Generic Rapamune(Sirolimus)

Generic Rapamune(Sirolimus)

Product Code: PSIS006
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Sirolimus is an immunosuppressant agent. It is normally used along with corticosteroid medications and cyclosporine to prevent the rejection of kidney organ transplants. Together, these medications suppress (decrease) the body's natural defense, the immune system. Sirolimus works by preventing the formation of cells (white blood cells) that would normally attack the transplanted organ. Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor. Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

 How should I use Rapamune?

Sirolimus is normally started as soon as possible after transplant. The dose prescribed will depend on your situation. The recommended first dose of sirolimus for new transplant recipients is 6 mg followed by a regular dose of 2 mg daily. For people who have previously had a transplant rejection or are at high risk of rejecting the transplant, the first dose is often 15 mg with a regular dose of 5 mg per day. Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor. Do not stop taking this medication without talking with your doctor. Sirolimus is normally given along with cyclosporine and corticosteroids. Sirolimus should be taken approximately 4 hours after the cyclosporine. Sirolimus should be taken at the same time each day, and taken the same way, either with or without food. It should not be taken with grapefruit juice. Sirolimus is available as an oral (by mouth) solution and in tablet form.

The oral solution bottles have oral dose syringes which should be used to withdraw the prescribed amount of sirolimus from the bottle. Empty the correct amount of sirolimus from the syringes into a glass or plastic container holding at least 2 ounces (60 mL) of water or orange juice. No other liquids should be used for dilution. Stir vigorously and drink at once. Rinse the container with an additional volume (minimum of 4 ounces or 120 mL) of water or orange juice, stir vigorously, and drink at once. This ensures that all the medication is rinsed from the container and that the entire dose is taken.

The preparation should be used immediately after dilution and the syringe discarded after one use.

Sirolimus solutions provided in bottles may develop a slight haze when refrigerated. If this occurs, allow the bottle to stand at room temperature and shake gently until the haze disappears. The presence of this haze does not affect the quality of the product.

Do not allow water or juice to contaminate the medication in the bottle. If the mouth of the bottle needs to be cleaned, wipe the bottle with a dry cloth.

The tablets should only be taken with water or orange juice.

It is extremely important to take this medication exactly as prescribed, since missing even a few doses of sirolimus may cause your body to reject the organ. Check with your doctor or pharmacist for the proper way to take sirolimus.

If you miss a dose, take the missed dose as soon as you remember, but not within 4 hours of your cyclosporine dose. If it is the next day before you realize you missed your dose, check with your doctor. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store sirolimus solution in the refrigerator, protect it from light, and keep it out of the reach of children. Once the bottle is opened, it should be kept in a refrigerator and the contents used within one month. If left at room temperature, the opened bottle must be used within 5 days. If the amber syringe is pre-filled, it may be kept at room temperature or in the refrigerator for a maximum of 24 hours.

Store sirolimus tablets at room temperature (15°C to 30°C), protect them from light and moisture, and keep out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Tablets
Each white, triangular-shaped tablet, marked "RAPAMUNE 1 mg" on one side, contains 1 mg of sirolimus. Nonmedicinal ingredients: calcium sulfate anhydrous NF, carnauba wax NF, glyceryl monooleate, ink, lactose monohydrate NF, magnesium stearate NF, microcrystalline cellulose NF, pharmaceutical glaze NF, polaxamer 188, polyethylene glycol 8000 powdered NF, polyethylene glycol type 20 000, povidone USP, sucrose NF, talc USP, titanium dioxide USP, and vitamin E (dl-alpha tocopherol).

Oral solution
Each mL of oral solution contains sirolimus 1 mg. The solution is supplied in amber glass 60 mL bottles with oral syringes for measuring the dose. Nonmedicinal ingredients: Phosal 50 PG® (phosphatidylcholine, propylene glycol, sunflower mono- and diglycerides, ascorbyl palmitate, ethanol, and soybean oil fatty acids) and polysorbate 80.

What other drugs could interact with Generic for Rapamune*?

·         Cimetidine

·         Cisapride

·         Diltiazem

·         Erythromycin

·         Itraconazole

·         Ketoconazole

·         Nifedipine

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