Tuesday, 29 May 2012

pergolide


PER-goe-lide


Oral route(Tablet)

The use of pergolide has been shown to increase the risk of cardiac valvular disease and is not recommended for use in patients with a history of cardiac valvulopathy. Some patients have required valve replacement, and deaths have been reported. Periodic echocardiograms are recommended during therapy. Pergolide increases the risk of fibrotic complications including pulmonary, pleural, and/or retroperitoneal fibrosis, pericarditis, pleuritis, and pericardial and/or pleural effusions. Pergolide is not recommended for use in patients with a history of fibrotic conditions and patients should be monitored for fibrotic complications during therapy .



Commonly used brand name(s)

In the U.S.


  • Permax

Available Dosage Forms:


  • Tablet

Therapeutic Class: Antiparkinsonian


Pharmacologic Class: Dopamine Agonist


Uses For pergolide


Pergolide belongs to the group of medicines known as ergot alkaloids. It is used with levodopa or with carbidopa and levodopa combination to treat people who have Parkinson's disease. It works by stimulating certain parts of the central nervous system (CNS) that are involved in this disease.


Pergolide was available only with your doctor's prescription.


pergolide was withdrawn from the U.S. market in March 2007 due to an increased risk for heart valve problems .


Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in the product labeling, pergolide is used in certain patients with the following medical condition:


  • Restless legs syndrome

Before Using pergolide


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For pergolide, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to pergolide or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Studies on pergolide have been done only in adult patients, and there is no specific information about its use in children.


Geriatric


pergolide has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding


Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking pergolide, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using pergolide with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Frovatriptan

Using pergolide with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Kava

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of pergolide. Make sure you tell your doctor if you have any other medical problems, especially:


  • Heart disease or

  • Mental problems (history of)—Pergolide may make the condition worse.

Proper Use of pergolide


If pergolide upsets your stomach, it may be taken with meals. If stomach upset continues, check with your doctor.


Dosing


The dose of pergolide will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of pergolide. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (tablets):
    • Adults—50 micrograms a day for the first two days. The dose may be increased every three days as needed. However, the usual dose is not more than 5000 micrograms.


Missed Dose


If you miss a dose of pergolide, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using pergolide


It is important that your doctor check your progress at regular visits, to make sure that pergolide is working and to check for unwanted effects.


pergolide may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to pergolide before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.


Dizziness, lightheadedness, or fainting may occur after the first doses of pergolide, especially when you get up from a lying or sitting position. Getting up slowly may help. Taking the first dose at bedtime or when you are able to lie down may also lessen problems. If the problem continues or gets worse, check with your doctor.


Pergolide may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.


It may take several weeks for pergolide to work. Do not stop taking pergolide or reduce the amount you are taking without first checking with your doctor.


pergolide Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


Rare
  • Chest pain (severe)

  • convulsions (seizures)

  • difficulty in breathing

  • fainting

  • fast heartbeat or irregular pulse

  • headache (severe or continuing)

  • high fever

  • high or low (irregular) blood pressure

  • increased sweating

  • loss of bladder control

  • nausea and vomiting (continuing or severe)

  • nervousness

  • severe muscle stiffness

  • sudden weakness

  • unexplained shortness of breath

  • unusual tiredness or weakness

  • unusually pale skin

  • vision changes, such as blurred vision or temporary blindness

Check with your doctor as soon as possible if any of the following side effects occur:


More common
  • Anxiety

  • bloody or cloudy urine

  • confusion

  • difficult or painful urination

  • frequent urge to urinate

  • hallucinations (seeing, hearing, or feeling things that are not there)

  • uncontrolled movements of the body, such as the face, tongue, arms, hands, head, and upper body

Less common
  • Dizziness

  • headache

  • swelling in hands and legs

Rare
  • Abdominal pain or pressure

  • chills

  • cough

  • decreased flow of urine

  • fever

  • pain in side or lower back

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Chest congestion

  • constipation

  • dizziness or lightheadedness, especially when getting up from a lying or sitting position

  • drowsiness

  • heartburn

  • lower back pain

  • muscle pain

  • nausea

  • runny or stuffy nose

  • trouble in sleeping

  • weakness

Less common
  • Diarrhea

  • dryness of mouth

  • loss of appetite

  • swelling of the face

  • vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: pergolide side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


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More pergolide resources


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


  • pergolide Concise Consumer Information (Cerner Multum)

  • Pergolide Prescribing Information (FDA)

  • Pergolide Mesylate Monograph (AHFS DI)

  • Permax Prescribing Information (FDA)

  • Permax MedFacts Consumer Leaflet (Wolters Kluwer)



Compare pergolide with other medications


  • Hyperprolactinemia
  • Parkinson's Disease
  • Tourette's Syndrome

Monday, 28 May 2012

Methadone Linctus BP





1. Name Of The Medicinal Product



Methadone Linctus BP


2. Qualitative And Quantitative Composition



Methadone Hydrochloride BP 0.04% w/v



3. Pharmaceutical Form



Oral Solution



4. Clinical Particulars



4.1 Therapeutic Indications



For the suppression of cough in terminal disease.



4.2 Posology And Method Of Administration



Oral












Recommended dose:




Adults and children over 12 years:




 




2.5ml-5ml every 4-6 hours, reduced to




 




twice daily on prolonged use.




 




Use with caution in the elderly.



Not recommended for use in children under 12 years.



4.3 Contraindications



• Hypersensitivity to methadone or to any of the excipients.



• Respiratory depression, obstructive airways disease, and during an asthma attack.



• Risk of paralytic ileus.



• Acute alcoholism.



• Avoid in raised intracranial pressure or head injury (in addition to interfering with respiration, affects pupillary responses vital for neurological assessment).



• Use during labour (prolonged duration of action increases the risk of neonatal depression).



• Contra-indicated in patients taking monoamine oxidase inhibitors (including moclobemide) or within 14 days of stopping such treatment.



4.4 Special Warnings And Precautions For Use



Tolerance and dependence of the morphine type may occur. Methadone should be given with caution to patients with asthma (see Section 4.3), convulsive disorders, depressed respiratory reserve, hypotension, shock, prostatic hyperplasia, adrenocortical insufficiency, inflammatory or obstructive bowel disorders, myasthenia gravis or hypothyroidism. In cases of hepatic or renal impairment the use of methadone should be avoided or given in reduced doses.



Dosage should be reduced in elderly and debilitated patients and those with a history of drug abuse.



Children are very sensitive to the depressant effects.



Cases of QT interval prolongation and torsade de pointes have been reported during treatment with methadone, particularly at high doses (>100mg/d). Methadone should be administered with caution to patients at risk of development of prolonged QT interval, e.g. in case of:



-history of cardiac conduction abnormalities,



-advanced heart disease or ischaemic heart disease,



-Liver disease,



-family history of sudden death,



-Electrolyte abnormalities, i.e. hypokalaemia, hypomagnesaemia



-concomitant treatments with drugs that have a potential for QT-prolongation,



-concomitant treatment with drugs which may cause electrolyte abnormalities,



-concominant treatment with cytochrome P450 CYP 3A4 inhibitors (see section 4.5).



In patients with recognised risk factors of QT prolongation, or in case of concomitant treatment with drugs that have a potential for QT prolongation, ECG monitoring is recommended prior to methadone treatment, with a further ECG test at dose stabilisation. ECG monitoring is recommended, in patients without recognised risk factors for QT prolongation, before dose titration above 100mg/d, and at seven days after titration.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Interactions potentiating the effects of methadone;



Cytochrome P450 3A4 inhibitors: methadone clearance is decreased when co-administered with drugs which inhibit CYP3A4 activity, such as some anti-HIV agents, macrolide antibiotics, cimetidine, ciprofloxacin and azole antifungal agents (since the metabolism of methadone is mediated by the CYP3A4 isoenzyme).



Cimetidine and phenytoin – may lead to potentiation of opioid activity due to displacement of methadone from protein binding sites. However, as phenytoin is also a hepatic enzyme inducer, it may lower plasma methadone levels (see below).



Fluvoxamine may increase plasma concentrations of methadone.



The depressant effects of methadone are likely to be enhanced by depressants of the CNS, such as other opioid analgesics, alcohol (see section 4.3), anaesthetics, antipsychotics, anxiolytics, hypnotics and sedatives, major and minor tranquilisers and phenothiazines. As well as CNS depression, there may be respiratory depression and/or hypotension. Tricyclic antidepressants may exert a similar effect.



Interactions reducing the effects of methadone;



The opioids antagonists, naloxone and naltrexone, will precipitate an acute withdrawal syndrome in methadone-dependent individuals. Naloxone will also antagonise the analgesic, CNS and respiratory depressant effects of methadone.



Buprenorphine and pentazocine may also rapidly precipitate withdrawal symptoms in patients addicted to methadone.



The hepatic enzyme-inducing drugs, nevirapine, rifampicin (and other rifamycins), phenytoin, phenobarbital and carbamazepine may lower plasma methadone levels and produce symptoms of withdrawal in methadone dependent patients. Similar effects have been reported with efavirenz nelfinavir, ritonavir and possibly abacavir.



Urinary acidifiers: Acidification of the urine will increase the rate of elimination of methadone by the kidney thereby reducing plasma concentrations.



Effects of methadone on other drugs;



Methadone may increase plasma desipramine levels and increase desipramine side-effects when given concurrently.



Zidovudine – methadone may increase the plasma concentrations of zidovudine.



Mexiletine – methadone may delay mexiletine absorption.



Metoclopramide and domperidone – the gastrointestinal effects may be antagonised by methadone.



Methadone treatment has been found to decrease the rate of absorption and decrease the bioavailability of the nucleoside reverse transcriptase inhibitors didanosine and to a lesser extent stavudine.



Other important interactions;



In patients taking drugs affecting cardiac conduction or drugs which may affect electrolyte balance, there is a risk of cardiac events when methadone is taken concurrently.



As serious and sometimes fatal reactions have occurred following administration of pethidine to patients receiving MAOIs, other drugs related to pethidine are contraindicated in patients taking MAOI's (including moclobemide) or within 14 days of stopping such treatment, (see section 4.3) as there is a risk of CNS excitation or depression.



Cross tolerance and cross dependence can be expected between other opioids acting at the same receptors.



4.6 Pregnancy And Lactation



Pregnancy;



There is no or inadequate evidence of safety in human pregnancy, but the drug has been widely used for many years without apparent ill consequence and animal studies have not shown any hazard.



Opioid analgesics taken in pregnancy may depress neonatal respiration and cause withdrawal effects in neonates of dependent mothers. May cause gastric stasis and risk of inhalation pneumonia in mothers during labour.



Lactation;



Methadone is excreted in breast milk. A decision must be made whether to discontinue breastfeeding or discontinue the methadone therapy.



Taken during breastfeeding may cause withdrawal symptoms in the infant.



A maintenance dose may be acceptable during breastfeeding, but the dose should be kept to a minimum and the baby should be monitored to avoid sedation.



4.7 Effects On Ability To Drive And Use Machines



May cause drowsiness and or dizziness. If affected do not drive or operate machinery.



4.8 Undesirable Effects



Blood and lymphatic system disorders



Lymphocytosis



Endocrine disorders



Increased prolactin concentrations



Psychiatric disorders



Dependence, hallucinations, confusion, mood changes including dysphoria, decreased libido, restlessness



Nervous system disorders



Raised intracranial pressure occurs in some patients. Dizziness, headache, drowsiness



Eye disorders



Miosis



Ear and labyrinth disorders



Vertigo



Cardiac disorders



Cases of QT prolongation and torsade de pointes have been rarely reported. Bradycardia, palpitations, tachycardia



Vascular disorders



Hypotension, facial flushing



Respiratory, thoracic and mediastinal disorders



Respiratory depression, Exacerbation of existing asthma



Gastrointestinal disorders



Nausea, vomiting, constipation, dry mouth



Hepatobiliary disorders



Biliary spasm



Skin and subcutaneous tissue disorders



Rashes, pruritus, urticaria, sweating



Renal and urinary disorders



Difficulty in micturation, ureteric spasm, antidiuretic effect



Reproductive system and breast disorders



Erectile dysfunction



General disorders and administration site conditions



Hypothermia.



Investigations



Globulins increased, blood albumin increased



4.9 Overdose



Symptoms of overdosage with opiods include respiratory depression, pinpoint pupils, pulmonary odema and coma. Hypotension may occur and rhabdomyolysis progressing to renal failure has been reported. The presence of signs of drug abuse supports the diagnosis. In children methadone overdose produces drowsiness, floppiness, pinpoint pupils and apnoea.



Treatment consists of the establishment of a patent airway together with supportive measures, and the administration of a specific opioid antagonist, preferably naloxone given as per local guidance. Reversal of coma and respiratory depression is seen within 2 minutes of naloxone administration. Repeated treatment with naloxone may be required to prevent recurrence of coma because the duration of action of naloxone is shorter than that of methadone. Patients should be monitored for signs of relapse for at least 48 hours.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Methadone hydrochloride is a potent analgesic with action similar to that of morphine, but having a less marked sedative effect. It has a depressant action on the cough centre and is given to control non-productive coughing of intractable disorders, such as lung cancer. It is also used as part of the treatment of dependence on opioid drugs. It is readily absorbed from the gastro-intestinal tract. It is widely distributed in the tissues and diffuses across the placenta. It is extensively protein bound. It is metabolised in the liver, mainly by n-demethylation and cyclisation and the metabolites are excreted in the bile and urine.



5.2 Pharmacokinetic Properties



The analgesic effect begins about 45 minutes after administration by mouth (about 15 minutes after subcutaneous injection) and the effect lasts about 4 hours. It has a prolonged half life. As accumulation occurs following repeated doses the effects become more prolonged.



5.3 Preclinical Safety Data



None.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Glycerol, tolu flavour solution, purified water, tartrazine compound solution, syrup.



6.2 Incompatibilities



None known.



6.3 Shelf Life



500ml : 24 months unopened.



6.4 Special Precautions For Storage



This product is subject to the Controlled Drugs Regulations. Store in an authorised location.



6.5 Nature And Contents Of Container



500ml: Plain amber glass bottle with plastic cap and viskring.



6.6 Special Precautions For Disposal And Other Handling



None.



7. Marketing Authorisation Holder



Thornton & Ross Ltd



Linthwaite Laboratories



Huddersfield



HD7 5QH



8. Marketing Authorisation Number(S)



00240/6420R



9. Date Of First Authorisation/Renewal Of The Authorisation



15.01.81 /16.07.98



10. Date Of Revision Of The Text



16.04.2010




Sunday, 27 May 2012

Trifungol Liquid


Pronunciation: un-deh-sil-EN-ik AS-id
Generic Name: Undecylenic Acid
Brand Name: Examples include Elon Dual Defense Anti-Fungal and Trifungol


Trifungol Liquid is used for:

Treating athlete's foot and ringworm. It may also be used for other conditions as determined by your doctor.


Trifungol Liquid is an antifungal. It works by preventing fungal growth.


Do NOT use Trifungol Liquid if:


  • you are allergic to any ingredient in Trifungol Liquid

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



Before using Trifungol Liquid:


Some medical conditions may interact with Trifungol Liquid. 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 diabetes or blood vessel problems in your arms or legs

Some MEDICINES MAY INTERACT with Trifungol Liquid. Because little, if any, of Trifungol Liquid is absorbed into the blood, the risk of interacting with another medicine is low.


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


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


  • Trifungol Liquid is for external use only. Do not get Trifungol Liquid in your eyes, ears, nose, or mouth. If you get Trifungol Liquid in your eyes, rinse immediately with cool tap water.

  • Wash your hands immediately before and after using Trifungol Liquid.

  • Wash and completely dry the affected area.

  • Apply a thin layer of medicine to the affected area. For athlete's foot, pay special attention to the spaces between the toes.

  • Do not cover with a bandage or dressing unless directed otherwise by your doctor.

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

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



Important safety information:


  • If your symptoms do not improve within 4 weeks or if they become worse, check with your doctor.

  • Do not use Trifungol Liquid on blistered or oozing skin or over deep puncture wounds.

  • For athlete's foot, it may be helpful to wear well-fitting, well-ventilated shoes and to change shoes and socks at least once daily.

  • Do not use Trifungol Liquid on the scalp or the nails. It is not effective on these areas.

  • It is important to use Trifungol Liquid for the full course of treatment. Failure to do so may decrease the effectiveness of Trifungol Liquid and may increase the risk that the fungus will no longer be sensitive to Trifungol Liquid and will not be able to be treated by this or certain other antifungals in the future.

  • Overuse of topical products may worsen your condition.

  • Trifungol Liquid may be harmful if swallowed. If you or someone you know may have taken Trifungol Liquid by mouth, contact your local poison control center or emergency room immediately.

  • CHILDREN younger than 18 years of age or patients with sensitive skin should use Trifungol Liquid only as directed by a doctor.

  • Supervise CHILDREN who are using Trifungol Liquid.

  • Use of Trifungol Liquid is not recommended in CHILDREN younger than 2 years of age without first checking with your doctor. Safety and effectiveness in this age group have not been confirmed.

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


Possible side effects of Trifungol Liquid:


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:



Mild stinging.



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); blistering, burning, itching, peeling, swelling, or reddening of your skin not present when you began using Trifungol Liquid.



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: Trifungol 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. Trifungol Liquid may be harmful if swallowed.


Proper storage of Trifungol Liquid:

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


General information:


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

  • Trifungol Liquid is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Trifungol Liquid. 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 Trifungol resources


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


Compare Trifungol with other medications


  • Onychomycosis
  • Tinea Corporis
  • Tinea Pedis

Tuesday, 22 May 2012

Imipramine Pamoate



Class: Tricyclics and Other Norepinephrine-reuptake Inhibitors
Note: This monograph also contains information on Imipramine Hydrochloride
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 Pamoate


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 Pamoate 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 Pamoate


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 Pamoate


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 Pamoate 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 Pamoate resources


  • Imipramine Pamoate Side Effects (in more detail)
  • Imipramine Pamoate Dosage
  • Imipramine Pamoate Use in Pregnancy & Breastfeeding
  • Drug Images
  • Imipramine Pamoate Drug Interactions
  • Imipramine Pamoate Support Group
  • 13 Reviews for Imipramine Pamoate - 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 Pamoate with other medications


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Hydroxyprogesterone


Pronunciation: hye-DROX-ee-proe-JES-ter-one
Generic Name: Hydroxyprogesterone
Brand Name: Makena


Hydroxyprogesterone is used for:

Reducing the risk of delivering a baby too early (preterm birth). Hydroxyprogesterone should only be used by women who are pregnant with one baby and have had a preterm delivery of one baby in the past.


Hydroxyprogesterone is a synthetic hormone (progestin). How it works to reduce the risk of recurrent preterm birth is not known.


Do NOT use Hydroxyprogesterone if:


  • you are allergic to any ingredient in Hydroxyprogesterone, including castor oil

  • you are pregnant with more than one baby or you have other risk factors for preterm birth

  • you have never had a preterm delivery of one baby in the past

  • you have blood clots, blood clotting problems, breast cancer or other hormone-sensitive cancers, or if you have a history of these conditions

  • you have undiagnosed abnormal vaginal bleeding not related to pregnancy, yellowing of the eyes or skin caused by pregnancy, liver tumors or other liver problems, or uncontrolled high blood pressure

  • you have been through menopause

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



Before using Hydroxyprogesterone:


Some medical conditions may interact with Hydroxyprogesterone. 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 diabetes or high blood sugar, edema (swelling), preeclampsia, or migraine headaches

  • if you have a history of epilepsy (seizures); asthma; heart, liver, or kidney problems; high blood pressure; or mental or mood problems (eg, depression)

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


  • Rifamycins (eg, rifampin) because they may decrease Hydroxyprogesterone's effectiveness

  • Acetaminophen, bupropion, clozapine, efavirenz, halothane, methadone, nicotine products (eg, gum, patch), theophylline, or tizanidine because their effectiveness may be decreased by Hydroxyprogesterone

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


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


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

  • Hydroxyprogesterone is usually given as an injection every 7 days at your doctor's office, hospital, or clinic.

  • Hydroxyprogesterone should appear as a clear, yellow solution. Do not use Hydroxyprogesterone if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

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

  • If you miss a dose of Hydroxyprogesterone, contact your doctor right away.

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



Important safety information:


  • Hydroxyprogesterone is not intended for use to stop active preterm labor. Discuss any questions or concerns with your doctor.

  • Diabetes patients - Hydroxyprogesterone may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Lab tests information required for safe and proper use.

  • Hydroxyprogesterone should not be used in women who have been through menopause; safety and effectiveness in these patients have not been confirmed.

  • Hydroxyprogesterone should not be used in CHILDREN younger than 16 years; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: Hydroxyprogesterone is intended for use in pregnant women. Discuss with your doctor the benefits and risks of using Hydroxyprogesterone while you are pregnant. Hydroxyprogesterone is found in breast milk. If you are or will be breast-feeding while you use Hydroxyprogesterone, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Hydroxyprogesterone:


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: Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Diarrhea; mild bruising, itching, or pain at the injection site; nausea.



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, throat, or tongue; unusual hoarseness); calf or leg pain, redness, swelling, tenderness, or warmth; chest pain; coughing up blood; hard bump, increased pain over time, oozing of blood or fluid, or swelling at the injection site; mental or mood problems (eg, depression); severe or persistent headache or dizziness; shortness of breath; swelling of the hands, ankles, or feet; 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: Hydroxyprogesterone side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.


Proper storage of Hydroxyprogesterone:

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


General information:


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

  • Hydroxyprogesterone is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Hydroxyprogesterone. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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