DRUGS & SUPPLEMENTS

Intradec

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Intradec uses


INDICATIONS AND USAGE

Intradec decanoate is indicated for the management of the anemia of renal insufficiency and has been shown to increase hemoglobin and red cell mass. Surgically induced anephric patients have been reported to be less responsive.

CONTRAINDICATIONS


  • Male patients with carcinoma of the breast or with known or suspected carcinoma of the prostate.

  • Carcinoma of the breast in females with hypercalcemia: androgenic anabolic steroids may stimulate osteolytic resorption of bones.
  • Pregnancy, because of masculinization of the fetus.
  • Nephrosis or the nephrotic phase of nephritis.

WARNINGS

PELIOSIS HEPATIS, A CONDITION IN WHICH LIVER AND SOMETIMES SPLENIC TISSUE IS REPLACED WITH BLOOD-FILLED CYSTS, HAS BEEN REPORTED IN PATIENTS RECEIVING ANDROGENIC ANABOLIC STEROID THERAPY. THESE CYSTS ARE SOMETIMES PRESENT WITH MINIMAL HEPATIC DYSFUNCTION, BUT AT OTHER TIMES THEY HAVE BEEN ASSOCIATED WITH LIVER FAILURE. THEY ARE OFTEN NOT RECOGNIZED UNTIL LIFE-THREATENING LIVER FAILURE OR INTRA-ABDOMINAL HEMORRHAGE DEVELOPS. WITHDRAWAL OF DRUG USUALLY RESULTS IN COMPLETE DISAPPEARANCE OF LESIONS.
LIVER CELL TUMORS ARE ALSO REPORTED. MOST OFTEN THESE TUMORS ARE BENIGN AND ANDROGEN-DEPENDENT, BUT FATAL MALIGNANT TUMORS HAVE BEEN REPORTED. WITHDRAWAL OF DRUG OFTEN RESULTS IN REGRESSION OR CESSATION OF PROGRESSION OF THE TUMOR. HOWEVER, HEPATIC TUMORS ASSOCIATED WITH ANDROGENS OR ANABOLIC STEROIDS ARE MUCH MORE VASCULAR THAN OTHER HEPATIC TUMORS AND MAY BE SILENT UNTIL LIFE-THREATENING INTRA-ABDOMINAL HEMORRHAGE DEVELOPS.
BLOOD LIPID CHANGES THAT ARE KNOWN TO BE ASSOCIATED WITH INCREASED RISK OF ATHEROSCLEROSIS ARE SEEN IN PATIENTS TREATED WITH ANDROGENS AND ANABOLIC STEROIDS. THESE CHANGES INCLUDE DECREASED HIGH-DENSITY LIPOPROTEIN AND SOMETIMES INCREASED LOW-DENSITY LIPOPROTEIN. THE CHANGES MAY BE VERY MARKED AND COULD HAVE A SERIOUS IMPACT ON THE RISK OF ATHEROSCLEROSIS AND CORONARY ARTERY DISEASE.

Hypercalcemia may develop both spontaneously and as a result of androgen therapy in women with disseminated breast carcinoma. If it develops while on this agent, the drug should be discontinued. Caution is required in administering these agents to patients with cardiac, renal or hepatic disease. Cholestatic jaundice is associated with therapeutic use of anabolic and androgenic steroids. Edema may occur occasionally with or without congestive heart failure. Concomitant administration of adrenal steroids or ACTH may add to the edema.

In children, anabolic steroid treatment may accelerate bone maturation without producing compensatory gain in linear growth. This adverse effect may result in compromised adult stature. The younger the child the greater the risk of compromising final mature height. The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every six months. This drug has not been shown to be safe and effective for the enhancement of athletic performance. Because of the potential risk of serious adverse health effects, this drug should not be used for such purpose.

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PRECAUTIONS

General

Women should be observed for signs of virilization. Discontinuation of drug therapy at the time of evidence of mild virilism is necessary to prevent irreversible virilization. Such virilization is usual following anabolic steroid use in high doses.

The insulin or oral hypoglycemic dosage may need adjustment in diabetic patients who receive anabolic steroids.

Information for patients

The physician should instruct patients to report any of the following side effects of androgenic anabolic steroids:

Hoarseness, acne, changes in menstrual periods, more hair on the face, nausea, vomiting, changes in skin color, or ankle swelling.

Laboratory tests

Women with disseminated breast carcinoma should have frequent determination of urine and serum calcium levels during the course of anabolic therapy.

If children are treated, periodic (every six months) X-ray examinations of bone age should be made during treatment to determine the rate of bone maturation and the effects of anabolic therapy on the epiphyseal centers. Hemoglobin and hematocrit should be checked periodically for polycythemia in patients who are receiving high doses of anabolic steroids. Serum lipids and high-density lipoprotein cholesterol should be determined periodically. Because of the hepatotoxicity associated with the use of 17-alpha-alkylated anabolic steroids, liver function tests should be obtained periodically.

Drug interactions

Anticoagulants. Anabolic steroids may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may have to be decreased in order to maintain the prothrombin time at the desired therapeutic level. Patients receiving oral anticoagulant therapy require close monitoring, especially when anabolic steroids are started or stopped.

Drug/laboratory test interactions

Anabolic steroid therapy may decrease thyroxine-binding globulin resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged.

Anabolic steroids may cause an increase in prothrombin time.

Carcinogenesis, mutagenesis, impairment of fertility

Intradec decanoate has not been tested in laboratory animals for carcinogenic or mutagenic effects. Liver cell tumors have been reported in patients receiving androgenic anabolic steroid therapy. Geriatric patients treated with anabolics may be at an increased risk for prostatic hypertrophy and prostatic carcinoma.

Pregnancy

Pregnancy Category X.

See CONTRAINDICATIONS section.

Nursing mothers

It is not known whether anabolic steroids are excreted in human milk. Many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from anabolic steroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use

The safety and efficacy of Intradec decanoate in children with metastatic breast cancer (rarely found) has not been established. Anabolic agents may accelerate epiphyseal maturation more rapidly than linear growth in children, and the effect may continue for six months after the drug has been stopped. Therefore, therapy should be monitored by X-ray studies at six month intervals in order to avoid the risk of compromising the adult height.

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ADVERSE REACTIONS

Hepatic:

Hepatocellular neoplasms and peliosis hepatis have been reported in association with long-term androgenic anabolic steroid therapy.Genitourinary System:In men. a. Prepubertal: Phallic enlargement and increased frequency of erections. b. Postpubertal: Inhibition of testicular function, testicular atrophy and oligospermia, impotence, chronic priapism, epididymitis and bladder irritability. In women: Clitoral enlargement, menstrual irregularities. In both sexes: Increased or decreased libido.CNS:Habituation, excitation, insomnia, depression.Gastrointestinal:Nausea, vomiting, diarrhea.Hematologic:Bleeding in patients on concomitant anticoagulant therapy.Breast:Gynecomastia.Larynx:Deepening of the voice in women.Hair:Hirsutism and male pattern of baldness in women.Skin:Acne (especially in women and prepubertal boys.)Skeletal:Premature closure of epiphyses in children.Fluid and Electrolytes:Edema, retention of serum electrolytes (sodium, chloride, potassium, phosphate, calcium).Metabolic/Endocrine:Decreased glucose tolerance, increased serum levels of low-density lipoprotein and decreased levels of high-density lipoprotein, increased creatine and creatinine excretion, increased serum levels of creatinine phosphokinase (CPK). Some virilizing changes in women are irreversible even after prompt discontinuance of therapy and are not prevented by concomitant use of estrogens.

DRUG ABUSE AND DEPENDENCE

Intradec decanoate injection is classified as a Schedule III controlled substance under the Anabolic Steroids Control Act of 1990.

OVERDOSAGE

There have been no reports of acute overdosage with the anabolics.

DOSAGE AND ADMINISTRATION

Intradec decanoate injection is intended for deep intramuscular injection only, into the gluteal muscle preferably.

Dosage should be based on therapeutic response and consideration of the benefit to risk ratio. Duration of therapy will depend on the response of the condition and the appearance of adverse reactions. If possible, therapy should be intermittent. Nandrolone decanoate should be regarded as adjunctive therapy and adequate quantities of nutrients should be consumed in order to obtain maximal therapeutic effects. For example, when it is used in the treatment of refractory anemia, adequate iron intake is required for a maximal response.Anemia of Renal DiseaseA dose of 50 to 100 mg per week is recommended for women and 100 to 200 mg per week for men. Drug therapy should be discontinued if no hematologic improvement is seen within the first six months. For children from 2 to 13 years of age, the average dose is 25 to 50 mg every 3 to 4 weeks. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

HOW SUPPLIED

Intradec Decanoate Injection USP, 100 mg per mL is available in multiple dose vials of 2 mL, in cartons of 10.

Intradec Decanoate Injection USP, 200 mg per mL is available in single dose vials of 1 mL, in cartons of 25.Store at 20°-25°C (68°-77°F).

PROTECT FROM LIGHT. Store in carton until contents are used.

Literature revised: March 2006Product Nos.: 0432-02, 0710-01Watson Laboratories, Inc.Corona, CA 92880 USA

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Intradec pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Intradec available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Intradec destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Intradec Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Intradec pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. "nandrolone". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).
  2. "Nandrolone". http://www.drugbank.ca/drugs/DB1316... (accessed August 28, 2018).
  3. "6PG9VR430D: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Dat... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Intradec?

Depending on the reaction of the Intradec after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Intradec not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Intradec addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sDrugs.com conducted a study on Intradec, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Intradec consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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