Tolexine GE Uses
What is Tolexine GE?
Tolexine GE is a tetracycline antibiotic that fights bacteria in the body.
Tolexine GE is used to treat many different bacterial infections, such as acne, urinary tract infections, intestinal infections, eye infections, gonorrhea, chlamydia, periodontitis (gum disease), and others.
Tolexine GE is also used to treat blemishes, bumps, and acne-like lesions caused by rosacea. Tolexine GE will not treat facial redness caused by rosacea.
Some forms of Tolexine GE are used to prevent malaria, to treat anthrax, or to treat infections caused by mites, ticks, or lice.
Tolexine GE may also be used for purposes not listed in this medication guide.
Tolexine GE indications
Tolexine GE® and Tolexine GE® CAP are indicated for treatment of Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsial pox, and tick fevers caused by Rickettsiae.
Sexually Transmitted Infections
Tolexine GE and Tolexine GE CAP are indicated for treatment of the following sexually transmitted infections:
- Uncomplicated urethral, endocervical or rectal infections caused by Chlamydia trachomatis.
- Nongonococcal urethritis caused by Ureaplasma urealyticum.
- Lymphogranuloma venereum caused by Chlamydia trachomatis.
- Granuloma inguinale caused by Klebsiella granulomatis.
- Uncomplicated gonorrhea caused by Neisseria gonorrhoeae.
- Chancroid caused by Haemophilus ducreyi.
Respiratory Tract Infections
Tolexine GE and Tolexine GE CAP are indicated for treatment of the following respiratory tract infections:
- Respiratory tract infections caused by Mycoplasma pneumoniae.
- Psittacosis (ornithosis) caused by Chlamydophila psittaci.
- Because many strains of the following groups of microorganisms have been shown to be resistant to Tolexine GE, culture and susceptibility testing are recommended.
- Tolexine GE is indicated for treatment of infections caused by the following microorganisms, when bacteriological testing indicates appropriate susceptibility to the drug:
- Respiratory tract infections caused by Haemophilus influenzae.
- Respiratory tract infections caused by Klebsiella species.
- Upper respiratory infections caused by Streptococcus pneumoniae.
Specific Bacterial Infections
Tolexine GE and Tolexine GE CAP are indicated for treatment of the following specific bacterial infections:
- Relapsing fever due to Borrelia recurrentis.
- Plague due to Yersinia pestis.
- Tularemia due to Francisella tularensis.
- Cholera caused by Vibrio cholerae.
- Campylobacter fetus infections caused by Campylobacter fetus.
- Brucellosis due to Brucella species (in conjunction with streptomycin).
- Bartonellosis due to Bartonella bacilliformis.
Because many strains of the following groups of microorganisms have been shown to be resistant to Tolexine GE, culture and susceptibility testing are recommended.
Tolexine GE and Tolexine GE CAP are indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriological testing indicates appropriate susceptibility to the drug:
- Escherichia coli
- Enterobacter aerogenes
- Shigella species
- Acinetobacter species
- Urinary tract infections caused by Klebsiella species.
Tolexine GE and Tolexine GE CAP are indicated for treatment of the following ophthalmic infections:
- Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated as judged by immunofluorescence.
- Inclusion conjunctivitis caused by Chlamydia trachomatis.
Anthrax Including Inhalational Anthrax (Post-Exposure)
Tolexine GE and Tolexine GE CAP are indicated for the treatment of Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure); to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.
Alternative Treatment for Selected Infections when Penicillin is Contraindicated
Tolexine GE and Tolexine GE CAP are indicted as an alternative treatment for the following selected infections when penicillin is contraindicated:
- Syphilis caused by Treponema pallidum.
- Yaws caused by Treponema pallidum subspecies pertenue.
- Listeriosis due to Listeria monocytogenes.
- Vincent’s infection caused by Fusobacterium fusiforme.
- Actinomycosis caused by Actinomyces israelii.
- Infections caused by Clostridium species.
Adjunctive Therapy for Acute Intestinal Amebiasis and Severe Acne
In acute intestinal amebiasis, Tolexine GE and Tolexine GE CAP may be a useful adjunct to amebicides.
In severe acne, Tolexine GE and Tolexine GE CAP may be useful adjunctive therapy.
Prophylaxis of Malaria
Tolexine GE and Tolexine GE CAP are indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (less than 4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tolexine GE and Tolexine GE CAP and other antibacterial drugs, Tolexine GE and Tolexine GE CAP 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.
How should I use Tolexine GE?
Use Tolexine GE kit as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Tolexine GE kit kit contains antibiotic capsules, eyelid cleansing pads, and a moisturizing spray.
- To use the eyelid cleansing pad:
- Remove contact lenses before you use Tolexine GE kit.
- Wash your hands before using Tolexine GE kit. Close the eyes and gently cleanse the eyelids using side to side strokes. Avoid touching the eyes directly. Rinse or leave on as directed by your doctor. Discard after use.
- To use the moisturizing spray:
- Hold the spray tip 4 to 6 inches away from the eye. Close the eye and spray directly onto the eyelid surface. Gently massage into the eyelids and lashes. If directed to do so by your doctor, repeat this procedure with the other eye.
- If you prefer, you may spray onto the inner side of the finger and then gently massage onto the eyelids and lashes. Do not spray directly into the eyes.
- To take the antibiotic:
- Take Tolexine GE kit by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Take Tolexine GE kit with a full glass of water (8 oz/240 mL) and drink plenty of fluids to prevent ulcers and reduce throat irritation.
- Do not eat or drink calcium-rich foods (eg, milk or other dairy products, calcium-enriched juices), or take an antacid that has aluminum, calcium, or magnesium in it; bismuth subsalicylate; iron; or urinary alkalinizers (eg, sodium bicarbonate) within 2 hours before or 2 hours after you take Tolexine GE kit.
- Use Tolexine GE kit on a regular schedule to get the most benefit from it. It may take several days to see the full effect of Tolexine GE kit.
- To clear up your infection completely, take Tolexine GE kit for the full course of treatment. Keep taking it even if your condition improves in a few days.
- Do not use Tolexine GE kit if it is past the expiration date on the bottle.
- If you miss a dose of Tolexine GE kit, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Tolexine GE kit.
Uses of Tolexine GE in details
This medication is used to treat a wide variety of bacterial infections, including those that cause acne. This medication is also used to prevent malaria. This medication is known as a tetracycline antibiotic. It works by stopping the growth of bacteria.
This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This drug may also be used to treat a certain skin condition (rosacea).
How to use Tolexine GE
This medication is best taken by mouth on an empty stomach, at least 1 hour before or 2 hours after a meal, usually 1 or 2 times daily or as directed by your doctor. Take this medication with a full glass of water (8 ounces/240 milliliters) unless directed otherwise. If stomach upset occurs, taking it with food or milk may help. However, Tolexine GE may not work as well if you take it with food or milk (or anything high in calcium – more details below ), so ask your doctor or pharmacist if you may take it that way. Do not lie down for 10 minutes after taking this medication.
Take this medication 2 to 3 hours before or after taking any products containing aluminum, calcium, iron, magnesium, zinc, or bismuth subsalicylate. Some examples include antacids, didanosine solution, quinapril, vitamins/minerals, dairy products (such as milk, yogurt), and calcium-enriched juice. These products bind with Tolexine GE, preventing your body from fully absorbing the drug.
When using to prevent malaria, this medication is usually taken once daily. Take the first dose of this medication 1 to 2 days before travel or as directed by your doctor. Continue to take this medication daily while in the malarious area. Upon returning home, you should keep taking this medication for 4 more weeks. If you are unable to finish this course of Tolexine GE, contact your doctor.
If you are using the liquid form of this medication, shake the bottle well before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.
The dosage is based on your medical condition and response to treatment. For children, the dosage may also be based on weight.
Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals.
Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, which may result in a return of the infection.
Tell your doctor if your condition persists or worsens.
Tolexine GE description
Tolexine GE is a broad-spectrum antibiotic synthetically derived from oxytetracycline and is available as Tolexine GE monohydrate and Tolexine GE hyclate (hydrochloride hemiethanolate hemihydrate). The chemical designation of this light-yellow crystalline powder is α-6-deoxy-5-oxytetracycline. Tolexine GE has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Tolexine GE will not degrade into an epianhydro form.
The molecular formula for Tolexine GE hydrochloride hemiethanolate hemihydrate is (C22H24N2O8·HCl)2·C2H6O·H2O and the molecular weight is 1025.89. Tolexine GE is a light-yellow crystalline powder. Tolexine GE hyclate is soluble in water, while Tolexine GE monohydrate is very slightly soluble in water.
Tolexine GE dosage
Tolexine GE (Tolexine GE hyclate) ® is a variable dose product dependent on the size, shape, and number of pockets being treated.
Preparation for Use
1. If refrigerated, remove the product from refrigeration at least 15 minutes prior to mixing.
2. Couple Syringe A (liquid delivery system) and Syringe B (drug powder).
3. Inject the liquid contents of Syringe A (indicated by red stripe) into Syringe B (Tolexine GE powder) and then push the contents back into Syringe A. This entire operation is one mixing cycle.
4. Complete 100 mixing cycles at a pace of one cycle per second using brisk strokes.
If immediate use is desired, skip to step 7.
5. If necessary, the coupled syringes can be stored at room temperature for a maximum of three days. Some of the Tolexine GE (Tolexine GE hyclate) systems are packaged in resealable pouches that can be used for this purpose. If the Tolexine GE (Tolexine GE hyclate) system is packaged in a try, use an airtight container.
6. After storage, perform an additional ten mixing cycles just prior to use.
Continue with immediate use instructions.
7. The contents will be in Syringe A (indicated by red stripe). Hold the coupled syringes vertically with Syringe A at the bottom. Pull back on the Syringe A plunger and allow the contents to flow down the barrel for several seconds.
8. Uncouple the two syringes and attach one of the provided cannulae to Syringe A.
Product is now ready for application.
Tolexine GE (Tolexine GE hyclate) ® does not require local anesthesia for placement. Bend the cannula to resemble a periodontal probe and explore the periodontal pocket in a manner similar to periodontal probing. Keeping the cannula tip near the base of the pocket, express the product into the pocket until the formulation reaches the top of the gingival margin. Withdraw the cannula tip from the pocket. In order to separate the tip from the formulation, turn the tip of the cannula towards the tooth, press the tip against the tooth surface, and pinch the string of formulation from the tip of the cannula. Variations on this technique may be needed to achieve separation between Tolexine GE (Tolexine GE hyclate) ® and cannula.
If desired, using an appropriate dental instrument, Tolexine GE (Tolexine GE hyclate) ® may be packed into the pocket. Dipping the edge of the instrument in water before packing will help keep Tolexine GE (Tolexine GE hyclate) ® from sticking to the instrument, and will help speed coagulation of Tolexine GE (Tolexine GE hyclate) ®. A few drops of water dripped onto the surface of Tolexine GE (Tolexine GE hyclate) ® once in the pocket will also aid in coagulation. If necessary, add more Tolexine GE (Tolexine GE hyclate) ® as described above and pack it into the pocket until the pocket is full.
Cover the pockets containing Tolexine GE (Tolexine GE hyclate) ® with either Coe-Pak™ periodontal dressing or a cyanoacrylate dental adhesive.
Application of Tolexine GE (Tolexine GE hyclate) ® may be repeated four months after initial treatment.
The final blended product is 500 mg of formulation containing 50 mg of Tolexine GE hyclate (Tolexine GE hyclate, 10%).
Tolexine GE (Tolexine GE hyclate) ® is available as a tray or pouch containing a Tolexine GE hyclate syringe (50 mg), an ATRIGEL® Delivery System syringe (450 mg), and a blunt cannula. The pouched product is available in a box of six (NDC 63646-191-00) a box of two (NDC63646-191-02), or a professional sample pouch (NDC 63646-191-01). The trayed product is available in a box of six (NDC 63646-191-05), a box of four (NDC 63646-191-04), or a professional sample box of two (NDC 63646-191-03).
Each Tolexine GE (Tolexine GE hyclate) ® syringe system is intended for use in only one patient. Do not use if packaging has been previously opened or damaged.
Manufactured by TOLMAR Inc. Fort Collins, CO 80526. Distributed by Zila Therapeutics, Inc. Rev. 02/11.
Tolexine GE interactions
Medications containing metal ions (antacids, products containing iron, magnesium, calcium) form inactive chelates with Tolexine GE, in connection with what it is necessary to avoid their simultaneous use.
It needed to avoid combination with penicillins, cephalosporins, bactericidal action and is an antagonist of bacteriostatic antibiotics (including Tolexine GE).
Absorption of Tolexine GE is reduced by cholestyramine and colestipol (observe the interval between the reception of at least 3 h).
Due to suppression of intestinal microflora Tolexine GE reduces prothrombin index which requires dose adjustment of indirect anticoagulants.
Alti-Tolexine GE reduces the reliability of contraception and increases the frequency of breakthrough bleeding while taking estrogen-containing oral contraceptives.
Simultaneous administration of Alti-Tolexine GE with:
Tolexine GE side effects
Applies to Tolexine GE: oral capsule, oral capsule delayed release, oral capsule extended release, oral powder for suspension, oral syrup, oral tablet, oral tablet delayed release
Along with its needed effects, Tolexine GE (the active ingredient contained in Tolexine GE) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking Tolexine GE:
Incidence Not Known
- Blistering, peeling, or loosening of the skin
- clay-colored stools
- dark urine
- decreased appetite
- diarrhea, watery and severe, which may also be bloody
- difficulty with swallowing
- fast heartbeat
- feeling of discomfort
- hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- hives or welts, itching, or rash
- increased thirst
- inflammation of the joints
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- numbness or tingling of the face, hands, or feet
- pain in the stomach, side, or abdomen, possibly radiating to the back
- red skin lesions, often with a purple center
- redness and soreness of the eyes
- redness of the skin
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- stomach cramps
- stomach pain or tenderness
- swelling of the feet or lower legs
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- tightness in the chest
- unusual tiredness or weakness
- unusual weight loss
- yellow eyes or skin
Some side effects of Tolexine GE may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence Not Known
- Back, leg, or stomach pains
- black, tarry stools
- bleeding gums
- blood in the urine or stools
- blurred vision
- bulging soft spot on the head of an infant
- change in the ability to see colors, especially blue or yellow
- chest pain, discomfort, or burning
- cracks in the skin
- decrease in vision
- difficulty breathing
- discoloration of the thyroid glands
- double vision
- general body swelling
- increased sensitivity of the skin to sunlight
- loss of heat from the body
- lower back or side pain
- pain or burning in the throat
- pain with swallowing
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- rash with flat lesions or small raised lesions on the skin
- red, swollen skin
- redness or other discoloration of the skin
- redness, swelling, or soreness of the tongue
- scaly skin
- severe nausea
- severe stomach pain
- severe sunburn
- tooth discoloration
- unusual bleeding or bruising
- vomiting blood
For Healthcare Professionals
Applies to Tolexine GE: injectable powder for injection, oral capsule, oral delayed release capsule, oral delayed release tablet, oral kit, oral powder for reconstitution, oral syrup, oral tablet, oral and topical kit
Very common (10% or more): Headache (up to 26%)
Common (1% to 10%): Sinus headache
Rare (0.01% to 0.1%): Bulging fontanels (in infants), benign intracranial hypertension (pseudotumor cerebri [symptoms include blurred vision, scotomata, diplopia]), tinnitus
Frequency not reported: Hypoesthesia, increased intracranial pressure, paresthesia, somnolence, stupor, taste loss, drowsiness, amnesia, paresthesias of body areas exposed to sunlight, phrenic nerve paralysis after sclerotherapy
Postmarketing reports: Pseudotumor cerebri, headache, dizziness
-Frequency not reported: Autoimmune syndromes
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Tolexine GE contraindications
Do not use this medicine if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life.
Tolexine GE can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using Tolexine GE.
You should not take this medicine if you are allergic to Tolexine GE or to other tetracycline antibiotics such as demeclocycline (Declomycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).
Before taking Tolexine GE, tell your doctor if you have liver disease, kidney disease, asthma, or if you are allergic to sulfites.
Drink plenty of liquids while you are taking Tolexine GE.
Children should not use Tolexine GE. Tolexine GE can cause permanent yellowing or graying of the teeth in children younger than 8 years old.
Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.