Glyceryl Trinitrate 1mg / ml solution for infusion

1. Name Of The Medicinal Product

Glyceryl Trinitrate 1 mg/ml solution for infusion

2. Qualitative And Quantitative Composition

1 ml solution contains 1 mg glyceryl trinitrate.

Amount of active substance per pack size:

Total Volume	Total GTN Content	Container
5ml	5mg	ampoule
10ml	10mg	ampoule
25ml	25mg	ampoule
50ml	50mg	vial

For excipients, see 6.1.

3. Pharmaceutical Form

Solution for infusion

The product is a clear and colourless solution.

4. Clinical Particulars

4.1 Therapeutic Indications

The following indications exist for Glyceryl Trinitrate:

- Unresponsive congestive heart failure, including that secondary to acute myocardial infarction; acute left-sided heart failure and acute myocardial infarction,

- Refractory unstable angina pectoris and coronary insufficiency, including Prinzmetal's angina,

- Control of hypertensive episodes and/or myocardial ischaemia during and after cardiac surgery,

- Induction of controlled hypotension for surgery.

4.2 Posology And Method Of Administration

For intravenous use. Glyceryl Trinitrate should be administered by means of a micro-drip set infusion pump or similar device which permits maintenance of constant infusion rate.

For instructions on dilution of the product before administration, see section 6.6.

Adults and the elderly - the dose should be titrated against the individual clinical response.

Unresponsive congestive heart failure, acute myocardial infarction and left-sided heart failure. The normal dose range is 10-100 micrograms / minute administered as a continuous intravenous infusion with frequent monitoring of blood pressure and heart rate. The infusion should be started at the lower rate and increased cautiously until the desired clinical response is achieved. Other haemodynamic measurements are extremely important in monitoring response to the drug: These may include pulmonary capillary wedge pressure, cardiac output and precordial electrocardiogram depending on the clinical picture.

Refractory unstable angina pectoris. An initial infusion rate of 10-15 micrograms / minute is recommended; this may be increased cautiously in increments of 5-10 micrograms until either relief of angina is achieved, headache prevents further increase in dose, or the mean arterial pressure falls by more than 20 mm Hg.

Use in surgery. An initial infusion rate of 25 micrograms / minute is recommended; this should be increased gradually until the desired systolic arterial pressure is attained. The usual dose is 25-200 micrograms / minute.

Children – Glyceryl Trinitrate 1 mg/ml solution for infusion is not recommended for use in children.

4.3 Contraindications

Glyceryl Trinitrate should not be used in the following cases: Known hypersensitivity to nitrates, severe anaemia, severe cerebral haemorrhage, head trauma, uncorrected hypovolaemia and hypotensive shock, arterial hypoxaemia and angina caused by hypertrophic obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade, toxic pulmonary oedema. Sildenafil potentiates the hypotensive effects of nitrates and its co-administration with Glyceryl Trinitrate is contraindicated.

Glyceryl Trinitrate should be administered with caution and under continuous monitoring to patients with acute left-sided heart failure or acute myocardial infarction and only when the systolic blood pressure exceeds 90 mm Hg.

4.4 Special Warnings And Precautions For Use

Caution should be exercised in patients with severe liver or renal disease, hypothermia, hypothyroidism.

Glyceryl Trinitrate should not be given by bolus injection.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Glyceryl trinitrate may potentiate the action of other hypotensive drugs, and the hypotensive and anticholinergic effects of tricyclic antidepressants; it may also slow the metabolism of morphine-like analgesics.

The hypotensive effects of nitrates are potentiated by concurrent administration of sildenafil. A severe and possibly dangerous fall in blood pressure may occur. This can result in collapse, unconsciousness and may be fatal. Such use is therefore contraindicated (section 4.3).

4.6 Pregnancy And Lactation

This product should not be used in pregnancy or in women who are breast feeding infants unless considered essential by the physician.

4.7 Effects On Ability To Drive And Use Machines

Not applicable, because the product is used in hospitalised patients.

4.8 Undesirable Effects

Frequencies of the adverse reactions are listed according to the following convention:

Very common (

Common (

Uncommon (

Rare (

Very rare (< 1/10000),

Not known (cannot be estimated from the available data).

Nervous system disorders:	Very Common: Headache*
Cardiac disorders:	Common: Paradoxical Bradycardia Uncommon: Tachycardia*
Vascular disorders:	Very common: Hypotension* Common: Dizziness*
Gastrointestinal disorders:	Common: Nausea Not known: Retrosternal discomfort
General disorders and administration site conditions:	Not known: Diaphoresis, Flushing*, Restlessness, Abdominal pain

*particularly if the infusion is administered too rapidly.

These symptoms should be readily reversible on reducing the rate of infusion or, if necessary, discontinuing treatment.

4.9 Overdose

Signs and symptoms: Vomiting, restlessness, hypotension, syncope, cyanosis, coldness of the skin, impairment of respiration, bradycardia, psychosis and methaemoglobinaemia may occur.

Treatment: The symptoms may be readily reversed by discontinuing treatment; if hypotension persists, raising the foot of the bed and the use of vasoconstrictors such as intravenous methoxamine or phenylephrine are recommended. Methaemoglobinaemia should be treated by intravenous methylene blue. Oxygen and assisted respiration may be required.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC-Code: C01DA02 Organic nitrates

Glyceryl trinitrate exerts a spasmolytic action on smooth muscle, particularly in the vascular system. This action is more marked on the venous capacitance vessels than the arterial vessels; the predominant increase in venous capacitance results in marked diminution of both the left ventricular filling pressure and volume (preload). The moderate dilation of the arteriolar resistance vessels results in a reduction in afterload. These haemodynamic changes (reductions) in preload and afterload lower the myocardial oxygen demand. In addition, by direct action and through the reduction of myocardial wall tension glyceryl trinitrate also lowers the resistance to flow in the coronary collateral channels and allows re-distribution of blood flow to ischaemic areas of the myocardium.

Administration of glyceryl trinitrate by intravenous infusion to patients with congestive heart failure results in a marked improvement in haemodynamics, reduction of elevated left ventricular filling pressure and systolic wall tension, and an increase in the depressed cardiac output. It reduces the imbalance that exists between myocardial oxygen demand and delivery, thereby diminishing myocardial ischaemia and controlling ischaemia-induced ventricular arrhythmias.

Glyceryl trinitrate relaxes smooth muscles cells in other organs to some extent. The cellular molecular mechanism of action is a synthesis of nitric oxide and cyclic guanosyl monophosphate which acts as a mediator for muscle relaxation.

5.2 Pharmacokinetic Properties

After intravenous administration, glyceryl trinitrate is widely distributed in the body with an estimated apparent volume of distribution of approximately 200 litres. It is strongly bound to erythrocytes and vessel walls; the plasma protein binding is approx. 60%. The therapeutic plasma concentration range is 0.1 to 3 ng/ml (up to 5 ng/ml).

Glyceryl trinitrate is rapidly metabolised to dinitrate and mononitrate and further metabolised by glucuronidation in the liver, showing a marked first-pass effect.

Spontaneous hydrolysis occurs in plasma. The estimated plasma half-life of glyceryl trinitrate is 1 to 4 minutes. The rapid disappearance from plasma is consistent with the high systemic clearance values (up to 3270 litres per hour). The less active metabolites resulting from biotransformation can be recovered from the urine within 24 hours.

5.3 Preclinical Safety Data

The acute toxicity has been reported for rats after intravenous (LD₅₀ 17-41 mg/kg body weight), as well as in dogs after intravenous administration (LD₅₀ 19-24 mg/kg body weight). Autopsy did not reveal any pathological findings.

Subacute studies in rats at doses of 2.5, 5.0 and 10.0 mg/kg per day, and in dogs at doses of 1.0 and 3.0 mg/kg per day elicited only minimal reactions. In rats, suppression of body weight gain and food consumption occurred among treated and vehicle-control animals. Mild tissue irritation at injection sites was noted in treated and vehicle-control groups. There were no clearly drug-related clinical or pathological findings in dogs. Further results of studies on repeated-dose toxicity in different species revealed no indication of drug-specific clinically relevant toxicity.

Glyceryl trinitrate is insufficiently tested for a potential mutagenic action. There are no adequate state-of-the-art long-term studies on a possible tumourigenic action of glyceryl trinitrate.

There is inadequate experience with glyceryl trinitrate during human pregnancy, particularly during the first trimester. Sufficient evidence is available from animal studies with intravenous, intraperitoneal and topical administration. Studies on fertility and embryotoxicity did not result in any toxic effect on the embryo or on reproductive performance. Any indication of a teratogenic potential of glyceryl trinitrate was not found. Doses in excess of 1 mg/kg/day (i.p.) or 28 mg/kg/day (topical) reduced the birth weight in rats. There are no investigations on the passage of glyceryl trinitrate into breast milk.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Water for injections

Glucose monohydrate

Hydrochloric acid

6.2 Incompatibilities

Glyceryl Trinitrate is not compatible with polyvinylchloride (PVC) and severe losses of glyceryl trinitrate (up to 50%) may occur if polyvinylchloride is used, resulting in a reduction of delivered dose and efficacy. Contact of the solution with polyvinylchloride bags should be avoided.

The product is compatible with glass infusion sets and with rigid infusion packs made of polyethylene; it may also be infused slowly using a syringe pump with a glass or plastic syringe.

6.3 Shelf Life

Unopened ampoules: 3 years

Unopened vials: 2 years

Opened ampoules or vials:

The product should be used immediately after opening the container.

Any unused solution from opened containers should be discarded.

Prepared infusion solutions:

Chemical and physical in-use stability has been demonstrated in glucose solution 5 % and sodium chloride solution 0.9 % for 24 hours at room temperature.

From a microbiological point of view, the product should be used immediately. 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°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4 Special Precautions For Storage

Keep the container in the outer carton.

Do not store above 25°C.

6.5 Nature And Contents Of Container

5 ml, 10 ml or 25 ml ampoules, made of colourless glass, type I.

50 ml vial, made of colourless glass, type I, rubber stopper.

Box of 10 ampoules with 5 ml

Box of 10 ampoules with 10 ml

Box of 10 ampoules with 25 ml

Box of 1 vial with 50 ml

Box of 10 vials with 50 ml

Box of 25 vials with 50 ml

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Glyceryl Trinitrate need not be diluted before use but can be diluted by 1:10 up to 1:40 with 5 % glucose solution, 5 % glucose solution and 0.9 % sodium chloride solution, or with 0.9 % sodium chloride solution.

The solution, whether or not diluted, should be infused slowly and not given by bolus injection. To ensure a constant infusion rate of glyceryl trinitrate it is recommended that Glyceryl Trinitrate be administered by means of a syringe pump or polyethylene infusion bag with a counter, or with a glass or rigid polyethylene syringe and polyethylene tubing. Systems made of polyvinyl chloride (PVC) may absorb up to 50% of the glyceryl trinitrate from the solution.

Vials of 50 ml Glyceryl Trinitrate are for single use only and should not be regarded as multi-dose containers.

7. Marketing Authorisation Holder

hameln pharma plus gmbh

Langes Feld 13

31789 Hameln

Germany

8. Marketing Authorisation Number(S)

PL 25215/0011

9. Date Of First Authorisation/Renewal Of The Authorisation

04/09/2008

10. Date Of Revision Of The Text

04/06/2009

Prescription-only medicine

Ziprasidone

Class: Atypical Antipsychotics
VA Class: CN709
Chemical Name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one monohydrochloride monohydrate
Molecular Formula: C₂₁H₂₁ClN₄OS•HCl•H₂OC₂₁H₂₁ClN₄OS•CH₄O₃S•3H₂O
CAS Number: 138982-67-9
Brands: Geodon

Special Alerts:

[Posted 02/22/2011] ISSUE: FDA notified healthcare professionals that the Pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated. The new drug labels now contain more and consistent information about the potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy.

The symptoms of EPS and withdrawal in newborns may include agitation, abnormally increased or decreased muscle tone, tremor, sleepiness, severe difficulty breathing, and difficulty in feeding. In some newborns, the symptoms subside within hours or days and do not require specific treatment; other newborns may require longer hospital stays.

BACKGROUND: Antipsychotic drugs are used to treat symptoms of psychiatric disorders such as schizophrenia and bipolar disorder.

RECOMMENDATION: Healthcare professionals should be aware of the effects of antipsychotic medications on newborns when the medications are used during pregnancy. Patients should not stop taking these medications if they become pregnant without talking to their healthcare professional, as abruptly stopping antipsychotic medications can cause significant complications for treatment. For more information visit the FDA website at: and .

• Increased Mortality in Geriatric Patients


• 
  

  Substantially higher mortality rate (4.5%) in geriatric patients with dementia-related psychosis† receiving atypical antipsychotic agents (e.g., aripiprazole, olanzapine, quetiapine, risperidone) compared with those receiving placebo (2.6%).^{1 68}

  
  


• 
  

  Most fatalities resulted from cardiac-related events (e.g., heart failure, sudden death) or infections (mostly pneumonia).^{1 68}

  
  


• 
  

  Atypical antipsychotics are not approved for the treatment of dementia-related psychosis.^{1 68} (See Increased Mortality in Geriatric Patients with Dementia-related Psychosis under Cautions.)

  
  

Introduction

Atypical or second-generation antipsychotic agent.^{1 4 10 11 29}

Uses for Ziprasidone

Schizophrenia

Symptomatic management of schizophrenia.¹

Should be reserved for patients whose disease fails to respond adequately to appropriate courses of other antipsychotic agents because of a greater capacity to prolong the QT/QT_c-interval compared with that of several other antipsychotic agents.¹ (See Prolongation of QT Interval under Cautions)

IM injection used for rapid control of behaviors that interfere with diagnosis and care (e.g., threatening behaviors, escalating or urgently distressing behavior, self-exhausting behavior).¹

Bipolar Disorder

Treatment of acute manic and mixed epsiodes (with or without psychotic features) associated with bipolar 1 disorder.^{1 73 74}

Ziprasidone Dosage and Administration

Administration

Administer orally or by IM injection.¹

Concomitant use of oral and IM ziprasidone not recommended by manufacturer.¹

Oral Administration

Administer orally twice daily with food.¹

IM Administration

Vials are for single use only.¹

Reconstitution

Reconstitute vial containing 20 mg with 1.2 mL of sterile water for injection to provide a solution containing 20 mg/mL.¹ Do not use other solutions to reconstitute the injection, and do not admix with other drugs.¹ Shake vigorously to ensure complete dissolution.¹

Observe strict aseptic technique since the drug contains no preservative.¹ Discard unused portions.¹

Dosage

Available as ziprasidone hydrochloride or ziprasidone mesylate; oral dosage expressed in terms of hydrochloride monohydrate and IM dosage expressed in terms of ziprasidone.^{1 12}

Adults

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Schizophrenia

Oral

Initially, 20 mg twice daily.¹

Dosage may be increased after a minimum of 2 days.^{1 12} Observe patients for several weeks prior to upward titrations of dosage to ensure use of the lowest effective dosage.¹

In patients responding to ziprasidone therapy, continue the drug as long as clinically necessary and tolerated, but at lowest possible effective dosage;¹² periodically reassess need for continued therapy.¹ Efficacy maintained for up to 52 weeks in clinical trials, but optimum duration of therapy currently is not known.¹

Acute Agitation in Schizophrenia

IM

Initially, 10–20 mg given as a single dose.¹

Repeat doses of 10 mg every 2 hours or 20 mg every 4 hours, up to a maximum cumulative dosage of 40 mg daily.¹

Oral therapy should replace IM therapy as soon as possible; safety and efficacy of administering ziprasidone IM injection for longer than 3 consecutive days not evaluated.¹

Bipolar Disorder

Oral

Initially, 40 mg twice daily on day 1.¹ Increase dosage to 60 or 80 mg twice daily on the second day.¹

Subsequent dosage adjustments based on efficacy and tolerability may be made within a dosage range of 40–80 mg twice daily.¹

Efficacy for long-term use (i.e., >3 weeks) or for prophylactic use in patients with bipolar disorder not systematically evaluated.¹ If used for extended periods, periodically reevaluate the long-term risks and benefits for the individual patient.¹

Prescribing Limits

Adults

Schizophrenia

Oral

Maximum 80 mg twice daily.^{1 12}

Acute Agitation

IM

Maximum cumulative dosage of 40 mg daily.

Bipolar Disorder

Oral

Maximum 80 mg twice daily.¹

Cautions for Ziprasidone

Contraindications

• 
  

  Known history of QT interval prolongation (including congenital long QT syndrome), recent AMI, or uncompensated heart failure.¹ (See Prolongation of QT Interval under Cautions.)

  
  


• 
  

  Concomitant therapy with other drugs that prolong the QT interval (e.g., class Ia and III antiarrhythmics, arsenic trioxide, chlorpromazine, dofetilide, dolasetron mesylate, droperidol, gatifloxacin, halofantrine, levomethadyl acetate, mefloquine, mesoridazine, moxifloxacin, pentamidine, pimozide, probucol, quinidine, sotalol, sparfloxacin, tacrolimus, thioridazine).¹ Ziprasidone also is contraindicated in patients receiving drugs shown to cause QT prolongation as an effect and for which this effect is described in the full prescribing information as a contraindication or a boxed or bolded warning.¹

  
  


• 
  

  Known hypersensitivity to ziprasidone.¹

  
  

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Increased Mortality in Geriatric Patients with Dementia-related Psychosis

Possible increased risk of death with use of atypical antipsychotics in geriatric patients with dementia-related psychosis.^{1 68} (See Boxed Warning and see Geriatric Use under Cautions.)

Atypical antipsychotics are not approved for the treatment of dementia-related psychosis.^{1 68}

Prolongation of QT Interval

Greater capacity to prolong the QT/QT_c interval compared with that of several other antipsychotic agents.¹

Experience is too limited to rule out the possibility that ziprasidone may be associated with a greater risk of ventricular arrhythmias (e.g., torsades de pointes) and/or sudden death than other antipsychotic agents.¹

Patients at particular risk of torsades de pointes include those with bradycardia, hypokalemia, or hypomagnesemia, those receiving concomitant therapy with other drugs that prolong the QT_c interval, and those with congenital prolongation of QT_c interval.¹ (See Contraindications under Cautions.) Avoid ziprasidone therapy in patients with history of cardiac arrhythmias.¹

Determine baseline serum potassium and magnesium concentrations in patients at risk for substantial electrolyte disturbances, particularly those receiving concomitant diuretic therapy.¹ Correct hypokalemia or hypomagnesemia prior to initiating ziprasidone.¹

Clinical and ECG monitoring of cardiac function, including appropriate ambulatory ECG monitoring (e.g., Holter monitoring), is recommended during ziprasidone therapy in patients with symptoms that could indicate torsades de pointes (e.g., dizziness, palpitations, syncope).¹

Discontinue ziprasidone if the QT_c interval exceeds 500 msec.¹

Neuroleptic Malignant Syndrome

Neuroleptic malignant syndrome (NMS), a potentially fatal syndrome requiring immediate discontinuance of the drug and intensive symptomatic treatment, may occur in patients receiving antipsychotic agents.^{1 12}

Tardive Dyskinesia

Tardive dyskinesia, a syndrome of potentially irreversible, involuntary, dyskinetic movements, has been reported.¹ Consider discontinuance of ziprasidone.¹

Hyperglycemia and Diabetes Mellitus

Severe hyperglycemia, sometimes associated with ketoacidosis, hyperosmolar coma, or death, reported in patients receiving atypical antipsychotic agents.^{1 13 14 15 16 17 18 19 20 21 22 23 24 25 26 40 41 42 43 47} Closely monitor patients with preexisting diabetes mellitus for worsening of glucose control, and perform fasting glucose tests at baseline and periodically for patients with risk factors for diabetes (e.g., obesity, family history of diabetes).^{1 13 14 16 17 18 19 20 21 22 23 24 25} If manifestations of hyperglycemia occur, test for diabetes mellitus.^{1 13 14 16 17 18 19 20 21 22 23 24 25}

Sensitivity Reactions

Rash

Rash and/or urticaria, possibly related to dose and/or duration of therapy, reported.¹ Adjunctive treatment with antihistamines or steroids and/or drug discontinuance may be required.¹ Discontinue ziprasidone if alternative etiology of rash cannot be identified.¹

General Precautions

Cardiovascular Effects

Orthostatic hypotension reported, particularly during initial dosage titration period.¹ Use with caution in patients with known cardiovascular or cerebrovascular disease and/or conditions that would predispose patients to hypotension (e.g., dehydration, hypovolemia, concomitant antihypertensive therapy).¹

Nervous System Effects

Possible risk of seizures;¹ use with caution in patients with a history of seizures or with conditions known to lower the seizure threshold (e.g., dementia of the Alzheimer’s type, geriatric patients).¹

Disruption of ability to reduce core body temperature possible; use caution in patients exposed to conditions that may contribute to an elevation in core body temperature (e.g., dehydration, extreme heat, strenuous exercise, concomitant use of anticholinergic agents).¹

Somnolence reported.¹ Potential impairment of judgment, thinking, or motor skills.¹

GI Effects

Esophageal dysmotility and aspiration possible; use with caution in patients at risk for aspiration pneumonia (e.g., geriatric patients, those with advanced Alzheimer’s dementia).¹ (See Boxed Warning and see Increased Mortality in Geriatric Patients with Dementia-related Psychosis under Cautions.)

Suicide

Attendant risk with psychotic illnesses; closely supervise high-risk patients.¹ Prescribe in the smallest quantity consistent with good patient management to reduce the risk of overdosage.¹

Sexual Dysfunction

Priapism possible.¹

Endocrine Effects

Elevated prolactin concentrations possible.⁷

Metabolic Effects

Weight gain possible.^{1 7} May cause less weight gain than clozapine, olanzapine, quetiapine, or risperidone.^{4 10 11 12}

Specific Populations

Pregnancy

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Category C.¹

Lactation

Not known whether ziprasidone is distributed into milk.¹ Women receiving ziprasidone should not breast-feed.¹

Pediatric Use

Safety and efficacy not established in children <18 years of age.¹

Geriatric Use

No substantial differences in safety of oral ziprasidone relative to younger adults.¹

Lower initial dosages, slower titration, and careful monitoring during the initial dosing period may be advisable in some geriatric patients.¹

IM ziprasidone mesylate not systematically evaluated in geriatric patients.¹

Possible increased risk of death in geriatric patients with dementia-related psychosis.^{1 68} Substantial (1.6- to 1.7-fold) increase in mortality rate reported in geriatric patients with dementia who received atypical antipsychotic agents (e.g., aripiprazole, olanzapine, quetiapine, risperidone) for treatment of behavioral disorders; most fatalities resulted from cardiac-related events (e.g., heart failure, sudden death) or infections (mostly pneumonia).^{1 68}

Atypical antipsychotics are not approved for the treatment of dementia-related psychosis.^{1 68} (See Boxed Warning and see Increased Mortality in Geriatric Patients with Dementia-related Psychosis under Cautions.)

Renal Impairment

Commercially available ziprasidone mesylate injections contain sulfobutylether β-cyclodextrin sodium, an excipient that is cleared by renal filtration; use with caution.¹

Common Adverse Effects

Oral therapy for schizophrenia: somnolence, respiratory tract infection.¹

Oral therapy for bipolar mania: somnolence, extrapyramidal symptoms, dizziness, akathisia, abnormal vision, asthenia, vomiting.^{1 73 74}

IM therapy for acute agitation in schizophrenia: somnolence, headache, nausea.¹

Interactions for Ziprasidone

Ziprasidone is metabolized by the CYP3A4 isoenzyme; CYP1A2 also may contribute but to a much lesser extent.¹ Little inhibitory effect on CYP isoenzymes 1A2, 2C9, 2C19, 2D6, or 3A4; pharmacokinetic interaction unlikely with drugs metabolized by these isoenzymes.¹

Drugs Affecting Hepatic Microsomal Enzymes

Potential pharmacokinetic interactions (altered metabolism) with inhibitors or inducers of CYP3A4.¹

Pharmacokinetic interaction with inhibitors or inducers of CYP1A2, CYP2C9, CYP2C19, or CYP2D6 are unlikely.¹

Drugs That Prolong QT Interval

Potential pharmacologic interaction (additive effect on QT interval prolongation; concomitant use contraindicated) when used with drugs that prolong the QT_c interval.¹ Ziprasidone also is contraindicated in patients receiving drugs shown to cause QT prolongation as an effect and for which this effect is described in the full prescribing information as a contraindication or a boxed or bolded warning.¹ (See Contraindications and Prolongation of QT Interval under Cautions.)

Specific Drugs

Drug	Interaction	Comments
Antacids	No effects on ziprasidone pharmacokinetics1
Antiarrhythmics (class Ia and III)	Increased risk of QT interval prolongation1	Concomitant use contraindicated1
Arsenic trioxide	Increased risk of QT interval prolongation1	Concomitant use contraindicated1
Benztropine	Pharmacokinetic interaction unlikely1
Carbamazepine	Increased ziprasidone metabolism1
Chlorpromazine	Increased risk of QT interval prolongation1	Concomitant use contraindicated1
Cimetidine	No change observed in ziprasidone pharmacokinetics1
CNS agents	Additive sedative effects12
Dextromethorphan	No change observed in dextromethorphan metabolism1
Dofetilide	Increased risk of QT interval prolongation1	Concomitant use contraindicated1
Dolasetron mesylate	Increased risk of QT interval prolongation1	Concomitant use contraindicated1
Dopamine agonists	Antagonistic effects1
Droperidol	Increased risk of QT interval prolongation1	Concomitant use contraindicated1
Gatifloxacin	Increased risk of QT interval prolongation1	Concomitant use contraindicated1
Halofantrine	Increased risk of QT interval prolongation1	Concomitant use contraindicated1
Hypotensive agents	Additive hypotensive effects1	Use with caution1
Ketoconazole	Increased plasma ziprasidone concentrations1
Levodopa	Antagonistic effects1
Levomethadyl acetate	Increased risk of QT interval prolongation1	Concomitant use contraindicated1
Lithium	No change observed in lithium clearance1
Lorazepam	Pharmacokinetic interaction unlikely1
Mefloquine	Increased risk of QT interval prolongation1	Concomitant use contraindicated1
Mesoridazine	Increased risk of QT interval prolongation1	Concomitant use contraindicated1
Moxifloxacin	Increased risk of QT interval prolongation1	Concomitant use contraindicated1
Oral contraceptives	No change observed in estradiol or levonorgestrel pharmacokinetics1
Pentamidine	Increased risk of QT interval prolongation1	Concomitant use contraindicated1
Pimozide	Increased risk of QT interval prolongation1	Concomitant use contraindicated1
Probucol	Increased risk of QT interval prolongation1	Concomitant use contraindicated1
Protein-bound drugs (e.g., propranolol, warfarin)	Pharmacokinetic interaction unlikely1
Quinidine	Increased risk of QT interval prolongation1	Concomitant use contraindicated1
Sotalol	Increased risk of QT interval prolongation1	Concomitant use contraindicated1
Sparfloxacin	Increased risk of QT interval prolongation1	Concomitant use contraindicated1
Tacrolimus	Increased risk of QT interval prolongation1	Concomitant use contraindicated1
Thioridazine	Increased risk of QT interval prolongation1	Concomitant use contraindicated1

Ziprasidone Pharmacokinetics

Absorption

Bioavailability

Absolute bioavailability is approximately 60% following a 20 mg oral dose under fed conditions.¹

Peak plasma concentrations occur 6–8 hours after oral administration or about 1 hour after IM injection.¹

Food

Food increases the absorption up to twofold.¹

Distribution

Extent

Not known whether the drug is distributed into milk in humans.¹

Plasma Protein Binding

>99% bound to plasma proteins, principally to albumin and α₁-acid glycoprotein.¹

Elimination

Metabolism

Extensively metabolized in the liver principally via reduction by aldehyde oxidase; about one-third of metabolic clearance is mediated by CYP isoenzymes, principally CYP3A4.¹

Elimination Route

Approximately 20% of a dose is excreted in the urine and about 66% in feces, principally as metabolites.¹ Not removed by hemodialysis.¹

Half-life

Mean terminal half-life following oral administration is about 7 hours;¹ following IM administration, the half-life is 2–5 hours.¹

Special Populations

In patients with clinically important (Child-Pugh class A or B) cirrhosis, half-life increased by 2.3 hours compared with that of patients in the control group.¹

Stability

Storage

Oral

Capsules

15–30°C.¹

Parenteral

Powder for Injection

15–30°C.¹

Following reconstitution, store at 15–30°C protected from light for up to 24 hours or at 2–8°C for up to 7 days.¹

ActionsActions

• 
  

  Exact mechanism of antipsychotic action has not been fully elucidated; may involve antagonism of central type 2 serotonergic (5-HT₂) receptors and central dopamine D₂ receptors.^{1 8 9}

  
  


• 
  

  Precise mechanism of antimanic action has not been fully elucidated.¹

  
  


• 
  

  Antagonism of other receptors (e.g., histamine H₁ receptors, α₁-adrenergic receptors) may contribute to other therapeutic and adverse effects (e.g., orthostatic hypotension, somnolence).¹

  
  

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

• 
  

  Importance of taking medication exactly as prescribed by the clinician.¹

  
  


• 
  

  Importance of avoiding driving, operating machinery, or performing hazardous tasks until gain experience with the drug’s effects.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription or OTC drugs, dietary supplements, and herbal products, as well as any concomitant illnesses (e.g., diabetes mellitus, seizures, dementia).¹

  
  


• 
  

  Importance of avoiding alcohol during ziprasidone therapy.¹

  
  


• 
  

  Importance of avoiding overheating or dehydration.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Ziprasidone Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	20 mg	Geodon	Pfizer
		40 mg	Geodon	Pfizer
		60 mg	Geodon	Pfizer
		80 mg	Geodon	Pfizer

Ziprasidone Mesylate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IM use only	20 mg (of ziprasidone) per mL	Geodon (with sulfobutylether β-cyclodextrin sodium 294 mg/mL)	Pfizer

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 04/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Geodon 20MG Capsules (PFIZER U.S.): 60/$478.01 or 180/$1402.96

Geodon 40MG Capsules (PFIZER U.S.): 60/$482.99 or 180/$1407.94

Geodon 60MG Capsules (PFIZER U.S.): 60/$574.97 or 180/$1687.92

Geodon 80MG Capsules (PFIZER U.S.): 60/$574.97 or 180/$1687.92

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 15, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

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

References

1. Pfizer Inc. Geodon (ziprasidone) capsules and for injection prescribing information. New York, NY; 2005 May.

2. Daniel DG, Zimbroff DL, Potkin SG et al. Ziprasidone 80 mg/day and 160 mg/day in the acute exacerbation of schizophrenia and schizoaffective disorder: a 6-week placebo-controlled trial. Ziprasidone Study Group. Neuropsychopharmacology. 1999; 20:491-505.

3. Keck P, Buffenstein A, Ferguson J et al. Ziprasidone 40 and 120 mg/day in the acute exacerbation of schizophrenia and schizoaffective disorder: a 4-week placebo-controlled trial. Psychopharmacology1998; 140:173-84.

4. Taylor D. Ziprasidone: an atypical antipsychotic. Pharmaceutical J. 2001; 266:396-401.

5. Bagnall AM, Lewis RA, Leitner ML. Ziprasidone for schizophrenia and severe mental illness. Cochrane Database Syst Rev. 2000; 4:CD001945. [PubMed 11034737]

6. Goff DC, Posever T, Herz L et al. An exploratory haloperidol-controlled dose-finding study of ziprasidone in hospitalized patients with schizophrenia or schizoaffective disorder. J Clin Psychopharmacol. 1998 Aug; 18:296-304.

7. Pfizer, New York, NY: Personal communication.

8. Lilly. Zyprexa (olanzapine tablets and orally disintegrating tablets) prescribing information. Indianapolis, IN; 2001 Feb.

9. Janssen Pharmaceutica. Risperdal (risperidone tablets and oral solution) prescribing information. Titusville, NJ; 1999 May.

10. Anon. Ziprasidone (Geodon) for schizophrenia. Med Lett Drugs Ther. 2001; 43:51-2. [PubMed 11402259]

11. Carnhan RM, Lund BC, Perry PJ. Ziprasidone, a new atypical antipsychotic drug. Pharmacotherapy. 2001; 21:717-30. [IDIS 465839] [PubMed 11401184]

12. Pfizer, New York, NY: Personal communication.

13. Eli Lilly and company. Zyprexa (olanzapine) tablets and Zyprexa Zydis (olanzapine) orally disintegrating tablets prescribing information. Indianapolis, IN; 2003 Sep 16.

14. Eli Lilly and Company. Lilly announces FDA notification of class labeling for atypical antipsychotics regarding hyperglycemia and diabetes. Indianapolis, IN; 2003 Sep 17. Press release.

15. Cunningham F, Lambert B, Miller DR et al. Antipsychotic induced diabetes in veteran schizophrenic patients. In: Abstracts of the 1st International Conference on Therapeutic Risk Management and 19th International Conference on Parmacoepidemiology, Philadelphia, PA, Aug 21-24. Pharmacoepidemiol Drug Saf. 2003; 12(suppl 1): S154-5.

16. Otsuka America Pharmaceutical, Inc. Abilify (aripiprazole) tablets prescribing information. Rockville, MD; 2004 Sep.

17. Novartis Pharmaceuticals. Clozaril (clozapine) prescribing information. East Hanover, NJ; 2003 Dec.

18. AstraZeneca Pharmaceuticals. Seroquel (quetiapine fumarate) tablets prescribing information. Wilmington, DE; 2004 Jul.

19. Janssen Pharmaceutica. Risperdal (risperidone) tablets and oral solution prescribing information. Titusville, NJ; 2003 Oct.

20. Lewis-Hall F. Dear health care professional letter regarding class labeling for atypical antipsychotics and risk of hyperglycemia and diabetes. Princeton, NJ: Bristol-Myers Squibb Company; 2004 Mar 25. From FDA website.

21. Bess AL, Cunningham SR. Dear health care professional letter regarding class labeling for atypical antipsychotics and risk of hyperglycemia and diabetes. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2004 Apr 1. From the FDA website.

22. Eisenberg P. Dear health care professional letter regarding safety data on Zyprexa (olanzapine) – hyperglycemia and diabetes. Indianapolis, IN: Eli Lilly and Company; 2004 Mar 1. From the FDA website.

23. Macfadden W. Dear health care professional letter regarding class labeling for atypical antipsychotics and risk of hyperglycemia and diabetes. Wilmington, DE: AstraZeneca Pharmaceuticals; 2004 Apr 22. From the FDA website.

24. Mahmoud RA. Dear health care professional letter regarding class labeling for atypical antipsychotics and risk of hyperglycemia and diabetes. Titusville, NJ: Janssen Pharmaceutica, Inc; 2004. From the FDA website.

25. Clary CM. Dear health care practitioner letter regarding class labeling for atypical antipsychotics and risk of hyperglycemia and diabetes. New York NY: Pfizer Global Pharmaceuticals; 2004 Aug. From the FDA website.

26. American Diabetes Association; American Psychiatric Association; American Association of Clinical Endocrinologists; North American Association for the Study of Obesity.. Consensus development conference on antipsychotic drugs and obesity and diabetes. Diabetes Care. 2004; 27:596-601. [PubMed 14747245]

27. Melkersson K, Dahl ML. Adverse metabolic effects associated with atypical antipsychotics. Drugs. 2004; 64:701-23. [PubMed 15025545]

28. Citrome LL, Jaffe AB. Relationship of atypical antipsychotics with development of diabetes mellitus. Ann Pharmacother. 2003; 37:1849-57. [IDIS 510453] [PubMed 14632602]

29. American Psychiatric Association. Practice guideline for the treatment of patients with schizophrenia. Am J Psychiatr. 2004; 161(Suppl):1-56.

30. Sumiyoshi T, Roy A, Anil AE et al. A comparison of incidence of diabetes mellitus between atypical antipsychotic drugs. J Clin Psychopharmacol. 2004; 24:345-8. [IDIS 515736] [PubMed 15118492]

31. Expert Group. ’Schizophrenia and Diabetes 2003’ expert consensus meeting, Dublin, 3–4 October 2003: consensus summary. Br J Psychiatry. 2004; 47(Suppl):S112-4.

32. Marder SR, Essock SM, Miller AL et al. Physical health monitoring of patients with schizophrenia. Am J Psychiatry. 2004; 161:1334-49. [IDIS 520856] [PubMed 15285957]

33. Holt RI. Consensus development conference on antipsychotic drugs and obesity and diabetes: response to consensus statement. Diabetes Care. 2004; 27:2086-7. [IDIS 524618] [PubMed 15277449]

34. Citrome L, Volavka J. Consensus development conference on antipsychotic drugs and obesity and diabetes: response to consensus statement. Diabetes Care. 2004; 27:2087-8. [IDIS 524619] [PubMed 15277450]

35. Isaac MT, Isaac MB. Consensus development conference on antipsychotic drugs and obesity and diabetes: response to consensus statement. Diabetes Care. 2004; 27:2088. [IDIS 524620] [PubMed 15277451]

36. Boehm G, Racoosin JA, Laughren TP et al. Consensus development conference on antipsychotic drugs and obesity and diabetes: response to consensus statement. Diabetes Care. 2004; 27:2088-9. [IDIS 524621] [PubMed 15277452]

37. Barrett EJ. Consensus development conference on antipsychotic drugs and obesity and diabetes: response to Holt, Citrome and Volevka, Isaac and Isaac, and Boehm et al. Diabetes Care. 2004; 27:2089-90.

38. Fuller MA, Shermock KM, Secic M et al. Comparative study of the development of diabetes mellitus in patients taking risperidone and olanzapine. Pharmacotherapy. 2002; 23:1037-43.

39. Koller EA, Cross JT, Doraiswamy PM et al. Risperidone-associated diabetes mellitus: a pharmacovigilance study. Pharmacotherapy. 2003; 23:735-44. [IDIS 498493] [PubMed 12820816]

40. Koller EA, Weber J, Doraiswamy PM et al. A survey of reports of quetiapine-associated hyperglycemia and diabetes mellitus. J Clin Psychiatry. 2004; 65:857-63. [IDIS 518849] [PubMed 15291665]

41. Ananth J, Johnson KM, Levander EM et al. Diabetic ketoacidosis, neuroleptic malignant syndrome, and myocardial infarction in a patient taking risperidone and lithium carbonate. J Clin Psychiatry. 2004; 65:724. [IDIS 516345] [PubMed 15163265]

42. Torrey EF, Swalwell CI. Fatal olanzapine-induced ketoacidosis. Am J Psychiatry. 2003; 160:2241. [IDIS 516756] [PubMed 14638601]

43. Wehring HJ, Kelly DL, Love RC et al. Deaths from diabetic ketoacidosis after long-term clozapine treatment. Am J Psychiatry. 2003; 160:2241-2. [IDIS 516757] [PubMed 14638600]

44. Koro CE, Fedder DO, L’Italien GJ et al. Assessment of independent effect of olanzapine and risperidone on risk of diabetes among patients with schizophrenia: population based nested case-control study. BMJ. 2002; 325:243. [IDIS 485916] [PubMed 12153919]

45. Citrome LL. Efficacy should drive atypical antipsychotic treatment. BMJ. 2003; 326:283. [IDIS 492968] [PubMed 12561827]

46. Anon. Which atypical antipsychotic for schizophrenia?. Drug Ther Bull. 2004; 42:57-60. [PubMed 15310154]

47. Anon. Atypical antipsychotics and hyperglycaemia. Aust Adv Drug React Bull. 2004; 23:11-2.

48. Sussman N. The implications of weight changes with antipsychotic treatment. J Clin Psychopharmacol. 2003; 23 (Suppl 1):S21-6.

49. Gianfrancesco F, Grogg A, Mahmoud R et al. Differential effects of antipsychotic agents on the risk of development of type 2 diabetes mellitus in patients with mood disorders. Clin Ther. 2003; 25:1150-71. [IDIS 497269] [PubMed 12809963]

50. Bushe C, Leonard B. Association between atypical antipsychotic agents and type 2 diabetes: review of prospective clinical data. Br J Psychiatry Suppl. 2004; 47:S87-93. [PubMed 15056600]

51. Cavazzoni P, Mukhopadhyay N, Carlson C et al. Retrospective analysis of risk factors in patients with treatment-emergent diabetes during clinical trials of antipsychotic medications. Br J Psychiatry Suppl. 2004; 47:s94-101. [PubMed 15056601]

52. Gianfrancesco FD, Grogg AL, Mahmoud RA et al. Differential effects of risperidone, olanzapine, clozapine, and conventional antipsychotics on type 2 diabetes: findings from a large health plan database. J Clin Psychiatry. 2002; 63:920-30. [IDIS 488480] [PubMed 12416602]

53. Etminan M, Streiner DL, Rochon PA. Exploring the association between atypical neuroleptic agents and diabetes mellitus in older adults. Pharmacotherapy. 2003; 23:1411-15. [IDIS 510498] [PubMed 14620387]

54. Leslie DL, Rosenheck RA. Incidence of newly diagnosed diabetes attributable to atypical antipsychotic medications. Am J Psychiatry. 2004; 161:1709-11. [IDIS 522186] [PubMed 15337666]

55. Sernyak MJ, Leslie DL, Alarcon RD et al. Association of diabetes mellitus with use of atypical neuroleptics in the treatment of schizophrenia. Am J Psychiatry. 2002; 159:561-6. [IDIS 494206] [PubMed 11925293]

56. Geller WK, MacFadden W. Diabetes and atypical neuroleptics. Am J Psychiatry. 2003; 160:388. [IDIS 513919] [PubMed 12562601]

57. Gianfrancesco FD. Diabetes and atypical neuroleptics. Am J Psychiatry. 2003; 160:388-9; author reply 389. [IDIS 513920] [PubMed 12562599]

58. Lamberti JS, Crilly JF, Maharaj K. Prevalence of diabetes mellitus among outpatients with severe mental disorders receiving atypical antipsychotic drugs. J Clin Psychiatry. 2004; 65:702-6. [IDIS 516341] [PubMed 15163259]

59. Lee DW, Fowler RB. Olanzapine/risperidone and diabetes risk. J Clin Psychiatry. 2003; 64:847-8; author reply 848. [IDIS 500324] [PubMed 12934988]

60. Reviewer Comments (personal observations).

61. Bristol-Myers Squibb., Princeton, NJ: Personal communication.

62. AstraZeneca. Wayne, PA: Personal communication.

63. Eli Lilly and Company. Indianapolis, IN: Personal communication.

64. Novartis Pharmaceuticals Corporation. East Hanover, NJ: Personal communication.

65. Janssen Pharmaceuticals. Titusville, NJ: Personal communicat

Epinephrine Auto-Injector

Pronunciation: EP-i-NEF-rin
Generic Name: Epinephrine
Brand Name: Adrenaclick or Twinject

Epinephrine Auto-Injector is used for:

Treating severe allergic reactions (eg, difficulty breathing; rash; hives; itching; tightness in the chest; swelling of the mouth, lips, or tongue) caused by insect stings or bites, foods, drugs, or other causes. It may also be used for other conditions as determined by your doctor.

Epinephrine Auto-Injector is a sympathomimetic. It works on different receptors in the body to relax the smooth muscle of the lungs, which improves breathing.

Do NOT use Epinephrine Auto-Injector if:

• you are allergic to any ingredient in Epinephrine Auto-Injector, unless your doctor tells you otherwise

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

Before using Epinephrine Auto-Injector:

Some medical conditions may interact with Epinephrine Auto-Injector. 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 (eg, sulfites)


• if you have glaucoma, heart disease, chest pain, high blood pressure, blood vessel problems, diabetes, Parkinson disease, thyroid problems, mood or mental disorders, depression, asthma, or an irregular heartbeat

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

• Alpha-blockers (eg, prazosin), beta-blockers (eg, propanolol), droxidopa, ergot alkaloids (eg, ergotamine), or phenothiazines (eg, chlorpromazine) because the risk of high or low blood pressure and fast or slow heartbeat may be increased


• Bromocriptine, furazolidone, linezolid, or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects, such as headache, high temperature, and high blood pressure, may be increased


• Antihistamines (eg, diphenhydramine), catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), digoxin, diuretics (eg, furosemide, hydrochlorothiazide), levothyroxine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), or medicines for irregular heartbeat (eg, quinidine) because they may increase the risk of Epinephrine Auto-Injector's side effects


• Guanethidine because its effectiveness may be decreased by Epinephrine Auto-Injector

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

Use Epinephrine Auto-Injector as directed by your doctor. Check the label on the medicine for exact dosing instructions.

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


• Epinephrine Auto-Injector may be given as an injection at your doctor's office, hospital, or clinic. If you will be using Epinephrine Auto-Injector at home, a health care provider will teach you how to use it. Be sure you understand how to use Epinephrine Auto-Injector. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Check Epinephrine Auto-Injector regularly. Replace the injector unit if it contains particles, is discolored (pink or brown), or is cracked or damaged in any way.


• Inject Epinephrine Auto-Injector only into the outer thigh. Do not inject into the buttocks or into a vein.


• Immediately after use, go to the nearest hospital emergency room. You may need further medical attention. Tell the doctor or health care provider that you have received an injection of epinephrine. Show the thigh where the injection was given to the doctor. Give your used auto-injector to the doctor for inspection and proper disposal.


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


• Epinephrine Auto-Injector is usually given as a one-time dose in an emergency situation. If you are unable to use Epinephrine Auto-Injector, seek medical attention immediately.


• If you miss a dose of Epinephrine Auto-Injector, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Epinephrine Auto-Injector.

Important safety information:

• Never put your thumb, fingers, or hand over the tip of the auto-injector. Do NOT remove the cap until ready to use.


• Only inject Epinephrine Auto-Injector into the outer thigh. Never inject Epinephrine Auto-Injector into hands, fingers, feet, or toes. Doing so may cause a loss of blood flow and result in tissue damage to these areas. If you accidentally inject Epinephrine Auto-Injector into any of these areas, seek immediate emergency medical attention.


• It may be helpful to train others how to give Epinephrine Auto-Injector in case you are unable to give it to yourself during a reaction.


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


• Patients with Parkinson disease may notice a temporary worsening of symptoms (eg, uncontrolled muscle movements). If these symptoms persist, contact your doctor.


• Use Epinephrine Auto-Injector with caution in the ELDERLY; they may be more sensitive to its effects.


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

Possible side effects of Epinephrine Auto-Injector:

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:

Anxiety; difficulty sleeping; dizziness; fearfulness; headache; nausea; nervousness; paleness; sweating; tremors; vomiting; 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); chest pain; fast or irregular heartbeat; wheezing.

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. Symptoms may include chest pain; extreme paleness or coldness of the skin; fast or irregular heartbeat; one-sided weakness; severe headache or dizziness; trouble breathing.

Proper storage of Epinephrine Auto-Injector:

Store Epinephrine Auto-Injector at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in the carrying case provided. Do not refrigerate or freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Epinephrine Auto-Injector out of the reach of children and away from pets.

General information:

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


• Epinephrine Auto-Injector 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 Epinephrine Auto-Injector. 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 Epinephrine resources

• Epinephrine Use in Pregnancy & Breastfeeding
• Epinephrine Drug Interactions
• Epinephrine Support Group
• 11 Reviews for Epinephrine - Add your own review/rating

Compare Epinephrine with other medications

• Adams-Stokes Syndrome
• Allergic Reactions
• Asthma, acute
• Asystole
• AV Heart Block
• COPD, Acute
• Electromechanical Dissociation
• Shock

suramin Injection

SUR-a-min

Uses For suramin

Suramin is used in the treatment of African sleeping sickness (African trypanosomiasis) and river blindness (onchocerciasis), infections caused by parasites. suramin works by causing the parasites to lose energy, which causes their death.

Suramin may cause serious side effects. Before you begin treatment with suramin, you and your doctor should talk about the good suramin will do as well as the risks of receiving it.

Suramin is administered in the hospital only by or under the immediate supervision of your doctor.

Before Using suramin

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 suramin, the following should be considered:

Allergies

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

Suramin can cause serious side effects in any patient. Therefore, it is especially important that you discuss with the child's doctor the good that suramin may do as well as the risks of receiving it.

Geriatric

Elderly people are especially sensitive to the effects of suramin. This may increase the chance of side effects during treatment.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 suramin. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease or


• Liver disease—Patients with kidney or liver disease may have an increased chance of side effects

Proper Use of suramin

To help clear up your infection completely, you must receive suramin on a regular schedule for the full time of treatment. It is also necessary for you to receive suramin in the hospital so your doctor can check on your condition.

Dosing

The dose of suramin 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 suramin. 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 injection dosage form:
  
  • For African sleeping sickness:
    
    • Adults and children—Dose is based on body weight and must be determined by your doctor.
    
    
  
  
  • For river blindness:
    
    • Adults—Dose is based on body weight and must be determined by your doctor.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Precautions While Using suramin

It is important that your doctor check your progress at regular visits. This is to help make sure that the infection is cleared up completely. Your doctor may also want to check for any side effects that may occur even after your treatment has ended.

suramin 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:

More common

• Cloudy urine


• crawling or tingling sensation of the skin


• diarrhea


• faintness, especially after missing meals


• headache


• increased skin color


• irritability


• itching


• joint pain


• loss of appetite


• nausea


• numbness or weakness in arms, hands, legs, or feet


• skin rash


• stinging sensation on skin


• swelling on skin


• tenderness of the palms and the soles


• tire easily


• vomiting

Less common

• Changes in or loss of vision


• extreme tiredness or weakness


• increased sensitivity of eyes to light


• painful tender glands in the neck, armpits, or groin


• swelling around eyes


• ulcers or sores in mouth


• watery eyes

Rare

• Cold and clammy skin


• convulsions


• decreased blood pressure


• difficulty in breathing


• fever and sore throat


• fever with or without chills


• increased heartbeat


• loss of consciousness


• pale skin


• pinpoint red spots on skin


• red, thickened, or scaly skin


• swelling and/or tenderness in upper abdominal or stomach area


• swollen and/or painful glands


• unusual bleeding or bruising


• unusual tiredness or weakness


• yellow eyes or skin

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

• Abdominal pain


• fever


• general feeling of discomfort


• metallic taste

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.

Tabloid

Pronunciation: THIGH-oh-GWAHN-een
Generic Name: Thioguanine
Brand Name: Tabloid

Tabloid is used for:

Treating certain types of cancer (eg, acute nonlymphocytic leukemias). It may also be used for other conditions as determined by your doctor.

Tabloid is an antineoplastic. It works by blocking cell protein production.

Do NOT use Tabloid if:

• you are allergic to any ingredient in Tabloid


• your cancer has previously not responded to Tabloid or to mercaptopurine

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

Before using Tabloid:

Some medical conditions may interact with Tabloid. 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 bone marrow depression, decreased blood platelets, decreased white blood cell count, or thiopurine methyltransferase deficiency


• if you have an infection, chickenpox, a weakened immune system, or kidney or liver problems


• if you are receiving radiation therapy or chemotherapy

Some MEDICINES MAY INTERACT with Tabloid. However, no specific interactions with Tabloid are known at this time.

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

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

• Tabloid may be taken with or without food.


• If you miss a dose of Tabloid, 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 Tabloid.

Important safety information:

• If nausea, vomiting, or loss of appetite occurs, ask your doctor or pharmacist for ways to lessen these effects.


• Tabloid may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rashes, or chills.


• Tabloid may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.


• Avoid vaccination with live virus vaccines (eg, measles, mumps, oral polio) while you are taking Tabloid.


• LAB TESTS, including complete blood cell counts, platelet levels, or liver function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


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


• PREGNANCY and BREAST-FEEDING: Tabloid has been shown to cause harm to the fetus. Avoid becoming pregnant while you are taking Tabloid. If you think that you may be pregnant, discuss with your doctor the benefits and risks of using Tabloid during pregnancy. It is unknown if Tabloid is excreted in breast milk. Do not breast-feed while taking Tabloid.

Possible side effects of Tabloid:

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:

Loss of appetite; nausea; vomiting.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); cough or sore throat; dark urine; fever or chills; infection; joint pain; pale stools; severe or prolonged nausea or vomiting; stomach pain or bloating; sudden weight gain; swelling of the mouth; unusual bruising or bleeding; unusual paleness; unusual tiredness; yellowing of the skin or eyes.

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

See also: Tabloid 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 sweating; general body discomfort; nausea; severe dizziness; vomiting; weakness.

Proper storage of Tabloid:

Store Tabloid at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tabloid out of the reach of children and away from pets.

General information:

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


• Tabloid 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 Tabloid. 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 Tabloid resources

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

• Tabloid Prescribing Information (FDA)


• Tabloid Concise Consumer Information (Cerner Multum)


• Thioguanine Prescribing Information (FDA)


• Thioguanine Monograph (AHFS DI)


• Thioguanine Professional Patient Advice (Wolters Kluwer)


• thioguanine Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Tabloid with other medications

• Acute Nonlymphocytic Leukemia

Zonatuss

Generic Name: benzonatate (ben ZOE na tate)

Brand Names: Tessalon, Tessalon Perles, Zonatuss

What is Zonatuss (benzonatate)?

Benzonatate is a non-narcotic cough medicine. It works by numbing the throat and lungs, making the cough reflex less active.

Benzonatate is used to relieve coughing.

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

What is the most important information I should know about Zonatuss (benzonatate)?

You should not use this medication if you are allergic to benzonatate or topical numbing medicines such as tetracaine or procaine (found in some insect bite and sunburn creams). Never suck or chew on a benzonatate capsule. Swallow the pill whole. Sucking or chewing the capsule may cause your mouth and throat to feel numb or cause other serious side effects.

Serious side effects of benzonatate include choking feeling, chest pain or numbness, feeling like you might pass out, confusion, or hallucinations. Some of these side effects may result from chewing or sucking on a benzonatate capsule.

Do not give this medication to a child younger than 10 years old without medical advice. An overdose of benzonatate can be fatal to a child.

What should I discuss with my healthcare provider before taking Zonatuss (benzonatate)?

You should not use this medication if you are allergic to benzonatate or topical numbing medicines such as tetracaine or procaine (found in some insect bite and sunburn creams). FDA pregnancy category C. It is not known whether benzonatate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether benzonatate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to a child younger than 10 years old without medical advice. An overdose of benzonatate can be fatal, especially to a child.

How should I take Zonatuss (benzonatate)?

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.

Always ask a doctor before giving a cough medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Take each dose with a full glass of water. Never suck or chew on a benzonatate capsule. Swallow the pill whole. Sucking or chewing the capsule may cause your mouth and throat to feel numb or cause other serious side effects. Store at room temperature away from moisture, heat, and light.

See also: Zonatuss 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. An overdose of benzonatate can be fatal, especially to a child. Accidental death has occurred in children under 2 years old who took only 1 or 2 capsules.

Overdose symptoms may include numbness in the mouth or throat, feeling restless or very sleepy, tremors or shaking, seizure (convulsions), slow heart rate, weak pulse, fainting, and slow breathing (breathing may stop).

What should I avoid while taking Zonatuss (benzonatate)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using benzonatate

Zonatuss (benzonatate) 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 benzonatate and call your doctor at once if you have a serious side effect such as:

• 
  

  a choking feeling;

  
  


• 
  

  chest pain or numbness;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  confusion; or

  
  


• 
  

  hallucinations.

  
  

Some of these side effects may result from chewing or sucking on a benzonatate capsule.

Less serious side effects may include:

• 
  

  headache;

  
  


• 
  

  dizziness;

  
  


• 
  

  drowsiness;

  
  


• 
  

  nausea, vomiting, constipation; or

  
  


• 
  

  mild itching or skin rash.

  
  

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

What other drugs will affect Zonatuss (benzonatate)?

Before taking benzonatate, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to drowsiness and other side effects of benzonatate.

There may be other drugs that can interact with benzonatate. 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 Zonatuss resources

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

• Zonatuss Prescribing Information (FDA)


• Zonatuss Advanced Consumer (Micromedex) - Includes Dosage Information


• Benzonatate Prescribing Information (FDA)


• Benzonatate Professional Patient Advice (Wolters Kluwer)


• Benzonatate MedFacts Consumer Leaflet (Wolters Kluwer)


• Benzonatate Monograph (AHFS DI)


• Tessalon Prescribing Information (FDA)

Compare Zonatuss with other medications

• Cough

Where can I get more information?

• Your pharmacist can provide more information about benzonatate.

See also: Zonatuss side effects (in more detail)

Aloe Vesta 2 in 1 Antifungal

Generic Name: miconazole topical (my CON a zole)

Brand Names: Aloe Vesta, Aloe Vesta 2 in 1 Antifungal, Baza, Cruex Prescription Strength, Desenex Prescription Strength, Fungoid, Fungoid Kit, Micatin, Micatin Cooling Action, Micatin Foot Powder, Micatin Foot Powder Deodorant, Micatin Jock Itch, Micatin Liquid Foot, Mitrazol, Monistat Derm, Ony-Clear, Zeasorb-AF

What is Aloe Vesta 2 in 1 Antifungal (miconazole topical)?

Miconazole topical is an antifungal medication. Miconazole topical prevents fungus from growing on your skin.

Miconazole topical is used to treat skin infections such as athlete's foot, jock itch, ringworm, tinea versicolor (a fungus that discolors the skin), and yeast infections.

Miconazole topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Aloe Vesta 2 in 1 Antifungal (miconazole topical)?

Use this medication for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Do not use bandages or dressings that do not allow air to circulate to the affected area (occlusive dressings) unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).

Avoid getting this medication in your eyes, nose, or mouth.

Who should not use Aloe Vesta 2 in 1 Antifungal (miconazole topical)?

Do not use miconazole topical if you have had an allergic reaction to it in the past.

It is not known whether miconazole topical will harm an unborn baby. Do not use miconazole topical without first talking to your doctor if you are pregnant. It is not known whether miconazole passes into breast milk. Do not use miconazole topical without first talking to your doctor if you are breast-feeding a baby.

How should I use Aloe Vesta 2 in 1 Antifungal (miconazole topical)?

Use miconazole topical exactly as directed by your doctor or follow the directions that accompany the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using this medication.

Clean and dry the affected area. Apply the cream, lotion, spray, or powder once or twice daily as directed for 2 to 4 weeks.

Use this medication for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

If the infection does not clear up in 2 weeks (or 4 weeks for athlete's foot), or if it appears to get worse, see your doctor.

Do not use bandages or dressings that do not allow air circulation over the affected area (occlusive dressings) unless otherwise directed by your doctor. A light cotton-gauze dressing may be used to protect clothing.

Avoid getting this medication in your eyes, nose, or mouth. Store miconazole topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the dose you missed and apply only the regular amount of miconazole topical. Do not use a double dose unless otherwise directed by your doctor.

What happens if I overdose?

An overdose of miconazole topical is unlikely to occur. If you do suspect that a much larger than normal dose has been used or that miconazole topical has been ingested, contact an emergency room or a poison control center.

What should I avoid while using Aloe Vesta 2 in 1 Antifungal (miconazole topical)?

Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Aloe Vesta 2 in 1 Antifungal (miconazole topical) side effects

Serious side effects of miconazole topical use are not expected. Stop using miconazole topical and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the skin.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Aloe Vesta 2 in 1 Antifungal (miconazole topical)?

Avoid using other topicals at the same time unless your doctor approves. Other skin medications may affect the absorption or effectiveness of miconazole topical.

More Aloe Vesta 2 in 1 Antifungal resources

• Aloe Vesta 2 in 1 Antifungal Side Effects (in more detail)
• Aloe Vesta 2 in 1 Antifungal Use in Pregnancy & Breastfeeding
• Aloe Vesta 2 in 1 Antifungal Drug Interactions
• 0 Reviews for Aloe Vesta 2 in Antifungal - Add your own review/rating

• Baza Antifungal Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Cruex Prescription Strength Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Lotrimin AF Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• Micatin Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Monistat 3 Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Monistat 3 Prescribing Information (FDA)


• Monistat 7 Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Zeasorb-AF Gel MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Aloe Vesta 2 in 1 Antifungal with other medications

• Cutaneous Candidiasis
• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor

Where can I get more information?

• Your pharmacist has additional information about miconazole topical written for health professionals that you may read.

See also: Aloe Vesta 2 in Antifungal side effects (in more detail)