Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour)

Pronunciation: gwye-FEN-e-sin/FEN-il-EF-rin
Generic Name: Guaifenesin/Phenylephrine
Brand Name: Examples include Gentex LA and Liquibid-D

Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) are used for:

Relieving symptoms of 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/Phenylephrine Sustained-Release Tablets (12 Hour) are a decongestant and expectorant combination. It works by constricting blood vessels and shrinking swollen and congested nasal tissues (mucous membranes) and by thinning and loosening mucus in the airway. This allows you to breathe more easily and makes coughs more productive.

Do NOT use Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) if:

• you are allergic to any ingredient in Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour)


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (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/Phenylephrine Sustained-Release Tablets (12 Hour):

Some medical conditions may interact with Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour). 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/Phenylephrine Sustained-Release Tablets (12 Hour). Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour)'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/Phenylephrine Sustained-Release Tablets (12 Hour)


• Guanethidine, guanadrel, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour)

This may not be a complete list of all interactions that may occur. Ask your health care provider if Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) 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/Phenylephrine Sustained-Release Tablets (12 Hour):

Use Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Take Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) with a full glass of water (8 oz/240 mL) unless your doctor directs otherwise.


• Swallow Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) whole. Do not break, crush, or chew before swallowing. Some brands of Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) may be broken in half before taking. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.


• If you miss a dose of Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour), 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/Phenylephrine Sustained-Release Tablets (12 Hour).

Important safety information:

• Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not take diet or appetite control medicines while you are taking Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) without checking with you doctor.


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


• Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) has phenylephrine in it. Before you start any new medicine, check the label to see if it has phenylephrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


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


• Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour).


• Tell your doctor or dentist that you take Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) before you receive any medical or dental care, emergency care, or surgery.


• Use Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) in CHILDREN; they may be more sensitive to its effects.


• Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) while you are pregnant. Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) are found in breast milk. Do not breast-feed while taking Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour).

Possible side effects of Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour):

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/Phenylephrine (12 Hour) 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/Phenylephrine Sustained-Release Tablets (12 Hour):

Store Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) 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/Phenylephrine Sustained-Release Tablets (12 Hour) out of the reach of children and away from pets.

General information:

• If you have any questions about Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour), please talk with your doctor, pharmacist, or other health care provider.


• Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) 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/Phenylephrine Sustained-Release Tablets (12 Hour). 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/Phenylephrine Sustained-Release Tablets (12 Hour) resources

• Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) Side Effects (in more detail)
• Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) Use in Pregnancy & Breastfeeding
• Drug Images
• Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) Drug Interactions
• Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) Support Group
• 8 Reviews for Guaifenesin/Phenylephrine (12 Hour) - Add your own review/rating

Compare Guaifenesin/Phenylephrine Sustained-Release Tablets (12 Hour) with other medications

• Cough and Nasal Congestion
• Sinus Symptoms

Guanabenz

Dosage Form: tablet
Guanabenz Acetate Tablets USP

Rx only

Guanabenz Description

Guanabenz acetate USP, an antihypertensive agent for oral administration, is an aminoguanidine derivative. The chemical name for Guanabenz acetate USP is [(2,6-Dichlorobenzylidene)amino] guanidine monoacetate, and its structural formula is:

C8H8Cl2N4•C2H4O2 M.W. 291.14

It is an odorless, white to off-white, crystalline substance, sparingly soluble in water and soluble in alcohol. Each tablet of Guanabenz USP acetate is equivalent to 4 mg or 8 mg of free Guanabenz base. Guanabenz acetate USP, available as 4 mg or 8 mg tablets for oral administration, contains the following inactive ingredients: FD&C Blue #2 Aluminum Lake (8 mg only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, and ferric oxide.

Guanabenz - Clinical Pharmacology

Guanabenz acetate is an orally active central alpha-2 adrenergic agonist. Its antihypertensive action appears to be mediated via stimulation of central alpha adrenergic receptors, resulting in a decrease of sympathetic outflow from the brain at the bulbar level to the peripheral circulatory system.

Pharmacokinetics

In human studies, about 75% of an orally administered dose of Guanabenz acetate is absorbed and metabolized with less than 1% of unchanged drug recovered from the urine. Peak plasma concentrations of unchanged drug occur between two and five hours after a single oral dose. The average half-life for Guanabenz is about 6 hours. The site or sites of metabolism of Guanabenz have not been determined. The effect of meals on the absorption of Guanabenz acetate tablets has not been studied.

Pharmacodynamics

The onset of the antihypertensive action of Guanabenz begins within 60 minutes after a single oral dose and reaches a peak effect within two to four hours. The effect of an acute single dose is reduced appreciably six to eight hours after administration, and blood pressure approaches baseline values within 12 hours of administration.

The acute antihypertensive effect of Guanabenz occurs without major changes in peripheral resistance, but its chronic effect appears to be a decrease in peripheral resistance. A decrease in blood pressure is seen in both the supine and standing positions without alterations of normal postural mechanisms, so that postural hypotension has not been observed. Guanabenz decreases pulse rate by about 5 beats per minute. Cardiac output and left ventricular ejection fraction are unchanged during long-term therapy.

In clinical trials, Guanabenz acetate, given orally to hypertensive patients, effectively controlled blood pressure without any significant effect on glomerular filtration rate, renal blood flow, body fluid volume or body weight. Guanabenz given parenterally to dogs has produced a natriuresis. Similarly, hypertensive subjects, 24 hours after salt loading, have shown a decrease in blood pressure and a natriuresis (5% to 240% increase in sodium excretion) following a single oral dose of Guanabenz acetate. After seven consecutive days of administration and effective blood-pressure control, no significant change on glomerular filtration rate, renal blood flow, or body weight was observed. However, in clinical trials of six to thirty months duration, hypertensive patients with effective blood-pressure control by Guanabenz lost one to four pounds of body weight. The mechanism of this weight loss has not been established. Tolerance to the antihypertensive effect of Guanabenz has not been observed.

During long-term administration of guanabenz, there is a small decrease in serum cholesterol and total triglycerides without any change in the high-density lipoprotein fraction. Plasma norepinephrine, serum dopamine beta-hydroxylase and plasma renin activity are decreased during chronic administration of guanabenz. No changes in serum electrolytes, uric acid, bloodurea nitrogen, calcium, or glucose have been observed.

Guanabenz and hydrochlorothiazide have been shown to have at least partially additive effects in patients not responding adequately to either drug alone.

Indications and Usage for Guanabenz

Guanabenz acetate tablets are indicated in the treatment of hypertension. It may be employed alone or in combination with a thiazide diuretic.

Contraindications

Guanabenz acetate is contraindicated in patients with a known sensitivity to the drug or any of the tablet ingredients.

Precautions

General

1. Sedation: Guanabenz causes sedation or drowsiness in a large fraction of patients. When Guanabenz is used with centrally active depressants, such as phenothiazines, barbiturates, and benzodiazepines, the potential for additive sedative effects should be considered.

2. Patients with vascular insufficiency: Guanabenz, like other antihypertensive agents, should be used with caution in patients with severe coronary insufficiency, recent myocardial infarction, cerebrovascular disease, or severe hepatic or renal failure.

3. Rebound: Sudden cessation of therapy with central alpha agonists like Guanabenz may rarely result in “overshoot” hypertension and more commonly produces an increase in serum catecholamines and subjective symptomatology.

4. Patients with hepatic impairment: The disposition of orally administered Guanabenz acetate is altered in patients with alcohol-induced liver disease. Mean plasma concentrations of Guanabenz were higher in these patients than in healthy subjects. The clinical significance of this finding is unknown. However, careful monitoring of blood pressure is suggested when Guanabenz is administered to patients with hypertension and coexisting chronic hepatic dysfunction.

5. Patients with renal impairment: The disposition of orally administered Guanabenz acetate is altered modestly in patients with renal impairment. Guanabenz’s half-life is prolonged and clearance decreased, more so in patients on hemodialysis. The clinical significance of these findings is unknown. Careful monitoring of blood pressure during Guanabenz dose titration is suggested in patients with coexisting hypertension and renal impairment.

Information for Patients

Patients who receive Guanabenz should be advised to exercise caution when operating dangerous machinery or driving motor vehicles until it is determined that they do not become drowsy or dizzy from the medication. Patients should be warned that their tolerance for alcohol and other CNS depressants may be diminished. Patients should be advised not to discontinue therapy abruptly.

Laboratory Tests

In clinical trials, no clinically significant laboratory-test abnormalities were identified during either acute or chronic therapy with guanabenz. Tests carried out included CBC, urinalysis, electrolytes, SGOT, bilirubin, alkaline phosphatase, uric acid, BUN, creatinine, glucose, calcium, phosphorus, total protein, and Coombs’ test. During long-term administration of guanabenz, there was a small decrease in serum cholesterol and total triglycerides without any change in the high-density lipoprotein fraction. In rare instances an occasional nonprogressive increase in liver enzymes has been observed. However, no clinical evidence of hepatic disease has been found.

Drug Interactions

Guanabenz has not been demonstrated to cause any drug interactions when administered with other drugs, such as digitalis, diuretics, analgesics, anxiolytics, and antiinflammatory or antiinfective agents, in clinical trials. However, the potential for increased sedation when Guanabenz is administered concomitantly with CNS-depressant drugs should be noted.

Drug/Laboratory Test Interactions

No laboratory-test abnormalities were identified with the use of guanabenz.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Two-year studies were conducted with oral Guanabenz administered in the diet to mice and rats. No evidence of carcinogenic potential was seen in mice given doses of up to 11.5 mg/kg/day (41.4 mg/m2/day) or in rats given doses of up to 9.5 mg/kg/day (83.8 mg/m2/day). On a body-weight basis, these doses are 9X and 7X, respectively, the maximum recommended human daily dose (MRHDD) of 64 mg (based on a 50 kg individual). On a body-surface-area basis, these doses are 1X (mice) and 2X (rats) the MRHDD. In the Salmonella microsome mutagenicity (Ames) test system, Guanabenz at 200 to 500 mcg per plate or at 30 to 50 mcg/mL in suspension gave dose-related increases in the number of mutants in one (TA 1537) of five Salmonella typhimurium strains with or without inclusion of rat liver microsomes. No mutagenic activity was seen at doses up to those which inhibit growth in the eukaryotic microorganism, Schizosaccharomyces pombe, or in Chinese hamster ovary cells at doses up to those which were lethal to the cells in culture. In another eukaryotic system, Saccharomyces cerevisiae, Guanabenz produced no activity in an assay measuring induction of repairable DNA damage. Reproductive studies showed a decreased pregnancy rate in rats administered high oral doses (9.6 mg/kg) of Guanabenz acetate, suggesting an impairment of fertility. The fertility of treated males (9.6 mg/kg) may also have been affected, as suggested by the decreased pregnancy rate of their mates, even though the females received Guanabenz only during the last third of pregnancy.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Guanabenz ACETATE MAY HAVE ADVERSE EFFECTS ON THE FETUS WHEN ADMINISTERED TO PREGNANT WOMEN. A teratology study in mice has indicated a possible increase in skeletal abnormalities when Guanabenz acetate is given orally at doses of 3 to 6 times the maximum recommended human dose of 1 mg/kg. These abnormalities, principally costal and vertebral, were not noted in similar studies in rats and rabbits. However, increased fetal loss has been observed after oral Guanabenz acetate administration to pregnant rats (14 mg/kg) and rabbits (20 mg/kg). Reproductive studies of Guanabenz in rats have shown slightly decreased live-birth indices, decreased fetal survival rate, and decreased pup body weight at oral doses of 6.4 and 9.6 mg/kg. There are no adequate, well-controlled studies in pregnant women. Guanabenz should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Guanabenz is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of Guanabenz in pediatric patients have not been established.

Geriatric Use

Clinical studies of Guanabenz did not include sufficient number 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.

Adverse Reactions

The incidence of adverse effects has been ascertained from controlled clinical studies conducted in the United States and is based on data from 859 patients who received Guanabenz for up to 3 years. There is some evidence that the side effects are dose-related.

The following table shows the incidence of adverse effects occurring in at least 5% of patients in a study comparing Guanabenz acetate to placebo, at a starting dose of 8 mg b.i.d.

Adverse Effect	Placebo (%) n=102	Guanabenz acetate (%) n=109
Dry mouth	7	28
Drowsiness or sedation	12	39
Dizziness	7	17
Weakness	7	10
Headache	6	5

In other controlled clinical trials at the starting dose of 16 mg/day in 476 patients, the incidence of dry mouth was slightly higher (38%) and that of dizziness was slightly lower (12%), but the incidence of the most frequent adverse effects was similar to the placebo-controlled trial. Although these side effects were not serious, they led to discontinuation of treatment about 15% of the time. In more recent studies using an initial dose of 8 mg/day in 274 patients, the incidence of drowsiness or sedation was lower, about 20%.

Other adverse effects were reported during clinical trials with Guanabenz but are not clearly distinguishable from placebo effects and occurred with a frequency of 3% or less:

Cardiovascular-chest pain, edema, arrhythmias, palpitations.

Gastrointestinal-nausea, epigastric pain, diarrhea, vomiting, constipation, abdominal discomfort.

Central nervous system-anxiety, ataxia, depression, sleep disturbances.

ENT disorders-nasal congestion.

Eye disorders-blurring of vision.

Musculoskeletal-aches in extremities, muscle aches.

Respiratory-dyspnea.

Dermatologic-rash, pruritus.

Urogenital-urinary frequency, disturbances of sexual function (decreased libido, impotence).

Other-gynecomastia, taste disorders.

In very rare instances atrioventricular dysfunction, up to and including complete AV block, has been caused by guanabenz.

Drug Abuse and Dependence

No reported dependence or abuse has been associated with the administration of guanabenz.

Overdosage

Accidental ingestion of Guanabenz caused hypotension, somnolence, lethargy, irritability, miosis, and bradycardia in two pediatric patients aged one and three years. Gastric lavage and administration of pressor substances, fluids, and oral activated charcoal resulted in complete and uneventful recovery within 12 hours in both patients.

Since experience with accidental overdosage is limited, the suggested treatment is mainly supportive while the drug is being eliminated from the body and until the patient is no longer symptomatic. Vital signs and fluid balance should be carefully monitored. An adequate airway should be maintained and, if indicated, assisted respiration instituted. There are no data available on the dialyzability of guanabenz.

Guanabenz Dosage and Administration

Dosage with Guanabenz acetate tablets should be individualized. A starting dose of 4 mg twice a day is recommended, whether Guanabenz acetate tablets are used alone or with a thiazide diuretic. Dosage may be increased in increments of 4 to 8 mg per day every one to two weeks, depending on the patient’s response. The maximum dose studied to date has been 32 mg twice daily, but doses as high as this are rarely needed.

How is Guanabenz Supplied

Guanabenz Acetate Tablets USP are available as peach, round, compressed tablets, debossed with company logo on one side and “4226” on the other side, containing Guanabenz acetate USP equivalent to 4 mg Guanabenz packaged in bottles of 100 tablets; and as grey, round, bisected compressed tablets, debossed with company logo on one side and “4227” on the other side, containing Guanabenz acetate USP equivalent to 8 mg Guanabenz packaged in bottles of 100 tablets.

PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

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

Manufactured In Ireland By: 0172

IVAX PHARMACEUTICALS IRELAND 01/08

Waterford, Ireland B7

Manufactured For:

IVAX PHARMACEUTICALS, INC.

Miami, FL 33137

Distributed By:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text

NDC 0172-4226-60

Guanabenz ACETATE

Tablets USP

4 mg*

*Each tablet contains Guanabenz acetate, USP equivalent to 4 mg guanabenz

Rx only

100 TABLETS

TEVA

PRINCIPAL DISPLAY PANEL

Principal Display Panel

NDC 0172-4227-60

Guanabenz ACETATE

Tablets USP

8 mg*

*Each tablet contains Guanabenz acetate, USP equivalent to 8 mg guanabenz

Rx only

100 TABLETS

TEVA

Guanabenz ACETATE  Guanabenz acetate  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0172-4226 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Guanabenz ACETATE (GUANABENZ) Guanabenz ACETATE 4 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE

Product Characteristics Color ORANGE (peach) Score no score Shape ROUND Size 5mm Flavor Imprint Code 4226 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0172-4226-60 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074149	11/22/2010

Guanabenz ACETATE  Guanabenz acetate  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0172-4227 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Guanabenz ACETATE (GUANABENZ) Guanabenz ACETATE 8 mg

Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 2   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE

Product Characteristics Color GRAY Score 2 pieces Shape ROUND Size 6mm Flavor Imprint Code 4227 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0172-4227-60 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA074149	11/22/2010

Labeler - Ivax Pharmaceuticals, Inc. (884075235)

Revised: 11/2010Ivax Pharmaceuticals, Inc.

More Guanabenz resources

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

• guanabenz Concise Consumer Information (Cerner Multum)


• guanabenz Advanced Consumer (Micromedex) - Includes Dosage Information


• Guanabenz MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Guanabenz with other medications

• High Blood Pressure

Guanfacine

Class: Central alpha-Agonists
VA Class: CV490
Chemical Name: N-Amidino-2-(2,6-dichlorophenyl) acetamide monohydrochloride
Molecular Formula: C₉H₉Cl₂N₃O
CAS Number: 29110-47-2
Brands: Tenex

Introduction

Phenylacetyl-guanidine derivative hypotensive agent; selective α₂-adrenergic agonist.^{1 2}

Uses for Guanfacine

Hypertension

Used alone or in combination with other classes of antihypertensive agents in the management of hypertension.^{1 3 4 5 6 8}

Thiazide diuretics are considered the preferred initial monotherapy for uncomplicated hypertension by JNC 7.^{6 7 8}

Hypotensive efficacy shown to be similar to that of clonidine and methyldopa.^{2 3 4}

Has been used in conjunction with diuretics (e.g., thiazides), producing a greater reduction in BP than is obtained with either drug alone.^{1 5 16}

Use of a diuretic or other antihypertensive agents may aid in overcoming tolerance to guanfacine and permit reduction of guanfacine dosage.²

Attention Deficit Hyperactivity Disorder

Has been used for the treatment of attention deficit hyperactivity disorder† (ADHD) in pediatric patients.^{9 10}

Produces a moderate reduction in symptoms of ADHD†; stimulants (e.g., methylphenidate, amphetamines) remain the drugs of choice for the management of ADHD because of their greater efficacy compared with that of other drugs (e.g., guanfacine).⁹

May be especially useful in pediatric patients with comorbid tic disorders, which can be triggered or worsened by stimulant therapy.⁹

Guanfacine Dosage and Administration

General

Hypertension

• 
  

  Adjust dosage carefully according to patient’s BP response and tolerance.^{1 2}

  
  


• 
  

  Carefully monitor BP during initial titration or subsequent upward adjustment in dosage.⁶

  
  


• 
  

  Avoid large or abrupt reductions in BP.¹¹

  
  


• 
  

  Adjust dosage at approximately monthly intervals (more aggressively in high-risk patients [stage 2 hypertension, comorbid conditions]) if BP control is inadequate at a given dosage; it may take months to control hypertension adequately while avoiding adverse effects of therapy.^{6 11}

  
  


• 
  

  SBP is the principal clinical end point, especially in middle-aged and geriatric patients.^{6 12 13} Once the goal SBP is attained, the goal DBP usually is achieved.⁶

  
  


• 
  

  The goal is to achieve and maintain a lifelong SBP <140 mm Hg and a DBP <90 mm Hg if tolerated.^{6 11 14}

  
  


• 
  

  The goal in hypertensive patients with diabetes mellitus or renal impairment is to achieve and maintain an SBP <130 mm Hg and a DBP <80 mm Hg.^{6 11 14 15}

  
  

Attention Deficit Hyperactivity Disorder

• 
  

  Monitor BP, especially during initial dosage adjustment;⁹ some experts also recommend ECG monitoring.¹⁰

  
  

Administration

Oral Administration

Minimize adverse effects (e.g., somnolence) by administering guanfacine initially at bedtime.¹

Dosage

Available as guanfacine hydrochloride; dosage expressed in terms of guanfacine.¹

Pediatric Patients

Hypertension

Oral

Children ≥12 years of age: Initially, 1 mg daily.¹

If a satisfactory response is not obtained after 3–4 weeks of therapy, may increase dosage to 2 mg once daily at bedtime, although most of the antihypertensive effect is observed at a dosage of 1 mg daily.^{1 5}

Although higher dosages (i.e., >2 mg daily) have been used, dosages >3 mg daily were associated with a substantially increased incidence of adverse effects.^{1 2}

Attention Deficit Hyperactivity Disorder†

Oral

Children 7–14 years of age: Initially, 0.5 mg daily (given as a single dose at bedtime) has been administered.⁹

Dosage has been increased with caution over 2–4 weeks (e.g., by 0.5 mg every 4 days) to a maximum of 4 mg daily in 3 divided doses.⁹

Adults

Hypertension

Oral

Initially, 1 mg daily.¹

If a satisfactory response is not obtained after 3–4 weeks of therapy, may increase dosage to 2 mg once daily at bedtime, although most of the antihypertensive effect is observed at a dosage of 1 mg daily.^{1 5}

Although higher dosages (i.e., >2 mg daily) have been used, dosages >3 mg daily were associated with a substantially increased incidence of adverse effects.^{1 2}

Prescribing Limits

Pediatric Patients

Hypertension

Oral

Children ≥12 years of age: Dosages >3 mg daily were associated with a substantially increased incidence of adverse effects.^{1 2 5}

Attention Deficit Hyperactivity Disorder†

Oral

Children 7–14 years of age: Maximum 4 mg daily.^{9 10 16}

Adults

Hypertension

Oral

Dosages >3 mg daily were associated with a substantially increased incidence of adverse effects.^{1 2 5}

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.¹

Renal Impairment

Administer dosages at the low end of the dosing range in patients with renal impairment.^{1 16 16}

May administer usual doses (possibly at low end of dosing range) in patients undergoing dialysis, because limited amounts of the drug are removed by dialysis.¹

Geriatric Patients

Select dosage with caution (usually starting at the low end of the dosing range) because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.¹

Cautions for Guanfacine

Contraindications

• 
  

  Known hypersensitivity to the drug.¹

  
  

Warnings/Precautions

Sensitivity Reactions

Rash

Skin rash with exfoliation reported.¹ Although causal relationship to guanfacine not established, discontinue drug if rash occurs and appropriately monitor patient.¹

General Precautions

Withdrawal Effects

Risk of symptoms of nervousness and anxiety and, less commonly, rebound hypertension, if drug is stopped abruptly.¹ Occurs less commonly than with clonidine;^{1 2 3} incidence may be about 3%.²

Following abrupt discontinuance of guanfacine, BP usually returns to pretreatment levels slowly (within 2–4 days) without ill effects.^{1 3} When rebound hypertension occurs, onset typically is 2–4 days after discontinuance of the drug (which is later than observed with clonidine hydrochloride).¹

Cardiovascular Effects

Like other antihypertensive agents, use with caution in patients with severe coronary insufficiency, recent AMI, or cerebrovascular disease.¹

Nervous System Effects

Risk of dose-related sedation/drowsiness, especially during initial therapy.¹ Performance of activities requiring mental alertness and physical coordination (operating machinery, driving a motor vehicle) may be impaired.¹

Specific Populations

Pregnancy

Category B.¹

Not recommended for the treatment of acute hypertension associated with toxemia of pregnancy.¹

Lactation

Distributed into milk in rats; not known whether distributed into human milk.¹ Use caution.¹

Pediatric Use

Safety and efficacy for management of hypertension not established in children <12 years of age; use not recommended.¹

Safe use for the management of ADHD in children has not been established, but clinical studies currently are under way to determine safety and efficacy.^{9 10}

Mania and aggressive behavioral changes reported in pediatric patients with ADHD receiving the drug;¹ all patients had medical or family risk factors for bipolar disorder.¹ All patients recovered following discontinuance of the drug.¹

Geriatric Use

Clinical trial data for patients ≥65 years of age insufficient to determine whether geriatric patients respond differently than younger adults. ¹ Other experience suggests that response is similar to that in younger adults.¹

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.¹

Hepatic Impairment

Like other antihypertensive agents, use guanfacine with caution in patients with chronic hepatic failure.¹

Renal Impairment

Like other antihypertensive agents, use with caution in patients with chronic renal failure.¹

Common Adverse Effects

Dry mouth,^{1 4 5} somnolence,^{1 3 4 5} dizziness,^{1 4 5} constipation,¹ fatigue,^{1 4 5} asthenia,^{1 5} impotence,^{1 4 5} headache.^{1 4 5}

Interactions for Guanfacine

Drugs Affecting Hepatic Microsomal Enzymes

In a limited number of patients with renal impairment, concomitant administration of guanfacine with a known microsomal enzyme inducer (phenobarbital or phenytoin) resulted in decreased elimination half-life and plasma concentrations of guanfacine.¹ More frequent dosing of guanfacine may be required in patients receiving such concomitant therapy.¹ (See Specific Drugs under Interactions.) Taper dosage of guanfacine when the drug is to be discontinued in patients receiving microsomal enzyme inducers; may avoid rebound hypertension or other symptoms.¹

Specific Drugs

Drug	Interaction	Comments
Anticoagulants	Pharmacokinetic interaction unlikely1
Antigout drugs	Pharmacokinetic interaction unlikely1
Antilipemic agents	Pharmacokinetic interaction unlikely1
β-Adrenergic blocking agents	Pharmacokinetic interaction unlikely1
Bronchodilators	Pharmacokinetic interaction unlikely1
Cardiac drugs (glycosides, coronary vasodilators)	Pharmacokinetic interaction unlikely1
CNS depressants (barbiturates, benzodiazepines, phenothiazines)	May potentiate CNS depression1	Use concomitantly with caution1
Contraceptives (oral)	Pharmacokinetic interaction unlikely1
Cough and cold preparations	Pharmacokinetic interaction unlikely1
Diuretics	Additive/potentiated hypotensive effect1 Pharmacokinetic interaction unlikely1	Usually used to therapeutic advantage in antihypertensive therapy1
Hypoglycemic agents (oral or insulin)	Pharmacokinetic interaction unlikely1
NSAIAs	Pharmacokinetic interaction unlikely1
Phenobarbital	Decreased elimination half-life and plasma concentration of guanfacine in patients with renal failure; 1 withdrawal reaction may occur1 2	In patients receiving phenobarbital, carefully taper guanfacine dosage when drug is to be discontinued1
Phenytoin	Decreased elimination half-life and plasma concentration of guanfacine in patients with renal failure; 1 withdrawal reaction may occur1	In patients receiving phenytoin, carefully taper guanfacine dosage when drug is to be discontinued 1

Guanfacine Pharmacokinetics

Absorption

Bioavailability

Absolute oral bioavailability is about 80%.¹ Peak plasma concentrations usually attained within 1–4 hours (average: 2.6 hours).¹

Duration

BP response persists ≤24 hours following single oral dose.¹

Distribution

Extent

Extensively distributed to tissues.^{1 2} Highest concentrations in highly perfused organs (e.g., kidney, liver); lower concentrations in the brain, testis, and plasma.²

Crosses the placenta in rats; not known whether crosses placenta in humans.¹

Distributed into milk in rats; not known whether distributed into human milk.¹

Plasma Protein Binding

Approximately 70%.¹

Elimination

Metabolism

Approximately 50–70% of a dose is metabolized rapidly in the liver,^{1 2} mainly by oxidative metabolism of the aromatic ring to form the inactive 3-hydroxy derivative (major metabolite),^{1 2} which undergoes conjugation.²

Elimination Route

It appears that the drug is excreted by tubular secretion.¹

In patients with normal renal function, eliminated principally in the urine as unchanged drug (about 50%; range: 40–75%),¹ with remainder eliminated mostly as glucuronide (30–40%) or sulfate (8%).²

Half-life

In patients with normal renal function: about 17 hours (range: 10–30 hours).^{1 2}

Special Populations

Clearance reduced in patients with renal impairment; however, plasma concentrations of drug only slightly increased.¹

Within the reported range of elimination half-lives (10–30 hours), elimination half-life tends to be shorter (13–14 hours) in younger patients and longer (in the upper end of the range) in older patients.¹

Stability

Storage

Oral

Tablets

Tight, light-resistant containers at 15–30°C.¹

ActionsActions

• 
  

  Appears to stimulate α₂-adrenergic receptors in the CNS, causing inhibition of sympathetic vasomotor centers.^{1 2} Contributes predominantly to hypotensive effects.^{1 2}

  
  


• 
  

  Central effects result in reduced peripheral sympathetic nerve impulses from the vasomotor center to the heart and blood vessels, resulting in a decrease in peripheral vascular resistance and a reduction in heart rate.¹

  
  


• 
  

  Under conditions of rest or exercise, cardiac output is not altered.¹

  
  


• 
  

  Reduces BP in both supine and standing positions;¹ hypotensive effects may be somewhat greater in the standing position.²

  
  


• 
  

  Peripheral effects (stimulation of peripheral α₂-adrenergic receptors) also may contribute to hypotensive effects.²

  
  


• 
  

  Lowers elevated plasma renin activity and plasma catecholamine concentrations in patients with hypertension, although these effects do not correlate with individual hypotensive responses.^{1 2}

  
  


• 
  

  Acute administration stimulates release of growth hormone, but the drug does not produce sustained elevation of growth hormone during chronic administration.^{1 2}

  
  


• 
  

  Does not affect plasma aldosterone, mean body weight, or electrolytes; slight but insignificant increase in plasma volume observed after 1 month of therapy.¹

  
  


• 
  

  Reduces serum prolactin concentrations in hypertensive patients with elevated serum prolactin concentrations.²

  
  


• 
  

  Enhances neurologic activity in the prefrontal cortex, an area of the brain involved in planning, impulse control, and organization.¹⁰ Shown in nonhuman primates to improve prefrontal cortical function through direct action on postsynaptic α_2A-adrenergic receptors located in the prefrontal cortex.⁹

  
  


• 
  

  Sedative effects, which are less severe than those seen with clonidine,^{3 9} are the result of inhibitory effects on noradrenergic locus ceruleus neurons and direct effects on the thalamus.⁹

  
  

Advice to Patients

• 
  

  Importance of advising patients not to discontinue therapy abruptly because of the risk of withdrawal symptoms (e.g., nervousness, anxiety) and, less commonly, rebound hypertension.¹ (See Withdrawal Effects under Cautions.)

  
  


• 
  

  Importance of advising patients to exercise caution when operating dangerous machinery or driving motor vehicles until it is known that the drug is not causing untoward dizziness or drowsiness.¹

  
  


• 
  

  Importance of advising patients of the potential for decreased tolerance for alcohol and other CNS depressants.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Guanfacine Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	1 mg (of guanfacine)*	Guanfacine Hydrochloride Tablets
			Tenex	Reddy
		2 mg (of guanfacine)*	Guanfacine Hydrochloride Tablets
			Tenex	Reddy

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 04/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Guanfacine HCl 1MG Tablets (MYLAN): 30/$20.99 or 90/$60.99

Guanfacine HCl 2MG Tablets (MYLAN): 30/$25.99 or 90/$75.99

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 01, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Watson Laboratories, Inc. Guanfacine hydrochloride tablets prescribing information. Corona, CA; 2003 Apr.

2. Cornish LA. Guanfacine hydrochloride: a centrally acting antihypertensive agent. Clin Pharm. 1988; 7:187-97. [PubMed 3281788]

3. Wilson MF, Haring G, Lewin A et al. Comparison of guanfacine versus clonidine for efficacy, safety, and occurrence of withdrawal syndrome in step-2 treatment of mild to moderate essential hypertension. Am J Cardiol. 1986; 57:E43-49.

4. Wilson MF, Blackshear J, Parsons OA et al. Antihypertensive efficacy of guanfacine and methyldopa in patients with mild to moderate essential hypertension. J Clin Pharmacol. 1991; 31:318-26. [PubMed 2037703]

5. Materson BJ, Kessler WB, Alderman MH et al. A multicenter, randomized, double-blind dose-response evaluation of step-2 guanfacine versus placebo in mild to moderate hypertension. Am J Cardiol. 1986; 57:E32-37.

6. National Heart, Lung, and Blood Institute National High BP Education Program. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High BP (JNC VII) Express. Bethesda, MD: May 14 2003. From NIH website. (Also published in JAMA. 2003; 289:2560-72.

7. The Guidelines Subcommittee of the WHO/ISH Mild Hypertension Liaison Committee. 1999 guidelines for the management of hypertension. J Hypertension. 1999; 17:392-403.

8. National Heart, Lung, and Blood Institute National High BP Education Program Coordinating Committee. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High BP (JNC 7) Complete Version. Bethesda, MD: 2003 Nov 5. Hypertension. 2003; 42:1206-52. [PubMed 14656957]

9. Scahill L, Chappell PB, Kim YS et al. A placebo-controlled study of guanfacine in the treatment of children with tic disorders and attention deficit hyperactivity disorder. Am J Psychiatry. 2001; 158:1067-74. [PubMed 11431228]

10. Yan J. Nonstimulant ADHD medication moves closer to FDA approval. Psychiatr News. 2007; 42:18.

11. National Heart, Lung, and Blood Institute National High BP Education Program. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High BP (JNC VI). Bethesda, MD: National Institutes of Health; 1997 Nov. (NIH publication No. 98-4080.)

12. Izzo JL, Levy D, Black HR. Importance of systolic BP in older Americans. Hypertension. 2000; 35:1021-4. [PubMed 10818056]

13. Frohlich ED. Recognition of systolic hypertension for hypertension. Hypertension. 2000; 35:1019-20. [PubMed 10818055]

14. Guidelines Committee. 2003 European Society of Hypertension–European Society of Cardiology guidelines for the management of arterial hypertension. J Hypertension. 2003; 21:1011-53.

15. American Diabetes Association. Treatment of hypertension in adults with diabetes. Diabetes Care. 2003; 26(Suppl 1):S80-2. [PubMed 12502624]

16. Reviewers’ comments (personal observations.)

More Guanfacine resources

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

• Guanfacine Prescribing Information (FDA)


• Guanfacine MedFacts Consumer Leaflet (Wolters Kluwer)


• Guanfacine Professional Patient Advice (Wolters Kluwer)


• Intuniv Prescribing Information (FDA)


• Intuniv Consumer Overview


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


• Tenex Prescribing Information (FDA)


• guanfacine Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Guanfacine with other medications

• ADHD
• High Blood Pressure

Guanidine HCl

Generic Name: guanidine (GWAN ih deen)

Brand Names: Guanidine HCl

What is Guanidine HCl (guanidine)?

Guanidine improves the action of a chemical in the body that regulates muscle cells.

Guanidine is used to treat muscle weakness caused by Eaton-Lambert syndrome. Guanidine will not treat myasthenia gravis.

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

What is the most important information I should know about Guanidine HCl (guanidine)?

Before taking this medication, tell your doctor if you have bone marrow depression or a weak immune system.

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.

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

Guanidine can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your urine may also need to be tested. It is important that you not miss any scheduled visits to your doctor.

What should I discuss with my health care provider before taking Guanidine HCl (guanidine)?

Before using this medication, tell your doctor if you have:

• 
  

  bone marrow depression; or

  
  


• 
  

  a weak immune system.

  
  

If you have any of these conditions, you may not be able to use guanidine, or you may need a dosage adjustment or special tests during treatment.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Guanidine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Guanidine HCl (guanidine)?

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.

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

Guanidine can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your urine may also need to be tested. It is important that you not miss any scheduled visits to your doctor.

Store guanidine at room temperature away from moisture and heat.

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 the 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.

Symptoms of a guanidine overdose may include loss of appetite, diarrhea, numbness or tingling of the lips and fingers, nervousness, tremors, severe muscle spasms or twitching, diarrhea, and vomiting.

What should I avoid while taking Guanidine HCl (guanidine)?

Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection.

Do not receive a vaccine while you are being treated with guanidine. Vaccines may not work as well during your treatment with guanidine.

Guanidine HCl (guanidine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• 
  

  easy bruising or bleeding, unusual weakness;

  
  


• 
  

  fever, chills, body aches, flu symptoms;

  
  


• 
  

  unusual thoughts, changes in behavior;

  
  


• 
  

  feeling light-headed, fainting;

  
  


• 
  

  confusion, hallucinations (seeing things that are not there);

  
  


• 
  

  weakness, lack of coordination;

  
  


• 
  

  numbness, coldness, or tingling in your face, lips, hands, or feet; or

  
  


• 
  

  fast or pounding heartbeats.

  
  

Other less serious side effects are more likely to occur, such as:

• 
  

  nausea, loss of appetite, diarrhea, stomach pain;

  
  


• 
  

  skin rash;

  
  


• 
  

  increased sweating; or

  
  


• 
  

  dry mouth, dry flaky skin.

  
  

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. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Guanidine HCl (guanidine)?

Before taking guanidine, tell your doctor if you are using any of the following drugs:

• 
  

  a steroid medicine;

  
  


• 
  

  cancer chemotherapy or radiation;

  
  


• 
  

  cyclosporine (Neoral, Sandimmune, Gengraf);

  
  


• 
  

  etanercept (Enbrel), efalizumab (Raptiva), tacrolimus (Prograf), sirolimus (Rapamune); or

  
  


• 
  

  any other medicines that can weaken your immune system.

  
  

If you are using any of these drugs, you may not be able to use guanidine, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect guanidine. 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 Guanidine HCl resources

• Guanidine HCl Drug Interactions
• Guanidine HCl Support Group
• 0 Reviews · Be the first to review/rate this drug

• Guanidine Prescribing Information (FDA)


• Guanidine Professional Patient Advice (Wolters Kluwer)

Where can I get more information?

• Your pharmacist has more information about guanidine written for health professionals that you may read.

Guaifenesin AC Liquid

Generic Name: codeine and guaifenesin (KOE deen and gwye FEN a sin)

Brand Names: Allfen CD, Allfen CDX, Brontex, Cheracol with Codeine, Cheratussin AC, Dex-Tuss, Diabetic Tussin C, Duraganidin NR, ExeClear-C, Guaiatussin AC, Guaifen-C, Guiatuss AC, Guiatussin with Codeine, Iophen-C NR, M-Clear WC, Mar-cof CG, Mytussin AC, Robafen AC, Robitussin-AC, Tussi-Organidin NR, Tussi-Organidin-S NR, Tussiden C, Tusso-C

What is Guaifenesin AC Liquid (codeine and guaifenesin)?

Codeine is in a group of drugs called narcotics. It is a cough suppressant that affects the signals in the brain that trigger cough reflex.

Guaifenesin is an expectorant. It helps loosen mucus congestion in your chest and throat, making it easier to cough out through your mouth.

The combination of codeine and guaifenesin is used to treat cough and to reduce chest congestion caused by upper respiratory infections or the common cold.

Codeine and guaifenesin will not treat a cough that is caused by smoking, asthma, or emphysema.

Codeine and guaifenesin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Guaifenesin AC Liquid (codeine and guaifenesin)?

Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains guaifenesin. This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Codeine may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

What should I discuss with my healthcare provider before taking Guaifenesin AC Liquid (codeine and guaifenesin)?

You should not take this medication if you are allergic to codeine or guaifenesin.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take codeine and guaifenesin:

• 
  

  heart disease, heart rhythm disorder;

  
  


• 
  

  asthma, COPD, emphysema, or other breathing disorders;

  
  


• 
  

  a history of head injury or brain tumor;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


• 
  

  a stomach or intestinal disorder;

  
  


• 
  

  Addison's disease or other adrenal gland disorders;

  
  


• 
  

  curvature of the spine;

  
  


• 
  

  a thyroid disorder;

  
  


• liver or kidney disease;


• 
  

  enlarged prostate; or

  
  


• 
  

  a history of depression, mental illness, or drug addiction;

  
  

FDA pregnancy category C. This medication may be harmful to an unborn baby, and could cause addiction or withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Codeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication if you are breast-feeding a baby. Codeine may be habit-forming and should be used only by the person it was prescribed for. Codeine should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Older adults may be more likely to have side effects from this medication.

Liquid forms of this medication may contain sugar or artificial sweetener (phenylalanine). Talk to your doctor before using this form of codeine and guaifenesin if you have diabetes or phenylketonuria (PKU).

How should I take Guaifenesin AC Liquid (codeine and guaifenesin)?

Take this medication exactly as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Follow the directions on your prescription label. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Take codeine and guaifenesin with food if it upsets your stomach. Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you also have a fever, headache, or skin rash.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using codeine and guaifenesin.

Do not stop using this medication suddenly after long-term use or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Store codeine and guaifenesin at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use. Keep track of how much of this medicine has been used from each new bottle. Codeine is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

What happens if I miss a dose?

Since cough medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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. An overdose of codeine can be fatal.

Overdose symptoms may include extreme dizziness or drowsiness, nausea, vomiting, sweating, confusion, hallucinations, cold and clammy skin, blue-colored lips or fingernails, weak or limp muscles, pinpoint pupils, weak pulse, slow breathing, fainting, or seizures (convulsions).

What should I avoid while taking Guaifenesin AC Liquid (codeine and guaifenesin)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. Guaifenesin is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains guaifenesin.

Avoid drinking alcohol. It can increase some of the side effects of this medication.

Guaifenesin AC Liquid (codeine and guaifenesin) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  severe dizziness or drowsiness;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  urinating less than usual or not at all; or

  
  


• 
  

  slow heart rate, weak pulse, fainting, weak or shallow breathing.

  
  

Less serious side effects include:

• 
  

  dizziness, drowsiness, headache;

  
  


• 
  

  warmth, redness, or tingling under your skin;

  
  


• 
  

  nausea, vomiting, upset stomach;

  
  


• 
  

  constipation; or

  
  


• 
  

  skin rash or itching.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Guaifenesin AC Liquid (codeine and guaifenesin)?

Before taking this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by codeine and guaifenesin.

Also tell your doctor if you are using any of the following drugs:

• 
  

  cimetidine (Tagamet);

  
  


• 
  

  quinidine (Quinaglute, Quinidex, Quin-Release);

  
  


• 
  

  naloxone (Narcan); or

  
  


• 
  

  naltrexone (Vivitrol).

  
  

This list is not complete and there may be other drugs that can interact with codeine and guaifenesin. 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 Guaifenesin AC Liquid resources

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

• Brontex MedFacts Consumer Leaflet (Wolters Kluwer)


• ExeClear-C Prescribing Information (FDA)


• Guiatuss AC Liquid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Guaifenesin AC Liquid with other medications

• Cough

Where can I get more information?

• Your pharmacist can provide more information about codeine and guaifenesin.

See also: Guaifenesin AC side effects (in more detail)

Guaifenex PSE 120

Generic Name: guaifenesin and pseudoephedrine (gwye FEN e sin, soo doe e FED rin)

Brand Names: Altarussin PE, Ambifed, Biotuss PE, D-Feda II, Despec-SR, Dynex, ExeFen, Guiatex II SR, Maxifed, Maxifed-G, Medent LD, Medent-LDI, Mucinex D, Nasabid SR, Nasatab LA, Nomuc-PE, Poly-Vent IR, Poly-Vent, Jr., Pseudatex, Pseudo GG, Pseudo GG TR, Pseudo Max, Q-Tussin PE, Respaire-120 SR, Robitussin Severe Congestion, Ru-Tuss Jr., Sudafed Non Drying Sinus, SudaTex-G, Touro LA-LD, Triaminic Softchews Chest Congestion, We Mist II LA, We Mist LA

What is Guaifenex PSE 120 (guaifenesin and pseudoephedrine)?

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of guaifenesin and pseudoephedrine is used to treat nasal and sinus congestion, and to reduce chest congestion caused by the common cold, infections, or allergies.

Guaifenesin and pseudoephedrine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Guaifenex PSE 120 (guaifenesin and pseudoephedrine)?

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Do not use any other over-the-counter cough or cold medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains a decongestant or expectorant.

What should I discuss with my healthcare provider before taking Guaifenex PSE 120 (guaifenesin and pseudoephedrine)?

Do not use this medication if you are allergic to guaifenesin or pseudoephedrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Before taking guaifenesin and pseudoephedrine, tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  heart disease or high blood pressure;

  
  


• 
  

  diabetes; or

  
  


• 
  

  a thyroid disorder.

  
  

If you have any of these conditions, you may not be able to use this medication, or you may need a dosage adjustment or special tests during treatment.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take Guaifenex PSE 120 (guaifenesin and pseudoephedrine)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Do not crush, chew, break, or open a controlled-release, delayed-release, or extended-release tablet or capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Take guaifenesin and pseudoephedrine with food if it upsets your stomach. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

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

What happens if I miss a dose?

Since cough or cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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 nausea, vomiting, dizziness, and feeling restless or nervous.

What should I avoid while taking Guaifenex PSE 120 (guaifenesin and pseudoephedrine)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol while you are taking this medicine.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cold, allergy, or cough medicine without first asking your doctor or pharmacist. Guaifenesin and pseudoephedrine are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains guaifenesin or pseudoephedrine.

Guaifenex PSE 120 (guaifenesin and pseudoephedrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

  
  


• 
  

  increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

  
  

Keep taking guaifenesin and pseudoephedrine and talk to your doctor if you have any of these less serious side effects:

• 
  

  dizziness or headache;

  
  


• 
  

  feeling excited or restless;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  nausea, vomiting, or stomach upset;

  
  


• 
  

  mild loss of appetite;

  
  


• 
  

  warmth, tingling, or redness under your skin; or

  
  


• 
  

  skin rash or itching.

  
  

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.

What other drugs will affect Guaifenex PSE 120 (guaifenesin and pseudoephedrine)?

Before taking guaifenesin and pseudoephedrine, tell your doctor if you are using any of the following drugs:

• 
  

  methyldopa (Aldomet);

  
  


• 
  

  medicines to treat high blood pressure;

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or

  
  


• 
  

  antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

  
  

This is not a complete list and there may be other drugs that can affect guaifenesin and pseudoephedrine. 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 Guaifenex PSE 120 resources

• Guaifenex PSE 120 Side Effects (in more detail)
• Guaifenex PSE 120 Use in Pregnancy & Breastfeeding
• Drug Images
• Guaifenex PSE 120 Drug Interactions
• Guaifenex PSE 120 Support Group
• 0 Reviews for Guaifenex PSE20 - Add your own review/rating

• Congestac MedFacts Consumer Leaflet (Wolters Kluwer)


• Entex PSE Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Mucinex D Prescribing Information (FDA)


• Mucinex D Consumer Overview


• Pseudovent Consumer Overview


• Robitussin Severe Congestion MedFacts Consumer Leaflet (Wolters Kluwer)


• Zephrex LA Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Guaifenex PSE 120 with other medications

• Cough and Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about guaifenesin and pseudoephedrine.

See also: Guaifenex PSE20 side effects (in more detail)