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PRODUCT DETAILS

Brand Name : Cyclomune
Composition : Cyclosporine
Strength availability : 50mg
Manufactured by : Sun Pharmaceuticals
Dosage Form : capsule
Packing : 50 capsules
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Cyclomune 50mg belongs to the classification of immunosuppressant drug largely used in post-allogeneic organ transplant to decrease the action of the patient's immune system and so the organ rejection risk. It has been designed in transplants of skin, heart, kidney, lung, pancreas, bone marrow and small intestine.
Cyclomune 50mgwhich used as prescription drug under the supervision of medical oncologist.

PRESCRIBED FOR

Cyclomune 50mg is used for the treatment ofProphylaxis of organ rejection in kidney, liver, and heart allogeneic transplants; has been used in combination with azathioprine and corticosteroids
Cyclomune 50mg isIndicated for the treatment of severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate; may be used in combination with methotrexate.
Cyclomune 50mg in adultis Indicated for treatment for nonimmune compromised patients with serious, recalcitrant, plaque psoriasis who have failed to behave to at least 1 systemic treatment.

DOSAGE

Solid Organ Transplantation :
Safety measures of organ rejection in kidney, liver,andheart allogeneic transplants; has been required in concomitant usewith azathioprine and corticosteroids.
In Oral route :
The regular dose for4-12 hours pre-transplant is 15 mg/kg orally for 1 dose required
The regular dose for 1-2 weeks post-transplant is 15 mg/kg/day orally divided twice daily required.
The regular dose for reduce 5% per week until can tolerateis 5-10 mg/kg/day orally divided twice daily required
In Intravenous (IV) route :
The regular dose for 4-12 hours pre-transplant IV is 5-6 mg/kg IV for 1 dose over 2-6 hours required.
The regular dose for Post-transplant, until can tolerate oral therapy is 5-6 mg/kg IV once/day required.
Solid Organ Transplantation, Paediatric (Off-Label) :
In 6 months, young children have gettingcyclomune to prevents solid organ transplant rejection.
Dosage is same as adults, even if children may need higher mg/kg dose than adults
In Oral route :
The regular dose for 4-12 hours pre-transplant is 15 mg/kg orally for 1 dose required
The regular dose for 1-2 weeks post-transplantis 15 mg/kg/day orally divided twice daily required.
The regular dose for reduce 5% per week until is 5-10 mg/kg/day orally divided twice daily required.
In Intravenous (IV) route :
The regular dose for 4-12 hours pre-transplant IV is 5-6 mg/kg IV for 1 dose over 2-6 hours required
The regular dose for Post-transplant, until can tolerate oral therapy is 5-6 mg/kg IV once/day required
Rheumatoid Arthritis :
Used for severe active, rheumatoid arthritis where the disease has not adequate responded to methotrexate; may be required in concomitant use with methotrexate.
Cyclomune the regular dose is 1.25 mg/kg orally twice daily; may increase by 0.5-0.75 mg/kg/day after 8 weeks and again after 12 weeks if needed, not to exceed 4 mg/kg/day
Stop if no improvement observed by 16 weeks
Lowers the dose by 25-50% at any time to regulate adverse effects (e.g., hypertension, elevations in serum creatine greater than 30% pre-treatment level
Psoriasis :
The regular dose of Cyclomune is 1.25 mg/kg orally twice daily; may raise by 0.5 mg/kg/day after 4 weeks and every 2 weeks if needed, not to exceed 4 mg/kg/day
Stop if no improvement seen at 6 weeks on maximum daily dose of 4 mg/kg/day
Lowers the dose by 25-50% at any time to regulateside effects (e.g., high blood pressure, elevations in serum creatine greater than 30% pre-treatment level

MECHANISM OF ACTION

Cyclosporine works by decrease your immune system. White blood cells, part of your immune system, normally fight substances in your body which aren’t there naturally, such as a transplanted organ. Cyclosporine blocks white blood cells from capturing a transplanted organ.
In the case of RA or psoriasis, cyclosporine interruptsyour immune system from wronglyattaching your own body tissues.

ADME PROPERTIES

The time to peak plasma concentration is 1.5-2.0 hours and bioavailability is 30%
The drug has plasma protein bound about 90%
In liver broadly metabolized by the cytochrome P450 3A enzyme system. To lesser degree is metabolized in gastrointestinal tract and kidney.
Mostly excreted in biliary and in urine 6% and 0.1% eliminated in urine as unchanged drug.
In adults Half-life is 19 hours and in children is 7 hours

DRUG INTERACTION

Concomitant use ofAdalimumab with Cyclomune 50mg both increase immunosuppressive effects and cause risk of infection. Avoid the usage of drug
Concomitant use of Cyclomune 50mg with carbamazepine will reduce the level or effect of cyclosporine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid the usage of drug or Use Alternate Drug.
Concomitant use of Acyclovir with Cyclomune 50mg both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely.
Concomitant use of Azathioprine with Cyclomune 50mg both increase immunosuppressive effects and cause risk of infection

PRECAUTION

When usage of Cyclomune 50mg may have high risk of serious infections. It may also raise the risk of developing a tumor or skin cancer.
When Cyclomune50mg treatmentreduce the immune system. If you administer this medication, you may be at higher risk for infections from bacteria, fungus, and viruses. These infections may be serious or life-threatening
Some patient if have psoriasis and have been treated with either psoralen plus ultraviolet A therapy, methotrexate, coal tar, radiation therapy, or ultraviolet light therapy, you may have anincreased chance of occurring a skin disease while taking Cyclomune 50mg capsules.
When Cyclomune 50mg treatment may cause hypertension and renal disease.
When Cyclomune 50mg treatment may cause liver repair and liver failure, specifically if you take high doses. It may even be fatal.

STORAGE

The drug stored at 20℃ - 25℃.
Do not place drug in moist or damp areas.
Keep away from light and high temperature.

MISSED DOSE

The patients forget to take a dose then have it soon the missed dose or leave the missed dose and follow regular schedule. Avoid taking extra dose Consult the doctor for more details

CONTRAINDICATIONS

Cyclomune 50mg is a contraindicated;
Hypersensitivity
Breastfeeding
Rheumatoid Arthritis (RA)/Psoriasis usage of drug while in Abnormal renal function, uncontrolled hypertension, malignancies
Co administration of PUVA, UVB radiation, coal tar, methotrexate, other immunosuppressants will cause psoriasis

SIDE EFFECTS

Serious side effects :
Liver damage :
• blood in urine
• dark urine
• pale stools
• skin becomes yellow colour or the whites of your eyes
• pain in your upper abdomen
Kidney damage :
• blood in urine
Heart problems :
• swelling of your feet or lower legs
Lung problems :
• trouble breathing.
More common side effects :
In kidneys, blood clots occur
Pain in Stomach
Hair growth
Acne
Tremors
Headache
Hypertension
Magnesium level is low in body
Gums size increased.

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