condom, whilst taking Sebomin MR capsules and for 7 days after stopping

  • medicines which can damage your liver (check with your doctor or pharmacist to see if this applies to any medicines you are taking)

  • medicines such as antacids or other medicines containing aluminium, calcium, iron, magnesium or zinc salts. These should be taken at least 3 hours before or after a dose of Sebomin MR capsules.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Sebomin MR capsules.




Pregnancy and breast-feeding


If you are pregnant, planning to become pregnant or are breast-feeding tell your doctor or pharmacist before taking any medicine. Minocycline can cause permanent discolouration and underdevelopment of tooth enamel or skeletal growth retardation in the child.




Driving and using machines


Sebomin MR capsules can cause headache, light-headedness, dizziness, a feeling of dizziness or spinning (vertigo) and impaired hearing. Make sure you are not affected before driving or operating machinery.




Important information about some of the ingredients in Sebomin MR capsules


Each capsule contains sunset yellow (E110) which may cause allergic reactions.




Tests


During long term treatment blood, kidney and liver tests will be carried out.




Taking with food or alcohol


Do not take the capsules at the same time as food, as it can make the medicine less effective. Speak to your doctor before taking Sebomin MR capsules with alcohol, they will advise you on how much you can drink.





How to take


Always take Sebomin MR capsules exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.



Swallow the capsules whole, followed by a glass of water when standing or sitting down. Do not take the capsules at the same time as food.



  • Adults (including elderly): 1 capsule (100mg) every 24 hours


  • Children over 12 years old: 1 capsule (100mg) every 24 hours


  • Children under 12 years old: Sebomin MR capsules are not recommended for use in children under 12 years old. Minocycline can cause permanent discolouration and underdevelopment of tooth enamel in children under 12 years old.


If you take more than you should


If you (or someone else) swallow a lot of capsules at the same time, or you think a child may have swallowed any go to your nearest hospital casualty department immediately or contact your doctor straight away.




If you forget to take the capsules


If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.




If you stop taking the capsules


Talk to your doctor before you stop taking the capsules and follow their advice.





Sebomin MR Side Effects


Like all medicines, Sebomin MR capsules can cause side effects, although not everybody gets them.



Stop taking Sebomin MR capsules and see a doctor or go to a hospital straight away if you experience any of the following:


  • You have an allergic reaction. The signs of an allergic reaction include a rash, swallowing or breathing problems and swelling of your face, lips, tongue or throat.


  • Symptoms of raised pressure in the skull. These include headache, visual problems including blurred vision, “blind” spots, double vision. Bulging of the skull can occur in infants.


  • Growth of bacteria resistant to tetracyclines. Symptoms include inflammation of the intestines, inflammation of the tongue and mouth, inflammation of the female genitals causing itching, discharge or pain on passing urine, irritation around your bottom, stomach upset.


  • Sensitivity to sunlight or artificial light (e.g. sunbeds). Symptoms include tingling, burning or redness of the skin.

  • Development or worsening of existing systemic lupus erythematosus (SLE). Symptoms include large areas of red scaly patches on the face, hair loss, weight loss, painful joints and fever.


  • A change in colour of the skin or nails (hyperpigmentation), teeth, mucous membrane of the mouth, eyes, breast milk, tears and sweat.


  • Symptoms of liver damage. These include fatigue, weakness, loss of appetite, weight loss, abdominal pain, fever.



Tell your doctor if the following side effects occur:



  • Common: feeling or being sick, loss of appetite, diarrhoea, hair loss, skin reactions including red patches (erythema multiforme), severe skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson syndrome), red lumps on the legs (erythema nodosum), flaky skin (exfoliative dermatitis), skin rashes with areas of altered skin colour, small raised spots or skin redness, allergic reactions (anaphylaxis or hypersensitivity) including a skin rash with pale or red irregular raised patches with severe itching (hives), swelling of the face, lips, throat or tongue, fever, joint pain (arthralgia) or inflammation (arthritis), muscle pain (myalgia), increase in the number of white blood cells in the lungs, wheezing, blood spots, brusing and discolouring of the skin, abnormal liver function test results, discolouration of the thyroid, changes in the numbers and types of your blood cells. If you notice increased bruising, nosebleeds, sore throats, infections, excessive tiredness, breathlessness on exertion or abnormal paleness of the skin, you should tell your doctor who may want you to have a blood test.


  • Uncommon: inflammation of the pancreas (pancreatitis).


  • Rare: inflammation of the liver (hepatitis), acute liver failure, skin rashes, inflammation of the heart muscle (myocarditis) or membrane around the heart (pericarditis), inflammation of blood vessels (vasculitis), kidney failure including inflammation of the kidney, a change in the colour of bones.


If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.




How to store


Keep out of the reach and sight of children.


Do not store above 30°C.


Keep container in the outer carton.


Do not use Sebomin MR capsules after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.


Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.




Further information



What Sebomin MR capsules contain


  • The active substance (the ingredient that makes the capsules work) is anhydrous minocycline (as the hydrochloride). Each capsule contains 100mg of the active substance.

  • The other ingredients in the capsule are glycerol monostearate 40-55, microcrystalline cellulose 101 (E460(i)), povidone K-30 (E1201), purified talc (E553b), gelatin, titanium dioxide (E171), sunset yellow (E110), quinoline yellow (E104), shellac (E904), ethyl alcohol, isopropyl alcohol, propylene glycol, butyl alcohol, povidone (E1201), sodium hydroxide.



What Sebomin MR capsules look like and contents of the pack


Sebomin MR capsules are orange, opaque, hard gelatin capsules.


Pack sizes are 28 and 56.




Marketing Authorisation Holder and manufacturer



Actavis

Barnstaple

EX32 8NS

UK




This leaflet was last revised in June 2009.




Actavis

Barnstaple

EX32 8NS

UK


50309920





Wednesday, 25 April 2012

Miscellaneous metabolic agents


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

See also

Medical conditions associated with miscellaneous metabolic agents:

  • Gaucher Disease
  • Phenylketonuria

Drug List:

Tuesday, 24 April 2012

Stavzor Delayed-Release Capsules


Pronunciation: val-PROE-ik AS-id
Generic Name: Valproic Acid
Brand Name: Stavzor

Severe and sometimes fatal liver problems have occurred with the use of Stavzor Delayed-Release Capsules. The risk is greater in children younger than 2 years old, especially those who have metabolic disorders, seizure disorders with mental retardation, brain disease, or who take multiple seizure medicines.


When liver problems have occurred, it usually has been during the first 6 months of treatment. Contact your doctor right away if symptoms of liver problems occur (eg, dark urine, general feeling of being unwell, loss of appetite, sluggishness, swelling of the face, vomiting, weakness, yellowing of the skin or eyes). Patients with seizure disorders may also experience worsening of seizures. Contact your doctor right away if this occurs. Liver function tests should be performed before you start Stavzor Delayed-Release Capsules and during treatment. Be sure to keep all doctor and lab appointments.


Stavzor Delayed-Release Capsules can cause severe birth defects if you take it while you are pregnant. Women who are able to become pregnant should discuss with their doctor the benefits and risks of using Stavzor Delayed-Release Capsules during pregnancy. Contact your doctor right away if you think you may be pregnant. An extra patient leaflet about this risk is available with Stavzor Delayed-Release Capsules. Read it carefully. Talk with your doctor if you have questions about this information.


Severe and sometimes fatal pancreas problems have occurred with the use of Stavzor Delayed-Release Capsules. These problems have occurred soon after starting Stavzor Delayed-Release Capsules, as well as after several years of treatment. Tell your doctor right away if you develop loss of appetite, nausea, stomach pain, or vomiting.





Stavzor Delayed-Release Capsules are used for:

Treating certain seizure disorders. It is used to treat mania in patients with bipolar disorder and to prevent migraine headaches. It may also be used for other conditions as determined by your doctor.


Stavzor Delayed-Release Capsules are an anticonvulsant. It works by increasing the amount of a certain chemical in the brain.


Do NOT use Stavzor Delayed-Release Capsules if:


  • you are allergic to any ingredient in Stavzor Delayed-Release Capsules

  • you have liver problems or a urea cycle disorder

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



Before using Stavzor Delayed-Release Capsules:


Some medical conditions may interact with Stavzor Delayed-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, are breast-feeding, or are of childbearing age

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have a history of liver problems, cancer, blood or bleeding problems (eg, low blood platelet levels), HIV infection, cytomegalovirus (CMV) infection, kidney problems, pancreas problems, low blood albumin levels, or high blood glycine levels

  • if you have a history of metabolic problems, brain disease, coma, high blood ammonia or glutamine levels, low body temperature, mental retardation, recurring vomiting and sluggishness, or recurring extreme irritability

  • if you have a history of mental or mood problems, suicidal thoughts or actions, or alcohol abuse or dependence

  • if you have decreased food or fluid intake, or if you are scheduled for surgery

  • if you have a family history of urea cycle disorders or unexplained infant deaths

  • if you take any other medicine for seizures

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


  • Clonazepam because the risk of seizures may be increased in certain patients

  • Topiramate because the risk of high ammonium levels and brain problems may be increased

  • Felbamate or salicylates (eg, aspirin) because they may increase the risk of Stavzor Delayed-Release Capsules's side effects

  • Carbamazepine, carbapenem antibiotics (eg, imipenem), hormonal birth control (eg, birth control pills), hydantoins (eg, phenytoin), mefloquine, or rifampin because they may decrease Stavzor Delayed-Release Capsules's effectiveness

  • Anticoagulants (eg, warfarin), barbiturates (eg, phenobarbital), benzodiazepines (eg, diazepam), ethosuximide, lamotrigine, primidone, tolbutamide, tricyclic antidepressants (eg, amitriptyline), or zidovudine because the risk of their side effects may be increased by Stavzor Delayed-Release Capsules

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


Use Stavzor Delayed-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • An extra patient leaflet is available with Stavzor Delayed-Release Capsules. Talk to your pharmacist if you have questions about this information.

  • Take Stavzor Delayed-Release Capsules by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

  • Swallow Stavzor Delayed-Release Capsules whole. Do not break, crush, or chew before swallowing.

  • Stavzor Delayed-Release Capsules works best if it is taken at the same time each day.

  • Continue to take Stavzor Delayed-Release Capsules even if you feel well. Do not miss any doses.

  • If you are taking Stavzor Delayed-Release Capsules to treat seizures, do not suddenly stop taking it; this may cause an increased risk of severe seizures. If you need to stop Stavzor Delayed-Release Capsules or add a new medicine, your doctor will gradually lower your dose.

  • If you miss a dose of Stavzor Delayed-Release Capsules, 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 Stavzor Delayed-Release Capsules.



Important safety information:


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

  • Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Stavzor Delayed-Release Capsules; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • Patients who take Stavzor Delayed-Release Capsules may be at increased risk for suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Patients who have bipolar (manic-depressive) illness may also have an increased risk for suicidal thoughts or actions. Watch patients who take Stavzor Delayed-Release Capsules 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.

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

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

  • Diabetes patients - Stavzor Delayed-Release Capsules may cause the results of some tests for urine ketones to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.

  • Stavzor Delayed-Release Capsules may interfere with certain lab tests, including thyroid function. Be sure your doctor and lab personnel know you are taking Stavzor Delayed-Release Capsules.

  • Lab tests, including complete blood cell counts and liver function, may be performed while you use Stavzor Delayed-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.

  • Use Stavzor Delayed-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially drowsiness.

  • Stavzor Delayed-Release Capsules should be used with extreme caution in CHILDREN, especially children younger than 2 years old; they may be at increased risk of serious and sometimes fatal liver problems.

  • PREGNANCY and BREAST-FEEDING: Stavzor Delayed-Release Capsules has been shown to cause harm to the fetus. Use an effective form of birth control while you take Stavzor Delayed-Release Capsules. If you think you may be pregnant or if you wish to become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Stavzor Delayed-Release Capsules while you are pregnant. Stavzor Delayed-Release Capsules are found in breast milk. Do not breast-feed while you are taking Stavzor Delayed-Release Capsules.


Possible side effects of Stavzor Delayed-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:



Constipation; diarrhea; dizziness; drowsiness; headache; increased or decreased appetite; mild hair loss; nausea; sore throat; stomach pain or upset; trouble sleeping; vomiting; weakness; weight gain.



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); abnormal thinking; behavior changes; blurred vision or other vision changes; change in menstrual period; change in the amount of urine produced; chest pain; confusion; dark urine; fast or irregular heartbeat; fever, chills, or persistent sore throat; general feeling of being unwell; hallucinations; hearing loss; joint or muscle pain or weakness; loss of coordination; memory loss; new or worsening mental or mood changes (eg, aggressiveness, agitation, anxiety, depression, exaggerated feeling of well-being, hostility, impulsiveness, inability to sit still, irritability, panic attacks, restlessness); pale stools; red, swollen, peeling, or blistered skin; ringing in the ears; severe or persistent nausea, vomiting, or loss of appetite; severe or persistent stomach pain or cramps; shortness of breath; sluggishness; suicidal thoughts or actions; swelling of the arms or legs; swollen lymph nodes; tremor; trouble speaking or walking; uncontrolled muscle movements; unusual bleeding or bruising; unusual tiredness or weakness; yellowing of the skin or eyes.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Stavzor 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 (http://www.aapcc.org ), or emergency room immediately. Symptoms may include irregular heartbeat; loss of consciousness; severe drowsiness.


Proper storage of Stavzor Delayed-Release Capsules:

Store Stavzor Delayed-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 Stavzor Delayed-Release Capsules out of the reach of children and away from pets.


General information:


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

  • Stavzor Delayed-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 Stavzor Delayed-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 Stavzor resources


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


Compare Stavzor with other medications


  • Hyperekplexia
  • Mania
  • Migraine Prevention
  • Schizoaffective Disorder
  • Seizure Prevention
  • Seizures

Sunday, 22 April 2012

Imipramine Hydrochloride



Class: Tricyclics and Other Norepinephrine-reuptake Inhibitors
Note: This monograph also contains information on Imipramine Pamoate
VA Class: CN601
CAS Number: 113-52-0
Brands: Tofranil, Tofranil-PM


  • Suicidality


  • Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need.i j Imipramine is not approved for use in pediatric patients except patients ≥6 years of age with enuresis.a b (See Pediatric Use under Cautions.)




  • In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.i j




  • Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.i j k




  • Appropriately monitor and closely observe all patients who are started on imipramine therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.i j k (See Worsening of Depression and Suicidality Risk under Cautions.)




Introduction

Dibenzazapine-derivative tricyclic antidepressant (TCA).a b f


Uses for Imipramine Hydrochloride


Major Depressive Disorder


Management of major depressive disorder.a b


Results of several studies of TCAs in preadolescent and adolescent patients with major depression indicate lack of overall efficacy in this age group.


Enuresis


Temporary adjunctive therapy in the treatment of nocturnal enuresis (bed-wetting) in children ≥6 years of age.a


Safety and efficacy of long-term use not established.a


Panic Disorder


Management of panic disorder with or without agoraphobia.c


Attention Deficit Hyperactivity Disorder


Second-line agent in attention deficit hyperactivity disorder (ADHD) in patients unable to tolerate or unresponsive to stimulants.


Associated with a narrower margin of safety than some other therapeutic agents; use only if clearly indicated and with careful monitoring, including baseline and subsequent determinations of ECG and other parameters.


Eating Disorders


Has been used for management of eating disorders (e.g., bulimia, anorexia nervosa) with equivocal results; avoid use in underweight individuals and in those exhibiting suicidal ideation.c


Bipolar Disorder


Has been used for the short-term management of acute depressive episodes in bipolar disorder.c


TCAs associated with a greater risk of precipitating hypomania or manic episodes than other classes of antidepressants;c should always be used in combination with a mood stabilizer (e.g., lithium).h


Schizophrenia


Has been used for the management of acute depressive episodes (in combination with an antipsychotic) in patients with schizophrenia.c


Anxiety Disorders


Has been used for the management of anxiety (in combination with an anxiolytic, a sedative, or an antipsychotic) in patients with depression.c


Postherpetic Neuralgia


Among the drugs of choice for the symptomatic treatment of postherpetic neuralgia.c


Insomnia


Less effective for insomnia and associated with more serious adverse reactions than conventional hypnotics.c


Imipramine Hydrochloride Dosage and Administration


General


Major Depressive Disorder



  • Allow at least 2 weeks to elapse between discontinuance of therapy with an MAO inhibitor and initiation of imipramine and vice versa.a b Also allow at least 5 weeks to elapse when switching from fluoxetine.a b




  • Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments.a b i j k (See Worsening of Depression and Suicidality Risk under Cautions.)




  • Sustained therapy may be required; administer lowest effective dosage and monitor periodically for need for continued therapy.a b




  • Avoid abrupt discontinuance of therapy in patients receiving high dosages for prolonged periods.f To avoid withdrawal reactions, taper dosage gradually.a b



Enuresis



  • Exclude organic causes of enuresis prior to initiation of therapy.a




  • If daytime urgency and frequency occur, perform appropriate examinations (e.g., voiding cystourethrography, cystoscopy).a




  • Tolerance (tachyphylaxis) to therapeutic effects possible with continuous administration of imipramine; consider instituting a drug-free period following an adequate therapeutic trial with favorable response.a




  • Long-term, chronic use not recommended; gradually discontinue therapy following a period of satisfactory response.a To minimize risk of relapse, avoid abrupt discontinuance of therapy.a




  • Children who relapse when the drug is discontinued may not respond to subsequent treatment with imipramine.a



Administration


Oral Administration


Administer orally in up to 4 divided doses (without regard to meals)g or as a single daily dose at bedtime to avoid daytime sedation.a b


Reserve use of Tofranil-PM capsules until recommended total daily imipramine hydrochloride dosage ≥75 mg.b Tofranil-PM usually administered once daily, but divided doses may be necessary in some patients.b Tofranil-PM should not be used in children of any age.b (See Pediatric Warnings under Cautions.)


Dosage


Available as imipramine hydrochloride or imipramine pamoate; dosage is expressed in terms of imipramine hydrochloride.a b f


Individualize dosage carefully according to individual requirements and response.a b


Pediatric Patients


Enuresis

Oral

Children ≥6 years of age: Initially, 25 mg daily, administered 1 hour prior to bedtime.a If satisfactory response not obtained within 1 week, dosage may be increased to 50 mg nightly for children <12 years of age or 75 mg nightly for children ≥12 years of age.a Higher dosages provide no additional therapeutic benefit but may increase risk of adverse effects.a Maximum 2.5 mg/kg daily.a


For children who are early-night bed-wetters, better results may be obtained by administering 25 mg in midafternoon and again at bedtime.a


Adults


Major Depressive Disorder

Outpatients

Oral

Initially, 75 mg daily.a b May increase dosage to 150 mg daily and then if necessary to 200 mg daily.a b


Maintenance dosages: 50–150 mg daily.a b


Hospitalized Patients

Oral

Initially, 100–150 mg daily (administered in divided doses).a b May increase dosages to 200 mg daily and then if there is no response after 2 weeks to 250–300 mg daily.a b


Prescribing Limits


Pediatric Patients


Enuresis

Oral

Maximum 2.5 mg/kg daily.a


Adults


Major Depressive Disorder

Outpatients

Oral

Maximum 200 mg daily.a b


Hospitalized Patients

Oral

Maximum 300 mg daily.a b


Special Populations


Geriatric Patients


Initially, 25–50 mg daily as imipramine hydrochloride (e.g., Tofranil).a b Increase dosage based on response and tolerance up to a maximum of 100 mg daily.a b


Cautions for Imipramine Hydrochloride


Contraindications



  • Concurrent or recent (i.e., within 2 weeks) therapy with an MAO inhibitor.a b (See Specific Drugs under Interactions.)




  • During the acute recovery phase following MI.a b




  • Known hypersensitivity to imipramine, other dibenzazepine-derivative TCAs, or any ingredient in the formulation.a b



Warnings/Precautions


Warnings


Worsening of Depression and Suicidality Risk

Possible worsening of depression and/or emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior in both adult and pediatric patients with major depressive disorder, whether or not they are taking antidepressants; may persist until clinically important remission occurs.i j k l However, suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.i j k


Appropriately monitor and closely observe patients receiving imipramine for any reason, particularly during initiation of therapy (i.e., the first few months) and during periods of dosage adjustments.i j k (See Boxed Warning and also see Pediatric Use under Cautions.)


Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and/or mania may be precursors to emerging suicidality.j k Consider changing or discontinuing therapy in patients whose depression is persistently worse or in those with emerging suicidality or symptoms that might be precursors to worsening depression or suicidality, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms.i j k (See General under Dosage and Administration.)


Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.a j


Observe these precautions for patients with psychiatric (e.g., major depressive disorder, obsessive-compulsive disorder [OCD]) or nonpsychiatric disorders.j


Bipolar Disorder

May unmask bipolar disorder.j (See Activation of Mania or Hypomania under Cautions.) Imipramine is not approved for use in treating bipolar depression.a b


Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.j


Cardiovascular Effects

Possible conduction defects, arrhythmias, CHF, MI, strokes, and tachycardia, particularly at higher dosages.a b


Patients with preexisting or prior history of cardiac disease, patients with disturbed eating behaviors (e.g., purging) that result in inadequate hydration and/or compromised cardiac status, geriatric patients, and children (see Pediatric Warnings) most at risk;a b c use with caution and monitor closely (e.g., perform ECG at baseline and as appropriate during therapy).a b c


Pediatric Warnings

ECG changes of unknown clinical importance reported in pediatric patients receiving twice the recommended maximum daily dosage for enuresis.a Do not exceed maximum recommended pediatric dosage (i.e., 2.5 mg/kg daily).a (See Pediatric Use under Cautions.)


Children may be more sensitive to an acute imipramine overdosage than adults;a b use of high-potency preparation, Tofranil-PM, not recommended for children of any age.b (See Worsening of Depression and Suicidality Risk and also see Pediatric Use under Cautions.)


Anticholinergic Effects

Use with caution in patients for whom excess anticholinergic activity could be harmful (e.g., history of urinary retention, increased intraocular pressure, angle-closure glaucoma).a b


Seizures

Lowers seizure threshold; use with caution in patients with a history of seizures.a b


Interactions

May block hypotensive actions of clonidine, guanethidine, and similar agents.a b


Possible pharmacokinetic (decreased imipramine metabolism) interaction with methylphenidate; imipramine dosage adjustments may be required.a b


May enhance CNS depressant effects of alcohol.a b Use with caution in patients with a history of excessive alcohol consumption.a b (See Interactions.)


Hyperthyroidism

Use with caution and under close supervision in hyperthyroid patients or patients receiving thyroid agents; possible adverse cardiovascular effects.a b


Cognitive/Physical Impairment

Mental alertness or physical coordination required for performing hazardous tasks (e.g., driving or operating machinery) may be impaired.a b


Sensitivity Reactions


Cross-hypersensitivity

Possible cross-sensitivity to other dibenzazepine-derivative TCAs (e.g., clomipramine, desipramine, trimipramine).a b c


Photosensitivity

Avoid excessive exposure to sunlight.a b


General Precautions


Adequate Patient Monitoring

Perform baseline ECG prior to initiation of therapy with larger than usual dosages and at periodic intervals thereafter until steady-state imipramine concentrations are achieved.a


Close supervision and more frequent cardiac monitoring recommended for patients with any evidence of cardiovascular disease.a (See Cardiovascular Effects.)


Activation of Mania or Hypomania

Possible activation of mania and hypomania, particularly in patients with bipolar disorder; decrease dosage and/or administer a benzodiazepine concomitantly.a b (See Bipolar Disorder under Cautions.)


Psychosis

Risk of manifestations of psychosis in patients with schizophrenia, particularly in patients with paranoid symptoms; decrease dosage and/or administer an antipsychotic (e.g., a phenothiazine) concomitantly.a b


Elective Surgery

Discontinue therapy several days prior to surgery whenever possible.a b


Electroconvulsive Therapy (ECT)

Possible increased ECT risks; limit to patients for whom concomitant use is essential.a b


Hematologic Effects

Obtain leukocyte and differential blood counts if fever and sore throat develop during therapy.a b


If there is evidence of pathological neutrophil depression, discontinue therapy.a b


Blood Glucose Effects

Possible alterations in blood glucose concentrations.a b


Specific Populations


Pregnancy

Category D.e Manifestations of withdrawal reported in neonates following maternal use of imipramine during pregnancy.e


Lactation

Distributed into milk.a b e Breast-feeding not recommended.a b


Pediatric Use

Safety and efficacy not established in treatment of enuresis in children <6 years of age or for treatment of any other disorders in children <18 years of age.a b (See Pediatric Warnings under Cautions.)


FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment (4%) compared with placebo (2%) in children and adolescents with major depressive disorder, OCD, or other psychiatric disorders based on pooled analyses of 24 short-term, placebo-controlled trials of 9 antidepressant drugs (SSRIs and others).j However, a more recent meta-analysis of 27 placebo-controlled trials of 9 antidepressants (SSRIs and others) in patients <19 years of age with major depressive disorder, OCD, or non-OCD anxiety disorders suggests that the benefits of antidepressant therapy in treating these conditions may outweigh the risks of suicidal behavior or suicidal ideation.l No suicides occurred in these pediatric trials.j l


Carefully consider these findings when assessing potential benefits and risks of imipramine in a child or adolescent for any clinical use.i j k l (See Worsening of Depression and Suicidality Risk under Cautions.)


Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.c


In pooled data analyses, a reduced risk of suicidality was observed in adults ≥65 years of age with antidepressant therapy compared with placebo.i j (See Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)


Possible increased sensitivity to anticholinergic (e.g., dry mouth, constipation, vision disturbance), cardiovascular, orthostatic hypotension, and sedative effects of TCAs.


Titrate dosage carefully.c (See Geriatric Patients under Dosage and Administration.)


Hepatic Impairment

Use with caution in patients with moderate to severe hepatic impairment.a b


Renal Impairment

Use with caution in patients with moderate to severe renal impairment.a b


Common Adverse Effects


Anticholinergic effects (e.g., dry mouth,c constipation,c vision disturbance),c orthostatic hypotension,c sedation, weakness, lethargy, fatigue.c


In children with enuresis: Nervousness, sleep disorders, tiredness, mild GI disturbances.a


Interactions for Imipramine Hydrochloride


Metabolized in the liver by various CYP isoenzymes (e.g., CYP1A2, CYP2C, CYP2D6, CYP3A4).c


Drugs Affecting Hepatic Microsomal Enzymes


Inhibitors of CYP2D6: Potential pharmacokinetic interaction (increased plasma imipramine concentrations).a b Consider imipramine dosage adjustment whenever a CYP2D6 inhibitor is added or discontinued.a b


Inducers of CYP2D6: Potential pharmacokinetic interaction (decreased plasma imipramine concentrations).a b Consider imipramine dosage adjustment whenever a CYP2D6 inducer is added or discontinued.a


Specific Drugs






















































Drug



Interaction



Comments



Alcohol



Potentiates CNS depressant effects of alcohola b



Increased risks if overdose or suicide attempt occursa b



Antiarrhythmics: class 1C (e.g., flecainide, propafenone); quinidine



Potential for decreased imipramine metabolisma b



Monitor for TCA toxicity; dosage adjustment may be neededa b



Anticholinergic agents



Hyperthermia, particularly during hot weather, and paralytic ileusa b c



Use with caution; dosage adjustment may be neededc



Antipsychotics (e.g., phenothiazines)



Potential for decreased imipramine metabolisma b



Barbiturates



Potential for increased imipramine metabolisma b



Dosage adjustment may be neededa b



Cimetidine



Potential for decreased imipramine metabolisma b



Monitor for TCA toxicity; dosage adjustment may be neededc



CNS depressants



Potentiates effects of CNS depressantsa b



Use with cautiona b



Hypotensive agents (e.g., clonidine, guanethidine)



Antagonizes antihypertensive effects of clonidine or guanethidinea b



Use with cautiona b



Levodopa



May interfere with levodopa absorption c



Monitor levodopa dosage carefullya



MAO inhibitors



Potentially life-threatening serotonin syndromea b



Concomitant use contraindicateda b


Allow at least 14 days to elapse when switching to or from these drugsa b



Methylphenidate



Potential for decreased imipramine metabolisma b



Use with caution; decreased imipramine dosage may be requireda b



Phenytoin



Potential for increased imipramine metabolisma b



Dosage adjustment may be neededa b



SSRIs (e.g., citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline)



Potential for decreased imipramine metabolism and increased plasma concentrationsa b



Use with caution; monitor for TCA toxicity; dosage adjustment may be neededa b


Allow at least 5 weeks to elapse when switching from fluoxetinea b



Smoking



Possible decreased steady-state imipramine concentrationsg



Sympathomimetic agents (e.g., amphetamines, epinephrine, isoproterenol, norepinephrine, phenylephrine)



Increased vasopressor, cardiac effectsc



Avoid concomitant usea b



Thyroid agents



Possible cardiac arrhythmiasc



Use with caution and under close supervisiona b


Imipramine Hydrochloride Pharmacokinetics


Absorption


Bioavailability


Well absorbed from the GI tract following oral administration, with peak plasma concentrations usually attained within 1–2 hours.f


Bioavailability is approximately 43%.g


Onset


Antidepressant effect usually occurs within 1–3 weeks.a b


Food


Food does not affect absorption.g


Distribution


Extent


Widely distributed in the body.g


Imipramine and its active metabolite, desipramine, are distributed into milk100 101 in concentrations similar to those present in maternal plasma.101


Plasma Protein Binding


Approximately 60–96%.g


Elimination


Metabolism


Extensively metabolized in the liver via demethylation to pharmacologically active metabolite, desipramine, by various CYP isoenzymes (e.g., CYP1A2, CYP2D6, CYP3A4, CYP2C).c


Elimination Route


Excreted principally in urine as inactive metabolites within 24 hours (40%) and within 72 hours (70%); small amounts excreted in feces via biliary elimination.f


Half-life


Imipramine: 8–20 hours.f g


Desipramine: Up to 125 hours.f g


Special Populations


Alcoholics found to have a threefold greater intrinsic clearance of imipramine.g


Stability


Storage


Oral


Capsules

Tight containers at <30°C.a b


Tablets

Tight containers at 15–30°C.a b


ActionsActions



  • Mechanism of action in the management of depression unknown but may involve inhibition of reuptake of norepinephrine and/or serotonin.a b




  • Mechanism of action in the treatment of enuresis is not known but may involve inhibition of urination due to anticholinergic activity, CNS stimulant activity resulting in easier arousal by the stimulus of a full bladder, and/or other mechanisms that are presently unknown.c




  • Associated with more frequent anticholinergic, sedative, or cardiovascular effects and weight gain than SSRIs.c



Advice to Patients



  • Risk of suicidality; importance of patients, family, and caregivers being alert to and immediately reporting emergence of suicidality, worsening depression, or unusual changes in behavior, especially during the first few months of therapy or during periods of dosage adjustment.i j k FDA recommends providing written patient information (medication guide) explaining risks of suicidality each time the drug is dispensed.i j k




  • Importance of considering possible impaired ability to perform hazardous activities (e.g., operating hazardous machinery, driving a motor vehicle).a b




  • Risk of concomitant use with alcohol.a b




  • Risk of photosensitivity reactions.a b




  • Importance of continuing imipramine therapy even if a response is not evident within 1–3 weeks, unless directed otherwise.a b




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




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses or planned surgery.a b




  • Importance of informing patients of other important precautionary information.a b (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





















































Imipramine Hydrochloride

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Tablets



10 mg*



Imipramine Hydrochloride Tablets



Par



Tofranil (with povidone)



Mallinckrodt



25 mg*



Imipramine Hydrochloride Tablets



Par



Tofranil (with povidone)



Mallinckrodt



50 mg*



Imipramine Hydrochloride Tablets



Par



Tofranil (with povidone)



Mallinckrodt



Tablets, film-coated



10 mg*



Imipramine Hydrochloride Tablets



Sandoz, Mutual, United Research



25 mg*



Imipramine Hydrochloride Tablets



Sandoz, Mutual, United Research



50 mg*



Imipramine Hydrochloride Tablets



Sandoz, Mutual, United Research




























Imipramine Pamoate

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Capsules



equivalent to imipramine hydrochloride 75 mg



Tofranil-PM (with parabens)



Mallinckrodt



equivalent to imipramine hydrochloride 100 mg



Tofranil-PM (with parabens)



Mallinckrodt



equivalent to imipramine hydrochloride 125 mg



Tofranil-PM (with parabens)



Mallinckrodt



equivalent to imipramine hydrochloride 150 mg



Tofranil-PM (with parabens)



Mallinckrodt


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.


Imipramine HCl 10MG Tablets (MUTUAL PHARMACEUTICAL): 30/$14.99 or 60/$19.98


Imipramine HCl 25MG Tablets (SANDOZ): 30/$14.99 or 90/$28.97


Imipramine HCl 50MG Tablets (MUTUAL PHARMACEUTICAL): 30/$17.61 or 90/$35.24


Imipramine Pamoate 75MG Capsules (MALLINCKRODT): 30/$443.83 or 90/$1275.65


Tofranil 50MG Tablets (MALLINCKRODT): 30/$189.98 or 90/$529.98


Tofranil-PM 125MG Capsules (MALLINCKRODT): 30/$555.97 or 90/$1528.04


Tofranil-PM 150MG Capsules (MALLINCKRODT): 30/$547.66 or 90/$1526.79


Tofranil-PM 75MG Capsules (MALLINCKRODT): 30/$532.51 or 90/$1452.66



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 September 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.


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




References


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



100. Geigy Pharmaceuticals. Tofranil prescribing information. In: Huff BB, ed. Physicians’ desk reference. 39th ed. Oradell, NJ: Medical Economics Company Inc; 1985:969-70.



101. Sovner R, Orsulak PJ. Excretion of imipramine and desipramine in human breast milk. Am J Psychiatry. 1979; 136:451-2. [PubMed 426114]



102. Aylward GP. Understanding and treatment of childhood depression. J Pediatr. 1985; 107:1-9. [PubMed 2409258]



103. Food and Drug Administration. Class suicidality labeling language for antidepressants. From the FDA website: ().



104. Food and Drug Administration. Public health advisory: suicidality in children and adolescents being treated with antidepressant medications. Rockville, MD; 2004 Oct 15. From the FDA website: ()



105. Food and Drug Administration. Medication guide: about using antidepressants in children or teenagers. Rockville, MD; 2005 Jan 16. From the FDA web site: ().



a. Tyco healthcare-Mallinckrodt. Tofranil (imipramine hydrochloride) prescribing information. St. Louis, MO; 2001 Oct 17.



b. Tyco healthcare-Mallinckrodt. Tofranil-PM (imipramine pamoate) prescribing information. St. Louis, MO; 2001 Apr 17.



c. AHFS drug information 2004. McEvoy GK, ed. Tricyclic antidepressants general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2004:2234-41.



e. Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and lactation. 5th ed. Baltimore, MD: Williams & Wilkins; 2002:693-4.



f. AHFS drug information 2004. McEvoy GK, ed. Imipramine. Bethesda, MD: American Society of Health-System Pharmacists; 2004:2254-5.



g. IPCS INTOX Programme. Imipramine. From the IPCS website (). Accessed 2004 Apr 7.



h. American Psychiatric Association. Practice guideline for the treatment of patients with bipolar disorder (revised). Am J Psychiatry. 2002; 159(Suppl):1-49.



i. Food and Drug Administration. FDA news: FDA proposes new warnings about suicidal thinking, behavior in young adults who take antidepressant medications. Rockville, MD; 2007 May 2. From the FDA web site:



j. Food and Drug Administration. Antidepressant use in children, adolescents, and adults: class revisions to product labeling. Rockville, MD; 2007 May 2. From the FDA web site:



k. Food and Drug Administration. Revisions to medication guide: antidepressant medicines, depression and other serious mental illnesses and suicidal thoughts or actions. Rockville, MD; 2007 May 2. From the FDA web site:



l. Bridge JA, Iyengar S, Salary CB. Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment: a meta-analysis of randomized controlled trials. JAMA. 2007; 297:1683-96. [PubMed 17440145]



More Imipramine Hydrochloride resources


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


  • Imipramine Professional Patient Advice (Wolters Kluwer)

  • Imipramine Prescribing Information (FDA)

  • Imipramine MedFacts Consumer Leaflet (Wolters Kluwer)

  • imipramine Concise Consumer Information (Cerner Multum)

  • imipramine Advanced Consumer (Micromedex) - Includes Dosage Information

  • Tofranil Prescribing Information (FDA)

  • Tofranil-PM Prescribing Information (FDA)

  • Tofranil-PM MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Imipramine Hydrochloride with other medications


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Saturday, 21 April 2012

Lercanidipine hydrochloride 10mg and 20mg film-coated tablets






Lercanidipine hydrochloride 10mg and 20mg film-coated tablets



Read all of this leaflet carefully before you start using this medicine.


  • Keep this leaflet. You may need to read it again.

  • If you have any further questions, ask your doctor or pharmacist.

  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.



In this leaflet:



1 What Lercanidipine hydrochloride tablets are and what they are used for

2 Before you take

3 How to take

4 Possible side effects

5 How to store

6 Further information





What Lercanidipine hydrochloride tablets are and what they are used for


Lercanidipine belongs to a group of medicines called calcium channel blockers that block the entry of calcium into the muscle cells of the heart and the blood vessels that carry blood away from the heart (the arteries). It is the entry of calcium into these cells that causes the heart to contract and arteries to narrow. By blocking the entry of calcium, calcium channel blockers decrease contraction of the heart and dilate (widen) the arteries, and the blood pressure is reduced.


Lercanidipine has been prescribed to you to treat your high blood pressure, also known as hypertension.




Before you take



Do not take Lercanidipine if you:


  • are allergic (hypersensitive) to lercanidipine or to any of the ingredients in Lercanidipine hydrochloride tablets

  • have had an allergic reaction to medicines that are closely related to Lercanidipine hydrochloride tablets (such as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine)

  • are suffering from certain heart diseases:

    • uncontrolled cardiac failure
    • an obstruction to flow of blood from the heart
    • unstable angina (angina at rest or progressively increasing)
    • have had a heart attack less than one month ago

  • have severe liver or kidney problems

  • are taking drugs that are inhibitors of CYP3A4 isoenzyme:

    • antifungal medicines (such as ketoconazole or intraconazole)
    • macrolide antibiotics (such as erythromycin or troleandomycin)
    • antivirals (such as ritonavir)
    • at the same time as another drug called ciclosporin or cyclosporin
    • with grapefruit or grapefruit juice

  • are pregnant, or if you wish to become pregnant or if you are a woman in child-bearing age and do not use any contraceptive method

  • if you are breast-feeding



Take special care with Lercanidipine


You should consult your doctor before taking Lercanidipine hydrochloride tablets if you:


  • have certain other heart conditions, or if you have a pacemaker

  • have angina pectoris, Lercanidipine may very rarely cause increased frequency of attacks that may last longer and become more severe. Myocardial infarction has been reported in isolated cases.

  • have problems with your liver or kidney, or you are on dialysis



Using other medicines


Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.


Taking Lercanidipine with certain other medicines (see below), may alter the effect of these medicines or of Lercanidipine.


It is especially important for your doctor to know if you are already being treated with any of the following medicines:


  • phenytoin or carbamazepine (medicines for epilepsy)

  • rifampicin (a medicine to treat tuberculosis)

  • midazolam (a medicine that helps you sleep)

  • cimetidine, more than 800mg (a medicine for ulcers, indigestion, or heartburn)

  • digoxin (a medicine to treat a heart problem)

  • terfenadine or astemizole (medicines for allergies)

  • amiodarone or quinidine (medicines to treat a fast heart beat)

  • metoprolol (a medicine to treat high blood pressure)

  • simvastatin (a medicine for high cholesterol value)



Using Lercanidipine with food and drink


You must not eat grapefruit or drink grapefruit juice as this may increase the effect of Lercanidipine.


If you use alcohol together with Lercanidipine you may experience dizziness/fainting, tiredness or weakness. This is because the medicine may lower your blood pressure considerably together with alcohol.




Pregnancy and breast-feeding


Ask your doctor for advice before taking any medicine.


If you are taking Lercanidipine and think that you may be pregnant, consult your doctor.


Do not use if you are pregnant, or if you wish to become pregnant or if you are a woman in childbearing age and do not use any contraceptive method.


Do not use if you are breast-feeding.




Driving and using machines


Lercanidipine has a negligible influence on the ability to drive or use machines. However, side effect such as dizziness, weakness, tiredness and rarely sleepiness may occur. You should be careful until you know how you react to Lercanidipine.




Important information about some of the ingredients of Lercanidipine


Lercanidipine contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.





How to take


Always take Lercanidipine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.


The usual dose is one Lercanidipine hydrochloride 10 mg film-coated tablet daily at the same time each day, preferably in the morning at least 15 minutes before breakfast, because a high fat meal significantly increases your blood levels of the medicine.


Your doctor may decide to increase your dose to one Lercanidipine hydrochloride 20mg film-coated tablet daily, if needed.


The tablets should preferably be swallowed whole with 1/2 glass of water. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.


Lercanidipine is not recommended for use in children and adolescents below 18 years.



If you take more Lercanidipine than you should


Immediately contact a doctor, the nearest hospital casualty department or the centre for poison information for advice.


Exceeding the correct dosage may cause blood pressure to become too low, and the heart to beat irregularly or faster. It may also lead to unconsciousness.




If you forget to take Lercanidipine


If you forget to take your tablet, take it as soon as you remember, unless it is almost time for your next dose. Then go on as before. Do not take a double dose.




If you stop taking Lercanidipine


If you stop taking Lercanidipine your blood pressure may increase again. Please consult your doctor before stopping the treatment.



If you have any further questions on the use of this product, ask your doctor or pharmacist.




Possible side effects


Like all medicines, Lercanidipine can cause side effects, although not everybody gets them.


The frequencies of side effects have been listed below according to the following definitions:



Very common: affects more than 1 user in 10

Common: affects 1 to 10 users in 100

Uncommon: affects 1 to 10 users in 1,000

Rare: affects 1 to 10 users in 10,000

Very rare, not known: affects less than 1 user in 10,000, frequency cannot be estimated from the available data



Uncommon: Headache, dizziness, faster heartbeats, awareness of the beating of the heart, flushing (transient episodic redness of the face and neck), ankle swelling.



Rare: Sleepiness, weakness, tiredness, nausea, vomiting, diarrhoea, abdominal pain, indigestion, rash, muscle pain, passage of large amounts of urine, angina pectoris.



Very rare, not known: Decrease in blood pressure which may lead to fainting, allergic reaction, swelling of gums, increase in liver enzyme blood test values, fall in blood pressure which can cause dizziness, light-headedness or fainting, increase in the usual number of times one urinates, chest pain and heart attack.


If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.




How to store


Keep out of the reach and sight of children.


Do not use Lercanidipine after the expiry date, which is stated on the label, carton or bottle after EXP. The expiry date refers to the last day of that month.



Storage conditions


Al/PVC blister: Do not store above 25°C. Store in the original package to protect from moisture.


HDPE bottles: Do not store above 25°C. Store in the original package. Keep the bottle tightly closed to protect from moisture.


Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.




Further information



What Lercanidipine hydrochloride tablets contains


  • The active substance is lercanidipine hydrochloride.

One 10mg film-coated tablet contains 10mg lercanidipine hydrochloride, equivalent to 9.4mg lercanidipine.


One 20mg film-coated tablet contains 20mg lercanidipine hydrochloride, equivalent to 18.8mg lercanidipine.


The other ingredients are: Tablet core: Magnesium stearate, povidone, sodium starch glycolate (Type A), lactose monohydrate, microcrystalline cellulose.


Film-coating 10mg tablets: Macrogol, polyvinyl alcohol (partly hydrolysed), talc, titanium dioxide (E 171), yellow iron oxide (E 172).


Film-coating 20mg tablets: Macrogol, polyvinyl alcohol (partly hydrolysed), talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).




What Lercanidipine hydrochloride tablets looks like and contents of the pack


Lercanidipine hydrochloride 10mg tablets are yellow, round, biconvex 6.5mm film-coated tablets, scored on one side, and marked ‘L’ on the other side.


Lercanidipine hydrochloride 20mg tablets are pink, round, biconvex 8.5mm film-coated tablets, scored on one side, and marked ‘L’ on the other side.


The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.



Pack sizes:


Blisters

28 tablets




Marketing Authorisation Holder



Actavis Group PTC ehf

Reykjavíkurvegi 76-78

220 Hafnarfjörõur

Iceland




Manufacturers



Balkanpharma – Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600

Bulgaria





This leaflet was last revised in – May 2010




Actavis

Barnstaple

EX32 8NS

UK


L19083DUP-30