Bausch Health

Altreno

Brand

Generic: Tretinoin

ID: 00187000520

NaN

Reviews

📜 Prescription Required

FORM

Lotion

STRENGTH

0.05%/20 gm

QUANTITY

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TL;DR — Quick Summary

Key facts from the full medication guide below

1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS

🩺What it's for

ALTRENO (tretinoin) lotion, 0.05% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. ALTRENO is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

💊How to take it

Apply a thin layer of ALTRENO to the affected areas once daily. Avoid the eyes, mouth, paranasal creases, and mucous membranes. ALTRENO is for topical use only. Not for ophthalmic, oral, or intravaginal use. Apply a thin layer of ALTRENO to affected areas once daily. Avoid eyes, mouth, paranasal creases, and mucous membranes. (2) Not for ophthalmic, oral, or intravaginal use.

ℹ️Common side effects

The most common adverse reactions occurring in 1% of subjects and greater than vehicle were dryness, pain, erythema, irritation and exfoliation (all at the application site). (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

⚠️Serious risks

Skin Irritation: Dryness, pain, erythema, irritation and exfoliation may occur with use of ALTRENO. (5.1) Ultraviolet Light and Environmental Exposure: Minimize exposure to sunlight and sunlamps. Use sunscreen and protective clothing when sun exposure cannot be avoided. (5.2) Fish Allergies: Use ALTRENO with caution if allergic to fish due to potential for allergenicity to fish protein. Advise patients to contact their healthcare provider if they develop pruritus or urticaria.

📦Storage & missed dose

ALTRENO (tretinoin) lotion, 0.05% is an opaque, pale yellow topical lotion and available as: 45 g tube (NDC 0187-0005-45) 20 g tube (NDC 0187-0005-20) 50 g pump (NDC 0187-0005-50) Storage and Handling Conditions Store at 20 to 25 C (68 to 77 F); excursions permitted to 15 to 30 C (59 to 86 F) [see USP Controlled Room Temperature]. Protect from freezing. Store pump upright.

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Risk Summary Available data from published observational studies of topical tretinoin in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are no data on ALTRENO use in pregnant women. The systemic levels following topical administration are lower than with administration of oral tretinoin; however, absorption of this product may result in fetal exposure. There are reports of major birth defects similar to those seen in infants exposed to oral retinoids, but these case reports do not establish a pattern or association with tretinoin-related embryopathy (see Data). Animal reproduction studies have not been conducted with ALTRENO. Topical administration of tretinoin in a different formulation to pregnant rats during organogenesis was associated with malformations (craniofacial abnormalities [hydrocephaly], asymmetrical thyroids, variations in ossification, and increased supernumerary ribs) at doses up to 0.5 mg tretinoin/kg/day, approximately 2 times the maximum recommended human dose (MRHD) based on body surface area (BSA) comparison and assuming 100% absorption. Oral administration of tretinoin to pregnant cynomolgus monkeys during organogenesis was associated with malformations at 10 mg/kg/day (approximately 100 times the MRHD based on BSA comparison and assuming 100% absorption) (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defects, loss, and other adverse outcomes. The background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. Data Human Data While available studies cannot definitively establish the absence of risk, published data from multiple prospective controlled observational studies on the use of topical tretinoin products during pregnancy have not identified an association with topical tretinoin and major birth defects or miscarriage. The available studies have methodologic limitations, including small sample size and in some cases, lack of physical exam by an expert in birth defects. There are published case reports of infants exposed to topical tretinoin during the first trimester that describe major birth defects similar to those seen in infants exposed to oral retinoids; however, no pattern of malformations has been identified and no causal association has been established in these cases. The significance of these spontaneous reports in terms of risk to the fetus is not known. Animal Data Tretinoin in a 0.05% gel formulation was topically administered to pregnant rats during organogenesis at doses of 0.1, 0.3 and 1 g/kg/day (0.05, 0.15, 0.5 mg tretinoin/kg/day). Possible tretinoin malformations (craniofacial abnormalities [hydrocephaly], asymmetrical thyroids, variations in ossification, and increased supernumerary ribs) were observed at maternal doses of 0.5 mg tretinoin/kg/day (approximately 2 times the MRHD based on BSA comparison and assuming 100% absorption). These findings were not observed in control animals. Other maternal and reproductive parameters in tretinoin-treated animals were not different from control. For purposes of comparison of the animal exposure to human exposure, the MRHD is defined as 4 g of ALTRENO applied daily to a 60 kg person. Other topical tretinoin embryofetal development studies have generated equivocal results. There is evidence for malformations (shortened or kinked tail) after topical administration of tretinoin to pregnant Wistar rats during organogenesis at doses greater than 1 mg/kg/day (approximately 5 times the MRHD based on BSA comparison and assuming 100% absorption). Anomalies (humerus: short 13%, bent 6%, os parietal incompletely ossified 14%) have also been reported when 10 mg/kg/day (approximately 50 times the MRHD based on BSA comparison and assuming 100% absorption) was topically applied to pregnant rats during organogenesis. Supernumerary ribs have been a consistent finding in rat fetuses when pregnant rats were treated topically or orally with retinoids. Oral administration of tretinoin during organogenesis has been shown to induce malformations in rats, mice, rabbits, hamsters, and nonhuman primates. Fetal malformations were observed when tretinoin was orally administered to pregnant Wistar rats during organogenesis at doses greater than 1 mg/kg/day (approximately 5 times the MRHD based on BSA comparison). In the cynomolgus monkey, fetal malformations were reported when an oral dose of 10 mg/kg/day was administered to pregnant monkeys during organogenesis (approximately 100 times the MRHD based on BSA comparison). No fetal malformations were observed at an oral dose of 5 mg/kg/day (approximately 50 times the MRHD based on BSA comparison). Increased skeletal variations were observed at all doses in this study and dose-related increases in embryo lethality and abortion were reported in this study. Similar results have also been reported in pigtail macaques. Oral tretinoin has been shown to be fetotoxic in rats when administered at doses 10 times the MRHD based on BSA comparison. Topical tretinoin has been shown to be fetotoxic in rabbits when administered at doses 4 times the MRHD based on BSA comparison.

PATIENT INFORMATIONALTRENO (al-TREN-oh)(tretinoin) lotion, 0.05%for topical use Important information: ALTRENO is for use on skin only. Do not use ALTRENO in your eyes, mouth, the corners of your nose, or vagina. What is ALTRENO? ALTRENO is a prescription medicine used on the skin (topical) to treat people with acne. Acne is a condition in which the skin has blackheads, whiteheads, and other pimples. It is not known if ALTRENO is safe and effective in children under 9 years of age. Before using ALTRENO, tell your healthcare provider about all your medical conditions, including if you: are allergic to fish. ALTRENO contains fish proteins. Tell your healthcare provider if you get hives or itching while using ALTRENO. have eczema or any other skin problems. have a sunburn. are pregnant or plan to become pregnant. It is not known if ALTRENO will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if ALTRENO passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I use ALTRENO? Use ALTRENO exactly as your healthcare provider tells you to use it. Apply a thin layer of ALTRENO to cover the affected areas 1 time each day. Applying ALTRENO: ALTRENO comes in a tube and a pump. If you have been prescribed the: Tube: Squeeze the lotion from the tube onto a fingertip. Apply a thin layer to cover the affected areas, as prescribed by your doctor. Spread ALTRENO evenly over the affected areas. Pump: Fully depress the pump to dispense ALTRENO onto a fingertip. Apply a thin layer to cover the affected areas, as prescribed by your doctor. Spread ALTRENO evenly over the affected areas. Wash your hands after applying ALTRENO. What should I avoid while using ALTRENO? You should avoid sunlamps, tanning beds, and ultraviolet light during treatment with ALTRENO. Minimize exposure to sunlight. If you have to be in the sunlight or are sensitive to sunlight, use a sunscreen with an SPF (sun protection factor) of 15 or more and wear protective clothing and a wide-brimmed hat to cover the treated areas. What are the possible side effects of ALTRENO? ALTRENO may cause serious side effects, including: Skin irritation. ALTRENO may cause irritation including skin dryness, pain, redness, excessive flaking or peeling. If you develop these symptoms, your healthcare provider may tell you to use a moisturizer, decrease the number of times you apply ALTRENO, or completely stop treatment with ALTRENO. Avoid applying ALTRENO to skin that is affected by eczema or sunburned skin. These are not all the possible side effects of ALTRENO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store ALTRENO? Store ALTRENO at room temperature between 68 to 77 F (20 to 25 C). Do not freeze. Store ALTRENO pump upright. Keep ALTRENO and all medicines out of the reach of children. General information about the safe and effective use of ALTRENO Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ALTRENO for a condition for which it was not prescribed. Do not give ALTRENO to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ALTRENO that is written for health professionals. What are the ingredients in ALTRENO? Active ingredient: tretinoin Inactive ingredients: benzyl alcohol, butylated hydroxytoluene, carbomer copolymer type B (Pemulen TR-1), carbomer homopolymer type A (Carbopol 981), glycerin, methylparaben, mineral oil, octoxynol-9, purified water, sodium hyaluronate, soluble collagen and trolamine. Distributed by: Bausch Health US, LLC, Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc., Laval, Quebec H7L 4A8, Canada For more information, call 1-800-321-4576. ALTRENO is a trademark of Bausch Health Companies Inc. or its affiliates. 2020 Bausch Health Companies Inc. or its affiliates This Patient Information has been approved by the U.S. Food and Drug Administration. 9650303 Revised: 03/2020