Drug Uses
Use Tetracycline to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
How Taken
The usual daily dose is 1g to 2g. Your doctor may increase the dosage in case of severe infections.
You should continue therapy for at least 24 to 48 hours after the symptoms and fever have subsided.
Warnings/Precautions
Talk to your physician before taking this medicine if you are hypersensitive to tetracyclines. Using Tetracycline in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit and increases the risk of the development of drug-resistant bacteria.
Missed Dose
If you skip doses or do not complete the full course of therapy, you may risk a decrease in the effectiveness of the immediate treatment. Also there is a chance that bacteria will develop resistance and will not be treatable by Tetracycline or other antibacterial drugs in the future.
Possible Side Effects
Side effects you may experience may include: anorexia, epigastric distress, nausea, vomiting, diarrhea, bulky loose stools, stomatitis, sore throat, glossitis, black hairy tongue, dysphagia, hoarseness, enterocolitis, and inflammatory lesions (with candidal overgrowth) in the anogenital region.
Storage
Store the tablets at room temperature; avoid excessive heat. Dispense in tight, light-resistant containers. Keep out of the reach of children.
Overdose
In case of overdosage, seek emergency medical attention.
More Information
If you are undergoing long-term therapy, periodic laboratory evaluation of organ system function, including renal, hepatic, and hematopoietic systems, should be performed.
Disclaimer
This drug information is for your information purposes only, it is not intended that this information covers all uses, directions, drug interactions, precautions, or adverse effects of your medication. This is only general information, and should not be relied on for any purpose. It should not be construed as containing specific instructions for any particular patient. We disclaim all responsibility for the accuracy and reliability of this information, and/or any consequences arising from the use of this information, including damage or adverse consequences to persons or property, however such damages or consequences arise. No warranty, either expressed or implied, is made in regards to this information.
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The Manufacturing Process
Although most antibiotics occur in nature, they are not normally available in the quantities necessary for large-scale production. For this reason, a fermentation process was developed. It involves isolating a desired microorganism, fueling growth of the culture and refining and isolating the final antibiotic product. It is important that sterile conditions be maintained throughout the manufacturing process, because contamination by foreign microbes will ruin the fermentation.
Starting the culture
* Before fermentation can begin, the desired antibiotic-producing organism must be isolated and its numbers must be increased by many times. To do this, a starter culture from a sample of previously isolated, cold-stored organisms is created in the lab. In order to grow the initial culture, a sample of the organism is transferred to an agar-containing plate. The initial culture is then put into shake flasks along with food and other nutrients necessary for growth. This creates a suspension, which can be transferred to seed tanks for further growth.
* The seed tanks are steel tanks designed to provide an ideal environment for growing microorganisms. They are filled with the all the things the specific microorganism would need to survive and thrive, including warm water and carbohydrate foods like lactose or glucose sugars. Additionally, they contain other necessary carbon sources, such as acetic acid, alcohols, or hydrocarbons, and nitrogen sources like ammonia salts. Growth factors like vitamins, amino acids, and minor nutrients round out the composition of the seed tank contents. The seed tanks are equipped with mixers, which keep the growth medium moving, and a pump to deliver sterilized, filtered air. After about 24-28 hours, the material in the seed tanks is transferred to the primary fermentation tanks.
Fermentation
* The fermentation tank is essentially a larger version of the steel, seed tank, which is able to hold about 30,000 gallons. It is filled with the same growth media found in the seed tank and also provides an environment inducive to growth. Here the microorganisms are allowed to grow and multiply. During this process, they excrete large quantities of the desired antibiotic. The tanks are cooled to keep the temperature between 73-81° F (23-27.2 ° C). It is constantly agitated, and a continuous stream of sterilized air is pumped into it. For this reason, anti-foaming agents are periodically added. Since pH control is vital for optimal growth, acids or bases are added to the tank as necessary.
Isolation and purification
* After three to five days, the maximum amount of antibiotic will have been produced and the isolation process can begin. Depending on the specific antibiotic produced, the fermentation broth is processed by various purification methods. For example, for antibiotic compounds that are water soluble, an ion-exchange method may be used for purification. In this method, the compound is first separated from the waste organic materials in the broth and then sent through equipment, which separates the other water-soluble compounds from the desired one. To isolate an oil-soluble antibiotic such as penicillin, a solvent extraction method is used. In this method, the broth is treated with organic solvents such as butyl acetate or methyl isobutyl ketone, which can specifically dissolve the antibiotic. The dissolved antibiotic is then recovered using various organic chemical means. At the end of this step, the manufacturer is typically left with a purified powdered form of the antibiotic, which can be further refined into different product types.
Refining
* Antibiotic products can take on many different forms. They can be sold in solutions for intravenous bags or syringes, in pill or gel capsule form, or they may be sold as powders, which are incorporated into topical ointments. Depending on the final form of the antibiotic, various refining steps may be taken after the initial isolation. For intravenous bags, the crystalline antibiotic can be dissolved in a solution, put in the bag, which is then hermetically sealed. For gel capsules, the powdered antibiotic is physically filled into the bottom half of a capsule then the top half is mechanically put in place. When used in topical ointments, the antibiotic is mixed into the ointment.
* From this point, the antibiotic product is transported to the final packaging stations. Here, the products are stacked and put in boxes. They are loaded up on trucks and transported to various distributors, hospitals, and pharmacies. The entire process of fermentation, recovery, and processing can take anywhere from five to eight days.
Quality Control
Quality control is of utmost importance in the production of antibiotics. Since it involves a fermentation process, steps must be taken to ensure that absolutely no contamination is introduced at any point during production. To this end, the medium and all of the processing equipment are thoroughly steam sterilized. During manufacturing, the quality of all the compounds is checked on a regular basis. Of particular importance are frequent checks of the condition of the microorganism culture during fermentation. These are accomplished using various chromatography techniques. Also, various physical and chemical properties of the finished product are checked such as pH, melting point, and moisture content.
In the United States, antibiotic production is highly regulated by the Food and Drug Administration (FDA). Depending on the application and type of antibiotic, more or less testing must be completed. For example, the FDA requires that for certain antibiotics each batch must be checked by them for effectiveness and purity. Only after they have certified the batch can it be sold for general consumption.
The Future
Since the development of a new drug is a costly proposition, pharmaceutical companies have done very little research in the last decade. However, an alarming development has spurred a revived interest in the development of new antibiotics. It turns out that some of the disease-causing bacteria have mutated and developed a resistance to many of the standard antibiotics. This could have grave consequences on the world's public health unless new antibiotics are discovered or improvements are made on the ones that are available. This challenging problem will be the focus of research for many years to come.
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