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Introduction About PROGRAF 1MG HARD CAPSULE

PROGRAF 1MG HARD CAPSULE contains Tacrolimus which belongs to the group of medicines called Immunosuppressants. It is used to manage graft rejection in patients undergoing organ transplantation. It can also be used to manage 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 PROGRAF 1MG HARD CAPSULE regularly as instructed by your doctor. While undergoing therapy with PROGRAF 1MG HARD 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 management with PROGRAF 1MG HARD CAPSULE, avoid exposing your skin towards direct sunlight. Wear protective loose-fitting clothes and apply sunscreen while going outdoors.

Before taking PROGRAF 1MG HARD CAPSULE inform your doctor if you have any liver, kidney or heart problems. Avoid consuming grapefruit or drinking grapefruit juice while taking PROGRAF 1MG HARD CAPSULE as it may increase the risk of side effects.

Do not take PROGRAF 1MG HARD CAPSULE without consulting your doctor if you are pregnant or breastfeeding. Both men and women taking PROGRAF 1MG HARD CAPSULE must use a suitable contraceptive method (such as condoms or oral contraceptive pills) to avoid pregnancy while undergoing therapy with PROGRAF 1MG HARD CAPSULE.

The most common side effects of taking PROGRAF 1MG HARD 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 PROGRAF 1MG HARD CAPSULE

Prevents graft rejection following organ transplantation

How PROGRAF 1MG HARD CAPSULE Works

PROGRAF 1MG HARD 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 manages the risk of graft rejection and increases the survival of the newly transplanted organ.

How to use PROGRAF 1MG HARD CAPSULE

Take PROGRAF 1MG HARD 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 PROGRAF 1MG HARD CAPSULE without consulting your doctor.

Side Effects Of PROGRAF 1MG HARD 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 PROGRAF 1MG HARD 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 PROGRAF 1MG HARD 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 PROGRAF 1MG HARD 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

PROGRAF 1MG HARD 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 PROGRAF 1MG HARD CAPSULE.

Breastfeeding

PROGRAF 1MG HARD 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 PROGRAF 1MG HARD CAPSULE.

Alcohol

Avoid consumption of alcohol while taking PROGRAF 1MG HARD CAPSULE as it might make you feel dizzier or sleepy.

Kidney

PROGRAF 1MG HARD CAPSULE should be used with caution in patients with kidney problems. Therefore, consult your doctor before taking it.

Liver

PROGRAF 1MG HARD 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 PROGRAF 1MG HARD CAPSULE if you are allergic to Tacrolimus or to any macrolide antibiotics (such as erythromycin, azithromycin).

Heart Disease

PROGRAF 1MG HARD 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 PROGRAF 1MG HARD 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 PROGRAF 1MG HARD 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:

PROGRAF 1MG HARD CAPSULE should be used with caution in elderly patients. Therefore, consult your doctor before taking it.

Interactions

A. Drug-Drug interactions:

Before taking PROGRAF 1MG HARD CAPSULE inform your doctor if you are taking the following medicines such as:

St. John’s Wart (an herbal medicine used to manage depression)
vaccinations
cyclosporin, mycophenolic acid (other medicines used to suppress immune functions)
medicines used to manage fungal infections (Ex. ketoconazole, fluconazole, clotrimazole, amphotericin B)
macrolide antibiotics (Ex. erythromycin, clarithromycin, azithromycin, flucloxacillin)
medicines used to manage tuberculosis (Ex. isoniazid, rifampicin)
medicines used to manage HIV infections (Ex. acyclovir, ritonavir, nelfinavir, saquinavir, efavirenz, etravirine, nevirapine)
Letemovir (a medicine used to manage human cytomegalovirus)
medicines to manage fever and pain (Ex. metamizole, ibuprofen)
medicines used to manage cancer (Ex. imatinib, crizotinib, nilotinib)
medicines used to manage hepatitis C infection (Ex. telaprevir, boceprevir, the combination ombitasvir/paritaprevir/ritonavir with or without dasabuvir, elbasvir/grazoprevir and glecaprevir/pibrentasvir)
medicines used to manage gastric problems (Ex. omeprazole, cimetidine, magnesium hydroxide, aluminum hydroxide)
medicines used to manage 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 manage bacterial infections)
oral contraceptives (birth control pills) Ex. ethinylestradiol
medicines used to manage heart problems (Ex. nifedipine, verapamil, diltiazem, amiodarone)
medicines used to control blood cholesterol levels (Ex. atorvastatin, fluvastatin)
medicines used to manage fits (Ex. carbamazepine, phenytoin, cannabidiol)
corticosteroids (used to manage allergic or autoimmune diseases) Ex. prednisolone, methylprednisolone
medicines used to manage depression (Ex. nefazodone)
medicines used to manage diabetes (Ex. metformin, glimepiride)
extracts of Schisandra sphenanthera (used to manage mental illness)
anticoagulants (used for blood thinning) Ex. warfarin, heparin

B. Drug-food interactions:

PROGRAF 1MG HARD CAPSULE may interact with food. To avoid this, take PROGRAF 1MG HARD CAPSULE 1 hour before meals or 2-3 hours after meals. Avoid consuming grapes or grapefruit juice while taking PROGRAF 1MG HARD CAPSULE as it may increase the risk of side effects.

Overdosage:

If you or anyone else accidentally took more PROGRAF 1MG HARD 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 PROGRAF 1MG HARD CAPSULE out of reach of children
Store PROGRAF 1MG HARD CAPSULE at room temperature

FAQs About PROGRAF 1MG HARD CAPSULE

What is the use of PROGRAF 1MG HARD CAPSULE?

PROGRAF 1MG HARD CAPSULE is used to manage graft rejection in patients undergoing organ transplantation. It can also be used to manage an ongoing graft rejection of the newly transplanted organ.

How PROGRAF 1MG HARD CAPSULE works?

How to take PROGRAF 1MG HARD CAPSULE?

Take PROGRAF 1MG HARD 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 PROGRAF 1MG HARD CAPSULE?

Take PROGRAF 1MG HARD 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 PROGRAF 1MG HARD CAPSULE an antibiotic?

No. PROGRAF 1MG HARD 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 PROGRAF 1MG HARD CAPSULE?

PROGRAF 1MG HARD CAPSULE must be taken 1 hour before meals or 2-3 hour after meals. Avoid drinking grapefruit juice while taking PROGRAF 1MG HARD CAPSULE. During management with PROGRAF 1MG HARD CAPSULE, avoid exposing your skin towards direct sunlight. Wear protective loose-fitting clothes and apply sunscreen while going outdoors. Before taking PROGRAF 1MG HARD 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 PROGRAF 1MG HARD CAPSULE must use a suitable contraceptive method (such as condoms or oral contraceptive pills) to avoid pregnancy while undergoing therapy with PROGRAF 1MG HARD CAPSULE.

How long should I take PROGRAF 1MG HARD CAPSULE?

You need to take PROGRAF 1MG HARD 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 PROGRAF 1MG HARD CAPSULE?

If you forgot to take a dose of PROGRAF 1MG HARD CAPSULE, take it as soon as you remember. However, if it is time for the next dose of PROGRAF 1MG HARD CAPSULE, skip the missed dose and take the next one regularly. Do not take a double dose of PROGRAF 1MG HARD CAPSULE to compensate for the missed ones.

Is PROGRAF 1MG HARD CAPSULE safe?

Can I stop taking PROGRAF 1MG HARD CAPSULE without consulting your doctor?

No. You should not stop taking PROGRAF 1MG HARD CAPSULE without consulting your doctor because your body’s immune system may once again attempt to reject the newly transplanted organ. Therefore, take PROGRAF 1MG HARD CAPSULE for the stipulated duration recommended by your doctor to achieve maximum results.

What happens if I take too more of PROGRAF 1MG HARD CAPSULE?

Can I use PROGRAF 1MG HARD CAPSULE if I suffer from kidney diseases?

PROGRAF 1MG HARD CAPSULE should be used with caution in patients with kidney problems. Therefore, consult your doctor before taking it.

Will taking a higher dose of PROGRAF 1MG HARD CAPSULE be more effective?

No, taking a higher dose of PROGRAF 1MG HARD 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 PROGRAF 1MG HARD CAPSULE?

It is not advisable to take medicines to control blood pressure while taking PROGRAF 1MG HARD CAPSULE without consulting your doctor as they have known interactions with PROGRAF 1MG HARD CAPSULE.

Can PROGRAF 1MG HARD CAPSULE be used in pregnant women?

PROGRAF 1MG HARD 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 PROGRAF 1MG HARD CAPSULE should I take?

PROGRAF 1MG HARD 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 PROGRAF 1MG HARD CAPSULE cause constipation?

Yes. Constipation is a common side effect of using PROGRAF 1MG HARD 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 PROGRAF 1MG HARD CAPSULE affect fertility?

PROGRAF 1MG HARD CAPSULE may affect fertility in both men and women. Therefore, try to avoid pregnancy while undergoing therapy with PROGRAF 1MG HARD 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

Author Details

Written By Srilekha. R - B.Pharm

Reviewed For Accuracy By Dr. M N Himaja - MBBS

Last updated on 27 Oct 2022 | 06:21 PM(IST)