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Benylin DM 12 Hour

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Benylin DM 12 Hour uses


1 INDICATIONS AND USAGE

Benylin DM 12 Hour 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.

Benylin DM 12 Hour is a combination product containing Benylin DM 12 Hour 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

2.1 Recommended Dose

The recommended starting dose of Benylin DM 12 Hour 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

Benylin DM 12 Hour capsules contain 20 mg Benylin DM 12 Hour hydrobromide and 10 mg quinidine sulfate in a brick red gelatin capsule with “DMQ 20-10” printed in white ink on the capsule.

Capsules: Benylin DM 12 Hour hydrobromide 20 mg/quinidine sulfate 10 mg. (3)

4 CONTRAINDICATIONS

4.1 Quinidine and Related D rugs

Benylin DM 12 Hour contains quinidine, and should not be used concomitantly with other drugs containing quinidine, quinine, or mefloquine.

4.2 Hypersensitivity

Benylin DM 12 Hour is contraindicated in patients with a history of Benylin DM 12 Hour, quinine, mefloquine or quinidine-induced thrombocytopenia, hepatitis, bone marrow depression or lupus-like syndrome. Benylin DM 12 Hour is also contraindicated in patients with a known hypersensitivity to Benylin DM 12 Hour [ see Warnings and Precautions ( 5.1 ) ].

4.3 MAOIs

Benylin DM 12 Hour 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 Benylin DM 12 Hour before starting an MAOI [ see Drug Interactions ( 7.1 ) ].

4.4 Cardiovascular

Benylin DM 12 Hour 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 ) ].

Benylin DM 12 Hour 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 ) ].

Benylin DM 12 Hour 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

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, Benylin DM 12 Hour should not be restarted in sensitized patients, because more rapid and more severe thrombocytopenia than the original episode can occur. Benylin DM 12 Hour 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

Benylin DM 12 Hour causes dose-dependent QTc prolongation [ see Clinical Pharmacology ]. QT prolongation can cause torsades de pointes-type ventricular tachycardia, with the risk increasing as the degree of prolongation increases. When initiating Benylin DM 12 Hour 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 Benylin DM 12 Hour. 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 Benylin DM 12 Hour, and should be monitored during treatment.

If patients taking Benylin DM 12 Hour experience symptoms that could indicate the occurrence of cardiac arrhythmias, e.g., syncope or palpitations, Benylin DM 12 Hour should be discontinued and the patient further evaluated.

5.4 Concomitant use of CYP2D6 Substrates

The quinidine in Benylin DM 12 Hour 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 Benylin DM 12 Hour that are metabolized by CYP2D6 [ see Drug Interactions ( 7.5 ) ].

5.5 Dizziness

Benylin DM 12 Hour may cause dizziness [ see Adverse Reactions ]. 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 Benylin DM 12 Hour, 10% of patients on Benylin DM 12 Hour 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), Benylin DM 12 Hour 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 Benylin DM 12 Hour is intended to inhibit CYP2D6 so that higher exposure to Benylin DM 12 Hour can be achieved compared to when Benylin DM 12 Hour 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 Benylin DM 12 Hour is not expected to contribute to the effectiveness of Benylin DM 12 Hour 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 Benylin DM 12 Hour.

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 Benylin DM 12 Hour 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 Benylin DM 12 Hour (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.

Benylin DM 12 Hour

N=107

%

Placebo

N=109

%

Diarrhea 13 6
Dizziness 10 5
Cough 5 2
Vomiting 5 1
Asthenia 5 2
Peripheral edema 5 1
Urinary tract infection 4 1
Influenza 4 1
Increased gamma-

glutamyltransferase

3 0
Flatulence 3 1

6.2 Long-Term Exposure with Benylin DM 12 Hour

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 Benylin DM 12 Hour, Benylin DM 12 Hour 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.

Benylin DM 12 Hour

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

7.1 MAOIs

Do not use Benylin DM 12 Hour 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 Benylin DM 12 Hour 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 Benylin DM 12 Hour with SSRIs or tricyclic antidepressants increases the risk of ‘serotonin syndrome’ [ see Warnings and Precautions ].

7.5 CYP2D6 Substrate

The co-administration of Benylin DM 12 Hour 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 Benylin DM 12 Hour concurrently. If Benylin DM 12 Hour 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 Benylin DM 12 Hour due to quinidine-mediated inhibition of CYP2D6. Consider use of alternative treatment with Benylin DM 12 Hour 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 Benylin DM 12 Hour; 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 Benylin DM 12 Hour 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 Benylin DM 12 Hour (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 Benylin DM 12 Hour 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 (AUC0-24) increased by 1.7 fold and Cmax increased by 1.5 fold. Consideration should be given to initiating treatment with a lower dose of paroxetine if given with Benylin DM 12 Hour. 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 Benylin DM 12 Hour concomitantly, and the digoxin dose reduced, as necessary.

7.7 Alcohol

As with any other CNS drug, caution should be used when Benylin DM 12 Hour is taken in combination with other centrally acting drugs and alcohol.

8 USE IN SPECIFIC POPULATIONS



8.1 Pregnancy

Pregnancy Category C:

There are no adequate and well-controlled studies of Benylin DM 12 Hour 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. Benylin DM 12 Hour 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 Benylin DM 12 Hour on labor and delivery are unknown.

8.3 Nursing Mothers

It is not known whether Benylin DM 12 Hour and/or quinidine are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Benylin DM 12 Hour is administered to a nursing mother.

8.4 Pediatric Use

The safety and effectiveness of Benylin DM 12 Hour 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 Benylin DM 12 Hour, 14 percent were 65 years old and over, while 2 percent were 75 and over. Clinical study of Benylin DM 12 Hour 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 Benylin DM 12 Hour is not required in patients with mild to moderate renal impairment [ see Clinical Pharmacology ]. The pharmacokinetics of Benylin DM 12 Hour 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 Benylin DM 12 Hour is not required in patients with mild to moderate hepatic impairment. The pharmacokinetics of Benylin DM 12 Hour have not been evaluated in patients with severe hepatic impairment; however, increases in Benylin DM 12 Hour and/or quinidine levels are likely to be observed.

9 DRUG ABUSE AND DEPENDENCE

Benylin DM 12 Hour 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, Benylin DM 12 Hour is a combination product containing Benylin DM 12 Hour and quinidine, and cases of Benylin DM 12 Hour 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 Benylin DM 12 Hour will be misused, diverted, and/or abused once marketed. Therefore, patients with a history of drug abuse should be observed closely for signs of Benylin DM 12 Hour misuse or abuse (e.g. development of tolerance, increases in dose, drug-seeking behavior).

10 OVERDOSAGE

Evaluation and treatment of Benylin DM 12 Hour overdose is based on experience with the individual components, Benylin DM 12 Hour and quinidine. Metabolism of the Benylin DM 12 Hour component of Benylin DM 12 Hour is inhibited by the quinidine component, such that adverse effects of overdose due to Benylin DM 12 Hour might be more severe or more persistent compared to overdose of Benylin DM 12 Hour alone.

During development of Benylin DM 12 Hour, dose combinations of dextromethorphan/quinidine containing up to 6-times higher Benylin DM 12 Hour 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 Benylin DM 12 Hour, potentially fatal cardiac arrhythmia, including torsades de pointes, can occur at quinidine exposures that are possible from Benylin DM 12 Hour overdose.

Adverse effects of Benylin DM 12 Hour 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. Benylin DM 12 Hour 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.

Benylin DM 12 Hour:

Treatment of Benylin DM 12 Hour overdosage should be directed at symptomatic and supportive measures.

11 DESCRIPTION

Benylin DM 12 Hour is an oral formulation of Benylin DM 12 Hour hydrobromide USP and quinidine sulfate USP in a fixed dose combination.

Benylin DM 12 Hour hydrobromide is the pharmacologically active ingredient of Benylin DM 12 Hour that acts on the central nervous system (CNS). The chemical name is Benylin DM 12 Hour 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 Benylin DM 12 Hour 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

Benylin DM 12 Hour is supplied as brick red gelatin capsules imprinted with “DMQ 20-10”. Benylin DM 12 Hour is supplied in the following package configuration:

Package Configuration

Capsule Strength (mg) NDC Code
Bottles of 60 (30 day supply) dextromethorphan 20 mg/ quinidine 10 mg 64597-301-60

Storage

Store Benylin DM 12 Hour 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 Benylin DM 12 Hour could occur. Patients should be instructed to seek medical attention immediately if they experience symptoms indicative of hypersensitivity after taking Benylin DM 12 Hour [ 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 Benylin DM 12 Hour 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 Benylin DM 12 Hour increases the risk of adverse drug interactions. Instruct patients to inform their healthcare provider about all the medications that they are taking before taking Benylin DM 12 Hour. Before taking any new medications, patients should tell their healthcare provider that they are taking Benylin DM 12 Hour [ s ee Drug Interactions ( 7 ) ].

Dosing Instructions

Instruct patients to take Benylin DM 12 Hour 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 Benylin DM 12 Hour 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 Benylin DM 12 Hour 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.

Benylin DM 12 Hour pharmaceutical active ingredients containing related brand and generic drugs:


Benylin DM 12 Hour available forms, composition, doses:


Benylin DM 12 Hour destination | category:


Benylin DM 12 Hour Anatomical Therapeutic Chemical codes:


Benylin DM 12 Hour pharmaceutical companies:


References

  1. Dailymed."ROBITUSSIN 12 HOUR COUGH RELIEF (DEXTROMETHORPHAN POLISTIREX) SUSPENSION, EXTENDED RELEASE [RICHMOND DIVISION OF WYETH]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."DEXTROMETHORPHAN HYDROBROMIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "dextromethorphan". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Benylin DM 12 Hour?

Depending on the reaction of the Benylin DM 12 Hour after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Benylin DM 12 Hour not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Benylin DM 12 Hour addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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