Guaifenesin and dextromethorphan hbr extended release 600 mg dosage

Guaifenesin and Dextromethorphan HBr Tablet

Class: OTC

TABLE OF CONTENTS

1. DESCRIPTION

Guaifenesin and dextromethorphan HBr tablets are available over-the-counter (OTC) for oral administration in:

Guaifenesin .............................. 600 mg, Dextromethorphan HBr ............. 30 mg

Guaifenesin ............................. 1200 mg, Dextromethorphan HBr ............ 60 mg

In a special base to provide a prolonged therapeutic eff ect. This product contains ingredients of the following therapeutic classes: expectorant and antitussive.

Guaifenesin is an expectorant. Expectorant is an agent that promotes the ejection of phlegm, mucus or other material from the throat, bronchi, trachea or lungs. It is used in many cough preparations, guaifenesin is a common compound for this application. Expectorants have muscle relaxing action. Its chemical name is 1,2-Propanediol, 3-(2-methoxyphenoxy)-, guaifenesin is a white to slightly gray, crystalline powder, having a bitter taste. It may have a slight characteristic odor. It is soluble in water, alcohol, chloroform, glycerin, and propylene glycol. Its structure follows:

Dextromethorphan is an antitussive. Its chemical name is 3 Methoxy-17-methylmorphinan monohydrate, which is the d isomer of levophenol, a codeine analogue and opioid analgesic.

Molecular formula: (Dextromethorphan Hydrobromide): C18H25NO.HBr.H2O. Molecular weight 370.3.

2. INDICATIONS AND USAGE

Guaifenesin and dextromethorphan HBr tablets are indicated for the temporary relief of coughs associated with upper respiratory tract infections and related conditions such as sinusitis, pharyngitis and bronchitis, particularly when these conditions are complicated by tenacious mucus and/or mucous plugs and congestion.

Guaifenesin and dextromethorphan HBr tablets are eff ective in productive as well as non-productive cough, but are of particular value in dry, non-productive cough which tends to injure the mucous membrane of the air passages.

3. DOSAGE AND ADMINISTRATION

Adults and children over 12 years of age: 1 tablet every 8 hours, or 1 to 2 tablets every 12 hours. Not to exceed 4 tablets in a 24 hour period.

Children under 12 years of age: Do not use.

4. CONTRAINDICATIONS

Guaifenesin and dextromethorphan HBr tablets are contraindicated in patients with hypersensitivity to guaifenesin or dextromethorphan. Guaifenesin and dextromethorphan HBr tablets should not be used in patients receiving monoamine oxidase inhibitor therapy (MAOI) and for 14 days after stopping MAOI therapy.

5. MECHANISM OF ACTION

Guaifenesin is an expectorant used frequently in cough medications to increase phlegm production and decrease its viscosity, in order to remove excess mucous in the airways during acute respiratory tract infections.

The theory for the medicinal effects of guaifenesin for Fibromyalgia (FM) is based on the premise developed by Paul St. Amand, MD. His theory postulates that a possible genetic defect in some individuals may be responsible for an abnormality in natural phosphate excretion, resulting in the accumulation of calcium and inorganic phosphate compounds within cells to produce a state of hyperpermeability and lead to symptoms of Fibromyalgia. Cells and their mitochondria malfunction, therefore, an energy deprivation syndrome develops and affects susceptible bodily functions. Guaifenesin is a weakly uricosuric and mucolytic drug, which is used to increase excretion of the over-accumulated phosphates.

The mode of actions of dextromethorphan are not completely defined. Dextromethorphan works by decreasing the activity in the part of the brain causes coughing.

6. USE IN SPECIFIC POPULATIONS

6.1 Usage in Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with guaifenesin or with dextromethorphan. It is also not known whether these drugs can cause fetal harm when administered to a pregnant woman or can aff ect reproduction capacity. This product should be given to a pregnant woman only if clearly needed.

6.2 Nursing Mothers

It is not known whether guaifenesin or dextromethorphan is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when these drugs are administered to a nursing woman and a decision should be made whether to discontinue nursing or to discontinue the drugs, taking into account the importance of the drugs to the mother.

6.3 Pediatric Use

Guaifenesin and dextromethorphan HBr is not recommended for use in children under 12 years of age.

6.4 Use in Elderly (Patients age 60 and older)

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

7. WARNINGS AND PRECAUTIONS

None.

8. ADVERSE REACTIONS

No serious side eff ects from guaifenesin or dextromethorphan have been reported.

Guaifenesin is well tolerated and has a wide margin of safety. Side effects are generally mild and infrequent. Nausea and vomiting are the most frequently occurring side effects.

9. OVERDOSAGE

Overdosage with guaifenesin is unlikely to produce toxic eff ects since its toxicity is low. Guaifenesin, when administered by stomach tube to test animals in doses up to 5 grams/kg, produced no signs of toxicity. In severe cases of overdosage, treatment should be aimed at reducing further absorption of the drug. Gastric emptying (Syrup of Ipecac) and/or lavage is recommended as soon as possible after ingestion. Overdosage with dextromethorphan may produce central excitement and mental confusion. Very high doses may produce respiratory depression. One case of toxic psychosis (hyperactivity, marked visual and auditory hallucinations) after ingestion of a single 300 mg dose has been reported.

10. DRUG INTERACTIONS

No drug interaction information is available.

11. PHARMACOKINETICS

No pharmacokinetics information is available.

12. HOW SUPPLIED/STORAGE AND HANDLING

1) How Available:

a) Brand name: MUCINEX DM (by RECKITT BENCKISER).

b) Generic drugs: None.

2) How Supplied:

Mucinex® DM 600 mg guaifenesin & 30 mg dextromethorphan HBr extended-release bi-layer tablets.

Mucinex® DM 1200 mg guaifenesin & 60 mg dextromethorphan HBr extended-release bi-layer tablets

3) Storage:

Store at controlled room temperature between 20°– 25°C (68°– 77°F); see USP Controlled Room Temperature. Dispense in tight, light-resistant containers as defined in the USP/NF, with child resistant closures.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Class: OTC

Rev 10/06