Class: Antitussive and expectorant combination

Trade Names: Bencof- DM A.F

– Syrup 15 mg dextromethorphan hydrobromide, 100 mg guaifenesin, 40 mg pseudoephedrine hydrochloride per 5 mL
– Tablets 32 mg dextromethorphan hydrobromide, 595 mg guaifenesin, 48 mg pseudoephedrine hydrochloride

Pharmacology

Pseudoephedrine

Causes vasoconstriction and subsequent shrinkage of nasal mucous membranes by alpha-adrenergic stimulation, which promotes nasal drainage.

Guaifenesin

May enhance output of respiratory tract fluid by reducing adhesiveness and surface tension, enhancing removal of viscous mucus and making nonproductive coughs more productive and less frequent.

Dextromethorphan

Suppresses cough by central action on cough center in medulla.

Indications and Usage

Temporary relief of nasal congestion and cough associated with respiratory tract infections and related conditions, such as sinusitis, pharyngitis, bronchitis, and asthma, when these conditions are complicated by tenacious mucus or mucus plugs and congestion.

Contraindications

Hypertension; severe coronary artery disease; MAOI therapy; pregnancy; nursing; hypersensitivity to any component of product or idiosyncrasy to sympathomimetic amines, which may manifest as insomnia, dizziness, weakness, tremor, or arrhythmias.

Dosage and Administration

Adults and Children older than 12 yr of age

PO 1 or 2 tablets every 12 h (max, 4 tablets in 24 h) or up to 2 tsp of syrup 3 to 4 times daily.

Children 6 to 12 yr of age

PO 1 tablet every 12 h (max, 2 tablets in 24 h) or up to 1 tsp 3 to 4 times daily, not to exceed 4 mg per kilogram of body weight of pseudoephedrine in 24 h.

General Advice

    • Tablets may be broken in half for ease of administration. Do not crush or chew tablets or half-tablets.
  • Administer without regard to meals. Administer with food if GI upset occurs.
  • Measure and administer prescribed dose of syrup using dosing syringe, dosing spoon, or dosing cup.

Storage/Stability

Store tablets and syrup at controlled room temperature (59° to 86°F).

Drug Interactions

Digitalis

Ectopic pacemaker activity may be increased by pseudoephedrine.

Guanethidine, mecamylamine, methyldopa, reserpine, veratrum alkaloids

Antihypertensive effects may be reduced by pseudoephedrine.

Kaolin

May increase pseudoephedrine absorption.

MAOIs (eg, isocarboxazid)

May increase the effects of pseudoephedrine. Dextromethorphan is contraindicated with MAOIs.

Laboratory Test Interactions

Guaifenesin may interfere with the interpretation of the test for urinary 5-hydroxyindoleacetic acid for the diagnosis of carcinoid syndrome.

Adverse Reactions

Cardiovascular

Tachycardia; palpitations; arrhythmias; CV collapse with hypotension.

CNS

Headache; dizziness; fear; anxiety; nervousness; restlessness; tremor; weakness; insomnia; hallucinations; convulsions; CNS depression.

GI

Nausea.

Genitourinary

Dysuria.

Respiratory

Respiratory difficulty.

Miscellaneous

Pallor.

Precautions

Pregnancy

Category C .

Lactation

Contraindicated in nursing women.

Children

Safety and efficacy in children younger than 6 yr of age not established for tablets and in children younger than 2 yr of age for syrup.

Elderly

Geriatric patients are more likely to exhibit adverse reactions, such as confusion or CNS depression.

Special Risk Patients

Use with caution in patients with hypertension, heart disease, asthma, hyperthyroidism, increased IOP, diabetes mellitus, prostatic hypertrophy.

Cough

To determine that appropriate therapy for the primary disease is instituted, ascertain underlying cause of cough prior to use of cough suppressants.

Drug abuse

Has abuse potential.

Overdosage

Symptoms

Pseudoephedrine

Excessive CNS stimulation (eg, excitement, tremor, restlessness, insomnia), tachycardia, hypertension, pallor, mydriasis, hyperglycemia, urinary retention, tachypnea, hyperpnea, hallucinations, convulsions, delirium, arrhythmias, hypotension, circulatory collapse, hypokalemia

Dextromethorphan

Drowsiness, ataxia, nystagmus, opisthotonos, convulsive disorders

Patient Information

    • Advise patient to take prescribed dose every 12 h as needed.
  • Advise patient to take with food if GI upset occurs.
  • Advise patient that if a dose is missed to take as soon as remembered unless it is nearing time for the next dose. Caution patient not to double the dose to catch up.
  • Instruct patient to discontinue use and report any of these symptoms to health care provider: nervousness, dizziness, sleeplessness.
  • Advise patient that if symptoms are not controlled, not to increase the dose of medication but to inform health care provider.

Description
Dextromethorphan (dex-troe-meth-OR-fan) is used to relieve coughs due to colds or influenza (flu). It should not be used for chronic cough that occurs with smoking, asthma, or emphysema or when there is an unusually large amount of mucus or phlegm (flem) with the cough.

Dextromethorphan relieves cough by acting directly on the cough center in the brain.

This medicine is available without a prescription; however, your doctor may have special instructions on the proper use of this medicine for your medical condition.

Other medical problems
The presence of other medical problems may affect the use of dextromethorphan. Make sure you tell your doctor if you have any other medical problems, especially:

* Asthma—Since dextromethorphan decreases coughing, it makes it difficult to get rid of the mucus that collects in the lungs and airways during asthma
* Diabetes (sugar diabetes)—Some products contain sugar and may affect control of blood glucose monitoring
* Liver disease—Dextromethorphan may build up in the body and cause unwanted effects
* Chronic bronchitis or
* Emphysema or
* Mucus or phlegm with cough—Since dextromethorphan decreases coughing, it makes it difficult to get rid of the mucus that may collect in the lungs and airways with some diseases
* Slowed breathing—Dextromethorphan may slow the rate of breathing even further

Make certain your health care professional knows if you are on a low-sodium, low-sugar, or any other special diet. Most medicines contain more than their active ingredient, and many liquid medicines contain alcohol.

Use this medicine only as directed by your doctor or the directions on the label . Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor or the label says. Although this effect has happened only rarely, dextromethorphan has become habit-forming (causing mental or physical dependence) in some persons who used too much for a long time.

Dosing
The dose of dextromethorphan will be different for different patients. Follow your doctor’s orders or the directions on the label . The following information includes only the average doses of dextromethorphan. If your dose is different, do not change it unless your doctor tells you to do so.

For syrup dosage form
For cough
o Adults and children 12 years of age and older—30 mg every six to eight hours, as needed.
o Children younger than 2 years of age—Use and dose must be determined by your doctor.
o Children 2 to 6 years of age—3.5 mg every four hours or 7.5 mg every six to eight hours, as needed.
o Children 6 to 12 years of age—7 mg every four hours or 15 mg every six to eight hours, as needed.

For extended-release oral suspension dosage form
For cough
o Adults and children 12 years of age and older—60 mg every twelve hours, as needed.
o Children younger than 2 years of age—Use and dose must be determined by your doctor.
o Children 2 to 6 years of age—15 mg every twelve hours, as needed.
o Children 6 to 12 years of age—30 mg every twelve hours, as needed.

Storage
To store this medicine
* Store away from heat and direct light.
* Keep out of the reach of children.
* Do not store the tablet form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
* Keep the liquid form of this medicine from freezing.
* Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine
If your cough has not improved after 7 days, if sore throat has not improved after 2 days, if you have a high fever, skin rash, or continuing headache with the cough, or if asthma or high blood pressure is present, check with your doctor. These signs may mean that you have other medical problems.

Dissolve lozenges in the mouth with caution, to lessen the risk of choking.
Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Symptoms of overdose
Blurred vision; confusion; difficulty in urination; drowsiness or dizziness; nausea or vomiting (severe); shakiness and unsteady walk; slowed breathing; unusual excitement, nervousness, restlessness, or irritability (severe)

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your health care professional if any of the following side effects continue or are bothersome:

Less common or rare
Confusion; constipation; dizziness (mild); drowsiness (mild); headache; nausea or vomiting; stomach pain