Sandimmune Oral Solution 100Mg Drug Medication Dosage Information
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Sandimmune: Oral solution (100mg)

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What is this Medicine?

CYCLOSPORINE (SYE kloe spor een) is used to decrease the immune system's response to a transplanted organ. The medicine (Neoral only) is also used for rheumatoid arthritis and psoriasis.

Similar Brand Name Drugs : SangCya: Oral solution (100mg)
Similar Generic Drugs : Cyclosporine: Oral solution (100mg)
In-Depth Information

Sandimmune 100mg/ml Solution

NDC: 000780110
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Heart Transplant Rejection Prophylaxis, Liver Transplant Rejection Prophylaxis, Kidney Transplant Rejection Prophylaxis, Graft-versus-host Disease (GVHD) Prophylaxis, Rheumatoid Arthritis, Graft-versus-host Disease (GVHD)

Sometimes used for but not FDA approved for the following conditions:
Psoriasis, Psoriatic Arthritis, Myasthenia Gravis, Crohn's Disease, Atopic Dermatitis, Ulcerative Colitis, Idiopathic Thrombocytopenic Purpura (ITP), Aplastic Anemia

Storage Information
Do not refrigerate
Product should be used within 2 months after opening
Store in original container
Store below 86 degrees F
Protect from freezing
Sandimmune 100mg/ml Solution

Reported Side Effects for Sandimmune 100mg/ml Solution

Conjunctivitis Incidence:
<2.0%*
Severity: MODERATE
Onset: DELAYED
Confusion Incidence:
<3.0%*
Severity: MODERATE
Onset: EARLY
Broken Bones Incidence:
<3.0%*
Severity: SEVERE
Onset: DELAYED
Weakness Incidence:
<3.0%*
Severity: MILD
Onset: DELAYED
Causing To Be Hungry Incidence:
<3.0%*
Severity: MILD
Onset: DELAYED
Secondary Malignancy Incidence:
<6.0%*
Severity: MODERATE
Onset: DELAYED
Inceased Urination Incidence:
<3.0%*
Severity: MILD
Onset: EARLY
Nerve Pain Incidence:
<3.0%*
Severity: MODERATE
Onset: DELAYED
Heart Attack Incidence:
<3.0%*
Severity: SEVERE
Onset: DELAYED
Low White Blood Cell Counts Incidence:
<6.0%*
Severity: MODERATE
Onset: DELAYED
Flu Incidence:
<9.9%*
Severity: MILD
Onset: DELAYED
Infection Incidence:
<24.7%*
Severity: MILD
Onset: DELAYED
Increased Blood Sugar Incidence:
<2.0%*
Severity: MODERATE
Onset: DELAYED
Blood In The Urine Incidence:
<3.0%*
Severity: MODERATE
Onset: DELAYED
Difficulty Swallowing Incidence:
<3.0%*
Severity: MODERATE
Onset: DELAYED
Cataracts Incidence:
<3.0%*
Severity: MODERATE
Onset: DELAYED
Bleeding Incidence:
<3.0%*
Severity: MODERATE
Onset: EARLY
Stomach Pain Incidence:
<15.0%*
Severity: MILD
Onset: EARLY
Dry Mouth Incidence:
<3.0%*
Severity: MILD
Onset: EARLY
Weight Loss Incidence:
<3.0%*
Severity: MILD
Onset: DELAYED
Weight Gain Incidence:
<3.0%*
Severity: MILD
Onset: DELAYED
Rhinitis Incidence:
<11.0%*
Severity: MILD
Onset: EARLY
Stomach Ulcer Incidence:
<3.0%*
Severity: SEVERE
Onset: DELAYED
Nighttime Urination Incidence:
<3.0%*
Severity: MILD
Onset: EARLY
Muscle And/Or Bone Pain Incidence:
<2.0%*
Severity: MILD
Onset: EARLY
Feeling Sick Incidence:
<3.0%*
Severity: MILD
Onset: EARLY
Enlarged Lymph Nodes Incidence:
<3.0%*
Severity: MODERATE
Onset: DELAYED
Increased Sexual Desire Incidence:
<3.0%*
Severity: MILD
Onset: DELAYED
Decreased Sexual Desire Incidence:
<3.0%*
Severity: MILD
Onset: DELAYED
Hypoesthesia Incidence:
<3.0%*
Severity: MILD
Onset: DELAYED
Hiccups Incidence:
<2.0%*
Severity: MILD
Onset: EARLY
Deafness Incidence:
<2.0%*
Severity: SEVERE
Onset: DELAYED
Gynecomastia Incidence:
<4.0%*
Severity: MILD
Onset: DELAYED
Inflamed Tongue Incidence:
<3.0%*
Severity: MODERATE
Onset: EARLY
Flushing Incidence:
<5.0%*
Severity: MILD
Onset: RAPID
Belching Incidence:
<3.0%*
Severity: MILD
Onset: EARLY
Emotional Lability Incidence:
<3.0%*
Severity: MILD
Onset: EARLY
Metallic Taste Incidence:
<3.0%*
Severity: MILD
Onset: EARLY
Low Blood Sugar Incidence:
<3.0%*
Severity: MODERATE
Onset: EARLY
High Uric Acid Level Incidence:
<3.0%*
Severity: MODERATE
Onset: DELAYED
High Potassium Level Incidence:
<3.0%*
Severity: SEVERE
Onset: DELAYED
High Cholesterol Incidence:
<3.0%*
Severity: MODERATE
Onset: DELAYED
Hot Flashes Incidence:
<3.0%*
Severity: MODERATE
Onset: EARLY
Heart Failure Incidence:
<3.0%*
Severity: SEVERE
Onset: DELAYED
Enlarged Thyroid Gland Incidence:
<3.0%*
Severity: MODERATE
Onset: DELAYED
Inflamed Stomach Incidence:
<3.0%*
Severity: MODERATE
Onset: DELAYED
Throat Inflammation Incidence:
<3.0%*
Severity: MODERATE
Onset: DELAYED
Nose Bleed Incidence:
<3.0%*
Severity: MILD
Onset: DELAYED
Swelling Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
Eczema Vaccinatum Incidence:
<3.0%*
Severity: SEVERE
Onset: DELAYED
Drowsiness Incidence:
<3.0%*
Severity: MILD
Onset: EARLY
Diabetes Incidence:
<3.0%*
Severity: MODERATE
Onset: DELAYED
Constipation Incidence:
<3.0%*
Severity: MODERATE
Onset: DELAYED
Nervousness Incidence:
<3.0%*
Severity: MILD
Onset: DELAYED
Decreased Appetite Incidence:
<3.0%*
Severity: MILD
Onset: DELAYED
Angioedema Incidence:
<3.0%*
Severity: SEVERE
Onset: RAPID
Anemia Incidence:
<3.0%*
Severity: MODERATE
Onset: DELAYED
Itching Incidence:
<3.0%*
Severity: MILD
Onset: RAPID
Urinary Urgency Incidence:
<3.0%*
Severity: MILD
Onset: EARLY
Muscle Pain Incidence:
<3.0%*
Severity: MILD
Onset: EARLY
Migraine Incidence:
<3.0%*
Severity: MODERATE
Onset: EARLY
Hives Incidence:
<3.0%*
Severity: MILD
Onset: RAPID
Psoriasis Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Uncontrolled Urination Incidence:
<3.0%*
Severity: MODERATE
Onset: EARLY
Sinus Infection Incidence:
<8.0%*
Severity: MILD
Onset: DELAYED
Balance Problems Incidence:
<3.0%*
Severity: MILD
Onset: EARLY
Dry Skin Incidence:
<3.0%*
Severity: MILD
Onset: DELAYED
Ringing In Ears Incidence:
<3.0%*
Severity: MILD
Onset: DELAYED
Increased Urination Incidence:
1.0-4.0%*
Severity: MILD
Onset: EARLY
Vaginal Discharge Incidence:
1.0%*
Severity: MILD
Onset: DELAYED
Painful Urination Incidence:
1.0%*
Severity: MODERATE
Onset: EARLY
Shortness Of Breath Incidence:
1.0-6.5%*
Severity: MODERATE
Onset: EARLY
Skin Ulcer Incidence:
1.0%*
Severity: MODERATE
Onset: DELAYED
Depression Incidence:
1.0-6.0%*
Severity: MODERATE
Onset: DELAYED
Fever Incidence:
1.0-3.0%*
Severity: MILD
Onset: EARLY
Yeast Infection Incidence:
1.0-2.9%*
Severity: MODERATE
Onset: DELAYED
Inflamed Hair Follicles Incidence:
1.0-2.9%*
Severity: MILD
Onset: DELAYED
Paresthesias Incidence:
1.0-11.0%*
Severity: MILD
Onset: DELAYED
Acne Incidence:
1.0-6.0%*
Severity: MILD
Onset: DELAYED
Convulsions Incidence:
1.0-5.0%*
Severity: SEVERE
Onset: DELAYED
Inability To Sleep Incidence:
1.0-4.0%*
Severity: MILD
Onset: EARLY
High Bilirubin Level Incidence:
1.0-7.0%*
Severity: MODERATE
Onset: DELAYED
Blistery Rash Incidence:
1.0%*
Severity: MODERATE
Onset: EARLY
Chest Pain Incidence:
1.0-6.0%*
Severity: MODERATE
Onset: EARLY
Irregular Periods Incidence:
1.0-3.0%*
Severity: MILD
Onset: DELAYED
Lightheadedness Incidence:
1.0-8.0%*
Severity: MILD
Onset: EARLY
Eye Pain Incidence:
1.0-5.0%*
Severity: MILD
Onset: EARLY
Joint Pain Incidence:
1.0-6.0%*
Severity: MILD
Onset: DELAYED
Gum Inflammation Incidence:
1.0-4.0%*
Severity: MILD
Onset: DELAYED
Headache Incidence:
2.0-25.0%*
Severity: MILD
Onset: EARLY
Muscle Cramps Incidence:
2.0-12.0%*
Severity: MILD
Onset: DELAYED
Upset Stomach Incidence:
2.0-23.0%*
Severity: MILD
Onset: EARLY
Vomiting Incidence:
2.0-10.0%*
Severity: MILD
Onset: EARLY
Bruises Incidence:
2.0-4.0%*
Severity: MILD
Onset: DELAYED
Gingival Hyperplasia Incidence:
2.0-16.0%*
Severity: MODERATE
Onset: DELAYED
Upset Stomach Incidence:
2.2-12.0%*
Severity: MILD
Onset: EARLY
Cough Incidence:
3.0-6.5%*
Severity: MILD
Onset: DELAYED
Hair Loss Incidence:
3.0-4.0%*
Severity: MILD
Onset: DELAYED
Loose Stools Incidence:
3.0-13.0%*
Severity: MILD
Onset: EARLY
Tired Incidence:
3.0-6.0%*
Severity: MILD
Onset: EARLY
Sore Throat Incidence:
3.0-5.0%*
Severity: MILD
Onset: DELAYED
Gas Incidence:
4.0-5.0%*
Severity: MILD
Onset: EARLY
Elevated Hepatic Enzymes Incidence:
4.0-7.0%*
Severity: MODERATE
Onset: DELAYED
Arthropathy Incidence:
4.0-5.0%*
Severity: MILD
Onset: DELAYED
Low Magnesium Levels Incidence:
4.0-6.0%*
Severity: MODERATE
Onset: DELAYED
Mouth Ulcers Incidence:
5.0-7.0%*
Severity: MODERATE
Onset: DELAYED
Breathing Difficulties Incidence:
5.0-6.5%*
Severity: SEVERE
Onset: RAPID
Ambras Syndrome Incidence:
6.6-19.0%*
Severity: MILD
Onset: DELAYED
Shaking Incidence:
7.0-55.0%*
Severity: MILD
Onset: EARLY
Skin Rash Incidence:
7.0-12.0%*
Severity: MILD
Onset: EARLY
High Blood Pressure Incidence:
8.0-53.0%*
Severity: MODERATE
Onset: EARLY
High Triglycerides Incidence:
15.0%*
Severity: MODERATE
Onset: DELAYED
Hirsutism Incidence:
21.0-45.0%*
Severity: MILD
Onset: DELAYED
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Daily Life Interactions for Sandimmune 100mg/ml Solution

Elements of your daily lifestyle may have an effect on the medications you are taking. Drug interactions can result in unwanted side effects, reduce the effectiveness of your medicine or possibly increase the action of a particular medicine.

Major Lifestyle Interaction
Grapefruit juice and Sandimmune 100mg/ml Solution(Cyclosporine)
Grapefruit juice and Cyclosporine(Cyclosporine)
Grapefruit juice can increase the amount of Cyclosporine your body absorbs and increase the risk of Cyclosporine side effects. If possible patients should avoid grapefruit or grapefruit juice while taking Cyclosporine. At the very least, patients receiving Cyclosporine should avoid large changes (i.e., either increases or decreases) in their daily intake of grapefruit juice. Do not mix cyclosporine oral solution with grapefruit juice.
Major Lifestyle Interaction
Alcohol and Sandimmune 100mg/ml Solution(Cyclosporine)
Alcohol and Cyclosporine(Cyclosporine)
Although it is probably not related to the alcohol content of the wine, red wine may decrease the levels of cyclosporine (the Sandimmune brands of capsules or solutions) in your blood. If you have received an organ transplant and take Cyclosporine, drinking red wine could increase the risk of organ rejection. If you notice increased tiredness or other symptoms, notify your prescriber right away.
Major Lifestyle Interaction
High Fat Foods and Sandimmune 100mg/ml Solution(Cyclosporine)
High Fat Foods and Cyclosporine(Cyclosporine)
It is important to take Cyclosporine consistently with or without food. The Sandimmune brand is affected by food more than other brands of Cyclosporine; although all can be affected to some degree. Grapefruit juice can increase the amount of Cyclosporine your body absorbs. If possible patients should avoid grapefruit or grapefruit juice while taking Cyclosporine. At the very least, patients receiving Cyclosporine should avoid large changes (i.e., either increases or decreases) in their daily intake of grapefruit and grapefruit juice. Do not mix cyclosporine oral solution with grapefruit juice.
Pregnancy & Lactation Information
FIRST Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

SECOND Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

THIRD Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

Lactation

Caution - Not enough information is available to rule out harm to infants when this drug is taken by nursing mothers.


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