Azmiro (testosterone cypionate)

Dosage of testosterone is variable and should be individualized according to the condition being treated; the severity of symptoms; the patient's age, gender, and history of prior androgenic therapy; and the specific testosterone preparation being used.

Various dosage regimens have been used to induce pubertal changes in hypogonadal males. Some clinicians recommend that lower dosages be used initially, followed by gradual increases in dosage as puberty progresses; subsequently, the dosage may be decreased to maintenance levels. Other clinicians state that higher dosages are required initially to induce pubertal changes and lower dosages can then be used for maintenance therapy after puberty. The chronologic and skeletal ages of the patient must be considered when determining the initial dosage and subsequent dosage adjustment.

Diagnosis of hypogonadism must be confirmed by laboratory testing prior to initiation of testosterone therapy. To confirm this diagnosis, serum testosterone concentrations should be measured in the morning on at least 2 separate days and must be consistently below the normal range. Serum testosterone concentrations may be low later in the day in men with or without hypogonadism; therefore, measuring testosterone concentrations later in the day should be avoided.

The manufacturers of testosterone enanthate injection, testosterone undecanoate injection, and testosterone transdermal system, topical gel, topical solution, nasal gel, and buccal tablets state that clinical studies involving patients with renal or hepatic impairment have not been conducted. Therefore, there are no special population dosage recommendations at this time.

Testosterone is administered by IM injection; percutaneously by topical application of a transdermal system, solution, or gel to the skin; intranasally; subcutaneously as a biodegradable implant; and intrabuccally (transmucosally) as a buccal tablet.

No dosing information is available for this tab.

Testosterone may potentiate the action of oral anticoagulants, causing bleeding in some patients. When testosterone therapy is initiated in patients receiving oral anticoagulants, dosage reduction of the anticoagulant may be required to prevent an excessive hypoprothrombinemic response. In patients receiving concomitant therapy with testosterone and anticoagulants, more frequent monitoring of INR and prothrombin time is recommended, especially during initiation or discontinuance of therapy.

Increased serum oxyphenbutazone concentrations have reportedly occurred in patients receiving androgens concurrently with oxyphenbutazone.

Changes in insulin sensitivity or glycemic control may occur in patients receiving androgen therapy. The metabolic effects of androgens may decrease blood glucose concentrations and insulin requirements in patients with diabetes.

Concomitant administration of testosterone with ACTH or corticosteroids may result in increased fluid retention and edema formation. Therefore, testosterone should be administered with caution in patients with cardiac, renal, and/or hepatic disease. Patients should be monitored for fluid retention and edema formation.

Administration of IM testosterone cypionate resulted in increased clearance of propranolol in one study. It is not known whether there is a potential for this interaction with topically administered testosterone gel.

Topical administration of 0.1% triamcinolone cream prior to application of a testosterone transdermal system did not alter absorption of testosterone; however, pretreatment with topical administration of triamcinolone ointment substantially reduced absorption of testosterone.

Administration of intranasal oxymetazoline, a sympathomimetic nasal decongestant, prior to administration of testosterone nasal gel (Natesto(R)) did not alter absorption of testosterone. Concomitant administration of testosterone nasal gel with other drugs administered intranasally has not been studied. The manufacturer does not recommend concomitant use with such drugs.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Selected Steroids/Sodium Fusidate

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Sodium fusidate and steroids may inhibit the biotransformation of each other by CYP P-450-3A4.(1)

CLINICAL EFFECTS: Concurrent use may result in toxicity from sodium fusidate and steroids.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The Australian manufacturer of sodium fusidate states that concurrent use of sodium fusidate and CYP P-450-3A4 biotransformed drugs such as steroids should be avoided.(1)

DISCUSSION: Although the specifics of sodium fusidate metabolic pathways are not known, an interaction between sodium fusidate and drugs that are biotransformed by CYP P-450-3A4 is suspected.(1)

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

• Lactation
• Malignant tumor of male breast
• Pregnancy
• Prostatic carcinoma

• Acute myocardial infarction
• Acutely decompensated chronic heart failure
• Benign prostatic hyperplasia
• Cerebrovascular accident
• Erythrocytosis
• Hyperlipidemia
• Neoplasm of liver
• Polycythemia vera
• Pulmonary thromboembolism
• Venous thrombosis

• Chronic heart failure
• Chronic obstructive pulmonary disease
• Diabetes mellitus
• Disease of liver
• Edema
• Gynecomastia
• Humoral hypercalcemia of malignancy
• Hypertension
• Kidney disease with reduction in glomerular filtration rate (GFr)
• Obesity
• Sleep apnea

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More Frequent

• Amenorrhea
• Bladder irritability
• Irregular menstrual periods
• Priapism
• Urinary tract infection
• Virilism

Less Frequent

• Benign prostatic hyperplasia
• Dizziness
• Edema
• Epididymitis
• Fatigue
• Flushing
• Hypercalcemia
• Hypertension
• Nausea
• Prostatic carcinoma
• Raised prostate specific antigen
• Sleep apnea
• Vomiting

Rare or Very Rare

• Acute myocardial infarction
• Acute respiratory distress syndrome
• Cerebrovascular accident
• Cholestatic hepatitis
• Deep venous thrombosis
• Drug-induced hepatitis
• Erythrocytosis
• Heart failure
• Hepatic necrosis
• Hypersensitivity drug reaction
• Increased hemoglobin
• Jaundice
• Leukopenia
• Malignant neoplasm of liver
• Peliosis hepatis
• Pulmonary thromboembolism
• Suicidal ideation
• Venous thrombosis

More Frequent

• Gynecomastia
• Mastalgia

Less Frequent

• Abdominal pain with cramps
• Acne vulgaris
• Diarrhea
• Erectile dysfunction
• Headache disorder
• Increased pubic hair
• Injection site infection
• Injection site sequelae
• Insomnia
• Libido changes
• Testicular atrophy

Rare or Very Rare

• Aggressive behavior
• Anorexia
• Depression
• Hostility
• Hypercholesterolemia
• Irritability
• Oligospermia

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No enhanced messaging available.

Testosterone may cause fetal harm when administered to pregnant women due to the potential for virilization of a female fetus. Androgenic effects including clitoral hypertrophy, labial fusion of the external genital fold to form a scrotal-like structure, abnormal vaginal development, and persistence of a urogenital sinus have occurred in the female offspring of women who were given androgens during pregnancy. The degree of masculinization is related to the amount of drug given to the woman and the age of the fetus; masculinization is most likely to occur in a female fetus when exposure to androgens occurs during the first trimester. Since the risks clearly outweigh the possible benefits in women who are or may become pregnant, testosterone is contraindicated in such women. Women who become pregnant while receiving the drug should be informed of the potential hazard to the fetus.

Pregnant women or those who may become pregnant should be aware of the possibility that testosterone could be transferred from patients treated with topical preparations of the drug such as their sexual partners or other individuals in close physical contact. (See Cautions: Precautions and Contraindications.) Testosterone transdermal system (Androderm(R)) has an occlusive backing that prevents the partner from coming in contact with active ingredient in the system. Transdermal systems that inadvertently are transferred to a sexual partner should be removed immediately and the contacted skin washed. Pregnant women should avoid skin contact with testosterone topical gel application sites in men. (See Cautions: Precautions and Contraindications.) If unwashed or unclothed skin to which testosterone topical gel has been applied comes in direct contact with the skin of a pregnant woman, the general area of contact by the woman should be washed with soap and water immediately. In vitro studies show that residual testosterone is removed by such washing.

It is not known whether testosterone is distributed into milk. The manufacturers of testosterone enanthate injection (Delatestryl(R)) and testosterone pellets (Testopel(R)) state that because of the potential for serious adverse reactions to androgens in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman. The manufacturer of testosterone cypionate injection (Depo(R)-testosterone) states that use in nursing women is not recommended. Testosterone topical gel, topical solution, nasal gel, transdermal system, and buccal tablets and testosterone undecanoate injection (Aveed(R)) are not indicated for use in women. Testosterone topical gel, topical solution, nasal gel, and buccal tablets and testosterone undecanoate injection also are contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants. Exposure of a female nursing infant to androgens may result in varying degrees of virilization. Testosterone and other androgens also may adversely affect lactation.

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