Cipol-N Soft 100mg Capsule 50 ‘S

Description

About

The immune system of the human body is a natural defense that consists of protective white blood cells, antibodies, and organs like the thymus, spleen, and bone marrow involvement in the production of immune cells. In case a foreign agent invades the body, the immune system is activated naturally protecting the body against this invasion which can lead to various problems such as organ rejection after transplantation from a donor, such as heart, kidney, liver, etc. Cipol-N Soft 100mg Capsule 50 ‘S belongs to a class of drugs called “immunosuppressants” or immunomodulators. Rejection may occur instantaneously within weeks or may take several months to occur. Cipol-N Soft 100mg Capsule 50 ‘S works by protecting the newly transplanted organ from damage by the body’s immune cells thus called suppressants. Also, it prevents your antibodies from attacking its tissues such as joints, skin, etc. which can lead to a disease called “autoimmune condition”.  It can be taken alone or in combination with other drugs such as steroids and other immunosuppressants.

Cipol-N Soft 100mg Capsule 50 ‘S is chemically composed of Cyclosporine that works by controlling the immune system via blocking the action of regulatory proteins, Cytokines particularly IL-2 involved in the direct activation of T-cells. These are immune cells that form protective antibodies against a particular foreign agent upon recognition and help fight any infection or damage because of it. Cyclosporine is available in 2 types, the regular one and the modified version which becomes more quickly available in the body. Clinical benefits may be evident in a couple of weeks, but it may take up to 3 months sometimes to obtain a complete advantage.  This medicine is known to cause serious birth defects in animal trials. Therefore, if you are pregnant and breastfeeding, avoid using it without a doctor’s advice. 

This medicine is available in the form of oral capsules. While Cipol-N Soft 100mg Capsule 50 ‘S can be prescribed to children (with organ transplant – safe age data is limited) and adults, the dosage depends on weight, age, the severity of the condition, patient’s response to the medicine, adjunct medicines, and their comorbidities. In general, it is taken once or twice a day. Cipol-N Soft 100mg Capsule 50 ‘S is adjusted throughout treatment to get desired clinical results with careful monitoring.  Abrupt withdrawal of Cipol-N Soft 100mg Capsule 50 ‘S can cause exacerbation of symptoms, for which reason you must consult a doctor first and decrease the dose in a stepwise manner. The most common side effects of this medication are nausea, headache, and dizziness, high blood pressure, mood changes, paresthesia of the hand and feet among others.

Indications

Cipol-N Soft 100mg Capsule 50 ‘S is prescribed to adults and children (consult your doctor for children) and it is used in the treatment of autoimmune conditions such as:

• Organ transplant management 
• Psoriasis 
• Rheumatoid arthritis (not responding to first-line drugs)
• Focal segmental glomerulosclerosis
• Amyotrophic lateral sclerosis
• Graft versus host disease
• Ulcerative colitis 
• Behcet’s disease/uveitis 

How does Cipol-N Soft 100mg Capsule 50 ‘S work?

Cipol-N Soft 100mg Capsule 50 ‘S has a powerful immune-suppressive action and it is chemically composed of Cyclosporine that works by controlling the immune system via blocking the action of regulatory proteins Cytokines, particularly IL-2 involved in the direct activation of T-cells. These are immune cells that form protective antibodies against a particular foreign agent upon recognition and help fight any infection or damage because of it. Cyclosporine is available in 2 types, the regular one and the modified version which becomes more quickly available in the body.

How to use Cipol-N Soft 100mg Capsule 50 ‘S?

Cipol-N Soft 100mg Capsule 50 ‘S is available in the form of capsules. Swallow the capsules with a glass of water without chewing, this can be taken with or without food. It is advised for better performance of the drug that if you can tolerate it, ingest the capsules 1 hour before or 2 hours after taking your meal. In general, the treatment with Cipol-N Soft 100mg Capsule 50 ‘S is started at a relatively low dose that can give clinical results, which can be increased in potency and over weeks in increments as the need arises. 

Cipol-N Soft 100mg Capsule 50 ‘S is usually prescribed to be taken once or twice a day, the dose being dependent on weight, age, the severity of the condition, patient’s response to the medicine, and any other drug being taken as an adjunct. Capsules are soft and must be handled with extra care, healthcare providers/assistants must avoid touching them directly by hand (protective gloves should be worn instead) because this has a potential to get absorbed via the skin into the system, causing suppressive effects.

Available Potency of Cipol-N Soft 100mg Capsule 50 ‘S

25 mg   –  Capsules

50 mg   –  Capsules

100 mg – Capsules

Dosage

Adult Dose

Organ Transplant

Prophylaxis: To be taken orally about 4 to 12 hours before transplant surgery. 

15 mg/kg as  a one-time dose

After transplant surgery: 5 to 15 mg/kg per day by mouth in divided doses, twice a day for 1 to 2 weeks.

Decrease the dose by 5% each week until 5 to 10 mg/kg per day is to be given orally in a divided dose twice per day.

Psoriasis

1.25 mg/kg orally twice a day at 12 hourly intervals.

The dose may be increased to 0.5 mg/kg after 4 weeks of therapy if needed.

The dose is decreased by reducing the amount in increments of 25 to 50% of the actual dose when the drug needs to be stopped.

Maximum safe dose: 4 mg/kg per day.

Focal segmental glomerulosclerosis

2.5 mg/kg per day every 12 hours, increase 0.5 to 0.75 mg/kg per day after eight weeks if the response has not been effective. Maximum dose: 4 mg/kg per day.

Rheumatoid Arthritis

1.25 mg/kg orally twice a day at 12 hourly intervals.

The dose may be increased to 0.5 to 0.75 mg/kg per day after 8 weeks of therapy if needed and further adjustment can be done after 12 weeks when indicated.

Maximum safe dose: 4 mg/kg per day.

Child Dose

Children with organ transplants have been treated with this medicine. The need to use Cipol-N Soft 100mg Capsule 50 ‘S in children should be assessed thoroughly by the doctor. Dose and frequency must be decided by your physician.

Elderly dose

The safety concerns of Cipol-N Soft 100mg Capsule 50 ‘S in the elderly population are still valid with increased risk of developing infections, hence caution must be taken. Your doctor should set the most appropriate dose for you based on your medical history. Doses are adjusted according to a liver impairment or other medications being taken concurrently, or other serious conditions. 

*Special Doses

Liver disease – dose adjustment and monitoring are advised

Kidney Disease – dose adjustment and monitoring of serum creatinine is advised

Pregnancy use and lactation

Cipol-N Soft 100mg Capsule 50 ‘S is FDA pregnancy risk category C, therefore if you are pregnant, think you may be pregnant, or are planning to conceive a baby, please consult your doctor. Also Cipol-N Soft 100mg Capsule 50 ‘S may be secreted into human milk, if you are breastfeeding, please consult your doctor before taking it.

Contraindications

Please inform your doctor if you have a history of any before using Cipol-N Soft 100mg Capsule 50 ‘S:

• Allergic reaction to Cipol-N Soft 100mg Capsule 50 ‘S or similar immune suppressants 
• Chronic liver disease with severe impairment of liver function
• Inadequate kidney function 
• History of Bleeding disorders 
• Asthma 
• Uncontrolled hypertension 
• Ongoing infection 
• Pregnancy 
• Breastfeeding 

Precautions‌ ‌

Please‌ ‌tell‌ ‌your‌ ‌doctor‌ ‌about‌ ‌any‌ ‌of‌ ‌the‌ ‌following‌ ‌conditions‌ ‌before using the ‌Cipol-N Soft 100mg Capsule 50 ‘S:‌ ‌

• A history of allergy to any or similar medicines 
• In the case of liver disease before starting the treatment with ‌Cipol-N Soft 100mg Capsule 50 ‘S check LFTs, which must be monitored during the treatment as well. In case of severe liver inadequacy, this drug is prohibited
• Compromised kidney function can cause serious side effects. Make sure to monitor the kidney’s performance throughout the treatment
• Cipol-N Soft 100mg Capsule 50 ‘S puts you at a high risk of infection, practice vigilance to avoid infections (read FAQs for lifestyle changes)
• The drug must not be stopped abruptly even if your symptoms have improved since it can produce worsening symptoms upon unplanned discontinuation. Always ask a doctor before stopping who will decrease it in increments per week
• There is an increased danger of developing cancer including lymphomas, skin cancer, etc. with Cipol-N Soft 100mg Capsule 50 ‘S especially those taking more than one immunosuppressants/methotrexate
• Cipol-N Soft 100mg Capsule 50 ‘S can make vaccinations less effective such as BCG, MMR, and other live attenuated vaccines, avoid getting shots while on immunosuppressants
• Watchful eye on blood cells such as WBCs, platelets, and clotting factors is advised to avoid hemorrhagic conditions affecting organs like the brain, gut, lungs, etc.
• If you have a history of blood pressure special consideration must be given since Cipol-N Soft 100mg Capsule 50 ‘S is known to cause hypertension which at times can become severe although rarely. Make sure to drink an adequate amount of water with this drug
• Serum levels of electrolytes/minerals like potassium, and uric acid should also be watched due to a probability of having increased levels with the use of Cipol-N Soft 100mg Capsule 50 ‘S
• If you are being treated for rheumatoid arthritis with Cipol-N Soft 100mg Capsule 50 ‘S and methotrexate, using NSAID analgesics can cause adverse effects on the kidney, monitor serum creatinine with this combination of drugs 
• Pregnant ladies must consult with their doctor who will only prescribe Cipol-N Soft 100mg Capsule 50 ‘S if considered necessary
• Regular monitoring of blood pressure blood levels of creatinine, LFTs, sodium, potassium, magnesium, thyroid function, clotting factors, and blood count is advised 

Interaction with other medications

Certain medications could interact with Cipol-N Soft 100mg Capsule 50 ‘S and may increase or decrease its absorption, in which case, your doctor might alter your dosage. A few of these interacting drugs are given below:

• Amphotericin 
• Atorvastatin 
• Neomycin 
• Methotrexate 
• Mifepristone 
• Simvastatin 
• Diltiazem/verapamil
• Carbamazepine 
• Phenytoin 
• Azole antifungals like ketoconazole 
• Azithromycin/clarithromycin 
• Allopurinol 
• Metoclopramide 
• Methylprednisolone 
• Bromocriptine 
• Live attenuated vaccines like BCG, MMR, etc.
• St. John’s Wort (Herb)
• Oral contraceptives (especially estrogen-based pills)

Adverse effects

Like most medicines, Cipol-N Soft 100mg Capsule 50 ‘S has some side effects which include:

Common Side effects

• Nausea 
• Headache 
• Indigestion 
• Diarrhea 
• Dizziness
• Increased risk of infections
• Kidney damage 
• Hypertension 

Rare side effects

• Anaphylactic reaction 
• Blurred vision
• Swollen gums 
• Male pattern hair growth 
• Itching/redness of eyes 
• Increased potassium/uric acid levels in the blood
• Low magnesium in the blood 
• Low sodium in the blood
• Paresthesia 
• Palpitations 
• Convulsions 
• Shaky hands/tremors  
• Altered blood cell count such as WBCs, platelets
• Gynecomastia 
• Goiter 
• Acute pancreatitis 
• Liver toxicity
• Abnormal bleeding
• Unexplained bruises
• Hirsutism
• Flu-like symptoms
• Skin rash 

LIST OF HOW TO DEAL WITH ADVERSE EFFECTS

Fatigue – Patients experiencing this adverse effect are advised to take deep breaths, intake tea or coffee, get a good night’s rest, and not overburden themselves for a few days.

Feeling drowsy – If the medication makes you feel drowsy or sleepy, stop what you’re doing and sit or lie down until you feel better, and do not rise too fast or immediately from a sitting or lying down position to a standing posture. Do not drive or use tools or machinery in case of any of these effects.

Headaches – In which case make sure you rest and drink plenty of fluids. Avoid the use of alcohol. Take a prescribed painkiller. Consult your doctor if the headaches last longer than a week or are severe

Feeling or being sick (nausea or vomiting) or diarrhea – Avoid eating rich or spicy food. It might help to take medication after food. If you’re sick, try drinking small, frequent sips of water. 

Feeling dizzy (lightheaded) or weak –If the medication makes you feel dizzy or weak, stop what you’re doing and sit or lie down until you feel better, and do not rise too fast or immediately from sitting or lying down position to a standing posture. Do not drive or use tools or machinery in case of any of these effects.

Flatulence – Can be eased by consuming smaller, more frequent meals that don’t trigger your flatulence. Getting a minimum of 30 minutes of daily exercise has shown great results in combating flatulence. 

Skin Rash- can be eased by applying soothing and healing lotions or creams such as calamine lotion/cream. Applying a cold compress to the rash helps reduce itchiness and redness caused by the rash. Antihistamine (prescribed by a doctor) is also recommended as an effective way to combat any skin rash.

Dehydration – Patients are recommended to always care around a water bottle with them wherever they go and periodically keep sipping to prevent thirst and extremely dry mouth. Ice pops in hot weather and energy drinks (verified by the doctor) help combat dehydration.

FAQs

#1. WHAT EXACTLY DOES Cipol-N Soft 100mg Capsule 50 ‘S DO?

Cipol-N Soft 100mg Capsule 50 ‘S is an immunosuppressant agent that helps you prevent antibodies from attacking your tissues like joints or a transplanted organ from donor antibodies recognized as a foreign agent by the body’s immune system. 

#2. HOW LONG DOES IT TAKE FOR Cipol-N Soft 100mg Capsule 50 ‘S TO START WORKING?

You will start feeling better within a couple of weeks but normally Cipol-N Soft 100mg Capsule 50 ‘S can take 3 to 4 months  2 weeks or more to show its full effects.

#3. HOW LONG WILL I HAVE TO TAKE Cipol-N Soft 100mg Capsule 50 ‘S FOR?

Time duration depends on why you’re taking Cipol-N Soft 100mg Capsule 50 ‘S. Consult your physician for this, Cipol-N Soft 100mg Capsule 50 ‘S can be taken for longer periods lasting up to 3 months or more, probably for life if you have received an organ transplant. Your doctor will assess your response to the treatment and adjust the dose accordingly.

#4. CAN I STOP TAKING Cipol-N Soft 100mg Capsule 50 ‘S?

Do not just stop taking the medicine, make sure to complete your treatment course even if you feel better. Stopping it suddenly may cause exacerbation of symptoms, having said that it is not addicting.

#5. CAN I DRINK ALCOHOL WITH Cipol-N Soft 100mg Capsule 50 ‘S?

Consuming alcohol when taking Cipol-N Soft 100mg Capsule 50 ‘S may cause excessive drowsiness and could increase the risk of liver damage and may interact with the drugs, hence should be avoided. 

#6. WHAT IF I TAKE TOO MUCH OF Cipol-N Soft 100mg Capsule 50 ‘S?

Taking more than required can cause serious damage to the liver and kidneys. If you have taken too much of the prescribed Cipol-N Soft 100mg Capsule 50 ‘S you may experience symptoms of toxicity which will vary depending on the dose ingested, for example, fast pounding, irregular heartbeat, upset stomach, blurred vision, fainting, dizziness, seizures, or life-threatening severe symptoms. Contact your doctor or emergency immediately if you have any of these symptoms. 

#7. WHAT IF I FORGET TO TAKE Cipol-N Soft 100mg Capsule 50 ‘S?

Cipol-N Soft 100mg Capsule 50 ‘S is taken once or twice a day 12 hours apart, so you can take the missed dose as soon as you remember unless it’s about time until your next dose, in which case you should skip the missed dose. If it helps to remind you, set an alarm or use a pill organizer or a mobile application so you do not miss any dose. Make sure to complete your course of treatment even if you feel better and think you do not need to take it anymore.

#8. CAN I TAKE Cipol-N Soft 100mg Capsule 50 ‘S DURING PREGNANCY OR BREASTFEEDING?

Cipol-N Soft 100mg Capsule 50 ‘S has safety concerns for unborn babies and is known to cause serious defects in these babies. If you are pregnant, think you may be pregnant, or are planning to conceive a baby, please consult your doctor before using Cipol-N Soft 100mg Capsule 50 ‘S. If you are breastfeeding, please consult your doctor before taking Cipol-N Soft 100mg Capsule 50 ‘S. 

#9. CAN I DRIVE OR RIDE A BIKE AFTER TAKING Cipol-N Soft 100mg Capsule 50 ‘S?

Know how your body handles the medicine. Cipol-N Soft 100mg Capsule 50 ‘S can make you dizzy so make sure you know how your body reacts while using ‘product’. Do not drive or use any sharp or heavy machinery until you feel normal again.

#10. HOW SHOULD Cipol-N Soft 100mg Capsule 50 ‘S BE STORED?

Store it at room temperature between 20 to 25 °C, away from excess heat, direct sunlight, and moisture. Make sure it is not consumed by pets, children, and other people. Dispose of the unused medicine. 

#11. CAN I TAKE ANALGESICS WITH Cipol-N Soft 100mg Capsule 50 ‘S?

If you are being treated for rheumatoid arthritis with Cipol-N Soft 100mg Capsule 50 ‘S and methotrexate, using NSAID analgesics can cause adverse effects on the kidney, monitor serum creatinine with this combination of drugs. You can take simple analgesics like Panadol with Cipol-N Soft 100mg Capsule 50 ‘S. Consult a doctor for this matter.

#12. CAN I TAKE CONTRACEPTIVES WITH Cipol-N Soft 100mg Capsule 50 ‘S?

Some oral contraceptives especially estradiol/estrogen-based pills interact with Cipol-N Soft 100mg Capsule 50 ‘S. Discuss with your doctor the most appropriate contraceptive for you.

#13. ANY LIFESTYLE CHANGES THAT I NEED TO MAKE?

Cipol-N Soft 100mg Capsule 50 ‘S is an immunosuppressant drug which means it is going to increase the likelihood of getting infections. Following measures can be taken to avoid life-threatening infections:

• Maintain a schedule for regular checks with your doctor to assess dose adjustment needs and general health check-ups
• Observe a very good overall hygiene, particularly hands must be kept clean
• Wash fruits and vegetables thoroughly before consuming 
• Avoid going out to very crowded public places with the risk of catching infections
• Wear a mask when stepping out 
• Maintain a healthy diet with prescribed supplements included 
• Avoid grapefruit juice and alcohol with this medicine 

#14. WILL I HAVE TO UNDERGO ANY TESTS?

You will be required to have regular blood tests and screening particularly during the first 3 months of your treatment at intervals and less frequently afterward. When you start taking Cipol-N Soft 100mg Capsule 50 ‘S your doctor would want to monitor your complete blood count (CBC), blood pressure, and kidney function during the initial 2 days of week 1. When dose adjustment is required lab work will be asked of you. Particular attention must be given to blood levels of creatinine, potassium, sodium, magnesium, LFTs, and blood pressure.