Androgel Instructions

ANDROGEL® INSTRUCTIONS FOR USE

REGISTRATION NUMBER

LS-000869-151012

TRADE NAME

Androgel®

INTERNATIONAL NON-PROPRIETARY NAME

Testosterone

DOSAGE FORM

Gel for external use

COMPOSITION

Per 1 g of gel:

• Active ingredient: Testosterone – 10 mg
• Excipients: Isopropyl myristate – 5 mg, Carbomer 980 – 9 mg, Sodium hydroxide – 47.2 mg, Ethanol 96% – 0.714 g, Purified water – up to 1 g

Per 2.5 g sachet:

• Active ingredient: Testosterone – 25 mg
• Excipients: Isopropyl myristate – 12.5 mg, Carbomer 980 – 22.5 mg, Sodium hydroxide – 118 mg, Ethanol 96% – 1.785 g, Purified water – up to 2.5 g

Per 5 g sachet:

• Active ingredient: Testosterone – 50 mg
• Excipients: Isopropyl myristate – 25 mg, Carbomer 980 – 45 mg, Sodium hydroxide – 236 mg, Ethanol 96% – 3.570 g, Purified water – up to 5 g

Per 1.25 g dose from pump bottle:

• Active ingredient: Testosterone – 12.5 mg
• Excipients: Isopropyl myristate – 6.25 mg, Carbomer 980 – 11.25 mg, Sodium hydroxide – 59 mg, Ethanol 96% – 0.892 g, Purified water – up to 1.25 g

DESCRIPTION

Transparent or slightly opalescent, colorless gel with an alcohol-like odor.

PHARMACOLOGICAL GROUP

Androgen

ATC CODE

G03BA03

PHARMACOLOGICAL PROPERTIES

PHARMACODYNAMICS

Endogenous androgens, mainly testosterone secreted by the testes, and its primary metabolite dihydrotestosterone are responsible for the development of male external and internal genitalia, secondary sexual characteristics (e.g., hair growth, voice deepening), libido, protein anabolism, skeletal muscle development, fat distribution, and decreased urinary excretion of nitrogen, sodium, potassium, chloride, phosphates, and water. Testosterone does not promote testicular growth and reduces gonadotropin secretion by the pituitary.

Some effects of testosterone in target organs occur after peripheral conversion to estradiol, which binds to estrogen receptors in tissues such as the pituitary, adipose tissue, brain, and bones.

PHARMACOKINETICS

Approximately 9–14% of the applied dose of testosterone is absorbed through the skin. After absorption, it enters systemic circulation at relatively constant concentrations over 24 hours.

Serum testosterone concentration increases within the first hour of application and stabilizes by the second day of treatment. Testosterone concentration fluctuations mimic circadian rhythms of endogenous testosterone.

Topical administration avoids the supraphysiological peaks seen with injectable testosterone. Unlike oral androgen therapy, topical application does not raise liver steroid concentrations above physiological levels.

Applying 5 g of Androgel® results in an average serum testosterone increase of approximately 2.5 ng/mL (8.7 nmol/L). Serum testosterone levels return to baseline within 72–96 hours after the last application.

The main active metabolites are dihydrotestosterone and estradiol. Testosterone is excreted primarily via urine and feces as conjugated metabolites.

INDICATIONS

Replacement therapy for testosterone deficiency in adult men.

CONTRAINDICATIONS

• Known or suspected breast or prostate cancer.
• Hypersensitivity to testosterone or any excipients in the product.
• Use in women or children.

USE WITH CAUTION

• Malignant tumors (due to risk of hypercalcemia or hypercalciuria).
• Severe heart, liver, or kidney failure.
• Ischemic heart disease, hypertension, epilepsy, or migraines.

DOSAGE AND ADMINISTRATION

Recommended dose:
5 g of gel (50 mg testosterone) applied once daily, preferably at the same time, preferably in the morning. Individual doses may be adjusted by the physician based on clinical and laboratory findings but should not exceed 10 g per day. Dosage adjustments should be made in increments of 2.5 g/day.

APPLICATION INSTRUCTIONS

• Apply to clean, dry, intact skin on the shoulders, upper arms, and/or abdomen.
• Avoid applying to genital areas due to high alcohol content, which may cause irritation.
• Let the gel dry for 3–5 minutes before dressing.
• Wash hands with soap after application.

For pump bottles, press the pump 5 times to prime before first use (discard the first dose). Each subsequent full press dispenses 1.25 g of gel containing 12.5 mg of testosterone.

DOSAGE GUIDELINES

SIDE EFFECTS

Common (>1/10):

• Skin reactions at application site, acne, dry skin.

Less Common (>1/100, <1/10):

• Prostate changes, gynecomastia, mastalgia.
• Dizziness, paresthesia, mood changes.
• Hypertension, headache, diarrhea, alopecia.

OVERDOSE

No cases of overdose have been reported. Symptoms of excessive testosterone may include irritability, weight gain, or frequent erections and require dosage adjustment.

STORAGE CONDITIONS

Store at temperatures not exceeding 25°C. Keep out of reach of children.

SHELF LIFE

3 years. Do not use beyond the expiration date.

DISPENSING CONDITIONS

Prescription only.

MANUFACTURER

Bezen Healthcare SA, 287 Avenue Louise, 1050 Brussels, Belgium

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