Acebutolol

Dosage Form: capsule
Acebutolol HYDROCHLORIDE CAPSULES

DESCRIPTION

Acebutolol HCl is a selective, hydrophilic beta-adrenoreceptor blocking agent with mild intrinsic sympathomimetic activity for use in treating patients with hypertension and ventricular arrhythmias. It is marketed in capsule form for oral administration. Acebutolol HCl capsules are provided in two dosage strengths which contain 200 or 400 mg of Acebutolol as the hydrochloride salt. The inactive ingredients present are D&C Red 28, D&C Yellow 10, FD&C Blue 1, FD&C Red 40, gelatin, maize starch, povidone, titanium dioxide and stearic acid.

Acebutolol HCl has the following structural formula:

C18H28N2O4•HCl M.W. 372.89

Acebutolol HCl is a white or slightly off-white powder freely soluble in water, and less soluble in alcohol. Chemically it is defined as the hydrochloride salt of (±) N-[3-Acetyl-4-[2-hydroxy-3-[(1-methylethyl) amino]propoxy]phenyl] butanamide.

CLINICAL PHARMACOLOGY

Acebutolol is a cardioselective, β-adrenoreceptor blocking agent, which possesses mild intrinsic sympathomimetic activity (ISA) in its therapeutically effective dose range.

PHARMACODYNAMICS

β1-cardioselectivity has been demonstrated in experimental animal studies. In anesthetized dogs and cats, Acebutolol is more potent in antagonizing isoproterenol-induced tachycardia (β1) than in antagonizing isoproterenolinduced vasodilatation (β2). In guinea pigs and cats, it is more potent in antagonizing this tachycardia than in antagonizing isoproterenol-induced bronchodilatation (β2). ISA of Acebutolol has been demonstrated in catecholamine-depleted rats by tachycardia induced by intravenous administration of this agent. A membrane-stabilizing effect has been detected in animals, but only with high concentrations of Acebutolol.

Clinical studies have demonstrated β1-blocking activity at the recommended doses by: a) reduction in the resting heart rate and decrease in exerciseinduced tachycardia; b) reduction in cardiac output at rest and after exercise; c) reduction of systolic and diastolic blood pressures at rest and postexercise; d) inhibition of isoproterenol-induced tachycardia.

The β1-selectivity of Acebutolol has also been demonstrated on the basis of the following vascular and bronchial effects:

Vascular Effects: Acebutolol has less antagonistic effects on peripheral vascular β2receptors at rest and after epinephrine stimulation than nonselective β-antagonists.

Bronchial Effects: In single-dose studies in asthmatics examining effects of various beta-blockers on pulmonary function, low doses of Acebutolol produce less evidence of bronchoconstriction and less reduction of beta2 agonist, bronchodilating effects, than nonselective agents like propranolol but more than atenolol.

ISA has been observed with Acebutolol in man, as shown by a slightly smaller (about 3 beats per minute) decrease in resting heart rate when compared to equivalent β-blocking doses of propranolol, metoprolol or atenolol. Chronic therapy with Acebutolol induced no significant alteration in the blood lipid profile.

Acebutolol has been shown to delay AV conduction time and to increase the refractoriness of the AV node without significantly affecting sinus node recovery time, atrial refractory period, or the HV conduction time. The membrane-stabilizing effect of Acebutolol is not manifest at the doses used clinically.

Significant reductions in resting and exercise heart rates and systolic blood pressures have been observed 1.5 hours after Acebutolol administration with maximal effects occurring between 3 and 8 hours postdosing in normal volunteers. Acebutolol has demonstrated a significant effect on exerciseinduced tachycardia 24 to 30 hours after drug administration.

There are significant correlations between plasma levels of Acebutolol and both the reduction in resting heart rate and the percent of β-blockade of exercise-induced tachycardia.

The antihypertensive effect of Acebutolol has been shown in double-blind controlled studies to be superior to placebo and similar to propranolol and hydrochlorothiazide. In addition, patients responding to Acebutolol administered twice daily had a similar response whether the dosage regimen was changed to once daily administration or continued on a b.i.d. regimen.

Most patients responded to 400 to 800 mg per day in divided doses.

The antiarrhythmic effect of Acebutolol was compared with placebo, propranolol, and quinidine. Compared with placebo, Acebutolol significantly reduced mean total ventricular ectopic beats (VEB), paired VEB, multiform VEB, R-on-T beats, and ventricular tachycardia (VT). Both Acebutolol and propranolol significantly reduced mean total and paired VEB and VT.

Acebutolol and quinidine significantly reduced resting total and complex VEB; the antiarrhythmic efficacy of Acebutolol was also observed during exercise.

PHARMACOKINETICS and METABOLISM

Acebutolol is well absorbed from the GI tract. It is subject to extensive firstpass hepatic biotransformation, with an absolute bioavailability of approximately 40% for the parent compound. The major metabolite, an Nacetyl derivative (diacetolol), is pharmacologically active. This metabolite is equipotent to Acebutolol and in cats is more cardioselective than Acebutolol;

therefore, this first-pass phenomenon does not attenuate the therapeutic effect of Acebutolol. Food intake does not have a significant effect on the area under the plasma concentration-time curve (AUC) of Acebutolol although the rate of absorption and peak concentration decreased slightly.

The plasma elimination half-life of Acebutolol is approximately 3 to 4 hours, while that of its metabolite, diacetolol, is 8 to 13 hours.The time to reach peak concentration for Acebutolol is 2.5 hours and for diacetolol, after oral administration of Acebutolol, 3.5 hours.

Within the single oral dose range of 200 to 400 mg, the kinetics are dose proportional. However, this linearity is not seen at higher doses, probably due to saturation of hepatic biotransformation sites. In addition, after multiple dosing the lack of linearity is also seen by AUC increases of approximately 100% as compared to single oral dosing. Elimination via renal excretion is

approximately 30% to 40% and by nonrenal mechanisms 50% to 60%, which includes excretion into the bile and direct passage through the intestinal wall.

Acebutolol has a low binding affinity for plasma proteins (about 26%). Acebutolol and its metabolite, diacetolol, are relatively hydrophilic and, therefore, only minimal quantities have been detected in the cerebrospinal fluid (CSF). Drug interaction studies with tolbutamide and warfarin indicated no influence on the therapeutic effects of these compounds. Digoxin and hydrochlorothiazide plasma levels were not affected by concomitant Acebutolol administration. The kinetics of Acebutolol were not significantly altered by concomitant administration of hydrochlorothiazide, hydralazine, sulfinpyrazone, or oral contraceptives.

In patients with renal impairment, there is no effect on the elimination half-life of Acebutolol, but there is decreased elimination of the metabolite, diacetolol, resulting in a two- to three-fold increase in its half-life. For this reason, the drug should be administered with caution in patients with renal insufficiency (see Precautions). Acebutolol and its major metabolite are dialyzable.

Acebutolol crosses the placental barrier and is secreted in breast milk.

In geriatric patients, the bioavailability of Acebutolol and its metabolite is increased, approximately two-fold, probably due to decreases in the first-pass metabolism and renal function in the elderly.

INDICATIONS & USAGE

HYPERTENSION: Acebutolol hydrochloride capsules are indicated for the management of hypertension in adults. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.

VENTRICULAR ARRHYTHMIAS: Acebutolol hydrochloride capsules are indicated in the management of ventricular premature beats; it reduces the total number of premature beats, as well as the number of paired and multiform ventricular ectopic beats, and R-on-T beats.

CONTRAINDICATIONS

Acebutolol HCl is contraindicated in: 1) persistently severe bradycardia; 2) second-and third-degree hear t block; 3) over t cardiac failure; and 4) cardiogenic shock. (See Warnings.)

WARNINGS

CARDIAC FAILURE: Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition by β-adrenergic receptor blockade may precipitate more severe failure. Although β-blockers should be avoided in overt cardiac failure, Acebutolol can be used with caution in patients with a history of heart failure who are controlled with digitalis and/or diuretics. Both digitalis and Acebutolol impair AV conduction. If cardiac failure persists, therapy with Acebutolol should be withdrawn.

IN PATIENTSWITHOUT A HISTORY OF CARDIAC FAILURE: In patients with aortic or mitral valve disease or compromised left ventricular function, continued depression of the myocardium with β-blocking agents over a period of time may lead to cardiac failure. At the first signs of failure, patients should be digitalized and/or be given a diuretic and the response observed closely. If cardiac failure continues despite adequate digitalization and/or diuretic, Acebutolol therapy should be withdrawn.

EXACERBATION OF ISCHEMIC HEART DISEASE FOLLOWING ABRUPT WITHDRAWAL: Following abrupt cessation of therapy with certain β-blocking agents in patients with coronary artery disease, exacerbation of angina pectoris and, in some cases, myocardial infarction and death have been reported. Therefore, such patients should be cautioned against interruption of therapy without a physician’s advice. Even in the absence of overt ischemic heart disease, when discontinuation of Acebutolol is planned, the patient should be carefully observed, and should be advised to limit physical activity to a minimum while Acebutolol is gradually withdrawn over a period of about two weeks. (If therapy with an alternative β-blocker is desired, the patient may be transferred directly to comparable doses of another agent without interruption of β-blocking therapy.) If an exacerbation of angina pectoris occurs, antianginal therapy should be restarted immediately in full doses and the patient hospitalized until his condition stabilizes.

PERIPHERAL VASCULAR DISEASE: Treatment with β-antagonists reduces cardiac output and can precipitate or aggravate the symptoms of arterial insufficiency in patients with peripheral or mesenteric vascular disease. Caution should be exercised with such patients, and they should be observed closely for evidence of progression of arterial obstruction.

BRONCHOSPASTIC DISEASES: PATIENTS WITH BRONCHOSPASTIC DISEASE SHOULD, IN GENERAL, NOT RECEIVE A β-BLOCKER. Because of its relative β1-selectivity, however, low doses of Acebutolol may be used with caution in patients with bronchospastic disease who do not respond to, or who cannot tolerate, alternative treatment. Since β1-selectivity is not absolute and is dose-dependent, the lowest possible dose of Acebutolol should be used initially, preferably in divided doses to avoid the higher plasma levels associated with the longer dose-interval. A bronchodilator, such as theophylline or a β2-stimulant, should be made available in advance with instructions concerning its use.

ANESTHESIA AND MAJOR SURGERY: The necessity, or desirability, of withdrawal of a β-blocking therapy prior to major surgery is controversial. β-adrenergic receptor blockade impairs the ability of the heart to respond to β-adrenergically mediated reflex stimuli. While this might be of benefit in preventing arrhythmic response, the risk of excessive myocardial depression during general anesthesia may be enhanced and difficulty in restarting and maintaining the heart beat has been reported with beta-blockers. If treatment is continued, particular care should be taken when using anesthetic agents which depress the myocardium, such as ether, cyclopropane, and trichlorethylene, and it is prudent to use the lowest possible dose of Acebutolol.

Acebutolol, like other β-blockers, is a competitive inhibitor of β-receptor agonists, and its effect on the hear t can be reversed by cautious administration of such agents (e.g., dobutamine or isoproterenol – see Overdosage).

Manifestations of excessive vagal tone (e.g., profound bradycardia, hypotension) may be corrected with atropine 1 to 3 mg IV in divided doses.

DIABETES AND HYPOGLYCEMIA: β-blockers may potentiate insulin-induced hypoglycemia and mask some of its manifestations such as tachycardia; however, dizziness and sweating are usually not significantly affected. Diabetic patients should be warned of the possibility of masked hypoglycemia.

THYROTOXICOSIS: β-adrenergic blockade may mask certain clinical signs (tachycardia) of hyperthyroidism. Abrupt withdrawal of β-blockade may precipitate a thyroid storm; therefore, patients suspected of developing thyrotoxicosis from whom Acebutolol therapy is to be withdrawn should be monitored closely.

PRECAUTIONS

RISK OF ANAPHYLACTIC REACTION: While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenged, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.

IMPAIRED RENAL OR HEPATIC FUNCTION: Studies on the effect of Acebutolol in patients with renal insufficiency have not been performed in the U.S. Foreign published experience shows that Acebutolol has been used successfully in chronic renal insufficiency. Acebutolol is excreted through the GI tract, but the active metabolite, diacetolol, is eliminated predominantly by the kidney. There is a linear relationship between renal clearance of diacetolol and creatinine clearance. Therefore, the daily dose of Acebutolol should be reduced by 50% when the creatinine clearance is less than 50 mL/min and by 75% when it is less than 25 mL/min. Acebutolol should be used cautiously in patients with impaired hepatic function.

Acebutolol has been used successfully and without problems in elderly patients in the U.S. clinical trials without specific adjustment of dosage. However, elderly patients may require lower maintenance doses because the bioavailability of both Acebutolol and its metabolite are approximately doubled in this age group.

INFORMATION FOR PATIENTS: Patients, especially those with evidence of coronary ar tery disease, should be warned against interruption or discontinuation of Acebutolol therapy without a physician’s supervision.  Although cardiac failure rarely occurs in properly selected patients, those being treated with β-adrenergic blocking agents should be advised to consult a physician if they develop signs or symptoms suggestive of impending CHF, or unexplained respiratory symptoms.

Patients should also be warned of possible severe hypertensive reactions from concomitant use of α-adrenergic stimulants, such as the nasal decongestants commonly used in OTC cold preparations and nasal drops.

CLINICAL LABORATORY FINDINGS: Acebutolol, like other β-blockers, has been associated with the development of antinuclear antibodies (ANA). In prospective clinical trials, patients receiving Acebutolol had a dose-dependent increase in the development of positive ANA titers, and the overall incidence was higher than that observed with propranolol. Symptoms (generally persistent arthralgias and myalgias) related to this laboratory abnormality were infrequent (less than 1% with both drugs). Symptoms and ANA titers were reversible upon discontinuation of treatment.

DRUG INTERACTIONS: Catecholamine-depleting drugs, such as reserpine, may have an additive effect when given with β-blocking agents. Patients treated with Acebutolol plus catecholamine depletors should, therefore, be observed closely for evidence of marked bradycardia or hypotension which may present as vertigo, syncope/presyncope, or orthostatic changes in blood pressure without compensatory tachycardia. Exaggerated hypertensive responses have been reported from the combined use of β-adrenergic antagonists and α-adrenergic stimulants, including those contained in proprietary cold remedies and vasoconstrictive nasal drops. Patients receiving β-blockers should be warned of this potential hazard.

Blunting of the antihypertensive effect of beta-adrenoreceptor blocking agents by nonsteroidal anti-inflammatory drugs has been reported.

No significant interactions with digoxin, hydrochlorothiazide, hydralazine, sulfinpyrazone, oral contraceptives, tolbutamide, or warfarin have been observed.

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: Chronic oral toxicity studies in rats and mice, employing dose levels as high as 300 mg/kg/day, which is equivalent to 15 times the maximum recommended (60 kg) human dose, did not indicate a carcinogenic potential for Acebutolol. Diacetolol, the major metabolite of Acebutolol in man, was without carcinogenic potential in rats when tested at doses as high as 1800 mg/kg/day. Acebutolol and diacetolol were also shown to be devoid of mutagenic potential in the Ames Test. Acebutolol, administered orally to two generations of male and female rats at doses of up to 240 mg/kg/day (equivalent to 12 times the maximum recommended therapeutic dose in a 60-kg human) and diacetolol, administered to two generations of male and female rats at doses of up to 1000 mg/kg/day, had no significant impact on reproductive performance or fertility.

PREGNANCY:

Teratogenic Effects:

Pregnancy Category B: Reproduction studies have been performed with Acebutolol in rats (up to 630 mg/kg/day) and rabbits (up to 135 mg/kg/day). These doses are equivalent to approximately 31.5 and 6.8 times the maximum recommended therapeutic dose in a 60-kg human, respectively. The compound was not teratogenic in either species. In the rabbit, however, doses of 135 mg/kg/day caused slight fetal growth retardation; this effect was considered to be a result of maternal toxicity, as evidenced by reduced food intake, a lowered rate of body weight gain, and mortality. Studies have also been performed in these species with diacetolol (at doses of up to 450 mg/kg/day in rabbits and up to 1800 mg/kg/day in rats). Other than a significant elevation in post-implantation loss with 450 mg/kg/day diacetolol, a level at which food consumption and body weight gain were reduced in rabbit dams and a nonstatistically significant increase in incidence of bilateral cataract in rat fetuses from dams treated with 1800 mg/kg/day diacetolol, there was no evidence of harm to the fetus. There are no adequate and wellcontrolled trials in pregnant women. Because animal teratology studies are not always predictive of the human response, Acebutolol should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

Nonteratogenic Effects:

Studies in humans have shown that both Acebutolol and diacetolol cross the placenta. Neonates of mothers who have received Acebutolol during pregnancy have reduced birth weight, decreased blood pressure, and decreased heart rate. In the newborn the elimination half-life of Acebutolol was 6 to 14 hours, while the half-life of diacetolol was 24 to 30 hours for the first 24 hours after birth, followed by a half-life of 12 to 16 hours. Adequate facilities for monitoring these infants at birth should be available.

LABOR AND DELIVERY: The effect of Acebutolol on labor and delivery in pregnant women is unknown. Studies in animals have not shown any effect of Acebutolol on the usual course of labor and delivery.

NURSING MOTHERS: Acebutolol and diacetolol also appear in breast milk with a milk:plasma ratio of 7.1 and 12.2, respectively. Use in nursing mothers is not recommended.

PEDIATRIC USE: Safety and effectiveness in pediatric patients have not been established.

GERIATRIC USE: Clinical studies of Acebutolol and other reported clinical experience is inadequate to determine whether there are differences in safety or effectiveness between patients above or below age 65. Elderly subjects evidence greater bioavailability of Acebutolol (see Clinical Pharmacology - PHARMACOKINETICS AND METABOLISM), presumably because of age related reduction in first-pass metabolism and renal function. Therefore, it may be appropriate to start elderly patients at the low end of the dosing range (see Dosage and Administration - USE IN OLDER PATIENTS).

ADVERSE REACTIONS

Acebutolol is well tolerated in properly selected patients. Most adverse reactions have been mild, not required discontinuation of therapy, and tended to decrease as duration of treatment  increases.

The following table shows the frequency of treatment-related side effects derived from controlled clinical trials in patients with hypertension, angina pectoris, and arrhythmia. These patients received Acebutolol, propranolol, or hydrochlorothiazide as monotherapy, or placebo.

The following selected (potentially important) side effects were seen in up to 2% of Acebutolol patients:

Cardiovascular: hypotension, bradycardia, heart failure.

Central Nervous System: anxiety, hyper/hypoesthesia, impotence.

Dermatological: pruritus.

Gastrointestinal: vomiting, abdominal pain.

Genitourinary: dysuria, nocturia.

Liver and Biliary System: A small number of cases of liver abnormalities (increased SGOT, SGPT, LDH) have been reported in association with Acebutolol therapy. In some cases increased bilirubin or alkaline phosphatase, fever, malaise, dark urine, anorexia, nausea, headache, and/or other symptoms have been reported. In some of the reported cases, the symptoms and signs were confirmed by rechallenge with Acebutolol. The abnormalities were reversible upon cessation of Acebutolol therapy.

Musculoskeletal: back pain, joint pain.

Respiratory: pharyngitis, wheezing.

Special Senses: conjunctivitis, dry eye, eye pain.

Autoimmune: In extremely rare instances, systemic lupus erythematosus has been reported.

The incidence of drug-related adverse effects (volunteered and solicited) according to Acebutolol dose is shown below. (Data from 266 hypertensive patients treated for 3 months on a constant dose.)

POTENTIAL ADVERSE EFFECTS

In addition, certain adverse effects not listed above have been reported with other β-blocking agents and should also be considered as potential adverse effects of Acebutolol.

Central Nervous System: Reversible mental depression progressing to catatonia (an acute syndrome characterized by disorientation for time and place), short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance (neuropsychometrics).

Cardiovascular: Intensification of AV block (see Contraindications).

Allergic: Erythematous rash, fever combined with aching and sore throat, laryngospasm, and respiratory distress.

Hematologic: Agranulocytosis, nonthrombocytopenic, and thrombocytopenic purpura.

Gastrointestinal: Mesenteric arterial thrombosis and ischemic colitis.

Miscellaneous: Reversible alopecia and Peyronie’s disease. The oculomucocutaneous syndrome associated with the β-blocker practolol has not been reported with Acebutolol during investigational use and extensive foreign clinical experience.

OVERDOSAGE

No specific information on emergency treatment of overdosage is available for Acebutolol.

However, overdosage with other β-blocking agents has been accompanied by extreme bradycardia, advanced atrioventricular block, intraventricular conduction defects, hypotension, severe congestive heart failure, seizures, and in susceptible patients, bronchospasm and hypoglycemia. Although specific information on the emergency treatment of Acebutolol overdose is not available on the basis of the pharmacological actions and the observations in treating overdoses with other β-blockers, the following general measures should be considered:

1. Empty stomach by emesis or lavage.

2. Bradycardia: IV atropine (1 to 3 mg in divided doses). If antivagal response is inadequate, administer isoproterenol cautiously since larger than usual doses of isoproterenol may be required.

3. Persistent hypotension in spite of correction of bradycardia: Administer vasopressor (e.g., epinephrine, norepinephrine, dopamine, or dobutamine) with frequent monitoring of blood pressure and pulse rate.

4. Bronchospasm: A theophylline derivative, such as aminophylline and/or parenteral β2-stimulant, such as terbutaline.

5. Cardiac failure: Digitalize the patient and/or administer a diuretic. It has been reported that glucagon is useful in this situation.

Acebutolol is dialyzable.

DOSAGE & ADMINISTRATION

HYPERTENSION: The initial dosage of Acebutolol in uncomplicated mild-to-moderate hypertension is 400 mg. This can be given as a single daily dose, but in occasional patients twice daily dosing may be required for adequate 24-hour blood-pressure control. An optimal response is usually achieved with dosages of 400 to 800 mg per day, although some patients have been maintained on as little as 200 mg per day. Patients with more severe hypertension or who have demonstrated inadequate control may respond to a total of 1200 mg daily (administered b.i.d.), or to the addition of a second antihypertensive agent. Beta-1 selectivity diminishes as dosage is increased.

VENTRICULAR ARRHYTHMIA: The usual initial dose of Acebutolol is 400 mg daily given as 200 mg b.i.d. Dosage should be increased gradually until an optimal clinical response is obtained, generally at 600 to 1200 mg per day. If treatment is to be discontinued, the dosage should be reduced gradually over a period of about two weeks.

USE IN OLDER PATIENTS: Older patients have an approximately 2-fold increase in bioavailability and may require lower maintenance doses. Doses above 800 mg/day should be avoided in the elderly.

HOW SUPPLIED

Acebutolol hydrochloride capsules are available as follows:

200 mg: Size “2” hard gelatin capsules with bright orange opaque body printed radially “669” with black ink and lavender opaque cap printed radially “Amneal” with black ink.

Bottles of 100 NDC 65162-669-10

Bottles of 500 NDC 65162-669-50

400 mg: Size “2” hard gelatin capsules with bright orange opaque body printed radially “670” with black ink and lavender opaque cap printed radially “Amneal” with black ink.

Bottles of 30   NDC 65162-670-03

Bottles of 100 NDC 65162-670-10

Bottles of 500 NDC 65162-670-50

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

Protect from light. Keep tightly closed. Dispense in a light resistant, tight container.

Manufactured by:

Amneal Pharmaceuticals of NY

Hauppauge, NY 11788

Distributed by:

Amneal Pharmaceuticals

Glasgow, KY 42164

Rev. 09-2010

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acebutolol HYDROCHLORIDE  Acebutolol hydrochloride  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65162-669 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acebutolol HYDROCHLORIDE (Acebutolol) Acebutolol HYDROCHLORIDE 200 mg

Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1

Product Characteristics Color PURPLE (Lavender Opaque) , ORANGE (Bright Orange Opaque) Score no score Shape CAPSULE (Hard Gelatin) Size 18mm Flavor Imprint Code Amneal;669 Contains

Packaging # NDC Package Description Multilevel Packaging 1 65162-669-10 100 CAPSULE In 1 BOTTLE None 2 65162-669-50 500 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075047	12/01/2009

Acebutolol HYDROCHLORIDE  Acebutolol hydrochloride  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 65162-670 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acebutolol HYDROCHLORIDE (Acebutolol) Acebutolol HYDROCHLORIDE 400 mg

Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1

Product Characteristics Color PURPLE (Lavender Opaque) , ORANGE (Bring Orange Opaque) Score no score Shape CAPSULE (Hard Gelatin) Size 23mm Flavor Imprint Code Amneal;670 Contains

Packaging # NDC Package Description Multilevel Packaging 1 65162-670-03 30 CAPSULE In 1 BOTTLE None 2 65162-670-10 100 CAPSULE In 1 BOTTLE None 3 65162-670-50 500 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075047	12/01/2009

Labeler - Amneal Pharmaceuticals, LLC (123797875)

Registrant - Amneal Pharmaceuticals (123797875)

Establishment
Name	Address	ID/FEI	Operations
Amneal Pharmaceuticals		831227801	ANALYSIS, MANUFACTURE, LABEL, PACK

Establishment
Name	Address	ID/FEI	Operations
Amneal Pharmaceuticals		831227777	ANALYSIS, MANUFACTURE, LABEL, PACK

Revised: 12/2010Amneal Pharmaceuticals, LLC

More Acebutolol resources

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

• Acebutolol MedFacts Consumer Leaflet (Wolters Kluwer)


• acebutolol Concise Consumer Information (Cerner Multum)


• acebutolol Advanced Consumer (Micromedex) - Includes Dosage Information


• Acebutolol Hydrochloride Monograph (AHFS DI)

Compare Acebutolol with other medications

• High Blood Pressure
• Premature Ventricular Depolarizations
• Ventricular Tachycardia

aluminum hydroxide

Generic Name: aluminum hydroxide (a LOO mi num hye DROX ide)

Brand names: Alternagel, Alu-Cap, Dialume, Amphojel, Alu-Tab, Aloh-Gel

What is aluminum hydroxide?

Aluminum is a naturally occurring mineral. Aluminum hydroxide is an antacid.

Aluminum hydroxide is used to treat symptoms of increased stomach acid, such as heartburn, upset stomach, sour stomach, or acid indigestion. Aluminum hydroxide is also used to reduce phosphate levels in people with certain kidney conditions.

Aluminum hydroxide may be used for other purposes not listed in this medication guide.

What is the most important information I should know about aluminum hydroxide?

Ask a doctor or pharmacist before taking this medication if you have kidney disease, kidney stones, severe constipation, if you are dehydrated, or if you drink alcohol frequently.

Do not take aluminum hydroxide for longer than 2 weeks without your doctor's advice.

Avoid taking other medications at the same time you take aluminum hydroxide. Antacids can make it harder for your body to absorb certain other drugs.

What should I discuss with my healthcare provider before taking aluminum hydroxide?

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:

• kidney disease, a history of kidney stones;


• 
  

  severe constipation;

  
  


• 
  

  if you are dehydrated; or

  
  


• 
  

  if you drink alcohol frequently.

  
  

It is not known whether aluminum hydroxide is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Aluminum hydroxide 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.

How should I take aluminum hydroxide?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Take this medication with a full glass (8 ounces) of water.

Aluminum hydroxide is usually taken between meals or at bedtime.

Do not take aluminum hydroxide for longer than 2 weeks without your doctor's advice. Store aluminum hydroxide at room temperature away from moisture, heat, and light.

See also: Aluminum hydroxide dosage (in more detail)

What happens if I miss a dose?

Since antacids are usually taken 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, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe constipation, weight loss, confusion, mood changes, or urinating less than usual or not at all.

What should I avoid while taking aluminum hydroxide?

Avoid taking other medications at the same time you take aluminum hydroxide. Antacids can make it harder for your body to absorb certain other drugs.

Aluminum hydroxide side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using the medication and call your doctor at once if you have a serious side effect such as:

• 
  

  severe stomach pain or constipation;

  
  


• 
  

  bloody, black, or tarry stools;

  
  


• 
  

  coughing up blood that looks like coffee grounds;

  
  


• 
  

  pain when you urinate;

  
  


• 
  

  extreme drowsiness; or

  
  


• 
  

  tired feeling, loss of appetite, and muscle weakness.

  
  

Less serious side effects are more likely, and you may have none at all.

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.

Aluminum hydroxide Dosing Information

Usual Adult Dose for Dyspepsia:

500 to 600 mg orally 4 to 6 times a day as needed, between meals and at bedtime.

Usual Adult Dose for Duodenal Ulcer:

500 to 1500 mg orally 4 to 6 times a day as needed, between meals and at bedtime.

Usual Adult Dose for Erosive Esophagitis:

500 to 1500 mg orally 4 to 6 times a day as needed, between meals and at bedtime.

Usual Adult Dose for Gastric Ulcer:

500 to 1500 mg orally 4 to 6 times a day as needed, between meals and at bedtime.

Usual Adult Dose for Gastroesophageal Reflux Disease:

500 to 1500 mg orally 4 to 6 times a day as needed, between meals and at bedtime.

Usual Adult Dose for Zollinger-Ellison Syndrome:

500 to 3600 mg orally 4 to 6 times a day as needed, between meals and at bedtime.

Usual Adult Dose for Hyperphosphatemia:

500 to 1000 mg orally 4 times a day, with meals and at bedtime. The dosage should be titrated to the serum phosphate level.

Usual Pediatric Dose for Gastrointestinal Hemorrhage:

G.I. hemorrhage prophylaxis:
0 to 4 weeks: 1 mL/kg orally every 4 hours as needed.
4 weeks to 1 year: 2 to 5 mL/dose every 1 to 2 hours, titrate to gastric pH > 3.5.
1 to 12 years: 5 to 15 mL/dose orally every 1 to 2 hours, titrate to gastric pH > 3.5.

Usual Pediatric Dose for Hyperphosphatemia:

1 to 12 years: use Al(OH)3 or aluminum carbonate gel product only: 50 to 150 mg/kg/day orally (as aluminum hydroxide gel) administered in equally divided doses every 4 to 6 hours; titrate to normal serum phosphate level.

Usual Pediatric Dose for Peptic Ulcer:

1 month to 1 year: 1 to 2 mL/kg/dose orally 1 to 3 hours after meals and at bedtime.
1 year to 12 years: 5 to 15 mL orally every 3 to 6 hours or 1 and 3 hours after meals and at bedtime.

What other drugs will affect aluminum hydroxide?

There may be other drugs that can interact with aluminum hydroxide. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More aluminum hydroxide resources

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

Compare aluminum hydroxide with other medications

• Duodenal Ulcer
• Erosive Esophagitis
• Gastrointestinal Hemorrhage
• GERD
• Hyperphosphatemia
• Indigestion
• Peptic Ulcer
• Stomach Ulcer
• Zollinger-Ellison Syndrome

Where can I get more information?

• Your pharmacist can provide more information about aluminum hydroxide.

See also: aluminum hydroxide side effects (in more detail)

ketorolac Oral, Intravenous, Injection, Intramuscular

kee-toe-ROLE-ak

Oral route(Tablet)

For short term use only (up to 5 days in adults). Not for use in pediatric patients and not indicated for minor or chronic pain. Contraindicated in patients with peptic ulcer disease, recent GI bleeding or perforation, peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery, advanced renal impairment, risk of renal failure due to volume depletion, cerebrovascular bleeding, hemorrhagic diathesis, incomplete homeostasis, high-risk of bleeding, prophylactic analgesic before major surgery, labor and delivery use, nursing mothers, and concomitant aspirin or NSAID use. Use caution with elderly patients due to high risk of GI adverse events and in patients with cardiovascular disease or risk factors. Adjust dosages for elderly patients, patients under 50 kg, and patients with moderately elevated serum creatinine .

Injection route(Solution)

For short term use only (up to 5 days in adults). Not for use in pediatric patients and not indicated for minor or chronic pain. Contraindicated in patients with peptic ulcer disease, recent GI bleeding or perforation, peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery, advanced renal impairment, risk of renal failure due to volume depletion, cerebrovascular bleeding, hemorrhagic diathesis, incomplete homeostasis, high-risk of bleeding, prophylactic analgesic before major surgery, previously demonstrated hypersensitivity reactions, intrathecal or epidural administration, labor and delivery use, nursing mothers, and concomitant aspirin or NSAID use. Use caution with elderly patients due to high risk of GI adverse events and in patients with cardiovascular disease or risk factors. Adjust dosages for elderly patients, patients under 50 kg, and patients with moderately elevated serum creatinine .

Commonly used brand name(s)

In the U.S.

• Toradol


• Toradol IV/IM

Available Dosage Forms:

• Tablet


• Solution


• Injectable

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Acetic Acid (class)

Uses For ketorolac

Ketorolac is used to relieve moderately severe pain, usually pain that occurs after an operation or other painful procedure. It belongs to the group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). Ketorolac is not a narcotic and is not habit-forming. It will not cause physical or mental dependence, as narcotics can. However, ketorolac is sometimes used together with a narcotic to provide better pain relief than either medicine used alone.

Ketorolac has side effects that can be very dangerous. The risk of having a serious side effect increases with the dose of ketorolac and with the length of treatment. Therefore, ketorolac should not be used for more than 5 days. Before using ketorolac, you should discuss with your doctor the good that ketorolac can do as well as the risks of using it.

Ketorolac is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, ketorolac is used in certain patients with the following medical conditions:

• Pain after surgery in children

Before Using ketorolac

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ketorolac, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ketorolac or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on ketorolac have been done only in adult patients, and there is no specific information comparing use of ketorolac in children up to 16 years of age with use in other age groups.

Geriatric

Stomach or intestinal problems, swelling of the face, feet, or lower legs, or sudden decrease in the amount of urine may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of ketorolac. Also, elderly people are more likely than younger adults to get very sick if the medicine causes stomach problems. Studies in older adults have shown that ketorolac stays in the body longer than it does in younger people. Your doctor will consider this when deciding on how much ketorolac should be given for each dose and how often it should be given.

Pregnancy

	Pregnancy Category	Explanation
1st Trimester	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd Trimester	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
3rd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking ketorolac, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ketorolac with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Aceclofenac


• Acemetacin


• Alclofenac


• Apazone


• Aspirin


• Benoxaprofen


• Bufexamac


• Carprofen


• Clometacin


• Clonixin


• Dexketoprofen


• Diclofenac


• Diflunisal


• Dipyrone


• Droxicam


• Etodolac


• Etofenamate


• Felbinac


• Fenbufen


• Fenoprofen


• Fentiazac


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Ibuprofen


• Indomethacin


• Indoprofen


• Isoxicam


• Ketoprofen


• Lornoxicam


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Nabumetone


• Naproxen


• Niflumic Acid


• Nimesulide


• Oxaprozin


• Oxyphenbutazone


• Pentoxifylline


• Phenylbutazone


• Pirazolac


• Piroxicam


• Pirprofen


• Probenecid


• Propyphenazone


• Proquazone


• Sulindac


• Suprofen


• Tenidap


• Tenoxicam


• Tiaprofenic Acid


• Tolmetin


• Zomepirac

Using ketorolac with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab


• Ardeparin


• Argatroban


• Beclamide


• Beta Glucan


• Bivalirudin


• Caramiphen


• Carbamazepine


• Certoparin


• Chlormethiazole


• Cilostazol


• Citalopram


• Clopidogrel


• Clovoxamine


• Dabigatran Etexilate


• Dalteparin


• Danaparoid


• Desirudin


• Diazepam


• Dipyridamole


• Enoxaparin


• Escitalopram


• Ethotoin


• Felbamate


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Fosphenytoin


• Gabapentin


• Ginkgo


• Heparin


• Lacosamide


• Lepirudin


• Levetiracetam


• Mephenytoin


• Mephobarbital


• Methotrexate


• Nadroparin


• Nefazodone


• Oxcarbazepine


• Paraldehyde


• Paramethadione


• Parnaparin


• Paroxetine


• Pemetrexed


• Phenacemide


• Phenobarbital


• Phenytoin


• Piracetam


• Pregabalin


• Protein C


• Reviparin


• Rivaroxaban


• Rufinamide


• Sertraline


• Sibutramine


• Stiripentol


• Tacrolimus


• Tiagabine


• Ticlopidine


• Tinzaparin


• Tirofiban


• Topiramate


• Trimethadione


• Valproic Acid


• Vigabatrin


• Vilazodone


• Zimeldine


• Zonisamide

Using ketorolac with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol


• Acetohexamide


• Alacepril


• Alprenolol


• Amiloride


• Arotinolol


• Atenolol


• Azilsartan Medoxomil


• Azosemide


• Befunolol


• Bemetizide


• Benazepril


• Bendroflumethiazide


• Benzthiazide


• Betaxolol


• Bevantolol


• Bisoprolol


• Bopindolol


• Bucindolol


• Bumetanide


• Bupranolol


• Buthiazide


• Candesartan Cilexetil


• Canrenoate


• Captopril


• Carteolol


• Carvedilol


• Celiprolol


• Chlorothiazide


• Chlorpropamide


• Chlorthalidone


• Cilazapril


• Clopamide


• Cyclopenthiazide


• Cyclosporine


• Delapril


• Desvenlafaxine


• Dilevalol


• Duloxetine


• Enalaprilat


• Enalapril Maleate


• Eprosartan


• Esmolol


• Ethacrynic Acid


• Fosinopril


• Furosemide


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Hydrochlorothiazide


• Hydroflumethiazide


• Imidapril


• Indapamide


• Irbesartan


• Labetalol


• Landiolol


• Levobetaxolol


• Levobunolol


• Lisinopril


• Lithium


• Losartan


• Mepindolol


• Methyclothiazide


• Metipranolol


• Metolazone


• Metoprolol


• Milnacipran


• Moexipril


• Nadolol


• Nebivolol


• Nipradilol


• Olmesartan Medoxomil


• Oxprenolol


• Penbutolol


• Pentopril


• Perindopril


• Pindolol


• Piretanide


• Polythiazide


• Propranolol


• Quinapril


• Ramipril


• Sotalol


• Spirapril


• Spironolactone


• Talinolol


• Tasosartan


• Telmisartan


• Temocapril


• Tertatolol


• Timolol


• Tolazamide


• Tolbutamide


• Torsemide


• Trandolapril


• Triamterene


• Trichlormethiazide


• Valsartan


• Venlafaxine


• Xipamide


• Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Alcohol abuse or


• Diabetes mellitus (sugar diabetes) or


• Edema (swelling of face, fingers, feet or lower legs caused by too much fluid in the body) or


• Kidney disease or


• Liver disease (severe) or


• Systemic lupus erythematosus (SLE)—The chance of serious side effects may be increased

• Asthma or


• Heart disease or


• High blood pressure—Ketorolac may make your condition worse.

• Bleeding in the brain (history of) or


• Hemophilia or other bleeding problems—Ketorolac may increase the chance of serious bleeding

• Bleeding from the stomach or intestines (history of) or


• Colitis, stomach ulcer, or other stomach or intestinal problems (or history of)—Ketorolac may make stomach or intestinal problems worse. Also, bleeding from the stomach or intestines is more likely to occur during ketorolac treatment in people with these conditions

Proper Use of ketorolac

For patients taking ketorolac tablets:

• To lessen stomach upset, ketorolac tablets should be taken with food (a meal or a snack) or with an antacid.


• Take ketorolac with a full glass of water. Also, do not lie down for about 15 to 30 minutes after taking it. This helps to prevent irritation that may lead to trouble in swallowing.

For patients using ketorolac injection:

• Medicines given by injection are sometimes used at home. If you will be using ketorolac at home, your health care professional will teach you how the injections are to be given. You will also have a chance to practice giving injections. Be certain that you understand exactly how the medicine is to be injected.

For safe and effective use of ketorolac, do not use more of it, do not use it more often, and do not use it for more than 5 days. Using too much of ketorolac increases the chance of unwanted effects, especially in elderly patients.

Ketorolac should be used only when it is ordered by your doctor for treating certain kinds of pain. Because of the risk of serious side effects, do not save any leftover ketorolac for use in the future, and do not share it with other people.

Dosing

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

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  • For pain:
    
    • Adults (patients 16 years of age and older)—One 10-milligram (mg) tablet four times a day, four to six hours apart. Some people may be directed to take two tablets for the first dose only.
    
    
    • Children up to 16 years of age—Use and dose must be determined by your doctor.
    
    
  
  


• For injection dosage form:
  
  • For pain:
    
    • Adults (patients 16 years of age and older)—15 or 30 mg, injected into a muscle or a vein four times a day, at least 6 hours apart. This amount of medicine may be contained in 1 mL or in one-half (0.5) mL of the injection, depending on the strength. Some people who do not need more than one injection may receive one dose of 60 mg, injected into a muscle.
    
    
    • Children up to 16 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of ketorolac, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Do not refrigerate. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using ketorolac

Taking certain other medicines together with ketorolac may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. Therefore, do not take acetaminophen (e.g., Tylenol) together with ketorolac for more than a few days, unless otherwise directed by your medical doctor or dentist. Also, do not take any of the following medicines together with ketorolac, unless your medical doctor or dentist has directed you to do so and is following your progress:

• Aspirin or other salicylates


• Diclofenac (e.g., Voltaren®)


• Diflunisal (e.g., Dolobid®)


• Etodolac (e.g., Lodine®)


• Fenoprofen (e.g., Nalfon®)


• Floctafenine (e.g., Idarac®)


• Flurbiprofen (e.g., Ansaid®)


• Ibuprofen (e.g., Motrin®)


• Indomethacin (e.g., Indocin®)


• Ketoprofen (e.g., Orudis®)


• Meclofenamate (e.g., Meclomen®)


• Mefenamic acid (e.g., Ponstel®)


• Nabumetone (e.g., Relafen®)


• Naproxen (e.g., Naprosyn®)


• Oxaprozin (e.g., Daypro®)


• Phenylbutazone (e.g., Butazolidin®)


• Piroxicam (e.g., Feldene®)


• Sulindac (e.g., Clinoril®)


• Tenoxicam (e.g., Mobiflex®)


• Tiaprofenic acid (e.g., Surgam®)


• Tolmetin (e.g., Tolectin®)


• Zomepirac (e.g., Zomax®)

Ketorolac may cause some people to become dizzy or drowsy. If either of these side effects occurs, do not drive, use machines, or do anything else that could be dangerous if you are not alert.

Serious side effects can occur during treatment with ketorolac. Sometimes serious side effects can occur without any warning. However, possible warning signs often occur, including swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, or unusual flushing or warmth of skin. Stop taking ketorolac and check with your doctor immediately if you notice any of these warning signs.

ketorolac Side Effects

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

Check with your doctor immediately if any of the following side effects occur:

More common

• Swelling of face, fingers, lower legs, ankles, and/or feet


• weight gain (unusual)

Less common

• Bruising (not at place of injection)


• high blood pressure


• skin rash or itching


• small, red spots on skin


• sores, ulcers, or white spots on lips or in mouth

Rare

• Abdominal or stomach pain, cramping, or burning that is severe


• bleeding from the rectum or bloody or black, tarry stools


• bloody or cloudy urine


• blue lips and fingernails


• blurred vision of other vision change


• burning, red, tender, thick, scaly, or peeling skin


• chest pain


• convulsions


• cough or hoarseness


• dark urine


• decrease in amount of urine that is sudden


• fainting


• fast, irregular, noisy, or troubled breathing


• fever with severe headache, drowsiness, confusion, and stiff neck or back


• fever with or without chills or sore throat


• hallucinations (seeing, hearing, or feeling things that are not there)


• hearing loss


• hives


• increase in amount of urine or urinating often


• light-colored stools


• loss of appetite


• low blood pressure


• mood changes or unusual behavior


• muscle cramps or pain


• nausea, heartburn, or indigestion that is severe and continues


• nosebleeds


• pain in lower back and/or side


• pain, tenderness, or swelling in the upper stomach area


• painful or difficult urination


• pale skin


• puffiness or swelling of the eyelids or eyes


• ringing or buzzing in ears


• runny nose


• severe restlessness


• shortness of breath


• swollen or painful glands


• swollen tongue


• thirst that continues


• tightness in the chest with or without wheezing


• unusual tiredness or weakness


• vomiting of blood or material that looks like coffee grounds


• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach pain (mild or moderate)


• bruising at place of injection


• diarrhea


• dizziness


• drowsiness


• headache


• indigestion


• nausea

Less common or rare

• Bloating or gas


• burning or pain at place of injection


• constipation


• feeling of fullness in abdominal or stomach area


• increased sweating


• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More ketorolac Oral, Intravenous, Injection, Intramuscular resources

• Ketorolac Oral, Intravenous, Injection, Intramuscular Use in Pregnancy & Breastfeeding
• Drug Images
• Ketorolac Oral, Intravenous, Injection, Intramuscular Drug Interactions
• Ketorolac Oral, Intravenous, Injection, Intramuscular Support Group
• 74 Reviews for Ketorolac Oral, Intravenous, Injection, Intramuscular - Add your own review/rating

Compare ketorolac Oral, Intravenous, Injection, Intramuscular with other medications

• Pain
• Postoperative Pain

Guanidine

Dosage Form: Tablets

Guanidine Description

Chemically, Guanidine (aminomethanamidine) hydrochloride is a crystalline powder freely soluble in water and alcohol. The aqueous solution is neutral.

The structural formula is:

Each tablet contains 125 mg of Guanidine hydrochloride with no color additive in the base. It also contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, mannitol, and microcrystalline cellulose.

Guanidine - Clinical Pharmacology

Guanidine apparently acts by enhancing the release of acetylcholine following a nerve impulse. It also appears to slow the rates of depolarization and repolarization of muscle cell membranes.

Indications and Usage for Guanidine

Guanidine is indicated for the reduction of the symptoms of muscle weakness and easy fatigability associated with the myasthenic syndrome of Eaton-Lambert. It is not indicated for treating myasthenia gravis. The Eaton-Lambert syndrome is ordinarily differentiated from myasthenia gravis by the usual association of the syndrome with small cell carcinoma of the lung, but myography may be necessary to make the diagnosis.

Contraindications

Guanidine is contraindicated in individuals with a history of intolerance or allergy to this drug.

Warnings

Fatal bone-marrow suppression, apparently dose related, can occur with Guanidine.

Safe use of Guanidine hydrochloride in pregnancy has not been established. Therefore, the benefits of therapy must be weighed against the potential hazards. Because Guanidine is excreted in milk, patients on this drug should discontinue breast-feeding.

Since there is inadequate experience in children who have received this drug, safety and efficacy in children have not been established.

Precautions

Baseline blood studies should be followed by frequent red and white blood cell and differential counts. The drug should be discontinued upon appearance of bone-marrow suppression. Concurrent therapy with other drugs that may cause bone-marrow suppression should be avoided.

Renal function may be affected in some patients receiving Guanidine. Patients should therefore have regular urine examinations and serum creatinine determinations while taking this drug.

Physicians should be given adequate precautions pertaining to the gastrointestinal side effects and the possibility of induced behavior disorders.

Treatment should not be continued longer than necessary.

Adverse Reactions

Anemia, leukopenia, and thrombocytopenia resulting from bone-marrow suppression attributable to Guanidine have been reported. Other adverse reactions that have been observed are:

General: sore throat, rash, fever.

Neurologic: paresthesia of lips, face, hands, feet; cold sensations in hands and feet; nervousness, lightheadedness, jitteriness, increased irritability; tremor, trembling sensation; ataxia; emotional lability; psychotic state; confusion; mood changes, and hallucinations.

Gastrointestinal: dry mouth; gastric irritation; anorexia; nausea; diarrhea; abdominal cramping. Gastrointestinal side effects may preclude the use of Guanidine as a desired form of therapy.

Dermatologic: rash, flushing or pink complexion; folliculitis; petechiae, purpura, ecchymoses; sweating; skin eruptions; dryness and scaling of the skin.

Renal: elevation of blood creatinine, uremia; chronic interstitial nephritis, acute interstitial nephritis, and renal tubular necrosis.

Hepatic: abnormal liver function tests.

Cardiac: palpitation, tachycardia, atrial fibrillation, hypotension.

Guanidine Dosage and Administration

Initial dosage is usually between 10 and 15 mg/kg (5 to 7 mg/pound) of body weight per day in 3 or 4 divided doses. This dosage may be gradually increased to a total daily dosage of 35 mg/kg (16 mg/pound) of body weight per day or up to the development of side effects. As individual tolerance is highly variable, the dosage must be carefully titrated. Once a tolerable dose has been established, it should be continued. Occasionally removal of the primary neoplastic lesion may result in improvement of symptoms, permitting the discontinuance of Guanidine.

Overdosage

Mild gastrointestinal disorders, such as anorexia, increased peristalsis, or diarrhea are early warnings that tolerance is being exceeded. These symptoms may be relieved by atropine, but nevertheless note should be taken of these symptoms and dosage reductions considered. Slight numbness or tingling of the lips and fingertips shortly after taking a dose of Guanidine has been reported. This per se is not an indication to discontinue treatment and/or reduce dosage.

Severe Guanidine intoxication is characterized by nervous hyperirritability, fibrillary tremors and convulsive contractions of muscle, salivation, vomiting, diarrhea, hypoglycemia, and circulatory disturbances. Administration of intravenous calcium gluconate may control the neuromuscular and convulsive symptoms and provide some relief of other toxic manifestations.

Atropine is more effective than calcium in relieving the G.I. symptoms, circulatory disturbances, and changes in blood sugar.

How is Guanidine Supplied

Guanidine hydrochloride tablets: 125 mg, white, round tablet; impressed with the product identification number "KEY 74" on one side. Guanidine hydrochloride tablets are available in bottles of 100 (NDC 0085-0492-01).

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].

Manufactured by

Schering Canada, Inc.

Pointe Claire, Quebec, Canada for

Key Pharmaceuticals, Inc.

Kenilworth, NJ 07033 USA

27051812

81-483544

Copyright © 1987, 1992,

Key Pharmaceuticals, Inc.,

Kenilworth, NJ 07033

USA. All rights reserved.

Guanidine HYDROCHLORIDE  Guanidine hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0085-0492 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Guanidine hydrochloride (Guanidine) Active 125 MILLIGRAM  In 1 TABLET colloidal silicon dioxide Inactive   magnesium stearate Inactive   mannitol Inactive   microcrystalline cellulose Inactive

Product Characteristics Color WHITE (white) Score no score Shape ROUND (ROUND) Size 10mm Flavor Imprint Code KEY;74 Contains          Coating false Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 0085-0492-01 100 TABLET In 1 BOTTLE None

Revised: 04/2006Key Pharmaceuticals, Inc.

More Guanidine resources

• Guanidine Side Effects (in more detail)
• Guanidine Drug Interactions
• Guanidine Support Group
• 0 Reviews · Be the first to review/rate this drug

• Guanidine Professional Patient Advice (Wolters Kluwer)


• guanidine Concise Consumer Information (Cerner Multum)

Hydromet Syrup

Pronunciation: HIGH-droe-KOE-dohn/hoe-MA-troe-peen
Generic Name: Hydrocodone/Homatropine
Brand Name: Examples include Hycodan and Hydromet

Hydromet Syrup is used for:

Temporary relief of cough. It may also be used for other conditions as determined by your doctor.

Hydromet Syrup is an anticholinergic and narcotic cough suppressant combination. The anticholinergic works by drying up secretions and the narcotic depresses the cough reflex in the brain.

Do NOT use Hydromet Syrup if:

• you are allergic to any ingredient in Hydromet Syrup or any morphine-related medicine (eg, codeine, oxycodone)


• you have diarrhea due to food poisoning or pseudomembranous colitis


• you are taking sodium oxybate (GHB)

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

Before using Hydromet Syrup:

Some medical conditions may interact with Hydromet Syrup. 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 (including any cough-and-cold products or medicines that cause drowsiness), herbal preparation, or dietary supplement


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


• if you have arteriosclerosis (hardening of the arteries) or other heart problems (eg, congestive heart failure)


• if you have high blood pressure, thyroid problems, stomach problems (eg, surgery, severe inflammatory bowel disease, chronic constipation, obstruction), or liver disease


• if you use alcohol or are dependent on drugs


• if you have lung disease (eg, asthma, history of severe breathing problems), a seizure disorder, serious head injury or brain disease, psychiatric problems (eg, suicidal thoughts), glaucoma, or sleep apnea

Some MEDICINES MAY INTERACT with Hydromet Syrup. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Barbiturate anesthetics (eg, thiopental), cimetidine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), narcotic pain medicines (eg, codeine), and sodium oxybate (GHB) because they may increase the risk of Hydromet Syrup's side effects


• Naltrexone because it may decrease Hydromet Syrup's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hydromet Syrup 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 Hydromet Syrup:

Use Hydromet Syrup as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Hydromet Syrup by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Hydromet Syrup and you are taking it regularly, 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 Hydromet Syrup.

Important safety information:

• Hydromet Syrup may cause dizziness, drowsiness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Hydromet Syrup with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• If your symptoms do not get better within 7 days or if you develop a high fever or persistent headache, check with your doctor.


• Hydromet Syrup may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Hydromet Syrup.


• Use Hydromet Syrup with caution in the ELDERLY; they may be more sensitive to its effects.


• Hydromet Syrup should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is not known if Hydromet Syrup can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hydromet Syrup while you are pregnant. It is not known if Hydromet Syrup is found in breast milk. Do not breast-feed while taking Hydromet Syrup.

Some people who use Hydromet Syrup for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Hydromet Syrup suddenly, you may have WITHDRAWAL symptoms. These may include feeling unwell or unhappy, anxious or irritable, dizzy, confused, or agitated. You may also have nausea, unusual skin sensations, mood swings, headache, trouble sleeping, or sweating. If you need to stop Hydromet Syrup, your doctor will lower your dose over time.

Possible side effects of Hydromet Syrup:

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:

Blurred vision; constipation; dizziness; drowsiness; dry mouth, throat, or nose; excitement; nausea; stomach upset; thickening or mucus in nose or throat.

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; flushing; rapid or pounding heartbeat; redness of face; severe drowsiness or dizziness.

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: Hydromet 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 agitation; coma; confusion; deep sleep or loss of consciousness; difficulty breathing; diminished mental alertness; hallucinations; hot or cold skin; large and unchanging pupils; sedation; seizures; shaking; sleeplessness; slow heartbeat; slowed breathing.

Proper storage of Hydromet Syrup:

Store Hydromet Syrup at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hydromet Syrup out of the reach of children and away from pets.

General information:

• If you have any questions about Hydromet Syrup, please talk with your doctor, pharmacist, or other health care provider.


• Hydromet Syrup is 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 Hydromet Syrup. 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 Hydromet resources

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

Compare Hydromet with other medications

• Cough

Geone

Generic Name: acetaminophen, butalbital, and caffeine (a SEET a MIN oh fen, bue TAL bi tal, and KAF een)

Brand Names: Alagesic, Anolor 300, Dolgic LQ, Dolgic Plus, Esgic, Esgic-Plus, Fioricet, Geone, Margesic, Medigesic, Repan, Zebutal

What is Geone (acetaminophen, butalbital, and caffeine)?

Acetaminophen is a pain reliever and fever reducer.

Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache.

Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.

The combination of acetaminophen, butalbital, and caffeine is used to treat tension headaches that are caused by muscle contractions.

Acetaminophen, butalbital, and caffeine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Geone (acetaminophen, butalbital, and caffeine)?

Do not use acetaminophen, butalbital, and caffeine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

What should I discuss with my healthcare provider before taking Geone (acetaminophen, butalbital, and caffeine)?

Do not use acetaminophen, butalbital, and caffeine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. You should not take this medication if you are allergic to acetaminophen, butalbital, or caffeine, or if you have porphyria.

To make sure you can safely take acetaminophen, butalbital, and caffeine, tell your doctor if you have any of these other conditions:

• 
  

  kidney disease,

  
  


• 
  

  liver disease; or

  
  


• 
  

  a history of mental illness or suicidal thoughts.

  
  

Butalbital may be habit forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. FDA pregnancy category C. It is not known whether acetaminophen, butalbital, and caffeine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Acetaminophen, butalbital, and caffeine 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 Geone (acetaminophen, butalbital, and caffeine)?

Take exactly as prescribed. Never take acetaminophen, butalbital, and caffeine in larger amounts, or for longer than recommended by your doctor. An overdose of this medication can damage your liver or cause death.Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain. Take the medicine with food or milk if it upsets your stomach. Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Butalbital is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Since this medication is usually taken 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. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include insomnia, restlessness, tremor, dizziness, drowsiness, diarrhea, increased sweating, shallow breathing, confusion, uneven heartbeats, seizure (convulsions), or coma.

What should I avoid while taking Geone (acetaminophen, butalbital, and caffeine)?

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. It may increase your risk of liver damage while taking acetaminophen. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

While you are taking this medication, avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice.

Geone (acetaminophen, butalbital, and caffeine) 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 using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  feeling light-headed or short of breath;

  
  


• 
  

  nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  
  


• 
  

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

  
  

Less serious side effects may include:

• 
  

  drowsiness;

  
  


• 
  

  dizziness, confusion or lightheadedness;

  
  


• 
  

  dry mouth;

  
  


• 
  

  nausea, vomiting, stomach pain, loss of appetite;

  
  


• 
  

  feeling anxious or jittery;

  
  


• 
  

  drunk feeling; or

  
  


• 
  

  headache.

  
  

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 Geone (acetaminophen, butalbital, and caffeine)?

Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by butalbital.

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

• 
  

  an antibiotic;

  
  


• 
  

  a blood thinner such as warfarin (Coumadin, Jantoven);

  
  


• 
  

  isoniazid (for treating tuberculosis);

  
  


• 
  

  zidovudine (Retrovir, AZT);

  
  


• 
  

  seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);

  
  


• 
  

  gout medications such as probenecid (Benemid) or sulfinpyrazone;

  
  


• 
  

  steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others; or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), and others.

  
  

This list is not complete and other drugs may interact with acetaminophen, butalbital, and caffeine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Geone resources

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

• Geone Advanced Consumer (Micromedex) - Includes Dosage Information


• Capacet Prescribing Information (FDA)


• Dolgic LQ Elixir MedFacts Consumer Leaflet (Wolters Kluwer)


• Dolgic Plus Prescribing Information (FDA)


• Dolgic Plus MedFacts Consumer Leaflet (Wolters Kluwer)


• Esgic Prescribing Information (FDA)


• Esgic-Plus Prescribing Information (FDA)


• Fioricet Consumer Overview


• Fioricet Prescribing Information (FDA)


• Margesic Prescribing Information (FDA)


• Nonbac Advanced Consumer (Micromedex) - Includes Dosage Information


• Orbivan Prescribing Information (FDA)


• Zebutal Prescribing Information (FDA)

Compare Geone with other medications

• Headache

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen, butalbital, and caffeine.

See also: Geone side effects (in more detail)