Thymoglobuline® 25 mg powder for solution for infusion

1. Name Of The Medicinal Product

Thymoglobuline^®25 mg powder for solution for infusion

2. Qualitative And Quantitative Composition

Rabbit anti-human thymocyte immunoglobulin 25 mg per vial. 1 ml reconstituted solution contains 5 mg rabbit, anti-human thymocyte immunoglobulin.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder for solution for infusion

4. Clinical Particulars

4.1 Therapeutic Indications

• Immunosuppression in solid organ transplantation

- Prevention of graft rejection in renal transplantation

- Treatment of steroid resistant graft rejection in renal transplantation

- Prevention of graft rejection in heart transplantation.

Thymoglobuline is usually used in combination with other immunosuppressive drugs

4.2 Posology And Method Of Administration

Thymoglobuline must always be used under strict medical supervision and prescribed by physicians with experience in using immunosuppressive agents.

Posology

The posology depends on the indication, the administration regimen and the combination with other immunosuppressive agents.

The following dosage may be used as a reference. Treatment can be discontinued without gradual tapering of the dose.

Immunosuppression in solid organ transplantation

Prophylaxis of graft rejection

1 to 1.5 mg/kg/day for 3 to 9 days after transplantation of a kidney, corresponding to a cumulative dose of 3 to 13.5 mg/kg.

1 to 2.5 mg/kg/day for 3 to 5 days after transplantation of a heart, corresponding to a cumulative dose of 3 to 12.5 mg/kg.

Treatment of steroid resistant graft rejection:

1.5 mg/kg/day for 7 to 14 days after transplantation of a kidney, corresponding to a cumulative dose of 10.5 to 21 mg/kg.

Dose modifications

For obese patients dosing should be based on ideal weight rather than actual weight.

Paediatric and elderly patients

The dosage recommendations in the paediatric population (infants, children and adolescents) and elderly patients are the same as for adults. There are no paediatric data for the treatment of graft rejection in renal transplantation.

Renal and hepatic impairment

In view of the PK and metabolism no dose adjustment is necessary in patients with hepatic and/or renal impairment.

Method of administration

Thymoglobuline is usually administered in the context of a therapeutic regimen combining multiple immunosuppressive agents.

It is recommended to administer pre-medication with intravenous corticosteroids and antihistamines prior to infusion of rabbit anti-human thymocyte globulin. Anti-pyretic agents (e.g. paracetamol) may also increase the tolerability of the initial infusion.

Rabbit anti-human thymocyte globulin is infused after dilution in isotonic 0.9 % sodium chloride or 5 % glucose solution. Inspect solution for particulate matter after reconstitution. To avoid inadvertent administration of particulate matter from reconstitution, it is recommended that Thymoglobuline is administered through a 0.22 μm in-line filter.

Infuse slowly into a high-flow vein. Adjust the infusion rate so that the total duration of infusion is not less than 6 hours. See “Special warnings and precautions for use” and section 4.8 “Adverse Events” for advice about the management of any adverse events associated with infusion.

4.3 Contraindications

Thymoglobuline is contraindicated in patients with:

• Hypersensitivity to rabbit proteins or to any product excipients (see Section 6.1 “Excipients”).

• Active acute or chronic infections, which would contraindicate any additional immunosuppression.

4.4 Special Warnings And Precautions For Use

Thymoglobuline should be used under strict medical supervision in a hospital setting. Thymoglobuline must only be administered according to the instructions of a physician with experience of immunosuppressive therapy in the transplant setting. Patients should be carefully monitored during the infusion. Particular attention must be paid to monitoring the patient for any symptoms of anaphylactic shock. Close monitoring of the patient must continue during the infusion and for a period of time following the end of the infusion until the patient is stable.

Prior to administration of Thymoglobuline it is advisable to determine whether the patient is allergic to rabbit proteins. Medical personnel and equipment, etc. must be readily at hand during the first days of therapy to provide emergency treatment if necessary.

Warnings

Immune-mediated reactions

In rare instances, serious immune-mediated reactions have been reported with the use of Thymoglobuline and consist of anaphylaxis or severe cytokine release syndrome (CRS).

Very rarely, fatal anaphylaxis has been reported (See section 4.8 “Adverse Events”). If an anaphylactic reaction occurs, the infusion should be terminated immediately and appropriate emergency treatment should be initiated. Equipment for emergency therapy for anaphylactic shock must be readily available.

Any further administration of Thymoglobuline to a patient who has a history of anaphylaxis to Thymoglobuline should only be undertaken after serious consideration.

Severe, acute infusion-associated reactions (IARs) are consistent with CRS which is attributed to the release of cytokines by activated monocytes and lymphocytes. In rare instances, these reported reactions are associated with serious cardiorespiratory events and/or death (See under “Precautions” and section 4.8 “Adverse Events”).

Infection

Thymoglobuline is routinely used in combination with other immunosuppressive agents. Infections (bacterial, fungal, viral and protozoal), reactivation of infection (particularly CMV) and sepsis have been reported after Thymoglobuline administration in combination with multiple immunosuppressive agents. In rare cases, these infections have been fatal.

Precautions

General

Appropriate dosing for Thymoglobuline is different from dosing for other anti-thymocyte globulin (ATG) products, as protein composition and concentrations vary depending on the source of ATG used. Physicians should therefore exercise care to ensure that the dose prescribed is appropriate for the ATG product being administered.

Thymoglobuline should be used under strict medical supervision in a hospital setting. Patients should be carefully monitored during the infusion and for a period of time following the end of the infusion until the patient is stable. Close compliance with the recommended dosage and infusion time may reduce the incidence and severity of IARs. Additionally, reducing the infusion rate may minimize many of these adverse reactions. Premedication with antipyretics, corticosteroids, and/or antihistamines may decrease both the incidence and severity of these adverse reactions.

Rapid infusion rates have been associated with case reports consistent with cytokine release syndrome (CRS). In rare instances, severe CRS can be fatal.

Haematological Effects

Thrombocytopenia and/or leukopenia (including lymphopenia and neutropenia) have been identified and are reversible following dose adjustments. When thrombocytopenia and/or leukopenia are not part of the underlying disease or associated with the condition for which Thymoglobuline is being administered, the following dose reductions are suggested:

• A reduction in dosage must be considered if the platelet count is between 50,000 and 75,000 cells/mm³ or if the white cell count is between 2,000 and 3,000 cells/mm³;

• Stopping Thymoglobuline treatment should be considered if persistent and severe thrombocytopenia (<50,000 cells/mm³) occurs or leukopenia (<2,000 cells/mm³) develops.

White blood cell and platelet counts should be monitored during and after Thymoglobuline therapy. Patients with severe neutropenic aplastic anaemia require very careful monitoring, appropriate prophylaxis and treatment of fevers and infections as well as adequate platelet transfusion support.

Infection

Infections, reactivation of infection (particularly CMV) , and sepsis have been reported after Thymoglobuline administration in combination with multiple immunosuppressive agents. Careful patient monitoring and appropriate anti-infective prophylaxis are recommended.

Malignancy

Use of immunosuppressive agents, including Thymoglobuline, may increase the incidence of malignancies, lymphoma or post-transplant lymphoproliferative disease (PTLD) (See section 4.8 “Adverse Events”).

Risk of Transmission of Infectious Agents

Human blood components (formaldehyde treated red blood cells), as well as thymus cells are used in the manufacturing process for Thymoglobuline. Standard measures to prevent infections resulting from the use of medicinal products prepared using human components include selection of donors, screening of individual donations for specific markers of infection and the inclusion of effective manufacturing steps for inactivation/removal of viruses.

Despite this, when medicinal products prepared using human components are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.

The measures taken for Thymoglobuline are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the non-enveloped viruses such as HAV and parvovirus B19

It is strongly recommended that every time that Thymoglobuline is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.

Special Considerations for Thymoglobuline Infusion

As with any infusion, reactions at the injection site can occur and may include pain, swelling, and erythema.

The recommended route of administration for Thymoglobulin is intravenous infusion using a high-flow vein; however, it may be administered through a peripheral vein. When Thymoglobuline is administered through a peripheral vein, concomitant use of heparin and hydrocortisone in an infusion solution of 0.9% sodium chloride may minimize the potential for superficial thrombophlebitis and deep vein thrombosis.

The combination of Thymoglobuline, heparin and hydrocortisone in a dextrose infusion solution has been noted to precipitate and is not recommended (See section 6.2 Incompatabilities).

Immunisations

The safety of immunisation with attenuated live vaccines following Thymoglobuline therapy has not been studied; therefore, immunisation with attenuated live vaccines is not recommended for patients who have recently received Thymoglobuline.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No drug interaction studies have been performed.

Interactions with food and drink are unlikely.

Thymoglobuline has not been shown to interfere with any routine clinical laboratory tests which use immunoglobulins. However, Thymoglobuline can induce production of human anti-rabbit antibodies which may interfere with rabbit antibody-based immunoassays and with cross-match or panel-reactive antibody cytotoxicity assays. Thymoglobuline may interfere with ELISA tests.

See also section 6.2 (incompatabilities).

4.6 Pregnancy And Lactation

Animal reproduction studies have not been conducted with Thymoglobuline. It is not known whether Thymoglobuline can cause foetal harm or can affect reproductive capacity. Thymoglobuline should be given to a pregnant woman only if clearly needed.

Thymoglobuline has not been studied in nursing women. It is not known whether this drug is excreted in human milk. Because other immunoglobulins are excreted in human milk, breast-feeding should be discontinued during Thymoglobuline therapy.

Thymoglobuline has not been studied in labour or delivery.

4.7 Effects On Ability To Drive And Use Machines

Given the possible adverse events which can occur during the period of Thymoglobuline infusion, in particular cytokine release syndrome, it is recommended that patients should not drive or operate machinery.

4.8 Undesirable Effects

Adverse events from French Multi-centre Post-marketing Surveillance Study

From June 1997 to March 1998, 18 French transplantation centres participated in the French Multicentre Post-marketing Surveillance Study-00PTF0.

A total of 240 patients participated in this prospective, single arm, observational cohort study. All patients received Thymoglobuline as prophylaxis of acute rejection for renal transplant.

The safety data in the table represent all adverse events reported in the study regardless of relationship to Thymoglobuline.

Blood and lymphatic system disorders

Very common** : lymphopenia, neutropenia, thrombocytopenia

Gastrointestinal disorders

Common* : Diarrhoea, dysphagia, nausea, vomiting

General disorders and administrative site conditions

Very common: Fever

Common: Shivering

Immune system disorders

Common: Serum sickness

Infections and infestations

Very common: Infection

Musculoskeletal and connective tissue disorders

Common: Myalgia

Neoplasms benign, malignant and unspecified (including cysts and polyps)

Common: Malignancy

Respiratory, thoracic and mediastinal disorders

Common: Dyspnoea

Skin and subcutaneous tissue disorder

Common: Pruritus, rash

Vascular disorder

Common: Hypotension

* Common : (

** Very common (

Undesirable effects which have been discussed in other sections of this document are listed per clinical disorder below. Because these events are from post marketing surveillance, their true frequencies are not known.

Infusion-Associated Reactions and Immune System Disorders

Infusion-associated reactions (IAR) may occur following the administration of Thymoglobuline and may occur as soon as the first or second dose. Clinical manifestations of IARs have included some of the following signs and symptoms: fever, chills/rigors, dyspnoea, nausea/vomiting, diarrhoea, hypotension or hypertension, malaise, rash, and/or headache. IARs with Thymoglobuline are usually mild and transient and are managed with reduced infusion rates and/or medications. Serious and in very rare instances, fatal anaphylactic reactions have been reported (See section 4.4 “Warnings”). These fatal reactions occurred in patients who did not receive adrenaline during the event.

IARs consistent with Cytokine Release Syndrome (CRS) have been reported. Severe and potentially life-threatening CRS is rarely reported. Post-marketing reports of severe Cytokine Release Syndrome have been associated with cardiorespiratory dysfunction (including hypotension, ARDS, pulmonary oedema, myocardial infarction, tachycardia, and/or death).

Serum Sickness

During post-marketing surveillance, reactions such as fever, rash, arthralgia, and/or myalgia, indicating possible serum sickness, have been reported. Serum sickness tends to occur 5 to 15 days after onset of Thymoglobuline therapy. Symptoms are usually self-limited or resolve rapidly with corticosteroid treatment.

Adverse events due to immunosuppression

Infections, reactivation of infection, and sepsis have been reported after Thymoglobuline administration in combination with multiple immunosuppressive agents., Malignancies including, but not limited to post-transplant lymphoproliferative disorder (PTLD) and other lymphomas as well as solid tumours have been reported (See section 4.4 “Precautions”).

These adverse events were always associated with a combination of multiple immunosuppressive agents.

For safety relating to transmissible agents, see section 4.4 “Precautions”

4.9 Overdose

Inadvertent overdose may induce leucopenia (including lymphopenia and neutropenia) and thrombocytopenia.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Immunosuppressive agents, ATC code: L04AA04

Rabbit anti-human thymocyte globulin is a selective immunosuppressive agent (mostly acting on T lymphocytes). Lymphocyte depletion probably constitutes the primary mechanism of the immunosuppression induced by rabbit anti-human thymocyte globulin. This depletion is both peripheral and central; peripheral lymphocyte depletion can be detected as early as 24 hours after the first infusion. Lymphocyte counts start to rise as soon as Thymoglobuline is discontinued.

This lymphocyte depletion has been shown to occur in vitro by a number of different mechanisms (eg apoptosis, complement dependent lysis and antibody dependent cytotoxicity); the exact mechanisms which take place in vivo remain undetermined.

In addition to the T cell depletion, Thymoglobuline also has effects on dendritic cells (causing apoptosis), and on B cells. In vitro, Thymoglobuline does not activate B-cells. Antiproliferative activity against B-cells and certain lymphoblastoid cell lines has also been demonstrated in vitro. This effect may be partially protective against the development of PTLD.

Thymoglobuline also has activity against a number of cell surface epitopes (eg CD 3, CD7, CD8, CD19, CD20, CD32, CD28), binding to them and causing downmodulation. The epitopes targeted include those involved in the immune response, in apoptosis, and in signal transduction, and include both B and T cell epitopes. In particular, Thymoglobuline has activity against both leucocyte and endothelial cell adhesion molecules (eg CD11a, CD18, CD11b, CD44, CD54, LPAM 1) which in animal studies has been shown to reduce tethering of leucocytes to the endothelium. Effector cells are thus unable to migrate through the endothelium to the graft. This effect may also, in theory, reduce ischaemia-reperfusion injury by allowing better flow through the microcirculation.

The combination of T cell depletion and downmodulation of adhesion molecules results in interference with multiple pathways by which rejection occurs.

5.2 Pharmacokinetic Properties

Following the first infusion of 1.25 mg/kg of Thymoglobuline (in kidney transplant recipients), total serum rabbit IgG levels of between 10 and 40 µg/ml are obtained. The serum levels decline steadily until the following infusion with an estimated elimination half-life of 2-3 days. There has been shown to be a relationship between dose given and total Thymoglobuline levels.

The trough rabbit IgG levels increase progressively reaching 20 to 170 µg/ml at the end of an 11-day course of treatment. A gradual decline is subsequently observed following discontinuation of treatment with rabbit anti-human thymocyte globulin. However, total rabbit IgG remains detectable in 81 % of patients at 2 months. Active Thymoglobuline (that is IgG which is available to bind to human lymphocytes and which causes the desired immunological effects) has a less noticeable relationship with dose given, and disappears from the circulation faster, with only 12% of patients having detectable active Thymoglobuline levels at day 90.

Significant immunisation against rabbit IgG is observed in about 40 % of patients. In most cases, immunisation develops within the first 15 days of treatment initiation. Patients presenting with immunisation show a faster decline in total but not active rabbit IgG levels.

5.3 Preclinical Safety Data

No mutagenicity, reproduction or genotoxicity studies have been conducted due to the nature and intended use of the product.

6. Pharmaceutical Particulars

6.1 List Of Excipients

− glycine

− sodium chloride

− mannitol

Other components:

Thymoglobuline may also contain residues of polysorbate, from the manufacturing process.

6.2 Incompatibilities

Based on a single compatibility study (Trissel LA,. 2003; Am J Health Syst Pharm) the combination of Thymoglobuline, heparin and hydrocortisone in a dextrose infusion solution has been noted to precipitate and is not recommended.

In the absence of additional pharmaceutical incompatibility data, Thymoglobuline should not be mixed with other medicinal products in the same infusion.

6.3 Shelf Life

3 years.

Immediate use after dilution is recommended in order to prevent microbial contamination.

If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless reconstitution or dilution has taken place in controlled and validated aseptic conditions.

6.4 Special Precautions For Storage

Store and transport refrigerated (at 2°C to 8).

Do not freeze.

During transport a temperature excursion up to 25°C for 3 days will not alter the product characteristics.

For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.

6.5 Nature And Contents Of Container

Powder in a vial (type I glass) closed with a stopper (chlorobutyl). Each pack contains one 10 ml vial.

6.6 Special Precautions For Disposal And Other Handling

Reconstitute the powder with 5 ml of sterile water for injections to obtain a solution containing 5 mg protein per ml. The solution is clear or slightly opalescent. Reconstituted product should be inspected visually for particulate matter and discoloration. Should some particulate matter remain, continue to gently rotate the vial until no particulate matter is visible. If particulate matter persists, discard the vial. Immediate use of reconstituted product is recommended. Each vial is for single use only. Depending on the daily dose, reconstitution of several vials of Thymoglobuline powder might be needed. Determine the number of vials to be used and round up to the nearest vial.To avoid inadvertent administration of particulate matter from reconstitution, it is recommended that Thymoglobuline is administered through a 0.22 μm in-line filter.

The daily dose is diluted in an infusion solution (0.9% sodium chloride or 5% glucose solution) so as to obtain a total infusion volume of 50 to 500 ml (usually 50 ml / vial).

The product should be administered on the same day.

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

7. Marketing Authorisation Holder

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

The Netherlands

8. Marketing Authorisation Number(S)

PL 12375/0021

9. Date Of First Authorisation/Renewal Of The Authorisation

19/03/2008

10. Date Of Revision Of The Text

08/2009

Ustell

Generic Name: hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium phosphate (Oral route)

hye-oh-SYE-a-meen SUL-fate, meth-EN-a-meen, METH-i-leen BLOO, FEN-il sal-I-si-late, SOE-dee-um FOS-fate, mono-BAY-sik

Commonly used brand name(s)

In the U.S.

• Phosphasal


• Urelle


• Uretron D/S


• Uribel


• Urimar-T


• UR N-C


• Ustell


• Uticap


• Utira-C


• Utrona-C

Available Dosage Forms:

• Tablet


• Capsule


• Tablet, Enteric Coated


• Tablet, Extended Release

Therapeutic Class: Urinary Antispasmodic

Pharmacologic Class: Hyoscyamine

Chemical Class: Salicylate, Non-Aspirin

Uses For Ustell

Urelle® is a combination of five medicines: hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium phosphate. It is used to relieve discomfort, swelling, pain, frequent urge to urinate, and cramps or spasms of the urinary tract caused by an infection or a diagnostic procedure.

Hyoscyamine is an antispasmodic drug, which relieves muscle cramps or spasms. Methenamine and methylene blue are antiseptic drugs, which help clear a urinary tract infection. Phenyl salicylate is a pain reliever. Sodium phosphate makes the urine more acidic, which helps methenamine work better.

This medicine is available only with your doctor's prescription.

Before Using Ustell

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Urelle® in children. However, use is not recommended in children 6 years of age and younger.

Geriatric

No information is available on the relationship of age to the effects of Urelle® in geriatric patients.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 this medicine, 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 this medicine 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.

• Amitriptyline


• Amoxapine


• Bupropion


• Cisapride


• Citalopram


• Clomipramine


• Desipramine


• Desvenlafaxine


• Doxepin


• Duloxetine


• Escitalopram


• Fluoxetine


• Fluvoxamine


• Imipramine


• Isocarboxazid


• Linezolid


• Maprotiline


• Mesoridazine


• Mirtazapine


• Nortriptyline


• Paroxetine


• Phenelzine


• Pimozide


• Potassium


• Protriptyline


• Selegiline


• Sertraline


• Sparfloxacin


• Thioridazine


• Tranylcypromine


• Trimipramine


• Venlafaxine


• Vilazodone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfuzosin


• Amiodarone


• Amitriptyline


• Amoxapine


• Apomorphine


• Arsenic Trioxide


• Asenapine


• Astemizole


• Azithromycin


• Buspirone


• Chloroquine


• Chlorpromazine


• Ciprofloxacin


• Citalopram


• Clarithromycin


• Clomipramine


• Clozapine


• Crizotinib


• Dasatinib


• Desipramine


• Disopyramide


• Dofetilide


• Dolasetron


• Droperidol


• Erythromycin


• Flecainide


• Fluconazole


• Gatifloxacin


• Gemifloxacin


• Granisetron


• Halofantrine


• Haloperidol


• Ibutilide


• Iloperidone


• Imipramine


• Lapatinib


• Levofloxacin


• Lopinavir


• Lumefantrine


• Mefloquine


• Methadone


• Moxifloxacin


• Nefazodone


• Nilotinib


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Ondansetron


• Paliperidone


• Pazopanib


• Perflutren Lipid Microsphere


• Posaconazole


• Procainamide


• Prochlorperazine


• Promethazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinidine


• Quinine


• Ranolazine


• Salmeterol


• Saquinavir


• Solifenacin


• Sorafenib


• Sotalol


• Sunitinib


• Telavancin


• Telithromycin


• Terfenadine


• Tetrabenazine


• Trazodone


• Trimipramine


• Vandetanib


• Vardenafil


• Vemurafenib


• Voriconazole


• Ziprasidone

Using this medicine 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.

• Aluminum Carbonate, Basic


• Aluminum Hydroxide


• Aluminum Phosphate


• Calcium Acetate


• Calcium Carbonate


• Calcium Citrate


• Dihydroxyaluminum Aminoacetate


• Dihydroxyaluminum Sodium Carbonate


• Magaldrate


• Magnesium Carbonate


• Magnesium Hydroxide


• Magnesium Oxide


• Magnesium Trisilicate

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

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

• Congestive heart failure or


• Coronary heart disease or


• Glaucoma or


• Heart disease (e.g., mitral stenosis) or


• Heart rhythm problems (e.g., arrhythmia) or


• Myasthenia gravis (severe muscle weakness) or


• Stomach or intestinal (bowel) blockage or


• Stomach ulcers or


• Urinary problems (e.g., bladder blockage due to an enlarged prostate)—Use with caution. May make these conditions worse.

• Allergy or intolerance to belladonna or salicylates—Use with caution. May be sensitive to this medicine also.

Proper Use of hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium phosphate

This section provides information on the proper use of a number of products that contain hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium phosphate. It may not be specific to Ustell. Please read with care.

Take this medicine for the full time of treatment, even if you begin to feel better. Also, keep your appointments with your doctor for check-ups so that your doctor will be better able to tell you when to stop taking this medicine.

Drink extra fluids after you take this medicine so you will pass more urine.

Dosing

The dose of this medicine 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 this medicine. 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):
  
  • For treatment of symptoms of urinary tract infection or diagnostic procedure:
    
    • Adults—One tablet four times a day
    
    
    • Children 7 years of age and older—Use and dose must be determined by your doctor.
    
    
    • Children 6 years of age and younger—Use is not recommended.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, 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 Ustell

It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

If your or your child's symptoms do not improve or if they get worse, call your doctor.

Stop using this medicine and check with your doctor right away if you or your child have blurred vision, dizziness, or rapid pulse.

This medicine will make your urine to be colored blue. This is normal and is nothing to worry about.

This medicine will not cure a serious urinary tract infection and will only work to relieve symptoms as long as you continue to take it.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Ustell 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:

Incidence not known

• Blurred vision


• dizziness


• rapid pulse

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:

Incidence not known

• Blue-colored urine

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.

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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Coreg CR

carvedilol phosphate

Dosage Form: capsule, extended release
FULL PRESCRIBING INFORMATION

Indications and Usage for Coreg CR

Heart Failure

COREG CR is indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see Clinical Studies (14.1)].

Left Ventricular Dysfunction Following Myocardial Infarction

COREG CR is indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of ≤40% (with or without symptomatic heart failure) [see Clinical Studies (14.2)].

Hypertension

COREG CR is indicated for the management of essential hypertension [see Clinical Studies (14.3, 14.4)]. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions (7.2)].

Coreg CR Dosage and Administration

COREG CR is an extended-release capsule intended for once-daily administration. Patients controlled with immediate-release carvedilol tablets alone or in combination with other medications may be switched to COREG CR extended-release capsules based on the total daily doses shown in Table 1.

Table 1. Dosing Conversion

Daily Dose of Immediate-Release Carvedilol Tablets	Daily Dose of COREG CR Capsules*
6.25 mg (3.125 mg twice daily)	10 mg once daily
12.5 mg (6.25 mg twice daily)	20 mg once daily
25 mg (12.5 mg twice daily)	40 mg once daily
50 mg (25 mg twice daily)	80 mg once daily
* When switching from carvedilol 12.5 mg or 25 mg twice daily, a starting dose of Coreg CR 20 mg or 40 mg once daily, respectively, may be warranted for elderly patients or those at increased risk of hypotension, dizziness, or syncope. Subsequent titration to higher doses should, as appropriate, be made after an interval of at least 2 weeks.

COREG CR should be taken once daily in the morning with food. COREG CR should be swallowed as a whole capsule. COREG CR and/or its contents should not be crushed, chewed, or taken in divided doses.

Alternative Administration: The capsules may be carefully opened and the beads sprinkled over a spoonful of applesauce. The applesauce should not be warm because it could affect the modified-release properties of this formulation. The mixture of drug and applesauce should be consumed immediately in its entirety. The drug and applesauce mixture should not be stored for future use. Absorption of the beads sprinkled on other foods has not been tested.

Heart Failure

DOSAGE MUST BE INDIVIDUALIZED AND CLOSELY MONITORED BY A PHYSICIAN DURING UP-TITRATION. Prior to initiation of COREG CR, it is recommended that fluid retention be minimized. The recommended starting dose of COREG CR is 10 mg once daily for 2 weeks. Patients who tolerate a dose of 10 mg once daily may have their dose increased to 20, 40, and 80 mg over successive intervals of at least 2 weeks. Patients should be maintained on lower doses if higher doses are not tolerated.

Patients should be advised that initiation of treatment and (to a lesser extent) dosage increases may be associated with transient symptoms of dizziness or lightheadedness (and rarely syncope) within the first hour after dosing. Thus during these periods they should avoid situations such as driving or hazardous tasks, where symptoms could result in injury. Vasodilatory symptoms often do not require treatment, but it may be useful to separate the time of dosing of COREG CR from that of the ACE inhibitor or to reduce temporarily the dose of the ACE inhibitor. The dose of COREG CR should not be increased until symptoms of worsening heart failure or vasodilation have been stabilized.

Fluid retention (with or without transient worsening heart failure symptoms) should be treated by an increase in the dose of diuretics.

The dose of COREG CR should be reduced if patients experience bradycardia (heart rate <55 beats/minute).

Episodes of dizziness or fluid retention during initiation of COREG CR can generally be managed without discontinuation of treatment and do not preclude subsequent successful titration of, or a favorable response to, COREG CR.

Left Ventricular Dysfunction Following Myocardial Infarction

DOSAGE MUST BE INDIVIDUALIZED AND MONITORED DURING UP-TITRATION. Treatment with COREG CR may be started as an inpatient or outpatient and should be started after the patient is hemodynamically stable and fluid retention has been minimized. It is recommended that COREG CR be started at 20 mg once daily and increased after 3 to 10 days, based on tolerability, to 40 mg once daily, then again to the target dose of 80 mg once daily. A lower starting dose may be used (10 mg once daily) and/or the rate of up-titration may be slowed if clinically indicated (e.g., due to low blood pressure or heart rate, or fluid retention). Patients should be maintained on lower doses if higher doses are not tolerated. The recommended dosing regimen need not be altered in patients who received treatment with an IV or oral β-blocker during the acute phase of the myocardial infarction.

Hypertension

DOSAGE MUST BE INDIVIDUALIZED. The recommended starting dose of COREG CR is 20 mg once daily. If this dose is tolerated, using standing systolic pressure measured about one hour after dosing as a guide, the dose should be maintained for 7 to 14 days, and then increased to 40 mg once daily if needed, based on trough blood pressure, again using standing systolic pressure one hour after dosing as a guide for tolerance. This dose should also be maintained for 7 to 14 days and can then be adjusted upward to 80 mg once daily if tolerated and needed. Although not specifically studied, it is anticipated the full antihypertensive effect of COREG CR would be seen within 7 to 14 days as had been demonstrated with immediate-release carvedilol. Total daily dose should not exceed 80 mg.

Concomitant administration with a diuretic can be expected to produce additive effects and exaggerate the orthostatic component of COREG CR action.

Hepatic Impairment

COREG CR should not be given to patients with severe hepatic impairment [see Contraindications (4)].

Geriatric Use

When switching elderly patients (65 years of age or older) who are taking the higher doses of immediate-release carvedilol tablets (25 mg twice daily) to Coreg CR, a lower starting dose (40 mg) of Coreg CR is recommended to minimize the potential for dizziness, syncope, or hypotension [see Dosage and Administration (2)]. Patients who have switched and who tolerate Coreg CR should, as appropriate, have their dose increased to after an interval of at least 2 weeks [see Use in Specific Populations (8.5)].

Dosage Forms and Strengths

The hard gelatin capsules are filled with white to off-white microparticles and are available in the following strengths:

• 10 mg – white and green capsule shell printed with GSK COREG CR and 10 mg


• 20 mg – white and yellow capsule shell printed with GSK COREG CR and 20 mg


• 40 mg – yellow and green capsule shell printed with GSK COREG CR and 40 mg


• 80 mg – white capsule shell printed with GSK COREG CR and 80 mg

Contraindications

Coreg CR is contraindicated in the following conditions:

• Bronchial asthma or related bronchospastic conditions. Deaths from status asthmaticus have been reported following single doses of immediate-release carvedilol.


• Second- or third-degree AV block


• Sick sinus syndrome


• Severe bradycardia (unless a permanent pacemaker is in place)


• Patients with cardiogenic shock or who have decompensated heart failure requiring the use of intravenous inotropic therapy. Such patients should first be weaned from intravenous therapy before initiating Coreg CR.


• Patients with severe hepatic impairment


• Patients with a history of a serious hypersensitivity reaction (e.g., Stevens-Johnson syndrome, anaphylactic reaction, angioedema) to carvedilol or any of the components of Coreg CR.

Warnings and Precautions

In clinical trials of COREG CR in patients with hypertension (338 subjects) and in patients with left ventricular dysfunction following a myocardial infarction or heart failure (187 subjects), the profile of adverse events observed with carvedilol phosphate was generally similar to that observed with the administration of immediate-release carvedilol. Therefore, the information included within this section is based on data from controlled clinical trials with COREG CR as well as immediate-release carvedilol.

Cessation of Therapy

Patients with coronary artery disease, who are being treated with COREG CR, should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported in angina patients following the abrupt discontinuation of therapy with β-blockers. The last 2 complications may occur with or without preceding exacerbation of the angina pectoris. As with other β-blockers, when discontinuation of COREG CR is planned, the patients should be carefully observed and advised to limit physical activity to a minimum. COREG CR should be discontinued over 1 to 2 weeks whenever possible. If the angina worsens or acute coronary insufficiency develops, it is recommended that COREG CR be promptly reinstituted, at least temporarily. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue therapy with COREG CR abruptly even in patients treated only for hypertension or heart failure.

Bradycardia

In clinical trials with immediate-release carvedilol, bradycardia was reported in about 2% of hypertensive patients, 9% of heart failure patients, and 6.5% of myocardial infarction patients with left ventricular dysfunction. Bradycardia was reported in 0.5% of patients receiving COREG CR in a study of heart failure patients and myocardial infarction patients with left ventricular dysfunction. There were no reports of bradycardia in the clinical trial of COREG CR in hypertension. However, if pulse rate drops below 55 beats/minute, the dosage of COREG CR should be reduced.

Hypotension

In clinical trials of primarily mild-to-moderate heart failure with immediate-release carvedilol, hypotension and postural hypotension occurred in 9.7% and syncope in 3.4% of patients receiving carvedilol compared to 3.6% and 2.5% of placebo patients, respectively. The risk for these events was highest during the first 30 days of dosing, corresponding to the up-titration period and was a cause for discontinuation of therapy in 0.7% of carvedilol patients, compared to 0.4% of placebo patients. In a long-term, placebo-controlled trial in severe heart failure (COPERNICUS), hypotension and postural hypotension occurred in 15.1% and syncope in 2.9% of heart failure patients receiving carvedilol compared to 8.7% and 2.3% of placebo patients, respectively. These events were a cause for discontinuation of therapy in 1.1% of carvedilol patients, compared to 0.8% of placebo patients.

In a trial comparing heart failure patients switched to Coreg CR or maintained on immediate-release carvedilol, there was a 2-fold increase in the combined incidence of hypotension, syncope or dizziness in elderly patients (> 65 years) switched from the highest dose of carvedilol (25 mg twice daily) to Coreg CR 80 mg once daily [see Dosage and Administration (2), Use in Specific Populations (8.5)].

In the clinical trial of COREG CR in hypertensive patients, syncope was reported in 0.3% of patients receiving COREG CR compared to 0% of patients receiving placebo. There were no reports of postural hypotension in this trial. Postural hypotension occurred in 1.8% and syncope in 0.1% of hypertensive patients receiving immediate-release carvedilol, primarily following the initial dose or at the time of dose increase and was a cause for discontinuation of therapy in 1% of patients.

In the CAPRICORN study of survivors of an acute myocardial infarction with left ventricular dysfunction, hypotension or postural hypotension occurred in 20.2% of patients receiving carvedilol compared to 12.6% of placebo patients. Syncope was reported in 3.9% and 1.9% of patients, respectively. These events were a cause for discontinuation of therapy in 2.5% of patients receiving carvedilol, compared to 0.2% of placebo patients.

Starting with a low dose, administration with food, and gradual up-titration should decrease the likelihood of syncope or excessive hypotension [see Dosage and Administration (2.1, 2.2, 2.3)]. During initiation of therapy, the patient should be cautioned to avoid situations such as driving or hazardous tasks, where injury could result should syncope occur.

Heart Failure/Fluid Retention

Worsening heart failure or fluid retention may occur during up-titration of carvedilol. If such symptoms occur, diuretics should be increased and the dose of COREG CR should not be advanced until clinical stability resumes [see Dosage and Administration (2)]. Occasionally it is necessary to lower the dose of COREG CR or temporarily discontinue it. Such episodes do not preclude subsequent successful titration of, or a favorable response to, COREG CR. In a placebo-controlled trial of patients with severe heart failure, worsening heart failure during the first 3 months was reported to a similar degree with immediate-release carvedilol and with placebo. When treatment was maintained beyond 3 months, worsening heart failure was reported less frequently in patients treated with carvedilol than with placebo. Worsening heart failure observed during long-term therapy is more likely to be related to the patients’ underlying disease than to treatment with carvedilol.

Nonallergic Bronchospasm

Patients with bronchospastic disease (e.g., chronic bronchitis and emphysema) should, in general, not receive β-blockers. COREG CR may be used with caution, however, in patients who do not respond to, or cannot tolerate, other antihypertensive agents. It is prudent, if COREG CR is used, to use the smallest effective dose, so that inhibition of endogenous or exogenous β-agonists is minimized.

In clinical trials of patients with heart failure, patients with bronchospastic disease were enrolled if they did not require oral or inhaled medication to treat their bronchospastic disease. In such patients, it is recommended that COREG CR be used with caution. The dosing recommendations should be followed closely and the dose should be lowered if any evidence of bronchospasm is observed during up-titration.

Glycemic Control in Type 2 Diabetes

In general, β-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia. Nonselective β-blockers may potentiate insulin-induced hypoglycemia and delay recovery of serum glucose levels. Patients subject to spontaneous hypoglycemia, or diabetic patients receiving insulin or oral hypoglycemic agents, should be cautioned about these possibilities.

In heart failure patients with diabetes, carvedilol therapy may lead to worsening hyperglycemia, which responds to intensification of hypoglycemic therapy. It is recommended that blood glucose be monitored when dosing with COREG CR is initiated, adjusted, or discontinued. Studies designed to examine the effects of carvedilol on glycemic control in patients with diabetes and heart failure have not been conducted.

In a study designed to examine the effects of immediate-release carvedilol on glycemic control in a population with mild-to-moderate hypertension and well-controlled type 2 diabetes mellitus, carvedilol had no adverse effect on glycemic control, based on HbA1c measurements [see Clinical Studies (14.4)].

Peripheral Vascular Disease

β-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Caution should be exercised in such individuals.

Deterioration of Renal Function

Rarely, use of carvedilol in patients with heart failure has resulted in deterioration of renal function. Patients at risk appear to be those with low blood pressure (systolic blood pressure <100 mm Hg), ischemic heart disease and diffuse vascular disease, and/or underlying renal insufficiency. Renal function has returned to baseline when carvedilol was stopped. In patients with these risk factors it is recommended that renal function be monitored during up-titration of COREG CR and the drug discontinued or dosage reduced if worsening of renal function occurs.

Major Surgery

 Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery; however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.

Thyrotoxicosis

β-adrenergic blockade may mask clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of β-blockade may be followed by an exacerbation of the symptoms of hyperthyroidism or may precipitate thyroid storm.

Pheochromocytoma

In patients with pheochromocytoma, an α-blocking agent should be initiated prior to the use of any β-blocking agent. Although carvedilol has both α- and β-blocking pharmacologic activities, there has been no experience with its use in this condition. Therefore, caution should be taken in the administration of carvedilol to patients suspected of having pheochromocytoma.

Prinzmetal’s Variant Angina

Agents with non-selective β-blocking activity may provoke chest pain in patients with Prinzmetal’s variant angina. There has been no clinical experience with carvedilol in these patients although the α-blocking activity may prevent such symptoms. However, caution should be taken in the administration of COREG CR to patients suspected of having Prinzmetal’s variant angina.

Risk of Anaphylactic Reaction

While taking β-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.

Intraoperative Floppy Iris Syndrome

 Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients treated with alpha-1 blockers (Coreg CR is an alpha/beta blocker). This variant of small pupil syndrome is characterized by the combination of a flaccid iris that billows in response to intraoperative irrigation currents, progressive intraoperative miosis despite preoperative dilation with standard mydriatic drugs, and potential prolapse of the iris toward the phacoemulsification incisions. The patient’s ophthalmologist should be prepared for possible modifications to the surgical technique, such as utilization of iris hooks, iris dilator rings, or viscoelastic substances. There does not appear to be a benefit of stopping alpha-1 blocker therapy prior to cataract surgery.

Adverse Reactions

Clinical Trials Experience

Carvedilol has been evaluated for safety in patients with heart failure (mild, moderate, and severe), in patients with left ventricular dysfunction following myocardial infarction, and in hypertensive patients. The observed adverse event profile was consistent with the pharmacology of the drug and the health status of the patients in the clinical trials. Adverse events reported for each of these patient populations reflecting the use of either COREG CR or immediate-release carvedilol are provided below. Excluded are adverse events considered too general to be informative, and those not reasonably associated with the use of the drug because they were associated with the condition being treated or are very common in the treated population. Rates of adverse events were generally similar across demographic subsets (men and women, elderly and non-elderly, blacks and non-blacks). COREG CR has been evaluated for safety in a 4-week (2 weeks of immediate-release carvedilol and 2 weeks of COREG CR) clinical study (n = 187) which included 157 patients with stable mild, moderate, or severe chronic heart failure and 30 patients with left ventricular dysfunction following acute myocardial infarction. The profile of adverse events observed with COREG CR in this small, short-term study was generally similar to that observed with immediate-release carvedilol. Differences in safety would not be expected based on the similarity in plasma levels for COREG CR and immediate-release carvedilol.

Heart Failure

The following information describes the safety experience in heart failure with immediate-release carvedilol.

Carvedilol has been evaluated for safety in heart failure in more than 4,500 patients worldwide of whom more than 2,100 participated in placebo-controlled clinical trials. Approximately 60% of the total treated population in placebo-controlled clinical trials received carvedilol for at least 6 months and 30% received carvedilol for at least 12 months. In the COMET trial, 1,511 patients with mild-to-moderate heart failure were treated with carvedilol for up to 5.9 years (mean 4.8 years). Both in US clinical trials in mild-to-moderate heart failure that compared carvedilol in daily doses up to 100 mg (n = 765) to placebo (n = 437), and in a multinational clinical trial in severe heart failure (COPERNICUS) that compared carvedilol in daily doses up to 50 mg (n = 1,156) with placebo (n = 1,133), discontinuation rates for adverse experiences were similar in carvedilol and placebo patients. In placebo-controlled clinical trials, the only cause of discontinuation >1%, and occurring more often on carvedilol was dizziness (1.3% on carvedilol, 0.6% on placebo in the COPERNICUS trial).

Table 2 shows adverse events reported in patients with mild-to-moderate heart failure enrolled in US placebo-controlled clinical trials, and with severe heart failure enrolled in the COPERNICUS trial. Shown are adverse events that occurred more frequently in drug-treated patients than placebo-treated patients with an incidence of >3% in patients treated with carvedilol regardless of causality. Median study medication exposure was 6.3 months for both carvedilol and placebo patients in the trials of mild-to-moderate heart failure, and 10.4 months in the trial of severe heart failure patients. The adverse event profile of carvedilol observed in the long-term COMET study was generally similar to that observed in the US Heart Failure Trials.

Table 2. Adverse Events (%) Occurring More Frequently With Immediate-Release Carvedilol Than With Placebo in Patients With Mild-to-Moderate Heart Failure (HF) Enrolled in US Heart Failure Trials or in Patients With Severe Heart Failure in the COPERNICUS Trial (Incidence >3% in Patients Treated With Carvedilol, Regardless of Causality)

	Mild-to-Moderate HF		Severe HF
	Carvedilol	Placebo	Carvedilol	Placebo
	(n = 765)	(n = 437)	(n = 1,156)	(n = 1,133)
Body as a Whole
Asthenia	7	7	11	9
Fatigue	24	22	—	—
Digoxin level increased	5	4	2	1
Edema generalized	5	3	6	5
Edema dependent	4	2	—	—
Cardiovascular
Bradycardia	9	1	10	3
Hypotension	9	3	14	8
Syncope	3	3	8	5
Angina pectoris	2	3	6	4
Central Nervous System
Dizziness	32	19	24	17
Headache	8	7	5	3
Gastrointestinal
Diarrhea	12	6	5	3
Nausea	9	5	4	3
Vomiting	6	4	1	2
Metabolic
Hyperglycemia	12	8	5	3
Weight increase	10	7	12	11
BUN increased	6	5	—	—
NPN increased	6	5	—	—
Hypercholesterolemia	4	3	1	1
Edema peripheral	2	1	7	6
Musculoskeletal
Arthralgia	6	5	1	1
Respiratory
Cough increased	8	9	5	4
Rales	4	4	4	2
Vision
Vision abnormal	5	2	—	—

Cardiac failure and dyspnea were also reported in these studies, but the rates were equal or greater in patients who received placebo.

The following adverse events were reported with a frequency of >1% but ≤3% and more frequently with carvedilol in either the US placebo-controlled trials in patients with mild-to-moderate heart failure, or in patients with severe heart failure in the COPERNICUS trial.

Incidence >1% to ≤3%

Body as a Whole: Allergy, malaise, hypovolemia, fever, leg edema.

Cardiovascular: Fluid overload, postural hypotension, aggravated angina pectoris, AV block, palpitation, hypertension.

Central and Peripheral Nervous System: Hypesthesia, vertigo, paresthesia.

Gastrointestinal: Melena, periodontitis.

Liver and Biliary System: SGPT increased, SGOT increased.

Metabolic and Nutritional: Hyperuricemia, hypoglycemia, hyponatremia, increased alkaline phosphatase, glycosuria, hypervolemia, diabetes mellitus, GGT increased, weight loss, hyperkalemia, creatinine increased.

Musculoskeletal: Muscle cramps.

Platelet, Bleeding and Clotting: Prothrombin decreased, purpura, thrombocytopenia.

Psychiatric: Somnolence.

Reproductive, male: Impotence.

Special Senses: Blurred vision.

Urinary System: Renal insufficiency, albuminuria, hematuria.

Left Ventricular Dysfunction Following Myocardial Infarction

The following information describes the safety experience in left ventricular dysfunction following acute myocardial infarction with immediate-release carvedilol.

Carvedilol has been evaluated for safety in survivors of an acute myocardial infarction with left ventricular dysfunction in the CAPRICORN trial which involved 969 patients who received carvedilol and 980 who received placebo. Approximately 75% of the patients received carvedilol for at least 6 months and 53% received carvedilol for at least 12 months. Patients were treated for an average of 12.9 months and 12.8 months with carvedilol and placebo, respectively.

The most common adverse events reported with carvedilol in the CAPRICORN trial were consistent with the profile of the drug in the US heart failure trials and the COPERNICUS trial. The only additional adverse events reported in CAPRICORN in >3% of the patients and more commonly on carvedilol were dyspnea, anemia, and lung edema. The following adverse events were reported with a frequency of >1% but ≤3% and more frequently with carvedilol: Flu syndrome, cerebrovascular accident, peripheral vascular disorder, hypotonia, depression, gastrointestinal pain, arthritis, and gout. The overall rates of discontinuations due to adverse events were similar in both groups of patients. In this database, the only cause of discontinuation >1%, and occurring more often on carvedilol was hypotension (1.5% on carvedilol, 0.2% on placebo).

Hypertension

COREG CR was evaluated for safety in an 8-week double-blind trial in 337 subjects with essential hypertension. The profile of adverse events observed with COREG CR was generally similar to that observed with immediate-release carvedilol. The overall rates of discontinuations due to adverse events were similar between COREG CR and placebo.

Table 3. Adverse Events (%) Occurring More Frequently With COREG CR Than With Placebo in Patients With Hypertension (Incidence ≥1% in Patients Treated With Carvedilol, Regardless of Causality)

	COREG CR (n = 253)	Placebo (n = 84)
Nasopharyngitis	4	0
Dizziness	2	1
Nausea	2	0
Edema peripheral	2	1
Nasal congestion	1	0
Paresthesia	1	0
Sinus congestion	1	0
Diarrhea	1	0
Insomnia	1	0

The following information describes the safety experience in hypertension with immediate-release carvedilol.

Carvedilol has been evaluated for safety in hypertension in more than 2,193 patients in US clinical trials and in 2,976 patients in international clinical trials. Approximately 36% of the total treated population received carvedilol for at least 6 months. In general, carvedilol was well tolerated at doses up to 50 mg daily. Most adverse events reported during carvedilol therapy were of mild to moderate severity. In US controlled clinical trials directly comparing carvedilol monotherapy in doses up to 50 mg (n = 1,142) to placebo (n = 462), 4.9% of carvedilol patients discontinued for adverse events versus 5.2% of placebo patients. Although there was no overall difference in discontinuation rates, discontinuations were more common in the carvedilol group for postural hypotension (1% versus 0). The overall incidence of adverse events in US placebo-controlled trials was found to increase with increasing dose of carvedilol. For individual adverse events this could only be distinguished for dizziness, which increased in frequency from 2% to 5% as total daily dose increased from 6.25 mg to 50 mg as single or divided doses.

Table 4 shows adverse events in US placebo-controlled clinical trials for hypertension that occurred with an incidence of ≥1% regardless of causality, and that were more frequent in drug-treated patients than placebo-treated patients.

Table 4. Adverse Events (% Occurrence) in US Placebo-Controlled Hypertension Trials With Immediate-Release Carvedilol (Incidence ≥1% in Patients Treated With Carvedilol, Regardless of Causality)*

	Carvedilol (n = 1,142)	Placebo (n = 462)
Cardiovascular
Bradycardia	2	—
Postural hypotension	2	—
Peripheral edema	1	—
Central Nervous System
Dizziness	6	5
Insomnia	2	1
Gastrointestinal
Diarrhea	2	1
Hematologic
Thrombocytopenia	1	—
Metabolic
Hypertriglyceridemia	1	—

*  Shown are events with rate >1% rounded to nearest integer.

Dyspnea and fatigue were also reported in these studies, but the rates were equal or greater in patients who received placebo.

The following adverse events not described above were reported as possibly or probably related to carvedilol in worldwide open or controlled trials with carvedilol in patients with hypertension or heart failure.

Maxiflu CD

Generic Name: acetaminophen, codeine, guaifenesin, and pseudoephedrine (a SEET oh MIN oh fen, KOE deen, gwye FEN e sin, SOO doe ee FED rin)

Brand Names: Maxiflu CD, Maxiflu CDX

What is Maxiflu CD (acetaminophen, codeine, guaifenesin, and pseudoephedrine)?

Acetaminophen is a pain reliever and fever reducer.

Codeine is a narcotic cough suppressant. It affects the signals in the brain that trigger cough reflex.

Guaifenesin is an expectorant. It helps loosen mucus congestion in your chest and throat, making it easier to cough out through your mouth.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of acetaminophen, codeine, guaifenesin, and pseudoephedrine is used to treat headache, fever, body aches, cough, chest congestion, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

This medicine will not treat a cough that is caused by smoking, asthma, or emphysema.

Acetaminophen, codeine, guaifenesin, and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about this medicine?

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You should not use this medicine if you have inflammatory bowel disease, severe constipation, a blockage in your stomach or intestines, severe colitis or toxic megacolon, if you have a colostomy or ileostomy, if you are unable to urinate, if you have been sick with diarrhea, if you recently drank large amounts of alcohol, or if you have a head injury or brain tumor. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Do not drink alcohol while you are taking this medicine.

Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

What should I discuss with my health care provider before taking this medicine?

You should not use this medicine if you have inflammatory bowel disease, severe constipation, a blockage in your stomach or intestines, severe colitis or toxic megacolon, if you have a colostomy or ileostomy, if you are unable to urinate, if you have been sick with diarrhea, if you recently drank large amounts of alcohol, or if you have a head injury or brain tumor. Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid.

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

• 
  

  liver disease, cirrhosis, a history of alcoholism or drug addiction, or if you drink more than 3 alcoholic beverages per day;

  
  


• 
  

  diabetes;

  
  


• 
  

  kidney disease;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  sleep apnea (breathing stops during sleep);

  
  


• 
  

  an adrenal gland tumor or disorder (pheochromocytoma or Addison's disease); or

  
  


• 
  

  enlarged prostate, urination problems;

  
  


• 
  

  low blood pressure, or if you are dehydrated.

  
  

FDA pregnancy category C. Codeine may cause addiction or withdrawal symptoms in a newborn if the mother takes the medication during pregnancy. Do not use this medicine without telling your doctor if you are pregnant. Codeine can pass into breast milk. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Decongestants may also slow breast milk production. Do not use this medicine without telling your doctor if you are breast-feeding a baby.

How should I take this medicine?

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. This medicine is usually taken for only a short time until your symptoms clear up.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling. If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days. Store at room temperature away from moisture and heat. Never share this medicine with another person. Keep track of the amount of medicine used from each new bottle. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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. An overdose of acetaminophen or codeine can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may include confusion, extreme weakness, pinpoint pupils, cold and clammy skin, weak pulse, slow breathing, fainting, or breathing that stops.

What should I avoid while taking this medicine?

Ask a doctor or pharmacist before using any other pain, cold, allergy, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Do not drink alcohol while you are taking this medicine. Dangerous side effects or death can occur when alcohol is combined with a narcotic medicine. Alcohol may also increase your risk of liver damage while you are taking acetaminophen. Check your food and medicine labels to be sure these products do not contain alcohol. This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

This medicine 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 this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  confusion, mood changes, severe dizziness or anxiety, feeling like you might pass out;

  
  


• 
  

  sudden severe headache or vomiting, pain or numbness in the arms or legs;

  
  


• 
  

  tremor, seizure (convulsions);

  
  


• 
  

  nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or

  
  


• 
  

  dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, uneven heartbeats, seizure).

  
  

Less serious side effects may include:

• 
  

  dizziness, drowsiness, mild headache;

  
  


• 
  

  mild nausea, upset stomach, constipation;

  
  


• 
  

  runny nose;

  
  


• 
  

  feeling nervous, restless, or anxious; or

  
  


• 
  

  sleep problems (insomnia).

  
  

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

What other drugs will affect this medicine?

Before taking this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as narcotic pain medication, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by codeine.

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

• 
  

  bupropion (Wellbutrin, Zyban);

  
  


• 
  

  droperidol (Inapsine);

  
  


• 
  

  leflunomide (Arava);

  
  


• 
  

  naloxone (Narcan, Suboxone);

  
  


• 
  

  tramadol (Ultram, Ultracet);

  
  


• 
  

  an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

  
  


• 
  

  birth control pills or hormone replacement therapy;

  
  


• 
  

  blood pressure medication;

  
  


• 
  

  bowel cleansing preparations (Half Lytely, Fleet Prep Kit, Evac-Q-Kwik, GoLytely, Supraprep, and others);

  
  


• 
  

  cancer medicine;

  
  


• 
  

  cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

  
  


• 
  

  gout or arthritis medications (including gold injections);

  
  


• 
  

  HIV/AIDS medication;

  
  


• 
  

  medicines to treat psychiatric disorders;

  
  


• 
  

  an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

  
  


• 
  

  seizure medication.

  
  

This list is not complete and there may be other drugs that can interact with acetaminophen, codeine, guaifenesin, and pseudoephedrine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Maxiflu CD resources

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

• Maxiflu CD MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Maxiflu CD with other medications

• Cold Symptoms
• Cough and Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen, codeine, guaifenesin, and pseudoephedrine.

See also: Maxiflu CD side effects (in more detail)

Sulfacetamide Foam

Pronunciation: sul-fa-SEE-ta-mide
Generic Name: Sulfacetamide
Brand Name: Ovace

Sulfacetamide Foam is used for:

Treating bacterial infections of the skin, including dandruff. It may also be used for other conditions as determined by your doctor.

Sulfacetamide Foam is a sulfonamide. It works by restricting the production of folic acid, which bacteria need for growth. This kills the bacteria.

Do NOT use Sulfacetamide Foam if:

• you are allergic to any ingredient in Sulfacetamide Foam


• you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any other sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide

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

Before using Sulfacetamide Foam:

Some medical conditions may interact with Sulfacetamide Foam. 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

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

• Silver-containing products (eg, silver sulfadiazine) because they may decrease Sulfacetamide Foam's effectiveness


• Methenamine because it may increase the risk of Sulfacetamide Foam's side effects

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

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

• Sulfacetamide Foam is for use on the skin only.


• Shake well before each use.


• Wash your hands before and after using Sulfacetamide Foam.


• Remove the clear cap from the can. Turn the can upside down and dispense a small amount of medicine (enough to cover the affected area) into your hand. Gently massage into the affected area until the foam disappears.


• If you are applying Sulfacetamide Foam to the scalp, your hair should be towel-dried or dry before applying.


• Do not wash the treated area immediately after using Sulfacetamide Foam.


• Hair styling products may be applied as usual after Sulfacetamide Foam has been applied.


• To clear up your infection completely, use Sulfacetamide Foam for the full course of treatment. Keep using it even if you feel better in a few days.


• Sulfacetamide Foam works best if it is used at the same time each day.


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


• If you miss a dose of Sulfacetamide Foam, 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 Sulfacetamide Foam.

Important safety information:

• Avoid getting Sulfacetamide Foam in your eyes, nose, or mouth.


• Talk with your doctor before you use any other medicines or cleansers on your skin.


• Do not apply Sulfacetamide Foam over large areas of the body or to open wounds or scraped, infected, or burned skin without first checking with your doctor.


• Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.


• Sulfacetamide Foam only works against bacteria; it does not treat viral infections.


• Be sure to use Sulfacetamide Foam for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Sulfacetamide Foam may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Large amounts of Sulfacetamide Foam may stain skin or white fabrics. This stain may be removed from fabric by ordinary laundering without bleach.


• Sulfacetamide Foam is flammable. Do not store or use near an open flame or while smoking.


• The contents of this can are under pressure. Do not puncture, burn, or break container, even if it appears to be empty.


• Sulfacetamide Foam should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.


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

Possible side effects of Sulfacetamide Foam:

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 irritation.

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); bloody diarrhea; fever; joint pain; red, swollen, or blistered skin; severe diarrhea; severe or persistent irritation; sores in the mouth; stomach cramps/pain.

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.

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. Sulfacetamide Foam may be harmful if swallowed. Symptoms of ingestion may include change in the amount of urine; nausea; vomiting.

Proper storage of Sulfacetamide Foam:

Store Sulfacetamide Foam at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Avoid temperatures above 104 degrees F (40 degrees C). Store away from heat and direct sunlight. Do not puncture, break, or burn the canister even if it appears to be empty. Store away from moisture and light. Do not freeze. Keep Sulfacetamide Foam out of the reach of children and away from pets.

General information:

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


• Sulfacetamide Foam 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 Sulfacetamide Foam. 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 Sulfacetamide resources

• Sulfacetamide Use in Pregnancy & Breastfeeding
• Sulfacetamide Support Group
• 0 Reviews for Sulfacetamide - Add your own review/rating

Compare Sulfacetamide with other medications

• Seborrheic Dermatitis
• Secondary Cutaneous Bacterial Infections

K-Y Jelly

Generic Name: topical emollients (TOP i kal ee MOL i ents)

Brand Names: Aloe Vesta Cream, AlphaSoft, AmeriPhor, Aqua Glycolic, Aqua Lube, Aquaphor, Aveeno, Baby Lotion, Baby Oil, Bag Balm, Baza-Pro, Beta Care, Blistex Lip Balm, Carmex, CarraKlenz, CeraVe, CeraVe AM, Cetaphil Lotion, Chap Stick, Citraderm, CoolBottoms, Corn Huskers Lotion, Curel Moisture Lotion, Derma Soothe, Dr Scholl's Essentials Cracked Skin Repair, Eucerin, Herpecin-L, K-Y Jelly, Keri Lotion, Lamisilk Heel Balm, Lubri-Soft, Lubriderm, Mederma, Moisturel, Natural Ice, NeutrapHor, NeutrapHorus Rex, Neutrogena Cleansing, Neutrogena Lotion, Nivea, Nutraderm, Pacquin, Phisoderm, Pretty Feet & Hands, Proshield Skincare Kit, Remedy 4-in-1 Cleansing Lotion, Replens, Secura, Sensi-Care, Soft Sense, St. Ives, Theraplex Lotion, Vaseline Intensive Care

What are K-Y Jelly (topical emollients)?

Emollients are substances that moisten and soften your skin.

Topical (for the skin) emollients are used to treat or prevent dry skin. Topical emollients are sometimes contained in products that also treat acne, chapped lips, diaper rash, cold sores, or other minor skin irritation.

There are many brands and forms of topical emollients available and not all are listed on this leaflet.

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

What is the most important information I should know about K-Y Jelly (topical emollients)?

You should not use a topical emollient if you are allergic to it. Topical emollients will not treat or prevent a skin infection.

Ask a doctor or pharmacist before using this medication if you have deep wounds or open sores, swelling, warmth, redness, oozing, bleeding, large areas of skin irritation, or any type of allergy.

What should I discuss with my healthcare provider before using K-Y Jelly (topical emollients)?

You should not use a topical emollient if you are allergic to it. Topical emollients will not treat or prevent a skin infection.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:

• 
  

  deep wounds or open sores;

  
  


• 
  

  swelling, warmth, redness, oozing, or bleeding;

  
  


• 
  

  large areas of skin irritation;

  
  


• 
  

  any type of allergy; or

  
  


• if you are pregnant or breast-feeding.

How should I use K-Y Jelly (topical emollients)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Clean the skin where you will apply the topical emollient. It may help to apply this product when your skin is wet or damp. Follow directions on the product label.

Shake the product container if recommended on the label.

Apply a small amount of topical emollient to the affected area and rub in gently.

If you are using a stick, pad, or soap form of topical emollient, follow directions for use on the product label.

Do not use this product over large area of skin. Do not apply a topical emollient to a deep puncture wound or severe burn without medical advice.

If your skin appears white or gray and feels soggy, you may be applying too much topical emollient or using it too often.

Some forms of topical emollient may be flammable and should not be used near high heat or open flame, or applied while you are smoking.

Store as directed away from moisture, heat, and light. Keep the bottle, tube, or other container tightly closed when not in use.

What happens if I miss a dose?

Since this product is used as needed, it does not have a daily dosing schedule. Seek medical advice if your condition does not improve after using a topical emollient.

What happens if I overdose?

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

What should I avoid while taking K-Y Jelly (topical emollients)?

Avoid getting topical emollients in your eyes, nose, or mouth. If this does happen, rinse with water. Avoid exposure to sunlight or tanning beds. Some topical emollients can make your skin more sensitive to sunlight or UV rays.

K-Y Jelly (topical emollients) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using the topical emollient and call your doctor if you have severe burning, stinging, redness, or irritation where the product was applied.

Less serious side effects are more likely, and you may have none at all.

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

What other drugs will affect K-Y Jelly (topical emollients)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied products. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More K-Y Jelly resources

• K-Y Jelly Use in Pregnancy & Breastfeeding
• K-Y Jelly Support Group
• 0 Reviews for K-Y - Add your own review/rating

• Biafine Emulsion MedFacts Consumer Leaflet (Wolters Kluwer)


• Campath Monograph (AHFS DI)


• Campral Monograph (AHFS DI)


• Camptosar Monograph (AHFS DI)


• Diabinese Monograph (AHFS DI)


• Kinerase Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Neosalus Foam MedFacts Consumer Leaflet (Wolters Kluwer)


• Promiseb Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Compare K-Y Jelly with other medications

• Dry Skin

Where can I get more information?

• Your pharmacist can provide more information about topical emollients.