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Panimun Bioral (Cyclosporine)
SELECT REF DESCRIPTION MANUFACTURER PACK SIZE STRENGTH OUR PRICE
P1318 Panimun Bioral (Cyclosporine) Panacea Biotec 5 caps 25 mg $11.38
P1319 Panimun Bioral (Cyclosporine) Panacea Biotec 5 caps 50 mg $22.23
P1320 Panimun Bioral (Cyclosporine) Panacea Biotec 5 caps 100 mg $48.91
Price is per pack & not per tab.. eg: if pack size is 10 tabs & price is $2.75 then for 100 tabs the price would be $27.50
What is cyclosporine?
Cyclosporine lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.

Cyclosporine is used to prevent organ rejection after a kidney, liver, or heart transplant.

Cyclosporine is also used to treat severe psoriasis or severe rheumatoid arthritis.

Cyclosporine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about cyclosporine?
You may not be able to use this medication if you have kidney disease, untreated or uncontrolled hypertension (high blood pressure), or any type of cancer.
If you are being treated for psoriasis, you should not receive light therapy (PUVA or UVB) or radiation treatments while you are receiving cyclosporine. Make sure all doctors involved in your care know you are taking cyclosporine.

You may take cyclosporine with or without food, but take it the same way each time. Cyclosporine should be given in two separate doses each day. Try to take the medication at the same dosing times each day.

If there are any changes in the brand or form of cyclosporine you use, your dosage needs may change. Always check your refills to make sure you have received the correct brand and type of medicine prescribed by your doctor. Call your doctor at once if you have any signs of kidney failure, such as urinating less than usual or not at all, drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting, swelling, weight gain, or feeling short of breath. Do not receive a "live" vaccine while you are being treated with cyclosporine. The live vaccine may not work as well during this time, and may not fully protect you from disease. This list is not complete and there are many other medicines that can cause serious medical problems if you take them together with cyclosporine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

What should I discuss with my health care provider before taking cyclosporine?
You should not use this medication if you are allergic to cyclosporine. You may not be able to use cyclosporine if you have:

kidney disease;

untreated or uncontrolled high blood pressure; or

any type of cancer.

If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before you take cyclosporine, tell your doctor if you have:

psoriasis that has been treated with PUVA, UVB, radiation, methotrexate (Trexall), or coal tar; or

if you are also taking an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), etodolac (Lodine), indomethacin (Indocin), and others.

FDA pregnancy category C. It is not known whether cyclosporine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Cyclosporine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take cyclosporine?
Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

You may take cyclosporine with or without food, but take it the same way each time. Cyclosporine should be given in two separate doses each day. Try to take the medication at the same dosing times each day.

If there are any changes in the brand or form of cyclosporine you use, your dosage needs may change. Always check your refills to make sure you have received the correct brand and type of medicine prescribed by your doctor.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Sandimmune oral solution may be mixed with milk, chocolate milk, or orange juice at room temperature to make the medicine taste better. Neoral "modified" (microemulsion) oral solution should be mixed with orange juice or apple juice that is at room temperature.

Cyclosporine can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your blood pressure and kidney function may also need to be checked. Do not miss any scheduled appointments.

Your condition may need to be treated with a combination of different drugs. For best treatment results, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor. Every person taking cyclosporine should remain under the care of a doctor.

Store cyclosporine at room temperature away from moisture and heat.

What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.

Overdose can cause nausea, vomiting, pain in your upper stomach, loss of appetite, jaundice (yellowing of the skin or eyes), and urinating less than usual or not at all.

What should I avoid while taking cyclosporine?
Avoid exposure to sunlight, sunlamps, or tanning beds. Cyclosporine can make your skin more sensitive to sunlight, and a sunburn may result. Wear protective clothing and use sunscreen (SPF 15 or higher) when you are outdoors.

If you are being treated for psoriasis, you should not receive light therapy (PUVA or UVB) or radiation treatments while you are receiving cyclosporine. Make sure all doctors involved in your care know you are taking cyclosporine.

Do not receive a "live" vaccine while you are being treated with cyclosporine. The live vaccine may not work as well during this time, and may not fully protect you from disease.
Avoid eating grapefruit or drinking grapefruit juice. Grapefruit may interact with cyclosporine and increase your blood levels of this medication.

Cyclosporine side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

urinating less than usual or not at all;

drowsiness, confusion, mood changes, increased thirst;

swelling, weight gain, feeling short of breath;

blurred vision, headache or pain behind your eyes, sometimes with vomiting;

seizure (convulsions);

muscle pain or weakness, fast heart rate, feeling light-headed;

pale skin, easy bruising or bleeding, unusual weakness; or

nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

tremors or shaking;

increased hair growth;

headache or body pain;

diarrhea, constipation, vomiting; or

numbness or tingly feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Cyclosporine Dosing Information
Usual Adult Dose for Organ Transplant -- Rejection Prophylaxis:

IV: 2 to 4 mg/kg/day IV infusion once a day over 4 to 6 hours or
1 to 2 mg/kg IV infusion twice a day over 4 to 6 hours or
2 to 4 mg/kg/day as a continuous IV infusion over 24 hours.
Capsules: 8 to 12 mg/kg/day orally in 2 divided doses.
Solution: 8 to 12 mg/kg orally once a day.

Doses are usually titrated downward with time to maintenance doses as low as 3 to 5 mg/kg/day. All doses should be adjusted to achieve the desired therapeutic concentration.

Usual Adult Dose for Rheumatoid Arthritis:

cyclosporine formulation for emulsion: 5 mg/kg/day orally divided in 2 doses. If possible, anti-inflammatory drugs should be discontinued to help avoid renal toxicity. A maximum dose of 5 mg/kg/day and a maximal increase in serum creatinine levels no more than 30% above baseline values are recommended to minimize renal toxic effects.

Cyclosporine capsules USP modified - Initial dose: 1.25 mg/kg orally twice a day.

Salicylates, nonsteroidal anti-inflammatory agents, and oral corticosteroids may be continued. Onset of action generally occurs between 4 and 8 weeks. If insufficient clinical benefit is seen and tolerability is good (including serum creatinine less than 30% above baseline), the dose may be increased by 0.5 to 0.75 mg/kg/day after 8 weeks and again after 12 weeks to a maximum of 4 mg/kg/day. If no benefit is seen by 16 weeks of therapy, cyclosporine capsules USP modified therapy should be discontinued. Dose decreases by 25% to 50% should be made at any time to control adverse events, e.g., hypertension elevations in serum creatinine (30% above the patient's pretreatment level) or clinically significant laboratory abnormalities.

If dose reduction is not effective in controlling abnormalities or if the adverse event or abnormality is severe, cyclosporine capsules USP modified should be discontinued. The same initial dose and dosage range should be used if cyclosporine capsules USP modified is combined with the recommended dose of methotrexate. Most patients can be treated with cyclosporine capsules USP modified doses of 3 mg/kg/day or below when combined with methotrexate doses of up to 15 mg/week.

There is limited long-term treatment data. Recurrence of rheumatoid arthritis disease activity is generally apparent within 4 weeks after stopping cyclosporine.

Usual Adult Dose for Ulcerative Colitis -- Active:

When refractory to corticosteroids: 4 mg/kg/day via continuous IV infusion. The dose should be titrated gradually to achieve clinical efficacy while avoiding unacceptable toxicity. Therapy should be continued for 7 to 14 days. In successful treatments, oral therapy should be instituted after 14 days of IV therapy and continued for 3 to 6 months.

Some clinicians have found a dose of 2 mg/kg/day via continuous IV infusion to be equally effective to the 4 mg/kg/day dosage regimen.

Usual Adult Dose for Psoriasis:

Refractory plaque-type psoriasis: cyclosporine formulation for emulsion: 2.5 mg/kg/day orally in 2 equally divided doses. The dose should be titrated gradually to achieve clinical efficacy while avoiding excessive toxicity. The incidence of serious toxicity increases with time thus limiting the duration of therapy. Disease relapse may occur after discontinuation or reduction in dose. A maximum dose of 5 mg/kg/day and a maximal increase in serum creatinine levels no more than 30% above baseline values are recommended to minimize renal toxic effects.

Cyclosporine capsules USP modified - Initial dose: 1.25 mg/kg twice a day.
Patients should be kept at that dose for at least 4 weeks, barring adverse events. If significant clinical improvement has not occurred in patients by that time, the patient's dosage should be increased at 2 week intervals. Based on patient response, dose increases of approximately 0.5 mg/kg/day should be made to a maximum of 4 mg/kg/day.

Dose decreases by 25% to 50% should be made at any time to control adverse events, e.g., hypertension, elevations in serum creatinine (25% above the patient's pretreatment level), or clinically significant laboratory abnormalities. If dose reduction is not effective in controlling abnormalities, or if the adverse event or abnormality is severe, cyclosporine capsules USP modified should be discontinued.

Patients generally show some improvement in the clinical manifestations of psoriasis in 2 weeks. Satisfactory control and stabilization of the disease may take 12 to 16 weeks to achieve. Treatment should be discontinued if satisfactory response cannot be achieved after 6 weeks at 4 mg/kg/day or the patient's maximum tolerated dose. Once a patient is adequately controlled and appears stable the dose of cyclosporine capsules USP modified should be lowered, and the patient treated with the lowest dose that maintains an adequate response. Doses below 2.5 mg/kg/day may also be equally effective.

Upon stopping treatment with cyclosporine, relapse will occur in approximately 6 weeks (50% of the patients) to 16 weeks (75% of the patients). In the majority of patients rebound does not occur after cessation of treatment with cyclosporine. Long-term experience with cyclosporine capsules USP modified in psoriasis patients is limited and continuous treatment for extended periods greater than one year is not recommended. Alternation with other forms of treatment should be considered in the long-term management of patients with this lifelong disease.

Usual Pediatric Dose for Organ Transplant -- Rejection Prophylaxis:

IV: 2 to 4 mg/kg/day IV infusion once a day over 4 to 6 hours or
1 to 2 mg/kg IV infusion twice a day over 4 to 6 hours or
2 to 4 mg/kg/day as a continuous IV infusion over 24 hours.
Capsules: 8 to 12 mg/kg/day orally in 2 divided doses.
Solution: 8 to 12 mg/kg orally once a day.
Doses are usually titrated downward with time to maintenance doses as low as 3 to 5 mg/kg/day. All doses should be adjusted to achieve the desired therapeutic concentration.

What other drugs will affect cyclosporine?
Many drugs can interact with cyclosporine. Below is just a partial list. Tell your doctor about all other medications you are using, especially:

lithium (Eskalith, Lithobid);

methotrexate (Rheumatrex, Trexall);

St. John's wort;

an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik);

a heart or blood pressure medication such as candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro, Avalide), losartan (Cozaar, Hyzaar), valsartan (Diovan), telmisartan (Micardis), or olmesartan (Benicar);

medicines used to treat ulcerative colitis, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);

other medicines used to prevent organ transplant rejection, such as sirolimus (Rapamune) or tacrolimus (Prograf);

pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), diclofenac (Voltaren), etodolac (Lodine), ibuprofen (Advil, Motrin), indomethacin (Indocin), naproxen (Aleve, Naprosyn), and others;

IV antibiotics such as amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), amikacin (Amikin), bacitracin (Baci-IM), capreomycin (Capastat), gentamicin (Garamycin), kanamycin (Kantrex), streptomycin, or vancomycin (Vancocin, Vancoled);

antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or

cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), plicamycin (Mithracin), streptozocin (Zanosar), or tretinoin (Vesanoid).

There are many other medicines that can cause serious medical problems if you take them together with cyclosporine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?
Your pharmacist can provide more information about cyclosporine.

 

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