Loderm Retinoico

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Loderm Retinoico uses

Loderm Retinoico consists of Erythromycin Laurilsulfate, Tretinoin.

Erythromycin Laurilsulfate:


INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Loderm Retinoico tablets and other antibacterial drugs, Loderm Retinoico (Erythromycin Laurilsulfate) 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.

Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate) 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. Loderm Retinoico (Erythromycin Laurilsulfate) is effective in eliminating the organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical studies suggest that Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate) 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, Loderm Retinoico (Erythromycin Laurilsulfate) 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, Loderm Retinoico (Erythromycin Laurilsulfate) is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum.

Primary syphilis caused by Treponema pallidum. Loderm Retinoico (Erythromycin Laurilsulfate) (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 Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate) 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

Loderm Retinoico (Erythromycin Laurilsulfate) is contraindicated in patients with known hypersensitivity to this antibiotic.

Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico products.

QT Prolongation

Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate). Fatalities have been reported. Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico does not reach the fetus in adequate concentration to prevent congenital syphilis. Infants born to women treated during pregnancy with oral Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate) concomitantly with lovastatin. Therefore, patients receiving concomitant lovastatin and Loderm Retinoico (Erythromycin Laurilsulfate) should be carefully monitored for creatine kinase (CK) and serum transaminase levels.

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PRECAUTIONS

General

Prescribing Loderm Retinoico 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 Loderm Retinoico (Erythromycin Laurilsulfate) is principally excreted by the liver, caution should be exercised when Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate) therapy.

There have been reports of infantile hypertrophic pyloric stenosis (IHPS) occurring in infants following Loderm Retinoico (Erythromycin Laurilsulfate) therapy. In one cohort of 157 newborns who were given Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate) for 8-14 days and 10% for infants who took Loderm Retinoico (Erythromycin Laurilsulfate) for 15-21 days.5 Since Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate) may result in an overgrowth of nonsusceptible bacteria or fungi. If superinfection occurs, Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate) during early pregnancy.

Information for Patients

Patients should be counseled that antibacterial drugs including Loderm Retinoico (Erythromycin Laurilsulfate) tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate) 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

Loderm Retinoico 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 Loderm Retinoico (Erythromycin Laurilsulfate) therapy.

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

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

Concomitant administration of Loderm Retinoico (Erythromycin Laurilsulfate) and digoxin has been reported to result in elevated digoxin serum levels.

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

Loderm Retinoico (Erythromycin Laurilsulfate) is a substrate and inhibitor of the 3A isoform subfamily of the cytochrome p450 enzyme system (CYP3A). Coadministration of Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate).

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 Loderm Retinoico (Erythromycin Laurilsulfate) products in post-marketing experience:

Ergotamine/dihydroergotamine

Post-marketing reports indicate that co-administration of Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate) with ergotamine or dihydroergotamine is contraindicated (see CONTRAINDICATIONS ).

Triazolobenzodiazepines and related benzodiazepines

Loderm Retinoico (Erythromycin Laurilsulfate) 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

Loderm Retinoico 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)

Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate) with cyclosporine, carbamazepine, tacrolimus, alfentanil, disopyramide, rifabutin, quinidine, methyl-prednisolone, cilostazol, vinblastine, and bromocriptine.

Concomitant administration of Loderm Retinoico (Erythromycin Laurilsulfate) with cisapride, pimozide, astemizole, or terfenadine is contraindicated. (See CONTRAINDICATIONS .)

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

Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate).

There have been post-marketing reports of drug interactions when Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate). Fatalities have been reported. (See CONTRAINDICATIONS ).

Colchicine

Colchicine is a substrate for both CYP3A4 and the efflux transporter P-glycoprotein. Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate). If co-administration of colchicine and Loderm Retinoico (Erythromycin Laurilsulfate) 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

Loderm Retinoico (Erythromycin Laurilsulfate) interferes with the fluorometric determination of urinary catecholamines.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term oral dietary studies conducted with Loderm Retinoico 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. Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico 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 Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate) on labor and delivery is unknown.

Nursing Mothers

Loderm Retinoico is excreted in human milk. Caution should be exercised when Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate). (See PRECAUTIONS - Drug Interactions ).

Loderm Retinoico (Erythromycin Laurilsulfate) 333 MG Tablets contain 0.5 mg (0.02 mEq) of sodium per individual dose.

Loderm Retinoico (Erythromycin Laurilsulfate) 500 MG Tablets do not contain sodium.

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ADVERSE REACTIONS

The most frequent side effects of oral Loderm Retinoico (Erythromycin Laurilsulfate) 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 .)

Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate).

OVERDOSAGE

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

Loderm Retinoico (Erythromycin Laurilsulfate) is not removed by peritoneal dialysis or hemodialysis.

DOSAGE AND ADMINISTRATION

In most patients, Loderm Retinoico tablets are well absorbed and may be dosed orally without regard to meals. However, optimal blood levels are obtained when either Loderm Retinoico (Erythromycin Laurilsulfate) 333 mg or Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate) should be administered for at least ten days.

The American Heart Association suggests a dosage of 250 mg of Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico 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 Loderm Retinoico (Erythromycin Laurilsulfate) by mouth four times a day or two Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico 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 Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico (Erythromycin Laurilsulfate) base orally every 12 hours, or 333 mg of Loderm Retinoico (Erythromycin Laurilsulfate) 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 Loderm Retinoico 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.

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HOW SUPPLIED

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

333 mg, pink-speckled white (imprinted with Loderm Retinoico (Erythromycin Laurilsulfate)):

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 Loderm Retinoico (Erythromycin Laurilsulfate): 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

Loderm Retinoico (Erythromycin Laurilsulfate)®

333 mg

TABLETS

Loderm Retinoico (Erythromycin Laurilsulfate)

PARTICLES

IN TABLETS

Rx only

arbor

PHARMACEUTICALS, LLC.

NDC 24338-114-13

100 Tablets

Loderm Retinoico (Erythromycin Laurilsulfate) ®

500 mg

TABLETS

Loderm Retinoico (Erythromycin Laurilsulfate)

particles in tablets

Rx only

arbor

PHARMACEUTICALS, LLC.

Tretinoin:


Loderm Retinoico information

Loderm Retinoico (Tretinoin) is a topical form of vitamin A. This vitamin is known for its ability to help the skin gradually renew itself. This medicine is mostly used in the treatment of acne, but it is sometimes prescribed to reduce the appearance of mottled skin discoloration and fine wrinkles (to make the patient's facial skin from rough to smooth and silky).

Loderm Retinoico indications

Loderm Retinoico (Tretinoin) is a popular topical form of vitamin A that has proven itself to be highly effective in the treatment of acne. However, this medicine might also be used to treat or to prevent the appearance of some other medical disorders that have not been listed here.

Loderm Retinoico warnings

Loderm Retinoico (Tretinoin) is a category C FDA pregnancy drug. Therefore, using this medicine during pregnancy could harm a growing fetus. Before you start a treatment with this medicine, you must inform your personal physician if you are pregnant or if you are planning to be so soon. It has been determined that this medicine's main ingredients are able to pass into breastmilk. Ask your personal physician if it is safe to start using Loderm Retinoico (Tretinoin) if you are currently nursing an infant.

During your treatment with Loderm Retinoico (Tretinoin) you should avoid prolonged and unprotected exposure to artificial UV rays (tanning beds or sunlamps) or to direct sunlight. A treatment with this medicine is known to increase the patient's skin's sensitivity to direct sunlight, thus leading to severe sunburn. However, if you cannot avoid exposure to sunlight, sunlamps or tanning beds, you must use an effective sunscreen (at least SPF 15). It is recommended that you should wear protective clothing. Avoid letting this medication get in direct contact with your eyes, nose, mouth or with your lips. However, if a small amount of this medicine somehow gets into contact with any of the areas that have been listed here, you should wash it with plenty of water.

You must avoid using Loderm Retinoico (Tretinoin) on windburned, sunburned, irritated, chapped, or broken skin or on skin areas that are suffering from any forms of Eczema. If you do have any of these medical conditions you should first wait for them to heal before you consider using this medicine. Do not stop your treatment with Loderm Retinoico (Tretinoin) without your physician's approval even if you start to feel better after a few days of treatment (in some cases, the symptoms improve even if the infection has not completely healed). Some patients have to use this medicine for several months before they can finally see the results of their treatment. If you have been prescribed this drug to treat acne, your skin condition might worsen for a short period of time at the beginning of the treatment. If this persists for more than 12 weeks or if your medical condition has not improved after 3 months of treatment you must alert your personal physician.

Loderm Retinoico intake guidelines

You ought to use this drug exactly how your personal doctor has prescribed you to. You can consult the medicine's label if you want to get further information. If you fail to understand some of the physician's instructions, you should contact a pharmacist, a nurse or a doctor and ask them to explain them to you. Using a higher dose of this medicine or applying the drug more often than your personal physician has prescribed you to, will not make the results appear faster (it might increase this Acta's unpleasant side effects). You must wash both your hands after and before you apply Loderm Retinoico (Tretinoin). Before you apply the medicine you should make sure that the skin area that you are about to treat is both clean and dry. Applying this medicine on a wet skin area can sometimes cause skin irritation.

You must not wash the skin area that you have treated with Loderm Retinoico (Tretinoin) for at least 60 minutes after applying the medicine. Avoid using any other type of skin products on the skin area that you have treated with this drug for at least 1 hour after using this drug topical. This medicine should be stored in a cool and dry place, away from heat, moisture and direct sunlight. Keep it in a place that is far from the reach of pets and children in order to avoid unwanted accidents such as poisoning. This medicine is highly flammable. Keep the drug container away from any open flame.

Loderm Retinoico dosage

Ask your personal physician to calculate the dose of this medicine that works best for your condition. Do not make any alterations to the dose of Loderm Retinoico (Tretinoin) that you have been prescribed without your physician's approval.

Loderm Retinoico overdose

If you suspect that you are suffering from an overdose with this medicine, you are probably in need of emergency medical care. Contact your local poison control center and your personal physician as soon as you can. An overdose with this medicine should not trigger any unpleasant symptoms.

Loderm Retinoico missed dose

In order to get the most benefits from your treatment with Loderm Retinoico (Tretinoin) you should take it on a regular basis. If you miss one of your prescribed doses of this medicine you should take it as soon as you remember. If it is already time for another prescribed dose, skip the one that you have missed and proceed with your regular treatment. Avoid using extra doses of this medicine without first consulting it with your personal physician.

Loderm Retinoico side effects

Alert your doctor if you experience anything bothersome during your treatment with Loderm Retinoico (Tretinoin).

Loderm Retinoico drug reactions

Ask your personal physician if it is safe to take any other medicines while using Loderm Retinoico (Tretinoin).

Loderm Retinoico 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.


Loderm Retinoico 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.


Loderm Retinoico 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.


Loderm Retinoico 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.


Loderm Retinoico 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."TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. 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).
  3. "erythromycin". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Loderm Retinoico?

Depending on the reaction of the Loderm Retinoico after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Loderm Retinoico 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 Loderm Retinoico 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 Loderm Retinoico, 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 Loderm Retinoico 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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