Viscodyne-D

Ammonium Chloride:

• Indications and usage
• Contraindications
• Warning
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Viscodyne-D (Ammonium Chloride) reviews

INDICATIONS AND USAGE

Viscodyne-D (Ammonium Chloride) Lactate Lotion, 12% is indicated for the treatment of dry, scaly skin (xerosis) and ichthyosis vulgaris, and for the temporary relief of itching associated with these conditions.

CONTRAINDICATIONS

Viscodyne-D (Ammonium Chloride) Lactate Lotion, 12% is contraindicated in those patients with a history of hypersensitivity to any of the label ingredients.

WARNING

Sun exposure (natural or artificial sunlight) to areas of the skin treated with Viscodyne-D (Ammonium Chloride) Lactate Lotion, 12% should be minimized or avoided (see PRECAUTIONS). The use of Viscodyne-D (Ammonium Chloride) Lactate Lotion, 12% should be discontinued if any hypersensitivity is observed.

PRECAUTIONS

General -

For external use only. Stinging or burning may occur when applied to skin with fissures, erosions, or that is otherwise abraded. Caution is advised when used on the face because of the potential for irritation. The potential for post-inflammatory hypo- or hyperpigmentation has not been studied.

Information for Patients

Patients using Viscodyne-D (Ammonium Chloride) Lactate Lotion, 12% should receive the following information and instructions:

• This medication is to be used as directed by the physician, and should not be used for any disorder other than for which it was prescribed. It is for external use only. Avoid contact with eyes, lips, or mucous membranes.
• Patients should minimize or avoid use of this product on areas of the skin that may be exposed to natural or artificial sunlight, including the face. If sun exposure is unavoidable, clothing should be worn to protect the skin.
• This medication may cause transient stinging or burning when applied to skin with fissures, erosions, or abrasions (for example, after shaving the legs).
• If the skin condition worsens with treatment, the medication should be promptly discontinued.

Carcinogenesis, Mutagenesis, Impairment of Fertility -

The topical treatment of CD-1 mice with 12%, 21% or 30% Viscodyne-D lactate formulations for two-years did not produce a significant increase in dermal or systemic tumors in the absence of increased exposure to ultraviolet radiation. The maximum systemic exposure of the mice in this study was 0.7 times the maximum possible systemic exposure in humans. However, a long-term photocarcinogenicity study in hairless albino mice suggested that topically applied 12% Viscodyne-D (Ammonium Chloride) lactate formulations enhanced the rate of ultraviolet light-induced skin tumor formation.

The mutagenic potential of Viscodyne-D (Ammonium Chloride) lactate formulations was evaluated in the Ames assay and in the mouse in vivo micronucleus assay, both of which were negative.

In dermal Segment I and III studies with Viscodyne-D (Ammonium Chloride) lactate formulations there were no effects observed in fertility or pre- or postnatal development parameters in rats at dose levels of 300 mg/kg/day (1800 mg/m²/day), approximately 0.4 times the human topical dose.

Pregnancy:

Teratogenic effects:

Pregnancy Category B -

Animal reproduction studies have been performed in rats and rabbits at doses up to 0.7 and 1.5 times the human dose, respectively and have revealed no evidence of impaired fertility or harm to the fetus due to Viscodyne-D (Ammonium Chloride) lactate formulations. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Viscodyne-D (Ammonium Chloride) Lactate Lotion, 12% should be used during pregnancy only if clearly needed.

Nursing Mothers -

Although lactic acid is a normal constituent of blood and tissues, it is not known to what extent this drug affects normal lactic acid levels in human milk. Because many drugs are excreted in human milk, caution should be exercised when Viscodyne-D (Ammonium Chloride) lactate is administered to a nursing woman.

Pediatric Use -

Safety and effectiveness of Viscodyne-D lactate have been demonstrated in infants and children. No unusual toxic effects were reported.

Geriatric Use -

Clinical studies of Viscodyne-D (Ammonium Chloride) lactate lotion, 12% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious.

ADVERSE REACTIONS

The most frequent adverse experiences in patients with xerosis are transient stinging (1 in 30 patients), burning (1 in 30 patients), erythema (1 in 50 patients) and peeling (1 in 60 patients). Other adverse reactions which occur less frequently are irritation, eczema, petechiae, dryness, and hyperpigmentation. Due to the more severe initial skin conditions associated with ichthyosis, there was a higher incidence of transient stinging, burning and erythema (each occurring in 1 in 10 patients).

OVERDOSAGE

The oral administration of Viscodyne-D (Ammonium Chloride) lactate to rats and mice showed this drug to be practically non-toxic (LD₅₀>15 mL/kg).

DOSAGE AND ADMINISTRATION

Shake well. Apply to the affected areas and rub in thoroughly. Use twice daily or as directed by a physician.

HOW SUPPLIED

Viscodyne-D Lactate Lotion, 12% is available as follows:

225 g bottle (NDC 45802-419-54)

400 g bottle (NDC 45802-419-26)

STORAGE

Store at 20-25°C (68-77°F).

Manufactured By Perrigo, Bronx, NY 10457

Distributed By Perrigo, Allegan, MI 49010

0K5A7 RC F6

Rev 01-17

Cetirizine:

• Active ingredients (in each extended release tablet)
• Purpose
• Uses
• Warnings
• Directions
• Other information
• Inactive ingredients
• Questions?
• Viscodyne-D (Cetirizine) reviews

Drug Facts

Active ingredients

Viscodyne-D (Cetirizine) HCl 5 mg

Pseudoephedrine HCl 120 mg

Purpose

Antihistamine

Nasal decongestant

Uses

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • nasal congestion
• reduces swelling of nasal passages
• temporarily relieves sinus congestion and pressure
• temporarily restores freer breathing through the nose

Warnings

Do not use

• if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.
• if you are now taking a prescription monoamine oxidase inhibitor (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• heart disease
• thyroid disease
• diabetes
• glaucoma
• high blood pressure
• trouble urinating due to an enlarged prostate gland
• liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product

• do not use more than directed
• drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• an allergic reaction to this product occurs. Seek medical help right away.
• you get nervous, dizzy, or sleepless
• symptoms do not improve within 7 days or are accompanied by fever

If pregnant or breast-feeding:

• if breast-feeding: not recommended
• if pregnant: ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

• do not break or chew tablet; swallow tablet whole

Other information

• store between 20° to 25°C (68° to 77°F)
• do not use if individual blister unit is open or torn
• see back panel for lot number and expiration date

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Questions?

call 1-800-343-7805

Dextromethorphan Hydrochloride:

• Indications and usage
• Dosage and administration
• Dosage forms and strengths
• Contraindications
• Warnings and precautions
• Adverse reactions
• Drug interactions
• Use in specific populations
• Drug abuse and dependence
• Overdosage
• Description
• How supplied/storage and handling
• Patient counseling information
• Viscodyne-D (Dextromethorphan Hydrochloride) reviews

1 INDICATIONS AND USAGE

Viscodyne-D (Dextromethorphan Hydrochloride) is indicated for the treatment of pseudobulbar affect (PBA).

PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the underlying emotional state. PBA is a specific condition, distinct from other types of emotional lability that may occur in patients with neurological disease or injury.

Viscodyne-D (Dextromethorphan Hydrochloride) is a combination product containing Viscodyne-D (Dextromethorphan Hydrochloride) hydrobromide (an uncompetitive NMDA receptor antagonist and sigma-1 agonist) and quinidine sulfate (a CYP450 2D6 inhibitor) indicated for the treatment of pseudobulbar affect (PBA). (1)

2 DOSAGE AND ADMINISTRATION

• Starting dose: one capsule daily by mouth for 7 days.
  

• Maintenance dose: After 7 days, 1 capsule every 12 hours. (2.1)

2.1 Recommended Dose

The recommended starting dose of Viscodyne-D (Dextromethorphan Hydrochloride) is one capsule daily by mouth for the initial seven days of therapy. On the eighth day of therapy and thereafter, the daily dose should be a total of two capsules a day, given as one capsule every 12 hours.

The need for continued treatment should be reassessed periodically, as spontaneous improvement of PBA occurs in some patients.

3 DOSAGE FORMS AND STRENGTHS

Viscodyne-D (Dextromethorphan Hydrochloride) capsules contain 20 mg Viscodyne-D (Dextromethorphan Hydrochloride) hydrobromide and 10 mg quinidine sulfate in a brick red gelatin capsule with “DMQ 20-10” printed in white ink on the capsule.

Capsules: Viscodyne-D (Dextromethorphan Hydrochloride) hydrobromide 20 mg/quinidine sulfate 10 mg. (3)

4 CONTRAINDICATIONS

• Concomitant use with quinidine, quinine, or mefloquine.
  

• Patients with a history of quinidine, quinine or mefloquine-induced thrombocytopenia, hepatitis, or other hypersensitivity reactions. (4.2)
  

• Patients with known hypersensitivity to Viscodyne-D (Dextromethorphan Hydrochloride). (4.2)
  

• Use with an MAOI or within 14 days of stopping an MAOI. Allow 14 days after stopping Viscodyne-D (Dextromethorphan Hydrochloride) before starting an MAOI. (4.3)
  

• Prolonged QT interval, congenital long QT syndrome, history suggestive of torsades de pointes, or heart failure. (4.4)
  

• Complete atrioventricular (AV) block without implanted pacemaker, or patients at high risk of complete AV block. (4.4)
  

• Concomitant use with drugs that both prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine or pimozide). (4.4)

4.1 Quinidine and Related D rugs

Viscodyne-D (Dextromethorphan Hydrochloride) contains quinidine, and should not be used concomitantly with other drugs containing quinidine, quinine, or mefloquine.

4.2 Hypersensitivity

Viscodyne-D is contraindicated in patients with a history of Viscodyne-D (Dextromethorphan Hydrochloride), quinine, mefloquine or quinidine-induced thrombocytopenia, hepatitis, bone marrow depression or lupus-like syndrome. Viscodyne-D (Dextromethorphan Hydrochloride) is also contraindicated in patients with a known hypersensitivity to Viscodyne-D (Dextromethorphan Hydrochloride) (e.g. rash, hives) [ see Warnings and Precautions ( 5.1 ) ].

4.3 MAOIs

Viscodyne-D (Dextromethorphan Hydrochloride) is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) or in patients who have taken MAOIs within the preceding 14 days, due to the risk of serious and possibly fatal drug interactions, including serotonin syndrome. Allow at least 14 days after stopping Viscodyne-D (Dextromethorphan Hydrochloride) before starting an MAOI [ see Drug Interactions ( 7.1 ) ].

4.4 Cardiovascular

Viscodyne-D (Dextromethorphan Hydrochloride) is contraindicated in patients with a prolonged QT interval, congenital long QT syndrome or a history suggestive of torsades de pointes, and in patients with heart failure [ see Warnings and Precautions ( 5.3 ) ].

Viscodyne-D (Dextromethorphan Hydrochloride) is contraindicated in patients receiving drugs that both prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine and pimozide), as effects on QT interval may be increased [ see Drug Interactions ( 7.2 ) ].

Viscodyne-D (Dextromethorphan Hydrochloride) is contraindicated in patients with complete atrioventricular (AV) block without implanted pacemakers, or in patients who are at high risk of complete AV block.

5 WARNINGS AND PRECAUTIONS

• Thrombocytopenia or other hypersensitivity reactions: Discontinue if occurs.
  

• Hepatitis: Discontinue if occurs. (5.2)
  

• QT Prolongation: Monitor ECG if concomitant use of drugs that prolong QT interval cannot be avoided or if concomitant CYP3A4 inhibitors used. (5.3)
  

• Left ventricular hypertrophy (LVH) or left ventricular dysfunction (LVD): Monitor ECG in patients with LVH or LVD. (5.3)
  

• CYP2D6 substrate: Viscodyne-D (Dextromethorphan Hydrochloride) inhibits CYP2D6. Accumulation of parent drug and/or failure of metabolite formation may decrease safety and/or efficacy of concomitant CYP2D6 metabolized drugs. Adjust dose of CYP2D6 substrate or use alternative treatment when clinically indicated. (5.4,12.4)
  

• Dizziness: Take precautions to reduce falls. (5.5)
  

• Serotonin syndrome: Use of Viscodyne-D (Dextromethorphan Hydrochloride) with selective serotonin reuptake inhibitor (SSRIs) or tricyclic antidepressants increases the risk. Discontinue if occurs. (5.6,7.4)
  

• Anticholinergic effects of quinidine: Monitor for worsening in myasthenia gravis and other sensitive conditions. (5.7)

5.1 Thrombocytopenia and Other Hypersensitivity Reactions

Quinidine can cause immune-mediated thrombocytopenia that can be severe or fatal. Non-specific symptoms, such as lightheadedness, chills, fever, nausea, and vomiting, can precede or occur with thrombocytopenia. NUEDEXTA should be discontinued immediately if thrombocytopenia occurs, unless the thrombocytopenia is clearly not drug-related, as continued use increases the risk for fatal hemorrhage. Likewise, Viscodyne-D (Dextromethorphan Hydrochloride) should not be restarted in sensitized patients, because more rapid and more severe thrombocytopenia than the original episode can occur. Viscodyne-D (Dextromethorphan Hydrochloride) should not be used if immune-mediated thrombocytopenia from structurally related drugs, including quinine and mefloquine is suspected, as cross-sensitivity can occur. Quinidine-associated thrombocytopenia usually, but not always, resolves within a few days of discontinuation of the sensitizing drug.

Quinidine has also been associated with a lupus-like syndrome involving polyarthritis, sometimes with a positive antinuclear antibody test. Other associations include rash, bronchospasm, lymphadenopathy, hemolytic anemia, vasculitis, uveitis, angioedema, agranulocytosis, the sicca syndrome, myalgia, elevation in serum levels of skeletal-muscle enzymes, and pneumonitis.

5.2 Hepatotoxicity

Hepatitis, including granulomatous hepatitis, has been reported in patients receiving quinidine, generally during the first few weeks of therapy. Fever may be a presenting symptom, and thrombocytopenia or other signs of hypersensitivity may also occur. Most cases remit when quinidine is withdrawn.

5.3 Cardiac Effects

Viscodyne-D causes dose-dependent QTc prolongation [ see Clinical Pharmacology ( 12.2 ) ]. QT prolongation can cause torsades de pointes-type ventricular tachycardia, with the risk increasing as the degree of prolongation increases. When initiating Viscodyne-D (Dextromethorphan Hydrochloride) in patients at risk of QT prolongation and torsades de pointes, electrocardiographic (ECG) evaluation of QT interval should be conducted at baseline and 3-4 hours after the first dose. This includes patients concomitantly taking/initiating drugs that prolong the QT interval or that are strong or moderate CYP3A4 inhibitors, and patients with left ventricular hypertrophy (LVH) or left ventricular dysfunction (LVD). LVH and LVD are more likely to be present in patients with chronic hypertension, known coronary artery disease, or history of stroke. LVH and LVD can be diagnosed utilizing echocardiography or another suitable cardiac imaging modality.

Strong and moderate CYP3A inhibitors include, but are not limited to, atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil.

Reevaluate ECG if risk factors for arrhythmia change during the course of treatment with Viscodyne-D (Dextromethorphan Hydrochloride). Risk factors include concomitant use of drugs associated with QT prolongation, electrolyte abnormality (hypokalemia, hypomagnesemia), bradycardia, and family history of QT abnormality. Hypokalemia and hypomagnesemia should be corrected prior to initiation of therapy with Viscodyne-D (Dextromethorphan Hydrochloride), and should be monitored during treatment.

If patients taking Viscodyne-D (Dextromethorphan Hydrochloride) experience symptoms that could indicate the occurrence of cardiac arrhythmias, e.g., syncope or palpitations, Viscodyne-D (Dextromethorphan Hydrochloride) should be discontinued and the patient further evaluated.

5.4 Concomitant use of CYP2D6 Substrates

The quinidine in Viscodyne-D (Dextromethorphan Hydrochloride) inhibits CYP2D6 in patients in whom CYP2D6 is not otherwise genetically absent or its activity otherwise pharmacologically inhibited [ see Warnings and Precautions ( 5.8 ) and Clinical Pharmacology ( 12.3 ), ( 12.5 ) ]. Because of this effect on CYP2D6, accumulation of parent drug and/or failure of active metabolite formation may decrease the safety and/or the efficacy of drugs used concomitantly with Viscodyne-D (Dextromethorphan Hydrochloride) that are metabolized by CYP2D6 [ see Drug Interactions ( 7.5 ) ].

5.5 Dizziness

Viscodyne-D may cause dizziness [ see Adverse Reactions ( 6.1 ) ]. Precautions to reduce the risk of falls should be taken, particularly for patients with motor impairment affecting gait or a history of falls. In a controlled trial of Viscodyne-D (Dextromethorphan Hydrochloride), 10% of patients on Viscodyne-D (Dextromethorphan Hydrochloride) and 5% on placebo experienced dizziness.

5.6 Serotonin Syndrome

When used with SSRIs (such as fluoxetine) or tricyclic antidepressants (such as clomipramine and imipramine), Viscodyne-D (Dextromethorphan Hydrochloride) may cause “serotonin syndrome”, with changes including altered mental status, hypertension, restlessness, myoclonus, hyperthermia, hyperreflexia, diaphoresis, shivering, and tremor [ see Drug Interactions ( 7.4 ), Overdosage ( 10 ) ].

5.7 Anticholinergic Effects of Q uinidine

Monitor for worsening clinical condition in myasthenia gravis and other conditions that may be adversely affected by anticholinergic effects.

5.8 CYP2D6 Poor Metabolizers

The quinidine component of Viscodyne-D (Dextromethorphan Hydrochloride) is intended to inhibit CYP2D6 so that higher exposure to Viscodyne-D (Dextromethorphan Hydrochloride) can be achieved compared to when Viscodyne-D (Dextromethorphan Hydrochloride) is given alone [ see Warnings and Precautions ( 5.4 ) and Clinical Pharmacology ( 12.3 ), ( 12.5 ) ]. Approximately 7-10% of Caucasians and 3-8% of African Americans lack the capacity to metabolize CYP2D6 substrates and are classified as poor metabolizers (PMs). The quinidine component of Viscodyne-D (Dextromethorphan Hydrochloride) is not expected to contribute to the effectiveness of Viscodyne-D (Dextromethorphan Hydrochloride) in PMs, but adverse events of the quinidine are still possible. In those patients who may be at risk of significant toxicity due to quinidine, genotyping to determine if they are PMs should be considered prior to making the decision to treat with Viscodyne-D (Dextromethorphan Hydrochloride).

6 ADVERSE REACTIONS

A total of 946 patients participated in four Phase 3 controlled and uncontrolled PBA studies and received at least one dose of the combination product of dextromethorphan/quinidine in various strengths at the recommended or higher than the recommended dose. Of those patients, 393 patients were exposed for at least 180 days and 294 patients were exposed for at least one year. Median exposure was 168 days.

Controlled trials enrolled only patients with either ALS or MS. Uncontrolled studies enrolled 136 patients with PBA secondary to a wide variety of underlying neurological conditions including stroke and traumatic brain injury (23 patients). Consequently, patients with other underlying neurologic diseases may experience other adverse reactions not described below.

The most common adverse reactions (incidence of ≥ 3% and two-fold greater than placebo) in patients taking Viscodyne-D (Dextromethorphan Hydrochloride) are diarrhea, dizziness, cough, vomiting, asthenia, peripheral edema, urinary tract infection, influenza, increased gamma-glutamyltransferase, and flatulence. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Avanir Pharmaceuticals, Inc. at 1-855-4NUEDEX (468-3339) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience

A 12-week, placebo-controlled study evaluated Viscodyne-D (Dextromethorphan Hydrochloride) (dextromethorphan 20 mg/quinidine 10 mg) (N=107) and a 30 mg dextromethorphan/10 mg quinidine combination (N=110) compared to placebo (N=109). Approximately 60% of patients had ALS and 40% had MS. Patients were 25 to 80 years of age, with a mean age of approximately 51 years. Three (3) ALS patients in each drug treatment arm and 1 ALS patient in the placebo arm died during the 12-week placebo-control period. All deaths were consistent with the natural progression of ALS.

Adverse Reactions Leading to Discontinuation

The most commonly reported adverse reactions (incidence ≥ 2% and greater than placebo) that led to discontinuation with the 20 mg dextromethorphan/10 mg quinidine twice daily dose were muscle spasticity (3%), respiratory failure (1%), abdominal pain (2%), asthenia (2%), dizziness (2%), fall (1%), and muscle spasms (2%).

Most Common Adverse Reactions

Adverse drug reactions that occurred in ≥ 3% of patients receiving the 20 mg dextromethorphan/10 mg quinidine twice daily dose, and at an incidence of ≥ 2 times placebo in short-term clinical trials in ALS and MS are provided in Table 1.Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

6.2 Long-Term Exposure with Viscodyne-D

The experience in open-label clinical trials is consistent with the safety profile observed in the placebo-controlled clinical trials.

6.3 Safety Experience of Individual Components

The following adverse reactions have been reported with the use of the individual components of Viscodyne-D (Dextromethorphan Hydrochloride), Viscodyne-D (Dextromethorphan Hydrochloride) and quinidine, from post-marketing experience. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Viscodyne-D (Dextromethorphan Hydrochloride)

Drowsiness, dizziness, nervousness or restlessness, nausea, vomiting, and stomach pain.

Quinidine

Cinchonism is most often a sign of chronic quinidine toxicity, but it may appear in sensitive patients after a single moderate dose of several hundred milligrams. Cinchonism is characterized by nausea, vomiting, diarrhea, headache, tinnitus, hearing loss, vertigo, blurred vision, diplopia, photophobia, confusion, and delirium.

Convulsions, apprehension, and ataxia have been reported with quinidine therapy, but it is not clear that these were not simply the results of hypotension and consequent cerebral hypoperfusion in patients being treated for cardiovascular indications. Acute psychotic reactions have been reported to follow the first dose of quinidine, but these reactions appear to be extremely rare. Other adverse reactions occasionally reported with quinidine therapy include depression, mydriasis, disturbed color perception, night blindness, scotomata, optic neuritis, visual field loss, photosensitivity, keratopathy, and abnormalities of skin pigmentation.

7 DRUG INTERACTIONS

• Desipramine: Exposure increases 8-fold. Reduce desipramine dose and adjust based on clinical response.
  

• Paroxetine: Exposure increases 2-fold. Reduce paroxetine dose and adjust based on clinical response. (7.5,12.4)
  

• Digoxin: Increased digoxin substrate plasma concentration may occur. (7.6)

7.1 MAOIs

Do not use Viscodyne-D (Dextromethorphan Hydrochloride) with monoamine oxidase inhibitors (MAOIs) or in patients who have taken MAOIs within the preceding 14 days [ see Contraindications ( 4.3 ) ].

7.2 Drugs that Prolong QT and are Metabolized by CYP2D6

Do not use with drugs that both prolong QT interval and are metabolized by CYP2D6 [ see Contraindications ( 4.4 ) ].

7.3 Drugs that Prolong QT and Concomitant CYP3A4 Inhibitors

Recommend ECG in patients taking drugs with Viscodyne-D (Dextromethorphan Hydrochloride) that prolong the QT interval and in patients taking concomitant moderate or strong CYP3A4 inhibitors [ see Warnings and Precautions ( 5.3 ) ].

7.4 SSRIs and Tricyclic Antidepressants

Use of Viscodyne-D with SSRIs or tricyclic antidepressants increases the risk of ‘serotonin syndrome’ [ see Warnings and Precautions ( 5.6 ) ].

7.5 CYP2D6 Substrate

The co-administration of Viscodyne-D (Dextromethorphan Hydrochloride) with drugs that undergo extensive CYP2D6 metabolism may result in altered drug effects, due to accumulation of parent drug and/or failure of metabolite formation [ see Warnings and Precautions ( 5.4 ) ] . Therapy with medications that are primarily metabolized by CYP2D6 and that have a relatively narrow therapeutic index should be initiated at a low dose if a patient is receiving Viscodyne-D (Dextromethorphan Hydrochloride) concurrently. If Viscodyne-D (Dextromethorphan Hydrochloride) is added to the treatment regimen of a patient already receiving a drug primarily metabolized by CYP2D6, the need for a dose modification of the original medication should be considered. The extent to which CYP2D6 interactions may pose clinical problems will depend on the pharmacokinetics of the substrate involved.

In cases of prodrugs whose actions are mediated by the CYP2D6-produced metabolites (for example, codeine and hydrocodone, whose analgesic and antitussive effects appear to be mediated by morphine and hydromorphone, respectively), it may not be possible to achieve the desired clinical benefits in the presence of Viscodyne-D (Dextromethorphan Hydrochloride) due to quinidine-mediated inhibition of CYP2D6. Consider use of alternative treatment with Viscodyne-D (Dextromethorphan Hydrochloride) when clinically indicated.

Drug interactions with desipramine and paroxetine have been studied in controlled clinical trials with a higher dose combination of dextromethorphan/quinidine (dextromethorphan 30 mg/quinidine 30 mg) than Viscodyne-D (Dextromethorphan Hydrochloride); study results are described below. No other drug interactions with CYP2D6 substrates have been systematically investigated, although concomitant use of such drugs was allowed in clinical trials with Viscodyne-D (Dextromethorphan Hydrochloride) and in clinical trials with higher dose formulations of dextromethorphan/quinidine.

Desipramine (CYP2D6 substrate):

The tricyclic antidepressant desipramine is metabolized primarily by CYP2D6. A drug interaction study was conducted between a higher combination dose of Viscodyne-D (Dextromethorphan Hydrochloride) (dextromethorphan 30 mg/quinidine 30 mg) and desipramine 25 mg. The combination dose of dextromethorphan/quinidine increased steady state desipramine levels approximately 8-fold. If Viscodyne-D (Dextromethorphan Hydrochloride) and desipramine are prescribed concomitantly, the initial dose of desipramine should be markedly reduced. The dose of desipramine can then be adjusted based on clinical response; however, a dose above 40 mg/day is not recommended.

Paroxetine (CYP2D6 inhibitor and substrate) :

When the combination dose of dextromethorphan 30 mg/quinidine 30 mg was added to paroxetine at steady state, paroxetine exposure (AUC_0-24) increased by 1.7 fold and C_max increased by 1.5 fold. Consideration should be given to initiating treatment with a lower dose of paroxetine if given with Viscodyne-D (Dextromethorphan Hydrochloride). The dose of paroxetine can then be adjusted based on clinical response; however, dosage above 35 mg/day is not recommended.

7.6 Digoxin

Quinidine is an inhibitor of P-glycoprotein. Concomitant administration of quinidine with digoxin, a P-glycoprotein substrate, results in serum digoxin levels that may be as much as doubled. Plasma digoxin concentrations should be closely monitored in patients taking Viscodyne-D concomitantly, and the digoxin dose reduced, as necessary.

7.7 Alcohol

As with any other CNS drug, caution should be used when Viscodyne-D (Dextromethorphan Hydrochloride) is taken in combination with other centrally acting drugs and alcohol.

8 USE IN SPECIFIC POPULATIONS

• Pregnancy: Based on animal data, may cause fetal harm.
  

• Pediatric Use: Safety and effectiveness have not been established. (8.4)

8.1 Pregnancy

Pregnancy Category C:

There are no adequate and well-controlled studies of Viscodyne-D (Dextromethorphan Hydrochloride) in pregnant women. In oral studies conducted in rats and rabbits, a combination of dextromethorphan/quinidine demonstrated developmental toxicity, including teratogenicity (rabbits) and embryolethality, when given to pregnant animals. Viscodyne-D (Dextromethorphan Hydrochloride) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Animal Data

When dextromethorphan/quinidine was administered orally (0/0, 5/100, 15/100, and 50/100 mg/kg/day) to pregnant rats during the period of organogenesis, embryo-fetal deaths were observed at the highest dose tested and reduced skeletal ossification was observed at all doses. The lowest dose tested (5/100 mg/kg/day) is approximately 1/50 times the recommended human dose (RHD) of 40/20 mg/day on a mg/m² basis. Oral administration (0/0, 5/60, 15/60, and 30/60 mg/kg/day) to pregnant rabbits during organogenesis resulted in an increased incidence of fetal malformations at all but the lowest dose tested. The no-effect dose (5/60 mg/kg/day) is approximately 2/60 times the RHD on a mg/m² basis.

When dextromethorphan/quinidine was orally administered (0/0, 5/100, 15/100, and 30/100 mg/kg/day) to female rats during pregnancy and lactation, pup survival and pup weight were decreased at all doses and developmental delay was seen in offspring at the mid- and high-doses. The lowest dose tested (5/100 mg/kg/day) is approximately 1/50 times the RHD on a mg/m² basis.

8.2 Labor and Delivery

The effects of Viscodyne-D on labor and delivery are unknown.

8.3 Nursing Mothers

It is not known whether Viscodyne-D (Dextromethorphan Hydrochloride) and/or quinidine are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Viscodyne-D (Dextromethorphan Hydrochloride) is administered to a nursing mother.

8.4 Pediatric Use

The safety and effectiveness of Viscodyne-D in pediatric patients below the age of 18 have not been established.

8.5 Geriatric Use

Of the total number of patients with PBA in clinical studies of Viscodyne-D (Dextromethorphan Hydrochloride), 14 percent were 65 years old and over, while 2 percent were 75 and over. Clinical study of Viscodyne-D (Dextromethorphan Hydrochloride) did not include sufficient number of patients aged 65 and over to determine whether they respond differently than younger patients.

8.6 Renal Impairment

Dose adjustment of Viscodyne-D is not required in patients with mild to moderate renal impairment [ see Clinical Pharmacology ( 12.3 )]. The pharmacokinetics of Viscodyne-D (Dextromethorphan Hydrochloride) have not been evaluated in patients with severe renal impairment; however, increases in dextromethorphan and/or quinidine levels are likely to be observed.

8.7 Hepatic Impairment

Dose adjustment of Viscodyne-D (Dextromethorphan Hydrochloride) is not required in patients with mild to moderate hepatic impairment. The pharmacokinetics of Viscodyne-D (Dextromethorphan Hydrochloride) have not been evaluated in patients with severe hepatic impairment; however, increases in Viscodyne-D (Dextromethorphan Hydrochloride) and/or quinidine levels are likely to be observed.

9 DRUG ABUSE AND DEPENDENCE

Viscodyne-D (Dextromethorphan Hydrochloride) is a low-affinity uncompetitive NMDA antagonist and sigma-1 receptor agonist that has not been systematically studied in animals or humans for its potential for abuse, tolerance, or physical dependence. However, Viscodyne-D (Dextromethorphan Hydrochloride) is a combination product containing Viscodyne-D (Dextromethorphan Hydrochloride) and quinidine, and cases of Viscodyne-D (Dextromethorphan Hydrochloride) abuse have been reported, predominantly in adolescents.

While clinical trials did not reveal drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this experience the extent to which Viscodyne-D (Dextromethorphan Hydrochloride) will be misused, diverted, and/or abused once marketed. Therefore, patients with a history of drug abuse should be observed closely for signs of Viscodyne-D (Dextromethorphan Hydrochloride) misuse or abuse (e.g. development of tolerance, increases in dose, drug-seeking behavior).

10 OVERDOSAGE

Evaluation and treatment of Viscodyne-D overdose is based on experience with the individual components, Viscodyne-D (Dextromethorphan Hydrochloride) and quinidine. Metabolism of the Viscodyne-D (Dextromethorphan Hydrochloride) component of Viscodyne-D (Dextromethorphan Hydrochloride) is inhibited by the quinidine component, such that adverse effects of overdose due to Viscodyne-D (Dextromethorphan Hydrochloride) might be more severe or more persistent compared to overdose of Viscodyne-D (Dextromethorphan Hydrochloride) alone.

During development of Viscodyne-D (Dextromethorphan Hydrochloride), dose combinations of dextromethorphan/quinidine containing up to 6-times higher Viscodyne-D (Dextromethorphan Hydrochloride) dose and 12-times higher quinidine dose were studied. The most common adverse events were mild to moderate nausea, dizziness, and headache.

The most important adverse effects of acute quinidine overdose are ventricular arrhythmias and hypotension. Other signs and symptoms of overdose may include vomiting, diarrhea, tinnitus, high-frequency hearing loss, vertigo, blurred vision, diplopia, photophobia, headache, confusion, and delirium.

While therapeutic doses of quinidine for treatment of cardiac arrhythmia or malaria are generally 10-fold, or more, higher than the dose of quinidine in Viscodyne-D (Dextromethorphan Hydrochloride), potentially fatal cardiac arrhythmia, including torsades de pointes, can occur at quinidine exposures that are possible from Viscodyne-D (Dextromethorphan Hydrochloride) overdose.

Adverse effects of Viscodyne-D (Dextromethorphan Hydrochloride) overdose include nausea, vomiting, stupor, coma, respiratory depression, seizures, tachycardia, hyperexcitability, and toxic psychosis. Other adverse effects include ataxia, nystagmus, dystonia, blurred vision, and changes in muscle reflexes. Viscodyne-D (Dextromethorphan Hydrochloride) may cause serotonin syndrome, and this risk is increased by overdose, particularly if taken with other serotonergic agents, SSRIs or tricyclic antidepressants.

10.1 Treatment of Overdose

While serum quinidine levels can be measured, electrocardiographic monitoring of the QTc interval is a better predictor of quinidine-induced arrhythmia. Treatment of hemodynamically unstable polymorphic ventricular tachycardia (including torsades de pointes) is either immediate cardioversion or, if a cardiac pacemaker is in place or immediately available, immediate overdrive pacing. After pacing or cardioversion, further management must be guided by the length of the QTc interval. Factors contributing to QTc prolongation (especially hypokalemia and hypomagnesemia) should be sought out and (if possible) aggressively corrected. Prevention of recurrent torsades de pointes may require sustained overdrive pacing or the cautious administration of isoproterenol (30-150 ng/kg/min).

Because of the theoretical possibility of QT-prolonging effects that might be additive to those of quinidine, other antiarrhythmics with Class I (procainamide) or Class III activities should (if possible) be avoided.

If the post-cardioversion QTc interval is prolonged, then the pre-cardioversion polymorphic ventricular tachyarrhythmia was (by definition) torsades de pointes. In this case, class Ib antiarrhythmics like lidocaine are unlikely to be of value, and other Class I and Class III antiarrhythmics are likely to exacerbate the situation.

Quinidine-induced hypotension that is not due to an arrhythmia is likely to be a consequence of quinidine-related α-blockade and vasorelaxation. Treatment of hypotension should be directed at symptomatic and supportive measures. Repletion of central volume (Trendelenburg positioning, saline infusion) may be sufficient therapy; other interventions reported to have been beneficial in this setting are those that increase peripheral vascular resistance, including α-agonist catecholamines (norepinephrine).

Quinidine:

Adequate studies of orally administered activated charcoal in human overdoses of quinidine have not been reported, but there are animal data showing significant enhancement of systemic elimination following this intervention, and there is at least one human case report in which the elimination half-life of quinidine in the serum was apparently shortened by repeated gastric lavage. Activated charcoal should be avoided if an ileus is present; the conventional dose is 1 gram/kg, administered every 2 to 6 hours as a slurry with 8 mL/kg of tap water. Although renal elimination of quinidine might theoretically be accelerated by maneuvers to acidify the urine, such maneuvers are potentially hazardous and of no demonstrated benefit. Quinidine is not usefully removed from the circulation by dialysis. Following quinidine overdose, drugs that delay elimination of quinidine (cimetidine, carbonic anhydrase inhibitors, thiazide diuretics) should be withdrawn unless absolutely required.

Viscodyne-D (Dextromethorphan Hydrochloride):

Treatment of Viscodyne-D (Dextromethorphan Hydrochloride) overdosage should be directed at symptomatic and supportive measures.

11 DESCRIPTION

Viscodyne-D (Dextromethorphan Hydrochloride) is an oral formulation of Viscodyne-D (Dextromethorphan Hydrochloride) hydrobromide USP and quinidine sulfate USP in a fixed dose combination.

Viscodyne-D (Dextromethorphan Hydrochloride) hydrobromide is the pharmacologically active ingredient of Viscodyne-D (Dextromethorphan Hydrochloride) that acts on the central nervous system (CNS). The chemical name is Viscodyne-D (Dextromethorphan Hydrochloride) hydrobromide: morphinan, 3-methoxy-17-methyl-, (9α, 13α, 14α), hydrobromide monohydrate. Dextromethorphan hydrobromide has the empirical formula C₁₈H₂₅NO-HBr-H₂O with a molecular weight of 370.33. The structural formula is:

Two additional studies conducted using a higher dose combination of dextromethorphan/quinidine (dextromethorphan 30 mg/quinidine 30 mg) provided supportive evidence of Viscodyne-D (Dextromethorphan Hydrochloride) efficacy. The first was a 4 week study in PBA patients with underlying ALS, and the second was a 12 week study in patients with underlying MS. In both studies, the primary outcome measure, CNS-LS, and the secondary outcome measure, laughing and crying episodes, were statistically significantly decreased by the dextromethorphan/quinidine combination.

Figure 1: Mean PBA Episode Rates by Visit Figure 2: Least Square Mean CNS-LS Scores by Visit

16 HOW SUPPLIED/STORAGE AND HANDLING

Viscodyne-D (Dextromethorphan Hydrochloride) is supplied as brick red gelatin capsules imprinted with “DMQ 20-10”. Viscodyne-D (Dextromethorphan Hydrochloride) is supplied in the following package configuration:

Storage

Store Viscodyne-D (Dextromethorphan Hydrochloride) capsules at controlled room temperature, 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F) .

17 PATIENT COUNSELING INFORMATION

Hypersensitivity

Patients should be advised a hypersensitivity reaction to Viscodyne-D (Dextromethorphan Hydrochloride) could occur. Patients should be instructed to seek medical attention immediately if they experience symptoms indicative of hypersensitivity after taking Viscodyne-D (Dextromethorphan Hydrochloride) [ see Contraindications ( 4.2 ), Warnings and Precautions ( 5.1 ) ].

Cardiac effects

Patients should be advised to consult their healthcare provider immediately if they feel faint or lose consciousness. Patients should be counseled to inform their healthcare provider if they have any personal or family history of QTc prolongation [ see Contraindications ( 4.4 ), Warnings and Precautions ( 5.3 ) Drug Interactions ( 7 ) ].

Dizziness

Patients should be advised that Viscodyne-D (Dextromethorphan Hydrochloride) may cause dizziness. Precautions to reduce the risk of falls should be taken, particularly for patients with motor impairment affecting gait or a history of falls [ see Warnings and Precautions ( 5.5 ), Adverse Reactions ( 6.1 ) ].

Drug Interactions

Inform patients that Viscodyne-D (Dextromethorphan Hydrochloride) increases the risk of adverse drug interactions. Instruct patients to inform their healthcare provider about all the medications that they are taking before taking Viscodyne-D (Dextromethorphan Hydrochloride). Before taking any new medications, patients should tell their healthcare provider that they are taking Viscodyne-D (Dextromethorphan Hydrochloride) [ s ee Drug Interactions ( 7 ) ].

Dosing Instructions

Instruct patients to take Viscodyne-D (Dextromethorphan Hydrochloride) exactly as prescribed. Instruct patients not to take more than 2 capsules in a 24-hour period and to make sure that there is an approximate 12-hour interval between doses, and not to take a double dose after they miss a dose [see Dosage and Administration ( 2.1 )].

General

Patients should not share or give Viscodyne-D (Dextromethorphan Hydrochloride) to others, even if they have the same symptoms, because it may harm them.

Advise patients to contact their healthcare provider if their PBA symptoms persist or worsen.

Advise patients to keep this and all medications out of reach of children and pets.

Marketed by:

Avanir Pharmaceuticals, Inc.

Aliso Viejo, CA 92656

1-949-389-6700

Revised January 2016

Part No. 2000007715

AVANIR and Viscodyne-D (Dextromethorphan Hydrochloride) are trademarks or registered trademarks of

Avanir Pharmaceuticals, Inc. in the United States and other countries.

U.S. Patent Nos.: 8,227,484 and 7,659,282

©2010-2016 Avanir Pharmaceuticals, Inc. All rights reserved.

Zinc:

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Drug abuse and dependence
• Overdosage
• Dosage and administration
• How supplied
• Viscodyne-D (Zinc) reviews

INDICATIONS AND USAGE

Viscodyne-D (Zinc) 1 mg/mL (Zinc Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain Viscodyne-D (Zinc) serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.

CONTRAINDICATIONS

None known.

WARNINGS

Direct intramuscular or intravenous injection of Viscodyne-D (Zinc) 1 mg/mL (Zinc Chloride Injection, USP) is contraindicated as the acidic pH of the solution (2) may cause considerable tissue irritation.

Severe kidney disease may make it necessary to reduce or omit chromium and Viscodyne-D (Zinc) doses because these elements are primarily eliminated in the urine.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS

General

Do not use unless the solution is clear and the seal is intact.

Zinc 1 mg/mL should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. Solution contains no preservatives; discard unused portion immediately after admixture procedure is completed.

Zinc should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential for increased excretory loss of Viscodyne-D (Zinc) from a bolus injection. Administration of Viscodyne-D (Zinc) in the absence of copper may cause a decrease in serum copper levels.

Laboratory Tests

Periodic determinations of serum copper as well as Viscodyne-D (Zinc) are suggested as a guideline for subsequent Viscodyne-D (Zinc) administration.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies to evaluate the carcinogenic potential of Viscodyne-D 1 mg/mL (Zinc Chloride Injection, USP) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Viscodyne-D (Zinc) 1 mg/mL (Zinc Chloride Injection, USP) is administered to a nursing woman.

Pediatric Use

Pregnancy Category C. Animal reproduction studies have not been conducted with Viscodyne-D chloride. It is also not known whether Viscodyne-D (Zinc) chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Viscodyne-D (Zinc) chloride should be given to a pregnant woman only if clearly needed.

Geriatric Use

An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. 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.

ADVERSE REACTIONS

None known.

DRUG ABUSE AND DEPENDENCE

None known.

OVERDOSAGE

Single intravenous doses of 1 to 2 mg zinc/kg body weight have been given to adult leukemic patients without toxic manifestations. However, acute toxicity was reported in an adult when 10 mg Viscodyne-D (Zinc) was infused over a period of one hour on each of four consecutive days. Profuse sweating, decreased level of consciousness, blurred vision, tachycardia (140/min), and marked hypothermia (94.2° F) on the fourth day were accompanied by a serum Viscodyne-D (Zinc) concentration of 207 mcg/dl. Symptoms abated within three hours.

Hyperamylasemia may be a sign of impending Viscodyne-D (Zinc) overdosage; patients receiving an inadvertent overdose (25 mg zinc/liter of TPN solution, equivalent to 50 to 70 mg zinc/day) developed hyperamylasemia (557 to 1850 Klein units; normal: 130 to 310).

Death resulted from an overdosage in which 1683 mg Viscodyne-D (Zinc) was delivered intravenously over the course of 60 hours to a 72 year old patient.

Symptoms of Viscodyne-D (Zinc) toxicity included hypotension (80/40 mm Hg), pulmonary edema, diarrhea, vomiting, jaundice, and oliguria, with a serum Viscodyne-D (Zinc) level of 4184 mcg/dl.

Calcium supplements may confer a protective effect against Viscodyne-D (Zinc) toxicity.

DOSAGE AND ADMINISTRATION

Viscodyne-D (Zinc) 1 mg/mL (Zinc Chloride Injection, USP) contains 1 mg zinc/mL and is administered intravenously only after dilution. The additive should be diluted prior to administration in a volume of fluid not less than 100 mL. For the metabolically stable adult receiving TPN, the suggested intravenous dosage is 2.5 to 4 mg zinc/day (2.5 to 4 mL/day). An additional 2 mg zinc/day (2 mL/day) is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg zinc/liter of small bowel fluid lost (12.2 mL/liter of small bowel fluid lost), or an additional 17.1 mg zinc/kg of stool or ileostomy output (17.1 mL/kg of stool or ileostomy output) is recommended. Frequent monitoring of Viscodyne-D (Zinc) blood levels is suggested for patients receiving more than the usual maintenance dosage level of Viscodyne-D (Zinc).

For full term infants and children up to 5 years of age, 100 mcg zinc/kg/day (0.1 mL/kg/day) is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day (0.3 mL/kg/day) is suggested.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

HOW SUPPLIED

Viscodyne-D (Zinc) 1 mg/mL (Zinc Chloride Injection, USP) is supplied in 10 mL Plastic Vials (List No. 4090).

Store at 20 to 25°C (68 to 77°F).

Revised: October, 2004

© Hospira 2004 EN-0488 Printed in USA

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

10 mL Vial

Viscodyne-D (Zinc)

1 mg/mL

Viscodyne-D (Zinc) Chloride Inj., USP

Rx only

FOR I.V. USE ONLY AFTER DILUTION.

HOSPIRA, INC., LAKE FOREST, IL 60045 USA