Testone CIK (Page 2 of 3)

Drug/Laboratory test interferences:

Androgens may decrease levels of thyroxine-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4 . Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

Carcinogenesis:

Animal data.

Testosterone has been tested by subcutaneous injection and implantation in mice and rats. The implant induced cervical-uterine tumors in mice, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically-induced carcinomas of the liver in rats.

Human data.

There are rare reports of hepatocellular carcinoma in patients receiving long-term therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumors in all cases.

Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking.

Pregnancy:

Teratogenic Effects.

Pregnancy Category X. (See CONTRAINDICATIONS.)

Nursing mothers:

Testosterone cypionate is not recommended for use in nursing mothers.

Pediatric use:

Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

ADVERSE REACTIONS

The following adverse reactions in the male have occurred with some androgens:

Endocrine and urogenital: Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages.

Skin and appendages: Hirsutism, male pattern of baldness, seborrhea, and acne.

Fluid and electrolyte disturbances: Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.

Gastrointestinal: Nausea, cholestatic jaundice, alterations in liver function tests, rarely hepatocellular neoplasms and peliosis hepatis (see WARNINGS).

Hematologic: Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia.

Nervous system: Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.

Allergic: Hypersensitivity, including skin manifestations and anaphylactoid reactions.

Vascular Disorders — venous thromboembolism

Miscellaneous: Inflammation and pain at the site of intramuscular injection.

To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG ABUSE AND DEPENDENCE

Controlled Substance Class:

Testosterone is a controlled substance under the Anabolic Steroids Control Act, and Testosterone Cypionate Injection has been assigned to Schedule III.

OVERDOSAGE

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

DOSAGE AND ADMINISTRATION

Testosterone cypionate injection is for intramuscular use only.

It should not be given intravenously. Intramuscular injections should be given deep in the gluteal muscle.

The suggested dosage for testosterone cypionate injection varies depending on the age, sex, and diagnosis of the individual patient. Dosage is adjusted according to the patient’s response and the appearance of adverse reactions.

Various dosage regimens have been used to induce pubertal changes in hypogonadal males; some experts have advocated lower dosages initially, gradually increasing the dose as puberty progresses, with or without a decrease to maintenance levels. Other experts emphasize that higher dosages are needed to induce pubertal changes and lower dosages can be used for maintenance after puberty. The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose.

For replacement in the hypogonadal male, 50 to 400 mg should be administered every two to four weeks.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Warming and shaking the vial should redissolve any crystals that may have formed during storage at temperatures lower than recommended.

HOW SUPPLIED

Testosterone Cypionate Injection, USP, 200 mg/mL is available as follows:

1 mL vials NDC 0574-0820-01
10 mL vials NDC 0574-0820-10

Vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Use carton to protect contents from light until used.

Manufactured By
PharmaForce, Inc.
Hilliard, OH 43026

Manufactured For
Perrigo®
Minneapolis, MN 55427

9Z800 RC J2

Rev 06-14 B

Sterile Alcohol Prep Pad

Active Ingredient Purpose

Isopropyl Alcohol 70% v/v Antiseptic

Use:

For preparation of the skin prior to injection.

Warnings:

  • For external use only
  • Flammable, keep away from flame or fire
  • Not for use with electrocautinary devices or procedures
  • Do not use in eyes

Stop use and ask a doctor if:

  • Irritation or redness develops
  • condition persists for more than 72 hours
  • Cleansing of an injection site

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Directions:

Wipe injection site vigorously and discard

Other information:

  • Store at room temperature: 15 deg C to 30 deg C 59 deg F to 86 deg F
  • avoid excessive heat

Inactive Ingredient

Inactive Ingredient

  • Water

Principal Display Panel — Carton Label

NDC 0574-0820 -01

Testosterone Cypionate Injection, USP CIII

200 mg/mL

For Intramuscular Use Only

One 1 mL Sterile Vial

Perrigo ®

Principal Display Panel -- Carton Label
(click image for full-size original)

Principal Display Panel — Case Label

1 Pad Medium

NDC# 67777-120-13

Sterile Alcohol Prep Pad

For External Use Only

Sterile unless pouch is opened or damaged

Saturated with 70% Isopropyl Alcohol

Latex Free

Made in China Reorder No. 1113

Principal Display Panel -- Case Label
(click image for full-size original)

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