Tegoyes 15 Capsule

Description of Tegoyes 15mg (Tegafur, Gimeracil ,Oteracil) capsule

The Tegafur, Gimeracil ,Oteracil  ternary combination, which forms the basis of an oral fluoropyrimidine antineoplastic regimen, has been incorporated into the Tegoyes 15mg capsule. The formulation has been developed, in order to enhance the activity of 5-fluorouracil (5-FU) without intensifying its side effects. Tegafur is a prodrug that is converted to 5 -FU in the body thus inhibiting the multiplication of DNA in malignant cells that proliferate very quickly. Gimeracil prevents the degradation of 5-FU by the enzyme and increases the pharmacological effect and the therapeutic index of the drug. Selective inhibition Oteracil reduces local toxicity by suppressing the activation of 5-FU in the gastrointestinal tract. As a result, the combination of these agents leads to an increase in therapeutic effects and tolerability.

Indications of Tegoyes 15mg (Tegafur, Gimeracil ,Oteracil) capsule

Tegoyes  15mg is mostly used in the treatment of gastric carcinoma and has demonstrated to be effective in other solid tumour, such as colorectal, pancreatic, and head and neck malignancy. It is commonly used with other cytotoxic drugs by the therapeutic regimen.

Mechanism of action of Tegoyes 15mg (Tegafur, Gimeracil ,Oteracil) capsule

The antitumour effect of Tegoyes 15mg is due to the synergistic pharmacodynamics of components. Tegafur is biotransformed to 5 -fluorouracil, a competitive inhibitor of the enzyme thymidylate synthase, which is essential to the de novo dTMP biosynthesis and, therefore, to DNA replication. Gimeracil inhibits the catabolism of 5‑FU by inhibiting dihydropyrimidine dehydrogenase, a process that prolongs the residence time of the drug. Oteracil is a selective inhibitor of 5-FU activation in the gastrointestinal mucosa, which decreases local adverse events. This concerted assembly provides effective tumour suppression that has a decreased toxicity consequence.

How to consume Tegoyes 15mg (Tegafur, Gimeracil ,Oteracil ) capsule

Tegoyes 15mg is administered by ingestion of the capsules orally, usually after food intake as per the prescription of the clinician who is treating the condition. It is based on body-surface area and clinical status of the patient to calculate the dosage. Treatment cycles are provided with rest intervals between them in order to promote normal tissue rest. Patients are also urged to stick to the schedules prescribed strictly.

Side Effects of Tegoyes 15mg (Tegafur, Gimeracil ,Oteracil) capsule

1. Common side effects

• Nausea
• Vomiting
• Diarrhea
• Fatigue
• Loss of appetite

2. Serious side effects

• Bone marrow suppression
• Neutropenia
• Severe diarrhea
• Mucositis
• Hepatotoxicity

3. Rare side effects

• Cardiotoxicity
• Hypersensitivity reactions
• Renal dysfunction

Safety Advice for Tegoyes 15mg (Tegafur, Gimeracil ,Oteracil) capsule

The patients under Tegoyes 15mg treatment should have regular complete blood counts and liver functioning tests, as the medication might cause inhibition in bone marrow functions and liver functioning performance.

Breastfeeding: During therapy, breastfeeding is not recommended, as active substances of Tegoyes 15mg can get into breast milk and then influence the neonate.

Pregnancy: The use of the drug during the pregnancy is contraindicated, as it might negatively interfere with the development of the foetus.

Alcohol: The use of the drug during the pregnancy is contraindicated, as it might negatively interfere with the development of the foetus.

Liver: Patient presenting with preexisting liver disease should be closely monitored and dose modifications may be necessary because of a change in the metabolism rate of the drug.

Lungs: Patients presenting with respiratory compromise, chest discomfort, etc. are expected to report this and especially with Tegoyes 15mg use these concomitantly with other chemotherapeutic agents.

Kidney: Renal functioning should be monitored at a regular period, since a compromised kidney may increase the chances of drug toxicity.

Driving: As side effects it can result in fatigue and generalised weakness; thus, driving should not take place in case of these symptoms.

Interaction of Tegoyes 15mg (Tegafur, Gimeracil ,Oteracil ) capsule

• Drug–Drug Interaction

Warfarin × Tegoyes 15mg 

The interaction between warfarin and Tegoyes 15mg is also likely to enhance the anticoagulant effect of warfarin hence risking bleeding occurrences.

Phenytoin × Tegoyes 15mg 

Tegoyes 15mg can increase the concentration of phenytoin in the serum and has a possibility of causing toxic effects including vertigo and neurological effect.

Allopurinol × Tegoyes 15mg 

Allopurinol has the potential of reducing the therapeutic effects of Tegoyes by disrupting its metabolic route.

Cisplatin × Tegoyes 15mg 

Even though the use of the cisplatin and Tegoyes 15mg combination is often used to increase the antineoplastic effect, it may also increase the treatment-related toxicity.

Other myelosuppressive drugs × Teysono. 

The concomitant use of Tegoyes 15mg with other myelosuppressive drugs can increase the level of bone marrow suppression and resultant infection.

• Drug–Food Interaction

Nutrition does not alter the pharmacodynamics profile of Teysono in a significant way, however, by eating the drug after a meal, it is possible to alleviate the effect of gastrointestinal irritation.

• Drug–Disease Interaction of Tegoyes 15mg (Tegafur, Gimeracil ,Oteracil ) capsule

Bone marrow suppression 

Tegoyes 15mg is capable of decreasing the hematopoietic cell production and thus increasing the risk of infections, anaemia and haemorrhage; stringent observation is thus a must.

Liver disease 

Weakened hepatic functioning can trigger upsurge in drug toxicity, thus requiring frequent evaluation of hepatic parameters.

Renal impairment 

A reduced renal clearance might lead to drug retention and an increase in adverse effects; a reduction in dose might be necessary.

Gastrointestinal disorders 

Patients who already have gastrointestinal pathology can have aggravated diarrhoea or mucositis.

Contraindication of Tegoyes 15mg (Tegafur, Gimeracil ,Oteracil ) capsule

Tegoyes 15mg should not be used in patients who show hypersensitivity to the ingredients, serious bone marrow suppression, pronounced hepatic impairment, and during pregnancy.

Dosage of Tegoyes 15mg (Tegafur, Gimeracil ,Oteracil) capsule

Dosage itself is varied depending on the surface area of the body and is covered in cycles, a change in dose can be introduced in response to patient tolerance and onset of side effects.

Storage of Tegoyes 15mg (Tegafur, Gimeracil ,Oteracil) capsule

The medicine must be kept at ambient temperature and be covered by wrapping and kept away as it is not to be exposed to heat or water, as well as children must be denied access to it.

Missed Dose of Tegoyes 15mg (Tegafur, Gimeracil ,Oteracil) capsule

In case of a missed scheduled dose, there is an option to skip the dose and continue with the next scheduled dose; however, one should not do two doses in a row.

Other General Information of Tegoyes 15mg (Tegafur, Gimeracil ,Oteracil ) capsule

It is advised that patients should keep their hydration and nutrition balanced during the course of therapy and regularly cheque their condition with the help of follow-up examinations to control therapeutic progress and timely identify any untoward event. All symptoms that present like severe diarrhoea, fever, or abnormal bleeding should be reported promptly.

FAQs of Tegoyes 15mg (Tegafur, Gimeracil ,Oteracil ) capsule

1. Why does this combination drug replace 5 FU?

The combination increases the activity of 5-fluorouracil (5-FU) and reduces its side effect profile especially gastrointestinal toxicity.

2. What is the position of Gimeracil in this drug?

Gimeracil is a dihydropyrimidine dehydrogenase inhibitor that inhibits the degradation of 5‑FU and therefore increases its clinical effect.

3. What is the inclusion of Oteracil in the combination?

Oteracil can be used to minimise gastrointestinal exposure to 5 -FU by curbing its phosphorylation in the gut mucosa, and thereby, reduce local toxicity.

4. Is the drug capable of severe diarrhoea?

Severe diarrhoea is one of the possible side effects; patients need to notify their doctors immediately in case of any serious cases of diarrhoea to prevent possible dehydration.

5. Is routine observation required in treatment?

Routine monitoring of haematological parameters and hepatic function is needed to improve the security and efficiency of treatment.

Fact Box of Tegoyes 15mg (Tegafur, Gimeracil ,Oteracil) capsule :

References

• European Medicines Agency (EMA) – Tegnat 20mg Product Information
  https://www.ema.europa.eu/en/documents/product-information/Tegnat 20mg-epar-product-information_en.pdf
• S. National Library of Medicine – Tegafur, Gimeracil, Oteracil
  https://pubchem.ncbi.nlm.nih.gov/compound/Tegafur
• DrugBank – Tegafur + Gimeracil + Oteracil
  https://go.drugbank.com
• National Cancer Institute (NCI) – Fluoropyrimidine Anticancer Drugs
  https://www.cancer.gov/about-cancer/treatment/drugs