Dht (Dihydrotachysterol)
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Dht (Dihydrotachysterol)

DHT™ Tablets
(Dihydrotachysterol Tablets USP):
0.125mg, 0.4mg

DRUG DESCRIPTION

Each tablet contains:

Dihydrotachysterol 0.125 mg, 0.2 mg, or 0.4 mg.

Each mL of Intensol TM Oral Solution (Concentrate) contains:

    Dihydrotachysterol.............................. 0.2 mg

    Alcohol 20%

Dihydrotachysterol is a synthetic reduction product of tachysterol, a close isomer of vitamin D. Chemically dihydrotachysterol is 9, 10-Secoer-gosta-5, 7,22-tri-en-3b-ol, which can be represented by the following molecular formula C28H46O with a molecular weight of 398.65. Its chemical structure is:

Dihydrotachysterol acts as a blood calcium regulator.

Inactive ingredients:

The tablets contain butylated hydroxyanisole, FD&C Red No. 3 (0.2 mg only), lactose, magnesium stearate, propyl gallate, starch, and sucrose.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Dihydrotachysterol is indicated for the treatment of acute, chronic, and latent forms of postoperative tetany, idiopathic tetany, and hypoparathyroidism.

DOSAGE AND ADMINISTRATION

The dosage depends on the nature and seriousness of the disorder and should be adapted to each individual patient. Serum calcium levels should be maintained between 9 to 10 mg per 100 mL.

The following dosage schedule will serve as a guide:

Initial dose: 0.8 mg to 2.4 mg daily for several days.

Maintenance dose: 0.2 mg to 1.0 mg daily as required for normal serum calcium levels. The average maintenance dose is 0.6 mg daily. This dose may be supplemented with 10 to 15 grams of calcium lactate or gluconate by mouth daily.

HOW SUPPLIED

DHTTM Dihydrotachysterol Tablets USP

0.125 mg white tablets

(Tablets identified 54 280).

NDC 0054-8172-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper.

NDC 0054-4190-19: Bottles of 50 Tablets

0.2 mg pink tablets (Identified 54 903).

NDC 0054-8182-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper.

NDC: 0054-4189-25: Bottles of 100 Tablets

0.4 mg white tablets (Tablets Identified 54 772).

NDC 0054-4191-19: Bottles of 50 Tablets

DHTTM Dihydrotachysterol IntensolTM

0.2 mg per mL

NDC 0054-3170-44: Bottles of 30 mL with calibrated dropper (graduated 0.25 mL to 1.0 mL).

Caution: Federal law prohibits dispensing without prescription.

 

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

No information provided.

Read the Dht (dihydrotachysterol) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Administration of thiazide diuretics to hypoparathyroid patients who are concurrently being treated with dihydrotachysterol may cause hypercalcemia.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

No information provided.

PRECAUTIONS

General

The difference between therapeutic dose and intoxicating dose may be small in any patient and therefore dosage must be individualized and periodically reevaluated.

In patients with renal osteodystrophy accompanied by hyperphosphatemia, maintenance of a normal serum phosphorus level by dietary phosphate restriction and/or administration of aluminum gels as intestinal phosphate binders is essential to prevent metastatic calcification.

Because of its effect on serum calcium, dihydrotachysterol should be administered to pregnant patients or to patients with renal stones only when, in the judgment of the physician, the potential banefits outweigh the possible hazards.

Laboratory Tests

To prevent hypercalcemia, treatment should always be controlled by regular determinations of blood calcium level, which should be maintained within the normal range.

Drug Interactions

Administration of thiazide diuretics to hypoparathyroid patients who are concurrently being treated with dihydrotachysterol may cause hypercalcemia.

Pregnancy

Teratogenic Effects -Pregnancy Category C: Animal reproduction studies have shown fetal abnormalities in several species associated with hypervitaminosis D. These are similar to the supravalvular aortic stenosis syndrome described in infants by Black in England (1963). This syndrome was characterized by supravalvular aortic stenosis, elfin facies, and mental retardation.

There are no adequate and well-controlled studies in pregnant women. Dihydrotachysterol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when dihydrotachysterol is a administered to a nursing woman.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

The effects of dihydrotachysterol can persist for up to one month after cessation of treatment.

Manifestations: Toxicity associated with dihydrotachysterol is similar to that seen with large doses of vitamin D. Overdosage is manifested by symptoms of hypercalcemia, i.e., weakness, headache, anorexia, nausea, vomiting, abdominal cramps, diarrhea, constipation, vertigo, tinnitus, ataxia, hypotonia, lethargy, depression, amnesia, disorientation, hallucinations, syncope, and coma. Impairment of renal function may result in polyuria, polydipsia, and albuminuria. Widespread calcification of soft tissues, including heart, blood vessels, kidneys, and lungs, can occur. Death can result from cardiovascular or renal failure.

Treatment: Treatment of overdosage consists of withdrawal of dihydrotachysterol, bed rest, liberal intake of fluids, a low-calcium diet, and administration of a laxative. Hypercalcemic crisis with dehydration, stupor, coma, and azotemia requires more vigorous treatment. The first step should be hydration of the patient. Intravenous saline may quickly and significantly increase urinary calcium excretion. A loop diurectic (furosemide or ethacrynic acid) may be given with the saline infusion to further increase renal calcium excretion. Other reported therapeutic measures include dialysis or the administration of citrates, sulfates, phosphates, corticosteroids, EDTA (ethylenediaminetetraacetic acids), and mithramycin via appropriate regimens.

CONTRAINDICATIONS

Contraindicated in patients with hypercalcemia, abnormal sensitivity to the effects of vitamin D, and hypervitaminosis D.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Dihydrotachysterol is hydroxylated in the liver to 25-hydroxydihydrotachysterol, which is the major circulating active form of the drug. It does not undergo further hydroxylation by the kidney and therefore is the analogue of 1, 25-dihydroxyvitamin D. Dihydrotachysterol is effective in the elevation of serum calcium by stimulating intestinal calcium absorption and mobilizing bone calcium in the absence of parathyroid hormone and of functioning renal tissue. Dihydrotachysterol also increases renal phosphate excretion. In contrast to parathyroid extract, dihydrotachysterol is active when taken orally, exerts a slow but persistent effect, and may be used for long periods without increasing the dosage or causing tolerance. Dihydrotachysterol is faster-acting than pharmacologic doses of vitamin D and is less persistent after cessation of treatment, thus decreasing the risk of accumulation and of hypercalcemia.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

See WARNINGS,PRECAUTIONS and CONTRAINDICATIONS.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

See WARNINGS,PRECAUTIONS and CONTRAINDICATIONS.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Dht Patient Information Including Side Effects

Brand Names: DHT, DHT Intensol, Hytakerol

Generic Name: dihydrotachysterol (Pronunciation: dy hy dro tak is TER ol)

What is dihydrotachysterol (Dht)?

Dihydrotachysterol is a form of vitamin D. Vitamin D is needed by the body to keep your bones and teeth healthy. It also helps your body absorb and use calcium more efficiently to help protect bones and teeth.

Dihydrotachysterol is used to treat hypocalcemia (lack of calcium in the blood) and hypoparathyroidism (lack of parathyroid hormone in the body).

Dihydrotachysterol may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of dihydrotachysterol (Dht)?

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.

Stop using dihydrotachysterol and call your doctor at once if you have any of these serious side effects:

  • bone pain, hard lumps under your skin;
  • eyes that are more sensitive to light;
  • eye redness or discharge;
  • weight loss;
  • metallic taste in your mouth;
  • urinating more than usual, especially at night;
  • nausea, vomiting;
  • severe stomach pain;
  • high fever; or
  • uneven heartbeats.

Continue using dihydrotachysterol and talk with your doctor if you have any of these less serious side effects:

  • dry skin;
  • changes in your bowel habits;
  • dry mouth; or
  • muscle pain.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Read the Dht (dihydrotachysterol) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about dihydrotachysterol (Dht)?

Before using this medication, tell your doctor if you are pregnant or breast-feeding.

Use this medication exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor.

Vitamin D is stored up in the body rather than passed in the urine like some other vitamins. Do not take more than the recommended dose, or your body could build up dangerously high levels of vitamin D, leading to vitamin D poisoning. Vitamin D is also taken in when you eat certain foods, which can add to the total amount in your body when you are taking dihydrotachysterol.

Symptoms of a dihydrotachysterol overdose may come on slowly. Early overdose symptoms may include bone pain, bowel problems, dry mouth, ongoing headache, increased thirst and urination, loss of appetite, muscle pain, and unusual weakness. Late signs of overdose include high fever, cloudy urine, mood changes, uneven heartbeats, nausea, vomiting, and severe stomach pain.

Dihydrotachysterol may be only part of a complete program of treatment that also includes a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must eat or avoid to help control your condition.

While you are taking dihydrotachysterol, avoid taking antacids that contain magnesium (such as Milk of Magnesia) or calcium (such as Rolaids Soft Chew, Maalox Quick Dissolve, Alka-Mints, Fast Acting Mylanta, and others).

Side Effects Centers

Dht Patient Information including How Should I Take

What should I discuss with my health care provider before taking dihydrotachysterol (Dht)?

Before using this medication, tell your doctor if you have:

  • heart disease;
  • circulation problems;
  • kidney disease; or
  • sarcoidosis.

If you have any of these conditions, you may not be able to use dihydrotachysterol , or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether dihydrotachysterol passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take dihydrotachysterol (Dht)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Vitamin D is stored up in the body rather than passed in the urine like some other vitamins. Do not take more than the recommended dose, or your body could build up dangerously high levels of vitamin D, leading to vitamin D poisoning. Vitamin D is also taken in when you eat certain foods, which can add to the total amount in your body when you are taking dihydrotachysterol.

Measure the liquid form of this medication with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Dihydrotachysterol may be only part of a complete program of treatment that also includes a special diet. It is very important to follow the diet plan created for you by your doctor or nutrition counselor. You should become very familiar with the list of foods you must eat or avoid to help control your condition.

To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Store this medication at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze.

Side Effects Centers

Dht Patient Information including If I Miss a Dose

What happens if I miss a dose (Dht)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Dht)?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a dihydrotachysterol overdose may come on slowly. Early overdose symptoms may include bone pain, bowel problems, dry mouth, ongoing headache, increased thirst and urination, loss of appetite, muscle pain, and unusual weakness. Late signs of overdose include high fever, cloudy urine, mood changes, uneven heartbeats, nausea, vomiting, and severe stomach pain.

What should I avoid while taking dihydrotachysterol (Dht)?

Avoid taking antacids that contain magnesium (such as Milk of Magnesia) or calcium (such as Rolaids Soft Chew, Maalox Quick Dissolve, Alka-Mints, Fast Acting Mylanta, and others).

What other drugs will affect dihydrotachysterol (Dht)?

Before taking dihydrotachysterol, tell your doctor if you are using any of the following drugs:

  • calcium or vitamin D supplements;
  • multivitamins that contain calcium or vitamin D; or
  • a diuretic (water pill) such as Aldactazide, Diuril, Maxzide, Moduretic, HCTZ, and others.

If you are using any of these drugs, you may not be able to use dihydrotachysterol, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect dihydrotachysterol. 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.

Where can I get more information?

Your pharmacist has more information about dihydrotachysterol written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse June 7, 2006drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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