Troxip Tablets

Troxipide Tablet 100mg

Each film coated tablet contains

Troxipide    100 mg

Colour: Lake quinoline yellow & Titanium Dioxide IP

Tablet

100mg

4.1 Therapeutic Indication

Troxipide is intended for use in the treatment of acute gastritis, acute exacerbation of chronic gastritis and peptic ulcers

4.2 Posology and method of administration

The recommended dose of Troxipide is 100mg thrice daily for 8-12 weeks

Method of administration: Oral

4.3 Contraindications

Troxipide is contraindicated in patients showing hypersensitivity to Troxipide

4.4 Special warnings and precautions for use

Troxipide should use with caution in children and pregnant women due to lack of safety data. It is known that sexual cycle dysfunction occurred in rats treated with Troxipide. Hence, caution should be exercised while treating women in the reproductive age group. It has to be used with caution in breast feeding women; they should stop breast feeding when on the drug. Troxipide has to be cautiously used in geriatric population.

4.5 Drugs interactions

There have been no reports of interactions with other drugs.

4.6 Use in special populations

Pregnancy and lactation

This drug should be administered to pregnant women or women who may be pregnant only if the therapeutic benefits are deemed to outweigh the risks.

Consider whether to continue or discontinue breast-feeding, taking into account the therapeutic benefits and the benefits of breast-feeding. Transfer of the drug into breast milk has been observed in animal studies (rats).

Children

No clinical trials have been conducted on children or other subjects.

Elderly

In general, physiological functions are often impaired.

4.7 Effects on ability to drive and use machines

Troxib tablets have no influence on the ability to drive and use machines.

4.8 Undesirable effects

Adverse reactions reported with Troxipide are generally mild to moderate in severity and disappear on discontinuation of the drug.

The commonly reported adverse events include:

• Gastrointestinal effects like occasional constipation, abdominal swelling, and stomach discomfort
• Abnormality in liver functions (raised SGOT, SGPT, ALP levels)
• General malaise

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email to: medico@zuventus.com

Website: https://www.zuventus.com/drug-safety-reporting

By reporting side effects, you can help provide more information on the safety of this medicine.

4.9 Overdose

No cases of overdosage due to Troxip therapy have been reported. In case of accidental overdose, discontinue use and seek professional assistance immediately. Gastric lavage may be necessary to remove drug already released into the stomach.

5.1 Mechanism of Action

The mechanism of action of this drug is to promote tissue repair of the gastric mucosa by increasing blood flow to the gastric mucosa, normalizing the components of the gastric mucosa, increasing the amount of prostaglandins in the gastric mucosa, and activating the metabolism of the gastric mucosa.

5.2 Pharmacodynamic properties

Troxipide protects against mucosal fragility and disruption of gastric mucosal barrier by increasing the gastric mucosal content of glucosamine and mucopolysaccharides, stimulating the synthesis of cytoprotective prostaglandins and by stimulating the regeneration of collagen fibers. Troxipide is proposed to act by the inhibition of Interleukin 8 (IL-8) stimulated migration of neutrophils in the gastric mucosa. Troxipide also suppresses formyl-methionyl-leucyl-phenylalanine (fMLP) or Platelet Activating Factor (PAF) stimulated superoxide generation and decreases inflammation in the mucosal tissues. It also increases the gastric mucosal blood flow and metabolism

5.3 Pharmacokinetic properties

It is well absorbed throughout the gastrointestinal tract after administration. Troxipide was detected in plasma from 0.05 hr after oral administration of 100 mg of film coated tablets, suggesting a rapid absorption. Bioavailability of Troxipide is 99.40%. A peak serum concentration of 1052.471±51.9318 ng/ml is obtained within 3.042±0. 1896 hrs of drug administration and the resultant area under the curve is 8737.481±315.4253 ng/ml.hr. It is found that, at any time, a mean concentration of 5.3 - 8.9 µg is present per gram of tissue, which is capable of inhibiting the chemotactic migration and superoxide generation in the gastric mucosa. Thus, even 3 hrs after attaining peak serum levels, Troxipide is found in therapeutically active concentrations in the small intestine, liver and stomach. It has a half life of 7.44± 1.85 hrs, and is mainly excreted in the urine (96%) as metabolites [61% after 24 hrs and 87% after 48 hrs].

6.1 Animal Toxicology or Pharmacology

• In a subacute toxicity test in rats, it has been reported that when 1,000 mg/kg/day or more was orally administered, there was more occult blood in the urine, which is thought to be due to inflammation and bleeding in the bladder, than in the control group1)
• Since animal experiments (rats) have reported disturbances of the estrous cycle presumably due to abnormal prolactin secretion2), menstrual abnormalities, lactation, etc. should be closely observed, and appropriate measures such as suspension or discontinuation of the drug should be taken if any abnormalities are found.

Troxipide, (±)-3,4,-5-trimethoxy-N-3-piperidylbenzamide, is a gastroprotective agent with a molecular formula of C H N O , and molecular weight of 294.3.

The molecular structure of Troxipide is given below.

8.1 Incompatibilities

Not applicable

8.2 Shelf-life

Refer on pack

8.3 Packaging information

A blister strip of 10 tablets

8.4 Storage and handing instructions

Store in a cool, dry & dark place.

Keep out of reach of children

• Troxipide is intended for use in the treatment of acute gastritis, chronic gastritis and peptic ulcers
• Advice patients not to take this medicine, if they are allergic to Troxipide. Signs of an allergic reaction include a rash, itching or shortness of breath.
• Pregnancy: Tell female patients Troxip™ should not be given during pregnancy and lactation. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible.
• Tell the patients if they get any side effects, talk to the doctor. This includes any possible side effects not listed in this leaflet. Advice patients if they have any further questions, ask the doctor or pharmacist.
• Tablet should be swallowed whole & not to be broken, crushed or chewed. Take it with or after food or a glass of milk.
• Do not stop taking it suddenly without talking to your doctor if you've been on it for a long time.
• Take it with food to avoid an upset stomach.

28/06/2024