Covaryx HS

Generic Name: esterified estrogens and methyltestosterone (Oral route)

es-TER-i-fide ES-troe-jenz, meth-il-tes-TOS-ter-one

Oral route(Tablet)

Estrogens increase the risk of endometrial cancer; monitor for abnormal vaginal bleeding. Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) have been reported. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older has also been reported. This product contains an estrogen and androgen, not a progestin. This combination should not be used during a known or suspected pregnancy.

Commonly used brand name(s)

In the U.S.

• Covaryx


• Covaryx HS


• Essian


• Estratest


• Menogen


• Syntest D.S.


• Syntest H.S.

Available Dosage Forms:

• Tablet

Therapeutic Class: Estrogen/Androgen Combination

Pharmacologic Class: Estrogen

Uses For Covaryx HS

Esterified estrogens and methyltestosterone combination is used to treat the symptoms of menopause in patients who did not get relief after being treated with estrogens alone. These symptoms may include a feeling of heat, sweating, and warmth in the face, neck, or chest ("hot flashes"); and dryness, burning, and itching in the vagina.

Esterified estrogens are a man-made mixture of estrogens. Estrogen is a hormone that is produced by the body in greater amounts in females. It is necessary for normal sexual development of the female and for regulation of the menstrual cycle during the childbearing years. Methyltestosterone is a man-made form of testosterone, a hormone that is produced by the body in greater amounts in males and small amounts in females. Menopause symptoms occur when the hormone balance changes in the female body. This combination of hormones will relieve the symptoms of menopause by adding more hormones to the body.

This medicine is available only with your doctor's prescription.

Before Using Covaryx HS

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

The use of esterified estrogens and methyltestosterone combination is not recommended in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of esterified estrogens and methyltestosterone combination in the elderly. However, elderly patients are more likely to develop dementia and age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

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 this medicine, 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 this medicine 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.

• Anisindione


• Bupropion


• Dicumarol


• Phenprocoumon

Using this medicine 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.

• Clarithromycin


• Ginseng


• Itraconazole


• Ketoconazole


• Levothyroxine


• Licorice


• Tipranavir


• Warfarin

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

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

• Abnormal vaginal bleeding, undiagnosed or


• Blood clotting problems (e.g., deep vein thrombosis, pulmonary embolism), history of or


• Breast cancer, or history of or


• Heart attack, recent or history of or


• Liver disease, severe or


• Stroke, recent or history of—Should not be used in patients with these conditions.

• Asthma or


• Cancer (e.g., breast, cervix, liver, vagina) or


• Depression, history of or


• Diabetes or


• Edema (fluid retention) or


• Endometriosis (problem with the lining of the uterus) or


• Epilepsy or


• Eye or vision problems (e.g., retinal vascular thrombosis) or


• Gallbladder disease or


• Hepatitis (including cholestatic jaundice), history of or


• Hypercalcemia (high calcium in the blood) or


• Hypocalcemia (high calcium in the blood) or


• Hypothyroidism (underactive thyroid) or


• Migraine headaches, history of or


• Porphyria (enzyme problem) or


• Systemic lupus erythematosus—Use with caution. May make these conditions worse.

• Heart or blood vessel disease or


• Hypercholesterolemia (high cholesterol in the blood) or


• Hypertension (high blood pressure) or


• Hypertriglyceridemia (high triglycerides or fat in the blood) or


• Venous thromboembolism (clot in the veins), history of—May increase risk for more serious side effects.

Proper Use of esterified estrogens and methyltestosterone

This section provides information on the proper use of a number of products that contain esterified estrogens and methyltestosterone. It may not be specific to Covaryx HS. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine 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 this medicine. 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 treatment of menopause symptoms:
    
    • Adults—One to two tablets once a day.
    
    
    • Children—Use is not recommended.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, 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. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Covaryx HS

It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly and to decide if you should continue to take it. These visits should be every 6 to 12 months or as otherwise directed by your doctor.

It is unlikely that a postmenopausal woman may become pregnant. But, you should know that using this medicine while you are pregnant could harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Very rarely, this medicine can cause serious side effects such as a heart attack or stroke. You are much more likely to have these side effects if you smoke cigarettes or are overweight, or if you have diabetes, high blood pressure, or a high blood cholesterol. Talk with your doctor if you think you might be at risk.

Using large doses of estrogen alone over a long period of time may increase the risk of some kinds of cancer (e.g., endometrial cancer). Talk with your doctor about this risk. If you have vaginal bleeding with this medicine, call your doctor right away.

This medicine may increase the risk of getting breast cancer. It is very important that you check your breasts on a regular basis for any unusual lumps or discharge, and that you have breast x-rays every year as directed by your doctor. These exams are very important if you have a family member with a history of breast cancer. Talk with your doctor about this risk.

This medicine may increase the risk of getting dementia in elderly women (above 65 years of age). Talk with your doctor if this concerns you.

Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Using large doses of methyltestosterone over a long period of time may increase the risk of serious liver problems (e.g., peliosis hepatis or liver cancer). Talk with your doctor about this risk.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine. Also, you may need to stop using this medicine for a few weeks before and after having surgery, or if you are inactive for a long period of time.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Covaryx HS 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

• Absent, missed, or irregular menstrual periods


• acne or oily skin


• decreased breast size


• enlarging clitoris


• hoarseness or deepening of the voice


• menstrual changes


• stopping of menstrual bleeding


• unnatural hair growth or loss

Rare

• Continuing nausea


• cough


• dark-colored urine


• difficulty with swallowing


• dizziness


• fast heartbeat


• fever


• hives


• itching


• light-colored stools


• loss of appetite


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• purple or red-colored spots on the body or inside the mouth or nose


• shortness of breath


• skin rash


• sore throat


• tightness in the chest


• unusual tiredness or weakness


• vomiting


• wheezing

Incidence not known

• Abdominal or stomach bloating, cramps, or pain


• anxiety


• bleeding from gums or nose


• blistering, peeling, or loosening of the skin


• bloating


• bloody or cloudy urine


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• change in vaginal discharge


• changes in skin color, pain, or tenderness


• chest pain or discomfort


• chills


• clay-colored stools


• clear or bloody discharge from nipple


• confusion


• constipation


• convulsions


• darkening of urine


• decrease in amount of urine


• diarrhea


• difficult, burning, or painful urination


• difficulty with breathing


• difficulty with moving


• difficulty with speaking


• dimpling of the breast skin


• dizziness or lightheadedness


• double vision


• eye pain


• fainting


• fever


• fluid-filled skin blisters


• frequent urge to urinate


• headache


• heavy bleeding


• inability to move the arms, legs, or facial muscles


• inability to speak


• indigestion


• inverted nipple


• irregular heartbeats


• itching of the vagina or genital area


• joint or muscle pain


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• light-colored stools


• loss of appetite


• lump in the breast or under the arm


• mood or mental changes


• muscle cramps in the hands, arms, feet, legs, or face


• muscle pain or stiffness


• nausea


• noisy, rattling breathing


• numbness and tingling around the mouth, fingertips, or feet


• pain


• pain during sexual intercourse


• pain in the ankles or knees


• pain or discomfort in the arms, jaw, back, or neck


• pain or feeling of pressure in pelvis


• painful, red lumps under the skin, mostly on the legs


• pains in the stomach, side, or abdomen, possibly radiating to the back


• pelvic pain


• persistent crusting or scaling of the nipple


• pinpoint red or purple spots on the skin


• poor insight and judgment problems with memory or speech


• red, irritated eyes


• redness or swelling of the breast


• ringing in the ears


• sensitivity to the sun


• shortness of breath


• skin thinness


• slow speech


• sore on the skin of the breast that does not heal


• sore throat


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


• stomach pain


• sudden shortness of breath or troubled breathing


• sweating


• swelling


• swelling of the fingers, hands, feet, or lower legs


• tenderness of the breast


• thick, white curd-like vaginal discharge without odor or with mild odor


• tiredness


• tremor


• trouble recognizing objects


• trouble thinking and planning


• trouble walking


• troubled breathing at rest


• unexpected or excess milk flow from breasts


• unpleasant breath odor


• vaginal bleeding


• vision changes


• vomiting of blood


• weakness


• weight gain


• 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:

Incidence not known

• Blemishes on the skin


• brown, blotchy spots on the exposed skin


• decreased interest in sexual intercourse


• depression


• headache, severe and throbbing


• inability to have or keep an erection


• increase or decrease in weight


• increased hair growth, especially on the face


• increased in sexual ability, desire, drive, or performance


• increased interest in sexual intercourse


• irritability


• leg cramps


• loss in sexual ability, desire, drive, or performance


• loss of hair


• mental depression


• pimples


• redness of the skin


• swelling or inflammation of the mouth


• twitching, uncontrolled movements of the tongue, lips, face, arms, or legs

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.

See also: Covaryx HS side effects (in more detail)

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More Covaryx HS resources

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

• Covaryx HS Concise Consumer Information (Cerner Multum)


• Estratest MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Covaryx HS with other medications

• Hot Flashes
• Menopausal Disorders
• Postmenopausal Symptoms

Procanbid

procainamide hydrochloride

Dosage Form: Extended Release Tablets

*Procanbid® is not USP for dissolution.

WARNINGS:

Positive ANA Titer: The prolonged administration of procainamide often leads to the development of a positive antinuclear antibody (ANA) test, with or without symptoms of a lupus erythematosus-like syndrome. If a positive ANA titer develops, the benefits versus risks of continued procainamide therapy should be assessed.

DESCRIPTION

Procanbid® (Procainamide Hydrochloride Extended-Release Tablets), a Group 1A cardiac antiarrhythmic drug, is p-amino-N-[2-(diethylamino) ethyl] benzamide monohydrochloride, molecular weight 271.79. Its structural formula is:

(*Site of acetylation to N-acetylprocainamide)

Procainamide hydrochloride differs from procaine which is the p-aminobenzoyl ester of 2-(diethylamino)-ethanol. Procainamide as the free base has a pKa of 9.24; the monohydrochloride is very soluble in water.

Procanbid® (Procainamide Hydrochloride Extended-Release Tablets) contains 500 mg or 1000 mg of procainamide hydrochloride for oral administration. The release of procainamide hydrochloride is controlled by 2 mechanisms using patented technology. The core of the tablet consists of a wax matrix which is then coated with a polymeric, control-release layer. Both strengths of Procanbid® contain this Polymatrix™ core. Both strengths of Procanbid® contain black iron oxide; candelilla wax, FCC; carnauba wax, NF; colloidal silicon dioxide, NF; hydroxypropyl cellulose, NF; hydroxypropylmethyl cellulose; magnesium stearate, NF; polyacrylate dispersion; polyethylene glycol 3350, NF; polyethylene glycol 8000, NF; propylene glycol; simethicone emulsion, USP; talc, USP; and titanium dioxide. The 1000-mg tablet additionally contains polysorbate 80.

CLINICAL PHARMACOLOGY

Mechanism of Action: Procainamide (PA) increases the effective refractory period of the atria, and to a lesser extent the bundle of His-Purkinje system and ventricles of the heart. It reduces impulse conduction velocity in the atria, His-Purkinje fibers, and ventricular muscle, but has variable effects on the atrioventricular (A-V) node, a direct slowing action and a weaker vagolytic effect that may speed A-V conduction slightly. Myocardial excitability is reduced in the atria, Purkinje fibers, papillary muscles, and ventricles by an increase in the threshold for excitation, combined with inhibition of ectopic pacemaker activity by retardation of the slow phase of diastolic depolarization, thus decreasing automaticity especially in ectopic sites. Contractility of the undamaged heart is usually not affected by therapeutic concentrations, although slight reduction of cardiac output may occur, and may be significant in the presence of myocardial damage. Therapeutic levels of PA may exert vagolytic effects and produce slight acceleration of heart rate, while high or toxic concentrations may prolong A-V conduction time or induce A-V block, or even cause abnormal automaticity and spontaneous firing, by unknown mechanisms.

The electrocardiogram may reflect these effects by showing slight sinus tachycardia (due to the anticholinergic action) and widened QRS complexes and, less regularly, prolonged Q-T and P-R intervals (due to longer systole and slower conduction), as well as some decrease in QRS and T wave amplitude. These direct effects of PA on electrical activity, conduction, responsiveness, excitability, and automaticity are characteristic of a Group 1A antiarrhythmic agent, the prototype for which is quinidine; PA effects are very similar. However, PA has weaker vagal blocking action than does quinidine, does not induce alpha-adrenergic blockade, and is less depressing to cardiac contractility.

Pharmacokinetics and Drug Metabolism

Absorption/Bioavailability: PA is well absorbed following oral administration. The absolute bioavailability from immediate-release PA HCl capsules is approximately 85% in patients and healthy subjects. Bioavailability of Procanbid® is similar to that of PA HCl extended-release tablets, USP which have been shown to be similar to that of immediate-release PA.

The Procanbid® patented delivery system is designed to control the rate of PA release such that absorption is sustained throughout a 12-hour dosing interval. After administration of Procanbid® with a high-fat meal, the extent of PA absorption was increased by about 20%. Peak, trough, and average plasma PA concentrations following twice daily administration of Procanbid® to healthy subjects are similar to those achieved when PA HCl extended-release tablets, USP are administered 4 times daily. In patients with frequent ventricular premature depolarizations (VPDs), peak and steady-state average PA concentrations following administration of Procanbid® every 12 hours are bioequivalent to those following administration of an equivalent daily dose of PA HCl extended-release tablets, USP. While corresponding minimum concentrations are slightly lower than those for PA HCl extended-release tablets, USP, they remain within the acceptable therapeutic range of 3 to 10 mcg/mL.

Figure 1. Mean Steady-State Plasma Concentrations Following Administration of Two 1000–mg Procanbid® Tablets Every 12 Hours or One 1000–mg PA HCl extended-release tablets, USP Tablet Every 6 Hours to Patients with VPDs.

Twice-daily administration of two 1000-mg Procanbid® tablets to patients with frequent VPDs produced a mean plasma PA concentration of 4.6 mcg/mL. Average peak and trough levels are within the generally accepted therapeutic range of 3 to 10 mcg/mL. Relative proportions of PA and N-acetylprocainamide (NAPA) during administration of Procanbid® are similar to those following administration of immediate-release PA or PA HCl extended-release tablets, USP.

Distribution: Plasma protein binding of PA is insignificant, approximately 20%. The apparent volume of distribution is approximately 2 L/kg. It is not known if PA crosses the placenta.

Metabolism/Excretion: The elimination half-life of PA is 3 to 4 hours in patients with normal renal function, but reduced renal function prolongs the half-life (see Special Populations). PA is mainly eliminated intact by the kidneys. The only metabolite of any significance is N-acetylprocainamide (NAPA). Renal excretion accounts for >80% of the elimination of NAPA. Approximately 16 to 21% of PA is metabolized to NAPA in “slow acetylators”; in “rapid acetylators” the range is 24 to 33%. In white and black populations the numbers of rapid and slow acetylators are about 50%. The plasma concentration of NAPA is lower than the PA concentration in most individuals. The reverse may occur in individuals forming more of the metabolite while also having reduced kidney function. NAPA has significant antiarrhythmic activity.

An average of 65% of the dose was recovered as intact drug in the urine after intravenous administration of PA. The renal clearance of PA ranged from 400 to 600 mL/min. Active renal secretion ranged from 300 to 500 mL/min, and is thus the major elimination pathway for PA. The tubular secretion utilizes the base-secreting system also responsible for secretion of metformin, cimetidine, ranitidine, triamterene, and flecainide. Thus there is a potential for drug-drug interactions at this level.

Special Populations: Patients with Renal Disease: Decline in renal function, such as that occurring with advancing age or renal disease, increases the PA elimination half-life which can result in relatively high plasma concentrations of PA (see WARNINGS). Accumulation of NAPA due to impaired renal function can be more extensive than accumulation of PA.

Patients with Congestive Heart Failure: PA clearance is reduced in patients with severe heart failure, in part due to decreased renal perfusion (see WARNINGS).

Age, Gender, and Race: PA clearance decreases with increasing patient age, in part due to concurrent decreases in renal function. However, the pharmacokinetics of PA and NAPA are similar in young healthy subjects (mean age 32 yr) and patients with frequent VPDs (mean age 60 yr) following administration of Procanbid® every 12 hours. Steady state plasma procainamide concentrations in women receiving Procanbid® are 30 percent higher than those seen in men receiving the same dosing regimen. When corrected for body surface area this difference is only 16 percent. Concentrations of N-acetylprocainamide are not significantly different among men and women whether corrected for body surface area or not. Procanbid® tablets produce similar PA and NAPA concentrations in black and caucasian individuals.

Pharmacodynamics: While therapeutic plasma PA concentrations have been reported to be 3 to 10 mcg/mL, patients such as those with sustained ventricular tachycardia may need higherconcentrations for adequate control. This may justify an increased risk of toxicity (see OVERDOSAGE). Where programmed ventricular stimulation has been used to evaluate efficacy of PA in preventing recurring ventricular tachyarrhythmias, an average plasma PA concentration of 13.6 mcg/mL was necessary for adequate control. Action of PA on the central nervous system is not prominent, but high concentrations may cause tremors.

A double-blind, placebo-controlled, dose-response, formulation-crossover study was conducted, comparing the suppression of VPDs by Procanbid® administered every 12 hours and PA HCl extended-release tablets, USP administered every 6 hours. Similar VPD suppression was observed following administration of both formulations for 1 week each. Procanbid® demonstrated significant pharmacologic activity (mean percent change from baseline in VPDs) compared with placebo, and a significant linear dose-response relationship was observed. VPD suppression was maintained throughout the dosing interval.

In this study, VPD rate tended to decrease with increasing concentration of PA and NAPA; however, PA concentration alone was a poor predictor of antiarrhythmic effect. The concentration-effect relationship for administration of Procanbid® every 12 hours was indistinguishable from that for administration of PA HCl extended-release tablets, USP every 6 hours.

INDICATIONS AND USAGE

Procanbid® tablets are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. Because of the proarrhythmic effects of procainamide, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature depolarizations should be avoided.

Initiation of procainamide treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital.

Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.

Because procainamide has the potential to produce serious hematologic disorders (0.5%), particularly leukopenia or agranulocytosis (sometimes fatal), its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment clearly outweigh the risks. (See WARNINGS and Boxed Warning.)

CONTRAINDICATIONS

Complete Heart Block: Procainamide should not be administered to patients with complete heart block because of its effects in suppressing nodal or ventricular pacemakers and the hazard of asystole. It may be difficult to recognize complete heart block in patients with ventricular tachycardia, but if significant slowing of ventricular rate occurs during PA treatment without evidence of A-V conduction appearing, PA should be stopped. In cases of second degree A-V block or various types of hemiblock, PA should be avoided or discontinued because of the possibility of increased severity of block unless the ventricular rate is controlled by an electrical pacemaker.

Idiosyncratic Hypersensitivity: In patients sensitive to procaine or other ester-type local anesthetics, cross sensitivity to PA is unlikely; however, it should be borne in mind, and PA should not be used if it produces acute allergic dermatitis, asthma, or anaphylactic symptoms.

Lupus Erythematosus: An established diagnosis of systemic lupus erythematosus is a contraindication to PA therapy, since aggravation of symptoms is highly likely.

Torsades De Pointes: In the unusual ventricular arrhythmia called “les torsades de pointes” (twisting of the points), characterized by alternation of 1 or more ventricular premature beats in the directions of the QRS complexes on ECG in persons with prolonged Q-T and often enhanced U waves, Group 1A antiarrhythmic drugs are contraindicated. Administration of PA in such cases may aggravate this special type of ventricular extrasystole or tachycardia instead of suppressing it.

WARNINGS

Mortality: In the National Heart, Lung, and Blood Institute's Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multi-centered, randomized, double-blind study in patients with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction more than 6 days but less than 2 years previously, an excessive mortality or non-fatal cardiac arrest rate (7.7%) was seen in patients treated with encainide or flecainide compared with that seen in patients assigned to carefully matched placebo-treated groups (3.0%). The average duration of treatment with encainide or flecainide in this study was 10 months.

The applicability of the CAST results to other populations (e.g., those without recent myocardial infarction) is uncertain. Considering the known proarrhythmic properties of procainamide and the lack of evidence of improved survival for any antiarrhythmic drug in patients without life-threatening arrhythmias, the use of Procanbid®as well as other antiarrhythmic agents should be reserved for patients with life-threatening ventricular arrhythmias.

BLOOD DYSCRASIAS: Agranulocytosis, bone marrow depression, neutropenia, hypoplastic anemia, and thrombocytopenia have been reported in patients receiving procainamide hydrochloride at a rate of approximately 0.5%. Most of these patients received procainamide hydrochloride within the recommended dosage range. Fatalities have occurred (with approximately 20%–25% mortality in reported cases of agranulocytosis). Since most of these events have been noted during the first 12 weeks of therapy, it is recommended that complete blood counts including white cell, differential, and platelet counts be performed at weekly intervals for the first 3 months of therapy, and periodically thereafter. Complete blood counts should be performed promptly if the patient develops any signs of infection (such as fever, chills, sore throat, or stomatitis), bruising, or bleeding. If any of these hematologic disorders are identified, procainamide hydrochloride should be discontinued. Blood counts usually return to normal within 1 month of discontinuation. Caution should be used in patients with pre-existing marrow failure or cytopenia of any type (see ADVERSE REACTIONS).

Digitalis Intoxication: Caution should be exercised in the use of procainamide in arrhythmias associated with digitalis intoxication. Procainamide can suppress digitalis-induced arrhythmias; however, if there is concomitant marked disturbance of atrioventricular conduction, additional depression of conduction and ventricular asystole or fibrillation may result. Therefore, use of procainamide should be considered only if discontinuation of digitalis, and therapy with potassium, lidocaine, or phenytoin are ineffective.

First Degree Heart Block: Caution should be exercised also if the patient exhibits or develops first degree heart block while taking PA, and dosage reduction is advised in such cases. If the block persists despite dosage reduction, continuation of PA administration must be evaluated on the basis of current benefit versus risk of increased heart block.

Predigitalization for Atrial Flutter or Fibrillation: Patients with atrial flutter or fibrillation should be cardioverted or digitalized prior to PA administration to avoid enhancement of A-V conduction which may result in ventricular rate acceleration beyond tolerable limits. Adequate digitalization reduces but does not eliminate the possibility of sudden increase in ventricular rate as the atrial rate is slowed by PA in these arrhythmias.

Congestive Heart Failure: For patients in congestive heart failure, and those with acute ischemic heart disease or cardiomyopathy, caution should be used in PA therapy, since even slight depression of myocardial contractility may further reduce the cardiac output of the damaged heart.

Concurrent Other Antiarrhythmic Agents: Concurrent use of PA with other Group 1A antiarrhythmic agents such as quinidine or disopyramide may produce enhanced prolongation of conduction or depression of contractility and hypotension, especially in patients with cardiac decompensation. Such use should be reserved for patients with serious arrhythmias unresponsive to a single drug and employed only if close observation is possible.

Renal Insufficiency: Renal insufficiency may lead to accumulation of high plasma concentrations of PA and/or NAPA from conventional oral doses of PA, with effects similar to those of overdosage (see OVERDOSAGE), unless dosage is adjusted for the individual patient.

Myasthenia Gravis: Patients with myasthenia gravis may show worsening of symptoms from PA due to its procaine-like effect on diminishing acetylcholine release at skeletal muscle motor nerve endings, so that PA administration may be hazardous without optimal adjustment of anticholinesterase medications and other precautions.

PRECAUTIONS

General: Immediately after initiation of PA therapy, patients should be closely observed for possible hypersensitivity reactions, especially if procaine or local anesthetic sensitivity is suspected, and for muscular weakness if myasthenia gravis is a possibility.

In conversion of atrial fibrillation to normal sinus rhythm by any means, dislodgment of mural thrombi may lead to embolization, which should be kept in mind.

Based upon the approximate half-life of 3 hours for PA, pharmacokinetic steady state would be reached within 1 day. After achieving and maintaining therapeutic plasma concentrations and satisfactory electrocardiographic and clinical responses, continued frequent periodic monitoring of vital signs and electrocardiograms is advised. If evidence of QRS widening of more than 25% or marked prolongation of the Q-T interval occurs, concern for overdosage is appropriate, and reduction in dosage is advisable if a 50% increase occurs. Elevated serum creatinine or urea nitrogen, reduced creatinine clearance, or history of renal insufficiency, as well as use in older patients (over age 50), provide grounds to anticipate that less than the usual dosage may suffice, since the urinary elimination of PA and NAPA may be reduced, leading to gradual accumulation beyond normally predicted amounts. If facilities are available for measurement of plasma PA and NAPA, or acetylation capability, individual dose adjustment for optimal therapeutic concentrations may be easier, but close observation of clinical effectiveness is the most important criterion.

In the longer term, periodic complete blood counts are useful to detect possible idiosyncratic hematologic effects of PA on neutrophil, platelet, or red cell homeostasis; agranulocytosis has been reported to occur occasionally in patients on long-term PA therapy. A rising titer of serum ANA may precede clinical symptoms of the lupoid syndrome (see Boxed Warning and ADVERSE REACTIONS). If the lupus erythematosus-like syndrome develops in a patient with recurrent life-threatening arrhythmias not controlled by other agents, corticosteroid suppressive therapy may be used concomitantly with PA. Since the PA-induced lupoid syndrome rarely includes dangerous pathologic renal changes, PA therapy may not necessarily have to be stopped unless the symptoms of serositis and the possibility of further lupoid effects are of greater risk than the benefit of PA in controlling arrhythmias. Patients with rapid acetylation capability are less likely to develop the lupoid syndrome after prolonged PA therapy.

Information for Patients: The physician is advised to explain to the patient that close cooperation in adhering to the prescribed dosage schedule is of great importance in controlling the cardiac arrhythmia safely. The patient should understand clearly that more medication is not necessarily better and may be dangerous, that skipping doses or increasing intervals between doses to suit personal convenience may lead to loss of control of the heart problem, and that “making up” missed doses by doubling up later may be hazardous.

The patient should be encouraged to disclose any past history of drug sensitivity, especially to procaine or other local anesthetic agents, and to report any history of kidney disease, congestive heart failure, myasthenia gravis, liver disease, or lupus erythematosus.

The patient should be counseled to report promptly any symptoms of arthralgia, myalgia, fever, chills, skin rash, easy bruising, sore throat or sore mouth, infections, dark urine or icterus, wheezing, muscular weakness, chest or abdominal pain, palpitations, nausea, vomiting, anorexia, diarrhea, hallucinations, dizziness, or depression.

The patient should be advised not to break or chew the tablet as this would interfere with designed dissolution characteristics. The tablet matrix of Procanbid® may be seen in the stool since it does not disintegrate following release of procainamide.

Laboratory Tests: Laboratory tests such as complete blood count (CBC), electrocardiogram, and serum creatinine or urea nitrogen may be indicated, depending on the clinical situation, and periodic rechecking of the CBC and ANA may be helpful in early detection of untoward reactions.

Drug Interactions: If other antiarrhythmic drugs are being used, additive effects on the heart may occur with PA administration, and dosage reduction may be necessary (see WARNINGS).

Anticholinergic drugs administered concurrently with PA may produce additive antivagal effects on A-V nodal conduction, although this is not as well documented for PA as for quinidine.

Coadministration of cimetidine decreases renal clearance of PA, potentially leading to clinically significant increases in plasma concentrations. Large (> 300 mg/day) doses of ranitidine possibly have this effect also. Plasma PA concentrations higher than those for administration of PA alone have been reported for coadministration with either amiodarone or trimethoprim. Alcohol (ethanol) consumption tends to decrease the half-life of PA in the blood through induction of its acetylation to NAPA.

Patients taking PA who require neuromuscular blocking agents such as succinylcholine may require less than usual doses of the latter, due to PA effects of reducing acetylcholine release.

Drug/Laboratory Test Interactions:

Suprapharmacologic concentrations of lidocaine and meprobamate may inhibit fluorescence of PA and NAPA, and propranolol shows a native fluorescence close to the PA/NAPA peak wavelengths, so that tests which depend on fluorescence measurement may be affected.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals have not been performed.

Pregnancy Category C: Animal reproduction studies have not been conducted with PA. It also is not known whether PA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. PA should be given to a pregnant woman only if clearly needed.

Nursing Mothers: Both PA and NAPA are excreted in human milk, and absorbed by the nursing infant. Because of the potential for serious adverse reactions in nursing infants, a decision to discontinue nursing or the drug should be made, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: Clinical studies of procainamide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substanitally excreted by the kidney, and the risk of toxic reactions to the drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function by calculating creatinine clearance and to monitor the plasma levels of procainamide and its major metabolite, N-acetyl-procainamide.

Adverse Reactions

Cardiovascular System: Hypotension following oral PA administration is rare. Hypotension and serious disturbances of cardiac rhythm such as ventricular asystole or fibrillation are more common after intravenous administration (see OVERDOSAGE, WARNINGS). Second degree heart block has been reported in 2 of almost 500 patients taking PA orally.

Multisystem Effects: A lupus erythematosus-like syndrome of arthralgia, pleural or abdominal pain, and sometimes arthritis, pleural effusion, pericarditis, fever, chills, myalgia, and possibly related hematologic or skin lesions (see below) is fairly common after prolonged PA administration, perhaps more often in patients who are slow acetylators (see Boxed Warning and PRECAUTIONS). While some studies have reported less than 1 in 500, others have reported the syndrome in up to 30% of patients on long-term oral PA therapy. If discontinuation of PA does not reverse the lupoid symptoms, corticosteroid treatment may be effective.

Hematologic System: Neutropenia, thrombocytopenia, or hemolytic anemia may rarely be encountered. Agranulocytosis has occurred after repeated use of PA, and deaths have been reported (see WARNINGS and Boxed Warning).

Skin: Angioneurotic edema, urticaria, pruritus, flushing, and maculopapular rash have also occurred occasionally.

Gastrointestinal System: Anorexia, nausea, vomiting, abdominal pain, bitter taste, or diarrhea may occur in 3 to 4 percent of patients taking oral procainamide.

Elevated Liver Enzymes: Elevations of transaminase with and without elevations of alkaline phosphatase and bilirubin have been reported in patients taking oral procainamide. Some patients have had clinical symptoms (e.g. malaise, right upper quadrant pain). Deaths from liver failure have been reported.

Nervous System: Dizziness or giddiness, weakness, mental depression, and psychosis with hallucinations have been reported occasionally.

OVERDOSAGE

Progressive widening of the QRS complex, prolonged Q-T and P-R intervals, lowering of the R and T waves, as well as increasing A-V block, may be seen with doses which are excessive for a given patient. Increased ventricular extrasystoles or even ventricular tachycardia or fibrillation may occur. After intravenous administration but seldom after oral therapy, transient high plasma concentrations of PA may induce hypotension, affecting systolic more than diastolic pressures, especially in hypertensive patients. Such high levels may also produce central nervous depression, tremor, and even respiratory depression.

Plasma levels above 10 mcg/mL are increasingly associated with toxic findings, which are seen occasionally in the 10 to 12 mcg/mL range, more often in the 12 to 15 mcg/mL range, and commonly in patients with plasma levels greater than 15 mcg/mL. A single oral dose of PA 2000 mg may produce overdosage symptoms, while 3000 mg of IR PA may be dangerous, especially if the patient is a slow acetylator, has decreased renal function, or underlying organic heart disease.

Treatment of overdosage or toxic manifestations includes general supportive measures, close observation, monitoring of vital signs and possibly intravenous pressor agents, and mechanical cardiorespiratory support. If available, PA and NAPA plasma levels may be helpful in assessing the potential degree of toxicity and response to therapy. Both PA and NAPA are removed from the circulation by hemodialysis but not peritoneal dialysis. No specific antidote for PA is known.

DOSAGE AND ADMINISTRATION

The dose should be adjusted for the individual patient, based on clinical assessment of the degree of underlying myocardial disease, the patient's age, and renal function. For patients who have been receiving another formulation of procainamide, the dose of the other formulation can function as a general guide, but re-titration with Procanbid® is recommended.

As a general guide, for younger patients with normal renal function, an initial total daily oral dose of up to 50 mg/kg of body weight of Procanbid® tablets may be used, given in 2 divided doses, every 12 hours, to maintain therapeutic blood concentrations. For older patients, especially those over 50 years of age, or for patients with renal, hepatic, or cardiac insufficiency, lesser amounts or longer intervals may produce adequate blood concentrations, and decrease the probability of occurrence of dose-related adverse reactions.

CARE SHOULD BE TAKEN WHEN DISPENSING Procanbid® TO ASSURE THE BID DOSAGE FORM HAS BEEN PRESCRIBED AND DISPENSED. Procanbid® tablets should be swallowed whole and should not be bitten or cut.

To provide up to 50 mg/kg of body weight per day*

Patients Weighing	Dose
88–110 lb (40–50 kg)	1000 mg q12 hrs
132–154 lb (60–70 kg)	1500 mg q12 hrs
176–198 lb (80–90 kg)	2000 mg q12 hrs
>220 lb (>100 kg)	2500 mg q12 hrs

*Initial dosage schedule guide only, to be adjusted for each patient individually, based on age, cardiorenal function, blood concentration (if available), and clinical response.

HOW SUPPLIED

Procanbid® tablets are supplied as follows:

500 mg: White, film-coated, elliptical tablets, coded “Procanbid 500” on one side.

NDC 61570-069-01  Bottles of 100

NDC 61570-069-70  Unit dose packages of 100 (10 strips of 10 tablets each).

1000 mg: Gray, film-coated, elliptical tablets, coded “Procanbid 1000” on one side.

NDC 61570-071-01 Bottles of 100

NDC 61570-071-70 Unit dose packages of 100 (10 strips of 10 tablets each).

Dispense in well-closed containers as defined in the USP.

Store at 20°–25°C (68°–77°F) [see USP].

Rx Only.

Prescribing Information as of August 2002.

Distributed by:

Monarch Pharmaceuticals, Inc., Bristol, TN 37620

Manufactured by:

DSM Pharmaceuticals, Inc., Greenville, NC 27834

Procanbid  procainamide hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 61570-069 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Procainamide Hydrochloride (procainamide) Active 500 MILLIGRAM  In 1 TABLET black iron oxide Inactive   candelilla wax Inactive   carnauba wax Inactive   colloidal silicon dioxide Inactive   hydroxypropyl cellulose Inactive   hydroxypropylmethyl cellulose Inactive   magnesium stearate Inactive   polyacrylate dispersion Inactive   polyethylene glycol 3350 Inactive   polyethylene glycol 8000 Inactive   propylene glycol Inactive   simethicone emulsion Inactive   talc Inactive   titanium dioxide Inactive

Product Characteristics Color WHITE (WHITE ) Score no score Shape OVAL (OVAL) Size 2mm Flavor Imprint Code Procanbid;500 Contains          Coating true Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 61570-069-01 100 TABLET In 1 BOTTLE None 2 61570-069-70 100 TABLET In 1 BLISTER PACK None

Procanbid  procainamide hydrochloride  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 61570-071 Route of Administration ORAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Procainamide Hydrochloride (procainamide) Active 1000 MILLIGRAM  In 1 TABLET black iron oxide Inactive   candelilla wax Inactive   carnauba wax Inactive   colloidal silicon dioxide Inactive   hydroxypropyl cellulose Inactive   hydroxypropylmethyl cellulose Inactive   magnesium stearate Inactive   polyacrylate dispersion Inactive   polyethylene glycol 3350 Inactive   polyethylene glycol 8000 Inactive   propylene glycol Inactive   simethicone emulsion Inactive   talc Inactive   titanium dioxide Inactive   polysorbate 80 Inactive

Product Characteristics Color GRAY (GRAY ) Score no score Shape OVAL (OVAL) Size 2mm Flavor Imprint Code Procanbid;1000 Contains          Coating true Symbol false

Packaging # NDC Package Description Multilevel Packaging 1 61570-071-01 100 TABLET In 1 BOTTLE None 2 61570-071-70 100 TABLET In 1 BLISTER PACK None

Revised: 10/2006Monarch Pharmaceuticals, Inc.

More Procanbid resources

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

• Procanbid injection Concise Consumer Information (Cerner Multum)


• Procanbid Controlled-Release MedFacts Consumer Leaflet (Wolters Kluwer)


• Procanbid Monograph (AHFS DI)


• Procainamide MedFacts Consumer Leaflet (Wolters Kluwer)


• procainamide Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


• Pronestyl MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Procanbid with other medications

• Arrhythmia

Sarnol-HC Maximum Strength

Generic Name: hydrocortisone (Topical application route)

hye-droe-KOR-ti-sone

Commonly used brand name(s)

In the U.S.

• Ala-Cort


• Ala-Scalp HP


• Anusol HC


• Aquanil HC


• Beta HC


• Caldecort


• Cetacort


• Corta-Cap


• Cortagel Extra Strength


• Cortaid


• CortAlo With Aloe


• Corticaine


• Corticool Maximum Strength


• Cortizone-10


• Cortizone-5


• Cotacort


• Delacort


• Dermarest


• Dermtex-HC


• Foille Cort


• Gly-Cort


• Hydrozone Plus


• Hytone


• Instacort-10


• Ivy Soothe


• IvyStat


• Keratol HC


• Kericort 10


• Lacticare-HC


• Locoid


• Locoid Lipocream


• Medi-Cortisone Maximum Strength


• Microcort


• Mycin Scalp


• Neutrogena T/Scalp


• NuCort


• Nupercainal HC


• Nutracort


• Pandel


• Pediaderm HC Kit


• Preparation H Hydrocortisone


• Proctocream-HC


• Recort Plus


• Sarnol-HC Maximum Strength


• Scalacort


• Scalpcort


• Summer's Eve Specialcare


• Texacort


• Therasoft Anti-Itch & Dermatitis


• U-Cort


• Westcort

In Canada

• Barriere-Hc


• Cortate


• Cort-Eze


• Cortoderm Mild Ointment


• Cortoderm Regular Ointment


• Emo-Cort


• Emo-Cort Scalp Solution


• Hydrocortisone Cream


• Novo-Hydrocort


• Novo-Hydrocort Cream


• Prevex Hc


• Sarna Hc

Available Dosage Forms:

• Solution


• Cream


• Spray


• Lotion


• Ointment


• Pad


• Liquid


• Gel/Jelly


• Kit


• Foam


• Stick


• Paste

Therapeutic Class: Corticosteroid, Weak

Pharmacologic Class: Adrenal Glucocorticoid

Uses For Sarnol-HC Maximum Strength

Hydrocortisone topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

Before Using Sarnol-HC Maximum Strength

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydrocortisone topical in the pediatric population. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully.

Geriatric

No information is available on the relationship of age to the effects of hydrocortisone topical in geriatric patients.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cushing's syndrome (adrenal gland disorder) or


• Diabetes or


• Hyperglycemia (high blood sugar) or


• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or


• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

Proper Use of hydrocortisone

This section provides information on the proper use of a number of products that contain hydrocortisone. It may not be specific to Sarnol-HC Maximum Strength. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

To use:

• Wash your hands with soap and water before and after using this medicine.


• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.


• With the lotion, shake it well before using.


• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.


• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.


• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

Dosing

The dose of this medicine 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 this medicine. 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 redness, itching, and swelling of the skin:
  
  • For topical dosage form (cream):
    
    • Adults—Apply to the affected area of the skin two or three times per day.
    
    
    • Children—Apply to the affected area of the skin two or three times per day.
    
    
  
  
  • For topical dosage form (lotion):
    
    • Adults—Apply to the affected area of the skin two to four times per day.
    
    
    • Children—Apply to the affected area of the skin two to four times per day.
    
    
  
  
  • For topical dosage form (ointment):
    
    • Adults—Apply to the affected area of the skin three or four times per day.
    
    
    • Children—Apply to the affected area of the skin three or four times per day.
    
    
  
  
  • For topical dosage form (solution):
    
    • Adults—Apply to the affected area of the skin three or four times per day.
    
    
    • Children—Apply to the affected area of the skin three or four times per day.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply 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.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Sarnol-HC Maximum Strength

It is very important that your doctor check your or your child's progress at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Do not use cosmetics or other skin care products on the treated areas.

Sarnol-HC Maximum Strength 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:

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin


• irritation


• itching, scaling, severe redness, soreness, or swelling of the skin


• redness and scaling around the mouth


• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)


• thinning, weakness, or wasting away of the 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:

Incidence not known

• Acne or pimples


• burning and itching of the skin with pinhead-sized red blisters


• burning, itching, and pain in hairy areas, or pus at the root of the hair


• increased hair growth on the forehead, back, arms, and legs


• lightening of normal skin color


• lightening of treated areas of dark skin


• reddish purple lines on the arms, face, legs, trunk, or groin


• softening of the skin

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 Sarnol-HC Maximum Strength resources

• Sarnol-HC Maximum Strength Use in Pregnancy & Breastfeeding
• Sarnol-HC Maximum Strength Drug Interactions
• Sarnol-HC Maximum Strength Support Group
• 15 Reviews for Sarnol-HC Maximum Strength - Add your own review/rating

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• Anal Itching
• Aphthous Stomatitis, Recurrent
• Atopic Dermatitis
• Dermatitis
• Eczema
• Gingivitis
• Hemorrhoids
• Proctitis
• Pruritus
• Psoriasis
• Seborrheic Dermatitis
• Skin Rash
• Ulcerative Colitis, Active

Keralyt

Generic Name: salicylic acid topical (SAL i SIL ik AS id TOP ik al)

Brand Names: Compound W, DermalZone, Dermarest Psoriasis Skin Treatment, Dr Scholl's Callus Removers, Dr Scholl's Clear Away Wart Remover, Dr Scholl's Corn Removers, Duofilm, Freezone Corn Remover, Hydrisalic, Keralyt, Mediplast, Oxy Face Scrub, Propa P.H., Salac, Salex, Scalpicin Scalp Relief, Sebucare, Stri-Dex, Wart-Off Treatment

What is Keralyt (salicylic acid topical)?

Salicylic acid is a keratolytic (peeling agent). Salicylic acid causes shedding of the outer layer of skin.

Salicylic acid topical is used in the treatment of acne, dandruff, corns, and warts.

Salicylic acid topical may also be used for purposes other than those listed here.

What is the most important information I should know about Keralyt (salicylic acid topical)?

Avoid the eyes, mouth, lips, inside the nose, genitals, and anal areas when applying salicylic acid topical. Do not use the wart remover on moles or birthmarks, or warts with hair growing from them, red edges, or unusual color. Also, do not use salicylic acid topical on sunburned, windburned, dry, chapped, irritated, or broken skin; or on open wounds. If medication is applied to any of these areas, wash with water.

What should I discuss with my healthcare provider before using Keralyt (salicylic acid topical)?

Avoid the eyes, mouth, lips, inside the nose, genitals, and anal areas when applying salicylic acid topical. Do not use the wart remover on moles or birthmarks, or warts with hair growing from them, red edges, or unusual color. Also, do not use salicylic acid topical on sunburned, windburned, dry, chapped, irritated, or broken skin; or on open wounds. If medication is applied to any of these areas, wash with water.

Before using salicylic topical, talk to your doctor if you

• have kidney disease;


• have liver disease;


• 
  

  have diabetes;

  
  


• 
  

  have poor circulation; or

  
  


• 
  

  are treating a child.

  
  

You may not be able to use salicylic acid topical, or you may require a dosage adjustment or special monitoring during treatment.

It is not known whether salicylic acid topical will be harmful to an unborn baby. Do not use salicylic acid topical without first talking to your doctor if you are pregnant or could become pregnant during treatment. Salicylic acid topical may pass into breast milk and affect a nursing baby. Do not use salicylic acid topical without first talking to your doctor if you are breast-feeding a baby.

How should I use Keralyt (salicylic acid topical)?

Use salicylic acid topical exactly as directed by your healthcare provider or as directed on the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Gently clean and dry the affected area. For the treatment of warts and calluses, gentle removal of loose skin with a soft brush, wash cloth, or emery board may be recommended before application of the medication.

Shake the lotion gently before application.

Apply a thin film of the medication to the affected area(s) as directed.

Use the soap and shampoo as directed on the package.

Apply the salicylic acid topical adhesive pads as directed on the package.

It is important to use salicylic acid topical regularly to get the most benefit. Do not stop using the medication if you do not see results immediately. Use the medication for the full amount of time directed.

Talk to your doctor if you experience excessive burning, dryness, or irritation of the skin, or changes in the color of the skin.

Store salicylic acid topical at room temperature away from moisture and heat. Some forms of salicylic acid topical may be flammable, keep away from heat and flame.

What happens if I miss a dose?

Use the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and use only the next regularly scheduled dose.

Do not apply a double dose of the medication.

What happens if I overdose?

An overdose of salicylic acid topical is unlikely to occur. If you do suspect an overdose, or if the medication has been ingested, call a poison control center or emergency room for advice.

What should I avoid while using Keralyt (salicylic acid topical)?

Do not use other topical preparations on the treated area unless otherwise directed by your healthcare provider. They may interfere with treatment or increase skin irritation.

Avoid the use of abrasive, harsh, or drying soaps and cleansers such as alcoholic cleansers, tinctures, astringents, abrasives, or other peeling agents while using salicylic acid topical.

Keralyt (salicylic acid topical) side effects

Serious side effects are not likely to occur with the use of salicylic acid topical. If you do experience any of the following rare serious side effects, stop using salicylic acid topical and seek emergency medical attention or contact your doctor:

• 
  

  an allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives); or

  
  


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  severe skin irritation.

  
  

Other, less serious side effects are more likely to occur. Continue to use salicylic acid topical and talk to your doctor if you experience skin burning; stinging; itching; dryness; redness; peeling; or irritation.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Keralyt (salicylic acid topical)?

Do not use other topical preparations on the treated area unless otherwise directed by your healthcare provider. They may interfere with treatment or increase skin irritation.

Avoid the use of abrasive, harsh, or drying soaps and cleansers such as alcoholic cleansers, tinctures, astringents, abrasives, or other peeling agents while using salicylic acid topical.

Drugs other than those listed here may also interact with salicylic acid topical. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

More Keralyt resources

• Keralyt Side Effects (in more detail)
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• Keralyt Support Group
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Where can I get more information?

• Your pharmacist has additional information about salicylic acid topical written for health professionals that you may read.

See also: Keralyt side effects (in more detail)

Acetaminophen/Pseudoephedrine

Pronunciation: a-seet-a-MIN-oh-fen/soo-do-e-FED-rin
Generic Name: Acetaminophen/Pseudoephedrine
Brand Name: Examples include Alka-Seltzer Plus Cold/Sinus and Ornex

Acetaminophen/Pseudoephedrine is used for:

Relieving symptoms such as pain and sinus congestion due to colds, upper respiratory infections, and allergies. It may also used for other conditions as determined by your doctor.

Acetaminophen/Pseudoephedrine is an analgesic and decongestant combination. The analgesic works in the brain to help decrease pain. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages, which decreases stuffiness.

Do NOT use Acetaminophen/Pseudoephedrine if:

• you are allergic to any ingredient in Acetaminophen/Pseudoephedrine


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


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

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

Before using Acetaminophen/Pseudoephedrine:

Some medical conditions may interact with Acetaminophen/Pseudoephedrine. 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 adrenal gland problems (eg, adrenal gland tumor), heart problems, high blood pressure, diabetes, blood vessel problems, stroke, glaucoma, an enlarged prostate or other prostate problems, seizures, an overactive thyroid, severe kidney problems, or liver problems (eg, hepatitis), or if you consume more than 3 alcohol-containing drinks per day

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

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because side effects of Acetaminophen/Pseudoephedrine may be increased


• Anticoagulants (eg, warfarin), digoxin, or droxidopa because risk of bleeding, irregular heartbeat, or heart attack may be increased


• Bromocriptine or hydantoins (eg, phenytoin) because side effects may be increased by Acetaminophen/Pseudoephedrine


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Acetaminophen/Pseudoephedrine

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

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

• Acetaminophen/Pseudoephedrine may be taken with or without food.


• If you miss a dose of Acetaminophen/Pseudoephedrine, 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 Acetaminophen/Pseudoephedrine.

Important safety information:

• Acetaminophen/Pseudoephedrine may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Acetaminophen/Pseudoephedrine. Using Acetaminophen/Pseudoephedrine alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Do not take diet or appetite control medicines while you are taking Acetaminophen/Pseudoephedrine without checking with you doctor.


• Acetaminophen/Pseudoephedrine contains acetaminophen and pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen or pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.


• Do NOT exceed the recommended dose or take Acetaminophen/Pseudoephedrine for longer than prescribed without checking with your doctor.


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


• Acetaminophen/Pseudoephedrine may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Acetaminophen/Pseudoephedrine. Use a sunscreen or protective clothing if you must be outside for a prolonged period.


• Acetaminophen/Pseudoephedrine may cause liver damage. If you consume 3 or more alcohol-containing drinks every day, ask your doctor if you should take Acetaminophen/Pseudoephedrine or other pain relievers/fever reducers. Alcohol use combined with Acetaminophen/Pseudoephedrine may increase your risk for liver damage.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Acetaminophen/Pseudoephedrine.


• Use Acetaminophen/Pseudoephedrine with caution in the ELDERLY because they may be more sensitive to its effects.


• Caution is advised when using Acetaminophen/Pseudoephedrine in CHILDREN because they may be more sensitive to its effects.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Acetaminophen/Pseudoephedrine, discuss with your doctor the benefits and risks of using Acetaminophen/Pseudoephedrine during pregnancy. Acetaminophen/Pseudoephedrine is excreted in breast milk. If you are or will be breast-feeding while you are using Acetaminophen/Pseudoephedrine, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Acetaminophen/Pseudoephedrine:

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:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mood or mental changes; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; stomach pain; tremor; vision changes; yellowing of 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/Pseudoephedrine side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Acetaminophen/Pseudoephedrine:

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

General information:

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


• Acetaminophen/Pseudoephedrine 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/Pseudoephedrine. 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/Pseudoephedrine resources

• Acetaminophen/Pseudoephedrine Side Effects (in more detail)
• Acetaminophen/Pseudoephedrine Dosage
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• Acetaminophen/Pseudoephedrine Support Group
• 2 Reviews for Acetaminophen/Pseudoephedrine - Add your own review/rating

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