Albuterol Oral Solution

Generic Name: albuterol sulfate

Dosage Form: oral solution
ALBUTEROL SULFATE SYRUP (ORAL SOLUTION)

2 mg/5 mL

Rx only

Albuterol Oral Solution Description

Albuterol Sulfate Syrup (Oral Solution) contains albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator. Albuterol sulfate has the chemical name α1-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1) (salt) and the following chemical structure:

Albuterol sulfate is a white or practically white powder freely soluble in water and slightly soluble in alcohol, in chloroform, and in ether per USP definition.

The World Health Organization recommended name for albuterol base is salbutamol.

Albuterol sulfate syrup (oral solution) for oral administration contains 2 mg of albuterol as 2.4 mg of albuterol sulfate in each teaspoonful (5 mL). Albuterol sulfate oral solution also contains the inactive ingredients citric acid, FD&C Yellow #6, hypromellose, purified water, saccharin sodium, sodium benzoate, and strawberry flavor. Albuterol sulfate syrup (oral solution) may contain sodium citrate for pH adjustment. The pH of the oral solution is 3.3 to 4.0.

Albuterol Oral Solution - Clinical Pharmacology

In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on beta2-adrenergic receptors compared with isoproterenol. While it is recognized that beta2-adrenergic receptors are the predominant receptors in bronchial smooth muscle, data indicate that there is a population of beta2-receptors in the human heart existing in a concentration between 10% and 50%. The precise function of these receptors has not been established (see WARNINGS).

The pharmacologic effects of beta-adrenergic agonist drugs, including albuterol, are at least in part attributable to stimulation through beta-adrenergic receptors of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.

Albuterol has been shown in most controlled clinical trials to have more effect on the respiratory tract, in the form of bronchial smooth muscle relaxation, than isoproterenol at comparable doses while producing fewer cardiovascular effects.

Albuterol is longer acting than isoproterenol in most patients by any route of administration because it is not a substrate for the cellular uptake processes for catecholamines nor for catechol-O-methyl transferase.

Preclinical:

Intravenous studies in rats with albuterol sulfate have demonstrated that albuterol crosses the blood brain barrier and reaches brain concentrations amounting to approximately 5% of the plasma concentrations. In structures outside the brain barrier (pineal and pituitary glands), albuterol concentrations were found to be 100 times those in the whole brain.

Studies in laboratory animals (minipigs, rodents, and dogs) have demonstrated the occurrence of cardiac arrhythmias and sudden death (with histologic evidence of myocardial necrosis) when beta-agonists and methylxanthines are administered concurrently. The clinical significance of these findings is unknown.

Pharmacokinetics:

Albuterol is rapidly absorbed after oral administration of 10 mL of albuterol sulfate syrup (oral solution) (4 mg of albuterol) in normal volunteers. Maximum plasma concentrations of about 18 ng/mL of albuterol are achieved within 2 hours, and the drug is eliminated with a half-life of about 5 hours.

In other studies, the analysis of urine samples of patients given 8 mg of tritiated albuterol orally showed that 76% of the dose was excreted over three days, with the majority of the dose being excreted within the first 24 hours. Sixty percent of this radioactivity was shown to be the metabolite. Feces collected over this period contained 4% of the administered dose.

Clinical Trials:

In controlled clinical trials in patients with asthma, the onset of improvement in pulmonary function, as measured by maximum midexpiratory flow rate (MMEF) and forced expiratory volume in 1 second (FEV1), was within 30 minutes after a dose of albuterol sulfate syrup (oral solution), with peak improvement occurring between 2 and 3 hours. In a controlled clinical trial involving 55 children, clinically significant improvement (defined as maintaining a 15% or more increase in FEV1 and a 20% or more increase in MMEF over baseline values) continued to be recorded up to 6 hours. No decrease in the effectiveness was reported in one uncontrolled study of 32 children who took albuterol sulfate syrup (oral solution) for a 3-month period.

Indications and Usage for Albuterol Oral Solution

Albuterol sulfate syrup (oral solution) is indicated for the relief of bronchospasm in adults and children 2 years of age and older with reversible obstructive airway disease.

Contraindications

Albuterol sulfate syrup (oral solution) is contraindicated in patients with a history of hypersensitivity to albuterol or any of its components.

Warnings

Cardiovascular Effects:

Albuterol sulfate syrup (oral solution), like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of albuterol sulfate syrup (oral solution) at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, albuterol sulfate syrup (oral solution), like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Deterioration of Asthma:

Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of albuterol sulfate syrup (oral solution) than usual, this may be a marker of destabilization of asthma and requires re-evaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.

Paradoxical Bronchospasm:

Albuterol sulfate syrup (oral solution) can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, albuterol sulfate syrup (oral solution) should be discontinued immediately and alternative therapy instituted.

Use of Anti-Inflammatory Agents:

The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids.

Immediate Hypersensitivity Reactions:

Immediate hypersensitivity reactions may occur after administration of albuterol, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema. Albuterol, like other beta-adrenergic agonists, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes.

Rarely, erythema multiforme and Stevens-Johnson syndrome have been associated with the administration of albuterol sulfate in children.

Precautions

General.

Albuterol, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines. Clinically significant changes in systolic and diastolic blood pressure have been seen in individual patients and could be expected to occur in some patients after use of any beta-adrenergic bronchodilator.

Large doses of intravenous albuterol have been reported to aggravate pre-existing diabetes mellitus and ketoacidosis. As with other beta-agonists, albuterol may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation.

Information for Patients:

The action of albuterol sulfate syrup (oral solution) may last up to 6 hours or longer. Albuterol sulfate syrup (oral solution) should not be taken more frequently than recommended. Do not increase the dose or frequency of albuterol sulfate syrup (oral solution) without consulting your physician. If you find that treatment with albuterol sulfate syrup (oral solution) becomes less effective for symptomatic relief, your symptoms get worse, and/or you need to take the product more frequently than usual, you should seek medical attention immediately. While you are taking albuterol sulfate syrup (oral solution), other asthma medications and inhaled drugs should be taken only as directed by your physician. Common adverse effects include palpitations, chest pain, rapid heart rate, and tremor or nervousness. If you are pregnant or nursing, contact your physician about the use of albuterol sulfate syrup (oral solution). Effective and safe use of albuterol sulfate syrup (oral solution) includes an understanding of the way that it should be administered.

Drug Interactions:

The concomitant use of albuterol sulfate syrup (oral solution) and other oral sympathomimetic agents is not recommended since such combined use may lead to deleterious cardiovascular effects. This recommendation does not preclude the judicious use of an aerosol bronchodilator of the adrenergic stimulant type in patients receiving albuterol sulfate syrup (oral solution). Such concomitant use, however, should be individualized and not given on a routine basis. If regular coadministration is required, then alternative therapy should be considered.

Monoamine Oxidase Inhibitors or Tricyclic Antidepressants:

Albuterol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of albuterol on the vascular system may be potentiated.

Beta-Blockers:

Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists, such as albuterol sulfate syrup (oral solution), but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

Diuretics:

The ECG changes and/or hypokalemia that may result from the administration of nonpotassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with nonpotassium-sparing diuretics.

Digoxin:

Mean decreases of 16% to 22% in serum digoxin levels were demonstrated after single-dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days. The clinical significance of these findings for patients with obstructive airway disease who are receiving albuterol and digoxin on a chronic basis is unclear. Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and albuterol.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

In a 2-year study in Sprague-Dawley rats, albuterol sulfate caused a significant dose-related increase in the incidence of benign leiomyomas of the mesovarium at dietary doses of 2, 10, and 50 mg/kg (approximately ½, 2, and 10 times, respectively, the maximum recommended daily oral dose for adults and children on a mg/m2 basis). In another study this effect was blocked by the coadministration of propranolol, a non-selective beta-adrenergic antagonist. In an 18-month study in CD-1 mice albuterol sulfate showed no evidence of tumorigenicity at dietary doses of up to 500 mg/kg (approximately 60 times the maximum recommended daily oral dose for adults and children on a mg/m2 basis). In a 22-month study in the Golden hamster albuterol sulfate showed no evidence of tumorigenicity at dietary doses of up to 50 mg/kg (approximately 8 times the maximum recommended daily oral dose for adults and children on a mg/m2 basis).

Albuterol sulfate was not mutagenic in the Ames test with or without metabolic activation using tester strains S. typhimurium TA1537, TA1538, and TA98 or E. coli WP2, WPuvrA, and WP67. No forward mutation was seen in yeast strain S. cerevisiae S9 nor any mitotic gene conversion in yeast strain S. cerevisiae JD1 with or without metabolic activation. Fluctuation assays in S. typhimurium TA98 and E. coli WP2, both with metabolic activation, were negative. Albuterol sulfate was not clastogenic in a human peripheral lymphocyte assay or in an AH1 strain mouse micronucleus assay at intraperitoneal doses of up to 200 mg/kg.

Reproduction studies in rats demonstrated no evidence of impaired fertility at oral doses up to 50 mg/kg (approximately 15 times the maximum recommended daily oral dose for adults on a mg/m2 basis).

Pregnancy:

Teratogenic Effects:

Pregnancy Category C:

Albuterol has been shown to be teratogenic in mice. A study in CD-1 mice at subcutaneous (sc) doses of 0.025, 0.25, and 2.5 mg/kg (approximately 3/1000, 3/100, and 3/10, respectively, the maximum recommended daily oral dose for adults on a mg/m2 basis), showed cleft palate formation in 5 of 111 (4.5%) fetuses at 0.25 mg/kg and in 10 of 108 (9.3%) fetuses at 2.5 mg/kg. The drug did not induce cleft palate formation at the lowest dose, 0.025 mg/kg. Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated with 2.5 mg/kg of isoproterenol (positive control) subcutaneously (approximately 3/10 times the maximum recommended daily oral dose for adults on a mg/m2 basis).

A reproduction study in Stride Dutch rabbits revealed cranioschisis in 7 of 19 (37%) fetuses when albuterol was administered orally at a 50 mg/kg dose (approximately 25 times the maximum recommended daily oral dose for adults on a mg/m2 basis).

There are no adequate and well-controlled studies in pregnant women. Albuterol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been rarely reported in the offspring of patients being treated with albuterol. Some of the mothers were taking multiple medications during their pregnancies. No consistent pattern of defects can be discerned, and a relationship between albuterol use and congenital anomalies has not been established.

Use in Labor and Delivery:

Because of the potential for beta-agonist interference with uterine contractility, use of albuterol sulfate syrup (oral solution) for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.

Tocolysis:

Albuterol has not been approved for the management of preterm labor. The benefit:risk ratio when albuterol is administered for tocolysis has not been established. Serious adverse reactions, including maternal pulmonary edema, have been reported during or following treatment of premature labor with beta2-agonists, including albuterol.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because of the potential for tumorigenicity shown for albuterol in some animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use:

Safety and effectiveness in children below 2 years of age have not been established.

Adverse Reactions

In clinical trials, the most frequent adverse reactions to albuterol sulfate syrup (oral solution) in adults and older children were:

Percent Incidence of Adverse Reactions in Adults and Children (6–14 Years of Age)

Reaction	Percent Incidence
Central nervous system
Tremor	10%
Nervousness	9%
Shakiness	9%
Headache	4%
Dizziness	3%
Hyperactivity	2%
Excitement	2%
Sleeplessness	1%
Disturbed sleep	<1%
Irritable behavior	<1%
Dilated pupils	<1%
Weakness	<1%
Cardiovascular
Tachycardia	1%
Palpitations	<1%
Sweating	<1%
Chest pain	<1%
Ear, nose, and throat
Epistaxis	1%
Gastrointestinal
Increased appetite	3%
Epigastric pain	<1%
Stomachache	<1%
Musculoskeletal
Muscle spasm	<1%
Respiratory
Cough	<1%

In clinical trials, the following adverse reactions to albuterol sulfate syrup (oral solution) were noted more frequently in young children 2 to 6 years of age than in older children and adults:

Percent Incidence of Adverse Reactions Noted More Frequently in Children 2 to 6 Years of Age Than in Older Children and Adults

Reaction	Percent Incidence
Central nervous system
Excitement	20%
Nervousness	15%
Hyperkinesia	4%
Sleeplessness	2%
Emotion lability	1%
Fatigue	1%
Cardiovascular
Tachycardia	2%
Pallor	1%
Gastrointestinal
Gastrointestinal symptoms	2%
Loss of appetite	1%
Ophthalmolologic
Conjuctivitis	1%

Cases of urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles) have been reported after the use of albuterol sulfate syrup (oral solution).

In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vomiting, vertigo, central nervous system stimulation, unusual taste, and drying or irritation of the oropharynx.

The reactions are generally transient in nature, and it is usually not necessary to discontinue treatment with albuterol sulfate syrup (oral solution). In selected cases, however, dosage may be reduced temporarily; after the reaction has subsided, dosage should be increased in small increments to the optimal dosage.

Overdosage

The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS, e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and sleeplessness. Hypokalemia may also occur. As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of albuterol sulfate syrup (oral solution). Treatment consists of discontinuation of albuterol sulfate syrup (oral solution) together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of albuterol sulfate syrup (oral solution).

The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 240 times the maximum recommended daily oral dose for adults and children on a mg/m2 basis). In mature rats the subcutaneous (sc) median lethal dose of albuterol sulfate is approximately 450 mg/kg (approximately 110 times the maximum recommended daily oral dose for adults and children on a mg/m2 basis). In small young rats the oral median lethal dose is approximately 2000 mg/kg (approximately 480 times the maximum recommended daily oral dose for adults and children on a mg/m2 basis).

Albuterol Oral Solution Dosage and Administration

The following dosages of albuterol sulfate syrup (oral solution) are expressed in terms of albuterol base.

Usual Dosage:

Adults and Children Over 14 Years of Age: The usual starting dosage for adults and children over 14 years of age is 2 mg (1 teaspoonful) or 4 mg (2 teaspoonfuls) three or four times a day.

Children Over 6 Years to 14 Years of Age: The usual starting dosage for children over 6 years to 14 years of age is 2 mg (1 teaspoonful) three or four times a day.

Children 2 to 5 Years of Age: Dosing in children 2 to 5 years of age should be initiated at 0.1 mg/kg of body weight three times a day. This starting dosage should not exceed 2 mg (1 teaspoonful) three times a day.

Dosage Adjustment:

Adult and Children Over 14 Years of Age: For adults and children over 14 years of age, a dosage above 4 mg four times a day should be used only  when the patient fails to respond. If a favorable response does not occur with the 4-mg initial dosage, it should be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated.

Children Over 6 Years to 14 Years of Age Who Fail to Respond to the Initial Starting Dosage of 2 mg Four Times a Day: For children over 6 years to 14 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses).

Children 2 to 5 Years of Age Who Do Not Respond Satisfactorily to the Initial Dosage: For children from 2 to 5 years of age who do not respond satisfactorily to the initial starting dosage the dosage may be increased stepwise to 0.2 mg/kg of body weight three times a day, but not to exceed a maximum of 4 mg (2 teaspoonfuls) given three times a day.

Elderly Patients and Those Sensitive to Beta-Adrenergic Stimulators: The initial dosage should be restricted to 2 mg three or four times a day and individually adjusted thereafter.

How is Albuterol Oral Solution Supplied

Albuterol Sulfate Syrup (Oral Solution), a clear, orange liquid with a strawberry flavor, contains 2 mg of albuterol (present as the sulfate) per 5 mL in bottles of 16 fluid ounces (one pint).

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

Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP/NF.

Manufactured for:

QUALITEST PHARMACEUTICALS

Huntsville, AL 35811

8182035

R5/08-R1

PRINCIPAL DISPLAY PANEL

 

ALBUTEROL SULFATE  albuterol sulfate  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0603-1008 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALBUTEROL SULFATE (ALBUTEROL) ALBUTEROL SULFATE 2 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength CITRIC ACID   FD&C YELLOW NO. 6   HYPROMELLOSES   WATER   SACCHARIN SODIUM   SODIUM BENZOATE   SODIUM CITRATE

Product Characteristics Color ORANGE (clear, orange) Score      Shape Size Flavor STRAWBERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0603-1008-58 473 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078105	12/27/2006

Labeler - Qualitest Pharmaceuticals (011103059)

Establishment
Name	Address	ID/FEI	Operations
Vintage Pharmaceuticals-Huntsville		825839835	MANUFACTURE

Revised: 06/2011Qualitest Pharmaceuticals

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• 34 Reviews for Albuterol - Add your own review/rating

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Slow-K

potassium chloride

Dosage Form: extended-release tablets USP

Slow - K®                                                   T2004-43

potassium chloride

Extended-Release Tablets USP

Rx only

Prescribing Information

DESCRIPTION

Slow-K, potassium chloride extended-release tablets USP, is a sugar-coated (not enteric-coated) tablet for oral administration, containing 600 mg of potassium chloride (equivalent to 8 mEq) in a wax matrix. This formulation is intended to provide an extended-release of potassium from the matrix to minimize the likelihood of producing high, localized concentrations of potassium within the gastrointestinal tract.

      Slow-K is an electrolyte replenisher. Its chemical name is potassium chloride, and its structural formula is KCI. Potassium chloride USP is a white, granular powder or colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol.

     Inactive Ingredients. Acacia, cetostearyl alcohol, gelatin, iron oxide, magnesium stearate, parabens, polyvinyl-pyrrolidone, sodium benzoate, starch, sucrose, talc, and titanium dioxide.

CLINICAL PHARMACOLOGY

The potassium ion is the principal intracellular cation of most body tissues. Potassium ions participate in a number of essential physiological processes, including the maintenance of intracellular tonicity, the transmission of nerve impulses, the contraction of cardiac, skeletal, and smooth muscle, and the maintenance of normal renal function.

      The intracellular concentration of potassium is approximately 150 to 160 mEq/L. The normal adult plasma concentration is 3.5-5.0 mEq/L. An active ion transport system maintains this gradient across the plasma membrane.

      Potassium is a normal dietary constituent; under steady-state conditions, the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of potassium is 50 to 100 mEq per day.

      Potassium depletion may occur whenever the rate of potassium loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of potassium intake. Such depletion usually develops slowly as a consequence of prolonged therapy with oral diuretics, primary or secondary hyperaldosteronism, diabetic ketoacidosis, severe diarrhea, or inadequate replacement of potassium in patients on prolonged parenteral nutrition. Depletion can develop rapidly with severe diarrhea, especially if associated with vomiting. Potassium depletion due to these causes is usually accompanied by a concomitant loss of chloride and is manifested by hypokalemia and metabolic alkalosis. Potassium depletion may produce weakness, fatigue, disturbances of cardiac rhythm (primarily ectopic beats), prominent U waves in the electrocardiogram, and, in advanced cases, flaccid paralysis and/or impaired ability to concentrate urine.

      If potassium depletion associated with metabolic alkalosis cannot be managed by correcting the fundamental cause of the deficiency, e.g., where the patient requires long-term diuretic therapy, supplemental potassium in the form of high-potassium food or potassium chloride may be able to restore normal potassium levels.

      In rare circumstances (e.g., patients with renal tubular acidosis) potassium depletion may be associated with metabolic acidosis and hyperchloremia. In such patients potassium replacement should be accomplished with potassium salts other than the chloride, such as potassium bicarbonate, potassium citrate, potassium acetate, or potassium gluconate.

      The potassium chloride in Slow-K is completely absorbed before it leaves the small intestine. The wax matrix is not absorbed and is excreted in the feces; in some instances the empty matrices may be noticeable in the stool. When the bioavailability of the potassium ion from Slow-K is compared to that of a true solution the extent of absorption is similar.

      The extended-release properties of Slow-K are demonstrated by the finding that a significant increase in time is required for renal excretion of the first 50% of the Slow-K dose as compared to the solution.

      Increased urinary potassium excretion is first observed 1 hour after administration of Slow-K, reaches a peak at 4 hours, and extends up to 8 hours. Mean daily steady-state plasma levels of potassium following daily administration of Slow-K cannot be distinguished from those following administration of a potassium chloride solution or from control plasma levels of potassium ion.

INDICATIONS AND USAGE

BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH EXTENDED-RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.

1. For therapeutic use in patients with hypokalemia, with or without metabolic alkalosis; in digitalis intoxication; and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia.
   


2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.

      The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated.

CONTRAINDICATIONS

Potassium supplements are contraindicated in patients with hyperkalemia, since a further increase in serum potassium concentration in such patients can produce cardiac arrest. Hyperkalemia may complicate any of the following conditions: chronic renal failure, systemic acidosis such as diabetic acidosis, acute dehydration, extensive tissue breakdown as in severe burns, adrenal insufficiency, or the administration of a potassium-sparing diuretic (e.g., spironolactone, triamterene, amiloride) (see OVERDOSAGE).

      Controlled-release formulations of potassium chloride have produced esophageal ulceration in certain cardiac patients with esophageal compression due to an enlarged left atrium. Potassium supplementation, when indicated in such patients, should be given as a liquid preparation.

      All solid dosage forms of potassium supplements are contraindicated in any patient in whom there is structural, pathological (e.g., diabetic gastroparesis), or pharmacologic (use of anticholinergic agents or other agents with anticholinergic properties at sufficient doses to exert anticholinergic effects) cause for arrest or delay in tablet passage through the gastrointestinal tract.

WARNINGS

Hyperkalemia (See OVERDOSAGE.)

In patients with impaired mechanisms for excreting potassium, the administration of potassium salts can produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given potassium by the intravenous route but may also occur in patients given potassium orally. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic.

      The use of potassium salts in patients with chronic renal disease, or any other condition which impairs potassium excretion, requires particularly careful monitoring of the serum potassium concentration and appropriate dosage adjustment.

Interaction With Potassium-Sparing Diuretics

Hypokalemia should not be treated by the concomitant administration of potassium salts and a potassium-sparing diuretic (e.g., spironolactone, triamterene, amiloride), since the simultaneous administration of these agents can produce severe hyperkalemia.

Interaction with Angiotensin-Converting Enzyme Inhibitors

Angiotensin-converting enzyme (ACE) inhibitors (e.g., captopril, enalapril) will produce some potassium retention by inhibiting aldosterone production. Potassium supplements should be given to patients receiving ACE inhibitors only with close monitoring.

Gastrointestinal Lesions

Solid oral dosage forms of potassium chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract. Based on spontaneous adverse reaction reports, enteric-coated preparations of potassium chloride are associated with an increased frequency of small-bowel lesions (40-50 per 100,000 patient years) compared to sustained-release, wax-matrix formulations (less than one per 100,000 patient years). Because of the lack of exensive marketing experience with microencapsulated products, a comparison between such products and wax-matrix or enteric-coated products is not available. Slow-K is a wax-matrix tablet formulated to provide a controlled rate of release of potassium chloride and thus to minimize the possibility of a high local concentration of potassium near the gastrointestinal wall.

      Prospective trials have been conducted in normal human volunteers in which the upper gastrointestinal tract was evaluated by endoscopic inspection before and after one week of solid oral potassium chloride therapy. The ability of this model to predict events occurring in usual clinical practice is unknown. Trials which approximated usual clinical practice did not reveal any clear differences between the wax-matrix and microencapsulated dosage forms. In contrast, there was a higher incidence of gastric and duodenal lesions in subjects receiving a high dose of wax-matrix, controlled-release formulation under conditions which did not resemble usual or recommended clinical practice

(i.e., 96 mEq per day in divided doses of potassium chloride administered to fasted patients, in the presence of an anticholinergic drug to delay gastric emptying). The upper gastrointestinal lesions observed by endoscopy were asymptomatic and were not accompanied by evidence of bleeding (hemoccult testing). The relevance of these findings to the usual conditions (i.e., non-fasting, no anticholinergic agent, smaller doses) under which controlled-release potassium chloride products are used is uncertain; epidemiologic studies have not identified an elevated risk, compared to microencapsulated products, for upper gastrointestinal lesions in patients receiving wax-matrix formulations. Slow-K should be discontinued immediately and the possibility of ulceration, obstruction, or perforation considered if severe vomiting, abdominal pain, distention, or gastroinestinal bleeding occurs.

Metabolic Acidosis

Hypokalemia in patients with metabolic acidosis should be treated with an alkalinizing potassium salt such as potassium bicarbonate, potassium citrate, potassium acetate, or potassium gluconate.

PRECAUTIONS

General

The diagnosis of potassium depletion is ordinarily made by demonstrating hypokalemia in a patient with a clinical history suggesting some cause for potassium depletion. In interpreting the serum potassium level, the physician should bear in mind that acute alkalosis per se can produce hypokalemia in the absence of a deficit in total body potassium, while acute acidosis per se can increase the serum potassium concentration into the normal range even in the presence of a reduced total body potassium. The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease, or acidosis requires careful attention to acid-base balance and appropriate monitoring of serum electrolytes, the electrocardiogram, and the clinical status of the patient.

Information for Patients

Physicians should consider reminding the patient of the following:

      To take each dose with meals and with a full glass of water or other liquid. 

      To take this medicine following the frequency and amount prescribed by the physician. This is especially important if the patient is also taking diuretics and/or digitalis preparations.

      To check with the physician if there is trouble swallowing tablets or if the tablets seem to stick in the throat.

      To check with the physician at once if tarry stools or other evidence of

gastrointestinal bleeding is noticed.

      To take each dose without crushing, chewing, or sucking the tablets.

Laboratory Tests

When blood is drawn for analysis of plasma potassium, it is important to recognize that artifactual elevations can occur after improper venipuncture technique or as a result of in vitro hemolysis of the sample.

Drug Interactions

Potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (see WARNINGS).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and fertility studies in animals have not been performed. Potassium is a normal dietary constituent.

Pregnancy Category C

Animal reproduction studies have not been conducted with Slow-K. It is unlikely that potassium supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus or would affect reproductive capacity.

Nursing Mothers

The normal potassium ion content of human milk is about 13 mEq per liter. It is not known if Slow-K has an effect on this content. Since oral potassium becomes part of the body potassium pool, so long as body potassium is not excessive, the contribution of potassium chloride supplementation should have little or no effect on the level in human milk.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of Slow-K tablets 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 the 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.

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

ADVERSE REACTIONS

One of the most severe adverse effects is hyperkalemia (see CONTRAINDICATIONS, WARNINGS, and OVERDOSAGE). There also have been reports of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, and perforation (see CONTRAINDICATIONS and WARNINGS).

      The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. These symptoms are due to irritation of the gastrointestinal tract and are best managed by taking the dose with meals or reducing the amount at one time.

      Skin rash has been reported rarely.

OVERDOSAGE

The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired or if potassium is administered too rapidly intravenously, potentially fatal hyperkalemia can result (see CONTRAINDICATIONS and WARNINGS). It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration (6.5-8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T waves, loss of P wave, depression of S-T segment, and prolongation of the Q-T interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9-12 mEq/L).

      Treatment measures for hyperkalemia include the following:

1. Elimination of foods and medications containing potassium and of any other agents with potassium-sparing properties;
   


2. Intravenous administration of 300-500 mL/hr of 10% dextrose solution containing 10-20 units of crystalline insulin per 1,000 mL;
   


3. Correction of acidosis, if present, with intravenous sodium bicarbonate;
   


4. Use of exchange resins, hemodialysis, or peritoneal dialysis.

      In treating hyperkalemia, it should be recalled that in patients who have been stabilized on digitalis, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity.

      The extended release feature means that absorption and toxic effects may be delayed for hours. Consider standard measures to remove any unabsorbed drug.

DOSAGE AND ADMINISTRATION

The usual dietary intake of potassium by the average adult is 50-100 mEq per day. Potassium depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of potassium from the total body store.

      Dosage must be adjusted to the individual needs of each patient. The dose for the prevention of hypokalemia is typically in the range of 20 mEq per day. Doses of 40-l00 mEq per day or more are used for the treatment of potassium depletion. Dosage should be divided if more than 20 mEq per day is given, such that no more than 20 mEq is given in a single dose.

      One Slow-K tablet provides 8 mEq of potassium chloride.

      Slow-K should be taken with meals and with a glass of water or other liquid. This product should not be taken on an empty stomach because of its potential for gastric irritation (see WARNINGS).

Note: Slow-K extended-release tablets must be swallowed whole and never crushed, chewed, or sucked.

HOW SUPPLIED

Tablets– 600 mg of potassium chloride (equivalent to 8 mEq) round, buff-colored, sugar-coated (imprinted Slow-K)

      Bottles of 100……………………………………………………………….      NDC 0078-0320-05

      Bottles of 1000……………………………………………………………...      NDC 0078-0320-09

 

Do not store above 86 °F (30 °C). Protect from moisture.

Protect from light.

Dispense in tight, light-resistant container (USP).

 

                T2004-43

REV: APRIL 2004     

Distributed by

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936

Slow-K  potassium chloride  tablet, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0078-0320 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength potassium chloride (potassium ion) Active 600 MILLIGRAM  In 1 TABLET Acacia Inactive   cetostearyl alcohol Inactive   gelatin Inactive   iron oxide Inactive   magnesium stearate Inactive   parabens Inactive   polyvinyl-pyrrolidone Inactive   sodium benzoate Inactive   starch Inactive   sucrose Inactive   talc Inactive   titanium dioxide Inactive

Product Characteristics Color BROWN (buff-colored) Score no score Shape ROUND Size 12mm Flavor Imprint Code Slow-K Contains          Coating true Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 0078-0320-05 100 TABLET In 1 BOTTLE None 2 0078-0320-09 1000 TABLET In 1 BOTTLE None

Revised: 06/2006Novartis Pharmaceuticals Corporation

More Slow-K resources

• Slow-K Side Effects (in more detail)
• Slow-K Dosage
• Slow-K Use in Pregnancy & Breastfeeding
• Drug Images
• Slow-K Drug Interactions
• Slow-K Support Group
• 0 Reviews for Slow-K - Add your own review/rating

• Glu-K Advanced Consumer (Micromedex) - Includes Dosage Information


• Klor-Con Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Klor-Con M10 Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Klor-con Consumer Overview


• Klor-con Powder MedFacts Consumer Leaflet (Wolters Kluwer)


• Micro-K Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Rum-K Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Slow-K with other medications

• Hypokalemia
• Prevention of Hypokalemia

tiagabine

Generic Name: tiagabine (tye AG a been)

Brand Names: Gabitril

What is tiagabine?

Tiagabine is an anti-epileptic medication, also called an anticonvulsant.

Tiagabine is used to alone or in combination with other medications to treat partial seizures in adults and children who are at least 12 years old.

Tiagabine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about tiagabine?

You should not use this medication if you are allergic to tiagabine.

Before taking tiagabine, tell your doctor if you are allergic to any drugs or if you have liver disease.

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Do not stop taking tiagabine without first talking to your doctor, even if you feel better. You may have increased seizures if you stop taking tiagabine suddenly. You will need to use less and less before you stop the medication completely.

Contact your doctor if your seizures get worse or you have them more often while taking tiagabine.

Carry an ID card or wear a medical alert bracelet stating that you are taking tiagabine, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication.

What should I discuss with my healthcare provider before taking tiagabine?

You should not use this medication if you are allergic to tiagabine.

If you have liver disease, you may need a dose adjustment or special tests to safely take this medication.

You may have thoughts about suicide while taking this medication. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several months of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

FDA pregnancy category C. It is not known whether tiagabine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether tiagabine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take tiagabine?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take tiagabine with food.

To make sure you are taking the right dose of tiagabine, your blood may need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Your doctor may occasionally change your dose over several weeks to make sure you get the best results from this medication.

Do not stop taking tiagabine without first talking to your doctor, even if you feel better. You may have increased seizures if you stop taking tiagabine suddenly. You will need to use less and less before you stop the medication completely. Contact your doctor if your seizures get worse or you have them more often while taking tiagabine.

Carry an ID card or wear a medical alert bracelet stating that you are taking tiagabine, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication.

It is important to use tiagabine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store this medication at room temperature away from moisture, heat, and light.

See also: Tiagabine dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include slurred speech, weakness, drowsiness, muscle stiffness, problems with coordination, confusion, vomiting, weak or shallow breathing, increased seizures, or feeling hostile or agitated.

What should I avoid while taking tiagabine?

Tiagabine can cause side effects that may impair your vision or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Avoid drinking alcohol. It can increase some of the side effects of tiagabine.

Tiagabine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; fever; swollen glands; painful sores in or around your eyes or mouth; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

• 
  

  new or worsened seizures;

  
  


• 
  

  confusion, hallucination;

  
  


• 
  

  problems with speech or vision;

  
  


• 
  

  severe blistering, peeling, and red skin rash;

  
  


• 
  

  tremor;

  
  


• 
  

  fever, chills, body aches, flu symptoms; or

  
  


• 
  

  chest pain, fast heart rate.

  
  

Less serious side effects may include:

• 
  

  dizziness, drowsiness, weakness, tired feeling;

  
  


• 
  

  feeling restless, irritable, or depressed;

  
  


• 
  

  nausea, vomiting, stomach pain, diarrhea;

  
  


• 
  

  trouble concentrating;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  lack of coordination;

  
  


• 
  

  cough, sore throat; or

  
  


• 
  

  weight changes.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Tiagabine Dosing Information

Usual Adult Dose for Seizures:

For use in the treatment of partial seizures:

Initial Dose: 4 mg orally once a day. A typical dosage titration regimen is described below for patients concurrently receiving enzyme inducing antiepileptic drugs (EIAEDs) such as phenytoin, carbamazepine, and barbiturates. Patients not concurrently receiving EIAEDs may need slower and more cautious titration regimen than that shown below.

After the first week of therapy, the total daily dose may be increased to 8 mg/day in two divided doses for the second week.

After two weeks, the total daily dose may be increased to 12 mg/day in three divided doses for the third week.

After three weeks, the total daily dose may be increased to 16 mg/day in two to four divided doses for the fourth week.

After four weeks, the total daily dose may be increased from 20 to 24 mg/day in two to four divided doses for the fifth week.

After five weeks, the total daily dose may be increased from 24 to 32 mg/day in two to four divided doses for the sixth week.

The usual maintenance dose ranges from 32 to 56 mg/day in two to four divided doses.

Usual Pediatric Dose for Seizures:

Less than 12 years: No dosing guidelines established.

Greater than or equal to 12 years: For use in the treatment of partial seizures:

Initial Dose: 4 mg orally once a day. A typical dosage titration regimen is described below for patients concurrently receiving enzyme inducing antiepileptic drugs (EIAEDs) such as phenytoin, carbamazepine, and barbiturates. Patients not concurrently receiving EIAEDs may need slower and more cautious titration regimen than that shown below.

After the first week of therapy, the total daily dose may be increased to 8 mg/day in two divided doses for the second week.

After two weeks, the total daily dose may be increased to 12 mg/day in three divided doses for the third week.

After three weeks, the total daily dose may be increased to 16 mg/day in two to four divided doses for the fourth week.

After four weeks, the total daily dose may be increased from 20 to 24 mg/day in two to four divided doses for the fifth week.

After five weeks, the total daily dose may be increased from 24 to 32 mg/day in two to four divided doses for the sixth week.

What other drugs will affect tiagabine?

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for depression or anxiety can add to sleepiness caused by tiagabine. Tell your doctor if you regularly use any of these medications, or other seizure medications.

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

• 
  

  medicine to treat a psychiatric disorder;

  
  


• 
  

  diet pills, stimulants, or ADHD medication;

  
  


• 
  

  carbamazepine (Carbatrol, Tegretol);

  
  


• 
  

  divalproex (Depakote);

  
  


• 
  

  phenobarbital (Luminal, Solfoton);

  
  


• 
  

  phenytoin (Dilantin);

  
  


• 
  

  primidone (Mysoline);

  
  


• 
  

  valproic acid (Depakene); or

  
  


• 
  

  narcotic medications such as fentanyl (Actiq, Duragesic), hydrocodone (Lortab, Vicodin), hydromorphone (Dilaudid, Palladone), morphine (Kadian, MS Contin, Oramorph, and others), oxycodone (OxyContin), oxymorphone (Numorphan, Opana), and others.

  
  

This list is not complete and there may be other drugs that can interact with tiagabine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More tiagabine resources

• Tiagabine Side Effects (in more detail)
• Tiagabine Dosage
• Tiagabine Use in Pregnancy & Breastfeeding
• Tiagabine Drug Interactions
• Tiagabine Support Group
• 1 Review for Tiagabine - Add your own review/rating

• tiagabine Advanced Consumer (Micromedex) - Includes Dosage Information


• Gabitril Prescribing Information (FDA)


• Gabitril Monograph (AHFS DI)


• Tiagabine MedFacts Consumer Leaflet (Wolters Kluwer)

Compare tiagabine with other medications

• Seizures

Where can I get more information?

• Your pharmacist can provide more information about tiagabine.

See also: tiagabine side effects (in more detail)

Cheracol Plus

Generic Name: chlorpheniramine/dextromethorphan/phenylpropanolamine (klor fen IR a meen/dex troe meth OR fan/fen ill proe pa NOLE a meen)

Brand Names: Cheracol Plus, Kophane, Therahist, Threamine DM, Triaminicol Multi Symptom Cough and Cold, Tricodene Forte, Tricodene NN, Triphenicol

What is Cheracol Plus (chlorpheniramine/dextromethorphan/phenylpropanolamine)?

Chlorpheniramine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body. Chlorpheniramine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

Dextromethorphan is a cough suppressant. It suppresses an area in the brain that causes coughing.

Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries). This reduces the blood flow and allows nasal and respiratory (breathing) passages to open up.

Chlorpheniramine/dextromethorphan/phenylpropanolamine is used to treat nasal congestion, sinusitis (inflammation of the sinuses), and coughs associated with allergies, hay fever, and the common cold.

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Chlorpheniramine/dextromethorphan/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Cheracol Plus (chlorpheniramine/dextromethorphan/phenylpropanolamine)?

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Use caution when driving, operating machinery, or performing other hazardous activities. Chlorpheniramine/dextromethorphan/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking chlorpheniramine/dextromethorphan/phenylpropanolamine.

Do not take more of this medication than is recommended. If your symptoms do not improve, or if they worsen, talk to your doctor.

Who should not take Cheracol Plus (chlorpheniramine/dextromethorphan/phenylpropanolamine)?

Do not take chlorpheniramine/dextromethorphan/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

• kidney disease,


• liver disease,


• 
  

  diabetes,

  
  


• 
  

  glaucoma,

  
  


• 
  

  any type of heart disease or high blood pressure,

  
  


• 
  

  thyroid disease,

  
  


• 
  

  emphysema or chronic bronchitis, or

  
  


• 
  

  difficulty urinating or have an enlarged prostate.

  
  

You may not be able to take chlorpheniramine/dextromethorphan/phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether chlorpheniramine/dextromethorphan/phenylpropanolamine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. This medication passes into breast milk and may harm a nursing baby. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. If you are over 65 years of age, you may be more likely to experience side effects from chlorpheniramine/dextromethorphan/phenylpropanolamine. You may require a lower dose of this medication. Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions.

How should I take Cheracol Plus (chlorpheniramine/dextromethorphan/phenylpropanolamine)?

Take chlorpheniramine/dextromethorphan/phenylpropanolamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

To ensure that you get a correct dose, measure the liquid form of chlorpheniramine/dextromethorphan/phenylpropanolamine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Do not take more of this medication than is recommended. An overdose of this medication can cause serious harm.

Do not take chlorpheniramine/dextromethorphan/phenylpropanolamine for longer than 7 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, talk to your doctor.

Store chlorpheniramine/dextromethorphan/phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a chlorpheniramine/dextromethorphan/phenylpropanolamine overdose include dry mouth, large pupils, flushing, nausea, vomiting, hyperactivity, or hallucinations.

What should I avoid while taking Cheracol Plus (chlorpheniramine/dextromethorphan/phenylpropanolamine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Chlorpheniramine/dextromethorphan/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking chlorpheniramine/dextromethorphan/phenylpropanolamine.

Cheracol Plus (chlorpheniramine/dextromethorphan/phenylpropanolamine) side effects

Serious side effects are unlikely to occur. Stop taking chlorpheniramine/dextromethorphan/phenylpropanolamine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take chlorpheniramine/dextromethorphan/phenylpropanolamine and talk to your doctor or try another similar medication if you experience

• 
  

  dryness of the eyes, nose, and mouth;

  
  


• 
  

  drowsiness or dizziness;

  
  


• 
  

  blurred vision;

  
  


• 
  

  difficulty urinating; or

  
  


• 
  

  excitation in children.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Cheracol Plus (chlorpheniramine/dextromethorphan/phenylpropanolamine)?

Do not take chlorpheniramine/dextromethorphan/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Do not take other over-the-counter cough, cold, allergy, diet, or sleep aids while taking chlorpheniramine/dextromethorphan/phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain chlorpheniramine, dextromethorphan, phenylpropanolamine, or other similar drugs. You may accidentally take too much of these medicines.

Chlorpheniramine/dextromethorphan/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if chlorpheniramine/dextromethorphan/phenylpropanolamine is taken with any of these medications.

Drugs other than those listed here may also interact with chlorpheniramine/dextromethorphan/phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Cheracol Plus resources

• Cheracol Plus Drug Interactions
• Cheracol Plus Support Group
• 0 Reviews for Cheracol Plus - Add your own review/rating

Compare Cheracol Plus with other medications

• Cold Symptoms

Where can I get more information?

• Your pharmacist has additional information about chlorpheniramine/dextromethorphan/phenylpropanolamine written for health professionals that you may read.

What does my medication look like?

Many formulations of chlorpheniramine/dextromethorphan/phenylpropanolamine are available over-the-counter. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Guaifenesin/Pseudoephedrine Controlled-Release Capsules

Pronunciation: gwye-FEN-ah-sin/sue-do-eh-FED-rin
Generic Name: Guaifenesin/Pseudoephedrine
Brand Name: Examples include Entex PSE and Nalex CR

Guaifenesin/Pseudoephedrine Controlled-Release Capsules are used for:

Relieving congestion, cough, and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Guaifenesin/Pseudoephedrine Controlled-Release Capsules are a decongestant and expectorant combination. It works by constricting blood vessels, reducing swelling in the nasal passages, and thinning and loosening mucus in the airway. This allows you to breathe more easily and makes coughs more productive.

Do NOT use Guaifenesin/Pseudoephedrine Controlled-Release Capsules if:

• you are allergic to any ingredient in Guaifenesin/Pseudoephedrine Controlled-Release Capsules


• you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)


• you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Guaifenesin/Pseudoephedrine Controlled-Release Capsules:

Some medical conditions may interact with Guaifenesin/Pseudoephedrine Controlled-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a fast, slow, or irregular heartbeat


• if you have a history of adrenal gland problems (eg, tumor), heart problems, high blood pressure, diabetes, heart blood vessel problems, stroke, glaucoma, an enlarged prostate, seizures, or an overactive thyroid


• if you have chronic cough

Some MEDICINES MAY INTERACT with Guaifenesin/Pseudoephedrine Controlled-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Guaifenesin/Pseudoephedrine Controlled-Release Capsules's side effects


• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Bromocriptine because the risk of its side effects may be increased by Guaifenesin/Pseudoephedrine Controlled-Release Capsules


• Guanethidine, guanadrel, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Guaifenesin/Pseudoephedrine Controlled-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Guaifenesin/Pseudoephedrine Controlled-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Guaifenesin/Pseudoephedrine Controlled-Release Capsules:

Use Guaifenesin/Pseudoephedrine Controlled-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Guaifenesin/Pseudoephedrine Controlled-Release Capsules by mouth with or without food.


• Take Guaifenesin/Pseudoephedrine Controlled-Release Capsules with a full glass of water (8 oz/240 mL) unless your doctor tells you otherwise.


• If you miss a dose of Guaifenesin/Pseudoephedrine Controlled-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Guaifenesin/Pseudoephedrine Controlled-Release Capsules.

Important safety information:

• Guaifenesin/Pseudoephedrine Controlled-Release Capsules may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Guaifenesin/Pseudoephedrine Controlled-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not take appetite suppressants while you are taking Guaifenesin/Pseudoephedrine Controlled-Release Capsules without checking with your doctor.


• Guaifenesin/Pseudoephedrine Controlled-Release Capsules has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.


• Guaifenesin/Pseudoephedrine Controlled-Release Capsules may interfere with certain lab test results. Make sure that all of your doctors and lab personnel know that you are taking Guaifenesin/Pseudoephedrine Controlled-Release Capsules.


• Tell your doctor or dentist that you take Guaifenesin/Pseudoephedrine Controlled-Release Capsules before you receive any medical or dental care, emergency care, or surgery.


• Use Guaifenesin/Pseudoephedrine Controlled-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Guaifenesin/Pseudoephedrine Controlled-Release Capsules in CHILDREN; they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Guaifenesin/Pseudoephedrine Controlled-Release Capsules, contact your doctor. You will need to discuss the benefits and risks of using Guaifenesin/Pseudoephedrine Controlled-Release Capsules while pregnant. It is not known if Guaifenesin/Pseudoephedrine Controlled-Release Capsules are found in breast milk. Do not breast-feed while taking Guaifenesin/Pseudoephedrine Controlled-Release Capsules.

Possible side effects of Guaifenesin/Pseudoephedrine Controlled-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Guaifenesin/Pseudoephedrine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Guaifenesin/Pseudoephedrine Controlled-Release Capsules:

Store Guaifenesin/Pseudoephedrine Controlled-Release Capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Guaifenesin/Pseudoephedrine Controlled-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Guaifenesin/Pseudoephedrine Controlled-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.


• Guaifenesin/Pseudoephedrine Controlled-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Guaifenesin/Pseudoephedrine Controlled-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Guaifenesin/Pseudoephedrine resources

• Guaifenesin/Pseudoephedrine Side Effects (in more detail)
• Guaifenesin/Pseudoephedrine Use in Pregnancy & Breastfeeding
• Drug Images
• Guaifenesin/Pseudoephedrine Drug Interactions
• Guaifenesin/Pseudoephedrine Support Group
• 58 Reviews for Guaifenesin/Pseudoephedrine - Add your own review/rating

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