Palgic

Generic Name: Carbinoxamine Maleate
Class: First Generation Antihistamines
ATC Class: R06AA08
VA Class: AH102
CAS Number: 3505-38-2

Special Alerts:

[Posted 10/09/2008] FDA notified healthcare professionals and consumers that the Consumer Healthcare Products Association (CHPA) is voluntarily modifying the product labels for consumers of over the counter (OTC) cough and cold medicines to state “do not use” in children under 4 years of age. FDA supports CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. FDA continues to assess the safety and efficacy of these products and to revise its OTC list of approved ingredients and amounts for these medicines. Parents and care givers should adhere to the dosage instructions and warnings on the label that accompanies OTC cough and cold medications before giving the product to children, and should consult their healthcare professionals if they have any questions or concerns. For more information visit the FDA website at: and .

Introduction

First generation antihistamine; an ethanolamine derivative.^{100 101}

Uses for Palgic

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

Acute Allergic Reactions

Amelioration of allergic reactions to blood or plasma.^{100 g}

Adjunct to epinephrine and other standard measures for management of anaphylaxis after acute symptoms have been controlled.^{100 g}

Allergic and Nonallergic Rhinitis

Symptomatic relief of seasonal (e.g., hay fever) or perennial (nonseasonal) allergic rhinitis or nonallergic (vasomotor) rhinitis.^{100 g}

Allergic Conjunctivitis

Symptomatic relief of allergic conjunctivitis caused by foods or inhaled allergens.^{100 g}

Allergic Skin Disorders

Symptomatic management of mild, uncomplicated allergic skin manifestations of urticaria and angioedema.^{100 g}

Treatment of dermatographism.^{100 g}

Regulations Governing Carbinoxamine-containing Preparations

Many unapproved carbinoxamine-containing preparations remaining on the US market as of June 2006 contained inappropriate labeling that promoted unapproved uses (including management of congestion†, cough†, or the common cold†, and use in children <2† years of age), which may pose serious health risks.^{101 102} (See Pediatric Use under Cautions and also see Preparations.)

Palgic Dosage and Administration

Administration

Oral Administration

Administer orally as tablets or oral solution on an empty stomach with water.¹⁰⁰

Dosage

Available as carbinoxamine maleate; dosage expressed in terms of the salt.¹⁰⁰

Individualize dosage according to patient’s response and tolerance.¹⁰⁰

Pediatric Patients

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

Allergic Conditions

Acute Allergic Reactions, Allergic and Nonallergic Rhinitis, Allergic Conjunctivitis, or Allergic Skin Disorders

Oral

Children ≥2 years of age: Usually, 0.2–0.4 mg/kg daily.¹⁰⁰

Children 2–3 years of age: 2 mg 3 or 4 times daily (as oral solution).¹⁰⁰

Children 3–6 years of age: 2–4 mg 3 or 4 times daily (as oral solution).¹⁰⁰

Children >6 years of age: 4–6 mg 3 or 4 times daily (as tablets or oral solution).¹⁰⁰

Adults

Allergic Conditions

Acute Allergic Reactions, Allergic and Nonallergic Rhinitis, Allergic Conjunctivitis, or Allergic Skin Disorders

Oral

Usually, 4–8 mg 3–4 times daily (as tablets or oral solution).¹⁰⁰

Special Populations

Geriatric Patients

Initiate at lower dosages and monitor closely.¹⁰⁰ (See Geriatric Use under Cautions.)

Cautions for Palgic

Contraindications

• 
  

  Children <2 years of age.¹⁰⁰

  
  


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  Women who are breast-feeding.¹⁰⁰

  
  


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  Patients receiving MAO inhibitor therapy.¹⁰⁰

  
  


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  Known hypersensitivity to carbinoxamine or any ingredient in the formulation.¹⁰⁰

  
  

Warnings/Precautions

Warnings

Anticholinergic Effects

Possible anticholinergic effects (e.g., dryness of mouth, nose, and throat; dysuria; urinary retention).^b Use with extreme caution, if at all, in patients with angle-closure glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, or bladder neck obstruction.^{100 b}

General Precautions

Concomitant Diseases

Use with caution in patients with increased IOP, hyperthyroidism, or cardiovascular disease (e.g., hypertension).^{100 b}

Use of antihistamines generally not recommended in asthmatics who previously experienced a serious antihistamine-induced adverse bronchopulmonary effect. Do not use to treat lower respiratory symptoms, including asthma.¹⁰⁰

CNS Effects

Risk of drowsiness.^{100 b} Caution when performing hazardous activities requiring mental alertness and motor coordination (e.g., driving a motor vehicle, operating machinery).^{100 b}

Possible excitability (especially in children).¹⁰⁰ (See Pediatric Use under Cautions.)

Concurrent use of other CNS depressants may have additive CNS depressant effects.^{100 b} (See Interactions.)

Specific Populations

Pregnancy

Category C.^{100 c}

Lactation

Discontinue nursing or the drug because of potential risk to nursing infants.¹⁰⁰

Pediatric Use

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

Risk of diminished mental alertness in children.¹⁰⁰

Possible paradoxical excitement (e.g., restlessness, insomnia, tremors, euphoria, nervousness, delirium, palpitation, seizures), particularly in young children.^{100 b}

Safety and efficacy not established in children <2 years of age;¹⁰¹ death reported in such patients, although causal relationship to carbinoxamine not established.^{101 102} Use contraindicated in children <2 years of age.¹⁰⁰

Risk of overdosage and toxicity (including death) in children <2 years of age receiving OTC preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection.^{105 106} Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established.¹⁰⁵ Do not use such preparations in children <2 years of age.^h Clinicians should use caution in prescribing and should ask caregivers about use of OTC cough/cold preparations to avoid overdosage.¹⁰⁵ Efficacy of OTC cough/cold preparations in children <6 years of age also has been questioned.ⁱ An FDA advisory panel recommended that these products not be used in these children;ⁱ FDA has not yet announced its decision.

Geriatric Use

Possible increased risk of dizziness, sedation, and hypotension in patients ≥60 years of age.^{100 b} Confusion or oversedation also may occur.¹⁰⁰ (See Geriatric Patients under Dosage and Administration.)

Common Adverse Effects

Sedation,^{100 g} sleepiness,¹⁰⁰ dizziness,¹⁰⁰ disturbed coordination,¹⁰⁰ epigastric distress,¹⁰⁰ thickening of bronchial secretions.¹⁰⁰

Interactions for Palgic

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
CNS depressants (alcohol, hypnotics, sedatives, tranquilizers)	Possible additive CNS depression100 b	Avoid alcohol;100 avoid concomitant use with other CNS depressants without consulting clinician100
MAO inhibitors	MAO inhibitors prolong and intensify anticholinergic effects of antihistamines100 b	Concomitant use contraindicated100
Test, antigen or histamine	Inhalation-challenge testing with histamine or antigen: Possible suppression of test response Antigen skin testing: Possible suppression of wheal and flare reactions

Palgic Pharmacokinetics

Absorption

Onset

Approximately 30 minutes.^g

Duration

Pharmacologic effects persist for approximately 4 hours.¹⁰⁰

Stability

Storage

Oral

Tablets and Oral Solution

Tight, light-resistant containers with child-resistant closures at 15–30°C.¹⁰⁰

ActionsActions

• 
  

  Blocks H₁-receptor sites and prevents the action of histamine on the cell.^{100 b g}

  
  


• 
  

  Suppresses flare and pruritus that accompany the endogenous release of histamine.^b

  
  


• 
  

  Has anticholinergic and sedative effects.¹⁰⁰

  
  


• 
  

  Exhibits some activities common to anticholinergics, ganglionic and adrenergic blocking agents, local anesthetics, and antispasmodics.^b

  
  


• 
  

  Antihistamines do not block the stimulating effect of histamine on gastric acid secretion, which is mediated by the H₂-receptors of the parietal cells.^b

  
  

Advice to Patients

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

• 
  

  Risk of drowsiness; avoid alcohol and use caution when engaging in activities requiring mental alertness or motor coordination (e.g., operating machinery, driving a motor vehicle).^{100 b}

  
  


• 
  

  Importance of administering tablets or oral solution on an empty stomach with water.¹⁰⁰

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹⁰⁰

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹⁰⁰

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹⁰⁰ (See Cautions.)

  
  

Preparations

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

In June 2006, FDA announced that it would take enforcement action against all firms attempting to illegally manufacture carbinoxamine-containing preparations after September 7, 2006, without an approved application.¹⁰¹ As of January 2008, only one manufacturer (Mikart) had approved abbreviated new drug applications (ANDAs) for carbinoxamine maleate preparations, which are licensed to Pamlab under the proprietary name Palgic.^{102 103} Approved carbinoxamine preparations also may be repackaged and marketed under other names.^{101 102 103}

Carbinoxamine Maleate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Solution	4 mg/5 mL	Carbinoxamine Maleate Solution (with parabens and propylene glycol)	Mikart
			Palgic (with parabens and propylene glycol)	Pamlab
	Tablets	4 mg	Carbinoxamine Maleate Tablets	Mikart
			Palgic (scored)	Pamlab

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 November 2008. 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

Only references cited for selected revisions after 1984 are available electronically.

100. Pamlab, LLC. Palgic (4 mg carbinoxamine maleate) tablet and oral solution prescribing information. Covington, IA; 2006 Jun.

101. Food and Drug Administration. Carbinoxamine products: Enforcement action dates (Docket No. 2006N-0229). Fed Regist. 2006; 71:33462-5.

102. Food and Drug Administration. Questions and answers about unapproved drugs and FDA’s enforcement action against carbinoxamine products. Rockville, MD; 2006 Jun. From FDA website.

103. Anon. Dear Pamlab customer letter. Covington, LA: Pamlab, LLC; 2006 June 12. From Palgic website.

104. US Department of Health and Human Services and Food and Drug Administration Center for Drug Evaluation and Research (CDER). Guidance for FDA staff and industry: Marketed unapproved drugs–Compliance policy guide. 2006 Jun. From FDA web site.

105. Srinivasan A, Budnitz D, Shehab N et al. Infant deaths associated with cough and cold medications—two states, 2005. MMWR Morb Mortal Wkly Rep. 2007; 56:1-4. [PubMed 17218934]

106. Food and Drug Administration. Cough and cold medications in children less than two years of age. Rockville, MD; 2007 Jan 12. From FDA website.

b. AHFS Drug Information 2008. McEvoy GK, ed. Antihistamines General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2008:1-8.

c. Carbinoxamine. In: Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005:229.

g. PamLab, LLC. Palgic (carbinoxamine maleate) product description. Covington, LA; Undated. From Pamlab website.

h. Food and Drug Administration. FDA news: FDA releases recommendations regarding use of over-the-counter cough and cold products. Rockville, MD; 2008 Jan 17. From the FDA web site.

i. Richwine L. U.S. panel against cold drugs for kids under 6. Reuters, 2007 Oct 19. From Reuters website.

More Palgic resources

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

• Palgic Concise Consumer Information (Cerner Multum)


• Palgic Prescribing Information (FDA)


• Palgic MedFacts Consumer Leaflet (Wolters Kluwer)


• Carbinoxamine Prescribing Information (FDA)


• Arbinoxa Prescribing Information (FDA)


• Carbinoxamine PD Concise Consumer Information (Cerner Multum)


• Histex CT Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Histex Pd Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Histex Pd 12 MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Palgic with other medications

• Allergic Reactions
• Allergic Urticaria
• Conjunctivitis, Allergic
• Dermatographism
• Hay Fever
• Vasomotor Rhinitis