Drug Name

Rocaltrol (Calcitriol)

Drug Uses

This is a form of vitamin D, a fat-soluble vitamin stored in the body. Vitamin D is necessary for normal bone development. This medication is used as a dietary supplement to help prevent and treat rickets (a vitamin D deficiency). It is also used to prevent and treat muscle cramps and certain types of calcium and phosphate disorders (such as with chronic dialysis), and to regulate parathyroid hormone.

How Taken

Capsules must be swallowed whole. Do not crush or chew them. If you are prescribed the liquid form, use as directed. Follow dosing instructions closely. Do not increase your dose without doctor's approval. Do not take this medication with mineral oil or magnesium containing antacids which may reduce its effects.

Drug Class and Mechanism

Rocaltrol (calcitriol) is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body. All dosage forms contain butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) as antioxidants. The capsules contain a fractionated triglyceride of coconut oil, and the oral solution contains a fractionated triglyceride of palm seed oil. Gelatin capsule shells contain glycerin, parabens (methyl and propyl) and sorbitol.

The two known sites of action of calcitriol are intestine and bone. A calcitriol receptor-binding protein appears to exist in the mucosa of human intestine. Additional evidence suggests that calcitriol may also act on the kidney and the parathyroid glands. Calcitriol is the most active known form of vitamin D3 in stimulating intestinal calcium transport. In acutely uremic rats calcitriol has been shown to stimulate intestinal calcium absorption. The kidneys of uremic patients cannot adequately synthesize calcitriol, the active hormone formed from precursor vitamin D. Resultant hypocalcemia and secondary hyperparathyroidism are a major cause of the metabolic bone disease of renal failure.

However, other bone-toxic substances which accumulate in uremia (eg, aluminum) may also contribute. The beneficial effect of Rocaltrol in renal osteodystrophy appears to result from correction of hypocalcemia and secondary hyperparathyroidism. It is uncertain whether Rocaltrol produces other independent beneficial effects. Rocaltrol treatment is not associated with an accelerated rate of renal function deterioration. No radiographic evidence of extraskeletal calcification has been found in predialysis patients following treatment. The duration of pharmacologic activity of a single dose of calcitriol is about 3 to 5 days.

Missed Dose

Take the missed dose as soon as you remember; do not take if it is almost time for the next dose. Instead, skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up.

Storage

Store at room temperature (77 degrees F/25 degrees C).

Warnings/Precautions

Tell your doctor if you have: heart disease, kidney disease or kidney stones, coronary artery disease (hardening of the arteries). This drug should be used only if clearly needed during pregnancy. It is not known if this medication appears in breast milk; consult your doctor before breast-feeding.

Possible Side Effects

Vitamin D is generally well tolerated. However, notify your doctor if you experience: nausea, vomiting, loss of appetite, constipation, diarrhea, stomach pain, thirst, weakness, headache, bone pain, dry mouth, increased urination. If you notice other effects not listed above, contact your doctor or pharmacist.

More Information

Foods rich in vitamin D include: fortified dairy products, eggs, sardines, cod liver oil, chicken livers and fresh-water fish.

Vitamin D is also obtained from periodic exposure to the sun. It is important to maintain a well-balanced diet while taking this medication. Calcium supplements may be recommended in addition to this medication. Discuss this with your doctor.

What is the shelf life of the pills?

• The expiry date is mentioned on each blister. It is different for different batches. The shelf life is 2 years from the date of manufacture and would differ from batch to batch depending on when they were manufactured.

Other Useful Information:

Radiation: 1. Rays of energy. Gamma rays and X-rays are two of the types of energy waves often used in medicine. 2. The use of energy waves to diagnose or treat disease.

Replantation: 1. Literally, the act of planting again. 2. In surgery, the restoration of any part of the body to its original site. Also known as reimplantation.

The Chinese surgeon Zhong Wei Chen (1929-2004) was the "father of replantation." Dr. Chen was the first to reattach a severed hand with success which he did in 1963. Dr. Chen also developed many microsurgical procedures including techniques for preserving severed extremities, reattaching amputated fingers and thumbs, reconstructing muscles and repairing nerves and blood vessels.

Rheumatism: Rheumatism is an older term, used to describe any of a number of painful conditions of muscles, tendons, joints, and bones.

Rheumatism conditions have been classified as either localized, regional, or generalized. Localized rheumatism conditions include bursitis and tendinitis. Regional rheumatism conditions include chest wall pain, temporomandibular joint pain, and myofascial pain syndromes. Generalized rheumatism conditions include fibromyalgia.

Another category of rheumatism is psychogenic rheumatism. With this term it is understood that the patient is reporting inconsistent pains of muscles and joints that do not correspond to true anatomy and physiology. The patient is felt to have underlying psychological causes for the symptoms.

Rheumatology: A subspecialty of internal medicine that involves the non-surgical evaluation and treatment of the rheumatic diseases and conditions. Rheumatic diseases and conditions are characterized by symptoms involving the musculoskeletal system. Many of the rheumatic diseases and conditions feature immune system abnormalities. Therefore, rheumatology also involves the study of the immune system. Classical rheumatology training includes 4 years of medical school, 1 year of internship in internal medicine, 2 years of internal medicine residency, and 2 years of rheumatology fellowship. There is a subspecialty board for rheumatology certification. The American College of Rheumatology is the official organization acting on behalf of the field of rheumatology in the United States.

T cell: A type of white blood cell that is of key importance to the immune system and is at the core of adaptive immunity, the system that tailors the body's immune response to specific pathogens. The T cells are like soldiers who search out and destroy the targeted invaders.

Immature T cells (termed T-stem cells) migrate to the thymus gland in the neck, where they mature and differentiate into various types of mature T cells and become active in the immune system in response to a hormone called thymosin and other factors. T-cells that are potentially activated against the body's own tissues are normally killed or changed ("down-regulated") during this maturational process.

There are several different types of mature T cells. Not all of their functions are known. T cells can produce substances called cytokines such as the interleukins which further stimulate the immune response. T-cell activation is measured as a way to assess the health of patients with HIV/AIDS and less frequently in other disorders.

T cell are also known as T lymphocytes. The "T" stands for "thymus" -- the organ in which these cells mature. As opposed to B cells which mature in the bone marrow.

Teleology: The study of the ultimate purpose of the design of something in nature.

For example, "what is the true purpose of the nose?" is a teleological question and, to say that all evolutionary changes occur for a definite purpose is a teleological explanation of evolution.

"Teleology" comes from ancient Greek roots but it (and teleological) did not enter English until the 18th century. It is a compound of the Greek "tele-, telos," meaning "end or purpose" + the ending "logos" meaning "the science or study of" = the study of the ends or purposes.

Testosterone: A "male hormone" -- a sex hormone produced by the testes that encourages the development of male sexual characteristics, stimulates the activity of the male secondary sex characteristics, and prevents changes in them following castration. Chemically, testosterone is 17-beta-hydroxy-4-androstene-3-one.

Testosterone is the most potent of the naturally occurring androgens. The androgens cause the development of male sex characteristics, such as a deep voice and a beard; they also strengthen muscle tone and bone mass.

High levels of testosterone appear to promote good health in men, for example, lowering the risks of high blood pressure and heart attack. High testosterone levels also correlate with risky behavior, however, including increased aggressiveness and smoking, which may cancel out these health benefits.

Testosterone may be given to treat medical conditions, including female (but not male) breast cancer, hypogonadism (low gonadal function) in the male, cryptorchism (nondescent of the testis into the scrotum), and menorrhagia (irregular periods).