Amoxapine

Class: Tricyclics and Other Norepinephrine-reuptake Inhibitors
VA Class: CN601
Chemical Name: 2-Chloro-11-(1-piperazinyl)dibenz[b,f ][1,4]oxazepine
Molecular Formula: C₁₇H₁₆CIN₃ O
CAS Number: 14028-44-5

• Suicidality


• 
  

  Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need.^{a d o p} Amoxapine is not approved for use in pediatric patients <16 years of age.^{a b} (See Pediatric Use under Cautions.)

  
  


• 
  

  In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.^{a o p}

  
  


• 
  

  Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.^{a o p q}

  
  


• 
  

  Appropriately monitor and closely observe all patients who are started on amoxapine therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.^{a d o p q} (See Worsening of Depression and Suicidality Risk and Pediatric Use under Cautions.)

  
  

Introduction

A dibenzoxazepine-derivative tricyclic antidepressant (TCA).^{101 a b c h i k l m}

Uses for Amoxapine

Depressive Disorders

Symptomatic management of neurotic or reactive depressive disorders, endogenous depression, or psychotic depression.^{101 a b k l s}

Treatment of depression accompanied by anxiety or agitation.^{101 a b k l s}

Amoxapine Dosage and Administration

General

Depressive Disorders

• 
  

  Allow at least 2 weeks to elapse between discontinuance of therapy with an MAO inhibitor and initiation of amoxapine and vice versa.^{a c} Also allow at least 5 weeks to elapse when switching from fluoxetine.^{a c}

  
  


• 
  

  Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments.^{a d o p q} (See Worsening of Depression and Suicidality Risk under Cautions.)

  
  


• 
  

  Duration of therapy depends on the condition being treated; during maintenance therapy, administer lowest effective dosage and periodically reassess need for continued therapy.^{a b c}

  
  

Administration

Oral Administration

Administer orally in up to 3 divided doses or as a single daily dose (if daily dosage ≤300 mg) at bedtime to avoid daytime sedation.^{101 a b k l} Daily dosages >300 mg daily should be administered in divided doses.^{101 a b k}

Dosage

Individualize dosage carefully according to individual requirements and response.^{101 a b}

Adults

Depressive Disorders

Outpatients

Oral

Initially, 50 mg 2 or 3 times daily; initial dosage of 300 mg daily may be given, but considerable sedation may occur during the first few days.^{101 a b k} Dosage may be increased to 100 mg 2 or 3 times daily by the end of the first week.^{101 a b}

Usual dosage: 200–300 mg daily.^{101 a b k} Dosage may be further increased to a maximum of 400 mg daily if a satisfactory response is not achieved at a dosage of 300 mg daily for at least 2 weeks and if tolerated.^{101 a b k}

After symptoms are controlled, gradually reduce dosage to the lowest level that will maintain relief of symptoms.^{101 a b}

Hospitalized Patients

Oral

Initially, 50 mg 2 or 3 times daily; initial dosage of 300 mg daily may be given, but considerable sedation may occur during the first few days.^{101 a b k} Dosage may be increased to 100 mg 2 or 3 times daily by the end of the first week.^{101 a b}

Usual dosage: 200–300 mg daily.^{101 a b k} Dosage may be further increased to a maximum of 600 mg daily if a satisfactory response is not achieved at a dosage of 300 mg daily for at least 2 weeks in patients without a history of seizure disorders and if tolerated.^{101 a b k l}

After symptoms are controlled, gradually reduce dosage to the lowest level that will maintain relief of symptoms.^{101 a b}

Prescribing Limits

Adults

Depressive Disorders

Outpatients

Oral

Maximum 400 mg daily.^{101 a b k}

Hospitalized Patients

Oral

Maximum 600 mg daily.^{101 a b k l}

Special Populations

Geriatric Patients

Select dosage at the lower end of recommended range since decreased hepatic and renal function are more frequent; increase dosage more gradually and monitor closely.^{101 a c k l} (See Geriatric Use under Cautions.)

Initially, 25 mg 2 or 3 times daily.^{101 a b k} Increase dosage to 50 mg 2 or 3 times daily by the end of the first week if tolerated.^{101 a} Usual dosage: 100–150 mg daily; some patients may require a higher dosage (up to a maximum of 300 mg daily).^{101 a b}

Cautions for Amoxapine

Contraindications

• 
  

  Concurrent or recent (i.e., within 2 weeks) therapy with an MAO inhibitor.^{101 a c} (See Specific Drugs under Interactions.)

  
  


• 
  

  During the acute recovery phase following MI.^{101 a c}

  
  

• 
  

  Known hypersensitivity to amoxapine or other dibenzoxazepine-derivative TCAs (e.g., doxepin).^{101 a c}

  
  

Warnings/Precautions

Warnings

Shares the toxic potentials of other tricyclic antidepressants; observe the usual precautions of tricyclic antidepressant therapy.^{101 a b c}

Worsening of Depression and Suicidality Risk

Possible worsening of depression and/or emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior in both adult and pediatric patients with major depressive disorder, whether or not they are taking antidepressants; may persist until clinically important remission occurs.^{a d g o p q} However, suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.^{a o p q}

Appropriately monitor and closely observe patients receiving amoxapine for any reason, particularly during initiation of therapy (i.e., the first few months) and during periods of dosage adjustments.^{a d o p q} (See Boxed Warning and also see Pediatric Use under Cautions.)

Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and/or mania may be precursors to emerging suicidality.^{p q} Consider changing or discontinuing therapy in patients whose depression is persistently worse or in those with emerging suicidality or symptoms that might be precursors to worsening depression or suicidality, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms.^{o p q}

Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.^{a c d p}

Observe these precautions for patients with psychiatric (e.g., major depressive disorder, obsessive-compulsive disorder) or nonpsychiatric disorders.^{a c p}

Bipolar Disorder

May unmask bipolar disorder.^{a p} (See Activation of Mania or Hypomania under Cautions.) Amoxapine is not approved for use in treating bipolar depression.^a

Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.^{a d p}

Tardive Dyskinesia

Tardive dyskinesia, a syndrome of potentially irreversible, involuntary, dyskinetic movements, reported rarely in patients receiving amoxapine.^{101 a b c} Consider discontinuance.^{101 a}

Neuroleptic Malignant Syndrome

Neuroleptic malignant syndrome (NMS), a potentially fatal syndrome requiring immediate discontinuance of the drug and intensive symptomatic treatment, has been reported with amoxapine.^{101 102 a b c}

Cardiovascular Effects

Possible conduction defects, arrhythmias, acute MI, stroke, and sinus tachycardia, particularly at higher dosages.^{101 a c f k l}

Patients with preexisting cardiac disease and patients with disturbed eating behaviors (e.g., purging) that result in inadequate hydration and/or compromised cardiac status most at risk; monitor closely (e.g., perform ECG at baseline and as appropriate during therapy).^{101 a c f k l}

Anticholinergic Effects

Use with caution in patients for whom excess anticholinergic activity could be harmful (e.g., history of urinary retention, increased IOP, angle-closure glaucoma).^{101 a c l}

Seizures

Seizures reported; use with extreme caution in patients with a seizure disorder.^{101 a c l}

Sensitivity Reactions

Possible sensitivity reactions including skin rash and drug fever; most likely during first few days of treatment.^{a c} Discontinue drug if rash and/or fever occur.^a

General Precautions

Activation of Mania or Hypomania

Possible activation of mania and hypomania, particularly in patients with bipolar disorder.^{101 a c} (See Bipolar Disorder under Cautions.)

Psychosis

Possible exacerbation of psychosis in patients with schizophrenia, particularly in patients with paranoid symptoms; decrease dosage and/or administer an antipsychotic agent concomitantly.^{101 a c}

Electroconvulsive Therapy (ECT)

Possible increased ECT risks.^{101 a}

Specific Populations

Pregnancy

Category C.^{101 a e}

Lactation

Distributed into milk.^{100 101 a e l} Caution if used in nursing women; carefully assess potential benefits and risks.^{101 a c e}

Pediatric Use

Safety and efficacy of amoxapine in pediatric patients <16 years of age have not been established.^{101 a b}

FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment (4%) compared with placebo (2%) in children and adolescents with major depressive disorder, obsessive-compulsive disorder (OCD), or other psychiatric disorders based on pooled analyses of 24 short-term, placebo-controlled trials of 9 antidepressant drugs (SSRIs and others).^{a d p} However, a more recent meta-analysis of 27 placebo-controlled trials of 9 antidepressants (SSRIs and others) in patients <19 years of age with major depressive disorder, OCD, or non-OCD anxiety disorders suggests that the benefits of antidepressant therapy in treating these conditions may outweigh the risks of suicidal behavior or suicidal ideation.^g No suicides occurred in these pediatric trials.^{a d g p}

Carefully consider these findings when assessing potential benefits and risks of amoxapine in a child or adolescent for any clinical use.^{a c g o p q} (See Worsening of Depression and Suicidality Risk under Cautions.)

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.^a

In pooled data analyses, a reduced risk of suicidality was observed in adults ≥65 years of age with antidepressant therapy compared with placebo.^{o p} (See Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)

Possible increased sensitivity to adverse effects of amoxapine (e.g., tardive dyskinesia, sedation)^{a c} and to anticholinergic (e.g., dry mouth, constipation, vision disturbance), cardiovascular, and orthostatic hypotension effects of TCAs.

Titrate dosage carefully.^a (See Geriatric Patients under Dosage and Administration.)

Common Adverse Effects

Anticholinergic effects (e.g., dry mouth, constipation, blurred vision), drowsiness, fatigue or lethargy, dizziness.^{101 a c k l s}

Interactions for Amoxapine

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors of CYP2D6: potential pharmacokinetic interaction (increased plasma amoxapine concentrations); use with caution.^{a c} Consider amoxapine dosage adjustment whenever a CYP2D6 inhibitor is added or discontinued.^{a c}

Specific Drugs

Drug	Interaction	Comments
Alcohol	Potential additive CNS effects101 a c
Antiarrhythmics: class 1C (e.g., flecainide, propafenone); quinidine	Potential for decreased amoxapine metabolisma c	Dosage adjustment may be neededa c
Anticholinergic agents	Possible additive anticholinergic effects; hyperthermia, particularly during hot weather, and paralytic ileus also possible 101 a c k l	Use with caution; dosage adjustment may be neededc
Antipsychotics (e.g., phenothiazines)	Potential for decreased amoxapine metabolisma c	Dosage adjustment may be neededc
Cimetidine	Possible increased plasma amoxapine concentrations101 a c Potential for tricyclic toxicity, particularly anticholinergic adverse effectsc	Monitor for TCA toxicity; dosage adjustment may be neededc
CNS depressants (e.g., analgesics, antihistamines, barbiturates, general anesthetics, opiates)	Potentiates the effects of CNS depressants101 a c l
Guanethidine and related compounds	Possible antagonism of the antihypertensive effects of guanethidine and related compoundsc l
Levodopa	May interfere with levodopa absorption c	Monitor levodopa dosage carefullyc
MAO inhibitors	Potentially life-threatening serotonin syndrome 101 a c l	Concomitant use contraindicated101 a c l Allow at least 2 weeks to elapse when switching to or from these drugs101 a c
Methylphenidate	Potential for decreased metabolism and increased therapeutic efficacy and toxicity of TCAsc
SSRIs (e.g., citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline)	Possible serotonin syndromec Potential for decreased amoxapine metabolism and increased plasma concentrationsa c	Use with caution and monitor for TCA toxicity; dosage adjustment may be neededa c Allow at least 5 weeks to elapse when switching from fluoxetinea c
Sympathomimetic agents (e.g., amphetamines, epinephrine, isoproterenol, norepinephrine, phenylephrine)	Increased vasopressor, cardiac effectsc l	Use with caution; dosage adjustment may be requiredc
Thyroid agents	Possible cardiac arrhythmiasc	Use with caution c

Amoxapine Pharmacokinetics

Absorption

Bioavailability

Rapidly and almost completely absorbed from the GI tract following oral administration.^{101 a b k l r s}

Peak plasma concentrations usually occur within 1–2 hours after oral administration.^{101 a b j k l s}

Onset

Antidepressant effects usually occur within 2 weeks in most patients who respond and may occur within 4–7 days.^{101 a b j}

Distribution

Extent

Widely distributed in the body.^{c k l s}

Amoxapine and its active metabolite, 8-hydroxyamoxapine, distribute into milk.^{100 101 a e l s}

Plasma Protein Binding

Approximately 90%.^{101 a c k s}

Elimination

Metabolism

Metabolized in the liver principally by CYP2D6 to 2 active metabolites, 8-hydroxyamoxapine and 7-hydroxyamoxapine.^{101 a b c h i j k l s} Poor metabolizers of CYP2D6 metabolize the drug more slowly than normal metabolizers.^a

Elimination Route

Excreted principally in urine as conjugated metabolites (60–69%) within 6 days and 7–18% excreted in feces principally as unconjugated metabolites; <5% excreted unchanged.^{101 a b c k l s}

Half-life

Amoxapine: Approximately 8 hours.^{101 a b k l s}

8-Hydroxyamoxapine: 30 hours.^{101 a b h j k l s}

7-Hydroxyamoxapine: 6.5 hours.^{b h j k l}

Stability

Storage

Oral

Tablets

Tight containers at 15–30°C.^{101 a b}

ActionsActions

• 
  

  Mechanism of action in the management of depressive disorders is unknown but may involve inhibition of reuptake of norepinephrine and to a lesser extent serotonin by amoxapine and its active metabolites, 8-hydroxyamoxapine and 7-hydroxyamoxapine.^{101 a c h k l m n s}

  
  

• 
  

  Amoxapine is a derivative of the antipsychotic agent loxapine and has dopamine-receptor blocking properties; may possess some antipsychotic activity but clinical importance is unknown.^{b h k l m n s}

  
  

Advice to Patients

• 
  

  Risk of suicidality; importance of patients, family, and caregivers being alert to and immediately reporting emergence of suicidality, worsening depression, or unusual changes in behavior, especially during the first few months of therapy or during periods of dosage adjustment.^{d o p q} FDA recommends providing written patient information (medication guide) explaining risks of suicidality each time the drug is dispensed.^{o p q}

  
  


• 
  

  Importance of clinicians informing patients in whom chronic use is contemplated of risk of tardive dyskinesia, taking into account clinical circumstances and competency of patient to understand information provided.^{101 a}

  
  


• 
  

  Importance of avoiding certain activities (e.g., operating machinery, driving a motor vehicle) until effects on the individual are known.^{101 a c}

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.^{101 a}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.^{101 a}

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{101 a} (See Cautions.)

  
  

Preparations

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

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Amoxapine

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, scored	25 mg*	Amoxapine Tablets	Watson
		50 mg*	Amoxapine Tablets	Watson
		100 mg*	Amoxapine Tablets	Watson
		150 mg*	Amoxapine Tablets	Watson

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Amoxapine 100MG Tablets (WATSON LABS): 30/$39.99 or 90/$119.96

Amoxapine 150MG Tablets (WATSON LABS): 30/$43.99 or 90/$109.98

Amoxapine 25MG Tablets (WATSON LABS): 60/$25.99 or 180/$68.99

Amoxapine 50MG Tablets (WATSON LABS): 60/$35.99 or 180/$85.96

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 October 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

100. Gelenberg AJ. Amoxapine, a new antidepressant, appears in human milk. J Nerv Ment Dis. 1979; 167:635-6. [PubMed 573779]

101. Lederle Laboratories. Asendin (amoxapine) prescribing information. Pearl River, NY; 1987 Nov.

102. Lesaca T. Amoxapine and neuroleptic malignant syndrome. Am J Psychiatry. 1987; 144:1514. [IDIS 235147] [PubMed 3118723]

103. Food and Drug Administration. Class suicidality labeling language for antidepressants. From the FDA website: ().

104. Food and Drug Administration. Public health advisory: suicidality in children and adolescents being treated with antidepressant medications. Rockville, MD; 2004 Oct 15. From the FDA website: ().

105. Food and Drug Administration. Medication guide: about using antidepressants in children or teenagers. Rockville, MD; 2005 Jan 16. From the FDA website: ().

a. Watson Laboratories, Inc. Amoxapine tablets prescribing information. Corona, CA; 2007 May.

b. AHFS drug information 2007. McEvoy GK, ed. Amoxapine. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2362.

c. AHFS drug information 2007. McEvoy GK, ed. Tricyclic antidepressants general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2353-60.

d. American Psychiatric Association Practice Guidelines. Practice guideline for the treatment of patients with major depressive disorder, second edition. From the APA website ().

e. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Baltimore, MD: Williams & Wilkins; 2005:72-3.

f. American Academy of Child and Adolescent Psychiatry. Summary of the practice parameters for the assessment and treatment of children and adolescents with depressive disorders. From the AACAP website: ().

g. Bridge JA, Iyengar S, Salary CB. Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment: a meta-analysis of randomized controlled trials. JAMA. 2007; 297:1683-96. [PubMed 17440145]

h. Midha KK, Hubbard JW, McKay G et al. The role of metabolites in a bioequivalence study II: amoxapine, 7-hydroxyamoxapine, and 8-hydroxyamoxapine. Int J Clin Pharmacol Ther. 1999; 37:428-38. [PubMed 10507241]

i. Selinger K, Lebel G, Hill HM et al. A high-performance liquid chromatographic method for the analysis of amoxapine in human plasma. J Pharm Biomed Anal. 1989; 7:1001-7. [PubMed 2490101]

j. Calvo B, Garcia MJ, Pedraz JL et al. Pharmacokinetics of amoxapine and its active metabolites. Int J Clin Pharmacol Ther Toxicol. 1985; 23:180-5. [PubMed 3997304]

k. Kinney JL, Evans RL Jr. Evaluation of amoxapine. Clin Pharm. 1982; 1:417-24. [PubMed 6764165]

l. Dugas JE, Weber SS. Amoxapine (Asendin, Lederle Laboratories). Drug Intell Clin Pharm. 1982; 16:199-204. [PubMed 7037342]

m. Apiquian R, Fresan A, Ulloa RE et al. Amoxapine as an atypical antipsychotic: a comparative study vs risperidone. Neuropsychopharmacology. 2005; 30:2236-44. [PubMed 15956984]

n. Apiquian R, Ulloa E, Fresan A et al. Amoxapine shows atypical antipsychotic effects in patients with schizophrenia: results from a prospective open-label study. Schizophr Res. 2003; 59:35-9. [PubMed 12413640]

o. Food and Drug Administration. FDA news: FDA proposes new warnings about suicidal thinking, behavior in young adults who take antidepressant medications. Rockville, MD; 2007 May 2. From the FDA web site: .

p. Food and Drug Administration. Antidepressant use in children, adolescents, and adults: class revisions to product labeling. Rockville, MD; 2007 May 2. From the FDA web site: .

q. Food and Drug Administration. Revisions to medication guide: antidepressant medicines, depression and other serious mental illnesses and suicidal thoughts or actions. Rockville, MD; 2007 May 2. From the FDA web site:

r. Rudorfer MV, Potter WZ. Metabolism of tricyclic antidepressants.Cell Mol Neurobiol. 1999; 19:373-409. [PubMed 10319193]

s. Greenblatt EN, Hardy RA, Kelly RG. Amoxapine. Pharmacol Biochem Prop Drug Subst. 1979; 2:1-18.

More Amoxapine resources

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

• Amoxapine MedFacts Consumer Leaflet (Wolters Kluwer)


• Amoxapine Prescribing Information (FDA)


• Amoxapine Professional Patient Advice (Wolters Kluwer)


• amoxapine Concise Consumer Information (Cerner Multum)


• amoxapine Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Amoxapine with other medications

• Depression

Fybogel Orange

1. Name Of The Medicinal Product

Fybogel Orange.

2. Qualitative And Quantitative Composition

A unit dose (one sachet or two level 5 ml spoonfuls) contains 3.5 g ispaghula husk BP.

3. Pharmaceutical Form

Effervescent granules.

4. Clinical Particulars

4.1 Therapeutic Indications

The treatment of patients requiring a high fibre regime: for example, for the relief of constipation, including constipation in pregnancy and the maintenance of regularity; for the management of bowel function in patients with colostomy, ileostomy, haemorrhoids, anal fissure, chronic diarrhoea associated with diverticular disease, irritable bowel syndrome and ulcerative colitis.

4.2 Posology And Method Of Administration

Fybogel Orange is intended for oral use as a suspension in a drink of water. The granules should be stirred into a glass of water and taken as soon as the effervescence subsides, preferably after meals.

Adults and children over 12 years:	One sachet or two level 5ml spoonfuls morning and evening.
Elderly:	There is no indication that dosage needs to be modified for the elderly.
Children aged 6 to 12 years:	Half to one level 5 ml spoonful, depending on age and size, morning and evening.
Children under 6 years:	To be taken only when prescribed by a doctor, half to one level 5 ml spoonful depending on age and size, morning and evening.

4.3 Contraindications

Fybogel Orange is contraindicated in cases of intestinal obstruction, faecal impaction and colonic atony such as senile megacolon.

4.4 Special Warnings And Precautions For Use

Due to its aspartame content Fybogel Orange should not be given to patients with phenylketonuria.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Fybogel Orange may be used during pregnancy and lactation since the ispaghula husk is not absorbed from the gastrointestinal tract.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

A small amount of abdominal distension and flatulence may sometimes occur.

4.9 Overdose

In the event of overdosage conservative measures should be taken. The patient may notice abdominal discomfort and flatulence, and attention should be paid to maintaining an adequate fluid intake, particularly if the granules have been taken without water contrary to administration instructions.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Ispaghula husk is capable of absorbing up to 40 times its own weight in water in vitro, and part of its activity can be attributed to its action as a simple bulking agent. In addition, colonic bacteria are believed to use the hydrated material as a metabolic substrate. This results in an increase in the bacterial cell mass with consequent softening of the faeces.

5.2 Pharmacokinetic Properties

The mode of action of Fybogel Orange is physical and does not depend on absorption into the systemic circulation.

5.3 Preclinical Safety Data

No preclinical findings relevant to the prescriber have been reported.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Potassium bicarbonate	USP
Sodium bicarbonate	Ph Eur
Citric acid	Ph Eur
Riboflavin sodium phosphate	Ph Eur
Beta-carotene 10% (E160a)	HSE
Aspartame	Ph Eur
Orange flavour	HSE
Saccharin sodium	Ph Eur
Polysorbate 80	Ph Eur
Silica, colloidal anhydrous	Ph Eur

6.2 Incompatibilities

None known.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Store below 30°C in a dry place.

6.5 Nature And Contents Of Container

Sachets, one, seven, ten or thirty sachets enclosed in a carton. Tub containing 100-300 g Fybogel Orange.

6.6 Special Precautions For Disposal And Other Handling

Fybogel Orange granules are to be dispersed in water forming a drink.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited,

Dansom Lane,

Hull,

HU8 7DS.

8. Marketing Authorisation Number(S)

PL 00063/0026

9. Date Of First Authorisation/Renewal Of The Authorisation

24^th April 1995 / 26^th June 1997.

10. Date Of Revision Of The Text

19/01/2007

Mediastinal Infection Medications

There are currently no drugs listed for "Mediastinal Infection".

Learn more about Mediastinal Infection

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Drug List:

Flebogamma 5% solution for infusion

1. Name Of The Medicinal Product

Flebogamma^® 5%.

Solution for infusion.

2. Qualitative And Quantitative Composition

Human normal immunoglobulin (IVIg)

The percentage of IgG subclasses is approximately 68.7% IgG₁, 25.9% IgG₂, 3.7% IgG₃ and 1.78% IgG₄.

Human protein content is 50 g/l of which at least 97% is IgG.

IgA content is lower than 0.05 mg/ml.

For excipients, see 6.1.

3. Pharmaceutical Form

Solution for infusion

4. Clinical Particulars

4.1 Therapeutic Indications

Flebogamma^® 5% is indicated for:

Replacement therapy in:

Primary immunodeficiency syndromes such as:

- congenital agammaglobulinaemia and hypogammaglobulinaemia

- common variable immunodeficiency

- severe combined immunodeficiency

- Wiskott Aldrich syndrome

Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.

Children with congenital AIDS and recurrent infections.

Immunomodulation

Idiopathic thrombocytopenic purpura (ITP), in children or adults at high risk of bleeding or prior to surgery to correct the platelet count.

Guillain Barré Syndrome.

Kawasaki disease.

Allogeneic bone marrow transplantation.

4.2 Posology And Method Of Administration

4.2.1. Posology

The dose and dosage regimen is dependent on the indication.

In replacement therapy the dosage may need to be individualised for each patient dependent on the pharmacokinetic and clinical response.

Replacement therapy in primary immunodeficiency syndromes

The dosage regimen should achieve a trough level of IgG (measured before the next infusion) of at least 4-6 g/l. Three to six months are required after the initiation of therapy for equilibration to occur. The recommended starting dose is 0.4-0.8 g/kg followed by at least 0.2 g/kg every three weeks.

The dose required to achieve a trough level of 6 g/l is of the order of 0.2-0.8 g/kg/month. The dosage interval when steady state has been reached varies from 2-4 weeks.

Trough levels should be measured in order to adjust the dose and dosage interval.

Replacement therapy in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinemia and recurrent infections; replacement therapy in children with AIDS and recurrent infections

The recommended dose is 0.2-0.4 g/kg every three to four weeks.

Idiopathic Thrombocytopenic Purpura

For the treatment of an acute episode, 0.8-1 g/kg on day one, which may be repeated once within 3 days, or 0.4 g/kg daily for two to five days. The treatment can be repeated if relapse occurs.

Guillain Barré syndrome

0.4 g/kg/day for 3 to 7 days.

Experience in children is limited.

Kawasaki Disease

1.6-2.0 g/kg should be administered in divided doses over two to five days or 2.0 g/kg as a single dose.

Patients should receive concomitant treatment with acetylsalicylic acid.

Allogeneic Bone Marrow Transplantation

Human normal immunoglobulin treatment can be used as part of the conditioning regimen and after the transplant.

For the treatment of infections and prophylaxis of graft versus host disease, dosage is individually tailored. The starting dose is normally 0.5 g/kg/week, starting seven days before transplantation and for up to 3 months after transplantation.

In case of persistent lack of antibody production, dosage of 0.5 g/kg/month is recommended until antibody level returns to normal.

The dosage recommendations are summarised in the following table:

Indication	Dose	Frequency
Replacement therapy in primary immunodeficiency	- starting dose: 0.4 – 0.8 g/kg - thereafter: 0.2 – 0.8 g/kg	every 2 – 4 weeks to obtain IgG trough level of at least 4 – 6 g/l
Replacement therapy in secondary immunodeficiency	0.2 – 0.4 g/kg	every 3 – 4 weeks to obtain IgG trough level of at least 4 – 6 g/l
Children with AIDS	0.2 – 0.4 g/kg	every 3 – 4 weeks
Immunomodulation:
Idiopathic Thrombocytopenic Purpura	0.8 – 1 g/kg or 0.4 g/kg/d	on day 1, possibly repeated once within 3 days   for 2 – 5 days
Guillain Barré syndrome	0.4 g/kg/d	for 3 – 7 days
Kawasaki disease	1.6 – 2g/kg or 2g/kg	in several doses for 2 – 5 days in association with acetylsalicylic acid in one dose in association with acetylsalicylic acid
Allogeneic bone marrow transplantation:
-treatment of infections and prophylaxis of graft versus host disease	0.5 g/kg	every week from day –7 up to 3 months after transplantation
-persistent lack of antibody production	0.5 g/kg	every month until antibody levels return to normal

4.2.2. Method of administration

Flebogamma^® 5% should be infused intravenously at an initial rate of 0.6-1.2 ml/kg/hour for the first thirty minutes. If well tolerated, the rate of administration may gradually be increased to a maximum of 4.2 ml/kg/hour.

4.3 Contraindications

Hypersensitivity to any of the components.

(See special warnings about excipients, section 4.4.).

Hypersensitivity to homologous immunoglobulins, especially in very rare cases of IgA deficiency, when the patient has antibodies against IgA.

4.4 Special Warnings And Precautions For Use

Certain severe adverse drug reactions may be related to the rate of infusion. The recommended infusion rate given under “4.2. Posology and method of administration” must be closely followed. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.

Certain adverse reactions may occur more frequently:

- in case of high rate of infusion,

- in patients with hypo- or agammaglobulinemia with or without IgA deficiency,

- in patients who receive human normal immunoglobulin for the first time, or in rare cases, when the human normal immunoglobulin product is switched or when there has been a long interval since the previous infusion.

True hypersensitivity reactions are rare. They can occur in the very seldom cases of IgA deficiency with anti-IgA antibodies.

Rarely, human normal immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who had tolerated previous treatment with human normal immunoglobulin.

Potential complications can often be avoided by ensuring:

- that patients are not sensitive to human normal immunoglobulin by first injecting the product slowly at an initial rate of 0.6-1.2 ml/kg/hour,

- that patients are carefully monitored for any symptoms throughout the infusion period. In particular, patients naive to human normal immunoglobulin, patients switched from an alternative IVIg product or when there has been a long interval since the previous infusion should be monitored during the first infusion and for the first hour after the first infusion, in order to detect potential adverse signs. All other patients should be observed for at least 20 minutes after administration.

There is clinical evidence of an association between IVIg administration and thromboembolic events such as myocardial infarction, stroke, pulmonary embolism and deep vein thromboses which is assumed to be related to a relative increase in blood viscosity through the high influx of immunoglobulin in at-risk patients. Caution should be exercised in prescribing and infusing IVIg in obese patients and in patients with pre-existing risk factors for thrombotic events (such as advanced age, hypertension, diabetes mellitus and a history of vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, patients with prolonged periods of immobilisation, severely hypovolemic patients, patients with diseases which increase blood viscosity).

Cases of acute renal failure have been reported in patients receiving IVIg therapy. In most cases, risk factors have been identified, such as pre-existing renal insufficiency, diabetes mellitus, hypovolemia, overweight, concomitant nephrotoxic medicinal products or age over 65.

In case of renal impairment, IVIg discontinuation should be considered.

While these reports of renal dysfunction and acute renal failure have been associated with the use of many of the licensed IVIg products, those containing sucrose as a stabiliser accounted for a disproportionate share of the total number. Flebogamma^® 5% does not contain sucrose. In patients at risk, the use of IVIg products that do not contain sucrose may be considered.

In patients at risk for acute renal failure or thromboembolic adverse reactions, IVIg products should be administered at the minimum rate of infusion and dose practicable.

In all patients, IVIg administration requires:

- adequate hydration prior to the initiation of the infusion of IVIg

- monitoring of urine output

- monitoring of serum creatinine levels

- avoidance of concomitant use of loop diuretics

In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped. The treatment required depends on the nature and severity of the side effect.

In case of shock, standard medical treatment for shock should be implemented.

Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.

The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV.

The measures taken may be of limited value against non-enveloped viruses such as HAV and parvovirus B19.

There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.

It is strongly recommended that every time that Flebogamma^® 5% is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.

Special warnings about excipients: this medicinal product contains 5 g of sorbitol per 100 ml as excipient. In case of fructose hereditary intolerance this product should not be used.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Live attenuated virus vaccines

Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps and varicella. After administration of this product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines. In the case of measles, this impairment may persist for up to 1 year. Therefore patients receiving measles vaccine should have their antibody status checked.

Interference with serological testing

After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patients blood may result in misleading positive results in serological testing.

Passive transmission of antibodies to erythrocyte antigens, e.g. A, B, D, may interfere with some serological tests for red cell allo-antibodies (e.g. Coombs test), reticulocyte count and haptoglobin.

4.6 Pregnancy And Lactation

The safety of Flebogamma^® 5% for use in human pregnancy has not been established and therefore should only be given with caution to pregnant women and breast feeding mothers. Human immunoglobulins are excreted into the milk.

Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and neonate are to be expected.

4.7 Effects On Ability To Drive And Use Machines

No effects on ability to drive and use machines have been observed.

4.8 Undesirable Effects

Adverse reactions such as chills, headache, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally.

Rarely human normal immunoglobulins may cause a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration.

Cases of reversible aseptic meningitis, isolated cases of reversible haemolytic anaemia/haemolysis and rare cases of transient cutaneous reactions, have been observed with human normal immunoglobulin.

Increase in serum creatinine level and/or acute renal failure have been observed.

Very rarely: Thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, deep vein thromboses.

For safety with respect to transmissible agents, see 4.4.

4.9 Overdose

Overdose may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with renal impairment.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration, ATC code: J06BA02.

Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents.

Human normal immunoglobulin contains the IgG antibodies present in the normal population. It is usually prepared from pooled plasma from not fewer than 1000 donors. It has a distribution of immunoglobulin G subclasses closely proportional to that in native human plasma. Adequate doses of this medicinal product may restore abnormally low immunoglobulin G levels to the normal range.

The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.

5.2 Pharmacokinetic Properties

Human normal immunoglobulin is immediately and completely bioavailable in the recipient's circulation after intravenous administration. It is distributed relatively rapidly between plasma and extravascular fluid, after approximately 3-5 days equilibrium is reached between the intra- and extravascular compartments.

Human normal immunoglobulin has a half-life of 46 days (range 33-65 days). This half-life may vary from patient to patient, in particular in primary immunodeficiency.

IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

- 5% D-sorbitol

- Water for Injections

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products or intravenous fluids. It should be administered by a separate intravenous line.

6.3 Shelf Life

2 years.

6.4 Special Precautions For Storage

Flebogamma^® 5% should be stored below 25 °C and protected from light. The contents must not be frozen.

Do not use after expiry date.

6.5 Nature And Contents Of Container

Flebogamma^® 5% is supplied in type II glass vials containing 10 ml, 50 ml, 100 ml and 200 ml of solution.

6.6 Special Precautions For Disposal And Other Handling

The product should be brought to room or body temperature before use.

The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or have deposits.

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

7. Marketing Authorisation Holder

Instituto Grifols, S.A.

Can Guasch, 2 - Parets del Vallès

08150 Barcelona - SPAIN

8. Marketing Authorisation Number(S)

PL 12930/0007

9. Date Of First Authorisation/Renewal Of The Authorisation

08/11/2005

10. Date Of Revision Of The Text

15/02/2006

Melatonin

Pronunciation: Not applicable.
Generic Name: Melatonin
Brand Name: Generics only. No brands available.

Melatonin is used for:

Sleep disorders such as difficulty sleeping (insomnia) and jet lag. Check with your pharmacist for more details regarding the particular brand you use.

Melatonin is a hormone product. It works by regulating the body's sleep cycles.

Do NOT use Melatonin if:

• you are allergic to any ingredient in Melatonin


• you are taking immunosuppressants (eg, cyclosporine), corticosteroids (eg, prednisone), or nifedipine


• you have a history of immune system disorders, liver disease, or stroke


• you are pregnant or breast-feeding

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

Before using Melatonin:

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

• if you are planning to become pregnant


• 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 kidney problems, depression, or a history of seizures

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

• Nifedipine because the effectiveness may be decreased by Melatonin

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

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

• Dosing depends on the use and the source of the product.


• Use as directed on the package, unless instructed otherwise by your doctor.


• Melatonin is usually taken 2 hours before bedtime for insomnia. Results may be seen within 30 minutes, but it may take 1 to 3 days for the effects to be noticed.


• If you miss taking a dose of Melatonin for 1 or more days, there is no cause for concern. If your doctor recommended that you take it, try to remember your dose every day.

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

Important safety information:

• Melatonin may cause drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to this product. Using this product alone, with certain other medicines or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.


• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking this product. This product will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.


• This product has not been approved by the Food and Drug Administration (FDA) as safe and effective for any medical condition. The long-term safety of dietary supplements is not known. Before using any alternative medicine, talk with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: Do not use this product if you plan to become pregnant. It may have a contraceptive effect. Melatonin is not recommended for use during pregnancy. Consult your doctor before using this product. Because of the potential risk to the infant, breast-feeding while using this product is not recommended. Consult your doctor before breast-feeding.

Possible side effects of Melatonin:

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:

Change in sleep pattern; headache.

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); confusion; depression; fast heartbeat; hypothermia (fast breathing, shivering).

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: Melatonin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Melatonin:

Store at room temperature away from heat, moisture, and light unless otherwise directed on the package label. Do not store in the bathroom. Most dietary supplements are not in childproof containers. Keep Melatonin out of the reach of children and away from pets.

General information:

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


• Melatonin 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 Melatonin. 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 Melatonin resources

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

• Melatonin Natural MedFacts for Professionals (Wolters Kluwer)


• Melatonin Natural MedFacts for Consumers (Wolters Kluwer)


• Melatonin Consumer Overview

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Erythromycin Solution

Pronunciation: eh-RITH-roe-MYE-sin
Generic Name: Erythromycin
Brand Name: Eryderm

Erythromycin Solution is used for:

Treating severe acne. It may also be used for other conditions as determined by your doctor.

Erythromycin Solution is a topical macrolide antibiotic that is thought to improve acne by slowing the growth of bacteria on the skin, which causes acne.

Do NOT use Erythromycin Solution if:

• you are allergic to any ingredient in Erythromycin Solution

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

Before using Erythromycin Solution:

Some medical conditions may interact with Erythromycin Solution. 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 liver disease or you have a blood disorder called porphyria

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

• Arsenic, cisapride, diltiazem, disopyramide, dofetilide, HIV protease inhibitors (eg, ritonavir), imidazoles (eg, ketoconazole), pimozide, QT-prolonging agents (eg, quinidine, sotalol), quinolones (eg, ciprofloxacin), streptogramins (eg, quinupristin/dalfopristin), or verapamil because side effects, such as heart toxicity or irregular heartbeat, may occur


• Anticoagulants (eg, warfarin), aldosterone blockers (eg, spironolactone), benzodiazepines (eg, alprazolam), buspirone, carbamazepine, cilostazol, corticosteroids (eg, hydrocortisone), cyclosporine, digoxin, ergot alkaloids (eg, ergotamine), felodipine, H₁ antagonists (eg, astemizole, terfenadine), HMG-CoA reductase inhibitors (eg, simvastatin), imatinib, macrolide immunosuppressants (eg, tacrolimus), midazolam, phosphodiesterase type 5 inhibitors (eg, sildenafil), rifampin, sumatriptan, theophyllines, or vinca alkaloids (eg, vincristine) because the risk of their side effects may be increased by Erythromycin Solution

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

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

• Wash affected areas with soap and warm water. Rinse well and pat dry before applying the medicine.


• To use the applicator, hold the bottle upside down and moisten applicator by pressing once on the applicator surface with a clean fingertip. Then apply Erythromycin Solution to the affected area using a dabbing motion. Use enough medicine to cover the entire affected area.


• Wash your hands immediately after applying Erythromycin Solution.


• Erythromycin Solution works best if it is used at the same time each day.


• To clear up your infection completely, take Erythromycin Solution for the full course of treatment. Keep taking it even if you feel better in a few days.


• If you miss a dose of Erythromycin Solution, 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 Erythromycin Solution.

Important safety information:

• Erythromycin Solution is for external use only. Avoid contact with the eyes, nose, mouth, and other mucous membranes. If you get Erythromycin Solution in your eyes, immediately wash them out with cool tap water.


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


• Once you begin using Erythromycin Solution, it may take 3 to 8 weeks before you begin to see improvement.


• If severe diarrhea or stomach pain or cramping develops during treatment or within several months after treatment with Erythromycin Solution, check with your doctor or pharmacist right away. Do not treat it without first checking with your doctor.


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


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


• Erythromycin Solution is flammable. Do not store or use near an open flame or while smoking.


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


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Erythromycin Solution while you are pregnant. Erythromycin Solution is found in breast milk. If you are or will be breast-feeding while you use Erythromycin Solution, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Erythromycin Solution:

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:

Burning; dryness; mild stinging; peeling.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; itching, burning, tenderness, or redness of skin; severe diarrhea; stomach cramps/pain.

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

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Erythromycin Solution may be harmful if swallowed.

Proper storage of Erythromycin Solution:

Store Erythromycin Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly-closed container. Store away from heat and light. Keep Erythromycin Solution out of the reach of children and away from pets.

General information:

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


• Erythromycin Solution 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 Erythromycin Solution. 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 Erythromycin resources

• Erythromycin Use in Pregnancy & Breastfeeding
• Erythromycin Support Group
• 1 Review for Erythromycin - Add your own review/rating

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• Acne
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