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INTRODUCTION
TACROMUS 0.5MG CAPSULE contains Tacrolimus which belongs to the group of medicines called Immunosuppressants. It is used to prevent graft rejection in patients undergoing organ transplantation. It can also be used to treat an ongoing graft rejection of the newly transplanted organ. It is mostly used in combination with other immune suppressants to achieve maximum benefits.
Tacrolimus suppresses your body’s immune functions and enables your body to accept the transplanted organ. Take TACROMUS 0.5MG CAPSULE regularly as instructed by your doctor. While undergoing therapy with TACROMUS 0.5MG CAPSULE your doctor will periodically monitor your heart functions and nerve functions to avoid the risk of side effects.
Your doctor may also prescribe you blood tests and urine tests at regular intervals to access the improvement in your health conditions. During treatment with TACROMUS 0.5MG CAPSULE, avoid exposing your skin towards direct sunlight. Wear protective loose-fitting clothes and apply sunscreen while going outdoors.
Before taking TACROMUS 0.5MG CAPSULE inform your doctor if you have any liver, kidney or heart problems. Avoid consuming grapefruit or drinking grapefruit juice while taking TACROMUS 0.5MG CAPSULE as it may increase the risk of side effects.
Do not take TACROMUS 0.5MG CAPSULE without consulting your doctor if you are pregnant or breastfeeding. Both men and women taking TACROMUS 0.5MG CAPSULE must use a suitable contraceptive method (such as condoms or oral contraceptive pills) to avoid pregnancy while undergoing therapy with TACROMUS 0.5MG CAPSULE.
The most common side effects of taking TACROMUS 0.5MG CAPSULE are an increase in blood sugar levels, increased blood cholesterol levels, difficulty in falling asleep, increased blood potassium levels, high blood pressure, headache, dizziness, indigestion, oedema and increased infections. Consult your doctor if any of these side effects worsen.
USES OF TACROMUS 0.5MG CAPSULE
- Prevents graft rejection following organ transplantation
HOW TACROMUS 0.5MG CAPSULE WORKS
TACROMUS 0.5MG CAPSULE is an immunosuppressive agent. It works by blocking the release of certain chemicals in the body (such as T-cells) that triggers the immune response. It suppresses your body’s immune functions and enables your body to accept the transplanted organ. As a result, it prevents the risk of graft rejection and increases the survival of the newly transplanted organ.
DIRECTIONS FOR USE
Take TACROMUS 0.5MG CAPSULE 1 hour before meals or 2-3 hours after meals or as directed 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 therapy for you depending on your age, body weight and disease condition. Do not stop taking TACROMUS 0.5MG CAPSULE without consulting your doctor.
SIDE EFFECTS OF TACROMUS 0.5MG CAPSULE
COMMON
- increased blood sugar levels (diabetes)
- increased blood pressure
- increased potassium levels in the blood
- difficulty in falling asleep
- feeling shaky or trembling
- headache, dizziness
- liver problems, kidney problems
- nausea, vomiting
- stomach pain, diarrhea, constipation, bloating
- mouth ulcers
- low RBC and platelet count
- oedema (swelling of body parts)
- increased blood cholesterol levels
- feeling anxious, confused, disoriented or depressed
- fits, tingling and numbness of hands and feet
- eye sensitivity towards light, ringing sound in the ears
- abnormal or faster heartbeat
- skin rash and itching, acne, hair loss
- increased sweating
- pain in joints, limbs, back and feet, muscle spasms
- weight gain
- increased acidity in the blood
RARE
Stop taking TACROMUS 0.5MG CAPSULE and contact your doctor immediately if you experience any of the following side effects such as:
- severe stomach pain with or without fever, chills, nausea and vomiting
- signs of skin cancer (such as growth or lump on the skin, dark patches on the skin, flesh-coloured or scar-like lesions, scaly patches on sun-exposed areas)
- signs of lymph cancer (enlarged lymph nodes with tiredness, fever, night sweats, itchy skin, weight loss)
- increased frequency of opportunistic infections (including skin infections, urinary tract infections, respiratory tract infections, stomach infections, oral infections, etc.)
- flu-like symptoms (such as fever, sore throat, cold, cough, feeling unwell)
- signs of brain infection (such as memory loss, difficulty in thinking, trouble in walking or vision loss)
- signs of kidney damage such as Haemolytic uraemic syndrome causing low urine output, extreme tiredness, yellowing of the skin or eyes and abnormal bruising or bleeding with signs of infection
- blurred vision, changes in colour of the vision or vision loss
- signs of allergic reactions (such as severe skin rash with itching, blistering and peeling of the skin, mouth, eyes, throat, genitals, swelling of the face and tongue, bleeding under the skin causing the appearance of red-pin point dots on the skin, skin swelling, along with fever, tiredness, confusion or jaundice)
- signs of heart problems (such as chest pain, vertigo, fainting, nausea, palpitations and difficulty in breathing)
HOW TO MANAGE SIDE EFFECTS
Nausea or vomiting:
Try to take TACROMUS 0.5MG CAPSULE with or just after meals. Stick to simple meals and avoid oil-rich or spicy foods. Consult your doctor if the nausea worsens.
Headache:
Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as water or electrolytes. Applying a pain-relieving balm on your forehead can be beneficial. Do not consume excessive alcohol, as it could aggravate your headache. Consult your doctor if your headache worsens.
Dizziness:
Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol, as it could aggravate your dizziness. Consult your doctor if your dizziness worsens.
Constipation:
Taking TACROMUS 0.5MG CAPSULE with meals may reduce the chances of constipation. However, if you experience constipation, eat plenty of fiber-rich foods such as fresh fruits, vegetables and cereals. Drink plenty of fluids. Exercise more regularly. Consult your doctor if this side effect bothers you.
WARNING & PRECAUTIONS
PREGNANCY
TACROMUS 0.5MG CAPSULE should be used in pregnant women only if it is considered necessary by the physician. Therefore, inform your doctor before taking it. Women of childbearing potential must use a suitable contraceptive method to avoid pregnancy while undergoing therapy with TACROMUS 0.5MG CAPSULE.
BREASTFEEDING
TACROMUS 0.5MG CAPSULE may pass through breast milk. Therefore, it is not recommended for use in breastfeeding woman. However, consult your doctor before taking it.
DRIVING AND USING MACHINES
Do not drive or operate any heavy tools or machines if you experience dizziness or sleepiness after taking TACROMUS 0.5MG CAPSULE.
ALCOHOL
Avoid consumption of alcohol while taking TACROMUS 0.5MG CAPSULE as it might make you feel dizzier or sleepy.
KIDNEY
TACROMUS 0.5MG CAPSULE should be used with caution in patients with kidney problems. Therefore, consult your doctor before taking it.
LIVER
TACROMUS 0.5MG CAPSULE should be used with caution in patients with liver problems. Therefore, consult your doctor before taking it.
ALLERGY
Talk to your doctor before taking TACROMUS 0.5MG CAPSULE if you are allergic to Tacrolimus or to any macrolide antibiotics (such as erythromycin, azithromycin).
HEART DISEASE
TACROMUS 0.5MG CAPSULE should be used with caution in patients with heart problems (such as prolonged QT interval). Therefore, consult your doctor before taking it.
OTHERS
Before taking TACROMUS 0.5MG CAPSULE inform your doctor if you:
- are scheduled for any vaccination in the upcoming days
- high blood cholesterol levels
- have high blood potassium levels
Use in pediatrics:
The safety and effectiveness of TACROMUS 0.5MG CAPSULE have not been established in children and adolescents (aged below 18 years) undergoing transplantation. Therefore, consult your doctor before taking it.
Use in geriatrics:
TACROMUS 0.5MG CAPSULE should be used with caution in elderly patients. Therefore, consult your doctor before taking it.
INTERACTIONS
A. Drug-Drug interactions:
Before taking TACROMUS 0.5MG CAPSULE inform your doctor if you are taking the following medicines such as:
- St. John’s Wart (an herbal medicine used to treat depression)
- vaccinations
- cyclosporin, mycophenolic acid (other medicines used to suppress immune functions)
- medicines used to treat fungal infections (Ex. ketoconazole, fluconazole, clotrimazole, amphotericin B)
- macrolide antibiotics (Ex. erythromycin, clarithromycin, azithromycin, flucloxacillin)
- medicines used to treat tuberculosis (Ex. isoniazid, rifampicin)
- medicines used to treat HIV infections (Ex. acyclovir, ritonavir, nelfinavir, saquinavir, efavirenz, etravirine, nevirapine)
- Letemovir (a medicine used to treat human cytomegalovirus)
- medicines to treat fever and pain (Ex. metamizole, ibuprofen)
- medicines used to treat cancer (Ex. imatinib, crizotinib, nilotinib)
- medicines used to treat hepatitis C infection (Ex. telaprevir, boceprevir, the combination ombitasvir/paritaprevir/ritonavir with or without dasabuvir, elbasvir/grazoprevir and glecaprevir/pibrentasvir)
- medicines used to treat gastric problems (Ex. omeprazole, cimetidine, magnesium hydroxide, aluminum hydroxide)
- medicines used to treat nausea and vomiting (Ex. metoclopramide)
- medicines that can increase blood potassium levels (such as potassium supplements or potassium-sparing diuretics (Ex. amiloride, triamterene or spironolactone))
- trimethoprim or cotrimoxazole (used to treat bacterial infections)
- oral contraceptives (birth control pills) Ex. ethinylestradiol
- medicines used to treat heart problems (Ex. nifedipine, verapamil, diltiazem, amiodarone)
- medicines used to control blood cholesterol levels (Ex. atorvastatin, fluvastatin)
- medicines used to treat fits (Ex. carbamazepine, phenytoin, cannabidiol)
- corticosteroids (used to treat allergic or autoimmune diseases) Ex. prednisolone, methylprednisolone
- medicines used to treat depression (Ex. nefazodone)
- medicines used to treat diabetes (Ex. metformin, glimepiride)
- extracts of Schisandra sphenanthera (used to treat mental illness)
- anticoagulants (used for blood thinning) Ex. warfarin, heparin
B. Drug-food interactions:
TACROMUS 0.5MG CAPSULE may interact with food. To avoid this, take TACROMUS 0.5MG CAPSULE 1 hour before meals or 2-3 hours after meals. Avoid consuming grapes or grapefruit juice while taking TACROMUS 0.5MG CAPSULE as it may increase the risk of side effects.
Overdosage:
If you or anyone else accidentally took more TACROMUS 0.5MG CAPSULE, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose might include tremors, abnormal kidney function results in less or no urine output, increased blood pressure, leg swelling and lack of energy.
SYNOPSIS
| Drug | : | Tacrolimus |
| Pharmacological Category | : | Calcineurin Inhibitors |
| Therapeutic Indication | : | Prevents graft rejection |
| Dosage Forms | : | Capsules, Tablets, Ointment, Lotion, solution, Topical Solution, Oral gel, eye ointment |
MORE INFORMATION
- Keep TACROMUS 0.5MG CAPSULE out of reach of children
- Store TACROMUS 0.5MG CAPSULE at room temperature
FAQs ABOUT TACROMUS 0.5MG CAPSULE
What is the use of TACROMUS 0.5MG CAPSULE?
TACROMUS 0.5MG CAPSULE is used to prevent graft rejection in patients undergoing organ transplantation. It can also be used to treat an ongoing graft rejection of the newly transplanted organ.
How TACROMUS 0.5MG CAPSULE works?
TACROMUS 0.5MG CAPSULE is an immunosuppressive agent. It works by blocking the release of certain chemicals in the body (such as T-cells) that triggers the immune response. It suppresses your body’s immune functions and enables your body to accept the transplanted organ. As a result, it prevents the risk of graft rejection and increases the survival of the newly transplanted organ.
How to take TACROMUS 0.5MG CAPSULE?
Take TACROMUS 0.5MG CAPSULE 1 hour before meals or 2-3 hour after meals or as directed by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine.
What is the best time to take TACROMUS 0.5MG CAPSULE?
Take TACROMUS 0.5MG CAPSULE 1 hour before meals or 2-3 hours after meals or as directed by your physician. It is usually taken twice daily. However, your doctor will decide the correct dose, duration of therapy and time of administration for you depending on your age, body weight and disease condition.
Is TACROMUS 0.5MG CAPSULE an antibiotic?
No. TACROMUS 0.5MG CAPSULE is an immunosuppressive agent. It suppresses your body’s immune functions and enables your body to accept the transplanted organ.
What precautions must be followed while taking TACROMUS 0.5MG CAPSULE?
TACROMUS 0.5MG CAPSULE must be taken 1 hour before meals or 2-3 hour after meals. Avoid drinking grapefruit juice while taking TACROMUS 0.5MG CAPSULE. During treatment with TACROMUS 0.5MG CAPSULE, avoid exposing your skin towards direct sunlight. Wear protective loose-fitting clothes and apply sunscreen while going outdoors. Before taking TACROMUS 0.5MG CAPSULE inform your doctor if you have any liver, kidney or heart problems or if you are pregnant or breastfeeding. Both men and women taking TACROMUS 0.5MG CAPSULE must use a suitable contraceptive method (such as condoms or oral contraceptive pills) to avoid pregnancy while undergoing therapy with TACROMUS 0.5MG CAPSULE.
How long should I take TACROMUS 0.5MG CAPSULE?
You need to take TACROMUS 0.5MG CAPSULE for the stipulated duration prescribed by your doctor. Your doctor will decide the correct dose and duration of therapy for you depending on your age, body weight and disease condition.
What to do if I forgot to take a dose of TACROMUS 0.5MG CAPSULE?
If you forgot to take a dose of TACROMUS 0.5MG CAPSULE, take it as soon as you remember. However, if it is time for the next dose of TACROMUS 0.5MG CAPSULE, skip the missed dose and take the next one regularly. Do not take a double dose of TACROMUS 0.5MG CAPSULE to compensate for the missed ones.
Is TACROMUS 0.5MG CAPSULE safe?
The most common side effects of taking TACROMUS 0.5MG CAPSULE are an increase in blood sugar levels, increased blood cholesterol levels, difficulty in falling asleep, increased blood potassium levels, high blood pressure, headache, dizziness, indigestion, oedema and increased infections. Consult your doctor if any of these side effects worsen.
Can I stop taking TACROMUS 0.5MG CAPSULE without consulting your doctor?
No. You should not stop taking TACROMUS 0.5MG CAPSULE without consulting your doctor because your body’s immune system may once again attempt to reject the newly transplanted organ. Therefore, take TACROMUS 0.5MG CAPSULE for the stipulated duration recommended by your doctor to achieve maximum results.
What happens if I take too more of TACROMUS 0.5MG CAPSULE?
If you or anyone else accidentally took more TACROMUS 0.5MG CAPSULE, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose might include tremors, abnormal kidney function results in less or no urine output, increased blood pressure, leg swelling and lack of energy.
Can I use TACROMUS 0.5MG CAPSULE if I suffer from kidney diseases?
TACROMUS 0.5MG CAPSULE should be used with caution in patients with kidney problems. Therefore, consult your doctor before taking it.
Will taking a higher dose of TACROMUS 0.5MG CAPSULE be more effective?
No, taking a higher dose of TACROMUS 0.5MG CAPSULE will not be effective rather it can lead to toxicity. Always take the dose prescribed by your doctor. If the prescribed dose is not effective for you, consult your doctor for advice. Your doctor might increase the dose or suggest an alternative therapy.
Can I take medication for high blood pressure along with TACROMUS 0.5MG CAPSULE?
It is not advisable to take medicines to control blood pressure while taking TACROMUS 0.5MG CAPSULE without consulting your doctor as they have known interactions with TACROMUS 0.5MG CAPSULE.
Can TACROMUS 0.5MG CAPSULE be used in pregnant women?
TACROMUS 0.5MG CAPSULE should be used in pregnant women only if it is considered necessary by the physician. Therefore, consult your doctor before taking it.
How much TACROMUS 0.5MG CAPSULE should I take?
TACROMUS 0.5MG CAPSULE should be used only under medical supervision. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body condition and severity of the disease condition.
Can TACROMUS 0.5MG CAPSULE cause constipation?
Yes. Constipation is a common side effect of using TACROMUS 0.5MG CAPSULE. Eat plenty of fiber-rich foods such as fresh fruits, vegetables, cereals as well as drink plenty of water and exercise more regularly when taking this medicine. Contact your doctor if this side effect bothers you.
Can the use of TACROMUS 0.5MG CAPSULE affect fertility?
TACROMUS 0.5MG CAPSULE may affect fertility in both men and women. Therefore, try to avoid pregnancy while undergoing therapy with TACROMUS 0.5MG CAPSULE. Both men and women must use a suitable contraceptive method (such as condoms or oral contraceptive pills) to avoid pregnancy while undergoing therapy with [GBNKEYWORD.
REFERENCES
1. KD. Tripathi. Autocoids and related drugs. Essentials of Medical Pharmacology. 8th edition. 2019. Page – 940-941.
2. Mahmoud Kamel, Manish Kadian, Titte Srinivas, David Taber, and Maria Aurora Posadas Salas. Tacrolimus confers lower acute rejection rates and better renal allograft survival compared to cyclosporine. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC. PubMed Central. December 2016. [Accessed on 26th October 2022]. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5175228/
3. Astellas Ireland Co. Ltd. European Medicines Compendium (EMC) [Revised on May 2022] [Accessed on 26th October 2022] https://www.medicines.org.uk/emc/files/pil.6720.pdf
4. Astellas Pharma. U S Food and Drug Administration. [Revised in February 2012]. [Accessed on 26th October 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050709s031lbl.pdf
5. Astellas Pharma Tech Co. Ltd. Tacrolimus [Revised in July 2021] [Accessed on 26th October 2022] https://www.astellas.com/us/system/files/prografwpi_3.pdf
6. Biocon Ltd. Tacrolimus Capsules. Tacrograf – 0.25/0.5/1/2/3/5mg. [Accessed on 26th October 2022] https://biocon.com/docs/prescribing_informatio/nephrology/tacrograf_pi.pdf
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