DRUGS & SUPPLEMENTS
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Betadac-DC is an antibiotic of group semisynthetic penicillins a wide spectrum of action. It is a 4-hydroxyl analog of ampicillin. It has bactericidal action. Betadac-DC (Amoxicillin) is active against aerobic gram-positive bacteria: Staphylococcus spp. (except strains producing penicillinase), Streptococcus spp; aerobic gram-negative bacteria: Neisseria Gonorrhoeae, Neisseria Meningitidis, Escherichia Coli, Shigella spp., Salmonella spp., Klebsiella spp.
Microorganisms producing penicillinase is resistant to Betadac-DC (Amoxicillin).
In combination with metronidazole Betadac-DC (Amoxicillin) is active against Helicobacter Pylori. It is believed that inhibits the development of Betadac-DC (Amoxicillin) resistance of Helicobacter pylori to metronidazole.
There is a cross-resistance between amoxycillin and ampicillin.
The spectrum of antibacterial action while expanding the application of Betadac-DC (Amoxicillin) and beta-lactamase inhibitor clavulanic acid. This combination increased the activity of Betadac-DC (Amoxicillin) against Bacteroides spp., Legionella spp., Nocardia spp., Pseudomonas (Burkholderia) Pseudomallei. However, Pseudomonas Aeruginosa, Serratia Marcescens, and many other gram-bacteria are resistant.
When Betadac-DC (Amoxicillin) administered orally Betadac-DC (Amoxicillin) rapidly and completely absorbed from the gastrointestinal tract and is not destroyed in the acidic environment of the stomach. Cmax of Betadac-DC (Amoxicillin) in the blood plasma is reached after 1-2 h. When increasing doses of 2 times the concentration also increased by 2 times. In the presence of food in the stomach does not reduce the overall removals. Similar concentrations of Betadac-DC (Amoxicillin) reached in the blood when administered orally, IV and IM.
The binding of Betadac-DC (Amoxicillin) to plasma proteins is about 20%.
Widely distributed in tissues and body fluids. Reported high concentrations of Betadac-DC (Amoxicillin) in the liver.
T1/2 from the plasma is 1-1.5 h. About 60% of the dose adopted by mouth, is excreted unchanged in the urine by glomerular filtration and tubular secretion, with a dose of 250 mg of Betadac-DC (Amoxicillin) concentration in urine exceeds 300 micrograms / ml. A number of Betadac-DC (Amoxicillin) is determined in feces.
T1/2 for Newborns and the elderly can be longer.
In renal insufficiency T1/2 may be 7-20 hours.
In small quantities Betadac-DC (Amoxicillin) penetrates through BBB in inflammation of the pia mater.
Betadac-DC (Amoxicillin) is removed by hemodialysis.
For use Betadac-DC (Amoxicillin) as monotherapy and in combination with clavulanic acid: an infectious-inflammatory diseases caused by susceptible microorganisms, including bronchitis, pneumonia, tonsillitis, pyelonephritis, urethritis, infections of the gastrointestinal tract, gynecological infections, infections of the skin and soft tissue, listeria, leptospirosis, gonorrhea.
For use Betadac-DC (Amoxicillin) in combination with metronidazole: chronic gastritis in acute, peptic ulcer and duodenal ulcer in acute, associated with Helicobacter Pylori.
Individual. For oral single dose for adults and children over 10 years is 250-500 mg, in case of serious illness - up to 1 g. For children aged 5-10 years, a single dose of 250 mg in age from 2 to 5 years - 125 mg for children aged under 2 years of daily dose is 20 mg / kg. For adults and children interval is 8 h. In the treatment of acute uncomplicated gonorrhea - 3 g once (in combination with probenecid). Patients with impaired renal function in creatinine clearance 10-40 ml / min interval between doses should be increased to 12 h and if creatinine clearance is less than 10 ml / min interval between doses should be 24 hours.
When parenteral use in adults IM - 1 g 2 times / day, IV (with normal renal function) - 2.12 g / day. Children IM 50 mg / kg / day, single dose - 500 mg, the frequency of administration - 2 times / day; IV - 100-200 mg / kg / day. Patients with impaired renal function the dose and the interval between the injections need to be adjusted in accordance with the values of creatinine clearance.
Allergic reactions: urticaria, erythema, edema Quincke, rhinitis, conjunctivitis, rarely - fever, joint pain, eosinophilia, in rare cases - anaphylactic shock.
Side effects associated with chemotherapy effect: possible development of super-infection (particularly in patients with chronic diseases or low resistance of the organism).
With prolonged use at high doses: dizziness, ataxia, confusion, depression, peripheral neuropathy, seizures.
Mostly when Betadac-DC (Amoxicillin) used in combination with metronidazole: nausea, vomiting, anorexia, diarrhea, constipation, epigastric pain, glossitis, stomatitis; rarely - hepatitis, pseudomembranous colitis, allergic reactions (urticaria, angioedema), interstitial nephritis, a violation of hematopoiesis.
Mostly when Betadac-DC (Amoxicillin) used in combination with clavulanic acid: cholestatic jaundice, hepatitis, rarely - erythema multiforme, toxic epidermal necrolysis, exfoliative dermatitis.
Infectious mononucleosis, lymphatic leukemia, severe gastrointestinal infections, accompanied by diarrhea or vomiting, respiratory viral infection, allergic diathesis, bronchial asthma, hay fever, sensitivity to penicillin and / or cephalosporins.
For use in combination with metronidazole: diseases of the nervous system; hemodyscrasia, lymphocytic leukemia, an infectious mononucleosis; Hypersensitivity to nitroimidazole derivatives.
For use in combination with clavulanic acid: a history of instructions for liver problems and jaundice, associated with the reception of Betadac-DC in combination with clavulanic acid.
Betadac-DC (Amoxicillin) crosses the placenta, in small amounts excreted in breast milk.
If necessary the use of Betadac-DC (Amoxicillin) during pregnancy should carefully weigh the potential benefits of therapy for the mother and the potential risk to the fetus.
With careful use Betadac-DC (Amoxicillin) during lactation (breastfeeding).
With caution used in patients prone to allergic reactions.
Betadac-DC in combination with metronidazole is not recommended to use in patients younger than 18 years should not be used for liver diseases.
In the combined therapy with metronidazole is recommended not to drink alcohol.
Treatment must continue 48-72 hours after the disappearance of clinical signs of disease, with streptococcal infections - 10 days.
During the course treatment is necessary to control the state functions of hematopoiesis, liver and kidneys.
Perhaps the development of superinfection due to growth insensitive to the drug microflora. In the case of superinfection requires removal of Betadac-DC (Amoxicillin) and the corresponding change in antibiotic therapy. When treating patients with bacteremia may develop bacteriolysis reaction (reaction of Jarisch-Herxheimer).
Patients who have an increased sensitivity to penicillin, may be cross-allergic reactions to cephalosporin antibiotics.
In the treatment of mild diarrhea at the background of the treatment should be avoided antidiarrhoeal drugs that reduce intestinal motility; can use kaolin or attapulgite containing antidiarrhoeal stuff. Patients with severe diarrhea should consult a doctor.
With simultaneous use of Betadac-DC (Amoxicillin) and oral contraceptives estrogensoderzhaschih and Betadac-DC (Amoxicillin) should if possible to use additional methods of contraception.
Betadac-DC (Amoxicillin) may decrease the effectiveness of contraceptives for oral administration.
With the simultaneous use of Betadac-DC (Amoxicillin) with bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) appears synergies; with bacteriostatic antibiotic (including macrolides, chloramphenicol, lincosamides, tetracyclines, sulphonamide) - antagonism.
Betadac-DC (Amoxicillin) increases the effects of indirect anticoagulants inhibiting intestinal microflora, reduces the synthesis of vitamin K and prothrombin index.
Betadac-DC (Amoxicillin) reduces the effect of drugs, in the process of metabolism that produce PABA.
Probenecid, diuretics, allopurinol, phenylbutazone, NSAIDs decrease the tubular secretion of Betadac-DC (Amoxicillin), which can be accompanied by an increase in its concentration in blood plasma.
Antacids, glucosamine, laxatives, aminoglycosides, slow down and reduce, and ascorbic acid increases the absorption of Betadac-DC (Amoxicillin).
With the combined use of Betadac-DC (Amoxicillin) and clavulanic acid pharmacokinetics of both components unchanged.
Symptoms: nausea, vomiting, diarrhea, disruption of water and electrolyte balance (as a result of vomiting and diarrhea); for prolonged use at high doses - neurotoxic reactions and thrombocytopenia (these phenomena are reversible and disappear after drug withdrawal).
Treatment: gastric lavage, the prescription of activated charcoal, saline laxatives, correction of water and electrolyte balance; hemodialysis.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Betadac-DC (Dicloxacillin) sodium capsules USP and other antibacterial drugs, Betadac-DC (Dicloxacillin) sodium capsules USP 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.
Betadac-DC (Dicloxacillin) is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organisms and their sensitivity to the drug. (see CLINICAL PHARMACOLOGY – Susceptibility Plate Testing).
Betadac-DC (Dicloxacillin) may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of laboratory test results. The penicillinase-resistant penicillins should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus, therapy should not be continued with a penicillinase-resistant penicillin.
A history of a hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication.
Serious and occasionally fatal hypersensitivity (anaphylactic shock with collapse) reactions have occurred in patients receiving penicillin. The incidence of anaphylactic shock in all penicillin-treated patients is between 0.015% and 0.04%. Anaphylactic shock resulting in death has occurred in approximately 0.002% of the patients treated. Although anaphylaxis is more frequent following a parenteral administration, it has occurred in patients receiving oral penicillins.
When penicillin therapy is indicated, it should be initiated only after a comprehensive patient drug and allergy history has been obtained. If an allergic reaction occurs, the drug should be discontinued and the patient should receive supportive treatment, e.g., artificial maintenance of ventilation, pressor amines, antihistamines and corticosteroids. Individuals with a history of penicillin hypersensitivity may also experience allergic reactions when treated with a cephalosporin.
Prescribing Betadac-DC sodium capsules USP 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.
Betadac-DC (Dicloxacillin) should generally not be administered to patients with a history of sensitivity to any penicillin.
Penicillin should be used with caution in individuals with histories of significant allergies and/or asthma. Whenever allergic reactions occur, penicillin should be withdrawn unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to penicillin therapy.
The oral route of administration should not be relied upon in patients with severe illness, or with nausea, vomiting, gastric dilatation, cardiospasm or intestinal hypermotility. Occasionally, patients will not absorb therapeutic amounts of orally administered penicillin.
The use of antibiotics may result in overgrowth of nonsusceptible organisms. If new infections due to bacteria or fungi occur, the drug should be discontinued and appropriate measures taken.
Patients should be counselled that antibacterial drugs including Betadac-DC (Dicloxacillin) sodium capsules USP should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Betadac-DC (Dicloxacillin) sodium capsules USP 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 Betadac-DC (Dicloxacillin) sodium capsules USP or other antibacterial drugs in the future.
Patients receiving penicillins should be given the following information and instructions by the physician:
Bacteriologic studies to determine the causative organisms and their susceptibility to the penicillinase-resistant penicillins should be performed. In the treatment of suspected staphylococcal infections, therapy should be changed to another active agent if culture tests fail to demonstrate the presence of staphylococci.
Periodic assessment of organ system function, including renal, hepatic and hematopoietic, should be made during prolonged therapy with the penicillinase-resistant penicillins.
Blood cultures, white blood cell and differential cell counts should be obtained prior to initiation of therapy and at least weekly during therapy with penicillinase-resistant penicillins.
Periodic urinalysis, blood urea nitrogen and creatinine determinations should be performed during therapy with the penicillinase-resistant penicillins and dosage alterations should be considered if these values become elevated. If any impairment of renal function is suspected or known to exist, a reduction in the total dosage should be considered and blood levels monitored to avoid possible neurotoxic reactions (see DOSAGE AND ADMINISTRATION).
SGOT and SGPT values should be obtained periodically during therapy to monitor for possible liver function abnormalities.
Tetracycline, a bacteriostatic antibiotic, may antagonize the bactericidal effect of penicillin and concurrent use of these drugs should be avoided.
No long-term animal studies have been conducted with these drugs.
Studies on reproduction in rats and rabbits reveal no fetal or maternal abnormalities before conception and continuously through weaning (one generation).
Reproduction studies performed in the mouse, rat and rabbit have revealed no evidence of impaired fertility or harm to the fetus due to the penicillinase-resistant penicillins. Human experience with the penicillins during pregnancy has not shown any positive evidence of adverse effects on the fetus. There are, however, no adequate or well-controlled studies in pregnant women showing conclusively that harmful effects of these drugs on the fetus can be excluded. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Penicillins are excreted in breast milk. Caution should be exercised when penicillins are administered to a nursing woman.
Because of incompletely developed renal function in newborns, penicillinase-resistant penicillins (especially methicillin) may not be completely excreted, with abnormally high blood levels resulting. Frequent monitoring of blood levels is advisable in this group, with dosage adjustments when necessary. All newborns treated with penicillins should be monitored closely for clinical and laboratory evidence of toxic or adverse effects (see DOSAGE AND ADMINISTRATION).
The reported incidence of allergic reactions to penicillin ranges from 0.7% to 10%. Sensitization is usually the result of treatment, but some individuals have had immediate reactions to penicillin when first treated. In such cases, it is thought that the patients may have had prior exposure to the drug via trace amounts present in milk and vaccines.
Two types of allergic reactions to penicillin are noted clinically, immediate and delayed.
Immediate reactions usually occur within 20 minutes of administration and range in severity from urticaria and pruritus to angioneurotic edema, laryngospasm, bronchospasm, hypotension, vascular collapse and death. Such immediate anaphylactic reactions are very rare (see WARNINGS) and usually occur after parenteral therapy, but have occurred in patients receiving oral therapy. Another type of immediate reaction, an accelerated reaction, may occur between 20 minutes and 48 hours after administration and may include urticaria, pruritus and fever. Although laryngeal edema, laryngospasm and hypotension occasionally occur, fatality is uncommon.
Delayed allergic reactions to penicillin therapy usually occur after 48 hours and sometimes as late as two to four weeks after initiation of therapy. Manifestations of this type of reaction include serum sickness-like symptoms (i.e., fever, malaise, urticaria, myalgia, arthralgia, abdominal pain) and various skin rashes. Nausea, vomiting, diarrhea, stomatitis, black or hairy tongue and other symptoms of gastrointestinal irritation may occur, especially during oral penicillin therapy.
Neurotoxic reactions similar to those observed with penicillin G may occur with large intravenous doses of the penicillinase-resistant penicillins, especially with patients with renal insufficiency.
Renal tubular damage and interstitial nephritis have been associated with the administration of methicillin sodium and, infrequently, with the administration of nafcillin and oxacillin. Manifestations of this reaction may include rash, fever, eosinophilia, hematuria, proteinuria and renal insufficiency. Methicillin-induced nephropathy does not appear to be dose-related and is generally reversible upon prompt discontinuation of therapy.
Agranulocytosis, neutropenia and bone marrow depression have been associated with the use of methicillin sodium and nafcillin. Hepatotoxicity, characterized by fever, nausea and vomiting associated with abnormal liver function tests, mainly elevated SGOT levels, has been associated with the use of oxacillin.
|Mild to Moderate||Severe||Mild to Moderate||Severe|
|Betadac-DC (Dicloxacillin)||125 mg every||250 mg every||12.5 mg/kg/day ||25 mg/kg/day |
|6 hours||6 hours||in equally||in equally|
|divided doses||divided doses|
|every 6 hours||every 6 hours|
Bacteriologic studies to determine the causative organisms and their sensitivity to the penicillinase-resistant penicillins should always be performed. Duration of therapy varies with the type and severity of infection as well as the overall condition of the patient, therefore it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with penicillinase-resistant penicillins should be continued for at least 14 days. Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic and cultures are negative. The treatment of endocarditis and osteomyelitis may require a longer term of therapy.
Concurrent administration of the penicillinase-resistant penicillins and probenecid increases and prolongs serum penicillin levels.
Probenecid decreases the apparent volume of distribution and slows the rate of excretion by competitively inhibiting renal tubular secretion of penicillin. Penicillin-probenecid therapy is generally limited to those infections where very high serum levels of penicillin are necessary.
Oral preparations of the penicillinase-resistant penicillins should not be used as initial therapy in serious, life-threatening infections (see PRECAUTIONS - General). Oral therapy with the penicillinase-resistant penicillins may be used to follow up the previous use of a parenteral agent as soon as the clinical condition warrants. For intramuscular gluteal injections, care should be taken to avoid sciatic nerve injury. With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.
NB: INFECTIONS CAUSED BY GROUP A BETA-HEMOLYTIC STREPTOCOCCI SHOULD BE TREATED FOR AT LEAST 10 DAYS TO HELP PREVENT THE OCCURRENCE OF ACUTE RHEUMATIC FEVER OR ACUTE GLOMERULONEPHRITIS.
Betadac-DC (Dicloxacillin) sodium capsules USP are available as follows:
250 mg: Each capsule contains Betadac-DC (Dicloxacillin) sodium monohydrate equivalent to 250 mg Betadac-DC (Dicloxacillin), with green colored cap and light green colored body, imprinted "TEVA" on the cap and “3123” on the body, available in bottles of 100.
500 mg: Each capsule contains Betadac-DC (Dicloxacillin) sodium monohydrate equivalent to 500 mg Betadac-DC (Dicloxacillin), with green colored cap and light green colored body, imprinted "TEVA" on the cap and “3125” on the body, available in bottles of 100.
Store at 20° to 25°C (68° to 77°F).
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
References Available Upon Request.
Manufactured In Canada By:
TEVA CANADA LIMITED
Toronto, Canada M1B 2K9
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. E 10/2010
Depending on the reaction of the Betadac-DC after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Betadac-DC 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 Betadac-DC 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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The information was verified by Dr. Rachana Salvi, MD Pharmacology