Hair Restore LF Foam

Latanoprost

• Receptor Interaction: Latanoprost acts as a selective agonist at the FP (prostanoid FP) receptor subtype.
• Primary Effect: By binding to the FP receptor, latanoprost increases the outflow of aqueous humor from the eye.
• Mechanism: The primary mechanism of action is believed to be increased uveoscleral outflow. This pathway helps to lower intraocular pressure (IOP), which is beneficial for conditions like open-angle glaucoma and ocular hypertension.

Finasteride

• Enzyme Inhibition: Finasteride is a synthetic 4-aza analog of testosterone and functions as a competitive, specific inhibitor of type II 5-alpha-reductase.
• Role of 5-alpha-reductase: This enzyme converts testosterone into 5-alpha-dihydrotestosterone (DHT), a potent androgen.
• Type II Isozyme: The type II isozyme of 5-alpha-reductase is predominantly found in the prostate, seminal vesicles, epididymides, hair follicles, and liver. It is responsible for producing about two-thirds of the circulating DHT.
• Impact on Prostate and Hair Follicles:
  • Benign Prostatic Hyperplasia (BPH): Inhibition of 5-alpha-reductase leads to reduced levels of DHT, which decreases prostate hypertrophy and improves urine flow.
  • Male Pattern Baldness: In the scalp, which contains miniaturized hair follicles and elevated DHT levels, finasteride lowers both scalp and serum DHT concentrations. This reduction interrupts a key factor in the development of androgenetic alopecia.
• Systemic Effects: Finasteride does not significantly alter the levels of circulating cortisol, estradiol, prolactin, thyroid-stimulating hormone, thyroxine, or cholesterol. It also appears not to impact the hypothalamic-pituitary-testicular axis.

The combination of latanoprost and finasteride in Hair Restore LF Foam utilizes these distinct mechanisms to address different aspects of hair loss and potentially improve hair restoration outcomes.

Latanoprost

• Receptor Interaction: Latanoprost acts as a selective agonist at the FP (prostanoid FP) receptor subtype.
• Primary Effect: By binding to the FP receptor, latanoprost increases the outflow of aqueous humor from the eye.
• Mechanism: The primary mechanism of action is believed to be increased uveoscleral outflow. This pathway helps to lower intraocular pressure (IOP), which is beneficial for conditions like open-angle glaucoma and ocular hypertension.

Finasteride

• Enzyme Inhibition: Finasteride is a synthetic 4-aza analog of testosterone and functions as a competitive, specific inhibitor of type II 5-alpha-reductase.
• Role of 5-alpha-reductase: This enzyme converts testosterone into 5-alpha-dihydrotestosterone (DHT), a potent androgen.
• Type II Isozyme: The type II isozyme of 5-alpha-reductase is predominantly found in the prostate, seminal vesicles, epididymides, hair follicles, and liver. It is responsible for producing about two-thirds of the circulating DHT.
• Impact on Prostate and Hair Follicles: Inhibition of 5-alpha-reductase leads to reduced levels of DHT, which decreases prostate hypertrophy and improves urine flow. In the scalp, which contains miniaturized hair follicles and elevated DHT levels, finasteride lowers both scalp and serum DHT concentrations. This reduction interrupts a key factor in the development of androgenetic alopecia.
• Systemic Effects: Finasteride does not significantly alter the levels of circulating cortisol, estradiol, prolactin, thyroid-stimulating hormone, thyroxine, or cholesterol. It also appears not to impact the hypothalamic-pituitary-testicular axis.

The combination of latanoprost and finasteride in Hair Restore LF Foam utilizes these distinct mechanisms to address different aspects of hair loss and potentially improve hair restoration outcomes.

Contraindications & Precautions

Latanoprost

• Contraindications:
  • Closed-Angle Glaucoma: Not suitable for patients with closed-angle glaucoma.
  • Inflammatory or Neovascular Glaucoma: Limited experience in treating these conditions.
• Precautions:
  • Aphakia and Pseudophakia: Use with caution in patients with aphakia, or pseudophakic patients with a torn posterior lens capsule, and those with risk factors for macular edema. Macular edema, including cystoid macular edema, has been reported.
  • Pigmentation Changes: May cause increased pigmentation of the iris and periorbital tissue. This change is usually permanent for the iris but may be reversible for periorbital tissue. Eyelash changes are usually reversible.
  • Active Intraocular Inflammation: Use with caution in patients with conditions like iritis or uveitis, as it may exacerbate inflammation.
  • Contact Lenses: Remove contact lenses before instilling drops. Lenses can be reinserted 15 minutes after administration due to the presence of benzalkonium chloride, which may be absorbed by soft contact lenses.
  • Risk of Infection: Multiple dose containers can increase the risk of bacterial keratitis. Care should be taken to avoid contamination, especially in patients with ocular infection or trauma. Reactivation of herpes simplex keratitis is a risk in those with a history of the condition.
  • Pregnancy: Classified as FDA pregnancy risk category C. Use only if the potential benefit outweighs the potential risk to the fetus.
  • Breastfeeding: Not well-studied, but systemic absorption is minimal. Apply pressure to the tear duct for 1-minute post-application to reduce systemic absorption. Exercise caution during breastfeeding.
  • Pediatric Use: Safety and efficacy in pediatric patients have not been established.
  • Renal and Hepatic Disease: Use cautiously in patients with renal or hepatic conditions. Limited studies exist on the safety in these populations.

Finasteride

• Contraindications:
  • Pediatric Use: Not indicated for use in adolescents, children, or infants. Safety and efficacy in patients under 18 have not been established.
• Precautions:
  • Hepatic Disease: Use with caution in patients with hepatic impairment, as finasteride is extensively metabolized in the liver.
  • Prostate-Specific Antigen (PSA) Levels: Finasteride decreases total serum PSA. If using PSA levels to screen for prostate cancer, values should be doubled for comparison with normal ranges in untreated men. An increase in PSA from baseline may indicate prostate cancer.
  • Prostate Cancer Risk: Potential increased risk of high-grade prostate cancer, particularly GS 8-10. Balance the benefits against the potential risks of treatment.
  • Urinary Tract Symptoms: Careful monitoring is required for patients with severe urinary tract symptoms or residual urinary volume.
  • Blood Donation: Men should refrain from donating blood while on finasteride to avoid exposure to pregnant women.
  • Elderly Patients: No specific dosage adjustment is needed based on pharmacokinetics, but efficacy in the elderly has not been established.
  • Semen Characteristics: May cause decreases in sperm count, motility, and semen volume. Effects on male fertility should be considered. Although significant decreases in sperm count were observed in some studies, normalization or improvement has also been reported after discontinuation.

Latanoprost

• Respiratory Issues:
  • Asthma exacerbations and bronchospasm.
  • Dyspnea.
• Infections:
  • Upper respiratory tract infection, nasopharyngitis, and influenza (reported in 3% of clinical trial participants).
  • Herpes keratitis (reported during postmarketing use).
• Cardiovascular:
  • Palpitations.
  • Unstable angina.
  • Chest pain (unspecified).
• Musculoskeletal:
  • Myalgia.
  • Arthralgia.
  • Musculoskeletal pain.
  • Back pain (reported in 1% of clinical trial participants).
• Skin Reactions:
  • Rash and other allergic skin reactions (reported in 1% of clinical trial participants).
  • Pruritus.
  • Toxic epidermal necrolysis (reported during postmarketing use).
• Neurological:
  • Dizziness.
  • Headache.

Finasteride

• Sexual Function:
  • Impotence (erectile dysfunction).
  • Decreased libido.
  • Decreased ejaculate volume.
  • Ejaculation dysfunction.
  • Breast enlargement and tenderness (mastalgia).
• Breast Issues:
  • Gynecomastia (reported frequently since market introduction).
  • Potential link to breast cancer, with cases reported during postmarketing surveillance.
• Other Post-Market Adverse Reactions:
  • Depression.
  • Testicular pain (persistent after discontinuation).
  • Hypersensitivity reactions (pruritus, urticaria, angioedema).
• Hair Loss Studies:
  • 1.4% of patients discontinued therapy due to adverse events; 1.2% due to drug-related sexual adverse experiences.
  • Decreased libido (1.8%).
  • Impotence (1.3%).
  • Ejaculation disorder (1.2%).
• Semen Characteristics:
  • Spermatogenesis inhibition or oligospermia.
  • Decreased sperm motility.
  • Decreased semen volume.
  • Decreased total sperm count by 34.3% at 26 weeks, with partial recovery noted.
• Teratogenic Effects:
  • Potential to cause abnormalities in the external genitalia of male fetuses (e.g., hypospadias).

These side effects provide a comprehensive view of the potential adverse reactions associated with both latanoprost and finasteride, helping healthcare providers monitor and manage patient responses to these treatments.

Latanoprost

• Pregnancy:
  • Classified as FDA pregnancy risk category C.
  • No adequate and well-controlled studies in pregnant women.
  • Limited human pregnancy experience has not shown clinically significant risk to the fetus.
  • Minimal systemic exposure suggests low fetal exposure.
  • Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Breastfeeding:
  • It is not known whether latanoprost or its metabolites are excreted in breast milk.
  • Systemic plasma concentrations are low and the half-life is short, so clinically significant amounts in breast milk are unlikely.
  • To minimize drug exposure, apply pressure over the tear duct for 1 minute after administration.
  • Caution is advised when administering latanoprost during breastfeeding.
  • Consider the benefits of breastfeeding against potential risks to the infant.
  • Report any adverse effects in breastfeeding infants related to maternal drug use to the FDA.

Finasteride

• Pregnancy:
  • Not FDA-approved for use in females of childbearing potential and contraindicated during pregnancy.
  • May cause fetal harm, including abnormalities in the external genitalia of male fetuses.
  • Pregnant women or females trying to conceive should avoid handling crushed or broken tablets.
  • Distribution into human semen is low, well below thresholds causing fetal anomalies in animal studies.
• Breastfeeding:
  • Not FDA-approved for use in females and should be avoided during breastfeeding.
  • The excretion of finasteride in human milk is unknown.
  • Effects on breastfeeding or nursing infants are undetermined.

Store this medication in a refrigerator between 36°F to 46°F (2°C – 8°C). Do not freeze. Protect from light. Keep all medicine out of the reach of children. Throw away any medicine after the beyond use date. Do not flush unused medications or pour down a sink or drain.