503A

Acne Ultra Gel

503A

Acne Ultra Gel

1 / 4 / 0.02%

Acne Ultra Gel

$100.00

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Product Overview

This product is available solely through our 503A Compounding Pharmacy, ensuring personalized care and precision in every order. Please note that a valid prescription is required for purchase. If you do not have an account, please contact us.

Acne Ultra Gel (Clindamycin / Niacinamide / Tretinoin) (30 mL)

1 / 4 / 0.02%

Clindamycin Phosphate, Niacinamide, and Tretinoin: How They Work and Why They Matter

Clindamycin Phosphate is an antibiotic that helps fight certain bacterial infections by stopping bacteria from making proteins they need to grow. It’s mostly used to treat skin problems like acne, though scientists are still figuring out exactly how it helps. However, overusing it can lead to resistant bacteria and gut issues like colitis.

Niacinamide is a form of vitamin B3 that’s important for energy, skin repair, and reducing inflammation. Unlike its cousin, niacin, it doesn’t cause flushing or irritation, which makes it great for sensitive skin conditions like acne and rosacea. It’s a safe, widely used ingredient in creams and supplements.

Tretinoin is a vitamin A derivative that helps renew skin cells and improve the texture of damaged or aging skin. It’s commonly prescribed for acne and sun-damaged skin but is also used in certain blood cancers. By encouraging healthy cell growth, tretinoin helps clear clogged pores and reduce wrinkles, though it doesn’t directly fight bacteria. In cancer treatment, it helps immature blood cells grow properly but requires careful monitoring for serious side effects.

Clindamycin Phosphate, Niacinamide, and Tretinoin: Mechanisms and Clinical Relevance
Clindamycin Phosphate – Bacteriostatic Antibiotic for Targeted Use

Clindamycin is a lincosamide antibiotic that exerts its action by binding to the 23S RNA of the 50S ribosomal subunit, halting bacterial protein synthesis. It is primarily bacteriostatic, although bactericidal activity may occur at high concentrations or against particularly susceptible organisms.

Clindamycin is widely used to treat infections caused by anaerobic bacteria, some Gram-positive cocci, and conditions like acne vulgaris, although the precise mechanism for its acne-fighting effect is still not fully understood.

Resistance to clindamycin typically arises from mutations in ribosomal RNA, and cross-resistance exists between clindamycin, lincomycin, and sometimes macrolides and streptogramin B. For organisms resistant to macrolides but appearing susceptible to clindamycin, a D-zone test is recommended to detect inducible resistance.

A major risk with clindamycin is pseudomembranous colitis, usually due to Clostridium difficile overgrowth, which necessitates caution during prolonged or repeated use. Some bacterial strains (e.g., C. perfringens, B. fragilis) are showing increasing resistance, particularly post-treatment of bacterial vaginosis.

Niacinamide – Essential B3 Vitamin with Distinct Pharmacologic Identity

Niacinamide (nicotinamide) is the amide form of vitamin B3, a vital nutrient involved in numerous metabolic redox reactions. It functions through coenzymes NAD and NADP, which support energy production, glucose metabolism, and cellular repair.

As a vitamin, both niacin (nicotinic acid) and niacinamide are biochemically equivalent, but they differ in pharmacologic effects:

Nicotinic acid produces vasodilation and is used as a lipid-lowering agent, albeit with side effects like flushing, pruritus, and potential hepatotoxicity.

Niacinamide, however, does not cause flushing, does not lower lipid levels, and is better tolerated, making it useful for topical dermatologic applications, including treatment of acne, rosacea, and inflammatory skin conditions.

Niacinamide plays a critical role in cellular energy balance, DNA repair, and anti-inflammatory responses, and is well-tolerated both orally and topically, making it a popular ingredient in skincare and supplements.

Tretinoin – A Retinoid for Acne, Photodamage, and Cancer

Tretinoin (all-trans-retinoic acid) is a vitamin A derivative that works by binding to retinoic acid receptors (RARs), modifying gene expression and promoting epithelial cell turnover and differentiation. Tretinoin affects RAR-alpha, -beta, and -gamma, which are variably distributed across tissues and associated with both skin health and cancer pathogenesis.

In dermatology, topical tretinoin is used to treat:

Acne vulgaris – by promoting comedone expulsion, reducing follicular hyperkeratinization, and normalizing skin cell turnover.

Photodamaged skin – by reducing fine wrinkles, pigmentation irregularities, and rough texture, largely through inhibition of UV-induced matrix metalloproteinases that degrade collagen.

Tretinoin does not affect P. acnes bacteria or sebum production but complements antimicrobial therapies like clindamycin for acne.

In oncology, oral tretinoin is used in acute promyelocytic leukemia (APL). APL is driven by a PML-RAR-alpha fusion protein that blocks normal myeloid differentiation. Tretinoin reverses this blockade, promoting the maturation of malignant cells without causing marrow suppression. However, a serious complication known as retinoic acid syndrome (differentiation syndrome) can occur, marked by fever, respiratory distress, and fluid retention.

Clindamycin Phosphate – Warnings & Precautions
You shouldn’t use clindamycin if you’re allergic to it or to similar antibiotics like lincomycin. It’s also not recommended for people with a history of serious gut issues like colitis or inflammatory bowel disease. Some severe reactions, such as skin peeling or life-threatening allergic responses, can occur, so stop using it right away if these happen. It may upset the balance of bacteria in your body and lead to fungal infections, so long-term use should be avoided.

Niacinamide – Warnings & Precautions
Niacinamide is generally safe, but it should be used carefully in people with liver or kidney issues, diabetes, gout, or bleeding problems. High doses should be avoided during pregnancy or breastfeeding unless prescribed. Some side effects include stomach upset, headaches, and skin irritation. It may also interfere with certain medications like statins.

Tretinoin – Warnings & Precautions
Tretinoin shouldn’t be used by those allergic to retinoids or vitamin A. It can make your skin sensitive to the sun, so sunscreen and protective clothing are essential. In rare cases, oral tretinoin can cause serious side effects like breathing problems or brain swelling. Avoid using it on irritated or broken skin and keep it away from eyes.

Clindamycin Phosphate
You shouldn’t use this medicine if you’re allergic to it or similar antibiotics, or if you’ve had serious gut diseases like colitis before. It can cause severe allergic reactions or life-threatening skin problems in rare cases. It may also disturb the balance of bacteria in your gut and lead to fungal infections, so be careful if you use it for a long time. Elderly people and those with asthma or bowel issues should take extra precautions. Even creams or gels can be absorbed into the body, so don’t overuse them.

Clindamycin Phosphate

Pregnancy:

  • No congenital abnormalities linked with systemic use in 2nd or 3rd trimester.

  • First trimester systemic use may increase risk of major congenital malformations (adjusted OR 1.34).

  • Higher risks noted for musculoskeletal defects and septal heart defects.

  • Use in first trimester only if clearly needed and benefits outweigh risks.

  • Vaginal clindamycin cream studied for preterm birth reduction with mixed results—some trials showed benefits; others showed increased adverse neonatal outcomes.

  • Contains benzyl alcohol in parenteral forms, which can be harmful to neonates.

Breastfeeding:

  • Clindamycin is excreted into breast milk.

  • Potential for serious GI adverse reactions in infants (diarrhea, thrush, antibiotic-associated colitis).

  • Use caution; consider alternatives.

  • Monitor infants if mother is on clindamycin.

  • Unknown if topical or vaginal forms pass into milk; avoid application on breasts to prevent infant ingestion.


Niacinamide (Niacin)

Pregnancy:

  • Safe at RDA doses (Pregnancy Category A).

  • Higher doses (used for dyslipidemia or pellagra) are Category C.

  • High doses not recommended in pregnancy due to lack of safety data.

  • Benefits must be weighed against potential risks at higher doses.

Breastfeeding:

  • No direct safety studies; manufacturer recommends discontinuing nursing or drug if using lipid-altering doses.

  • Adequate dietary intake usually sufficient during lactation.

  • Monitor infant for adverse effects if maternal high-dose therapy is necessary.


Tretinoin

Pregnancy:

  • Teratogenic and embryotoxic effects demonstrated in animals.

  • Human data limited but retinoids are known to increase risks of spontaneous abortion and major fetal abnormalities.

  • Topical tretinoin should be used cautiously, avoiding large areas or prolonged use.

  • Oral tretinoin has a high risk of birth defects; strict contraception required.

  • Pregnancy testing before and during therapy is mandatory.

Breastfeeding:

  • Breastfeeding should be stopped prior to oral tretinoin.

  • Unknown if topical tretinoin passes into breast milk; systemic absorption from topical use is low.

  • Alternative topical agents may be preferred during breastfeeding.

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.

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503A vs 503B

  • 503A pharmacies compound products for specific patients whose prescriptions are sent by their healthcare provider.
  • 503B outsourcing facilities compound products on a larger scale (bulk amounts) for healthcare providers to have on hand and administer to patients in their offices.

Frequently asked questions

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A clinical pharmacist cannot recommend a specific doctor. Because we are licensed in Arizona, California, New Mexico, Texas, we can accept prescriptions from many licensed prescribers if the prescription is written within their scope of practice and with a valid patient-practitioner relationship.

*Licensing is subject to change.

Each injectable IV product will have the osmolarity listed on the label located on the vial.

Given the vastness and uniqueness of individualized compounded formulations, it is impossible to list every potential compound we offer. To inquire if we currently carry or can compound your prescription, please fill out the form located on our Contact page or call us at (806) 744-8477.

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