Tritop

A component of Neomycin (Tritop) that is produced by Streptomyces fradiae. On hydrolysis it yields neamine and neobiosamine B. (From Merck Index, 11th ed). Neomycin (Tritop) is a bactericidal aminoglycoside antibiotic that binds to the 30S ribosome of susceptible organisms. Binding interferes with mRNA binding and acceptor tRNA sites and results in the production of non-functional or toxic peptides.

Tetracaine (Tritop) is an ester local anaesthetic currently available in combination with lidocaine as a cream and patch.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Neomycin (Tritop) tablets and other antibacterial drugs, Neomycin (Tritop) 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.

Suppression of Intestinal Bacteria

Neomycin (Tritop) tablets are indicated as adjunctive therapy as part of a regimen for the suppression of the normal bacterial flora of the bowel, e.g., preoperative preparation of the bowel. It is given concomitantly with erythromycin enteric-coated base.

Hepatic Coma (Portal-Systemic Encephalopathy)

Neomycin (Tritop) has been shown to be effective adjunctive therapy in hepatic coma by reduction of the ammonia-forming bacteria in the intestinal tract. The subsequent reduction in blood ammonia has resulted in neurologic improvement.

Subarachnoid

Spinal anaesthesia

Adult: 1% solution diluted with an equal volume of CSF immediately prior to admin or 5 mg of powder dissolved in 1 ml of CSF and admin slowly at a rate of 1 ml/5 sec. For anaesthesia of perineum: 5 mg. For anaesthesia of perineum and lower extremities: 10 mg. For spinal anaesthesia extending up to the costal margin: 15-20 mg. For low spinal (saddle block) anaesthesia in vaginal delivery: 2-5 mg admin as a hyperbaric solution.

Elderly: Dose reduction may be needed.

Ophthalmic

Anaesthesia of the eye

Adult: Instil 0.5-1% Tetracaine (Tritop) solution or 0.5% ointment.

Topical/Cutaneous

Topical anaesthesia

Adult: Apply as 1% cream or 0.5% ointment. For percutaneous local anaesthesia before venepuncture or venous cannulation: Apply 4% gel to the centre of the area to be anaesthetised and covered with an occlusive dressing. Remove gel and dressing after 30 minutes for venepuncture and after 45 minutes for venous cannulation.

Neomycin (Tritop) is an antibiotic that fights bacteria in the body.

Neomycin (Tritop) is used to reduce the risk of infection during surgery of your intestines. Neomycin (Tritop) is also used to reduce the symptoms of hepatic coma.

Neomycin (Tritop) may also be used for purposes not listed in this medication guide.

Tetracaine (Tritop) eye drops are used to numb the eye before surgery, certain tests, or procedures. The eye drops are used to prevent pain during the procedure.

Tetracaine (Tritop) belongs to the group of medicines called local anesthetics. It works by blocking the pain signals at the nerve endings in the eye.

Tetracaine (Tritop) is to be administered only by or under the direct supervision of an eye doctor.

To minimize the risk of toxicity, use the lowest possible dose and the shortest possible treatment period to control the condition. Treatment for periods longer than two weeks is not recommended.

Hepatic Coma

For use as an adjunct in the management of hepatic coma, the recommended dose is 4-12 grams per day given in the following regimen:

1. Withdraw protein from diet. Avoid use of diuretic agents.

2. Give supportive therapy, including blood products, as indicated.

3. Give Neomycin (Tritop) Tablets in doses of 4-12 grams of Neomycin (Tritop) per day (eight to 24 tablets) in divided doses. Treatment should be continued over a period of five to six days, during which time protein should be returned incrementally to the diet.

4. If less potentially toxic drugs cannot be used for chronic hepatic insufficiency, Neomycin (Tritop) in doses of up to four grams daily (eight tablets per day) may be necessary. The risk for the development of Neomycin (Tritop)-induced toxicity progressively increases when treatment must be extended to preserve the life of a patient with hepatic encephalopathy who has failed to fully respond. Frequent periodic monitoring of these patients to ascertain the presence of drug toxicity is mandatory. Also, Neomycin (Tritop) serum concentrations should be monitored to avoid potentially toxic levels. The benefits to the patient should be weighed against the risks of nephrotoxicity, permanent ototoxicity and neuromuscular blockade following the accumulation of Neomycin (Tritop) in the tissues.

Preoperative Prophylaxis for Elective Colorectal Surgery

Listed below is an example of a recommended bowel preparation regimen. A proposed surgery time of 8:00 am. has been used.

Pre-op Day 3: Minimum residue or clear liquid diet. Bisacodyl, 1 tablet orally at 6:00 p. m.

Pre-op Day 2: Minimum residue or clear liquid diet. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., 2:00 p.m., and 6:00 p.m. Enema at 7:00 p.m. and 8:00 p.m.

Pre-op Day 1: Clear liquid diet. Supplemental (IV) fluids as needed. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a. m., and 2:00 p.m. Neomycin (Tritop) (1 g) and erythromycin base (1 g) orally at 1:00 p. m., 2:00 p.m. and 11:00 p.m. No enema.

Day of Operation: Patient evacuates rectum at 6:30 a.m. for scheduled operation at 8:00 a.m.

How supplied

Neomycin (Tritop) Tablets, USP, 500 mg (equivalent to 350 mg of Neomycin (Tritop) base per tablet) are available as round, off-white, unscored tablets, imprinted "BL" and "18", in bottles of 100 tablets.

Store at controlled room temperature 15°-30° C( 59°-86° F). Dispense in tight containers as defined in the USP/NF.

CAUTION: Federal law prohibits dispensing without prescription.

As with all anesthetics, the dosage varies and depends upon the area to be anesthetized, the number of neuronal segments to be blocked, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. For specific techniques and procedures, refer to standard textbooks.

The extent and degree of spinal anesthesia depend upon dosage, specific gravity of the anesthetic solution, volume of solution used, force of the injection, level of puncture, position of the patient during and immediately after injection, etc.

When spinal fluid is added to either the Tetracaine (Tritop) or the 1% Solution, some turbidity results, the degree depending on the pH of the spinal fluid, the temperature of the solution during mixing, as well as the amount of drug and diluent employed. This cloudiness is due to the release of the base from the hydrochloride. Liberation of base (which is completed within the spinal canal) is held to be essential for satisfactory results with any spinal anesthetic.

The specific gravity of spinal fluid at 25°C/25°C varies under normal conditions from 1.0063 to 1.0075. A solution of the instantly soluble form (Tetracaine (Tritop)) in spinal fluid has only a slightly greater specific gravity. The 1% concentration in saline solution has a specific gravity of 1.0060 to 1.0074 at 25°C/25°C.

A hyperbaric solution may be prepared by mixing equal volumes of the 1% Solution and Dextrose Solution 10% (which is available in ampuls of 3 mL).

If the Tetracaine (Tritop) form is preferred, it is first dissolved in Dextrose Solution 10% in a ratio of 1 mL dextrose to 10 mg of the anesthetic. Further dilution is made with an equal volume of spinal fluid. The resulting solution now contains 5% dextrose with 5 mg of anesthetic agent per milliliter.

A hypobaric solution may be prepared by dissolving the Tetracaine (Tritop) in Sterile Water for Injection, USP (1 mg per milliliter). The specific gravity of this solution is essentially the same as that of water, 1.000 at 25°C/25°C.

Examine ampuls carefully before use. Do not use solution if crystals, cloudiness, or discoloration is observed.

These formulations of Tetracaine (Tritop) hydrochloride do not contain preservatives; therefore, unused portions should be discarded and the reconstituted Tetracaine (Tritop) should be used immediately.

STERILIZATION OF AMPULS

The drug in intact ampuls is sterile. The preferred method of destroying bacteria on the exterior of ampuls before opening is heat sterilization (autoclaving). Immersion in antiseptic solution is not recommended.

Autoclave at 15-pound pressure, at 121°C (250°F), for 15 minutes. The Tetracaine (Tritop) form may also be autoclaved in the same way but may lose its snowlike appearance and tend to adhere to the sides of the ampul. This may slightly decrease the rate at which the drug dissolves but does not interfere with its anesthetic potency.

Autoclaving increases likelihood of crystal formation. Unused autoclaved ampuls should be discarded. Under no circumstance should unused ampuls which have been autoclaved be returned to stock.

See also:
What is the most important information I should know about Neomycin (Tritop)?

You should not take this medicine if you are allergic to Neomycin (Tritop) or similar antibiotics such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi).

You should not take Neomycin (Tritop) if you have ulcerative colitis, Crohn's disease, a blockage in your intestines, or other inflammatory bowel disease.

Do not use Neomycin (Tritop) if you are pregnant. It could harm the unborn baby.

Before you take Neomycin (Tritop), tell your doctor if you have kidney disease, myasthenia gravis, or Parkinson's disease.

Never take Neomycin (Tritop) in larger amounts than recommended, or for longer than 2 weeks. High doses or long-term use of Neomycin (Tritop) can cause serious kidney problems, or hearing loss that may not be reversible. The longer you take Neomycin (Tritop), the more likely you are to develop these serious side effects.

To be sure this medication is not causing harmful effects, your kidney function, and your nerve and muscle function will need to be tested often. You may also need hearing tests. Neomycin (Tritop) can have long lasting effects on your body. Do not miss any follow up visits to your doctor for blood or urine tests.

Neomycin (Tritop) can harm your kidneys, and this effect is increased when you also use certain other medicines harmful to the kidneys. Before using Neomycin (Tritop), tell your doctor about all other medicines you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

If you are being treated for hepatic coma, avoid eating foods that are high in protein. Follow your doctor's instructions about any other restrictions on food, beverages, or activity.

See also:
What is the most important information I should know about Tetracaine (Tritop)?

Spinal anesthesia with Tetracaine (Tritop) hydrochloride is contraindicated in patients with known hypersensitivity to Tetracaine (Tritop) hydrochloride or to drugs of a similar chemical configuration (ester-type local anesthetics), or aminobenzoic acid or its derivatives; and in patients for whom spinal anesthesia as a technique is contraindicated.

The decision as to whether or not spinal anesthesia should be used for an individual patient should be made by the physician after weighing the advantages with the risks and possible complications. Contraindications to spinal anesthesia as a technique can be found in standard reference texts, and usually include generalized septicemia, infection at the site of injection, certain diseases of the cerebrospinal system, uncontrolled hypotension, etc.

Use Neomycin (Tritop) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Neomycin (Tritop) by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Take Neomycin (Tritop) with plenty of water to avoid dehydration.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Take Neomycin (Tritop) on a regular schedule to get the most benefit from it.
• To clear up your infection completely, use Neomycin (Tritop) for the full course of treatment. Keep using it even if you feel better in a few days.
• If you miss a dose of Neomycin (Tritop), 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. If more than one dose is missed, contact your health care provider.

Ask your health care provider any questions you may have about how to use Neomycin (Tritop).

Use Tetracaine (Tritop) drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Tetracaine (Tritop) drops is administered at your doctor's office, hospital, or clinic. Ask your doctor or pharmacist any questions that you may have about Tetracaine (Tritop) drops.
• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
• Do not touch or rub the eye until the effect of the medicine has worn off. Your doctor may instruct you to wear an eye patch to prevent you or anything else from touching your eye.
• If you miss a dose of Tetracaine (Tritop) drops, check with your doctor.

Ask your health care provider any questions you may have about how to use Tetracaine (Tritop) drops.

Oral Neomycin (Tritop) is used before the operation of the gut to kill the bacteria which normally live in the gut that may cause a serious infection and in treatment of patients with coma due to liver disease (hepatic coma).

Use: Labeled Indications

Anesthesia, ocular: Local anesthesia for various ophthalmic procedures requiring rapid, short-acting topical anesthesia, including tonometry, gonioscopy removal of corneal foreign bodies, conjunctival scraping for diagnostic purposes, suture removal from the cornea or conjunctiva, and other short corneal and conjunctival procedures.

See also:
What other drugs will affect Neomycin (Tritop)?

Acarbose: Neomycin (Tritop) may enhance the adverse/toxic effect of Acarbose. Neomycin (Tritop) may decrease the metabolism of Acarbose. Monitor therapy

Amphotericin B: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Arbekacin: May enhance the nephrotoxic effect of Aminoglycosides. Arbekacin may enhance the ototoxic effect of Aminoglycosides. Monitor therapy

Ataluren: May enhance the adverse/toxic effect of Aminoglycosides. Specifically, an increased risk of nephrotoxicity may occur with the concomitant use of ataluren and aminoglycosides. Avoid combination

Bacitracin (Systemic): Neomycin (Tritop) may enhance the nephrotoxic effect of Bacitracin (Systemic). Avoid combination

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Bisphosphonate Derivatives: Aminoglycosides may enhance the hypocalcemic effect of Bisphosphonate Derivatives. Monitor therapy

Botulinum Toxin-Containing Products: Aminoglycosides may enhance the neuromuscular-blocking effect of Botulinum Toxin-Containing Products. Monitor therapy

Capreomycin: May enhance the neuromuscular-blocking effect of Aminoglycosides. Monitor therapy

CARBOplatin: Aminoglycosides may enhance the ototoxic effect of CARBOplatin. Especially with higher doses of carboplatin. Monitor therapy

Cardiac Glycosides: Aminoglycosides may decrease the serum concentration of Cardiac Glycosides. This effect has only been demonstrated with oral aminoglycoside administration. Monitor therapy

Cefazedone: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Cephalosporins (2nd Generation): May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Cephalosporins (3rd Generation): May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Cephalosporins (4th Generation): May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Cephalothin: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Cephradine: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

CISplatin: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Colistimethate: Aminoglycosides may enhance the nephrotoxic effect of Colistimethate. Aminoglycosides may enhance the neuromuscular-blocking effect of Colistimethate. Management: Avoid coadministration of colistimethate and aminoglycosides whenever possible due to the risk of nephrotoxicity and neuromuscular blockade. If coadministration cannot be avoided, monitor renal and neuromuscular function. Consider therapy modification

CycloSPORINE (Systemic): Aminoglycosides may enhance the nephrotoxic effect of CycloSPORINE (Systemic). Monitor therapy

Distigmine: Aminoglycosides may diminish the therapeutic effect of Distigmine. Monitor therapy

Foscarnet: May enhance the nephrotoxic effect of Aminoglycosides. Avoid combination

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Loop Diuretics: May enhance the adverse/toxic effect of Aminoglycosides. Specifically, nephrotoxicity and ototoxicity. Monitor therapy

Mannitol (Systemic): May enhance the nephrotoxic effect of Aminoglycosides. Avoid combination

Mecamylamine: Aminoglycosides may enhance the neuromuscular-blocking effect of Mecamylamine. Avoid combination

Methoxyflurane: Aminoglycosides may enhance the nephrotoxic effect of Methoxyflurane. Avoid combination

Neuromuscular-Blocking Agents: Aminoglycosides may enhance the therapeutic effect of Neuromuscular-Blocking Agents. Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: May decrease the excretion of Aminoglycosides. Data only in premature infants. Monitor therapy

Oxatomide: May enhance the ototoxic effect of Aminoglycosides. Monitor therapy

Penicillins: May decrease the serum concentration of Aminoglycosides. Primarily associated with extended spectrum penicillins, and patients with renal dysfunction. Exceptions: Amoxicillin; Ampicillin; Bacampicillin; Cloxacillin; Dicloxacillin; Nafcillin; Oxacillin; Penicillin G (Parenteral/Aqueous); Penicillin G Benzathine; Penicillin G Procaine; Penicillin V Benzathine; Penicillin V Potassium. Consider therapy modification

Regorafenib: Neomycin (Tritop) may decrease serum concentrations of the active metabolite(s) of Regorafenib. Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

SORAfenib: Neomycin (Tritop) may decrease the serum concentration of SORAfenib. Monitor therapy

Tenofovir Products: Aminoglycosides may increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Aminoglycosides. Monitor therapy

Vancomycin: May enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Vitamin K Antagonists (eg, warfarin): Neomycin (Tritop) may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy

See also:
What other drugs will affect Tetracaine (Tritop)?

May antagonise activity of sulfonamides and aminosalicylic acid; increased Tetracaine (Tritop) levels with anticholinesterases; increased neuromuscular blocking action of suxamethonium.

See also:
What are the possible side effects of Neomycin (Tritop)?

Applies to Neomycin (Tritop): oral solution, oral tablet

In addition to its needed effects, some unwanted effects may be caused by Neomycin (Tritop) (the active ingredient contained in Neomycin (Tritop)). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Neomycin (Tritop):

Rare

• Any loss of hearing
• clumsiness
• diarrhea
• difficulty in breathing
• dizziness
• drowsiness
• greatly decreased frequency of urination or amount of urine
• increased amount of gas
• increased thirst
• light-colored, frothy, fatty-appearing stools
• ringing or buzzing or a feeling of fullness in the ears
• skin rash
• unsteadiness
• weakness

Minor Side Effects

Some of the side effects that can occur with Neomycin (Tritop) may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:

• Irritation or soreness of the mouth or rectal area
• nausea or vomiting

See also:
What are the possible side effects of Tetracaine (Tritop)?

Systemic adverse reactions to Tetracaine (Tritop) hydrochloride are characteristic of those associated with other local anesthetics and can involve the central nervous system and the cardiovascular system. Systemic reactions usually result from high plasma levels due to excessive dosage, rapid adsorption, or inadvertent intravascular injection.

A small number of reactions to Tetracaine (Tritop) hydrochloride may result from hypersensitivity, idiosyncrasy or diminished tolerance to normal dosage.

Central nervous system effects are characterized by excitation or depression. The first manifestation may be nervousness, dizziness, blurred vision, or tremors, followed by drowsiness, convulsions, unconsciousness and possibly respiratory and cardiac arrest. Since excitement may be transient or absent, the first manifestation may be drowsiness, sometimes merging into unconsciousness and respiratory and cardiac arrest. Other central nervous system effects may be nausea, vomiting, chills, constriction of the pupils, or tinnitus.

Cardiovascular system reactions include depression of the myocardium, blood pressure changes (usually hypotension), and cardiac arrest.

Allergic reactions, which may be due to hypersensitivity, idiosyncrasy, or diminished tolerance, are characterized by cutaneous lesions (eg. urticaria), edema, and other manifestations of allergy. Detection of sensitivity by skin testing is of limited value. Severe allergic reactions including anaphylaxis have rarely occurred and are not usually dose-related.

Reactions Associated with Spinal Anesthesia Techniques: Central Nervous System: post-spinal headache, meningismus, arachnoiditis, palsies, or spinal nerve paralysis. Cardiovascular: hypotension due to vasomotor paralysis and pooling of the blood in the venous bed. Respiratory: respiratory impairment or paralysis due to the level of anesthesia extending to the upper thoracic and cervical segments. Gastrointestinal: nausea and vomiting.

Treatment of Reactions: Toxic effects of local anesthetics require symptomatic treatment; there is no specific cure. The most important measure is oxygenation of the patient by maintaining an airway and supporting ventilation. Supportive treatment of the cardiovascular system includes intravenous fluids and, when appropriate, vasopressors (preferably those that stimulate the myocardium). Convulsions are usually controlled with adequate oxygenation alone but intravenous administration in small increments of a barbiturate (preferably an ultrashort-acting barbiturate such as thiopental and thiamylal), or diazepam can be utilized.

Intravenous barbiturates or anticonvulsant agents should only be administered by those familiar with their use and only if ventilation and oxygenation have first been assured. In spinal anesthesia, sympathetic blockade also occurs as a pharmacological action, resulting in peripheral vasodilation and often hypotension. The extent of the hypotension will usually depend on the number of dermatomes blocked. The blood pressure should therefore be monitored in the early phases of anesthesia. If hypotension occurs, it is readily controlled by vasoconstrictors administered either by the intramuscular or the intravenous route, the dosage of which would depend on the severity of the hypotension and the response to treatment.