Yentreve 20mg and 40mg hard gastro-resistant capsules

1. Name Of The Medicinal Product

YENTREVE* 20mg and 40mg hard gastro-resistant capsules.

2. Qualitative And Quantitative Composition

Each 20mg capsule contains 20mg of duloxetine (as hydrochloride).

Excipients 20mg: Each capsule contains 5.7mg sucrose.

Each 40mg capsule contains 40mg of duloxetine (as hydrochloride).

Excipients 40mg: Each capsule contains 11.5mg sucrose.

For the full list of excipients, see section 6.1.

3. Pharmaceutical Form

Hard gastro-resistant capsule.

The 20mg capsule has an opaque blue body, imprinted with '20mg', and an opaque blue cap, imprinted with '9544'.

The 40mg capsule has an opaque orange body, imprinted with '40mg', and an opaque blue cap, imprinted with '9545'.

4. Clinical Particulars

4.1 Therapeutic Indications

YENTREVE is indicated for women for the treatment of moderate to severe stress urinary incontinence (SUI).

YENTREVE is indicated in adults.

For further information see section 5.1.

4.2 Posology And Method Of Administration

Posology

The recommended dose of YENTREVE is 40mg twice daily, without regard to meals. After 2-4 weeks of treatment, patients should be re-assessed in order to evaluate the benefit and tolerability of the therapy. Some patients may benefit from starting treatment at a dose of 20mg twice daily for two weeks before increasing to the recommended dose of 40mg twice daily. Dose escalation may decrease, though not eliminate, the risk of nausea and dizziness.

A 20 mg capsule is also available. However, limited data are available to support the efficacy of YENTREVE 20mg twice daily.

The efficacy of YENTREVE has not been evaluated for longer than 3 months in placebo-controlled studies. The benefit of treatment should be re-assessed at regular intervals.

Combining YENTREVE with a pelvic floor muscle training (PFMT) programme may be more effective than either treatment alone. It is recommended that consideration be given to concomitant PFMT.

Hepatic impairment

YENTREVE must not be used in women with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).

Renal impairment

No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/min). YENTREVE must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min; see section 4.3).

Elderly

Caution should be exercised when treating the elderly.

Children and Adolescents

Duloxetine is not recommended for use in children and adolescents due to insufficient data on safety and efficacy (see section 4.4).

Discontinuation of Treatment

Abrupt discontinuation should be avoided. When stopping treatment with YENTREVE the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8). If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate.

Method of Administration

For oral use.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Liver disease resulting in hepatic impairment (see section 5.2).

YENTREVE should not be used in combination with non selective, irreversible monoamine oxidase inhibitors (MAOIs) (see section 4.5).

YENTREVE should not be used in combination with CYP1A2 inhibitors, like fluvoxamine, ciprofloxacin, or enoxacin, since the combination results in elevated plasma concentrations of duloxetine (see section 4.5).

Severe renal impairment (creatinine clearance <30ml/min) (see section 4.4).

The initiation of treatment with YENTREVE is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and 4.8).

4.4 Special Warnings And Precautions For Use

Mania and Seizures

YENTREVE should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/or seizures.

Use with Antidepressants

The use of YENTREVE in combination with antidepressants (especially with SSRI, SNRI, and reversible MAOIs) is not recommended (see below, 'Depression, suicidal ideation and behaviour', and section 4.5).

St John's Wort

Adverse reactions may be more common during concomitant use of YENTREVE and herbal preparations containing St John's Wort (Hypericum perforatum).

Mydriasis

Mydriasis has been reported in association with duloxetine; therefore, caution should be used when prescribing duloxetine in patients with increased intra ocular pressure, or those at risk of acute narrow-angle glaucoma.

Blood Pressure and Heart Rate

Duloxetine has been associated with an increase in blood pressure and clinically significant hypertension in some patients. This may be due to the noradrenergic effect of duloxetine. Cases of hypertensive crisis have been reported with duloxetine, especially in patients with pre-existing hypertension. Therefore, in patients with known hypertension and/or other cardiac disease, blood pressure monitoring is recommended, especially during the first month of treatment. Duloxetine should be used with caution in patients whose conditions could be compromised by an increased heart rate or by an increase in blood pressure. Caution should also be exercised when duloxetine is used with medicinal products that may impair its metabolism (see section 4.5). For patients who experience a sustained increase in blood pressure while receiving duloxetine, either dose reduction or gradual discontinuation should be considered (see section 4.8). In patients with uncontrolled hypertension, duloxetine should not be initiated (see section 4.3).

Renal Impairment

Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on haemodialysis (creatinine clearance <30ml/min). For patients with severe renal impairment, see section 4.3. See section 4.2 for information on patients with mild or moderate renal dysfunction.

Haemorrhage

There have been reports of bleeding abnormalities, such as ecchymoses, purpura, and gastrointestinal haemorrhage, with selective serotonin reuptake inhibitors (SSRIs) and serotonin/noradrenaline reuptake inhibitors (SNRIs), including duloxetine. Caution is advised in patients taking anticoagulants and/or medicinal products known to affect platelet function (e.g. NSAIDs or acetylsalicyclic acid (ASA)), and in patients with known bleeding tendencies.

Discontinuation of Treatment

Withdrawal symptoms when treatment is discontinued are common, particularly if discontinuation is abrupt (see section 4.8). In a clinical trial, adverse events seen on abrupt treatment discontinuation occurred in approximately 44% of patients treated with YENTREVE and 24% of patients taking placebo.

The risk of withdrawal symptoms seen with SSRIs and SNRIs may be dependent on several factors, including the duration and dose of therapy and the rate of dose reduction. The most commonly reported reactions are listed in section 4.8. Generally, these symptoms are mild to moderate; however, in some patients they may be severe in intensity. They usually occur within the first few days of discontinuing treatment, but there have been very rare reports of such symptoms in patients who have inadvertently missed a dose. Generally, these symptoms are self-limiting and usually resolve within 2 weeks, though in some individuals they may be prolonged (2-3 months or more). It is therefore advised that duloxetine should be gradually tapered when discontinuing treatment over a period of no less than 2 weeks, according to the patient's needs (see section 4.2).

Hyponatraemia

Hyponatraemia has been reported when administering YENTREVE, including cases with serum sodium lower than 110 mmol/l. Hyponatraemia may be due to a syndrome of inappropriate anti-diuretic hormone secretion (SIADH). The majority of cases of hyponatraemia were reported in the elderly, especially when coupled with a recent history of, or condition pre-disposing to, altered fluid balance. Caution is required in patients at increased risk for hyponatraemia, such as elderly, cirrhotic, or dehydrated patients or patients treated with diuretics.

Depression, Suicidal Ideation and Behaviour

Although YENTREVE is not indicated for the treatment of depression, its active ingredient (duloxetine) also exists as an antidepressant medicinal product. Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery. Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal thoughts prior to commencement of treatment are known to be at a greater risk of suicidal thoughts or suicidal behaviour, and should receive careful monitoring during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressant medicinal products in psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old. Cases of suicidal thoughts and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.8). Physicians should encourage patients to report any distressing thoughts or feelings or depressive symptoms at any time. If, while on YENTREVE therapy, the patient develops agitation or depressive symptoms, specialised medical advice should be sought, as depression is a serious medical condition. If a decision to initiate antidepressant pharmacological therapy is taken, the gradual discontinuation of YENTREVE is recommended (see section 4.2).

Use in Children and Adolescents Under 18 Years of Age

No clinical trials have been conducted with duloxetine in paediatric populations. YENTREVE should not be used in the treatment of children and adolescents under the age of 18 years. Suicide-related behaviours (suicide attempts and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour, and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. Long-term safety data in children and adolescents concerning growth, maturation, and cognitive and behavioural development are lacking.

Medicinal Products Containing Duloxetine

Duloxetine is used under different trademarks in several indications (treatment of diabetic neuropathic pain, major depressive disorder, generalised anxiety disorder and stress urinary incontinence). The use of more than one of these products concomitantly should be avoided.

Hepatitis/Increased Liver Enzymes

Cases of liver injury, including severe elevations of liver enzymes (>10-times upper limit of normal), hepatitis, and jaundice, have been reported with duloxetine (see section 4.8). Most of them occurred during the first months of treatment. The pattern of liver damage was predominantly hepatocellular. Duloxetine should be used with caution in patients treated with other medicinal products associated with hepatic injury.

Akathisia/Psychomotor Restlessness

The use of duloxetine has been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move, often accompanied by an inability to sit or stand still. This is most likely to occur within the first few weeks of treatment. In patients who develop these symptoms, increasing the dose may be detrimental.

Sucrose

YENTREVE hard gastro-resistant capsules contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Monoamine oxidase inhibitors (MAOIs): Due to the risk of serotonin syndrome, duloxetine should not be used in combination with non selective, irreversible monoamine oxidase inhibitors (MAOIs), or within at least 14 days of discontinuing treatment with an MAOI. Based on the half-life of duloxetine, at least 5 days should be allowed after stopping YENTREVE before starting an MAOI (see section 4.3).

Inhibitors of CYP1A2: Because CYP1A2 is involved in duloxetine metabolism, concomitant use of YENTREVE with potent inhibitors of CYP1A2 is likely to result in higher concentrations of duloxetine. Fluvoxamine (100mg once daily), a potent inhibitor of CYP1A2, decreased the apparent plasma clearance of duloxetine by about 77% and increased AUC_0-t 6-fold. Therefore, YENTREVE should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine (see section 4.3).

CNS medicinal products: Caution is advised when YENTREVE is taken in combination with other centrally acting medicinal products or substances, including alcohol and sedative medicinal products (e.g., benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).

Serotonin syndrome: In rare cases, serotonin syndrome has been reported in patients using SSRIs concomitantly with serotonergic medicinal products. The use of YENTREVE in combination with serotonergic antidepressants like SSRIs, tricyclics like clomipramine or amitriptyline, venlafaxine, or triptans, tramadol and tryptophan is not recommended.

Effect of Duloxetine on Other Medicinal Products

Medicinal products metabolised by CYP1A2: The pharmacokinetics of theophylline, a CYP1A2 substrate, were not significantly affected by co-administration with duloxetine (60mg twice daily).

Medicinal products metabolised by CYP2D6: Duloxetine is a moderate inhibitor of CYP2D6. When duloxetine was administered at a dose of 60mg twice daily with a single dose of desipramine, a CYP2D6 substrate, the AUC of desipramine increased 3-fold. The co-administration of duloxetine (40mg twice daily) increases steady state AUC of tolterodine (2mg twice daily) by 71%, but does not affect the pharmacokinetics of its active 5-hydroxyl metabolite and no dosage adjustment is recommended. Caution is advised if YENTREVE is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs], such as nortriptyline, amitriptyline, and imipramine), particularly if they have a narrow therapeutic index (such as flecainide, propafenone, and metoprolol).

Oral contraceptives and other steroidal agents: Results of in vitro studies demonstrate that duloxetine does not induce the catalytic activity of CYP3A. Specific in vivo drug interaction studies have not been performed.

Anticoagulants and antiplatelet agents: Caution should be exercised when duloxetine is combined with oral anticoagulants or antiplatelet agents due to a potential increased risk of bleeding attributable to a pharmacodynamic interaction. Furthermore, increases in INR values have been reported when duloxetine was co-administered to patients treated with warfarin. However, concomitant administration of duloxetine with warfarin under steady state conditions, in healthy volunteers, as part of a clinical pharmacology study, did not result in a clinically significant change in INR from baseline or in the pharmacokinetics of R- or S-warfarin.

Effects of Other Medicinal Products on Duloxetine

Antacids and H₂-antagonists: Co-administration of YENTREVE with aluminium- and magnesium-containing antacids or with famotidine had no significant effect on the rate or extent of duloxetine absorption after administration of a 40mg oral dose.

Inducers of CYP1A2: Population pharmacokinetic studies analyses have shown that smokers have almost 50% lower plasma concentrations of duloxetine compared with non-smokers.

4.6 Pregnancy And Lactation

Pregnancy: There are no adequate data on the use of duloxetine in pregnant women. Studies in animals have shown reproductive toxicity at systemic exposure levels (AUC) of duloxetine lower than the maximum clinical exposure (see section 5.3). The potential risk for humans is unknown.

Epidemiological data have suggested that the use of SSRIs in pregnancy, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn (PPHN). Although no studies have investigated the association of PPHN to SNRI treatment, this potential risk cannot be ruled out with duloxetine taking into account the related mechanism of action (inhibition of the re-uptake of serotonin).

As with other serotonergic medicinal products, discontinuation symptoms may occur in the neonate after maternal duloxetine use near term. Discontinuation symptoms seen with duloxetine may include hypotonia, tremor, jitteriness, feeding difficulty, respiratory distress and seizures. The majority of cases have occurred either at birth or within a few days of birth.

YENTREVE should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus. Women should be advised to notify their physician if they become pregnant, or intend to become pregnant, during therapy.

Breast-feeding: Duloxetine is very weakly excreted into human milk based on a study of 6 lactating patients who did not breast feed their children. The estimated daily infant dose on a mg/kg basis is approximately 0.14% of the maternal dose (see section 5.2). As the safety of duloxetine in infants is not known, the use of YENTREVE while breast-feeding is not recommended.

4.7 Effects On Ability To Drive And Use Machines

No studies on the effects on the ability to drive and use machines have been performed. YENTREVE may be associated with sedation and dizziness. Patients should be instructed that if they experience sedation or dizziness they should avoid potentially hazardous tasks such as driving or operating machinery.

4.8 Undesirable Effects

a. Summary of the safety profile

The most commonly reported adverse events in patients treated with YENTREVE in clinical trials in SUI and other lower urinary tract disorders were nausea, dry mouth, fatigue and constipation. The data analysis of four 12-week, placebo-controlled clinical trials in patients with SUI, including 958 duloxetine-treated and 955 placebo-treated patients, showed that the onset of the reported adverse events typically occurred in the first week of therapy. However, the majority of the most frequent adverse events were mild to moderate and resolved within 30 days of occurrence (e.g., nausea).

b. Tabulated summary of adverse reactions

Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials (comprising a total of 8241 patients, 4504 on duloxetine and 3737 on placebo) in SUI and other lower urinary tract disorders.

Table 1: Adverse reactions

Frequency estimate: Very common (

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Very common	Common	Uncommon	Rare	Very Rare
Infections and Infestations
		Laryngitis
Immune System Disorders
		Hyper-sensitivity disorder	Anaphylactic reaction
Endocrine Disorders
		Hypo-thyroidism
Metabolism and Nutrition Disorders
	Appetite decreased	Dehydration	Hyperglycaemia (reported especially in diabetic patients) Hyponatraemia SIADH6
Psychiatric Disorders
	Insomnia Agitation Libido decreased Anxiety Sleep disorder	Bruxism Disorientation Apathy Orgasm abnormal Abnormal dreams	Suicidal behaviour5,6 Suicidal ideation5,7 Mania6 Hallucinations Aggression and anger4,6
Nervous System Disorders
	Headache Dizziness Lethargy Somnolence Tremor Paraesthesia	Nervousness Disturbance in attention Dysgeusia Poor quality sleep	Serotonin syndrome6 Convulsions1,6 Myoclonus Akathisia6 Psychomotor restlessness6 Extra-pyramidal symptoms6 Dyskinesia Restless legs syndrome
Eye Disorders
	Blurred vision	Mydriasis Visual impairment Dry eye	Glaucoma
Ear and Labyrinth Disorders
	Vertigo	Tinnitus1 Ear pain
Cardiac Disorders
		Palpitations Tachycardia	Supra-ventricular arrhythmia, mainly atrial fibrillation6
Vascular Disorders
	Hypertension3,7 Flushing	Syncope2 Blood pressure increase3	Hypertensive crisis3 Orthostatic hypotension2 Peripheral coldness
Respiratory, Thoracic and Mediastinal Disorders
		Yawning	Throat tightness Epistaxis
Gastrointestinal Disorders
Nausea (22.8%) Dry mouth (12.1%) Constipation (10.3%)	Diarrhoea Abdominal pain Vomiting Dyspepsia	Gastrointestinal haemorrhage7 Gastroenteritis Stomatitis Eructation Gastritis Flatulence Breath odour	Haematochezia
Hepato-biliary Disorders
		Hepatitis3 Elevated liver enzymes (ALT, AST, alkaline phosphatase) Acute liver injury	Hepatic failure6 Jaundice6
Skin and Subcutaneous Tissue Disorders
	Sweating increased	Rash Night sweats Urticaria Dermatitis contact Cold sweat Increased tendency to bruise	Stevens-Johnson Syndrome6 Angio-neurotic oedema6 Photo-sensitivity reactions
Musculoskeletal and Connective Tissue Disorders
		Musculo-skeletal pain Muscle tightness Muscle spasm Trismus	Muscle twitching
Renal and Urinary Disorders
		Urinary hesitation Dysuria Nocturia Urine odour abnormal	Urinary retention6 Polyuria Urine flow decreased
Reproductive System and Breast Disorders
		Gynaecological haemorrhage Menopausal symptoms	Menstrual disorder Galactorrhoea Hyperprolactinaemia
General Disorders and Administration Site Conditions
Fatigue (10.9%)	Asthenia Chills	Chest pain7 Falls8 Feeling abnormal Feeling cold Thirst Malaise Feeling hot	Gait disturbance
Investigations
		Weight decrease Weight increase Blood cholesterol increased Blood creatine phosphokinase increased	Blood potassium increased

¹ Cases of convulsion and cases of tinnitus have also been reported after treatment discontinuation.

² Cases of orthostatic hypotension and syncope have been reported especially at the initiation of treatment.

³ See section 4.4.

⁴ Cases of aggression and anger have been reported particularly early in treatment or after treatment discontinuation.

⁵ Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.4).

⁶ Estimated frequency of post-marketing surveillance reported adverse reactions; not observed in placebo-controlled clinical trials.

⁷ Not statistically significantly different from placebo.

⁸ Falls were more common in the elderly (65 years old).

c. Description of selected adverse reactions

Discontinuation of duloxetine (particularly when abrupt) commonly leads to withdrawal symptoms. Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), fatigue, somnolence, agitation or anxiety, nausea and/or vomiting, tremor, headache, irritability, diarrhoea, hyperhydrosis and vertigo are the most commonly reported reactions.

Generally, for SSRIs and SNRIs, these events are mild to moderate and self-limiting; however, in some patients they may be severe and/or prolonged. It is therefore advised that when duloxetine treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see sections 4.2 and 4.4).

The heart rate-corrected QT interval in duloxetine-treated patients did not differ from that seen in placebo-treated patients. No clinically significant differences were observed for QT, PR, QRS, or QTcB measurements between duloxetine-treated and placebo-treated patients.

In the 12 week acute phase of three clinical trials of duloxetine in patients with diabetic neuropathic pain, small but statistically significant increases in fasting blood glucose were observed in duloxetine-treated patients. HbA_1c was stable in both duloxetine-treated and placebo-treated patients. In the extension phase of these studies, which lasted up to 52 weeks, there was an increase in HbA_1c in both the duloxetine and routine care groups, but the mean increase was 0.3% greater in the duloxetine-treated group. There was also a small increase in fasting blood glucose and in total cholesterol in duloxetine-treated patients, while those laboratory tests showed a slight decrease in the routine care group.

4.9 Overdose

Cases of overdoses, alone or in combination with other medicinal products, with duloxetine doses of 5400 mg were reported. Some fatalities have occurred, primarily with mixed overdoses, but also with duloxetine alone at a dose of approximately 1000 mg. Signs and symptoms of overdose (duloxetine alone or in combination with other medicinal products) included somnolence, coma, serotonin syndrome, seizures, vomiting and tachycardia.

No specific antidote is known for duloxetine but if serotonin syndrome ensues, specific treatment (such as with cyproheptadine and/or temperature control) may be considered. A free airway should be established. Monitoring of cardiac and vital signs is recommended, along with appropriate symptomatic and supportive measures. Gastric lavage may be indicated if performed soon after ingestion or in symptomatic patients. Activated charcoal may be useful in limiting absorption. Duloxetine has a large volume of distribution and forced diuresis, haemoperfusion, and exchange perfusion are unlikely to be beneficial.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Other antidepressants. ATC code: N06AX21.

Mechanism of action: Duloxetine is a combined serotonin (5-HT) and noradrenaline (NA) reuptake inhibitor. It weakly inhibits dopamine reuptake, with no significant affinity for histaminergic, dopaminergic, cholinergic, and adrenergic receptors.

Pharmacodynamic effects: In animal studies, increased levels of 5-HT and NE in the sacral spinal cord lead to increased urethral tone via enhanced pudendal nerve stimulation to the urethral striated sphincter muscle only during the storage phase of the micturition cycle. A similar mechanism in women is believed to result in stronger urethral closure during urine storage with physical stress that could explain the efficacy of duloxetine in the treatment of women with SUI.

Clinical efficacy and safety: The efficacy of duloxetine 40mg given twice daily in the treatment of SUI was established in four double-blind, placebo-controlled studies that randomised 1,913 women (22 to 83 years) with SUI; of these, 958 patients were randomised to duloxetine and 955 to placebo. The primary efficacy measures were incontinence episode frequency (IEF) from diaries and an incontinence specific Quality of Life Questionnaire score (I-QoL).

Incontinence episode frequency: In all four studies the duloxetine-treated group had a 50% or greater median decrease in IEF compared with 33% in the placebo-treated group. Differences were observed at each visit after 4 weeks (duloxetine 54% and placebo 22%), 8 weeks (52% and 29%), and 12 weeks (52% and 33%) of medication.

In an additional study limited to patients with severe SUI, all responses with duloxetine were achieved within 2 weeks.

The efficacy of YENTREVE has not been evaluated for longer than 3 months in placebo-controlled studies. The clinical benefit of YENTREVE compared with placebo has not been demonstrated in women with mild SUI, defined in randomised trials as those with IEF <14 per week. In these women, YENTREVE may provide no benefit beyond that afforded by more conservative behavioural interventions.

Quality of Life: Incontinence Quality of Life (I-QoL) Questionnaire scores were significantly improved in the duloxetine-treated patient group compared with the placebo-treated group (9.2 versus 5.9 score improvement; P <0.001). Using a global improvement scale (PGI), significantly more women using duloxetine considered their symptoms of stress incontinence to be improved with treatment compared with women using placebo (64.6% versus 50.1%; P <0.001).

YENTREVE and prior continence surgery: There are limited data that suggest that the benefits of YENTREVE are not diminished in women with stress urinary incontinence who have previously undergone continence surgery.

YENTREVE and pelvic floor muscle training (PFMT): During a 12-week blinded, randomised, controlled study, YENTREVE demonstrated greater reductions in IEF compared with either placebo treatment or with PFMT alone. Combined therapy (duloxetine + PFMT) showed greater improvement in both pad use and condition-specific quality of life measures than YENTREVE alone or PFMT alone.

Paediatric population: The European Medicines Agency has waived the obligation to submit the results of studies with Yentreve in all subsets of the paediatric population in the treatment of stress urinary incontinence. See section 4.2 for information on paediatric use.

5.2 Pharmacokinetic Properties

Duloxetine is administered as a single enantiomer. Duloxetine is extensively metabolised by oxidative enzymes (CYP1A2 and the polymorphic CYP2D6), followed by conjugation. The pharmacokinetics of duloxetine demonstrate large intersubject variability (generally 50-60%), partly due to gender, age, smoking status, and CYP2D6 metaboliser status.

Absorption: Duloxetine is well absorbed after oral administration, with a C_max occurring 6 hours post-dose. The absolute oral bioavailability of duloxetine ranged from 32% to 80% (mean of 50%). Food delays the time to reach the peak concentration from 6 to 10 hours and it marginally decreases the extent of absorption (approximately 11 %). These changes do not have any clinical significance.

Distribution: Duloxetine is approximately 96% bound to human plasma proteins. Duloxetine binds to both albumin and alpha₁ acid glycoprotein. Protein binding is not affected by renal or hepatic impairment.

Biotransformation: Duloxetine is extensively metabolised and the metabolites are excreted principally in urine. Both cytochromes P450-2D6 and 1A2 catalyse the formation of the two major metabolites, glucuronide conjugate of 4-hydroxy duloxetine and sulphate conjugate of 5-hydroxy 6-methoxy duloxetine. Based upon in vitro studies, the circulating metabolites of duloxetine are considered pharmacologically inactive. The pharmacokinetics of duloxetine in patients who are poor metabolisers with respect to CYP2D6 has not been specifically investigated. Limited data suggest that the plasma levels of duloxetine are higher in these patients.

Elimination: The elimination half-life of duloxetine ranges from 8 to 17 hours (mean of 12 hours). After an intravenous dose, the plasma clearance of duloxetine ranges from 22 l/hr to 46 l/hr (mean of 36 l/hr). After an oral dose, the apparent plasma clearance of duloxetine ranges from 33 to 261 l/hr (mean 101 l/hr).

Special Populations

Gender: Pharmacokinetic differences have been identified between males and females (apparent plasma clearance is approximately 50% lower in females). Based upon the overlap in the range of clearance, gender-based pharmacokinetic differences do not justify the recommendation for using a lower dose for female patients.

Age: Pharmacokinetic differences have been identified between younger and elderly females (

Renal impairment: End stage renal disease (ESRD) patients receiving dialysis had 2-fold higher duloxetine C_max and AUC values compared with healthy subjects. Pharmacokinetic data on duloxetine is limited in patients with mild or moderate renal impairment.

Hepatic impairment: Moderate liver disease (Child-Pugh Class B) affected the pharmacokinetics of duloxetine. Compared with healthy subjects, the apparent plasma clearance of duloxetine was 79% lower, the apparent terminal half-life was 2.3 times longer, and the AUC was 3.7 times higher in patients with moderate liver disease. The pharmacokinetics of duloxetine and its metabolites have not been studied in patients with mild or severe hepatic insufficiency.

Breast-feeding mothers: The disposition of duloxetine was studied in 6 lactating women who were at least 12- weeks postpartum. Duloxetine is detected in breast milk, and steady state concentrations in breast milk are about one-fourth those in plasma. The amount of duloxetine in breast milk

Sprycel

Generic Name: dasatinib (da SAT in ib)

Brand Names: Sprycel

What is dasatinib?

Dasatinib is a cancer medication that slows the growth and spread of cancer cells in the body.

Dasatinib is used to treat chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) when other cancer treatments have not been effective.

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

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

Do not use dasatinib if you are pregnant. It could harm the unborn baby. Use birth control to prevent pregnancy while you are receiving dasatinib, whether you are a man or a woman. Dasatinib use by either parent may cause birth defects.

Before taking dasatinib, tell your doctor if you have liver disease, low levels of potassium or magnesium in your blood, heart disease or a heart rhythm disorder, or if you have a personal or family history of "Long QT syndrome."

Do not crush, chew, or break a dasatinib tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time. There are many other drugs that can interact with dasatinib. 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.

Dasatinib can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Tell your doctor at once if you develop signs of infection.

Some people using dasatinib have developed a rare but serious condition called pulmonary arterial hypertension (PAH). PAH may be irreversible if not promptly treated, and this condition can be fatal. Talk to your doctor about your specific risk of developing PAH.

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

You should not use dasatinib if:

• 
  

  you have not first received a medication called imatinib (Gleevec); or

  
  


• 
  

  if you are pregnant or planning to become pregnant during treatment with dasatinib.

  
  

Some people using dasatinib have developed a rare but serious condition called pulmonary arterial hypertension (PAH). PAH occurs when blood pressure increases inside the arteries in your lungs. This makes it harder for your heart to pump blood through the lungs, which also weakens muscles in the heart. PAH may be irreversible if not promptly treated, and this condition can be fatal. Talk to your doctor about your specific risk of developing PAH.

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

• 
  

  low levels of potassium or magnesium in your blood;

  
  


• 
  

  anemia (lack of red blood cells);

  
  


• 
  

  liver disease;

  
  


• 
  

  lung disease;

  
  


• 
  

  heart disease or a heart rhythm disorder; or

  
  


• 
  

  a personal or family history of Long QT syndrome.

  
  

FDA pregnancy category D. Do not use dasatinib if you are pregnant. It could harm the unborn baby. Tell your doctor if you become pregnant during treatment. Use birth control to prevent pregnancy while you are receiving dasatinib, whether you are a man or a woman. Dasatinib use by either parent may cause birth defects. A man taking dasatinib should use a condom during any sexual activity.

This medication may affect fertility (your ability to have children), whether you are a man or a woman.

It is not known whether dasatinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while taking dasatinib.

Dasatinib tablets contain lactose. Talk to your doctor before using this medication if you are lactose-intolerant.

How should I take dasatinib?

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 once per day in the morning or evening. Follow your doctor's instructions. You may take the medication with or without food.

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

Do not crush, chew, or break a dasatinib tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time. Do not use a pill that has been accidentally broken. The medicine from a crushed or broken pill can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water. Ask your doctor or pharmacist how to safely handle and dispose of a broken tablet.

Dasatinib can lower blood cells that help your body fight infections. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Visit your doctor regularly.

Store at room temperature away from moisture and heat.

See also: Sprycel 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 some of the serious side effects listed in this medication guide.

What should I avoid while taking dasatinib?

Avoid taking an antacid within 2 hours before or 2 hours after you take dasatinib. Use only the type of antacid your doctor recommends. Some antacids can make it harder for your body to absorb dasatinib.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Grapefruit and grapefruit juice may interact with dasatinib and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Dasatinib 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 taking dasatinib and call your doctor right away if you have any symptoms of pulmonary arterial hypertension (PAH), such as:

• 
  

  feeling tired or short of breath (even with mild exertion);

  
  


• 
  

  swelling in your feet or lower legs;

  
  


• 
  

  rapid weight gain;

  
  


• 
  

  blue-colored lips and skin; and

  
  


• 
  

  feeling light-headed or fainting.

  
  

Stop using dasatinib and call your doctor at once if you have any of these other serious side effects:

• 
  

  pale skin, rapid heart rate, trouble concentrating;

  
  


• 
  

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

  
  


• 
  

  fever, chills, body aches, flu symptoms, sores in your mouth and throat;

  
  


• 
  

  black, bloody, or tarry stools;

  
  


• 
  

  coughing up blood or vomit that looks like coffee grounds; or

  
  


• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

  
  

Less serious side effects may include:

• 
  

  headache;

  
  


• 
  

  tired feeling;

  
  


• 
  

  nausea, diarrhea; or

  
  


• 
  

  mild 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.

What other drugs will affect dasatinib?

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

• 
  

  alfentanil (Alfenta), fentanyl (Abstral, Actiq, Fentora, Duragesic, Ionsys, Lazanda, Onsolis);

  
  


• 
  

  bosentan (Tracleer);

  
  


• 
  

  conivaptan (Vaprisol);

  
  


• 
  

  cyclosporine (Gengraf, Neoral, Sandimmune);

  
  


• 
  

  dexamethasone (Cortastat, Dexasone, Solurex, DexPak);

  
  


• 
  

  ergotamine (Ergomar, Cafergot, Migergot);

  
  


• 
  

  imatinib (Gleevec);

  
  


• 
  

  isoniazid (for treating tuberculosis);

  
  


• 
  

  pimozide (Orap);

  
  


• 
  

  rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), or rifapentine (Priftin);

  
  


• 
  

  St. John's wort;

  
  


• 
  

  an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek);

  
  


• 
  

  an antidepressant such as nefazodone;

  
  


• 
  

  antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);

  
  


• 
  

  phenobarbital (Solfoton) and other barbiturates;

  
  


• 
  

  aspirin, or a blood thinner such as warfarin (Coumadin, Jantoven);

  
  


• 
  

  heart or blood pressure medication such as nicardipine (Cardene) or quinidine (Quin-G);

  
  


• 
  

  HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), saquinavir (Invirase), or ritonavir (Kaletra, Norvir);

  
  


• 
  

  medicines to treat narcolepsy, such as armodafanil (Nuvigil) or modafanil (Progivil);

  
  


• 
  

  medication used to prevent blood clots, such as bivalirudin (Angiomax), clopidogrel (Plavix), dalteparin (Fragmin), dipyridamole (Persantine, Aggrenox), enoxaparin (Lovenox), fondaparinux (Arixtra), lepirudin (Refludan), ticlopidine (Ticlid);

  
  


• 
  

  medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf);

  
  


• 
  

  seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline); or

  
  


• 
  

  stomach acid reducers such as cimetidine (Tagamet), esomeprazole (Nexium), famotidine (Pepcid), lansoprazole (Prevacid), nizatidine (Axid), omeprazole (Prilosec, Zegerid), pantoprazole (Protonix), rabeprazole (Aciphex), or ranitidine (Zantac).

  
  

This list is not complete and there are many other drugs that can interact with dasatinib. 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 Sprycel resources

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

• Sprycel Prescribing Information (FDA)


• Sprycel Monograph (AHFS DI)


• Sprycel Advanced Consumer (Micromedex) - Includes Dosage Information


• Sprycel Consumer Overview


• Sprycel MedFacts Consumer Leaflet (Wolters Kluwer)


• Dasatinib Professional Patient Advice (Wolters Kluwer)

Compare Sprycel with other medications

• Acute Lymphoblastic Leukemia
• Chronic Myelogenous Leukemia
• Leukemia

Where can I get more information?

• Your pharmacist can provide more information about dasatinib.

See also: Sprycel side effects (in more detail)

Isoptin retard

Isoptin Retard may be available in the countries listed below.

Ingredient matches for Isoptin Retard

Verapamil

Verapamil is reported as an ingredient of Isoptin Retard in the following countries:

• Lithuania

Verapamil hydrochloride (a derivative of Verapamil) is reported as an ingredient of Isoptin Retard in the following countries:

• Austria


• Denmark


• Iceland


• Norway

International Drug Name Search

E Pherol

Generic Name: vitamin E (VYE ta min E)

Brand Names: Amino-Opti-E, Aqua-E, Aquasol E, Aquavite-E, Aqueous Vitamin E, E Pherol, E-400 Clear, Vita-Plus E Natural

What is E Pherol (vitamin E)?

Vitamin E is an antioxidant that occurs naturally in foods such as nuts, seeds, and leafy green vegetables. Vitamin E is important for many processes in the body.

Vitamin E is used to prevent and to treat a deficiency vitamin E. People with certain diseases may need extra vitamin E.

Vitamin E may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about E Pherol (vitamin E)?

Before using vitamin E, tell your healthcare provider if you have liver disease, diabetes, active bleeding, a vitamin K deficiency, retinitis pigmentosa, chronic diarrhea, if you are being treated for cancer, or if you have a history of heart attack, stroke, blood clot, or recent surgery.

Do not use this product without a doctor's advice your doctor if you are pregnant or breast-feeding. Your dose needs may be different during pregnancy or while you are nursing a baby. Do not take vitamin E without a doctor's advice if you are using any type of medication to treat or prevent blood clots.

There are many other drugs that can interact with or be made less effective by vitamin E. 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.

Stop taking vitamin E and call your doctor at once if you have any unusual bleeding or bruising, or if you feel like you might pass out.

What should I discuss with my healthcare provider before taking E Pherol (vitamin E)?

Before using vitamin E, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to take vitamin E if you have certain medical conditions.

You may need a dose adjustment or special tests if you have:

• 
  

  liver disease;

  
  


• 
  

  diabetes;

  
  


• 
  

  active or uncontrolled bleeding;

  
  


• 
  

  a vitamin K deficiency;

  
  


• 
  

  retinitis pigmentosa;

  
  


• 
  

  short bowel syndrome;

  
  


• 
  

  chronic diarrhea;

  
  


• 
  

  a history of heart attack, stroke, or blood clot;

  
  


• 
  

  if you have recently had surgery; or

  
  


• 
  

  if you are receiving cancer treatment (chemotherapy or radiation).

  
  

It is not known whether vitamin E is harmful to an unborn baby. Your dose needs may be different during pregnancy. Do not use this product without a doctor's advice if you are pregnant or plan to become pregnant while using vitamin E. It is not known whether vitamin E passes into breast milk or if it could harm a nursing baby. Your dose needs may be different while you are nursing. Do not use this product without a doctor's advice if you are breast-feeding a baby.

How should I take E Pherol (vitamin E)?

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

Take vitamin E with a full glass of water.

The chewable tablet must be chewed completely before you swallow it.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

You may take vitamin E with or without food. You do not need to eat extra fat to help your body absorb vitamin E.

The recommended dietary allowance of vitamin E increases with age. Follow your healthcare provider's instructions. You may also consult the National Academy of Sciences "Dietary Reference Intake" or the U.S. Department of Agriculture's "Dietary Reference Intake" (formerly "Recommended Daily Allowances" or RDA) listings for more information.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Skip the missed dose if it is almost time for your next scheduled dose. Do not use 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 unusual bleeding or bruising.

What should I avoid while taking E Pherol (vitamin E)?

Avoid taking other vitamins, mineral supplements, or nutritional products without your doctor's advice.

E Pherol (vitamin E) 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 taking vitamin E and call your doctor at once if you have a serious side effect such as:

• 
  

  feeling like you might pass out;

  
  


• 
  

  easy bruising; or

  
  


• 
  

  unusual bleeding (nose, mouth, vagina, or rectum).

  
  

Less serious side effects may include:

• 
  

  nausea, diarrhea, stomach cramps;

  
  


• 
  

  tired feeling;

  
  


• 
  

  headache;

  
  


• 
  

  blurred vision; or

  
  


• 
  

  mild rash.

  
  

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

What other drugs will affect E Pherol (vitamin E)?

Do not take vitamin E without a doctor's advice if you are using any type of medication to treat or prevent blood clots, such as:

• 
  

  heparin, warfarin (Coumadin);

  
  


• 
  

  alteplase (Activase), tenecteplase (TNKase), urokinase (Abbokinase);

  
  


• 
  

  argatroban (Acova), bivalirudin (Angiomax), lepirudin (Refludan);

  
  


• 
  

  dalteparin (Fragmin), enoxaparin (Lovenox), fondaparinux (Arixtra); or

  
  


• 
  

  abciximab (ReoPro), anagrelide (Agrylin), cilostazol (Pletal), clopidogrel (Plavix), dipyridamole (Persantine, Aggrenox), eptifibatide (Integrelin), prasugrel (Effient), ticlopidine (Ticlid), tirofiban (Aggrastat).

  
  

The following drugs can interact with or be made less effective by vitamin E. Tell your doctor if you are using any of these:

• 
  

  cyclosporine (Gengraf, Neoral, Sandimmune);

  
  


• 
  

  diazepam (Valium) and other sedatives;

  
  


• 
  

  fluoxetine (Prozac) and other antidepressants;

  
  


• 
  

  mineral oil, orlistat (alli, Xenical);

  
  


• 
  

  an antibiotic such as clarithromycin (Biaxin), doxycycline (Doryx, Vibramycin), trimethoprim (Bactrim, Septra, SMX-TMP), and others;

  
  


• 
  

  antifungal medication such as itraconazole (Sporanox) or ketoconazole (Extina, Ketozole, Nizoral, Xolegal);

  
  


• 
  

  cholesterol-lowering medicines such as atorvastatin (Lipitor), cholestyramine (Questran), colestipol (Colestid), simvastatin (Zocor, Simcor), lovastatin (Mevacor, Advicor), pravastatin (Pravachol), niacin (Niaspan, Slo-Niacin), and others;

  
  


• 
  

  heart or blood pressure medications such as diltiazem (Cartia, Cardizem), losartan (Cozaar), propranolol (Inderal), verapamil (Calan, Covera, Isoptin), and others;

  
  


• 
  

  HIV medicines such as fosamprenavir (Lexiva), ritonavir (Norvir, Kaletra), and others;

  
  


• 
  

  narcotic medication such as fentanyl (Actiq, Duragesic, Fentora);

  
  


• 
  

  seizure medication such as carbamazepine (Carbatrol, Tegretol), phenobarbital (Solfoton), phenytoin (Dilantin), and others; or

  
  


• 
  

  stomach acid reducers such as cimetidine (Tagamet), omeprazole (Prilosec), lansoprazole (Prevacid), and others.

  
  

This list is not complete and there are many other drugs that can interact with vitamin E. 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 E Pherol resources

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

• Aquasol E Advanced Consumer (Micromedex) - Includes Dosage Information


• Aquasol E Monograph (AHFS DI)


• Vitamin E Natural MedFacts for Professionals (Wolters Kluwer)


• Vitamin E Natural MedFacts for Consumers (Wolters Kluwer)

Compare E Pherol with other medications

• Alzheimer's Disease
• Anemia, Sickle Cell
• Cystic Fibrosis
• Dietary Supplementation
• Nocturnal Leg Cramps
• Retinopathy Prophylaxis
• Tardive Dyskinesia
• Vitamin E Deficiency

Where can I get more information?

• Your pharmacist can provide more information about vitamin E.

See also: E Pherol side effects (in more detail)

Sal-Acid Plaster Topical

Generic Name: salicylic acid (Topical route)

sal-i-SIL-ik AS-id

Commonly used brand name(s)

In the U.S.

• Akurza


• Aliclen


• Avosil


• Betasal


• Compound W


• Corn Removing


• Dermarest Psoriasis


• DHS Sal


• Drytex


• Duofilm


• Duoplant


• Durasal


• Freezone


• Fung-O


• Gets-It Corn/Callus Remover


• Gordofilm


• Hydrisalic


• Ionil


• Ionil Plus


• Keralyt


• Keralyt Scalp


• Lupicare


• Mediplast


• Mg217 Sal-Acid


• Mosco Corn & Callus Remover


• Neutrogena


• Occlusal-HP


• Off-Ezy


• Oxy Balance


• P & S


• Palmer's Skin Success Acne Cleanser


• Propa pH


• Salac


• Sal-Acid Plaster


• Salactic Film


• Salex


• Salitop


• Salkera


• Sal-Plant Gel


• Salvax


• Seba-Clear


• Stri-Dex


• Thera-Sal


• Therasoft Anti-Acne


• Tinamed


• Ti-Seb


• Virasal


• Wart-Off Maximum Strength


• Zapzyt

In Canada

• Acnex


• Acnomel Acne Mask


• Clear Away Wart Removal System


• Compound W One-Step Wart Remover


• Compound W Plus


• Dr. Scholl's Clear Away One Step Plantar Wart Remover


• Dr. Scholl's Cushlin Ultra Slim Callus Removers


• Dr. Scholl's Cushlin Ultra Slim Corn Removers


• Duoforte 27


• Freezone - One Step Callus Remover Pad


• Freezone - One Step Corn Remover Pad

Available Dosage Forms:

• Soap


• Lotion


• Liquid


• Foam


• Ointment


• Gel/Jelly


• Solution


• Cream


• Pad


• Paste


• Shampoo


• Dressing


• Stick

Therapeutic Class: Antiacne

Pharmacologic Class: NSAID

Chemical Class: Salicylate, Non-Aspirin

Uses For Sal-Acid Plaster

Salicylic acid is used to treat many skin disorders, such as acne, dandruff, psoriasis, seborrheic dermatitis of the skin and scalp, calluses, corns, common warts, and plantar warts, depending on the dosage form and strength of the preparation.

Some of these preparations are available only with your doctor's prescription.

Before Using Sal-Acid Plaster

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

Young children may be at increased risk of unwanted effects because of increased absorption of salicylic acid through the skin. Also, young children may be more likely to get skin irritation from salicylic acid. Salicylic acid should not be applied to large areas of the body, used for long periods of time, or used under occlusive dressing (air-tight covering, such as kitchen plastic wrap) in infants and children. Salicylic acid should not be used in children younger than 2 years of age.

Geriatric

Elderly people are more likely to have age-related blood vessel disease. This may increase the chance of problems during treatment with this medicine.

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 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.

• Abciximab


• Argatroban


• Bivalirudin


• Cilostazol


• Citalopram


• Clovoxamine


• Dabigatran Etexilate


• Dipyridamole


• Escitalopram


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Heparin


• Lepirudin


• Nefazodone


• Paroxetine


• Protein C


• Rivaroxaban


• Sertraline


• Sibutramine


• Ticlopidine


• Tirofiban


• Vilazodone


• Zimeldine

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.

• Acenocoumarol


• Anisindione


• Ardeparin


• Azilsartan Medoxomil


• Azosemide


• Bemetizide


• Bendroflumethiazide


• Benzthiazide


• Bumetanide


• Buthiazide


• Candesartan Cilexetil


• Certoparin


• Chlorothiazide


• Chlorthalidone


• Clopamide


• Cyclopenthiazide


• Dalteparin


• Danaparoid


• Dicumarol


• Enoxaparin


• Eprosartan


• Ethacrynic Acid


• Furosemide


• Hydrochlorothiazide


• Hydroflumethiazide


• Indapamide


• Irbesartan


• Losartan


• Methyclothiazide


• Metolazone


• Nadroparin


• Olmesartan Medoxomil


• Parnaparin


• Phenindione


• Phenprocoumon


• Piretanide


• Polythiazide


• Probenecid


• Reviparin


• Tamarind


• Tasosartan


• Telmisartan


• Tinzaparin


• Torsemide


• Trichlormethiazide


• Valsartan


• Warfarin


• Xipamide

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Blood vessel disease

• Diabetes mellitus (sugar diabetes)—Use of this medicine may cause severe redness or ulceration, especially on the hands or feet

• Inflammation, irritation, or infection of the skin—Use of this medicine may cause severe irritation if applied to inflamed, irritated, or infected area of the skin

• Influenza (flu) or


• Varicella (chicken pox)—This medicine should not be used in children and teenagers with the flu or chicken pox. There is a risk of Reye's syndrome.

• Kidney disease or


• Liver disease—Using this medicine for a long time over large areas could result in unwanted effects

Proper Use of salicylic acid

This section provides information on the proper use of a number of products that contain salicylic acid. It may not be specific to Sal-Acid Plaster. Please read with care.

It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of absorption through the skin and the chance of salicylic acid poisoning.

If your doctor has ordered an occlusive dressing (airtight covering, such as kitchen plastic wrap) to be applied over this medicine, make sure you know how to apply it. Since an occlusive dressing will increase the amount of medicine absorbed through your skin and the possibility of salicylic acid poisoning, use it only as directed. If you have any questions about this, check with your doctor.

Keep this medicine away from the eyes and other mucous membranes, such as the mouth and inside of the nose. If you should accidentally get some in your eyes or on other mucous membranes, immediately flush them with water for 15 minutes.

To use the cream, lotion, or ointment form of salicylic acid:

• Apply enough medicine to cover the affected area, and rub in gently.

To use the gel form of salicylic acid:

• Before using salicylic acid gel, apply wet packs to the affected areas for at least 5 minutes. If you have any questions about this, check with your health care professional.


• Apply enough gel to cover the affected areas, and rub in gently.

To use the pad form of salicylic acid:

• Wipe the pad over the affected areas.


• Do not rinse off medicine after treatment.

To use the plaster form of salicylic acid for warts, corns, or calluses:

• This medicine comes with patient instructions. Read them carefully before using.


• Do not use this medicine on irritated skin or on any area that is infected or reddened. Also, do not use this medicine if you are a diabetic or if you have poor blood circulation.


• Do not use this medicine on warts with hair growing from them or on warts on the face, in or on the genital (sex) organs, or inside the nose or mouth. Also do not use on moles or birthmarks. To do so may cause severe irritation.


• Wash the area to be treated and dry thoroughly. Warts may be soaked in warm water for 5 minutes before drying.


• Cut the plaster to fit the wart, corn, or callus and apply.


• For corns and calluses:
  
  • Repeat every 48 hours as needed for up to 14 days, or as directed by your doctor, until the corn or callus is removed.
  
  
  • Corns or calluses may be soaked in warm water for 5 minutes to help in their removal.
  
  


• For warts:
  
  • Depending on the product, either:
    
    • Apply plaster and repeat every 48 hours as needed, or
      
      • Apply plaster at bedtime, leave in place for at least 8 hours, remove plaster in the morning, and repeat every 24 hours as needed.
      
      
    
    
  
  
  • Repeat for up to 12 weeks as needed, or as directed by your doctor, until wart is removed.
  
  


• If discomfort gets worse during treatment or continues after treatment, or if the wart spreads, check with your doctor.

To use the shampoo form of salicylic acid:

• Before applying this medicine, wet the hair and scalp with lukewarm water. Apply enough medicine to work up a lather and rub well into the scalp for 2 or 3 minutes, then rinse. Apply the medicine again and rinse thoroughly.

To use the soap form of salicylic acid:

• Work up a lather with the soap, using hot water, and scrub the entire affected area with a washcloth or facial sponge or mitt.


• If you are to use this soap in a foot bath, work up rich suds in hot water and soak the feet for 10 to 15 minutes. Then pat dry without rinsing.

To use the topical solution form of salicylic acid for acne:

• Wet a cotton ball or pad with the topical solution and wipe the affected areas.


• Do not rinse off medicine after treatment.

To use the topical solution form of salicylic acid for warts, corns, or calluses:

• This medicine comes with patient instructions. Read them carefully before using.


• This medicine is flammable. Do not use it near heat or open flame or while smoking.


• Do not use this medicine on irritated skin or on any area that is infected or reddened. Also, do not use this medicine if you are a diabetic or if you have poor blood circulation.


• Do not use this medicine on warts with hair growing from them or on warts on the face, in or on the genital (sex) organs, or inside the nose or mouth. Also do not use on moles or birthmarks. To do so may cause severe irritation.


• Avoid breathing in the vapors from the medicine.


• Wash the area to be treated and dry thoroughly. Warts may be soaked in warm water for 5 minutes before drying.


• Apply the medicine one drop at a time to completely cover each wart, corn, or callus. Let dry.


• For warts—Repeat one or two times a day as needed for up to 12 weeks, or as directed by your doctor, until wart is removed.


• For corns and calluses—Repeat one or two times a day as needed for up to 14 days, or as directed by your doctor, until the corn or callus is removed.


• Corns and calluses may be soaked in warm water for 5 minutes to help in their removal.


• If discomfort gets worse during treatment or continues after treatment, or if the wart spreads, check with your doctor.

Unless your hands are being treated, wash them immediately after applying this medicine to remove any medicine that may be on them.

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 cream dosage form:
  
  • For corns and calluses:
    
    • Adults and children—Use the 2 to 10% cream as needed. Use the 25 to 60% cream one time every three to five days.
    
    
  
  


• For gel dosage form:
  
  • For acne:
    
    • Adults and children—Use the 0.5 to 5% gel one time a day.
    
    
  
  
  • For psoriasis:
    
    • Adults and children—Use the 5% gel one time a day.
    
    
  
  
  • For common warts:
    
    • Adults and children—Use the 5 to 26% gel one time a day.
    
    
  
  


• For lotion dosage form:
  
  • For acne:
    
    • Adults and children—Use the 1 to 2% lotion one to three times a day.
    
    
  
  
  • For dandruff and antiseborrhic dermatitis of the scalp:
    
    • Adults and children—Use the 1.8 to 2% lotion on the scalp one or two times a day.
    
    
  
  


• For ointment dosage form:
  
  • For acne:
    
    • Adults and children—Use the 3 to 6% ointment as needed.
    
    
  
  
  • For psoriasis and seborrheic dermatitis:
    
    • Adults and children—Use the 3 to 10% ointment as needed.
    
    
  
  
  • For common warts:
    
    • Adults and children—Use the 3 to 10% ointment as needed. Use the 25 to 60% ointment one time every three to five days.
    
    
  
  


• For pads dosage form:
  
  • For acne:
    
    • Adults and children—Use one to three times a day.
    
    
  
  


• For plaster dosage form:
  
  • For corns, calluses, common warts, or plantar warts:
    
    • Adults and children—Use one time a day or one time every other day.
    
    
  
  


• For shampoo dosage form:
  
  • For dandruff or seborrheic dermatitis of the scalp:
    
    • Adults and children—Use on the scalp one or two times a week.
    
    
  
  


• For soap dosage form:
  
  • For acne:
    
    • Adults and children—Use as needed.
    
    
  
  


• For topical solution dosage form:
  
  • For acne:
    
    • Adults and children—Use the 0.5 to 2% topical solution one to three times a day.
    
    
  
  
  • For common warts and plantar warts:
    
    • Adults and children—Use the 5 to 27% topical solution one or two times a day.
    
    
  
  
  • For corns and calluses:
    
    • Adults and children—Use the 12 to 27% topical solution one or two times a day.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply 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.

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.

Precautions While Using Sal-Acid Plaster

When using salicylic acid, do not use any of the following preparations on the same affected area as this medicine, unless otherwise directed by your doctor:

• Abrasive soaps or cleansers


• Alcohol-containing preparations


• Any other topical acne preparation or preparation containing a peeling agent (for example, benzoyl peroxide, resorcinol, sulfur, or tretinoin [vitamin A acid])


• Cosmetics or soaps that dry the skin


• Medicated cosmetics


• Other topical medicine for the skin

To use any of the above preparations on the same affected area as salicylic acid may cause severe irritation of the skin.

Check with your doctor right away if you have nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy hyperpnea, diarrhea, and psychic disturbances. These could be symptoms of a serious condition called salicylate toxicity, especially in children under 12 years of age and patients with kidney or liver problems.

Sal-Acid Plaster 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 as soon as possible if any of the following side effects occur:

Less common or rare

• Skin irritation not present before use of this medicine (moderate or severe)

Frequency not known

• Dryness and peeling of skin


• flushing


• redness of skin


• unusually warm skin

Symptoms of salicylic acid poisoning

• Confusion


• diarrhea


• dizziness


• fast or deep breathing


• headache (severe or continuing)


• hearing loss


• lightheadedness


• nausea


• rapid breathing


• ringing or buzzing in ears (continuing)


• severe drowsiness


• stomach pain


• vomiting

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

More common

• Skin irritation not present before use of this medicine (mild)


• stinging

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.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Sal-Acid Plaster Topical resources

• Sal-Acid Plaster Topical Use in Pregnancy & Breastfeeding
• Sal-Acid Plaster Topical Drug Interactions
• Sal-Acid Plaster Topical Support Group
• 0 Reviews for Sal-Acid Plaster Topical - Add your own review/rating

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Moduretic

Pronunciation: a-MILL-oh-ride/hye-droe-klor-oh-THYE-a-zide
Generic Name: Amiloride/Hydrochlorothiazide
Brand Name: Moduretic

Moduretic can increase potassium levels in your body. This is more likely to occur in elderly patients, patients who are severely ill, or patients with kidney problems and diabetes. If not treated, high potassium levels can be fatal. Potassium levels must be closely monitored in people with any of these problems or illnesses. Lab tests will be required so be sure to keep appointments. If you develop muscle weakness or an unusual heartbeat, notify your doctor immediately.

Moduretic is used for:

Treating fluid retention (edema) and high blood pressure. It may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.

Moduretic is a diuretic (water pill) and is a combination of a potassium-sparing diuretic (amiloride) and a thiazide diuretic (hydrochlorothiazide). It works by making the kidneys eliminate sodium (salt) and water from the body, which helps to lower blood pressure. The amiloride component helps minimize potassium loss.

Do NOT use Moduretic if:

• you are allergic to any ingredient in Moduretic or any other sulfonamide (eg, sulfamethoxazole)


• you are unable to urinate, have severely decreased kidney function, or high blood potassium


• you are taking other potassium-sparing diuretics (eg, spironolactone), potassium supplements, salt substitutes containing potassium, or dofetilide

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

Before using Moduretic:

Some medical conditions may interact with Moduretic. 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 cirrhosis or liver problems, diabetes, gout, kidney problems or kidney stones, asthma, heart problems, or systemic lupus erythematosus (SLE or lupus)


• if you have elevated blood acid, low folic acid levels, or electrolyte problems, or are dehydrated

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

• Potassium-sparing diuretics (eg, spironolactone), potassium supplements, or salt substitutes containing potassium because high blood potassium levels may occur and cause listlessness, confusion, abnormal skin sensations of the arms and legs, heaviness of limbs, slowed heart rate, irregular heart rhythm, or stopping of the heart


• Cholestyramine or colestipol because they may decrease Moduretic's effectiveness


• Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, indomethacin) because they may decrease Moduretic's effectiveness of Moduretic may be decreased and the risk of kidney problems may be increased


• Barbiturates (eg, phenobarbital), certain chemotherapy medicines, corticosteroids (eg, prednisone), digoxin, dofetilide, ketanserin, narcotic pain medicines (eg, codeine), or medicines for high blood pressure because the risk of their side effects may be increased by Moduretic


• Diazoxide, lithium, or nondepolarizing neuromuscular blockers (eg, pancuronium) because their actions and the risk of their side effects may be increased by Moduretic


• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) because the risk of high blood potassium and kidney problems may be increased by Moduretic


• Diabetes medicines (eg, glipizide) or insulin because their effectiveness may be decreased by Moduretic

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

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

• Take Moduretic by mouth with food.


• Moduretic may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.


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

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

Important safety information:

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


• Moduretic may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.


• Moduretic may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Moduretic. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Tell your doctor or dentist that you take Moduretic before you receive any medical or dental care, emergency care, or surgery.


• Diabetes patients - Moduretic may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Lab tests, including liver function, kidney function, lung function, blood pressure, and fasting blood glucose, may be performed while you use Moduretic. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Moduretic should not be used in CHILDREN; safety and effectiveness in 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 Moduretic while you are pregnant. It is not known if Moduretic is found in breast milk. Do not breast-feed while taking Moduretic.

Possible side effects of Moduretic:

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:

Changes in blood sugar; constipation; dizziness; fatigue; headache; inflammation of a salivary gland; loss of appetite; nausea; sensitivity to sunlight; stomach pain; weakness.

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); dry mouth; excessive thirst; impotence; leg or muscle cramps; mental confusion; rapid, weak, or irregular heartbeat; stomach pain; urination problems; vomiting; yellowing of skin or eyes.

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

See also: Moduretic side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include excessive urination; flushed face; lightheadedness especially upon standing; nausea; vomiting; weakness.

Proper storage of Moduretic:

Store Moduretic at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Moduretic out of the reach of children and away from pets.

General information:

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


• Moduretic 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 Moduretic. 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 Moduretic resources

• Moduretic Side Effects (in more detail)
• Moduretic Use in Pregnancy & Breastfeeding
• Moduretic Drug Interactions
• Moduretic Support Group
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