Suprenza

phentermine hydrochloride

Dosage Form: tablet, orally disintegrating
FULL PRESCRIBING INFORMATION

Indications and Usage for Suprenza

Suprenza is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).

Below is a chart of body mass index (BMI) based on various heights and weights.

BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters.

BODY MASS INDEX (BMI), kg/m2 Height (feet, inches)
Weight (pounds)	5'0"	5'3"	5'6"	5'9"	6'0"	6'3"
140	27	25	23	21	19	18
150	29	27	24	22	20	19
160	31	28	26	24	22	20
170	33	30	28	25	23	21
180	35	32	29	27	25	23
190	37	34	31	28	26	24
200	39	36	32	30	27	25
210	41	37	34	31	29	26
220	43	39	36	33	30	28
230	45	41	37	34	31	29
240	47	43	39	36	33	30
250	49	44	40	37	34	31

The limited usefulness of agents of this class, including Suprenza, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.

Suprenza Dosage and Administration

Exogenous Obesity

Dosage should be individualized to obtain an adequate response with the lowest effective dose.

The usual adult dose is one tablet as prescribed by the physician, administered in the morning, with or without food. Suprenza is not recommended for use in pediatric patients ≤ 16 years of age.

Late evening medication should be avoided because of the possibility of resulting insomnia.

With dry hands, gently remove the Suprenza (phentermine hydrochloride ODT) tablet from the bottle. Immediately place the Suprenza tablet on top of the tongue where it will dissolve, then swallow with or without water.

Dosage Forms and Strengths

Orally disintegrating tablets (ODT) containing 15 mg or 30 mg phentermine hydrochloride (equivalent to 12 mg or 24 mg phentermine base, respectively). The tablets are not scored. The 15 mg ODT is a yellow with blue spots round tablet embossed with AX4 on one side. The 30 mg ODT is a yellow round tablet embossed with AX7 on one side.

Contraindications

• History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension)


• During or within 14 days following the administration of monoamine oxidase inhibitors


• Hyperthyroidism


• Glaucoma


• Agitated states


• History of drug abuse


• Pregnancy [see Use in Specific Populations (8.1)]


• Nursing [see Use in Specific Populations (8.3)]


• Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines

Warnings and Precautions

Coadministration with Other Drug Products for Weight Loss

Suprenza is indicated only as short-term (a few weeks) monotherapy for the management of exogenous obesity. The safety and efficacy of combination therapy with Suprenza and any other drug products for weight loss including prescribed drugs, over-the-counter preparations, and herbal products, or serotonergic agents such as selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. Therefore, coadministration of Suprenza and these drug products is not recommended.

Primary Pulmonary Hypertension

Primary Pulmonary Hypertension (PPH) - a rare, frequently fatal disease of the lungs - has been reported to occur in patients receiving a combination of phentermine with fenfluramine or dexfenfluramine. The possibility of an association between PPH and the use of Suprenza alone cannot be ruled out; there have been rare cases of PPH in patients who reportedly have taken phentermine alone. The initial symptom of PPH is usually dyspnea. Other initial symptoms may include angina pectoris, syncope or lower extremity edema. Patients should be advised to report immediately any deterioration in exercise tolerance. Treatment should be discontinued in patients who develop new, unexplained symptoms of dyspnea, angina pectoris, syncope or lower extremity edema, and patients should be evaluated for the possible presence of pulmonary hypertension.

Valvular Heart Disease

Serious regurgitant cardiac valvular disease, primarily affecting the mitral, aortic and/or tricuspid valves, has been reported in otherwise healthy persons who had taken a combination of phentermine with fenfluramine or dexfenfluramine for weight loss. The possible role of phentermine in the etiology of these valvulopathies has not been established and their course in individuals after the drugs are stopped is not known. The possibility of an association between valvular heart disease and the use of Suprenza alone cannot be ruled out; there have been rare cases of valvular heart disease in patients who reportedly have taken phentermine alone.

Development of Tolerance, Discontinuation in Case of Tolerance

When tolerance to the anorectant effect develops, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued.

Effect on the Ability to Engage in Potentially Hazardous Tasks

Suprenza may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly.

Risk of Abuse and Dependence

Suprenza is related chemically and pharmacologically to amphetamine (d- and dll-amphetamine) and to other related stimulant drugs that have been extensively abused. The possibility of abuse of Suprenza should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. See Drug Abuse and Dependence (9) and Overdosage (10).

The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Usage with Alcohol

Concomitant use of alcohol with Suprenza may result in an adverse drug reaction.

Use in Patients with Hypertension

Use caution in prescribing Suprenza for patients with even mild hypertension (risk of increase in blood pressure).

Use in Patients on Insulin or Oral Hypoglycemic Medications for Diabetes Mellitus

A reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be required.

Adverse Reactions

The following adverse reactions are described, or described in greater detail, in other sections:

 

- Primary pulmonary hypertension [see Warnings and Precautions (5.2)]

 

- Valvular heart disease [see Warnings and Precautions (5.3)]

 

- Effect on the ability to engage in potentially hazardous tasks [see Warnings and Precautions (5.5)]

 

- Withdrawal effects following prolonged high dosage administration [see Drug Abuse and Dependence (9.3)]

The following adverse reactions to phentermine have been identified:

Cardiovascular

Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevation of blood pressure, ischemic events.

Central Nervous System

Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis.

Gastrointestinal

Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances.

Allergic

Urticaria.

Endocrine

Impotence, changes in libido.

Drug Interactions

Monoamine Oxidase Inhibitors

Use of Suprenza is contraindicated during or within 14 days following the administration of monoamine oxidase inhibitors because of the risk of hypertensive crisis.

Alcohol

Concomitant use of alcohol with Suprenza may result in an adverse drug reaction.

Insulin and Oral Hypoglycemic Medications

Requirements may be altered [see Warnings and Precautions (5.9)].

Adrenergic Neuron Blocking Drugs

Suprenza may decrease the hypotensive effect of adrenergic neuron blocking drugs.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category X

Suprenza is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to obligatory weight gain that occurs in maternal tissues during pregnancy. Phentermine has pharmacologic activity similar to amphetamine (d- and dll-amphetamine) [see Clinical Pharmacology (12.1)]. Animal reproduction studies have not been conducted with phentermine. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

Nursing Mothers

It is not known if Suprenza is excreted in human milk; however, other amphetamines are present in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Because pediatric obesity is a chronic condition requiring long-term treatment, the use of this product, approved for short-term therapy, is not recommended.

Geriatric Use

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Renal Impairment

Suprenza was not studied in patients with renal impairment. Based on the reported excretion of phentermine in urine, exposure increases can be expected in patients with renal impairment. Use caution when administering Suprenza to patients with renal impairment [see Clinical Pharmacology (12.3)].

Drug Abuse and Dependence

Controlled Substance

Phentermine is a Schedule IV controlled substance.

Abuse

Phentermine is related chemically and pharmacologically to the amphetamines. Amphetamines and other stimulant drugs have been extensively abused and the possibility of abuse of phentermine should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program.

Dependence

Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage of these drugs to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. A severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.

Overdosage

The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Acute Overdosage

Manifestations of acute overdosage include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, and panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmia, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Overdosage of pharmacologically similar compounds has resulted in fatal poisoning usually terminates in convulsions and coma.

Management of acute phentermine hydrochloride intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard. Intravenous phentolamine (Regitine®, CIBA) has been suggested on pharmacologic grounds for possible acute, severe hypertension, if this complicates overdosage.

Chronic Intoxication

Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia. See Drug Abuse and Dependence (9.3).

Suprenza Description

Suprenza is an orally disintegrating tablet (ODT) of phentermine hydrochloride, USP. Phentermine hydrochloride is a sympathomimetic amine anorectic. Its chemical name is α,α,-dimethylphenethylamine hydrochloride. The structural formula is as follows:

Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether.

Suprenza is available as an orally disintegrating tablet (ODT) containing 15 mg or 30 mg of phentermine hydrochloride (equivalent to 12 mg or 24 mg of phentermine base).

Suprenza contains the inactive ingredients mannitol powder, citric acid powder, Povidone CL, Povidone K 30, sucralose, magnesium stearate, peppermint flavor, talc, sodium lauryl sulfate, and mannitol pregranulated. Suprenza 15 mg ODT also contains FD&C Blue # 1 lake and FD&C Yellow # 5 lake. Suprenza 30 mg ODT also contains FD&C Yellow # 5 lake.

Suprenza - Clinical Pharmacology

Mechanism of Action

Suprenza is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and dll-amphetamine). Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics." It has not been established that the primary action of such drugs in treating obesity is one of appetite suppression since other central nervous system actions, or metabolic effects, may also be involved.

Pharmacodynamics

Typical of amphetamines include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for.

Pharmacokinetics

In terms of rate and extent of exposure, phentermine orally disintegrating tablets are equivalent to phentermine capsules and tablets administered under fasting conditions.

Following the administration of the oral disintegrating tablet (ODT), phentermine reaches peak concentrations (Cmax) after 3.0 to 4.4 hours. Swallowing the ODT after disintegration with or without water did not affect the extent (AUC) of phentermine exposure.

Administration of the ODT after a high fat/high calorie breakfast decreased the Cmax of phentermine by approximately 5% and the AUC by approximately 12%. Despite the decrease in Cmax and AUC, phentermine ODT can be administered with or without food.

Swallowing the ODT without prior disintegration decreased the Cmax of phentermine by approximately 7% and the AUC by approximately 8% compared to swallowing the ODT after disintegration.

Specific Populations

Renal Impairment

Suprenza was not studied in patients with renal impairment. The literature reported cumulative urinary excretion of phentermine under uncontrolled urinary pH conditions is 62%-85%. Exposure increases can be expected in patients with renal impairment. Use caution when administering Suprenza to patients with renal impairment.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies have not been performed with Suprenza to determine the potential for carcinogenesis, mutagenesis or impairment of fertility.

Clinical Studies

No clinical studies have been conducted with Suprenza.

In relatively short-term clinical trials, adult obese subjects instructed in dietary management and treated with "anorectic" drugs lost more weight on the average than those treated with placebo and diet.

The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an "anorectic" drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drugs prescribed, such as the physician-investigator, the population treated and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.

The natural history of obesity is measured over several years, whereas the studies cited are restricted to a few weeks' duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.

How Supplied/Storage and Handling

Available as orally disintegrating tablets (ODT) containing 15 mg or 30 mg of phentermine hydrochloride (equivalent to 12 mg or 24 mg phentermine base, respectively). The tablets are not scored. The 15 mg ODT is a yellow with blue spots round tablet embossed with AX4 on one side. The 30 mg ODT is a yellow round tablet embossed with AX7 on one side.

Suprenza is available as described in Table 2.

Table 2. Suprenza Orally Disintegrating Tablet Presentations

Tablet Strength	Tablet Color/Shape	Tablet Markings	NDC Code
15 mg	Round, embossed tablets Yellow with blue spots	AX4 on one side	NDC: 24090 720
30 mg	Round, embossed tablets Yellow	AX7 on one side	NDC: 24090 721

Suprenza 15 mg and 30 mg ODT are packaged in bottles of 30 and 100.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

Keep out of the reach of children.

Patient Counseling Information

Patients must be informed that Suprenza is a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity, and that coadministration of phentermine with other drugs for weight loss is not recommended [see Indications and Usage (1) and Warnings and Precautions (5.1)].

Patients must be instructed on how much Suprenza to take, and when and how to take it [see Dosage and Administration (3)].

Advise pregnant women and nursing mothers not to use Suprenza (see Use in Specific Populations (8.1, 8.3)].

Patients must be informed about the risks of use of phentermine (including the risks discussed in Warnings and Precautions), about the symptoms of potential adverse reactions and when to contact a physician and/or take other action. The risks include, but are not limited to:

• Development of primary pulmonary hypertension [see Warnings and Precautions (5.2)]


• Development of serious valvular heart disease [see Warnings and Precautions (5.3)]


• Effects on the ability to engage in potentially hazardous tasks [see Warnings and Precautions (5.5)]


• The risk of an increase in blood pressure [see Warnings and Precautions (5.8) and Adverse Reactions (6)]


• The risk of interactions [see Contraindications (4), Warnings and Precautions (5.7, 5.9) and Drug Interactions (7)]

See also, for example, Adverse Reactions (6) and Use in Specific Populations (8).

The patients must also be informed about

• the potential for developing tolerance and actions if they suspect development of tolerance [see Warnings and Precautions (5.4)] and


• the risk of dependence and the potential consequences of abuse [see Warnings and Precautions (5.6), Drug Abuse and Dependence (9), and Overdosage (10)].

Tell patients to keep Suprenza in a safe place to prevent theft, accidental overdose, misuse or abuse. Selling or giving away Suprenza may harm others and is against the law.

Manufactured by:

Alpex Pharma SA

Lugano, Switzerland

Marketed and Distributed by:

Akrimax Pharmaceuticals, LLC

Cranford, NJ 07016

272F001

PRINCIPAL DISPLAY PANEL - 15 mg ODT Tablets

NDC 24090-720-85

Suprenza™

(Phentermine Hydrochloride)

Orally Disintegrating Tablets

15 mg

Rx Only

30 Tablets

C IV

PRINCIPAL DISPLAY PANEL - 30 mg ODT Tablets

NDC 24090-721-85

Suprenza™

(Phentermine Hydrochloride)

Orally Disintegrating Tablets

30 mg

Rx Only

30 Tablets

C IV

 

Suprenza  phentermine hydrochloride  tablet, orally disintegrating

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 24090-720 (52871-720) Route of Administration ORAL DEA Schedule CIV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENTERMINE HYDROCHLORIDE (PHENTERMINE) PHENTERMINE HYDROCHLORIDE 15 mg

Inactive Ingredients Ingredient Name Strength MANNITOL   CITRIC ACID MONOHYDRATE   POVIDONE   POVIDONE K30   SUCRALOSE   MAGNESIUM STEARATE   PEPPERMINT   TALC   SODIUM LAURYL SULFATE   FD&C BLUE NO. 1   FD&C YELLOW NO. 5

Product Characteristics Color yellow (yellow) , blue (blue) Score no score Shape ROUND (ROUND) Size 10mm Flavor PEPPERMINT (PEPPERMINT) Imprint Code AX4 Contains

Packaging # NDC Package Description Multilevel Packaging 1 24090-720-85 30 TABLET In 1 BOTTLE, PLASTIC None 2 24090-720-77 7 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA202088	12/01/2011

Suprenza  phentermine hydrochloride  tablet, orally disintegrating

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 24090-721 (52871-721) Route of Administration ORAL DEA Schedule CIV

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENTERMINE HYDROCHLORIDE (PHENTERMINE) PHENTERMINE HYDROCHLORIDE 30 mg

Inactive Ingredients Ingredient Name Strength MANNITOL   CITRIC ACID MONOHYDRATE   POVIDONE   POVIDONE K30   SUCRALOSE   MAGNESIUM STEARATE   PEPPERMINT   TALC   SODIUM LAURYL SULFATE   FD&C YELLOW NO. 5

Product Characteristics Color yellow (yellow) Score no score Shape ROUND (ROUND) Size 13mm Flavor PEPPERMINT (PEPPERMINT) Imprint Code AX7 Contains

Packaging # NDC Package Description Multilevel Packaging 1 24090-721-85 30 TABLET In 1 BOTTLE, PLASTIC None 2 24090-721-77 7 TABLET In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA202088	12/01/2011

Labeler - Akrimax Pharmaceuticals, LLC (804790124)

Registrant - Citius Pharmaceuticals (872692764)

Establishment
Name	Address	ID/FEI	Operations
Alpex Pharma SA		481608818	manufacture

Establishment
Name	Address	ID/FEI	Operations
Siegfried (USA), Inc.		001213784	api manufacture

Revised: 10/2011Akrimax Pharmaceuticals, LLC

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• Suprenza Drug Interactions
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Prednicarbate

Prednicarbate EMOLLIENT CREAM 0.1%

FOR DERMATOLOGIC USE ONLY.

NOT FOR USE IN EYES.

Prednicarbate Description

Prednicarbate emollient cream 0.1% contains Prednicarbate, a synthetic corticosteroid for topical dermatologic use. The chemical name of Prednicarbate is 11β, 17, 21-trihydroxypregna-1,4-diene-3,20-dione 17-(ethyl carbonate) 21-propionate. Prednicarbate has the empirical formula C27H36O8 and a molecular weight of 488.58. Topical corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents.

The CAS Registry Number is 73771-04-7. The chemical structure is:

Prednicarbate is a practically odorless white to yellow-white powder insoluble to practically insoluble in water and freely soluble in ethanol.

Each gram of Prednicarbate emollient cream 0.1% contains 1.0 mg of Prednicarbate in a base consisting of white petrolatum USP, purified water USP, isopropyl myristate NF, lanolin alcohols NF, mineral oil USP, cetostearyl alcohol NF, aluminum stearate, edetate disodium USP, lactic acid USP, and magnesium stearate DAB 9.

Prednicarbate - Clinical Pharmacology

In common with other topical corticosteroids, Prednicarbate has anti-inflammatory, antipruritic, and vasoconstrictive properties. In general, the mechanism of the anti-inflammatory activity of topical steroids is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Use of occlusive dressings with hydrocortisone for up to 24 hours have not been shown to increase penetration; however, occlusion of hydrocortisone for 96 hours does markedly enhance penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption.

Studies performed with Prednicarbate emollient cream 0.1 % indicate that the drug product is in the medium range of potency compared with other topical corticosteroids.

Indications and Usage for Prednicarbate

Prednicarbate emollient cream 0.1% is a medium-potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Prednicarbate emollient cream 0.1% may be used with caution in pediatric patients 1 year of age or older. The safety and efficacy of drug use for longer than 3 weeks in this population have not been established. Since safety and efficacy of Prednicarbate emollient cream 0.1% have not been established in pediatric patients below 1 year of age, its use in this age group is not recommended.

Contraindications

Prednicarbate emollient cream 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparations.

Precautions

General

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment.

Patients applying a topical steroid to a large surface area or under occlusion should be evaluated periodically for evidence of HPA-axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests.

Prednicarbate emollient cream 0.1% did not produce significant HPA-axis suppression when used at a dose of 30g/day for a week in 10 adult patients with extensive psoriasis or atopic dermatitis. Prednicarbate emollient cream 0.1% did not produce HPA-axis suppression in any of 59 pediatric patients with extensive atopic dermatitis when applied BID for 3 weeks to > 20% of the body surface (See PRECAUTIONS, Pediatric Use.)

If HPA-axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of the application, or to substitute a less potent corticosteroid. Recovery of HPA-axis function is generally prompt upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur, requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.

Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See PRECAUTIONS, Pediatric Use.)

If irritation develops, Prednicarbate emollient cream 0.1% should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing a failure to heal rather than noting a clinical exacerbation, as observed with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used.

If a favorable response does not occur promptly, use of Prednicarbate emollient cream 0.1% should be discontinued until the infection has been adequately controlled.

Information for Patients

Patients using topical corticosteroids should receive the following information and instructions:

1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.


2. This medication should not be used for any disorder other than that for which it was prescribed.


3. The treated skin area should not be bandaged, otherwise covered or wrapped so as to be occlusive, unless directed by the physician.


4. Patients should report to their physician any signs of local adverse reactions.


5. Parents of pediatric patients should be advised not to use this medication in the treatment of diaper dermatitis. This medication should not be applied in the diaper area as diapers or plastic pants may constitute occlusive dressing (See DOSAGE AND ADMINISTRATION).


6. This medication should not be used on the face, underarms, or groin areas.


7. Contact between Prednicarbate emollient cream 0.1% and latex containing products (eg. condoms, diaphragm etc.) should be avoided since paraffin in contact with latex can cause damage and reduce the effectiveness of any latex containing products. If latex products come into contact with Prednicarbate emollient cream 0.1%, patients should be advised to discard the latex products. Patients should be advised that this medication is to be used externally only, not intravaginally.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within two weeks, contact the physician.

Laboratory Tests

The following tests may be helpful in evaluating patients for HPA-axis suppression:

 

ACTH stimulation test

 

A.M. plasma cortisol test

 

Urinary free cortisol test

Carcinogenesis, Mutagenesis, and Impairment of Fertility

In a study of the effect of Prednicarbate on fertility, pregnancy, and postnatal development in rats, no effect was noted on the fertility or pregnancy of the parent animals or postnatal development of the offspring after administration of up to 0.80 mg/kg of Prednicarbate subcutaneously.

Prednicarbate has been evaluated in the Salmonella reversion test (Ames test) over a wide range of concentrations in the presence and absence of an S-9 liver microsomal fraction, and did not demonstrate mutagenic activity. Similarly, Prednicarbate did not produce any significant changes in the numbers of micronuclei seen in erythrocytes when mice were given doses ranging from 1 to 160 mg/kg of the drug.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.

Prednicarbate has been shown to be teratogenic and embryotoxic in Wistar rats and Himalayan rabbits when given subcutaneously during gestation at doses 1900 times and 45 times the recommended topical human dose, assuming a percutaneous absorption of approximately 3%. In the rats, slightly retarded fetal development and an incidence of thickened and wavy ribs higher than the spontaneous rate were noted.

In rabbits, increased liver weights and slight increase in the fetal intrauterine death rate were observed. The fetuses that were delivered exhibited reduced placental weight, increased frequency of cleft palate, ossification disorders in the sternum, omphalocele, and anomalous posture of the forelimbs.

There are no adequate and well-controlled studies in pregnant women on teratogenic effects of Prednicarbate. Prednicarbate emollient cream 0.1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Prednicarbate emollient cream 0.1% is administered to a nursing woman.

Pediatric Use

Prednicarbate emollient cream 0.1% may be used with caution in pediatric patients 1 year of age or older, although the safety and efficacy of drug use longer than 3 weeks have not been established. The use of Prednicarbate emollient cream 0.1% is supported by results of a three-week, uncontrolled study in 59 pediatric patients between the ages of 4 months and 12 years of age with atopic dermatitis. None of the 59 pediatric patients showed evidence of HPA-axis suppression. Safety and efficacy of Prednicarbate emollient cream 0.1% in pediatric patients below 1 year of age have not been established, therefore use in this age group is not recommended. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA-axis suppression and Cushing's syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. In an uncontrolled study in pediatric patients with atopic dermatitis, the incidence of adverse reactions possibly or probably associated with the use of Prednicarbate emollient cream 0.1% was limited.

Mild signs of atrophy developed in 5 patients (5/59, 8%) during the clinical trial, with 2 patients exhibiting more than one sign. Two patients (2/59, 3%) developed shininess, and two patients (2/59, 3%) developed thinness. Three patients (3/59, 5%) were observed with mild telangiectasia. It is unknown whether prior use of topical corticosterioids was a contributing factor in the development of telangiectasia in 2 of the patients. Adverse effects including striae have also been reported with inappropriate use of topical corticosteroids in infants and children. Pediatric patients applying topical corticosteroids to greater than 20% of body surface are at higher risk for HPA-axis suppression.

HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corti-costeroids. Manifestations of adrenal suppression in children include low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Prednicarbate emollient cream 0.1% should not be used in the treatment of diaper dermatitis.

Adverse Reactions

In controlled adult clinical studies, the incidence of adverse reactions probably or possibly associated with the use of Prednicarbate emollient cream 0.1% was approximately 4%. Reported reactions included mild signs of skin atrophy in 1% of treated patients, as well as the following reactions which were reported in less than 1% of patients: pruritis, edema, paresthesia, urticaria, burning, allergic contact dermatitis and rash.

In an uncontrolled study in pediatric patients with atopic dermatitis, the incidence of adverse reactions possibly or probably associated with the use of Prednicarbate emollient cream 0.1 % was limited. Mild signs of atrophy developed in 5 patients (5/59, 8%) during the clinical trial, with 2 patients exhibiting more than one sign. Two patients (2/59, 3%) developed shininess, and 2 patients (2/59, 3%) developed thinness. Three patients (3/59, 5 %) were observed with mild telangiectasia. It is unknown whether prior use of topical corticosteroids was a contributing factor in the development of telangiectasia in 2 of the patients (See PRECAUTIONS, Pediatric Use.)

The following additional local adverse reactions have been reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, secondary infection, striae and miliaria.

Overdosage

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)

Prednicarbate Dosage and Administration

Apply a thin film of Prednicarbate emollient cream 0.1% to the affected skin areas twice daily. Rub in gently.

Prednicarbate emollient cream 0.1 % may be used in pediatric patients 1 year of age or older. Safety and efficacy of Prednicarbate emollient cream 0.1% in pediatric patients for more than 3 weeks of use have not been established. Use in pediatric patients under 1 year of age is not recommended.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

Prednicarbate emollient cream 0.1% should not be used with occlusive dressings unless directed by the physician. Prednicarbate emollient cream 0.1% should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.

How is Prednicarbate Supplied

Prednicarbate emollient cream 0.1% is supplied in 15 g (NDC 66993-880-15) and 60 g (NDC 66993-880-61) tubes.

Store between 41 and 77°F (5 and 25°C).

Manufactured by:

Dermik Laboratories

a business of sanofi-aventis U.S. LLC

Bridgewater, NJ 08807

Manufactured for:

Prasco Laboratories

Mason, OH 45040 USA

Prescribing information as of October 2010

© 2010 sanofi-aventis U.S. LLC

PRINCIPAL DISPLAY PANEL - 15 gram tube carton

NDC 66993-880-15

PRASCO

Prednicarbate Emollient Cream 0.1%

FOR DERMATOLOGIC USE ONLY

NOT FOR USE IN EYES

One 15g Tube

Rx Only

Prednicarbate  Prednicarbate  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66993-880 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Prednicarbate (Prednicarbate) Prednicarbate 1 mg  in 1 g

Inactive Ingredients Ingredient Name Strength petrolatum   water   isopropyl myristate   mineral oil   cetostearyl alcohol   aluminum stearate   edetate disodium   lactic acid

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 66993-880-15 15 g In 1 TUBE None 2 66993-880-61 60 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA authorized generic	NDA020279	04/30/2007

Labeler - Prasco Laboratories (065969375)

Registrant - sanofi-aventis U.S. LLC (824676584)

Establishment
Name	Address	ID/FEI	Operations
sanofi-aventis Deutschland GmbH		313218430	MANUFACTURE

Revised: 12/2010Prasco Laboratories

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• Prednicarbate Side Effects (in more detail)
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• Prednicarbate Drug Interactions
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• Dermatop Concise Consumer Information (Cerner Multum)


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• Atopic Dermatitis
• Eczema
• Psoriasis
• Skin Rash

Plasma Protein Fraction

Class: Blood Derivatives
ATC Class: B05AA
VA Class: BL500
CAS Number: 55963-80-9
Brands: Plasmanate

Introduction

Protein colloid; sterile solution of selected proteins prepared from pooled human plasma.¹⁰⁴

Uses for Plasma Protein Fraction

Fluid Resuscitation (Shock)

Used for plasma volume expansion in the treatment of certain types of shock, including shock resulting from burns, crushing injuries, abdominal emergencies, or any other cause where there is a predominant loss of plasma fluids and not RBCs.¹⁰⁴

Adequate replacement for human plasma in the treatment of shock and suitable means of providing human proteins for their osmotic effect;¹⁰⁴ however, albumin solutions may be preferable because they contain a greater percentage of albumin and, since they are more purified, are less likely to cause hypotensive reactions.^a (See Hypotension under Cautions.)

Initial therapy in infants and small children for shock resulting from dehydration and infection.¹⁰⁴

Emergency treatment of shock due to hemorrhage.¹⁰⁴ Following the emergency phase of therapy, transfusions of whole blood or RBCs may be indicated, depending on the severity of the blood loss.¹⁰⁴

Plasma Protein Fraction Dosage and Administration

Administration

IV Administration

Administer by IV infusion, preferably at a site at some distance from any site of infection or trauma.¹⁰⁴

Swab the rubber stopper on vial with iodine tincture followed by a sterile antiseptic swab.¹⁰⁴ Insert a 16-gauge needle or dispensing pin perpendicular to the stopper in the area delineated by a raised ring.¹⁰⁴

Does not contain preservatives; discard any partially used vials.¹⁰⁴

Do not mix with protein hydrolysates or solutions containing alcohol.¹⁰⁴

To minimize administration errors, consult the manufacturer’s administration instructions for proper use.¹⁰⁴

Rate of Administration

Adjust rate of infusion according to the clinical response of the patient and changes in BP.¹⁰⁴

For hypovolemic shock in infants and young children: Infusion at a rate of up to 5–10 mL/minute has been suggested.^a

As plasma volume approaches normal, do not exceed 5–8 mL/minute.^a Rapid IV infusion (e.g., >10 mL/minute) may cause vascular overload.^{104 a} (See Infusion Effects under Cautions.)

Dosage

Dosage depends on the patient’s condition and response to therapy.¹⁰⁴

Pediatric Patients

Fluid Resuscitation (Shock)

Hypovolemic Shock

IV

Infants and young children: Initially, 6.6–33 mL/kg (0.33–1.65 g/kg of protein).^a Subsequent dosage is determined by the patient’s condition.^a

Adults

Fluid Resuscitation (Shock)

Hypovolemic Shock

IV

Usual minimum effective dosage: 250–500 mL (12.5–25 g of protein).¹⁰⁴ Subsequent dosage is determined by the patient’s condition.^a

Prescribing Limits

Adults

Fluid Resuscitation (Shock)

Hypovolemic Shock

IV

Do not exceed 5–8 mL/minute.^a

Special Populations

No special population dosage recommendations at this time.¹⁰⁴

Cautions for Plasma Protein Fraction

Contraindications

• 
  

  Cardiopulmonary bypass procedures.¹⁰⁴ (See Hypotension under Cautions.)

  
  


• 
  

  Severe anemia.¹⁰⁴

  
  


• 
  

  CHF.¹⁰⁴

  
  


• 
  

  Increased blood volume.¹⁰⁴

  
  

Warnings/Precautions

Warnings

Risk of Transmissible Agents in Plasma-derived Preparations

Potential vehicle for transmission of human viruses, including hepatitis virus, or other infectious agents.¹⁰⁴

Despite screening for certain viruses (e.g., human immunodeficiency virus [HIV], hepatitis B virus [HBV], hepatitis C virus [HCV]) and a pasteurization procedure to reduce viral infectious potential associated with plasma protein fraction (PPF), a risk for transmission of infectious agents still remains.^a

Transmission of nonenveloped viruses, including hepatitis HAV and parvovirus B19, has been documented following administration of plasma-derived coagulation factors.¹⁰⁵

Report any suspected PPF-associated infections to the manufacturer.¹⁰⁴

Risk of Creutzfeldt-Jakob Disease

May carry a risk of transmitting the causative agent of Creutzfeldt-Jacob disease (CJD) or variant CJD (vCJD).^{100 101 102 103 106 107}

There have been 3 probable cases of vCJD acquired through transfusion of human RBCs,¹¹⁷ although, transmission via human plasma derivatives (including plasma-derived albumin) has not been documented to date.^{106 107 108}

Risk of West Nile Virus

Evidence exists that West Nile Virus (WNV) can be transmitted in transplanted organs (e.g., heart, liver, kidney) and blood products (e.g., whole blood, packed RBCs, fresh frozen plasma).^{110 111 113 114} However, WNV transmission unlikely through commercially available plasma-derived preparations since WNV is an enveloped virus, like HCV, which is known to be inactivated by the heat and solvent/detergent viral inactivation procedures used in the manufacture of these preparations.^{111 112}

For further information on WNV precautions related to blood and blood products, the FDA’s guidance for industry should be consulted ().¹¹¹

General Precautions

Infusion Effects

Rapid infusion may cause vascular overload.^a

Observe all patients (especially those with normal or increased circulatory volumes) for signs of hypervolemia, including dyspnea, fluid in the lungs, pulmonary edema, cardiac failure, or abnormal increases in BP or central venous pressure.^a

Hypotension

Hypotension may occur, especially following rapid IV infusion (i.e., at rates >10 mL/minute) in patients undergoing surgery or in the pre- or postoperative period or during intra-arterial administration in patients on cardiopulmonary bypass.¹⁰⁴ Monitor BP during administration; slow or stop the infusion if sudden hypotension occurs.¹⁰⁴ BP may return to normal spontaneously following slowing or discontinuance of the infusion; vasopressors also may be used to correct hypotension.¹⁰⁴

Sodium Content

Commercially available PPF contains approximately 145 mEq of sodium per liter.¹⁰⁴

Trauma or Surgery Risk

Rapid rise in BP accompanying administration of PPF following injuries or surgery may reveal bleeding points that were not apparent at the lower BP; observe patient carefully to prevent hemorrhage and subsequent shock.^a

Hematologic Effects

Does not contain coagulation factors and, therefore, cannot be used to correct coagulation disorders.¹⁰⁴ Contains trace amounts of blood groups A and B isohemagglutins; however, these are at such low concentrations that use of PPF should have no effect on routine blood typing procedures.¹⁰⁴

Specific Populations

Pregnancy

Category C.¹⁰⁴

Pediatric Use

Manufacturer states that safety and efficacy not established in pediatric patients; however, protein colloid has been found to be very useful in infants and small children for initial treatment of shock resulting from dehydration and infection.¹⁰⁴

Hepatic Impairment

Use with caution in patients with hepatic failure because of added protein, fluid, and sodium load.^a

Renal Impairment

Use with caution in patients with renal failure because of added protein, fluid, and sodium load.^a

Common Adverse Effects

Flushing,¹⁰⁴ urticaria,¹⁰⁴ nausea,¹⁰⁴ headache,¹⁰⁴ back pain.¹⁰⁴

Plasma Protein Fraction Pharmacokinetics

Absorption

Duration

Following IV administration, increased blood volume may last up to 48 hours.¹⁰⁴

Stability

Storage

Parenteral

Solution for Injection

Room temperature (not >30°C).¹⁰⁴ Do not freeze.¹⁰⁴

Do not use solutions that appear turbid.¹⁰⁴

Do not start administration if >4 hours have elapsed since the container was first entered.¹⁰⁴

Do not use solutions that have been frozen, since the container may crack and permit contamination of the contents.¹⁰⁴

ActionsActions

• 
  

  Pharmacologic properties of PPF are similar to those of its primary constituent, albumin.^a

  
  


• 
  

  Replacement for human plasma in the treatment of shock.¹⁰⁴

  
  


• 
  

  IV administration of PPF results in an increased blood volume.¹⁰⁴

  
  


• 
  

  Causes a shift of fluid from the interstitial spaces into the circulation and a slight increase in the concentration of plasma protein.^a

  
  

Advice to Patients

• 
  

  Potential risk of transmission of infectious agents (e.g., human viruses).¹⁰⁴

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.¹⁰⁴

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant.¹⁰⁴

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹⁰⁴ (See Cautions.)

  
  

Preparations

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

Plasma Protein Fraction (Human)

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for IV infusion	50 mg/mL	Plasmanate	Talecris

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 August 2009. 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. Nightingale SL. Dear doctor letter regarding withdrawal of certain plasma products. Rockville, MD: Department of Health and Human Services. Public Health Service. Food and Drug Administration; 1995 Mar 29.

101. Department of Health and Human Services, Food and Drug Administration. Precautionary measures to further reduce the possible risk of transmission of Creutzfeldt-Jakob disease by blood and blood products. 1995 Aug 8. Memorandum.

102. Department of Health and Human Services, Food and Drug Administration. Precautionary measures to further reduce the possible risk of transmission of Creutzfeldt-Jakob disease by blood and blood products. 1995 Aug 8. (Supplemental recommendations to 1987 Nov 25 memorandum on deferral of donors who have received human pituitary-derived growth hormone.)

103. Vidor A. Dear customer letter regarding withdrawal of certain lots of Buminate 25%. Lakewood, NJ: Baxter Healthcare Corp; 1997 Mar 13.

104. Talecris. Plasmanate (plasma protein fraction [human] 5%) prescribing information. Research Triangle Park, NC; 2005 Jan.

105. Medical and Scientific Advisory Council (MASAC), National Hemophilia Foundation. MASAC recommendations concerning the treatment of hemophilia and other bleeding disorders (revised October 2005). MASAC recommendation #165. From National Hemophilia Foundation website ().

106. Medical and Scientific Advisory Council (MASAC), National Hemophilia Foundation. MASAC recommendations regarding the use of recombinant clotting factor products with respect to pathogen transmission (June 3, 2006). MASAC recommendation #169. From National Hemophilia Foundation website ().

107. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). Guidance for industry. Revised preventive measures to reduce the possible risk of transmission of Creutzfeldt-Jacob disease (CJD) and variant Creutzfeldt-Jacob disease (vCJD) by blood and blood products. January 2002. From FDA website ().

108. Ricketts MN, Cashman NR, Stratton EE et al. Is Creutzfeldt-Jacob disease transmitted in blood? Emerg Infectious Dis. 1997; 3:155-63.

109. Brown P, Will RG, Bradley R et al. Bovine spongiform encephalopathy and variant Creutzfeldt-Jakob disease: background, evolution, and current concerns. Emerg Infectious Dis. 2001; 7:6-16.

110. Centers for Disease Control and Prevention. West Nile virus activity—United States, October 10–16, 2002, and update on West Nile virus infections in recipients of blood transfusions. MMWR Morb Mortal Wkly Rep. 2002; 51:929-31. [PubMed 12403410]

111. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). Guidance for industry. Revised recommendations for the assessment of donor suitability and blood and blood product safety in cases of known or suspected West Nile virus infection. May 2003. From FDA website ().

112. National Hemophilia Foundation. West Nile virus fact sheet. From National Hemophilia Foundation website ().

113. Harrington T, Kuehnert MF, Kamel H et al. West Nile virus infection transmitted by blood transfusion. Transfusion. 2003; 43:1018-22. [PubMed 12869105]

114. Iwamoto M, Jernigan DB, Gausch A et al. Transmission of West Nile virus from an organ donor to four transplant recipients. N Engl J Med. 2003; 348:2196-203. [PubMed 12773646]

115. Chiron. New test developed to screen donated blood for West Nile virus by July 1 deadline. Press release. 2003 June 18.

116. Centers for Disease Control and Prevention. Questions and answers: blood transfusions and organ donations. From the CDC website ().

117. Hewitt PE, Llewelyn CA, Mackenzie J et al. Creutzfeldt-Jakob disease and blood transfusion: result of the UK transfusion medicine epidemiological review study. Vox Sang. 2006; 91:221-30. [PubMed 16958834]

a. AHFS Drug Information 2007. McEvoy GK, ed. Plasma protein fraction. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 1405–6.

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• Plasma Protein Fraction Support Group
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• Plasmanate

Cotuss V

Generic Name: guaifenesin and hydrocodone (gwye FEN e sin and HYE droe KOE done)

Brand Names: A-Cof DH, Canges-XP, Codiclear DH, Condasin, Cotuss V, Execlear, Extendryl HC, Hycotuss Expectorant, Hydrocod-GF, Kwelcof, Monte-G HC, Narcof, Pancof XP, Pneumotussin 2.5, Relasin-HCX, Touro HC, Tussicle, Tusso-DF, Vi-Q-Tuss, Vitussin Expectorant, Xpect-HC, Z-Cof HCX

What is Cotuss V (guaifenesin and hydrocodone)?

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Hydrocodone is a narcotic cough suppressant.

Guaifenesin and hydrocodone is used to treat cough and reduce chest congestion caused by the common cold, flu, or allergies.

Guaifenesin and hydrocodone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Cotuss V (guaifenesin and hydrocodone)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of guaifenesin and hydrocodone. Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by guaifenesin and hydrocodone. Hydrocodone may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.

What should I discuss with my healthcare provider before taking Cotuss V (guaifenesin and hydrocodone)?

Hydrocodone may be habit forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Do not use this medicine if you are allergic to hydrocodone or guaifenesin.

To make sure you can safely take guaifenesin and hydrocodone, tell your doctor if you have any of these other conditions:

• 
  

  liver or kidney disease;

  
  


• 
  

  asthma;

  
  


• 
  

  urination problems;

  
  


• 
  

  an enlarged prostate;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  seizures or epilepsy;

  
  


• 
  

  gallbladder disease;

  
  


• 
  

  a head injury; or

  
  


• 
  

  Addison's disease.

  
  

FDA pregnancy category C. It is not known whether this medication will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Guaifenesin and hydrocodone can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Cotuss V (guaifenesin and hydrocodone)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Guaifenesin and hydrocodone can be taken with or without food.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Call your doctor if your symptoms do not improve, or if they get worse. Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Guaifenesin and hydrocodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include extreme drowsiness, sweating, pinpoint pupils, nausea, vomiting, dry mouth, confusion, cold and clammy skin, muscle weakness, fainting, weak pulse, slow heart rate, seizure (convulsions), weak or shallow breathing, or breathing that stops.

What should I avoid while taking Cotuss V (guaifenesin and hydrocodone)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of guaifenesin and hydrocodone.

Ask a doctor or pharmacist before using any other cough, cold, allergy, pain, or sleep medicine. Guaifenesin is contained in many combination medicines. Taking certain products together can cause you to get too much guaifenesin. Check the label to see if a medicine contains guaifenesin.

Cotuss V (guaifenesin and hydrocodone) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  slow heart rate, weak or shallow breathing;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  confusion, fear, unusual thoughts or behavior;

  
  


• 
  

  seizure (convulsions); or

  
  


• 
  

  urinating less than usual or not at all.

  
  

Less serious side effects may include:

• 
  

  dizziness, drowsiness;

  
  


• 
  

  nausea, vomiting, upset stomach;

  
  


• 
  

  blurred vision;

  
  


• 
  

  constipation;

  
  


• 
  

  dry mouth; or

  
  


• 
  

  sweating.

  
  

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 Cotuss V (guaifenesin and hydrocodone)?

Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by guaifenesin and hydrocodone.

Tell your doctor about all other medicines you use, especially:

• 
  

  antidepressants such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), nortriptyline (Pamelor), and others;

  
  


• 
  

  atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), glycopyrrolate (Robinul), mepenzolate (Cantil), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

  
  


• 
  

  bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

  
  


• 
  

  a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva); or

  
  


• 
  

  irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

  
  

This list is not complete and other drugs may interact with guaifenesin and hydrocodone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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Compare Cotuss V with other medications

• Cough

Where can I get more information?

• Your pharmacist can provide more information about guaifenesin and hydrocodone.

See also: Cotuss V side effects (in more detail)