HUMAN PAPILLOMAVIRUS 9-VALENT VACCINE

CICLOSPORIN

Ciclosporin is a powerful immunosuppressant that targets helper T-cells. It reduces cell-mediated immune response by inhibiting calcineurin activation and blocking the release and synthesis of interleukin-II. It is also known as cyclosporin A or cyclosporine.

Use this medication precisely as recommended by your physician. Follow the prescription of your doctor carefully.

The medication dose given by your physician is based on your health conditions, other medications or food supplements taken, and your reaction to the treatment. To diminish risks for adverse effects, do not increase your dosage, thus take it regularly, or take it as instructed by your physician. Adverse events may still happen even at usual prescription dosages.

If your physician requests you to use this drug consistently, take it regularly to get the most benefits from it. To make you remember it better, take it at a fixed time every day.

Your doctor may need to modify your dosages to ease your symptoms or if you develop adverse reactions.

Ciclosporin is used in the following conditions:

  • Prophylaxis of graft rejection in bone marrow transplantation
  • Immunosuppression in organ transplantation
  • Graft versus host disease
  • Keratoconjunctivitis sicca
  • Severe keratitis in dry eye disease
  • Nephrotic syndrome
  • Severe active rheumatoid arthritis
  • Severe psoriasis
  • Immunosuppression in organ transplantation
  • Severe atopic dermatitis
  • Prophylaxis of graft rejection in bone marrow transplantation
  • Graft versus host disease

This medicine may be recommended for different uses. Approach your physician or pharmacist for more information.  

Do not use Ciclosporin in people with the following conditions:

Non-transplant indications: 

  • Abnormal renal function (except in nephrotic syndrome)
  • Uncontrolled hypertension
  • Malignant neoplasms
  • Uncontrolled infections
  • Psoriasis
  • Atopic dermatitis
  • Patient receiving psoralen and ultraviolet A (PUVA) photochemotherapy, ultraviolet B (UVB) irradiation, or other radiation therapy
  • Concomitant use with coal tar, methotrexate or other immunosuppressive agents (in psoriatic patient)
  • Lactation

Ophthalmic:

  • Active or suspected ocular or peri-ocular infection, malignancies or premalignant conditions

Ciclosporin may have the following side effects:

  • Infections (bacterial, fungal, parasitic, viral)
  • Gingival hyperplasia
  • Nephrotoxicity
  • Seizures
  • Encephalopathy (including posterior reversible encephalopathy syndrome)
  • Hypertension
  • Microangiopathic hemolytic anemia
  • Thrombocytopenia
  • Hyperkalemia
  • Hyperuricemia
  • Anaphylactoid reactions (IV)
  • Anemia
  • Leucopenia
  • Myocardial infarction
  • Eye pain
  • Burning or foreign body sensation in the eye
  • Visual disturbance
  • Conjunctival hyperemia
  • Blepharitis
  • Epiphora
  • Eye discharge
  • Eye irritation
  • Nausea
  • Vomiting
  • Diarrhea
  • Abdominal pain or discomfort
  • Dyspepsia
  • Flatulence
  • Tongue and tooth disorders
  • Constipation
  • Dysphagia
  • Eructation
  • Esophagitis
  • Peptic ulcer
  • Gastritis
  • Gastroenteritis
  • Glossitis
  • Salivary gland enlargement
  • Pancreatitis
  • Pyrexia
  • Fatigue
  • Increased sweating
  • Asthenia
  • Angioedema
  • Decreased or increased weight
  • Anorexia
  • Hyperglycemia
  • Hyperlipidemia
  • Hypomagnesemia
  • Muscle cramps
  • Arthralgia
  • Myalgia
  • Tremor
  • Headache
  • Paresthesia
  • Neuropathy
  • Anxiety
  • Confusion
  • Hematuria
  • Urinary Tract Infection
  • Micturition urgency
  • Gynecomastia
  • Menstrual disorder
  • Bronchospasm
  • Upper respiratory tract infections
  • Dyspnea
  • Rhinitis
  • Cough
  • Hirsutism or hypertrichosis
  • Rash
  • Abnormal pigmentation
  • Dermatitis
  • Dry skin
  • Eczema
  • Pruritus
  • Urticaria
  • Acne
  • Nail disorder
  • Flushing

Potentially Fatal: 

  • Polyoma virus infections 
  • Lymphomas and other malignancies (particularly of the skin)
  • Hepatotoxicity (increased hepatic enzymes and bilirubin) 
  • Cholestasis
  • Jaundice
  • Hepatitis
  • Liver failure

Keep in mind that your physician has recommended this drug since he or she has known that the advantage to you is more significant than the risk of adverse reactions. Many individuals utilizing this medicine don’t have serious side effects.  

A severe allergy to this medication is uncommon. In any case, seek emergency medical help if you see any manifestations of a serious allergic response, including a rash, tingling or swelling particularly of the face or tongue or throat, dizziness or difficulty in breathing.

This is not a complete list of side effects. If you see other effects not recorded above, contact your physician or pharmacist.

Precautions

Take extra caution in patients with the following medical conditions:

  • Patients with hyperuricemia
  • On K-rich diet
  • History of ocular herpes
  • Glaucoma (ophthalmic)
  • Hepatic impairment
  • Children
  • Pregnancy
  • Patient taking substrates of P-glycoprotein (P-gp) or organic anion transporter proteins (OATP) and products containing St. John’s wort
  • Avoid immunisation with live vaccines

Prior in taking this medicine, tell your physician or pharmacist if you have allergies or other hypersensitivity reactions with the drug. This drug may contain inert ingredients which can cause unfavorable side effects or different issues. Talk with your pharmacist for more information.

Interactions

Ciclosporin may interact with the following medicines:

  • Carbamazepine
  • Nevirapine
  • Phenytoin
  • Phenobarbital
  • Rifampicin
  • Bosentan
  • Orlistat
  • Ketoconazole
  • Azithromycin
  • Ritonavir
  • Delavirdine
  • HMG-CoA reductase inhibitors (statins) 
  • Nifedipine
  • Amlodipine
  • K-sparing diuretics
  • Angiotensin II receptor antagonists
  • ACE inhibitors
  • K-containing products
  • Live vaccines
  • Aliskiren
  • Dabigatran
  • OATP
  • Aminoglycosides
  • Amphotericin B
  • Ciprofloxacin
  • Vancomycin
  • Trimethoprim
  • Sulfamethoxazole
  • Fibric acid derivatives 
  • NSAIDs
  • Melphalan
  • H2-receptor blockers 
  • Methotrexate
  • Tacrolimus
  • Everolimus

Potentially Fatal: 

  • Immunosuppressive agents

Inform your physician about the drugs you take including over-the-counter medications, prescribed drugs, supplements and vitamins.

This is not a complete list of drug interactions. Approach your physician or pharmacist for more details.

The effects of certain medications can change if you consume different medications or herbal products simultaneously. This can build your risk for side effects or may cause your drugs not to work effectively. These interactions are possible, yet don’t generally happen. Your physician or pharmacist can prevent or oversee interactions by changing how you utilize your prescriptions or by close checking.

While utilizing this drug, don’t start, stop, or change the dose of other medicines you are using without your physician’s advice.

Symptoms of overdose may include the following:

  • Headache
  • Drowsiness
  • Vomiting
  • Tachycardia
  • Transient hepatotoxicity
  • Nephrotoxicity

If an overdose is suspected, call your health care provider immediately.

Available brands:

  • Sandimmune
  • Gengraf
  • Neoral

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