Gengraf Capsules

DRUG DESCRIPTION

Gengraf ® (cyclosporine capsules, USP [MODIFIED]) is a modified oral formulation of cyclosporine that forms an aqueous dispersion in an aqueous environment.

Cyclosporine, the active principle in Gengraf®, is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species Aphanocladium album.

Chemically, cyclosporine is designated as [R-[R*, R*-(E)]]-cyclic-(L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl-3-hydroxy-N,4-dimethyl-L-2-amino-6-octenoyl-L-a-amino-butyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl).

Gengraf® Capsules (cyclosporine capsules, USP [MODIFIED]) are available in 25 mg and 100 mg strengths. Each 25 mg capsule contains: cyclosporine, 25 mg, alcohol, USP, absolute, 12.8% v/v (10.1% wt/vol.). Each 100 mg capsule contains: cyclosporine, 100 mg, alcohol, USP, absolute, 12.8% v/v (10.1% wt/vol.).

Inactive Ingredients: FD&C Blue No. 2, gelatin NF, polyethylene glycol NF, polyoxyl 35 castor oil NF, polysorbate 80 NF, propylene glycol USP, sorbitan monooleate NF, titanium dioxide.

The chemical structure for cyclosporine USP is:

GENGRAF® (cyclosporine)  Structural Formula Illustration

What are the possible side effects of cyclosporine (Gengraf, Neoral, Sandimmune)?

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...

Read All Potential Side Effects and See Pictures of Gengraf Capsules »


Gengraf Capsules Patient Information Including Side Effects

Brand Names: Gengraf, Neoral, Sandimmune

Generic Name: cyclosporine (Pronunciation: SYE kloe SPOR een)

  • What is cyclosporine (Gengraf Capsules)?
  • What are the possible side effects of cyclosporine (Gengraf Capsules)?
  • What is the most important information I should know about cyclosporine (Gengraf Capsules)?
  • What should I discuss with my health care provider before taking cyclosporine (Gengraf Capsules)?
  • How should I take cyclosporine (Gengraf Capsules)?
  • What happens if I miss a dose (Gengraf Capsules)?
  • What happens if I overdose (Gengraf Capsules)?
  • What should I avoid while taking cyclosporine (Gengraf Capsules)?
  • What other drugs will affect cyclosporine (Gengraf Capsules)?
  • Where can I get more information?

What is cyclosporine (Gengraf Capsules)?

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 are the possible side effects of cyclosporine (Gengraf Capsules)?

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;
  • signs of infection such as fever, chills, sore throat, flu symptoms;
  • 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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about cyclosporine (Gengraf Capsules)?

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.

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.

Related Drug Centers
  • Sandimmune
  • Neoral
  • Gengraf Capsules
  • Gengraf Oral Solution


Related Drugs Index: