"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Clinolipid Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Clinolipid (lipid injectable emulsion) for Intravenous Use is a lipid emulsion containing a mixture of refined olive oil and refined soybean oil used in adults as a source of calories and essential fatty acids for parenteral (intravenous) nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Common side effects include nausea and vomiting, high levels of fat in the blood (hyperlipidemia), high blood sugar (hyperglycemia), low blood protein levels (hypoproteinemia), urinary tract infection, septicemia, and fever.
The dosing of Clinolipid injection depends on energy expenditure, the patient's clinical status, body weight, tolerance, and ability to metabolize Clinolipid injection, as well as additional energy given orally/enterally to the patient. Clinolipid may interact with coumarin. Tell your doctor all medications and supplements you use. During pregnancy, Clinolipid should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Clinolipid (lipid injectable emulsion) for Intravenous Use Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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 Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Clinolipid FDA Prescribing Information: Side Effects
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The CLINOLIPID injection trials had small sample sizes and patients had a variety of underlying medical conditions both between different trials and within the individual trials. Patients had gastrointestinal diseases/dysfunction or were recovering from gastrointestinal or other surgeries, trauma, burns, or were afflicted by other chronic illness. The largest trial (Study 1, 48 subjects) enrolled patients with many different underlying diagnoses. The rates of treatment emergent adverse reactions can therefore not be directly compared to rates observed in the clinical trials of other related products and may not reflect the rates observed in clinical practice.
Commonly observed adverse reactions in 261 adult patients who received CLINOLIPID injection were nausea and vomiting, hyperlipidemia, hyperglycemia, hypoproteinemia and abnormal liver function tests and occurred in 2-10 % of patients. In Study 1 the most common adverse reactions were infectious complications (urinary tract infection, septicemia, and fever of unknown origin), treatment emergent abnormalities on liver/gallbladder ultrasound and abnormalities of serum chemistries, principally, hepatic function tests. Adverse reactions in Study 2 were similar.
Adverse reactions reported in long-term use with other intravenous lipid emulsions include hepatomegaly, jaundice due to central lobular cholestasis, splenomegaly, thrombocytopenia, leukopenia, abnormalities in liver function tests, brown pigmentation of the liver and overloading syndrome (focal seizures, fever, leukocytosis, hepatomegaly, splenomegaly and shock).
The following adverse reactions have been identified during use of CLINOLIPID injection, and listed by MedDRA System Organ Class, then by Preferred Term in order of severity. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal Disorders: Diarrhea
Skin And Subcutaneous Tissue Disorders: Pruritus
Investigations: International normalized ratio (INR) Decreased*
*(In anticoagulated patients, CLINOLIPID injection may lower the INR)
Read the entire FDA prescribing information for Clinolipid (Lipid Injectable Emulsion for Intravenous Use) »
Additional Clinolipid Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.