Amoclan

Generic Name: amoxicillin and clavulanate (Oral route)

a-mox-i-SIL-in, KLAV-ue-la-nate poe-TAS-ee-um

Commonly used brand name(s)

In the U.S.

• Amoclan


• Augmentin


• Augmentin ES-600


• Augmentin XR

In Canada

• Alti-Amoxi Clav


• Apo-Amoxi Clav


• Novo-Clavamoxin 125


• Novo-Clavamoxin 250


• Ratio-Amoxi Clav 250f

Available Dosage Forms:

• Tablet


• Tablet, Extended Release


• Powder for Suspension


• Tablet, Chewable

Therapeutic Class: Antibiotic

Pharmacologic Class: Penicillin, Aminopenicillin

Uses For Amoclan

Amoxicillin and clavulanate combination is used to treat bacterial infections in many different parts of the body.

Amoxicillin and clavulanate combination is an antibiotic that belongs to the group of medicines known as penicillins and beta-lactamase inhibitors. It works by killing the bacteria and preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

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

Before Using Amoclan

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 amoxicillin and clavulanate chewable tablets and oral suspension in children.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of amoxicillin and clavulanate tablets in children weighing 40 kilograms (kg) or more. However, safety and efficacy have not been established in children weighing less than 40 kg.

Appropriate studies have not been performed on the relationship of age to the effects of amoxicillin and clavulanate extended-release tablets in teenagers and children younger than 16 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amoxicillin and clavulanate combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving amoxicillin and clavulanate combination.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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.

• Methotrexate


• Venlafaxine

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.

• Acenocoumarol


• Desogestrel


• Dienogest


• Drospirenone


• Estradiol Cypionate


• Estradiol Valerate


• Ethinyl Estradiol


• Ethynodiol Diacetate


• Etonogestrel


• Khat


• Levonorgestrel


• Medroxyprogesterone Acetate


• Mestranol


• Norelgestromin


• Norethindrone


• Norgestimate


• Norgestrel


• Probenecid


• 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. 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:

• Diarrhea or


• Liver disease—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Kidney disease, severe—The extended-release tablets should not be used in patients with this condition.

• Liver disease, history of with amoxicillin and clavulanate combination or


• Mononucleosis ("mono")—Should not be used in patients with these conditions.

• Phenylketonuria (PKU)—The chewable tablet and oral suspension contain phenylalanine, which can make this condition worse.

Proper Use of amoxicillin and clavulanate

This section provides information on the proper use of a number of products that contain amoxicillin and clavulanate. It may not be specific to Amoclan. Please read with care.

Take this medicine exactly 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.

You may take this medicine with or without meals. However, it is best to take this medicine at the start of a meal or snack to avoid an upset stomach.

Swallow the extended-release tablet whole. Do not crush, break, or chew it.

If you are using the chewable tablets, chew the tablet completely before swallowing.

There are certain flavors that can be mixed with the oral suspension to make it taste better. If you or your child do not like the taste of this medicine, ask your pharmacist about these flavorings.

Keep the oral suspension refrigerated. Shake it well before measuring the dose. Use a dosing spoon or medicine dropper to measure the dose. The average household teaspoon may not hold the right amount of liquid. Rinse the dosing spoon or dropper with water after each use.

Do not change brands or dosage forms of amoxicillin and clavulanate combination without first checking with your doctor. Different products may not work the same way. If you refill your medicine and it looks different, ask your pharmacist about the change.

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 bacterial infections:
  
  • For oral dosage form (chewable tablets, suspension):
    
    • Adults, teenagers, and children weighing 40 kilograms (kg) or more—250 to 500 milligrams (mg) every eight hours or 500 to 875 mg every twelve hours.
    
    
    • Children and infants above 3 months of age and weighing less than 40 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The usual dose is 20 to 40 milligrams (mg) per kilogram (kg) of body weight per day (mg/kg/day), divided and given every 8 hours, or 25 to 90 mg/kg/day, divided and given every 12 hours.
    
    
    • Infants younger than 3 months of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 30 milligrams (mg) per kilogram (kg) of body weight per day, divided and given every 12 hours.
    
    
  
  
  • For oral dosage form (extended-release tablets):
    
    • Adults—2000 milligrams (mg) every 12 hours.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For oral dosage form (tablets):
    
    • Adults, teenagers, and children weighing 40 kilograms (kg) or more—250 to 500 milligrams (mg) every eight hours or 500 to 875 mg every twelve hours.
    
    
    • Children weighing less than 40 kilograms (kg)—Use and dose must be determined by your doctor.
    
    
  
  

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

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.

Store the chewable tablets, regular tablets, and extended-release tablets at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the oral suspension in the refrigerator. Throw away any unused portion after 10 days. Keep from freezing.

Precautions While Using Amoclan

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

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have itching; hives; hoarseness; shortness of breath; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth after you receive this medicine.

Amoxicillin and clavulanate combination may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

In some young patients, tooth discoloration may occur while using this medicine. The teeth may appear to have brown, yellow, or gray stains. To help prevent this, brush and floss your teeth regularly or have a dentist clean your teeth.

Amoxicillin and clavulanate combination may decrease the effects of some oral contraceptives (birth control pills). To avoid an unwanted pregnancy, it is a good idea to use additional contraceptive measures with your pills (e.g., condoms, a diaphragm, or a contraceptive foam or jelly) while using this medicine.

Before you or your child have any medical tests, tell the doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

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.

Amoclan 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:

Less common

• Hives or welts


• itching


• itching of the vagina or genital area


• pain during sexual intercourse


• redness of the skin


• skin rash


• thick, white vaginal discharge with no odor or with a mild odor

Rare

• Bloody or cloudy urine


• fever


• greatly decreased frequency of urination or amount of urine


• seizures


• swelling of the feet or lower legs

Incidence not known

• Abdominal or stomach cramps or tenderness


• back, leg, or stomach pains


• black, hairy tongue


• black, tarry stools


• bleeding gums


• blistering, peeling, or loosening of the skin


• bloating


• blood in the stools


• bloody nose


• chest pain


• chills


• clay-colored stools


• cough or hoarseness


• cracks in the skin


• dark urine


• diarrhea


• diarrhea, watery and severe, which may also be bloody


• difficulty with breathing


• difficulty with moving


• difficulty with swallowing


• dizziness


• fast heartbeat


• fever with or without chills


• general body swelling


• general feeling of tiredness or weakness


• headache


• heavier menstrual periods


• increased thirst


• 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


• loss of heat from the body


• lower back or side pain


• muscle stiffness


• nausea or vomiting


• pain


• pain, swelling, or redness in the joints


• painful or difficult urination


• pale skin


• pinpoint red spots on the skin


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


• rash


• red skin lesions, often with a purple center


• red, irritated eyes


• red, swollen skin


• scaly skin


• shortness of breath


• sore throat


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


• swollen glands


• tightness in the chest


• troubled breathing with exertion


• unpleasant breath odor


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight loss


• upper right abdominal pain


• vomiting of blood


• wheezing


• white patches in the mouth or throat or on the tongue


• white patches with diaper rash


• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Abdominal or stomach pain


• bloody or cloudy urine


• diarrhea


• fever


• greatly decreased frequency of urination or amount of urine


• pain or burning while urinating


• skin rash


• sleepiness


• swelling of the feet or lower legs


• vomiting

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:

Rare

• Anxiety


• dry mouth


• hyperventilation


• irregular heartbeats


• irritability


• nervousness


• restlessness


• shaking


• sleeplessness


• tooth discoloration


• trouble sitting still


• trouble with sleeping


• unable to sleep

Incidence not known

• Burning feeling in the chest or stomach


• indigestion


• redness, swelling, or soreness of the tongue


• stomach upset


• swelling or inflammation of the mouth

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: Amoclan side effects (in more detail)

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 Amoclan resources

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

Compare Amoclan with other medications

• Aspiration Pneumonia
• Bacterial Infection
• Bronchitis
• Febrile Neutropenia
• Kidney Infections
• Melioidosis
• Otitis Media
• Pneumonia
• Sinusitis
• Skin and Structure Infection
• Skin Infection
• Small Bowel Bacterial Overgrowth
• Strep Throat
• Upper Respiratory Tract Infection
• Urinary Tract Infection

acetic acid otic

Generic Name: acetic acid (otic) (a SEET ik AS id)

Brand names: Acetasol, Vosol, Vasotate

What is acetic acid?

Acetic acid otic (for the ear) is an antibiotic that treats infections caused by bacteria or fungus.

Acetic acid is used to treat infections in the ear canal. This medication will not treat an inner ear infection (also called otitis media).

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

What is the most important information I should know about acetic acid?

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

If you miss a dose, use it as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

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.

Less serious side effects are more likely, and you may have none at all. You may feel a slight burning or stinging when you first apply acetic acid ear drops. Talk to your doctor about any unusual or bothersome side effects.

What should I discuss with my health care provider before using acetic acid?

Do not use this medication if you are allergic to acetic acid, or if you have a hole in your ear drum (ruptured ear drum).

Before using acetic acid, tell your doctor if you are allergic to any drugs, or if you have severe ear pain, fever, or hearing problems. You may not be able to use acetic acid.

This medication is not expected to be harmful to an unborn baby. Before using any medication, tell your doctor if you are pregnant or breast-feeding a baby. Do not use acetic acid ear drops in a child younger than 3 years old.

How should I use acetic acid?

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

For best results, remove any ear wax or other debris before using acetic acid ear drops. Ask your doctor about safe methods of ear wax removal.

Acetic acid ear drops can be applied directly into the ear, or using a cotton wick. You can make a cotton wick by using a small piece of a cotton ball.

It is best to use the ear drops with a cotton wick because it will keep the medication in constant contact with the skin inside your ear.

You may soak the wick with the ear drops and then insert it into your ear. You may also insert the wick into the ear first and then drop in enough acetic acid to make the wick moist inside the ear canal.

Keep the cotton wick in place for at least 24 hours, and keep it moist by applying 3 to 5 drops of acetic acid placed into the affected ear every 4 to 6 hours.

After removing the wick, you may then use the ear drops directly in your ear without a wick. The usual dose is 5 drops of acetic acid used 3 or 4 times daily. Follow your doctor's instructions about how long to keep using the ear drops.

Do not place the dropper tip into your ear, or allow the tip to touch any surface. It may become contaminated.

Wipe the dropper tip with a clean tissue. Do not wash the tip with water or soap.

Store acetic acid ear drops at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

An overdose of acetic acid placed into the ear is not likely to cause life-threatening symptoms.

What should I avoid while using acetic acid?

Avoid using other ear drops to treat your condition unless your doctor has told you otherwise.

Acetic acid 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.

You may feel a slight stinging or burning when you first use acetic acid ear drops.

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

What other drugs will affect acetic acid?

There may be other drugs that can affect acetic acid. 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 acetic acid resources

• Acetic acid Use in Pregnancy & Breastfeeding
• Acetic acid Support Group
• 0 Reviews for Acetic acid - Add your own review/rating

• Vosol Prescribing Information (FDA)

Compare acetic acid with other medications

• Otitis Externa

Where can I get more information?

• Your pharmacist can provide more information about acetic acid.

Alodox

doxycyline hyclate

Dosage Form: tablet
Alodox Convenience Kit

DESCRIPTION:

The structural formula of doxycycline hyclate is:

with a molecular formula of (C22H24N2O8.HCI)2.C2H6O.H2O and a molecular weight of 1025.89. The chemical designation for doxycycline is 4-(dimethylamino)-1, 4, 4a, 5, 5a, 6, 11, 12a-octahydro-3, 5, 10, 12, 12a-pentahydroxy-6 -methyl-1, 11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate.

Doxycycline hyclate is a yellow to light-yellow crystalline powder which is soluble in water.

Each tablet for oral administration contains 23mg doxycycline hyclate equivalent to 20 mg of doxycycline. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, croscarmellose sodium, hypromellose, magnesum stearate, microcrystalline cellulose, poldextrose, polyethylene glycol, titanium dioxide, and triacetin.

CLINICAL PHARMACOLOGY:

After oral administration, doxycycline hyclate is rapidly and nearly completely absorbed from the gastrointestinal tract. Doxycycline is eliminated with a half-life of approximately 18 hours by renal and fecal excretion of unchanged drug.

Mechanism of Action:

Doxycycline has been shown to inhibit collagenase activity in vitro. 1 Additional studies have shown that doxycycline reduces the elevated collagenase activity in the gingival crevicular fluid of patients with adult periodontitis.23 The clinical significance of these findings is not known.

Microbiology:

Doxycycline is a member of the tetracycline class of antibiotics. The dosage of doxycycline achieved with this product during administration is well below the concentration required to inhibit microorganisms commonly associated with adult periodontitis. Clinical studies with this product demonstrated no effect on total anaerobic and facultative bacteria in plaque samples from patients administered this dose regimen for 9 to 18 months. This product should not be used for reducing the numbers of or eliminating those microorganisms associated with periodontitis.

Pharmacokinetics:

The pharmacokinetics of doxycline following oral administration of doxycycline hyclate were investigated in 4 volunteer studies involving 107 adults. Additionally, doxycycline pharmacokinetics have been characterized in numerous scientific publications4.

INDICATIONS AND USAGE:

To reduce the development of drug-resistant bacteria and maintain the effectiveness

of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate

Tablets should be used only to treat or prevent infections that are proven or strongly

suspected to be caused by susceptible bacteria. When culture and susceptibility

information are available, they should be considered in selecting or modifying

antibacterial therapy. In the absence of such data, local epidemiology and

susceptibility patterns may contribute to the empiric selection of therapy.

Doxycycline hyclate is indicated for use as an adjunct to scaling and root planing to

promote attachment level gain and to reduce pocket depth in patients with adult

periodontitis.

CONTRAINDICATIONS:

This drug is contraindicated in persons who have shown hypersensitivity to

doxycycline or any of the other tetracyclines.

WARNINGS:

THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH

DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY AND CHILDHOOD TO

THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE

TEETH (YELLOW-GRAY-BROWN). This adverse reaction is more common during

long-term use of the drugs but has been observed following repeated short term

courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS,

THEREFORE, SHOULD NOT BE USED IN THIS AGE GROUP AND IN

PREGNANT OR NURSING MOTHERS UNLESS THE POTENTIAL BENEFITS

MAY BE ACCEPTABLE DESPITE THE POTENTIAL RISKS


All tetracyclines form a stable calcium complex in any bone forming tissue. A

decrease in fibula growth rate has been observed in premature infants given oral

tetracyclines in doses of 25 mg/kg every 6 hours. This reaction was shown to be

reversible when the drug was discontinued.


Doxycycline can cause fetal harm when administered to a pregnant woman. Results

of animal studies indicate that tetracyclines cross the placenta, are found in fetal

tissues, and can have toxic effects on the developing fetus (often related to

retardation of skeletal development). Evidence of embryotoxicity has also been

noted in animals treated early in pregnancy. If any tetracyclines are used during

pregnancy, or if the patient becomes pregnant while taking this drug, the patient

should be apprised of the potential hazard to the fetus.


The catabolic action of the tetracyclines may cause an increase in BUN. Previous

studies have not observed an increase in BUN with the use of doxycycline in

patients with impaired renal function.


Photosensitivity manifested by an exaggerated sunburn reaction has been observed

in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight

or ultraviolet light should be advised that this reaction can occur with tetracycline

drugs, and treatment should be discontinued at the first evidence of skin erythema.

PRECAUTIONS:

General: Prescribing Doxycycline Hyclate Tablets in the absence of a proven or

strongly suspected bacterial infection or a prophylactic indication is unlikely to

provide benefit to the patient and increases the risk of the development of drugresistant

bacteria.


While no overgrowth by opportunistic microorganisms such as yeast were noted

during clinical studies, as with other antimicrobials, doxycycline hyclate therapy

may result in overgrowth of nonsusceptible

microorganisms including fungi.


The use of tetracyclines may increase the incidence of vaginal candidiasis.


Doxycycline hyclate should be used with caution in patients with a history or

predisposition to oral candidiasis. The safety and effectiveness of doxycycline

hyclate has not been established for the treatment of periodontitis in patients with

coexistant oral candidiasis.


If superinfection is suspected, appropriate measures should be taken.

Information for Patients:

Patients should be counseled that antibacterial drugs

including Doxycycline Hyclate Tablets should only be used to treat bacterial

infections. They do not treat viral infections (e.g., the common cold). When

Doxycycline Hyclate Tablets are prescribed to treat a bacterial infection, patients

should be told that although it is common to feel better early in the course of therapy,

the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Doxycycline Hyclate Tablets or other antibacterial drugs in the future.

Laboratory Tests:

In long term therapy, periodic laboratory evaluations of organ

systems, including hematopoietic, renal, and hepatic studies should be performed.

Drug Interactions:

Because tetracyclines have been shown to depress plasma

prothrombin activity, patients who are on anticoagulant therapy may require

downward adjustment of their anticoagulant dosage.


Since bacterial antibiotics, such as the tetracycline class of antibiotics, may interfere

with the bactericidal action of members of the ‚-lactam (e.g., penicillin) class of

antibiotics, it is not advisable to administer these antibiotics concomitantly.


Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or

magnesium, and iron-containing preparations, and by bismuth subsalicylate.


Barbiturates, carbamazepine, and phenytoin decrease the half-life of doxycycline.


The concurrent use of tetracycline and methoxyflurane has been reported to result

in fatal renal toxicity.


Concurrent use of tetracyclines may render oral contraceptives less effective.

Drug/Laboratory Test Interactions:

False elevations of urinary catecholamine

levels may occur due to interference with the fluorescence test.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Doxycycline hyclate was assessed for potential to induce carcinogenesis in a study in which the compound

was administered to Sprague-Dawley rats by gavage at dosages of 20, 75, and 200

mg/kg/day for two years. An increased incidence of uterine polyps was observed in

female rats that received 200 mg/kg/day, a dosage that resulted in a systemic

exposure to doxycycline approximately nine times that observed in female humans

that used doxycycline hyclate (exposure comparison based upon AUC values). No

impact upon tumor incidence was observed in male rats at 200 mg/kg/day, or in

either gender at the other dosages studied. Evidence of oncogenic activity was

obtained in studies with related compounds, i.e., oxytetracycline (adrenal and

pituitary tumors), and minocycline (thyroid tumors).


Doxycycline hyclate demonstrated no potential to cause genetic toxicity in an in

vitro point mutation study with mammalian cells (CHO/HGPRT forward mutation

assay) or in an in vivo micronucleus assay conducted in CD-1 mice. However, data

from an in vitro assay with CHO cells for potential to cause chromosomal aberrations

suggest that doxycycline hyclate is a weak clastogen.


Oral administration of doxycycline hyclate to male and female Sprague-Dawley rats

adversely affected fertility and reproductive performance, as evidenced by increased

time for mating to occur, reduced sperm motility, velocity, and concentration,

abnormal sperm morphology, and increased pre-and post-implantation losses.

Doxycycline hyclate induced reproductive toxicity at all dosages that were examined

in this study, as even the lowest dosage tested (50 mg/kg/day) induced a statistically

significant reduction in sperm velocity. Note that 50 mg/kg/day is approximately 10

times the amount of doxycycline hyclate contained in the recommended daily dose

of doxycycline hyclate for a 60 kg human when compared on the basis of body

surface area estimates (mg/m2). Although doxycycline impairs the fertility of rats

when administered at sufficient dosage, the effect of doxycycline hyclate on human

fertility is unknown.

Pregnancy:

Teratogenic Effects: Pregnancy Category D. (See WARNINGS

Section). Results from animal studies indicate that doxycycline crosses the placenta

and is found in fetal tissues.

Nonteratogenic effects:

(See WARNINGS Section).

Labor and Delivery:

The effect of tetracyclines on labor and delivery is unknown.

Nursing Mothers:

Tetracyclines are excreted in human milk. Because of the

potential for serious adverse reactions in nursing infants from doxycycline, the use

of doxycycline hyclate in nursing mothers is contraindicated. (See WARNINGS

Section).

Pediatric Use:

Pediatric Use: The use of doxycycline hyclate tablets in infancy and childhood is contraindicated. (See WARNINGS Section).

Adverse Reactions

The following adverse reactions have been

observed in patients receiving tetracyclines:

Gastrointestinal: anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia,

enterocolitis, and inflammatory lesions (with vaginal candidiasis) in the anogenital

region. Hepatotoxicity has been reported rarely. Rare instances of esophagitis and

esophageal ulcerations have been reported in patients receiving the capsule forms

of the drugs in the tetracycline class. Most of these patients took medications

immediately before going to bed. (See DOSAGE AND ADMINISTRATION Section).

Skin: maculopapular and erythematous rashes. Exfoliative dermatitis has been

reported but is uncommon. Photosensitivity is discussed above. (See WARNINGS

Section).

Renal toxicity: Rise in BUN has been reported and is apparently dose related. (See

WARNINGS Section).

Hypersensitivity reactions: urticaria, angioneurotic edema, anaphylaxis,

anaphylactoid purpura, serum sickness, pericarditis, and exacerbation of systemic

lupus erythematosus.

Blood: Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have

been reported.

Overdosage

In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdose.

Alodox Dosage and Administration

THE DOSAGE OF DOXYCYCLINE HYCLATE TABLETS DIFFERS FROM THAT

OF DOXYCYCLINE USED TO TREAT INFECTIONS. EXCEEDING THE

RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF

SIDE EFFECTS INCLUDING THE DEVELOPMENT OF RESISTANT

MICROORGANISMS.

Doxycycline hyclate tablets 20 mg twice daily as an adjunct following scaling and

root planing may be administered for up to 9 months. Doxycycline hyclate tablets

should be taken twice daily at 12 hour intervals, usually in the morning and evening.

It is recommended that if doxycycline hyclate tablets is taken close to meal times,

allow at least one hour prior to or two hours after meals. Safety beyond 12 months

and efficacy beyond 9 months have not been established.

Administration of adequate amounts of fluid along with the tablets is recommended

to wash down the drug and reduce the risk of esophageal irritation and ulceration.

(See ADVERSE REACTIONS Section).

How is Alodox Supplied

Doxycycline hyclate tablets USP equivalent to 20 mg of doxycycline, round, white,

unscored, film coated tablet, debossed MP 573 on one side and blank on the other

side.

Bottles of 60 NDC 54799-533-60

Store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature]

DISPENSE IN A TIGHT, LIGHT-RESISTANT CONTAINER.

REFERENCES

1. Golub L.M., Sorsa T., Lee H-M, Ciancio S., Sorbi D., Ramamurthy N.S., Gruber

B., Salo T.,Konttinen Y.T.: Doxycycline inhibits Neutrophil (PMN)-type Matrix

Metalloproteinases in Human Adult Periodontitis Gingiva. J. Clin. Periodontol

1995; 22: 100-109.

2. Golub L.M., Ciancio S., Ramamurthy N.S., Leung M., McNamara T.F.: Low-dose

Doxycycline Therapy: Effect on Gingival and Crevicular Fluid Collagenase

Activity in Humans. J. Periodont Res 1990; 25: 321-330.

3. Golub L.M., Lee H.M., Greenwald R.A., Ryan M.E., Salo T., Giannobile W.V.: A

Matrix Metalloproteinase Inhibitor Reduces Bone-type Collagen Degradation

Fragments and Specific Collegenases in Gingival Crevicular Fluid During Adult

Periodontitis. Inflammation Research 1997; 46: 310-319.

4. Saivain S., Houin G.: Clinical Pharmacokinetics of Doxycycline and Minocycline.

Clin. Pharmacokinetics 1988; 15: 355-366.

5. Schach von Wittenau M., Twomey T.: The Disposition of Doxycycline by Man

and Dog. Chemotherapy 1971; 16: 217-228.

6. Campistron G., Coulais Y., Caillard C., Mosser J., Pontagnier H., Houin G.:

Pharmacokinetics and Bioavailability of Doxycycline in Humans. Arzneimittel

Forschung 1986; 36: 1705-1707.

Alodox   doxycyline hyclate  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 54799-533 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Doxycycline Hyclate (DOXYCYCLINE ANHYDROUS) Doxycycline Hyclate 20 mg

Inactive Ingredients Ingredient Name Strength anhydrous lactose   carnauba wax   croscarmellose sodium   HYPROMELLOSES   magnesium stearate   CELLULOSE, MICROCRYSTALLINE   polydextrose   polyethylene glycol   Titanium dioxide   triacetin

Product Characteristics Color white Score no score Shape ROUND Size 7mm Flavor Imprint Code LCI;1336 Contains

Packaging # NDC Package Description Multilevel Packaging 1 54799-533-60 60 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA065277	10/01/2008

Labeler - OCuSOFT INC. (174939207)

Registrant - OCuSOFT INC. (174939207)

Revised: 02/2011OCuSOFT INC.

More Alodox resources

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

• Alodox Advanced Consumer (Micromedex) - Includes Dosage Information


• Doxycycline Monograph (AHFS DI)


• Doxycycline Professional Patient Advice (Wolters Kluwer)


• Doxycycline MedFacts Consumer Leaflet (Wolters Kluwer)


• Adoxa MedFacts Consumer Leaflet (Wolters Kluwer)


• Doryx Delayed-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Doxycycline Calcium Monograph (AHFS DI)


• Ocudox Convenience Kit MedFacts Consumer Leaflet (Wolters Kluwer)


• Oracea Consumer Overview


• Periostat MedFacts Consumer Leaflet (Wolters Kluwer)


• Vibra-Tabs MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Alodox with other medications

• Skin Infection

Apresazide

Generic Name: hydralazine and hydrochlorothiazide (Oral route)

hye-DRAL-a-zeen hye-droe-KLOR-ide, hye-droe-klor-oh-THYE-a-zide

Oral route(Capsule)

This fixed-combination drug is not indicated for initial therapy of hypertension. Hypertension requires therapy titrated to the individual patient. If the fixed combination represents the dosage so determined, its use may be more convenient in patient management. The treatment of hypertension is not static but must be reevaluated as conditions in each patient warrant .

Commonly used brand name(s)

In the U.S.

• Apresazide

Available Dosage Forms:

• Capsule


• Tablet

Therapeutic Class: Vasodilator/Thiazide Combination

Pharmacologic Class: Diuretic

Chemical Class: Thiazide

Uses For Apresazide

Hydralazine and hydrochlorothiazide combination is used to treat high blood pressure (hypertension).

High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure also may increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Hydralazine works by relaxing blood vessels and increasing the supply of blood and oxygen to the heart while reducing its workload. The hydrochlorothiazide is a type of medicine known as a thiazide diuretic and helps reduce the amount of water in the body by acting on the kidneys to increase the flow of urine.

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

Before Using Apresazide

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 have not been performed on the relationship of age to the effects of hydralazine and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established .

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of hydralazine and hydrochlorothiazide combination in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults. However, dizziness or lightheadedness or symptoms of too much potassium loss may be more likely to occur in the elderly, who are usually more sensitive to the effects of this medicine. Also, this medicine may reduce tolerance to cold temperatures in elderly patients.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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

• Dofetilide

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.

• Acetyldigoxin


• Arsenic Trioxide


• Deslanoside


• Digitalis


• Digitoxin


• Digoxin


• Droperidol


• Flecainide


• Ketanserin


• Levomethadyl


• Lithium


• Metildigoxin


• Ouabain


• Proscillaridin


• Sotalol

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.

• Alacepril


• Apazone


• Aspirin


• Benazepril


• Bepridil


• Bromfenac


• Captopril


• Carbamazepine


• Celecoxib


• Chlorpropamide


• Cholestyramine


• Cilazapril


• Cyclophosphamide


• Delapril


• Diclofenac


• Diflunisal


• Enalaprilat


• Enalapril Maleate


• Etodolac


• Fenoprofen


• Flurbiprofen


• Fosinopril


• Ginkgo


• Glipizide


• Gossypol


• Ibuprofen


• Ibuprofen Lysine


• Imidapril


• Indomethacin


• Ketoprofen


• Ketorolac


• Licorice


• Lisinopril


• Magnesium Salicylate


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Metoprolol


• Moexipril


• Nabumetone


• Naproxen


• Nepafenac


• Oxaprozin


• Pentopril


• Perindopril


• Piroxicam


• Quinapril


• Ramipril


• Salicylic Acid


• Salsalate


• Spirapril


• Sulindac


• Temocapril


• Tolmetin


• Topiramate


• Trandolapril


• Zofenopril

Interactions with Food/Tobacco/Alcohol

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

• Enteral Nutrition


• food

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:

• Gout (history of)


• Hyperuricemia (high uric acid in the blood) or—Hydrochlorothiazide may increase the amount of uric acid in the blood, which can lead to gout .

• Heart or blood vessel disease or


• Stroke (recent)—Lowering blood pressure may make problems resulting from these conditions worse.

• Hypochloremia (low chloride in the blood) or


• Hypokalemia (low potassium in the blood)


• Hypomagnesemia (low magnesium in the blood) or


• Hyponatremia (low sodium in the blood) or


• Parathyroid disease or


• Systemic lupus erythematosus (history of)—Use with caution. This medicine may make these conditions worse .

• Kidney disease—Hydrochlorothiazide may worsen this condition. Also, the blood pressure lowering effects may be increased because of slower removal of hydralazine from the body.

• Liver disease—If hydrochlorothiazide causes loss of too much water from the body, liver disease can become much worse.

• Sympathectomy—Use with caution. The effects of this medicine may be increased .

• Type 2 diabetes mellitus—Hydrochlorothiazide may change the amount of diabetes medicine needed .

Proper Use of Apresazide

This medicine may cause you to have an unusual feeling of tiredness when you begin to take it. You may also notice an increase in the amount of urine or in your frequency of urination. After taking the medicine for a while, these effects should lessen. To keep the increase in urine from affecting your sleep:

• If you are to take a single dose a day, take it in the morning after breakfast.


• If you are to take more than one dose a day, take the last dose no later than 6 p.m., unless otherwise directed by your doctor.

However, it is best to plan your dose or doses according to a schedule that will least affect your personal activities and sleep. Ask your health care professional to help you plan the best time to take this medicine.

In addition to the use of the medicine your doctor has prescribed, treatment for your high blood pressure may include weight control and care in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life . If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

To help you remember to take your medicine, try to get into the habit of taking it at the same time each day.

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 forms (capsules):
  
  • For high blood pressure:
    
    • Adults—1 capsule two times a day.
    
    
    • Children—Use and dose must be determined by your doctor .
    
    
  
  

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 Apresazide

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects .

Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

This medicine may cause some people to have headaches or to feel dizzy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. This is more likely to occur in the morning. Getting up slowly may help. When you get up from lying down, sit on the edge of the bed with your feet dangling for 1 or 2 minutes. Then stand up slowly. If the problem continues or gets worse, check with your doctor.

The dizziness, lightheadedness, or fainting is also more likely to occur if you drink alcohol, stand for a long time, exercise, or if the weather is hot. While you are taking this medicine, be careful in the amount of alcohol you drink. Also, use extra care during exercise or hot weather or if you must stand for a long time.

This medicine may cause a loss of potassium from your body.

• To help prevent this, your doctor may want you to:
  
  • eat or drink foods that have a high potassium content (for example, orange or other citrus fruit juices), or
  
  
  • take a potassium supplement, or
  
  
  • take another medicine to help prevent the loss of the potassium in the first place.
  
  


• It is very important to follow these directions. Also, it is important not to change your diet on your own. This is more important if you are already on a special diet (as for diabetes), or if you are taking a potassium supplement or a medicine to reduce potassium loss. Extra potassium may not be necessary and, in some cases, too much potassium could be harmful.

Check with your doctor if you become sick and have severe or continuing nausea, vomiting, or diarrhea. These problems may cause you to lose additional water and potassium.

For diabetic patients:

• Thiazide diuretics may raise blood sugar levels. While you are using this medicine, be especially careful in testing for sugar in your blood or urine. If you have any questions about this, check with your doctor.

Some people who take this medicine may become more sensitive to sunlight than they are normally. Exposure to sunlight, even for brief periods of time, may cause severe sunburn; skin rash, redness, itching, or discoloration; or vision changes. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.


• Wear protective clothing, including a hat and sunglasses.


• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.


• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

Apresazide 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 as soon as possible if any of the following side effects occur:

Signs and symptoms of too much potassium loss

• Dryness of mouth


• increased thirst


• irregular heartbeats


• mood or mental changes


• muscle cramps or pain


• weak pulse

Signs and symptoms of too much sodium loss

• Confusion


• convulsions


• decreased mental activity


• irritability


• muscle cramps


• unusual tiredness or weakness

Less common

• Blisters on skin


• chest pain


• general feeling of discomfort or illness or weakness


• joint pain


• numbness, tingling, pain, or weakness in hands or feet


• skin rash or itching


• sore throat and fever


• swelling of the lymph glands

Rare

• Lower back or side pain


• severe stomach pain with nausea and vomiting


• unusual bleeding or bruising


• yellow eyes or skin

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

More common

• Diarrhea


• fast or irregular heartbeat


• headache


• loss of appetite


• nausea or vomiting

Less common

• Constipation


• decreased sexual ability


• dizziness or lightheadedness, especially when getting up from a lying or sitting position


• increased sensitivity of skin to sunlight


• redness or flushing of face


• shortness of breath with exercise or work


• stuffy nose


• watering or irritated eyes

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: Apresazide side effects (in more detail)

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 Apresazide resources

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

• Hydra-Zide Concise Consumer Information (Cerner Multum)

Compare Apresazide with other medications

• Heart Failure
• High Blood Pressure

Actiprofen

Generic Name: ibuprofen (Oral route)

eye-bue-PROE-fen

Oral route(Tablet;Suspension;Capsule, Liquid Filled;Tablet, Chewable)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Ibuprofen is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Commonly used brand name(s)

In the U.S.

• Addaprin


• Advil


• A-G Profen


• Bufen


• Genpril


• Haltran


• I-Prin


• Midol


• Motrin


• Nuprin


• Proprinal


• Q-Profen

In Canada

• Actiprofen


• Advil Children's


• Advil Pediatric


• Children's Motrin


• Children's Motrin Berry Flavor


• Children's Motrin Bubble Gum Flavor


• Children's Motrin Grape Flavor


• Equate Children's Ibuprofen - Berry - Dye Free


• Infants' Motrin


• Teddy's Choice Children's Ibuprofen - Berry


• Teddy's Choice Children's Ibuprofen - Bubble Gum


• Teddy's Choice Children's Ibuprofen - Grape

Available Dosage Forms:

• Suspension


• Tablet


• Capsule, Liquid Filled


• Tablet, Chewable


• Capsule

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

Uses For Actiprofen

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain, and helps to relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, or juvenile arthritis), such as inflammation, swelling, stiffness, and joint pain. This medicine does not cure arthritis and will help you only as long as you continue to take it .

In addition, ibuprofen can be used to treat fever, menstrual cramps, and other conditions as determined by your doctor .

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

Before Using Actiprofen

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 have not been performed on the relationship of age to the effects of ibuprofen in children below 6 months of age. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of ibuprofen in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require adjustment of dosage in patients receiving ibuprofen .

Pregnancy

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

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ketorolac


• Pentoxifylline

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.

• Abciximab


• Ardeparin


• Argatroban


• Beta Glucan


• Bivalirudin


• Certoparin


• Cilostazol


• Citalopram


• Clopidogrel


• Clovoxamine


• Dabigatran Etexilate


• Dalteparin


• Danaparoid


• Desirudin


• Dipyridamole


• Enoxaparin


• Escitalopram


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Ginkgo


• Heparin


• Lepirudin


• Methotrexate


• Nadroparin


• Nefazodone


• Parnaparin


• Paroxetine


• Pemetrexed


• Protein C


• Reviparin


• Rivaroxaban


• Sertraline


• Sibutramine


• Tacrolimus


• Ticlopidine


• Tinzaparin


• Tirofiban


• Vilazodone


• Zimeldine

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.

• Acebutolol


• Acetohexamide


• Alacepril


• Alprenolol


• Amikacin


• Amiloride


• Arotinolol


• Aspirin


• Atenolol


• Azilsartan Medoxomil


• Azosemide


• Befunolol


• Bemetizide


• Benazepril


• Bendroflumethiazide


• Benzthiazide


• Betaxolol


• Bevantolol


• Bisoprolol


• Bopindolol


• Bucindolol


• Bumetanide


• Bupranolol


• Buthiazide


• Candesartan Cilexetil


• Canrenoate


• Captopril


• Carteolol


• Carvedilol


• Celiprolol


• Chlorothiazide


• Chlorpropamide


• Chlorthalidone


• Cilazapril


• Clopamide


• Cyclopenthiazide


• Cyclosporine


• Delapril


• Desipramine


• Desvenlafaxine


• Dilevalol


• Duloxetine


• Enalaprilat


• Enalapril Maleate


• Eprosartan


• Esmolol


• Ethacrynic Acid


• Fosinopril


• Furosemide


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Hydrochlorothiazide


• Hydroflumethiazide


• Imidapril


• Indapamide


• Irbesartan


• Labetalol


• Landiolol


• Levobetaxolol


• Levobunolol


• Lisinopril


• Lithium


• Losartan


• Mepindolol


• Methyclothiazide


• Metipranolol


• Metolazone


• Metoprolol


• Milnacipran


• Moexipril


• Nadolol


• Nebivolol


• Nipradilol


• Olmesartan Medoxomil


• Oxprenolol


• Penbutolol


• Pentopril


• Perindopril


• Phenytoin


• Pindolol


• Piretanide


• Polythiazide


• Propranolol


• Quinapril


• Ramipril


• Sotalol


• Spirapril


• Spironolactone


• Tacrine


• Talinolol


• Tasosartan


• Telmisartan


• Temocapril


• Tertatolol


• Timolol


• Tolazamide


• Tolbutamide


• Torsemide


• Trandolapril


• Triamterene


• Trichlormethiazide


• Valsartan


• Venlafaxine


• Voriconazole


• Xipamide


• Zofenopril

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

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

• Anemia or


• Asthma or


• Bleeding problems or


• Blood clots or


• Edema (fluid retention or body swelling) or


• Heart attack, history of or


• Heart disease (e.g., congestive heart failure) or


• High blood pressure or


• Kidney disease or


• Liver disease (e.g., hepatitis) or


• Stomach or intestinal ulcers or bleeding or


• Stroke, history of—Use with caution. This medicine may make these conditions worse .

• Aspirin sensitivity, history of—This medicine should NOT be used in patients with this condition .

• Diabetes—Use with caution. The suspension form of this medicine contains sugar .

• Heart surgery (e.g., coronary artery bypass graft [CABG] surgery)—This medicine should NOT be used to relieve pain right before or after the surgery .

Proper Use of ibuprofen

This section provides information on the proper use of a number of products that contain ibuprofen. It may not be specific to Actiprofen. Please read with care.

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients .

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine .

To lessen stomach upset, you may take this medicine with food or milk .

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 and suspension):
  
  • For fever:
    
    • Children over 2 years of age—Use and dose must be determined by your doctor.
    
    
    • Children 6 months of age up to 2 years—Dose is based on body weight and body temperature, and must be determined by your doctor. For fever lower than 102.5 °F (39.2 °C), the dose usually is 5 milligrams (mg) per kilogram (kg) (about 2.2 mg per pound) of body weight. For higher fever, the dose usually is 10 mg per kg (about 4.5 mg per pound) of body weight. The medicine may be given every six to eight hours, as needed, up to 40 mg per kg per day.
    
    
    • Infants younger than 6 months of age—Use and dose must be determined by your doctor .
    
    
  
  
  • For menstrual cramps:
    
    • Adults—400 milligrams (mg) every four hours, as needed.
    
    
    • Children—Use and dose must be determined by your doctor .
    
    
  
  
  • For mild to moderate pain:
    
    • Adults and teenagers—400 milligrams (mg) every four to six hours, as needed.
    
    
    • Children over 6 months of age—Dose is based on body weight and must be determined by your doctor. The dose usually is 10 milligrams (mg) per kilogram (kg) of body weight every six to eight hours, as needed, up to 40 mg per kg per day.
    
    
    • Infants younger than 6 months of age—Use and dose must be determined by your doctor .
    
    
  
  
  • For osteoarthritis and rheumatoid arthritis:
    
    • Adults and teenagers—1200 milligrams (mg) up to 3200 mg per day divided into three or four equal doses.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The dose usually is 30 milligrams (mg) to 40 mg per kilogram (kg) of body weight per day, divided into three or four doses.
    
    
    • Infants younger than 6 months of age—Use and dose must be determined by your doctor .
    
    
  
  

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.

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Actiprofen

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects .

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk .

This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years old, if you are in poor health, or if you are using certain other medicines (a steroid or a blood thinner) .

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, white spots in mouth or on lips, or unusual tiredness or weakness .

Possible warning signs of some serious side effects that can occur during treatment with this medicine may include swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; bleeding or bruising; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Stop taking this medicine and check with your doctor immediately if you notice any of these warning signs .

This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in skin color of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swelling of the eyelids or around the eyes. If these effects occur, get emergency help at once .

Some people who have used this medicine had symptoms of meningitis. If you have fever, headache, nausea, vomiting, and stiff neck or back while using this medicine, check with your doctor right away .

Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away .

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

Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure .

Actiprofen 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

• Abdominal pain


• acid or sour stomach


• belching


• bloating


• cloudy urine


• decrease in amount of urine


• decrease in urine output or decrease in urine-concentrating ability


• diarrhea


• difficulty having a bowel movement (stool)


• excess air or gas in stomach or intestines


• full feeling


• heartburn


• indigestion


• itching skin


• pain or discomfort in chest, upper stomach, or throat


• pale skin


• passing gas


• nausea


• noisy, rattling breathing


• rash with flat lesions or small raised lesions on the skin


• shortness of breath


• swelling of face, fingers, hands, feet, lower legs, or ankles


• troubled breathing at rest


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness


• vomiting


• weight gain

Less common

• Abdominal cramps


• stomach soreness or discomfort

Rare

• Agitation


• back, leg, or stomach pains


• bleeding gums


• blistering, peeling, loosening of skin


• blood in urine or stools


• bloody, black, or tarry stools


• blurred vision


• burning feeling in chest or stomach


• change in vision


• chest pain


• chills


• clay-colored stools


• coma


• confusion


• constipation


• cough or hoarseness


• dark urine


• decreased urine output


• depression


• difficulty breathing


• difficulty swallowing


• dilated neck veins


• dizziness


• dry mouth


• extreme fatigue


• fast, irregular, pounding, or racing heartbeat or pulse


• fever with or without chills


• frequent urination


• general body swelling


• general feeling of tiredness or weakness


• hair loss, thinning of hair


• headache


• hives or welts


• hostility


• impaired vision


• increased blood pressure


• increased volume of pale, dilute urine


• irregular breathing


• irritability


• itching


• joint or muscle pain


• lab results that show problems with liver


• lethargy


• light-colored stools


• loss of appetite


• lower back or side pain


• muscle twitching


• nosebleeds


• painful or difficult urination


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


• pinpoint red spots on skin


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


• rash


• red skin lesions, often with a purple center


• red, irritated eyes


• redness of skin


• seizures


• severe abdominal pain, cramping, burning


• severe and continuing nausea


• sore throat


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


• stiff neck or back


• stomach upset


• stupor


• swollen or painful glands


• tenderness in stomach area


• thirst


• tightness in chest


• unpleasant breath odor


• upper right abdominal pain


• vomiting of blood


• vomiting of material that looks like coffee grounds


• wheezing


• yellow eyes and skin

Symptoms of overdose

• Bluish lips or skin


• difficulty sleeping


• disorientation


• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• drowsiness to profound coma


• hallucination


• lightheadedness or fainting


• mood or other mental changes


• muscle tremors


• not breathing


• rapid, deep breathing


• restlessness


• slow or irregular heartbeat


• stomach cramps


• sudden fainting


• sweating

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

More common

• Continuing ringing or buzzing or other unexplained noise in ears


• hearing loss


• nervousness

Rare

• Crying


• depersonalization


• discouragement


• dry eyes


• dysphoria


• euphoria


• feeling sad or empty


• lack of appetite


• loss of interest or pleasure


• mental depression


• paranoia


• quick to react or overreact


• rapidly changing moods


• runny nose


• sleepiness or unusual drowsiness


• sleeplessness


• sneezing


• stuffy nose


• trouble concentrating


• trouble sleeping


• unable to sleep

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: Actiprofen side effects (in more detail)

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 Actiprofen resources

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

Compare Actiprofen with other medications

• Aseptic Necrosis
• Back Pain
• Costochondritis
• Cystic Fibrosis
• Diffuse Idiopathic Skeletal Hyperostosis
• Dysautonomia
• Fever
• Frozen Shoulder
• Gout, Acute
• Headache
• Muscle Pain
• Osteoarthritis
• Pain
• Patent Ductus Arteriosus
• Period Pain
• Rheumatoid Arthritis
• Sciatica
• Spondylolisthesis
• Temporomandibular Joint Disorder