Ipecac Syrup

Class: Emetics
VA Class: GA600
CAS Number: 8012-96-2

Introduction

Central and local emetic;^{a b} contains the major alkaloids emetine and cephaeline.^a

Uses for Ipecac Syrup

Acute Poisoning

Induce vomiting in the early management of acute oral drug overdosage and in certain cases of oral poisoning.^{a b} Does not preclude using other appropriate measures in the emergency treatment of poisonings.^a

If attempting to manage an acute poisoning in a medically unsupervised setting, contact a poison control center (800-222-1222), emergency medical facility, or other qualified healthcare professional before administering ipecac.^{a b}

Use may be justifiable in certain cases where benefit outweighs potential risk^{130 132 133} (e.g., when drug is not contraindicated, if substantial risk of serious toxicity, if no effective alternative treatment available, if delay is >1 hour before emergency treatment, if ipecac syrup administered within 30–90 minutes of ingestion, and if ipecac syrup is unlikely to affect more definitive treatments).¹³² In these circumstances, administer only after specific recommendation by poison control center, emergency medical facility, or other qualified clinician.¹³²

Emesis may not evacuate all toxic material from the GI tract; observe patients carefully for signs of increasing intoxication.^a

Once considered a mainstay in the management of overdosage and poisoning in adults and children; however, many experts now consider ipecac syrup to have a limited role in the emergency management of poisoned patients and recommend selective, rather than routine, use.^{132 133 146}

Insufficient evidence of improved outcomes;^{132 133} use of ipecac syrup may delay administration or reduce the efficacy of activated charcoal, oral antidotes, or other therapies.¹³³

Experts no longer recommend routine use of ipecac syrup in the emergency department;¹³³ activated charcoal is preferred for the immediate treatment of most oral poisonings.^a If gastric emptying indicated, consult specialized references and experts to select appropriate gastric-emptying technique.^a

Do not use if risks associated with vomiting and aspiration outweigh risks associated with systemic absorption of ingested substance.¹⁴⁶

Consult specialized references and experts for additional information about the use of ipecac syrup in the management of poisoning caused by specific agents.^a (See Ingested Substances under Cautions.)

Cough

In small doses (0.3–1 mL) as an expectorant† in cough preparations; however, therapeutic efficacy is doubtful.^a

Eating Disorders

Misused and abused to induce vomiting† following recurrent food binges in individuals with eating disorders (e.g., anorexia nervosa, bulimia nervosa).^{104 105 106 108 109 111 119 130 132 145 152 153 154 155 156 157 158 159 160} Efficacy may diminish with repeated use, resulting in use of increasing dosages, further systemic absorption and toxic effects.^{104 155 159} May result in myopathy, cardiomyopathy, and death.^{104 108 109 111 119 152 153 154 155 156 157 158 159 160} (See Cardiovascular Effects and also see Chronic Toxicity under Cautions.)

Factitious Disorder by Proxy

Misused by abusive parents and caregivers to intentionally produce factitious chronic illnesses† in individuals under their care.^{130 132 135 136 137 138 139 140 141 142 143 144 161} (See Factitious Disorder by Proxy and also see Chronic Toxicity under Cautions.)

Ipecac Syrup Dosage and Administration

General

Before administering drug for acute poisoning management in a medically unsupervised setting (e.g., at home), contact a poison control center (800-222-1222), emergency medical center, or other qualified healthcare professional for advice.^{118 b}

Administration

Oral Administration

Administer orally.^{a b} Whenever possible, keep patients active and moving following administration.^{118 b}

Give 200–480 mL of water or other clear liquid to adults and children >1 year of age immediately following administration of the drug to facilitate emetic action.^{a b} In children 6 months to <1 year of age, give 120–240 mL of water or other clear liquid.^b

Giving liquid prior to administration of ipecac syrup may be more successful in young and frightened children.^a Gently bouncing young children may induce emetic effects earlier.^a

Some experts state that clear carbonated beverages may be administered in children who will not drink water.¹¹⁸

Manufacturers state that ipecac syrup should not be administered with milk.^b (See Specific Drugs and Foods under Interactions.)

Dosage

Pediatric Patients

Acute Poisoning

Oral

Children <6 months of age: Generally, administer under medical direction or supervision.^{118 b}

Children 6 months to <12 months of age: May administer 5 mL;^{118 b} however, to avoid aspiration of vomitus, obtain professional advice and guidance on proper positioning.¹¹⁸

Children 1 to <12 years of age: Usually, 15 mL.^{118 b}

Children ≥12 years of age: Usually, 30 mL.^{118 b}

If no emesis within 30 minutes, may repeat dose.^{118 b}

If no emesis within 30 minutes of second dose, initiate measures to minimize absorption of the emetic and poison (e.g., gastric lavage, activated charcoal) to avoid toxicity from either agent.^a

In a medically unsupervised setting: If no emesis within 30 minutes after administering second dose, contact a poison control center, emergency medical facility, or other qualified healthcare professional for advice.^a

Adults

Acute Poisoning

Oral

Usually, 30 mL.¹¹⁸

If no emesis within 30 minutes, may repeat dose.^{118 a b}

If no emesis within 30 minutes of second dose, initiate measures to minimize absorption of the emetic and poison (e.g., gastric lavage, activated charcoal) to avoid toxicity from either agent.^a

In medically unsupervised setting: If no emesis within 30 minutes after administering second dose, contact a poison control center, emergency medical facility, or other qualified healthcare professional for advice.^a

Cautions for Ipecac Syrup

Contraindications

• 
  

  Patient who is less than fully conscious.^{133 146 b}

  
  


• 
  

  Severe inebriation.^{133 146}

  
  


• 
  

  Shock.^{133 146}

  
  


• 
  

  Seizure activity.^{133 146}

  
  


• 
  

  Lack of gag reflex.^{133 146}

  
  


• 
  

  Rapid (current or expected) deterioration of clinical condition.^{133 146}

  
  


• 
  

  If ingested substance may alter mental status, compromise airway protective reflexes, or cause seizures.^{132 133}

  
  

Warnings/Precautions

Warnings

Physical Injury

Physical injury may result from act of vomiting.^{132 133}

GI Effects

Risk of diarrhea.^{132 133 154 162 163}

Risk of prolonged vomiting.^{132 133 134 163 165 166 167 168} Rarely, prolonged vomiting associated with serious adverse effects and death in patients treated with ipecac syrup.^{100 115 116 117 132 133}

CNS Effects

Risk of lethargy, irritability, and hyperactivity.^{132 133 154 162 163 168 171}

Cardiovascular Effects

Risk of cardiotoxicity, principally when drug is overdosed (e.g., as fluidextract [not commercially available in the US]) or abused chronically.^a

Contains a specific cardiotoxin; at high doses, may cause interstitial edema of heart muscle and necrosis of some fibers, tachycardia, T-wave depression, depressed myocardial contractility, atrial fibrillation, CHF, and myocarditis.^a

Risk of hemorrhage or vascular accidents in patients with impaired cardiac function and sclerotic or other pathologic changes in blood vessels; vomiting may increase BP.^{132 133}

Cardiotoxicity (possibly fatal) associated with chronic use^{105 106 107 112 120 152 154} (e.g., supraventricular tachycardia,^{103 104 105 106 107 119} atrial premature contractions,^{103 104 119} flattened or inverted T waves,^{103 104 105 106 119} prolonged QT and PR intervals,^{103 104 106 119} alterations in QRS complex,^{103 104 119} decreased contractility,^{107 119} ventricular tachycardia and fibrillation,^{103 104 105} cardiac arrest,^{103 104 105} precordial chest pain, dyspnea, hypotension, cardiac failure, pericardial effusions, and pulmonary congestion).^{104 105 106 107 119 120} (See Major Toxicities under Cautions and also see Eating Disorders under Uses.)

Musculoskeletal Effects

Risk of myopathy with chronic abuse (e.g., generalized weakness [especially in neck and proximal muscles of extremities], muscle aching, hyporeflexia, tenderness, stiffness, dysphagia, slurred speech, difficulty with tasks requiring muscular activity).^{104 106 107 109 111 114 119} (See Chronic Toxicity under Cautions and see Eating Disorders under Uses.)

Laboratory abnormalities possible with ipecac-induced myopathy (e.g., increased AST, LDH, creatine kinase, aldolase, and ALT).^{104 106 108 119}

Sensitivity Reactions

Dermatologic Reactions

Fixed eruptions and toxic epidermal necrolysis reported rarely; however, effects not directly attributed to the drug.^a

Major Toxicities

Acute Toxicity

Substantial margin of safety when administered at therapeutic dosages for emergency management of acute ingestions in patients with no contraindications to use.^{130 133 146} However, if emesis does not occur following administration, emetine may be absorbed and cause adverse systemic effects.^a

Cases of severe toxicity usually have involved ipecac fluidextract (not commercially available in the US); 14 times more concentrated than ipecac syrup.^a Volumes of ipecac fluidextract for administration are substantially smaller than those for ipecac syrup.^a

Possible toxic manifestations of acute overdosage include nausea, bloody stools and vomitus, cramping and abdominal pain, hypotension, dyspnea, shock, seizures, and coma.^a Heart failure is the usual cause of death following overdose.^a (See Cardiovascular Effects under Cautions.)

Chronic Toxicity

Serious, potentially fatal adverse effects associated with chronic abuse in eating disorders (e.g., anorexia nervosa, bulimia nervosa); adverse effects may be secondary to complications of chronic ipecac-induced vomiting (e.g., metabolic abnormalities [e.g., hypokalemia, hypochloremia, metabolic alkalosis], dental abnormalities, esophagitis, gastric reflux, Mallory-Weiss syndrome, parotid gland enlargement, aspiration pneumonitis)^{102 103} or secondary to the adverse systemic effects of ipecac (e.g., skeletal and cardiac muscle cell toxicities from emetine).^{102 103 104 105 106 107 108 109 110 111 112 113 114 119 120 144 176}

Other chronically abused drugs (e.g., cathartics, laxatives, diuretics) may also contribute to the observed spectrum of adverse effects.^{102 103 108}

General Precautions

Possible Prescribing and Dispensing Errors

Ensure accuracy of medication; similarity in names of ipecac syrup and ipecac fluidextract may result in errors.^a Ipecac fluidextract (not commercially available in the US) is 14 times more potent than ipecac syrup and inadvertent administration of ipecac fluidextract has resulted in serious toxicity and fatalities.^a

Alcohol Content

Syrup contains 1–2.5% alcohol, which exceeds FDA established maximum concentration (0.5%) for nonprescription drugs intended for use in children ≤6 years of age.¹²⁷ However, nonprescription containers of ipecac syrup (≤30 mL) are exempted due to small size and insignificant total alcohol content (0.75 mL).¹²⁷

Alcohol and ipecac syrup usually are vomited along with other stomach contents; benefits outweigh risk of adverse effects associated with ingestion of the alcohol (0.375–0.75 mL) in the syrup.¹²⁷

Ingested Substances

In a medically unsupervised setting (e.g., at home), do not administer if strychnine were ingested, turpentine, petroleum distillates, volatile oils, alkali (e.g., lye) or strong acid, or caustic or corrosive substances, unless otherwise advised by a poison control center, medical emergency facility, or other qualified healthcare professional.^{132 178 a b}

If low-viscosity petroleum distillates (e.g., gasoline, kerosene, fuel oil, paint thinner, cleaning fluid) are ingested, many clinicians advise against the use of ipecac syrup due to the high potential for aspiration.^{132 133}

After ingestion of liquid hydrocarbons by alert patients, the decision to induce emesis depends on the amount ingested and the relative toxicity of the particular hydrocarbon or chemical dissolved in it.^a If no other contraindications, induction of emesis is indicated with benzene or hydrocarbon preparations containing camphor, pesticides, or substantial amounts of heavy metals or halogenated solvents.^a

In oral antiemetic poisonings, ipecac syrup may be useful if given within 1 hour and before toxic or antiemetic effects appear.^a

Use with caution after acute overdose of cardiac glycosides; may potentiate hazards of high degrees of AV block and of increased vagal activity.^a (See Cardiovascular Effects under Cautions.)

Do not administer ipecac if ingested substance may alter mental status, compromise airway protective reflexes, or cause seizures.^{132 133} (See Contraindications under Cautions.)

Consult specialized references and experts for additional information about the use of ipecac syrup in the management of poisoning caused by specific agents.^a

Concurrent Medical Conditions

Some clinicians state that ipecac syrup should not be used in debilitated patients or those with medical conditions (e.g., severe hypertension, bradycardia, hemorrhagic diathesis) that may be further compromised by induction of emesis.^{132 133} (See Cardiovascular Effects and also see Geriatric Use under Cautions.)

Seizures

If convulsants are ingested and patient is not having seizures, ipecac-induced vomiting and retching may precipitate seizures.^a

Factitious Disorder by Proxy

Consider ipecac toxicity in the differential diagnosis in children with unexplained colitis, especially if vomiting or neuromuscular or cardiac manifestations are present.¹³⁶

Unusual symptom complexes possible with chronic ipecac syrup administration (e.g., persistent or recurrent diarrhea and vomiting, muscle weakness, colitis, cardiomyopathy, fever, edema, and/or electrolyte disturbances).^{135 136 137 138 139 140 141} (See Chronic Toxicity under Cautions.)

Expiration Date

Periodically check expiration date; use after the expiration date may not result in emesis and is not recommended.^a Only consider use in emergency situations where the expired syrup is the only emetic readily available.^a

Specific Populations

Pregnancy

Category C.^a

Lactation

Not known whether ipecac syrup is distributed into milk.^a Use caution.^a

Pediatric Use

Safety and efficacy not established for children <6 months of age in medically unsupervised setting.^b

Syrup exceeds FDA established maximum alcohol concentration (0.5%) for nonprescription drugs intended for use in children ≤6 years.¹²⁷ (See Alcohol Content under Cautions.)

Experts no longer recommend routinely keeping ipecac in homes with small children for emergency use.^{130 132} No consensus by experts on which homes might benefit from having ipecac syrup; consult individual clinicians and poison control centers for guidance.¹³² Evidence of efficacy in out-of-hospital settings is insufficient to support even limited use.^{130 132 133 134} (See Acute Poisoning under Uses.)

Geriatric Use

Some clinicians state that ipecac syrup should not be used in geriatric patients.^{132 133} (See Cardiovascular Effects and also see Concurrent Medical Conditions under Cautions.)

Common Adverse Effects

Diarrhea,^{132 133 154 162 163} lethargy,^{132 133 154 163 168 171} prolonged vomiting.^{132 133 134 163 165 166 167 168}

Interactions for Ipecac Syrup

Specific Drugs and Foods

Drug or Food	Interaction	Comments
Activated charcoal	Adsorbs ipecac syrupa b	Administer ipecac first; do not give activated charcoal until vomiting completed a b
Milk	Manufacturer states do not administer with milkb	Studies suggest combination may delay the onset of emesis;125 126 however, other evidence indicates concomitant administration does not substantially reduce emetic efficacy124

Ipecac Syrup Pharmacokinetics

Absorption

Bioavailability

Limited GI absorption data; may exhibit considerable interindividual variation.^a Recovery of alkaloids in vomitus ranges from 2–100% (mean 45%).¹⁰¹

Onset

80–85% of patients: vomiting usually occurs ≤15–30 minutes after first dose.^{132 150 151 162 174} If second dose required, onset usually ≤10 minutes.^{132 150 151 162 174}

Duration

Induces an average of 3 vomiting episodes (range:1–8); average duration of each episode is 23–60 minutes.^{146 162 174 175}

Food

Some studies suggest milk may delay onset of emesis;^{125 126} however, other evidence indicates concomitant administration does not substantially reduce emetic efficacy.¹²⁴

Distribution

Not known whether alkaloids of ipecac are distributed into milk.^a

Stability

Storage

Oral

Syrup

Tight container at <25°C.^a Periodically check expiration date.^a (See Expiration Date under Cautions.)

ActionsActions

• 
  

  Emetogenic effects are the result of two major alkaloids, emetine and cephaeline; cephaeline is the more potent emetogenic agent of the two.^{146 173 176}

  
  


• 
  

  Acts centrally by stimulating the medullary chemoreceptor trigger zone (CTZ) and locally by irritating the gastric mucosa.^a Vomiting is induced by the drug only when the medullary centers are responsive.^a

  
  


• 
  

  Type 3 serotonergic (5-HT₃) receptors appear to mediate drug-induced nausea and vomiting.^{146 172}

  
  


• 
  

  Produces regurgitation of contents from the stomach and upper GI tract; however, entire GI contents not regurgitated.^a

  
  

Advice to Patients

• 
  

  Importance of contacting a poison control center (800-222-1222), emergency medical facility, or other qualified healthcare professional before giving ipecac.^a

  
  


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  Importance of only giving to a fully conscious patient.^{133 146 b}

  
  


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  Importance of giving additional water or other clear liquid following dose.^{a b}

  
  


• 
  

  Importance of keeping patient active and moving.^{118 b}

  
  


• 
  

  Advise patient to save poison container, if possible.^b

  
  


• 
  

  When activated charcoal is indicated, importance of giving ipecac syrup first.^{a b} Do not give activated charcoal until vomiting is finished.^{a b}

  
  


• 
  

  Importance of using a preparation that has not expired.^a

  
  


• 
  

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

  
  


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  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.^a

  
  


• 
  

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

  
  

Preparations

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

Ipecac

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Syrup	70 mg (of powdered ipecac) per mL*	Ipecac Oral Solution

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 June 2009. 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

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160. Ho PC, Dweik R, Cohen MC. Rapidly reversible cardiomyopathy associated with chronic ipecac ingestion. Clin Cardiol. 1998; 21:780-3. [PubMed 9789704]

161. Cooper C, Kilham H, Ryan M. Ipecac--a substance of abuse. Med J Aust. 1998; 168:94-5. [IDIS 400346] [PubMed 9469196]

162. Litovitz TL, Klein-Schwartz W, Oderda GM et al. Ipecac administration in children younger than 1 year of age. Pediatrics. 1985; 76:761-4. [IDIS 209480] [PubMed 2865716]

163. Wrenn K, Rodewald L, Dockstader L. Potential misuse of ipecac. Ann Emerg Med. 1993; 22:1408-12. [PubMed 8103307]

164. Wax PM, Caobaugh DJ, Lawrence RA. Should home ipecac-induced emesis be routinely recommended in the managment of toxic berry ingestions? Vet Hum Toxicol. 1999; 41:394-7.

165. Veltri JC, Temple AR. Telephone management of poisonings using syrup of ipecac. Clin Toxicol. 1976; 9:407-17. [PubMed 8236]

166. Saincher A, Sitar DS, Tenenbein M. Efficacy of ipecac during the first hour after drug ingestion in human volunteers. J Toxicol Clin Toxicol. 1997; 35: 609-15.

167. McNamara RM, Aaron CK, Gemborys M et al. Efficacy of charcoal cathartic versus ipecac in reducing serum acetaminophen in a simulated overdose. Ann Emerg Med. 1989; 18: 934-8 [PubMed 2569851]

168. Czajka PA, Russell SL. Nonemetic effects of ipecac syrup. Pediatrics. 1985, 75:1101-4.

169. Knight KM, Doucet HJ. Gastric rupture and death caused by ipecac syrup. South Med J. 1987; 80: 786-7. [IDIS 230855] [PubMed 2884730]

170. Robertson WO. Syrup of ipecac associated fatality: a case report. Vet Hum Toxicol. 1979; 21: 87-9.

171. Chafee-Bahamon C, Lacouture PG, Lovejoy FH. Risk assessment of ipecac in the home. Pediatrics. 1985; 75:1105-9. [IDIS 2000190] [PubMed 2860633]

172. Forster ER, Palmer JL, Bedding AW et al. Syrup of Ipecacuanha-induced nausea and emesis is mediated by 5HT₃ receptors in man. J Physiol. (London). 1994; 477:72.

173. Stewart J. Effects of emetic and cathartic agents on the gastrointestinal tract and the treatment of toxic ingestion. J Toxicol Clin Toxicol. 1983; 20:199-253. [IDIS 177474] [PubMed 6137573]

174. MacLean W. A comparison of ipecac syrup and apomorphine in the immediate treatment of igestion of poisons. J Pediatr. 1973; 82:121-4. [IDIS 30570] [PubMed 4404603]

175. Rauber A, Maroncelli R. The duration of emetic effects of ipecac: Duration and frequency of vomiting. Vet Hum Toxicol. 1982; 24:281.

Scholl Complete Corn Treatment Kit

1. Name Of The Medicinal Product

Scholl Complete Corn Treatment Kit

2. Qualitative And Quantitative Composition

Salicylic Acid 40% w/w.

3. Pharmaceutical Form

Medicated adhesive plaster.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of corns.

4.2 Posology And Method Of Administration

Adults: For best results, the feet should be washed and dried before use. One medicated disc should be placed on the corn, covered with a cover plaster. This should be repeated daily until the corn can be removed. Treatment should not continue for more than two weeks. No distinction is made between different categories of patient. Children: Not recommended for children under sixteen, except following a doctor's recommendation.

4.3 Contraindications

Not to be used on diabetics or those with severe circulatory disorders, except following a doctor's permission and recommendation. Not to be used by those sensitive to salicylic acid or any of the other constituents of the product. Not to be used if the corn or surrounding skin is broken or inflamed.

4.4 Special Warnings And Precautions For Use

Discontinue use and remove plaster if excessive discomfort is experienced. Do not apply to normal skin. For external use only.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Not relevant to cutaneous use.

4.6 Pregnancy And Lactation

Safety and use in pregnancy and during lactation has not been established.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

Local irritation or dermatitis may occur.

4.9 Overdose

None stated.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic Classification (ATC): D11 AF. Salicylic Acid: Keratolytic agent.

5.2 Pharmacokinetic Properties

Not relevant to topical dosage form.

5.3 Preclinical Safety Data

No other information relevant to the prescriber other than that already stated in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Polyvinyl Alkyl Ether (Low Molecular Weight); Polyvinyl Alkyl Ether (High Molecular Weight); Titanium Dioxide; Liquid Paraffin; 4,4'-thio-bis-2-tert-butyl-5-methylphenol; Red Iron Oxide; Black Iron Oxide; Backing material.

6.2 Incompatibilities

Not relevant.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Store below 25^oC. Keep out of the reach of children.

6.5 Nature And Contents Of Container

Sachet contents: 6 medicated adhesive discs mounted onto a silicone backed paper.

6 Twill cloth cover plasters with pressure sensitive adhesive mounted onto a silicone backed paper.

9 foam corn cushions mounted onto a silicone backed paper.

Outer container: cardboard carton or polypropylene flow wrap.

6.6 Special Precautions For Disposal And Other Handling

Apply with medicated disc to centre of corn, fabric side uppermost. Cover with pad.

7. Marketing Authorisation Holder

Scholl Consumer Products Limited, Tubiton House, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 0587/5015R.

9. Date Of First Authorisation/Renewal Of The Authorisation

17^th September 1990 / 13^th December 2004

10. Date Of Revision Of The Text

July 2005

Depixol Tablets 3mg

1. Name Of The Medicinal Product

Depixol^® Tablets 3 mg

2. Qualitative And Quantitative Composition

3.504 mg flupentixol dihydrochloride corresponding to 3 mg flupentixol base

3. Pharmaceutical Form

Round, biconvex, yellow, sugar-coated tablets.

4. Clinical Particulars

4.1 Therapeutic Indications

The treatment of schizophrenia and other psychoses.

4.2 Posology And Method Of Administration

Route of administration

Oral.

Adults

1 - 3 tablets twice daily to a maximum of 18 mg (6 tablets) per day. It is recommended that commencement of treatment and increase in dosage should be carried out under close supervision. As with all antipsychotic drugs, the dose of Depixol should be titrated to the needs of each patient.

When transferring patients from oral to depot antipsychotic treatment, the oral medication should not be discontinued immediately, but gradually withdrawn over a period of several days after administering the first injection.

Elderly

In accordance with standard medical practice, initial dosage may need to be reduced to a quarter or half the normal starting dose in the frail or elderly.

Children

Not indicated for children.

Reduced renal function

Flupentixol has not been studied in renal impairment. Increased cerebral sensitivity to antipsychotics has been noted in severe renal impairment (see section 4.4).

Reduced hepatic function

Flupentixol has not been studied in hepatic impairment. It is extensively metabolised by the liver and particular caution should be used in this situation and serum level monitoring is advised (see section 4.4).

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients (see section 6.1).

Circulatory collapse, depressed level of consciousness due to any cause (e.g. intoxication with alcohol, barbiturates or opiates), coma.

Not recommended for excitable or agitated patients.

4.4 Special Warnings And Precautions For Use

Caution should be exercised in patients having: liver disease; cardiac disease or arrhythmias; severe respiratory disease; renal failure; epilepsy (and conditions predisposing to epilepsy e.g. alcohol withdrawal or brain damage); Parkinson's disease; narrow angle glaucoma; prostatic hypertrophy; hypothyroidism; hyperthyroidism; myasthenia gravis; or phaeochromocytoma; and in patients who have shown hypersensitivity to thioxanthenes or other antipsychotics.

The elderly require close supervision because they are especially prone to experience such adverse effects as sedation, hypotension, confusion and temperature changes.

The possibility of development of neuroleptic malignant syndrome (hyperthermia, muscle rigidity, fluctuating consciousness, instability of the autonomous nervous system) exists with any neuroleptic. The risk is possibly greater with the more potent agents. Patients with pre-existing organic brain syndrome, mental retardation, and opiate and alcohol abuse are overrepresented among fatal cases.

Treatment: Discontinuation of the neuroleptic. Symptomatic treatment and use of general supportive measures. Dantrolene and bromocriptine may be helpful.

Symptoms may persist for more than a week after oral neuroleptics are discontinued and somewhat longer when associated with the depot forms of the drugs.

Blood dyscrasias, including thrombocytopenia, have been reported rarely. Blood counts should be carried out if a patient develops signs of persistent infection.

As described for other psychotropics, flupentixol may modify insulin and glucose responses calling for adjustment of the antidiabetic therapy in diabetic patients.

Acute withdrawal symptoms, including nausea, vomiting, sweating and insomnia have been described after abrupt cessation of antipsychotic drugs. Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported. Therefore, gradual withdrawal is advisable.

When transferring patients from oral to depot antipsychotic treatment, the oral medication should not be discontinued immediately, but gradually withdrawn over a period of several days after administering the first injection.

An approximately 3-fold increased risk of cerebrovascular adverse events has been seen in randomised placebo controlled clinical trials in the dementia population with some atypical antipsychotics. The mechanism for this increased risk is not known. An increased risk cannot be excluded for other antipsychotics or other patient populations.

Flupentixol should be used with caution in patients with risk factors for stroke.

As with other drugs belonging to the therapeutic class of antipsychotics, flupentixol may cause QT prolongation. Persistently prolonged QT intervals may increase the risk of malignant arrhythmias. Therefore, flupentixol should be used with caution in susceptible individuals (with hypokalaemia, hypomagnesia or genetic predisposition) and in patients with a history of cardiovascular disorders, e.g. QT prolongation, significant bradycardia (<50 beats per minute), a recent acute myocardial infarction, uncompensated heart failure, or cardiac arrhythmia.

Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Depixol and preventive measures undertaken.

Concomitant treatment with other antipsychotics should be avoided (see section 4.5).

Suicide/suicidal thoughts or clinical worsening

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. Other psychiatric conditions for which flupentixol is prescribed can also be associated with an increased risk of suicide-related events. In addition, these conditions may be co-morbid with major depressive disorder. The same precautions observed when treating patients with major depressive disorder should, therefore, be observed when treating patients with other psychiatric disorders. Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.

Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.

Increased Mortality in Elderly people with Dementia

Data from two large observational studies showed that elderly people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated. There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known.

Depixol is not licensed for the treatment of dementia-related behavioural disturbances.

Excipients

The tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not receive this medicine.

The tablets also contain Sunset yellow FCF (E110), which may cause allergic reactions.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

In common with other antipsychotics, flupentixol enhances the response to alcohol, the effects of barbiturates and other CNS depressants. Flupentixol may potentiate the effects of general anaesthetics and anticoagulants and prolong the action of neuromuscular blocking agents.

The anticholinergic effects of atropine or other drugs with anticholinergic properties may be increased. Concomitant use of drugs such as metoclopramide, piperazine or antiparkinson drugs may increase the risk of extrapyramidal effects such as tardive dyskinesia. Combined use of antipsychotics and lithium or sibutramine has been associated with an increased risk of neurotoxicity.

Antipsychotics may enhance the cardiac depressant effects of quinidine; the absorption of corticosteroids and digoxin. The hypotensive effect of vasodilator antihypertensive agents such as hydralazine and α-blockers (e.g. doxazosin), or methyl-dopa may be enhanced.

Increases in the QT interval related to antipsychotic treatment may be exacerbated by the co-administration of other drugs known to significantly increase the QT interval.

Co-administration of such drugs should be avoided. Relevant classes include:

• class Ia and III antiarrhythmics (e.g. quinidine, amiodarone, sotalol, dofetilide)

• some antipsychotics (e.g. thioridazine)

• some macrolides (e.g. erythromycin)

• some antihistamines

• some quinolone antibiotics (e.g. moxifloxacin)

The above list is not exhaustive and other individual drugs known to significantly increase QT interval (e.g. cisapride, lithium) should be avoided.

Drugs known to cause electrolyte disturbances such as thiazide diuretics (hypokalaemia) and drugs known to increase the plasma concentration of flupentixol should also be used with caution as they may increase the risk of QT prolongation and malignant arrythmias (see section 4.4).

Antipsychotics may antagonise the effects of adrenaline and other sympathomimetic agents, and reverse the antihypertensive effects of guanethidine and similar adrenergic-blocking agents. Antipsychotics may also impair the effect of levodopa, adrenergic drugs and anticonvulsants.

The metabolism of tricyclic antidepressants may be inhibited and the control of diabetes may be impaired.

4.6 Pregnancy And Lactation

As the safety of this drug during pregnancy has not been established, use during pregnancy, especially the first and last trimesters, should be avoided, unless the expected benefit to the patient outweighs the potential risk to the foetus.

Flupentixol is excreted into the breast milk. If the use of Depixol is considered essential, nursing mothers should be advised to stop breast feeding.

The newborn of mothers treated with antipsychotics in late pregnancy, or labour, may show signs of intoxication such as lethargy, tremor and hyperexcitability, and have a low Apgar score.

4.7 Effects On Ability To Drive And Use Machines

Alertness may be impaired, especially at the start of treatment, or following the consumption of alcohol; patients should be warned of this risk and advised not to drive or operate machinery until their susceptibility is known. Patients should not drive if they have blurred vision.

4.8 Undesirable Effects

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

Undesirable effects are for the majority dose dependent. The frequency and severity are most pronounced in the early phase of treatment and decline during continued treatment.

Extrapyramidal reactions may occur, especially in the early phase of treatment. In most cases these side effects can be satisfactorily controlled by reduction of dosage and/or use of antiparkinsonian drugs. The routine prophylactic use of antiparkinsonian drugs is not recommended. Antiparkinsonian drugs do not alleviate tardive dyskinesia and may aggravate them. Reduction in dosage or, if possible, discontinuation of flupentixol therapy is recommended. In persistent akathisia a benzodiazepine or propranolol may be useful.

Cardiac disorders	Tachycardia, palpitations. Electrocardiogram QT prolonged.
Blood and lymphatic system disorders	Thrombocytopenia, neutropenia, leukopenia, agranulocytosis
Nervous system disorders	Somnolence, akathisia, hyperkinesia, hypokinesia. Tremor, dystonia, dizziness, headache, disturbance in attention. Tardive dyskinesia, dyskinesia, parkinsonism, speech disorder, convulsion. Neuroleptic malignant syndrome.
Eye disorders	Accommodation disorder, vision abnormal. Oculogyration.
Respiratory, thoracic and mediastinal disorders	Dyspnoea.
Gastrointestinal disorders	Dry mouth. Salivary hypersecretion, constipation, vomiting, dyspepsia, diarrhoea. Abdominal pain, nausea, flatulence.
Renal and urinary disorders	Micturition disorder, urinary retention.
Skin and subcutaneous tissue disorders	Hyperhidrosis, pruritus. Rash, photosensitivity reaction, dermatitis.
Musculoskeletal and connective tissue disorder	Myalgia. Muscle rigidity.
Endocrine disorder	Hyperprolactinaemia.
Metabolism and nutrition disorders	Increased appetite, weight increased. Decreased appetite. Hyperglycaemia, glucose tolerance abnormal.
Vascular disorders	Hypotension, hot flush.
General disorders and administration site conditions	Asthenia, fatigue. Injection site reaction1.
Immune system disorders	Hypersensitivity, anaphylactic reaction.
Hepatobiliary disorders	Liver function test abnormal. Jaundice
Reproductive system and breast disorders	Ejaculation failure, erectile dysfunction. Gynaecomastia, galactorrhoea, amenorrhoea.
Psychiatric disorders	Insomnia, depression, nervousness, agitation, libido decreased. Confusional state.

¹For injectable flupentixol presentations.

As with other drugs belonging to the therapeutic class of antipsychotics, rare cases of QT prolongation, ventricular arrhythmias - ventricular fibrillation, ventricular tachycardia, Torsade de Pointes and sudden unexplained death have been reported for flupentixol (see section 4.4).

Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychoticdrugs - frequency unknown.

Abrupt discontinuation of flupentixol may be accompanied by withdrawal symptoms. The most common symptoms are nausea, vomiting, anorexia, diarrhoea, rhinorrhoea, sweating, myalgias, paraesthesias, insomnia, restlessness, anxiety, and agitation. Patients may also experience vertigo, alternate feelings of warmth and coldness, and tremor. Symptoms generally begin within 1 to 4 days of withdrawal and abate within 7 to 14 days.

4.9 Overdose

Overdosage may cause somnolence, or even coma, extrapyramidal symptoms, convulsions, hypotension, shock, hyper- or hypothermia. ECG changes, QT prolongation, Torsade de Pointes, cardiac arrest and ventricular arrhythmias have been reported when administered in overdose together with drugs known to affect the heart.

Treatment is symptomatic and supportive, with measures aimed at supporting the respiratory and cardiovascular systems. The following specific measures may be employed if required.

• anticholinergic antiparkinson drugs if extrapyramidal symptoms occur.

• sedation (with benzodiazepines) in the unlikely event of agitation or excitement or convulsions.

• noradrenaline in saline intravenous drip if the patient is in shock. Adrenaline must not be given.

• ingestion of activated charcoal and gastric lavage should be considered.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Flupentixol is an antipsychotic of the thioxanthene series.

The antipsychotic effect of antipaychotic is believed to be related to their dopamine receptor blocking effect. The thioxanthenes have high affinity for D1 and D2 receptors.

5.2 Pharmacokinetic Properties

Oral administration to volunteers (8 mg single dose and 1.5 mg/day) and patients (5-60 mg/d) resulted in serum drug concentration curves with a maximum around four hours after administration. Mean biological half-life was about 35 hours in patients. No difference was seen in patients between half-lives estimated after single-dose administration and those estimated after repeated administration. Mean oral bioavailability of flupentixol varied between 40% and 55%.

5.3 Preclinical Safety Data

Nil of relevance

6. Pharmaceutical Particulars

6.1 List Of Excipients

Potato starch, Lactose, Gelatin, Talc, Magnesium Stearate, Sucrose and Yellow Iron Oxide (E172).

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Depixol tablets are stable for 2 years. Each container has an expiry date.

6.4 Special Precautions For Storage

Store in original container, protected from light and moisture. Do not store above 25°C.

6.5 Nature And Contents Of Container

Grey polypropylene container with screw cap or glass bottles with white plastic stoppers. Contents: 100 tablets.

White, High Density Polyethylene tablet container. Contents: 100 tablets

6.6 Special Precautions For Disposal And Other Handling

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

7. Marketing Authorisation Holder

Lundbeck Limited

Lundbeck House

Caldecotte Lake Business Park

Milton Keynes

MK7 8LG

8. Marketing Authorisation Number(S)

PL 0458/0076

9. Date Of First Authorisation/Renewal Of The Authorisation

29 January 1987 / 17 March 2002

10. Date Of Revision Of The Text

14/04/2011

LEGAL CATEGORY:

POM

posaconazole

poe-sa-KON-a-zole

Commonly used brand name(s)

In the U.S.

• Noxafil

Available Dosage Forms:

• Suspension

Therapeutic Class: Antifungal

Chemical Class: Triazole

Uses For posaconazole

Posaconazole is used to prevent certain fungus infections in patients 13 years of age and older, who have a weakened immune system (e.g., hematopoietic stem cell transplant or HSCT recipients, or patients with blood cancers). Posaconazole is also used to treat a fungus infection of the mouth or throat called oral thrush (candidiasis). posaconazole may be used as an initial treatment or after treatment with other antifungal medicines (e.g., itraconazole or fluconazole) have failed.

posaconazole is available only with your doctor's prescription.

Before Using posaconazole

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 posaconazole, the following should be considered:

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of posaconazole in children and teenagers 13 to 17 years of age. However, safety and efficacy have not been established in children younger than 13 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of posaconazole in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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

• Alfuzosin


• Amiodarone


• Astemizole


• Cisapride


• Clarithromycin


• Clozapine


• Crizotinib


• Dasatinib


• Dihydroergotamine


• Disopyramide


• Dofetilide


• Dronedarone


• Ergoloid Mesylates


• Ergonovine


• Ergotamine


• Erythromycin


• Halofantrine


• Iloperidone


• Lapatinib


• Lopinavir


• Lumefantrine


• Mefloquine


• Mesoridazine


• Methadone


• Methylergonovine


• Methysergide


• Nilotinib


• Ondansetron


• Pazopanib


• Pimozide


• Propafenone


• Quetiapine


• Quinidine


• Quinine


• Ranolazine


• Salmeterol


• Saquinavir


• Simvastatin


• Sirolimus


• Solifenacin


• Sorafenib


• Sparfloxacin


• Sunitinib


• Telithromycin


• Terfenadine


• Thioridazine


• Toremifene


• Trazodone


• Vardenafil


• Vemurafenib


• Voriconazole


• Ziprasidone

Using posaconazole 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.

• Amitriptyline


• Amoxapine


• Apomorphine


• Arsenic Trioxide


• Asenapine


• Atorvastatin


• Azithromycin


• Boceprevir


• Chloroquine


• Chlorpromazine


• Cimetidine


• Ciprofloxacin


• Citalopram


• Clomipramine


• Cyclosporine


• Desipramine


• Dolasetron


• Droperidol


• Efavirenz


• Etravirine


• Everolimus


• Flecainide


• Fluconazole


• Gatifloxacin


• Gemifloxacin


• Granisetron


• Haloperidol


• Ibutilide


• Imipramine


• Levofloxacin


• Lovastatin


• Midazolam


• Moxifloxacin


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Paliperidone


• Perflutren Lipid Microsphere


• Phenytoin


• Procainamide


• Prochlorperazine


• Promethazine


• Protriptyline


• Rifabutin


• Rifampin


• Rivaroxaban


• Ruxolitinib


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Sotalol


• Tacrolimus


• Telavancin


• Tetrabenazine


• Trifluoperazine


• Trimipramine


• Vandetanib


• Vinblastine


• Vincristine


• Vincristine Liposome


• Vinorelbine

Using posaconazole 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.

• Atazanavir


• Digoxin


• Esomeprazole


• Metoclopramide


• Ritonavir


• Topiramate

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

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

• Heart disease, history of or


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


• Liver disease or


• Mineral imbalance (low potassium, magnesium, or calcium in the blood)—These conditions may cause side effects to become worse.

• Kidney disease, severe—May cause the medicine to not work as well.

Proper Use of posaconazole

posaconazole comes with a patient information leaflet. Read and follow these instructions carefully. Talk to your doctor if you have any questions.

Shake the oral suspension well before measuring the dose. Use the dosing spoon in the package to measure the dose. The average household teaspoon may not hold the right amount of liquid. Rinse the measuring spoon with water after using and before storage.

Take posaconazole during or right after (within 20 minutes) a full meal or liquid nutritional supplement. posaconazole may also be taken with an acidic beverage (e.g., ginger ale).

posaconazole works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take each dose at the same time every day. If you need help in planning the best time to take your medicine, check with your doctor.

Dosing

The dose of posaconazole 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 posaconazole. If your dose is different, do not change it unless your doctor tells you to do so.

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

• For oral dosage form (suspension):
  
  • For prevention of fungus infections:
    
    • Adults and teenagers—200 milligrams (mg) or 5 milliliters (mL) three times a day.
    
    
    • Children younger than 13 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For initial treatment of oral candidiasis:
    
    • Adults and teenagers—100 milligrams (mg) or 2.5 milliliters (mL) two times a day on the first day, then 100 mg or 2.5 mL once a day for 13 days.
    
    
    • Children younger than 13 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For treatment of oral candidiasis after failed treatment with itraconazole or fluconazole:
    
    • Adults and teenagers—400 milligrams (mg) or 10 milliliters (mL) two times a day.
    
    
    • Children younger than 13 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using posaconazole

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests will be needed to check for unwanted effects.

You should not use ergotamine medicines (e.g., bromocriptine, dihydroergotamine, ergonovine, ergotamine, methylergonovine, methysergide, Ergomar®, Ergotrate®, Methergine®, Migranal®, Parlodel®, or Sansert®), pimozide (Orap®), quinidine (Quinaglute®), simvastatin (Zocor®), or sirolimus (Rapamune®). Using any of them together with posaconazole may increase the chance of unwanted effects.

posaconazole can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

Stop using posaconazole and check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor right away if you have severe diarrhea or vomiting while using posaconazole.

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

posaconazole Side Effects

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

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

More common

• abdominal or stomach pain


• black, tarry stools


• bleeding gums


• bloody nose


• blurred vision


• body aches or pain


• burning or stinging of the skin


• chills


• confusion


• cough


• cracked lips


• decreased urine


• diarrhea


• difficult or labored breathing


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


• drowsiness


• dry mouth


• dry or sore throat


• ear congestion


• feeling unusually cold


• fever


• flushed, dry skin


• fruit-like breath odor


• headache


• heavy non-menstrual vaginal bleeding


• increased hunger


• increased thirst


• increased urination


• irregular heartbeats


• loss of appetite


• loss of voice


• mood changes


• muscle pain


• muscle spasms or twitching


• nasal congestion


• nausea or vomiting


• numbness or tingling in the hands, feet, lips, mouth, or fingertips


• painful cold sores or blisters on the lips, nose, eyes, or genitals


• painful or difficult urination


• pale skin


• pounding in the ears


• runny nose


• shivering


• slow or fast heartbeat


• small red or purple spots on the skin


• sneezing


• sores, ulcers, or white spots on the lips, tongue, or inside mouth


• sweating


• tender, swollen glands in the neck


• tightness in the chest


• trembling


• trouble with swallowing


• unexplained weight loss


• yellow eyes or skin

Less common

• Fainting


• irregular heartbeat, recurrent

Incidence not known

• Anxiety


• change in mental status


• chest pain or discomfort


• darkening of the skin


• difficulty speaking


• itching


• mental depression


• seizures


• skin rash


• sudden shortness of breath or troubled breathing


• swelling of the eyes or eyelids


• swelling of the face, fingers, feet, or lower legs


• weakness

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

• Acid or sour stomach


• back pain


• belching


• bone pain


• difficulty having a bowel movement (stool)


• difficulty with moving


• heartburn


• indigestion


• muscle stiffness


• pain in the joints


• sleeplessness


• stomach discomfort or upset


• trouble sleeping


• unable to sleep


• weight loss

Less common

• Bad, unusual, or unpleasant (after) taste


• change in 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.

See also: posaconazole side effects (in more detail)

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More posaconazole resources

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

• Posaconazole Professional Patient Advice (Wolters Kluwer)


• Posaconazole Monograph (AHFS DI)


• Posaconazole Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Noxafil Prescribing Information (FDA)


• Noxafil Consumer Overview

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