Erythromycin and Sulfisoxazole

Dosage Form: granule, for oral suspension
ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL FOR ORAL SUSPENSION, USP

Revised MARCH 2007

11001190

Rx only

DESCRIPTION:

Erythromycin ethylsuccinate and sulfisoxazole acetyl, when reconstituted with water as directed on the label, the granules form a white, cherry flavored suspension that provides the equivalent of 200 mg erythromycin activity and the equivalent of 600 mg of sulfisoxazole activity per teaspoonful (5 mL).

Erythromycin is produced by a strain of Saccaropolyspora erythraea and belongs to the macrolide group of antibiotics. It is basic and readily forms salts and esters. Erythromycin ethylsuccinate is the 2’-ethylsuccinyl ester of erythromycin. It is essentially a tasteless form of the antibiotic suitable for oral administration, particularly in suspension dosage forms. The chemical name is erythromycin 2’-(ethylsuccinate). Erythromycin ethylsuccinate has the following structural formula:

C45H75NO16 Molecular Weight: 862.06

Sulfisoxazole acetyl or N1-acetyl sulfisoxazole is an ester of sulfisoxazole. Chemically, sulfisoxazole is N1-(3,4-dimethyl-5-isoxazotyl) sulfanilamide. Sulfisoxazole acetyl has the following structural formula:

C13H15N3O4S Molecular Weight: 309.34

Inactive Ingredients:

Artificial flavor, lactose anhydrous, methylparaben, polysorbate 80, povidone, simethicone, sodium citrate anhydrous and sucrose.

CLINICAL PHARMACOLOGY:

Orally administered erythromycin ethylsuccinate suspensions are readily and reliably absorbed. Erythromycin ethylsuccinate products have demonstrated rapid and consistent absorption in both fasting and nonfasting conditions. However, higher serum concentrations are obtained when these products are given with food. Erythromycin is largely bound to plasma proteins. After absorption, erythromycin diffuses readily into most body fluids. In the absence of meningeal inflammation, low concentrations are normally achieved in the spinal fluid, but the passage of the drug across the blood-brain barrier increases in meningitis. Erythromycin crosses the placental barrier and is excreted in human milk. Erythromycin is not removed by peritoneal dialysis or hemodialysis.

In the presence of normal hepatic function, erythromycin is concentrated in the liver and is excreted in the bile; the effect of hepatic dysfunction on biliary excretion of erythromycin is not known. After oral administration, less than 5% of the administered dose can be recovered in the active form in the urine.

Wide variation in blood levels may result following identical doses of a sulfonamide. Blood levels should be measured in patients receiving these drugs for serious infections. Free sulfonamide blood levels of 50 to 150 mcg/mL may be considered therapeutically effective for most infections, with blood levels of 120 to 150 mcg/mL being optimal for serious infections. The maximum sulfonamide level should be 200 mcg/mL, because adverse reactions occur more frequently above this concentration.

Following oral administration, sulfisoxazole is rapidly and completely absorbed; the small intestine is the major site of absorption, but some of the drug is absorbed from the stomach. Sulfonamides are present in the blood as free, conjugated (acetylated and possibly other forms), and protein-bound forms. The amount present as “free” drug is considered to be the therapeutically active form. Approximately 85% of a dose of sulfisoxazole is bound to plasma proteins, primarily to albumin; 65% to 72% of the unbound portion is in the nonacetylated form.

Maximum plasma concentrations of intact sulfisoxazole following a single 2 g oral dose of sulfisoxazole to healthy adult volunteers ranged from 127 to 211 mcg/mL (mean 169 mcg/mL), and the time of peak plasma concentration ranged from 1 to 4 hours (mean, 2.5 hours). The elimination half-life of sulfisoxazole ranged from 4.6 to 7.8 hours after oral administration. The elimination of sulfisoxazole has been shown to be slower in elderly subjects (63 to 75 years) with diminished renal function (creatine clearance 37 to 68 mL/min).1 After multiple-dose oral administration of 500 mg q.i.d. to healthy volunteers, the average steady-state plasma concentrations of intact sulfisoxazole ranged from 49.9 to 88.8 mcg/mL (mean 63.4 mcg/mL).2

Sulfisoxazole and its acetylated metabolites are excreted primarily by the kidneys through glomerular filtration. Concentrations of sulfisoxazole are considerably higher in the urine than in the blood. The mean urinary recovery following oral administration of sulfisoxazole is 97% within 48 hours; 52% of this is intact drug, and the remainder is the N4-acetylated metabolite.

Sulfisoxazole is distributed only in extracellular body fluids. It is excreted in human milk. It readily crosses the placental barrier. In healthy subjects, cerebrospinal fluid concentrations of sulfisoxazole vary; in patients with meningitis, however, concentrations of free drug in cerebrospinal fluid as high as 94 mcg/mL have been reported.

Microbiology:

This product has been formulated to contain sulfisoxazole for concomitant use with erythromycin.

Erythromycin acts by inhibition of protein synthesis by binding 50 S ribosomal sub-units of susceptible organisms. It does not affect nucleic acid synthesis. Antagonism has been demonstrated in vitro between erythromycin and clindamycin, lincomycin, and chloramphenicol.

The sulfonamides are bacteriostatic agents, and the spectrum of activity is similar for all. Sulfonamides inhibit bacterial synthesis of dihydrofolic acid by preventing the condensation of the pteridine with para-aminobenzoic acid through competitive inhibition of the enzyme dihydropteroate synthetase. Resistant strains have altered dihydropteroate synthetase with reduced affinity for sulfonamides or produce increased quantities of para-aminobenzoic acid.

Susceptibility Testing:

Quantitative methods that require measurement of zone diameter give the most precise estimates of the susceptibility of bacteria to antimicrobial agents. One such standardized single-disc procedure3 has been recommended for use with discs to test susceptibility to Erythromycin and Sulfisoxazole. Interpretation involves correlation of the zone diameters obtained in the disc test with minimal inhibitory concentration (MIC) values for Erythromycin and Sulfisoxazole.

If the standardized procedure of disc susceptibility is used, a 15 mcg erythromycin disc should give a zone diameter of at least 18 mm when tested against an erythromycin-susceptible bacterial strain, and a 250-300 mcg sulfisoxazole disc should give a zone diameter of at least 17 mm when tested against a sulfisoxazole-susceptible bacterial strain.

In vitro sulfonamides susceptibility tests are not always reliable because media containing excessive amounts of thymidine are capable of reversing the inhibitory effect of sulfonamides, which may result in false resistant reports. The tests must be carefully coordinated with bacteriological and clinical responses. When the patient is already taking sulfonamides, follow-up cultures should have aminobenzoic acid added to the isolation media but not to subsequent susceptibility test media.

INDICATIONS AND USAGE:

For treatment of ACUTE OTITIS MEDIA in children that is caused by susceptible strains of Haemophilus influenzae.

CONTRAINDICATIONS:

Erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension is contraindicated in the following patient populations:

 

Patients with a known hypersensitivity to either of its components, children younger than 2 months, pregnant women at term, and mothers nursing infants less than 2 months of age.

Use in pregnant women at term, in children less than 2 months of age, and in mothers nursing infants less than 2 months of age is contraindicated because sulfonamides may promote kernicterus in the newborn by displacing bilirubin from plasma proteins.

Erythromycin is contraindicated in patients taking terfenadine. (See PRECAUTIONS, Drug Interactions:.)

WARNINGS:

FATALITIES ASSOCIATED WITH THE ADMINISTRATION OF SULFONAMIDES, ALTHOUGH RARE, HAVE OCCURRED DUE TO SEVERE REACTIONS, INCLUDING STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, FULMINANT HEPATIC NECROSIS, AGRANULOCYTOSIS, APLASTIC ANEMIA, AND OTHER BLOOD DYSCRASIAS.

SULFONAMIDES, INCLUDING SULFONAMIDE-CONTAINING PRODUCTS SUCH AS ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL FOR ORAL SUSPENSION, SHOULD BE DISCONTINUED AT THE FIRST APPEARANCE OF SKIN RASH OR ANY SIGN OF ADVERSE REACTION. In rare instances, a skin rash may be followed by a more severe reaction, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, hepatic necrosis, and serious blood disorders. (See PRECAUTIONS.)

Clinical signs such as sore throat, fever, pallor, rash, purpura, or jaundice may be early indications of serious reactions.

There have been reports of hepatic dysfunction, with or without jaundice, occurring in patients receiving oral erythromycin products.

Cough, shortness of breath, and pulmonary infiltrates are hypersensitivity reactions of the respiratory tract that have been reported in association with sulfonamide treatment.

The sulfonamides should not be used for the treatment of group A beta-hemolytic streptococcal infections. In an established infection, they will not eradicate the streptococcus and, therefore, will not prevent sequelae such as rheumatic fever.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of “antibiotic-associated colitis”.

After diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.

There have been reports suggesting that erythromycin does not reach the fetus in adequate concentration to prevent congenital syphilis. Infants born to women treated during pregnancy with erythromycin for early syphilis should be treated with an appropriate penicillin regimen.

Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving erythromycin concomitantly with lovastatin. Therefore, patients receiving concomitant lovastatin and erythromycin should be carefully monitored for creatine kinase (CK) and serum transaminase levels. (See package insert for lovastatin.)

PRECAUTIONS:

General:

Erythromycin is principally excreted by the liver. Caution should be exercised when erythromycin is administered to patients with impaired hepatic function. (See CLINICAL PHARMACOLOGY and WARNINGS sections.)

Prolonged or repeated use of erythromycin may result in an overgrowth of nonsusceptible bacteria or fungi. If superinfection occurs, erythromycin should be discontinued and appropriate therapy instituted.

There have been reports that erythromycin may aggravate the weakness of patients with myasthenia gravis.

When indicated, incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy.

Sulfonamides should be given with caution to patients with impaired renal or hepatic function and to those with severe allergy or bronchial asthma. In glucose-6-phosphate dehydrogenase-deficient individuals, hemolysis may occur; this reaction is frequently dose-related.

Information For Patients:

Patients should maintain an adequate fluid intake to prevent crystalluria and stone formation.

Laboratory Tests:

Complete blood counts should be done frequently in patients receiving sulfonamides. If a significant reduction in the count of any formed blood element is noted, erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension should be discontinued. Urinalysis with careful microscopic examination and renal function tests should be performed during therapy, particularly for those patients with impaired renal function. Blood levels should be measured in patients receiving a sulfonamide for serious infections. (See INDICATIONS AND USAGE.)

Drug Laboratory Test Interactions:

Erythromycin interferes with the fluorometric determination of urinary catecholamines.

Drug Interactions:

Erythromycin use in patients who are receiving high doses of theophylline may be associated with an increase in serum theophylline levels and potential theophylline toxicity. In case of theophylline toxicity and/or elevated serum theophylline levels, the dose of theophylline should be reduced while the patient is receiving concomitant erythromycin therapy.

Concomitant administration of erythromycin and digoxin has been reported to result in elevated digoxin serum levels.

There have been reports of increased anticoagulant effects when erythromycin and oral anticoagulants were used concomitantly. Increased anticoagulation effects due to this drug may be more pronounced in the elderly.

Concurrent use of erythromycin and ergotamine or dihydroergotamine has been associated in some patients with acute ergot toxicity characterized by severe peripheral vasospasm and dysesthesia.

Erythromycin has been reported to decrease the clearance of triazolam and midazolam and thus may increase the pharmacologic effect of these benzodiazepines.

The use of erythromycin in patients concurrently taking drugs metabolized by the cytochrome P450 system may be associated with elevations in serum levels of these other drugs. There have been reports of interactions of erythromycin with carbamazepine, cyclosporine, hexobarbital, phenytoin, allentanil, diisopyramide, lovastatin, and bromocriptine. Serum concentrations of drugs metabolized by the cytochrome P450 system should be monitored closely in patients concurrently receiving erythromycin.

Erythromycin significantly alters the metabolism of terfenadine when taken concomitantly. Rare cases of serious cardiovascular adverse events, including death, cardiac arrest, torsades de pointes, and other ventricular arrhythmias, have been observed. (See CONTRAINDICATIONS.)

It has been reported that sulfisoxazole may prolong the prothrombin time in patients who are receiving the anticoagulant warfarin. This interaction should be kept in mind when erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension is given to patients already on anticoagulant therapy, and the coagulation time should be reassessed.

It has been proposed that sulfisoxazole competes with thiopental for plasma protein binding. In one study involving 48 patients, intravenous sulfisoxazole resulted in a decrease in the amount of thiopental required for anesthesia and in a shortening of the awakening time. It is not known whether chronic oral doses of sulfisoxazole have a similar effect. Until more is known about this interaction, physicians should be aware that patients receiving sulfisoxazole might require less thiopental for anesthesia.

Sulfonamides can displace methotrexate from plasma protein binding sites, thus increasing free methotrexate concentrations. Studies in man have shown sulfisoxazole infusions to decrease plasma protein-bound methotrexate by one fourth.

Sulfisoxazole can also potentiate the blood-sugar-lowering activity of sulfonylureas.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Carcinogenesis:

Erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension has not undergone adequate trials relating to carcinogenicity: each component, however, has been evaluated separately. Long-term (21 month) oral studies conducted in rats with erythromycin ethylsuccinate did not provide evidence of tumorigenicity. Sulfisoxazole was not carcinogenic in either sex when administered to mice by gavage for 103 weeks at dosages up to approximately 18 times the recommended human dose or to rats at 4 times the human dose. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides, and long-term administration of sulfonamides has resulted in thyroid malignancies in this species.

Mutagenesis:

There are no studies available that adequately evaluate the mutagenic potential of erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension or either of its components. However, sulfisoxazole was not observed to be mutagenic in E. coli Sd-4-73 when tested in the absence of a metabolic activating system. There was no apparent effect on male or female fertility in rats fed erythromycin (base) at levels up to 0.25% of diet.

Impairment of Fertility:

Erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension has not undergone adequate trials relating to impairment of fertility. In a reproduction study in rats given 7 times the human dose per day of sulfisoxazole, no effects were observed regarding mating behavior, conception rate or fertility index (percent pregnant).

Pregnancy:

Teratogenic Effects:

Pregnancy Category C:

At dosages 7 times the human daily dose, sulfisoxazole was not teratogenic in either rats or rabbits. However, in two other teratogenicity studies, cleft palates developed in both rats and mice after administration of 5 to 9 times the human therapeutic dose of sulfisoxazole.

There is no evidence of teratogenicity or any other adverse effects on reproduction in female rats fed erythromycin base (up to 0.25% of diet) prior to and during mating, during gestation, and through weaning of two successive litters. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Erythromycin has been reported to cross the placental barrier in humans, but fetal plasma levels are generally low.

There are no adequate or well-controlled studies of erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension in either laboratory animals or in pregnant women. It is not known whether erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension can cause fetal harm when administered to a pregnant woman prior to term or can affect reproduction capacity. Erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects:

Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with sulfonamides. (See CONTRAINDICATIONS:.)

Labor and Delivery:

The effects of Erythromycin and Sulfisoxazole on labor and delivery are unknown.

Nursing Mothers:

Both Erythromycin and Sulfisoxazole are excreted in human milk. Because of the potential for the development of kernicterus in neonates due to the displacement of bilirubin from plasma proteins by sulfisoxazole, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. (See CONTRAINDICATIONS:

Pediatric Use:

See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections. Not for use in children under 2 months of age. (See CONTRAINDICATIONS.)

ADVERSE REACTIONS:

Erythromycin Ethylsuccinate:

The most frequent side effects of oral erythromycin preparations are gastrointestinal and are dose-related. They include nausea, vomiting, abdominal pain, diarrhea and anorexia. Symptoms of hepatic dysfunction and/or abnormal liver-function test results may occur (see WARNINGS section). Pseudomembranous colitis has been rarely reported in association with erythromycin therapy.

Allergic reactions ranging from urticaria and mild skin eruptions to anaphylaxis have occurred.

There have been isolated reports of reversible hearing loss occurring chiefly in patients with renal insufficiency and in patients receiving high doses of erythromycin.

Onset of pseudomembranous colitis symptoms may occur during of after antibiotic treatment. (See WARNINGS.)

Sulfisoxazole Acetyl:

Included in the listing that follows are adverse reactions that have been reported with other sulfonamide products: pharmacologic similarities require that each of the reactions be considered with erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension administration.

Allergic/Dermatologic:

Anaphylaxis, erythema multiforme (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), exfoliative dermatitis, angioedema, arteritis, vasculitis, allergic myocarditis, serum sickness, rash, urticaria, pruritus, photosensitivity, and conjunctival and scleral injection. In addition, periarteritis nodosa and systemic lupus erythematosus have been reported. (See WARNINGS.)

Cardiovascular:

Tachycardia, palpitations, syncope, and cyanosis.

Rarely, erythromycin has been associated with the production of ventricular arrhythmias, including ventricular tachycardia and torsade de pointes, in individuals with prolonged QT intervals.

Endocrine:

The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. Cross-sensitivity may exist with these agents. Developments of goiter, diuresis, and hypoglycemia has occurred rarely in patients receiving sulfonamides.

Gastrointestinal:

Hepatitis, hepatocellular necrosis, jaundice, pseudomembranous colitis, nausea, emesis, anorexia, abdominal pain, diarrhea, gastrointestinal hemorrhage, melena, flatulence, glossitis, stomatitis, salivary gland enlargement, and pancreatitis. Onset of pseudomembranous colitis symptoms may occur during or after treatment with sulfisoxazole, a component of erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension. (See WARNINGS.)

 

The sulfisoxazole acetyl component of erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension has been reported to cause increased elevation of liver-associated enzymes in patients with hepatitis.

Genitourinary:

Crystalluria, hematuria, BUN and creatinine elevations, nephritis, and toxic nephrosis with oliguria and anuria. Acute renal failure and urinary retention have also been reported.

 

The frequency of renal complications, commonly associated with some sulfonamides, is lower in some patients receiving the more soluble sulfonamides such as sulfisoxazole.

Hematologic:

Leukopenia, agranulocytosis, aplastic anemia, thrombocytopenia, purpura, hemolytic anemia, anemia, eosinophilia, clotting disorders including hypopro-thrombinemia and hypofibrinogenemia, sulfhemoglobinemia, and methemoglobinemia.

Neurologic:

Headache, dizziness, peripheral neuritis, paresthesia, convulsions, tinnitus, vertigo, ataxia, and intracranial hypertension.

Psychiatric:

Psychosis, hallucinations, disorientation, depression, and anxiety.

Respiratory:

Cough, shortness of breath, and pulmonary infiltrates. (See WARNINGS)

Vascular:

Angioedema, arteritis, and vasculitis.

Miscellaneous:

Edema, (including periorbital), pyrexia, drowsiness, weakness, fatigue, lassitude, rigors, flushing, hearing loss, insomnia, and pneumonitis.

Overdosage:

No information is available on a specific result of overdose with erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension. Overdosage of erythromycin should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures. Erythromycin is not removed by peritoneal dialysis or hemodialysis.

The amount of a single dose of sulfisoxazole that is either associated with symptoms of overdosage or is likely to be life-threatening has not been reported. Signs and symptoms of overdosage reported with sulfonamides include anorexia, colic, nausea, vomiting, dizziness, headache, drowsiness and unconsciousness. Pyrexia, hematuria and crystalluria may be noted. Blood dyscrasias and jaundice are potential late manifestations of overdosage.

General principles of treatment include the immediate discontinuation of the drug, instituting gastric lavage or emesis, forcing oral fluids, and administering intravenous fluids if urine output is low and renal function is normal. The patient should be monitored with blood counts and appropriate blood chemistries, including electrolytes. If the patient becomes cyanotic, the possibility of methemoglobinemia should be considered and, if present, the condition should be treated appropriately with intravenous 1% methylene blue. If a significant blood dyscrasia or jaundice occurs, specific therapy should be instituted for these complications. Peritoneal dialysis is not effective, and hemodialysis is only moderately effective in removing sulfonamides.

The acute toxicity of sulfisoxazole in animals is as follows:

Species	LD50=S.E. (mg/kg)
mouse	5700 = 235
rats	± 10,000
rabbits	± 2000

DOSAGE AND ADMINISTRATION:

ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL FOR ORAL SUSPENSION SHOULD NOT BE ADMINISTERED TO INFANTS UNDER 2 MONTHS OF AGE BECAUSE OF CONTRAINDICATIONS OF SYSTEMIC SULFONAMIDES IN THIS AGE GROUP.

For Acute Otitis Media in Children:

The dose of erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension can be calculated based on the erythromycin component (50 mg/kg/day) or the sulfisoxazole component (150 mg/kg/day to a maximum of 6 g/day). The total daily dose of erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension should be administered in equally divided doses three or four times a day for 10 days. Erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension may be administered without regard to meals.

The following approximate dosage schedules are recommended for using erythromycin ethylsuccinate and sulfisoxazole acetyl for oral suspension:

Children:

Two months of age or older

FOUR-TIMES-A-DAY SCHEDULE
Weight	Dose - every 6 hours
Less than 8 kg (<18 lbs)	Adjust dosage by body weight
8 kg (18 lbs)	1/2 teaspoonful (2.5 mL)
16 kg (35 lbs)	1 teaspoonful (5 mL)
24 kg (53 lbs)	1-1/2 teaspoonfuls (7.5 mL)
Over 32 kg (over 70 lbs)	2 teaspoonfuls (10 mL)
THREE-TIMES-A-DAY SCHEDULE
Weight	Dose - every 8 hours
Less than 6 kg (>13 lbs)	Adjust dosage by body weight
6 kg (13 lbs)	1/2 teaspoonful (2.5 mL)
12 kg (26 lbs)	1 teaspoonful (5 mL)
18 kg (40 lbs)	1-1/2 teaspoonfuls (7.5 mL)
24 kg (53 lbs)	2 teaspoonfuls (10 mL)
Over 30 kg (over 66 lbs)	2-1/2 teaspoonfuls (12.5 mL)

HOW SUPPLIED:

Erythromycin Ethylsuccinate and Sulfisoxazole Acetyl for Oral Suspension is available for teaspoon dosage in 100 mL (NDC 51285-445-22), 150 mL (NDC 51285-445-21) and 200 mL (NDC 51285-445-23) bottles, in the form of granules to be reconstituted with water. The suspension provides erythromycin ethylsuccinate equivalent to 200 mg erythromycin activity and sulfisoxazole acetyl equivalent to 600 mg sulfisoxazole per teaspoonful (5 mL).

Store at room temperature in dry form.

REFERENCES:

1. Biovert A, Barbeau G. Belanger PM: Pharmacokinetics of sulfisoxazole in young and elderly subjects. Gerontology 1984; 30: 125-131.


2. Oie S. Gambertoglio JG, Fleckenstein L: Comparison of the disposition of total and unbound sulfisoxazole after single and multiple dosing. J Pharmacokinet Biopharm 1982; 10: 157 - 172.


3. National Committee for Clinical Laboratory Standards: Performance Standards for Antimicrobial Disk Susceptibility Tests, ed 4. Approved Standard NCCLS Document M2-A4, Vol 10, No. 7. Villanova, Pa: NCCLS, 1990.

Manufactured by Duramed Pharmaceuticals, Inc.

Packaged by Pharmaceutics International, Inc.

Hunt Valley, Maryland 21031

for Duramed Pharmaceuticals, Inc.

Subsidiary of Barr Pharmaceuticals, Inc.

Pomona, NY 10970

Revised MARCH 2007

BR-0445

PRINCIPAL DISPLAY PANEL

100 mL Label Text

NDC 51285-445-22

E.S.P. (R)

Erythromycin Ethylsuccinate

and Sulfisoxazole Acetyl

for Oral Suspension, USP

200 mg erythromycin activity

and the equivalent of

600 mg sulfisoxazole

per 5 mL reconstituted

100 mL (when mixed) DURAMED(R) Rx only

ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL  erythromycin ethylsuccinate and sulfisoxazole acetyl  granule, for suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51285-445 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ERYTHROMYCIN ETHYLSUCCINATE (ERYTHROMYCIN) ERYTHROMYCIN ETHYLSUCCINATE 200 mg  in 5 mL SULFISOXAZOLE ACETYL (SULFISOXAZOLE) SULFISOXAZOLE ACETYL 600 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength LACTOSE, ANHYDROUS   METHYLPARABEN   POLYSORBATE 80   POVIDONE   ANHYDROUS TRISODIUM CITRATE   SUCROSE

Product Characteristics Color      Score      Shape Size Flavor CHERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 51285-445-22 100 mL In 1 BOTTLE None 2 51285-445-21 150 mL In 1 BOTTLE None 3 51285-445-23 200 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA062759	05/20/1988

Labeler - Duramed Pharmaceuticals Inc. (017038951)

Revised: 11/2009Duramed Pharmaceuticals Inc.

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Ambifed-G

Generic Name: guaifenesin and pseudoephedrine (gwye FEN e sin, SOO doe ee FED rin)

Brand Names: Altarussin PE, Ambifed, Ambifed-G, Biotuss PE, Congestac, D-Feda II, Despec-SR, Dynex, Entex PSE, ExeFen, ExeFen-IR, Guiatex II SR, Levall G, Maxifed, Maxifed-G, Medent LD, Medent-LDI, Mucinex D, Mucinex D Max Strength, Nasabid SR, Nasatab LA, Nomuc-PE, Poly-Vent, Poly-Vent IR, Poly-Vent, Jr., Pseudatex, Pseudo GG, Pseudo GG TR, Pseudo Max, Q-Tussin PE, Respaire-120 SR, Respaire-30, Respaire-60 SR, Robitussin PE, Robitussin Severe Congestion, Ru-Tuss Jr., Sinutab Non Drying, Stamoist E, SudaTex-G, Tenar PSE, Touro LA, Touro LA-LD, Triaminic Softchews Chest Congestion, We Mist II LA, We Mist LA

What is Ambifed-G (guaifenesin and pseudoephedrine)?

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of guaifenesin and pseudoephedrine is used to treat stuffy nose, sinus congestion, and cough caused by allergies or the common cold.

Guaifenesin and pseudoephedrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Ambifed-G (guaifenesin and pseudoephedrine)?

Do not give this medication to a child younger than 4 years old. Alwayss ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Guaifenesin and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or pseudoephedrine.

What should I discuss with my healthcare provider before taking Ambifed-G (guaifenesin and pseudoephedrine)?

You should not use this medication if you are allergic to guaifenesin or pseudoephedrine, or to other decongestants, diet pills, stimulants, or ADHD medications. Do not use a cough or cold medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

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

• 
  

  heart disease or high blood pressure;

  
  


• 
  

  diabetes; or

  
  


• 
  

  a thyroid disorder.

  
  

It is not known whether guaifenesin and pseudoephedrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Guaifenesin and pseudoephedrine may pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially sweetened liquid cough or cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take Ambifed-G (guaifenesin and pseudoephedrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cough and cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication. Take with food if this medicine upsets your stomach. Do not take guaifenesin and pseudoephedrine for longer than 7 days in a row. Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need surgery, tell the surgeon ahead of time if you have taken a cough or cold medicine within the past few days.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Since cough or cold medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include nausea, vomiting, dizziness, and feeling restless or nervous.

What should I avoid while taking Ambifed-G (guaifenesin and pseudoephedrine)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of guaifenesin and pseudoephedrine.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Guaifenesin and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains guaifenesin or pseudoephedrine.

Ambifed-G (guaifenesin and pseudoephedrine) side effects

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

• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  severe dizziness, anxiety, or nervousness;

  
  


• 
  

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

  
  


• 
  

  increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

  
  

Less serious side effects may include:

• 
  

  dizziness or headache;

  
  


• 
  

  feeling restless or excited;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  mild nausea, vomiting, or stomach upset;

  
  


• 
  

  mild loss of appetite;

  
  


• 
  

  warmth, redness, or tingly feeling under your skin; or

  
  


• 
  

  skin rash or itching.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Ambifed-G (guaifenesin and pseudoephedrine)?

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

• 
  

  methyldopa (Aldomet);

  
  


• 
  

  blood pressure medications;

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or

  
  


• 
  

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

  
  

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

More Ambifed-G resources

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

• Congestac MedFacts Consumer Leaflet (Wolters Kluwer)


• Entex PSE Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Mucinex D Prescribing Information (FDA)


• Mucinex D Consumer Overview


• Pseudovent Consumer Overview


• Robitussin Severe Congestion MedFacts Consumer Leaflet (Wolters Kluwer)


• Zephrex LA Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Ambifed-G with other medications

• Cough and Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about guaifenesin and pseudoephedrine.

See also: Ambifed-G side effects (in more detail)

Alupent Syrup

Alupent Syrup

(orciprenaline sulphate)

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets troublesome or serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What ALUPENT Syrup is and what it is used for


• 2. Before you take ALUPENT Syrup


• 3. How to take ALUPENT Syrup


• 4. Possible side effects


• 5. How to store ALUPENT Syrup


• 6. Further information

What Alupent Syrup Is And What It Is Used For

ALUPENT Syrup contains a medicine called orciprenaline. This belongs to a group of medicines called bronchodilators.

ALUPENT Syrup is used for something called ‘reversible airways obstruction’. This is where there is a narrowing of the airways of the lungs. Reversible airways obstruction is common in asthma and chronic obstructive pulmonary disease (COPD).

ALUPENT Syrup works to help people breathe more easily by relaxing the muscles and opening up the airways in their lungs.

Before You Take Alupent Syrup

Do not take ALUPENT Syrup if:

• You are allergic (hypersensitive) to orciprenaline or any of the other ingredients of ALUPENT Syrup (listed in Section 6 below)


• You have a heart problem called ‘hypertrophic obstructive cardiomyopathy’. This is where the wall between the two sides of the heart gets bigger and blocks the blood flow


• You have a very fast heart beat (called ‘tachyarrhythmia’)


• You are pregnant, likely to get pregnant or are breast-feeding

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist.

Take special care with ALUPENT Syrup

Check with your doctor or pharmacist before taking your medicine if:

• You have recently had a heart attack or have any other heart or circulation problems


• You have an over-active thyroid gland


• You have diabetes


• You have ever had something called ‘pheochromocytoma’. This is a rare tumour that is not malignant. The chemicals the tumour produces may make the effects of the medicine stronger.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking ALUPENT Syrup.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because ALUPENT Syrup can affect the way some other medicines work. Also some other medicines can affect the way ALUPENT Syrup works.

In particular tell your doctor or pharmacist if you are taking any of the following medicines:

• Other medicines for breathing problems such as theophylline


• Medicines for high blood pressure such as beta-blockers and diuretics (water pills)


• Medicines for depression such as ‘monoamine oxidase inhibitors’ (MAOIs) for example phenelzine or ‘tricyclic antidepressants’ for example amitriptyline


• Medicines called ‘anti-cholinergics’. These are often in products for colicky pain.

Operations

Some gases used in operations (anaesthetic gases) may affect how your medicine works. If you are about to have surgery, make sure you mention that you are taking ALUPENT Syrup to the doctor, dentist or anaesthetist.

Pregnancy and breast-feeding

Do not take ALUPENT Syrup if you are pregnant, likely to get pregnant or if you are breast-feeding.

Important information about some of the ingredients of ALUPENT Syrup

ALUPENT Syrup contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). These can cause allergic reactions in some people that could occur some time after taking the medicine.

ALUPENT Syrup also contains sodium metabisulphite which can cause allergic type reactions (including severe reactions and breathing problems) in some people, especially those with a history of asthma or allergies.

Each 300 ml bottle of syrup also contains 84 g of sorbitol. When taken according to the dosage recommendations, each 5 ml dose supplies up to 1.4 g of sorbitol which has a calorific value of 3.64Kcal. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. The sorbitol in the product may have a mild laxative effect. If in doubt ask your doctor or pharmacist.

How To Take Alupent Syrup

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

• Use a 5 ml plastic spoon to take the syrup. They are available from your pharmacist


• ALUPENT Syrup should only be taken by mouth

How much to take

Children under 1 year

• The usual starting dose is half a 5 ml spoonful (2.5 ml) three times a day


• This may be increased up to one 5 ml spoonful three times a day by your doctor


• The most your doctor will prescribe to be taken in a day is three 5 ml spoonfuls

Children between 1 and 3 years

• The usual starting dose is half a 5 ml spoonful (2.5 ml) four times a day


• This may be increased up to one 5 ml spoonful four times a day by your doctor


• The most your doctor will prescribe to be taken in a day is four 5 ml spoonfuls

Children between 3 and 12 years

• The usual starting dose is one 5 ml spoonful four times a day


• This may be increased to two 5 ml spoonfuls three times a day by your doctor


• The most your doctor will prescribe to be taken in a day is six 5 ml spoonfuls

Adults

• The usual dose is two 5 ml spoonfuls four times a day


• The most your doctor will prescribe to be taken in a day is eight 5 ml spoonfuls

If you take more ALUPENT Syrup than you should

If you take more of this medicine than you should, see your doctor or go to a hospital straight away. Take the medicine container with you even if there is no ALUPENT Syrup left.

If you forget to take ALUPENT Syrup

• If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose


• Do not take a double dose to make up for a forgotten dose

If you think this medicine is not working well enough

If your medicine does not seem to be working for you, talk to your doctor as soon as possible.

Do not take extra ALUPENT Syrup unless your doctor tells you to.

Alupent Syrup Side Effects

Like all medicines, ALUPENT Syrup can cause side effects, although not everybody gets them.

The following side effects may happen with this medicine:

Allergic reactions

If you have a severe allergic reaction, stop taking this medicine and see a doctor straight away. The signs may include:

• swelling of the mouth and face


• sudden breathing difficulties


• your blood pressure being lower than it normally is

Other side effects

• Feeling shaky, nervous or moody


• Feeling sick (nausea), being sick (vomiting) or having an upset stomach


• Feeling weak, dizzy, sweating or having a headache


• Muscle cramps or pain


• A faster or uneven heartbeat or a change in blood pressure


• Tightness of the chest


• Chest pain (due to heart problems such as angina). Tell your doctor or pharmacist if this occurs but do not stop taking this medicine unless told to do so.


• Mild skin reactions or allergic reactions

If any of the side effects gets troublesome or serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

If very high doses of ALUPENT are taken, it may cause unusually low levels of potassium in the blood (hypokalemia).

How To Store Alupent Syrup

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of the month.

The bottle containing ALUPENT Syrup should be stored in the outer carton and not above 25°C.

Keep the bottle tightly closed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What ALUPENT Syrup contains

• Each 5 ml of your medicine contains 10 mg of the active substance orciprenaline sulphate


• The other ingredients are sodium metabisulphite, disodium edetate dihydrate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, hydroxyethylcellulose, saccharin, sorbitol solution, woodruff aroma, sodium hydroxide and purified water

What ALUPENT Syrup looks like and content of the pack

ALUPENT Syrup is 300 ml of syrup in a bottle.

This bottle comes in a carton.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for ALUPENT Syrup is held by:

Boehringer Ingelheim Limited

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

United Kingdom

And the syrup is manufactured by:

Istituto de Angeli S.r.l.

Localitá Prulli di Sotto n.103/C

50066 Reggello (FI)

Italy

This leaflet was revised in February 2009.

© Boehringer Ingelheim Limited 2009

437123/GB/6

20081216

Colsalide

Generic Name: colchicine (Oral route)

KOL-chi-seen

Commonly used brand name(s)

In the U.S.

• Colcrys


• Colsalide

Available Dosage Forms:

• Tablet

Therapeutic Class: Antigout

Uses For Colsalide

Colchicine is used to prevent or treat attacks of gout (also called gouty arthritis). This condition is caused by too much uric acid in the blood. An attack of gout occurs when uric acid causes inflammation (pain, redness, swelling, and heat) in a joint. Colchicine does not cure gout, but it will help prevent gout attacks. Colchicine is not an ordinary pain reliever and will not relieve most kinds of pain.

Colchicine is also used to treat a rare condition called familial Mediterranean fever (FMF) in adults and children above 4 years of age.

Colchicine may also be used for other conditions as determined by your doctor.

Colchicine may be used in 2 ways. Most people take small amounts of it regularly for a long time (months or even years) to prevent severe attacks or other problems caused by inflammation. Other people take large amounts of colchicine during a short period of time (several hours) only when the medicine is needed to relieve an attack that is occurring. The chance of serious side effects is much lower with the first (preventive) kind of treatment.

Because some of colchicine's side effects can be very serious, you should discuss with your doctor about the good that this medicine can do as well as the risks of using it.

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

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

• Amyloidosis.


• Behçet's syndrome.


• Calcium pyrophosphate deposition disease (pseudogout).


• Cirrhosis of the liver.


• Pericarditis.


• Sarcoid arthritis.

If you are taking colchicine for any of these conditions, the following information may apply:

• For all of these conditions, colchicine is usually given regularly in small amounts to reduce inflammation (preventive treatment). This usually decreases the occurrence of severe attacks or other problems caused by inflammation.


• Colchicine is not a cure for these conditions. It will help prevent problems caused by inflammation only as long as you continue to take it.


• Some patients with calcium pyrophosphate deposition disease (pseudogout) or familial Mediterranean fever may take larger amounts of colchicine only when an attack occurs, to relieve the attack.

Before Using Colsalide

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 colchicine in children with gout. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of colchicine in children with FMF. However, safety and efficacy of colchicine have not been established in children with FMF younger than 4 years of age.

Geriatric

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

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

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.

• Atazanavir


• Boceprevir


• Clarithromycin


• Darunavir


• Indinavir


• Itraconazole


• Ketoconazole


• Lopinavir


• Nefazodone


• Nelfinavir


• Ritonavir


• Saquinavir


• Telithromycin


• Tipranavir

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.

• Amprenavir


• Aprepitant


• Cyclosporine


• Diltiazem


• Erythromycin


• Fluconazole


• Fosamprenavir


• Gemfibrozil


• Interferon Alfa-2a


• Lovastatin


• Pravastatin


• Quinidine


• Ranolazine


• Reserpine


• Simvastatin


• Tacrolimus


• Telaprevir


• Verapamil

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.

• Atorvastatin


• Bezafibrate


• Ciprofibrate


• Clofibrate


• Digoxin


• Fenofibrate


• Fluvastatin

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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other Medical Problems

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

• Alcohol abuse or


• Bowel disease or


• Stomach ulcer or other stomach problems—The chance of stomach upset may be increased. Also, colchicine can make some kinds of stomach or intestinal problems worse.

• Blood disorders (e.g., aplastic anemia, granulocytopenia, leukopenia, pancytopenia) or


• Muscle or nerve problems—Use with caution. May make these conditions worse.

• Kidney disease or


• Liver disease—Should not be used in patients with these conditions.

Proper Use of colchicine

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

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take more of it, and do not take it for a longer time than your doctor ordered. Do not change your dose or stop using this medicine without checking first with your doctor.

For patients taking small amounts of colchicine regularly (preventive treatment):

• Take this medicine regularly as directed by your doctor, even if you feel well. If you are taking colchicine to prevent gout attacks, and you are also taking another medicine to reduce the amount of uric acid in your body, you probably will be able to stop taking colchicine after a while. However, if you stop taking it too soon, your attacks may return or get worse. If you are taking colchicine for certain other medical conditions, you may need to keep taking it for the rest of your life.


• If you are taking colchicine to prevent gout attacks, ask your doctor to recommend other medicine to be taken if an attack occurs. Most people receiving preventive amounts of colchicine should not take extra colchicine to relieve an attack. However, some people cannot take the other medicines that are used for gout attacks and will have to take extra colchicine. If you are one of these people, ask your doctor to tell you the largest amount of colchicine you should take for an attack and how long you should wait before starting to take the smaller preventive amounts again. Be sure to follow these directions carefully.

For patients taking large amounts of colchicine only when needed to relieve an attack:

• Start taking this medicine at the first sign of the attack for best results.


• Stop taking this medicine as soon as the pain is relieved or at the first sign of nausea, vomiting, stomach pain, or diarrhea . Also, stop taking colchicine when you have taken the largest amount that your doctor ordered for each attack, even if the pain is not relieved or none of these side effects occurs.


• The first few times you take colchicine, keep a record of each dose as you take it. Then, whenever stomach upset (nausea, vomiting, stomach pain, or diarrhea) occurs, count the number of doses you have taken. The next time you need colchicine, stop taking it before that number of doses is reached. For example, if diarrhea occurs after your fifth dose of medicine, take no more than four doses the next time. If taking fewer doses does not prevent stomach upset from occurring after a few treatments, check with your doctor.


• After taking colchicine tablets to treat an attack, do not take any more colchicine for at least 3 days. Also, after receiving the medicine by injection for an attack, do not take any more colchicine (tablets or injection) for at least 7 days. Elderly patients may have to wait even longer between treatments and should check with their doctor for directions.


• If you are taking colchicine for an attack of gout, and you are also taking other medicine to reduce the amount of uric acid in your body, do not stop taking the other medicine. Continue taking the other medicine as directed by your doctor.

You may take this medicine with or without food.

Dosing

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

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

• For oral dosage form (tablets):
  
  • For familial mediterranean fever (FMF):
    
    • Adults and teenagers—1.2 to 2.4 milligrams (mg) given in one or two divided doses a day. Your doctor may adjust your dose as needed.
    
    
    • Children 6 to 12 years of age—0.9 to 1.8 milligrams (mg) given in one or two divided doses a day.
    
    
    • Children 4 to 6 years of age—0.3 to 1.8 milligrams (mg) given in one or two divided doses a day.
    
    
    • Children younger than 4 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For gout attacks:
    
    • Adults—1.2 milligrams (mg) at the first sign of a gout attack, followed by 0.6 mg after one hour. The dose is usually 1.8 mg over a 1 hour period.
    
    
    • Children—Use is not recommended.
    
    
  
  

Missed Dose

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

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Colsalide

If you must take colchicine for a long time (preventive treatment), your doctor may want to check your progress at regular visits. Blood tests may be needed to check for unwanted effects.

Stomach problems may be more likely to occur if you drink large amounts of alcoholic beverages while taking colchicine. Also, drinking too much alcohol may increase the amount of uric acid in your blood. This may lessen the effects of colchicine when it is used to prevent gout attacks. Therefore, people who take colchicine should be careful to limit the amount of alcohol they drink.

For patients taking small amounts of colchicine regularly (preventive treatment):

• Attacks of gout or other problems caused by inflammation may continue to occur during treatment. However, the attacks or other problems should occur less often, and they should not be as severe as they were before you started taking colchicine. Even if you think the colchicine is not working, do not stop taking it and do not increase the dose. Check with your doctor instead.

Colchicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur.

If your doctor tells you to increase the amount of medicine you are taking or if you are just starting this medicine, make sure you tell the doctor right away if you get muscle pain, tenderness, or weakness.

Grapefruits and grapefruit juice may increase the effects of colchicine by increasing the amount of this medicine in your body. You should not eat grapefruit or drink grapefruit juice while you taking 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.

Colsalide 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

• Diarrhea


• nausea or vomiting


• stomach pain

Rare

• Black, tarry stools


• blood in the urine or stools


• burning, "crawling", or tingling feeling in the skin


• difficulty in breathing when exercising


• fever with or without chills


• headache


• large, hive-like swellings on the face, eyelids, mouth, lips, or tongue


• muscle weakness


• numbness in the fingers or toes (usually mild)


• pain


• peeling of the skin


• pinpoint red spots on the skin


• redness


• skin rash or hives


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


• sore throat


• swelling


• tenderness


• unusual bleeding or bruising


• unusual tiredness or weakness

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

Symptoms of overdose

• Bleeding


• burning feeling in the stomach, throat, or skin


• convulsions (seizures)


• diarrhea (severe or bloody)


• fast, shallow breathing


• muscle weakness (very severe)


• nausea, stomach pain, or vomiting (severe)

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:

Less common

• Hair loss


• loss of appetite

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: Colsalide 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 Colsalide resources

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

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Kao-Tin Advanced Formula Liquid

Pronunciation: at-ah-PULL-gyte
Generic Name: Attapulgite
Brand Name: Examples include Ka-Pec and Kao-Tin Advanced Formula

Kao-Tin Advanced Formula Liquid is used for:

Treating diarrhea and cramping. It may also be used for other conditions as determined by your doctor.

Kao-Tin Advanced Formula Liquid is an adsorbent. It works by adsorbing fluid, which helps to decrease the number of diarrhea stools.

Do NOT use Kao-Tin Advanced Formula Liquid if:

• you are allergic to any ingredient in Kao-Tin Advanced Formula Liquid


• you have a fever, or if you have blood or mucus in your stool


• you are taking a citrate salt (found in some calcium supplements, antacids, and laxatives)

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

Before using Kao-Tin Advanced Formula Liquid:

Some medical conditions may interact with Kao-Tin Advanced Formula Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


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


• if you have Alzheimer disease or inflammation of the appendix (appendicitis)

Some MEDICINES MAY INTERACT with Kao-Tin Advanced Formula Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Penicillamine or thyroid hormones (eg, levothyroxine) because the effectiveness of these medicines may be decreased


• Citrate salts because the risk of toxic effects from Kao-Tin Advanced Formula Liquid may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Kao-Tin Advanced Formula Liquid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Kao-Tin Advanced Formula Liquid:

Use Kao-Tin Advanced Formula Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Kao-Tin Advanced Formula Liquid may be taken with or without food.


• Shake well before using.


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


• Drinking extra fluids while you are taking Kao-Tin Advanced Formula Liquid is recommended. Check with your doctor for instructions.


• Take Kao-Tin Advanced Formula Liquid with a full glass of water.


• Do not take Kao-Tin Advanced Formula Liquid at the same time as a bisphosphonate (eg, alendronate), quinolone (eg, ciprofloxacin), or tetracycline (eg, doxycycline). Talk to your doctor or pharmacist about how to separate these medicines from your dose of Kao-Tin Advanced Formula Liquid.


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

Ask your health care provider any questions you may have about how to use Kao-Tin Advanced Formula Liquid.

Important safety information:

• If your symptoms do not improve within 48 hours or if they become worse, check with your doctor.


• Check with your doctor before using Kao-Tin Advanced Formula Liquid if you have abdominal pain, nausea, or vomiting.


• Do not use Kao-Tin Advanced Formula Liquid in CHILDREN younger than 6 years of age without first consulting a doctor.


• PREGNANCY and BREAST-FEEDING: It is unknown if Kao-Tin Advanced Formula Liquid can cause harm to the fetus. If you become pregnant while taking Kao-Tin Advanced Formula Liquid, discuss with your doctor the benefits and risks of using Kao-Tin Advanced Formula Liquid during pregnancy. It is unknown if Kao-Tin Advanced Formula Liquid is excreted in breast milk. If you are or will be breast-feeding while you are using Kao-Tin Advanced Formula Liquid, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Kao-Tin Advanced Formula Liquid:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Kao-Tin Advanced Formula side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Kao-Tin Advanced Formula Liquid:

Store Kao-Tin Advanced Formula Liquid at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Kao-Tin Advanced Formula Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Kao-Tin Advanced Formula Liquid, please talk with your doctor, pharmacist, or other health care provider.


• Kao-Tin Advanced Formula Liquid is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Kao-Tin Advanced Formula Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Kao-Tin Advanced Formula resources

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

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