Thursday, May 31, 2012

Tramapap




Generic Name: tramadol hydrochloride, acetaminophen

Dosage Form: compounding kit
Tramapap

LWP


381 Van Ness Ave. Suite 1507


Torrance CA, 90501


S/N: LWP304326                              3/29/2010                     LWP,MD


ACETAMINOPHEN GRANULAR, USP #75 GM


BATCH: 03292010Z                                                            HEALTH: 1


MFG: LIVING WELL PHARMACY                                        FIRE: 1


NDC: 64038-0135-75                                                           REACTIVITY: 0


CAS #: 103-90-2



LWP


381 Van Ness Ave. Suite 1507


Torrance CA, 90501


S/N: LWP307039                              4/6/2010                     LWP,MD


TRAMADOL HCL #15GM


BATCH: 04062010Z                                                            HEALTH: 2


MFG: LIVING WELL PHARMACY                                        FIRE: 1


NDC: 64038-0738-15                                                           REACTIVITY: 0


CAS #: 73806-49-2


  1. RX Only

For Prescription Compounding Only




Tramapap Kit

Tramadol HCl and Acetaminophen Compound Kit


Description


Each Tramapap Kit is comprised of 15 grams of tramadol hydrochloride powder and  75 grams of acetaminophen powder.


Certificate of Analysis on File


Tramapap Kit also contains 23.25 grams of Lactose Monohydrate (Spray dried) powder and 1.5 grams of

riboflavin USP powder. When compounded, the final product provides a homogeneous product of 300

capsules each capsule containing 50mg of tramadol and 250mg of acetaminophen.

Equipment


Required supplies needed to compound this kit



















Equipment
Item
Quantity
Tramadol HCl (Included)
15 grams
Acetaminophen (Included)
75 grams
Lactose Monohydrate Spray Dried Powder ( Included)
23.25 grams
Riboflavin Powder (Included)
1.5 grams
Red/Blue #1 Capsules ( Required Not Included)
300 Capsules





Equipment


Recommended supplies not included in this kit


















Equipment
Item
Quantity
16 oz Glass Mortar and Pestle
1 each
300 Capsule Machine Number 2 Notch
1
Scraper ( Recommended Not Included)
1
Tamper (Recommended Not Included)
1
Capsule Locker (Recommended Not Included)
1



Directions


1. Using a 16 oz mortar and pestle triturate powders well to reduce particle size until uniform.


2. Using a 300 capsule machine encapsulate triturate powder mixture into number 1 red/blue capsules



Prior to compounding, store Tramapap Kit at room temperature. Store the final product at room temperature.



Final product for oral use only. Keep out the reach of children. Compounded product, as dispensed,


is stable for at least 180 days or the time remaining on the expiration date of any given ingredient,


which ever is shorter.



























Tramapap 
tramadol hydrochloride, acetaminophen  kit






Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)64038-059










Packaging
#NDCPackage DescriptionMultilevel Packaging
164038-059-031 KIT In 1 KITNone











QUANTITY OF PARTS
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE  15 g
Part 21 BOTTLE  75 g



Part 1 of 2
TRAMADOL HCL 
tramadol hydrochloride  powder










Product Information
NDC Product Code (Source)64038-738  
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Tramadol Hydrochloride (Tramadol)Tramadol Hydrochloride1 g  in 1 g





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
164038-738-1515 g In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/07/2010




Part 2 of 2
ACETAMINOPHEN CRYSTAL 
acetaminophen  powder










Product Information
NDC Product Code (Source)64038-135  
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen)Acetaminophen1 g  in 1 g





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
164038-135-7575 g In 1 BOTTLENone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/07/2010











Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/07/2010


Labeler - Living Well Pharmacy, Inc. (070488957)

Registrant - Living Well Pharmacy, Inc. (070488957)









Establishment
NameAddressID/FEIOperations
Living Well Pharmacy, Inc.070488957api manufacture









Establishment
NameAddressID/FEIOperations
Letco830193582api manufacture









Establishment
NameAddressID/FEIOperations
Spectrum Laboratory Products, Inc.075295246api manufacture









Establishment
NameAddressID/FEIOperations
Medisca627218576api manufacture
Revised: 05/2010Living Well Pharmacy, Inc.




More Tramapap resources


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


Compare Tramapap with other medications


  • Pain
  • Rheumatoid Arthritis


Wednesday, May 30, 2012

Somatuline Depot


Pronunciation: lan-REE-oh-tide
Generic Name: Lanreotide
Brand Name: Somatuline Depot


Somatuline Depot is used for:

Treating certain patients with acromegaly. It may also be used for other conditions as determined by your doctor.


Somatuline Depot is a somatostatin analog. It works by reducing the levels of certain hormones (eg, growth hormone, insulin-like growth factor-1) in the blood.


Do NOT use Somatuline Depot if:


  • you are allergic to any ingredient in Somatuline Depot

  • you are allergic to latex or rubber

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



Before using Somatuline Depot:


Some medical conditions may interact with Somatuline Depot. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

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

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

  • if you have a history of gallstones or gallbladder problems, liver problems, thyroid problems, heart problems (eg, slow heartbeat, heart valve problems), high blood pressure, or pancreas problems

  • if you have a history of kidney problems or are on dialysis

  • if you have diabetes or use insulin or other medicine to lower your blood sugar

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


  • Medicines that may lower heart rate, such as beta-blockers (eg, propranolol), because the risk of slow heartbeat may be increased. Ask your doctor if you are unsure if any of your medicines might lower your heart rate

  • Bromocriptine, quinidine, or terfenadine because the risk of their side effects may be increased by Somatuline Depot

  • Cyclosporine because its effectiveness may be decreased by Somatuline Depot

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


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


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

  • Somatuline Depot is usually given as an injection every 4 weeks at your doctor's office, hospital, or clinic.

  • Do not use Somatuline Depot if it contains particles, is 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 Somatuline Depot, contact your doctor right away.

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



Important safety information:


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

  • Somatuline Depot may lower your blood sugar levels. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. If these symptoms occur, tell your doctor right away.

  • Somatuline Depot may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.

  • Lab tests, including growth hormone levels, blood sugar levels, and thyroid function, may be performed while you use Somatuline Depot. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Somatuline Depot should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Somatuline Depot while you are pregnant. It is not known if Somatuline Depot is found in breast milk. Do not breast-feed while taking Somatuline Depot.


Possible side effects of Somatuline Depot:


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; gas; headache; joint pain; mild stomach pain or discomfort; minor redness, pain, or swelling at the injection site; nausea; vomiting; weight loss.



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); blurred vision; dizziness; severe or persistent headache; severe or persistent nausea, stomach pain, or vomiting; slow or irregular heartbeat; symptoms of gallstones (eg, sudden pain around the upper right stomach area, right shoulder area, or between your shoulder blades; yellowing of the skin or eyes; fever with chills); unusual tiredness or weakness.



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


See also: Somatuline Depot 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 Somatuline Depot:

Somatuline Depot is usually handled and stored by a health care provider.


General information:


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

  • Somatuline Depot 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 Somatuline Depot. 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 Somatuline Depot resources


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


  • Somatuline Depot Prescribing Information (FDA)

  • Somatuline Depot Monograph (AHFS DI)

  • Somatuline Depot Advanced Consumer (Micromedex) - Includes Dosage Information

  • Somatuline Depot Consumer Overview



Compare Somatuline Depot with other medications


  • Acromegaly


Sunday, May 27, 2012

Triamcinolone



Class: Adrenals
Note: This monograph also contains information on Triamcinolone Acetonide, Triamcinolone Hexacetonide
VA Class: RE101
CAS Number: 124-94-7
Brands: Aristocort, Aristospan, Azmacort, Kenalog

Introduction

Synthetic glucocorticoid; virtually no mineralocorticoid activity.c j


Uses for Triamcinolone


Treatment of a wide variety of diseases and conditions principally for glucocorticoid effects as an anti-inflammatory and immunosuppressant agent and for its effects on blood and lymphatic systems in the palliative treatment of various diseases.b


Usually inadequate alone for adrenocortical insufficiency because essentially devoid of mineralocorticoid activity.b c j


Adrenocortical Insufficiency


Corticosteroids are administered in physiologic dosages to replace deficient endogenous hormones in patients with adrenocortical insufficiency.b


Because production of both mineralocorticoids and glucocorticoids is deficient in adrenocortical insufficiency, hydrocortisone or cortisone (in conjunction with liberal salt intake) usually is the corticosteroid of choice for replacement therapy.b j


If triamcinolone is used, must also administer a mineralocorticoid (fludrocortisone), particularly in infants.b j


Adrenogenital Syndrome


Lifelong glucocorticoid treatment of congenital adrenogenital syndrome.b


In salt-losing forms, cortisone or hydrocortisone is preferred in conjunction with liberal salt intake; a mineralocorticoid may be necessary in conjunction through at least 5–7 years of age.b A glucocorticoid, usually alone, is continued for long-term therapy after early childhood.b j


In hypertensive forms, a “short-acting” glucocorticoid with minimal mineralocorticoid activity (e.g., methylprednisolone, prednisone) is preferred;b avoid long-acting glucocorticoids because of tendency toward overdosage and growth retardation.b


Hypercalcemia


Treatment of hypercalcemia associated with malignancy.b j


Usually ameliorates hypercalcemia associated with bone involvement in multiple myeloma.b


Treatment of hypercalcemia associated with sarcoidosis.b m


Treatment of hypercalcemia associated with vitamin D intoxication.b


Not effective for hypercalcemia caused by hyperparathyroidism.b


Thyroiditis


Treatment of granulomatous (subacute, nonsuppurative) thyroiditis.b d j Anti-inflammatory actions relieve fever, acute thyroid pain, and swelling.b


Usually reserved for palliative therapy in severely ill patients unresponsive to salicylates and thyroid hormones.b


May reduce orbital edema in endocrine exophthalmos (thyroid ophthalmopathy).b


Rheumatic Disorders and Collagen Diseases


Short-term palliative treatment of acute episodes or exacerbations and systemic complications of rheumatic disorders (e.g., rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, acute gouty arthritis, posttraumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis, ankylosing spondylitis, acute and subacute bursitis, Reiter syndromem , rheumatic fever [especially with carditis]m ) and collagen diseases (e.g., acute rheumatic carditis, systemic lupus erythematosus, polyarteritis nodosam , vasculitism ) refractory to more conservative measures.b c d e g h j


Relieves inflammation and suppresses symptoms but not disease progression.b


Rarely indicated as maintenance therapy.b


May be used as maintenance therapy (e.g., in rheumatoid arthritis, acute gouty arthritis, systemic lupus erythematosus, acute rheumatic carditis) as part of a total treatment program in selected patients when more conservative therapies have proven ineffective.b However, glucocorticoid withdrawal is extremely difficult in these patients; relapse and recurrence usually occur with drug discontinuance.b


Local injection can provide dramatic relief initially for articular manifestations of rheumatic disorders (e.g., rheumatoid arthritis) that involve only a few persistently inflamed joints or for inflammation of tendons or bursae;b inflammation tends to recur and sometimes is more intense after drug cessation.b


Local injection can prevent invalidism by facilitating movement of joints that might otherwise become immobile.b


Controls acute manifestations of rheumatic carditisb m more rapidly than salicylates and may be life-saving; cannot prevent valvular damage and is no better than salicylates for long-term treatment.b


Adjunctively for severe systemic complications of Wegener's granulomatosis, but cytotoxic therapy is the treatment of choice.b


Primary treatment to control symptoms and prevent severe, often life-threatening complications in patients with polyarteritis nodosa, relapsing polychondritis, polymyalgia rheumatica, or mixed connective tissue disease syndrome.b High dosage may be required for acute situations; after a response has been obtained, drug must often be continued for long periods at low dosage.b


In osteoarthritis, intra-articular injections may be beneficial but should be limited in number as joint damage may occur.b d e


Dermatologic Diseases


Treatment of pemphigus and pemphigoidm , bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, uncontrollable eczemam , cutaneous sarcoidosism , mycosis fungoides, lichen planus, severe psoriasis, and severe seborrheic dermatitis.b d e h j


Rarely indicated for psoriasis.b d j If used, exacerbation may occur when the drug is withdrawn or dosage is decreased.b j


Usually reserved for acute exacerbations unresponsive to conservative therapy.b


Early initiation of systemic glucocorticoid therapy may be life-saving in pemphigus vulgaris and pemphigoid, and high or massive doses may be required.b


For control of severe or incapacitating allergic conditions (e.g., contact dermatitis, atopic dermatitis) intractable to adequate trials of conventional treatment.d j


Chronic skin disorders seldom an indication for systemic glucocorticoids.b


Intralesional or sublesional injections occasionally indicated for localized chronic skin disorders including keloids, psoriatic plaques, alopecia areata, discoid lupus erythematosus, necrobiosis lipoidica diabeticorum, granuloma annulare, or lichen simplex chronics (neurodermatitis)e unresponsive to topical therapy.b e h


Rarely indicated systemically for alopecia (areata, totalis, or universalis).b May stimulate hair growth, but hair loss returns when the drug is discontinued.b


Allergic Conditions


For control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment and control of acute manifestations, including serum sickness, drug hypersensitivity reactions, and severe seasonal or perennial rhinitis.b d j


Systemic therapy usually reserved for acute conditions and severe exacerbations.b


For acute conditions, usually used in high dosage and with other therapies (e.g., antihistamines, sympathomimetics).b


Reserve prolonged treatment of chronic allergic conditions for disabling conditions unresponsive to more conservative therapy and when risks of long-term glucocorticoid therapy are justified.b


Ocular Disorders


To suppress a variety of allergic and nonpyogenic ocular inflammations.b


To reduce scarring in ocular injuries.b


For the treatment of severe acute and chronic allergic and inflammatory processes involving the eye and adnexa (e.g., allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, herpes zoster ophthalmicus, iritis and iridocyclitis, chorioretinitis, diffuse posterior uveitis and choroiditis, anterior segment inflammation, optic neuritis, sympathetic ophthalmia).b d j


Acute optic neuritis optimally treated with initial high-dose IV therapy (e.g., methylprednisolone) followed by chronic oral therapy. Can slow progression to clinically definite multiple sclerosis.


Less severe allergic and inflammatory allergic conditions of the eye are treated with topical (to the eye) corticosteroids.i


Systemically in stubborn cases of anterior segment eye disease and when deeper ocular structures are involved.b


Asthma


Used by oral inhalation for the long-term prevention of bronchospasm in patients with asthma.102 104 105


Used orally for severe bronchial asthma intractable to conventional treatment.j


Used orally for treatment of moderate to severe acute exacerbations of asthma (oral prednisone usually preferred).j Speeds resolution of airflow obstruction and reduces rate of relapse.j


Because onset of effects is delayed, do not use alone for emergency treatment.


Early systemic glucocorticoid therapy particularly important for asthma exacerbations in infants and children.i


In hospital management of an acute asthma exacerbation, systemic adjunctive glucocorticoids if response to oral inhalation therapy is not immediate, if oral corticosteroids were used as self-medication prior to hospitalization, or if the episode is severe.b


For severe persistent asthma once initial control is achieved, high dosages of inhaled corticosteroids are preferable to oral corticosteroids for maintenance because inhaled corticosteroids have fewer systemic effects.


Maintenance therapy with low doses of an orally inhaled corticosteroid is preferred treatment for adults and children with mild persistent asthma (i.e., patients with daytime symptoms of asthma more than twice weekly but less than once daily, and nocturnal symptoms of asthma more than twice per month).102 104


A long-acting β2-agonist (e.g., formoterol, salmeterol) added to low- to medium-dose inhaled corticosteroids is the preferred therapy in patients with moderate persistent asthma (i.e., patients with daily asthmatic symptoms); 102 104 alternatively, may increase (e.g., double) maintenance dosage of inhaled corticosteroid within medium-dosage range in such patients.102 104


Orally as an adjunct to other therapy to speed resolution of all but the mildest exacerbations of asthma when response to a short-acting inhaled β2-agonist is not prompt or sustained after 1 hour or in those who have a history of severe exacerbations.c


Oral glucocorticoids with minimal mineralocorticoid activity and relatively short half-life (e.g., prednisone, prednisolone, methylprednisolone) are preferred.


Do not use oral inhalation for the treatment of nonasthmatic bronchitis or for relief of acute bronchospasm.105


COPD


For severe exacerbations of COPD, a short (e.g., 1–2 weeks) course of oral glucocorticoids can be added to existing therapy.


Effects in stable COPD are much less dramatic than in asthma, and role of glucocorticoids in the management of stable COPD is limited to very specific indications.


Inhaled corticosteroids are not appropriate in the treatment of acute exacerbations of COPD.


Sarcoidosis


Management of symptomatic sarcoidosis.b d j


Systemic glucocorticoids are indicated for hypercalcemia; ocular, CNS, glandular, myocardial, or severe pulmonary involvement; or severe skin lesions unresponsive to intralesional injections of glucocorticoids.b


Advanced Pulmonary and Extrapulmonary Tuberculosis


Systemically as adjunctive therapy with effective antimycobacterial agents (e.g., streptomycin, isoniazid) to suppress manifestations related to the host’s inflammatory response to the bacillus (Mycobacterium tuberculosis) and ameliorate complications in severe pulmonary or extrapulmonary tuberculosis.


Adjunctive glucocorticoid therapy may enhance short-term resolution of disease manifestations (e.g., clinical and radiographic abnormalities) in advanced pulmonary tuberculosis and also may reduce mortality associated with certain forms of extrapulmonary disease (e.g., meningitis, pericarditis).


Systemic adjunctive glucocorticoids may reduce sequelae (e.g., intellectual impairment) and/or improve survival in moderate to severe tuberculous meningitis.


Systemic adjunctive glucocorticoid therapy rapidly reduces the size of pericardial effusions and the need for drainage procedures and decreases mortality (probably through control of hemodynamically threatening effusion) in acute tuberculous pericarditis.


Hastens the resolution of pain, dyspnea, and fever associated with tuberculous pleurisy.b


Loeffler’s Syndrome


Symptomatic relief of acute manifestations of symptomatic Loeffler’s syndrome not manageable by other means.j


Berylliosis


Symptomatic relief of acute manifestations of berylliosis.j


Aspiration Pneumonitis


Symptomatic relief of acute manifestations of aspiration pneumonitis.j


Hematologic Disorders


Management of acquired (autoimmune) hemolytic anemia, idiopathic thrombocytopenic purpura (ITP), secondary thrombocytopenia, erythroblastopenia, or congenital (erythroid) hypoplastic anemia.d j


High or even massive glucocorticoid dosages decrease bleeding tendencies and normalize blood counts; does not affect the course or duration of hematologic disorders.b


Glucocorticoids, immune globulin IV (IGIV), or splenectomy are first-line therapies for moderate to severe ITP, depending on the extent of bleeding involved.


Glucocorticoids may not affect or prevent renal complications in Henoch-Schoenlein purpura.b


Insufficient evidence of effectiveness of glucocorticoids in aplastic anemia in children, but widely used.b


Pericarditis


To reduce the pain, fever, and inflammation of pericarditis, including that associated with MI.b m


Glucocorticoids can provide effective symptomatic relief, but aspirin considered the treatment of choice for post-MI pericarditis because of greater evidence establishing benefit.


Important to distinguish between pain caused by pericarditis and that caused by ischemia since management will differ.


Glucocorticoids may cause thinning of developing scar and myocardial rupture.g Consider possibility that cardiac rupture may account for recurrent pain since use of glucocorticoids may be a risk factor in its development. (See Cardiovascular Effects under Cautions.)


Management of tuberculous pericarditis. (See Advanced Pulmonary and Extrapulmonary Tuberculosis under Uses.)


GI Diseases


Short-term palliative therapy for acute exacerbations and systemic complications of ulcerative colitis, regional enteritis, and Crohn's diseasem .b d j


Do not use if a probability of impending peforation, abscess, or other pyogenic infection.b


Rarely indicated for maintenance therapy in chronic GI diseases (e.g., ulcerative colitis) since does not prevent relapses and may produce severe adverse reactions with long-term administration.b


Occasionally, low dosages, in conjunction with other supportive therapy, may be useful for disease unresponsive to the usual therapy indicated for chronic conditions.b


Neoplastic Diseases


Alone or as a component of various chemotherapeutic regimens in the palliative treatment of neoplastic diseases of the lymphatic system (e.g., leukemias and lymphomas in adults and acute leukemias in children).d j


Treatment of breast cancerm ; glucocorticoids alone not as effective as other agents (e.g., cytotoxic agents, hormones, antiestrogens) and should be reserved for unresponsive disease.b


Glucocorticoids alone or as a component of various combination chemotherapeutic regimens for palliative treatment of advanced, symptomatic (i.e., painful) hormone-refractory prostate cancer.m


Low Back Pain


Has been used epidurally (alone or combined with a local anesthetic and/or an opiate analgesic) for symptomatic relief of low back pain; although use remains controversial and convincing evidence of efficacy is lacking, most experts consider such therapy an option for short-term relief of acute, subacute, or chronic radicular pain in patients with low back pain and radiculopathy associated with disk disease or herniation or spinal stenosis when more conservative therapies (e.g., rest, analgesics, physical therapy) fail and as a means of potentially avoiding surgery.


Limited evidence suggests that therapeutic facet joint and intradiscal glucocorticoid injections are minimally effective or ineffective in the treatment of low back pain, although facet joint injections may be useful in some patients with facet arthropathy. Inclusion of a glucocorticoid in trigger point injections does not appear to be beneficial.


Sacroiliac joint injections performed using fluoroscopic guidance may provide temporary pain relief in some patients when the principal source of spinal pain is the sacroiliac joint.


Oral glucocorticoids have been used; however, they do not appear to be effective and evidence supporting such use is lacking.


Multiple Sclerosis


Glucocorticoids are drugs of choice for the management of acute relapses of multiple sclerosis.j


Anti-inflammatory and immunomodulating effects accelerate neurologic recovery by restoring the blood-brain barrier, reducing edema, and possibly improving axonal conduction.


Shortens the duration of relapse and accelerates recovery; remains to be established whether the overall degree of recovery improves or the long-term course is altered.


Myasthenia Gravis


Management of myasthenia gravis, usually when there is an inadequate response to anticholinesterase therapy.m


Organ Transplants


In massive dosage, used concomitantly with other immunosuppressive drugs to prevent rejection of transplanted organs.b m


Incidence of secondary infections is high with immunosuppressive drugs; limit to clinicians experienced in their use.b


Trichinosis


Treatment of trichinosis with neurologic or myocardial involvement.j


Nephrotic Syndrome and Lupus Nephritis


Treatment of idiopathic nephrotic syndrome without uremia.d


Can induce diuresis and remission of proteinuria in nephrotic syndromed secondary to primary renal disease, especially when there is minimal renal histologic change.b


Treatment of lupus nephritis.d


Carpal Tunnel Syndrome


Local injection of glucocorticoids into the tissue near the carpal tunnel has been used in a limited number of patients to relieve symptoms (e.g., pain, edema, sensory deficit) of carpal tunnel syndrome.


Triamcinolone Dosage and Administration


General



  • Route of administration and dosage depend on the condition being treated and patient response.c




  • Individualize dosage carefully according to the diagnosis, severity, prognosis and probable duration of the disease, and patient response and tolerance.b d e j




  • Long-term therapy should not be initiated without due consideration of its risks.b If necessary, administer in the smallest dosage possible.b j Continual monitoring is recommended for signs that indicate dosage adjustment is necessary (e.g., remission or exacerbations of the disease and stress [surgery, infection, trauma]).b j



Alternate-Day Therapy



  • Alternate-day therapy in which a single dose is administered every other morning is the dosage regimen of choice for long-term oral glucocorticoid treatment of most conditions.b This regimen provides relief of symptoms while minimizing adrenal suppression, protein catabolism, and other adverse effects.b




  • Although triamcinolone's HPA-axis suppression persists for 2.25 days, the manufacturer recommends that an alternate-day dosage regimen may be considered for some patients receiving long-term oral therapy.j However, most authorities consider only a “short-acting” glucocorticoid that suppresses the HPA axis <1.5 days after a single oral dose (e.g., prednisone, prednisolone, methylprednisolone) to be suitable.b c




  • Some conditions (e.g., rheumatoid arthritis, ulcerative colitis) require daily glucocorticoid therapy because symptoms of the underlying disease cannot be controlled by alternate-day therapy.b



Discontinuance of Therapy



  • A steroid withdrawal syndrome consisting of lethargy, fever, myalgia can develop following abrupt discontinuance.b Symptoms often occur without evidence of adrenal insufficiency (while plasma glucocorticoid concentrations were still high but were falling rapidly).b




  • If used for only brief periods (a few days) in emergency situations, may reduce and discontinue dosage quite rapidly.b




  • Very gradually withdraw systemic glucocorticoids until recovery of HPA-axis function occurs following long-term therapy with pharmacologic dosages.b g (See Adrenocortical Insufficiency under Warnings.)




  • Exercise caution when transferring from systemic glucocorticoid to oral or nasal inhalation corticosteroid therapy.b (See Conversion to Orally Inhaled Therapy in Patients Receiving Systemic Corticosteroids under Dosage and Administration.)




  • Many methods of slow withdrawal or “tapering” have been described.b




  • In one suggested regimen, decrease by 2–4 mg every 3–7 days until the physiologic dose (4 mg) is reached.b




  • Other recommendations state that decrements usually should not exceed 2 mg every 1–2 weeks.b




  • When a physiologic dosage has been reached, single 20-mg oral morning doses of hydrocortisone can be substituted for whatever glucocorticoid the patient has been receiving.b After 2–4 weeks, may decrease hydrocortisone dosage by 2.5 mg every week until a single morning dosage of 10 mg daily is reached.b




  • For certain acute allergic conditions (e.g., contact dermatitis such as poison ivy) or acute exacerbations of chronic allergic conditions, glucocorticoids may be administered short term (e.g., for 6 days).b Administer an initially high dose on the first day of therapy, and then withdraw therapy by tapering the dose over several days.b



Conversion to Orally Inhaled Therapy in Patients Receiving Systemic Corticosteroids



  • When switching from systemic corticosteroids to orally inhaled triamcinolone acetonide in patients with asthma, asthma should be reasonably stable before initiating treatment with the oral inhalation.a




  • Initially, administer the aerosol concurrently with the maintenance dosage of the systemic corticosteroid.a After about 1 week, gradually withdraw systemic corticosteroid by reducing the daily or alternate daily dosage.a c Generally, decrease dosage in decrements of ≤2 mg of triamcinolone acetonide after intervals of 1–2 weeks, depending on patient response.a b




  • Death has occurred in some individuals in whom systemic corticosteroids were withdrawn too rapidly.105 (See Adrenocortical Insufficiency under Warnings.)




  • During withdrawal of oral therapy, symptoms of systemic corticosteroid withdrawal may occur, despite maintenance or even improvement in pulmonary function;a continue oral inhalation therapy but monitor for objective signs of adrenal insufficiency.a If evidence of adrenal insufficiency occurs, increase systemic corticosteroid dosage temporarily and then continue withdrawal more slowly.a




  • If exacerbations of asthma occur during oral inhalation therapy after systemic corticosteroids have been withdrawn, administer short courses of systemic corticosteroids, then taper dosage as symptoms subside.c Supplemental systemic corticosteroid therapy may also be required during periods of stress.a



Administration


Administer orally,j by oral inhalation,a or by IM injection.c d Not for IV injection.d e g h


Administer for local effect by intra-articular, intrabursal, intrasynovial, intralesional (intradermal), sublesional, soft-tissue, or epidural injection.b c d e g h


Generally reserve IM therapy for patients who are not able to take the drug orally.c d


Oral Administration


Triamcinolone

Administer orally as tablets.j


Oral Inhalation


Triamcinolone Acetonide

Prime inhaler prior to first use and after a period of nonuse >3 days by shaking upright inhaler gently and then pressing the canister firmly (away from eyes) and quickly to release spray; repeat procedure so a total of 2 sprays are released.a


Shake well immediately before each use and invert inhaler prior to actuation.a c Exhale as completely as possible and place the mouthpiece of the inhaler well into the mouth with lips closed firmly around it.a c Inhale slowly and deeply through the mouth while pressing the metal canister down with the forefinger.a c After holding the breath for as long as possible (about 10 seconds), remove the mouthpiece and exhale very slowly.a c If additional inhalations are required, wait ≥1 minute between inhalations, shake the inhaler again, and repeat the procedure.a c


Following each treatment, rinse mouth thoroughly with water or mouthwashc to remove drug deposited in the oropharyngeal area.a c


Clean inhaler once daily by removing canister from the inhaler, pulling apart the 2 plastic parts of inhaler, removing mouthpiece cap, and gently washing in lukewarm water; dry thoroughly.a


IM Administration


Triamcinolone Acetonide

Administer 40-mg/mL sterile suspension by deep IM injection into gluteal muscle.d The 10-mg/mL sterile suspension is not suitable for IM administration.e


Shake vial before use to insure uniform suspension.d For adults, a minimum needle length of 1.5 inches recommended; a longer needle may be required in obese patients.d Use alternate sites for subsequent injections.d


Because it is slowly absorbed, IM administration is not indicated when an immediate effect or short duration is required.c


Do not administer IM for conditions prone to bleeding (e.g., ITP).d


Intra-articular, Intrabursal, Intrasynovial, Intralesional, or Soft-tissue Administration


For treatment of joints, consult standard textbooks for administration techniques.d e


Triamcinolone Acetonide

Administer by intra-articular, intrabursal, intrasynovial, soft-tissue, intralesional, or sublesional injection.c d e


Shake vial before use to insure uniform suspension.d e


For intralesional (or sublesional) injection, use the 10-mg/mL sterile suspension;e the-40 mg/mL sterile suspension is not intended for intralesional (intradermal) use.d


Use a tuberculin syringe to facilitate intralesional or sublesional dosage measurement.c May inject multiple sites if they are ≥1 cm apart.c


For intra-articular, intrabursal, intrasynovial, or soft-tissue injection, may use either the 10- or 40-mg/mL sterile suspension.c A local anesthetic (e.g., procaine hydrochloride) may be infiltrated into soft tissue surrounding the joint and/or injected into the joint before administration of triamcinolone acetonide.c d


Triamcinolone Hexacetonide

Administer by intra-articular, soft-tissue, intralesional, or sublesional injection.c g h


For intralesional (or sublesional) injection, use the 5-mg/mL sterile suspension.c h For intra-articular or soft-tissue injection, use the 20-mg/mL sterile suspension.g


Dilution of Triamcinolone Hexacetonide

May dilute with a local anesthetic (e.g., 1% or 2% lidocaine hydrochloride) prior to intra-articular or intralesional injection.c g h May dilute with sterile water for injection, 0.9% sodium chloride injection, or 5 or 10% dextrose in 0.9% sodium chloride injection prior to intralesional injection.c h


Determine optimum dilution by nature and location of lesion, lesion size, depth of injection, and necessary volume; generally, perform more superficial injections with greater dilution.h


Avoid diluents containing preservatives (e.g., parabens, phenols).g h


Epidural Administration


Long-acting injectable suspension has been administered by epidural injection, although safety of epidural injections using preserved formulations is controversial and epidural administration of these formulations is not recommended by the manufacturer.b Limited evidence suggests that large particles in glucocorticoid suspensions may cause embolic vascular occlusion following inadvertent intra-arterial injection.


Inject into the epidural space near the site where the nerve roots pass before entering the intervertebral foramen.


Epidural injections may be performed by caudal, interlaminar, or transforaminal approaches; the transforaminal approach requires the smallest injection volume and appears to be the most specific and possibly most effective route.


Because of the potential for complications related to improper needle placement or drug administration, many experts state that epidural injections should be performed by an experienced clinician using fluoroscopic guidance and contrast control to ensure that the needle is correctly positioned and that the injection is not performed intravascularly, intrathecally, or into tissues other than the epidural space.


Optimal technique, dosage, timing of initial injection, injection frequency, and maximum number of injections remain to be established.


Dosage


Available as triamcinolone, triamcinolone acetonide, and triamcinolone hexacetonide. Dosage of triamcinolone acetonide or hexacetonide is expressed in terms of the respective salt.d g


Triamcinolone acetonide oral aerosol inhaler delivers about 100 mcg of drug per metered spray.a Commercially available aerosol delivers at least 240 metered sprays;a c do not use after 240 actuations.a c


After a satisfactory response is obtained, decrease dosage in small decrements to the lowest level that maintains an adequate clinical response, and discontinue the drug as soon as possible.b c


Monitor patients continually for signs that indicate dosage adjustment is necessary, such as remissions or exacerbations of the disease and stress (surgery, infection, trauma).b


High dosages may be required for acute situations of certain rheumatic disorders and collagen diseases; after a response has been obtained, drug often must be continued for long periods at low dosage.b


High or massive dosages may be required in the treatment of pemphigus, exfoliative dermatitis, bullous dermatitis herpetiformis, severe erythema multiforme, or mycosis fungoides.b Early initiation of systemic glucocorticoid therapy may be life-saving in pemphigus vulgaris.b Reduce dosage gradually to the lowest effective level, but discontinuance may not be possible.b


Pediatric Patients


Base pediatric dosage on severity of the disease and patient response rather than on strict adherence to dosage indicated by age, body weight, or body surface area.c j


Usual Dosage

Oral

Some clinicians recommend 0.117–1.66 mg/kg daily or 3.3–50 mg/m2 daily, administered in 4 divided doses.c


IM

Triamcinolone acetonide in children <6 years of age: Dosage not established; insufficient clinical experience to recommend use in this age group.c d


Triamcinolone acetonide in children 6–12 years of age: Initially, 40 mg depending on the severity of the condition.d Some clinicians recommend 0.03–0.2 mg/kg or 1–6.25 mg/m2 at 1- to 7-day intervals.c


Triamcinolone acetonide in children >12 years of age: Initially, 60 mg (using the 40-mg/mL sterile suspension).c d May administer additional doses of 20–100 mg (usually 40–80 mg) when signs and symptoms recur; c d some clinicians recommend administration at 6-week intervals, if possible, to minimize HPA suppression.c Some patients may be well controlled on doses ≤20 mg.d


Intra-articular or Soft-tissue Injection

Triamcinolone hexacetonide: Initially, 0.11–1.6 mg/kg daily or 3.2–48 mg/m2 daily, administered in 3–4 divided doses; dosage may vary depending on disease being treated.g


Asthma

Oral Inhalation

Triamcinolone acetonide in children <6 years of age: manufacturer does not recommended use in this age group.105


Triamcinolone acetonide in children 6–12 years of age: Initially, 100 or 200 mcg (1 or 2 sprays) 3 or 4 times daily (300–800 mcg total) or 200–400 mcg (2–4 sprays) twice daily (400–800 mcg total); adjust dosage according to patient response.105 Maximum dosage recommended by manufacturer is 1200 mcg (12 sprays) daily;105 some experts state that higher dosages may be used in children with severe persistent asthma.102 104


Continually monitor patients for signs that indicate dosage adjustment is necessary (e.g., remissions or exacerbations of disease and stress [surgery, infection, trauma]).c j (See Conversion to Orally Inhaled Therapy in Patients Receiving Systemic Corticosteroids under Dosage and Administration.)


Neoplastic Diseases

Oral

In children with acute leukemia, usually 1 mg/kg daily, but up to 2 mg/kg may be necessary.j Initial response usually observed within 6–21 days and therapy continued for 4–6 weeks.j


Adults


Usual Dosage

Oral

Initially, 4–48 mg daily, usually administered in 1–4 doses, depending on disease being treated.j


IM

Triamcinolone acetonide: Usually, 60 mg (using the 40-mg/mL sterile suspension).c d May administer additional doses of 20–100 mg (usually 40–80 mg) when signs and symptoms recur.c d Some clinicians recommend administration at 6-week intervals, if possible, to minimize HPA suppression.c Some patients may be well controlled with doses ≤20 mg.d


Intra-articular, Intrabursal, Intrasynovial, or Soft-tissue Injection

Dosage varies depending on location, size, and degree of inflammation.b d e


Triamcinolone acetonide: Initially, 5–15 mg for large joints; 2.5–5 mg for small joints.c d e Symptom relief generally occurs with dosages ≤40 mg for large joints and ≤10 mg for small joints.d e For soft-tissue injection in treatment of tendon sheath inflammation, 2.5–10 mg.c Repeat when signs and symptoms recur.b d e


Intra-articular or Soft-tissue Injection

Dosage varies depending on location, size, and degree of inflammation.c g


Triamcinolone hexacetonide: 10–20 mg for large joints; 2–6 mg for small joints.c g Determine subsequent dosage and frequency based on patient response.c g Repeat every 3–4 weeks as necessary; more frequent administration is not recommended.c g


Intralesional or Sublesional Injection

Dosage varies depending on location, size, and degree of inflammation.d e


Triamcinolone acetonide: ≤1 mg per injection site; may repeat at intervals of ≥1 week, depending on patient response.c e May inject intralesionally into multiple sites if ≥1 cm apart, but do not exceed total dosage of 30 mg at any one time.c


Triamcinolone hexacetonide: average dose ≤0.5 mg per square inch of affected skin.h Administer additional injections according to patient response.c


Asthma

Oral Inhalation

Triamcinolone acetonide: Initially, 200 mcg (2 sprays) 3 or 4 times daily (600 or 800 mcg total) or 400 mcg (4 sprays) twice daily.a In adults with severe asthma, it may be advisable to start with 12–16 sprays daily (1200–1600 mcg total), and then reduce dosage to the lowest effective level.a Maximum 1600 mcg (16 sprays) daily recommended by manufacturer,105 but some experts state that higher dosages may be used.100 102 a


Oral

For severe or incapacitating asthma, 8–16 mg daily.j


Adrenocortical Insufficiency

Oral

Usually, 4–12 mg daily in addition to mineralocorticoid therapy.j


Rheumatic Disorders and Collagen Diseases

Oral

In patients with rheumatoid arthritis, acute gouty arthritis, ankylosing spondylitis, select cases of psoriatic arthritis, acute and subacute bursitis, or acute nonspecific tenosynovitis, initially, 8–16 mg once daily (morning) or on alternate days.j Occasionally, more effective relief achieved with administration 2–4 times daily.j


In patients with systemic lupus erythematosus, initially, 20–32 mg daily until desired response is achieved, then reduce to maintenance dosage.j In patients with more severe symptoms, ≥48 mg daily initially and higher maintenance dosages may be required.


Saturday, May 26, 2012

Testolactone


Pronunciation: TES-toe-LAK-tone
Generic Name: Testolactone
Brand Name: Teslac


Testolactone is used for:

Treating certain types of breast cancer in women who have been through menopause or whose ovaries no longer function. It may also be used for other conditions as determined by your doctor.


Testolactone is an antineoplastic that is related to testosterone (male sex hormone) but has not been shown to have the masculine effects of testosterone. It works by blocking the production of estrogen, which helps prevent the growth of breast cancers that are activated by estrogen. It may also prevent tumor cells from being activated by other hormones.


Do NOT use Testolactone if:


  • you are allergic to any ingredient in Testolactone

  • you are a man with breast cancer

  • you are pregnant

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



Before using Testolactone:


Some medical conditions may interact with Testolactone. 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 heart disease (eg, ischemic heart disease), kidney disease, or liver problems

  • if you have high levels of calcium in your blood

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


  • Anticoagulants (eg, warfarin) because the risk of side effects such as bleeding may be increased

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


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


  • Take Testolactone by mouth with or without food.

  • If nausea, vomiting, or loss of appetite occur, check with your doctor or pharmacist for ways to lessen these effects.

  • Continue to use Testolactone even if you feel well. Do not miss any doses.

  • If you miss a dose of Testolactone, contact your doctor immediately.

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



Important safety information:


  • Lab tests, including calcium blood levels, may be performed while you use Testolactone. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

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

  • PREGNANCY and BREAST-FEEDING: Do not use Testolactone if you are pregnant. If you think you may be pregnant, contact your doctor immediately. It is not known if Testolactone is found in breast milk. If you are or will be breast-feeding while you use Testolactone, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Testolactone:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Abnormal skin sensations; aches of the legs and arms; general body discomfort; hair loss; loss of appetite; nausea; redness of the tongue; vomiting.



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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; dizziness; increased thirst or urination; severe drowsiness; severe muscle weakness; swelling of the hands or feet.



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: Testolactone 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.


Proper storage of Testolactone:

Store Testolactone at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Testolactone out of the reach of children and away from pets.


General information:


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

  • Testolactone 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 Testolactone. 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 Testolactone resources


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


  • testolactone Advanced Consumer (Micromedex) - Includes Dosage Information

  • testolactone Concise Consumer Information (Cerner Multum)

  • Teslac Prescribing Information (FDA)



Compare Testolactone with other medications


  • Breast Cancer, Palliative


Saturday, May 19, 2012

Thioridazine


Generic Name: thioridazine (THYE oh RID a zeen)

Brand names: Mellaril, Mellaril-S


What is thioridazine?

Thioridazine is an anti-psychotic medication in a group of drugs called phenothiazines (FEEN-oh-THYE-a-zeens). It works by changing the actions of chemicals in your brain.


Thioridazine is used to treat psychotic disorders such as schizophrenia.


Thioridazine is usually given after other medications have been tried without successful treatment of schizophrenia.


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


What is the most important information I should know about thioridazine?


Stop using this medication and call your doctor at once if you have twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs. These could be early signs of dangerous side effects. Thioridazine is not for use in psychotic conditions related to dementia. Thioridazine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. You should not use thioridazine if you have brain damage, bone marrow depression, severe heart disease, a heart rhythm disorder, a history of "Long QT syndrome," or if you are also using large amounts of alcohol or medicines that make you sleepy.

Do not take thioridazine together with large amounts of alcohol or medicines that make you sleepy, or with medications that can affect heart rhythm. There are many medicines that should not be taken together with thioridazine because they may cause serious medical problems. Tell your doctor about all other medications you use.


Before you take thioridazine, tell your doctor if you have heart disease, high blood pressure, a heart rhythm disorder, low levels of calcium or potassium in your blood, past or present breast cancer, liver or kidney disease, severe asthma or breathing problems, a history of seizures, Parkinson's disease, adrenal gland tumor, enlarged prostate or urination problems, glaucoma, or if you have ever had a serious side effect while using thioridazine or a similar medication.


What should I discuss with my healthcare provider before taking thioridazine?


Thioridazine is not for use in psychotic conditions related to dementia. Thioridazine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. You should not use thioridazine if you are allergic to it, or if you have brain damage, bone marrow depression, severe heart disease, a heart rhythm disorder, a history of "Long QT syndrome," or if you are also using large amounts of alcohol or medicines that make you sleepy.

There are many medicines that should not be taken together with thioridazine because they may cause serious medical problems. Tell your doctor about all other medications you take, including:



  • antibiotics;




  • antidepressants;




  • blood pressure medications;




  • medications to treat or prevent malaria;




  • cancer medications;




  • certain HIV/AIDS medications;




  • migraine headache medicine;




  • heart rhythm medications;




  • medicine to prevent or treat nausea and vomiting;




  • certain narcotic pain medicines; and




  • other anti-psychotic medicines.



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



  • heart disease, high blood pressure, or a heart rhythm disorder;




  • low levels of potassium in your blood (hypokalemia);




  • past or present breast cancer;



  • liver or kidney disease;


  • severe asthma, emphysema, or other breathing problem;




  • a history of seizures;




  • Parkinson's disease;




  • adrenal gland tumor (pheochromocytoma);




  • enlarged prostate or urination problems;




  • low levels of calcium in your blood (hypocalcemia);




  • glaucoma; or




  • if you have ever had a serious side effect while using thioridazine or another phenothiazine.




It is not known whether thioridazine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking thioridazine, do not stop taking it without your doctor's advice. Thioridazine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take thioridazine?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.


To be sure this medication is not causing harmful effects, your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG). This machine measures electrical activity of the heart. Visit your doctor regularly.


Store thioridazine at room temperature away from moisture, heat, and light.

See also: Thioridazine dosage (in more detail)

What happens if I miss a dose?


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


What happens if I overdose?


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

Overdose symptoms may include stomach cramps, extreme dizziness, dry skin, decreased urination, uncontrollable muscle movements, confusion, agitation, feeling hot or cold, fast or pounding heartbeat, fainting, slow heart rate, weak or shallow breathing, and seizure (convulsions).


What should I avoid while taking thioridazine?


Thioridazine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Drinking alcohol can increase certain side effects of thioridazine. Avoid exposure to sunlight or tanning beds. Thioridazine can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Thioridazine side effects


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

  • fast or pounding heartbeat;




  • twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;




  • tremor (uncontrolled shaking), drooling, trouble swallowing, problems with balance or walking;




  • feeling restless, jittery, or agitated;




  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;




  • seizure (convulsions);




  • decreased night vision, tunnel vision, watery eyes, increased sensitivity to light;




  • pale skin, easy bruising or bleeding, sore throat, flu symptoms;




  • urinating less than usual or not at all;




  • nausea and stomach pain, skin rash, and jaundice (yellowing of the skin or eyes);




  • joint pain or swelling with fever, swollen glands, muscle aches, chest pain, vomiting, unusual thoughts or behavior, and patchy skin color; or




  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).



Less serious side effects may include:



  • dizziness, drowsiness, anxiety;




  • dry mouth, stuffy nose, constipation;




  • blurred vision, headache;




  • breast swelling or discharge;




  • changes in your menstrual periods;




  • weight gain, swelling in your hands or feet;




  • impotence, trouble having an orgasm;




  • increased or decreased interest in sex;




  • sleep problems (insomnia), strange dreams; or




  • mild itching or skin rash.



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


Thioridazine Dosing Information


Usual Adult Dose for Schizophrenia:

Initial dose: 50 to 100 mg orally 3 times a day.
Maintenance dose: May gradually increase to 200 to 800 mg/day in 2 to 4 divided doses.

Usual Pediatric Dose for Schizophrenia:


2 to 12 years:
Initial dose: 0.5 mg/kg/day in 2 to 3 divided doses.
Maintenance dose: May gradually increase up to a maximum of 3 mg/kg/day in divided doses.

13 to 18 years:
Initial dose: 50 to 100 mg orally 3 times a day.
Maintenance dose: May gradually increase to 200 to 800 mg/day in 2 to 4 divided doses.


What other drugs will affect thioridazine?


Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by thioridazine. Tell your doctor if you regularly use any of these medicines, or any other anti-psychotic medications.

  • atropine (Atreza, Sal-Tropine);




  • lithium (Eskalith, Lithobid);




  • an antibiotic;




  • birth control pills or hormone replacement estrogens;




  • a blood thinner such as warfarin (Coumadin);




  • certain asthma medications or bronchodilators;




  • incontinence medications;




  • insulin or diabetes medications you take by mouth;




  • medication for nausea, vomiting, or motion sickness;




  • medications used for general anesthesia;




  • numbing medicine such as lidocaine or Novocain;




  • medicines used to prevent organ transplant rejection;




  • a stimulant or ADHD medication;




  • ulcer or irritable bowel medications; or




  • medicines to treat Parkinson's disease, restless leg syndrome, or pituitary gland tumor (prolactinoma).




This list is not complete and there are many other drugs that can cause serious or life-threatening medical problems if you take them together with thioridazine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More thioridazine resources


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


  • Thioridazine Prescribing Information (FDA)

  • Thioridazine MedFacts Consumer Leaflet (Wolters Kluwer)



Compare thioridazine with other medications


  • Schizophrenia


Where can I get more information?


  • Your pharmacist can provide more information about thioridazine.

See also: thioridazine side effects (in more detail)