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Androderm
Overview
What is Androderm?
ANDRODERM (testosterone transdermal system) is designed to deliver testosterone continuously for 24 hours following application to intact, non-scrotal skin (e.g., back, abdomen, thighs, upper arms).
Two strengths of ANDRODERM are available that deliverapproximately 2 mg or 4 mg of testosterone per day.
ANDRODERM has a central drug delivery reservoir surrounded by a peripheral adhesive area. The ANDRODERM 2 mg/day system has a total contact surface area of 32 cm with a 6.0 cm central drug delivery reservoir containing 9.7 mg testosterone USP, dissolved in an alcohol-based gel. The ANDRODERM 4 mg/day system has a total contact surface area of 39 cmwith a 12.0 cm central drug delivery reservoir containing 19.5 mg testosterone USP, dissolved in an alcohol-based gel. Testosterone USP is a white, or creamy white crystalline powder or crystals chemically described as 17ß-hydroxyandrost-4-en-3-one.
The ANDRODERM systems have six components as shown in Figure 1. Proceeding from the top toward the surface attached to the skin, the system is composed of (1) metallized polyester/Surlyn (ethylene-methacrylic acid copolymer)/ethylene vinyl acetate backing film with alcohol resistant ink, (2) a drug reservoir of testosterone USP, alcohol USP, glycerin USP, glycerol monooleate, methyl laurate, sodium hydroxide NF, to adjust pH, and purified water USP, gelled with carbomer copolymer Type B NF, (3) a permeable polyethylene microporous membrane, and (4) a peripheral layer of acrylic adhesive surrounding the central, active drug delivery area of the system. Prior to opening of the system and application to the skin, the central delivery surface of the system is sealed with a peelable laminate disc (5) composed of a five-layer laminate containing polyester/polyesterurethane adhesive/aluminum foil/polyester-urethane adhesive/polyethylene. The disc is attached to and removed with the release liner (6), a silicone-coated polyester film, which is removed before the system can be used.
The active ingredient in the system is testosterone. The remaining components of the system are pharmacologically inactive.
What does Androderm look like?
What are the available doses of Androderm?
Transdermal system: 2 mg/day and 4 mg/day. ()
What should I talk to my health care provider before I take Androderm?
There are insufficient long-term safety data in geriatric patients using ANDRODERM to assess the potential risks of cardiovascular disease and prostate cancer. ()
How should I use Androderm?
ANDRODERM is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
Limitations of use
What interacts with Androderm?
Sorry No Records found
What are the warnings of Androderm?
Sorry No Records found
What are the precautions of Androderm?
Sorry No Records found
What are the side effects of Androderm?
Sorry No records found
What should I look out for while using Androderm?
Men with carcinoma of the breast or known or suspected carcinoma of the prostate. (, )
Pregnant or breastfeeding women. Testosterone may cause fetal harm. (, , )
What might happen if I take too much Androderm?
No cases of overdose with ANDRODERM have been reported in clinical trials. There is one report of acute overdosage by injection of testosterone enanthate: testosterone concentrations of up to 11,400 ng/dL were implicated in a cerebrovascular accident. Treatment of overdosage would consist of discontinuation of ANDRODERM together with appropriate symptomatic and supportive care.
How should I store and handle Androderm?
Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. Protect from light and moisture.ANDRODERM (testosterone transdermal system) 2 mg/day.Each system contains 9.7 mg testosterone USP for delivery of 2 mg of testosterone per day [ ].Cartons of 60 systems NDC 0023-5990-60 ANDRODERM (testosterone transdermal system) 4 mg/day.Each system contains 19.5 mg testosterone USP for delivery of 4 mg of testosterone per day [ ].Cartons of 30 systems NDC 0023-5992-30Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Apply to skin immediately upon removal from the protective pouch. Do not store outside the pouch provided. Damaged systems should not be used. The drug reservoir may be burst by excessive pressure or heat. Discard systems in household trash in a manner that prevents accidental application or ingestion by children, pets or others.ANDRODERM (testosterone transdermal system) 2 mg/day.Each system contains 9.7 mg testosterone USP for delivery of 2 mg of testosterone per day [ ].Cartons of 60 systems NDC 0023-5990-60 ANDRODERM (testosterone transdermal system) 4 mg/day.Each system contains 19.5 mg testosterone USP for delivery of 4 mg of testosterone per day [ ].Cartons of 30 systems NDC 0023-5992-30Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Apply to skin immediately upon removal from the protective pouch. Do not store outside the pouch provided. Damaged systems should not be used. The drug reservoir may be burst by excessive pressure or heat. Discard systems in household trash in a manner that prevents accidental application or ingestion by children, pets or others.ANDRODERM (testosterone transdermal system) 2 mg/day.Each system contains 9.7 mg testosterone USP for delivery of 2 mg of testosterone per day [ ].Cartons of 60 systems NDC 0023-5990-60 ANDRODERM (testosterone transdermal system) 4 mg/day.Each system contains 19.5 mg testosterone USP for delivery of 4 mg of testosterone per day [ ].Cartons of 30 systems NDC 0023-5992-30Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Apply to skin immediately upon removal from the protective pouch. Do not store outside the pouch provided. Damaged systems should not be used. The drug reservoir may be burst by excessive pressure or heat. Discard systems in household trash in a manner that prevents accidental application or ingestion by children, pets or others.ANDRODERM (testosterone transdermal system) 2 mg/day.Each system contains 9.7 mg testosterone USP for delivery of 2 mg of testosterone per day [ ].Cartons of 60 systems NDC 0023-5990-60 ANDRODERM (testosterone transdermal system) 4 mg/day.Each system contains 19.5 mg testosterone USP for delivery of 4 mg of testosterone per day [ ].Cartons of 30 systems NDC 0023-5992-30Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Apply to skin immediately upon removal from the protective pouch. Do not store outside the pouch provided. Damaged systems should not be used. The drug reservoir may be burst by excessive pressure or heat. Discard systems in household trash in a manner that prevents accidental application or ingestion by children, pets or others.ANDRODERM (testosterone transdermal system) 2 mg/day.Each system contains 9.7 mg testosterone USP for delivery of 2 mg of testosterone per day [ ].Cartons of 60 systems NDC 0023-5990-60 ANDRODERM (testosterone transdermal system) 4 mg/day.Each system contains 19.5 mg testosterone USP for delivery of 4 mg of testosterone per day [ ].Cartons of 30 systems NDC 0023-5992-30Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Apply to skin immediately upon removal from the protective pouch. Do not store outside the pouch provided. Damaged systems should not be used. The drug reservoir may be burst by excessive pressure or heat. Discard systems in household trash in a manner that prevents accidental application or ingestion by children, pets or others.ANDRODERM (testosterone transdermal system) 2 mg/day.Each system contains 9.7 mg testosterone USP for delivery of 2 mg of testosterone per day [ ].Cartons of 60 systems NDC 0023-5990-60 ANDRODERM (testosterone transdermal system) 4 mg/day.Each system contains 19.5 mg testosterone USP for delivery of 4 mg of testosterone per day [ ].Cartons of 30 systems NDC 0023-5992-30Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Apply to skin immediately upon removal from the protective pouch. Do not store outside the pouch provided. Damaged systems should not be used. The drug reservoir may be burst by excessive pressure or heat. Discard systems in household trash in a manner that prevents accidental application or ingestion by children, pets or others.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement; vocal cord thickening; and alterations in body musculature and fat distribution. Testosterone and DHT are necessary for the normal development of secondary sex characteristics.
Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).
Non-Clinical Toxicology
Men with carcinoma of the breast or known or suspected carcinoma of the prostate. (, )Pregnant or breastfeeding women. Testosterone may cause fetal harm. (, , )
Inhibitors of CYP3A4 and CYP2D6
The concomitant use of Oxycodone and Acetaminophen Tablets and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), and protease inhibitors (e.g., ritonavir), can increase the plasma concentration of oxycodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of Oxycodone and Acetaminophen Tablets and CYP3A4 and CYP2D6 inhibitors, particularly when an inhibitor is added after a stable dose of Oxycodone and Acetaminophen Tablets is achieved [see ].
After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the oxycodone plasma concentration will decrease [see ], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to Oxycodone and Acetaminophen Tablets.
If concomitant use is necessary, consider dosage reduction of Oxycodone and Acetaminophen Tablets until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, consider increasing the Oxycodone and Acetaminophen Tablets dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.
Inducers of CYP3A4
The concomitant use of Oxycodone and Acetaminophen Tablets and CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin, can decrease the plasma concentration of oxycodone [see ], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to Oxycodone and Acetaminophen Tablets [see ].
After stopping a CYP3A4 inducer, as the effects of the inducer decline, the oxycodone plasma concentration will increase [see ], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.
If concomitant use is necessary, consider increasing the Oxycodone and Acetaminophen Tablets dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider Oxycodone and Acetaminophen Tablets dosage reduction and monitor for signs of respiratory depression.
Benzodiazepines and other CNS Depressants
Due to additive pharmacologic effect, the concomitant use of benzodiazepines and other CNS depressants such as benzodiazepines and other sedative hypnotics, anxiolytics, and tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation [see ].
Serotonergic Drugs
The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tryptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), and monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue), has resulted in serotonin syndrome [see ].
If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue Oxycodone and Acetaminophen Tablets if serotonin syndrome is suspected.
Monoamine Oxidase Inhibitors (MAOIs)
The concomitant use of opioids and MAOIs, such as phenelzine, tranylcypromine, linezolid, may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma) [see ].
The use of Oxycodone and Acetaminophen Tablets is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.
If urgent use of an opioid is necessary, use test doses and frequent titration of small doses to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression.
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
The concomitant use of opioids with other opioid analgesics, such as butorphanol, nalbuphine, pentazocine, may reduce the analgesic effect of Oxycodone and Acetaminophen Tablets and/or precipitate withdrawal symptoms.
Advise patient to avoid concomitant use of these drugs.
Muscle Relaxants
Oxycodone and Acetaminophen Tablets may enhance the neuromuscular-blocking action of skeletal muscle relaxants and produce an increase in the degree of respiratory depression.
If concomitant use is warranted, monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of Oxycodone and Acetaminophen Tablets and/or the muscle relaxant as necessary.
Diuretics
Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
If concomitant use is warranted, monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.
Anticholinergic Drugs
The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
If concomitant use is warranted, monitor patients for signs of urinary retention or reduced gastric motility when Oxycodone and Acetaminophen Tablets are used concomitantly with anticholinergic drugs.
Alcohol, ethyl
Hepatotoxicity has occurred in chronic alcoholics following various dose levels (moderate to excessive) of acetaminophen.
Oral Contraceptives
Increase in glucuronidation resulting in increased plasma clearance and a decreased half-life of acetaminophen.
Charcoal (activated)
Reduces acetaminophen absorption when administered as soon as possible after overdose.
Beta Blockers (Propranolol)
Propranolol appears to inhibit the enzyme systems responsible for the glucuronidation and oxidation of acetaminophen. Therefore, the pharmacologic effects of acetaminophen may be increased.
Loop Diuretics
The effects of the loop diuretic may be decreased because acetaminophen may decrease renal prostaglandin excretion and decrease plasma renin activity.
Lamotrigine
Serum lamotrigine concentrations may be reduced, producing a decrease in therapeutic effects.
Probenecid
Probenecid may increase the therapeutic effectiveness of acetaminophen slightly.
Zidovudine
The pharmacologic effects of zidovudine may be decreased because of enhanced non-hepatic or renal clearance of zidovudine
Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH. ()
Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone products. Evaluate patients with signs or symptoms consistent with DVT or PE. ()
Some postmarketing studies have shown an increased risk of myocardial infarction and stroke associated with the use of testosterone replacement therapy. ()
Avoid exposure of women or children to ANDRODERM. ()
Exogenous administration of testosterone may lead to azoospermia. ()
Edema with or without congestive heart failure, may be a complication in patients with pre-existing cardiac, renal, or hepatic disease. ()
Sleep apnea may occur in those with risk factors. ()
Monitor serum testosterone, prostate specific antigen (PSA), liver function, lipid concentrations, hematocrit and hemoglobin periodically. (, , , )
Skin burns have been reported at the application site in patients wearing an aluminized transdermal system during a magnetic resonance imaging scan (MRI). Because ANDRODERM contains aluminum, it is recommended to remove the system before undergoing an MRI. ()
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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