Hydrocodone Bitartrate

Class: Opiate Agonists
ATC Class: R05DA03
VA Class: RE301
CAS Number: 34195-34-1
Brands: Anaplex-HD Cough, Anexsia, Ceta-Plus, Codal-DH, Codiclear DH, Codimal DH, Co-Gesic, Cyndal HD, Cytuss HC, Damason-P, Detussin, Donatussin DC, Duratuss HD, Endal HD, Entuss, Entuss-D, Entuss Expectorant, G-Tuss, Histinex HC, Histinex-D, Histussin HC, Histussin-D, Hycomine Compound, Hycosin Expectorant, Hydrogesic, Hydromet, Hydromide, Hydrophene DH, Hydro-Tussin HD, Hyphed, KG-Dal HD, KG-Dal HD Plus, KG-Tuss HD, KG-Tussin, Kwelcof, Lorcet Plus, Lortab, Maxidone Cough, Nalex DH, Norco, Pneumotussin, Protuss, Protuss-D, P-V-Tussin, Reprexain, Su-Tuss-HD, Tussafed-HC, Tuss-DS, Tussend, Tuss-HC, Tussigon, Tussionex Pennkinetic, Tuss-PD, Tuss-S Expectorant, Vanex HD, Vicodin, Vicodin ES, Vicodin Tuss Expectorant, Vicoprofen, Vitussin Expectorant, Zydone

Introduction

Opiate agonist; phenanthrene derivative.^{a b c}

Uses for Hydrocodone Bitartrate

Pain

Symptomatic relief of moderate to moderately severe pain.^{a d}

Combinations of hydrocodone and NSAIAs or acetaminophen may produce additive analgesic effects because of differing mechanisms of action.^c

Cough

Symptomatic relief of nonproductive cough, alone or in combination with other antitussives or expectorants.^b

Hydrocodone Bitartrate Dosage and Administration

Administration

Oral Administration

Administer orally.^{a b 109}

Extended-release Suspension containing Hydrocodone Polistirex and Chlorpheniramine Polistirex (Tussionex Pennkinetic)

Use a calibrated dosing device when measuring doses of the suspension.^{109 112} Use of a household teaspoon could result in overdosage, especially when pediatric doses (2.5 mL of suspension) are measured.^{109 112}

Do not give more frequently than every 12 hours; if cough is not controlled, contact clinician.¹¹²

Do not dilute with fluids or mix with other drugs; shake well prior to administration.¹⁰⁹

Dosage

Available as hydrocodone bitartrate and hydrocodone polistirex; dosage expressed in terms of hydrocodone bitartrate.^{a b c 109}

Pediatric Patients

Cough

Hydrocodone Bitartrate

Oral

Children 6–12 years of age: 2.5 mg every 4–6 hours as needed.¹⁰⁸

Extended-release Suspension containing Hydrocodone Polistirex and Chlorpheniramine Polistirex (Tussionex Pennkinetic)

Oral

Children 6–11 years of age: 2.5 mL (5 mg when expressed in terms of hydrocodone bitartrate) every 12 hours.¹⁰⁹

Children ≥12 years of age: 5 mL (10 mg when expressed in terms of hydrocodone bitartrate) every 12 hours.¹⁰⁹

Adults

Cough

Hydrocodone Bitartrate

Oral

Usual dosage is 5 mg every 4–6 hours as needed.¹⁰⁸

Extended-release Suspension Containing Hydrocodone Polistirex and Chlorpheniramine Polistirex (Tussionex Pennkinetic)

Oral

5 mL (10 mg when expressed in terms of hydrocodone bitartrate) every 12 hours.¹⁰⁹

Pain

Oral

5–10 mg every 4–6 hours as needed.^a Adjust dosage according to severity of pain and response and tolerance of the patient.^a

Nonopiate-containing analgesic fixed combinations: Nonopiate component may limit dosage of opiate component.^{117 119 120 121} Nonopiate analgesics are available in various fixed ratios with hydrocodone and also are available in many other prescription and OTC preparations; ensure that therapy is not duplicated and that nonopiate dosage does not exceed maximum recommended dosages.^{117 118 119 121}

Prescribing Limits

Pediatric Patients

Cough

Hydrocodone Bitartrate

Oral

Children 6–12 years of age: Maximum is 15 mg daily.¹⁰⁸

Extended-release Suspension Containing Hydrocodone Polistirex and Chlorpheniramine Polistirex (Tussionex Pennkinetic)

Oral

Children 6–11 years of age: Maximum 5 mL (10 mg when expressed in terms of hydrocodone bitartrate) daily.¹⁰⁹

Children ≥12 years of age: Maximum 10 mL (20 mg when expressed in terms of hydrocodone bitartrate) daily.¹⁰⁹

Adults

Cough

Hydrocodone Bitartrate

Oral

Maximum 30 mg daily.¹⁰⁸

Extended-release Suspension Containing Hydrocodone Polistirex and Chlorpheniramine Polistirex (Tussionex Pennkinetic)

Oral

Maximum 10 mL (20 mg when expressed in terms of hydrocodone bitartrate) daily.¹⁰⁹

Special Populations

Geriatric Patients

Reduce dosage in older patients.^{a b d 109}

Cautions for Hydrocodone Bitartrate

Contraindications

• 
  

  Known hypersensitivity to hydrocodone or any ingredient in the formulation.^{b 109}

  
  


• 
  

  Possible cross-sensitivity to hydrocodone if hypersensitive to other opiates.^d

  
  


• 
  

  Extended-release oral suspension containing hydrocodone polistirex and chlorpheniramine polistirex (Tussionex Pennkinetic): Contraindicated in children <6 years of age.¹⁰⁹

  
  

Warnings/Precautions

Warnings

Respiratory Depression

Possible dose-related respiratory depression.^{b c d e 109 112}

Potential for increased viscosity of bronchial secretions and suppression of cough reflex, with subsequent respiratory insufficiency, in patients with asthma or pulmonary emphysema who indiscriminately use antitussives.^b

Overdosage and toxicity (including fatal respiratory depression) reported in adults and children receiving the extended-release oral suspension containing hydrocodone polistirex and chlorpheniramine polistirex (Tussionex Pennkinetic).^{109 112} Patients should seek immediate medical assistance if they experience respiratory depression.^{109 112} (See Advice to Patients.)

CNS Depression

Performance of activities requiring mental alertness and physical coordination may be impaired.^{b c d e 109}

Concurrent use of other CNS depressants may potentiate CNS depression.^{b d e 109} (See Specific Drugs under Interactions.)

Abuse Potential

Possible tolerance, psychologic dependence, and physical dependence following prolonged administration.^{b c d e 109} Use only with careful surveillance in patients with a history of drug or alcohol dependence or abuse.^{d e}

Sensitivity Reactions

Sulfite Sensitivity

Some formulations contain sulfites, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.^b

Tartrazine Sensitivity

Some formulations may contain the dye tartrazine (FD&C yellow No. 5), which may cause allergic reactions including bronchial asthma in susceptible individuals.^b Although the incidence of tartrazine sensitivity is low, it frequently occurs in patients who are sensitive to aspirin.^{100 101 102 103 104}

General Precautions

Increased Intracranial Pressure or Head Trauma

Potential for increased respiratory depressant effects and elevation of CSF pressure in patients with increased intracranial pressure, head trauma, or other intracranial lesions.^{b c d e 109}

Adverse effects of opiates may obscure the existence, extent, or course of intracranial pathology.^{b c d e 109}

Acute Abdominal Conditions

Administration may complicate assessment of patients with acute abdominal conditions.^{d e 109} Reduce initial dosage in patients who have undergone GI surgery.

Obstructive Bowel Disease

Use may result in obstructive bowel disease, especially in patients with underlying intestinal motility disorder.¹⁰⁹

Postoperative Patients

Suppression of cough reflex following thoracotomy or laparotomy may lead to postoperative retention of secretions; cautious use recommended.^{b 109}

Debilitated and Special Risk Patients

Use with caution in debilitated patients and in those with hypothyroidism, Addison’s disease, prostatic hypertrophy, urethral stricture, or pulmonary disease.^{b c d e 109}

Fixed-Combination Preparations

When used in fixed combination with other drugs, consider the cautions, precautions, and contraindications associated with the other drug(s).^a

Specific Populations

Pregnancy

Category C.^{d e 109}

Lactation

Not known whether hydrocodone is distributed into milk.^{d 109} Discontinue nursing or the drug.^{d 109}

Pediatric Use

Safety and efficacy for the management of moderate to moderately severe pain has not been established.^d

Safety and efficacy as an antitussive not established in children <6 years of age.^{105 106 107 108 109 112}

Extended-release oral suspension containing hydrocodone polistirex and chlorpheniramine polistirex (Tussionex Pennkinetic): Contraindicated in children <6 years of age; use with caution in children ≥6 years of age due to the risk of respiratory depression.^{109 112} Risk of potentially fatal respiratory depression is increased with overdosage or concomitant use of other respiratory depressants.¹⁰⁹ (See Warnings/Precautions and see Dosage and Administration.)

Benefit-to-risk ratio should be carefully considered, especially in children with respiratory embarrassment (e.g., croup).¹⁰⁹

Risk of overdosage and toxicity (including death) in children <2 years of age receiving preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection.^{110 111} Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established.¹¹⁰ Therefore, FDA recommends not to use such preparations in children <2 years of age; safety and efficacy in older children currently under evaluation. Because children 2–3 years of age also are at increased risk of overdosage and toxicity, some manufacturers of oral nonprescription cough and cold preparations recently agreed to voluntarily revise the product labeling to state that such preparations should not be used in children <4 years of age. During the transition period, some preparations on pharmacy shelves will have the new recommendation (“do not use in children <4 years of age”), while others will have the previous recommendation (“do not use in children <2 years of age”). FDA recommends that parents and caregivers adhere to dosage instructions and warnings on the product labeling that accompanies the preparation and consult a clinician about any concerns. Clinicians should ask caregivers about use of OTC cough/cold preparations to avoid overdosage.

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.^{d 109} Use with caution.^{d 109} (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Use with caution in severe hepatic impairment.^{d 109}

Renal Impairment

Use with caution in severe renal impairment.^{d 109}

Common Adverse Effects

Lightheadedness, dizziness, sedation, nausea, vomiting.^{b d 109} Adverse effects occur infrequently with usual oral antitussive dosages.^b

Interactions for Hydrocodone Bitartrate

Specific Drugs

Drug	Interaction	Comments
Anticholinergic agents	Possible paralytic ileuse 109
Antidepressants, MAO inhibitors and tricyclics	Potentiation of antidepressant adverse effectd e 109	Use with caution; reduce dosage of hydrocodonee
CNS depressants (e.g., alcohol, antihistamines, general anesthetics, opiate agonists, phenothiazines, sedatives/hypnotics, tranquilizers)	Additive CNS effectsd 109	Reduce dosage of one or both agentsd e 109

Hydrocodone Bitartrate Pharmacokinetics

Absorption

Bioavailability

Well absorbed from the GI tract following oral administration.^b

Conventional (immediate-release) preparations: Peak serum concentrations of hydrocodone occur after 1.3 hours.^{b d e}

Extended-release oral suspension containing hydrocodone polistirex and chlorpheniramine polistirex (Tussionex Pennkinetic): Peak plasma concentrations of hydrocodone occur after 3.4 hours.¹⁰⁹

Duration

Conventional (immediate-release) preparations: Antitussive action is maintained for 4–6 hours.^b

Extended-release oral suspension containing hydrocodone polistirex and chlorpheniramine polistirex (Tussionex Pennkinetic): Symptom control maintained for up to 12 hours.¹⁰⁹

Distribution

Extent

Distributed into skeletal muscle, kidneys, liver, intestinal tract, lungs, spleen, and brain.^c

Not known whether distributed into milk.^{d 109}

Readily crosses the placenta.^c

Elimination

Metabolism

Metabolized in the liver.^b

Elimination Route

Excreted mainly in the urine.^b

Half-life

3.8 hours.^{d e 109}

Stability

Storage

Oral

Tablets

Tight, light resistant containers at 15–30°C.^d

Solution

Tight, light resistant containers at 15–30°C.^e

Extended-release Suspension

Tussionex Pennkinetic: Tight containers at 20–25ºC (may be exposed to 15–30°C).¹⁰⁹ Shake well before use.¹⁰⁹

ActionsActions

• 
  

  Principal pharmacologic effects are on CNS and intestines.^c

  
  


• 
  

  Mild analgesic effect.^a Acts at several sites within the CNS involving several systems of neurotransmitters to produce analgesia; precise mechanism of action not fully elucidated.^c

  
  


• 
  

  Suppresses cough reflex by direct effect on cough center in medulla of brain.^{b 109}

  
  


• 
  

  Exerts drying effect on respiratory tract mucosa and increases viscosity of bronchial secretions.^b

  
  


• 
  

  Antitussive activity is slightly greater than that of codeine (on a weight basis).^b

  
  

Advice to Patients

• 
  

  Importance of not exceeding the recommended dosage.¹⁰⁹

  
  


• 
  

  Consequences of overdosage may include potentially fatal respiratory depression.¹⁰⁹

  
  


• 
  

  Importance of seeking medical attention if trouble breathing, slow heartbeat, severe sleepiness, dizziness, confusion, or cold, clammy skin develops.^{109 112}

  
  


• 
  

  When the extended-release oral suspension containing hydrocodone polistirex and chlorpheniramine polistirex (Tussionex Pennkinetic) is used, importance of ensuring that the correct amount of medication required for the intended dose is administered (e.g., importance of using a calibrated dosing device).¹⁰⁹

  
  


• 
  

  Potential for drug to impair mental alertness or physical coordination; use caution when driving or operating machinery until effects on individual are known.^{b c d e 109}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and alcohol consumption.^{d e} Importance of avoiding alcohol-containing beverages or products.^d

  
  


• 
  

  Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.^{d e 109}

  
  


• 
  

  Importance of advising patients of other important precautionary information.^{d e 109} (See Cautions.)

  
  

Preparations

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

Subject to control under the Federal Controlled Substances Act of 1970 as schedule III (C-III) drugs when available as a fixed-combination preparation in a concentration of ≤15 mg per dosage unit or 5 mL combined with a therapeutic amount of one or more nonopiate drugs or with a fourfold or greater quantity of isoquinolone opium alkaloid.

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

Hydrocodone Bitartrate Combinations

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	5 mg with Acetaminophen 500 mg*	Ceta-Plus (C-III)	Seatrace
			Hydrocodone Bitartrate and Acetaminophen Capsules (C-III)
			Hydrogesic (C-III)	Edwards
	Solution	1.67 mg/5 mL with Chlorpheniramine Maleate 2 mg/5 mL and Phenylephrine Hydrochloride 5 mg/5 mL	Cyndal HD Syrup (C-III)	Cypress
			Hydrocodone Bitartrate Chlorpheniramine Maleate and Phenylephrine Hydrochloride Liquid (C-III)
			Hydrocodone HD Syrup (C-III)	Morton Grove
			KG-Dal HD Syrup (C-III)	King
			Tuss-PD (C-III)	Seatrace
			Vanex HD (C-III)	Jones Pharma
		1.67 mg/5 mL with Phenylephrine Hydrochloride 5 mg/5 mL	Nalex DH (C-III)	Blansett
		1.67 mg/5 mL with Phenylephrine Hydrochloride 5 mg/5 mL and Pyrilamine Maleate 8.33 mg/5 mL	Codal-DH Syrup (C-III)	Cypress
			Codimal DH Syrup (C-III)	Schwarz
			Hydrophene DH Syrup (C-III)	Morton Grove
		1.7 mg/5 mL with Brompheniramine Maleate 2 mg/5 mL and Pseudoephedrine Hydrochloride 30 mg/5 mL	Anaplex-HD Cough Syrup (C-III)	ECR
		2 mg/5 mL with Chlorpheniramine Maleate 2 mg/5 mL and Phenylephrine Hydrochloride 5 mg/5 mL	Endal HD Syrup (C-III)	Propst
		2.5 mg/5 mL with Acetaminophen 167 mg/5 mL	Hydrocodone Bitartrate and Acetaminophen Elixir (C-III)
			Lortab Elixir (C-III)	UCB
		2.5 mg/5 mL with Chlorpheniramine Maleate 2 mg/5 mL and Phenylephrine Hydrochloride 5 mg/5 mL	Cytuss HC Syrup (C-III)	Cypress
			Histinex HC (C-III)	Ethex
			Histussin HC Syrup (C-III)	Sanofi-Synthelabo
			Hydrocodone CP Syrup (C-III)
			KG-Dal HD Plus Syrup (C-III)	King
			Tuss-HC (C-III)	Seatrace
		2.5 mg/5 mL with Chlorpheniramine Maleate 2 mg/5 mL and Pseudoephedrine Hydrochloride 30 mg/5 mL	Hyphed Syrup (C-III)	Cypress
			KG-Tussin Syrup (C-III)	King
			P-V-Tussin Syrup (C-III)	Numark
			Tussend Syrup (C-III)	Monarch
		2.5 mg/5 mL with Guaifenesin 50 mg/5 mL and Phenylephrine Hydrochloride 7.5 mg/5 mL	Donatussin DC Syrup (C-III)	Laser
			Tussafed-HC (C-III)	Everett
		2.5 mg/5 mL with Guaifenesin 100 mg/5 mL and Pseudoephedrine Hydrochloride 30 mg/5 mL	Duratuss HD Elixir (C-III)	UCB
			Hydro-Tussin HD Elixir (C-III)	Ethex
			KG-Tuss HD Elixir (C-III)	King
			Su-Tuss-HD Elixir (C-III)	Cypress
			Tussend Expectorant (C-III)	Monarch
		2.5 mg/5 mL with Guaifenesin 200 mg/5 mL	Pneumotussin 2.5 Cough Syrup (C-III)	ECR
		3.5 mg/5 mL with Chlorpheniramine Maleate 2 mg/5 mL and Phenylephrine Hydrochloride 5 mg/5 mL	Endal HD Plus Syrup (C-III)	Propst
		5 mg/5 mL with Chlorpheniramine Maleate 2 mg/5 mL and Phenylephrine Hydrochloride 5 mg/5 mL	Tuss-DS (C-III)	Seatrace
		5 mg/5 mL with Guaifenesin 100 mg/5 mL	Codiclear DH Syrup (C-III)	Schwarz
			G-Tuss Syrup (C-III)	Seatrace
			Hycosin Expectorant (C-III)	Alpharma
			Hydrocodone Bitartrate and Guaifenesin Expectorant (C-III)
			Hydrocodone GF Syrup (C-III)	Morton Grove
			Kwelcof Liquid (C-III)	Ascher
			Vicodin Tuss Expectorant Syrup (C-III)	Abbott
			Vitussin Expectorant (C-III)	Cypress
		5 mg/5 mL with Homatropine Methylbromide 1.5 mg/5 mL	Hydrocodone Bitartrate and Homatropine Methylbromide Syrup (C-III)
			Hydromet Syrup (C-III)	Alpharma
			Hydromide Syrup (C-III)	Major
		5 mg/5 mL with Potassium Guaiacolsulfonate 300 mg/5 mL	Entuss Expectorant (C-III)	Lee
			Protuss (C-III)	First Horizon
		5 mg/5 mL with Potassium Guaiacolsulfonate 300 mg/5 mL and Pseudoephedrine Hydrochloride 30 mg/5 mL	Entuss-D Liquid (C-III)	Lee
			Protuss-D (C-III)	First Horizon
		5 mg/5 mL with Pseudoephedrine Hydrochloride 60 mg/5 mL	Detussin Liquid (C-II)	Alpharma
			Histinex-D (C-III)	Ethex
			Histussin-D (C-III)	Sanofi-Synthelabo
			Tuss-S Expectorant (C-III)	Seatrace
		10 mg/5 mL with Potassium Guaiacolsulfonate 400 mg/5 mL	Protuss (C-III)	First Horizon
	Tablets	2.5 mg with Acetaminophen 500 mg	Hydrocodone Bitartrate and Acetaminophen Tablets (C-III)
			Lortab (C-III; scored)	UCB Pharma
		2.5 mg with Guaifenesin 300 mg	Pneumotussin (C-III)	ECR
		5 mg with Acetaminophen 250 mg, Caffeine Anhydrous 30 mg, Chlorpheniramine Maleate 2 mg, and Phenylephrine Hydrochloride 10 mg	Hycomine Compound (C-III; scored)	Endo
		5 mg with Acetaminophen 400 mg*	Zydone (C-III)	Endo
		5 mg with Acetaminophen 500 mg*	Anexsia 5/500 (C-III; scored)	Mallinckrodt
			Co-Gesic (C-III; scored)	Schwarz
			Lortab 5/500 (C-III; scored)	UCB
			Vicodin (C-III; scored)	Abbott
		5 mg with Aspirin 500 mg	Damason-P (C-III)	Mason
		5 mg with Chlorpheniramine Maleate 4 mg and Pseudoephedrine Hydrochloride 60 mg	Tussend (C-III)	Monarch
		5 mg with Guaifenesin 300 mg	Entuss (C-III)	Lee
		5 mg with Homatropine Methylbromide 1.5 mg	Tussigon (C-III; scored)	Jones Pharma
		5 mg with Pseudoephedrine Hydrochloride 60 mg	P-V-Tussin (C-III; scored)	Numark
		7.5 mg with Acetaminophen 400 mg*	Zydone (C-III)	Endo
		7.5 mg with Acetaminophen 500 mg*	Lortab (C-III; scored)	UCB
		7.5 mg with Acetaminophen 650 mg*	Anexsia 7.5/650 (C-III; scored)	Mallinckrodt
			Lorcet Plus (C-III; scored)	Forest
		7.5 mg with Acetaminophen 750 mg*	Vicodin ES (C-III; scored)	Abbott
		10 mg with Acetaminophen 325 mg	Hydrocodone Bitartrate and Acetaminophen Tablets (C-III)
			Norco (C-III; scored)	Watson
		10 mg with Acetaminophen 400 mg	Zydone (C-III)	Endo
		10 mg with Acetaminophen 500 mg*	Lortab 10/500 (C-III; scored)	UCB
		10 mg with Acetaminophen 650 mg*	Lorcet 10/650 (C-III; scored)	Forest
		10 mg with Acetaminophen 660 mg	Anexia 10/660 (C-III)	Mallinckrodt
			Vicodin HP (C-III; scored)	Abbott
		10 mg with Acetaminophen 750 mg	Maxidone 2.5 Cough Syrup (C-III)	Watson
	Tablets, film-coated	2.5 mg with Ibuprofen 200 mg	Reprexain (C-III)	Hawthorn
		5 mg with Ibuprofen 200 mg	Reprexain (C-III)	Hawthorn
		7.5 mg with Ibuprofen 200 mg*	Hydrocodone Bitartrate and Ibuprofen Film-coated Tablets (C-III)
			Vicoprofen (C-III)	Abbott
		10 mg with Ibuprofen 200 mg	Reprexain (C-III)	Hawthorn

Hydrocodone Polistirex Combinations

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Suspension, extended-release	equivalent to Hydrocodone Bitartrate 10 mg/5 mL with Chlorpheniramine Polistirex equivalent to Chlorpheniramine Maleate 8 mg/5 mL	Tussionex Pennkinetic (C-III)	UCB

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.

Hydrocodone-Acetaminophen 10-325MG Tablets (MALLINCKRODT PHARM): 30/$16.99 or 90/$44.97

Hydrocodone-Acetaminophen 10-500MG Tablets (MALLINCKRODT PHARM): 30/$14.99 or 90/$38.98

Hydrocodone-Acetaminophen 10-650MG Tablets (MALLINCKRODT PHARM): 30/$13.99 or 90/$29.97

Hydrocodone-Acetaminophen 10-660MG Tablets (MALLINCKRODT PHARM): 30/$15.99 or 90/$35.97

Hydrocodone-Acetaminophen 10-750MG Tablets (MALLINCKRODT PHARM): 30/$32.99 or 90/$89.97

Hydrocodone-Acetaminophen 2.5-500MG Tablets (QUALITEST): 30/$12.99 or 90/$27.27

Hydrocodone-Acetaminophen 5-500MG Tablets (MALLINCKRODT PHARM): 30/$11.99 or 60/$16.98

Hydrocodone-Acetaminophen 7.5-325MG Tablets (MALLINCKRODT PHARM): 30/$18.99 or 90/$51.97

Hydrocodone-Acetaminophen 7.5-500MG/15ML Solution (QUALITEST): 473/$60.98 or 1419/$182.95

Hydrocodone-Acetaminophen 7.5-500MG Tablets (MALLINCKRODT PHARM): 30/$13.99 or 60/$17.98

Hydrocodone-Acetaminophen 7.5-650MG Tablets (MALLINCKRODT PHARM): 100/$15.99 or 300/$35.97

Hydrocodone-Acetaminophen 7.5-750MG Tablets (MALLINCKRODT PHARM): 30/$12.99 or 90/$23.99

Lorcet 10/650 10-650MG Tablets (FOREST): 30/$57.99 or 90/$159.97

Lorcet Plus 7.5-650MG Tablets (FOREST): 30/$48.49 or 90/$131.14

Lortab 7.5-500MG/15ML Elixir (UCB PHARMA): 120/$40.99 or 360/$115.97

Lortab 10 10-500MG Tablets (UCB PHARMA): 30/$55.99 or 90/$150.97

Lortab 2.5 2.5-500MG Tablets (UCB PHARMA): 30/$30.99 or 90/$78.97

Lortab 5 5-500MG Tablets (UCB PHARMA): 30/$54.99 or 90/$140.97

Lortab 7.5 7.5-500MG Tablets (UCB PHARMA): 30/$54.99 or 90/$145.96

Norco 10-325MG Tablets (WATSON LABS): 30/$64.29 or 90/$178.55

Norco 5-325MG Tablets (WATSON LABS): 30/$45.99 or 90/$115.97

Norco 7.5-325MG Tablets (WATSON LABS): 30/$49.99 or 90/$139.97

Stagesic 5-500MG Capsules (MAGNA PHARMACEUTICALS INC): 30/$24.99 or 90/$51.97

Vicodin 5-500MG Tablets (ABBOTT): 30/$49.99 or 90/$119.98

Vicodin ES 7.5-750MG Tablets (ABBOTT): 30/$51.9 or 90/$138.37

Vicodin HP 10-660MG Tablets (ABBOTT): 30/$51.99 or 90/$145.98

Xodol 10-300MG Tablets (VICTORY PHARMA): 100/$265.99 or 300/$749.97

Zydone 10-400MG Tablets (ENDO PHARMACEUTICALS): 30/$31.99 or 90/$83.97

Zydone 5-400MG Tablets (ENDO PHARMACEUTICALS): 30/$27.99 or 90/$65.97

Zydone 7.5-400MG Tablets (ENDO PHARMACEUTICALS): 30/$32.99 or 90/$72.58

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 February 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

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

100. American Medical Association Council on Scientific Affairs. Aspartame: review of safety issues. JAMA. 1985; 254:400-2. [IDIS 202002] [PubMed 2861297]

101. Gossel TA. A review of aspartame: characteristics, safety and uses. US Pharm. 1984; 9:26,28-30.

102. Food and Drug Administration. Aspartame as an inactive ingredient in human drug products; labeling requirements. Proposed rule. [21 CFR Part 201] Fed Regist. 1983; 48:54993-5. (IDIS 178728)

103. Food and Drug Administration. Food additives permitted for direct addition to food for human consumption; aspartame. Final rule. [21 CFR Part 172] Fed Regist. 1983; 48:31376-82. (IDIS 172957)

104. Anon. Aspartame and other sweeteners. Med Lett Drugs Ther. 1982; 24:1-2. [PubMed 7054648]

105. Food and Drug Administration. FDA takes action to stop marketing of unapproved hydrocodone products. Rockville, MD; 2007 Sep 28. From FDA website.

106. Food and Drug Administration. Questions and answers about FDA's enforcement action regarding unapproved hydrocodone drug products. Rockville, MD; 2007 Oct 1. From FDA website.

107. Food and Drug Administration. Drug products containing hydrocodone; enforcement action dates. Notice. [Docket No. 2007N-0353]. Fed Regist. 2007; 72:55780-4.

108. Endo Pharmaceuticals, Inc. Hycodan (hydrocodone bitartrate and homatropine methylbromide) tablets and suspension prescribing information. Chadds Ford, PA; 2001 Nov.

109. UCB, Inc. Tussionex Pennkinetic (hydrocodone polistirex and chlorpheniramine polistirex) extended-release suspension prescribing information. Smyrna, GA; 2008 Jan.

110. 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]

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

112. Food and Drug Administration. FDA public health advisory: Important information for the safe use of Tussionex Pennkinetic extended-release suspension. Rockville, MD; 2008 Mar 11. From FDA web site.

117. Jackson KC II, Lipman AG. Nonopioid analgesics. In: Lipman AG, ed. Pain management for primary care clinicians. Bethesda, MD: American Society of Health-System Pharmacists; 2004:43-58.

118. Cranmer KW, Mason M. Special considerations in geriatric pain management. In: Lipman AG, ed. Pain management for primary care clinicians. Bethesda, MD: American Society of Health-System Pharmacists; 2004:219-232.

119. Fakata KL, Miaskowski C, Lipman AG. Chronic malignant pain. In: Lipman AG, ed. Pain management for primary care clinicians. Bethesda, MD: American Society of Health-System Pharmacists; 2004:139-52.

120. McNicol E, Carr DB. Pharmacological treatment of pain. In: McCarberg B, Passik SD, eds. Expert guide to pain management. Philadelphia: American College of Physicians; 2005:145-78.

121. American Pain Society. Principles of analgesic use in the treatment of acute pain and cancer pain. 5th edition. Glenview, IL; 2003:3,9,13,14.

a. AHFS Drug Information 2008. McEvoy GK, ed. Hydrocodone Bitartrate. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2186-7.

b. AHFS Drug Information 2008. McEvoy GK, ed. Hydrocodone Bitartrate. Bethesda, MD; American Society of Health-System Pharmacists; 2008:2805-7.

c. AHFS drug information 2004. McEvoy GK, ed. Opiate agonists general statement. Bethesda, MD: American Society of Hospital Pharmacists; 2004:2030-5.

d. Watson Laboratories. Hydrocodone Bitartrate and Acetaminophen tablets prescribing information. Corona, CA; 2003 Jan.

e. Monarch Pharmaceuticals. Tussend tablets and syrup prescribing information. Bristol, TN; 1998 Sep.

More Hydrocodone Bitartrate resources

• Hydrocodone Bitartrate Drug Interactions
• Hydrocodone Bitartrate Support Group
• 0 Reviews · Be the first to review/rate this drug

HD 85 Suspension

barium sulfate

Dosage Form: suspension
LAFAYETTE

HD 85™

BARIUM SULFATE SUSPENSION


Rx only

HD 85 Suspension Description

HD 85 is a raspberry flavored barium sulfate suspension. It is a contrast medium developed for use in x-ray diagnosis of the gastrointestinal tract.

The product contains 85% w/v barium sulfate USP, suspending and dispersing agents, simethicone, citric acid, flavoring, potassium sorbate, sodium citrate, saccharin sodium and water. Barium sulfate has the empirical formula of BaSO4.

HD 85 Suspension - Clinical Pharmacology

Barium sulfate is an insoluble material which, because of its density, provides a positive contrast during x-ray examination. Barium sulfate is an inert radiopaque material which is not absorbed or metabolized and is eliminated intact from the body in a manner similar to other non-absorbed inorganic materials. Excretion rate is a function of gastrointestinal transit time.

Indications and Usage for HD 85 Suspension

HD 85 is indicated for use as a contrast medium in x-ray diagnosis of the gastrointestinal tract. The suspension may be administered without dilution for double contrast colon examinations. Aqueous dilutions of HD 85 may be administered rectally for routine filled colon studies or given orally for esophageal swallow, filled stomach or enteroclysis procedures.

Contraindications

Barium sulfate products are contraindicated in patients with known or suspected obstruction of the colon, known or suspected gastrointestinal tract perforation, suspected tracheoesophageal fistula, obstructing lesions of the small intestine, pyloric stenosis, inflammation or neoplastic lesions of the rectum, recent rectal biopsy, or known hypersensitivity to barium sulfate formulations.

Barium sulfate suspensions should not be used for infants with swallowing disorders or for newborns with complete duodenal or jejunal obstruction or when distal small bowel or colon obstruction is suspected. Barium sulfate suspension is not recommended for very small preterm infants and young babies requiring small volumes of contrast media or for infants and young children when there is a possibility of leakage from the gastrointestinal tract, such as necrotizing enterocolitis, unexplained pneumoperitoneum, gasless abdomen, other bowel perforation, esophageal perforation or post operative anastomosis.

Known hypersensitivity or allergy to latex is a contraindication for the use of balloon retention enema tips containing latex. The use of a retention cuff enema tip is not necessary or desirable in patients with normal sphincter tone. The presence of adequate sphincter tone can be judged by preliminary rectal digital examination.

Warnings

Serious adverse reactions, including death, have been reported with the administration of barium sulfate formulations and are usually associated with the technique of administration, the underlying pathological condition and/or patient hypersensitivities.

Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis. Oral administration of barium sulfate suspension by an infant sucking a bottle and administration of large quantities by catheter are reported to be likely to result in aspiration into the tracheobronchial tree. Cardiopulmonary arrest leading to fatality has been reported in infants following aspiration. Aspiration of smaller amounts may cause inflammation.

Barium sulfate preparations used as radiopaque media contain a number of additives to provide diagnostic properties and patient palatability. Allergic responses following the use of barium sulfate suspensions have been reported. Skin irritation, redness, inflammation and hives have been reported for infants and small children following spillage of barium sulfate suspension on their skin. These responses are thought to be caused by the flavors and/or preservatives used in the product.

Barium sulfate suspension has been reported to cause obstruction of the small bowel (impaction) in pediatric patients with cystic fibrosis. It has also been reported to cause fluid overload from the absorption of water during studies in infants when Hirschsprung’s Disease is suspected.

Barium sulfate suspension intravasation can be a serious complication. Mortality has been reported as a result of vaginal or rectal intravasation and is believed to be due to massive pulmonary embolism occurring within minutes of the inciting event.

In patients with increased cranial pressure, barium sulfate suspension enemas present an additional risk of further increasing intracranial pressure.

Care must be taken during the insertion of an enema tip into the patient to prevent application of pressure to the vagus nerve which can lead to vasovagal reactions and syncopal episodes. Cardiac arrhythmia or other cardiovascular side effects can occur as a result of colon distention.

Precautions

General

Diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the requisite training and with a thorough knowledge of the particular procedure to be performed. A history of bronchial asthma, atopy, as evidenced by hay fever and eczema, a family history of allergy, or a previous reaction to a contrast agent warrant special attention. Caution should be exercised with the use of radiopaque media in severely debilitated patients and in those with marked hypertension or advanced cardiac disease.

Anaphylactic and allergic reactions have been reported during double contrast examinations in which glucagon has been used.

An increased risk of perforation has been reported in neonates with intussusception. In patients with cystic fibrosis or blind loops of the bowel or ileus, there is a risk of inspissation leading to partial or complete obstruction.

In neonates and infants with motility disorders such as Hirschsprung’s Disease, retention of large amounts of barium sulfate suspension may result in absorption of water from the suspension and fluid overload. The addition of small amounts of salt to the barium sulfate suspension has been reported to reduce the problem.

Ingestion of barium sulfate suspension is not recommended in patients with a history of food aspiration. If barium sulfate suspension is aspirated into the larynx, further administration of the suspension should be immediately discontinued.

Patient preparation for diagnostic gastrointestinal examinations frequently requires cathartics and a liquid diet. The various preparations can result in water loss for the patient. Patients should be rehydrated quickly following a barium sulfate suspension examination of the gastrointestinal tract. In patients with reduced colon motility, saline cathartics may be required after the barium sulfate suspension enema. Saline cathartics are recommended on a routine basis in patients with a history of constipation unless clinically contraindicated.

Where enema tips are used, care must be taken during insertion into the patient, since forceful or too deep insertion may cause tearing or perforation of the rectum. Insertion of an enema tip should be done only after digital examination by qualified medical personnel. When balloon retention tips are used, care should be taken to avoid overinflation of the balloon, since overfilling or asymmetrical filling may cause displacement of the tip. Such a displacement can lead to rectal perforation or barium sulfate granulomas. Inflation of the balloon should be done under fluoroscopic control by qualified medical personnel. Do not unnecessarily move the enema tip once inserted.

A specially designed enema tip is required for a barium sulfate suspension examination of a colostomy patient.

Intubation of an enteroclysis catheter should be done by qualified medical personnel. Perforation of the duodenum has been reported.

Because of reported anaphylactoid reactions to latex, the use of non-latex gloves during the procedure should be considered.

Pregnancy

Safe use of barium sulfate during pregnancy has not been established. Barium sulfate should be used in pregnant women only if the possible benefits outweigh the potential risks. Elective radiography of the abdomen is considered to be contraindicated during pregnancy due to the risk to the fetus from radiation exposure. Radiation is known to cause harm to the unborn fetus exposed in utero.

Pediatric Use

The radiographic contrast agents used for examination of children do not differ substantially from those used for adults. The variation in physical sizes of pediatric patients requires more thorough attention to individualizing dosage. The volume of barium sulfate suspension and the barium sulfate content required will also depend upon the technique used and the clinical need.

Adverse Reactions

Adverse reactions accompanying the use of barium sulfate formulations are infrequent and usually mild, though severe reactions (approximately 1 in 500,000) and fatalities (approximately 1 in 2,000,000) have occurred. Procedural complications are rare, but may include aspiration pneumonitis, barium sulfate impaction, granuloma formation, intravasation, embolization and peritonitis following intestinal perforation, vasovagal and syncopal episodes, and fatalities. EKG changes have been shown to occur following or during barium sulfate suspension enemas. It is of the utmost importance to be completely prepared to treat any such occurrence.

Due to increased likelihood of allergic reactions in atopic patients, a complete history of known and suspected allergies as well as allergic-like symptoms, such as rhinitis, bronchial asthma, eczema and urticaria, must be obtained prior to any medical procedure.

Aspiration of large amounts of barium sulfate suspension may cause pneumonitis or nodular granulomas of interstitial lung tissues and lymph nodes; asphyxiation and death have been reported.

Transient bacteremia, beginning almost immediately and lasting up to 15 minutes, may also occur during rectal administration of barium sulfate suspension and rarely septicemia has been reported.

A rare mild allergic reaction would most likely be generalized pruritus, erythema or urticaria (approximately 1 in 100,000 reactions). Such reactions will often respond to an antihistamine. More serious reactions (approximately 1 in 500,000) may result in laryngeal edema, bronchospasm or hypotension.

Severe reactions which may require emergency measures are often characterized by peripheral vasodilation, hypotension, reflex tachycardia, dyspnea, bronchospasm, agitation, confusion and cyanosis, progressing to unconsciousness. Treatment should be initiated immediately according to established standard of care.

Apprehensive patients may develop weakness, pallor, tinnitus, diaphoresis and bradycardia following the administration of any diagnostic agent. Such reactions are usually non-allergic in nature.

Allergic reactions to the enema examination accessories, in particular to retention catheters (tips) with latex cuffs, can occur. Such reactions could occur immediately and result in the previously mentioned acute allergic-like responses or might be delayed in appearance and result in a contact dermatitis. Known atopic patients, particularly those with a history of asthma or eczema, should be evaluated for alternative methods of administration in order to avoid these adverse reactions. These plastic/rubber accessories are disposable, single-use devices that must not be reused or left in the body cavity for an extended period of time.

Postmarketing Experiences

The following adverse experiences have been reported in patients receiving products containing barium sulfate. These adverse experiences are listed alphabetically: abdominal cramping, abdominal pain, diarrhea, fever, foreign body trauma relating to procedural complications, headache, laryngeal burning and irritation, leukocytosis, procedural site reactions, rash, and vomiting.

Overdosage

In rare instances, immediate repeat oral examinations utilizing standard dosages may lead to severe stomach cramps and diarrhea. Cases reported in adults implicate a total dose in the range of 30 ounces (900 mL) of suspension. Instances of this type have resolved spontaneously and they are not considered to be life-threatening.

HD 85 Suspension Dosage and Administration

Suspension Preparation

The volume and concentration used will vary depending upon the method of patient preparation, the desired level of contrast density, individual variation in patient anatomy and radiographic equipment. The following dilutions are suggested for HD 85:

TEST Double Contrast Colon Routine Filled Colon Esophageal Swallow Filled stomach and Enteroclysis Rectal Localization

DILUTION FORMULA HD 85 undiluted 3 parts water to 1 part HD 85 1 part water to 2 parts HD 85 1 part water 1 part HD 85 HD 85 undiluted Shake well before using.

% BARIUM SULFATE (w/v) 85% 21% 57% 42% 85%

Patient Preparation

Successful examination of the upper gastrointestinal tract requires that the stomach be empty and essentially free of fluid. This can usually be accomplished by instructing the patient to abstain from eating or drinking anything after the evening meal before the examination. The preparation for small bowel examinations, done separately or combined with an upper gastrointestinal series, is the same.

For examinations of the colon, the patient should be given a low solid diet for a minimum of 24 hours before the examination. Laxatives should also be used to clean the colon. In order to obtain thorough cleansing of the colon, a 2 liter water enema one hour before the examination may be necessary.

Double Contrast Colon Examination

The following procedure is suggested for double contrast examination of a well prepared adult colon. The procedure is intended as a guide only. The actual procedure will depend upon patient symptoms and conditions as well as physician preference and judgement. The examination should be performed by a trained physician or properly trained medical personnel.

An enema administration system with 1/2” ID tubing, such as Aircon, is used for ease of administration. At the physician’s discretion, fluoroscopy may be used during the introduction of the barium sulfate suspension to determine contraindications for continuing the examination.

Start with the patient either prone or in the left lateral position (physician preference). The enema tip is inserted and taped to the buttocks with one or two pieces of tape. Approximately 500 mL of HD 85 Suspension (or enough to reach the splenic flexure) is introduced into the colon.

After introducing HD 85 to the splenic flexure, the clamp on the large bore tubing is shut. The patient is now turned left anterior oblique and air is introduced.

The patient is turned to the prone position, air is introduced and the patient is rotated onto the right side. Additional air is introduced to move the column of HD 85 to the hepatic flexure. The patient is turned onto their back and additional air is introduced. If HD 85 has not reached the cecum, the head of the table may be raised to 45º. Finally, the patient is turned onto their left side and additional air is introduced. Additional turning of the patient with the introduction of air may be required to achieve complete distention of the colon.

With the patient prone, the enema bag is placed on the floor and the large bore tubing clamp opened in order to drain the barium sulfate suspension from the rectum. Spot films of the rectosigmoid may now be obtained. Additional air may be insufflated to provide adequate distention of the colon.

Removal of the exam tip at this time is optional, according to the preference of the examiner. Rotate the patient slowly 360° taking spot films and overhead radiographs.

Enteroclysis Examination

A barium sulfate concentration of 40 to 50% w/v is suggested. One part water added to one part HD 85 will provide a 42% w/v barium sulfate suspension.

Rectal Localization

HD 85 barium sulfate suspension may be used undiluted to radiographically locate the rectal area prior to radiation treatment.

Pediatric Use

The quantity of suspension used and the barium sulfate concentration will depend upon patient size, technique used and clinical need.

For single patient use only. Properly discard unused portion.

How is HD 85 Suspension Supplied

Catalog No. 139244. NDC 68240-029-45. 450 mL (15 fl. oz.) bottle; twenty-four (24) bottles per case.

Catalog No. 139294. NDC 68240-029-90. 900 mL (30 fl. oz.) bottle; twelve (12) bottles per case.

Shake well before using.

Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59° to 86°F). Protect from freezing.

HD 85 is a trademark of Lafayette Pharmaceuticals, Incorporated.

Made in Mexico

Manufactured by:

Mallinckrodt Inc.

St. Louis, MO 63042 USA

www.Mallinckrodt.com

MID 1295015 Rev 04/2009

DOUBLE CONTRAST

G.I. EXAMS

• Multi-purpose


• High Density


• Dilute for single contrast

tyco

Healthcare

Mallinckrodt

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 900 mL Bottle

LAFAYETTE

HD 85™

BARIUM SULFATE SUSPENSION

DOUBLE CONTRAST / G.I. EXAMS


Rx only


NDC 68240-029-90


Catalog No. 139294


A raspberry flavored 85% w/v barium sulfate USP suspension for use

as a contrast medium in x-ray diagnosis of the gastrointestinal tract.


Contents: Barium sulfate USP, suspending and dispersing agents,

simethicone, citric acid, flavoring, potassium sorbate, sodium citrate, saccharin sodium and water.


Contraindications: Do not use in patients with suspected gastrointestinal tract perforation or known hypersensitivity to barium sulfate formulations.


Dosage and Administration: See package insert for complete instructions.


Shake well before using.


For single patient use only. Properly discard unused portion.


Storage: Store at 25ºC (77ºF); excursions

permitted to 15º to 30ºC (59º to 86ºF).

Protect from freezing.


Net Contents: 900 mL (30 fl. oz.)


O3™ ANTIMICROBIAL TECHNOLOGY


Made in Mexico

Manufactured by Mallinckrodt Inc.

St. Louis, MO 63042 USA

www.Mallinckrodt.com


MID 1600160 Rev 04/2009


tyco/Healthcare


MALLINCKRODT

HD 85  barium sulfate  for suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68240-029 Route of Administration RECTAL, ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BARIUM SULFATE (BARIUM CATION) BARIUM SULFATE .85 g  in 1 mL

Inactive Ingredients Ingredient Name Strength SACCHARIN SODIUM   POTASSIUM SORBATE   SODIUM HYPOCHLORITE   SODIUM CITRATE   WATER   HYDROGEN PEROXIDE   CROSCARMELLOSE SODIUM   CITRIC ACID MONOHYDRATE   BENTONITE

Product Characteristics Color      Score      Shape Size Flavor RASPBERRY (RASPBERRY) Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68240-029-45 24 BOTTLE In 1 CASE contains a BOTTLE, PLASTIC 1 450 mL In 1 BOTTLE, PLASTIC This package is contained within the CASE (68240-029-45) 2 68240-029-90 12 BOTTLE In 1 CASE contains a BOTTLE, PLASTIC 2 900 mL In 1 BOTTLE, PLASTIC This package is contained within the CASE (68240-029-90)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved other		12/01/2009

Labeler - Mallinckrodt Inc. (810407189)

Establishment
Name	Address	ID/FEI	Operations
Mallinckrodt Medical, S.A. de C.V.		810407189	manufacture, analysis

Revised: 06/2009Mallinckrodt Inc.

More HD 85 Suspension resources

• HD 85 Suspension Side Effects (in more detail)
• HD 85 Suspension Use in Pregnancy & Breastfeeding
• 0 Reviews for HD 85 - Add your own review/rating

Compare HD 85 Suspension with other medications

• Computed Tomography

Hytinic

Generic Name: iron polysaccharide (I ern paw lee SACK ah ride)

Brand Names: Ezfe, Ferrex-150, Ferus Pic-150, Niferex, Niferex Elixir, Nu-Iron 150, Poly Iron, Polysaccharide Iron

What is Hytinic (iron polysaccharide)?

Iron polysaccharide is a form of the mineral iron. Iron is important for many functions in the body, especially for the transport of oxygen in the blood.

Iron polysaccharide is used as a dietary supplement, and to prevent and to treat iron deficiencies and iron deficiency anemia.

Iron polysaccharide may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Hytinic (iron polysaccharide)?

Keep this medication out of the reach of children. An accidental overdose of iron by a child can be fatal.

Iron polysaccharide may decrease the absorption of other medicines. Talk to your doctor and pharmacist before taking iron polysaccharide if you take any other prescription or over-the-counter medicines.

Who should not take Hytinic (iron polysaccharide)?

Do not take iron polysaccharide if you have

• 
  

  hemochromatosis,

  
  


• 
  

  hemosiderosis, or

  
  


• 
  

  hemolytic anemia.

  
  

Iron polysaccharide may be dangerous if you have any of the conditions listed above.

If you do not have an iron deficiency, talk to your doctor about the use of iron polysaccharide. Generally, iron polysaccharide should not be taken chronically by individuals with a normal iron balance.

Talk to your doctor before taking iron polysaccharide if you are pregnant. Talk to your doctor before taking iron polysaccharide if you are breast-feeding a baby.

How should I take Hytinic (iron polysaccharide)?

Take iron polysaccharide exactly as directed by your doctor, or as directed on the package. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each tablet with a full glass of water. Shake the suspension well before measuring a dose. To ensure you get the correct dose, use a dose-measuring cup or spoon, not a regular table spoon to measure the dose. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Mix the liquid forms of iron polysaccharide with water, juice, or another beverage as directed and drink the mixture through a straw to prevent staining of the teeth.

Take iron polysaccharide on an empty stomach for best results. If stomach upset occurs, take iron polysaccharide with food or following a meal.

Iron polysaccharide may decrease the absorption of other medicines. Talk to your doctor and pharmacist before taking iron polysaccharide if you take any other prescription or over-the-counter medicines.

Store iron polysaccharide at room temperature, away from moisture and heat. Keep this medication out of the reach of children. An accidental overdose of iron by a child can be fatal.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time to take the next dose, skip the dose you missed and take the next regularly scheduled dose as directed. Do not take a double dose.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a iron polysaccharide overdose include decreased energy; nausea; vomiting; abdominal pain; tarry stools; a weak, rapid pulse; fever; coma; seizures; and death.

What should I avoid while taking Hytinic (iron polysaccharide)?

Keep this medication out of the reach of children. An accidental overdose of iron by a child can be fatal.

Iron polysaccharide may decrease the absorption of other medicines. Talk to your doctor and pharmacist before taking iron polysaccharide if you take any other prescription or over-the-counter medicines.

Hytinic (iron polysaccharide) side effects

If you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives), stop taking iron polysaccharide and seek emergency medical attention.

Other less serious side effects are more likely to occur. Continue taking iron polysaccharide and talk to your doctor or pharmacist if you experience

• 
  

  stomach upset,

  
  


• 
  

  nausea or vomiting,

  
  


• 
  

  constipation,

  
  


• 
  

  diarrhea,

  
  


• 
  

  black or darker than normal appearing stools, or

  
  


• 
  

  temporary staining of the teeth.

  
  

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

What other drugs will affect Hytinic (iron polysaccharide)?

Do not take iron polysaccharide within 2 hours of a dose of any of the following medicines

• 
  

  a tetracycline antibiotic such as tetracycline (Achromycin, Sumycin), minocycline (Minocin, Dynacin), doxycycline (Vibramycin, Monodox), demeclocycline (Declomycin), oxytetracycline (Terramycin), or troleandomycin (TAO);

  
  


• 
  

  a fluoroquinolone antibiotic such as ciprofloxacin (Cipro), enoxacin (Penetrex) ofloxacin (Floxin), norfloxacin (Noroxin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), grepafloxacin (Raxar), sparfloxacin (Zagam), or trovafloxacin (Trovan);

  
  


• 
  

  levodopa (Larodopa, Dopar, Sinemet);

  
  


• 
  

  levothyroxine (Synthroid, Levoxyl, others);

  
  


• 
  

  methyldopa (Aldomet); or

  
  


• 
  

  penicillamine (Cuprimine).

  
  

Iron polysaccharide may decrease the absorption of the drugs listed above.

Do not take antacids within 2 hours of a dose of iron polysaccharide. Antacids may decrease the absorption of iron polysaccharide.

Drugs other than those listed here may also interact with iron polysaccharide. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines while taking iron polysaccharide.

More Hytinic resources

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

• Niferex Elixir MedFacts Consumer Leaflet (Wolters Kluwer)


• Niferex Consumer Overview

Compare Hytinic with other medications

• Iron Deficiency Anemia

Where can I get more information?

• Your pharmacist can provide more information about iron polysaccharide.

See also: Hytinic side effects (in more detail)

Hydrocortisone/Neomycin/Polymyxin B Suspension

Pronunciation: HYE-droe-KOR-ti-sone/NEE-oh-MYE-sin/POL-ee-MIX-in
Generic Name: Hydrocortisone/Neomycin/Polymyxin B
Brand Name: Examples include Cortisporin and Cortomycin

Hydrocortisone/Neomycin/Polymyxin B Suspension is used for:

Treating infections of the ear caused by certain bacteria. It may also be used for other conditions as determined by your doctor.

Hydrocortisone/Neomycin/Polymyxin B Suspension is a combination of 2 antibiotics and a corticosteroid. The antibiotics work by slowing the growth of, or killing, sensitive bacteria. The corticosteroid reduces inflammation.

Do NOT use Hydrocortisone/Neomycin/Polymyxin B Suspension if:

• you are allergic to any ingredient in Hydrocortisone/Neomycin/Polymyxin B Suspension, to other aminoglycosides (eg, gentamicin), or to other corticosteroids (eg, prednisone)


• you have a viral infection of the ear (eg, herpes simplex, chickenpox, shingles)


• you have a perforated ear drum

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

Before using Hydrocortisone/Neomycin/Polymyxin B Suspension:

Some medical conditions may interact with Hydrocortisone/Neomycin/Polymyxin B Suspension. 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 asthma

Some MEDICINES MAY INTERACT with Hydrocortisone/Neomycin/Polymyxin B Suspension. Because little, if any, of Hydrocortisone/Neomycin/Polymyxin B Suspension is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Hydrocortisone/Neomycin/Polymyxin B Suspension 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 Hydrocortisone/Neomycin/Polymyxin B Suspension:

Use Hydrocortisone/Neomycin/Polymyxin B Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Hydrocortisone/Neomycin/Polymyxin B Suspension is only for the ear. Do not get it in your eyes, nose, or mouth. If you get Hydrocortisone/Neomycin/Polymyxin B Suspension in your eyes, rinse immediately with cool tap water.


• Wash your hands before and after using Hydrocortisone/Neomycin/Polymyxin B Suspension.


• Wash and dry the outer ear with a sterile cotton applicator.


• Shake well before each use.


• Lie down or tilt your head so that the affected ear faces up. For adults, gently pull the earlobe up and back to straighten the ear canal. For children, gently pull the earlobe down and back to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for several minutes so the medicine can run to the bottom of the ear canal. A clean cotton plug may be gently inserted into the ear canal to prevent medicine from leaking out. To prevent germs from getting into your medicine, do not touch the applicator to any surface, including the ear. Keep the container tightly closed.


• To clear up your infection completely, use Hydrocortisone/Neomycin/Polymyxin B Suspension for the full course of treatment. Keep using it even if you feel better in a few days.


• If you miss a dose of Hydrocortisone/Neomycin/Polymyxin B Suspension, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Hydrocortisone/Neomycin/Polymyxin B Suspension.

Important safety information:

• Hydrocortisone/Neomycin/Polymyxin B Suspension only works against bacteria; it does not treat fungal or viral infections.


• Be sure to use Hydrocortisone/Neomycin/Polymyxin B Suspension 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 Hydrocortisone/Neomycin/Polymyxin B Suspension 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.


• If your symptoms do not get better within 7 days or if they get worse, check with your doctor.


• Do NOT take more than the recommended dose or use for longer than 7 days without checking with your doctor.


• Do not use Hydrocortisone/Neomycin/Polymyxin B Suspension for other ear conditions at a later time.


• Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.


• Tell your doctor or dentist that you take Hydrocortisone/Neomycin/Polymyxin B Suspension before you receive any medical or dental care, emergency care, or surgery.


• Hydrocortisone/Neomycin/Polymyxin B Suspension should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these 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 Hydrocortisone/Neomycin/Polymyxin B Suspension while you are pregnant. It is not known if Hydrocortisone/Neomycin/Polymyxin B Suspension is found in breast milk after topical use. If you are or will be breast-feeding while you use Hydrocortisone/Neomycin/Polymyxin B Suspension, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Hydrocortisone/Neomycin/Polymyxin B Suspension:

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:

Mild, temporary burning or stinging.

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); acne-like rash; changes in hearing; decreased urination; dry, scaly, or peeling skin at the application site; continued burning or stinging; excessive hair growth; inflamed hair follicles; inflammation around the mouth; loss of hearing; muscle weakness; pain, redness, itching, irritation, or swelling not present when you began using Hydrocortisone/Neomycin/Polymyxin B Suspension; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

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.

Proper storage of Hydrocortisone/Neomycin/Polymyxin B Suspension:

Store Hydrocortisone/Neomycin/Polymyxin B Suspension between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Keep the container tightly closed. Keep Hydrocortisone/Neomycin/Polymyxin B Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Hydrocortisone/Neomycin/Polymyxin B Suspension, please talk with your doctor, pharmacist, or other health care provider.


• Hydrocortisone/Neomycin/Polymyxin B Suspension 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 Hydrocortisone/Neomycin/Polymyxin B Suspension. 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.

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