"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"...
Procalamine Consumer (continued)
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
It is important to keep your IV site clean. Tell your doctor immediately if you notice: any signs of infection (e.g., fever, chills), unusual redness, swelling, or severe pain at the IV site.
Although unlikely to occur, you may develop an imbalance of body fluid, minerals, or nutrients while receiving this medication. Your therapy may need to be changed to correct the imbalance. It is important to keep your medical and laboratory appointments for regular monitoring by your healthcare professional. Tell your doctor immediately if any of these unlikely but serious side effects occur: change in the amount of urine, increased thirst/urination, mental/mood changes, muscle weakness, slow/irregular heartbeat, swelling of hands/feet/ankles.
A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Procalamine (amino acid and glycerin) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to any amino acid or to glycerin; or if you have any other allergies. This product may contain inactive ingredients (such as latex, sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney or liver disease, certain metabolic disorder (impaired nitrogen utilization).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, bleeding problems, congestive heart failure, diabetes.
This product contains aluminum which may build up with prolonged use and may have harmful effects in certain patients (e.g., patients with kidney problems including premature newborns and the elderly). Consult your doctor for more details.
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding.
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