Tretinoin (Altreno)

Trade Name : Altreno

Bausch Health Americas, Inc.

LOTION

Strength 0.5 mg/g

TRETINOIN Retinoid [EPC],Retinoids [CS]

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Tretinoin (Altreno) which is also known as Altreno and Manufactured by Bausch Health Americas, Inc.. It is available in strength of 0.5 mg/g per ml. Read more

Tretinoin (Altreno) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

No data

ALTRENOu2122 (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. n

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.

Lotion, 0.05%
Each gram of ALTRENO contains 0.5 mg (0.05%) tretinoin in an opaque, pale yellow topical lotion.
Lotion, 0.05% ()
Each gram of ALTRENO contains 0.5 mg (0.05%) tretinoin. ()

None.
None. ()

No data

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In 2 randomized, double-blind, vehicle-controlled trials, subjects age 9 years and older applied ALTRENO or vehicle once daily for 12 weeks. The majority of subjects were White (74%) and female (55%). Approximately 47% were Hispanic/Latino and 45% were younger than 18 years of age. Adverse reactions reported by u22651% of subjects treated with ALTRENO and more frequently than vehicle are summarized in Table 1.
Application site pain defined as application site stinging, burning or pain.Skin irritation was evaluated by active assessment of erythema, scaling, hypopigmentation, hyperpigmentation, itching, burning and stinging. The percentage of subjects who were assessed to have these signs and symptoms at any post baseline visit are summarized in Table 2.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or n

u2022
6.1

No data

ALTRENO (tretinoin) lotion is an opaque, pale yellow lotion containing 0.05% tretinoin by weight for topical administration.
Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid class of compounds and a metabolite of vitamin A. Tretinoin has the following chemical structure:
Molecular Formula: CHO Molecular Weight: 300.44
Each gram of ALTRENO contains 0.5 mg (0.05%) of tretinoin in an opaque, pale yellow lotion base consisting of 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.

No data

A 2-year dermal mouse carcinogenicity study was conducted with topical administration of 0.005%, 0.025% and 0.05% of a tretinoin gel formulation. Although no drug-related tumors were observed in surviving animals, the irritating nature of the drug product precluded daily dosing, confounding data interpretation and reducing the biological significance of these results.
Studies in hairless albino mice with a different formulation suggest that concurrent exposure to tretinoin may enhance the tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator. This effect was confirmed in a later study in pigmented mice, and dark pigmentation did not overcome the enhancement of photocarcinogenesis by 0.05% tretinoin. Although the significance of these studies to humans is not clear, patients should minimize exposure to sunlight or artificial ultraviolet irradiation sources.
The genotoxic potential of tretinoin was evaluated in an in vitro bacterial reversion test, an in vitro chromosomal aberration assay in human lymphocytes and an in vivo rat micronucleus assay. All tests were negative.
In dermal fertility studies of another tretinoin formulation in rats, slight (not statistically significant) decreases in sperm count and motility were seen at 0.5u00a0mg/kg/day (approximately 2 times the MRHD based on BSA comparison and assuming 100% absorption), and slight (not statistically significant) increases in the number and percent of nonviable embryos in females treated with 0.25u00a0mg/kg/day and above (approximately the MRHD based on BSA comparison and assuming 100% absorption) were observed.

The safety and efficacy of once daily use of ALTRENO for the treatment of acne vulgaris were assessed in two multicenter, randomized, double-blind clinical trials enrolling 1640 subjects age 9 years and older with acne vulgaris. Enrolled subjects had a score of moderate (3) or severe (4) on the Evaluatoru2019s Global Severity Score (EGSS), 20 to 40 inflammatory lesions (papules, pustules, and nodules), 20 to 100 non-inflammatory lesions (open and closed comedones) and two or fewer facial nodules. The coprimary efficacy endpoints of success on the EGSS, absolute change in noninflammatory lesion count, and absolute change in inflammatory lesion count were assessed at Week 12. Success on the EGSS was defined as at least a 2-grade improvement from Baseline and an EGSS score of clear (0) or almost clear (1). Table 3 lists the efficacy results for trials 1 (NCT02491060) and 2 (NCT02535871).

ALTRENO (tretinoin) lotion, 0.05% is an opaque, pale yellow topical lotion and available as:
Storage and Handling Conditions
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature]. Protect from freezing.
Store pump upright.

Advise the patient to read the FDA-approved patient labeling (Patient Information).
Manufactured for:
Bausch Health Americas, Inc.Bridgewater, NJ 08807 USA
By:
U.S. Patent Number: 6,517,847

PATIENT INFORMATIONALTRENOu2122 (al-TREN-oh)(tretinoin) lotion, 0.05%for topical use
Important information:
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
Tell your healthcare provider about all the medicines you take,
How should I use ALTRENO?
Applying ALTRENO:
Tube:
Pump:
What should I avoid while using ALTRENO?
What are the possible side effects of ALTRENO?
ALTRENO may cause serious side effects, including:
Skin irritation
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?
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:
Inactive ingredients:
Manufactured for:
By:
For more information, call 1-800-321-4576.
U.S. Patent Number: 6,517,847
ALTRENO is a trademark of Bausch Health Companies Inc. or its affiliates.
u00a9 2019 Bausch Health Companies Inc. or its affiliatesThis Patient Information has been approved by the U.S. Food and Drug Administration.
9650302Revised: 11/2019

NDC
For Topical Use Onlyn- Not for Eye Use
ALTRENOn
Rx only
Net Wt. 45 g
Ortho Dermatologics

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Tretinoin (Altreno)

Trade Name : Altreno

LOTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Tretinoin (Altreno)

Trade Name : Altreno

LOTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?