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Generic Synthroid
(Thyroxine 25/50/100/200mcg)

1. Denomination

Prograf

2. Active Substance

Tacrolimus

3. Indications for Use.

Should be used for treatment and prevention of rejection reactions of allotransplants of kidneys, liver or heart.

4. Action

The medication works as an immunodepressant and has the ability to suppress the elaboration of cytotoxic in educated cells. Such cells are in most cases responsible for grafts� rejection.
Graft rejection reactions on the background of by immune suppressive treatment, which contains Tacrolimus happen more rarely, than in case if treatment uses cyclosporine. The proceeding is usually easier and the yield to arresting is easier as well.

5. Posology and Administration

Tacrolimus can be applied either orally or intravenously. Levin tube can be used for introduction of water-based solutions.
The rate of dosage for treatment with Tacrolimus should be defined depending on individual conditions of a patient and depending on the monitoring results of the level of medication in the blood of a patient.
The recommended daily dose should be divided into two intakes, if possible, which should be taken in the morning and in the evening. It is recommended to take the medication fasting (on empty stomach) or at least 1 hours before the next meal and 2-3 hours after the last meal. The medication should be taken preferably with water or can be rinsed with some other liquid.

Recommendations on Dosage Rate in Liver Transplantation
In case of treatment of adult patient with primary immune suppression. Peroral treatment with Tacrolimus should be started with dose of 0.10-0.20mg per 1 kilo of weight per day, which should be split into two intakes (one in the morning and one in the evening). Medication should be first applied in 12 hours after the end of transplantation operation. If the patient�s condition is not good enough to administer the medication orally, then it should be used in the form of intravenous injections. The starting dose for such treatment should be from 0.01 to 0.05mg per 1 kilo of weight per day. The intravenous intake of medication should be done in the form of infusions, which should be taken during 24 hours.

For treatment of children patients, when there is need for primary suppression of immune system the treatment should start with oral doses of 0.30mg per day, which should be split into 2 intakes. The medication should be taken in the morning and in the evening. If the clinical condition of a patient is insufficient for oral administration of the medication, it should be taken in the form of intravenous diffusions. In case of intravenous treatment, the dose should be 0.05mg per day.

For supporting treatment of adult patients and children Tacrolimus dose should be slowly lowered. In some patients it is allowed to cancel the intake of the medication of a concomitant immune suppression treatment. In this case Tacrolimus should be left in the form of monotherapy. The pharmokinetics of Tacrolimus can be changed by the improvement of the patient�s condition after transplantation, so the correction of dosage will be necessary. In order to have the same effect from the medication in the blood of children it is necessary to intake the dose 1.5-2 times higher that that for adult patients.

For treatment of rejection reactions in adult patients and children. It is needed to use higher doses of Tacrolimus for treatment of episodes of rejections in combination with supplemental corticosteroid treatment. For short-term it is recommended to use mono/polyclonal antibodies. In case of hacing evidenced symptoms of toxicity it is recommended to use lower doses of Tacrolimus.

For treatment of elderly patients there is no need to correct the dose during treatment with Tacrolimus.

When transferring from treatment with Cyclosporine. Combined use of Tacrolimus and Cyclosporine has the ability to increase the length of toxic performance. It is necessary to be cautious in treatment of patients, who are transferring from Cycloporine to Tacrolimus treatment. Treatment with Tacrolimus should be started only atter evaluating the concentration of Cycloporine in the blood of a patient. In case if the level of concentration of Cycloporine is elevated, then treatment with Tacrolimus should be postponed. Usually treatment with Tacrolimus should start after 12-24 hours after stopping treatment with Cycloporine. The treatment should be started with the basic oral dose for treatment, which is usually prescribed for treatment of initial immune suppression for both adult patients and children with particular allotransplantate. The level of Cyclosporine should be monitored even after transferring patient to treatment with Tacrolimus, as there is a chance of having clearance disorder of Cyclosporine.

Recommendations on the Achievement of the Needed Level of Drug Concentration in Whole Blood
For treatment of elderly patients who have just undergone a surgery Tacrolimus should be used in the minimal amount and its level in blood should be controlled. In order to define the minimal level of the medication in blood, in case of peroral use of the medication,m the analysis should be carried out after 12 hours following the intake and immediately before taking the next dose for treatment. Level of medication in blood should be regularly monitored, with frequency determined by the clinical condition of a patient. As Tacrolimus has low level of clearance, the correction of regimen of dosage may take several days, until there are visible changes of the level of medication in blood. It is recommended to control the minimal level of medication concentration in blood not less than once or twice a week, especially in the early period after transplantation. It should be often done during supporting treatment as well. When the dosage of medication was changed, control of level of medication in blood should be monitored more often, as well as after combination of use of Tacrolimus with some other medications, which can affect the concentration of Tacrolimus in the blood of a patient.

According to clinical studies, Tacrolimus has the ability to treat majority of patients successfully, as long as the minimal level of concentration of Tacrolimus in blood of patients is maintained at the level below 20ng per ml.

According to clinical practice, especially during the starting period after surgery of transplantation, the minimal level of concentration of the medication in blood varies from 5 to 20ng per ml in those patients, which received transplant of liver. When the medication is used for supporting treatment, the concentration of it in blood should be from 5 to 15 ng per ml for both patients which received transplant of liver and kidney.

6. Counterindications

- period of pregnancy;
- a known hypersensitivity to Tacrolimus or other macrolides;
- period of lactation.

7. Should Be Taken with Precautions, if…

Patients, who are treated with immune suppressive medications are at higher risk of development of malign tumors. Patients, who are treated with Tacrolimus are more likely to be at risk of developing such infections diseases, as bacterial, virus, protozoan and fungal infections. It is also risky to take the medication, if infectious diseases were previously detected.
Tacrolimus medication has the ability to affect the metabolist of steroid contraceptives and for this reason patients should be especially careful in terms of protection and regulation of pregnancy.
Just as when other immune suppressive medications are used, because of the high risk of development and aggravation of skin malign changes, it is not recommended to be exposed to UV-radiation and sun rays should be avoided. It is recommended to cover skin with light clothes and use protective sun-screen lotions.

8. Interface with Other Medications

Tacrolimus has the ability to actively interact with other medication. It is not allowed to take any other medications in combination with Prograf without consulting with your doctor about the possible outcomes in the form of side effects, aggravations, poisoning or bad assimilability. It is recommended that patients stay on diet, which is prescribed by a doctor during treatment, as some kinds of foods may enhance of weaken the effect from intake of Tacrolimus.

9. Overdosing

Headaches, tremor, nausea, infections, vomiting, lethargy, hives, high level of urea nitrogen in blood and elevation of concentration of serum of creatinine. Inform your doctor and see a medical specialist immediately if you suspect that you got overdosed!

10. Side Effects

Many side effects from the medications are inversive and they easily go away when the dosage rate is lowered. When the medication is used perorally there is a lower chance of development of progressions of side effects, than in case of intravenous introduction.

Very often (>1/100):
- diarrhea, hypertension, nausea and/or vomiting, hyperglycemia, failure of kidneys function (for example, high level of creatinine in serum of blood), diabetes, headache, tremor, topalgia (such as athralgia), insomnia.

Often (>1/100, - tachycardia, hypotonia, abnormal heart rhythms, stenocardia, conduction abnormality, ischemic presentations and thromboembolic, vessels diseases, stomach pains, dysfunction of intestinal tract (for example, dyspepsia), constipation, deviations in levels of liver ferments, changes in appetite and weight, ulcers and inflammation of the intestinal tract, anemia, yellow sickness, leucopenia, diseases of gall bladder and biliary tracts, thrombocytopenia, leukocytosis, hemorrhagic disease, failures of coagulation, kidney failure, injury of tissues of kidney, hypomagnesimia, hyerkalemia, hyperlipidemia, hyperurikemia, hypophosphatemia, hypocalcemia, hyponatremia, acid intoxication, hypovolemia, and other disorders of electrolyte balance, convulsions, water deprivation, sense shock (for example, paresthesia), mental fog, vision disorders, depression, agitation, dizziness, neuropathy, de-coordination, convulsions, mental affection, disturbance of sleep, anxiety, impairment of consciousness, hallucinations, emotional instability, hearing disorders, encephalopathy, thought disorder, disorders of respiratory function (panting), itching, pleural fluid, baldness, sweating, rash, acne, fever, photosensitivity, peripheral hydrops, acraturesis, asthenia.

Not often (>1/100, 1/1000,

- infarction, deflections in ECG, cardiac failure, myocardial hypertrophy, shock, cardiac standstill, obstruction of bowels (ileums), abdominal dropsy, injury of liver tissue, pancreatitis, proteinuria, failure of hematopoietic system, such as pancytopenia, myasthenia, thrombolytic microangiopathy, arthropathy, illness of eyes, hypertension, amnesia, disorders of speech, cataract, paralysis, deafness, coma, atelectasia, liver failure, bronchial spasm, puffiness and other genital disorders in women.

11. Pregnancy and Lactation

According to the results of clinical studies, Tacrolimus has the ability to excret in breast milk through placenta. It is not well determined if the medication is safe for use on pregnant women and the medication should not be used for administration to this group of patients, except for the situations, when the expected positive outcome for the mother justifies the potential risk for unborn baby.

It is known that Tacrolimus is excreted into breast-milk. It is impossible to avoid development of side effects in infants and babies, so it is recommended to avoid intake of the medication during breast-feeding, or it should be stopped during treatment.

12. Driving

Tacrolimus medication has the ability to cause neurological and visual disorders as well as it can affect the ability to operate machinery or drive vehicles. Interaction of the medication with alcohol may enhance its effects.

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A. We are fully dedicated to your privacy and security. Please refer to the current privacy policy in the terms & conditions section of our order page. Rest assured that our online order system makes use of the latest Security encryption technology to ensure that your credit card information is submitted safely and with the highest level of protection. All of our computer systems undergo regular security checks to ensure that our ordering system is properly protected.

Q. How do I track my order of Prograf ?
A. At this time, your order is sent through Registered Mail, which provides delivery confirmation but not real-time tracking.If you need to know the status of order Prograf or ask for a reshipment, please do not hesitate to get in touch with us.You are provided with real-time order status updates via our order status form, found on the left-hand side of the screen.

Q. How do I cancel my order of Prograf ?
A. If you wish to cancel your order, you must let us know before 11am EST the following day. We will not be able to cancel any orders after this time. For all cancellations, please contact us.

Q. Can you tell me if I should be taking Prograf ? Or, will it work for me?
A. We cannot advise you in any capacity in this matter. You should not take any medication without consulting a physician first.

Q. What is your returns policy?
A. By law, we regret that we are unable to accept returned pharmaceuticals. If your purchase is defective in any way, we will be pleased to replace it at no cost to you.

Q. What is your refund policy
A. Refunds are solely at our discretion. If you are not satisfied with the product or service provided, contact us immediately via email with your order number. We will investigate and work hard to resolve the issue to your satisfaction. Sometimes this can take up to 10 business days. If the matter cannot be resolved, we will issue refunds as necessary.

Q. What is your cancellation policy
A. We debit your Credit Card only once we have shipped your order. Therefore, if you wish to cancel your order prior to us charging your card you will be able to do so without penalty. Once your order has been shipped we will be unable to cancel your order.

Q. What about importing of Prograf to my country ?
A. Importation of prescription medication is legal in most countries (including the US, UK, France, Spain, Hong Kong, Japan and S. Korea) provided the medication is for personal use and is not a controlled substance. If you are in doubt about the situation in your country, check with your local Post Office.