Rubitracine

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Rubitracine uses

Rubitracine consists of Erythromycin Estolate, Erythromycin Propionate, Lysozyme Hydrochloride, Tetracycline, Tetracycline Hydrochloride.

Erythromycin Estolate:


Pharmacological action

Rubitracine is a macrolide antibiotic. Has bacteriostatic action. However at higher doses against susceptible organisms has a bactericidal effect. erythromycin is reversibly bound to the ribosome of bacteria, thereby inhibiting protein synthesis. Rubitracine (Erythromycin Estolate) is active against gram-positive bacteria: Staphylococcus spp. (strains producing and not producing penicillinase), Streptococcus spp. (including Streptococcus pneumoniae); gram-negative bacteria: Neisseria gonorrhoeae, Haemophilus influenzae, Bordetella pertussis, Brucella spp., Legionella spp., Bacillus anthracis, Corynebacterium diphtheriae; anaerobic bacteria: Clostridium spp. erythromycin is also active against Mycoplasma spp., Chlamydia spp., Spirochaetaceae, Rickettsia spp. To erythromycin resistant gram-negative bacilli, including Escherichia coli, Pseudomonas aeruginosa, Shigella spp., Salmonella spp.

Pharmacokinetics

Rubitracine (Erythromycin Estolate) bioavailability is 30-65%. Distributed in most tissues and body fluids. Plasma protein binding is 70-90%. Metabolised in the liver, partly with the formation of inactive metabolites. T1/2 is 1.4-2 hours. It is derived from bile and urine.

Why is Rubitracine prescribed?

Infectious-inflammatory diseases caused by microorganisms sensitive to erythromycin, including diphtheria, pertussis, trachoma, brucellosis, a disease Legionnaires, sore throat, scarlet fever, otitis media, sinusitis, cholecystitis, pneumonia, gonorrhea, syphilis. Also Rubitracine (Erythromycin Estolate) used for the treatment of infectious-inflammatory diseases caused by pathogens (eg staphylococci) are resistant to penicillin, tetracycline, chloramphenicol, streptomycin.

For external use: acne vulgaris.

For local use: the infectious-inflammatory diseases of eyes.

Dosage and administration

Rubitracine prescribed individually depending on the location and severity of infection, the sensitivity of the parasite. In adults use a daily dose of 1-4 g. Children under the age of 3 months - 20-40 mg / kg / day, aged from 4 months to 18 years - 30-50 mg / kg / day. Multiplicity is 4 times / day. The treatment course - 5-14 days after the disappearance of symptoms treatment should be continued for a further 2 days. Accepts up to 1 hour before eating or 2-3 hours after eating.

Solution for external applications lubricate the affected skin.

The ointment is applied to the affected area and in diseases of the eye lay behind the lower eyelid. The dose, frequency and duration of application is determined individually.

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Rubitracine (Erythromycin Estolate) side effects, adverse reactions

Digestive system: nausea, vomiting, epigastric pain, cholestatic jaundice, tenesmus, diarrhea, dysbacteriosis; rarely - pseudomembranous enterocolitis, abnormal liver function, increase in liver transaminases, pancreatitis.

Allergic reactions: skin rash, urticaria, eosinophilia, rarely - anaphylactic shock.

Effects due to the influence of chemotherapy: oral candidiasis, vaginal candidiasis.

From the senses: the reversible ototoxicity - hearing loss and / or tinnitus (in the application of high doses - more than 4 g / day).

Since the cardiovascular system: rarely - tachycardia, prolongation of the QT interval on ECG, flickering and / or atrial flutter (patients with long QT interval on the ECG).

Local reactions: phlebitis at the site of / in the introduction.

Rubitracine contraindications

Jaundice in history, marked disturbances of liver function, hypersensitivity to macrolides.

Using during pregnancy and breastfeeding

Erythromycin crosses the placental barrier, excreted in breast milk.

In the application of erythromycin in pregnancy should assess the intended benefits to the mother and the potential risk to the fetus. If necessary, use during lactation should decide on the termination of breastfeeding.

Special instructions

With careful use Rubitracine when disorders of liver function and / or kidneys. Medications that increase the acidity of gastric juice and acidic drinks inactivate erythromycin. erythromycin can not drink milk and dairy products.

Precautionary measures

The use of erythromycin containing benzene for IV injection sometimes accompanied by the development of a fatal syndrome Gaspinga in children, as well as acute hepatitis drug in adults and children.

Rubitracine drug interactions

With simultaneous use of Rubitracine (Erythromycin Estolate) with theophylline, aminophylline, caffeine, there is an increase in their concentration in blood plasma and thus increases the risk of toxic effects.

Erythromycin increases the concentrations of cyclosporine in the blood plasma and may increase the risk of nephrotoxicity.

Drugs that block tubular secretion prolongs T1/2 of erythromycin.

Incompatible with lincomycin, clindamycin and chloramphenicol (antagonism).

Rubitracine (Erythromycin Estolate) reduces the bactericidal action of beta-lactam antibiotics (penicillins, cephalosporins, carbapenems).

With simultaneous use of erythromycin increases the concentration of theophylline.

At the same time receiving chemotherapy, which is carried metabolism in the liver (carbamazepine, valproic acid, hexobarbital, phenytoin, alfentanil, dizopiramid, lovastatin, bromocriptine), may increase the concentration of these drugs in plasma (an inhibitor of microsomal liver enzymes).

IV injection of erythromycin increases the effects of ethanol (accelerating gastric emptying and decrease the duration of alcohol dehydrogenase in the gastric mucosa).

Erythromycin reduces the clearance of triazolam and midazolam and therefore may increase the pharmacological effects of benzodiazepines.

At the same time taking with terfenadine or astemizole may develop arrhythmias (fibrillation and ventricular flutter, ventricular tachycardia, until death); with dihydroergotamine or non hydrated ergot alkaloids may vasoconstriction to spasm, dysesthesia.

With simultaneous application Rubitracine (Erythromycin Estolate) slows elimination (increases the effect) of methylprednisolone, felodipine and anticoagulants of cumarine series.

In a joint appointment with lovastatin increased rhabdomyolysis.

Erythromycin increases the bioavailability of digoxin.

Erythromycin reduces the effectiveness of hormonal contraceptives.

Rubitracine in case of emergency / overdose

Symptoms: disruption of the liver until the acute liver failure, and hearing loss.

Treatment: gastric lavage, forced diuresis, hemo-and peritoneal dialysis. Produced a constant monitoring of vital functions (ECG, electrolyte composition of blood).

Erythromycin Propionate:


INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Rubitracine tablets and other antibacterial drugs, Rubitracine (Erythromycin Propionate) tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Rubitracine (Erythromycin Propionate) tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below:

Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes; Streptococcus pneumoniae; Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the Rubitracine (Erythromycin Propionate) concentrations ordinarily achieved).

Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenes or Streptococcus pneumoniae.

Listeriosis caused by Listeria monocytogenes.

Respiratory tract infections due to Mycoplasma pneumoniae.

Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment).

Pertussis (whooping cough) caused by Bordetella pertussis. Rubitracine (Erythromycin Propionate) is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that Rubitracine (Erythromycin Propionate) may be helpful in the prophylaxis of pertussis in exposed susceptible individuals.

Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers.

Erythrasma: In the treatment of infections due to Corynebacterium minutissimum.

Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents.

Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythrocin® Lactobionate-I.V. (erythromycin lactobionate for injection, USP) followed by Rubitracine (Erythromycin Propionate) base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving Rubitracine (Erythromycin Propionate) as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months.

Erythromycins are indicated for treatment of the following infections caused by Chlamydia trachomatis: conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, Rubitracine (Erythromycin Propionate) is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis.

When tetracyclines are contraindicated or not tolerated, Rubitracine (Erythromycin Propionate) is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum.

Primary syphilis caused by Treponema pallidum. Rubitracine (Erythromycin Propionate) (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy.

Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that Rubitracine (Erythromycin Propionate) may be effective in treating Legionnaires' Disease.

Prophylaxis

Prevention of Initial Attacks of Rheumatic Fever

Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever.4 Rubitracine (Erythromycin Propionate) is indicated for the treatment of penicillin-allergic patients. The therapeutic dose should be administered for ten days.

Prevention of Recurrent Attacks of Rheumatic Fever

Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral Rubitracine (Erythromycin Propionate) is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).4

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CONTRAINDICATIONS

Rubitracine (Erythromycin Propionate) is contraindicated in patients with known hypersensitivity to this antibiotic.

Rubitracine (Erythromycin Propionate) is contraindicated in patients taking terfenadine, astemizole, cisapride, pimozide, ergotamine or dihydroergotamine. (See PRECAUTIONS – Drug Interactions .)

WARNINGS

Hepatotoxicity

There have been reports of hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, occurring in patients receiving oral Rubitracine products.

QT Prolongation

Rubitracine (Erythromycin Propionate) has been associated with prolongation of the QT interval and infrequent cases of arrhythmia. Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving Rubitracine (Erythromycin Propionate). Fatalities have been reported. Rubitracine (Erythromycin Propionate) should be avoided in patients with known prolongation of the QT interval, patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT interval.

Syphilis in Pregnancy

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

Clostridium difficile Associated Diarrhea

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Rubitracine (Erythromycin Propionate) tablets, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Drug Interactions

Serious adverse reactions have been reported in patients taking Rubitracine (Erythromycin Propionate) concomitantly with CYP3A4 substrates. These include colchicine toxicity with colchicine; rhabdomyolysis with simvastatin, lovastatin, and atorvastatin; and hypotension with calcium channel blockers metabolized by CYP3A4 (e.g., verapamil, amlodipine, diltiazem) (see PRECAUTIONS – Drug Interactions ).

There have been post-marketing reports of colchicine toxicity with concomitant use of Rubitracine (Erythromycin Propionate) and colchicine. This interaction is potentially life-threatening, and may occur while using both drugs at their recommended doses (see PRECAUTIONS – Drug Interactions ).

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

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PRECAUTIONS

General

Prescribing Rubitracine tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Since Rubitracine (Erythromycin Propionate) is principally excreted by the liver, caution should be exercised when Rubitracine (Erythromycin Propionate) is administered to patients with impaired hepatic function. (See CLINICAL PHARMACOLOGY and WARNINGS .)

Exacerbation of symptoms of myasthenia gravis and new onset of symptoms of myasthenic syndrome has been reported in patients receiving Rubitracine (Erythromycin Propionate) therapy.

There have been reports of infantile hypertrophic pyloric stenosis (IHPS) occurring in infants following Rubitracine (Erythromycin Propionate) therapy. In one cohort of 157 newborns who were given Rubitracine (Erythromycin Propionate) for pertussis prophylaxis, seven neonates (5%) developed symptoms of non-bilious vomiting or irritability with feeding and were subsequently diagnosed as having IHPS requiring surgical pyloromyotomy. A possible doseresponse effect was described with an absolute risk of IHPS of 5.1% for infants who took Rubitracine (Erythromycin Propionate) for 8-14 days and 10% for infants who took Rubitracine (Erythromycin Propionate) for 15-21 days.5 Since Rubitracine (Erythromycin Propionate) may be used in the treatment of conditions in infants which are associated with significant mortality or morbidity (such as pertussis or neonatal Chlamydia trachomatis infections), the benefit of Rubitracine (Erythromycin Propionate) therapy needs to be weighed against the potential risk of developing IHPS. Parents should be informed to contact their physician if vomiting or irritability with feeding occurs.

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

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

Observational studies in humans have reported cardiovascular malformations after exposure to drug products containing Rubitracine (Erythromycin Propionate) during early pregnancy.

Information for Patients

Patients should be counseled that antibacterial drugs including Rubitracine (Erythromycin Propionate) tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Rubitracine (Erythromycin Propionate) tablets are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Rubitracine (Erythromycin Propionate) tablets or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Drug Interactions

Theophylline

Rubitracine 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 Rubitracine (Erythromycin Propionate) therapy.

There have been published reports suggesting that when oral Rubitracine (Erythromycin Propionate) is given concurrently with theophylline there is a decrease in Rubitracine (Erythromycin Propionate) serum concentrations of approximately 35%. The mechanism by which this interaction occurs is unknown. The decrease in Rubitracine (Erythromycin Propionate) concentrations due to co-administration of theophylline could result in subtherapeutic concentrations of Rubitracine (Erythromycin Propionate).

Hypotension, bradyarrhythmias, and lactic acidosis have been observed in patients receiving concurrent verapamil, belonging to the calcium channel blockers drug class.

Concomitant administration of Rubitracine (Erythromycin Propionate) and digoxin has been reported to result in elevated digoxin serum levels.

There have been reports of increased anticoagulant effects when Rubitracine (Erythromycin Propionate) and oral anticoagulants were used concomitantly. Increased anticoagulation effects due to interactions of Rubitracine (Erythromycin Propionate) with oral anticoagulants may be more pronounced in the elderly.

Rubitracine (Erythromycin Propionate) is a substrate and inhibitor of the 3A isoform subfamily of the cytochrome p450 enzyme system (CYP3A). Coadministration of Rubitracine (Erythromycin Propionate) and a drug primarily metabolized by CYP3A may be associated with elevations in drug concentrations that could increase or prolong both the therapeutic and adverse effects of the concomitant drug. Dosage adjustments may be considered, and when possible, serum concentrations of drugs primarily metabolized by CYP3A should be monitored closely in patients concurrently receiving Rubitracine (Erythromycin Propionate).

The following are examples of some clinically significant CYP3A based drug interactions. Interactions with other drugs metabolized by the CYP3A isoform are also possible. The following CYP3A based drug interactions have been observed with Rubitracine (Erythromycin Propionate) products in post-marketing experience:

Ergotamine/dihydroergotamine

Post-marketing reports indicate that co-administration of Rubitracine (Erythromycin Propionate) with ergotamine or dihydroergotamine has been associated with acute ergot toxicity characterized by vasospasm and ischemia of the extremities and other tissues including the central nervous system. Concomitant administration of Rubitracine (Erythromycin Propionate) with ergotamine or dihydroergotamine is contraindicated (see CONTRAINDICATIONS ).

Triazolobenzodiazepines and related benzodiazepines

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

HMG-CoA Reductase Inhibitors

Rubitracine has been reported to increase concentrations of HMG-CoA reductase inhibitors (e.g., lovastatin and simvastatin). Rare reports of rhabdomyolysis have been reported in patients taking these drugs concomitantly.

Sildenafil (Viagra)

Rubitracine (Erythromycin Propionate) has been reported to increase the systemic exposure (AUC) of sildenafil. Reduction of sildenafil dosage should be considered.

There have been spontaneous or published reports of CYP3A based interactions of Rubitracine (Erythromycin Propionate) with cyclosporine, carbamazepine, tacrolimus, alfentanil, disopyramide, rifabutin, quinidine, methyl-prednisolone, cilostazol, vinblastine, and bromocriptine.

Concomitant administration of Rubitracine (Erythromycin Propionate) with cisapride, pimozide, astemizole, or terfenadine is contraindicated. (See CONTRAINDICATIONS .)

In addition, there have been reports of interactions of Rubitracine (Erythromycin Propionate) with drugs not thought to be metabolized by CYP3A, including hexobarbital, phenytoin, and valproate.

Rubitracine (Erythromycin Propionate) has been reported to significantly alter the metabolism of the nonsedating antihistamines terfenadine and astemizole when taken concomitantly. Rare cases of serious cardiovascular adverse events, including electrocardiographic QT/QTc interval prolongation, cardiac arrest, torsades de pointes, and other ventricular arrhythmias, have been observed. (See CONTRAINDICATIONS .) In addition, deaths have been reported rarely with concomitant administration of terfenadine and Rubitracine (Erythromycin Propionate).

There have been post-marketing reports of drug interactions when Rubitracine (Erythromycin Propionate) was co-administered with cisapride, resulting in QT prolongation, cardiac arrhythmias, ventricular tachycardia, ventricular fibrillation, and torsades de pointes, most likely due to the inhibition of hepatic metabolism of cisapride by Rubitracine (Erythromycin Propionate). Fatalities have been reported. (See CONTRAINDICATIONS ).

Colchicine

Colchicine is a substrate for both CYP3A4 and the efflux transporter P-glycoprotein. Rubitracine (Erythromycin Propionate) is considered a moderate inhibitor of CYP3A4. A significant increase in colchicine plasma concentration is anticipated when co-administered with moderate CYP3A4 inhibitors such as Rubitracine (Erythromycin Propionate). If co-administration of colchicine and Rubitracine (Erythromycin Propionate) is necessary, the starting dose of colchicine may need to be reduced, and the maximum colchicine dose should be lowered. Patients should be monitored for clinical symptoms of colchicine toxicity.

Drug/Laboratory Test Interactions

Rubitracine (Erythromycin Propionate) interferes with the fluorometric determination of urinary catecholamines.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term oral dietary studies conducted with Rubitracine stearate in rats up to 400 mg/kg/day and in mice up to about 500 mg/kg/day (approximately 1-2 fold of the maximum human dose on a body surface area basis) did not provide evidence of tumorigenicity. Rubitracine (Erythromycin Propionate) stearate did not show genotoxic potential in the Ames, and mouse lymphoma assays or induce chromosomal aberrations in CHO cells. There was no apparent effect on male or female fertility in rats treated with Rubitracine (Erythromycin Propionate) base by oral gavage at 700 mg/kg/day (approximately 3 times the maximum human dose on a body surface area basis).

Pregnancy

Teratogenic Effects

Pregnancy Category B

There is no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed Rubitracine base by oral gavage at 350 mg/kg/day (approximately twice the maximum recommended human dose on a body surface area) prior to and during mating, during gestation, and through weaning. No evidence of teratogenicity or embryotoxicity was observed when Rubitracine (Erythromycin Propionate) base was given by oral gavage to pregnant rats and mice at 700 mg/kg/day and to pregnant rabbits at 125 mg/kg/day (approximately 1-3 times the maximum recommended human dose).

Labor and Delivery

The effect of Rubitracine (Erythromycin Propionate) on labor and delivery is unknown.

Nursing Mothers

Rubitracine is excreted in human milk. Caution should be exercised when Rubitracine (Erythromycin Propionate) is administered to a nursing woman.

Pediatric Use

See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION .

Geriatric Use

Elderly patients, particularly those with reduced renal or hepatic function, may be at increased risk for developing erythromycin-induced hearing loss. (See ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION ).

Elderly patients may be more susceptible to development of torsades de pointes arrhythmias than younger patients. (See WARNINGS ).

Elderly patients may experience increased effects of oral anticoagulant therapy while undergoing treatment with Rubitracine (Erythromycin Propionate). (See PRECAUTIONS - Drug Interactions ).

Rubitracine (Erythromycin Propionate) 333 MG Tablets contain 0.5 mg (0.02 mEq) of sodium per individual dose.

Rubitracine (Erythromycin Propionate) 500 MG Tablets do not contain sodium.

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ADVERSE REACTIONS

The most frequent side effects of oral Rubitracine (Erythromycin Propionate) preparations are gastrointestinal and are dose-related. They include nausea, vomiting, abdominal pain, diarrhea and anorexia. Symptoms of hepatitis, hepatic dysfunction and/or abnormal liver function test results may occur. (See WARNINGS .)

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

Rubitracine (Erythromycin Propionate) has been associated with QT prolongation and ventricular arrhythmias, including ventricular tachycardia and torsades de pointes. (See WARNINGS .)

Allergic reactions ranging from urticaria to anaphylaxis have occurred. Skin reactions ranging from mild eruptions to erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported rarely.

There have been reports of interstitial nephritis coincident with Rubitracine (Erythromycin Propionate) use.

There have been rare reports of pancreatitis and convulsions.

There have been isolated reports of reversible hearing loss occurring chiefly in patients with renal insufficiency and in patients receiving high doses of Rubitracine (Erythromycin Propionate).

OVERDOSAGE

In case of overdosage, Rubitracine (Erythromycin Propionate) should be discontinued. Overdosage should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures should be instituted.

Rubitracine (Erythromycin Propionate) is not removed by peritoneal dialysis or hemodialysis.

DOSAGE AND ADMINISTRATION

In most patients, Rubitracine tablets are well absorbed and may be dosed orally without regard to meals. However, optimal blood levels are obtained when either Rubitracine (Erythromycin Propionate) 333 mg or Rubitracine (Erythromycin Propionate) 500 mg tablets are given in the fasting state (at least 1/2 hour and preferably 2 hours before meals).

Adults

The usual dosage of Rubitracine (Erythromycin Propionate) tablets are one 333 mg tablet every 8 hours or one 500 mg tablet every 12 hours. Dosage may be increased up to 4 g per day according to the severity of the infection. However, twice-a-day dosing is not recommended when doses larger than 1 g daily are administered.

Children

Age, weight, and severity of the infection are important factors in determining the proper dosage. The usual dosage is 30 to 50 mg/kg/day, in equally divided doses. For more severe infections this dosage may be doubled but should not exceed 4 g per day.

In the treatment of streptococcal infections of the upper respiratory tract, the therapeutic dosage of Rubitracine (Erythromycin Propionate) should be administered for at least ten days.

The American Heart Association suggests a dosage of 250 mg of Rubitracine (Erythromycin Propionate) orally, twice a day in long-term prophylaxis of streptococcal upper respiratory tract infections for the prevention of recurring attacks of rheumatic fever in patients allergic to penicillin and sulfonamides.4

Conjunctivitis of the Newborn Caused by Chlamydia trachomatis

Oral Rubitracine (Erythromycin Propionate) suspension 50 mg/kg/day in 4 divided doses for at least 2 weeks.4

Pneumonia of Infancy Caused by Chlamydia trachomatis

Although the optimal duration of therapy has not been established, the recommended therapy is oral Rubitracine suspension 50 mg/kg/day in 4 divided doses for at least 3 weeks.

Urogenital Infections During Pregnancy Due to Chlamydia trachomatis

Although the optimal dose and duration of therapy have not been established, the suggested treatment is 500 mg of Rubitracine (Erythromycin Propionate) by mouth four times a day or two Rubitracine (Erythromycin Propionate) 333 mg tablets orally every 8 hours on an empty stomach for at least 7 days. For women who cannot tolerate this regimen, a decreased dose of one Rubitracine (Erythromycin Propionate) 500 mg tablet orally every 12 hours, one 333 mg tablet orally every 8 hours or 250 mg by mouth four times a day should be used for at least 14 days.6

For adults with uncomplicated urethral, endocervical, or rectal infections caused by Chlamydia trachomatis, when tetracycline is contraindicated or not tolerated

500 mg of Rubitracine by mouth four times a day or two 333 mg tablets orally every 8 hours for at least 7 days.6

For patients with nongonococcal urethritis caused by Ureaplasma urealyticum when tetracycline is contraindicated or not tolerated

500 mg of Rubitracine (Erythromycin Propionate) by mouth four times a day or two 333 mg tablets orally every 8 hours for at least seven days.6

Primary Syphilis

30 to 40 g given in divided doses over a period of 10 to 15 days.

Acute Pelvic Inflammatory Disease Caused by N. gonorrhoeae

500 mg Erythrocin Lactobionate-I.V. every 6 hours for 3 days, followed by 500 mg of Rubitracine (Erythromycin Propionate) base orally every 12 hours, or 333 mg of Rubitracine (Erythromycin Propionate) base orally every 8 hours for 7 days.

Intestinal Amebiasis

Adults

500 mg every 12 hours, 333 mg every 8 hours or 250 mg every 6 hours for 10 to 14 days.

Children

30 to 50 mg/kg/day in divided doses for 10 to 14 days.

Pertussis

Although optimal dosage and duration have not been established, doses of Rubitracine utilized in reported clinical studies were 40 to 50 mg/kg/day, given in divided doses for 5 to 14 days.

Legionnaires' Disease

Although optimal dosage has not been established, doses utilized in reported clinical data were 1 to 4 g daily in divided doses.

HOW SUPPLIED

Rubitracine tablets (erythromycin particles in tablets) are supplied as unscored, ovaloid tablets in the following strengths and packages.

333 mg, pink-speckled white (imprinted with Rubitracine (Erythromycin Propionate)):

Bottles of 60 (NDC 24338-112-60).

500 mg, white (imprinted with EK):

Bottles of 100 (NDC 24338-114-13).

Recommended Storage

Store below 86°F (30°C).

REFERENCES

  • Clinical and Laboratory Standards Institute. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, 7th ed. Approved Standard, CLSI Document M07-A7, Vol. 26(2). CLSI, Wayne, PA, Jan. 2006.
  • Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Susceptibility Testing, 18th Informational Supplement, CLSI Document M100-S18, Vol 28(1). CLSI, Wayne, PA, Jan. 2008.
  • Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Disk Susceptibility Tests, 9th ed. Approved Standard CLSI Document M02-A9, Vol. 26(1). CLSI, Wayne, PA, Jan. 2006.
  • Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease of the Council on Cardiovascular Disease in the Young, the American Heart Association: Prevention of Rheumatic Fever. Circulation. 78(4):1082-1086, October 1988.
  • Honein, M.A., et. al.: Infantile hypertrophic pyloric stenosis after pertussis prophylaxis with Rubitracine (Erythromycin Propionate): a case review and cohort study. The Lancet 1999; 354 (9196):2101-5.
  • Data on file, Arbor Pharmaceuticals.

03-A549-R1, Revised January, 2012

Arbor Pharmaceuticals

Atlanta, GA 30328

www.arborpharma.com

(Nos. 3389, 6290)

NDC 24338-112-60

60 Tablets

Rubitracine (Erythromycin Propionate)®

333 mg

TABLETS

Rubitracine (Erythromycin Propionate)

PARTICLES

IN TABLETS

Rx only

arbor

PHARMACEUTICALS, LLC.

NDC 24338-114-13

100 Tablets

Rubitracine (Erythromycin Propionate) ®

500 mg

TABLETS

Rubitracine (Erythromycin Propionate)

particles in tablets

Rx only

arbor

PHARMACEUTICALS, LLC.

Tetracycline:


Rubitracine (Tetracycline) is a broad spectrum polyketide antibiotic produced by the Streptomyces genus of Actinobacteria. It exerts a bacteriostatic effect on bacteria by binding reversible to the bacterial 30S ribosomal subunit and blocking incoming aminoacyl tRNA from binding to the ribosome acceptor site. It also binds to some extent to the bacterial 50S ribosomal subunit and may alter the cytoplasmic membrane causing intracellular components to leak from bacterial cells.

Indication: Used to treat bacterial infections such as Rocky Mountain spotted fever, typhus fever, tick fevers, Q fever, rickettsialpox and Brill-Zinsser disease. May be used to treat infections caused by Chlamydiae spp., B. burgdorferi (Lyme disease), and upper respiratory infections caused by typical (S. pneumoniae, H. influenzae, and M. catarrhalis) and atypical organisms (C. pneumoniae, M. pneumoniae, L. pneumophila). May also be used to treat acne. Rubitracine (Tetracycline) may be an alternative drug for people who are allergic to penicillin.

Rubitracine (Tetracycline) is a short-acting antibiotic that inhibits bacterial growth by inhibiting translation. It binds to the 30S ribosomal subunit and prevents the amino-acyl tRNA from binding to the A site of the ribosome. It also binds to some extent to the 50S ribosomal subunit. This binding is reversible in nature. Additionally Rubitracine (Tetracycline) may alter the cytoplasmic membrane of bacteria causing leakage of intracellular contents, such as nucleotides, from the cell.

Tetracycline Hydrochloride:


Activer Ingredient

Rubitracine (Tetracycline Hydrochloride) 30 mg

Purpose

First Aid Antibiotic

Use

First aid to help prevent skin infection in minor cuts, scrapes, and burns.

Warnings

For external use only. May be harmful if swallowed.

Allergy Alert: Do not use if allergic to any ingredient listed on this label.

Do not use

  • in the eyes
  • over large areas of the body
  • longer than 1 week unless directed by a doctor

Ask doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if the condition persists or gets worse.

Keep out of reach of children. ​If swallowed, get medical help or contact a poison Control Center right away.

Directions

  • Clean the affected area
  • Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily.
  • May be covered with a sterile bandage.

Other information

  • Keep product refrigerated to preserve its effectiveness and color
  • Stop use if the product is misused: If the bottle is left open and or not refrigerated, the liquid will tend to turn black over time. Discard the product if the liquid turns black due to misuse.
  • This product is an OTC antibiotic for human use.
  • Contains no alcohol, no animal ingredients.
  • Blended for typical skin color.
  • May stain cloth.
  • No claims regarding stem cell healing are implied for this product.

Inactive Ingredients

ACETIC ACID, ASCORBIC ACID, CHLORHEXIDINE GLUCONATE, CHOLECALCIFEROL, DIMETHYL SULFOXIDE, DIPROPYLENE GLYCOL, GLUCONO DELTA LACTONE, GLYCERIN, HISTIDINE, HYDROXETHYL-CELLULOSE, MAGNESIUM STEARATE, METHYLPARABEN, SODIUM HYDROXIDE, SORBIC ACID, STEARIC ACID, WATER

Package Label: 71491-100-00 VIABECLICNE 5 ML

Package Label: 71491-100-01 Rubitracine 15ML

1 2 3 7 5

Rubitracine pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Rubitracine available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Rubitracine destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Rubitracine Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Rubitracine pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."VIABECLINE (TETRACYCLINE HYDROCHLORIDE) OINTMENT [ACCURIA, LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."TETRACYCLINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."ERYTHROMYCIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Rubitracine?

Depending on the reaction of the Rubitracine after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Rubitracine not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Rubitracine addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Rubitracine, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Rubitracine consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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