Acella Hydrocortisone Acetate - Pramoxine Singles

Generic Name: hydrocortisone acetate and pramoxine

Dosage Form: cream
Acella Hydrocortisone Acetate - Pramoxine Singles

DESCRIPTION: Hydrocortisone Acetate 2.5%-Pramoxine HCl 1% Cream is a topical preparation containing Hydrocortisone Acetate 2.5% w/w and Pramoxine HCl 1% w/w in a hydrophilic base containing Purified Water, Petrolatum, PEG 40 Stearate, Mineral Oil, Ceresin Wax, Cetostearyl Alcohol, Stearic Acid, TEA-Lauryl Sulfate, Isopropyl Palmitate, Carbomer 940, Methyl Paraben, Propyl Paraben, Citric Acid, Sodium Citrate and Triethanolamine. Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The structural formula, the chemical name, molecular formula and molecular weight for active ingredients are presented below.

CLINICAL PHARMACOLOGY: Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pramoxine hydrochloride is a topical anesthetic agent which provides temporary relief from itching and pain. It acts by stabilizing the neuronal membrane of nerve endings with which it comes into contact.

Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE AND ADMINISTRATION.) Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS: Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

PRECAUTIONS: General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area and under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. (See Precautions-Pediatric Use.) If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Information for the patient: Patients using topical corticosteroids should receive the following information and instructions:

1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with eyes.

2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.

3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.

4. Patients should report any signs of local adverse reactions especially under occlusive dressings.

5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

Laboratory Tests: Urinary free cortisol test and ACTH stimulation test may be helpful in evaluating the HPA axis suppression.

Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Pregnancy: Teratogenic Effects: Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts or for prolonged periods of time.

Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities NOT likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroids induced HPA axis suppression and Cushing’s syndrome than mature patients because of larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

ADVERSE REACTIONS: The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria.

OVERDOSAGE: Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS.)

DOSAGE AND ADMINISTRATION: Topical corticosteroids are generally applied to the affected area as a thin film three to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED: Hydrocortisone Acetate 2.5%-Pramoxine HCl 1% Cream Singles are supplied in 30 x 4 gram tubes (NDC 42192-108-04).

Storage Conditions: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].

Rx Only

Manufactured for:

Acella Pharmaceuticals, LLC

9005 Westside Parkway                                                                         L700

Alpharetta, GA 30009                                                                             Rev.0310

NDC 42192 - 108 - 04                     Rx Only                     Net Wt. 4 g

Hydrocortisone Acetate 2.5% -

Pramoxine HCl 1% Cream

CONTAINS: Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% in a hydrophilic base containing Purified Water, Petrolatum, PEG 40 Stearate, Mineral Oil, Ceresin Wax, Cetostearyl Alcohol, Stearic Acid, TEA-Lauryl Sulfate, Isopropyl Palmitate, Carbomer Homopolymer Type C, Methyl Paraben, Propyl Paraben, Citric Acid, Sodium Citrate and Triethanolamine.

USUAL DOSAGE: Apply to affected area 3 - 4 times daily. See enclosed package insert for full prescribing information.

FOR EXTERNAL USE ONLY. NOT FOR OPTHALMIC USE.

Store at controlled room temperature 15 degree - 30 degree C (59 degree - 86 degree F) Keep tightly closed.

TO OPEN: Remove cap and use point to puncture foil seal.

MANUFACTURED FOR: Acella Pharmaceuticals, LLC                            L697

Alpharetta, GA 30009                                                                           Rev. 0610

- Helps relieve itching, burning and inflammation.

- 2.5% Hydrocortisone Acetate: Treats inflammation and itching while maintaining an excellent safety profile.

- 1% Pramoxine HCl: Provides fast, soothing relief from pain and itching.

                                                                                              NDC 42192-108-04

Hydrocortisone Acetate 2.5% -

Pramoxine HCl 1% Cream Singles

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

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

CONTAINS: Hydrocortisone Acetate 2.5% and Pramoxine HCl 1% in a hydrophilic base containing Purified Water, Petrolatum, PEG 40 Stearate, Mineral Oil, Ceresin Wax, Cetostearyl Alcohol, Stearic Acid, TEA-Lauryl Sulfate, Isopropyl Palmitate, Carbomer 940, Methyl Paraben, Propyl Paraben, Citric Acid, Sodium Citrate and Triethanolamine.



USUAL DOSAGE: Apply to affected area 3 - 4 times daily or as directed by a physician. See enclosed package Insert for full prescribing information. Store at 20 degree - 25 degree C (68 degree - 77 degree F) ; excursions permitted to 15 degree - 30 degree C (59 degree - 86 degree F) [see USP Controlled Room Temperature].


                                         Acella Pharmaceuticals, LLC


                                                                                              NDC 42192-108-04

Hydrocortisone Acetate 2.5% -

Pramoxine HCl 1% Cream Singles


DIRECTIONS FOR USE WITH APPLICATOR:

1. Remove the cap and use point to puncture foil seal. Do not peel foil seal away.

2. Attach applicator to the tube.

3. Squeeze the tube to fill applicator and lubricate the tip with cream.

4. Gently insert only the tip of the applicator into the anus and squeeze again to

    force contents of tube into the anal canal.

5. Discard empty tube and applicator.


MANUFACTURED FOR:

Acella Pharmaceuticals, LLC

Alpharetta, GA 30009                                                                           L701

1 - 800 - 541 - 4902                                                                                    Rev. 0310


                                                                                              NDC 42192-108-04

Hydrocortisone Acetate 2.5% -

Pramoxine HCl 1% Cream Singles


                                                 4 gram Single Use Tubes


                                                             Rx Only


                            Contents: 30 Single Use 4 gram Tubes and Applicators



                                               Acella Pharmaceuticals, LLC

Acella Hydrocortisone Acetate - Pramoxine Singles  hydrocortisone acetate, pramoxine  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 42192-108 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 2.5 g  in 100 g PRAMOXINE (PRAMOXINE) PRAMOXINE 1 g  in 100 g

Inactive Ingredients Ingredient Name Strength WATER   PETROLATUM   MINERAL OIL   CETOSTEARYL ALCOHOL   STEARIC ACID   TROLAMINE LAURYL SULFATE   ISOPROPYL PALMITATE   CARBOMER HOMOPOLYMER TYPE C   METHYLPARABEN   CITRIC ACID MONOHYDRATE   SODIUM CITRATE   TROLAMINE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 42192-108-04 30 TUBE In 1 CARTON contains a TUBE, WITH APPLICATOR 1 4 g In 1 TUBE, WITH APPLICATOR This package is contained within the CARTON (42192-108-04)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/08/2010

Labeler - Acella Pharmaceuticals, LLC (825380939)

Revised: 12/2010Acella Pharmaceuticals, LLC

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• Acella Hydrocortisone Acetate - Pramoxine Singles Side Effects (in more detail)
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Accolate

Pronunciation: ZA-fir-LOO-kast
Generic Name: Zafirlukast
Brand Name: Accolate

Accolate is used for:

Prevention and long-term treatment of asthma in patients 5 years old and older. It should not be used to treat acute asthma attacks. It may also be used for other conditions as determined by your doctor.

Accolate is a leukotriene receptor antagonist. It works by blocking the action of certain chemicals that are responsible for some forms of asthma.

Do NOT use Accolate if:

• you are allergic to any ingredient in Accolate


• you have liver problems (eg, cirrhosis)

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

Before using Accolate:

Some medical conditions may interact with Accolate. 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 history of liver problems


• if you have a history of mental or mood problems (eg, depression) or suicidal thoughts or actions


• if you have been taking a steroid (eg, prednisone) and will be stopping it or lowering its dose

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

• Anticoagulants (eg, warfarin) because the risk of bleeding may be increased by Accolate


• Erythromycin because it may decrease Accolate's effectiveness


• Certain anticonvulsants (eg, carbamazepine, phenobarbital, phenytoin), certain calcium channel blockers (eg, amlodipine), cisapride, cyclosporine, theophylline, or tolbutamide because the risk of their side effects may be increased by Accolate

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

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

• An extra patient leaflet is available with Accolate. Talk to you pharmacist if you have questions about this information.


• Take Accolate by mouth on an empty stomach at least 1 hour before or 2 hours after eating.


• Taking Accolate at the same time each day will help you remember to take it.


• Take Accolate on a regular schedule to get the most benefit from it.


• Continue to take Accolate even if you feel well. Do not miss any doses.


• If you miss a dose of Accolate, 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 Accolate.

Important safety information:

• Accolate will not stop an asthma attack once one has started. If you are also using a bronchodilator inhaler, be sure to always carry the bronchodilator inhaler with you to use during asthma attacks.


• If your symptoms do not get better or if they get worse, check with your doctor.


• Do not decrease your dose or stop using Accolate or other asthma medicines without first checking with your doctor.


• Accolate may rarely cause severe and sometimes fatal liver problems. Tell your doctor right away if you experience symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, flu-like symptoms, itching, loss of appetite, persistent nausea or stomach pain, unusual tiredness).


• If your doctor tells you that you have had liver damage because of use of Accolate, do not take Accolate again.


• Some patients taking Accolate have developed mental or mood changes. Contact your doctor immediately if you experience symptoms such as agitation, aggression, hostility, anxiety, depression, strange dreams, trouble sleeping, sleepwalking, tremor, hallucinations, restlessness, irritability, or any unusual change in mood or behavior. Contact your doctor immediately if any signs of suicidal thoughts or actions occur.


• Lab tests, including liver function, may be performed while you use Accolate. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


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


• Accolate should be used with extreme caution in CHILDREN younger than 5 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 Accolate while you are pregnant. Accolate is found in breast milk. Do not breast-feed while taking Accolate.

Possible side effects of Accolate:

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:

Diarrhea; headache; mild stomach pain; nausea.

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

Severe allergic reactions (rash; blisters; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); burning, numbness, or tingling of the skin, hands, or feet; chest pain; fever, chills, or persistent sore throat; joint or muscle aches and pains; mental or mood changes (eg, agitation, aggression, hostility, anxiety, depression, severe or persistent trouble sleeping, strange dreams, sleepwalking, tremor, hallucinations, restlessness, irritability, any unusual change in behavior); new or worsening shortness of breath or other breathing problems; suicidal thoughts or actions; swelling of the hands, ankles, or feet; symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, flu-like symptoms, itching, loss of appetite, persistent nausea or stomach pain, unusual tiredness); unusual bruising or bleeding; unusual sinus pain or swelling.

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: Accolate 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 rash; stomach upset.

Proper storage of Accolate:

Store Accolate 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 Accolate out of the reach of children and away from pets.

General information:

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


• Accolate 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 Accolate. 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.

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Accupril

Generic Name: Quinapril Hydrochloride
Class: Angiotensin-Converting Enzyme Inhibitors
VA Class: CV800
Chemical Name: [3S-[2[R*(R)],3R*]]-2-[2-[[1-Ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2 ,3,4-tetrahydro-3-isoquinolinecarboxylic acid monohydrochloride
Molecular Formula: C₂₅H₃₀N₂O₅•HCl
CAS Number: 82586-55-8

• 
  

  May cause fetal and neonatal morbidity and mortality if used during pregnancy.^{1 47 65 66} (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

  
  


• 
  

  If pregnancy is detected, discontinue quinapril as soon as possible.^{1 47 66}

  
  

Introduction

Nonsulfhydryl ACE inhibitor.^{1 2 3 47}

Uses for Accupril

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).^{1 2 4 11 28 47}

One of several preferred initial therapies in hypertensive patients with heart failure, postmyocardial infarction, high coronary disease risk, diabetes mellitus, chronic renal failure, and/or cerebrovascular disease.⁵⁰

Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.⁵⁰

CHF

Management of symptomatic CHF, usually in conjunction with cardiac glycosides, diuretics, and β-adrenergic blocking agents.¹

Diabetic Nephropathy

A first-line agent in the treatment of diabetic nephropathy† in hypertensive patients with type 2 diabetes mellitus.^{42 54 55 56 57 58 59 60 61}

Accupril Dosage and Administration

General

Hypertension

• 
  

  Quinapril/hydrochlorothiazide fixed combinations should not be used for initial treatment of hypertension.⁴⁷

  
  

Administration

Oral Administration

Administer orally once or twice daily.^{1 47}

Manufacturer makes no specific recommendation regarding administration of quinapril with meals;^{1 47} administer quinapril/hydrochlorothiazide fixed combinations without regard to meals.⁴⁷ (See Food under Pharmacokinetics.)

Dosage

Available as quinapril hydrochloride; dosage expressed in terms of quinapril.^{1 47}

Pediatric Patients

Hypertension†

Oral

Some experts recommend an initial dosage of 5–10 mg once daily.⁶² Increase dosage as necessary to a maximum dosage of 80 mg once daily.⁶²

Adults

Hypertension

Oral

Initially, 10 or 20 mg once daily as monotherapy.^{1 2 3 11 28 50} Adjust dosage at ≥2-week intervals to achieve BP control.¹

In patients currently receiving diuretic therapy, discontinue diuretic, if possible, 2–3 days before initiating quinapril.¹ May cautiously resume diuretic therapy if BP not controlled adequately with quinapril alone.¹ If diuretic cannot be discontinued, increase sodium intake and initiate quinapril at 5 mg daily under close medical supervision for several hours and until BP has stabilized.¹

Usual dosage: 20–80 mg daily, given in 1 dose or 2 divided doses.^{1 28 50}

If effectiveness diminishes toward end of dosing interval in patients treated once daily, consider increasing dosage or administering drug in 2 divided doses.^{1 28}

Quinapril/Hydrochlorothiazide Combination Therapy

Oral

If BP is not adequately controlled by monotherapy with quinapril or hydrochlorothiazide, can switch to the fixed-combination preparation containing quinapril 10 mg and hydrochlorothiazide 12.5 mg or, alternatively, quinapril 20 mg and hydrochlorothiazide 12.5 mg.⁴⁷ Adjust dosage of either or both drugs according to patient’s response.⁴⁷

If BP is controlled by monotherapy with hydrochlorothiazide 25 mg daily but potassium loss is problematic, can switch to fixed-combination preparation containing quinapril 10 mg and hydrochlorothiazide 12.5 mg or, alternatively, quinapril 20 mg and hydrochlorothiazide 12.5 mg.⁴⁷

If BP is controlled with quinapril 20 mg and hydrochlorothiazide 25 mg (administered separately) and if no clinically important electrolyte disturbance is observed, can switch to the fixed-combination preparation containing these corresponding doses for convenience.⁴⁷

CHF

Oral

Initially, 5 mg twice daily.¹ Monitor closely for ≥2 hours until BP has stabilized.¹ To minimize risk of hypotension, reduce diuretic dosage, if possible.¹

Adjust dosage at weekly intervals to reach usual dosage.¹

Usual dosage: 20–40 mg daily, given in 2 equally divided doses.¹

Prescribing Limits

Pediatric Patients

Hypertension†

Oral

Maximum 80 mg daily.⁶²

Special Populations

Renal Impairment

Hypertension

Oral

Initially, 10 mg once daily in adults with Cl_cr >60 mL/minute; 5 mg once daily in those with Cl_cr 30–60 mL/minute; or 2.5 mg once daily in those with Cl_cr 10–30 mL/minute.¹ Titrate at 2-week intervals until BP is controlled.¹ (See Renal Impairment under Cautions.)

Quinapril/hydrochlorothiazide fixed combinations are not recommended in patients with severe renal impairment (Cl_cr ≤30 mL/minute or S_cr >3 mg/dL).⁴⁷

CHF

Oral

Initially (first day), 5 mg in patients with moderate renal impairment (Cl_cr >30 mL/minute) or 2.5 mg in patients with severe renal impairment (Cl_cr 10–30 mL/minute) under close medical supervision.¹ If well tolerated, administer as twice-daily regimen on subsequent days.¹ Titrate at weekly intervals based on clinical and hemodynamic response.¹

Geriatric Patients

Hypertension

Oral

Initially, 10 mg once daily as monotherapy.¹ Adjust dosage at ≥2-week intervals to achieve BP control.¹

Cautions for Accupril

Contraindications

• 
  

  Known hypersensitivity (e.g., history of angioedema) to quinapril or another ACE inhibitor.^{1 47}

  
  

Warnings/Precautions

Warnings

Hepatic Effects

Clinical syndrome that usually is manifested initially by cholestatic jaundice and may progress to fulminant hepatic necrosis (occasionally fatal) reported rarely with ACE inhibitors.^{1 47}

If jaundice or marked elevation of liver enzymes occurs, discontinue drug and monitor patient.^{1 47}

Hypotension

Possible symptomatic hypotension, sometimes associated with oliguria and/or progressive azotemia and, rarely, acute renal failure and/or death.^{1 47} Patients at particular risk include those with intensive diuretic therapy or recent increase in diuretic dose, dialysis, or severe volume and/or salt depletion.^{1 47}

Risk of marked hypotension in patients with CHF.^{1 47} Potential for MI or stroke in patients with ischemic cardiovascular or cerebrovascular disease.^{1 47}

Hypotension may occur in patients undergoing surgery or during anesthesia with agents that produce hypotension; recommended treatment is fluid volume expansion.^{1 47}

To minimize potential for hypotension, consider recent antihypertensive therapy, extent of BP elevation, sodium intake, fluid status, and other clinical conditions.^{1 47} May minimize potential for hypotension by withholding diuretic therapy (except in patients with CHF), reducing diuretic dosage, and/or increasing sodium intake (except in patients with CHF) prior to initiation of quinapril.^{1 47} (See Dosage under Dosage and Administration.)

In patients at risk of excessive hypotension, initiate therapy under close medical supervision; monitor closely for first 2 weeks following initiation of quinapril or any increase in quinapril or diuretic dosage.^{1 47}

If excessive hypotension occurs, immediately place patient in supine position and, if necessary, administer IV infusion of 0.9% sodium chloride solution.^{1 47} Quinapril therapy usually can be continued following restoration of volume and BP.^{1 47} If symptomatic hypotension develops, dosage reduction or discontinuance of quinapril or diuretic may be necessary.^{1 47}

Hematologic Effects

Neutropenia and agranulocytosis reported with captopril; risk appears to depend principally on presence of renal impairment and/or presence of collagen vascular disease.^{1 47} Data insufficient to rule out similar incidence of agranulocytosis with quinapril.^{1 47}

Consider monitoring leukocytes in patients with collagen vascular disease and/or renal disease.^{1 47}

Fetal/Neonatal Morbidity and Mortality

Possible fetal and neonatal morbidity and mortality when used during pregnancy.^{1 47 65 66} (See Boxed Warning.) Such potential risks occur throughout pregnancy, especially during the second and third trimesters.⁶⁶

Also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.^{65 66}

Discontinue as soon as possible when pregnancy is detected, unless continued use is considered lifesaving.⁶⁶ Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.^{1 47}

Sensitivity Reactions

Anaphylactoid reactions and/or head and neck angioedema possible; if associated with laryngeal edema, may be fatal.^{1 47 b} Immediate medical intervention (e.g., epinephrine) for involvement of tongue, glottis, or larynx.^{1 47}

Intestinal angioedema reported; sometimes occurs in patients with no prior history of facial angioedema.^{1 b} Manifestations include abdominal pain (with or without nausea or vomiting).^{1 b} Consider intestinal angioedema in the differential diagnosis of patients receiving ACE inhibitors presenting with abdominal pain.^{1 b}

Anaphylactoid reactions reported in patients receiving ACE inhibitors while undergoing LDL apheresis with dextran sulfate absorption or following initiation of hemodialysis that utilized high-flux membrane.^{1 47}

Life-threatening anaphylactoid reactions reported in at least 2 patients receiving ACE inhibitors while undergoing desensitization treatment with hymenoptera venom.^{1 47}

Contraindicated in patients with a history of angioedema associated with ACE inhibitors.^{1 47}

General Precautions

Renal Effects

Transient increases in BUN and S_cr possible, especially in patients with preexisting renal impairment or those receiving concomitant diuretic therapy.^{1 47} Possible increases in BUN and S_cr in patients with unilateral or bilateral renal artery stenosis; generally reversible following discontinuance of ACE inhibitor and/or diuretic.^{1 47}

Possible oliguria, progressive azotemia, and, rarely, acute renal failure and/or death in patients with severe CHF.^{1 47}

Closely monitor renal function for the first few weeks of therapy in hypertensive patients with unilateral or bilateral renal-artery stenosis.^{1 47} Some patients may require dosage reduction or discontinuance of ACE inhibitor or diuretic.^{1 47}

Hyperkalemia

Possible hyperkalemia, especially in patients with renal impairment or diabetes mellitus and those receiving drugs that can increase serum potassium concentration (e.g., potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes).^{1 47} (See Specific Drugs under Interactions.)

Monitor serum potassium concentration carefully in these patients.^{1 47}

Cough

Persistent and nonproductive cough; resolves after drug discontinuance.^{1 47}

Use of Fixed Combinations

When used in fixed combination with hydrochlorothiazide, consider the cautions, precautions, and contraindications associated with hydrochlorothiazide.⁴⁷

Specific Populations

Pregnancy

Category C (1st trimester); Category D (2nd and 3rd trimesters).^{1 47} (See Fetal/Neonatal Morbidity and Mortality under Cautions and see Boxed Warning.)

Lactation

Distributed into milk.^{1 47} Caution if used in nursing women.^{47 3 4}

Pediatric Use

Safety and efficacy remain to be fully established in children;^{1 47} however, some experts have recommended dosages for hypertension based on current limited clinical experience.⁶²

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.^{1 47} However, cautious dosing recommended due to greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly.^{1 47}

Renal Impairment

Deterioration of renal function may occur. (See Renal Effects under Cautions.)^{1 47}

Initial dosage adjustment recommended in patients with renal impairment.¹ (See Renal Impairment under Dosage and Administration.) Safety and efficacy not established in patients with Cl_cr <10 mL/minute.^{1 47}

Quinapril/hydrochlorothiazide fixed combinations are not recommended in patients with severe renal impairment (Cl_cr ≤30 mL/minute or S_cr >3 mg/dL).⁴⁷

Hepatic Impairment

Use with caution in patients with hepatic impairment or progressive liver disease.⁴⁷

Blacks

BP reduction may be smaller in black patients compared with nonblack patients;^{1 24 25 47 48 49} however, no apparent population difference during combined therapy with ACE inhibitor and thiazide diuretic.^{11 24 26 27 28 47} Use in combination with a diuretic.^{11 42}

Higher incidence of angioedema reported with ACE inhibitors in blacks compared with other races.^{1 47 49 50}

Common Adverse Effects

Patients with hypertension: Headache, dizziness, fatigue, cough, nausea, vomiting, abdominal pain.^{1 47} With fixed combination preparation, myalgia, virus infection, rhinitis, back pain, diarrhea, upper respiratory tract infection, insomnia, somnolence, bronchitis, dyspepsia, asthenia, pharyngitis, vasodilation, vertigo, chest pain.⁴⁷

Patients with CHF: Dizziness, cough, fatigue, nausea, vomiting, chest pain, hypotension, dyspnea, diarrhea, headache, myalgia, rash, back pain, increased serum creatinine concentration, increased BUN.¹

Interactions for Accupril

Drugs That Interact with Magnesium

Possible decreased absorption of drugs that interact with magnesium, possibly due to high magnesium content in quinapril-containing preparations.^{1 47}

Specific Drugs

Drug	Interaction	Comments
Atorvastatin	Pharmacokinetic interaction unlikely1
Cimetidine	Pharmacokinetic interaction unlikely1 47
Digoxin	Pharmacokinetic interaction unlikely1 47
Diuretics	Increased hypotensive effect1 47	If possible, discontinue diuretic before initiating quinapril1 47 (See Dosage under Dosage and Administration)
Diuretics, potassium-sparing (amiloride, spironolactone, triamterene)	Enhanced hyperkalemic effect1 47	Use with caution; monitor serum potassium concentrations frequently1 47
Lithium	Increased serum lithium concentrations; possible toxicity1 47	Monitor serum lithium concentrations frequently1 47
Potassium supplements or potassium-containing salt substitutes	Enhanced hyperkalemic effect1 47	Use with caution; monitor serum potassium concentrations frequently1 47
Propranolol	Pharmacokinetic interaction unlikely1 47
Tetracycline	Decreased tetracycline absorption1 47
Warfarin	Pharmacologic interaction unlikely1 47

Accupril Pharmacokinetics

Absorption

Bioavailability

About 60% of oral dose is absorbed.^{1 47}

Peak plasma concentrations of quinapril and quinaprilat are achieved within 1 and 2 hours, respectively.^{1 47}

Onset

Following a single oral dose, antihypertensive effects are observed within 1 hour, with peak BP reduction at 2–4 hours.^{1 47}

During chronic therapy, maximum antihypertensive effect is achieved after 1–2 weeks.^{1 47}

Duration

Inhibition of >80% of ACE activity persists for about 24 hours.^{1 47} Inhibition of 75% of the pressor response to angiotensin I persists for about 4 hours.^{1 47}

Food

High-fat meals result in moderate (25–30%) reductions in rate and extent of absorption of quinapril.^{1 47} When quinapril/hydrochlorothiazide combination is administered with high-fat meals, rate of quinapril absorption is reduced by 14%, but extent of absorption is unaffected.⁴⁷

Special Populations

Decreased quinaprilat concentrations in patients with alcoholic cirrhosis.^{1 47}

Distribution

Extent

Quinapril and quinaprilat do not cross the blood-brain barrier.^{1 47}

Crosses the placenta in rats.^{1 47} Distributed into human milk.^{1 47}

Plasma Protein Binding

97% for both quinapril and quinaprilat.^{1 47}

Elimination

Metabolism

Metabolized principally to an active metabolite, quinaprilat (approximately 38% of oral dose).^{1 47}

Elimination Route

Eliminated principally in urine (as metabolites).^{1 47}

Not removed by hemodialysis or peritoneal dialysis.^{1 47}

Half-life

Quinaprilat: Elimination: 2 hours; prolonged terminal phase of 25 hours.^{1 47}

Special Populations

In patients with renal impairment, elimination half-life increases with decreasing Cl_cr.^{1 47}

Decreased elimination of quinaprilat in patients ≥65 years of age.^{1 47}

Stability

Storage

Oral

Tablets

Conventional tablets: 15–30°C.¹ Protect from light.¹

Fixed combination tablets: 20–25°C.⁴⁷

ActionsActions

• 
  

  Prodrug; not pharmacologically active until hydrolyzed in the liver to quinaprilat.^{1 2 3 47}

  
  


• 
  

  Suppresses the renin-angiotensin-aldosterone system.^{1 47}

  
  

Advice to Patients

• 
  

  Risk of angioedema, anaphylactoid reactions, or other sensitivity reactions.^{1 47} Importance of reporting sensitivity reactions (e.g., edema of face, eyes, lips, tongue, or extremities; hoarseness; swallowing or breathing with difficulty) immediately to clinician and of discontinuing the drug.^{1 47}

  
  


• 
  

  Importance of reporting signs of infection (e.g., sore throat, fever).^{1 47}

  
  


• 
  

  Risk of hypotension.^{1 47} Importance of informing clinicians promptly if lightheadedness or fainting occurs.^{1 47}

  
  


• 
  

  Importance of adequate fluid intake; risk of volume depletion with excessive perspiration, dehydration, vomiting, or diarrhea.^{1 47}

  
  


• 
  

  Risks of use during pregnancy.^{1 47 65 66} (See Boxed Warning.)

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (including salt substitutes containing potassium).^{1 47}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{1 47}

  
  


• 
  

  Importance of advising patients of other important precautionary information.^{1 47} (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

Quinapril Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	5 mg (of quinapril)*	Accupril (scored)	Pfizer
			Quinapril Hydrochloride Tablets	Ranbaxy
		10 mg (of quinapril)*	Accupril	Pfizer
			Quinapril Hydrochloride Tablets	Ranbaxy
		20 mg (of quinapril)*	Accupril	Pfizer
			Quinapril Hydrochloride Tablets	Ranbaxy
		40 mg (of quinapril)*	Accupril	Pfizer
			Quinapril Hydrochloride Tablets	Ranbaxy

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

Quinapril Hydrochloride Combinations

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	10 mg (of quinapril) with Hydrochlorothiazide 12.5 mg*	Accuretic (with povidone; scored)	Pfizer
			Quinapril Hydrochloride and Hydrochlorothiazide Tablets	Mylan
			Quinaretic	Amide
		20 mg (of quinapril) with Hydrochlorothiazide 12.5 mg*	Accuretic (with povidone)	Pfizer
			Quinapril Hydrochloride and Hydrochlorothiazide Tablets	Mylan
			Quinaretic	Amide
		20 mg (of quinapril) with Hydrochlorithiazide 25 mg*	Accuretic (with povidone)	Pfizer
			Quinapril Hydrochloride and Hydrochlorothiazide Tablets	Mylan
			Quinaretic	Amide

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Accupril 10MG Tablets (PFIZER U.S.): 30/$66.99 or 90/$175.98

Accupril 20MG Tablets (PFIZER U.S.): 30/$66.99 or 90/$176.97

Accupril 40MG Tablets (PFIZER U.S.): 30/$66.99 or 90/$176.97

Accupril 5MG Tablets (PFIZER U.S.): 30/$65.97 or 90/$167.84

Accuretic 10-12.5MG Tablets (PFIZER U.S.): 30/$59.99 or 90/$179.98

Accuretic 20-12.5MG Tablets (PFIZER U.S.): 30/$64.2 or 90/$166.24

Accuretic 20-25MG Tablets (PFIZER U.S.): 30/$60.99 or 90/$182.97

Quinapril HCl 10MG Tablets (GREENSTONE): 30/$19.99 or 90/$50.97

Quinapril HCl 20MG Tablets (LUPIN PHARMACEUTICALS): 30/$26.97 or 90/$59.97

Quinapril HCl 40MG Tablets (LUPIN PHARMACEUTICALS): 30/$21.99 or 90/$50.97

Quinapril HCl 5MG Tablets (GREENSTONE): 30/$21.99 or 90/$50.97

Quinapril-Hydrochlorothiazide 10-12.5MG Tablets (MYLAN): 30/$35.99 or 90/$89.97

Quinapril-Hydrochlorothiazide 20-25MG Tablets (MYLAN): 90/$86.99 or 100/$95.97

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 April 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. Parke Davis. Accupril (quinapril hydrochloride) tablets prescribing information. New York, NY; 2003 Feb.

2. Wadworth AN, Brogden RN. Quinapril: a review of its pharmacological properties, and therapeutic efficacy in cardiovascular disorders. Drugs. 1991; 41:378-99. [PubMed 1711445]

3. Anon. Quinapril for hypertension. Med Lett Drugs Ther. 1992; 34:27-8. [PubMed 1542279]

4. McAreavey D, Robertson JI. Angiotensin converting enzyme inhibitors and moderate hypertension. Drugs. 1990; 40:326-45. [PubMed 2226219]

5. Squibb. Capoten (captopril) tablets prescribing information. In: Physician’s desk reference. 47th ed. Montvale, NJ: Medical Economics Company Inc; 1993:2356-62.

6. Reviewers’ comments in Enalaprilat/Enalapril 24:32.04 (personal observations).

7. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The 1984 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Ann Intern Med. 1984; 144:1045-57.

8. Anon. Drugs for hypertension. Med Lett Drugs Ther. 1984; 26:107-12. [PubMed 6150424]

9. Joint National Committee on Detection, Evaluation, and Treatnent of High Blood Pressure. The 1988 report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1988; 148:1023-38. [IDIS 242588] [PubMed 3365073]

10. US Food and Drug Administration. Dangers of ACE inhibitors during second and third trimesters of pregnancy. FDA Med Bull. 1992; 22:2.

11. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The fifth report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC V). Arch Intern Med. 1993; 153:154-83. [IDIS 309043] [PubMed 8422206]

12. Cetnarowski-Cropp AB. Quinapril: a new second-generation ACE inhibitor. DICP. 1991; 25:499-504. [IDIS 280753] [PubMed 2068835]

13. Packer M, Lee WH, Medina N. Functional renal insufficiency during long-term therapy with captopril and enalapril in severe chronic heart failure. Ann Intern Med. 1987; 106:346-54. [IDIS 226752] [PubMed 3028221]

14. Packer M, Lee WH, Yushak M. Comparison of captopril and enalapril in patients with severe chronic heart failure. N Engl J Med. 1986; 315:847-53. IDIS 221364.

15. Oster JR, Materson BL. Renal and electrolyte complications of congestive heart failure and effects of therapy with angiotensive-converting enzyme inhibitors. Arch Intern Med. 1992; 152:704-10. [IDIS 295733] [PubMed 1558426]

16. Mason N. Angiotensin-converting enzyme inhibitors and renal function. DICP. 1990; 24:496-505. [IDIS 266588] [PubMed 2188438]

17. Gottlieb SS, Robinson S, Weir MR et al. Determinant of the renal response to ACE inhibition in patients with congestive heart failure. Am Heart J. 1992; 124:131-6. [IDIS 298621] [PubMed 1615796]

18. Riegger GA. The effects of ACE inhibitors on exercise capacity in the treatment of congestive heart failure. J Cardiovasc Pharmacol. 1990; 15(Suppl 2):S41-6.

19. Frank GJ. Does the duration of action of angiotensin converting enzyme inhibitors affect their safety and adverse effects? J Hypertension. 1989; 7(Suppl 5):S17-22.

20. Baker DW, Konstam MA, Bottorff M. Management of heart failure JAMA. 1994; 272:1361-6.

21. Young JB. Angiotensin-converting enzyme inhibitors in heart failure: new strategies justified by recent clinical trials. Int J Cardiol. 1994; 43:151-63. [PubMed 8181869]

22. Sharpe N. ACE inhibitors versus diuretics: when to choose which drug: Cardiovasc Drugs Ther. 1993; 7:877-9. Abstract.

23. Magestro P (Parke-Davis, Morris Plains, NJ); personal communication.

24. Saundes E. Tailoring treatment to minority patients. Am J. 1990; 88(Suppl 3B):21-3S.

25. Chrysant SG, Danise K, Kern DC et al. Racial differences in pressure, volume and renin interrelationships in essential hypertension, Hypertension. 1979; 1:136-41.

26. Holland OB, Kuhnert L, Campbell WB et al. Synergistic effect of captopril with hydrochlorothiazide for the treatment of low-renin hypertensive black patients. Hypertension. 1983; 5:235-9. [PubMed 6337951]

27. Ferguson RK, Vlasses PH, Rotmesch HH. Clinical applications of angiotensin-enzyme inhibitors. Am J Med. 1984; 77:690-8.

28. Parke-Davis. Accupril (quinapril hydrochloride) tablets prescribing information. In: Physicians’ desk reference. 51st ed. Montvale, NJ: Medical Economics Company Inc; 1997(Suppl A):A241.

29. Rey E, LeLorier J, Burgess E et al. Report of the Canadian Hypertension Society consensus conference: 3. pharmacologic treatment of hypertensive disorders in pregnancy. CMAJ. 1997; 157:1245-54. [IDIS 396283] [PubMed 9361646]

30. American College of Obstetricians and Gynecologists. ACOG technical bulletin No. 219: hypertension in pregnancy. 1996 Jan.

31. Hanssens M, Keirse MJ, Van Assche FA. Fetal and neonatal effects of treatment with angiotensin-converting enzyme inhibitors in pregnancy. Obstet Gynecol. 1991; 78:128-35. [IDIS 284531] [PubMed 2047053]

32. Brent Rl, Beckman D. Angiotensin-converting enzyme inhibitors, an embryopathic class of drugs with unique properties: information for clinical teratology counselors. Teratology. 1991; 43:543-6. [PubMed 1882342]

33. Piper JM, Ray WA, Rosa FW. Pregnancy outcome following exposure to angiotensin-converting enzyme inhibitors. Obstet Gynecol. 1992; 80:429-32. [IDIS 300973] [PubMed 1495700]

34. Sibai BM. Treatment of hypertension in pregnant women. N Engl J Med. 1996; 335:257-65. [IDIS 369138] [PubMed 8657243]

35. Barr M, Cohen MM. ACE inhibitor fetopathy and hypocalvaria: the kidney-skull connection. Teratology. 1991; 44:485-95. [PubMed 1771591]

36. US Food and Drug Administration. Dangers of ACE inhibitors during pregnancy. FDA Med Bull. 1992; 22:2.

37. Pitt B, Zannad F, Remme WJ et al. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. N Engl J Med. 1999; 341:709-17. [IDIS 431313] [PubMed 10471456]

38. Anon. Consensus recommendations for the management of chronic heart failure. On behalf of the membership of the advisory council to improve outcomes nationwide in heart failure. Part II. Management of heart failure: approaches to the prevention of heart failure. Am J Cardiol. 1999; 83:9A-38A.

39. Weber KT. Aldosterone and spironolactone in heart failure. N Engl J Med. 1999; 341:753-4. [IDIS 431314] [PubMed 10471464]

40. Anon. Spironolactone for heart failure. Med Lett Drugs Ther. 1999; 41:81-2. [PubMed 10505071]

41. Packer M, Poole-Wilson PA, Armstrong PW et al. Comparative effects of low and high doses of the angiotensin-converting enzyme inhibitor, lisinopril, on morbidity and mortality in chronic heart failure. Circulation. 1999; 100:2312-8. [IDIS 440440] [PubMed 10587334]

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

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

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

45. Bakris GL, Williams M, Dworkin L et al. Preserving renal function in adults with hypertension and diabetes: a consensus approach. Am J Kidney Dis. 2000; 36:646-61. [IDIS 452007] [PubMed 10977801]

46. Associated Press (American Diabetes Association). Diabetics urged: drop blood pressure. Chicago, IL; 2000 Aug 29. Press Release from web site.

47. Parke Davis. Accuretic (quinapril hydrochloride/hydrochlorothiazide) tablets prescribing information. New York, NY; 2001 Sep.

48. Appel LJ. The verdict from ALLHAT—thiazide diuretics are the preferred initial therapy for hypertension. JAMA. 2002; 288:3039-60. [IDIS 490723] [PubMed 12479770]

49. The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002; 288:2981-97. [IDIS 490721] [PubMed 12479763]

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

51. American Diabetes Association. Treatment of hypertension in adults with diabetes. Diabetes Care. 2003; 26(Suppl 1):S80-2.

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

53. Novartis. Diovan (valsartan) tablets prescribing information. East Hanover, NJ; 2002 Aug.

54. American Diabetes Association. Treatment of hypertension in adults with diabetes. Diabetes Care. 2002; 25:134-47. [IDIS 479088] [PubMed 11772914]

55. American Diabetes Association. Standards of medical care for patients with diabetes mellitus. Diabetes Care. 2002; 25(Suppl 1):S33-43.

56. American Diabetes Association. Clinical Practice Recommendations 2002. Position Statement. Diabetic nephropathy. Diabetes Care. 2002; 25(Suppl 1):S85-9.

57. Lewis EJ, Hunsicker LG, Bain RP et al. The effect of angiotensin-converting-enzyme inhibition on diabetic nephropathy. N Engl J Med. 1993; 329:1456-62. [IDIS 321612] [PubMed 8413456]

58. Remuzzi G. Slowing the progression of diabetic nephropathy. N Engl J Med. 1993; 329:1496-7. [PubMed 8413463]

59. Kaplan NM. Choice of initial therapy for hypertension. JAMA. 1996; 275:1577-80. [IDIS 365188] [PubMed 8622249]

60. Viberti G, Mogensen CE, Groop LC et al. Effect of captopril on progression to clinical proteinuria in patients with insulin-dependent diabetes mellitus and microalbuminuria. JAMA. 1994; 271:275-9. [IDIS 324307] [PubMed 8295285]

61. Fournier A. The effect of angiotensin-converting-enzyme inhibition on diabetic nephropathy. N Engl J Med. 1994; 330:937. [PubMed 8114873]

62. National High Blood Pressure Education Program Working Group on Hypertension Control in Children and Adolescents. The fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and adolescents. Pediatrics. 2004;114(Suppl

Acetaminophen Elixir

Pronunciation: a-seet-a-MIN-oh-fen
Generic Name: Acetaminophen
Brand Name: Examples include Children's Silapap and Febrol Solution

Acetaminophen Elixir is used for:

Treating minor aches and pains due to headache, muscle aches, backache, arthritis, the common cold, flu, toothache, menstrual cramps, and immunizations, and for temporarily reducing fever.

Acetaminophen Elixir is an analgesic and antipyretic (lowers fever). It works by lowering a chemical in the brain that stimulates pain nerves and the heat-regulating center in the brain.

Do NOT use Acetaminophen Elixir if:

• you are allergic to any ingredient in Acetaminophen Elixir

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

Before using Acetaminophen Elixir:

Some medical conditions may interact with Acetaminophen Elixir. 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 history of alcohol abuse or you drink more than 3 alcohol-containing drinks every day


• if you have liver or kidney problems, hepatitis, or phenylketonuria (PKU)

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

• Anticoagulants (eg, warfarin) because the risk of their side effects, including bleeding, may be increased by Acetaminophen Elixir


• Isoniazid because the risk of liver problems may be increased

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

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

• Take Acetaminophen Elixir by mouth with or without food.


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


• Replace original bottle cap to maintain child resistance.


• If you miss a dose of Acetaminophen Elixir and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Acetaminophen Elixir.

Important safety information:

• Acetaminophen Elixir has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Acetaminophen Elixir may harm your liver. Your risk may be greater if you drink alcohol while you are using Acetaminophen Elixir. Talk to your doctor before you take Acetaminophen Elixir or other fever reducers if you drink more than 3 drinks with alcohol per day.


• Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use for more than 2 days or give to children younger than 3 years old unless directed by a doctor.


• Acetaminophen Elixir may cause the results of some in-home test kits for blood cholesterol to be wrong. Check with your doctor or pharmacist if you are taking Acetaminophen Elixir and need to check your blood cholesterol at home.


• For pain and fever in ADULTS: Stop use of Acetaminophen Elixir and ask your doctor if pain gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days, or new symptoms occur or redness or swelling is present.


• For pain and fever in CHILDREN: Stop use and ask a doctor if fever gets worse or lasts more than 3 days, pain gets worse or lasts more than 5 days, or redness or swelling is present or any new symptoms appear.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Acetaminophen Elixir while you are pregnant. Acetaminophen Elixir is found in breast milk. If you are or will be breast-feeding while you use Acetaminophen Elixir, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Acetaminophen Elixir:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. 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); dark urine or pale stools; unusual fatigue; yellowing of the skin or eyes.

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: Acetaminophen 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 dark urine; excessive sweating; extreme fatigue; nausea and vomiting; stomach pain.

Proper storage of Acetaminophen Elixir:

Store Acetaminophen Elixir 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 Acetaminophen Elixir out of the reach of children and away from pets.

General information:

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


• Acetaminophen Elixir 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 Acetaminophen Elixir. 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 Acetaminophen resources

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

Compare Acetaminophen with other medications

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acamprosate

Generic Name: acamprosate (a KAM proe sate)

Brand names: Campral, Campral EC

What is acamprosate?

Acamprosate affects chemicals in the brain that may become unbalanced in a person who is addicted to alcohol. Acamprosate works by restoring this chemical balance in the brain in an alcohol-dependent person who has recently quit drinking.

Acamprosate is used to help a person who has recently quit drinking alcohol continue to choose not to drink (remain abstinent from alcohol). It is used together with behavior modification and counseling support to help you stop drinking.

Acamprosate is not likely to be helpful to a person who has not already quit drinking or undergone detoxification. It may not be helpful to a person who is also addicted to other substances besides alcohol.

Acamprosate may also be used for other purposes not listed in this medication guide.

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

You should not use this medication if you are allergic to acamprosate, or if you have severe kidney disease.

Acamprosate will not treat or prevent alcohol withdrawal symptoms.

Before you take acamprosate, tell your doctor if you have any type of kidney problem. You may need a dose adjustment or special tests to safely use this medication.

You may have thoughts about suicide while you are taking acamprosate. Tell your doctor if you feel depressed or have any suicidal thoughts or actions during treatment.

Your family or other caregivers should also be alert to changes in your mood or behavior. Make sure your caregivers know how to contact your doctor in case you have mood changes or suicidal thoughts or actions.

Acamprosate 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. Take this medication for the full prescribed length of time, even if you relapse and drink alcohol. While you are taking acamprosate, tell your doctor about any alcoholic drinks you consume, no matter how many.

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

You should not use this medication if you are allergic to acamprosate, or if you have severe kidney disease.

Acamprosate will not treat or prevent alcohol withdrawal symptoms.

Before you take acamprosate, tell your doctor if you have any type of kidney problem. You may need a dose adjustment or special tests to safely use this medication.

FDA pregnancy category C. It is not known whether acamprosate is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether acamprosate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. You may have thoughts about suicide while you are taking acamprosate. Tell your doctor if you feel depressed or have any suicidal thoughts or actions during treatment.

Your family or other caregivers should also be alert to changes in your mood or behavior. Make sure your caregivers know how to contact your doctor in case you have mood changes or suicidal thoughts or actions.

How should I take acamprosate?

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

Acamprosate treatment should be started as soon as possible after you have quit drinking.

Take this medicine with water.

Acamprosate is usually taken 3 times daily, and may be taken with or without food. If you regularly eat 3 meals per day, it may help you remember to take your acamprosate if you take a dose with each meal. Follow your doctor's instructions.

Acamprosate is only part of a complete program of treatment that also includes counseling support and continued abstinence from alcohol.

Take this medication for the full prescribed length of time, even if you relapse and drink alcohol. While you are taking acamprosate, tell your doctor about any alcoholic drinks you consume, no matter how many.

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

Store acamprosate at room temperature away from moisture and heat.

See also: Acamprosate dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, 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 if you think you have used too much of this medicine.

Overdose can cause diarrhea but is not expected to produce serious side effects.

What should I avoid while taking acamprosate?

Acamprosate 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.

Acamprosate 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 a serious side effects such as:

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  mood or behavior changes;

  
  


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  thoughts about hurting yourself;

  
  


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  severe anxiety or depression;

  
  


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  feeling like you might pass out;

  
  


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  fast or pounding heartbeats;

  
  


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  swelling, weight gain, feeling short of breath;

  
  


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  confusion, increased thirst; or

  
  


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  urinating less than usual or not at all.

  
  

Less serious side effects may include:

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  nausea, vomiting, stomach pain, loss of appetite;

  
  


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  constipation, diarrhea;

  
  


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  headache, dizziness, drowsiness;

  
  


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  vision problems;

  
  


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  problems with memory or thinking;

  
  


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  weakness, cold or flu-like symptoms;

  
  


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  back pain, joint or muscle pain;

  
  


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  dry mouth, decreased or distorted sense of taste;

  
  


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  sleep problems (insomnia);

  
  


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  impotence, loss of interest in sex;

  
  


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  sweating, mild skin rash; or

  
  


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  numbness or tingly feeling.

  
  

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.

Acamprosate Dosing Information

Usual Adult Dose for Alcohol Dependence:

666 mg orally three times a day

Usual Geriatric Dose for Alcohol Dependence:

666 mg orally three times a day

Since geriatric patients may be more prone to a decrease in renal function, the manufacturer advises greater care in dose selection and close monitoring of renal function during therapy in this population.

Usual Pediatric Dose for Alcohol Dependence:

There are no data on the safety and efficacy of acamprosate in this population.

What other drugs will affect acamprosate?

There may be other drugs that can interact with acamprosate. 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 acamprosate resources

• Acamprosate Side Effects (in more detail)
• Acamprosate Dosage
• Acamprosate Use in Pregnancy & Breastfeeding
• Acamprosate Support Group
• 52 Reviews for Acamprosate - Add your own review/rating

• acamprosate Advanced Consumer (Micromedex) - Includes Dosage Information


• Acamprosate MedFacts Consumer Leaflet (Wolters Kluwer)


• Acamprosate Calcium Monograph (AHFS DI)


• Campral Prescribing Information (FDA)


• Campral Consumer Overview

Compare acamprosate with other medications

• Alcohol Dependence

Where can I get more information?

• Your pharmacist can provide more information about acamprosate.

See also: acamprosate side effects (in more detail)