AUMENTO is a high dosage form of Nandrolone Decanoate designed especially for adjuvant therapy in the treatment of certain blood disorders. Nandrolone the pharmacologically active substance of the preparation is chemically related to the male hormone. Compared to testosterone, it has an enhanced anabolic and reduced androgenic activity

AUMENTO stimulates erythropoiesis as demonstrated by rises in the red blood cell mass, and in the hemoglobin and hematocrit values. This effect is utilized therapeutically in the treatment of anemia due to a decreased production of erythropoietin, bone marrow depression induced by chemotherapy, or hypoplasia of the stem cells in the bone marrow. In the latter condition (e.g. aplastic anemia) the erythropoietic response is frequently accompanied by a positive on leucopoiesis and thrombopoises. Androgenic effects (e.g. virilisation) are relatively uncommon at the recommended dosages. Nandrolone lacks the C17 alpha-alkyl group which is associated with the occurrence of liver dysfunction and cholestatsis.

Composition

Each ml of AUMENTO contains 100mg Nandrolone Decanoate I.P. in an oily base

Each ml of AUMENTO-50 contains 50mg Nandrolone Decanoate I.P. in an oily base

Indications

  • Anemia of chronic renal failure
  • Aplastic Anemia
  • Anemia due to cytotoxic therapy

Contra-indications

  • Pregnancy
  • Known or suspected carcinoma of the prostate or breast in the male

Use during pregnancy and breast-feeding

This medicine is contraindicated during pregnancy because of possible masculinization of the fetus. There are insufficient data on the use of the medicine during breastfeeding to assess potential harm to the infant or a possible influence on milk production.

Warnings and Precautions

The recommended dosage should not be exceeded

If signs of virilisation develop, discontinuation of the treatment should be considered, preferably in consultation with the patient.

It is recommended to monitor patients with any of the following conditions:

  • Latent or overt cardiac failure, renal dysfunction, hypertension or migraine (or a history of these conditions), since anabolic steroids may occasionally induce fluid retention:
  • Incomplete stature growth, since anabolic steroids in high dosages may accelerate epiphyseal closure:
  • Skeletal metastestes of breast carcinoma. In these patients hypercalcaemia may develop both spontaneously and as a result of anabolic steroid therapy. The latter can be indicative of a positive tumor response to the hormonal treatment. Nevertheless, the hypercalcaemia should first be treated properly and after restoration of normal calcium levels, hormone therapy can be resumed.
  • Liver dysfunction
  • The use of anabolic steroids to enhance athletic ability may carry severe risks to the user's health and should be discouraged.

Adverse Effects

The high dosages, which are required to obtain a therapeutic effect in the indications may cause

  • Virilisation which appears in sensitive women as hoarseness, acne, hirsutism and increase of libido; in prepubertal boys as an increase in the frequency of erections and phallic enlargement, and in girls as an increase of pubic hair and clitoral hypertrophy. Hoarseness may be the first symptom of vocal change which may end in a long-lasting, sometimes irreversible deepening of the voice.
  • Amenorrhea
  • Inhibition of spermatogenesis
  • Premature epiphyseal closure
  • Fluid retention
  • Occasional, abnormal values in some liver function tests. These changes appear to be reversible after completion of treatment of the course.

Drug Interactions

Anabolic Steroids may improve glucose tolerance and decrease the need for insulin or other antidiabetic medicines in diabetes.

Although only one possible case of interaction with an oral anticoagulant has been observed, it is advisable to check the prothrombin time regularly when AUMENTO is used in patients on anticoagulant therapy.

Dosage and Administration

  • Anemia of chronic renal failure - Males: 200mg every week, Females:100mg every week
  • Aplastic Anemia - 50-150mg every week
  • Anemia due to cytotoxic therapy - 200mg every week, starting 2 weeks prior to the course of cytotoxic therapy. This treatment should be continued throughout cytotoxic therapy and thereafter during the recovery period until the blood count has returned to normal.

AUMENTO should be administered by deep intramuscular injection.

N.B

  • Treatment with AUMENTO does not substitute for other therapeutic measures
  • The onset of a therapeutic effect may vary widely among patients. If no satisfactory response occurs after 3-6 months of treatment administration should be discontinued.
  • After a satisfactory improvement or a normalisation of the red blood picture has been obtained, treatment should be withdrawn gradually on the basis of regular monitoring of the hematological parameters. Should a relapse occur at any time whilst the dose is being reduced, or after stopping the treatment, re-institution of therapy should be considered.
  • A dosage scheme for children cannot be given because of insufficient clinical experience

Overdosage

The acute toxicity of Nandrolone Decanoate in animals is very low. There are no reports of acute overdosage with AUMENTO in the human.

Storage

Keep in a dry place away from light.

Presentation

AUMENTO is available 1 ml ampule along with sterile disposable syringe packed in a blister as dispo pack

AUMENTO-50 is available 1 ml ampule along with sterile disposable syringe packed in a blister as dispo pack