Vantin

Mechanism of Action

Bactericidal against gram-positive and gram-negative bacteria; inhibits bacterial cell-wall synthesis by binding to 1 or more of penicillin-binding proteins; bacteria eventually lyse because activity of cell-wall autolytic enzymes continues while cell-wall assembly is arrested

Absorption

Bioavailability: 50%; acid stable

Peak plasma time: ≤1 hr

Distribution

Distributed well into tissues, including lungs and tonsils; penetrates into pleural fluid

Protein bound: 18-23%

Metabolism

Metabolized in liver to active metabolite

Elimination

Half-life: 2-3 hr; prolonged with renal impairment

Excretion: Urine (80% as unchanged drug) in 24 hr

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

Call your doctor at once if you have any of these serious side effects:

• diarrhea that is watery or bloody;
• fever, chills, body aches, flu symptoms;
• unusual bleeding or bruising;
• cough, wheezing, chest tightness, trouble breathing;
• fast or pounding heartbeats;
• feeling like you might pass out;
• seizure (convulsions);
• pale or yellowed skin, dark colored urine, fever, confusion or weakness;
• jaundice (yellowing of the skin or eyes);
• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
• swelling, rapid weight gain, feeling short of breath (even with mild exertion); or
• increased thirst, loss of appetite, urinating less than usual or not at all.

Less serious side effects may include:

• nausea, vomiting, stomach pain, mild diarrhea, bloating, gas, constipation;
• stiff or tight muscles;
• back pain, muscle pain;
• headache, tired feeling;
• anxiety, nervousness, feeling restless or hyperactive;
• numbness or tingly feeling, warmth or redness under your skin;
• dizziness, spinning sensation;
• strange dreams, nightmares;
• stuffy nose;
• dry mouth, unusual or unpleasant taste in your mouth;
• white patches or sores inside your mouth or on your lips;
• diaper rash in an infant taking liquid cefpodoxime
• mild itching or skin rash; or
• vaginal itching or discharge.

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.

Do not take this medication if you are allergic to cefpodoxime, or to similar antibiotics, such as Ceftin, Cefzil, Keflex, Omnicef, and others.

Before taking this medication, tell your doctor if you are allergic to any drugs (especially penicillin). Also tell your doctor if you have kidney disease or a history of intestinal problems.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Cefpodoxime will not treat a viral infection such as the common cold or flu.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Do not take this medication if you are allergic to cefpodoxime or to other cephalosporin antibiotics, such as:

• cefaclor (Raniclor);

• cefadroxil (Duricef);

• cefazolin (Ancef);

• cefdinir (Omnicef);

• cefditoren (Spectracef);

• cefixime (Suprax);

• cefprozil (Cefzil);

• ceftibuten (Cedax);

• cefuroxime (Ceftin);

• cephalexin (Keflex); or

• cephradine (Velosef); and others.

Before taking cefpodoxime, tell your doctor if you are allergic to any drugs (especially penicillins) or if you have:

• kidney disease (or if you are on dialysis); or

• a history of intestinal problems, such as colitis.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Cefpodoxime passes into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, stomach pain, and diarrhea.

Administration

Oral Administration

Administer orally.1 66

Administer tablets with food.1 (See Food under Pharmacokinetics.)

Administer oral suspension without regard to meals.66

Reconstitute oral suspension at time of dispensing by adding amount of water specified on the container in 2 portions; invert bottle and shake after each addition.66

Reconstituted suspension contains 50 or 100 mg of cefpodoxime/5 mL.66

Shake suspension well prior to administration of each dose.66

Dosage

Available as cefpodoxime proxetil; dosage expressed in terms of cefpodoxime.1 66

Pediatric Patients

Children beyond neonatal period: AAP recommends 10 mg/kg daily in 2 equally divided doses for treatment of mild or moderate infections.10 AAP states the drug is inappropriate for treatment of severe infections.10

Children 2 months through 12 years of age: 5 mg/kg every 12 hours for 5 days.66

AAP does not recommend oral anti-infective regimens of <10 days’ duration in children <2 years of age or in patients with severe symptoms.37

Children 2 months through 12 years of age: 5 mg/kg every 12 hours for 5–10 days.66

Children ≥12 years of age: 100 mg every 12 hours for 5–10 days.1 66

IDSA and AHA do not recommend cephalosporin regimens of ≤5 days’ duration.16 17

Children 2 months through 12 years of age: 5 mg/kg every 12 hours for 10 days.66

Children ≥12 years of age: 200 mg every 12 hours for 10 days.1 66

Children ≥12 years of age: 200 mg every 12 hours for 10 days.1 66

Children ≥12 years of age: 200 mg every 12 hours for 14 days.1 66

Children ≥12 years of age: 400 mg every 12 hours for 7–14 days.1 66

Children ≥12 years of age: 100 mg every 12 hours for 7 days.1 66

Uncomplicated urethral or cervical gonorrhea in adolescents ≥12 years of age: Manufacturer recommends 200 mg as a single dose.1 66

Uncomplicated anorectal gonorrhea in adolescent girls ≥12 years of age: Manufacturer recommends 200 mg as a single dose.1 66

Not recommended by CDC as first-line treatment.68 (See Gonorrhea and Associated Infections under Uses.)

Adults

100 mg every 12 hours for 5–10 days.1 66

IDSA and AHA do not recommend cephalosporin regimens of ≤5 days’ duration.16 17

200 mg every 12 hours for 10 days.1 66

200 mg every 12 hours for 10 days.1

200 mg every 12 hours for 14 days.1 66

400 mg every 12 hours for 7–14 days.1 66

100 mg every 12 hours for 7 days.1 66

Uncomplicated urethral or cervical gonorrhea: Manufacturer recommends 200 mg as a single dose.1 66

Uncomplicated anorectal gonorrhea in women: Manufacturer recommends 200 mg as a single dose.1 66

Not recommended by CDC as first-line treatment.68 (See Gonorrhea and Associated Infections under Uses.)

Prescribing Limits

Pediatric Patients

Maximum 200 mg every 12 hours for children 2 months to 12 years of age.66

Maximum 100 mg every 12 hours for children 2 months to 12 years of age.66

Maximum 200 mg every 12 hours for children 2 months to 12 years of age.66

Special Populations

Hepatic Impairment

Dosage adjustments not required in patients with cirrhosis (with or without ascites).1 66

Renal Impairment

Patients with Clcr <30 mL/minute: Give usual dose once every 24 hours.1 66

Patients maintained on hemodialysis: Give usual dose 3 times weekly after dialysis.1 66

Geriatric Patients

No dosage adjustments except those related to renal impairment.1 (See Renal Impairment under Dosage and Administration.)

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

Cefpodoxime may cause diarrhea, and in some cases it can be severe. Do not take any medicine or give medicine to your child 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.

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

Quantitative methods are used to determine antimicrobial inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of microorganisms to antimicrobial compounds. The MICs should be determined using a standardized procedure. Standardized procedures are based on dilution methods1,2 (broth or agar) or equivalent using standardized inoculum concentrations, and standardized concentrations of cefpodoxime from a powder of known potency. The MIC values should be interpreted according to the following criteria:

For Susceptibility Testing of Streptococcus spp. other than Streptococcus pneumoniae.1

A streptococcal isolate that is susceptible to penicillin (MIC ≤0.12 mcg/mL) can be considered susceptible to cefpodoxime for approved indications, and need not be tested against cefpodoxime.

A report of "Susceptible" indicates that the pathogen is likely to be inhibited if the concentration of the antimicrobial compound in the blood reaches usually achievable levels. A report of "Intermediate" indicates that the results should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone which prevents small technical factors from causing major discrepancies in interpretation. A report of "Resistant" indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.

Quality Control

A standardized susceptibility test procedure requires the use of laboratory control organisms to control the technical aspects of the laboratory procedures. Standard cefpodoxime powder should provide the following MIC values with the indicated quality control strains:

Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 10 mcg cefpodoxime to test the susceptibility of microorganisms to cefpodoxime. Reports from the laboratory providing results of the standard single-disk susceptibility test with a 10 mcg cefpodoxime disk should be interpreted according to the following criteria:

For Susceptibility Testing of Streptococcus pneumoniae.2

Isolates of pneumococci with oxacillin zone sizes of ≥20 mm are susceptible (MIC ≤0.06 mcg/mL) to penicillin and can be considered susceptible to cefpodoxime for approved indications, and cefpodoxime need not be tested.

For Susceptibility Testing of Streptococcus spp. other than Streptococcus pneumoniae.3

A streptococcal isolate that is susceptible to penicillin (zone diameter ≥28 mm) can be considered susceptible to cefpodoxime for approved indications, and cefpodoxime need not be tested.

Quality Control

As with standardized dilution techniques, diffusion methods require the use of laboratory control microorganisms that are used to control the technical aspects of the laboratory procedures. For the diffusion technique, the 10 mcg cefpodoxime disk should provide the following zone diameters with the quality control strains listed below:

ATCC® is a registered trademark of the American Type Culture Collection.

Clinical Trials

In clinical trials using multiple doses of cefpodoxime proxetil film-coated tablets, 4696 patients were treated with the recommended dosages of cefpodoxime (100 to 400 mg Q 12 hours). There were no deaths or permanent disabilities thought related to drug toxicity. One-hundred twenty-nine (2.7%) patients discontinued medication due to adverse events thought possibly or probably related to drug toxicity. Ninety-three (52%) of the 178 patients who discontinued therapy (whether thought related to drug therapy or not) did so because of gastrointestinal disturbances, nausea, vomiting, or diarrhea. The percentage of cefpodoxime proxetil-treated patients who discontinued study drug because of adverse events was significantly greater at a dose of 800 mg daily than at a dose of 400 mg daily or at a dose of 200 mg daily. Adverse events thought possibly or probably related to cefpodoxime in multiple-dose clinical trials (N=4696 cefpodoxime-treated patients) were:

Incidence Greater Than 1%:

Diarrhea                                                                                7.0%
Diarrhea or loose stools were dose-related: decreasing from 10.4% of patients receiving 800 mg per day to 5.7% for those receiving 200 mg per day. Of patients with diarrhea, 10% had C. difficile organism or toxin in the stool. (See WARNINGS.)
Nausea                                                                                  3.3%
Vaginal Fungal Infections                                                        1.0%
Vulvovaginal Infections                                                           1.3%
Abdominal Pain                                                                      1.2%
Headache                                                                               1.0%

Incidence Less Than 1%: By body system in decreasing order:

Clinical Studies

Adverse events thought possibly or probably related to cefpodoxime proxetil that occurred in less than 1% of patients (N=4696)

Body - fungal infections, abdominal distention, malaise, fatigue, asthenia, fever, chest pain, back pain, chills, generalized pain, abnormal microbiological tests, moniliasis, abscess, allergic reaction, facial edema, bacterial infections, parasitic infections, localized edema, localized pain.

Cardiovascular - congestive heart failure, migraine, palpitations, vasodilation, hematoma, hypertension, hypotension.

Digestive - vomiting, dyspepsia, dry mouth, flatulence, decreased appetite, constipation, oral moniliasis, anorexia, eructation, gastritis, mouth ulcers, gastrointestinal disorders, rectal disorders, tongue disorders, tooth disorders, increased thirst, oral lesions, tenesmus, dry throat, toothache.

Hemic and Lymphatic - anemia.

Metabolic and Nutritional - dehydration, gout, peripheral edema, weight increase.

Musculo-skeletal - myalgia.

Nervous - dizziness, insomnia, somnolence, anxiety, shakiness, nervousness, cerebral infarction, change in dreams, impaired concentration, confusion, nightmares, paresthesia, vertigo.

Respiratory - asthma, cough, epistaxis, rhinitis, wheezing, bronchitis, dyspnea, pleural effusion, pneumonia, sinusitis.

Skin - urticaria, rash, pruritus non-application site, diaphoresis, maculopapular rash, fungal dermatitis, desquamation, dry skin non-application site, hair loss, vesiculobullous rash, sunburn.

Special Senses - taste alterations, eye irritation, taste loss, tinnitus.

Urogenital - hematuria, urinary tract infections, metrorrhagia, dysuria, urinary frequency, nocturia, penile infection, proteinuria, vaginal pain.

In clinical trials using multiple doses of cefpodoxime proxetil granules for oral suspension, 2128 pediatric patients (93% of whom were less than 12 years of age) were treated with the recommended dosages of cefpodoxime (10 mg/kg/day Q 24 hours or divided Q 12 hours to a maximum equivalent adult dose). There were no deaths or permanent disabilities in any of the patients in these studies. Twenty-four patients (1.1%) discontinued medication due to adverse events thought possibly or probably related to study drug. Primarily, these discontinuations were for gastrointestinal disturbances, usually diarrhea, vomiting, or rashes.

Adverse events thought possibly or probably related, or of unknown relationship to cefpodoxime proxetil for oral suspension in multiple-dose clinical trials (N=2128 patients treated with cefpodoxime) were:

Incidence Greater Than 1%:

Diarrhea                                                                             6.0%
The incidence of diarrhea in infants and toddlers (age 1 month to 2 years) was 12.8%.
Diaper rash/Fungal skin rash                                               2.0% (includes moniliasis)
The incidence of diaper rash in infants and toddlers was 8.5%.
Other skin rashes                                                                1.8%
Vomiting                                                                             2.3%

Incidence Less Than 1%:

Body: Localized abdominal pain, abdominal cramp, headache, monilia, generalized abdominal pain, asthenia, fever, fungal infection.

Digestive: Nausea, monilia, anorexia, dry mouth, stomatitis, pseudomembranous colitis.

Hemic & Lymphatic: Thrombocythemia, positive direct Coombs' test, eosinophilia, leukocytosis, leukopenia, prolonged partial thromboplastin time, thrombocytopenic purpura.

Metabolic & Nutritional: Increased SGPT.

Musculo-Skeletal: Myalgia.

Nervous: Hallucination, hyperkinesia, nervousness, somnolence.

Respiratory: Epistaxis, rhinitis.

Skin: Skin moniliasis, urticaria, fungal dermatitis, acne, exfoliative dermatitis, maculopapular rash.

Special Senses: Taste perversion.

In clinical trials using a single dose of cefpodoxime proxetil film-coated tablets, 509 patients were treated with the recommended dosage of cefpodoxime (200 mg). There were no deaths or permanent disabilities thought related to drug toxicity in these studies.

Adverse events thought possibly or probably related to cefpodoxime in single-dose clinical trials conducted in the United States were:

Incidence Greater Than 1%:
Nausea                                                                                1.4%
Diarrhea                                                                               1.2%

Incidence Less Than 1%:
Central Nervous System: Dizziness, headache, syncope.
Dermatologic: Rash.
Genital: Vaginitis.
Gastrointestinal: Abdominal pain.
Psychiatric: Anxiety.

Laboratory Changes

Significant laboratory changes that have been reported in adult and pediatric patients in clinical trials of cefpodoxime proxetil, without regard to drug relationship, were:

Hepatic: Transient increases in AST (SGOT), ALT (SGPT), GGT, alkaline phosphatase, bilirubin, and LDH.

Hematologic: Eosinophilia, leukocytosis, lymphocytosis, granulocytosis, basophilia, monocytosis, thrombocytosis, decreased hemoglobin, decreased hematocrit, leukopenia, neutropenia, lymphocytopenia, thrombocytopenia, thrombocythemia, positive Coombs' test, and prolonged PT, and PTT.

Serum Chemistry: Hyperglycemia, hypoglycemia, hypoalbuminemia, hypoproteinemia, hyperkalemia, and hyponatremia.

Renal: Increases in BUN and creatinine.

Most of these abnormalities were transient and not clinically significant.

The following serious adverse experiences have been reported: allergic reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme and serum sickness-like reactions, pseudomembranous colitis, bloody diarrhea with abdominal pain, ulcerative colitis, rectorrhagia with hypotension, anaphylactic shock, acute liver injury, in utero exposure with miscarriage, purpuric nephritis, pulmonary infiltrate with eosinophilia, and eyelid dermatitis.

One death was attributed to pseudomembranous colitis and disseminated intravascular coagulation.

In addition to the adverse reactions listed above which have been observed in patients treated with cefpodoxime proxetil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin class antibiotics:

Adverse Reactions and Abnormal Laboratory Tests: Renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, serum sickness-like reaction, hemorrhage, agranulocytosis, and pancytopenia.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. (See DOSAGE AND ADMINISTRATION and OVERDOSAGE.) If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

(See INDICATIONS AND USAGE for indicated pathogens.)

FILM-COATED TABLETS

Vantin Tablets should be administered orally with food to enhance absorption. (See CLINICAL PHARMACOLOGY.)

The recommended dosages, durations of treatment, and applicable patient population are as described in the following chart:

GRANULES FOR ORAL SUSPENSION

Vantin Oral Suspension may be given without regard to food. The recommended dosages, durations of treatment, and applicable patient populations are as described in the following chart:

For patients with severe renal impairment (<30 mL/min creatinine clearance), the dosing intervals should be increased to Q 24 hours. In patients maintained on hemodialysis, the dose frequency should be 3 times/week after hemodialysis.

When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to estimate creatinine clearance (mL/min). For this estimate to be valid, the serum creatinine level should represent a steady state of renal function.

Cefpodoxime pharmacokinetics in cirrhotic patients (with or without ascites) are similar to those in healthy subjects. Dose adjustment is not necessary in this population.

After mixing, the suspension should be stored in a refrigerator, 2° to 8°C (36° to 46°F). Shake well before using. Keep container tightly closed. The mixture may be used for 14 days. Discard unused portion after 14 days.

NDC 0009-3618-02
6505-01-368-2870

Vantin®
cefpodoxime proxetil
tablets, USP

200 mg

100 Tablets

Applies to cefpodoxime: oral powder for suspension, oral tablet

Along with its needed effects, cefpodoxime (the active ingredient contained in Vantin) 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 while taking cefpodoxime:

• Diarrhea
• loose stools

• Change in the color, amount, or odor of vaginal discharge

• Abdominal or stomach cramps or tenderness
• black, tarry stools
• bladder pain
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody nose
• bloody or cloudy urine
• blurred vision
• burning while urinating
• chest pain
• collection of blood under the skin
• confusion
• continuing ringing or buzzing or other unexplained noise in the ears
• cough or hoarseness
• cough producing mucus
• dark urine
• decreased urination
• decreased urine output
• deep, dark purple bruise
• diarrhea, watery and severe, which may also be bloody
• difficult or labored breathing
• difficult, burning, or painful urination
• difficulty with breathing or troubled breathing
• dilated neck veins
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• extreme fatigue
• fainting
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling of warmth or heat
• fever or chills
• flushing or redness of the skin, especially on the face and neck
• frequent urge to urinate
• general body swelling
• headache
• hearing loss
• heavier menstrual periods
• increase in heart rate
• increased thirst
• increased urge to urinate during the night
• increased weight
• irregular breathing
• irregular heartbeat
• itching of the vagina or genital area
• itching, pain, redness, or swelling
• loss of appetite
• lower back or side pain
• nausea or vomiting
• nervousness
• noisy breathing
• nosebleeds
• pain
• pain during sexual intercourse
• pain or swelling of the treated skin
• pain or tenderness around the eyes and cheekbones
• pain, warmth, or burning in the fingers, toes, and legs
• pale skin
• pinpoint red spots on the skin
• pounding in the ears
• problems with vision or hearing
• rapid breathing
• rapid weight gain
• runny nose
• shortness of breath or troubled breathing
• skin rash
• slow or fast heartbeat
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stuffy or runny nose
• sunken eyes
• sweating
• swelling of the face, fingers, feet, or lower legs
• swelling or puffiness of the face
• swollen glands
• thick, white vaginal discharge with no odor or with a mild odor
• thirst
• tightness of the chest or wheezing
• tingling of the hands or feet
• troubled breathing
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• waking to urinate at night
• weight gain
• wheezing
• wrinkled skin
• yellowing of the eyes or skin

• Abdominal or stomach pain
• blistering, peeling, or loosening of the skin
• bloody, black, or tarry stools
• clay-colored stools
• feeling of discomfort
• fever with or without chills
• general feeling of tiredness or weakness
• high fever
• inflammation of the joints
• irritation or inflammation of the eyelid
• itching
• joint or muscle pain
• muscle aches
• rectal bleeding
• red skin lesions, often with a purple center
• red, irritated eyes
• seizures
• sudden decrease in the amount of urine
• swollen lymph glands
• swollen or painful glands
• unpleasant breath odor
• vomiting of blood

Some side effects of cefpodoxime 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:

• Accumulation of pus
• acid or sour stomach
• ankle, knee, or great toe joint pain
• bad, unusual, or unpleasant (after) taste
• belching
• blemishes on the skin
• bloated or full feeling
• burning feeling in the chest or stomach
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in taste
• constipation
• cracks in the skin
• decreased appetite
• difficulty with moving
• dry skin
• excess air or gas in the stomach or intestines
• fear or nervousness
• feeling of constant movement of self or surroundings
• frequent urge to defecate
• general feeling of discomfort or illness
• hair loss
• headache, severe and throbbing
• heartburn
• hives or welts
• increase in body movements
• increased sweating
• increased thirst
• indigestion
• irritation or soreness of the mouth
• joint stiffness or swelling
• lack or loss of strength
• loss of heat from the body
• lower back or side pain
• muscle aching or cramping
• muscle pains or stiffness
• passing of gas
• peeling of the skin
• pimples
• poor concentration
• pressure in the stomach
• red, sore eyes
• red, swollen skin
• redness of the skin
• scaly skin
• seeing, hearing, or feeling things that are not there
• sensation of spinning
• sleepiness or unusual drowsiness
• sleeplessness
• sore mouth or tongue
• soreness or redness around the fingernails and toenails
• stomach discomfort, upset, or pain
• stomach upset
• straining while passing stool
• swelling of the abdominal or stomach area
• swelling or inflammation of the mouth
• swollen, red, or tender area of infection
• trouble with sleeping
• unable to sleep
• white patches in the mouth, tongue, or throat