Aging Ultra Cream

1. Ascorbic Acid (Vitamin C)

• Pregnancy: Oral vitamin C has been used safely in pregnancy with no adverse developmental outcomes reported at doses up to 1,000 mg/day. The safety of high-dose intravenous ascorbic acid in pregnancy is not well-documented. Follow recommended daily allowances for pregnant women.
• Breastfeeding: Vitamin C is distributed into breast milk. Oral intake within recommended limits is generally safe for breastfeeding women. Monitor vitamin C levels in milk, which can range from 34 to 115 mg/L depending on supplementation.
• Renal Risk: High doses may lead to oxalate nephropathy and increased risk of kidney stones. Patients with renal conditions or a history of nephrolithiasis should be monitored for renal function.
• G6PD Deficiency: High doses can cause hemolysis in individuals with glucose-6-phosphate dehydrogenase deficiency. Monitor blood counts and reduce dosage if needed.
• Iron Overload: Vitamin C can exacerbate iron toxicity, particularly in patients with hemochromatosis. Limit intake to 500 mg/day to avoid risk of fatal arrhythmias.
• Lab Interference: Ascorbic acid can interfere with certain lab tests, leading to false negatives. Avoid ingestion before tests like glucose or stool occult blood tests.

2. Azelaic Acid

• Propylene Glycol Sensitivity: Avoid formulations with propylene glycol if allergic. Also, be cautious with other potential allergens in the formulation.
• Hypopigmentation Risk: Use cautiously in patients with dark complexions to prevent hypopigmentation.
• Occlusive Dressings: Do not use occlusive dressings with azelaic acid.
• Ocular Exposure: Avoid contact with eyes and mucous membranes. Rinse thoroughly with water if contact occurs.
• Pediatric Use: Safety and efficacy are not established in children under 12. The foam formulation is not approved for those under 18.
• Herpes Labialis: Avoid use on areas affected by herpes simplex.
• Asthma: May worsen asthma; monitor for exacerbations.

3. Estriol

• Contraindications: Not recommended for individuals with breast, ovarian, or endometrial cancers, coronary artery disease, thromboembolism, or a history of stroke or certain other conditions. Use cautiously in those with hypertension, hyperlipidemia, or liver disease.

4. Progesterone

• Contraindications: Avoid in patients with pre-existing cancers of reproductive organs, undiagnosed vaginal bleeding, or a history of thrombosis. Not recommended for children or adolescents before menarche, or in neonates due to risks of benzyl alcohol.
• Hormone Replacement Therapy (HRT) Risks: Increases the risk of breast cancer, cardiovascular events (e.g., DVT, PE), and dementia in women over 65. Regular breast exams and mammography are advised.
• Fertility: High doses can cause temporary infertility.
• Other Conditions: Use cautiously in patients with diabetes, hyperlipidemia, asthma, renal disease, major depression, migraine, or seizure disorders. Progesterone may cause fluid retention and exacerbate these conditions.
• Intrauterine Device: Avoid if there’s infection or inflammation in the reproductive tract.

Ascorbic Acid

• Pregnancy:
  • Oral Ascorbic Acid: No adverse developmental outcomes have been reported in pregnant women using oral ascorbic acid within recommended daily allowances (RDA). A meta-analysis of randomized studies with doses ranging from 500 to 1,000 mg/day did not show an increased risk of adverse pregnancy outcomes.
  • Injection: No data available on the safety of injectable ascorbic acid during pregnancy.
• Breastfeeding:
  • Distribution: Ascorbic acid is distributed into breast milk. The vitamin C content in milk varies with maternal intake, but it generally falls within safe limits.
  • Safety: Use within recommended daily allowances is considered safe. The amount in milk increases with higher maternal intake, but breastfeeding benefits should be weighed against any potential risks.

Azelaic Acid

• Pregnancy:
  • FDA Risk Category: B (no evidence of risk in animal studies, but no adequate human studies).
  • Use: Should be used only if clearly needed. Animal studies have shown embryotoxic effects at high doses but no teratogenic effects.
• Breastfeeding:
  • Distribution: Azelaic acid may be distributed into breast milk, though less than 4% of a topically applied dose is absorbed systemically.
  • Caution: Use with caution and consider the benefits of breastfeeding against potential risks. If adverse effects are observed in the infant, report them to the FDA.

Progesterone

• Pregnancy:
  • Use in ART: Progesterone is used to support early pregnancy in assisted reproductive technology (ART) programs and is generally safe in this context. It should be used under the supervision of an ART specialist.
  • Preterm Delivery: Effective in preventing preterm delivery in high-risk singleton pregnancies when administered between 16 and 24 weeks of gestation through 34 weeks.
  • Contraindications: Should not be used in cases of ectopic pregnancy, missed/incomplete abortion, or during diagnostic pregnancy tests. Progesterone capsules are contraindicated during pregnancy.
• Breastfeeding:
  • Distribution: Detectable amounts of progestational drugs can be found in breast milk. The effect on the breastfeeding infant is not well studied.
  • Safety: Generally, use of progestins has not adversely affected lactation. Balance the benefits of breastfeeding with the mother’s need for progesterone and potential risks to the infant.

Ascorbic Acid (Vitamin C)

• Collagen Formation: Essential for synthesizing collagen, a key structural protein in connective tissues, including skin. Vitamin C helps in the hydroxylation of proline and lysine residues in collagen, stabilizing its triple helix structure.
• Antioxidant Action: Vitamin C scavenges free radicals, reducing oxidative stress and cellular damage.
• Other Functions: Involved in the metabolism of various compounds, including tyrosine and carbohydrates. It also enhances iron absorption, supports immune function, and aids in the regeneration of other antioxidants like glutathione.

Azelaic Acid

• Antimicrobial Effects: Inhibits microbial protein synthesis, targeting bacteria such as Staphylococcus epidermidis and Propionibacterium acnes. It reduces acne-related inflammation by lowering bacterial counts.
• Anti-inflammatory Action: Scavenges oxygen radicals, helping to decrease skin inflammation.
• Keratinization Regulation: Acts as a keratolytic agent by reducing the synthesis of filaggrin, normalizing follicular keratinization, and reducing acne lesions.
• Hyperpigmentation Treatment: Decreases epidermal melanogenesis and replaces abnormal melanocytes, thus treating melasma and other pigmentation issues.

Alpha Lipoic Acid (ALA)

• Antioxidant Activity: Scavenges a wide range of free radicals, including hydroxyl radicals, superoxide radicals, and nitric oxide, mitigating oxidative stress.
• Anti-inflammatory Properties: Modulates inflammatory responses and reduces visible skin redness and blotchiness.
• Cellular Functions: Plays a role in mitochondrial dehydrogenase processes, improving cellular energy production and skin health.

Aloe Vera

• Wound Healing: Contains auxin and gibberellins that promote wound healing and reduce inflammation.
• Cell Growth: Stimulates the growth of new skin cells, aiding in the repair and regeneration of damaged skin.

Estriol

• Estrogen Receptor Binding: Binds to estrogen receptors on skin cells, initiating gene transcription that enhances collagen synthesis, skin thickness, and elasticity. Estriol primarily affects the skin when applied topically, minimizing systemic effects.

Progesterone

• Hormonal Balance: Regulates the menstrual cycle and supports endometrial receptivity and pregnancy. It may help maintain skin health during menopause by counteracting estrogen-related skin changes.
• Contraceptive Use: Suppresses ovulation by altering hormonal signals in the hypothalamus and pituitary, and modifies cervical mucus to prevent sperm entry.

Ascorbic Acid

• Common Adverse Effects:
  • Oral Dosage: Diarrhea, vomiting, abdominal cramps (more than 1 g daily)
  • IV Administration: Faintness, nausea, lethargy, flushing, dizziness, headache (rapid administration should be avoided)
• Serious Adverse Effects:
  • Nephrolithiasis: Risk of oxalate, urate, or cystine renal stones, especially in those with renal disease, on hemodialysis, or with a history of nephrolithiasis.
  • Hemolytic Anemia: Observed in patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency after large doses.
  • Dental Issues: Chewable formulations can cause dental caries or sensitivity.
• Injection Site Reactions: Pain and swelling.

Azelaic Acid

• Common Adverse Effects:
  • Dermatologic: Burning, stinging, paresthesias, pruritus, dry skin, erythema, irritation, dermatitis, peeling, edema.
• Less Common Adverse Effects:
  • Skin Changes: Hypopigmentation, vitiligo, hypertrichosis.
  • Eye Exposure: Iridocyclitis (inflammation of the iris) from accidental exposure.
• Rare Adverse Effects:
  • Hypersensitivity: Angioedema, ocular inflammation, facial swelling, urticaria.
  • Asthma Exacerbation: Dyspnea, wheezing.

Alpha Lipoic Acid (ALA)

• Drug Interactions:
  • Alcohol: May diminish therapeutic effect of ALA.
  • Antidiabetic Agents: May enhance the therapeutic effect of ALA.
  • Calcium Salts, Iron Salts, Magnesium Salts: May decrease absorption of ALA and vice versa.
  • Cisplatin: May diminish therapeutic effect of Cisplatin.

Progesterone

• Common Adverse Effects:
  • Menstrual Changes: Irregularity, flow changes, dysmenorrhea, amenorrhea.
  • Other Symptoms: Spotting, breakthrough bleeding, weight gain, nausea, vomiting, breast tenderness, mild headache.
• Less Common Adverse Effects:
  • Dermatologic: Melasma, chloasma, hirsutism.
  • Gastrointestinal: Abdominal pain, bloating, nausea, vomiting, dyspepsia.
  • Emotional: Mood swings, irritability, anxiety.
  • Cardiovascular: Fluid retention, exacerbation of heart failure or renal disease.
• Serious Adverse Effects:
  • Thrombotic Disorders: Thrombophlebitis, deep vein thrombosis, pulmonary embolism.
  • Cardiovascular Risk: Increased risk of stroke, myocardial infarction, and deep vein thrombosis (increased risk noted in postmenopausal women on estrogen-progestin HRT).
• Hormone Replacement Therapy (HRT):
  • Breast Cancer Risk: Increased risk with long-term use.
  • Endometrial Cancer Risk: Elevated risk with unopposed estrogen, reduced but not eliminated by adding progestin.
  • Ovarian Cancer Risk: Uncertain, but there is an increased risk associated with HRT.

Store this medication in its original container at 68°F to 77°F (20°C to 25°C) and away from heat, moisture and light. Keep all medicine out of the reach of children. Throw away any unused medicine after the beyond use date. Do not flush unused medications or pour down a sink or drain.