INTRODUCTION

SYNTRAN SB CAPSULE contains Itraconazole which belongs to the group of medicines called Anti-fungals. It is used to treat infections of the mouth or vagina (causing thrush), skin infections and infections affecting other parts of the body.

Fungal infections also known as mycosis is a disease caused by fungus, which can affect people of all age groups. People with injuries and suppressed immune system are more susceptible to fungal infections. 

SYNTRAN SB CAPSULE should be used with caution in patients with kidney or liver problems and heart problems such as heart failure. SYNTRAN SB CAPSULE is not recommended for use in patients when the immune system is not functioning well or have acquired immunodeficiency syndrome (AIDS). 

Do not take any medicine without consulting your doctor while on treatment with SYNTRAN SB CAPSULE especially medicines given to treat indigestion or stomach ulcers. If the duration of the treatment with SYNTRAN SB CAPSULE is more than a month your doctor will advise you to take some blood tests to monitor your liver function.  

SYNTRAN SB CAPSULE is not recommended for use in pregnant women unless advised by the doctor and it is not recommended for use in breast-feeding women. SYNTRAN SB CAPSULE is not recommended for use in children less than 12 years of age, however your child’s doctor may advise them in special cases. 

SYNTRAN SB CAPSULE is normally not recommended for use in elderly patients, however, your doctor may prescribe them in special cases. The common side effects of taking SYNTRAN SB CAPSULE are stomach pain, nausea and headache. Consult your doctor if any of the side effects worsen.   

USES OF SYNTRAN SB CAPSULE

• infections of the mouth or vagina (causing thrush)
• skin infections and infections affecting other parts of the body

HOW SYNTRAN SB CAPSULE WORKS

SYNTRAN SB CAPSULE works by preventing the fungal growth by blocking the production of enzymes responsible for the growth of fungal cell. This inhibition results in breakage of cell membranes and fungal cell abnormalities, finally leading to alterations in membrane-based activity of fungus. These leads to fungal cell death and prevention of further fungal growth. 

DIRECTIONS FOR USE

Take SYNTRAN SB CAPSULE as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration of SYNTRAN SB CAPSULE for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF SYNTRAN SB CAPSULE

HOW TO MANAGE SIDE EFFECTS

Headache:

Drink ample amount of water and avoid skipping meals. Get adequate rest. Try to be relaxed and stress free. Apply pain relieving balm on your forehead if necessary. Consult your doctor if the symptom does not improve.    

Nausea or vomiting:

Stick to simple meals while taking this medicine. Avoid eating oily rich, fried or spicy foods. Do not lie down or sleep immediately after eating. Consult your doctor if the symptom does not improve.      

Diarrhoea:

Drink lot of fluids, such as water to keep yourself hydrated. Avoid eating high-fat or spicy foods. Try to avoid taking any medicine on your own to treat diarrhea and consult your doctor if the symptom gets worse.       

Stomach pain:

Try to rest and relax. Eat and drink slowly or try to have smaller meals more frequently. Keep a heat pad on your stomach. If the symptom does not improve, consult your doctor.    

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before taking SYNTRAN SB CAPSULE, inform your doctor if you are taking any of the following medicines:

• medicines used to treat allergies or hay fever Ex. terfenadine, astemizole, ebastine, mizolastine
• medicines used to lower blood cholesterol levels Ex. atorvastatin, lovastatin, simvastatin
• medicines used to treat irregular heartbeat Ex. quinidine, disopyramide, dronedarone or dofetilide
• medicines used to treat chest pain and high blood pressure Ex. bepridil, , lercanidipine, ivabradine, ranolazine, nisoldipine, aliskiren, nadolol, digoxin, cilostazol dihydropyridines such as amlodipine, felodipine, verapamil
• medicines used to treat migraine headaches Ex. dihydroergotamine, eletriptan, ergotamine
• medicines used to treat drug abuse Ex. levacetylmethadol and methadone
• medicines used to treat digestive problems Ex. cisapride
• colchicine (used to treat gout)
• medicines used to treat fluid accumulation Ex. Eplerenone
• medicines used after labour Ex. ergometrine, methylergometrine
• medicine used to treat malaria Ex. halofantrine
• medicines used to treat cancer Ex. irinotecan, bortezomib, busulphan, docetaxel, erlotinib, ixabepilone, trimetrexate, axitinib, dabrafenib, dasatinib, ibrutinib, lapatinib, nilotinib, sunitinib and trabectedin
• medicines used as blood thinners Ex. dabigatran, ticagrelor, rivaroxaban, warfarin
• medicines used to treat mental illness Ex. quetiapine, pimozide, lurasidone, aripiprazole, haloperidol, perospirone, ramelteon, risperidone, reboxetine, and sertindole
• medicines used to treat urinary bladder disorders Ex. darifenacin, tamsulosin, fesoterodine, imidafenacin, solifenacin, tolterodine
• medicines used to treat anxiety Ex. midazolam, triazolam, buspirone, alprazolam, brotizolam
• medicines used after an organ transplant Ex. everolimus, ciclesonide, temsirolimus, ciclosporin, tacrolimus, sirolimus
• medicines used to relive pain Ex. fentanyl, alfentanil, buprenorphine, oxycodone
• medicines used to treat inflammation or asthma Ex. salmeterol, methylprednisolone, fluticasone, budesonide, dexamethasone
• medicines used to treat erection problems Ex. vardenafil, sildenafil and tadalafil
• medicines used to treat indigestion, stomach ulcers or heartburn Ex. Pantoprazole, omeprazole
• medicines used to treat HIV infection Ex. ritonavir, darunavir, indinavir, fosamprenavir, saquinivir
• medicines used to treat bacterial infections Ex. ciprofloxacin, clarithromycin, erythromycin
• medicines used to treat tuberculosis Ex. rifampicin, rifabutin or isoniazid
• medicines used to treat epilepsy Ex. phenytoin, carbamazepine or phenobarbital
• st. john’s wort (used to treat depression)
• medicines used to treat eczema Ex. alitretioin
• medicines used to treat vomiting Ex. aprepitant, domperidone
• medicines used to treat excess thyroid hormone secretion Ex. cinacalcet
• medicines used to treat low sodium blood levels Ex. mozavaptan or tolvaptan
• medicines used to treat worms Ex. praziquantel
• medicines used to treat high blood sugar Ex. Repaglinide, saxagliptin
• medicines used to relive inflammation and pain Ex. meloxicam

Overdosage:

If you or anyone else accidentally takes too much of SYNTRAN SB CAPSULE, consult your doctor immediately or visit the nearby hospital.  

SYNOPSIS

MORE INFORMATION

• Keep SYNTRAN SB CAPSULE out of reach of children
• Store SYNTRAN SB CAPSULE at room temperature

FAQs ABOUT SYNTRAN SB CAPSULE

What is SYNTRAN SB CAPSULE used for?

SYNTRAN SB CAPSULE contains itraconazole which belongs to the group of medicines called anti-fungals. It is used to treat infections of the mouth or vagina (causing thrush), skin infections and infections affecting other parts of the body.

How does SYNTRAN SB CAPSULE work?

SYNTRAN SB CAPSULE works by preventing the fungal growth by blocking the production of enzymes responsible for the growth of fungal cell. This inhibition results in breakage of cell membranes and fungal cell abnormalities, finally leading to alterations in membrane-based activity of fungus. These leads to fungal cell death and prevention of further fungal growth.  

Does SYNTRAN SB CAPSULE cause stomach pain?

The most common side effect of SYNTRAN SB CAPSULE is stomach pain. To manage this effect, try to rest and relax. Eat and drink slowly or try to have smaller meals more frequently. Keep a heat pad on your stomach. If the symptom does not improve, consult your doctor.    

Is SYNTRAN SB CAPSULE safe to use in pregnant women?

SYNTRAN SB CAPSULE is not recommended for use in pregnant women unless advised by the doctor. You should use contraception to make sure that you do not become pregnant during treatment with this medicine. Consult your doctor before taking SYNTRAN SB CAPSULE.

Can SYNTRAN SB CAPSULE be used in children?

SYNTRAN SB CAPSULE is not recommended for use in children less than 12 years of age. However, your child’s doctor may advise them in special cases. Consult your child’s doctor for advice. 

REFERENCES

1. K.D. Tripathi. Antifungal Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page 794.

2. Heidi Kurn; Roopma Wadhwa. Itraconazole. NIH National Library of Medicine. National Center for Biotechnology Information. StatPearls [Internet]. April 2022. [Accessed on 7th July 2022] https://www.ncbi.nlm.nih.gov/books/NBK557874/

3. Stiefel, a GSK Company. Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail. NIH. National Library of medicine. Clinical trials.gov. [Revised in February 2017] [Accessed on 7th July 2022] https://clinicaltrials.gov/ct2/show/NCT00356915

4. Laboratorios Liconsa, S.A. Electronic Medicines Compendium (EMC) [Revised in January 2021] [Accessed on 7th July 2022] https://www.medicines.org.uk/emc/files/pil.5914.pdf

5. Janssen Pharmaceutical Companies [Revised in May 2018] [Accessed on 7th July 2022] https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SPORANOX-Capsules-pi.pdf

6. Mint Pharmaceuticals Inc Health Canada [Revised in March 2018] [Accessed on 7th July 2022] https://pdf.hres.ca/dpd_pm/00044442.PDF

7. Mayne Pharma International Pty Ltd [Revised in April 2020] [Accessed on 7th July 2022] https://www.nps.org.au/medicine-finder/lozanoc-capsules#product-description

USEFUL DIAGNOSTIC TESTS

• Complete blood count
• Fungal culture test