Antibiotics

Generic name: Doxycycline

Trade name: Doxycycline

Buy Doxycycline Online

Doxycycline and associated names is a powder to be used in drinking water containing the active substance doxycycline iclato 500 mg/g. Doxycycline is an antibiotic semisynthetic from the tetracycline class. Tetracyclines have a broad spectrum of activity against Gram-positive and Gram-negative bacteria, mycoplasmas, chlamydia, rickettsias and some protozoans. Doxycyline is a synthetic antibiotic of broad spectrum action derived from tetracycline and used to treat various bacterial infections such as urinary tract infections, acne, gonorrhea, chlamydiosi, periodontitis (gum disease), spots, neoplesie, acne-like lesion caused by rosacea.

Doxycycline 100 mg

Doxycycline 100 mg


More info about Generic Doxycycline

Common use

Doxycycline is a synthetic broad-spectrum antibiotic derived from tetracycline and used to treat various bacterial infections, such as urinary tract infections, acne, gonorrhea, chlamydiosis, periodontitis (gum disease), spots, bumps and acne-like lesions caused by rosacea.

Dosage and indications

This medication should be taken after a meal with a large glass of water to decrease irritation of the esophagus. The daily dose should be taken as a single dose or divided into two (12 hours between each). Do not take in larger amounts or continue to take after the period of administration. Some brands of this medication cannot be used with dairy products. Do not crush, break, or open a delayed-release capsule, eat it all pill. If it is an oral suspension Shake before use and measure with a measuring spoon. Do not take this medication if it has expired as it may damage the kidney.

Precautions

The use of doxycycline during the growth of the teeth may result in their permanent color change. Infections caused by staphylococcus, Escherichia, Shigella, is possible only after the sensitivity to the drug is determined. Avoid prolonged UV exposure of the body during treatment and 4-5 days after. If long treatment with this medication has been prescribed a regular check of peripheral blood cell content, liver function test and determination of nitrogen and urea in serum.

Contraindications

Hypersensitivity to doxycycline and tetracyclines, pregnancy (second half of the term), breastfeeding, early childhood (for children under the age of 9 years), leukopenia, porphyria, severe liver failure.

Possible side effects

Side effects caused by Doxycycline may appear as headache, dizziness, blurred vision, fever, chills, muscle pain, red rash, pale or yellowed skin, dark colored urine, severe upper stomach pain, loss of appetite, jaundice, easy bruising or bleeding. Consult your doctor if you experience serious effects listed above.

Drug interaction

Co-administration with aluminum, magnesium, calcium, or antacid-based is not recommended as doxycycline absorption may be slowered. Minerals (such as calcium or iron) or with bismuth subsalicylate have the same effect. Doxycycline is reported to potentiate warfarin activity. Phenytoin (Dilantin), carbamazepine (Tegretol), and barbiturates (such as phenobarbital) can increase the metabolism of doxycycline.

Dose

Never take a double dose of this medication. If it is almost time for your next dose skip the missed portion and continue to take the medicine according to your schedule.

Overdose

In case of severe and persistent nausea, vomiting, diarrhea and seek medical advice.

Storage

Store at room temperature between 59-77 degrees F (15-25 degrees C) away from light and moisture, children and pets. Do not use after expiration date.

Disclaimer of liability

We only provide general information about medications that does not cover all directions, drug integrations, or precautions. Information at the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim the reliability of this information and may contain errors. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.

Special precautions for use in animals

1g of powder contains 500 mg of doxycycline ictate (equivalent to 433 mg of doxycycline base).

Directions

Pigs: For the treatment of clinical signs associated with respiratory diseases in pigs, caused by Actinobacillus pleuropneumoniae, Pasteurella multocida and Mycoplasma hyopneumoniae susceptible to doxycycline.

Chickens: Where clinically manifest disease is present in the flock, to decrease mortality, morbidity and clinical signs and to reduce lesions due to Pasteurellosis caused by Pasteurella multocida or to reduce morbidity and lesions in respiratory infections caused by Ornithobacterium rhinotracheale.

Dosage

  • Intake orally with drinking water

The recommended dose in pigs is: 12,5 mg doxycycline ictate (25 mg product) per kg body weight per day for 4 consecutive days. If no improvement in clinical signs is observed during this time period, review the diagnosis and modify the treatment. In case of severe infections, the duration of treatment may be extended for up to 8 consecutive days as determined by the treating veterinarian.

The recommended dose in chickens is:

10 mg doxycycline icate (20 mg product) per kg body weight per day for 3-4 consecutive days in case of infections caused by P. multocida and 20 mg doxycycline icate (40 mg product) per kg body weight per day for 3-4 consecutive days in case of infections caused by O. rhinotracheale.

The exact daily quantity of the product is calculated on the basis of the dose to be used and the number and weight of animals to be treated. To calculate the concentration of the product in the drinking water, you can use the following formula:

  • mg of product/ kg of body weight/day x average body weight (kg) of the animals to be treated / average daily water consumption (in litres) per animal = mg of product per 1 litre of water to be drunk.

To ensure a correct dosage, it is necessary to determine the body weight as precisely as possible. The intake of medicated drinking water depends on the clinical condition of the chickens. To obtain the correct dosage, the concentration of doxycycline should be adjusted accordingly. It is recommended to use properly calibrated weighing devices if partially used packaging is used. The daily amount should be added to the drinking water in such a way that the entire medicine is consumed within 24 hours. The medicated beverage water should be re-prepared or replaced every 24 hours. It is recommended to prepare a concentrated presolution - about 100 grams of product per litre of beverage water - and to further dilute it to therapeutic concentrations if necessary. Alternatively, the concentrated solution can be used in a proportional water dosing device. The solubility of the product is pH dependent and may precipitate if hard alkaline drink is mixed in water. Use at minimum concentrations of 200 mg of powder per litre of beverage water in areas with hard alkaline beverage water (hardness above 10.2 °d and pH above 8.1). During the treatment period, animals should not have access to any other source of water than medicated water.

Warnings

Given the possible variability (time, geographical area) in the sensitivity of bacteria to doxycycline, especially the sensitivities of A. pleuropeumoniae and O. rhinotracheale may vary from country to country and also from farm to farm, bacteriological sampling and sensitivity testing are recommended. The use of the product should be based on the culture and sensitivity of micro-organisms isolated from sick subjects in the herd. If this is not possible, treatment should be based on local epidemiological information (regional, at farm level) on the susceptibility of the target bacteria. Eradication of the target pathogens is not possible and therefore the drug should be associated with good management practices, e.g. good hygiene, adequate ventilation, no overpopulation of livestock.

More information

As a result of divergent national decisions taken by Member States on authorisation of Doxycycline and associated names, the matter was submitted to the CVMP to the pursuant to Article of Directive in order to resolve the differences between the Member States laws, regulations and administrative provisions.

The main disharmonies of the existing SPCs concerned:

  • - target species;
  • - indications;
  • - quantity to be administered;
  • - waiting periods.

Poultry

No data on the minimum inhibitory concentration have been submitted for the following specifically isolated from target pathogens from chickens. A pharmacokinetics study has shown that when Doxycycline has been administered in drinking water to broiler chickens to a dose of doxycycline ictate of 25 mg/kg bw/day for 5 days, stationary status concentration of doxycycline in plasma of 2 μg/ml was achieved after 6 hours. Data submitted from Goren, 19831, on the in vitro sensitivity of pathogens isolated from poultry between 1978 and 1981 have showed that the sensitivity of P. multocida was greater than 70%, but that E. coli ranged between 4 and 34% in the period of time studied. A study examined the safety of Doxycycline 50% WSP administered at doses of 0.25 and 75 mg doxycycline iclate/kg body weight/day for 5 days.

  • No health abnormalities were detected

Two literature references have reported that doxycycline at 50 mg per liter in water from drinking for 3-5 days was effective in treating controls infected with E.coli and M. gallisepticum. A study by Goren, which used a control infected with an E.coli strain with a MIC of 1 μg/ml demonstrated a therapeutic effect dose- employee, highlighting effects from moderate to good in groups that had received doxycycline in the doses between 96 and 196 mg/kg body weight/day. plasma between 1,7 and 3,6 μg/ml. A standard field study of good clinical practice in which the efficacy of Doxycycline 50% WSP in the treatment of outbreaks of hummingbird disease due to natural causes in five farms in the Netherlands in 1998. These were an uncontrolled study in which poultry houses were excluded where strains of E. coli were not found sensitive to doxycycline in in vitro tests. A dose of doxycycline ictate of 25 mg/kg by weight body/day in drinking water for 3 days resulted in a reduction in mortality and the disappearance of clinical signs in all but one of the herds by the end of the treatment. The study highlighted the importance of sensitivity testing prior to treatment with doxycycline. No data were presented regarding Haemophilus paragallinarum infections, Bordetella avium and Clostridia spp.

Pharmacovigilance data (summary of the Periodic Safety Update Reports) from the use of the product in chickens in the last 5 years have been reviewed on the the basis for the recent Article referral for all concentrations of dust water soluble and oral solutions containing doxycycline ictate for poultry to be administered in drinking water. There were no adverse events in chickens, including reports of suspected lack of expected effectiveness during this period. Data on the depletion of residues for chicken meat support a waiting period for the 5-day meat if chickens are given a dose of 25 mg doxycycline iclate/kg by weight body/day for 5 days.

  • No data were provided for poultry species other than chickens.

Risk/benefit assessment

Chickens

Since no data were provided for poultry species other than chickens, it was agreed that the target species should be restricted to "chickens" in all Member States where the product is authorized or pending authorization. In accordance with the recent referral under Article for all concentrations of water-soluble powders and oral solutions containing doxycycline ictate for poultry and drinking water, it has been agreed that the following indications:

  • - respiratory tract infections caused by Mycoplasma spp., Escherichia coli, Haemophilus comparagallinarium and Bordetella avium;
  • - enteritis caused by Clostridium perfringens and Clostridium colinum.

The data for some indications were not provided, however, at the time of the referral under of Article, there was no documented evidence of the suspected absence of expected efficacy of doxycycline products in chickens. In the absence of data supporting the scheme for infections other than colibacillosis, the harmonised dosing regimen of 25 mg of doxycycline iclate/kg body weight for 3-5 days for all indications can be accepted because it represents the highest value of the dose range that has been used in the past, and poses no security risk.

Data on the depletion of residues in chickens support a waiting period for meat of 5 days if chickens are given a dose of 25 mg doxycycline iclate/kg body weight/day for five days.

Pigs

As pigs are a target species in all current SPCs (excluding the product from the Netherlands) it is it was agreed to accept "pigs" as a target species in the harmonised information on product. There were no apparent discrepancies in the Member States as regards the following indications:

  • - Atrophic rhinitis caused by Pasteurella multocida and Bordetella bronchiseptica;
  • - bronchopneumonia caused by Pasteurella multocida, Streptococcus suis and Mycoplasma hyorhinis;
  • - pleuropneumonia caused by Actinobacillus pleuropneumoniae.

Limited clinical data have been provided to support the use of the product to treat pleuropneumoniae. pleuropneumoniae and no clinical or other data have been submitted on the field in support of the use of doxycycline in the treatment of atrophic rhinitis or bronchopneumonia in pigs. There was no clear discrepancy between the Member States in the Dosage regimen of 10 mg of doxycycline iclate/kg body weight for 3-5 days. Although the data have shown that this dose may not be optimal and the recent literature has shown that the confirmed the development of resistance to tetracyclines in respiratory pathogens in pigs, is not there is clear evidence on which to base a revision of the dose/label. The summary of the PSUR data has not highlighted any security problem nor the suspected lack of expected efficacy with regard to this indication or duration of the dose. Data on the depletion of residues in pigs are in favour of a waiting time for meat of 8 days if pigs are given a dose of 10 mg doxycycline iclate/kg body weight/day for five days.

Calves

Calves are a target species in all current SPCs (excluding the Dutch product). It has been agreed that in the harmonised product information, the target species should be specified as "preuminant calves". No discrepancies were found in the Member States as regards concerns the following indications:

  • - bronchopneumonia and pleuropneumonia caused by Pasteurella spp

Arcanobacterium pyogenes, Histophilus somni and Mycoplasma spp. Field data were submitted to support the use of the product in the treatment of pneumonia caused by Mycoplasma and P. haemolytica in calves, but no clinical data emerged or in the field in support of the use of the product in the treatment of pleuropneumonia, or bronchopneumonia caused by pleuropneumonia, P. multocida, Streptococcus spp. or A. pyogenes. The summary of the PSUR data did not reveal any security problem, nor does the suspected expected lack of efficacy in relation to this indication or duration of the dose. Recitals all factors there is insufficient evidence to justify a change in the dosing regime. The data on depletion of residues in calves support a waiting period for meat from 7 days if calves are given a dose of 5 mg doxycycline iclate/kg body weight, two days if calves are given a dose of 5 mg doxycycline iclate/kg body weight, two days if calves are given a dose of 5 mg doxycycline iclate/kg body weight, two days if calves are given a dose of 5 mg doxycycline iclate/kg body weight.

Risk assessment

According to the WHO criteria of 2007 doxycycline is classified as "very important antibiotic". for human use and "critically important" for veterinary use. In human medicine, the doxycycline is the treatment of choice for the treatment of acute tracheobronchitis, acute bronchitis and acute bronchiolitis caused by primary bacterial infections (Mycoplasma pneumoniae, Chlamydia pneumoniae) and bacterial superinfections (Pneumococci, Haemophilus spp.). Transmission food, direct and environmental resistance of microorganisms (resistant determinants) must be considered to be a risk related to the use of the product despite the fact that the quantification of the transmission of zoonotic agents and horizontal transfer of resistance genes between animal and human bacteria is extremely difficult in vivo. It has been highlighted, at time of referral in accordance with Article for water-soluble powders and oral solutions containing doxycycline iclate, which there was a high percentage of resistance to tetracyclines in E. coli isolated from chickens. High levels of resistance to tetracyclines in respiratory pathogens of the pigs have also been documented. The appropriate definition of indications providing users of the product with clear information on the expected efficacy, together with the appropriate dosage for the indications, it is necessary in order to ensure a use of effective and safe product in the field.

Since the calf data presented in the dossier in support of the clinical data concern calves preuminants, with an unclear rumen maturity for some of the studies submitted, and considering the changes in key pharmacokinetic parameters following i.v. administration. in non-ruminant calves compared to ruminant calves and the absence of a clear safety margin which may allow a review of the daily intake in calves, the target species must be clearly defined as preuminant calves.

There are no proposals to change the dosing regime for chickens, pigs and calves. Therefore environmental exposure to doxycycline is not likely to increase. Use of the product as proposed does not pose any risk to the environment.

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